Age: 30.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wife had to be induced due to medical complications/ wife was induced and baby was born pre-term; Husband states at the time of vaccination wife was 35 weeks pregnant; patient is 30 year old and she was given Arexvy; went to pharmacy to receive RSV vaccine that is approved for a pregnant woman instead she was given Arexvy which is not indicated for a pregnant woman; This serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of induced labor in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5BN3T, expiry date 05-NOV-2024) for prophylaxis.   On 28-SEP-2023, the patient received Arexvy (left deltoid). On 28-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: patient is 30 year old and she was given Arexvy) and wrong vaccine administered (Verbatim: went to pharmacy to receive RSV vaccine that is approved for a pregnant woman instead she was given Arexvy which is not indicated for a pregnant woman). The patient experienced induced labor (Verbatim: wife had to be induced due to medical complications/ wife was induced and baby was born pre-term) (serious criteria hospitalization) and live birth. On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Husband states at the time of vaccination wife was 35 weeks pregnant). The outcome of the induced labor was not reported and the outcome of the live birth, vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the induced labor to be related to Arexvy.     It was unknown if the company considered the induced labor to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: baby was born pre-term   See case US2023AMR164071 for details regarding the baby case.   Additional Information: GSK Receipt Date: 16-NOV-2023 The reporter was a husband called on behalf of his wife (patient).  The reporter stated that his wife went to the pharmacy to receive the RSV vaccine that was approved for a pregnant woman instead, she was given Arexvy at the age of 30  year which was not indicated for a pregnant woman, which led to wrong vaccine administered and inappropriate age at vaccine administration. The husband stated at the time of vaccination wife was 35 weeks pregnant, which led to vaccine exposure during pregnancy. At 36 weeks of pregnancy his wife had to be induced due to medical complications.   The patient was induced and baby was born pre-term. The husband reported that after delivery his son needed to be transferred from birth hospital to another hospital for a diagnosis of HIE (Hypoxic Ischemic Encephalopathy). The reporter adamantly welcomed all physicians to receive follow up and he would like consent to follow up paperwork sent to his email address.  The reporter would sign and return Authorization to GlaxoSmithKline. The reporter consented to follow up. The case had been linked to the case US2023AMR164071 reported by the same reporter for baby case.; Sender's Comments:  US-GSK-US2023AMR164071: