Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update 22
11.02.2022
Reporting period 01.01.2021–08.02.2022
12,334 reports of suspected adverse reactions evaluated – the overall positive benefit-risk ratio of the vaccines remains
Up to 8 February 2022, Swissmedic evaluated 12,334 reports on suspected adverse drug reactions (ADRs).
7,649 (62%) were reported to Swissmedic as “not serious”, while 4,685 suspected cases (38%) were classified as «serious».1 The majority of the reports involved more than one reaction. In total, 39,991 reactions were reported, corresponding to an average of 3.24 reactions per report.
1 The reporting individuals themselves defined whether they classified the cases as serious or not serious. According to international pharmacovigilance practice, this categorisation is revised only for events that were reported as not serious if the ADR is subsequently classified as serious on the basis of further information.
Reports
12,334
Non-serious
7,649 (62.0 %)
Reporting rate
0.79
Serious
4,685 (38.0 %)
Vaccine doses
15 492 711
Vaccinated people
6 103 662
Primary reporter
The Therapeutic Products Act (TPA) requires healthcare professionals to report serious adverse effects occurring in Switzerland to Swissmedic. 6,006 (47.7%) reports were submitted by healthcare professionals. Members of the public may voluntarily report suspected side effects of medicines: 6,318 reports (51.3%) were received directly from those affected, i.e. the patients, or their relatives.
Age and gender of persons affected
Most of those affected were aged between 18 and 64 years (51.6 years on average). 22.3 % of the individuals were older than 65, while 1.2 % were 12 to 17 years old.
7,799 (63.3%) of the reports concerned women, 4,163 (33.8%) of the reports concerned men. In a few reports no age or gender was specified.
Evaluations of individual vaccines
8,350 (67.7%) of the reports involve Moderna’s COVID-19 vaccine Spikevax® (with approx. 63 % of the vaccine doses administered, this is the most widely used vaccine in Switzerland) while 3,627 (29.7%) are associated with Pfizer/BioNTech’s Comirnaty® (approx. 37 % of administered vaccine doses). In some cases, the vaccine was not specified.
Number of reports by vaccine and dose
Vaccine
Total reports
of which non-serious
of which serious
Total vaccine doses * [3]
Spikevax® (Moderna) [1]
7,955 (64.5 %)
5,216 (68.2 %)
2 739 (58.5 %)
9,726,695 (62.8 %)
Spikevax® (Moderna) [2]
395 (3.2 %)
253 (3.3 %)
142 (3.0 %)
Comirnaty® (Pfizer/BioNTech) [1]
3,445 (27.9 %)
1,905 (24.9 %)
1,540 (32.9 %)
5,706,885 (36.8 %)
Comirnaty® (Pfizer/BioNTech) [2]
182 (1.5 %)
107 (1.4 %)
75 (1.6 %)
COVID-19 Vaccine Janssen
101 (0.8 %)
54 (0.7 %)
47 (1.0 %)
59,131 (0.4 %)
Unknown [1]
252 (2.0 %)
114 (1.5 %)
138 (2.9 %)
Unknown [2]
4 (0.0 %)
0 (0.0 %)
4 (0.1 %)
Total
12,334 (100 %)
7,649 (100 %)
4,685 (100 %)
15,492,711 (100 %)
[1] Basic immunisation (two doses)
[2]Booster
[3]Basic immunisation and booster
* Switzerland and Principality of Liechtenstein, 21.12.2020–08.02.2022 (Source: FOPH)
Reports classified as serious
Around 38 % of cases were classified by the reporters as serious. In these reports, the average age of those affected was 54. The most commonly reported reactions were fever, headache, fatigue, shivering, nausea and dizziness. These known reactions also predominated in the cases classified as not serious.
In 199 of the serious cases, a fatality was reported at differing intervals after receiving the vaccine. The average age of those who died was 79.5 years. Despite a temporal association, an in-depth analysis of the data available for these cases showed that there were other more likely causes of the reported deaths.
Booster doses
581 reports of suspected adverse reactions to the more than 3.5 million booster doses administered to date were evaluated. Apart from the reports on skin reactions (see information on individual safety aspects below), the profile for the adverse effects reported after a booster was similar to the profile for the effects reported after the first and second vaccine doses.
Reported vaccine reactions and affected organ systems by vaccine
Overview of reported reactions for the vaccine COVID-19 Vaccine Janssen (Johnson & Johnson)
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065)
152
Nervous system disorders (10029205)
88
Musculoskeletal and connective tissue disorders (10028395)
56
Gastrointestinal disorders (10017947)
33
Respiratory, thoracic and mediastinal disorders (10038738)
21
Eye disorders (10015919)
19
Infections and infestations (10021881)
19
Skin and subcutaneous tissue disorders (10040785)
17
Investigations (10022891)
12
Cardiac disorders (10007541)
12
Psychiatric disorders (10037175)
8
Reproductive system and breast disorders (10038604)
8
Vascular disorders (10047065)
6
Injury, poisoning and procedural complications (10022117)
5
Metabolism and nutrition disorders (10027433)
5
Ranking of the 15 most frequently reported adverse effects
Headache (10019211)
36
Pyrexia (10037660)
32
Fatigue (10016256)
22
Pain in extremity (10033425)
19
Dizziness (10013573)
17
Nausea (10028813)
15
Chills (10008531)
14
Injection site pain (10022086)
12
Vaccination failure (10046862)
11
Asthenia (10003549)
11
Myalgia (10028411)
10
Arthralgia (10003239)
9
Malaise (10025482)
9
Paraesthesia (10033775)
9
Dyspnoea (10013968)
8
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 March 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
Reports of urticaria (hives, nettle rash) after a booster dose
The profile for the adverse effects reported after a vaccine booster/third dose largely resembles the profile after the first and second vaccine doses. However, Swissmedic has observed an increase in the reports of urticaria (hives, nettle rash) particularly after a booster shot with Spikevax. While the reported cases are very rare relative to the number of administered booster doses, the possibility of underreporting (i.e. unreported cases) cannot be ruled out.
Although urticaria is known to be a possible symptom of acute hypersensitivity or of a local reaction at the injection site, some of the reports indicate the occurrence of delayed reactions in various parts of the body, with latency periods ranging from a few days to 1 or 2 weeks after vaccination, in some cases with recurrent episodes.
Sufficient information that would allow a definitive evaluation of these reactions, e.g. including as regards their duration, clinical forms or intensity, is not yet available. Swissmedic will provide updates when the evaluation of the case reports and sharing with partner authorities in other countries reveal new findings.
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.
By 8 February 2022, 347 cases of myocarditis and/or pericarditis with a suspected link to vaccinations had been reported in Switzerland and evaluated out of a total of around 15.5 million vaccine doses administered. Of these, 72 were linked chronologically with Comirnaty (nine of which were after the third dose) and 263 with Spikevax (seven of which were after the third dose); in 9 cases, the vaccine has not yet been identified, while 3 cases concerned the COVID-19 vaccine from Janssen. The large majority of cases involved males (n = 259, 74.6%), and the mean age was 36.7 years (median 33, range 14 to 88 years). The persons affected received medical treatment and most have now recovered.
Various studies have shown that inflammation of the heart muscle and heart sac in those under 30 years of age is observed more frequently after vaccination with Spikevax than after vaccination with Comirnaty. Newly published data will be analysed continuously and, if necessary, the vaccination recommendation for mRNA vaccines against COVID-19 will be reviewed by the Federal Commission for Vaccination (FCV).
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.
