Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12 decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (nurse). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number: EL3246, administration time 12:00 PM, vaccine location: Left arm), administration date: 11Jan2021, when the patient was 49 years old, for COVID-19 immunization. There were no other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: SJOGREN'S SYNDROME (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "Worsening Sjogren's"; PYREXIA (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "high fever"; MIGRAINE WITH AURA (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "Severe migraines with auras"; PARAESTHESIA (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "paresthesias"; FATIGUE (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "fatigue"; PAIN (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "body aches"; HYPERHIDROSIS (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "sweats"; IRON DEFICIENCY ANAEMIA (medically significant), VITAMIN B12 DECREASED (medically significant) all with onset Jul2021, outcome "unknown" and all described as "Iron deficiency anemia with low vitamin B12 first detected Jul2021"; APHASIA (medically significant) with onset 01Feb2021 12:00, outcome "not recovered", described as "dysphasia"; HYPERTENSION (medically significant) with onset Jun2021, outcome "unknown", described as "Developed hypertension in Jun2021"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), outcome "unknown", described as "POTS"; FLUSHING (medically significant), outcome "not recovered", described as "flushing"; GENERAL PHYSICAL HEALTH DETERIORATION (medically significant), outcome "unknown", described as "drastic decline in health". The events "worsening Sjogren's", "high fever", "severe migraines with auras", "paresthesias", "fatigue", "body aches", "sweats", "iron deficiency anemia with low vitamin B12 first detected Jul2021", "iron deficiency anemia with low vitamin B12 first detected Jul2021", "dysphasia", "developed hypertension in Jun2021", "pots", "flushing" and "drastic decline in health" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin B12: (Jul2021) low. Therapeutic measures (Iron infusion, multiple B12 injections, labs, meds) were taken as a result of Sjogren's syndrome, pyrexia, migraine with aura, paraesthesia, fatigue, pain, hyperhidrosis, iron deficiency anaemia, vitamin B12 decreased, aphasia, hypertension, postural orthostatic tachycardia syndrome, flushing, general physical health deterioration. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 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 product and on the conduct of the study 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.