Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Numbness at base of skull; Bell's Palsy; Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull; This is a spontaneous report from a contactable pharmacist via medical information team. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9269), via an unspecified route of administration, administered in Arm Right on 04Mar2021 at 15:30 as a single dose for COVID-19 immunization. Medical history included osteoporosis. There were no concomitant medications. Reported that pharmacist was involved in administering the Pfizer COVID-19 vaccines at her work and due to the increase in concerns about Guillain-Barre syndrome developing with the Johnson and Johnson COVID-19 vaccine it prompted her to call Pfizer because she remembered 1 patient who was diagnosed with Guillain-Barre syndrome after receiving the second dose and she remembers 2 patients who developed Bell's Palsy after receiving their first doses of the Pfizer COVID-19 vaccines and they were not given the second doses due to these adverse events. She stated that she did report these events through the VAERS reporting system per their hospital protocol. These doses were given as outpatient. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks of vaccinations. No AE(s) following prior vaccinations. On 04Mar2021, the patient experienced bell's palsy, numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull, on an unspecified date in Jun2021, the patient experienced numbness at base of skull. Term highlighted by the reporter for Bell's palsy, Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull, Numbness at base of skull. Relatedness of drug to reaction(s)/event(s) assessed for Bell's palsy, Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull, Numbness at base of skull by method of assessment as related. All reported events were medically significant. It was reported that the patient's symptoms started around 1600-1615 on the day of their vaccine, 04Mar2021. The patient did not seek medical attention so was never formally diagnosed. Experienced numbness starting on the left side of the tongue that went up to the jaw and cheek. The numbness travelled up the left side of their face to the back of their head at the base of their skull. These symptoms lasted for about 48 hours and they were recovered completely. About a month ago, in June, the patient experienced the same kind of numbness at the base of their skull. It lasted for a couple of hours and then was gone. No AE(s) require a visit to emergency Room and physician Office. The outcome of event (Bell's Palsy, Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull) was recovered on an unspecified date in Mar2021 and the outcome of event (Numbness at base of skull) was recovered on an unspecified date in Jun2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events Bell's palsy and Hypoaesthesia due to close temporal relationship. The case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021895191 same reporter/drug/event, different patient