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