Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Haemoglobin, Haemoglobin decreased, Haemoglobin urine, Investigation
Clinical narrative: Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar; platelets have also dropped down to 59 11Mar from 80 on 06Mar; She had a max AST 206 09Mar down to 118 11Mar; ALT 93 10Mar now 86 11Mar; Coombs negative hemolytic anemia; Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine; migraine; fever; nausea; diarrhea; This is a spontaneous report from a contactable physician. A 22-year-old female patient received second dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 04Mar2021 at 11:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included allergic rhinitis. Concomitant medications included ibuprofen (IBUPROFEN), cefuroxime (CEFUROXIME), clarithromycin (MACROBID [CLARITHROMYCIN]), ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), spironolactone (SPIRONOLACTONE), acetaminophen (ACETAMINOPHEN), ondansetron (ZOFRAN [ONDANSETRON]) and topical tretinoin, oil of oregano, Olly probiotic/prebiotic. The patient received first dose on 11Feb2021 (lot number EL9267), 11:45 AM, Intramuscular to left arm. The patient experienced coombs negative hemolytic anemia (medically significant) on 04Mar2021 at 11:45, within minutes of 2nd dose of vaccine, pt had urination of dark brown urine on 04Mar2021 11:45, migraine on 04Mar2021 11:45, fever on 04Mar2021 11:45, nausea on 04Mar2021 11:45, diarrhea on 04Mar2021 11:45, her hgb has been dropping from 11.9 06Mar down to 8.3 11Mar on 11Mar2021, platelets have also dropped down to 59 11Mar from 80 on 06Mar on 11Mar2021, she had a max ast 206 09Mar down to 118 11Mar on 11Mar2021, alt 93 10Mar now 86 11Mar on 11Mar2021. It was reported that Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which is not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar and it appears she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 11Mar from 80 on 6Mar. WBC/diff are normal. Her LDH was 2019 10Mar, improved today 1728. Blood smear had no schistocytes, but ADAMTS13 is pending. Her creatinine remains normal and electrolytes are largely normal. She had a max AST 206 9Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Alk phos was 137 mild elev 09Mar, now normal. Her symptoms are slowly improving but she still feels poorly. Several other tests are pending and we are checking daily labs right now. The patient underwent lab tests and procedures which included alanine aminotransferase: 93 (unit unspecified) on 10Mar2021, alanine aminotransferase: 86 (unit unspecified) on 11Mar2021, aspartate aminotransferase: 206 (unit unspecified) on 09Mar2021, aspartate aminotransferase: 118 (unit unspecified) on 11Mar2021, blood alkaline phosphatase: 137 (unit unspecified) on 09Mar2021, blood creatinine: normal on an unspecified date, blood electrolytes: largely normal on an unspecified date, blood lactate dehydrogenase: 2019 (unit unspecified) on 10Mar2021, blood lactate dehydrogenase: 1728 (unit unspecified) on 11Mar2021, haemoglobin: 11.9 (unit unspecified) on 06Mar2021, haemoglobin: 8.3 (unit unspecified) on 11Mar2021, haemoglobin urine: 3+ (unit unspecified) on an unspecified date, adamts-13: with pending results on an unspecified date, platelet count: 80 (unit unspecified) on 06Mar2021, platelet count: 59 (unit unspecified) on 11Mar2021 and WBC: Normal on an unspecified date. Therapeutic measures were taken as a result of the events Coombs negative hemolytic anemia, Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine, Migraine, Fever, Nausea, Diarrhea, Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar, She had a max AST 206 09Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Outcome of all the events  was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  Coombs negative hemolytic anemia and other events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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.