Market surveillance of COVID-19 vaccines: reporting suspected side effects correctly

Since the start of the COVID-19 vaccination campaign in Switzerland, Swissmedic has received many reports of suspected adverse drug reactions (ADR) and numerous inquiries about safety aspects of the vaccines used. Healthcare professionals and affected individuals can make a crucial contribution to the efficient market surveillance of COVID-19 vaccines by following the advice given below.

Apart from their desired effect, medicines can also produce side effects in some patients. In order to quickly identify safety signals, i.e. information about very rare or as yet unknown adverse drug reactions, correct side effect reports are essential. Only then can new drug risks be rapidly identified and safety measures promptly introduced and communicated.

As part of the worldwide vaccination campaigns against the new coronavirus, the spontaneous reporting system has, for example, enabled rare allergic reactions (anaphylaxis), delayed local skin reactions or a possible link between vector-based COVID-19 vaccines and the very rare condition of thrombocytopenia thrombosis syndrome (TTS, also known as vaccine-induced immune thrombotic thrombocytopenia (VITT)) to be identified in good time and measures to be taken to improve drug safety.

Serious or as yet unknown adverse drug reactions (ADR), i.e. those not listed in the product information, should be reported. During the vaccination campaign against COVID-19, doctors should report all ADR that they feel are medically relevant.

For this purpose, please always use the electronic Swissmedic reporting portal "ElViS" (Electronic Vigilance System). Since the end of January, users with a HIN account can also use their access details to report via the Swissmedic online tool.

After authentication, a red button leads directly to a specific report form for COVID-19 vaccines. When the respective vaccine in this form is selected, some of the fields are prefilled automatically in order to further simplify the reporting process.

Reports sent using other forms or by e-mail lead to considerable delays in processing and often necessitate follow-up queries that could otherwise be avoided.

If, after being vaccinated against COVID-19, you notice signs or symptoms that could be a side effect, in the first instance please contact the agency that administered the vaccination or consult your own doctor or pharmacist. Healthcare professionals can assess whether this involves a side effect that must be reported or symptoms that are more likely to be caused by something else. Please ask your healthcare professional (doctor, pharmacist) to report the side effect.

If you are reporting a side effect yourself, please use only the electronic report form for patients and enter as much information as possible (date of birth, gender, initials, date of vaccination/s, name of vaccine/batch number, observed reaction/side effect, course and outcome of the side effect, concurrent illnesses, co-medication).

Anyone who reports a side effect using more than one route should mention this fact in any subsequent reports so that double-reporting can be identified if possible.

While Swissmedic understands that questions will arise in connection with the safety of COVID-19 vaccines, we are unable to comment on individual medical queries. For these, patients are asked to contact their doctor or pharmacist directly.

You can find a lot of information and answers relating to COVID-19 vaccinations online:

Coronavirus:Vaccination
(www.bag.admin.ch)

Coronavirus: Frequently Asked Questions (FAQ)
(www.bag.admin.ch)

To obtain information by phone in connection with the COVID-19 pandemic, please call the following infolines:

• COVID-19 vaccination infoline: +41 58 377 88 92, daily 6 a.m. to 11 p.m.
• Coronavirus infoline: +41 58 463 00 00, daily 6 a.m. to 11 p.m.