Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mastoid disorder, Maternal exposure during pregnancy, Off label use, Product use issue, Speech disorder
Clinical narrative: difficulty speaking; intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise; intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise; intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise; Day 1 L cheek numbness- resolved; unable to lift eyebrow-blink eyelid; unable to lift eyebrow-blink eyelid- smile symmetrically, puff cheek on left; Onset unable to drink without spilling liquid; Patient recieved COVID 19, Pfizer on 11Jan2021, Patient is pregnant (delivery date: 27Feb2021); Patient recieved COVID 19, Pfizer on 11Jan2021, Patient is pregnant (delivery date: 27Feb2021); Patient recieved COVID 19, Pfizer on 11Jan2021, Patient is pregnant (delivery date: 27Feb2021); This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EH9899) via an unspecified route of administration on Left arm on 11Jan2021 19:15, at single dose for covid-19 immunisation. Medical history included pregnancy related anemia, hemorrhoids at 32 weeks. Covid prior vaccination was reported as no. Known allergies reported was none. Concomitant medication included first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP, Lot number: 57C57) (Boostrix) on 22Dec2020 (other vaccine 4 weeks) on Left Arm for immunization. Other medications in two weeks included meclozine hydrochloride, pyridoxine hydrochloride (PNV), iron, docusate sodium (COLACE), hydrocortisone supp. Patient stated, "onset unable to drink without spilling liquid, no wrinkles, unable to lift eyebrow-blink eyelid- smile symmetrically, puff cheek on left. Day 1 L cheek numbness- resolved Day 3. Day 2 difficulty speaking, that night intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise. Day 4 able to partially puff cheek, improved again Day 6 - not fully able yet. Day 5 able to move eyelid slightly". The patient experienced 'unable to lift eyebrow-blink eyelid', 'puff cheek on left', 'onset unable to drink without spilling liquid' on 24Jan2021 19:00, 'day 1 l cheek numbness- resolved' on 25Jan2021, 'difficulty speaking' and 'intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise' on 26Jan2021. The events resulted in disability or permanent damage. No treatment was received for the events. The patient experienced exposure during pregnancy on 11Jan2021 19:15. Last menstrual date was 23May2020. The gestational period was 33 weeks. The mother (patient) was due to deliver on 27Feb2021. Outcome of 'Maternal exposure during pregnancy, third trimester', 'Drug use in unapproved population' and 'Off label use' was unknown while other events was recovering.  No follow-up attempts are possible. No further information is expected.; 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 cannot be excluded. It is noted that Drug use in unapproved population.  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.