Up to 1 September 2021, Swissmedic evaluated 6.603 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. The majority of the reports involved more than one reaction. At 4,442 (67.3 %), most of the reports were classified as not serious, while 2,161 (32.7 %) reports were classified as serious.
Most of the reports were submitted by medical professionals, while a relatively large number (2,644, or 40 %) came directly from those affected, i.e. the patients.
The average age of those affected was 55.5 years (range 0,25–101), with 18,1% aged 75 or over. In the cases classified as serious, the average age was 59,2 years, and for reports temporally linked to a death it was 80.3 years. In 137 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.
4,298 (65.1 %) reports involve Moderna's COVID-19 vaccine, while 2,191 (33.2 %) are associated with Pfizer/BioNTech’s Comirnaty®. In 114 (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) | 4,298 (65.1 %) | 3,059 (68.87 %) | 1,239 (57.3 %) | 6 431 207 | 2 979 352 |
| Comirnaty® (Pfizer/BioNTech) | 2,191 (33.2 %) | 1,324 (29.8 %) | 867 (40.1 %) | 3 254 523 | 1 505 529 |
| Unknown | 114 (1.7%) | 59 (1.33 %) | 55 (2.5 %) | ||
| Total | 6,603 (100%) | 4,442 (100 %) | 2,161 (100 %) | 9 685 730 | 4 484 881 |
* Switzerland and Principality of Liechtenstein, 21.12.2020 - 01.09.2021 (Source: FOPH)
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
6 065 |
Nervous system disorders (10029205) |
1 891 |
Musculoskeletal and connective tissue disorders (10028395) |
1 358 |
Skin and subcutaneous tissue disorders (10040785) |
1 188 |
Gastrointestinal disorders (10017947) |
910 |
Infections and infestations (10021881) |
431 |
Respiratory, thoracic and mediastinal disorders (10038738) |
367 |
Reproductive system and breast disorders (10038604) |
329 |
Cardiac disorders (10007541) |
275 |
Vascular disorders (10047065) |
221 |
Blood and lymphatic system disorders (10005329) |
171 |
Psychiatric disorders (10037175) |
159 |
Eye disorders (10015919) |
114 |
Metabolism and nutrition disorders (10027433) |
111 |
Immune system disorders (10021428) |
110 |
Ranking of the 15 most frequent adverse effects
Pyrexia (10037660) |
1 276 |
Headache (10019211) |
1 014 |
Fatigue (10016256) |
792 |
Chills (10008531) |
718 |
Injection site erythema (10022061) |
595 |
Myalgia (10028411) |
534 |
Skin reaction (10040914) |
500 |
Injection site pain (10022086) |
498 |
Nausea (10028813) |
397 |
Arthralgia (10003239) |
325 |
Injection site swelling (10053425) |
265 |
Dizziness (10013573) |
250 |
Injection site pruritus (10022093) |
244 |
Herpes zoster (10019974) |
235 |
Injection site reaction (10022095) |
230 |
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065) |
1 576 |
Nervous system disorders (10029205) |
916 |
Musculoskeletal and connective tissue disorders (10028395) |
565 |
Gastrointestinal disorders (10017947) |
381 |
Skin and subcutaneous tissue disorders (10040785) |
364 |
Infections and infestations (10021881) |
347 |
Respiratory, thoracic and mediastinal disorders (10038738) |
290 |
Vascular disorders (10047065) |
163 |
Cardiac disorders (10007541) |
143 |
Reproductive system and breast disorders (10038604) |
120 |
Immune system disorders (10021428) |
100 |
Blood and lymphatic system disorders (10005329) |
84 |
Psychiatric disorders (10037175) |
77 |
Ear and labyrinth disorders (10013993) |
74 |
Eye disorders (10015919) |
73 |
Ranking of the 15 most frequent adverse effects
Headache (10019211) |
399 |
Pyrexia (10037660) |
314 |
Fatigue (10016256) |
293 |
Myalgia (10028411) |
220 |
Chills (10008531) |
192 |
Herpes zoster (10019974) |
177 |
Nausea (10028813) |
139 |
Dizziness (10013573) |
134 |
Arthralgia (10003239) |
121 |
Injection site pain (10022086) |
98 |
Rash (10037844) |
84 |
Malaise (10025482) |
82 |
Dyspnoea (10013968) |
74 |
Pain in extremity (10033425) |
73 |
Vomiting (10047700) |
64 |
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 24 September 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 (inflammation of the heart muscle) / pericarditis (inflammation of the pericardium)
Very rare cases of myocarditis and pericarditis (inflammation of the heart muscle/pericardium) have been reported following vaccination with the COVID-19 mRNA vaccines. To date, Swissmedic has received 123 reports.
Cases in connection with COVID-19 vaccines generally occur within 14 days of vaccination and more frequently after the second dose and in younger men. After evaluating all available data, 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.
Internationally binding criteria exist for classifying a suspected adverse reaction to a drug or vaccine as "serious". It is always classified as serious if the suspected adverse reaction was life-threatening, resulted in hospitalisation or prolonged an existing hospitalisation, or in cases involving a fatal outcome. Cases are also considered to be serious if they have resulted in disability or permanent damage that caused substantial disruption to a person's ability to conduct normal life functions. If the administration of a drug to a pregnant woman has led to an adverse reaction or damage in the newborn child, this situation should always be classified as serious. Another criterion for classifying a case as serious is whether it is described as "medically important" or resulting in "temporary severe impairment". This criterion often leads to misunderstandings. It refers to cases in which the affected individuals were specifically at risk and required a medical intervention in order to prevent serious damage in terms of the above-mentioned criteria.
Criteria for a serious adverse reaction to a drug or vaccine:
Occasionally, the criterion of "medically important/temporary severe impairment" is checked inappropriately in reports of suspected reactions. Thus, for example, a person can experience a fever after a vaccination and feel ill for several days, or have severe headaches and joint pains, and yet the case is not "serious" according to the categories described above. Although such symptoms are obviously "severe" or "pronounced" for the individual concerned, and thus very unpleasant and stressful, the crucial aspect of a specific medical threat is lacking.
As regards reports of suspected adverse reactions submitted to Swissmedic, the reporting individuals themselves decide whether to classify the effect as serious and according to what criterion. Even if the information on seriousness proves to be incorrect on inspection, the classification is not usually changed by Swissmedic according to the standard international procedure in drug safety: this means that a case reported as "serious" is not downgraded to "non-serious". A correction is made only in exceptional cases, and then only for the purpose of "upgrading". This may be the case, for example, if an adverse reaction was incorrectly classified as "non-serious" on the basis of further information in the report, and is clearly classified as "serious" by Swissmedic.
However, the incorrect application of the seriousness criteria in reports of suspected reactions to the COVID-19 vaccines can lead to an overestimation of the number of "serious" side effects. In this context, around 2,160 suspected reports from more than 9.5 million administered vaccine doses were reported to Swissmedic as "serious".
In less than half of these cases the clear criteria (hospitalisation/prolongation 31.7%, life-threatening 5.3%, death 6.3%, permanent damage or disability 3%) were stated as the reason for classifying them as "serious". In 53.6% of cases, "medically important/temporary severe impairment" was checked by the reporting individuals.
