Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Investigation, Oxygen saturation
Clinical narrative: hair loss; extreme fatigue; Spiked a fever of 102.9 less than 24 hrs after; extreme shortness of breath; coughing; bronchitis; O2 levels dropped to 90 at times; diagnosed with COVID; auto immune disease; This is a spontaneous report from a contactable Other HCP (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: EW0158) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. Known allergies: NKDA; no food allergies; seasonal allergies. Concomitant medications included losartan potassium (LOSARTIN) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had spiked a fever of 102.9 less than 24 hrs after; was diagnosed with COVID 4 days later; had extreme shortness of breath and coughing; bronchitis; O2 levels dropped to 90 at times; fever for ten days; cough lasted for several weeks; now the patient had hair loss and extreme fatigue. DR was concerned that patient may have an auto immune disease now and now patient having bloodwork done to test for this (unknown results); still have shortness of breath some days and require an inhaler when that happens. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient underwent lab tests and procedures which included body temperature: 102.9 on 14Apr2021, oxygen saturation: dropped to 90 at times on 14Apr2021, sars-cov-2 test: covid on 17Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19 (as reported).  Therapeutic measures were taken as a result of the events and included administration of steroids. The patient was considered recovered with sequelae from the events on an unspecified date in 2021.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event autoimmune disorder cannot be excluded.  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.