During the phase of application to the general population of the vaccines against Covid-19 authorized in Europe (Pfizer, AstraZeneca, Moderna and Janssen), new side effects have been reported and recorded. The best known is the Janssen and AstraZeneca serum thrombosis, but there are more.
Pfizer Vaccine Side Effects
1. The most frequent and common. The fifth pharmacovigilance report of the Spanish Agency for Medicines and Health Products (AEMPS) revealed the following adverse reactions: feverish state (40%), headache (30%), muscle pain (22%), pain in the vaccination (15%), malaise (12%), nausea (9%), arthralgia (8%), chills (8%), fatigue (8%), lymphadenopathy (8%).
2. New or suspected side effects: during the application of the Pfizer vaccine in the general population, new side effects have been detected, some are already listed in the vaccine package insert and others are suspected:
– Skin rash and pruritus: the European Medicines Agency (EMA) recommended that the technical sheet and package insert of the Pfizer vaccine be modified by adding skin rash and pruritus (itching of the skin), as adverse reactions of infrequent appearance (they occur in less than 1 in 100 people). For their part, urticaria (raised, red, itchy skin rash) and angioedema (rapid swelling under the skin) should be updated as adverse reactions that occur rarely (in less than 1 in 1,000 people).
– Localized swelling with Pfizer in people who have previously received injections of dermal fillers in the face: the EMA has also concluded that this effect may be related to the vaccine, so it will be included as a possible adverse reaction in the data sheet and the prospect.
– Myocarditis and pericarditis: The EMA continues to evaluate the cases reported after vaccination against Covid-19 of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane that surrounds the heart). For its part, the FDA, the US drug agency, already reports on this cardiac inflammation in the prospectuses of the Pfizer/BioNTech vaccines.
Moderna Vaccine Side Effects
1. The most common side effects. The fifth AEMPS pharmacovigilance report revealed the following: feverish state (51%), headache (34%), muscle pain (24%), pain in the vaccination area (18%), chills (12%) , malaise (12%), nausea (11%), arthralgia (9%), fatigue (9%), lymphadenopathy (7%).
2. New or suspected side effects. The latest AEMPS report also reveals a series of new adverse reactions such as: diarrhea and immune thrombocytopenia, which produces bruising and bleeding. Another side effect, which is also included in the latest update of the Spanish vaccination strategy, is a series of late skin reactions near the injection site that occur about 7 days (between 2 and 12 days) after receiving the vaccine. Likewise, the EMA also monitors myocarditis and pericarditis.
AstraZeneca Vaccine Side Effects
1. The 10 most frequent side effects recorded by the AEMPS: pyrexia (57%), headache (41%), myalgia (26%), chills (15%), malaise (14%), pain in the vaccination area ( 11%), fatigue (10%), nausea (10%), dizziness (9%), arthralgia (7%).
2. New or suspected side effects. The latest pharmacovigilance report from the AEMPS describes some adverse reactions that have been reported during the application phase of the vaccine to the general population.
– Thrombosis syndrome with thrombocytopenia: this is a rare adverse reaction reported in the package insert. Until May 30, 21 of this syndrome have been registered in Spain. Five of these patients died.
– Urticaria and angioedema: the EMA concluded the evaluation of hypersensitivity (allergic) reactions with an update of the summary of product characteristics and package insert of this vaccine, to include urticaria (a raised, red, itchy skin rash), as a new uncommon side effect (occurring in less than 1 in 100 people), as well as angioedema (rapid swelling under the skin in areas such as the face, lips, mouth and throat, which can cause difficulty in swallowing or breathing). Hypersensitivity, rash, pruritus (itchy skin) and anaphylaxis (severe allergic reaction), are already included in the information on this vaccine as possible adverse reactions.
– Systemic capillary leak syndrome: EMA is also a serious but very rare condition, characterized by an increase in capillary permeability that allows fluid and protein to leak from the circulatory system into the interstitial space, which can lead to shock and massive oedema.
– Immune thrombocytopenia: it is a reaction that produces bruising and bleeding, but has not yet been described as an established side effect.
– Acute macular neuroretinopathy: the EMA is still reviewing the notifications received of this very rare condition characterized by the sudden appearance of spots that partially obstruct vision.
Janssen Vaccine Side Effects
1. The 10 most frequent secondary effects registered by AEMPS: pyrexia (29%), headache (27%), myalgia (20%), malaise (9%), dizziness (9%), pain in the vaccination area (7 %), nausea (7%), arthralgia (6%), injection site pain (6%), fatigue (6%).
2. New or suspected side effects. The AEMPS has not recorded any side effects other than those in the prospectus, which already includes thrombosis syndrome with thrombocytopenia. A condition, the latter, which has not registered cases in Spain.
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