Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update 21

14.01.2022

Reporting period 01.01.2021–12.01.2022

11,467 reports of suspected adverse reactions to COVID-19 vaccines evaluated – the overall positive benefit-risk ratio of the vaccines remains

Up to 12 January 2022, Swissmedic evaluated 11,467 reports on suspected adverse drug reactions to COVID-19 vaccinations that occured with a temporal link to the vaccinations. At 7,190 (62.7 %), most of the reports were classified as not serious, while 4,276 (37.3 %) reports were classified as serious.

Reports

11,467

Reactions

37,550

Non-serious

7,190 (62,7 %)

Serious

4,277 (37.3 %)

Vaccine doses

14 544 345

Vaccinated people

6 034 634

*The majority of the reports involved more than one reaction

About half of the reports were submitted by medical professionals, while 5,797 or 50.5 % came directly from those affected, i.e. the patients.

The average age of those affected was 52 years, with 12.9% aged 75 or over. In the cases classified as serious, the average age was 54.3 years, and for reports temporally linked to a death it was 79.6 years.

In 192 serious cases, the people concerned died at differing intervals after receiving the vaccine. Despite a chronological correlation, there is no concrete evidence to suggest that the vaccination was the cause of death.

The majority of the reports concerned women and there were a few cases where no gender was specified.

Evaluations of individual vaccines

7,789 (68 %) reports involve Moderna's COVID-19 vaccine Spikevax® (for approx. 63% of the vaccine doses administered – this is the most widely used COVID-19 vaccine in Switzerland), while 3,354 (29.3 %) are associated with Pfizer/BioNTech’s Comirnaty® (approx. 36% administered vaccine doses).

Number of reports by vaccine

Vaccine

Total reports

of which non-serious

of which serious

Total vaccine doses * [3]

Spikevax® (Moderna) [1]

7,723 (67.4 %)

5,119 (71.2 %)

2,604 (60.9 %)

9,206,426 (63.3 %)

Spikevax® (Moderna) [2]

66 (0.6 %)

32 (0.4 %)

34 (0.8 %)

Comirnaty® (Pfizer/BioNTech) [1]

3,298 (28.8 %)

1,852 (25.8 %)

1,446 (33.8 %)

5,281,783 (36.3 %)

Comirnaty® (Pfizer/BioNTech) [2]

56 (0.5 %)

31 (0.4 %)

25 (0.6 %)

COVID-19 Vaccine Janssen

85 (0.7 %)

45 (0.6 %)

40 (0.9 %)

56,136 (0.4 %)

Unknown [1]

238 (2.1 %)

111 (1.5 %)

127 (3.0 %)

 

Unknown [2]

1 (0 %)

0 (0 %)

1 (0 %)

 

Total

11,467 (100 %)

7,190 (100 %)

4,277 (100 %)

14,544,345 (100 %)

[1] Basic immunisation (two doses)

[2] Booster

[3] Basic immunisation and booster

* Switzerland and Principality of Liechtenstein, 21.12.2020–12.01.2022 (Source: FOPH)

Organ systems most frequently affected/ most frequent adverse effects


The reports of adverse reactions received and analysed to date do not alter the positive benefit-risk profile of the COVID-19 vaccines used in Switzerland. This largely confirms their known side effects profile. Known side effects of COVID-19 vaccines are listed in the continually updated medicinal product information texts published on www.swissmedicinfo.ch.

The reports of suspected adverse drug reactions (ADR) to COVID-19 vaccinations are evaluated in collaboration with the regional pharmacovigilance centres and in particular with the Ticino reference centre (EOC cantonal hospital authority).

The next report of suspected adverse reactions of COVID-19 vaccines in Switzerland will be released on 11 February 2022.
You can find the latest report on suspected adverse reactions to COVID-19 vaccines in Switzerland at the following permalink: www.swissmedic.ch/covid-19-vaccines-safety-update-en

Information from Swissmedic on individual safety aspects

Myocarditis / pericarditis

Very rare cases of myocarditis and pericarditis (inflammation of the heart muscle/pericardium) have been reported following vaccination with the COVID-19 mRNA vaccines. Cases generally occur within 14 days of vaccination and more frequently after the second dose and in younger men.

