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.

Background There is strong evidence regarding the efficacy and effectiveness of BNT162b2 vaccine in preventing symptomatic infection with SARS-CoV-2 virus. There is a relative paucity of data regarding effectiveness in prevention of asymptomatic infection. Methods In this real-world observational study, we identified a sub-population of individuals in a large health maintenance organization who were repeatedly tested for SARS-CoV-2 infection by PCR. We included these individuals in the study cohort, and compared those who were vaccinated with BNT162b2 mRNA vaccine to the unvaccinated ones. A positive SARS-CoV-2 PCR test result was used as the outcome. Follow-up period was from January 1,2021 until February 11, 2021. Findings 6,286 individuals were included in the cohort. Seven days following the second vaccine dose, a rate of six positive PCR tests per 10,000 person-days was recorded, compared with a rate of 53 positive tests per 10,000 person-days for the unvaccinated group. The estimated vaccine effectiveness against infection with SARS-CoV-2 virus after two vaccine doses was 89% (95% confidence interval 82%-94%). The estimated effectiveness two weeks following the first vaccine dose was 61% (95% confidence interval 49%-71%). Interpretation In this study, vaccination with BNT162b2 reduced infection rates among individuals who underwent screening by frequent SARS-CoV-2 PCR testing. Using a cohort of frequently tested individuals reduced the indication bias for the PCR testing, which enabled estimation of infection rates. Funding This study received no funding.

One in five new users of sedative-hypnotics will become a long-term user, but only 0.5% will become excessive users. Z-drugs were associated with an increased risk of chronic use.