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VAERS Report 2157379

Case Report Section

Vaer Report Details

Age: 5 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: HEP B (ENGERIX-B)

Type: Hepatitis B virus vaccine

Manufacturer: GLAXOSMITHKLINE BIOLOGICALS

Lot: unknown


Name: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)

Type: Measles, mumps, rubella and varicella vaccine live

Manufacturer: MERCK & CO

Lot: u017056


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-11-23
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

likely convulsive episode (loss of consciousness, hypertonia, eye rotation, diffused clonia), after 15 min spontaneous resolution.; information has been downloaded from the regulatory authority (it-minisal02-843948). this spontaneous report was received from a physician regarding a 5-year-old female patient. the patient's concomitant medication included hepatitis b vaccine rhbsag (yeast) (engerix b). no information was provided regarding the patient's relevant medical history, concurrent conditions, or previous drug reactions/allergies. on 23-nov-2021, the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (therapy type: recombinant human albumin (rha)) (proquad) administered at a dose of 1 dosage form, 1 cyclical via intramuscular route (lot # u017056 has been verified to be a valid lot number, expiration date was not reported but upon internal validation was established as 31-oct-2022) (formulation, strength anatomical location and indication was not reported). on the same day, the patient experienced seizure like phenomena (reported as "likely convulsive episode (loss of consciousness, hypertonia, eye rotation, diffused clonia), after 15 minutes spontaneous resolution"). on 23-nov-2021, the patient recovered from seizure like phenomena. the relatedness between the event and the suspect vaccine was not reported. the agency considered the event seizure like phenomena to be medically significant

Lab Data
na
List of symptoms
gaze palsy hypertonia loss of consciousness seizure seizure like phenomena
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Unknown
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na