FDA: 137 out of 240,000 vaccinees reported serious side effects

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Metro Manila (CNN Philippines, March 18) — At least 137 out of more than 240,000 Filipinos who got their first COVID-19 shot experienced serious adverse effects, the Food and Drug Administration bared Thursday.

In a briefing with the Health Department, FDA Director General Rolando Domingo said 83 reported serious side effects after receiving the CoronaVac vaccine by China's Sinovac Biotech while 54 were from those who received the first shot from British-Swedish drugmaker AstraZeneca.

Serious adverse reactions reported by both set of vaccinees include chest pain, nasal congestion, and allergic reactions.

According to Domingo, adverse reactions experienced after vaccination are only considered serious if they meet any of the following criteria:

- Results in death and life-threatening situation

- Requires in-patient hospitalization or results in prolongation of existing hospitalization

- Results in persistent or significant disability/incapacity

- Is a congenital anomaly/birth defect

- Is a medically important event or reaction

Common minor side effects after inoculation include an increase in blood pressure, pain in injection site, rashes, headache, and nausea.

At least 240,297 vaccinees — mostly health workers — already received their first dose, based on the government's cumulative data as of Wednesday, March 17. Of this number, 167,798 Sinovac doses were administered while 72,499 are from AstraZeneca.

Meanwhile, medical authorities stressed that the recent report on the local health worker who died after getting her first dose of CoronaVac cannot be related to the vaccine, as CoronaVac is a chemically inactivated virus vaccine.

"The patient died from COVID infection. We all know that the vaccine is inactivated," said Dr. Rommel Lobo, member of the National Adverse Events Following Immunization Committee.

He added that the patient had comorbidities such as diabetes, hypertension, and bronchial asthma "that put her at risk for getting infected."

RELATED: COVID-19 vaccine did not cause local health worker's death – DOH 

Director Beverly Ho of the Health Department's Health Promotion Bureau and Disease Prevention and Control Bureau said there is no reason to stop the country's vaccine rollout as "benefits still outweigh the risks" of getting inoculated against COVID-19.

Meanwhile, Domingo noted that Sinovac has already been informed about the incident and they will give an update on whether similar incidents in other countries were reported.

"We must keep in mind na kapag nabakunahan tayo, yung first few weeks, wala pang proteskyon na nabibigay against COVID-19," Domingo also reminded.

[Translation: We must keep in mind that once we get vaccinated, we are not yet fully protected against COVID-19 in the first few weeks.]

Vaccine czar Carlito Galvez Jr. previously said more CoronaVac vaccines will be administered next month as the brand provides a shorter time interval of four weeks between the administration of the two doses.

The Department of Health said CoronaVac is still 100% effective against moderate and severe symptoms and can reduce morbidity and mortality despite previous warning from the FDA that it has a low efficacy rate of 50.4% among health workers. Medical frontliners currently have the freedom to decide whether or not they would take this vaccine.