Short term safety of BNT162b2 (Pfizer-BioNTech) SARS-CoV-2 vaccine among children aged 5-11 years, a nationwide parental survey.

PURPOSE: SARS-CoV-2 vaccine safety is of major interest worldwide, and transparent information about potential side effects is essential to decrease vaccine hesitancy. The aim of this study was to assess SARS-CoV-2 BNT162b2 vaccine short-term side effects among children aged 5-11 years. METHODS: An observational, cross sectional study of vaccine side-effects using electronic surveys sent to parents one week post administration of BNT162b2 vaccine to their child in a large health maintenance organization in Israel. RESULTS: First dose and second dose surveys were filled for 5,842 and 6,126 children, respectively, with a response rate of 32.1% and 24.8%. Local side effects were reported by 68.7% and 69.1% of the first and second survey respondents, and general side effects were reported by 20.8% and 34.5% of them. The symptoms most frequently reported were fatigue, headache and myalgia. Duration of symptoms lasted three days or less among 86.5% and 81.5% of first and second dose survey respondents. Most respondents (92%) reported that their child did not need any medical consultation following vaccination. CONCLUSIONS: We found further support for the BNT162b2 SARS-CoV-2 vaccine short- term safety among children aged 5-11 years. With ongoing pandemic and future booster COVID-19 vaccines, these findings can encourage vaccine confidence for parents and providers.

Immediate side effects of Comirnaty COVID-19 vaccine: A nationwide survey of vaccinated people in Israel, December 2020 to March 2021.

BackgroundCOVID-19 vaccine safety is of major interest worldwide, since there is no prior experience with it. Israel was one of the first countries to widely use the Comirnaty vaccine.AimWe aimed to assess the vaccine's short-term side effects directly from a large population and to predict influencing factors for self-reporting side effects.MethodsIn a retrospective cohort study, we investigated self-reported systemic vaccine side-effects using electronic surveys sent to vaccinated individuals between 20 December 2020 and 11 March 2021, within 3 days following administration of the first and second dose. We determined predictors for reporting systemic side effects by logistic regression.ResultsA total of 1,213,693 patients received at least one vaccine dose and 301,537 (24.8%) answered at least one survey. Among them, 68,162 (30.4%) and 89,854 (59.9%) individuals filled the first and the second dose surveys, respectively, and reported one or more side effects. Most common side effects were fatigue, headache and myalgia. Several respondents reported facial paraesthesia after first and second dose, respectively (n = 1,675; 0.7% and n = 1,601; 1.1%). Individuals younger than 40 years and women reported side effects more frequently than others, but pregnant women reported less. Pregnancy was a weak predictor for reporting any side effect in general and in particular fatigue, myalgia, headache, chills and fever.ConclusionsWe found further support for minor short-term side effects, within 3 days of receiving the Comirnaty vaccine. These findings from vaccine recipients in general and pregnant women in particular can improve vaccine acceptance.

Reactogenicity of a third BNT162b2 mRNA COVID-19 vaccine among immunocompromised individuals and seniors - A nationwide survey.

BACKGROUND: Since July 13, 2021, a third SARS-CoV-2 vaccine BNT162b2 was approved in Israel to immunocompromised and seniors 60 years of age or older. We aimed to evaluate vaccine's reactogenicity. METHODS: A retrospective cohort, using electronic surveys sent to booster vaccine recipients, during July 20-August 10, 2021. RESULTS: 17,820 participated in the survey, with a response rate of 30.2%. 3195 (17.9%) were immunocompromised. Fatigue, myalgia and fever were the most frequent systemic side effects reported (19.6%, 9.2% and 8.1% respectively among immunocompromised; 21.3%, 9.9% and 9.2% respectively among seniors). 67.3% of immunocompromised and 62% of seniors reported experiencing a better or a similar response to the third dose, compared to the second. CONCLUSIONS: Local and systemic reactions after third BNT162b2 vaccine, reported by immunocompromised and seniors, were similar to those observed following previous vaccines and mostly self-resolved. These findings may aid promoting confidence among vaccine providers and recipients.

Longitudinal symptom dynamics of COVID-19 infection.

As the COVID-19 pandemic progresses, obtaining information on symptoms dynamics is of essence. Here, we extracted data from primary-care electronic health records and nationwide distributed surveys to assess the longitudinal dynamics of symptoms prior to and throughout SARS-CoV-2 infection. Information was available for 206,377 individuals, including 2471 positive cases. The two datasources were discordant, with survey data capturing most of the symptoms more sensitively. The most prevalent symptoms included fever, cough and fatigue. Loss of taste and smell 3 weeks prior to testing, either self-reported or recorded by physicians, were the most discriminative symptoms for COVID-19. Additional discriminative symptoms included self-reported headache and fatigue and a documentation of syncope, rhinorrhea and fever. Children had a significantly shorter disease duration. Several symptoms were reported weeks after recovery. By a unique integration of two datasources, our study shed light on the longitudinal course of symptoms experienced by cases in primary care.