Annual report: surveillance of adverse events following immunisation in Australia, 2011

The adverse events following immunisation surveillance aims to monitor vaccine and immunisation program safety and to detect population-specific, rare, late-onset or unexpected adverse events that may not be detected in pre-licensure vaccine trials. In 2011 there were 2,327 AEFI records for vaccines administered, which was a decrease of 40% from 3,894 in 2010.

Page last updated: 21 December 2012

Deepika Mahajan, Jane Cook, Aditi Dey, Kristine Macartney, Rob I Menzies

Abstract

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13-valent pneumococcal conjugate vaccine (13vPCV) replaced the 7-valent pneumococcal conjugate vaccine (7vPCV) and was suspected of involvement in 236 AEFI cases (48  per 100,000  doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTPa-IPV also increased (from 94 to 139 per 100,000 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged ≥65  years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorised as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominately due to reports of injection site reactions (49%  increase in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI. Commun Dis Intell 2012;36(4):E315–E332.

Keywords: AEFI, adverse events, vaccines, surveillance, immunisation, vaccine safety

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Introduction

This report summarises national passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) to 28 February 2012. The report focuses on AEFI reported for vaccines administered during 2011 and trends in AEFI reporting over the 12-year period 1 January 2000 to 31 December 2011.

An adverse event following immunisation is defined as any untoward medical occurrence that follows immunisation and which does not necessarily have a causal relationship with the use of the vaccine.1 The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.1

Thus, AEFI may be caused by a vaccine(s) or may be coincidental. Adverse events may also include conditions that occur following the incorrect handling and/or administration of a vaccine(s). The post-marketing surveillance of AEFI is particularly important for detecting rare, late onset and unexpected events, which are difficult to detect in pre-registration vaccine trials.

Reports summarising national AEFI surveillance data have been published regularly since 2003. Trends in reported adverse events following immunisation are heavily influenced by changes to vaccines provided through the National Immunisation Program (NIP). Changes in previous years have been reported elsewhere.2–10 Recent changes that impact on AEFI surveillance data presented in this report are:

  1. From 1 July 2011, Prevenar 13® (13-valent pneumococcal conjugate vaccine, 13vPCV) replaced Prevenar® (7-valent pneumococcal conjugate vaccine, 7vPCV) on the NIP for children at 2, 4 and 6 months of age in all states and territories except the Northern Territory (which adopted 13vPCV from 1 October 2011).11 In addition, children aged between 12 and 35 months, who had completed a primary pneumococcal vaccination course with 7vPCV were eligible to receive a free supplementary dose of Prevenar 13® from 1  October 2011 to 30 September 2012. The Northern Territory Government provided a free dose of Prevenar 13® at 18 months for children who previously received a primary course of Synflorix® (10vPCV) or a mixed primary pneumococcal course with Synflorix® and Prevenar®.12
  2. On 25 March 2011, TGA issued a recall of Batch N3336 of the 23 valent pneumococcal polysaccharide vaccine (23vPPV, Pneumovax® 23), as a precautionary measure following an increased number of reports of adverse reactions in patients who had received the vaccine.13 Further advice to health professionals not to administer a second or subsequent dose of Pneumovax 23 vaccine was provided in April 2011.14 Revised recommendations regarding which patients should be re-vaccinated under the NIP was provided in December 2011.15

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A number of other important changes to vaccine funding and availability that impact on the interpretation of trend data have been described in detail in previous reports published regularly since 2003.2–10 These are listed in Table 1 in chronological order. To assist readers, at the end of this report is a glossary of the abbreviations of the vaccines referred to in this report.

Table 1: Changes to the Australian Standard Vaccination Schedule (2003–2010)2–10

Date Intervention
2003 Commencement of the meningococcal C conjugate vaccine (MenCCV) immunisation program.

18-month dose of DTPa vaccine removed from the National Immunisation Program.

2004 dTpa funded at 15–17 years of age replacing the diphtheria-tetanus dose.
2005

From January 2005, universal funded infant 7-valent pneumococcal conjugate vaccine (7vPCV) program replaced the previous targeted childhood program, with a catch-up program for children aged <2 years.

Universal 23-valent pneumococcal polysaccharide vaccine (23vPPV) for adults aged ≥65 years replaced previous subsidy through the Pharmaceutical Benefits Scheme.

From November 2005, universal funded immunisation against varicella at 18 months of age with a school-based catch-up program for children at 10–13 years of age not previously vaccinated and without a history of varicella infection (no funded catch-up for children 2–10 years of age).

IPV funded to replace OPV, in combination vaccines.

2007

From April 2007, funded immunisation against human papillomavirus for all Australian girls aged 12–13 years delivered through a school-based program from April 2007, with a temporary catch-up program through schools or primary care providers for females aged 13–26 years until December 2009.

From July 2007, universal funded immunisation against rotavirus at 2 and 4 months of age (Rotarix®) or at 2, 4 and 6 months of age (RotaTeq®).

2008

Western Australia commenced a seasonal influenza vaccination program for all children aged 6 months to <5 years (born after 1 April 2003).

In March 2008, Queensland, South Australia and Victoria changed from using two combination vaccines (quadrivalent DTPa-IPV and Hib-HepB) to the single hexavalent DTPa-IPV-HepB-Hib vaccine.

2009

By late 2009, all states and territories were using the single hexavalent DTPa-IPV-Hib-HepB (Infanrix hexa®) vaccine for all children at 2, 4 and 6 months of age, due to an international shortage of Haemophilus influenzae type b (Hib) (PedvaxHib® [monovalent] and Comvax® [Hib-HepB]) vaccines.

Pandemic H1N1 2009 influenza vaccine (Panvax®) was rolled out across Australia from 30 September 2009 for people aged ≥10 years. From December 2009, the pandemic vaccine was made available to children aged 6 months to 10 years.

2010

Annual vaccination with seasonal trivalent influenza vaccine (TIV, containing 3 influenza strains: A/H1N1, A/H3N2 and B) was funded under the National Immunisation Program for people aged ≥6 months with medical risk factors (previously subsidised through the Pharmaceutical Benefits Scheme) and all Indigenous people aged ≥15 years (previously all Indigenous adults ≥50 years and 15–49 years with medical risk factors).

On 23 April 2010, the use of the 2010 seasonal TIV in children <5 years of age was suspended by Australia's Chief Medical Officer due to an increased number of reports of fever and febrile convulsions post vaccination. A subsequent investigation identified that Fluvax®and Fluvax junior®(CSL Biotherapies), but neither of the other two available brands registered for use in young children, were associated with an unacceptably high risk of febrile convulsions.The recommendation to resume the use of seasonal influenza vaccine in children aged 6 months to 5 years, using brands other than Fluvax®and Fluvax junior®, occurred in August 2010.

2011

From 1 July 2011, Prevenar 13® replaced Prevenar® on the NIP for children at 2, 4 and 6 months of age in all states and territories except the Northern Territory, which adopted 13vPCV from 1 October 2011.

From 1 October 2011 to 30 September 2012 all children aged between 12–35 months who had completed a primary pneumococcal vaccination course with 7vPCV were eligible to receive a free supplementary dose of Prevenar 13®

On 25 March 2011, TGA issued a recall of Batch N3336 of the 23 valent pneumococcal polysaccharide vaccine 23vPPV, Pneumovax® 23. In April 2011 health professionals were advised not to administer a second or subsequent dose of Pneumovax 23 vaccine.In December 2011 revised recommendations regarding which patients should be re-vaccinated under the National Immunisation Program were provided.

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Methods

AEFI are notified to the TGA by state and territory health departments, health professionals, vaccine manufacturers and members of the public.16,17 All reports are assessed using internationally consistent criteria18 and entered into the Australian Adverse Drug Reactions System (ADRS) database. All serious reports for drugs and vaccines are reviewed by the TGA. Other reports are used in data mining and signal detection activities.

AEFI data

De-identified information on all AEFI reported to the TGA from 1 January 2000 to 28 February 2012 and stored in the ADRS database were released to the National Centre for Immunisation Research and Surveillance (NCIRS). Readers are referred to previous AEFI surveillance reports for a description of the surveillance system.2,3

Records contained in the ADRS database were eligible for inclusion in the analysis if a vaccine was recorded as ‘suspected’ of involvement in the reported adverse event and either

  1. the vaccination occurred between 1 January 2000 and 31 December 2011, or
  2. for records where the vaccination date was not recorded, the date of onset of symptoms or signs occurred between 1 January 2000 and 31  December 2011.

Study definitions of AEFI outcomes and reactions

AEFI were defined as ‘serious’ or ‘non-serious’ based on information recorded in the ADRS database and criteria similar to those used by the World Health Organization18 and the US Vaccine Adverse Events Reporting System (VAERS).19 In this report, an event is defined as ‘serious’ if the record indicated that the person had recovered with sequelae, was admitted to a hospital, experienced a life-threatening event, or died.

