The data collected from the PVSC child survey has not raised any new safety concerns with the Pfizer vaccine.
The Post Vaccine Symptom Check (PVSC) survey is an additional way to report suspected reactions to the Pfizer COVID-19 vaccine (Comirnaty).
The information from the Post Vaccine Symptom Check survey supports ongoing safety monitoring of Comirnaty, the Pfizer COVID-19 vaccine used in New Zealand. Find out more about how we are monitoring COVID-19 vaccine safety.
Tamariki (children) aged 5 to 11 years became eligible for the paediatric Pfizer COVID-19 vaccine on 17 January 2022. From 28 January 2022 to 31 October 2022, the Ministry of Health sent text messages to a random sample of parents/caregivers whose tamariki had received their paediatric Pfizer COVID-19 vaccinations. The text messages asked parents/caregivers if their child had experienced an adverse event/reaction after vaccination. Answering this text message was optional. Parents/caregivers who indicated their child had experienced an adverse event to the vaccine were asked to fill out a survey to provide more information about the event.
The information here shows the number of reports from a randomly sampled population, as part of the PVSC campaign, not the total number of tamariki who experienced an adverse event after their vaccination. Not everyone will report a reaction to the vaccine, and some might submit a CARM report themselves, which is part of the Medsafe Safety Reports.
The number of vaccine adverse event reports in the PVSC can be influenced by the number of participants, the nature of the symptoms (eg, how painful the vaccination was), and other factors (eg, concurrent viral infection or other medications taken), which vary over time.
The information presented below is limited by the responses to the survey. Note that survey responses may change over time.
There were 24,623 text messages received (Table 1). Of those received on behalf of vaccinated tamariki:
Of the responses received (Table 2):
More adverse events were reported after the second dose than after the first dose (Table 2).
The proportion of tamariki for whom an adverse event was reported was similar for each ethnic group (Figure 1 and Table 3).
The most frequently reported adverse events were injection site reaction, tiredness, headache, and body pain (Figure 2 and Table 4). These are common adverse reactions linked to the immune response following immunisation.
For tamariki who missed school or other daily activities, the majority were reported to have missed 1 day or less (Figure 3 and Table 5). Less than one percent (0.32%) of tamariki visited a doctor after vaccination (
The profile of reported events to PVSC for the Pfizer (Comirnaty) COVID-19 vaccine is similar to that reported in clinical trials and from post-marketing surveillance in New Zealand and overseas.
Based on this data, we have not identified any new safety concerns.
|
Number of people sent text messages |
Number of responses received |
Percentage of responses |
|
52,919 |
24,623 |
47% |
|
Dose |
Did not report an adverse event |
Reported at least one adverse event |
||
|
Number |
Percentage |
Number |
Percentage |
|
|
Dose 1 |
7,526 |
82% |
1,626 |
18% |
|
Dose 2 |
12,032 |
78% |
3,429 |
22% |
|
Totala |
19,558 |
79% |
5,055 |
21% |
Note:
a. A small number of texts were sent out for dose 3 immunocompromised tamariki: 34 texts were sent and 10 responses were received. Due low numbers, analysis of these 10 responses is not shown to protect privacy. Therefore, the sum of the responses in this table is different from Table 1.
Note:
a. The percentage for each ethnicity group is calculated based on the number of people that responded in those groups.
|
Ethnicity |
Experienced no adverse event |
Reported at least one adverse event |
||
|
Number |
Percentagea |
Number |
Percentagea |
|
|
Māori |
2,501 |
79% |
647 |
21% |
|
Pacific peoples |
1,131 |
81% |
263 |
19% |
|
Asian |
4,872 |
84% |
926 |
16% |
|
European or Other |
11,060 |
77% |
3,221 |
23% |
|
Totalb |
19,564 |
79% |
5,057 |
21% |
Notes:
a. The percentage for each ethnicity group is calculated based on the number of people that responded in those groups.
b. A small number of responses did not contain ethnicity data and are not shown here to protect privacy. Therefore, the sum of the responses in this table is different from that shown in Table 1.
Notes:
a. PVSC survey answers may come from one person, but that person may report more than one adverse event. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes.
b. For the percentage calculations, the numerator is the number of times the reaction was reported by dose and the denominator is the total number of responses for each dose.
|
Reported reaction |
Dose 1 |
Dose 2 |
||
|
Number |
Percentage |
Number |
Percentage |
|
|
Injection site reaction |
715 |
7.8% |
1,646 |
10.6% |
|
Tiredness |
501 |
5.5% |
1,031 |
6.7% |
|
Headache, muscle/body aches |
336 |
3.7% |
810 |
5.2% |
|
Stomach symptoms |
138 |
1.5% |
319 |
2.1% |
|
Fever |
133 |
1.5% |
283 |
1.8% |
|
Chills |
68 |
0.7% |
260 |
1.7% |
|
Swollen lymph node(s) |
29 |
0.3% |
136 |
0.9% |
|
Rash (not at injection site) |
19 |
0.2% |
33 |
0.2% |
Notes:
a. PVSC survey answers may come from one person, but that person may report more than one adverse event. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes.
b. For the percentage calculations, the numerator is the number of times the reaction was reported by dose and the denominator is the total number of responses for each dose.
|
Dose |
Percentage |
|
Dose 1 |
0.9% |
|
Dose 2 |
2.4% |
