Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, C-reactive protein, Computerised tomogram, Guillain-Barre syndrome
Clinical narrative: Developed Guillian Barre Syndrome with Miller Fisher variant; Bell's palsy; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received the second dose of BNT162B2 (BNT162B2, lot number was not reported), intramuscular, on 08Jan2021 at a single dose for COVID-19 immunisation. He received the vaccine at a school/student health clinic. The patient did not have COVID prior to vaccination. He did not receive any other vaccines 4 weeks prior to receiving BNT162B2. Medical history included hypertension and hypercholesterolemia, both were from unspecified dates and ongoing. Concomitant medications included ramipril (ALTACE) for hypertension, rosuvastatin calcium (CRESTOR) for hypercholesterolemia, acetylsalicylic acid (ASPIRIN), loratadine (LORATIDINE), evolocumab (REPATHA) for hypercholesterolemia. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number was not reported), intramuscular, on 18Dec2020 for COVID-19 immunisation, at the age of 65-year-old. It was reported that patient developed Guillian Barre Syndrome with Miller Fisher variant 10 days (as reported) after receiving the 2nd dose of the COVID vaccine on 18Jan2021. He lost the ability to use his hands/legs. He received 2 g/kg of IVIG over 4 days starting on 21Jan2021. At the time of initial report (02Mar2021), he was recovering in an inpatient rehab center. The patient also experienced Bell's Palsy on 24Jan2021. The patient further reported that all started with a headache on 18Jan2021 and then he began to lose the ability to use his hands and legs. So, he visited the ER (emergency room) on 20Jan2021 and got hospitalized. On 22Jan2021, he was completely unable to walk. On 24Jan2021, he was also diagnosed with Bell's Palsy which was still ongoing at the time of report. The patient stated that he just got out of the inpatient rehab center on 03Mar2021. At the time of follow-up report (04Mar2021), he stated that he feels better but it is not recovered yet. The patient had undergone laboratory tests and procedures on 20Jan2021 which includes: Blood test: normal, Urine test: normal, CR Protein: elevated, Covid19 test: negative, CT (computer tomography) Scan: normal, MRI (magnetic resonance imaging): normal. It was reported that adverse event Guillain Barre Syndrome with Miller Fisher variant required visit to ER. The patient was hospitalized for Guillian Barre Syndrome with Miller Fisher variant from 20Jan2021 to 03Mar2021. The patient received treatment for Guillian Barre Syndrome with Miller Fisher variant, while he did not receive any treatment for Bell's palsy. Outcome of the event Guillian Barre Syndrome with Miller Fisher variant was recovering, while outcome of Bell's Palsy was not recovered.   Information on batch/lot number was requested.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events  Guillian Barre Syndrome with Miller Fisher variant and Bell's palsy cannot be excluded.  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.