Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count normal, Facial paralysis, Full blood count normal, International normalised ratio normal, Liver function test abnormal
Clinical narrative: unilateral facial paralysis with no forehead sparing most likely secondary to Bell's Palsy; unilateral facial paralysis with no forehead sparing most likely secondary to Bell's Palsy; Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping.; This is a spontaneous report from a contactable pharmacist.    A 60-year-old female (non-pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL0142)intramuscular at single dose in the left arm on 12Jan2021 at 09:00 AM for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (DMT2), hyperlipidaemia (HLD), known allergies: Latex (unknown reaction). Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) 81mg qday (once a day); fluticasone propionate (FLOVENT) 50mcg; dextran 70, glycerol, hypromellose (GENTEAL TEARS [DEXTRAN 70;GLYCEROL;HYPROMELLOSE]); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]) 100mg qday; ketotifen 0.025% ophthalmic solution; insulin detemir (LEVEMIR); losartan 50mg qday (once a day); metformin 500mg bid (twice a day); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) 25mcg qday (once a day).  Previously the patient received the first dose of BNT162B2 (Lot Number: EJ1685) intramuscular at single dose in the left arm on 17Dec2020 for COVID-19 immunisation.   On 12Jan2021 09:00, the patient experienced unilateral facial paralysis with no forehead sparing most likely secondary to bell's palsy  (medically significant), unilateral facial paralysis with no forehead sparing most likely secondary to bell's palsy (medically significant), left upper abdominal pain after receiving covid vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included valacyclovir 1000mg tid (three times a day) and prednisone 50mg qday (once a day) x 7 days. The events were described as follows: Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell's Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid (three times a day) and prednisone 50mg qday (once a day) x 7 days.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Bell's palsy and Facial paralysis cannot be excluded.  The case will be reassessed if additional information becomes 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.