Published: 12 September 2023
COVID-19
Post Vaccine Symptom Check: Concomitant Bivalent
Comirnaty COVID-19 and influenza vaccine survey
results 1 April through to 5 June
Introduction
The information from the Post Vaccine Symptom Check (PVSC) survey supports ongoing safety monitoring of vaccines used in Aotearoa New Zealand. Find out more about how we monitor vaccine safety.
The data collected from the PVSC survey has not raised any new safety concerns for the Comirnaty (Pfizer) bivalent (BA4/5) COVID-19 vaccine if given alone or together with influenza vaccine.
About the concomitant administration of bivalent Comirnaty COVID-19 and influenza vaccines
On 1 March 2023, the Comirnaty (Pfizer) bivalent (original /omicron BA4/5) COVID-19 vaccine replaced the existing Comirnaty (Pfizer) vaccine used in New Zealand. On 1 March 2023, the influenza vaccine annual winter rollout also began. This year, concomitant administration (receiving both vaccines at the same time) of the bivalent and flu vaccines was offered to those who were eligible for both by the immunisation programme. The bivalent vaccine targets two strains of the COVID-19 virus (the original and the BA 4/5 Omicron subvariants), and the influenza vaccine targets four strains of influenza.
The bivalent Comirnaty COVID-19 vaccine PVSC campaign began on 1 April 2023. Te Whatu Ora sent text messages to a random sample of people who had received the bivalent vaccine. The text messages asked people if they had experienced an adverse event/reaction after their vaccination. Participants who answered that they had experienced an adverse event/reaction were invited to completed day 7 and day 42 surveys to provide more information about their experiences after vaccination. Data from the day 42 survey has not yet been analysed, and so is not included in this page. One of the questions in the day 7 survey asked participants if they had received concomitant doses of the bivalent Comirnaty COVID-19 and this year’s influenza vaccines.
The information on this page shows data collected from the participants who indicated that they experienced at least one adverse event and completed the day 7 survey. It does not represent the total number of people who were vaccinated nor the total number of people who experienced an adverse event after their vaccination. This page also does not include any information on people who did not experience a reaction, more information on this can be found here.
The number of vaccine adverse event reports in a PVSC campaign can be influenced by the number of participants, the nature of the symptoms (e.g., how painful the vaccination was), and other factors (e.g., concurrent viral infection or other medicines taken), which vary over time.
Based on this data, we have not identified any new safety concerns for the Comirnaty (Pfizer) bivalent COVID-19 vaccine if given alone or together with influenza vaccine.
Survey results – from 1 April to 5 June 2023
From 1 April through 5 June 2023, a total of 16,747 surveys were completed. Of those that completed the survey, 48% indicated that they had received only the bivalent Comirnaty COVID-19 vaccine, and 51% indicated that they had received concomitant administration of the bivalent Comirnaty COVID-19 and influenza vaccinations. The remaining 1% (103) were unsure or did not answer the question.
The most frequently reported adverse events were injection site reactions, fatigue or tiredness, headache, muscle aches or pain, flu symptoms and chills (Figure 1). These are common adverse reactions linked to the immune response following immunisation.
Of those who completed the day 7 survey (16,747 people), 29% reported missing work or daily activities. Of these, the majority were reported to have missed one day or less. Of those who completed the survey, 8,124 indicated that they had received only bivalent Comirnaty COVID-19 vaccination and 8,520 indicated that they had received concomitant bivalent and influenza vaccination (Table 1). Three percent of people indicated that they visited a doctor after receiving either a bivalent Comirnaty COVID-19 vaccine or concomitant bivalent and influenza vaccination (Figure 2).
The profile of reported events to PVSC for Comirnaty (Pfizer) bivalent COVID-19 vaccine and concomitant administration of the bivalent vaccine and influenza vaccine is similar to that reported for the Comirnaty (Pfizer) dose 1, 2 and booster PVSC campaigns.
Table 1: Vaccine administered to participants who completed the PVSC survey, 1 April through to 5 June 2023
| Vaccine(s) administered | Number of people | Percentage of survey participants |
|---|---|---|
| Bivalent Comirnaty COVID-19 | 8,124 | 48% |
| Concomitant Comirnaty bivalent COVID-19 vaccine and influenza vaccine | 8,520 | 51% |
Note: This is from a total of 16,747 completed surveys. The remaining 1% (103) is made up of responses indicating they received only flu, or were unsure how to answer
Figure 1: Most frequently reporteda adverse events following bivalent Comirnaty COVID-19 vaccine only, or coadministered COVID-19 vaccine and influenza vaccine, percentageb by vaccination, 1 April through to 5 June 2023
Table 2: Most frequently reporteda adverse events following bivalent Comirnaty COVID-19 vaccine only, and coadministered COVID-19 vaccine and influenza vaccine , percentageb by vaccination, 1 April through to 5 June 2023
| Adverse eventc | Comirnaty Bivalent vaccine only | Comirnaty Bivalent and influenza vaccine | ||
|---|---|---|---|---|
| Number | Percentage | Number | Percentage | |
| Injection site reaction (pain, redness, swelling, itching at or near the injection site) | 5,932 | 35% | 6,381 | 38% |
| Fatigue or tiredness | 5,822 | 35% | 6,205 | 37% |
| Headache, muscle or body aches or pain | 5,610 | 33% | 5,758 | 34% |
| Flu-like symptoms | 2,792 | 17% | 3,140 | 19% |
| Chills (shivering or feeling cold) | 2,224 | 13% | 2,175 | 13% |
Notes:
- 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.
- For the percentage, the numerator is the number of times the reaction was reported, and the denominator is the total number of completed surveys which were received for the bivalent Comirnaty COVID-19 vaccine, or concomitantly administered vaccines.
- Adverse events reflect wording of survey questions presented to participants, this may differ from other PVSC campaigns, as survey question wording is subject to change.
Figure 2: Number of people who completed a survey that visited a doctor after vaccination with Comirnaty bivalent vaccine only, or coadministered Comirnaty bivalent vaccine and influenza vaccine, 1 April through to 5 June 2023
Of those who experienced side effects after receiving either the Comirnaty bivalent COVID-19 vaccine, or after concomitant administration of the Comirnaty bivalent COVID-19 and influenza vaccine, approximately three in every 100 people reported visiting a doctor in the days after their vaccination(s)
Note:
- 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.
