Received Jul 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | Z7L7H | — |
hyperbilirubinemia; Fetal exposure during pregnancy; This serious retrospective pregnancy case was reported by a other health professional via registry and described the occurrence of hyperbilirubinemia in a male neonate exposed to DTPa (Reduced antigen) (Boostrix) solution for injection (batch number Z7L7H) in utero. The mother received the product for prophylaxis. The parent's medical history included anxiety, asthma, depression, migraine, polycystic ovarian syndrome, premenstrual dysphoric disorder, dermatographism, gravid (Gravidity:1), infertility, parity (Parity:0), spontaneous abortion (Spontaneous Abortion:2), therapeutic abortion (Therapeutic Abortion:0), benadryl (oral 25 mg.2.5 week), caffeine (oral 0.25. serving 1 month), choline (oral 2 pill.1 day), colace (oral 1 pill,1 day), covid-19 mrna vaccine (intramuscular 1 shot ,1 day), covid-19 mrna vaccine (intramuscular 1 shot, 1 day), dha (oral 300 mg ,2 day), flexiril (oral 10 mg,1.5 week), influenza vaccine (received Flu vaccine NOS, intramuscular 1 shot 1 day), l-methylfolate (Oral 400 mg, 1 day), miralax (oral 1 serving for 3.5 week.), moderna covid-19 vaccine (1 shot 1 day), prenatal vitamin (Oral 1 pill,1 day), prenatal vitamin (oral 4 pill,1 day), probiotics (Oral 1 pill, 1 day), prozac (oral 10 mg,1 day), reglan (Oral 10 mg,2.5 week), sumatriptan succinate (Subcutaneous 3 mg,3 total), tamiflu (oral 1 serving 1 day), triamcinolone (topical-face, scalp and/or skin , 2 day), tylenol (oral 500 mg,2.5 week), unisom (oral 12.5 mg ,1 day), vitamin b6 (oral 25 mg, 3 day), vitamin d (oral 5000 IU ,1 day), zyrtec (Oral 10 mg, 2 day) and zyrtec (oral 10 mg ,1 day). On an unknown date, the 40-year-old mother received Boostrix (intramuscular), Prozac (oral) 10 mg daily and omeprazole. The action taken with Prozac was unknown. The action taken with omeprazole was unknown. The neonate was diagnosed with hyperbilirubinemia (Verbatim: hyperbilirubinemia) (serious criteria hospitalization and GSK medically significant). On an unknown date, the neonate experienced fetal exposure during pregnancy (Verbatim: Fetal exposure during pregnancy). The action taken with Prozac was unknown. The action taken with omeprazole was unknown. The outcome of the hyperbilirubinemia was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the hyperbilirubinemia to be related to Boostrix. The company considered the hyperbilirubinemia to be unrelated to Boostrix. Pregnancy exposure: Pregnancy Exposure (Boostrix): To foetus directly in utero Pregnancy Exposure (Prozac): To foetus directly in utero Pregnancy Exposure (omeprazole): To foetus directly in utero Last Menstrual Period Date: 20-OCT-2023 Estimated Delivery/Due date: 26-JUL-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 37 weeks and 5 days Delivery Type: vaginal Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3351 grams (7lbs 6oz) Apgar Scores: 8 and 9 Delivery Notes: male baby with birth weighs 3351 grams, birth length 48.9 cm, birth head circumference 36.2 cm, gestational age at delivery 37.71; Sender's Comments: A case of Hyperbilirubinaemia in a male neonate, on an unknown time after vaccination with a dose of Boostrix, in a 40-year-old 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.
PROZAC; OMEPRAZOLE