Received Jul 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | H4K3S | — |
mother received Boostrix and flu vaccine; small Ventricular Septal Defect; small-to-moderate Patent Ductus Arteriosus; Patent Foramen Ovate; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID 187178) and described the occurrence of ventricular septal defect in a female neonate exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number H4K3S) in utero. The mother received the product for prophylaxis. The parent's medical history included cold (had on 31-JAN-2025 and end on 05-FEB-2025), influenza (had on 31-JAN-2025 and end on 05-FEB-2025), choline (received on 01-FEB-2025 for baby brain development with route of administration orally and dose is 500mg), dha (received on 01-FEB-2025 for baby brain development with route of administration orally and dose is 2 pills), iron (received on 01-FEB-2025 for low levels with route of administration orally and dose is 55mg), lexapro (received on 01-JAN-2025 and stopped on 30-JAN-2025 with route of administration orally and dose is 10mg), magnesium (received on 01-FEB-2025 for muscle support with route of administration oral and dose is 250mg) and Received Coffee on 01-JAN-2025 with route of administration oral and the dose is 75mg, cold plus flu product on 31-JAN-2025 and stopped on 31-JAN-2025 with route of administration oral and dose is 2 pills, GAS-X on 01-FEB-2025 and stopped on 15-FEB-2025 for bloat with route of administration oral and dose is 125mg. Nyquil Liquil Liquicaps (new for 11/2005) on 31-JAN-2025 and stopped on 01-FEB-2025 for flu with route of administration oral and dose is 2 Pills, Prenatal vitamin on 01-FEB-2025with route of administration oral and dose is 3 pills and prebiotic on 01-FEB-2025 for gut health with route of administration oral and dose is 1 pills. On 10-SEP-2025, the 34-year-old mother received Boostrix (transplacental) and Flu vaccine (transplacental). The neonate was diagnosed with ventricular septal defect (Verbatim: small Ventricular Septal Defect) (serious criteria GSK medically significant and congenital anomaly), patent ductus arteriosus (Verbatim: small-to-moderate Patent Ductus Arteriosus) (serious criteria GSK medically significant and congenital anomaly) and foramen ovale patent (Verbatim: Patent Foramen Ovate) (serious criteria congenital anomaly). On an unknown date, the neonate experienced fetal exposure during pregnancy (Verbatim: mother received Boostrix and flu vaccine). The outcome of the ventricular septal defect and patent ductus arteriosus were resolved and the outcome of the foramen ovale patent was not resolved and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the ventricular septal defect, patent ductus arteriosus and foramen ovale patent to be related to Boostrix and Flu vaccine. The company considered the ventricular septal defect, patent ductus arteriosus and foramen ovale patent to be unrelated to Boostrix and Flu vaccine. Pregnancy exposure: Gestation time at first exposure (Boostrix): 36 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Flu vaccine): 36 Weeks Pregnancy Exposure (Flu vaccine): To mother in third trimester Last Menstrual Period Date: 01-JAN-2025 Estimated Delivery/Due date: 06-OCT-2025 Pregnancy Details (Neonate 1): Actual Delivery Date: XX-OCT-2025 Gestation Time at Delivery: 39 weeks and 6 days Delivery Type: vaginal Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3500 grams (7lbs 11oz) Apgar Scores: 8 and 9 Delivery Notes: Gestational age at delivery is 40.14, Birth length is 50.8cm and Birth head circumference is 33, Gravidity: 2, Parity: 0, Spontaneous Abortion: 0, Therapeutic Abortion: 1 Additional Information: GSK Receipt Date: 23-JUN-2026 The date of conception was reported as 13-JAN-2025. On 08-OCT-2025 providers at the delivery hospital noted a heart murmur in the infant. At a pediatric clinic visit on 17-DEC-2025 it was noted that the child had been seen by the pediatric cardiology service and that everything was cleared except for the patent foramen ovate, which she would return to check at 3 years old. The mother patient parent was withheld and race was withheld.; Sender's Comments: Ventricular septal defect, Patent ductus arteriosus and Atrial septal defect, 29 days after vaccination with Boostrix in a female neonate patient. Case lacks further information on concurrent conditions and laboratory data. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Test Date: 20251009; Test Name: Echocardiogram; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Comments: showed a small Ventricular Septa! Defect, a small-t0-moderate Patent Ductus Arteriosus,; Comments: LabComments: Echocardiogram 09-OCT-25: showed a small Ventricular Septa! Defect, a small-t0-moderate Patent Ductus Arteriosus,