key: cord-0978262-njia35in authors: Repajic, Michael; Lai, Xue Lei; Xu, Prissilla; Liu, Antonio title: Bell’s Palsy After Second Dose of Pfizer COVID-19 Vaccination in a Patient with History of Recurrent Bell’s Palsy date: 2021-02-10 journal: Brain Behav Immun Health DOI: 10.1016/j.bbih.2021.100217 sha: 052ed24924838a0849f880b25f8a52b80dcb882f doc_id: 978262 cord_uid: njia35in OBJECTIVE: To report a patient with history of recurrent Bell’s Palsy who developed Bell’s Palsy 36 hours after the administration of the second dose of the Pfizer-BioNTech COVID-19 vaccine. CASE: The patient is a 57-year-old female with past medical history of 3 episodes of Bell’s Palsy. She responded to prednisone treatment and returned to her baseline after each occurrence. Less than 36 hours following the second dose of the vaccine, the patient developed a left Bell’s Palsy. The facial droop progressed in severity over the next 72 hours. CONCLUSION: Given the expedited production of the vaccine and the novelty associated with its production, there may be information pertaining to side effects and individual response that remain to be discovered. Since both the Moderna and Pfizer Vaccine trials reported Bell’s Palsy as medically attended adverse events, the association between vaccine administration and onset of symptomatic Bell’s Palsy may warrant further investigation. With medical and technological advancements, the ability to produce expedited, approved vaccines is now a reality as evidenced by the production of the COVID-19 Vaccines. Advancements in computational biology, protein engineering, and gene synthesis along with new manufacturing platforms have allowed for the production of vaccines with speed and precision [1] . In addition to the known minor risks associated with vaccine administration [2] , some consideration may need to be given to potential novel side effect profile with expedited vaccine production. In both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine clinical trials, incidents of Bell's Palsy were cited as medically attended adverse events (MAAE). In the Pfizer-BioNTech COVID-19 Vaccine trials, Bell's Palsy was reported by 4 vaccine participants. From Dose 1 through 1 month after Dose 2, there were 3 reports of Bell's Palsy in the vaccine group and none in the placebo group. This observed frequency of reported event is consistent with the expected background rate in the general population, which suggests that a causal relationship to the vaccine cannot be made [3] . (Figure 1 and 2) . There was left hyperacusis, which was also present back in 2018. On the 8 th , ageusia has resolved. There was no oro-facial edema or tongue furrowing this time nor in 2018. Her motor, sensory, and cerebellar examination were normal. She walked with normal gait. Prednisone and an antiviral agent were started promptly. Besides the one time that her temperature reached 99.1F, she has always been afebrile. Her symptoms began to improve by Day 14. With the dissemination of the COVID-19 Vaccine to the general population, it will be important to monitor individual response to determine side effect profile and any contraindications that may not have been previously elucidated. The Center for Disease Control and Prevention (CDC) recently updated guidelines for contraindication to the vaccine to include anyone with a history of allergic reaction to polysorbate or polyethylene glycol [7]. In this same report, the CDC stated that post-authorization safety surveillance will be important to monitor Bell's Palsy symptoms, in patients with prior episodes, following vaccine administration to further assess any potential causal association. As more of the population becomes vaccinated, more information will likely be validated. Given these considerations, the CDC recommends it is important to monitor response and report findings to the Vaccine Adverse Event Reporting System (VAERS). The current patient's response to the Pfizer-BioNTech COVID-19 Vaccine warrants some attention. With previous association found between the administration of the inactivated Influenza Vaccine and onset of Bell's Palsy symptoms, there remains the possibility of a causal association between these symptoms and the COVID-19 vaccine. The Pfizer data did not indicate if any of the 4 patients in their trial had previous history of Bell's Palsy or the time frame of these occurrences. Our patient does not have the triad of Melkersson-Rosenthal Syndrome. Generally, no particular etiologies have been identified for people with recurrent Bell's Palsy [8]. In our patient, although Bell's Palsy recurrence took place within 36 hours after the second dose of Pfizer COVID-19 vaccination, proof of association as well as exact pathophysiology await further investigation. Whether history of Bell's Palsy predisposes a person to a higher chance of recurrence after COVID-19 vaccination is also to be determined. The patient has read this draft and given us consent to submit for publication. The incident has also been reported by the vaccine administration site to the Vaccine Adverse Event Reporting System (VAERS) per FDA requirement. Rapid COVID-19 vaccine development Vaccine Adverse Events: Separating Myth from Reality Pfizer-BioNTech COVID-19 Vaccine Vaccines and Related Biological Products Advisory Committee Meeting (VRBPAC) Briefing Document December Moderna COVID-19 Vaccine Vaccines and Related Biological Products Advisory Committee Meeting (VRBPAC) Briefing Document December A potential signal of Bell's palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)--United States Use of the inactivated intranasal influenza vaccine and the risk of Bell's palsy in Switzerland The patient has read this draft (including the picture/photo) and has given us consent to submit for publication. The incident has also been reported by the vaccine administration site to the Vaccine Adverse Event Reporting System (VAERS) per FDA requirement.