FDA data: Below 1% adverse events reported since March vax rollout

By Alec Go

Only 0.61% adverse events following immunization were reported from the 6.9 million COVID-19 vaccine doses administered from the beginning of the country’s vaccine rollout until June 13, data from the government showed.

Based on a Food and Drug Administration (FDA) report, there were 42,879 reports in the country since March 1, of which 42,062 are considered “non-serious events” and 817 are “serious events.” 

Among the common reactions to the vaccines are body pain, chills, fatigue, fever, headache, nausea, and pain in the injection site which may last for 2 to 3 days. 

For inactivated vaccines such as Sinovac’s CoronaVac, the most common adverse events are blood pressure increase at 40.94%, headache at 13.90%, injection site pain at 12.70%, fever or pyrexia at 7.78%, and dizziness at 7.72%.

The top reported event for viral vector vaccine AstraZeneca is pyrexia at 41.80%, followed by headache at 36.71%, injection site pain at 25.33%, malaise or general feeling of discomfort at 24.44%, and myalgia or muscle pain at 18.13%. 

For Sputnik V, reported blood pressure increase was at 33.33%, followed by pyrexia at 6.43%, headache at 6.14%, rash at 4.97%, and dizziness at 3.80%. 

For Pfizer-BioNTech’s Comirnaty, an mRNA vaccine, the top recorded mild reactions were blood pressure increase at 46.02%, pyrexia at 14.49%, headache at 12.78%, injection site pain at 10.51%, and dizziness at 6.25%, 

The report said there were no reported incidents of death directly related to current available vaccines in the country, such as those developed by Sinovac, Oxford AstraZeneca, Gamaleya, and Pfizer-BioNTech. 

Read more: EXPLAINER: Why senior citizens should get the jab

The FDA said most of the adverse events or 81% of the total figures have been resolved.

Eight vaccines have been granted emergency use authorization in the Philippines, including Janssen, Moderna, Covaxin, and Sinopharm.

Read more: LIST: What to do in case of vax adverse events

According to the World Health Organization (WHO), the common side effects of vaccines are indications that it is working. The Philippine Department of Health (DOH) advises the use of ibuprofen for pain-related reactions, and cold compress for injection site swelling.

Meanwhile, vaccinees with very “rare” severe adverse events such as difficulty breathing, wheezing, swelling of the face, and tightening of the throat should go to the nearest hospital. -rir

Read more: Vaccines okay for breastfeeding, menstruating women

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