Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 2 | MM9159 | OT / LA |
Anemia of pregnancy; 2 doses of Abrysvo to a pregnant patient; This is a spontaneous report received from an Other HCP and a Physician from medical information team, Program ID:. A 31-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Oct2025 as dose 2, 0.5 ml single (Lot number: MM9159, Expiration Date: Sep2026) at the age of 31 years intramuscular, in left deltoid for maternal immunisation. The patient's relevant medical history included: "preeclampsia" (unspecified if ongoing), notes: previous pregnancy complications; "pregnancy" (unspecified if ongoing), notes: 1 live birth; "thyroid nodules", start date: 14Aug2023 (unspecified if ongoing); "cleft palate with repair" (unspecified if ongoing); "cleft palate with repair" (unspecified if ongoing); "subchorionic hemorrhage", start date: 18Apr2025 (unspecified if ongoing). Date of last menstrual period: 05Mar2025. 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 one baby(s) on 10Dec2025. Concomitant medication(s) included: BABY ASPIRIN taken for pre-eclampsia. Past drug history included: Biaxin, reaction(s): "Hives". Vaccination history included: abrysvo (DOSE 1, SINGLE, Lot number: MM9159, Expiration date: Sep2026, at the left deltoid), administration date: 17Oct2025, when the patient was 31-year-old, for Maternal immunization, reaction(s): "No adverse event"; Influenza vaccine (given at another facility), for Immunization; Tdap gsk (DOSE 1, SINGLE, Lot number: 5GY34, Expiration date: 03Jan2028, at the right deltoid), for Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 31Oct2025, outcome "unknown", described as "2 doses of Abrysvo to a pregnant patient"; ANAEMIA OF PREGNANCY (non-serious) with onset 03Nov2025, outcome "unknown", described as "Anemia of pregnancy". Therapeutic measures were not taken as a result of incorrect dose administered. Additional information: pregnant patient who was 34 weeks and 2 days pregnant on 31Oct2025 and was given first dose of Abrysvo on 17Oct2025. However, patient was also given a second dose today, 31Oct2025. Dose was given again, two doses given to patient. Reporter was asking how to proceed with the treatment recommendations. On 24Nov2025, the following were reported: The patient did not smoke, drink alcohol and use illicit drug during this pregnancy. The patient did not receive any other vaccines on the same date as Abrysvo. The patient was taking other medications within 2 weeks prior to the event onset (drug taken during pregnancy): Prenatal vitamin for Pregnancy 1 daily and Baby Aspirin for history of preeclampsia 81 mg, 1 daily. The medication error occurred when the product was administered to/taken by the patient. The medication error was not noticed and intercepted before the product was supplied to the patient. Inadvertent human error was the factor considered to be responsible for the medication error. The patient did not experience any adverse event as a consequence of the error. Ante-natal check up results for this pregnancy were reported as follows: 18Apr2025: IVP at 6w 2d 2 subchorionic hemorrhage (as reported), 25Apr2025 : IVP 7w 2d adequate growth (as reported), 01Aug2025: normal anatomy/breech. Follow-up (24Nov2025): This is a follow-up spontaneous report received from a physician. Updated information: patient details, relevant medical history, historical vaccine, past drug event, concomitant medication, suspect vaccine details (vaccination facility information, vaccination route/anatomical location), new event (anemia of pregnancy).
Medical History/Concurrent Conditions: Cleft palate; Cleft palate repair; Preeclampsia (previous pregnancy complications); Pregnancy (1 live birth); Subchorionic hemorrhage; Thyroid nodule
BABY ASPIRIN