Causality ratings of ‘certain’, ‘probable’ and ‘possible’ are assigned to individual records by the TGA. They describe the likelihood that a suspected vaccine or vaccines was/were associated with the reported reaction at the level of the individual vaccine recipient. Factors that are considered in assigning causality ratings include the timing (minutes, hours), the spatial correlation of symptoms and signs in relation to vaccination (for injection site reactions), and whether one or more vaccines were administered, and are outlined in more detail elsewhere.3 However, in many instances a causal association between vaccines administered to an individual and events that subsequently occurred cannot be clearly ruled in or out. In addition, children in particular often receive several vaccines at the same time. Therefore, all administered vaccines are usually listed as ‘suspected’ of involvement in a systemic adverse event as it is usually not possible to attribute the event to a single vaccine.

Typically, each record lists several symptoms, signs and/or diagnoses that have been coded by TGA staff from the reporter’s description, into standardised terms using the Medical Dictionary for Regulatory Activities (MedDRA®).20

To analyse reported AEFI, MedDRA® coding terms were grouped to create a set of reaction categories. Firstly, reaction categories were created that were analogous to the reactions listed and defined in The Australian Immunisation Handbook (9th edition). 17 Where MedDRA® coding terms could not be categorised into Handbook categories, additional categories were created for those that were listed in more than 1% of records (e.g. headache, dizziness, change in heart or respiratory rate or rhythm). Reaction terms listed in less than 1% of records were grouped into broader categories based on the organ system where the reaction was manifested (e.g. gastrointestinal, neurological).

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Data analysis

All data analyses were performed using SAS software version 9.3.21 Average annual population-based reporting rates were calculated for each state and territory and by age group using population estimates obtained from the Australian Bureau of Statistics.

Reporting rates per 100,000 administered doses were estimated where reliable information was available on the number of doses administered. This was done for 12 vaccines funded through the NIP for children aged <7 years, for influenza vaccine in adults aged ≥18 years, and for 23vPPV in adults aged ≥65 years.

Denominator data to estimate reporting rates for influenza and 23vPPV vaccines were obtained from a national adult coverage survey conducted in 2009.22 For 23vPPV, the number of people vaccinated in 2011 was derived from the number of people who reported receipt of the vaccine within the previous 5 years, divided by five. The number of administered doses of each of the 10 childhood vaccines was obtained from the Australian Childhood Immunisation Register (ACIR), a national population-based register of approximately 99% of children aged <7 years.23

Notes on interpretation

Caution is required when interpreting the data presented in this report. Due to reporting delays and the late onset of some AEFI, the data are considered preliminary, particularly for the fourth quarter of 2011. Data published in previous reports for 2000–20102–10 may differ from that presented in this report for the same period because this report has been updated to include delayed notifications to the TGA that were not included in prior publications. Data can also differ because reports may be updated and recoded when follow-up information is received.

The information collated in the ADRS database is intended primarily for signal detection and hypothesis generation. While reporting rates can be estimated using appropriate denominators, they cannot be interpreted as incidence rates due to under-reporting and biased reporting of suspected events, and the variable quality and completeness of information provided in individual notifications.2–10,24

It is important to note that this report is based on vaccine and reaction term information collated in the ADRS database and not on comprehensive clinical notes or case reviews. The reaction categories are created from available information and are similar, but not identical, to The Australian Immunisation Handbook17 AEFI case definitions.

Comparison with online Database of Adverse Events Notifications

In August 2012, the TGA made a searchable database, the Database of Adverse Event Notifications (DAEN) publicly available on its web site. DAENS contains data of all adverse event reports for medicines (including vaccines).25 This annual report includes data from the ADRS database sent to NCIRS by TGA in March 2012, and includes more detailed data than those provided by DAEN. The numbers published in this report may be different to the numbers in the DAEN database, due to different dates of data extraction. In addition, this report provides several features that are not available from the DAEN database, including long-term trends and population and dose-based reporting rates, put in the context of changes in vaccine policy and use, and reporting practices.

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Results

The ADRS database included a total of 2,327 records where the date of vaccination (or onset of adverse event, if vaccination date was not reported) was between 1 January and 31 December 2011.

In 2011, 83% of AEFI (n=1,933) were reported to the TGA via states and territories, while the rest were reported directly to the TGA; 13% (n=291) by doctors or health care providers, 2% (n=42) by members of the public, 1% (n=29) by hospitals, and 1% (n=32) by drug companies. The proportion reported directly to the TGA by members of the public during 2011 (2%; n=42) was substantially lower than in 2009 (28%; n=664) and 2010 (13%; n=502) mainly because of the active promotion of the direct reporting of AEFI to TGA following the monovalent pandemic H1N1 influenza (pH1N1) vaccine in 2009, as well as a high level of public interest in both the pH1N1 and seasonal TIV vaccines during 2009 and 2010.

Reporting trends

The overall AEFI reporting rate for 2011 was 10.4  per 100,000 population, compared with 17.4  in 2010. The AEFI reporting rate was the third highest for the period 2000 to 2011, after peaks in 2010 (17.4) predominantly due to reports in children following vaccination with the 2010 seasonal TIV, and in 2009 (11.0) following the commencement of the pandemic (pH1N1) influenza vaccine program.9,10

Figure 1: Adverse events following immunisation, ADRS database, 2000 to 2011, by date of vaccination

combined bar and line chart showing dverse events following immunisation, ADRS database, 2000 to 2011, by date of vaccination. See the appendix for the data table.

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

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Data table for Figure 1

Figure 2a: Adverse events following immunisation for people aged ≥7 years for frequently reported vaccines, ADRS database, 2000 to 2011, by date of vaccination

line chart showing adverse events following immunisation for children under 7 years for frequently reported vaccines, ADRS database, 2000 to 2011, by date of vaccination. see appendix for data table.

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

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Data table for Figure 2a

 

Figure 2b: Adverse events following immunisation for children aged 1 to <7 years for frequently reported vaccines, ADRS database, 2000 to 2011, by date of vaccination line chart showing adverse events following immunisation for children aged 1 to less than 7 years for frequently reported vaccines, ADRS database, 2000 to 2011, by date of vaccination. see appendix for data table.

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

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Data table for Figure 2b

Figure 2c: Frequently suspected vaccines,* adverse events following immunisation for children aged <1 year, ADRS database, 2000 to 2011, by date of vaccination

line chart showing frequently suspected vaccines, adverse events following immunisation for children aged 1 year, ADRS database, 2000 to 2011, by date of vaccination. see appendix for data table.

* Meningococcal C conjugate vaccine (MenCCV) was introduced into the NIP schedule on 1 January 2003; 7-valent pneumococcal conjugate vaccine (7vPCV) on 1 January 2005; DTPa-IPV and DTPa-IPV-HepB-Hib (hexavalent) vaccines in November 2005; rotavirus (RotaTeq® and Rotarix®) vaccines on 1 July 2007; pH1N1 influenza vaccine for children 6 months to 10 years on December 2009; seasonal trivalent influenza vaccine in 2010; and the 13-valent pneumococcal conjugate vaccine (13vPCV) on 1 July 2011 (Table 1).

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

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Data table for Figure 2c

There was a substantial drop in reported events as well as reporting rate per 100,000 population during 2011, and the vast majority of reported events (from all reporter types) were of a non-serious nature (Figure 1). There were marked variations in reporting levels in association with previous changes to the NIP from 2000 onwards (Figures 2a, 2b and 2c). There was an increase in the number of in reports following the receipt of 7vPCV, 13vPCV, and DTPa-containing vaccines in children aged <7  years compared with previous years (Figures 2b and 2c). There was a spike in reports following 23vPPV vaccination in adults. However, this was consistent with the usual seasonal pattern of reporting from older Australians who typically receive 23vPPV and influenza vaccine during the autumn months (March–June) (Figure 2a).

Age distribution

In 2011, the AEFI reporting rate per 100,000 population declined for all age groups <65 years compared with 2010 (Figure 3). These decreases were almost entirely related to the decline in the number of reports following the receipt of the influenza vaccine; primarily seasonal influenza vaccine. An increase was observed in reporting rates per 100,000 doses of certain vaccines and age groups as shown in Table 2. Reporting rates per 100,000 doses were higher in 2011 compared with 2010 for all age groups, but the increase was significant in children aged 2 to <7 years (80.2 vs 44.7) compared with children aged <1 years (17.6  vs  12.8) and 1  to <2 years (14.2 vs 9.2). The increase in reporting of AEFI in children aged 2 to <7 years in 2011 is primarily because of increased reporting of injection site reaction (ISR) following vaccination with DTPa-IPV containing vaccines and 13vPCV. The increase was largely seen in Victoria followed by Queensland and New South Wales.

