Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update
18.06.2021
Reporting period 01.01.2021 - 15.06.2021
2,944 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains
Up to 15 June 2021, Swissmedic evaluated 2,944 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 7,738 reactions in the 2,944 reports, equating to an average of 2.6 reactions per report). At 1,901 (64.6 %), most of the reports were classified as not serious, while 1,043 (35.4 %) reports were classified as serious.
Reports
2,944
Reactions
7,738
Non-serious
1,901 (64.6 %)
Serious
1,043 (35.4 %)
Vaccine doses
6 120 202
Vaccinated people
3 768 490
Most of the reports were submitted by medical professionals, while a relatively large number (497, or 16.9 %) came directly from those affected, i.e. the patients.
The average age of those affected was 62.5 years (range 16–101), with 31.9% aged 75 or over. In the cases classified as serious, the average age was 66.1 years, and for reports temporally linked to a death it was 81.1 years.
The majority of the reports concerned women and there were a few cases where no gender was specified.
Number of reports by vaccine
1,201 (40.8 %) reports involve Pfizer/BioNTech’s Comirnaty®, while 1,697 (57.6 %) are associated with Moderna's COVID-19 vaccine. In 46 (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)
1,201 (40.8 %)
674 (35.5 %)
527 (50.5 %)
2,838 (36.7 %)
COVID-19 Vaccine Moderna®
1,697 (57.6 %)
1,209 (63.6 %)
488 (46.8 %)
4,808 (62.1 %)
unknown
46 (1.6 %)
18 (0.9 %)
28 (2.7 %)
92 (1.2 %)
Total
2,944 (100 %)
1,901 (100 %)
1,043 (100%)
7,738 (100 %)
In 97 serious cases, the people concerned died at differing intervals after receiving the vaccine. Their average age was 81.1 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)
2 234
Skin and subcutaneous tissue disorders (10040785)
539
Nervous system disorders (10029205)
527
Musculoskeletal and connective tissue disorders (10028395)
387
Gastrointestinal disorders (10017947)
307
Respiratory, thoracic and mediastinal disorders (10038738)
151
Infections and infestations (10021881)
139
Vascular disorders (10047065)
95
Cardiac disorders (10007541)
80
Psychiatric disorders (10037175)
62
Immune system disorders (10021428)
52
Blood and lymphatic system disorders (10005329)
50
Eye disorders (10015919)
40
Metabolism and nutrition disorders (10027433)
30
Ear and labyrinth disorders (10013993)
29
Ranking of the 15 most frequent adverse effects
Reported prefered terms (MedDRA)
Pyrexia (10037660)
375
Injection site erythema (10022061)
364
Skin reaction (10040914)
276
Headache (10019211)
252
Chills (10008531)
222
Fatigue (10016256)
199
Myalgia (10028411)
169
Injection site pain (10022086)
154
Injection site swelling (10053425)
146
Injection site pruritus (10022093)
135
Arthralgia (10003239)
123
Nausea (10028813)
115
Rash (10037844)
92
Dizziness (10013573)
82
Herpes zoster (10019974)
74
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).
Given the methodology of the spontaneous reporting system, the following factors need to be taken into account when interpreting the data presented here:
The figures provided relate to suspected reactions reported to Swissmedic 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 serious preexisting condition.
This can influence the occurrence of certain reactions which, however, are only indirectly related to the particular vaccine.
The figures for suspected cases of vaccination reactions are just one of many elements used to monitor the risk-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.
