A total of 432 adverse events were reported by healthcare professionals in Singapore to the Health Sciences Authority (HSA) as of Jan. 27, 2021, as a result of the Pfizer-BioNTech Covid-19 vaccination.
Out of the 432 events, three were cases of anaphylaxis, which is a rapid onset of severe allergic reactions that can be potentially life-threatening.
These details were released by the Ministry of Health (MOH) on Jan. 28 in a press release.
Relatively young individuals who suffered allergic reactions
The three individuals who had allergic reactions are in their 20s and 30s.
They had developed an array of symptoms, such as rash, breathlessness, lip swelling, throat tightness and giddiness.
All of them had a history of allergies, including allergic rhinitis, as well as food allergy, such as to shellfish.
However, as none of them had a history of anaphylaxis, it would not have ruled them out of receiving the vaccine, added MOH.
MOH said: “Anaphylaxis can be controlled when detected and treated in a timely manner. 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.”
Majority of adverse events mild
The majority of reports of adverse events 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, and lip.
“These symptoms are reactions generally associated with all vaccinations and they generally resolved on their own within a few days,” MOH added.
Anaphylaxis incidence rate: 2.7 per 100,000 doses
More than 113,000 people in Singapore have received the Pfizer-BioNTech vaccine, MOH said, which brings the incidence rate of anaphylaxis locally to about 2.7 per 100,000 doses administered, MOH said.
Variations in the incidence rate are to be expected initially as the numbers vaccinated in Singapore to-date are relatively small, MOH also said.
Director of Medical Services at MOH Kenneth Mak noted that anaphylaxis is a known, but rare side effect of the Pfizer-BioNTech Covid-19 vaccine.
He also said that 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,” Mak said.
He emphasised that vaccination remains safe for those who are eligible.
MOH introduces vaccine injury financial assistance programme
MOH said it will introduce a vaccine injury financial assistance programme for Covid-19 vaccination (VIFAP).
This is to provide financial assistance for affected individuals, in the rare event of serious side effects that are assessed to be related to Covid-19 vaccines administered in Singapore.
The programme will give a greater peace of mind for those taking the vaccination, the ministry added, but it expects "few to need this”.
The VIFAP will provide the following tiers of financial support:
- A one-time pay-out of up to S$10,000 will be provided 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.
- A one-time pay-out of S$225,000 will be provided to an individual who dies or suffers permanent severe disability as a result of Covid-19 vaccination.
- Any individual who experiences serious side effects after the 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.
To qualify for the VIFAP, individuals must be a Singaporean, a permanent resident or a long-term pass holder who has received the Covid-19 vaccination in Singapore.
They must also have experienced a serious side effect that is potentially life-threatening or fatal, and has required inpatient hospitalisation or has caused persistent incapacity or disability.
The serious side effects must be assessed by a doctor to be linked to the individual’s Covid-19 vaccination.
“As the severity of serious side effects can be broad, and assessment by the treating doctors may vary, the MOH has appointed an independent clinical panel comprising experts in relevant fields such as neurology, immunology and infectious diseases, to assess and adjudicate VIFAP applications,” added the MOH.
Over 50 individuals in Singapore have received their second dose of the vaccine and completed the full vaccination regimen.
Top photo via Ministry of Health