Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Thrombosis, Vaccination site pain
Clinical narrative: Caller made mention to blood clots being reported with the Moderna vaccine; Fever; headache; fatigue; pain at vaccination siye; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Caller made mention to blood clots being reported with the Moderna vaccine) 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.     The patient's past medical history included Blood transfusion (Caller states her condition can affect her platelets and white blood cells.). Previously administered products included for Drug use for unknown indication: Pfizer Covid Vaccine (First vaccine) and Pfizer Covid Vaccine (second dose). Past adverse reactions to the above products included No adverse event with Pfizer Covid Vaccine and Pfizer Covid Vaccine. Concurrent medical conditions included Chronic anemia (she has a condition called atypical chronic anemia in which her bone marrow, occasionally does not make blood cells).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Caller made mention to blood clots being reported with the Moderna vaccine) (seriousness criterion medically significant), PYREXIA (Fever), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at vaccination siye). At the time of the report, THROMBOSIS (Caller made mention to blood clots being reported with the Moderna vaccine), PYREXIA (Fever), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at vaccination siye) outcome was unknown.            Caller states her condition can affect her platelets and white blood cells. Caller also states that in the past, she had some side effects with different vaccines. Caller says with the Hepatitis B vaccine she had a104.5 degree temperature, with the MMR she almost lost consciousness at work and had a 104 degree temperature, with Tetanus she developed a 104 degree temperature and had big welts on her arm that lasted for a week. Caller states she often gets the rare and severe symptoms. Caller says that she did not have any of these symptoms with her first and second dose of the Pfizer Covid Vaccine.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of unspecified age with relevant medical history of Anemia reported, who experienced the unexpected serious (medically significant) AESI of Thrombosis that occurred in the context of mRNA-1273 vaccination (booster dose). Latency cannot be assessed since vaccination date was not disclosed. Patient had received initial two doses of TOZINAMERAN on unknown dates. No further information on clinical course and treatment received was available in the report. Outcome of the event was not known at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with relevant medical history of Anemia reported, who experienced the unexpected serious (medically significant) AESI of Thrombosis that occurred in the context of mRNA-1273 vaccination (booster dose). Latency cannot be assessed since vaccination date was not disclosed. Patient had received initial two doses of TOZINAMERAN on unknown dates. No further information on clinical course and treatment received was available in the report. Outcome of the event was not known at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement