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Write-up: BLOOD CLOT; BROKE TAIL BONE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report was received from a pharmacist via a company representative, and concerned an approximately 40 year old female. The patient''s height, weight, and medical history were not reported. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of administration not reported, batch number: unknown) dose and vaccination site were not reported, administered in 2021 for prophylactic vaccination. No concomitant medications were reported. In 2021, the patient experienced vaccine exposure during pregnancy. The date of the patient''s last menstrual period and expected delivery date were not provided. In 2021, the patient experienced broke tail bone during labor and gave birth (live birth). On an unspecified date in 2021, the patient experienced a blood clot and died. It was noted that she was at high risk for clots because she was 4 weeks post partum (gravida 1, para 1). Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. The patient died of a blood clot and broke tail bone in 2021; the outcome of vaccine exposure during pregnancy was not reported. It was unspecified if an autopsy was performed. This report was serious (Death). This case, from the same reporter is linked to 20210430297.; Sender''s Comments: V0: The case concerns a pregnant female subject around age of 40, who developed thrombosis, skeletal injury and exposure during pregnancy an unspecified time after Janssen COVID-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The subject''s past medial history, last menstrual period, estimated date of delivery and concomitant medications were not provided. Per the reporter (pharmacist) the patient was at a high risk for blood clots because she was 4 weeks post-partum. The patient broke her tail bone during the labor, gave a birth, and later died of a blood clot. No additional information was provided. It is not known whether the autopsy was performed. Given alternative explanation and risk factors of pregnancy, labor and skeletal injury (trauma) the event of thrombosis is considered inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization. Events of skeletal injury was result of an accident and therefore not considered related. Company causality for event of thrombosis is considered not related to Janssen COVID-19 vaccine (Level 4 -Insufficient information available to confirm a possible, probable or a definitive case of venous thrombosis, per the Brighton Collaboration case definition); Reported Cause(s) of Death: BLOOD CLOTS; BROKE TAIL BONE
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