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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 1||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Bell's palsy
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? Yes
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Other Medications: METFORMIN
Current Illness: Diabetes (treated with metformin.)
Diagnostic Lab Data:
CDC 'Split Type': PEPFIZER INC2021709676
Write-up: Bell''s palsy; This is a spontaneous report from a contactable physician (patient''s brother-in-law) received through Medical Information Team. A 62-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was unknown), intramuscular on 30May2021 as first dose, single dose (at the age of 62-year-old) for COVID-19 immunisation. Medical history included ongoing diabetes from 2018 (start date reported as: 3 years ago). Concomitant medications included ongoing metformin at 850 mg, oral, 1 daily, taken for diabetes mellitus from 2018 (start date reported as: 3 years ago). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. After 8 days, on 03Jun2021, the patient started to experience right-sided facial paralysis, which was diagnosed as Bell''s palsy by a neurologist. The neurologist considered that the event might be related to the vaccine; therefore, the reporter wanted to know if the patient should receive the second dose of the vaccine or what to do. Reporter (physician) described the event as abrupt onset: the day before (02Jun2021), the patient was normal; then, he went to sleep and the following day (03Jun2021) he noticed difficulty in spitting. On 05Jun2021, the patient was seen by a neurologist, who, based on the physical examination and the symptoms, diagnosed the patient with Bell''s palsy. The neurologist indicated the following oral treatment: prednisone for 5 days; acyclovir for 7 days; DUO CVPK. The patient started the treatment indicated by the neurologist on 05Jun2021 and 3 or 4 days after starting the treatment, improvement was evidenced. At the time of this report, the patient was recovered at 70%: the patient still has the right face down, the pain disappeared, and he could close the right eye. The neurologist considered that the event might be related to the vaccine. Reporter further wanted to know if the patient should receive the second dose of the vaccine or what to do. The outcome of event was recovering. Information on the lot/batch number has been requested.; Sender''s Comments: Based on close temporal relationship the causal association between the reported event bell''s palsy with the usage of the vaccine BNT162B2 cannot be excluded. The case will be reassigned if there is any new information 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 RAs, Ethics Committees, and Investigators, as appropriate.
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