Sex: F
Vaccine: RSV
Symptoms: Amniotic fluid index decreased, Amniotic membrane rupture test negative, Cervical dilatation, Exposure during pregnancy, Foetal non-stress test normal
Clinical narrative: preterm delivery; amniotic fluid was low; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2723200-1 (VAERS ID).  A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Nov2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Exercise-induced asthma" (unspecified if ongoing). The patient was 256 days pregnant at the event onset. The patient is expected to deliver one baby(s). Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]; DOCUSATE. Past drug history included: Amoxil, reaction(s): "childhood reaction of hives", notes: Amoxil - childhood reaction of hives. The following information was reported: AMNIOTIC FLUID INDEX DECREASED (hospitalization) with onset 08Dec2023, outcome "recovered", described as "amniotic fluid was low"; PREMATURE DELIVERY (hospitalization) with onset 08Dec2023, outcome "recovered" (Dec2023), described as "preterm delivery". The patient was hospitalized for premature delivery (start date: Dec2023, discharge date: Dec2023, hospitalization duration: 3 day(s)); for amniotic fluid index decreased (hospitalization duration: 3 day(s)). The baby was delivered premature, delivery date 08Dec2023. The baby weighed 2693.2 grams. APGAR Score was 8, 9. The patient underwent the following laboratory tests and procedures: Amniotic fluid index: (08Dec2023) Decreased/low; Amniotic membrane rupture test: (unspecified date) Negative; Foetal non-stress test: (unspecified date) normal; actiprom: (06Dec2023) Negative; (unspecified date) dilated 1cm and 80% effaced, notes: At 35 weeks and 4 days was dilated 1cm and 80% effaced; (unspecified date) dilated 3cm, notes: In 36 weeks and 2 days was dilated 3cm; (unspecified date) Normal; (06Dec2023) WNL. Therapeutic measures were taken as a result of premature delivery, amniotic fluid index decreased.  Clinical course: The patient had no concerns during pregnancy. The patient was vaccinated on 07Nov2023, via intramuscular route on right arm. At 35 weeks and 4 days, she was dilated 1cm and 80% effaced. In 36 weeks and 2 days, she was dilated 3cm and amniotic fluid was low. For this reason, a fetal stress test was done which was normal and 2 doses of betamethasone were given on 36 weeks and 2 days and 36 weeks and 3 days. The patient had preterm delivery, delivered at 36 weeks and 4 days. Baby weighed 51b 150z and was healthy although APGAR was 8/9 for coloring as it took longer for baby to pink up. The report was assessed serious, patient was hospitalized for 3 days.   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: "maternal exposure during pregnancy " was deleted as an event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400006664 baby case;