Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | UNK | — |
| FLU4 | INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | NR5DX | — |
acute severe malnutrition; 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 foetal malnutrition in a male infant exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number NR5DX) in utero. The mother received the product for prophylaxis. The parent's medical history included allergy, anemia, asthma, depression, heartburn, hypothyroidism, anxiety, chronic sinusitis, corona virus infection, fever (flu vaccine, 2hrs), gravid (Gravidity: 3), hypothyroidism, infertility, nasal polyp, spontaneous abortion (Spontaneous Abortion: 2), albuterol (inhaled, 1 puff 1 month), baby aspirin (oral 81 mg 1day), bupropion er (oral 300mg 1 day), calcium (oral 500mg 1 day), desvenlafaxine (oral 100mg 1 day), doxepin (oral 25mg 3 weeks), dupixent (subcutaneous 300mg 2 months), iron (oral 45mg 1 day), levothyroxine sodium (oral 125mcg 1 day), melatonin (oral 1 mg 3 weeks), moderna covid-19 vaccine (received on 18-NOV-2021 via intramuscular, 1 shot), moderna covid-19 vaccine (received on 20-MAR-2021 via intramuscular, 1 shot), moderna covid-19 vaccine (received on 24-APR-2021 via intramuscular, 1 shot), pantoprazole sodium (oral 40mg 1 day), prenatal vitamin (oral 2 pills 1day), progesterone (via intramuscular 1 shot for 1 day), progesterone injection in oil (intramuscular 1 shot 1 day), tums (oral 2 pills 2 days) and xyzal (oral 5 mg 1 day). On 09-OCT-2023, the mother received Boostrix (intramuscular). On 13-SEP-2023, the mother received Fluarix Quadrivalent 2023-2024 season (intramuscular). On 18-NOV-2023, the mother received RSV vaccine (intramuscular). On 06-OCT-2023, the mother received PFIZER BIONTECH COVID-19 VACCINE (intramuscular). On 09-OCT-2023, the mother started Rhogam (intramuscular). On 01-NOV-2023, the mother started Tylenol (oral) 500 mg. The action taken with Rhogam was unknown. The action taken with Tylenol was unknown. The infant was diagnosed with foetal malnutrition (Verbatim: acute severe malnutrition) (serious criteria hospitalization). On an unknown date, the infant experienced fetal exposure during pregnancy (Verbatim: fetal exposure during pregnancy). The action taken with Rhogam was unknown. The action taken with Tylenol was unknown. The outcome of the foetal malnutrition was resolving and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the foetal malnutrition to be related to Boostrix, Fluarix Quadrivalent 2023-2024 season, Fluarix Pre-Filled Syringe Device and RSV vaccine. The company considered the foetal malnutrition to be unrelated to Boostrix, Fluarix Quadrivalent 2023-2024 season, Fluarix Pre-Filled Syringe Device and RSV vaccine. Pregnancy exposure: Gestation time at first exposure (Boostrix): 28 Weeks Gestation time at first exposure (Fluarix Quadrivalent 2023-2024 season): 24 Weeks Gestation time at first exposure (RSV vaccine): 34 Weeks Gestation time at first exposure (PFIZER BIONTECH COVID-19 VACCINE): 27 Weeks Gestation time at first exposure (Rhogam): 28 Weeks Gestation time at first exposure (Tylenol): 31 Weeks Last Menstrual Period Date: 25-MAR-2023 Estimated Delivery/Due date: 30-DEC-2023 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 37 weeks and 5 days Delivery Type: cesarean Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3720 grams (8lbs 3oz) Apgar Scores: 8 and 9 Delivery Notes: Birth height in cm: 52.5, Birth head circumference in cm: 34.5, Gestational age at delivery: 37.71, Date of conception: 08-Apr-2023, Estimated date of confinement: 30-Dec-2023 This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-JUL-2026 Woman enrolled prospectively in the study with pregnancy exposed to Boostrix on 09-OCT-2023 (Preg ID). She delivered a liveborn infant (ID). The mother of the patient exposed to Allergy shots from 15-APR-2023 to 31-AUG-2023, injected 2 shots 1 months and from 14-OCT-2023 to 09-DEC-2023. She also had coffee from 25-MAR-2023 to 14-DEC-2023 oral 1 serving 4 weeks and Endometrin vaginal insert from 15-MAR-2023 to 31-MAY-2023 In Vitro Fertilization topical-vaginal or anal for 2 days.; Sender's Comments: A case of Foetal malnutrition in a male patient, 80 days after vaccination with a dose of Boostrix, 106 days after mothers' vaccination with a dose of Fluarix Quadrivalent 2023-2024 season, and 40 days after vaccination with a dose of RSV vaccine. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alterative risk factors (The parent's medical history included anemia, hypothyroidism).
RHOGAM; TYLENOL