Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Haemorrhage, Interchange of vaccine products
Clinical narrative: Bleeding; GI events; Pfi zer COVID-19vaccine primary series and booster dose Moderna; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (Bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (GI events) and INTERCHANGE OF VACCINE PRODUCTS (Pfi zer COVID-19vaccine primary series and booster dose Moderna). At the time of the report, HAEMORRHAGE (Bleeding) and GASTROINTESTINAL DISORDER (GI events) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Pfi zer COVID-19vaccine primary series and booster dose Moderna) outcome was unknown.            No concomitant medication were reported. It was reported that patient experienced GI events and bleeding after receiving the Pfizer COVID-19 vaccine primary series. She expressed that this also continued after switching to Moderna for her booster dose and didn't resolved. No treatment medication were reported.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhage, unknown days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with Pfizer COVID 19 vaccine, with no reported adverse events. Interchange of vaccine products was noted. The patient also reported of gastrointestinal disorder along with the event. No further information on details of immunization schedule, risk factors, co morbidities, detailed clinical course, investigations and treatment details of the event was available in the report. The event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhage, unknown days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with Pfizer COVID 19 vaccine, with no reported adverse events. Interchange of vaccine products was noted. The patient also reported of gastrointestinal disorder along with the event. No further information on details of immunization schedule, risk factors, co morbidities, detailed clinical course, investigations and treatment details of the event was available in the report. The event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.