Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | C7747 | — |
Fetal exposure during pregnancy; Hidden penis with penoscrotal webbing; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID) and described the occurrence of penoscrotal fusion in a male infant exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number C7747) in utero. The mother received the product for prophylaxis. The parent's medical history included atopic dermatitis (in 2024), eczema (in 2024), clobetasol, flucelvax (intramuscular 1 shot,1 total), nasal (intranasal 2 puffs 6 total), pfizer-biontech covid-19 vaccine (intramuscular 1 shot,1 total), prednisone (20 mg oral once day), prednisone (30 mg oral once day), pregnyl (1 shot subcutaneous once day), prenatal vitamin (2 pill oral once day), progesterone (400 mg oral once day), tylenol (2 pill oral PRN), vitamin b6 (100 mg oral once day) and Gravidity: 2 Parity: 1 Spontaneous Abortion: 2 Theraputic Abortion: 0. On 16-APR-2024, the mother received Boostrix (intramuscular). On 16-MAY-2024, the mother received RSV vaccine and PFIZER BIONTECH COVID-19 VACCINE (intramuscular). The infant was diagnosed with penoscrotal fusion (Verbatim: Hidden penis with penoscrotal webbing) (serious criteria GSK medically significant and congenital anomaly). On an unknown date, the infant experienced fetal exposure during pregnancy (Verbatim: Fetal exposure during pregnancy). The outcome of the penoscrotal fusion was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the penoscrotal fusion to be related to Boostrix and RSV vaccine. The company considered the penoscrotal fusion to be unrelated to Boostrix and RSV vaccine. Pregnancy exposure: Pregnancy Exposure (Boostrix): To foetus directly in utero Pregnancy Exposure (RSV vaccine): To foetus directly in utero Pregnancy Exposure (PFIZER BIONTECH COVID-19 VACCINE): To foetus directly in utero Last Menstrual Period Date: 28-SEP-2023 Estimated Delivery/Due date: 04-JUL-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 38 weeks and 2 days Delivery Type: vaginal Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3260 grams (7lbs 3oz) Apgar Scores: 8 and 9 Delivery Notes: Male baby with birth weight 3260 gm, birth length 48 cm, birth head circumference 33.5 Date of conception: 12-OCT-2023 See case US2026AMR099739 for details regarding the mother case. 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 On 01-JUL-2026, the infant was diagnosed with a concealed hidden penis and penoscrotal webbing.; Sender's Comments: A case of Penoscrotal fusion, 76 days after vaccination with a dose of Boostrix and 46 days after vaccination with a dose of RSV vaccine, in a male infant patient. Causal relation is indeterminate considering multiple vaccines given.