Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| 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 | UNK | — |
The infant had a fever and hospitalized on 24-JAN-2025 and diagnosed with an Escherichia coli urinary tract infection and was discharged home 27-JAN-2025; 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 escherichia urinary tract infection in a male patient exposed to DTPa (Reduced antigen) (Boostrix) solution for injection in utero. The mother received the product for prophylaxis. The parent's medical history included alcohol use (Oral one serving per day from 01-AUG-2024 to 15-AUG-2024 Oral one serving per day on 19-OCT-2024), coronavirus infection, hypothyroidism, ovarian cyst, polycystic ovarian syndrome, covid-19 vaccine (Intramuscular 1 shot on 07-APR-2021 Intramuscular 1 shot on 06-MAY-2021 Intramuscular 1 shot on 23-NOV-2021 Intramuscular 1 shot on 14-OCT-2022 Intramuscular 1 shot on 01-JAN-2023), fish oil (Oral 2 pill per day as per doctor recommendation), levothyroxine sodium (13.5 mg orally per day), magnesium (175 mg orally 5 times a week and used for cramping, stress, general health), prenatal vitamin (oral 2.5 pill per day), prenatal vitamin (oral 3 pill per day), tums (Oral 2 pill per day), tylenol (1000mg per day) and the participant's obstetric history included a current pregnancy (Gravidity 3, Parity 1) with one history of spontaneous abortion and no therapeutic abortion. The conception date was 09-APR-2024, and the estimated delivery date was 31-DEC-2024. On 07-OCT-2024, the mother received Boostrix (intramuscular). On 25-SEP-2024, the mother received Flu vaccine (intramuscular). On 06-NOV-2024, the mother received RSV vaccine (intramuscular). On 04-NOV-2024, the mother received PFIZER BIONTECH COVID-19 VACCINE (intramuscular). The patient was diagnosed with escherichia urinary tract infection (Verbatim: The infant had a fever and hospitalized on 24-JAN-2025 and diagnosed with an Escherichia coli urinary tract infection and was discharged home 27-JAN-2025) (serious criteria hospitalization). On an unknown date, the patient experienced fetal exposure during pregnancy (Verbatim: Fetal exposure during pregnancy). The outcome of the escherichia urinary tract infection was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the escherichia urinary tract infection to be related to Boostrix, Flu vaccine and RSV vaccine. . The company considered the escherichia urinary tract infection to be unrelated to Boostrix, Flu vaccine and RSV vaccine. Pregnancy exposure: Pregnancy Exposure (Boostrix): To foetus directly in utero Last Menstrual Period Date: 19-MAR-2024 Estimated Delivery/Due date: 24-DEC-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 42 weeks and 2 days Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 3700 grams (8lbs 3oz) Apgar Scores: 9 and 9 Additional Information: GSK Receipt Date: 22-JUL-2026 The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Escherichia urinary tract infection in a male patient, on an unknown time after vaccination with unknown doses of Boostrix, RSV vaccine and Flu vaccine, in a mother. 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.