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VAERS Report 2157411

Case Report Section

Détails du rapport Vaer

Âge: 0

Genre: Male

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: MENINGOCOCCAL (NO BRAND NAME)

Type : Meningococcal polysaccharide vaccine

Fabricant: UNKNOWN

Lot: abxb13aa


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

fever 37.5 after 6/12 hours, diarrea day 4; fever 37.5 after 6/12 hours, diarrea day 4; this case was reported by a physician via regulatory authority and described the occurrence of fever in a 4-month-old male patient who received men b nvs (bexsero) (batch number abxb13aa, 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 3rd september 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 3rd september 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced fever (serious criteria other: serious as per reporter) and diarrhea (serious criteria other: serious as per reporter). on 8th september 2021, the outcome of the fever and diarrhea were recovered/resolved. it was unknown if the reporter considered the fever and diarrhea 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: on 3rd september 2021, the body temperature of patient was recorded as 37.5 degree celsius. the duration for events fever and diarrhea was 5 days. the time to onset was reported as fever after 6/12 hours and diarrhea on day 4 however time to onset was captured as less than a day as per the event onset date. initial information was received from a physician via regulatory authority on 28th february 2022: fever 37.5 after 6/12 hours, diarrhea day 4

Données de laboratoire
test date: 20210903; test name: body temperature; result unstructured data: (test result:37.5,unit:degree c,normal low:,normal high:)
Liste des symptômes
diarrhoea pyrexia
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