Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
obstuctive sleep apnea; central sleep apnea; tachycardia; tachypnea; hypotonia; RSV; This serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of obstructive sleep apnea in a male infant exposed to RSVPreF3 adjuvanted (Arexvy) in utero. The mother received the product for prophylaxis. On an unknown date, the 33-year-old mother received Arexvy. The infant was diagnosed with obstructive sleep apnea (Verbatim: obstuctive sleep apnea) (serious criteria hospitalization), central sleep apnea syndrome (Verbatim: central sleep apnea) (serious criteria hospitalization and GSK medically significant), tachycardia (Verbatim: tachycardia) (serious criteria hospitalization), tachypnea (Verbatim: tachypnea) (serious criteria hospitalization), hypotonia (Verbatim: hypotonia) (serious criteria hospitalization) and respiratory syncytial virus infection (Verbatim: RSV) (serious criteria hospitalization). The outcome of the obstructive sleep apnea, central sleep apnea syndrome, tachycardia, tachypnea and hypotonia were not resolved and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the obstructive sleep apnea, central sleep apnea syndrome, tachycardia, tachypnea, hypotonia and respiratory syncytial virus infection to be related to Arexvy. The company considered the obstructive sleep apnea, central sleep apnea syndrome, tachycardia, tachypnea, hypotonia and respiratory syncytial virus infection to be unrelated to Arexvy. Pregnancy Details (Neonate 1): Actual Delivery Date: Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: She delivered at 37 weeks and 1 day See case US2025021327 for details regarding the mother case. Additional Information: GSK Receipt Date: 19-FEB-2025 The health care professional reported that a patient's mother received Arexvy at 33 weeks gestation and the child was have having sleep apnea (central and obstructive) which began shortly after coming home from the hospital and also experienced tachycardia, tachypnea, and hypotonia. This all began after one week of being home and has been hospitalized a couple times since. Patient was seen as and outpatient today for a second opinion. The child was still continuing to experience symptoms. The child was on oxygen. The child also developed respiratory syncytial virus infection twice and was hospitalized for it. The first date of occurrence for respiratory syncytial virus infection was unknown as there are no details available but the child was hospitalized a second time for respiratory syncytial virus infection on 28-Jan-2025 respiratory syncytial virus infection for 5 days. The child also had an adverse reaction to his 2 month vaccines a very lethargic response that lasted for several days afterwards. The health care professional was unsure which vaccines the child received at his 2 month visit. No details regarding lot or expiration date of Arexvy is available or date which patient received Arexvy.; Sender's Comments: Obstructive sleep apnoea syndrome, Central sleep apnoea syndrome, Tachycardia, Tachypnoea, Hypotonia and Respiratory syncytial virus infection are unlisted event which is considered unrelated to GSK vaccine Arexvy. US-GSK-US2025021327:Mother case