Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | OT |
Drug exposure during pregnancy; Death; Absent limb; Congenital limb malformation NOS; Exomphalos; This spontaneous report was received from a/an Other health professional and refers to a(n) Foetus patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-May-2011, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Injection administered by Unknown route (lot # and expiration date were not reported). On 27-Jul-2011, the patient started therapy with Injection (lot #668229/1569Z) administered by Transplacental route (expiration date was not reported). The patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), for the treatment of ??. The patient started therapy with GARDASIL Aqueous Suspension for Intramuscular Injection Syringe for the treatment of ??. On Sep-2011, the patient experienced Death. On 2011, the patient experienced Absent limb. On 2011, the patient experienced Congenital limb malformation NOS. On 2011, the patient experienced Exomphalos. On an unknown date, the patient experienced Drug exposure during pregnancy. On Sep-2011, Investigation showed Test Result: normal. On 14-Sep-2011, Ultrasound scan showed Test Result: Fetus was no longer viable/ alive.. At the reporting time, the patient had not recovered from Absent limb, Congenital limb malformation NOS and Exomphalos. At the reporting time, the outcome of Drug exposure during pregnancy was unknown. On 01-Sep-2011, the patient died because of the event(s) of Death. It was unknown whether an autopsy was performed. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was reported as not applicable. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Suspension for injection was reported as not applicable. The reporter considered the event of Drug exposure during pregnancy to be not related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine. The causal relationship between the event of Death and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Absent limb and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Congenital limb malformation NOS and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Exomphalos and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The reporter considered the event(s) of Absent limb Congenital limb malformation NOS and Exomphalos to be congenital anomaly/birth defect.; Reported Cause(s) of Death: death
Test Date: 201109; Test Name: Investigation; Result Unstructured Data: Test Result: normal; Test Date: 20110914; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: Fetus was no longer viable/ alive.