Sex: F
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: INFANT DELIVERED AT 36 WEEKS AND TWO DAYS; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate of an unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.061 kilograms, and height was not reported. No concurrent conditions were reported. The patient's mother's estimated delivery date (EDD) was calculated to be 25-FEB-2022. On 02-OCT-2021 gestational age was 19 weeks and one day. On date, at gestational age 36 weeks and two days, the mother delivered vaginally a live, pre-term, female neonate. The reason for mother's pre-term labor was reported to be gestational diabetes, pre-existing high-blood pressure, pre-eclampsia, and gallbladder inflammation along with induced labor due to elevated liver enzymes and gallbladder inflammation. The mother spent four days in the hospital for the delivery. The mother past medical history included: miscarriage of pregnancy (1 miscarriage), and artificial insemination, and concurrent conditions included: multigravida (2 past pregnancies / 1 live baby), blood pressure high, body mass index increased, non-tobacco user, abstains from alcohol, and abstains from recreational drugs. The patient's mother's experienced joint pain, chills, sore arm, gallbladder inflammation, gestational diabetes, premature delivery, pre-eclampsia, whole body type iv allergic rash and severe iron deficiency after vaccination with covid-19 vaccine ad26.cov2.s. On 02-OCT-2021 (at gestational age was 19 weeks and one day), The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 02-OCT-2021 for covid-19 immunization. Concomitant medications included acetylsalicylic acid, prenatal vitamins and famotidine.  02-OCT-2021, the patient experienced foetal exposure during pregnancy. On date (at gestational age 36 weeks and two days), the patient's mother's delivered vaginally a live, pre-term, female neonate. The mother spent four days in the hospital for the delivery. The neonate's birth weight was 6 pounds and 12 ounces, body length unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the foetal exposure during pregnancy and infant delivered at 36 weeks and two days was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and infant delivered at 36 weeks and two days, and foetal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211142332.; Sender's Comments: V0: 20220929959-covid-19 vaccine ad26.cov2.s- Infant delivered at 36 weeks and two days. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (maternal medical history of advanced maternal age,  blood pressure high, body mass index increased, and events experienced by mother during pregnancy like Gall bladder inflammation, Gestational diabetes, Pre-eclampsia are risk factors for premature birth). Therefore, this event(s) is considered not related.  20220929959-covid-19 vaccine ad26.cov2.s- Fetal exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.