Up to 12 October 2021, Swissmedic evaluated 8,757 reports on suspected adverse drug reactions to COVID-19 vaccinations that occured wit a temporal link to the vaccinations. At 5,779 (66 %), most of the reports were classified as not serious, while 2,978 (34 %) 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 4,206 or 48 % came directly from those affected, i.e. the patients.
The average age of those affected was 53.3 years, with 14.7% aged 75 or over. In the cases classified as serious, the average age was 56.1 years, and for reports temporally linked to a death it was 79.8 years. In 150 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.
6,021 (68.8%) 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 2,578 (29.4%) are associated with Pfizer/BioNTech's Comirnaty® (approx. 34% administered vaccine doses). In 158 (1.8%) cases, the vaccine was not specified.
| Vaccine | Total reports | of which non-serious | of which serious | Total vaccine doses * | Number of fully vaccinated people * |
|---|---|---|---|---|---|
| Spikevax® (Moderna) | 6,021 (68.8%) | 4,180 (70.7%) | 1,841 (61.8%) | 7,074,669 (65.73%) | 3,475,368 (65.95%) |
| Comirnaty® (Pfizer/BioNTech) | 2,578 (29.4%) | 1,521 (28%) | 1,057 (35.5%) | 3,683,840 (34.22%) | 3,683,840 (33.96%) |
| Unknown/other | 158 (1.8%) | 78 (1.3%) | 80 (2.7%) | 4,755 (0.05%) | 4,710 (0.09%) |
| Total | 8,757 (100%) | 5,779 (100%) | 2,978 (100%) | 10,763,264 | 5,269,749 |
* Switzerland and Principality of Liechtenstein, 21.12.2020 - 12.10.2021 (Source: FOPH)
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
8 897 |
Nervous system disorders (10029205) |
3 118 |
Musculoskeletal and connective tissue disorders (10028395) |
2 146 |
Skin and subcutaneous tissue disorders (10040785) |
1 597 |
Gastrointestinal disorders (10017947) |
1 475 |
Respiratory, thoracic and mediastinal disorders (10038738) |
623 |
Infections and infestations (10021881) |
569 |
Reproductive system and breast disorders (10038604) |
435 |
Cardiac disorders (10007541) |
425 |
Vascular disorders (10047065) |
299 |
Psychiatric disorders (10037175) |
266 |
Blood and lymphatic system disorders (10005329) |
264 |
Eye disorders (10015919) |
179 |
Metabolism and nutrition disorders (10027433) |
173 |
Ear and labyrinth disorders (10013993) |
147 |
Ranking of the 15 most frequent adverse effects
Pyrexia (10037660) |
2 029 |
Headache (10019211) |
1 683 |
Fatigue (10016256) |
1 255 |
Chills (10008531) |
1 158 |
Injection site pain (10022086) |
754 |
Myalgia (10028411) |
750 |
Nausea (10028813) |
659 |
Injection site erythema (10022061) |
658 |
Skin reaction (10040914) |
602 |
Arthralgia (10003239) |
471 |
Injection site reaction (10022095) |
458 |
Dizziness (10013573) |
418 |
Musculoskeletal pain (10028391) |
328 |
Injection site swelling (10053425) |
319 |
Herpes zoster (10019974) |
290 |
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
1 914 |
Nervous system disorders (10029205) |
1 091 |
Musculoskeletal and connective tissue disorders (10028395) |
687 |
Gastrointestinal disorders (10017947) |
456 |
Skin and subcutaneous tissue disorders (10040785) |
425 |
Infections and infestations (10021881) |
423 |
Respiratory, thoracic and mediastinal disorders (10038738) |
391 |
Vascular disorders (10047065) |
191 |
Cardiac disorders (10007541) |
188 |
Reproductive system and breast disorders (10038604) |
147 |
Immune system disorders (10021428) |
109 |
Blood and lymphatic system disorders (10005329) |
101 |
Psychiatric disorders (10037175) |
95 |
Ear and labyrinth disorders (10013993) |
90 |
Investigations (10022891) |
86 |
Ranking of the 15 most frequent adverse effects
Headache (10019211) |
466 |
Pyrexia (10037660) |
386 |
Fatigue (10016256) |
351 |
Myalgia (10028411) |
256 |
Chills (10008531) |
226 |
Herpes zoster (10019974) |
197 |
Nausea (10028813) |
161 |
Dizziness (10013573) |
158 |
Arthralgia (10003239) |
152 |
Injection site pain (10022086) |
126 |
Dyspnoea (10013968) |
103 |
Rash (10037844) |
99 |
Pain in extremity (10033425) |
93 |
Malaise (10025482) |
89 |
Vomiting (10047700) |
77 |
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 5 November 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 probable 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.
Some Scandinavian countries recently suspended vaccination with the COVID-19 vaccine from Moderna for people under 30 (Sweden, Finland) and under 18 (Denmark) years of age. These measures were taken in response to the results of a study performed in Scandinavia which identified an elevated risk of myocarditis, which nonetheless remains rare, in people in this age group after vaccination with Spikevax from Moderna.
There are also differences in the reporting rates of this adverse reaction for the two vaccines in the spontaneous reporting from Switzerland. By 12 October, 173 reports of myocarditis and/or pericarditis with a suspected link to vaccinations had been evaluated. Of these, 30 were linked with Comirnaty and 140 with Spikevax; in 3 cases, the vaccine had not yet been identified. The large majority of cases involved males (n = 136) and the mean age was 38 years (median: 53, range: 14 to 88 years).
However, when interpreting these data it should be borne in mind that substantially more people have been vaccinated with the Moderna vaccine in Switzerland (see table) and that, for reasons relating to the methodology used, spontaneous reports are only suitable to a limited extent as a basis for direct comparisons between individual vaccines. Swissmedic will carefully examine the results of the Scandinavian study and other available data on myocarditis to ascertain whether measures need to be taken and will inform the public promptly. The agency is also in discussions with other international authorities on this matter. Swissmedic points out that myocarditis following vaccination is still rare and that the frequency of myocarditis following COVID-19 infection is substantially higher in the population as a whole.
