Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Rash erythematous, Scar, Syncope
Clinical narrative: Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, she was bleeding from  that scar; hit her nose, got the scar in the nose, she was bleeding from  that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown.   Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).  The case will be reassessed should additional information become 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.