Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | OT |
laryngmalasia; series of 3-4 upper respiratory infections; contracting influenza A & B; daughter inhaled amniotic fluid when birth occurred; This serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of laryngomalacia in a female infant exposed to RSVPreF3 adjuvanted (Arexvy) in utero. The mother received the product for prophylaxis. The parent's medical history included glipizide, prenatal vitamin and the mother was also taking a prenatal vitamin (started on 24th June 2023 and ended on 26th February 2024) and was also taking Glipizide 2.5mg for gestational diabetes (started on 18th December 2023 and ended on 26th February 2024). On 24-JAN-2024, the mother received Arexvy. The infant was diagnosed with laryngomalacia (Verbatim: laryngmalasia) (serious criteria GSK medically significant), upper respiratory tract infection (Verbatim: series of 3-4 upper respiratory infections), influenza (Verbatim: contracting influenza A & B) and fetal exposure during pregnancy (Verbatim: daughter inhaled amniotic fluid when birth occurred). The outcome of the laryngomalacia was not resolved and the outcome of the upper respiratory tract infection and influenza were not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the laryngomalacia, upper respiratory tract infection and influenza to be related to Arexvy. The company considered the laryngomalacia to be unrelated to Arexvy. It was unknown if the company considered the upper respiratory tract infection and influenza to be related to Arexvy. Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Details (Neonate 1): Actual Delivery Date: Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Delivery Notes: The mother was 34 weeks pregnant during time of vaccination See case US2025AMR031575 for details regarding the mother case. Additional Information: GSK Receipt Date: 12-MAR-2025 The mother reported that she received Arexvy vaccine on from pharmacy and claimed that daughter (patient) inhaled amniotic fluid when birth occurred and had lungs drained. The mother claimed that daughter's pediatrician was not concerned and at 2.5 months,reporter's daughter sounded as if she smoked 1.5 packs of cigarettes per day (voice hoarseness, raspy voice, snoring, difficulty breathing). The reporter claimed that daughter's pediatrician stated there was not much that could be done, considering reporters' child's young age, but sucking out phlegm from nasal passages was the best treatment. The reporter claimed that daughter had multiple visits to pediatrician and hospital (no hospitalization required) for chest x-rays after contracting influenza A and B and also having a series of 3 to 4 upper respiratory infections. The reporter's daughter was taken to see Ear, Nose, and Throat (ENT) doctor and was then diagnosed with laryngomalacia. The reporter was requesting a call back to discuss that and claimed that none of her daughter's symptoms have subsided or have been cured. This case is linked with US2025AMR031575, reported by same reporter.; Sender's Comments: Laryngomalacia is an unlisted event which is considered unrelated to GSK vaccine Arexvy. US-GSK-US2025AMR031575:mother case
Test Name: chest x-rays; Result Unstructured Data: (Test Result:influenza A & B, upper respiratory infections,Unit:unknown,Normal Low:,Normal High:)