Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | — | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
Consumer was informed one week after that it was the wrong dosage.; Consumer stated that child was cranky and it lasted five days; he would be more immune, it is not giving Tylenol he will not overdose; This spontaneous report was received from a consumer referring to a 14-month-old male patient. The patient's pertinent medical history included asthma. There were no drug reactions/allergies or concomitant therapies. On 23-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the three vaccines were all administered by Intramuscular route (strength, dose, dose number, anatomical site, lot # and expiration date were not reported) for prophylaxis (also reported as 15 months vaccinations). The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) were reconstituted with sterile diluent (MERCK STERILE DILUENT) (Intramuscular route; strength, dose, lot # and expiration date were not reported). The consumer reported that their child healthcare professional office gave the child the 12-month vaccinations when he was 15 months. On the same day, the patient was cranky (irritability), the event was recovered on 29-May-2025 (conflicting information: also reported as lasted five days). Consumer was also informed one week after that it was the wrong dosage (Incorrect dose administered). The doctor stated that "he would be more immune, it is not giving Tylenol he will not overdose" (ill-defined disorder with onset unknown date in 2025). At the reporting time, the outcome of ill-defined disorder was unknown. The action taken with all suspect vaccines was not applicable. The causal relationship between the events of irritability and ill-defined disorder and the suspect vaccines was not provided. Lot# is being requested and will be submitted if received.
Asthma
Sterile diluent