The Spanish Agency for Medicines and Health Products (AEMPS) has presented the seventh pharmacovigilance report on vaccines against Covid-19 that reveals new suspected side effects of the Pfizer drug.
This latest report reveals that, as of July 11, 2021, 33,455,291 doses of Pfizer have been administered in Spain. Of this sample, a total of 17,387 notifications of adverse events have been registered in the FEDRA database, the majority corresponding to women (79%) and people between 18 and 65 years of age (83%). Of all the notifications registered, 3,361 were considered serious.
New suspected side effects from Pfizer
The AEMPS states that it is studying whether the following events may be possible adverse reactions of this vaccine, in which case they will be included in its technical data sheet and package insert: asthenia (lack of energy or strength), lethargy (state of indifference or inactivity), decreased appetite, and nighttime hyperhidrosis (excessive sweating). Its frequency of appearance in any case is low according to the available data.
Side Effects Discovered During Vaccination With Pfizer
During the immunization phase in the general population of the Pfizer and BioNTech vaccine, a series of adverse reactions have been recorded that, finally, have been included in the technical data sheet. These symptoms are as follows:
1. Myocarditis and pericarditis: the AEMPS collects in its seventh report the conclusions of the Pharmacovigilance Risk Assessment Committee (PRAC) of the Spanish Medicines Agency (EMA), which report that after the administration of the BioNTech / Pfizer vaccines and Moderna, myocarditis and / or pericarditis can occur very rarely.
Specifically, in the countries of the European Economic Area (EEA), up to May 31, 2021, 145 cases of myocarditis and 138 of pericarditis have been reported after the administration of Pfizer (having administered approximately 177 million doses), and 19 cases of myocarditis and 19 of pericarditis with Moderna (having administered around 20 million doses).
In the particular case of Spain, until July 11, 2021, there have been 53 notifications of myocarditis and / or pericarditis after the administration of Pfizer and 14 after the administration of Moderna. Most of the registered cases evolve favorably and appear after the second dose in young men.
2. Rash and pruritus: the PRAC recommended that the Pfizer vaccine label and package insert be modified by adding rash and pruritus (itching of the skin), as uncommon adverse reactions (occur in less than 1 of every 100 people). For their part, urticaria (raised, red and 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).
3. Localized inflammation with Pfizer in people who have previously received injections of dermal fillers in the face: the PRAC has also concluded that it is possible that this effect is related to the vaccine, so it will be incorporated as a possible adverse reaction to the technical data sheet and the prospectus.
The most common side effects of the Pfizer vaccine
The seventh pharmacovigilance report of the AEMPS also reveals the 10 adverse events that have been reported the most in Spain.
– Fever: 37%
– Headache: 27%
– Muscle pain: 20%
– Pain in the vaccination area: 14%
– Upset: 12%
– Nausea: 8%
– Fatigue: 8%
– Joint pain: 8%
– Chills: 8%
– Lymphadenopathy: 7%
