Report #2885480

Overview

Sex

Male

Age

1 yrs

State

MD

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

was diagnosed with expressive speech delay; behavioral problem; This spontaneous report was received from a/ Physician and refers to a(n) 16-month-old male patient. The patient's medical history included a macrocephaly (big head but was acting normal). He was" referred to a Neurologist, but there was no concern." The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (at 12 months of age), the patient was vaccinate with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccines were reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported). On an unknown date, the patient experienced speech disorder developmental and behaviour disorder. At 16 months of age, the patient developed "a speech delay and behavioral problem." At 2 years old, he was in the "Infant and Toddler program and was diagnosed with expressive speech delay." At the reporting time, the outcome of the events was unknown. The causal relationship between the events of speech disorder developmental, behaviour disorder, Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), and sterile diluent (Hollister-Stier STERILE DILUENT) was unknown/not reported/not provided. The health-care professional (HCP) reported the mom thinks it may be related to the vaccine and HCP stated they cannot determine either way.

Medical history

Medical History/Concurrent Conditions: Macrocephaly NOS

Other medications

Sterile diluent