Received Jul 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | UNK | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9429J | — |
the mother received Boostrix, RSV vaccine, Flu vaccine and Moderna COVID-19 vaccine in pregnancy/ child was diagnosed with polydactyly of the first toe of the left foot; polydactyly of the first toe of the left foot; This serious retrospective pregnancy case was reported by a physician via registry (registry ID 179449) and described the occurrence of polydactyly of toes in a female infant exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number 9429J) in utero. The mother received the product for prophylaxis. The parent's medical history included infertility (in 2003), baby aspirin (From 12-AUG-2024 to 12-MAY-2025), estradiol (from 14-Sep-2024 to 02-Nov-2024, injected 10 mg, 2.3 weeks), estratest (from 07-Sep-2024 to 02-Nov-2024, oral, 1 mg, qd), fish oil (from 24-AUG-2024 to 12-MAY-2025, oral, qd), insulin nos (from 18-Apr-2025 to 12-May-2025,subcutaneous, qd), lupron (from 28-Aug-2024 to 06-Sep-2024, injected), magnesium (oral 1 pill,2.5 week), metformin hcl (oral 1 pill,1 day), pfizer biontech covid-19 vaccine (intramuscular 1 shot,1 day), pfizer-biontech covid-19 vaccine (intramuscular 1 shot,1 day), prenatal vitamin (oral 1 pill,1 day), progesterone (oral 100 mg,1 day), tylenol (oral 1 pill,1 week), vitamin b6 (oral 1 pill,1 day), vitamin d (oral 1 pill,1 day), wegovy (injected 1.5 mg,1 day) and Gravidity: 3 Parity: 0 Spontaneous Abortion: 2 Theraputic Abortion: 0. On 14-MAR-2025, the mother received Boostrix (transplacental). On 19-APR-2025, the mother received RSV vaccine (transplacental). On 01-DEC-2024, the mother received Flu vaccine (transplacental). On 07-DEC-2024, the mother received Pfizer BioNTech COVID-19 vaccine (transplacental). The infant was diagnosed with polydactyly of toes (Verbatim: polydactyly of the first toe of the left foot) (serious criteria congenital anomaly). On an unknown date, the infant experienced fetal exposure during pregnancy (Verbatim: the mother received Boostrix, RSV vaccine, Flu vaccine and Moderna COVID-19 vaccine in pregnancy/ child was diagnosed with polydactyly of the first toe of the left foot). The outcome of the polydactyly of toes was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the polydactyly of toes to be related to Boostrix, RSV vaccine and Flu vaccine. The company considered the polydactyly of toes to be unrelated to Boostrix, RSV vaccine and Flu vaccine. Pregnancy exposure: Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To foetus directly in utero Gestation time at first exposure (RSV vaccine): 34 Weeks Pregnancy Exposure (RSV vaccine): To foetus directly in utero Gestation time at first exposure (Flu vaccine): 14 Weeks Pregnancy Exposure (Flu vaccine): To foetus directly in utero Gestation time at first exposure (Pfizer BioNTech COVID-19 vaccine): 15 Weeks Pregnancy Exposure (Pfizer BioNTech COVID-19 vaccine): To foetus directly in utero Last Menstrual Period Date: 24-AUG-2024 Estimated Delivery/Due date: 31-MAY-2025 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 37 weeks and 2 days Delivery Type: cesarean Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3050 grams (6lbs 12oz) Apgar Scores: 3 and 8 Delivery Notes: Female baby with birth weight 3050 gm, birth length 46.99 cm, birth head circumference 33.5 See case US2026AMR099552 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. The mother delivered a liveborn infant. The child was diagnosed with polydactyly of the first toe of the left foot, confirmed by X ray.; Sender's Comments: A case of Polydactyly in a female infant, 59 days after vaccination with a dose of Boostrix, 23 days after vaccination with a dose of RSV vaccine, and 162 days after vaccination with a dose of Flu vaccine, in a mother 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. The company has assessed that the event Polydactyly was not caused by the study vaccines.
Test Date: 20250512; Test Name: x-ray; Result Unstructured Data: (Test Result:polydactyly of the first toe of the left foot,Unit:unknown,Normal Low:,Normal High:)