Received Jul 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Fetal exposure during pregnancy; showed a left ovarian dominant follicle or simple cyst/Ovarian cyst; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID 156504) and described the occurrence of ovarian cyst in a female neonate 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 0.75 serving qd on 11-FEB-2023 Oral 0.25 serving qd on 02-DEC-2022 Oral 3.5 serving qd on 19-MAR-2023 Oral 1 serving qd on 03-JUN-2023), depression, prothrombin mutation g20210a, rheumatoid arthritis, baby aspirin (oral 81 mg qd), benadryl (oral 0.5 pill qd from 15-APR-2023 to 30-APR-2023 oral 1 pill qd from 01-MAY-2023 to 26-JUL-2023), claritin (oral 1 pill qd), colace (oral 100 mg qd), covid-19 vaccine (Intramuscular 1 shot on 22-DEC-2020 Intramuscular 1 shot on 12-JAN-2021 Intramuscular 1 shot on 28-OCT-2021 Intramuscular 1 shot on 02-JAN-2023), estradiol (Intramuscular, 4 mg 2W from 18-OCT-2022 to 01-NOV-2022 Intramuscular, 3.5 mg 2W from 02-NOV-2022 to 27-DEC-2022), folic acid (Oral 4 mg qd), humira (and from 20-NOV-2022 to 30-APR-2023 Subcutaneous, 40 mg twice in a month), influenza vaccine (Intramuscular, 1 shot total), iron (Oral 25 mg qd), lupron (Subcutaneous, 10 units qd), melatonin (Oral 12.5 mg qd), miralax (Oral 17 gm 4W from 12-DEC-2022 to 28-DEC-2022 Oral 17 gm 2W from 23-JAN-2023 to 26-JAN-2023), multivitamins (Oral 1 pill qd), prenatal vitamin (Oral 1 pill qd), progesterone (Topical-vaginal anal 200 mg qd Intramuscular 50 mg qd), tums (Oral 1000 mg 2W from 19-DEC-2022 to 20-MAR-2023 Oral 1500 mg 2.5W from 16-MAY-2023 to 26-JUL-2023 Oral 1500 mg 3.5W from 21-MAR-2023 to 15-MAY-2023), tylenol (Oral 500 mg 1.5W), vitamin b12 (Oral 1 mg qd), vitamin b6 (Oral 100 mg qd) and wellbutrin (Oral 200 mg qd). On 16-MAY-2023, the mother received Boostrix (intramuscular). The neonate was diagnosed with ovarian cyst (Verbatim: showed a left ovarian dominant follicle or simple cyst/Ovarian cyst) (serious criteria congenital anomaly). On an unknown date, the neonate experienced fetal exposure during pregnancy (Verbatim: Fetal exposure during pregnancy). The outcome of the ovarian cyst was resolving and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the ovarian cyst to be related to Boostrix. The company considered the ovarian cyst to be unrelated to Boostrix. Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To foetus directly in utero Last Menstrual Period Date: 18-OCT-2022 Estimated Delivery/Due date: 25-JUL-2023 Pregnancy Details (Neonate 1): Actual Delivery Date: XX-JUL-2023 Gestation Time at Delivery: 40 weeks and 1 day Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 3280 grams (7lbs 4oz) Apgar Scores: 8 and 9 Delivery Notes: The participant's obstetric history included a current pregnancy (Gravidity 1, Para 0) with no history of spontaneous or therapeutic abortion. The conception date was 01-Nov-2022, and the estimated delivery date was 25-Jul-2023 Additional Information: GSK Receipt date: 21-JUL-2026 Per obstetric medical record, on 5-JUN-2023, at approximately 33 weeks' gestation, fetal ultrasound revealed a left-sided simple cystic structure measuring 2.0 x 2.0 x 1.8 cm within the fetal pelvis. The mother reported that a follow-up ultrasound performed in December 2023 showed that the ovarian cyst was almost completely gone. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Ovarian cyst in a female neonate, 72 days after mothers vaccination with a dose of Boostrix. 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.
Test Date: 20230727; Test Name: Ultrasound; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:) left ovarian dominant follicle or simple cyst measuring 1.2X0.6X1.0 cm; Test Date: 202312; Test Name: Ultrasound; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:) Ovarian cyst almost completely gone