Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | Z7L7H | SYR |
vomiting; abdominal distention; cholestasis; hyperbilirubinemia; straining to stool; fetal exposure during pregnancy; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID) and described the occurrence of vomiting in a female infant exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number Z7L7H) in utero. The mother received the product for prophylaxis. The parent's medical history included allergy, atopic dermatitis, constipation, iron decreased, corona virus infection (Covid 19), gravid (Gravidity: 1), baby aspirin (oral 81 mg 1 day), caffeine (Coffee/Tea/Soda, oral 200 mg per 3.5 weeks), claritin (oral 1 pill 1 day), colace (oral 2 pill 1 day), cyclosporine (Oral 1 pill 1 day), dupixent (subcutaneous 300mg 2months), iron (oral 325 mg 1 day), pfizer biontech covid 19 vaccine (intramuscular 1 shot 1 Total), pfizer biontech covid 19 vaccine (received on 01-FEB-2021 Intramuscular 1 shot totally), pfizer biontech covid 19 vaccine (received on 01-JAN-2021 Intramuscular 1 shot totally), prenatal vitamin (oral 1 pill 1 day) and Parity: 0 Spontaneous Abortion: 0 Theraputic Abortion: 0. On 16-MAY-2024, the 25-year-old mother received Boostrix. On 15-JUN-2024, the mother started iron 325 mg daily (325 mg daily). The action taken with iron was unknown. The infant was diagnosed with vomiting (Verbatim: vomiting) (serious criteria hospitalization), abdominal distension (Verbatim: abdominal distention) (serious criteria hospitalization), cholestasis (Verbatim: cholestasis) (serious criteria hospitalization and GSK medically significant), hyperbilirubinemia (Verbatim: hyperbilirubinemia) (serious criteria hospitalization and GSK medically significant) and ineffective straining at stool (Verbatim: straining to stool) (serious criteria hospitalization and GSK medically significant). On an unknown date, the infant experienced fetal exposure during pregnancy (Verbatim: fetal exposure during pregnancy). The action taken with iron was unknown. The outcome of the vomiting, abdominal distension, cholestasis, hyperbilirubinemia and ineffective straining at stool were not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the vomiting, abdominal distension, cholestasis, hyperbilirubinemia and ineffective straining at stool to be related to Boostrix. The company considered the vomiting, abdominal distension, cholestasis, hyperbilirubinemia and ineffective straining at stool to be unrelated to Boostrix. Pregnancy exposure: Gestation time at first exposure (Boostrix): 27 Weeks Gestation time at first exposure (iron): 31 Weeks Last Menstrual Period Date: 08-NOV-2023 Estimated Delivery/Due date: 14-AUG-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 40 weeks Delivery Type: vaginal Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3850 grams (8lbs 8oz) Apgar Scores: 8 and 9 Delivery Notes: Female baby with birth head circumference 34 cm, gestational age at delivery: 40, Date of conception: 22-NOV-2023, Estimated date of confinement: Additional Information: GSK Receipt Date: 22-JUL-2026 The mother of the patient mentioned she enrolled prospectively in the study with pregnancy exposed to Boostrix. The mother delivered a liveborn infant.; Sender's Comments: A case of Vomiting, Abdominal distension, Cholestasis, Hyperbilirubinaemia and Rectal tenesmus in a female infant, 120 days after vaccination with a dose of Boostrix, in a mother patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.
IRON