Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
Within 2-3 months of receiving the vaccine, the daughter had "full blown Graves"; thyroid disease; This spontaneous report was received from a Pharmacist (the patient's mother or grandmother, discrepancy) and refers to an Adult female patient (exact age unknown). The patient's medical history was not reported. The patient's concurrent conditions included Grave's disease. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, formulation, route and site of administration, lot # and expiration date were not reported) administered with a sterile diluent (MERCK STERILE DILUENT) (strength, dose, formulation, route and site of administration, lot # and expiration date were not reported) for prophylaxis. It was stated that the patient, who was the reporter's daughter, who had been diagnosed with Grave's disease (concurrent condition), had to get the with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine when she went to college. Then, on an unknown date, reported as within 2-3 months of receiving the suspect vaccine, the daughter had "full blown Grave's". The reporter did not provide any further details on when this happened. She also asked if single measles and mumps vaccines were available, because her granddaughter (conflicting information) had thyroid disease (since unknown date), and showed signs of Graves. For this reason, she was unable to get the shot. The reporting pharmacist also mentioned that the Rubella portion is contraindicated in pregnancy and mentioned being allergic to components in Rubella. For this reason, the reporter was not able to get the shot. She said it would be beneficial if the single measles and mumps vaccines were still available, and that there were benefits to having access to the single components so that people with issues to Rubella could get vaccinated. The reporter mentioned being a registered pharmacist and would like to be contacted regarding her feedback. She was hoping the Company would reconsider the decision to discontinue the monovalent components as she could not get the vaccine because she was allergic. She asked why should MMR be given if people only need to get vaccinated against measles, the Rubella was causing the issues. At the reporting time, the outcome of the events was not reported. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided. Upon internal review, the event of Grave's disease was determined to be medically significant. Lot # is being requested and will be submitted if received.; Sender's Comments: Based on the clinical information currently available for this individual case, there is no sufficient evidence to suggest a reasonable possibility for a causal relationship between M-M-R II vaccine and the adverse event of Grave´s disease. More information regarding if the vaccine was administered and the exact date of administration (if administered), the clinical course and relevant diagnostic evaluation is needed for further assessment. No changes to the product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product.
Graves' disease
sterile diluent