Up to 23 November 2021, Swissmedic evaluated 10,386 reports on suspected adverse drug reactions to COVID-19 vaccinations that occured wit a temporal link to the vaccinations. At 6,756 (65 %), most of the reports were classified as not serious, while 3,630 (35 %) reports were classified as serious.
*The majority of the reports involved more than one reaction
About half of the reports were submitted by medical professionals, while 5,232 or 50.4 % came directly from those affected, i.e. the patients.
The average age of those affected was 52.1 years, with 13.1% aged 75 or over. In the cases classified as serious, the average age was 54.8 years, and for reports temporally linked to a death it was 79.7 years.
In 159 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.
7,129 (68.6%) reports involve Moderna's COVID-19 vaccine Spikevax® (for approx. 66% of the vaccine doses administered – this is the most widely used COVID-19 vaccine in Switzerland), while 3,007 (29 %) are associated with Pfizer/BioNTech’s Comirnaty® (approx. 34% administered vaccine doses).
| Vaccine | Total reports | of which non-serious | of which serious | Total vaccine doses * | Number of fully vaccinated people * |
|---|---|---|---|---|---|
| Spikevax® (Moderna) | 7,129 (68.6%) | 4,874 (71.1%) | 2,255 (62.1%) | 7 562 744 (64.7%) | 3 721 885 (65.3%) |
| Comirnaty® (Pfizer/BioNTech) | 3,007 (29%) | 1,755 (26%) | 1,252 (34.5%) | 4 081 688 (35%) | 1 944 144 (34.1%) |
| COVID-19 Vaccine Janssen | 41 (0.4%) | 28 (0.4%) | 13 (0.4%) | 36,333 (0.3%) | 35,934 (0.6%) |
| Unknown/other | 209 (2%) | 99 (1.5%) | 110 (3%) | ||
| Total | 10,386 (100%) | 6,756 (100%) | 3,630 (100%) | 11 680 765 (100%) | 5 701 963 (100%) |
* Switzerland and Principality of Liechtenstein, 21.12.2020 - 24.11.2021 (Source: FOPH)
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
10 203 |
Nervous system disorders (10029205) |
3 878 |
Musculoskeletal and connective tissue disorders (10028395) |
2 599 |
Skin and subcutaneous tissue disorders (10040785) |
1 840 |
Gastrointestinal disorders (10017947) |
1 774 |
Respiratory, thoracic and mediastinal disorders (10038738) |
822 |
Infections and infestations (10021881) |
702 |
Cardiac disorders (10007541) |
589 |
Reproductive system and breast disorders (10038604) |
549 |
Vascular disorders (10047065) |
379 |
Psychiatric disorders (10037175) |
367 |
Blood and lymphatic system disorders (10005329) |
339 |
Eye disorders (10015919) |
247 |
Metabolism and nutrition disorders (10027433) |
202 |
Ear and labyrinth disorders (10013993) |
202 |
Ranking of the 15 most frequent adverse effects
Pyrexia (10037660) |
2 287 |
Headache (10019211) |
1 932 |
Fatigue (10016256) |
1 478 |
Chills (10008531) |
1 314 |
Myalgia (10028411) |
852 |
Injection site pain (10022086) |
831 |
Nausea (10028813) |
777 |
Injection site erythema (10022061) |
669 |
Skin reaction (10040914) |
620 |
Injection site reaction (10022095) |
559 |
Arthralgia (10003239) |
542 |
Dizziness (10013573) |
538 |
Musculoskeletal pain (10028391) |
354 |
Herpes zoster (10019974) |
337 |
Injection site swelling (10053425) |
331 |
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
2 217 |
Nervous system disorders (10029205) |
1 320 |
Musculoskeletal and connective tissue disorders (10028395) |
812 |
Gastrointestinal disorders (10017947) |
543 |
Skin and subcutaneous tissue disorders (10040785) |
506 |
Infections and infestations (10021881) |
492 |
Respiratory, thoracic and mediastinal disorders (10038738) |
477 |
Cardiac disorders (10007541) |
235 |
Vascular disorders (10047065) |
217 |
Reproductive system and breast disorders (10038604) |
196 |
Investigations (10022891) |
120 |
Psychiatric disorders (10037175) |
119 |
Eye disorders (10015919) |
118 |
Immune system disorders (10021428) |
117 |
Blood and lymphatic system disorders (10005329) |
117 |
Ranking of the 15 most frequent adverse effects
Headache (10019211) |
526 |
Pyrexia (10037660) |
428 |
Fatigue (10016256) |
411 |
Myalgia (10028411) |
279 |
Chills (10008531) |
239 |
Herpes zoster (10019974) |
211 |
Dizziness (10013573) |
191 |
Nausea (10028813) |
184 |
Arthralgia (10003239) |
175 |
Injection site pain (10022086) |
138 |
Dyspnoea (10013968) |
131 |
Pain in extremity (10033425) |
128 |
Rash (10037844) |
112 |
Malaise (10025482) |
99 |
Diarrhoea (10012735) |
90 |
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
63 |
Nervous system disorders (10029205) |
27 |
Musculoskeletal and connective tissue disorders (10028395) |
19 |
Gastrointestinal disorders (10017947) |
15 |
Infections and infestations (10021881) |
11 |
Skin and subcutaneous tissue disorders (10040785) |
9 |
Eye disorders (10015919) |
7 |
Respiratory, thoracic and mediastinal disorders (10038738) |
6 |
Psychiatric disorders (10037175) |
5 |
Investigations (10022891) |
4 |
Injury, poisoning and procedural complications (10022117) |
4 |
Vascular disorders (10047065) |
4 |
Cardiac disorders (10007541) |
3 |
Metabolism and nutrition disorders (10027433) |
2 |
Ear and labyrinth disorders (10013993) |
2 |
Headache (10019211) |
19 |
Pyrexia (10037660) |
14 |
Pain in extremity (10033425) |
8 |
Fatigue (10016256) |
8 |
Chills (10008531) |
7 |
COVID-19 (10084268) |
7 |
Vaccination failure (10046862) |
6 |
Injection site pain (10022086) |
6 |
Nausea (10028813) |
6 |
Malaise (10025482) |
5 |
Myalgia (10028411) |
5 |
Hyperhidrosis (10020642) |
4 |
Pain (10033371) |
3 |
Vomiting (10047700) |
3 |
Palpitations (10033557) |
3 |
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 17 December 2021.
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
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 23 November 2021, 238 cases of myocarditis and/or pericarditis with a suspected link to vaccinations had been reported out of a total of more than 11.6 million vaccine doses administered. Of these, 42 were linked with Comirnaty and 187 with Spikevax; in 9 cases, the vaccine has not yet been identified. The large majority of cases involved males (n = 180, 76%) 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.1
1Addendum from 29.11.2021
In addition to the two mRNA vaccines Comirnaty and Spikevax, the vector-based vaccine from Janssen has also recently been used in Switzerland (though in a limited number of persons). The side effects profile of this vaccine differs from that of the mRNA vaccines in certain respects. However, it is important to have information about any specific, very rare side effects of this vaccine, such as thrombocytopenia thrombosis syndrome, capillary leak syndrome or Guillain-Barré syndrome, so that appropriate diagnostic and therapeutic measures can be taken in good time in such cases. For details regarding this vaccine, please consult the current Swiss Information for healthcare professionals.
Medical professionals are requested to report any serious and previously unknown side effects to Swissmedic. In doing so, they can actively help to improve knowledge of the safety profile of a medicinal product or vaccine. To submit reports, please use our electronic reporting portal ElViS.
