Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Intestinal perforation, Premature baby
Clinical narrative: INTESTINAL PERFORATION; PREMATURITY; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate. The patient was enrolled in a non-company sponsored study.The patient's weight was 5.8 pounds, and height was not reported. The patient's other pre-existing medical conditions included: The neonate birth weight was 3 pounds 1 ounce. The patient's parent's medical history included: mother had no history of using drugs for recreational use or tobacco during pregnancy and used alcoholic beverage once per month prior to knowing she was pregnant. The mother had a medical history of hyperthyroidism. The maternal obstetrical history included two previous pregnancies which resulted in two live babies. On 19-JUL-2021, the mother had developed HELLP syndrome. The mothers body mass index was 28.09. The patient's parent initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUN-2021) dose was not reported (Dose Number in Series: 1), 1 total administered on 31-MAR-2021 for covid-19 immunisation. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos (prenatal vitamins) On 31-MAR-2021, the patient experienced foetal exposure during pregnancy. On JUL-2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) baby passed hearing test, and Cardiac function test (NR: not provided) babys heart is fine. The patients mother delivered premature live female neonate (prematurity) by caesarean method of delivery. On 23-JUL-2021, the patient underwent surgery due to intestinal perforation. The neonate spent more than ten days in the hospital after birth and was in neonatal intensive care unit due to prematurity. On 13-SEP-2021, the baby's weight was 5 pounds 8 ounces. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and intestinal perforation, prematurity, and foetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210761753.; Sender's Comments: V0: 20211156274-covid-19 vaccine ad26.cov2.s-intestinal perforation. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211156274 - covid-19 vaccine ad26.cov2.s prematurity. This event(s) is considered not related. 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 20211156274  - covid-19 vaccine ad26.cov2.s- Foetal exposure during pregnancy. This event(s) is considered not related. 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.