Figure 3: Reporting rates of adverse events following immunisation per 100,000 population, ADRS database, 2000 to 2011, by age group and year of vaccination

line chart showing reporting rates of adverse events following immunisation per 100,000 population, ADRS database, 2000 to 2011, by age group and year of vaccination. see appendix for data table

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Data table for Figure 3

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Table 2: Vaccine types recorded as ‘suspected’ of involvement in adverse events following immunisation, ADRS database, 2011, by selected age group

Vaccines*
AEFI records (n) Vaccine doses (n) Reporting rate per 100,000 doses§ (95% CI)
    2011 2010
<7 years
DTPa-containing vaccines
757
1,135,635
66.7 (62.0–71.6)
44.0 (40.2–48.1)
DTPa-IPV
419
301,607
138.9 (125.9–152.9)
94.1 (83.2–106.2)
Pentavalent (DTPa-IPV-HepB)
1
252
396.8 (11.9–2222.2)
1033.6 (281.7–2646.0)
Hexavalent (DTPa-IPV-HepB-Hib)
337
833,776
40.4 (36.2–45.0)
26.5 (23.2–30.3)
Haemophilus influenzae type b
72
282,350
25.5 (19.9–32.1)
31.9 (25.6–39.2)
Measles-mumps-rubella
324
591,059
54.8 (49–61.1)
48.2 (42.6–54.2)
Meningococcal C conjugate
78
296,320
16.9 (20.8–32.8)
28.6 (22.8–35.4)
Pneumococcal conjugate –7vPCV
176
460,353
33.7 (32.8–44.3)
26.3 (22.9–30.0)
Pneumococcal conjugate –13vPCV
236
488,896
48.3 (42.3–54.8)
na
Rotavirus vaccine
294
522,638
56.3 (50.0–63.1)
39.8 (34.6–45.6)
Varicella
61
280,837
21.7 (16.6–27.9)
35.2 (28.5–42.9)
Seasonal influenza
52
na
na
na
pH1N1
2
na
na
na
Total|| (<7 years)
1,121
4,058,431
27.6 (26.0–29.3)
19.3 (18.0–20.8)
7–17 years
HPV
128
na
na
na
Hepatitis B
96
na
na
na
dTpa
93
na
na
na
Varicella
31
na
na
na
Seasonal influenza
66
na
na
na
pH1N1
na
na
na
Total 7–17 years)
346
na
na
na
18–64 years
Seasonal influenza**
226
3,170,300
7.1 (6.2–8.1)
10.8 (9.7–12.0)
pH1N1
na
na
na
dTpa
108
na
na
na
23vPPV
84
132,520
63.4 (50.6–78.4)
22.6 (15.3–32.3)
Total|| (18–64 years)††
467
3,302,820
9.4 (8.4–10.5)
11.3 (10.2–12.5)
≥65 years
23vPPV**
288
317,400
90.7 (80.6–101.8)
48.8 (41.4–57.2)
Seasonal influenza**
129
2,176,000
5.9 (4.9–7.0)
7.0 (6.0–8.2)
pH1N1
na
na
na
dTpa
27
na
na
na
Total|| (≥65 years)††
363
2,493,400
16.7 (15.2–18.4)††
12.4 (11.0–13.8)††

* Records where at least one of the vaccines shown in the table was suspected of involvement in the reported adverse event.

† Number of AEFI records in which the vaccine was coded as ‘suspected’ of involvement in the reported adverse event and the vaccination was administered between 1 January and 31 December 2011. More than one vaccine may be coded as ‘suspected’ if several were administered at the same time.

‡ Number of vaccine doses recorded on the Australian Childhood Immunisation Register (ACIR) and administered between 1  January and 31 December 2011.

§ The estimated reporting rate per 100,000 vaccine doses recorded.

|| Total number of AEFI records analysed, not the total in each column as categories are not mutually exclusive and an AEFI record may list more than one reaction term.

¶ Number of AEFI records excluding influenza vaccines

** Number of administered doses of seasonal influenza vaccine estimated from the 2009 AIHW national adult vaccination survey.24

††  Seasonal influenza and 23vPPV only

Na Not applicable

There were reductions in population-based reporting rates in all age groups over the age of 7 years in 2011 compared with 2010, with the exception of the ≥65 year age group in which rates increased from 9.2 to 12.1 per 100,000. Also, reporting rates per 100,000 vaccine doses were higher overall in 2011 compared with 2010 for the ≥65 years age group (from 12.4 to 16.7) especially for 23vPPV (from 48.8 to 90.7) (Table 2).

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Geographical distribution

Population-based reporting patterns varied between states and territories during 2011 (Table 3) as in previous years.2–10 The highest rates were in the Northern Territory, the Australian Capital Territory and South Australia (27.7, 17.4, 15.1, respectively), while New South Wales had the lowest rate (6.2). Reporting rates dropped in most jurisdictions in 2011 compared with 2010. There was a 75% decline in Western Australia (from 42.1 to 10.5); 57% decline in South Australia (from 34.9 to 15.1) and a more than 45% decline in Tasmania (from 15.6 to 8.4) and the Australian Capital Territory (from 32.6 to 17.4).

Table 3: Adverse events following immunisation, ADRS database, 1 January to 31 December 2011, by state or territory

State or territory
AEFI records Annual reporting rate per 100,000 population*
n % Overall 'Certain'/'probable' causality rating 'Serious' outcome Aged <7 years
Australian Capital Territory
64
3
17.4 (13.4–22.2)
3.8
1.4
7.3
New South Wales
449
19
6.2 (5.7–6.8)
1.4
0.6
2.1
Northern Territory
64
3
27.7 (21.3–35.3)
7.8
3.5
14.7
Queensland
433
18
9.7 (8.8–10.6)
3.1
0.8
5.1
South Australia
248
11
15.1 (13.3–17.1)
2.7
0.5
7.4
Tasmania
43
2
8.4 (6.1–11.3)
2.2
0.0
3.3
Victoria
738
31
13.3 (12.4–14.3)
2.6
0.7
7.6
Western Australia
248
11
10.5 (9.3–11.9)
2.1
0.6
4.7
Other§
40
2
na
na
na
na
Total
2,327
100
10.4 (10.0–10.9)
2.3
0.7
5.0

* Average annual rates per 100,000 population calculated using mid-2010 population estimates (Australian Bureau of Statistics).

† See previous reports2,3 for criteria used to assign causality ratings.

‡ Adverse events following immunisation (AEFI) records defined as ‘serious’ (i.e. recovery with sequelae, hospitalisation, life-threatening or death).

§ Records where the jurisdiction in which the AEFI occurred was not reported or was unclear. AEFI records in this category were notified mainly by pharmaceutical companies (n=32), members of the public (n=6), and health care providers (n=2).

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Vaccines

Thirty-one different vaccines were included in the 2,327 records received in 2011 (Table 4). The percentage of records where only one vaccine was reported differed by vaccine, typically varying according to whether multiple vaccines were routinely co-administered for the patient’s age. The percentage of records assigned causality ratings of ‘certain’ or ‘probable’ also varied, in accordance with the frequency of injection site reactions, for which the attribution of causality is more straightforward. There were also slight variations in the numbers with outcomes defined as ‘serious’, which have remained low as in previous years.

The individual vaccines most frequently suspected to have been related to AEFI events were seasonal influenza vaccine with 483 records (21%), followed by DTPa-IPV (n=426; 18%) and 23vPPV (n=405; 17%) (Table 4).

Table 4: Vaccine types listed as ‘suspected’ in records of adverse events following immunisation, ADRS database, 2011

AEFI records One suspected vaccine or drug only 'Certain'/ 'probable' causality rating 'Serious' outcome§ Age group||
  <7 years ≥7 years
Suspected vaccine type*
n n % n % n % n % n %
Influenza
483
356
74
68
14
34
7
52
11
427
88
DTPa-IPV
426
198
46
161
38
16
4
419
98
4
1
23vPPV
405
281
69
106
26
17
4
16
4
386
95
MMR
348
34
10
14
4
20
6
324
93
22
6
DTPa-IPV-HepB-Hib
339
28
8
16
5
40
12
337
99
2
1
Rotavirus
296
31
10
7
2
36
12
294
99
1
0.3
13vPCV
236
78
33
43
18
20
8
235
99.6
1
0.4
dTpa
235
173
74
73
31
13
6
4
2
229
97
7vPCV
176
8
5
6
3
24
14
176
100
0
0
Hepatitis B
140
54
39
9
6
9
6
11
8
127
91
HPV
133
58
44
9
7
4
3
1
0.8
129
97
Varicella
96
55
57
10
10
8
8
61
64
35
36
MenCCV
83
3
4
0
0
9
11
78
94
5
6
Hib
73
2
3
0
0
9
12
72
99
1
1
Hepatitis A
25
3
12
1
4
3
12
6
24
19
76
DTPa
24
15
63
8
33
4
17
11
46
12
50
Typhoid
21
4
19
0
0
3
14
0
0
21
100
dT
19
13
68
6
32
1
5
0
0
19
100
Yellow fever
16
6
38
1
6
6
38
1
6
15
94
Hepatitis A + B
14
6
43
0
0
1
7
1
7
13
93
Rabies
13
6
46
0
0
4
31
2
15
11
85
10vPCV
11
2
18
0
0
1
9
9
82
2
18
Hepatitis A-Typhoid
9
2
22
0
0
2
22
2
22
7
78
Q fever
7
7
100
2
29
0
0
0
0
7
100
BCG
6
5
83
2
33
0
0
6
100
0
0
IPV
4
0
0
0
0
0
0
1
25
3
75
Japanese encephalitis
4
1
25
0
0
1
25
0
0
4
100
Men4PV
4
0
0
0
0
2
50
1
25
3
75
Cholera
2
2
100
0
0
2
100
0
0
2
100
dTpa-IPV
2
0
0
0
0
0
0
0
0
2
100
DTPa-IPV-HepB
1
0
0
0
0
0
0
1
100
0
0
Total**
2,327
1,421
61
523
22
158
7
1,121
48
1,189
51

* See appendix for abbreviations of vaccine names.

