Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lichen sclerosus, Off label use, Pyrexia
Clinical narrative: Wheezing; SOB; Temp>102; Tachycardia; Pain left face/ear; Pain left face/ear; Fatigue; white lesions on arms, inner thighs; pain/irritation vulvar; pain/irritation vulvar; Lichen Sclerosis; 3rd Booster; 3rd Booster; This is a spontaneous report from contactable nurse (patient). This 64-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171, Expiry date: Not reported), via intramuscular route into left arm on 17Aug2021 (Age at vaccination: 64-year-old) as dose 3, single (Booster dose) for COVID-19 immunization. Relevant medical history and concurrent conditions included: HTN (Hypertension), History of dermal fillers, remote history of shingles and Guttate Psoriasis and was diagnosed with suspected FMD (Foot and mouth disease) in April 2021. Concomitant medications (within 2 weeks of vaccination) included: Cholecalciferol (VITAMIN D), Acetylsalicylic Acid (BABY ASPIRIN), Niacin, Atenolol and Multi Vitamin (unspecified). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685, Expiry date: Not reported), on 16Dec2020 as dose 1, single (Age at vaccination: 63-year-old); Second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), on 06Jan2021 as dose 2, single (Age at vaccination: 63-year-old), both doses were taken via intramuscular route into left arm for Covid-19 immunization. The patient experienced suspected FMD (Foot and mouth disease) with second dose of vaccine. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Azithromycin (ZITHROMAX) and experienced allergies to it. On 17Aug2021, the patient received 3rd booster dose as off label use. On 20Aug2021, the patient had Wheezing, SOB (Short of breath), Temp greater than 102, Tachycardia, Pain left face/ear, Fatigue, developed white lesions on arms, inner thighs, pain/irritation vulvar, diagnosed with Lichen Sclerosis by performing biopsy. The patient visited Doctor or other healthcare professional office/Clinic, Emergency room/department or urgent care due to events. The lab data included: Rapid swab and PCR test (nasal swab) on 19Aug2021 resulted negative, Body temperature on 20Aug2021 noted greater than 102, and biopsy on 20Aug2021 revealed Lichen Sclerosis. The patient received treatment with Steroids, Inhaler for immediate response. Events (Wheezing, SOB (Short of breath), Temp greater than 102, Tachycardia, Pain left face/ear, Fatigue, developed white lesions on arms, inner thighs, pain/irritation vulvar, diagnosed with Lichen Sclerosis) were assessed as serious (medically significant). The patient was under treatment (unspecified) for Lichen Sclerosis at the time of reporting. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Wheezing, Pyrexia, Dyspnoea, Tachycardia, Facial pain, Ear pain, Fatigue, Skin lesion, Vulvovaginal pain , Vulvovaginal discomfort, Lichen sclerosus  cannot be excluded.  The case will be reassessed if additional information becomes available. Given the nature of the events of Immunisation and Off label use, role of suspect product BNT162B2 cannot be assessed. 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.