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