Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update 25
06.05.2022
Reporting period 01.01.2021–03.05.2022
15,228 reports of suspected adverse reactions evaluated – the overall positive benefit-risk ratio of the vaccines remains
Up to 3 May 2022, Swissmedic evaluated 15,228 reports on suspected adverse drug reactions (ADRs).
9,515 (62.5 %) were reported to Swissmedic as “not serious”, while 5,713 suspected cases (37.5 %) were classified as «serious».1 The majority of the reports involved more than one reaction. In total, 47,647 reactions were reported, corresponding to an average of 3.13 reactions per report.
1 The reporting individuals themselves defined whether they classified the cases as serious or not serious. According to international pharmacovigilance practice, this categorisation is revised only for events that were reported as not serious if the ADR is subsequently classified as serious on the basis of further information.
Reports
15,228
Not serious
9,515 (62,5 %)
Reporting rate
0.97
Serious
5,713 (37.5 %)
Vaccine doses
15 738 701
Vaccinated people
6 108 264
Primary reporter
The Therapeutic Products Act (TPA) requires healthcare professionals to report serious adverse effects and as yet unknown effects to Swissmedic. 6,893 (45.3%) reports were submitted by healthcare professionals. Members of the public may voluntarily report suspected side effects of medicines: 8,307 reports (54.7%) were received directly from those affected, i.e. the patients, or their relatives.
Age and gender of persons affected
Most of those affected (66.8 %) were aged between 18 and 64 years (50.2 years on average). 20 % of the individuals were older than 65, while 1.2 % were 12 to 17 years old.
9,454 (62.2%) of the reports concerned women, 5,324 (35%) of the reports concerned men. In a few reports no age or gender was specified.
Evaluations of individual vaccines
10,521 (69.1%) of the reports involve Moderna’s COVID-19 vaccine Spikevax® (with approx. 63 % of the vaccine doses administered, this is the most widely used vaccine in Switzerland) while 4,246 (27.9%) are associated with Pfizer/BioNTech’s Comirnaty® (approx. 37 % of administered vaccine doses). In some cases, the vaccine was not specified.
Number of reports by vaccine and dose
Vaccine
Total reports
of which non-serious
of which serious
Total vaccine doses * [3]
Spikevax® (Moderna) [1]
8,564 (56.2 %)
5.561 (58.4 %)
3,003 (52.6 %)
9,829,351 (62.5 %)
Spikevax® (Moderna) [2]
1,957 (12.9 %)
1,433 (15.1 %)
524 (9.2 %)
Comirnaty® (Pfizer/BioNTech) [1]
3,843 (25.2 %)
2,068 (21.7 %)
1,775 (31.1 %)
5,848,526 (37.2 %)
Comirnaty® (Pfizer/BioNTech) [2]
403 (2.6 %)
238 (2.5 %)
165 (2.9 %)
COVID-19 Vaccine Janssen [1]
143 (0.9 %)
73 (0.8 %)
70 (0.8 %)
60 824 (0.4 %)
Unknown [1]
291 (1,9 %)
126 (1.3 %)
165 (2.9 %)
Unknown [2]
27 (0.2 %)
16 (0.2 %)
11 (0.2 %)
Total
15 228 (100 %)
9,515 (100 %)
5,713 (100 %)
15,738,701 (100 %)
[1] Basic immunisation (two doses)
[2]Booster
[3]Basic immunisation and booster
* Switzerland and Principality of Liechtenstein, 21.12.2020–02.05.2022 (Source: FOPH)
Reports classified as serious
Around 37.5 % of cases were classified by the reporters as serious. In these reports, the average age of those affected was 52.8. The most commonly reported reactions were fever, headache, fatigue, shivering, nausea and dizziness. These known reactions also predominated in the cases classified as not serious.
In 210 of the serious cases, a fatality was reported at differing intervals after receiving the vaccine. The average age of those who died was 79.4 years. Despite a temporal association, an in-depth analysis of the data available for these cases showed that there were other more likely causes of the reported deaths.
