Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Investigation, Musculoskeletal discomfort, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell were affected; This is a spontaneous report from a non-contactable other healthcare professional (patient).  A 54-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported) administered in Arm Right in Feb2021 as 2nd single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 in Jan2021 (at the age of 54years) for Covid-19 immunization. Medical history included lupus, fatty liver disease (genetic, not caused by any other issues), asthma, heart disorder, rheumatoid arthritis, various food allergy, latex allergy, and allergic to Sulfa drugs; all from an unknown date and unknown if ongoing. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for an unspecified indication and salbutamol (ALBUTEROL) for asthma; start and stop date of both were not reported. The patient previously took Phenergan and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Feb2021, the patient experienced pain in the right arm following the 2nd dose that never went away, and instead got a lot worse. It has affected her rotator cuff and required a cortisone injection. In 6 weeks, if that has not worked, further testing will be done beyond the X-ray on an unspecified date. Also, following the 2nd dose, her taste and smell were affected, and she has not been able to handle the taste of coffee. She added that she has Lupus and genetic fatty liver disease. The hepatologist had her drinking coffee for that reason. The only thing off on her blood work related to not being able to drink the coffee (as reported). The patient also mentioned that she was having difficulty working at this point in time, because she works at a computer and it's affecting the arm she uses for the mouse. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with cortisone injection and X-ray. She also has tested negative to Covid 19, and negative to the antibodies in Mar2021. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-event temporal association, the company cannot completely exclude a causal relationship between BNT162b2 administration and the onset of the reported, serious events. The event 'pain in extremity' is also expected in the safety profile of the suspect product.  The impacts 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.