† Adverse events following immunisation (AEFI) records where only one vaccine was suspected of involvement in a reported adverse event.

‡ Causality ratings were assigned to AEFI records using criteria described previously.2,3

§ ‘Serious’ outcomes are defined in the Methods section.

|| AEFI records are not shown if both age and date of birth were not reported.

¶ Percentages are calculated for the number of AEFI records where the vaccine was suspected of involvement in the AEFI, e.g. HPV was ‘suspected’ in 133 AEFI records; this was the only suspected vaccine in 44% of the 133 AEFI records, 7% had ‘certain’ or ‘probable’ causality ratings, 3% were defined as ‘serious’ and 97% were for those aged ≥7 years.

** Total number of AEFI records analysed, not the total in each column as categories are not mutually exclusive and an AEFI record may list more than one vaccine.

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Reactions

The distribution and frequency of reactions listed in records for vaccines received in 2011 are shown in Tables 5a and 5b. In Table 5a, only the reaction categories analogous to those listed in The Australian Immunisation Handbook17 are shown. In Table 5b, other reaction categories are listed in descending order of frequency.

Table 5a: Reaction categories of interest* mentioned in records of adverse events following immunisation, ADRS database, 2011

AEFI records Only reaction reported 'Certain'/'probable' causality rating Age group§
  <7 years ≥7 years
Reaction category*
n n %|| n %|| n %|| n %||
Injection site reaction
1,073
244
23
481
45
531
49
533
50
Fever
549
11
2
34
6
301
55
245
45
Allergic reaction
426
53
12
14
3
173
41
250
59
Rash**
190
66
35
1
1
134
71
54
28
Syncope
106
64
60
12
11
19
18
84
79
Abnormal crying
82
3
4
5
6
79
96
3
4
Convulsions
56
31
55
1
2
44
79
12
21
Lymphadenopathy/lymphadenitis††
42
4
10
13
31
7
17
35
83
Hypotonic-hyporesponsive episodes
38
29
76
1
3
38
100
0
0
Arthralgia
36
3
8
4
11
3
8
33
92
Abscess
16
5
31
6
38
4
25
12
75
Anaphylactic reaction
13
11
85
1
8
2
15
11
85
Arthritis
12
1
8
2
17
5
42
7
58
Intussusception
6
6
100
0
0
6
100
0
0
Guillain-Barré syndrome
3
2
67
1
33
0
0
3
100
Death
3
2
67
0
0
1
33
2
67
Brachial neuritis
1
1
100
0
0
0
0
1
100
Parotitis
1
0
0
0
0
0
0
1
100
Thrombocytopenia
1
1
100
0
0
1
100
0
0
Encephalitis
0
0
0
0
0
0
0
0
0
Encephalopathy
0
0
0
0
0
0
0
0
0
Orchitis
0
0
0
0
0
0
0
0
0
Osteitis
0
0
0
0
0
0
0
0
0
Sepsis
0
0
0
0
0
0
0
0
0
Total‡‡
2,327
1,421
61
523
22
1,121
48
1,189
51

* Reaction categories were created for the Adverse events following immunisation (AEFI) of interest listed and defined in The Australian Immunisation Handbook, (9th edition, p 58–65 and 360–3)17 as described in the Methods section.

† AEFI records where only one reaction was reported.

‡ Causality ratings were assigned to AEFI records using criteria described previously.2,3

§ Not shown if neither age nor date of birth were recorded.

|| Percentages relate to the number of AEFI records in which the specific reaction term was listed, e.g. of 1,073 AEFI records listing injection site reaction, 23% listed only one type of reaction while 45% had a causality rating of ‘certain’ or ‘probable’ and 49% were for children aged <7 years.

¶ Allergic reaction includes skin reactions including pruritus, urticaria, periorbital oedema, facial oedema, erythema multiforme etc. (excludes skin reactions presented elsewhere in this table); and/or gastrointestinal (e.g. diarrhoea, vomiting) symptoms and signs but does not include other abdominal symptoms like abdominal pain, nausea, flatulence, abnormal faeces, hematochezia etc. Does not include anaphylaxis.

** Includes general terms of rash but does not include pruritic rash.

††  Includes lymphadenitis following Bacille Calmette-Guérin vaccination and the more general term of ‘lymphadenopathy’.

‡‡ Total number of AEFI records analysed, not the total in each column as categories are not mutually exclusive and an AEFI record may list more than one reaction term.

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Table 5b: ‘Other’* reaction terms listed in records of adverse events following immunisation, ADRS database, 2011

AEFI records Only reaction reported 'Certain'/'probable' causality rating Age group§
<7 years ≥7 years
Reaction term*
n n %|| n %|| n %|| n %||
Malaise
240
0
0
16
7
80
33
160
67
Headache
180
4
2
6
3
19
11
59
88
Pain
176
6
3
2
1
16
9
159
90
Neurological/psychological
169
1
0.6
6
4
133
79
36
21
Oedema
146
9
6
2
1
35
24
110
75
Nausea
126
0
0
9
7
6
5
118
94
Myalgia
121
5
4
6
5
12
10
110
89
Erythema
118
16
14
2
2
41
35
77
65
Gastrointestinal – RVV
107
8
7
3
3
106
99
0
0
Abdominal pain
91
4
4
4
4
45
49
45
49
Respiratory
88
12
13
4
5
39
44
49
56
Dizziness
75
1
1
3
4
2
3
73
97
Reduced sensation
44
1
2
4
9
1
2
43
98
Increased sweating
39
0
0
0
0
7
18
32
82
Somnolence
39
0
0
3
8
28
72
11
28
Pallor
35
0
0
2
6
22
63
13
37
ENT**
32
1
3
4
13
5
16
27
84
Circulatory
25
2
8
1
4
7
28
18
72
Weakness
21
0
0
0
0
2
10
19
90
Flushing
17
1
6
2
12
2
12
15
88
Tremor
17
1
6
2
12
4
24
12
71
Vision impaired
16
0
0
1
6
5
31
11
69
Other
242
22
9
15
6
111
46
130
54

eye or ear

25
0
0
2
8
12
48
13
52

cardiovascular

14
0
0
1
7
5
6
9
64

general non-specific

38
10
26
3
8
16
42
22
58

infection

20
3
15
0
0
10
50
10
50

respiratory

10
0
0
0
0
5
50
5
50

psychological

15
0
0
3
20
8
53
7
47

neurological

14
4
29
1
7
7
50
7
50

skin††

17
2
12
2
12
9
53
8
47

renal/urogenital

11
0
0
0
0
1
9
10
91

gastrointestinal‡‡

15
0
0
1
7
8
53
6
40

musculoskeletal

11
2
18
0
0
2
18
9
82

metabolic/endocrine

15
0
0
1
7
9
60
6
40

pregnancy/congenital

5
1
20
1
20
1
20
4
80

miscellaneous

3
0
0
1
33
2
67
1
33

haematological

5
0
0
0
0
3
60
2
40

* Reaction terms not listed in The Australian Immunisation Handbook17 but included in adverse events following immunisation (AEFI) records in the ADRS database. The top part of the table shows reaction terms included in 1% or more of AEFI records; the bottom part of the table shows reaction terms, grouped by organ system, that were included in less than 1% of AEFI records.

† AEFI records where only one reaction was reported.

‡ Causality ratings were assigned to AEFI records using criteria described previously.2,3

§ Not shown if neither age nor date of birth were recorded.

|| Percentages relate to the number of AEFI records in which the specific reaction term was listed, e.g. of 1,073 AEFI records listing injection site reaction, 23% listed only one type of reaction while 45% had a causality rating of ‘certain’ or ‘probable’ and 49% were for children aged <7 years.

