Sex: F
Vaccine: RSV, TDAP, RSV, TDAP
Symptoms: Cervical dilatation, Exposure during pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: Patient describes having lost mucusplug week prior to delivery date 3-7-24; water breaking without having contractions; CERVICAL DILATATION; the timeof birth was early after having received the Abrysvo (RSV) vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2786461 (VAERS ID).  A 24-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Feb2024 as dose 1, single (Lot number: HF5018) intramuscular, in right arm for maternal immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), on 23Feb2024 as dose number unknown, single (Lot number: MX2Z9) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient was 3 trimester pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 3 trimester pregnant at the event onset. The patient is expected to deliver a baby(s) on 24Mar2024. There were no concomitant medications. The following information was reported: CERVICAL DILATATION (hospitalization, disability, life threatening) with onset 07Mar2024, outcome "unknown"; PREMATURE RUPTURE OF MEMBRANES (hospitalization, disability, life threatening) with onset 07Mar2024, outcome "unknown", described as "Patient describes having lost mucusplug week prior to delivery date 3-7-24; water breaking without having contractions"; PREMATURE DELIVERY (hospitalization, disability, life threatening) with onset 07Mar2024, outcome "unknown", described as "the timeof birth was early after having received the Abrysvo (RSV) vaccine". The patient was hospitalized for premature rupture of membranes, cervical dilatation, premature delivery (hospitalization duration: 42 day(s)). The events "patient describes having lost mucusplug week prior to delivery date 3-7-24; water breaking without having contractions", "cervical dilatation" and "the timeof birth was early after having received the abrysvo (rsv) vaccine" required physician office visit. The baby was delivered premature, delivery date 07Mar2024. The baby weighed 2862.718 grams. Clinical course: The time of birth was early after having received the Abrysvo (RSV) vaccine. Patient was concerned by the information regarding possibility of pre-term due to the vaccine. After birth, the baby experienced brain bleeds and seizures, which resulted in hydrocephalus and brain damage. Treatment was ongoing for baby at this time. Patient describes having lost mucus plug week prior to delivery date 07Mar2024; water breaking without having contractions. Lab Data: Baby required shunt placement, MRI's, Cat Scans, and ultrasounds. Baby required seizure medications. Baby is now in occupational therapy. Neurologist suspects possibility of Cerebral Palsy, but results are inconclusive at this time. Baby is required to receive MRI's on an annual basis due to shunt placement. Neurologist appointments ongoing.  No follow-up attempts are possible.  Amendment: This follow-up report is being submitted to amend previously reported information: concomitant therapy details was provided as none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400275853 baby case;