Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
hyperbilirubinemia; mother received Boostrix in pregnancy; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID) and described the occurrence of hyperbilirubinemia in a female neonate exposed to DTPa (Reduced antigen) (Boostrix) solution for injection in utero. The mother received the product for prophylaxis. The parent's medical history included allergic asthma, anxiety, asthma, hashimoto's disease, vitamin d low, atopic dermatitis, gravid (Gravidity: 2), hypothyroidism, therapeutic abortion (Therapeutic Abortion: 1), advair (150/50, inhaled 1 puff 1 day), albuterol (90mcg/actuation, inhaled 1 puff 8 months), aspirin (oral 81 mg, 1 day), caffeine (soda, oral 1 serving 1 day), doxylamine (oral 1 pill 1 day), doxylamine (oral 1 pill 14 months), dupixent (subcutaneous 300mg 2 months), flonase (asthma/allergy intranasal 1puff 14 months), iron (IV 200mg % total), iron (oral 27 mg 1 day), levothyroxine sodium (oral 175mcg 1 day), levothyroxine sodium (oral 200mcg 1 day), montelukast sodium (oral 10mg 1 day), pfizer biontech covid 19 vaccine (intramuscular 1 shot), prenatal vitamin nos (oral 2pills 1 day), sertraline hydrochloride (oral 100mg 1 day), sertraline hydrochloride (oral 150mg 1 day), vitamin b6 (oral 100mg 1 day), vitamin d (oral 2000 IU 1 day) and zyrtec allergy (oral 1 pill 1 day). On an unknown date, the 35-year-old mother received Boostrix (intramuscular), RSV vaccine (intramuscular) and RHOGAM (intramuscular). The neonate was diagnosed with hyperbilirubinemia (Verbatim: hyperbilirubinemia) (serious criteria hospitalization and GSK medically significant). On an unknown date, the neonate experienced fetal exposure during pregnancy (Verbatim: mother received Boostrix in pregnancy). The outcome of the hyperbilirubinemia was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the hyperbilirubinemia to be related to Boostrix and RSV vaccine. The reporter considered the hyperbilirubinemia and fetal exposure during pregnancy to be not reported if related to RHOGAM. The company considered the hyperbilirubinemia to be unrelated to Boostrix and RSV vaccine. The company considered the hyperbilirubinemia and fetal exposure during pregnancy to be not reported if related to RHOGAM. Pregnancy exposure: Pregnancy Exposure (Boostrix): To foetus directly in utero Pregnancy Exposure (RSV vaccine): To foetus directly in utero Pregnancy Exposure (RHOGAM): To foetus directly in utero Last Menstrual Period Date: 25-MAR-2024 Estimated Delivery/Due date: 30-DEC-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 38 weeks and 3 days Delivery Type: vaginal Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3147 grams (6lbs 15oz) Apgar Scores: 6 and 8 Delivery Notes: she delivered a liveborn infant at gestational age at delivery: 38.43 female baby with birth weight 3147 gm, birth length 48.26 cm, birth head circumference 35.56 cm Additional Information: GSK Receipt Date: 22-JUL-2026 The mother of the patient exposed to Flu vaccine NOS on 07-OCT-2024 via intramuscular, 1 shot and coffee from 25-MAR-2024 to 09-DEC-2024, oral 1 serving 1 day. The batch number was not provided and request for this information has been made.; Sender's Comments: A case of Hyperbilirubinemia, unknown time after vaccination with Boostrix and RSV vaccine, in a female neonate. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
RHOGAM