Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood glucose, Blood glucose decreased, Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: INTRAUTERINE GROWTH RESTRICTION; FOETAL EXPOSURE DURING PREGNANCY; LOW BLOOD SUGAR; 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 4.14 pounds, and height was 18 inches. The patient's other pre-existing medical conditions included: The patient had no birth defects, genetic or inherited disorders had been diagnosed. The patient's parent's medical history included endometriosis and polycystic ovary syndrome. Maternal obstetrical history included one previous pregnancy, resulting in a live baby. The mother had no history of tobacco, alcohol or recreational drug use. Maternal first day of the last menstrual period (LMP) was reported to be 08-AUG-2021 and the estimated delivery date (EDD) was calculated to be 15-MAY-2022. Maternal type of pregnancy was singleton. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental (parent's route of admin was not reported), batch number: 1808980 expiry: UNKNOWN) dose was not reported, (Drug start and last period: 235 days), 1 total administered on 09-SEP-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid (drug start date 09-NOV-2021) for drug used for unknown indication, and minerals nos/vitamins nos (4 to 6 times a week) for drug used for unknown indication through transplacental route. On 09-SEP-2021, the patient experienced foetal exposure during pregnancy at gestational age four weeks and four days (Reaction first and last time reported as 1 day). On 24-MAR-2022, the patient experienced intrauterine growth restriction (Reaction first and last time reported as 197 days). At gestational age 38 weeks, the mother delivered vaginally a live, full-term, female neonate. Labor was induced due to intrauterine growth restriction IUGR. The mother spent two days at the hospital for the delivery. On MAY-2022, Laboratory data included: Hearing test (NR: not provided) not reported. On 02-May-2022, the neonate was admitted in the neonatal intensive care unit (NICU) due to low blood sugar ((Reaction first and last time reported as 236 days). On 05-May-2022, low blood sugar resolved and the neonate was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 01-MAY-2022 (duration was 235 days), and low blood sugar on 05-MAY-2022 (duration was 4 days), and the outcome of intrauterine growth restriction was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy, low blood sugar, and intrauterine growth restriction as not related. Company causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy, low blood sugar, and intrauterine growth restriction was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20211155869.  This case was reassessed as serious based on additional information was received from consumer on 19-MAY-2022. The following information was updated and incorporated into the case narrative: Baby birth details, (weight, gender and length), event Small for gestational age updated to Intrauterine growth restriction. Seriousness for the event foetal exposure during pregnancy was updated. Low blood sugar added as an adverse event. Case upgraded to serious. Narrative updated accordingly.; Sender's Comments: V1: Follow up information received in the current version is regarding Baby birth details, (weight, gender and length), event Small for gestational age updated to Intrauterine growth restriction. Seriousness for the event foetal exposure during pregnancy is updated. Low blood sugar added as serious adverse event. Case upgraded to serious. Narrative updated accordingly. 20220520426-covid-19 vaccine ad26.cov2.s-intrauterine growth restriction and low blood sugar. Follow-up received regarding Clinical Details. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Considering latency of more than 6 months for reported events, Temporal relationship is not suggestive.) 20220520426-covid-19 vaccine ad26.cov2.s-foetal exposure during pregnancy. Follow-up received regarding Clinical Details. 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.