Received Mar 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | — |
The HCP reports that one of her staff members recently had a titer test and showed no immunity to Rubella; This spontaneous Prospective pregnancy report was received from a medical assistant regarding a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date, the patient may have been vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), injection, 0.5 mL/series, reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route of administration, lot number, and expiration date were not reported) or may have been vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection 0.5 mL (0.5 ml/series) (vaccination scheme frequency, lot number, expiration date, route of administration and anatomical site of injection were not reported for any of the vaccines), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, formulation, route of administration, lot number, and expiration date were not reported); both vaccines indicated as prophylaxis. On an unknown date, the patient became pregnant. Her last menstrual period was estimated as 23-DEC-2024 and her pregnancy due date was estimated as 29-SEP-2025. The pregnancy and fetal outcome were not provided. She was 10 weeks pregnant at the time of the report. The reporter stated that on an unknown date (reported as recently), the patient had a titer test that showed no immunity to Rubella (Rubella antibody negative). It was reported that the patient´s vaccination history is unknown, but the physician mentioned Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) because they contain rubella. The reporter also stated that it could not be confirmed if the patient received any vaccines/medications during her pregnancy. At the reporting time, the outcome of the event Rubella antibody negative was unknown. The causal relationship between the suspect vaccines and sterile diluents, regarding the event was not provided.
Diluent MRK
Test Name: Titer test; Result Unstructured Data: No immunity to rubella