Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
The patient recently had a miscarriage (before PROQUAD administration); HCP reports that the patient has received her MMR and varicella vaccines in the past (unknown brand name) but recently undergone titer testing that did not show immunity.; the patient has received her MMR and varicella vaccines in the past; the patient recently had a miscarriage; This spontaneous report was received from a physician assistant (reported as medical assistant and refers to a 27-year-old female patient. The patient's concurrent conditions included drug allergy (minocycline). Historical drugs included minocycline. The patient concomitant therapies, previous drugs reactions and allergies were not reported. This was a retrospective pregnancy case. On an unknown date, the subject became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. On an unknown date (reported as in the past), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (reported as MMR vaccine) (manufacturer unknown, reported as unknown brand name) and with a dose of varicella virus vaccine live (oka-merck) (VARIVAX) (reported as varicella vaccine) (manufacturer unknown reported as unknown brand name) both administered as prophylaxis (strengths, Lot numbers, expirations dates, dose numbers, exact dose quantity volumes, routes and anatomical locations of administration and vaccination scheme frequencies were not provided); that were reconstituted with sterile diluent (Lot No., expiration date, route and indication were not reported). On an unspecified date (reported as recently) it was stated that the patient undergone a titer testing that did not show immunity (antibody test abnormal) and that the patient recently had a miscarriage (abortion spontaneous) (exposure during pregnancy). On an unknown date, the patient was inadvertently given a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (PROQUAD)(product use issue) in order to provide a booster for the series (captured in PV smart # 2333373). The outcome of the events of antibody test abnormal and abortion spontaneous was not reported. The outcome of exposure during pregnancy was reported as recovered. The causal relationship between the events of antibody test abnormal and abortion spontaneous was not reported. Upon internal review, the event of abortion spontaneous was determined to be medically significant.
Drug allergy
Sterile diluent
Test Name: Titer testing; Result Unstructured Data: not show immunity