Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Haemoglobin, Haemoglobin decreased, Haemorrhage, Serum ferritin
Clinical narrative: Miscarriage 9 days later; blood loss that lasted until 2022, with clots the size of a softball. I lost points of blood daily and wore adult diapers (8-10) daily to contain blood loss.; blood loss that lasted until 2022, with clots the size of a softball. I lost points of blood daily and wore adult diapers (8-10) daily to contain blood loss.; Hemoglobin eventually hit a 7; ferratin a 4; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient (pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EW0178), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "hospitalisation" (ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Vaccination history included: BNT162b2 (Dose 1, Lot number: EW0176, Vaccine location=Left arm), administration date: 29Apr2021, for COVID-19 Immunisation, reaction(s): "exposure during pregnancy". The following information was reported: HAEMOGLOBIN DECREASED (prolonged hospitalization, disability, life threatening) with onset 29May2021, outcome "unknown", described as "Hemoglobin eventually hit a 7"; ABORTION SPONTANEOUS (prolonged hospitalization, disability, medically significant, life threatening) with onset 29May2021, outcome "unknown", described as "Miscarriage 9 days later"; HAEMORRHAGE (prolonged hospitalization, disability, medically significant, life threatening), THROMBOSIS (prolonged hospitalization, disability, medically significant, life threatening) all with onset 29May2021, outcome "recovered" (2022) and all described as "blood loss that lasted until 2022, with clots the size of a softball. I lost points of blood daily and wore adult diapers (8-10) daily to contain blood loss."; SERUM FERRITIN DECREASED (prolonged hospitalization, disability, life threatening) with onset 29May2021, outcome "unknown", described as "ferratin a 4". The events "miscarriage 9 days later", "blood loss that lasted until 2022, with clots the size of a softball. i lost points of blood daily and wore adult diapers (8-10) daily to contain blood loss.", "hemoglobin eventually hit a 7" and "ferratin a 4" required physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion. The patient underwent the following laboratory tests and procedures: Haemoglobin: (29May2021) 7; Serum ferritin: (29May2021) 4. Therapeutic measures were taken as a result of abortion spontaneous, haemorrhage, thrombosis, haemoglobin decreased, serum ferritin decreased. Additional information: The patient was a cross fit, iron man athlete, and was part of a junior Olympic team. The vaccination of second dose of BNT162B2 was administered in a Pharmacy or drug store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that 9 days after the second dose vaccination, the patient experienced miscarriage. There was a blood loss with clots the size of a softball that lasted until 2022. The patient lost points of blood daily and wore adult diapers (8 to 10 daily) to contain the blood loss. The patient's hemoglobin eventually hit a 7 and ferratin was 4. The patient qualified for 2 blood transfusions, 2 iron transfusions and got another round of iron transfusions but the doctors continuously brushed her under the rug. The patient received third dose COVID-19 vaccine (Moderna ; lot number: 083J21A) on 11Feb2022 in the left arm.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be 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.