Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
pacemaker; This spontaneous report was received from a physician regarding to a 94-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not reported), as prophylaxis; in combination with sterile diluent (BAXTER STERILE DILUENT) (strength, dose, frequency, lot number, expiration date and indication were not reported). Inbound call was received from physician who had a medical information question on administering a 3rd booster dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) to a 94 year old male who had a pacemaker. After caller disconnected, precautionary AE was identified to due the patient having a pacemaker. Unknown date of when patient received pacemaker and unknown date when patient initially received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) doses. Because a correlation could not be ruled out, precautionary AE filed. Since HCP had already disconnected, most information was unknown. Permission to contact for follow up is unknown. No additional information available. No additional AE/PQC. At the reporting time, the outcome of pacemaker was unknown. The causal relationship between the event of pacemaker and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and sterile diluent was not provided. Upon an internal review, the event of pacemaker was determined to be medically significant. Lot # is being requested and will be submitted if received.