Healthcare professionals should pay attention to the signs and symptoms of myocarditis and pericarditis and inform vaccinated people that they should seek immediate medical advice and assistance in the event of chest pains, shortness of breath or palpitations. Strong physical exertion should be avoided if such symptoms occur until the cause of the symptoms has been ascertained.

In Switzerland, by 11 January 2022, 307 cases of myocarditis and/or pericarditis with a suspected link to vaccinations had been reported out of a total of more than 14.5 million vaccine doses administered. Of these, 55 were linked chronologically with Comirnaty and 240 with Spikevax (one of which was after the third vaccination); in 10 cases, the vaccine has not yet been identified, while 2 cases were reported after vaccination with the COVID-19 vaccine from Janssen.

The large majority of cases involved males (229, 74.6 %) and the mean age was 37 years (median: 51, range: 14 to 88 years). The persons affected received medical treatment and most have now recovered.

The reporting rates from the spontaneous reporting system and provisional results from studies in Scandinavia and France suggest that the risk of myocarditis/pericarditis in young men could be higher with Spikevax than with Comirnaty, though for both vaccines the risk is significantly less than that of myocarditis in COVID-19 disease.

Given these data, the Federal Commission for Vaccination (FCV) has made the vaccination recommendation for persons under 30 years of age more specific.

Previous reports

17.12.2021

Reports of suspected adverse reactions to COVID-19 vaccines

10,842 reports of suspected adverse vaccination reactions evaluated

26.11.2021

Reports of suspected adverse reactions to COVID-19 vaccines

10,386 reports of suspected adverse vaccination reactions evaluated

05.11.2021

Reports of suspected adverse reactions to COVID-19 vaccines

9,834 reports of suspected adverse vaccination reactions evaluated

15.10.2021

Reports of suspected adverse reactions to COVID-19 vaccines

8,757 reports of suspected adverse vaccination reactions (ADR) evaluated – the overall positive benefit-risk ratio of the vaccines remains

24.09.2021

Reports of suspected adverse reactions to COVID-19 vaccines

7,571 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

03.09.2021

Reports of suspected adverse reactions to COVID-19 vaccines

6,603 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

13.08.2021

Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update

5,304 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

23.07.2021

Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update

4,319 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

02.07.2021

Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update

3,419 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

18.06.2021

Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update

2,944 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

04.06.2021

Side effects of COVID-19 vaccines in Switzerland – update

2,701 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

21.05.2021

Side effects of COVID-19 vaccines in Switzerland – update

2269 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

07.05.2021

Side effects of COVID-19 vaccines in Switzerland – update

1953 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

22.04.2021

Side effects of COVID-19 vaccines in Switzerland – update

1485 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

09.04.2021

Side effects of COVID-19 vaccines in Switzerland – update

1174 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

11.03.2021

Side effects of COVID-19 vaccines in Switzerland – update

597 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

26.02.2021

Side effects of COVID-19 vaccines in Switzerland – update

364 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated

05.02.2021

Reports of suspected adverse reactions to the COVID-19 vaccines in Switzerland – Update

To date, 63 side effect reports in connection with COVID-19 vaccinations in Switzerland have been evaluated

22.01.2021

Reports of suspected adverse reactions to the COVID-19 vaccines in Switzerland

Reports to date in line with the known risk profile

Supplementary information

Guide to interpreting the data

Given the methodology of the spontaneous reporting system, the following factors need to be taken into account when interpreting the data presented here:

  • The figures provided relate to suspected reactions reported to Swissmedic and entered in the database after being reviewed.
  • All the reactions reported are suspected cases. In individual cases it has not been ascertained whether the reported reaction was only observed in a temporal relationship with the vaccination or was actually caused by it.
  • The number of suspected cases for each vaccine can depend greatly on how many people received this vaccine in the period in question.The nu mber of vaccination reactions could be higher than the number of reports. Depending on the authorised use (e.g. age group, high-risk individual) and the latest vac cination recommendations, certain vaccines are more frequently administered to people with a serious preexisting condition.
  • This can influence the occurrence of certain reactions which, however, are only indirectly related to the particular vaccine.
  • The figures for suspected cases of vaccination reactions are just one of many elements used to monitor the risk-benefit profile of vaccines. Only a detailed scientific evaluation of all the available data will enable the correct conclusions to be made about a vaccine’s safety profile.