¶ Gastrointestinal – RVV includes GI reactions following rotavirus vaccination only.

** Includes all the conditions related to ear, nose and throat

††  Other, skin includes purpura, petechia, blister, burning, dermatitis, dry skin etc. but does not include skin reactions.

‡‡ Other, gastrointestinal does not include reaction categories coded as GI reactions or Gastrointestinal – RVV signs and symptoms.

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The most frequently reported adverse events were ISR (46%), fever (24%), allergic reaction (18%), malaise (10%), rash, headache and pain (8% each) (Tables 5a and 5b; Figure 4).

Of the 1,073 cases of ISR, 531 (49%) were children aged less than 7 years. The vaccines most commonly suspected to have been related to AEFI for the <7  years age group related to ISR were: DTPa-IPV (n=345); MMR (n=183); 13vPCV (n=77); hexavalent vaccine (n=61) and 7vPCV (n=24). For the ≥7 years age group (n=533), these were 23vPPV (n=269); seasonal influenza vaccine (n=163); and dTpa (n=116) either given alone or co-administered with other vaccines. As expected, reports for 23vPPV and seasonal influenza vaccine were predominantly in the ≥65 years age group (72% and 39% respectively), while dTpa was commonly reported in the 12–17 years (26%) and 18–64 years age groups (58%).

The number of reports in each reaction category has changed over time (Figure 4). In previous years, reports of allergic reactions peaked in 2003 and 2007, coinciding with the national school-based MenCCV immunisation program and the human papillomavirus school program. Much of the variation in reporting of ISR over time is related to specific changes in the immunisation schedules for vaccines that are known to have higher rates of ISR, including DTPa-containing vaccines, MenCCV, 23vPPV and HPV vaccine.2–10,26,27 Increases in reports of fever were largely associated with time periods when new vaccines were added to the NIP in the reporting period, such as rotavirus and HPV in 2007. However, by far the largest peaks in reports since 2000 have been associated with the pH1N1 and seasonal influenza 2010 vaccines. In particular, there were large peaks of reports of fever and allergic reactions in 2009 associated with the pH1N1 vaccine, and in 2010 associated with both the pH1N1 and seasonal influenza vaccines. Reports of convulsions peaked in 2010, mainly associated with the seasonal influenza vaccine but also to a lesser extent with pH1N1. The peaks in neurological/psychological conditions in both years were mainly related to the pH1N1 and seasonal influenza vaccine. In 2011, the increase in ISR was associated with non-influenza vaccines, particularly 23vPPV and DTPa-containing vaccines.

Figure 4: Selected frequently reported adverse events following immunisation, ADRS database, 2000 to 2011, by date of vaccination

line chart showing selected frequently reported adverse events following immunisation, ADRS database, 2000 to 2011, by date of vaccination. see appendix for data table

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Data table for Figure 4

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Severity of outcomes

Summary data on outcomes are presented in Table  6. Fifty-eight per cent of reported events in 2011 were defined as ‘non-serious’ while 7% were defined as ‘serious’ (i.e. recovery with sequelae, requiring hospitalisation, experiencing a life-threatening event or death) (Table 6). This is similar to the proportion of serious AEFI observed in previous years.9,10 A further 22% were recorded as not fully recovered at the time of reporting; 41% of these reports came from Victoria, followed by Western Australia (20%) and Queensland (15%). Ninety-three per cent of cases recorded as ‘not fully recovered’ had missing information in various fields including hospitalisation; 77% were reported by states and territories, 17% by health care providers, 3% by members of the public, and 1% each by hospital, pharmacist and drug companies. Information on severity could not be determined for 14% (n=316) of records due to insufficient data and the majority of these reports came from states and territories (77%). Forty-four per cent of these reports were reported by Victoria. Of those without information describing severity, the most commonly reported adverse reactions were: ISR (49%); fever (23%); and allergic reactions (15%).

Table 6: Outcomes of adverse events following immunisation, ADRS database, 2011

    Age group
AEFI records 'Certain'/ 'probable' causality rating <7 years ≥7 years
Outcome
n %* n %§ n %§ n %§
Non-serious:
1,341
58
290
22
611
46
720
54
Not recovered at time of report
512
22
119
23
248
48
258
50
Not known (missing data) – total
316
14
87
28
172
54
144
46
Serious:
158
7
27
17
90
57
67
42
recovered with sequelae
1
1
hospital treatment – admission
148
25
89
58
life-threatening event
6
2
6
Death
3
1
2
Total
2,327
100
523
22
1,121
48
1,189
51

* Percentages relate to the total number of adverse events following immunisation (AEFI) records (n=2,327).

†  Causality ratings were assigned to AEFI records using criteria described previously.2,3

‡ AEFI records where both age and date of birth were not recorded are not shown (17 missing).

§ Percentages relate to the number of AEFI records with the specific outcome, e.g. of 1,341 AEFI records with a ‘non-serious’ outcome, 22% had causality ratings of ‘certain’ or ‘probable’ and 46% were for children aged <7 years.

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A total of 523 (22%) records were assigned causality ratings of either ‘certain’ (n=466; 20%) or ‘probable’ (n=57; 2%) and the rest (78%) were rated as ‘possible’.

The reactions recorded as ‘serious’ (n=158) were ISR (n=40; 25%); fever (n=37; 23%); allergic reactions (n=23; 15%); convulsions (n=18; 11%), including 11 febrile convulsions; diarrhoea/vomiting (n=11; 7%); hypotonic-hyporesponsive episode (HHE) (n=6; 4%); anaphylaxis (n=4; 3%); Guillain-Barré syndrome (GBS) (n=3; 2%); intussusception (n=3; 2%); 3 cases of syncope (2%); 3 reports of death (2%); and 1 case of idiopathic thrombocytopenic purpura. Other relatively severe reactions that were not classified as ‘serious’, either because they did not satisfy the criteria, or due to a lack of information about their outcome and/or hospitalisation status, included: convulsion (n=38; 38/56=68%), including 20 febrile convulsions; HHE (n=32; 32/38=84%); anaphylaxis (n=9; 9/13=69%); and intussusception (n=3; 3/6=50%).

All the reported cases of HHE (38) were from children aged <7 years. Seventeen reports (45%) were following co-administration of hexavalent, 7vPCV and rotavirus vaccines while 11 reports were following hexavalent, 13vPCV and rotavirus vaccines. Another 10 cases were following vaccination with MenC, MMR, BCG and DTPa/IPV administered simultaneously or individually.

All the 3 cases of GBS were in people aged >60 years. All of the three reports were following receipt of the seasonal influenza vaccine (2 following vaccination with Fluvax®, and one with Vaxigrip®).The timing in relation to administration of vaccine and onset of symptoms varied between same day to 7 weeks.

Of the 6 reports of intussusception, 5 were from infants (<1 year of age): 3 were following hexavalent, 7vPCV and rotavirus vaccines and 2 were following hexavalent, 13vPCV and rotavirus vaccines administered together. One report of intussusception was from a 19-month-old child following varicella vaccine administered alone. Five of the 13  reports of anaphylaxis in 2011 occurred following receipt of one of the influenza vaccines administered alone or in combination with other vaccines, while another 5 reports were following adult dTpa vaccine administered alone or in combination with other vaccines. Other individual vaccines leading to anaphylaxis were rotavirus, 13vPCV, and typhoid vaccine.

Three deaths were recorded as temporally associated with receipt of vaccines; two were following receipt of seasonal influenza vaccine.

  • One was an infant who had received hexavalent, 13vPCV and rotavirus vaccine 3 days prior to death. The cause of death was recorded as sudden infant death syndrome.
  • The second reported death was a middle-aged person, with motor neurone disease, who died 4 days after receiving the seasonal influenza vaccine. He developed flu-like-illness after vaccination and had a cardiac arrest. The cause of the death was documented as complications of motor neurone disease.
  • The third death was of a very elderly person, who developed progressive neurological dysfunction and died 29 days after receiving seasonal influenza vaccine. The cause of the death was documented as acute disseminated encephalomyelitis (ADEM).

All deaths were investigated by the TGA and no clear causal relation to vaccination was found.

Pneumococcal conjugate vaccine

In 2011, pneumococcal conjugate vaccines (7vPCV and 13vPCV) were suspected of involvement in 412  records (236 for 13vPCV and 176 for 7vPCV) for people aged <7 years with 44 cases being coded as serious (24 for 7vPCV and 20 for 13vPCV). Eighty-five per cent of the 7vPCV reports were from the first half of the year and 97% of 13vPCV in the second half, consistent with their usage, with 13vPCV replacing 7vPCV in July 2011. The AEFI reporting rates in people aged < 7 years were 48.3 per 100,000 doses for 13vPCV and 33.7 per 100,000 doses for 7vPCV (Table 2). The rate for 7vPCV was about 28% higher in 2011 than in 2010 (26.3) and 33% higher than in 2009 (25.4). The majority of the 7vPCV vaccines were co-administered with hexavalent and rotavirus vaccines and only 5% were administered alone while in the case of 13vPCV, 29% (n=68) cases were administered alone. Of the 68 cases, 95% (n=65) of children were between 12  months and <36 months, who received vaccine under the catch-up program offered to children between 12 months and 35 months.

