Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | LN5502 | OT / RA |
chills; body aches; temperature 99.6 F/100F; Thought they had given an HPV Vaccine, but instead they had given Abrysvo; This is a spontaneous report received from a Pharmacist, Program ID. A 22-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Nov2024 as dose 1, single (Lot number: LN5502, Expiration Date: 10Jan2025) at the age of 22 years intramuscular, in right deltoid for immunisation. The patient didn't receive hpv vaccine (HPV VACCINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Nov2024, outcome "unknown", described as "Thought they had given an HPV Vaccine, but instead they had given Abrysvo"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "temperature 99.6 F/100F". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that Abryvso vaccine was given to the wrong patient. The patient is post-partum. They thought they had given an HPV Vaccine, but instead they had given Abrysvo. The patient did not receive any other vaccine on the same day as the Pfizer vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient did not previously receive the Pfizer suspect vaccine. The patient was not allergic to ang previous vaccinations, medications, food or other products. There was no any other diagnosed illness/medical history/chronic health conditions. The event did not require a visit to the emergency room or physician's office. Treatment was not received for the adverse event. There was no adverse events following this vaccination. Amendment: This follow-up report is being submitted to amend previously reported information: suspect vaccine Indication was updated from "Maternal exposure timing unspecified" to "Immunization". Follow-up (16Jan2025): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained. Follow-up (29Jan2025): This is a spontaneous follow-up report received from a Pharmacist in response to follow-up letter. Updated information: patient's details (name, date or birth, age, weight, height) added, product details (vaccination date, anatomical location, route, dose number, lot number, expiration date), event details (onset date), removed event Drug use in unapproved population, new event chills, General body pain, fever added, additional information added.
Test Name: temperature; Result Unstructured Data: Test Result:99.6 Fahrenheit; Test Name: temperature; Result Unstructured Data: Test Result:100 Fahrenheit