432 adverse events, 3 of them serious, linked to Pfizer-BioNTech vaccine

Singapore — A total of 432 adverse events, three of which were severe allergic reactions to the Pfizer-BioNTech Covid-19 vaccine, have been reported by healthcare professionals, according to the Ministry of Health (MOH).
In a press release on Thursday (Jan 28), the MOH provided an update on the ongoing nationwide vaccination initiative in Singapore. “We have made good progress in our Covid-19 vaccination programme,” it said, noting that more than 113,000 individuals had received their first dose as at Wednesday (Jan 27).
Meanwhile, more than 50 individuals have received their second dose, completing the Covid-19 vaccination process.
“These numbers are expected to rise substantially in the coming weeks as we continue to ramp up our vaccination operations safely,” said MOH.
Out of the 113,000 individuals, a total of 432 adverse events were reported by healthcare professionals as at Jan 27, it said.
“Most of these reports were for regular symptoms such as injection site pain and swelling, fever, headache, fatigue, body aches, giddiness, nausea and allergic reactions (such as itch, rash, swelling of eyes or lip). These symptoms are reactions generally associated with all vaccinations, and they generally resolved on their own within a few days.”
Furthermore, three reported cases of anaphylaxis, the rapid onset of severe allergic reactions, were quickly resolved by healthcare professionals.
The individuals, who are in their 20s and 30s, developed multiple symptoms such as rash, breathlessness, lip swelling, throat tightness and giddiness. “All three individuals had a history of allergies, including allergic rhinitis and food allergy such as to shellfish, but none had a history of anaphylaxis which would have precluded them from receiving the vaccine,” the report noted.
The MOH confirmed that the reaction could be controlled when detected and treated promptly. “As all vaccinated persons in Singapore are closely monitored, the symptoms in these three individuals were promptly detected and treated. All have recovered from the episode and were discharged from the hospital after a day’s observation or treatment.”
Locally, the incidence rate of the allergic reaction is about 2.7 per 100,000 doses administered. The incidence rates reported abroad are around one to two per 100,000 doses after millions of vaccine doses have been administered.
“Variations in the incidence rate are to be expected initially as the numbers vaccinated in Singapore to-date are relatively small,” said the MOH.
“Currently, the benefits of getting vaccinated to protect oneself from the effects of severe Covid-19 disease and its complications far outweigh the risk of any potential adverse events known to be associated with vaccination.”
Both the MOH and the Health Sciences Authority (HSA) are closely monitoring the safety profile of the Pfizer-BioNTech vaccine while it is administered to the public. The agencies are working with the Expert Committee on Covid-19 Vaccination to ensure the vaccines used in Singapore are safe for the population groups.
“Anaphylaxis is a known but rare side-effect of the Pfizer-BioNTech Covid-19 vaccine. As with all vaccines, there will always be a small proportion of susceptible persons who experience severe allergic reactions upon vaccination. We have put in place precautionary measures such as pre-vaccination screening and post-vaccination observation, to ensure that our vaccination programme can be carried out safely,” noted the Director of Medical Services, Associate Professor Kenneth Mak.
“Vaccination remains safe for those who are eligible, and I encourage all Singaporeans and long-term residents to be vaccinated when your turn comes.”
In its press release, the MOH announced a new Vaccine Injury Financial Assistance Programme for Covid-19 vaccination (VIFAP). The scheme would provide financial assistance for affected persons in the rare event of serious side-effects assessed to be related to vaccinations. “This programme will give a greater peace of mind for those taking the vaccination,” it said.
The VIFAP will provide a one-time payout of up to S$10,000 to an eligible individual who is hospitalised requiring care in the High Dependency or Intensive Care Unit but subsequently recovers from medically significant serious side-effects.
The scheme would also provide a one-time payout of S$225,000 to an individual who dies or suffers permanent severe disability due to Covid-19 vaccination.
“Any individual who experiences serious side-effects after Covid-19 vaccination can also continue to concurrently receive support through applicable healthcare schemes, such as MediShield Life and subsidies at our public healthcare institutions,” added MOH.
To become eligible for VIFAP, an individual must be a Singapore citizen, Permanent Resident or long-term pass holder who has received the vaccine in Singapore.
The person should experience a serious side-effect that is potentially life-threatening or fatal, and has required in-patient hospitalisation, or has caused persistent incapacity or disability, said MOH. “The serious side-effects must be assessed by a doctor to be linked to the individual’s Covid-19 vaccination.”
The MOH noted that vaccination “is not a silver bullet” even as more individuals receive their vaccine doses. “We must continue to adhere to the safe management measures to help us mitigate the spread and keep community transmission low.” /TISG
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