The most frequently reported reactions for 7vPCV were vomiting/diarrhoea (n=46, 26% each); fever (n=39, 22%); rash (n=34, 19%); screaming (n=31, 18%); allergic reactions (n=26, 15% each); ISR (n=24, 14%) and 1 case of syncope (Figure  5a). All reports recorded the co-administration of other vaccines.

Figure 5a: Percentage of reported adverse events following immunisation with 7vPCV,* 2011, by reaction type and vaccine suspected of involvement in the reported event

bar chart showing the percentage of reported adverse events following immunisation with 7vPCV, 2011, by reaction type and vaccine suspected of involvement in the reported event. See appendix for data table.

* Per cent of 176 adverse events following immunisation records where 7vPCV was listed as suspected of involvement in the reported adverse event following immunisation.

Source: Adverse Drug Reactions Reporting System database, Therapeutic Goods Administration.

Data table for Figure 5a

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The spectrum of reactions for 13vPCV included 77  (33%) reports of ISR; 66 (28%) of fever; 43 (18%) of rash; 37 (16%) of vomiting/diarrhoea; 31 (13%) of allergic reactions; 2 case of syncope; 1 case of anaphylaxis and 1 reported death following co-administration of hexavalent, 13vPCV and rotavirus vaccine (Figure 5b).

Figure 5b: Percentage of reported adverse events following immunisation with 13vPCV,* 2011, by reaction type and vaccine suspected of involvement in the reported event

bar chart showing the percentage of reported adverse events following immunisation with 13vPCV, 2011, by reaction type and vaccine suspected of involvement in the reported event. see the appendix for the data table.

* Per cent of 236 AEFI records (13vPCV) where 13vPCV was listed as suspected of involvement in the reported adverse event following immunisation.

Source: Adverse Drug Reactions Reporting System database, Therapeutic Goods Administration.

Data table for Figure 5b

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Pneumococcal polysaccharide vaccine (23vPPV)

A single dose of 23vPPV is recommended for all non-Indigenous persons aged ≥65 years and all Indigenous persons aged ≥50 years. A second dose, 5 years later, should only be given to non-Indigenous persons aged ≥65 years with specified medical conditions that put them at increased risk of invasive pneumococcal disease, and to Indigenous persons who received their 1st dose at age ≥50 years.

There were a total of 405 records for 2011 where 23vPPV was listed as a suspected vaccine. Twenty-seven records were from those aged <18 year (16 in the 0–6 years and 11 in the 8–17 years age groups). There were 375 records for adults aged ≥18 years, with 13 cases coded as serious. There were 288  reports for older adults (≥65 years) including 194 (67%) reports of ISR, 76 (26%) oedema, 60  (21%) fever, 43 (15%) erythema, 4 reports of syncope, and 1 report of anaphylaxis (Figure 6.). Using the 2009 estimate of the number of doses of 23vPPV administered to people aged ≥65 years (n=317,400), the reporting rate was 90.7 per 100,000 doses, with rates of 3.2 for events classified as serious and 61.0 for ISR. This is substantially higher than the overall rate reported for 2010 (from 48.8 to 90.7). Reporting rates for ISR also increased substantially (from 39.7 per 100,000 to 61.0 per 100,000).

Figure 6: Percentage of reported adverse events following immunisation with pneumococcal polysaccharide (23vPPV),* 2011, by reaction type and vaccines suspected of involvement in the reported event

this is a bar chart showing the percentage of reported adverse events following immunisation with pneumococcal polysaccharide (23vPPV), 2011, by reaction type and vaccines suspected of involvement in the reported event. see the appendix for the data tabl

* Per cent of 405 adverse events following immunisation records where the pneumococcal polysaccharide vaccine (23vPPV) was listed as suspected of involvement in the reported adverse event following immunisation.

Source: Adverse Drug Reactions Reporting System database, Therapeutic Goods Administration

Data table for Figure 6

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An initial increase in reports of adverse events following vaccination with 23vPPV was noted in early 2011 up to 25 March 2011, which was much greater than the historical average (Figure 7). These initial reports triggered a national investigation, which led to a batch recall on 25 March and a subsequent increase in reporting.

Figure 7: Injection site reactions following 23vPPV immunisation for individuals aged ≥65 years, 2002 to 2011, by week of vaccination (2002–2010)* and week of report (2011)

line chart showing iInjection site reactions following 23vPPV immunisation for individuals aged &ge;65 years, 2002 to 2011, by week of vaccination and week of report. see appendix for the data table.

Data table for Figure 7

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Discussion

In 2011 there was a substantial drop in the total number of reports of AEFI and population-based reporting rates compared with 2010, predominantly due to a large decline in reports following vaccination with seasonal influenza vaccine and pH1N1 influenza vaccines. The reduction in reports follows the temporary suspension of the Western Australia vaccination program for children under 5 years and the national vaccination program for at-risk children under age 5 years in 2010 and the subsequent recommendations against using the CSL vaccine (Fluvax®) in young children (<10 year),28,29 which was associated with fever and febrile convulsions in children <5 years and has been discussed in detail elsewhere.30

However in 2011, reporting rates per 100,000 doses, which excluded influenza vaccine in children due to unreliable dose data, increased in all age groups except those aged 18–64 years, as shown in Table 2. The increase in reports for children aged 2 to <7  years is primarily due to ISR following vaccination with DTPa-IPV and 13vPCV. The increase was largely seen in Victoria, Queensland and New South Wales.

Data from the clinical studies of Prevenar 13® demonstrated an increase in ISR and systemic reactions following the 4th dose of 7vPCV or 13vPCV vaccine in the second year of life compared with earlier doses.31 From October 2011 children aged between 12 and 35 months who had completed a primary pneumococcal vaccination course with 7vPCV have been eligible to receive a free supplementary dose of Prevenar 13®,11 and the increased reporting rate of ISR for 13vPCV may be in part because it is being given as a fourth dose of a PCV vaccine. It may also be attributed to the ‘Weber effect’,32 which describes increased reporting frequently observed following the introduction of new vaccines.

The reporting rate of ISR in children aged 2 to <7  years has declined in recent years, as was expected following the removal of the dose of DTPa-IPV due at 18 months of age from the NIP schedule in September 2003. However, an increase in ISR following DTPa-IPV was observed in 2011. The reasons for the increase in 2011 are not entirely clear but are at least partly due to general changes in AEFI surveillance. One additional suggested hypothesis is that some ISR’s are ‘Arthus reactions’ caused by the presence of high levels of prevaccination IgG antibody in the vaccinees, which have been associated with higher rates of ISR.33,34 Possible causes of higher pre-vaccination antibody levels include immunity induced by natural infection during the pertussis epidemic from 2008, which was notable for high notification rates in pre-school aged children,35 as well as the earlier age of administration of the pre-school DTPa-IPV booster since the change of eligibility rules for provider and parent incentive payments.36

The higher overall numbers of reports in 2011 (excluding influenza vaccines) is also suggestive of generally increased propensity to report by providers in 2011, and may also reflect changes in the proportion of reports that were sent to TGA from individual state or territory surveillance systems. For example, in 2011, Victoria changed to submitting all reports to TGA, irrespective of severity, whereas previously minor/expected AEFI reports had not been submitted [personal communication: Dr Nigel Crawford, Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Victoria].

Reports of adverse events following 23vPPV vaccination in those aged ≥65 years increased substantially in 2011 compared with 2010 in all AEFI (from 48.8 to 90.7 per 100,000 doses). This increase may have been due to a larger number of people receiving second doses (recommended 5 years after the second dose) following the commencement of nationally funded vaccine in 2005. However, the current method of estimating the number of doses administered does not allow the detection of changes in vaccinations by year and cannot distinguish between the first and subsequent doses. In response to the continued increase in reports of severe ISR reports, in April 2011, the  TGA issued advice to health professionals not to administer a second or subsequent dose of Pneumovax 23 vaccine.14 An expert multidisciplinary working group was convened to investigate all reports of ISR following 23vPPV. Revised recommendations regarding which patients should be re-vaccinated under the NIP was provided in December 2011, with revaccination no longer recommended for those in the ≥65 years age group without predisposing medical conditions.15

Conclusion

There was a decline of 40% in the number of AEFI reported in 2011 compared with 2010 when a large number of reports were submitted in association with influenza vaccination. However, reporting rates for selected vaccines were higher in various age groups in 2011, mainly due to reports of ISR. Increases in reports in infants were related to the introduction of 13vPCV onto the schedule from July 2011, particularly including the supplementary booster dose for children aged 12–35 months, which as a booster dose, is known to be associated with increased ISRs. Increases in the 2 to <7 year age group were related to the DTP-IPV vaccine, and continue the trend of increasing reports since 2009. There was also an increase in the 12–17 year age group associated with dTPa. Increases in reactions in the ≥65 years age group were mostly of ISR following 23vPPV, many of which may have been second doses. The increase in the reporting rate for most vaccines might also be due to the greater propensity by providers to report in 2011 due to the heightened awareness of adverse events following influenza vaccine safety issues in 2010.

