FDA: 3.1% of vaccinated individuals report adverse effects

The Food and Drug Administration (FDA) on Thursday said 3.1% or 7,469 of the 240,297 individuals vaccinated against COVID-19, as of March 16, reported an adverse event following immunization (AEFI).

FDA chief Eric Domingo said 7,331 of these AEFIs were non-serious and 138 were serious, including a case that involved death.

Domingo explained that a serious AEFI is one that results in death, a life-threatening situation like anaphylaxis, in-patient and prolonged hospitalization, persistent or significant disability, congenital anomaly or birth defect, or a medically important event.

Some of the most common AEFIs were pain at the injection site, chills, chest discomfort, fatigue, and headache.

Among the reported AEFIs, 3,700 were linked to the Sinovac jab and 3,769 were connected to the AstraZeneca vaccine.

Over 2,400 AEFIs were also recorded in Metro Manila, where the bulk of the initial vaccine shipments were rolled out.

National Adverse Events Following Immunization Committee (NAEFIC) vice chairman Dr. Rommel Lobo said not all untoward medical events that follow immunization “have a causal relationship with the administration of a vaccine.”

“For example, you get vaccinated and then you get bitten by a dog. You should also report that as an AEFI. Whether it’s related or unrelated, there should be reporting and it should be documented,” he said.

All reported adverse events undergo causality assessments by the NAEFIC, its regional counterparts, and the Department of Health.

Lobo said the assessment involves conducting field investigations, reviewing clinical records, and compiling information about the circumstances associated with adverse events.

“Every single report of AEFI reported in the Philippines is treated with utmost seriousness… [There] is a thorough examination of every step of the vaccination process and it is done with great care,” he said.

The NAEFIC earlier said the health worker who succumbed to COVID-19 after receiving a Sinovac shot died of the respiratory illness and not the vaccine.

Domingo also urged the public to continue following health protocols even after getting vaccinated since “during the first few weeks after you are injected with a vaccine, you have no protection.”

“This is the time that your immune system is trying to develop… Your risk of developing COVID-19, getting the illness, and getting severe illness and possibly dying from it is the same as a non-vaccinated person,” he said.—AOL, GMA News