Up to 21 September 2021, Swissmedic evaluated 7,571 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. At 4,970 (65.6 %), most of the reports were classified as not serious, while 2,601 (34.4 %) reports were classified as serious.
*The majority of the reports involved more than one reaction
Most of the reports (4'256 or 56.2 %) were submitted by medical professionals, while a relatively large number (3,314, or 56.2 %) came directly from those affected, i.e. the patients.
The average age of those affected was 54.4 years, with 16.4% aged 75 or over. In the cases classified as serious, the average age was 57.1 years, and for reports temporally linked to a death it was 80.1 years. In 145 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.
5,070 (67 %) reports involve Moderna's COVID-19 vaccine (around 66% of the vaccine doses administered), while 2,371 (31.3%) are associated with Pfizer/BioNTech’s Comirnaty® (approx. 33% administered vaccine doses). In 130 (1.7%) cases, the vaccine was not specified.
| Vaccine | Total reports | of which non-serious | of which serious | Total vaccine doses * | Number of fully vaccinated people * |
|---|---|---|---|---|---|
| COVID-19 Vaccine Moderna® (Spikevax) | 5 070 (67%) | 3 514 (70.7%) | 1 556 (59.8 %) | 6 752 039 (66.17 %) | 3 077 815 (66.24%) |
| Comirnaty® (Pfizer/BioNTech) | 2 371 (31.3%) | 1 391 (28 %) | 980 (37.7 %) | 3 452 353 (33.83 %) | 1 568 371 (33.75%) |
| Unknown | 130 (1.7%) | 65 (1.3%) | 65 (2.5%) | ||
| Total | 7 571 (100%) | 4 970 (100%) | 2 601 (100%) | 10 204 392 (100%) | 4 646 186 (100%) |
* Switzerland and Principality of Liechtenstein, 21.12.2020 - 21.09.2021 (Source: FOPH)
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
7 383 |
Nervous system disorders (10029205) |
2 421 |
Musculoskeletal and connective tissue disorders (10028395) |
1 717 |
Skin and subcutaneous tissue disorders (10040785) |
1 378 |
Gastrointestinal disorders (10017947) |
1 154 |
Infections and infestations (10021881) |
503 |
Respiratory, thoracic and mediastinal disorders (10038738) |
459 |
Reproductive system and breast disorders (10038604) |
351 |
Cardiac disorders (10007541) |
338 |
Vascular disorders (10047065) |
254 |
Blood and lymphatic system disorders (10005329) |
208 |
Psychiatric disorders (10037175) |
207 |
Eye disorders (10015919) |
143 |
Metabolism and nutrition disorders (10027433) |
138 |
Immune system disorders (10021428) |
124 |
Ranking of the 15 most frequent adverse effects
Pyrexia (10037660) |
1 631 |
Headache (10019211) |
1 330 |
Fatigue (10016256) |
1 005 |
Chills (10008531) |
939 |
Injection site erythema (10022061) |
641 |
Myalgia (10028411) |
638 |
Injection site pain (10022086) |
598 |
Skin reaction (10040914) |
570 |
Nausea (10028813) |
522 |
Arthralgia (10003239) |
383 |
Injection site reaction (10022095) |
359 |
Dizziness (10013573) |
318 |
Injection site swelling (10053425) |
295 |
Herpes zoster (10019974) |
284 |
Musculoskeletal pain (10028391) |
276 |
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
1 720 |
Nervous system disorders (10029205) |
993 |
Musculoskeletal and connective tissue disorders (10028395) |
606 |
Gastrointestinal disorders (10017947) |
417 |
Infections and infestations (10021881) |
401 |
Skin and subcutaneous tissue disorders (10040785) |
398 |
Respiratory, thoracic and mediastinal disorders (10038738) |
343 |
Vascular disorders (10047065) |
183 |
Cardiac disorders (10007541) |
172 |
Reproductive system and breast disorders (10038604) |
129 |
Immune system disorders (10021428) |
105 |
Blood and lymphatic system disorders (10005329) |
91 |
Psychiatric disorders (10037175) |
89 |
Ear and labyrinth disorders (10013993) |
78 |
Eye disorders (10015919) |
75 |
Ranking of the 15 most frequent adverse effects
Headache (10019211) |
426 |
Pyrexia (10037660) |
345 |
Fatigue (10016256) |
315 |
Myalgia (10028411) |
230 |
Chills (10008531) |
202 |
Herpes zoster (10019974) |
194 |
Nausea (10028813) |
148 |
Dizziness (10013573) |
146 |
Arthralgia (10003239) |
133 |
Injection site pain (10022086) |
110 |
Rash (10037844) |
91 |
Dyspnoea (10013968) |
89 |
Malaise (10025482) |
85 |
Pain in extremity (10033425) |
77 |
Vomiting (10047700) |
70 |
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 15 October 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
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. After evaluating all available data, it may be concluded that there is at least a possible causal link between the vaccines and myocarditis/pericarditis. 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 21 September 2021, 151 reports of myocarditis and/or pericarditis with a temporal connection to COVID-19 vaccinations had been evaluated. Of these, 26 were linked with Comirnaty and 124 with the COVID-19 vaccine from Moderna; in one case, the vaccine had not yet been identified. The large majority of cases involved males (n = 120) and the average age was 37.8 years (range: 16 to 88 years).