The majority of AEFIs reported to the TGA were mild transient events and the data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule.

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Acknowledgements

We thank Brynley Hull and Donna Armstrong, NCIRS, for assisting in the preparation of this report.

The National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases is supported by the Australian Government Department of Health and Ageing, the NSW Department of Health and The Children’s Hospital at Westmead, Australia.

Author details

Deepika Mahajan1

Jane Cook2

Aditi Dey1

Kristine Macartney1

Rob Menzies1

1. National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, University of Sydney and The Children’s Hospital at Westmead, Sydney, New South Wales

2. Office of Product Review, Therapeutic Goods Administration, Canberra, Australian Capital Territory

Corresponding author: Dr Deepika Mahajan, National Centre for Immunisation Research and Surveillance, Locked Bag 4001, WESTMEAD NSW 2145. Telephone: +61 2 9845 1433. Facsimile: +61 2 9845 1418. Email: Deepika.mahajan@ health.nsw.gov.au

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References

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2. Lawrence G, Menzies R, Burgess M, McIntyre P, Wood N, Boyd I, et al. Surveillance of adverse events following immunisation: Australia, 2000–2002. Commun Dis Intell 2003;27:307–323.

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30. Blyth CC. Currie AJ. Wiertsema SP. Conway N. Kirkham LA. Fuery A. et al. Trivalent influenza vaccine and febrile adverse events in Australia, 2010:clinical features and potential mechanisms. Vaccine 2011;29(32):5107–13.

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Abbreviations for vaccine types

BCG Bacille Calmette-Guérin (i.e. tuberculosis)

dT diphtheria-tetanus – adolescent and adult formulation

DTPa diphtheria-tetanus-pertussis (acellular) – paediatric formulation

dTpa diphtheria-tetanus-pertussis (acellular) – adolescent and adult formulation

dTpa-IPV combined dTpa and inactivated poliovirus

DTPa-HepB combined diphtheria-tetanus-pertussis (acellular) and hepatitis B

DTPa-IPV combined diphtheria-tetanus-pertussis (acellular) and inactivated poliovirus (quadrivalent)

DTPa-IPV-HepB combined diphtheria-tetanus-pertussis (acellular), inactivated poliovirus and hepatitis B (pentavalent)

DTPa-IPV-HepB-Hib combined diphtheria-tetanus-pertussis (acellular), inactivated poliovirus, hepatitis  B and Haemophilus influenzae type b vaccine (hexavalent)

HepB hepatitis B

Hib Haemophilus influenzae type b

Hib-HepB combined Haemophilus influenzae type b and hepatitis B

HPV human papillomavirus

IPV inactivated poliovirus vaccine

Men4PV meningococcal polysaccharide tetravalent vaccine

MenCCV meningococcal C conjugate vaccine

MMR measles-mumps-rubella

pH1N1 pandemic H1N1 influenza 2009

7vPCV 7-valent pneumococcal conjugate vaccine

10vPCV 10-valent pneumococcal conjugate vaccine

23vPPV 23-valent pneumococcal polysaccharide vaccine

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Appendix - data for Figures

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Figure 1: Adverse events following immunisation, ADRS database, 2000 to 2011, by date of vaccination

   Other  Serious outcome  Annual reporting rate per 100,000 population - Total  Annual reporting rate per 100,000 population excluding members of the public
2000 127
13
  159
21
  112
16
  105
20
3.0
2.8
2001 183
26
3.4
3.3
  202
33
3.9
3.8
  229
27
4.3
4.2
  215
16
4.8
4.7
2002 361
29
5.3
5.2
  368
34
5.9
5.8
  285
21
6.5
6.3
  267
20
7.0
6.8
2003 394
31
7.1
6.9
  409
43
7.3
7.1
  301
38
7.4
7.2
  254
21
7.5
7.3
2004 298
39
7.0
6.8
  275
26
6.5
6.4
  264
25
6.0
5.9
  160
14
5.5
5.4
2005 272
25
5.3
5.2
  212
27
5.0
4.9
  155
17
4.8
4.7
  188
19
4.5
4.4
2006 253
34
4.6
4.5
  229
35
4.7
4.6
  215
24
4.8
4.7
  199
30
4.9
4.8
2007 236
26
4.6
4.5
  562
58
4.7
4.6
  375
42
4.8
4.7
  328
37
7.8
7.6
2008 488
40
7.8
7.6
  487
50
7.7
7.5
  266
45
7.7
7.5
  257
29
7.6
7.4
2009 339
48
8.5
7.5
  315
41
9.3
7.7
  181
27
10.2
7.8
  1341
70
11.0
7.9
2010 972
77
12.6
9.7
  2,150
134
14.2
11.6
  319
33
15.8
13.4
  272
27
17.4
15.2
2011 597
39
15.7
14.0
  801
66
13.9
12.7
  410
30
12.2
11.5
  361
23
10.4
10.2

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Back to report

Figure 2a: Adverse events following immunisation for people aged ≥7 years for frequently reported vaccines, ADRS database, 2000 to 2011, by date of vaccination

   MenCCV  Seasonal influenza  HPV pH1N1 23vPPV
2000
42
17
 
35
12
 
3
1
 
1
1
2001
0
30
16
 
0
46
22
 
0
8
8
 
0
1
5
2002
3
32
29
 
8
78
66
 
6
2
6
 
26
1
8
2003
35
33
56
 
55
54
63
 
112
3
7
 
79
0
7
2004
90
41
46
 
77
38
36
 
67
4
6
 
30
0
7
2005
5
38
60
 
2
62
44
 
2
5
5
 
3
1
3
2006
0
38
43
 
2
56
60
 
0
6
9
 
0
0
11
2007
2
53
8
50
 
0
67
368
46
 
0
6
203
13
 
0
0
170
4
2008
0
39
225
53
 
0
100
159
50
 
0
4
90
8
 
1
0
63
10
2009
1
50
70
25
 
2
83
48
40
 
1
6
24
14
6
 
0
7
12
1220
8
2010
3
114
33
131
58
 
0
511
21
44
107
 
0
21
12
8
25
 
0
5
13
1
12
2011
1
136
61
0
170
 
1
273
37
0
190
 
3
16
17
0
21
 
0
2
14
0
5

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Back to report

Figure 2b: Adverse events following immunisation for children aged 1 to <7 years for frequently reported vaccines, ADRS database, 2000 to 2011, by date of vaccination

   other DTPa-containing vaccines  MenCCV MMR pH1N1  DTPa-IPV  Seasonal flu
2000
18
14
 
24
18
 
27
15
 
22
12
2001
53
23
 
59
22
 
92
36
 
111
35
2002
167
7
43
 
101
7
35
 
112
17
31
 
108
31
30
2003
123
96
46
 
117
65
28
 
111
44
40
 
66
28
39
2004
64
34
51
 
55
21
32
 
66
39
47
 
46
20
36
2005
57
17
35
 
50
11
31
 
64
11
39
1
 
43
13
45
36
2006
5
17
38
74
4
 
4
12
31
46
3
 
4
28
46
54
0
 
5
18
57
70
0
2007
3
8
32
51
2
 
6
6
17
40
2
 
3
9
37
50
22
 
2
12
40
52
1
2008
1
9
40
64
0
 
1
14
53
66
17
 
4
9
47
72
3
 
1
20
74
76
0
2009
2
14
59
73
1
 
1
13
47
42
13
 
0
9
45
45
1
 
0
10
37
12
34
0
2010
3
15
47
128
45
354
 
1
41
89
142
59
1,103
 
1
10
64
2
77
4
 
0
15
66
1
81
2
2011
4
13
62
0
79
9
 
3
18
86
0
108
36
 
1
23
82
0
116
2
 
1
17
84
0
109
0

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Back to report

Figure 2c: Frequently suspected vaccines,* adverse events following immunisation for children aged <1 year, ADRS database, 2000 to 2011, by date of vaccination

   7vPCV Rotavirus  pH1N1  DTPa-IPV  Hexavalent Seasonal flu 13vPCV
2000
 
 
 
2001
 
 
7
 
1
2002
3
 
2
 
1
 
2
2003
2
 
3
 
3
 
5
2004
3
 
3
 
13
 
4
2005
53
 
27
 
26
 
34
19
8
2006
42
20
18
 
37
1
26
10
4
 
46
2
39
10
0
 
29
19
17
9
0
2007
42
12
23
13
0
 
33
7
24
5
0
 
43
39
31
11
3
 
55
44
40
13
0
2008
67
66
39
28
0
 
56
60
4
50
1
 
52
53
5
48
1
 
53
51
1
56
0
2009
66
66
2
61
2
 
51
52
2
51
4
 
45
47
2
46
1
 
40
37
7
0
43
0
2010
42
40
23
1
41
62
 
57
51
30
2
58
174
 
78
75
4
2
74
0
 
67
67
0
1
67
0
2011
65
65
0
2
69
1
2
 
76
82
0
0
84
3
5
 
21
89
0
2
95
1
74
 
4
57
0
3
63
0
64

* Meningococcal C conjugate vaccine (MenCCV) was introduced into the NIP schedule on 1 January 2003; 7-valent pneumococcal conjugate vaccine (7vPCV) on 1 January 2005; DTPa-IPV and DTPa-IPV-HepB-Hib (hexavalent) vaccines in November 2005; rotavirus (RotaTeq® and Rotarix®) vaccines on 1 July 2007; pH1N1 influenza vaccine for children 6 months to 10 years on December 2009; seasonal trivalent influenza vaccine in 2010; and the 13-valent pneumococcal conjugate vaccine (13vPCV) on 1 July 2011 (Table 1).

