3 419 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains
Up to 29 June 2021, Swissmedic evaluated 3,419 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. The majority of the reports involved more than one reaction. At 2,125 (62.2 %), most of the reports were classified as not serious, while 1,294 (37.8 %) reports were classified as serious.
Most of the reports were submitted by medical professionals, while a relatively large number (632, or 18.5 %) came directly from those affected, i.e. the patients.
The average age of those affected was 62 years (range 16–101), with 30.3% aged 75 or over. In the cases classified as serious, the average age was 65.2 years, and for reports temporally linked to a death it was 80.6 years. In 116 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.
1,377 (40.3 %) reports involve Pfizer/BioNTech’s Comirnaty®, while 1,983 (58 %) are associated with Moderna's COVID-19 vaccine. In 59 (1.7 %) cases, the vaccine was not specified.
| Vaccine | Total reports | of which non-serious | of which serious | Total number of reactions |
|---|---|---|---|---|
| Comirnaty® (Pfizer/BioNTech) | 1,377 (40.3 %) | 753 (35,5 %) | 624 (48.2%) | 3,184 (36 %) |
| COVID-19 Vaccine Moderna® | 1,983 (58 %) | 1,351 (63.6 %) | 632 (48.8 %) | 5,547 (62.7 %) |
| unknown | 59 (1,7 %) | 21 (0.9 %) | 38 (2.9%) | 113 (1.3 %) |
| Total | 3,419 (100 %) | 2,125 (100 %) | 1,294 (100 %) | 8,844 (100 %) |
Ranking of the 15 organ systems most frequently affected
Reaction (MedDRA) |
|
|---|---|
General disorders and administration site conditions (10018065) |
885 |
Nervous system disorders (10029205) |
533 |
Musculoskeletal and connective tissue disorders (10028395) |
318 |
Gastrointestinal disorders (10017947) |
235 |
Skin and subcutaneous tissue disorders (10040785) |
234 |
Infections and infestations (10021881) |
211 |
Respiratory, thoracic and mediastinal disorders (10038738) |
196 |
Vascular disorders (10047065) |
123 |
Cardiac disorders (10007541) |
90 |
Immune system disorders (10021428) |
84 |
Blood and lymphatic system disorders (10005329) |
53 |
Psychiatric disorders (10037175) |
42 |
Eye disorders (10015919) Ear and labyrinth disorders (10013993) |
40 |
Investigations (10022891) |
38 |
General disorders and administration site conditions (10018065) |
33 |
Ranking of the 15 most frequent adverse effects
Reported prefered terms (MedDRA) |
|
|---|---|
Headache (10019211) |
219 |
Pyrexia (10037660) |
185 |
Fatigue (10016256) |
141 |
Myalgia (10028411) |
140 |
Chills (10008531) |
110 |
Herpes zoster (10019974) |
104 |
Dizziness (10013573) |
83 |
Nausea (10028813) |
83 |
Arthralgia (10003239) |
77 |
Malaise (10025482) |
61 |
Rash (10037844) |
60 |
Injection site pain (10022086) |
53 |
Dyspnoea (10013968) |
53 |
Hypersensitivity (10020751) |
51 |
Hypertension (10020772) |
46 |
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).
The next report of suspected adverse reactions of COVID-19 vaccines in Switzerland will be released on 23 July 2021.
*Addendum from 5.7.2021
