10 children aged 5-11 had serious COVID vaccine side effects: HSA

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SINGAPORE — There were 10 children aged 5 to 11 years who have experienced serious side effects after being administered a COVID-19 vaccine, with symptoms including seizures (fits), appendicitis, allergic reactions and abnormal renal function reported.

However, this does not necessarily mean that the vaccine caused the serious adverse events (SAE) as they may be related to an underlying or undiagnosed disease, or it may be coincidental that they occurred around the same time that the vaccine was given, said the Health Sciences Authority (HSA).

No cases of myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the thin tissue sac around the heart) have been reported in this age group so far. "HSA is closely monitoring the AEs reported in children and is assessing them in the context of background incidence rates," added the agency.

In the latest vaccine safety update, published on Wednesday (23 February) and covering events up to end-January, HSA noted that some 280 AE reports for the 5 to 11 age group have been received so far. This represents 0.12 per cent out of 238,253 administered doses.

In comparison, the reporting rate of SAEs for that observed in adolescents and adults was 0.004 per cent of administered doses. The commonly reported AEs are also similar to that observed in adolescents (12-17 years old) and include angioedema (swelling of eyelids, face or lips), hives, dizziness, fever, rash, chest discomfort/pain, palpitations and shortness of breath.

Singapore began rolling out its vaccination programme to children aged 5-11 on 27 December 2021.

More than 15,000 AE reports

INFOGRAPHIC: Health Sciences Authority
INFOGRAPHIC: Health Sciences Authority (Health Sciences Authority)

As of 31 January, HSA has received a total of 15,655 suspected AE reports, or 0.12 per cent of doses administered, associated with the use of Pfizer-BioNTech/Comirnaty and Moderna/Spikevax COVID-19 vaccines.

The most commonly reported AEs are consistent with those typically observed following vaccination such as with the flu vaccine. These include allergic reactions – such as rash, itch, hives and swelling of eyelids, face and lips – dizziness, shortness of breath, chest discomfort/pain, palpitations, fever, headache, muscle aches and injection site reactions such as pain and swelling.

These reported AEs generally resolved within a few days.

According to HSA, the reporting rate of serious AEs has remained stable between 0.004 per cent and 0.007 per cent. Of the 15,655 suspected AE reports received for the mRNA vaccines, 820 were assessed as serious.

Serious AEs comprised 0.006 per cent of doses administered. Of the reports received, many of the suspected AEs had resolved or were resolving at the time of reporting.

The most frequently reported serious AEs were anaphylaxis, or a severe and potentially life-threatening allergic reaction, at 88 reports and other severe allergic reactions (55 reports). Other serious AEs include:

  • immunological – rheumatoid arthritis and other autoimmune conditions

  • cardiovascular – chest pain, drop or increase in blood pressure, irregular heartbeat, tachycardia (fast heart rhythm), myocarditis and pericarditis

  • neurological – migraine, nerve damage or dysfunction resulting in numbness or tingling/pricking sensation, muscle or limb weakness and pain in the affected area, syncope, seizures (fits), inflammation of the brain tissues, Bell’s Palsy (facial muscle weakness or paralysis) and cerebral venous thrombosis (CVT)

  • haematological involving the blood cells - low platelets and blood clots

  • musculoskeletal - joint inflammation or pain and muscle injury

  • dermatological - severe skin reactions, eczema flare and skin blisters

  • renal - reduced kidney function and inflammation of the kidney

  • visual inflammation and visual disturbances

  • tinnitus (ringing in the ears) and hearing loss

  • respiratory - exacerbation of underlying asthma and breathing difficulties

  • Other SAEs such as increase in liver enzymes, appendicitis, thyroid gland dysfunction, menstrual disorders, and infections.

These serious AEs are being closely monitored, said HSA. Background disease incidence underlying medical conditions are taken into consideration when determining if the vaccines had any contributory role to these events.

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