Received Jul 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | SYR |
Woman residing enrolled prospectively in the OTIS study with pregnancy exposed to Boostrix/ she delivered a liveborn infant; right Pelvicaliectasis/ right pyelectasis; Penile Chordee; This serious case was reported by a other health professional via registry (registry ID 219588) and described the occurrence of pyelectasia in a infant male patient who received DTPa (Reduced antigen) (Boostrix) solution for injection (batch number DD7F7) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) suspension for injection for prophylaxis and paracetamol (Tylenol) for covid-19. On 28-DEC-2023, the patient received Boostrix (transplacental). On 11-JAN-2024, the patient received RSV vaccine (transplacental). On 10-JAN-2024, the patient started Tylenol (transplacental) 825 mg. On 15-FEB-2024, 49 days after receiving Boostrix, 35 days after receiving RSV vaccine and 36 days after starting Tylenol, the patient experienced pyelectasia (Verbatim: right Pelvicaliectasis/ right pyelectasis) (serious criteria GSK medically significant and congenital anomaly) and chordee (Verbatim: Penile Chordee) (serious criteria congenital anomaly). On an unknown date, the patient experienced fetal exposure during pregnancy (Verbatim: Woman residing enrolled prospectively in the OTIS study with pregnancy exposed to Boostrix/ she delivered a liveborn infant). The action taken with Tylenol was unknown. The outcome of the pyelectasia 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 pyelectasia and chordee to be related to Boostrix and RSV vaccine. The company considered the pyelectasia and chordee to be unrelated to Boostrix and RSV vaccine. Additional Information: GSK Receipt Date: 22-JUL-2026 The woman with pregnancy exposure to Boostrix. She delivered liveborn twins. The male twin was diagnosed with two congenital anomalies Penile Chordee was diagnosed on 15-FEB-2024 and right pyelectasis was noted on ultrasound and right Pelvicaliectasis was diagnosed via ultrasound on 27-FEB-2024. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Pyelocaliectasis and Chordee, 49 days after vaccination with Boostrix, 35 days after vaccination with RSV vaccine and 36 days after starting Tylenol, in a infant male patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (two congenital anomalies Penile Chordee and right pyelectasis).
Test Date: 20240215; Test Name: Ultrasound; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Comments: The right pyelectasis was noted on ultrasound on 15-FEB-2024