Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z004246 | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
No additional AE; Caller reported patient received VARIVAX while pregnant. Caller states patient does not currently have a rash or any symptoms. No other information provided; This spontaneous report was received from a nurse practitioner and refers to a 38-year-old female pregnant patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. This was a prospective pregnancy case. On an unknown date reported (approximately on 01-Jul-2025) the patient became pregnant. The last menstrual period (LMP) was (17-Jun-2025) and estimated date of delivery (EDD) was (24-Mar-2026) and with estimated 7 week and 2 days of pregnancy gestation. On 07-Aug-2025, the patient was vaccinated while pregnant with a dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, 0.5 mL, administered subcutaneously as prophylaxis (Lot No. Z004246 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)] expiration date reported, and upon internal validation established as 10-Feb-2027) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent, administered subcutaneously (Lot No, expiration date and indication was not provided (exposure during pregnancy). Additionally, it was stated that the patient did not currently have a rash or any symptoms. No other information provided. No additional adverse event (no adverse event).