![]() It may not have a causal relationship to vaccination. 12 However, this observed frequency was consistent with the expected background rate of Bell’s palsy in the general population. ![]() There were 4 cases of Bell’s palsy (acute peripheral facial paralysis) reported in the clinical trial in people aged 16 years and older who received the vaccine (out of 18,860 vaccine recipients). From post-licensure data, rare adverse events associated with Pfizer original formulation vaccines include anaphylaxis (refer to Contraindications and precautions) and myopericarditis (refer to Myocarditis and pericarditis after mRNA COVID-19 vaccines). The clinical trials for Pfizer original formulation were not powered to detect rare adverse events. Most hypersensitivity reactions reported were common skin disorders for these age groups, such as rash, eczema, and dermatitis. Hypersensitivity reactions were reported by 2.1% of vaccine recipients and 2.0% of placebo recipients aged 6 to 23 months, and 0.9% of vaccine recipients and 0.4% of placebo recipients aged 2 to 4 years. In the phase II/III study of children aged 6 months to 4 years, safety data were reported up to 1 month after dose 3. The rashes occurred more than 7 days after vaccination and were considered to be related to vaccination. There were 4 cases of rash (on the arm, torso, face, or body with no consistent pattern) in children aged 5 to 11 years. In the phase II/III study of children aged 5 to 11 years, safety data were reported up to 1 month after dose 2. In the clinical trials of Pfizer original formulation, lymphadenopathy was reported in <1% of people aged 16 and older, in 0.8% of people aged 12 to 25, 0.9% of children aged 5 to11, 0.1% of children aged 2 to 4 years and 0.2% of children aged 6 to 23 months. Table 1a: Frequency of select common adverse events reported within 7 days following each dose of Pfizer original formulation in the phase II/III trial 3-5,9 In children aged 5 to 11 years, headache, muscle pain and use of antipyretic or pain medication were reported slightly more frequently after a booster dose of Pfizer original formulation than after dose 2. 6,7 The Pfizer bivalent formulations as a booster dose had similar rates of adverse events to primary doses or first or second boosters of the Pfizer original formulation (see Tables 1a and 1b). Both local and systemic adverse events after the booster (third) dose were mainly mild to moderate. 4 Adverse events following booster doses and bivalent formulationsĪdverse event rates after a booster dose with Pfizer original formulation in the booster clinical trial were similar to rates following the second primary course dose of Pfizer original formulation. There were 5 febrile convulsions reported in the trial vaccine recipients (out of 3,013 vaccine recipients), but only one of these (in a 6 month old participant) was considered possibly related to the Pfizer vaccination, and may also have been caused by a concurrent viral infection. In the phase II/III clinical trial in children aged 6 months to 4 years, 0.1% to 0.3% of participants reported a fever >40.0 oC. The median onset of fever was 2 to 5 days after vaccination, and usually resolved within 1 to 1.5 days after the dose. Similar rates of fever were reported after each of the 3 doses in children aged 6 to 23 months (7%) and aged 2 to 4 years (5%). Children aged 6 months to 4 years who received a 3-dose primary series did not show a pattern of increasing systemic adverse events with each subsequent dose. Irritability, drowsiness, and decreased appetite were the most frequently reported systemic adverse events among children aged 6 to 23 months (see Table 1c). 5įatigue and headache were the most frequently reported systemic adverse events among people aged 2 to 25 years (Table 1a). ![]() Symptoms resolved in a median of 1 to 2 days. The median onset of systemic adverse events in adults was 1 to 2 days after vaccination. Severe pain was rare, and reported in 55 years) than in those aged 16 to 55 years. They were more common in adults than in children, and slightly more common in adults aged 55 years and under than in adults aged over 55 years. In clinical trials of Pfizer original formulation, injection site reactions were very common (see Table 1a). Pfizer and Moderna COVID-19 vaccines – adverse events reported in clinical trials Pfizer (Comirnaty) Injection site reactions The TGA and state and territory governments will actively monitor COVID-19 vaccine safety. Report any adverse events after COVID-19 vaccination through the usual reporting mechanisms. ![]()
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