FDA: Only 76,837 adverse events after administration of 75 M COVID-19 vaccine doses

MANILA, Philippines — The Food and Drug Administration (FDA) has recorded only 76,837 adverse events following immunization (AEFI) or 0.1 percent of more than 75 million vaccinations against COVID-19.

“So far, our suspected adverse events are less than 0.1 percent of total doses administered, but we’ve had reports of 76,000, and a majority of them are very mild. Only 0.005 percent (3,874) are serious adverse reactions,” FDA Director General Eric Domingo said in a webinar, citing government data as of November 21.

The FDA defines AEFI as “any untoward event that follows immunization and that does not necessarily have a causal relationship with the usage of the vaccine.” “The adverse event may be an unfavorable or unintended sign, abnormal laboratory symptom or disease,” Domingo said in his presentation. The Department of Health earlier said that some serious adverse events experienced by few vaccine recipients are difficulty in breathing and chest pain.

“In our country, the most common things that are reported are an increase in blood pressure, especially before and right after vaccination. Of course, patients tend to be anxious on the day of vaccination. A fever would be the second one, headaches, pain on the area of vaccination, panghihina (fatigue), some get chills, muscle pain, cough, dizziness, and tiredness. These are the most common adverse events that we see,” Domingo said.

Despite these AEFI reports, Domingo stressed that all vaccines in the national immunization program are safe and effective.

He added that the majority of events thought to be related to the administration of a vaccine are “actually not due to the vaccine itself” and that many are “simply coincidental events.”

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