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VAERS Report 2157379

Case Report Section

Détails du rapport Vaer

Âge: 5 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: HEP B (ENGERIX-B)

Type : Hepatitis B virus vaccine

Fabricant: GLAXOSMITHKLINE BIOLOGICALS

Lot: unknown


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

Type : Measles, mumps, rubella and varicella vaccine live

Fabricant: MERCK & CO

Lot: u017056


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-11-23
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

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

Données de laboratoire
na
Liste des symptômes
gaze palsy hypertonia loss of consciousness seizure seizure like phenomena
Patient décédé?
Non
Date de décès
N/A
Anomalie congénitale
false
Vaccin administré par :
Unknown
Vaccin acheté par :
Inconnu
Visite d’un patient à l’urgence?
Non
Patient hospitalisé?
Non
Séjour à l’hôpital
Non
Nombre de jours à l’hôpital
Non spécifié
Invalidité permanente?
Non
Allergies:
na
Maladie actuelle
na