Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | KY27J | SYR |
pregnancy exposed to Boostrix; having Microcephaly based on two head circumference measurements under the 3rd percentile (at birth and at three months of age); This serious retrospective pregnancy case was reported by a physician via registry (registry ID) and described the occurrence of microcephaly in a female infant exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number KY27J) in utero. The mother received the product for prophylaxis. The parent's medical history included attention deficit hyperactivity disorder, cold (09-SEP-2024 to 23-SEP-2024), depression (in 2022), gravid (1 previous pregnancy), infertility (in 2023), migraine (in 2019), benadryl (03-AUG-2024 to 25-AUG-2024 oral 1 pill for 3 weeks), caffeine (09-JAN-2024 to 23-SEP-2024), covid 19 vaccine (on 19-MAR-2021, intramuscular), covid 19 vaccine (on 20-MAR-2021, intramuscular), covid 19 vaccine (on 21-NOV-2021, intramuscular), letrozole (from 12-JAN-2026 to 16-JAN-2026), lexapro (04-JAN-2026 to 23-JAN-2026, 10 mg oral once day), ovidrel (23-JAN-2024), prenatal vitamins (15-OCT-2023 to 23-SEP-2024) and vyvanse (04-JAN-2024 to 23-SEP-2024). On 29-JUL-2024, the 29-year-old mother received Boostrix (intramuscular). The infant was diagnosed with microcephaly (Verbatim: having Microcephaly based on two head circumference measurements under the 3rd percentile (at birth and at three months of age)) (serious criteria GSK medically significant and congenital anomaly). On an unknown date, the infant experienced fetal exposure during pregnancy (Verbatim: pregnancy exposed to Boostrix). The outcome of the microcephaly was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the microcephaly to be related to Boostrix. The company considered the microcephaly to be unrelated to Boostrix. Pregnancy exposure: Gestation time at first exposure (Boostrix): 29 Weeks Pregnancy Exposure (Boostrix): To foetus directly in utero Last Menstrual Period Date: 04-JAN-2024 Estimated Delivery/Due date: 13-OCT-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 37 weeks and 4 days Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 2860 grams (6lbs 5oz) Apgar Scores: 7 and 8 Delivery Notes: Birth length 50.8 cm, head circumference 30.5 cm See case US2026AMR100465 for details regarding the mother case. Additional Information: GSK Receipt Date:20-JUL-2026 The mother of the patient mentioned she enrolled prospectively in the study with pregnancy exposed to Boostrix.; Sender's Comments: A case of Microcephaly, 56 days after vaccination with unknown dose of Boostrix, in a female infant patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.