Received Jul 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 37F34 | — |
multiple hemangiomas on her arm, hand, and scalp and additional hemangiomas had appeared on the buttocks, scalp, and flank; mother received RSV vaccine in pregnancy; mother received Flu vaccine in pregnancy; mother received Boostrix in pregnancy; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID) and described the occurrence of hemangioma in a female patient exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number 37F34) in utero. The mother received the product for prophylaxis. The parent's medical history included blood cholesterol increased, type ii diabetes mellitus, alcohol use (Margarita, oral, 1.3 serving standard and on 02-JUL-2025 Margarita, oral, 0.75 estimated standard), alcohol use (Vodka mixed drink, oral, 1.3 serving standard), genital herpes simplex, atorvastatin (oral 40 mg qd), baby aspirin (oral 81 mg qd), ezetimibe (oral 10 mg qd), levocetirizine dihydrochloride (oral 10 mg qd), montelukast sodium (oral 5 mg qd), tirzepatide (subcutaneous 60 units one week), valtrex (oral 500 mg one day), vitamin d3 (for General health) and vitamin k2 (for General health). Additional patient notes included Hispanic/ Latino. On 06-OCT-2025, the mother received the 1st dose of Boostrix (intramuscular). On 13-DEC-2025, the mother received the 1st dose of RSV vaccine (intramuscular). On 20-OCT-2025, the mother received the 1st dose of Flu vaccine (intramuscular). The patient was diagnosed with fetal exposure during pregnancy (Verbatim: mother received Boostrix in pregnancy). On 20-OCT-2025, the patient experienced fetal exposure during pregnancy (Verbatim: mother received Flu vaccine in pregnancy). On 13-DEC-2025, the patient experienced fetal exposure during pregnancy (Verbatim: mother received RSV vaccine in pregnancy). On 30-JAN-2026, the patient experienced hemangioma (Verbatim: multiple hemangiomas on her arm, hand, and scalp and additional hemangiomas had appeared on the buttocks, scalp, and flank) (serious criteria congenital anomaly).The outcome of the hemangioma was not reported and the outcome of the fetal exposure during pregnancy, fetal exposure during pregnancy and fetal exposure during pregnancy were not applicable. It was unknown if the reporter considered the hemangioma to be related to Boostrix, RSV vaccine and Flu vaccine. The company considered the hemangioma to be unrelated to Boostrix, RSV vaccine and Flu vaccine. Pregnancy exposure: Gestation time at first exposure (Boostrix): 26 Weeks Gestation time at first exposure (RSV vaccine): 36 Weeks Gestation time at first exposure (Flu vaccine): 28 Weeks Last Menstrual Period Date: 05-APR-2025 Estimated Delivery/Due date: 10-JAN-2026 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 37 weeks and 1 day Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 2650 grams (5lbs 13oz) Apgar Scores: 6 and 9 Delivery Notes: She delivered a liveborn infant, gestational age at delivery was 37.14, sex was female, birth length was 48.9 cm, birth head circumference was 31.8 cm. The participant's last menstrual period (LMP) was 05-Apr-2025, with an estimated date of conception of 19-Apr-2025. This is the participant's first pregnancy (G1P0). There is no history of previous live births, spontaneous abortions (miscarriages), or therapeutic abortions. The current pregnancy is included in the gravidity co date of conception of 19-Apr-2025. Additional Information: GSK Receipt Date: 17-JUL-2026 The mother patient enrolled in the pregnancy study after exposure to Boostrix during pregnancy. The mother patient gave birth to a live infant. According to medical records, the infant was diagnosed with multiple hemangiomas on her the arm, hand, and scalp on 30-JAN-2026. On 27-APR-2026, additional hemangiomas had appeared on the buttocks, scalp, and flank. The medical records did not report the total number or sizes of the hemangiomas. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Haemangioma, 116 days after vaccination with the 1st dose of Boostrix, 48 days after vaccination with the 1st dose of RSV vaccine, 102 days after vaccination with the 1st dose of Flu vaccine, in a mother patient. Based on the available information a possible causality that the event was caused by GSK vaccine products cannot be ascertained. Causal relation is indeterminate considering multiple vaccines given during pregnancy.
Comments: Hispanic/ Latino