Side effects of COVID-19 vaccines in Switzerland – update
04.06.2021
Reporting period 01.01.2021 - 02.06.2021
2,701 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated
Up to 2 June 2021, Swissmedic evaluated 2,701 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. The majority of the reports involved more than one reaction (a total of 7,065 reactions in the 2,701 reports, equating to an average of 2.6 reactions per report). At 1,751 (64,8 %), most of the reports were classified as not serious, while 950 (35,2 %) reports were classified as serious.
Reports
2,701
Reactions
7,065
Non-serious
1,751 (64,8 %)
Serious
950 (35,2 %)
Vaccine doses
4 823 933
Vaccinated people
3 073 533
Most of the reports were submitted by medical professionals, while a relatively large number (413, or 15,3 %) came directly from those affected, i.e. the patients.
The average age of those affected was 63.8 years (range 16–101), with 33% aged 75 or over. In the cases classified as serious, the average age was 66.5 years, and for reports temporally linked to a death it was 83.6 years.
The majority of the reports concerned women and there were a few cases where no gender was specified.
Number of reports by vaccine
1'120 (41,5 %) reports involve Pfizer/BioNTech’s Comirnaty®, while 1'538 (56,9 %) are associated with Moderna's COVID-19 vaccine. In 43 (1,6 %) cases, the vaccine was not specified.
Vaccine
Total reports
of which non-seriousd
of which serious
Total number of reactions
Comirnaty (Pfizer/BioNTech)
1,120
628
492
2,656
Moderna
1,538
1,105
433
4,323
unknown
43
18
25
86
Total
2,701
1,751
950
7,065
In 90 serious cases, the people concerned died at differing intervals after receiving the vaccine. Their average age was 83.6 and the majority of them had serious pre-existing conditions. These reports were analysed with particular care and, in a very few cases, the final results from autopsies are still pending. As far as is known at present, death was caused by conditions such as infections, cardiovascular events or diseases of the lungs and airways that occurred independently of the vaccinations, even though there was a chronological correlation. At present there are no indications globally that the two mRNA vaccines are associated with an increased fatality rate.
Overview of reported reactions for the vaccine COVID-19 Vaccine Moderna
Ranking of the 15 organ systems most frequently affected
Reaction (MedDRA)
General disorders and administration site conditions (10018065)
2'019
Skin and subcutaneous tissue disorders (10040785)
498
Nervous system disorders (10029205)
463
Musculoskeletal and connective tissue disorders (10028395)
341
Gastrointestinal disorders (10017947)
280
Respiratory, thoracic and mediastinal disorders (10038738)
139
Infections and infestations (10021881)
124
Vascular disorders (10047065)
83
Cardiac disorders (10007541)
73
Psychiatric disorders (10037175)
59
Blood and lymphatic system disorders (10005329)
46
Immune system disorders (10021428)
43
Eye disorders (10015919)
31
Investigations (10022891)
27
Metabolism and nutrition disorders (10027433)
26
Other
71
Ranking of the 15 most frequent adverse effects
Reported prefered terms (MedDRA)
Injection site erythema (10022061)
343
Pyrexia (10037660)
334
Skin reaction (10040914)
257
Headache (10019211)
224
Chills (10008531)
197
Fatigue (10016256)
165
Myalgia (10028411)
148
Injection site swelling (10053425)
135
Injection site pain (10022086)
135
Injection site pruritus (10022093)
127
Arthralgia (10003239)
112
Nausea (10028813)
102
Rash (10037844)
87
Dizziness (10013573)
72
Herpes zoster (10019974)
64
Other
1'820
In evaluating the safety aspects of the COVID-19 vaccines, Swissmedic is also in close and regular contact with other international drug regulatory agencies. As soon as valid findings are available on possible risks, we will provide information about these and about any measures that can be taken to alleviate them.
The reports now provide us with a clearer picture of the vaccines’ safety in daily use. 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).
Guide to interpreting the data
The figures provided relate to suspected reactions reported to Swis smedic 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 seriou s preexisting condition. This can influence the occurrence of certain rea ctions which, however, are only indirectly related to the parti cular vaccine.
The figures for suspected cases of vaccination reactions are just one of many elements used to monitor the ri sk-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.
