Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | SYR |
respiratory issues in newborn; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of respiratory disorder neonatal in a neonate patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy (transplacental). On an unknown date, an unknown time after receiving Arexvy, the patient experienced respiratory disorder neonatal (Verbatim: respiratory issues in newborn). The outcome of the respiratory disorder neonatal was not reported. It was unknown if the reporter considered the respiratory disorder neonatal to be related to Arexvy. It was unknown if the company considered the respiratory disorder neonatal to be related to Arexvy. See case US2025030425 for details regarding the mother case. Additional Information: GSK Receipt Date: 12-MAR-2025 The pharmacist mentioned that a patient received Arexvy while she was pregnant and now, the newborn had respiratory issues. The pharmacist asked if GlaxoSmithKline had any study showing a correlation of giving Arexvy to pregnant women and respiratory issues in newborns.; Sender's Comments: US-GSK-US2025030425:Mother case