Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Melaena, Red blood cell scan, SARS-CoV-2 test
Clinical narrative: systolic BP 88; Hemoglobin (Hgb) on admission was 8 (prior was 11); Bleeding; 4 hours after vaccine large black tarry stools; lightheaded/feeling dizzy; vomited light brown vomitus; This is a spontaneous report from a contactable nurse (patient) via program. A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 03Mar2021 10:00 (Batch/Lot Number: EN6205) as dose 1, single dose for COVID-19 immunization. Medical history included hypertension (HTN), hyperlipidemia and seasonal allergy. Concomitant medications included amlodipine; candesartan; montelukast; simvastatin; and ascorbic acid; zinc (reported as vit c with zinc); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 03Mar2021, 12:00 PM 2 hours after vaccine the patient experienced lightheaded and vomited light brown vomitus. At 14:00 4 hours after vaccine large black tarry stools. Overnight large black tarry stools total to maybe 4. On 04Mar2021 04:00 took blood pressure (bp) - systolic BP 88, lightheaded, feeling dizzy. At around 05:00 decided to call ambulance, not allowing spouse to drive her to the hospital as she started to be symptomatic. Hemoglobin (Hgb) on admission was 8 (prior was 11), given 2 units of packed red blood cells (PRBC) right away. Since the patient had nothing to eat midnight of 04Mar2021 she had upper endoscopy done right away with a negative (-) result. Colonoscopy, still with black tarry stools occasional bloody, was negative. Hemoglobin and hematocrit (H&H) trended, hgb went down to as low as 6.5, total units PRBC received was 6. Bleeding scan was negative. The patient was on pantoprazole (PROTONIX) IVP & IVF while admitted and ice chips. Bleeding stopped on an unspecified date and was discharged on 08Mar2021. On 15Mar2021 capsule endoscopy was negative. The patient reported that she also received blood transfusions as treatment. Since the vaccination, the patient has been tested for COVID-19 in 03May2021 with a negative nasal swab. The patient considered the events to be serious requiring emergency room visit, hospitalization and life-threatening events. The patient recovered from bleeding in Mar2021 and recovered from the remaining events on an unspecified date in 2021.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of Dizziness, Discoloured vomit, Melaena, Blood pressure systolic decreased, Haemoglobin decreased, Bleeding cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes 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.