Introduction

The data collected from the PVSC survey has not raised any new safety concerns for the Pfizer COVID-19 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.

About the PVSC surveys

The first PVSC campaign took place from 27 August to 5 October 2021 and surveyed people who had received dose 1 or dose 2 of the Pfizer COVID-19 vaccine. On 29 November 2021, a booster dose of the Pfizer COVID-19 vaccine became available to those aged 18 years and over. On 2 July 2022, a second booster became available for eligible individuals. From 14 December 2021 to 31 October 2022, the Ministry of Health sent text messages to random samples of people who had received a booster dose.

Text messages asked eligible participants if they had experienced an adverse event/reaction after their vaccination. Participants who answered YES were asked to complete a survey to provide more information about the event. This publication includes the PVSC survey results from dose 1, dose 2, booster dose 1 and booster dose 2 of the Pfizer COVID-19 vaccine.

The information on this page shows the number of reports from a sampled population as part of the PVSC campaign. It does not represent the total number of people who experience an adverse event after their vaccination. Not everyone will report a reaction to the vaccine, and some might submit a CARM report themselves. This report to CARM then forms 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 for dose 1, 2, booster 1 and booster 2 in those aged 18 years and over. Further surveys may be run to coincide with the requirements of the COVID-19 vaccine programme. The results below will be updated to reflect any further surveys.

Survey results – up to and including 31 October 2022

In the surveys, 319,136 responses were received (Table 1). Of those who responded to the survey:

  • 56% were female and 44% were male
  • 14% of respondents were Māori, and 6.2% were Pacific peoples.

 

Of the responses received for all campaigns (Table 2):

  • 100,996 (32%) reported that they experienced at least one adverse event/reaction to the vaccine
  • 218,140 (68%) reported that they did not experience an adverse event.

Of those that reported an adverse event, the proportion was highest after dose 2 (42%) and lowest after booster 2 (25%) (Table 2).

After each dose, the proportion of people who reported an adverse event was similar for each ethnic group (Figure 1 and Table 3).

The most frequently reported adverse events were injection site reaction, headache, muscle and body aches, joint pain, chills, fatigue and tiredness (Figure 2 and Table 4). These are common adverse reactions linked to the immune response following immunisation.

Ten percent of people who participated in the booster 1 campaign and 4% who participated in the booster 2 campaign reported missing work or other daily activities. Of these, the majority were reported to have missed one day or less. Less than 1% of people visited a doctor after any dose (Figure 3).

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.

Table 1: Summary of text message responses, up to and including 31 October 2022

Campaign

Number of people sent text messages

Number of responses received

Percentage of responses received

Dose 1 and 2

94,417

50,258

53%

Booster 1

391,665

98,698

25%

Booster 2

289,575

170,180

59%

Table 2: Responses by vaccine dose and adverse event, up to and including 31 October 2022

Dose

Did not report an adverse event

Reported at least one adverse event

Number

%

Number

%

Dose 1

15,029

66%

7,684

34%

Dose 2

16,021

58%

11,524

42%

Booster 1

58,740

60%

39,958

40%

Booster 2

128,350

75%

41,830

25%

Total

218,140

68%

100,996

32%

Figure 1: Percentage of people that reported an adverse event, by ethnicity, up to and including 31 October 2022

Graph Graph Graph

Table 3: Number and percentage of people that reported an adverse event, by ethnicity, up to and including 31 October 2022

Ethnicity

Dose 1

Dose 2

Booster 1

Booster 2

Number

%

Number

%

Number

%

Number

%

Māori

768

36%

850

41%

8,707

40%

4,475

25%

Pacific Peoples

309

30%

405

39%

4,105

39%

1,738

24%

Asian

942

26%

1,687

40%

6,035

44%

4,486

28%

European or other

5,665

35%

8,582

42%

21,111

40%

31,131

24%

 

Figure 2: Most frequently reported adverse events, percentage by dose, up to and including 31 October 2022

Graph Graph Graph

Table 4: Most frequently reported adverse events, number and percentage by dose, up to and including 31 October 2022

Adverse event

Dose 1

Dose 2

Booster 1

Booster 2

Number

%

Number

%

Number

%

Number

%

Injection site reaction (pain, redness, swelling, itching at or near the injection site)

3,310

10.4%

5,057

18.4%

15,364

15.6%

16,913

9.9%

Headache, muscle/body aches, joint aches/pain, or chills (shivering and feeling cold)

2,626

8.2%

5,271

19.2%

15,636

15.8%

14,015

8.2%

Fatigue or tiredness

2,567

8.0%

4,946

18.0%

15,388

15.6%

13,559

8.0%

Fever/high temperature

377

1.2%

1,202

4.4%

4,811

4.9%

2569

1.5%

Stomach symptoms (nausea, vomiting, diarrhoea, stomach pain)

496

1.6%

872

3.2%

2,601

2.6%

2105

1.2%

Rash (not at injection site)

88

0.3%

107

0.4%

381

0.4%

266

0.2%

Notes: 

  1. 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.
  2. 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 participants from which responses were received by dose.

Figure 3: People that visited a doctor after vaccination, up to and including 31 October 2022

Dose 1

Less than 1 in 100 people (0.4%) reported visiting a doctor in the days after the first dose

Dose 2

Less than 1 in 100 people (0.6%) reported visiting a doctor in the days after the second dose

Booster Dose 1

Less than 1 in 100 people (0.7%) reported visiting a doctor in the days after the first booster dose

Booster Dose 2

Less than 1 in 100 people (0.2%) reported visiting a doctor in the days after the second booster dose

a. The PVSC survey does not specifically ask for the reason why the person accessed medical care in the days following vaccination. Therefore, medical attendance reported may or may not be related to any adverse events reported.

Infographic Infographic Infographic

Note:

a. The PVSC survey does not specifically ask parents/caregivers the reason why they accessed medical care for their child in the days following vaccination. Therefore, medical attendance reported may or may not be related to any adverse events reported.