Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobinuria, Heavy menstrual bleeding, Migraine, Nausea, Platelet count
Clinical narrative: platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021; LDH was 2019; Alk phos was 137 mild elevated; felt poorly; AST 206 on 09Mar2021 down to 118 on 11Mar2021; red/bloody urine; red/bloody urine; migraine; Fever; nausea; diarrhea; very heavy period; Coombs negative hemolytic anemia; Hgb urine was 3+; presumed UTI; This is a spontaneous report from a contactable physician. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), second dose intramuscular, administered in the left arm on 04Mar2021 11:30 (lot number: EN6205) as single dose (at the age of 22-years-old) for COVID-19 immunisation. Medical history included rhinitis allergic. The patient has no known allergies. Concomitant medications included ibuprofen; cefuroxime; clarithromycin (MACROBID [CLARITHROMYCIN]); ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); spironolactone; acetaminophen; origanum minutiflorum oil (OREGANO OIL); tretinoin; ondansetron (ZOFRAN [ONDANSETRON]) and "Olly probiotic/prebiotic"; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2, intramuscular on the left arm on 11Feb2021 11:45 (lot number: EL9267) for COVID-19 immunisation at the age of 22-years-old. The patient did not have other vaccine in four weeks. The events started on 04Mar2021 at 11:45. Within minutes of second dose of vaccine, the patient 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 was 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 on 06Mar2021 down to 8.3 on 11Mar2021 and it appeared she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 on 11Mar2021 from 80 on 06Mar2021. WBC/diff are normal. LDH was 2019 on 10Mar2021 and improved to 1728 on 11Mar2021. Blood smear had no schistocytes, but ADAMTS13 was pending (unknown results). Her creatinine remains normal and electrolytes were largely normal. She had max AST 206 on 09Mar2021 down to 118 on 11Mar2021. Alk phos was 137 mild elevated on 09Mar2021 and was now normal. Her symptoms were slowly improving but she still felt poorly. Several other tests were pending, and they were checking daily labs. The adverse events resulted in a clinic visit and a visit to the emergency room. The patient received unspecified antibiotics twice for presumed UTI, ER visit gave fluids, Tylenol and Zofran ODT. The patient had no covid prior to vaccination. The patient was not covid tested post vaccination. The patient has not recovered from the events.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events coombs negative haemolytic anaemia and aspartate aminotransferase increased and the suspect drug BNT162B2. 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.