Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Immune thrombocytopenia, Pain in extremity
Clinical narrative: immune thrombocytopenia; bleeding out of right nostril like a fountain; sore arm; This is a spontaneous report from a contactable nurse. A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number EN6199, Expiry date not reported) dose 1 via intramuscular route of administration in left arm on 03Mar2021 (at age of 70-years-old) as single dose for COVID-19 immunisation. Patient medical history include blood pressure, cholesterol. Patient previously took historical vaccine include the flu vaccine, tetanus booster and shingles vaccine experienced sore arm. The patient's concomitant medications were not reported. Patient reported that she had severe reaction to Bactrim. She broke out in hives and had anaphylactic shock. She had to get 2 injections with a hypo, a big needle, they gave her a big needle in the butt. NDC, lot, expiry for Bactrim unknown. She reports the first 2 times she was administered Bactrim, for a bad UTI (urinary tract infection) the first 2 times she didn't have any problems. It was the 3rd time she took the Bactrim her lips swelled, her face swelled, she had itching and heat. It was years apart that she took the third dose of Bactrim from the second dose of Bactrim. Patient concomitant medications were not reported. She reported that she had some over the counter supplements. She takes her cholesterol medication every other day. Patient did not receive any other vaccine within 4 weeks prior vaccinations. Caller reported that she had her first vaccine on 03Mar2021. On 09Mar2021 06:30 (6 days 6 hrs 30 min after vaccination) Patient experienced she started bleeding out of her right nostril like a fountain. This has never happened before. The bleeding lasted about 4-5 minutes. She used compression and leaned her head back. Her sister looked it up and found immune thrombocytopenia. The caller is asking if the Covid 19 vaccine has attacked her blood platelets. Her sister looked it up and there was one person who had this and they died, they hemorrhaged. Caller reports she is shaking, she is fearful. She reached out to her primary health care doctor, and they want her to come to the office to get a blood test. They would know immediately if it was affecting her platelets. The nosebleed could have been just dry air. Her eyes were dry this morning, but it never happened before it happened, and she couldn't believe her eyes it was running out of her nose. She states she had a sore arm. Her arm hurt for a day maybe an afternoon. Patient received treatment for nosebleed by compression and leaning head back. Patient was supposed to get her 2nd Covid 19 vaccine on 23Mar2021 and that's something else she needs to know, about getting the second vaccine. When querying seriousness, states she is concerned about getting the second vaccine. It was reported that the relatedness of Covid 19 Vaccine for bleeding out of right nostril like a fountain was unknown; sore arm was related through primary source of reporter by global introspection. The Outcome of the events was nosebleed was recovered on 09Mar2021; sore arm recovered on 04Mar2021; Immune thrombocytopenia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Immune thrombocytopenia " and suspected vaccine BNT162B2 cannot be completely excluded, but consider also possible contributory effects from the confounding factors of patient medical history and/or concomitant medications and being geriatric age group.  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.