Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine, historical cohort study

Shasha, David; Bareket, Ronen; Sikron, Fabienne Hershkowitz; Gertel, Omer; Tsamir, Judith; Dvir, David; Mossinson, David; Heymann, Anthony D.; Zacay, Galia

OBJECTIVE: The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce. Bell’s palsy, herpes-zoster, Guillain-Barré syndrome (GBS) and other neurological complaints in proximity to vaccination have received special public attention. We compared their rates among vaccinated and unvaccinated individuals. METHODS: Individuals ≥16 years vaccinated with at least one dose of BNT162b2 were eligible for this historical-cohort study in a health maintenance organization insuring 1.2 million citizens. Each vaccinee was matched to a non-vaccinated control by sex, age, population sector (general Jewish, Arab, ultra-orthodox Jewish) and comorbidities. Diagnosis of Covid-19 before or after vaccination was an exclusion criterion. The outcome was a diagnosis of: Bell’s palsy, GBS, herpes-zoster, or symptoms of numbness or tingling, coded in the visit diagnosis field using ICD-9 codes. Diagnoses of Bell’s palsy and GBS were verified by individual file review. RESULTS: Of 406,148 individuals vaccinated during the study period, 394,609 (97.2%) were eligible (11,539 excluded). 233,159 (59.1%) were matched with unvaccinated controls. Mean follow was 43±15.14 days. In vaccinated and unvaccinated individuals there were 23 versus 24 cases of Bell’s palsy (RR 0.96, CI 0.54-1.70), 1 versus 0 cases of GBS, 151 versus 141 cases of herpes-zoster (RR 1.07, CI 0.85-1.35), and 605 versus 497 cases of numbness or tingling (RR 1.22, CI 1.08-1.37), respectively. CONCLUSIONS: No association was found between vaccination, Bell’s palsy, herpes-zoster or GBS. Symptoms of numbness or tingling were more common among vaccinees. This study adds reassuring data regarding the safety of the BNT162b2 vaccine.