Received Jul 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | T3Z7D | — |
bilateral inguinal hernias; Fetal exposure during pregnancy; Chordee; hypospadias; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID 219588) and described the occurrence of hypospadias in a male neonate exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number T3Z7D) in utero. The mother received the product for prophylaxis. The parent's medical history included multiple allergies, asthma, attention deficit hyperactivity disorder, constipation (pregnancy-related constipation), anxiety, atopic dermatitis, coronavirus infection, depression, fertility testing (Fertility treatment), gravid (Gravidity: 2), infertility, parity, polycystic ovarian syndrome (Polyendocrine Metabolic Ovarian Syndrome), respiratory infection, spontaneous abortion, therapeutic abortion, adderall (Adderall oral 2.5 mg, 2 weeks), adderall (Adderall oral 25 mg, 1 day), albuterol (inhaled 2 puff 1 day), albuterol (inhaled 2 puff 3 weeks), claritin (Claritin oral, 1 pill 1 day), clomid (Clomid oral, 1 pill 1 day), docusate sodium (oral, 1 pill 1 day), flonase (intranasal, 2 puff 1 day), flonase (intranasal, 4 puff 1 month), flovent (inhaled, 1 puff 1 day), influenza vaccine (flu vaccine intramuscular), magnesium (for sleep and Muscle relaxation oral 1 pill 1 day), moderna covid-19 vaccine (Moderna covid-19 vaccine intramuscular), montelukast sodium (oral 10 mg, 1 day), pfizer biontech covid-19 vaccine (Pfizer BioNTech COVID-19 vaccine intramuscular 1 shot on 01-OCT-2021), pfizer biontech covid-19 vaccine (Pfizer BioNTech COVID-19 vaccine intramuscular 1 shot on 16-MAR-2021), pfizer biontech covid-19 vaccine (Pfizer BioNTech COVID-19 vaccine intramuscular 1 shot on 25-FEB-2021), pfizer biontech covid-19 vaccine (Pfizer BioNTech COVID-19 vaccine intramuscular 1 shot on 25-SEP-2022), prenatal vitamin (oral 1 pill 1 day), trazodone hcl (oral 150 mg 1 day.), tylenol (2 pills oral), unisom (0.5 pill oral) and wellbutrin (15 mg oral 1 day). On an unknown date, the 32-year-old mother received Boostrix (intramuscular), Betamethasone, PAXLOVID (oral) and Zyrtec (oral). The action taken with Zyrtec was unknown. The neonate was diagnosed with hypospadias (Verbatim: hypospadias) (serious criteria GSK medically significant and clinically significant/intervention required). On 09-APR-2024, the neonate experienced bilateral inguinal hernia (Verbatim: bilateral inguinal hernias) (serious criteria hospitalization and clinically significant/intervention required). On 17-APR-2024, the neonate experienced chordee (Verbatim: Chordee) (serious criteria clinically significant/intervention required). On an unknown date, the neonate experienced fetal exposure during pregnancy (Verbatim: Fetal exposure during pregnancy). The action taken with Zyrtec was unknown. The outcome of the hypospadias, bilateral inguinal hernia and chordee were not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the hypospadias, bilateral inguinal hernia and chordee to be related to Boostrix. The company considered the hypospadias, bilateral inguinal hernia and chordee to be unrelated to Boostrix. Pregnancy exposure: Last Menstrual Period Date: 13-JUL-2023 Estimated Delivery/Due date: 18-APR-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: XXMAR-2024 Gestation Time at Delivery: 34 weeks and 2 days Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 1780 grams (3lbs 15oz) Delivery Notes: she delivered a liveborn infant on XX-MAR-2024 at gestational age 34 weeks and 2 days male baby with birth weight 1780 gm, birth length 45 cm, birth head circumference 31 cm See case US2026AMR085182 for details regarding the mother case. Additional Information: GSK Receipt Date: 24-JUN-2026 Woman residing in (withheld) enrolled prospectively in the Study with pregnancy exposed to Boostrix (Preg ID withheld). She delivered a liveborn infant on XX-Mar-2024 at gestational age 34 weeks and 2 days (ID withheld). On XX-Mar-2024 (first day of life) the child was noted to have hypospadias. On 17-Apr-2024 he was diagnosed with Chordee with 2nd Degree Hypospadias. Surgical repair was performed on 13-Dec-2024. On 09-Apr-2024 he was noted to have bilateral inguinal hernias. Surgical repair was performed on 22-May-2024. He was admitted to hospital for this procedure on 22-May-2024 and discharged home on 23-May-2024. The batch number was not provided and request for this information has been made.; Sender's Comments: Hypospadias, Inguinal hernia and Chordee, unknown time after vaccination with Boostrix in a male neonate. Case lacks further information on time to onset, concurrent conditions. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
PAXLOVID; Betamethasone; ZYRTEC