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Life Threatening? No
Write-up: Fetal death; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal death) in a 22-week-old male infant exposed to mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001945) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Vaccine exposure during pregnancy. No Medical History information was reported. On 09-May-2021, the mother received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the infant was diagnosed with FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The infant died on 20-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intra-uterine), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company Comment : Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case Sender''s (Case) Safety Report Unique Identifier : FR-AFSSAPS-2021061999; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case; Reported Cause(s) of Death: Unknown cause of death
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