Received Jul 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | IM |
urinary tract infections; mother received Boostrix, Flu vaccine in pregnancy; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID) and described the occurrence of urinary tract infection in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) solution for injection (batch number CX4HL) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) solution for injection for prophylaxis. The patient's past medical history included infertility (Infertility 2024), urinary tract infection, coronavirus infection, gravid (Gravidity: 3), parity (Parity: 2), urinary retention (emergency room visit), urinary retention (emergency room visit, urinary retention and catheter-associated urinary tract infection), urinary retention (emergency room visit), catheter related infection (emergency room visit, Catheter-associated Urinary Tract Infection.), urinary retention (emergency room visit), urinary retention (emergency room visit, Urinary retention andrelapse of incarcerated uterus), incarcerated retroverted uterus (Hospitalization, Incarcerated uterus), urinary retention (Hospitalization, Urinary retention and relapse of incarcerated uterus), pre-eclampsia, urinary tract infection, urinary tract infection, urinary tract infection, prophylaxis urinary tract infection, urinary tract infection, prophylaxis urinary tract infection, back pain, back pain, urinary tract infection, back pain, urinary tract infection, prophylaxis urinary tract infection, intrauterine infection (Intrauterine Insemination), heartburn and urinary tract infection. Previously administered products included BABY ASPIRIN (oral 81 mg 1 day), CEPHALEXIN (oral 500 mg 2 day), FLU VACCINE NOS (intramuscular 1 shot 1 day), IMURAN (oral 100 mg 3.5 week), LETROZOLE (oral 7.5 mg 1 day), MACROBID (oral 100 mg 2 day), Pfizer BioNTech COVID-19 vaccine (PFIZER-BIONTECH intramuscular 1 shot 1 day), Pfizer BioNTech COVID-19 vaccine (PFIZER-BIONTECH intramuscular 1 shot 1 day), Pfizer BioNTech COVID-19 vaccine (PFIZER-BIONTECH intramuscular 1 shot 1 day), PRENATAL VITAMIN NOS (oral 2 pill 1 day), PRENATAL VITAMIN NOS (oral 1 pill 1 day), STELARA (subcutaneous 80 mg 6 year), VITAMIN D3 (oral 50 mcg 1 day), CEFPODOXIME PROXETIL (oral 100 mg 2 days) and OVIDREL (injected 250 mcg 1 day). Concurrent medical conditions included crohn's disease (Crohn's Disease 2006). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), cyclobenzaprine, fentanyl, hydromorphone hydrochloride (Hydromorphone Hcl), lidocaine, midazolam hydrochloride (Midazolam Hcl), ondansetron, ampicillin, cefpodoxime proxetil, cefalexin (Cephalexin) and nitrofurantoin. On 06-SEP-2024, the patient received Boostrix (intramuscular). On 27-SEP-2024, the patient received Flu vaccine (intramuscular). On 11-SEP-2024, 5 days after receiving Boostrix and not applicable after receiving Flu vaccine, the patient experienced urinary tract infection (Verbatim: urinary tract infections) (serious criteria hospitalization). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: mother received Boostrix, Flu vaccine in pregnancy). The outcome of the urinary tract infection was not reported and the outcome of the vaccine exposure during pregnancy was not applicable. It was unknown if the reporter considered the urinary tract infection to be related to Boostrix. The company considered the urinary tract infection to be unrelated to Boostrix. Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Flu vaccine): 33 Weeks Pregnancy Exposure (Flu vaccine): To mother in third trimester Last Menstrual Period Date: 05-FEB-2024 Estimated Delivery/Due date: 11-NOV-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 34 weeks and 2 days Delivery Type: cesarean Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 2390 grams (5lbs 4oz) Apgar Scores: 9 and 9 Delivery Notes: She delivered a liveborn infant, gestational age at delivery was 34.29, sex was male, birth length was 43.5 cm, birth head circumference was 32, Apgars 1min / 5min was 9/9 Additional Information: GSK Receipt Date: 22-JUL-2026 This was a spontaneous event report. It was reported the patient conceived on 19-FEB-2024. Woman (patient) residing enrolled prospectively in the study with pregnancy exposed to Boostrix. Per participant, she was hospitalized on 11-SEP-2024 for infection control and pain management due to recurrent urinary tract infections. She delivered a liveborn male infant. She was discharged from the hospital on 06-OCT-2024. The patient took prenatal vitamins NOS orally at a dose of 1 pill once daily from 11-SEP-2024 to 02-OCT-2024. The patient took probiotics NOS for general health orally at a dose of 1 pill once daily from 01-AUG-2024 to 02-OCT-2024. The patient took TUMS (New Form 1975) for heartburn orally at a dose of 2 pills twice daily from 11-SEP-2024 to 02-OCT-2024.; Sender's Comments: A case of Urinary tract infection, 5 days after vaccination with a dose of Boostrix and not applicable after vaccination with a dose of Flu vaccine, in a 37-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (The patient's past medical history included urinary tract infection, and urinary retention)
Crohn's disease (Crohn's Disease 2006); Heartburn; Prophylaxis urinary tract infection
Medical History/Concurrent Conditions: Back pain; Catheter related infection (emergency room visit, Catheter-associated Urinary Tract Infection.); Coronavirus infection; Gravid (Gravidity: 3); Incarcerated retroverted uterus (Hospitalization, Incarcerated uterus); Infertility (Infertility 2024); Intrauterine infection (Intrauterine Insemination); Parity (Parity: 2); Pre-eclampsia; Prophylaxis urinary tract infection; Urinary retention (Hospitalization, Urinary retention and relapse of incarcerated uterus); Urinary retention (emergency room visit, Urinary retention andrelapse of incarcerated uterus); Urinary retention (emergency room visit, urinary retention and catheter-associated urinary tract infection); Urinary retention (emergency room visit); Urinary retention (emergency room visit); Urinary retention (emergency room visit); Urinary tract infection;
PFIZER BIONTECH COVID-19 VACCINE; CYCLOBENZAPRINE; FENTANYL; HYDROMORPHONE HCL; LIDOCAINE; MIDAZOLAM HCL; ONDANSETRON; AMPICILLIN; CEFPODOXIME PROXETIL; CEPHALEXIN; NITROFURANTOIN
Test Date: 20240724; Test Name: Magnetic resonance imaging; Result Unstructured Data: (Test Result:abnormal result,Unit:unknown,Normal Low:,Normal High:) Participant unsure of exact reason for this imaging 20 mins; Test Date: 20240311; Test Name: Ultrasound; Result Unstructured Data: (Test Result:abnormal result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240318; Test Name: Ultrasound; Result Unstructured Data: (Test Result:abnormal result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240617; Test Name: Ultrasound; Result Unstructured Data: (Test Result:abnormal result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240703; Test Name: Ultrasound; Result Unstructured Data: (Test Result:abnormal result,Unit:unknown,Normal Low:,Normal High:); Comments: Glucose tolerance test results were normal on 15-Aug-2024. An MRI was performed on 24 July 2024 for an unspecified reason. Multiple ultrasounds were conducted throughout the pregnancy, with abnormal findings reported on 11 March 2024, 18 March 2024, 17 June 2024, and 03 July 2024, while all other ultrasound evaluations were reported as normal.