Sex: U
Vaccine: COVID19
Symptoms: Death neonatal, Foetal exposure during pregnancy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) in a  neonate of an unknown age and gender exposed to mRNA-1273 (Spikevax), while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy. No Medical History information was reported. On an unknown date, the mother received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the neonate was diagnosed with DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) (seriousness criteria death, hospitalization and medically significant) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The neonate was diagnosed with DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. The neonate died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) had resolved. No concomitant and treatment information were reported. Company comment: This spontaneous case concerns a neonate with no reported medical history, who experienced unexpected, fatal (hospitalization, medically significant) event of Death neonatal which occurred at an unknown time with regards to the mRNA-1273 vaccination. Fetal exposure during pregnancy was also noted. The caller inquired if mRNA-1273 has trials with pregnant women. The caller also claims that people are dying, and three babies died in the hospital, with two still born and one was brought to the intensive care unit. The cause of death is unknown, and no autopsy report was given. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-586147 (Patient Link). Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a neonate with no reported medical history, who experienced unexpected, fatal (hospitalization, medically significant) event of Death neonatal which occurred at an unknown time with regards to the mRNA-1273 vaccination. Fetal exposure during pregnancy was also noted. The caller inquired if mRNA-1273 has trials with pregnant women. The caller also claims that people are dying, and three babies died in the hospital, with two still born and one was brought to the intensive care unit. The cause of death is unknown, and no autopsy report was given. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.