Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia, Skin abrasion
Clinical narrative: I ended up losing consciousness & fell down a flight of concrete stairs; I ended up losing consciousness & fell down a flight of concrete stairs; Body aches; Fever; Chills; Eye pain; Diarrhea; Nausea; Extreme fatigue; Extreme shortness of breath; Dizziness/ Feeling lightheaded; I have multiple facial abrasions; a deep wound sustained from my face hitting the bolts that hold the rail down; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2588), via an unspecified route of administration, administered in left arm on 20Sep2021 14:30 (at the age of 42 years) as dose 2, single for COVID-19 immunization. She also received Influenza Vaccine (INFLUENZA) via an unspecified route of administration, administered in left deltoid on 20Sep2021 (Batch/Lot number was not reported), at unspecified dose for an unspecified indication. Patient had no relevant medical history and concurrent conditions. Patient had no relevant past drug history including no known drug allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2588), via an unspecified route of administration, administered in arm right on 30Aug2021 15:00 (at the age of 42 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID- 19. Concomitant medication included Hepatitis B Vaccine (HEPATITIS-B) taken for an unspecified indication on 14Sep2021. On 21Sep2021 13:30 (day after her shot) patient had all the common side effects all morning; body aches, fever, chills, eye pain, diarrhea, nausea, extreme fatigue. By the early afternoon she was experiencing extreme shortness of breath, dizziness and feeling lightheaded. She ended up losing consciousness and fell down a flight of concrete stairs. She had multiple facial abrasions and a deep wound sustained from her face hitting the bolts that hold the rail down. This resulted in visit to Emergency room/department or urgent care but didn't prolong hospitalization. On an unspecified date patient underwent lab tests and procedures which included Head CT scan, leg and chest X-ray, EKG. The result of which are unknown. Therapeutic measures were taken because of events. Outcome of all the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported loss of consciousness cannot be completely excluded based on information provided. 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.