Sex: F
Vaccine: RSV, RSV
Symptoms: Foetal exposure during pregnancy, Foetal growth restriction, Premature baby
Clinical narrative: I went into labor and I had my baby; her due date was 04Jan2024; IUGR; she measured 6th percentile during a growth ultrasound; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2722480-1 (VAERS ID).  A fetus female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), via other route, administration details for the mother: on 17Nov2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal immunisation. The mother of the patient was 32 years old at the time of vaccination. The mother's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The mother is expected to deliver a baby(s) on 04Jan2024. Concomitant medication(s) included: CONCERTA transplacental not provided; CELEXA [CELECOXIB] transplacental not provided; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] transplacental not provided; ASPIRIN [ACETYLSALICYLIC ACID] transplacental not provided; BNT162B2;BNT162B2 OMI BA.4-5 transplacental taken for covid-19 immunisation as dose number unknown, single. The following information was reported: PREMATURE BABY (hospitalization) with onset, outcome "unknown", described as "her due date was 04Jan2024"; MATERNAL EXPOSURE DURING PREGNANCY (hospitalization), outcome "unknown", described as "I went into labor and I had my baby"; FOETAL GROWTH RESTRICTION (medically significant), outcome "unknown", described as "IUGR"; ULTRASOUND ANTENATAL SCREEN ABNORMAL (non-serious), outcome "unknown", described as "she measured 6th percentile during a growth ultrasound". The patient was hospitalized for premature baby, maternal exposure during pregnancy (start date, discharge date, hospitalization duration: 1 day(s)). The events "her due date was 04jan2024", "i went into labor and i had my baby", "iugr" and "she measured 6th percentile during a growth ultrasound" required emergency room visit. The baby was delivered premature, delivery date. The baby weighed 2285 grams. The patient underwent the following laboratory tests and procedures: tests: Normal; Ultrasound antenatal screen: 6th percentile; 27th percentile. Clinical course: The patient's mother was vaccinated on 17Nov2023. The patient's mother went into labor and she had her baby, days of onset. Her due date was 04Jan2024. A week before delivery she diagnosed with IUGR because she measured 6th percentile during a growth ultrasound. All other tests were normal. She was 27th percentile when she was born. Birth weight was 2285g. The report was assessed as serious. She went into emergency room and was hospitalized for 1 day.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from the same Consumer via FDA (2722480-1).   Updated information: parent race and ethnic group added, patient's age group was updated to fetus; concomitant medication 'BNT162B2;BNT162B2 OMI BA.4-5' was added, route of concomitant medications was added as transplacental, onset date of "I went into labor and I had my baby", "IUGR", "she measured 6th percentile during a growth ultrasound" was removed, emergency room visit required for "her due date was 04jan2024", "i went into labor and i had my baby", "iugr" and "she measured 6th percentile during a growth ultrasound".   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: route of suspect product rsv vaccine prot.subunit pref 2v was updated to "other".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400002835 mother case;