Received May 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | MM9150 | — |
DVT; PE; The provider gave the vaccine at 37.1 weeks gestational age; The provider gave the vaccine at 37.1 weeks gestational age; This is a spontaneous report received from a Nurse. A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Feb2026 as dose 1, single (Lot number: MM9150, Expiration Date: Oct2026) for maternal immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 27May2025. The patient was 37 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 03Mar2026. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]; OMEPRAZOLE; ASA; IRON; METRONIDAZOL [METRONIDAZOLE] taken for bacterial vaginosis; VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; NYSTATIN taken for fungal infection.The patient history included she was pregnant 5times with 4childers live birth/miscarriage. The patient not had any complications in previous pregnancy and no fetal or neonatal abnormalities. The patient not had any infertility or sub fertility issues. The patient had ante natal check on 8/6, 8/20, 19/9, 9/24, 11/20, 2/4, and visits 10/15, 11/20, 12/11, 12/30, 1/13, 2/4, 2/11, 2/17, 2/24 and 3/3. The patient last menstrual period was on 27May2025, number of fetus for this pregnancy was 1. Estimated delivery date was on 03Mar2026 and gestational period at the time initial suspect was 37.1weeks. The patient was not smoking, not having illicit drugs and not drinking alcohol during pregnancy. The patient not experienced any problems during delivery. The mode of delivery was vaginal, full term live birth. The neonate was male with weight 7lb 13oz, length at birth 18.5nch, head circumference 35cm, APGAR score at 1min 8 and APGAR score at 5min was 09, gestational age at birth was 40weeks 6days. The outcome of fetus was healthy newborn. The father was adult and not took any drugs, illicit drugs, alcohol and not had smoke. The following information was reported: SUSPECTED OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Feb2026, outcome "unknown" and all described as "The provider gave the vaccine at 37.1 weeks gestational age"; DEEP VEIN THROMBOSIS (medically significant) with onset 12Apr2026, outcome "unknown", described as "DVT"; PULMONARY EMBOLISM (medically significant) with onset 12Apr2026, outcome "unknown", described as "PE". The baby was delivered full-term, via vaginal route, delivery date 09Mar2026. The baby weighed 3542.968 grams. APGAR Score was 8, 9. The patient underwent the following laboratory tests and procedures: Rubella antibody test: RPR non reactive. Follow-up (13May2026): This is a spontaneous follow up report received from a Nurse. updated information included. patient demographics added (pregnancy details and delivery details), lab data added, suspect information added, concomitant medication added and new events added (DVT and pulmonary embolism).; Sender's Comments: Based on known vaccine safety data, deep vein thrombosis and pulmonary embolism are unlikely related to Abrysvo .The events are more likely due to pregnancy-associated hypercoagulability or underlying risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS; OMEPRAZOLE; ASA; IRON; METRONIDAZOL [METRONIDAZOLE]; VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; NYSTATIN
Test Name: Rubella immune; Result Unstructured Data: Test Result:RPR non reactive