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VAERS Report 2157404

Case Report Section

Détails du rapport Vaer

Âge: 0

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: MENINGOCOCCAL B (BEXSERO)

Type : Meningococcal group b vaccine, rDNA absorbed

Fabricant: NOVARTIS VACCINES AND DIAGNOSTICS

Lot: abxb76ac


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-09-17
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

fever greater than or equal to 39.5; fever greater than or equal to 39.5; this case was reported by a other health professional via regulatory authority and described the occurrence of hyperpyrexia in a 7-month-old female patient who received men b nvs (bexsero) (batch number abxb76ac, expiry date unknown) for prophylaxis. co-suspect products included meningococcal b recom vaccine + aloh + omv pre-filled syringe device (meningococcal b vaccine pre-filled syringe device) injection syringe for prophylaxis. on 17th september 2021, the patient received bexsero (intramuscular) and meningococcal b vaccine pre-filled syringe device. on 17th september 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced hyperpyrexia (serious criteria gsk medically significant and other: serious as per reporter) and restlessness (serious criteria other: serious as per reporter). on 20th september 2021, the outcome of the hyperpyrexia and restlessness were recovered/resolved. it was unknown if the reporter considered the hyperpyrexia and restlessness to be related to bexsero and meningococcal b vaccine pre-filled syringe device. this report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. additional details were reported as follows: patient received bexsero on right thigh. on 17th september 2021, the body temperature of patient was recorded as greater than or equal to 39.5 degree celsius. the duration for events hyperpyrexia and restlessness was 3 days. initial information was received from a other health professional via regulatory authority on 25th february 2022: fever greater than or equal to 39.5. reporter's comments: inoculation site: right thigh

Données de laboratoire
test date: 20210917; test name: body temperature; result unstructured data: (test result:greater than or equal to 39.5,unit:degree c,normal low:,normal high:)
Liste des symptômes
restlessness hyperpyrexia
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