Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Premature delivery, Premature labour, Premature rupture of membranes, Protein urine present, Urine protein/creatinine ratio increased
Clinical narrative: Premature rupture of membranes and labor; Premature rupture of membranes and labor; I went to the hospital, where I was then found to have pre eclampsia with severe features; my blood pressure was up to 145/90; protein in my urine; protein:creatinine ratio of 0.34 in my urine; liver function tests were elevated more than 5 times the upper limit of normal; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2743680-1.  A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Jan2024 at 12:19 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years intramuscular, in right arm for maternal immunisation. The patient's relevant medical history was not reported. The patient was 35 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 12Feb2024. Concomitant medication(s) included: 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]. The following information was reported: PRE-ECLAMPSIA (hospitalization) with onset 14Jan2024 at 22:20, outcome "recovered" (2024), described as "I went to the hospital, where I was then found to have pre eclampsia with severe features"; PRETERM PREMATURE RUPTURE OF MEMBRANES (hospitalization), PREMATURE LABOUR (hospitalization) all with onset 14Jan2024 at 22:20, outcome "recovered" (2024) and all described as "Premature rupture of membranes and labor"; LIVER FUNCTION TEST INCREASED (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "liver function tests were elevated more than 5 times the upper limit of normal"; BLOOD PRESSURE INCREASED (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "my blood pressure was up to 145/90"; PROTEIN URINE (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "protein in my urine"; URINE PROTEIN/CREATININE RATIO INCREASED (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "protein:creatinine ratio of 0.34 in my urine". The patient was hospitalized for preterm premature rupture of membranes, premature labour, pre-eclampsia (start date: Jan2024, discharge date: Jan2024, hospitalization duration: 5 day(s)). The events "premature rupture of membranes and labor" and "i went to the hospital, where i was then found to have pre eclampsia with severe features" required emergency room visit. The baby was delivered premature, via vaginal route, delivery date XXJan2024. The baby weighed 2721 grams. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) had been normal; (Jan2024) 145/90, notes: blood pressure was up to 145/90; Previous medical test in pregnancy: (unspecified date) all been normal, notes: Previous medical tests in the pregnancy had all been normal; Urine protein/creatinine ratio: (Jan2024) 0.34; Liver function test: (Jan2024) 200s, notes: elevated more than 5 times the upper limit of normal. Therapeutic measures were taken as a result of premature labour, pre-eclampsia. Clinical course: Premature rupture of membranes and labor - pregnancy history had previously been uncomplicated. This was the patient's first pregnancy, and she was 35 weeks, 6 days along on the day that she got the vaccine; her estimated due date was Feb 12. 10 hours after receiving the vaccine, her water broke spontaneously without any apparent precipitating factor - she has not been having contractions and was not in labor. She went to the hospital, where she was then found to have pre-eclampsia with severe features. This had not been previously diagnosed in her pregnancy - she had been receiving regular prenatal care and her blood pressure and labs had been normal. However, when presented to the hospital after receiving the vaccine, her blood pressure was up to 145/90, she had protein in her urine, and her liver function tests were elevated more than 5 times the upper limit of normal. She received IV Pitocin to accelerate her contractions and her son was born with a birth weight of 6 lb, 13 oz. Lab Data: Previous medical tests in the pregnancy had all been normal. As stated above, after she went into premature labor, she was found to have pre-eclampsia with BP 145/90, protein:creatinine ratio of 0.34 in her urine, and LFTs in the 200s, over 5 times the upper limit of normal. She was given IV Pitocin to accelerate her labor. Her son was born via vaginal delivery. She was then given a 24 hour infusion Of IV magnesium for the pre-eclampsia. The patient never had an adverse event following any previous vaccine.  Follow up (30Oct2024): This is a spontaneous follow up report received from the same consumer via FDA [VAERS ID: 2743680-1].  Updated information: patient data, event details (time, outcome), Concomitant drug coded, Lab data, Age at Vaccination, Vaccination details.  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: Recoded "Premature rupture of membranes and labor" from Premature rupture of membranes to Preterm premature rupture of membranes.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400221797 baby case;