Registered a new adverse reaction of the covid vaccine in children



Health announces the twelve most reported side effects after vaccinating minors against the coronavirus

The North

THE NORTH Valladolid

Saturday, May 28, 2022, 18:37

The new report prepared by the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Pharmacovigilance Centers and coordinated by the Spanish Agency for Medicines and Health Products (AEMPS), includes a new side effect of the vaccine against covid reported as frequent in children: abdominal pain.

Among the most frequent side effects among minors, the Spanish Agency for Medicines and Health Products (Aemps) indicates a total of twelve in its latest Pharmacovigilance Report on Vaccines against covid, published on May 25. These effects are usually transitory, they can appear in the first days after vaccination and were already identified in the technical data sheet and the Pfizer package insert -the vaccine that is administered to children in Spain-, except for abdominal pain.

It should be noted that the number of side effects of the covid vaccine reported in minors is very low. In fact, only 354 notifications of the 38,624 registered in the database of the pharmacovigilance service of the Spanish Agency for Medicines and Health Products until May 8, 2022 correspond to side effects in minors. The percentage is very similar between boys and girls: 181 notifications (51%) compared to 170 (48%).

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Until May 8, more than 3.1 million doses were inoculated in Spain to minors, so the rate of notification of adverse reactions is only eleven per 100,000 doses administered.

Most reported reactions in minors

Pyrexia (fever): 62 (18%)

Lymphadenopathy (swollen lymph nodes or glands): 62 (18%)

Headache: 47 (13%)

Pain in the vaccination area: 27 (8%)

Vomiting: 24 (7%)

Discomfort: 20 (6%)

Urticaria: 19 (5%)

Diarrhea: 17 (5%)

Rash: 13 (4%)

Fatigue: 12 (3%)

Abdominal pain: 10 (3%)

Dizziness: 10 (3%)

This new notification comes at a time when Pfizer-BioNTech has reported in a statement that the three doses of its vaccine produce a strong immune response in children, with an efficacy of 80.3%, according to a preliminary estimate. “We are pleased that our compound for children, which we carefully selected to be one-tenth of the adult dose, was well tolerated and produced a strong immune response,” Pfizer CEO Albert Bourla said in a statement. .

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