Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pemphigus
Clinical narrative: extreme tiredness; sore arm; slight headache; exacerbation of pemphigus; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Feb2021 15:30 (Lot number: EN9809) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing); "Mucous Membrane Pemphigus", start date: 2018 (ongoing), notes: Autoimmune Diagnosis in 2019 with Biopsy, 7 blisters inside of her mouth (Feb2021), One on Each Arm (Apr2021); "High Blood Pressure" (ongoing); "High cholesterol" (ongoing), notes: Cholesterol Medication, States has been on it for 27 years. Concomitant medication(s) included: DAPSONE taken for pemphigus, start date: 2019 (ongoing); LISINOPRIL taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (dose number:1, lot number: EL1283, Time:10.30, Anatomical location: Upper left Arm muscle), administration date: 19Jan2021, when the patient was 76 years old, for covid-19 immunisation; Shingrix, administration date: Nov2020, for shingles shot; Flu shot, administration date: Dec2020. The following information was reported: PEMPHIGUS (medically significant) with onset Feb2021, outcome "unknown", described as "exacerbation of pemphigus"; FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness"; PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "sore arm"; HEADACHE (non-serious), outcome "recovered" (2021), described as "slight headache". The reporter's assessment of the causal relationship of Worsening of Mucous Membrane Pemphigus; 7 blisters inside of her mouth, Pemphigus Blisters, one on Each Arm, Slight Headaches, Tired for a Week was: [Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: Related].  Clinical course: The patient had provided the information regarding the reported adverse event with the use of the Pfizer product and had a casual effect to the adverse event. Patient had pemphigus blisters, one on each arm on Apr2021 and was ongoing as medically significant with outcome as worsened also had physician Office visit to Periodontist and Dermatologist for AE(s) Mucous Membrane Pemphigus Worsening and Pemphigus on Arms. Prior Vaccinations (within 4 weeks) other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) whereas had first shingles shot and pneumonia shot and in Dec2020, had the Flu shot also had the first Covid Shot and 3 weeks later, the second covid shot and a month after that, second Shingles shot. AE(s) following prior vaccinations where Sore Arm and it was Horrendous, had to stay in bed for 2 days.  Follow-up (24May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that: Age, medical history, event.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Pemphigus and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.