Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | RA |
Headache; nausea; vomiting; cramping; fever; increased blood pressure; soreness at injection site; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Sep2025 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in right arm for maternal immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing); "Allergy: Iodine" (unspecified if ongoing). The patient was 34 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Oct2025. Concomitant medication(s) included: LAMICTAL, start date: 22Aug2020. Past drug history included: Bactrim, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering"; MUSCLE SPASMS (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "cramping"; FATIGUE (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering"; PYREXIA (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "fever"; BLOOD PRESSURE INCREASED (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "increased blood pressure"; NAUSEA (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "soreness at injection site"; VOMITING (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nausea, vomiting, muscle spasms, pyrexia, blood pressure increased, vaccination site pain, fatigue.
Medical History/Concurrent Conditions: Iodine allergy; Latex allergy; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: Bipolar
LAMICTAL
Test Date: 20250903; Test Name: blood pressure; Result Unstructured Data: Test Result:increased; Comments: 21:15