Reported vaccine reactions and affected organ systems by vaccine
Overview of reported reactions for the vaccine COVID-19 Vaccine Janssen (Johnson & Johnson)
Ranking of the 15 organ systems most frequently affected
General disorders and administration site conditions (10018065)
187
Nervous system disorders (10029205)
120
Musculoskeletal and connective tissue disorders (10028395)
68
Gastrointestinal disorders (10017947)
40
Respiratory, thoracic and mediastinal disorders (10038738)
31
Skin and subcutaneous tissue disorders (10040785)
31
Infections and infestations (10021881)
25
Eye disorders (10015919)
21
Cardiac disorders (10007541)
15
Ear and labyrinth disorders (10013993)
13
Psychiatric disorders (10037175)
13
Investigations (10022891)
12
Reproductive system and breast disorders (10038604)
9
Vascular disorders (10047065)
6
Injury, poisoning and procedural complications (10022117)
5
Ranking of the 15 most frequently reported adverse effects
Headache (10019211)
46
Pyrexia (10037660)
41
Fatigue (10016256)
27
Pain in extremity (10033425)
23
Dizziness (10013573)
21
Chills (10008531)
20
Nausea (10028813)
16
Asthenia (10003549)
15
Injection site pain (10022086)
13
Arthralgia (10003239)
13
Paraesthesia (10033775)
12
Vaccination failure (10046862)
12
Dyspnoea (10013968)
11
Tinnitus (10043882)
11
Myalgia (10028411)
10
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 1 July 2022.
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
Information from Swissmedic on individual safety aspects
Reports of urticaria (hives, nettle rash) after booster vaccination
The profile for the adverse effects reported after a vaccine booster/third dose largely resembles the profile after the first and second vaccine doses. There is, however, an exception: cases of urticaria reported to Swissmedic, mostly after booster vaccinations with Spikevax.
Up to 3 May 2022, 1,060 such reports have been received that have a correlation in time with the vaccination (interval of 0-72 days), most of which (approx. 80%) were sent by the people affected themselves. The cases reported often relate to urticaria that appears on various parts of the body with a time lag (on average around 11 days after the booster vaccination), with episodes recurring over a lengthy period. The clinical pic-ture as described in many of the reports corresponds most closely to an acute (< 6 weeks) or chronic (> 6 weeks) spontaneous urticaria. On average, the reports were submitted 32 days after the onset of symptoms and for most of the persons affected the symptoms had not yet receded by the time of writing. 60% of the reports related to women and 40% to men. The mean age was approximately 40 years.
Urticaria is a relatively common disorder that can have many different causes. This should be taken into account when evaluating the cases reported, which must be seen against the background of over 2.2 million booster vaccinations given with Spikevax in Switzerland.
Swissmedic is continuing to investigate the reports of urticaria and is in contact with drug regulatory authorities abroad as well as with medical experts and the manufacturer. To date, it has mostly been in Switzerland that cases of urticaria following booster vaccinations have been reported. It has not yet been properly established whether this is due to particular attention being focused on these reactions in Switzerland or whether other factors are involved. The possible connection between urticaria and the booster vaccination with Spikevax will continue to be investigated by Swissmedic and the benefit-risk ratio of COVID vaccines reevaluated as necessary.
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.
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.
By 3 May 2022, 407 cases of myocarditis and/or pericarditis with a suspected link to vaccinations had been reported in Switzerland and evaluated out of a total of around 15.75 million vaccine doses administered. Of these, 90 were linked chronologically with Comirnaty (15 of which were after the third dose) and 301 with Spikevax (21 of which were after the third dose); in 12 cases, the vaccine has not yet been identified, while 4 cases concerned the COVID-19 vaccine from Janssen. The large majority of cases involved males (n = 297, 73 %), and the mean age was 36.8 years (median 34, range 14 to 88 years). The persons affected received medical treatment and most have now recovered. There is currently no indication that the number of reports of myocarditis and/or pericarditis is increasing following booster shots/third vaccinations.
Various studies have shown that inflammation of the heart muscle and heart sac in those under 30 years of age is observed more frequently after vaccination with Spikevax than after vaccination with Comirnaty. Newly published data will be analysed continuously and, if necessary, the vaccination recommendation for mRNA vaccines against COVID-19 will be reviewed by the Federal Commission for Vaccination (FCV).
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.
