Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
getting his vaccines along with dupixent; fever and diarrhea after getting his vaccines; fever ans diarrhea after getting his vaccines; more fussy and "not like self after getting the vaccine"; more fussy and "not like self after getting the vaccine"/ cranky; fussiness and crankiness to patient teething; This spontaneous report was received from a consumer via other company and refers to a 1-year-old male patient. His medical history was not reported. The patient's concurrent conditions included ongoing multiple food allergies. Concomitant therapies were not reported. On 31-Dec-2024, the patient started therapy with Dupixent (Dupilumab) solution for injection 200 mg (strength 200mg), administered by subcutaneous route for the treatment of eczema (lot # and expiration date were not reported). On 08-Jun-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Hepatitis A Vaccine, Inactivated (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); and with Typhoid Conjugate Vaccine (reported as TCV vaccine) administered by unknown route (lot # and expiration date were not reported). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown) were reconstituted with sterile diluent (no details provided). On 08 -JUN-2025, per mom, the patient had a fever and diarrhea after getting his vaccines. They did not know about avoiding live vaccines regarding Dupixent injection (contraindicated product administered). She stated patient did seem more fussy and "not like self" after getting the vaccines (altered state of consciousness) (onset: 2025), fever and diarrhea had resolved the next day, on 09-JUN-2025 (reported also as 7/9/2025, discrepancy). The patient was administered Tylenol (date unknown). He was still a little fussy and cranky (irritability) (onset: 2025) but better, the fussiness and crankiness were attributed to the patient's teething (irritability) (onset: 2025). The action taken was not applicable for all of the vaccines. Dupilumab was continued for all events. The patient recovered from the event of fever and diarrhea after getting his vaccines on 09-Jun-2025. At the reporting time, the patient was recovering from irritability. The outcome of the patient's teething and altered state of consciousness was unknown. The causal relationship between the events and the suspect vaccines was not provided. Upon internal review, all of the events were determined to be medically significant.
Food allergy
DUPIXENT; Sterile diluent