Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, X-ray
Clinical narrative: booster; bleeding; attack; She still may be experiencing some symptoms and/or have flare ups; can't breath; anxiety; hurt foot; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hurt foot (twisted ankle)" (unspecified if ongoing); "Known allergies : gluten" (unspecified if ongoing), notes: Known allergies : gluten (may be self-diagnosed); "Known allergies: potential dairy/lactose sensitivity" (unspecified if ongoing), notes: Known allergies: potential dairy/lactose sensitivity; "Known allergies: potential dairy/lactose sensitivity" (unspecified if ongoing), notes: Known allergies: potential dairy/lactose sensitivity. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Product= Covid-19, Brand= Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Product= Covid-19, Brand= Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization.The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "booster"; HAEMORR HAGE (medically significant) with onset Dec2021, outcome "unknown", described as "bleeding"; MYOCARDIAL INFARCTION (medically significant) with onset Dec2021, outcome "unknown", described as "attack"; CONDITION AGGRAVATED (non-serious) with onset Dec2021, outcome "unknown", described as "She still may be experiencing some symptoms and/or have flare ups"; DYSPNOEA (non-serious) with onset Dec2021, outcome "unknown", described as "can't breath"; ANXIETY (non-serious) with onset Dec2021, outcome "unknown", described as "anxiety"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "hurt foot". The events "bleeding" and "hurt foot" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (Dec2021) unknown result; electrocardiogram: (Dec2021) unknown result; laboratory test: (Dec2021) clear; sars-cov-2 antibody test: (Dec2021) positive - but unsure; sars-cov-2 test: (Dec2021) negative; (Dec2021) positive - but unsure, notes: Regularly tested for covid at their old occupation. I believe at one point may have had an antibody test that showed positive - but unsure; (31Dec2021) positive; x-ray: (Dec2021) clear. Therapeutic measures were taken as a result of dyspnoea, anxiety. She reported at 07:36 on 30Dec2021 that they have been to the ER three times this week trying to figure out what was wrong with them and couldn't seem to find any answers. They said they were okay for right now, but would keep posted. She was 26 or 27 years old. She believed they received the Pfizer vaccine initially (not 100 percent sure), but not sure the booster received. Booster was received on the week of 13Dec2021-17Dec2021. She used to be regularly tested for covid at their old occupation. She believed at one point may have had an antibody test that showed positive - but unsure. May have been prior to initial vaccination; cannot remember the timeline. She would keep all posted in response to asking if there was anything that could be done to help her in the meantime. It does not necessarily give an indication of her physical state. She was also almost positive the first two vaccine doses were Pfizer, so indicated this information in the vaccine info in this follow-up. She reported that she was out and taking part in social activities. She still may be experiencing some symptoms and/or have flare ups, as alluded to with the "attack" she had at the movie theatre. However, she was not housebound. Post vaccination she was tested Covid. She had twisted ankle and for ER visits may have a slight dairy/lactose sensitivity, if relevant (not necessarily associated with vaccine). She updated this morning at around 09:00 - was at the ER for 17 hours (12 of which was just waiting on doctor). All labs and X rays came back clear, and she was Covid negative. She was being sent to a pulmonary doctor to see why she felt like she couldn't breathe even though her oxygen was 100%. It could possibly anxiety even though she didn't feel anxious. However, she said lately she had been clenching her teeth a lot so she knew her body was very tense. She in general felt like she couldn't get a good breath in and has had difficulties breathing but the doctors could not find anything. A doctor during one of the visits gave her Xanax but it freaked her out because it slowed her breathing after she was already thinking she could not breathe. She did at least at one of her visits get a chest X-ray and EKG. She reported it was worse at night and that she had an attack while at the movie theatre. Will go to pulmonary therapist next month. On an unspecified date in Dec2021, results of tests and procedures for investigation of the patient was Negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  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.