Two vaccines are currently available for use in the United States – a vaccine from Pfizer and one from Moderna – and both are called messenger RNA (mRNA) vaccines. While the vaccines were quick to market, the trials were rigorous, and they are proven safe with normal side effects. Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability or incapacity.įew SAEs were reported from dose 1 to data cutoff (April 29, 2022) among the vaccine and placebo groups, (1.4% and 2.3%, respectively in the younger age group and 0.7% and 0.If you have not yet received a COVID-19 vaccine, your opportunity to get one will be coming soon as more vaccine is available and larger groups within the community are vaccinated. Lymphadenopathy was reported by 2 (0.2%) vaccine recipients 6-23 months of age, 1 (0.1%) vaccine recipient 2 – 4 years of age, and no placebo recipients. The most commonly observed adverse events were consistent with those reported as local and systemic reactions and/or were consistent with events frequently reported in this age group, including infections and injuries, that were not considered related to vaccination. 18.5% in the older age group, respectively. 26.3% for the younger age group and 18.5% vs.

The overall incidence of unsolicited non-serious adverse events from dose 1 to data cutoff (April 29, 2022) were similar in the vaccine and placebo groups in both age groups: 29.1% vs. Systemic reactions in children 2-4 years, Pfizer BioNTech BNT162b2 COVID-19 vaccine and placeboī Mild: does not interfere with activity moderate: some interference with activity severe: prevents daily activity Grade 4: emergency room visit or hospitalizationĬ Mild: 1 to 2 times in 24 hours moderate: >2 times in 24 hours severe: requires intravenous hydration Grade 4: emergency room visit or hospitalizationĭ Mild: 2 to 3 loose stools in 24 hours moderate: 4 to 5 loose stools in 24 hours severe: 6 or more loose stools in 24 hours Grade 4: emergency room visit or hospitalization Use of antipyretic or pain medication, n (%)ī Mild: decreased interest in eating moderate: decreased oral intake severe: refusal to feed Grade 4: emergency room visit or hospitalizationĬ Mild: increased or prolonged sleeping bouts moderate: slightly subdued interfering with daily activity severe: disabling not interested in usual daily activity Grade 4: emergency room visit or hospitalizationĭ Mild: easily consolable moderate: requiring increased attention severe: inconsolable crying cannot be comforted Grade 4: emergency room visit or hospitalization Local reactions in persons aged 2 – 4 years, Pfizer BioNTech BNT162b2 COVID-19 vaccine and placeboĪ Mild: ≥0.5 to 2.0 cm moderate: >2.0 to 7.0 cm severe: >7.0 cm Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only)ī Mild: does not interfere with activity moderate: interferes with activity severe: prevents daily activity Grade 4: emergency room visit or hospitalization Tenderness at the injection site b, n (%)ĪMild: ≥0.5 to 2.0 cm moderate: >2.0 to 7.0 cm severe: >7.0 cm Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only)īMild: hurts if gently touched moderate: hurts if gently touched with crying severe: causes limitation of limb movement Grade 4: emergency room visit or hospitalization for severe tenderness at the injection site. Local reactions in persons aged 6-23 months, Pfizer BioNTech BNT162b2 COVID-19 vaccine and placebo Overall, the median onset of local reactions in the vaccine group was 1 to 2 days after either dose, with a median duration of 1 day after onset. No grade 4 local reactions were reported. Redness and swelling were more common after dose 2 than dose 1 or 3. Injection site swelling following either dose was reported less frequently. Redness was reported slightly more frequently in the older age group than the younger age group (10.9% vs 7.5% after dose 3). Injection site redness was the second most frequently reported local reaction. After dose 1, the older age group (2 – 4 years) reported pain/tenderness more frequently than the younger age group (6 – 23 months) (30.8% vs 16.6%) a similar pattern was observed after dose 2 and 3 (31.0% vs 15.0% and 26.7% vs 16.0%, respectively). Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. Vaccine recipients reported similar rates of local reactions after dose 1 and dose 2, but slightly lower after dose 3. Local reactions were reported by half (48%) of vaccine recipients and at higher rates than placebo recipients.

Persons Aged 6 Months – 4 Years Local Reactions

Covid vaccine side effect