Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Nausea, Pain, Photophobia, Pyrexia
Clinical narrative: headache; arm pain injection site; nausea; chills; fever  the highest it ran was 103.5; severe inner ear pain; eardrums were bulging on both sides and red; eardrums were bulging on both sides and red; I was completely exhausted zero strength could not tolerate light; my left eye was swollen; lymph nodes have swelled up all over my body in places that I did not even know I had lymph nodes that are very tender to touch.; Body aches especially in neck and head.; Body aches especially in neck and head.; This is a spontaneous report from a contactable consumer, other healthcare professional (the patient). A 47-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunization. Medical history included polycystic ovaries, Known allergies Penicillin. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration ad-ministered in left arm on 26Feb2021 22:30 as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had allergies with penicillin. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 05:00 pm, the patient had headache arm pain injection site nausea chills then fever the highest it ran was 103.5 lasting from Wednesday through Saturday. Causing severe inner ear pain went to urgent care they said her eardrums were bulging on both sides and red, she was completely exhausted zero strength could not tolerate light for 3 days her left eye was swollen and lymph nodes have swelled up all over her body in places that she did not even know she had lymph nodes that are very tender to touch. Body aches especially in neck and head. The adverse event resulted patient to emergency room/department or urgent care visit. The patient received treatment. They put her on Voltaren 75 mg for ear pain. Outcome of the event at the time of last observation was not recovered.   Follow-up attempts are needed. Further information is requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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