Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | DN273 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y008591 | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015101 | — |
This spontaneous report was received from a consumer or other non-health professional and refers to a(n) 1-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies were not reported. On 28-MAR-2025, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y008591, expiration date: 30-APR-2026) administered by intramuscular (IM) route, additionally, she received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015101, expiration date: 06-SEP-2026) administered by IM route and the Hepatitis A Vaccine, inactivated (VAQTA), (lot #DN273) administered by IM route (expiration date were not reported, lot verification was not found, invalid lot number).All reported vaccines were reconstituted with sterile diluent solution for injection (MERCK STERILE DILUENT) (lot number and expiration date not provided). All reported vaccines were for treatment of recommended vaccinations/prophylaxis. On 29-MAR-2025, the patient experienced oral sores (canker), fever, and losing appetite. As treatment the heath care professional (HCP), recommended over the counter medications, such as ibuprofen and acetaminophen (TYLENOL). At the reporting time, the patient had not recovered from the events. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), and Hepatitis A Vaccine, inactivated (VAQTA) was not provided. Executive Summary: On 02-APR-2025, Pharmacovigilance requested a Medium Priority Adverse Event Quality Investigation Report (AEQIR) for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Package Lot # Y008591 (Fill Batch # 0001722121) following receipt of an adverse event report. Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Batch # 0001722121 was confirmed to be processed at the Merck site with a date of Manufacture of 27-OCT-2023. The entire batch quantity was shipped to the Merck Site, where it was partially packaged into Package Lot # Y008591 with an expiry of 30-APR-2026. The remainder Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Fill Batch # 0001722121 was packaged into Package Lot # Y008583. This Full Investigation has assessed the following elements: Scope and Background, Complaint Sample Evaluation, AEQIR Lot History, Event History, Use of Product and Reported Patient Outcome, Vendor/Supplier Investigation Retention Sample Evaluation and Testing, Batch Record Review, Logs, Deviations Review, Vendor/Supplier Investigation, Release Testing, Component and Raw Material Release Testing, Change Control Review, Stability Results, Merck Supporting Investigation, Distribution Center Supporting Investigation, Potential Quality Issues Identified, and Review of Previous CAPAs. There is no complaint sample associated with this AEQIR as the report was initiated for a dose that was administered. On 30-APR-2025, queries in the systems were performed and indicate that this is the first and only Adverse Event Quality Investigation Report (AEQIR) assigned to the Merck Complaint Investigation Unit (CIU) associated with M-M-R®II Fill Batch # 0001722121 / associated Package Lot #s Y008591 and Y008583. Downstream investigation into packaging, warehousing and distribution of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Fill Batch # 0001722121 / Package Lot # Y008591 by the Merck CIU and Distribution Center were completed, and no quality issues were identified. A review of the manufacturing documents and quality system records determined that the manufacturing processes at Merck were in a state of control during the processing of this batch and confirmed that all results for this batch met requirements and specifications. All Quality Notifications were investigated in accordance with procedure and were determined to have no product impact. Overall, there were no safety, purity, or potency concerns identified with the Merck processing of M-M-R®II, Fill Batch # 0001722121 / Package Lot # Y008591. On 02-APR-2025, Pharmacovigilance requested a Medium Priority Adverse Event Quality Investigation Report (AEQIR) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Package Lot # Y015101 (Fill Batch # 0001784932) following receipt of an adverse event report. Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Fill Batch # 0001784932 was confirmed to be processed at the Merck site with a Date of Manufacture of 06-MAY-2025. The entire batch quantity was shipped to the Merck Site, where it was fully packaged into Package Lot # Y015101 with an expiry of 06-SEP-2026. This Full Investigation has assessed the following elements: Scope and Background, Complaint Sample Evaluation, AEQIR Lot History, Event History, Use of Product and Reported Patient Outcome, Vendor/Supplier Investigation Retention Sample Evaluation and Testing, Batch Record Review, Logs, Deviations Review, Vendor/Supplier Investigation, Release Testing, Component and Raw Material Release Testing, Change Control Review, Stability Results, Merck Supporting Investigation, Distribution Center Supporting Investigation, Potential Quality Issues Identified, and Review of Previous CAPAs. There is no complaint sample associated with this AEQIR as the report was initiated for a dose that was administered. On 30-APR-2025, queries in the systems were performed and indicate that this is the first and only Adverse Event Quality Investigation Report (AEQIR) assigned to the Merck Complaint Investigation Unit (CIU) associated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Fill Batch # 0001784932 / associated Package Lot # Y015101. Downstream investigation into packaging, warehousing and distribution of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Fill Batch # 0001784932 / Package Lot # Y015101 by the Merck CIU and Distribution Center were completed, and no quality issues were identified. A review of the manufacturing documents and quality system records determined that the manufacturing processes at Merck were in a state of control during the processing of this batch and confirmed that all results for this batch met requirements and specifications. All Quality Notifications were investigated in accordance with procedure and were determined to have no product impact. Overall, there were no safety, purity, or potency concerns identified with the Merck processing of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Fill Batch # 0001784932, Package Lot # Y015101.