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Back to report

Figure 3: Reporting rates of adverse events following immunisation per 100,000 population, ADRS database, 2000 to 2011, by age group and year of vaccination

  2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
<1 year
53.3
85.8
72.3
61.7
52.2
68.8
66.2
79.6
98.5
92.1
180.4
134.9
1 to <2 years
47.8
113.1
128.6
96.4
27.5
33.6
34.4
24.7
30.8
27.2
221.6
53.8
2 to <7 years
3.9
10.0
27.4
32.9
25.2
23.2
19.0
18.4
24.6
18.5
101.2
40.4
7 to <20 years
0.8
1.6
3.3
9.0
8.9
1.4
1.5
14.8
10.4
5.6
10.0
9.6
20 to 64 years
1.4
1.4
2.3
1.5
1.2
1.2
1.2
2.8
2.6
8.2
4.3
3.4
65 years +
2.2
2.3
4.5
5.1
3.2
4.2
3.8
3.4
3.7
15.5
9.2
12.1

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

Back to report

Figure 4: Selected frequently reported adverse events following immunisation, ADRS database, 2000 to 2011, by date of vaccination

  Injection site reaction Fever Allergic reaction Convulsions Neurological/psychological
2000
43
27
37
4
6
 
54
40
43
5
10
 
44
19
32
5
17
 
42
29
21
8
16
2001
86
39
36
3
11
 
97
43
47
5
7
 
115
49
34
10
13
 
126
34
29
3
8
2002
220
53
55
5
22
 
193
63
59
12
13
 
166
55
50
15
18
 
158
43
53
10
17
2003
213
102
85
11
31
 
221
75
76
6
17
 
165
57
67
11
13
 
130
35
50
15
11
2004
145
60
69
7
24
 
133
53
64
10
12
 
151
71
64
8
21
 
86
35
45
4
8
2005
162
51
70
4
24
 
129
46
43
7
13
 
100
17
27
4
9
 
108
39
34
3
9
2006
154
54
47
7
13
 
145
39
35
9
13
 
108
32
43
3
18
 
106
47
49
6
22
2007
130
43
38
5
15
 
178
91
127
8
41
 
131
65
77
16
33
 
126
56
61
15
19
2008
199
94
135
13
40
 
223
77
140
17
29
 
131
51
65
10
32
 
112
49
64
9
24
2009
157
79
77
18
22
 
135
63
86
16
30
 
67
41
50
4
17
 
217
262
401
10
100
2010
174
616
407
51
78
 
306
1624
1004
130
277
 
137
90
81
8
27
 
118
79
52
7
33
2011
248
139
123
10
41
 
401
200
177
20
64
 
216
110
69
11
38
 
208
100
57
15
26

For reports where the date of vaccination was not recorded, the date of onset or the date the event was reported to the Therapeutic Goods Administration was used as a proxy for vaccination date.

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Figure 5a: Percentage of reported adverse events following immunisation with 7vPCV,* 2011, by reaction type and vaccine suspected of involvement in the reported event

  7vPCV only 7vPCV + other vaccines/drugs 7vPCV + other vaccines/drugs (total)
Vomiting and/or diarrhoea
0.0
26.1
26.1
Fever
1.1
21.1
22.2
Rash
0.0
19.3
19.3
Screaming
0.6
17.0
17.6
Allergic reaction
1.1
13.7
14.8
Injection site reaction
1.1
12.5
13.6
HHE
0.0
9.7
9.7
Abdominal pain
0.0
5.7
5.7
convulsions
0.0
5.1
5.1
Somnolence
0.0
5.1
5.1
Malaise
0.0
5.1
5.1
Erythema
0.0
2.8
2.8
Pallor
0.0
2.8
2.8
Arthritis
0.0
0.6
0.6
Syncope
0.6
0.0
0.6
Anaphylaxis
0.0
0.0
0.0
Death
0.0
0.0
0.0

* Per cent of 176 adverse events following immunisation records where 7vPCV was listed as suspected of involvement in the reported adverse event following immunisation.

Source: Adverse Drug Reactions Reporting System database, Therapeutic Goods Administration.

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Figure 5b: Percentage of reported adverse events following immunisation with 13vPCV,* 2011, by reaction type and vaccine suspected of involvement in the reported event

  13vPCV only 13vPCV + other vaccines/drugs 13vPCV + other vaccines/drugs (total)
Vomiting and/or diarrhoea
0.0
15.7
15.7
Fever
8.1
19.9
28.0
Rash
3.4
14.8
18.2
Screaming
0.85
10.2
11.02
Allergic reaction
5.5
7.6
13.1
Injection site reaction
24.2
8.5
32.6
HHE
0.4
5.5
5.9
Abdominal pain
0.0
4.2
4.2
convulsions
1.7
4.2
5.9
Somnolence
0.4
3.0
3.4
Malaise
0.9
4.7
5.5
Erythema
0.9
1.7
2.5
Pallor
0.42
3.4
3.81
Arthritis
0.4
0.0
0.42
Syncope
0.4
0.4
0.9
Anaphylaxis
0.4
0.0
0.4
Death
0.0
0.4
0.4

Source: Adverse Drug Reactions Reporting System database, Therapeutic Goods Administration.

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Figure 6: Percentage of reported adverse events following immunisation with pneumococcal polysaccharide (23vPPV),* 2011, by reaction type and vaccines suspected of involvement in the reported event

  23vPPV vaccine 23vPPV + other vaccines/drugs 23vPPV + other vaccines/drugs
Injection site reaction
52.4
17.3
69.6
Fever
14.1
10.1
24.2
Oedema
13.83
8.6
22.47
Pain
10.37
6.2
16.54
Erythema
7.7
5.9
13.6
Malaise
5.4
4.7
10.1
Allergic reaction
3.5
5.2
8.7
Nausea
3.95
3.2
7.16
Headache
2.72
3.5
6.17
Myalgia
4.44
1.7
6.17
Arthralgia
1.98
0.7
2.72
Abscess
1.73
0.5
2.22
Rash
1.2
0.8
2.0
Dizziness
0.99
1.0
1.98
Syncope
0.5
1.2
1.7
Somnolence
0.7
0.5
1.2
Arthritis
0.74
0.3
0.99
Weakness
0.25
0.5
0.74

* Per cent of 405 adverse events following immunisation records where the pneumococcal polysaccharide vaccine (23vPPV) was listed as suspected of involvement in the reported adverse event following immunisation.

Source: Adverse Drug Reactions Reporting System database, Therapeutic Goods Administration

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Figure 7: Injection site reactions following 23vPPV immunisation for individuals aged ≥65 years, 2002 to 2011, by week of vaccination (2002–2010)* and week of report (2011)

Week ACT+NSW (2011) Others (2011) ACT+NSW (2002-2010 annualised)* Others (2002-2010 annualised)*
1
1
1
0.0
0.1
2
0
0
0.1
0.2
3
0
2
0.2
0.7
4
0
1
0.0
0.0
5
0
1
0.2
0.3
6
0
4
0.2
0.4
7
0
1
0.0
0.6
8
1
3
0.2
0.6
9
0
2
0.3
4.0
10
0
4
0.8
3.1
11
3
3
2.0
4.9
12
10
3
1.2
5.0
13
49
14
1.9
6.1
14
19
19
2.6
2.7
15
10
9
2.2
3.4
16
16
19
0.4
2.9
17
1
4
0.7
2.3
18
0.4
1.0
19
0.7
1.2
20
0.2
1.2
21
0.4
1.7
22
0.4
1.1
23
0.3
0.3
24
0.6
1.1
25
0.1
0.3