Détails du rapport Vaer
Âge: 0
Genre: Female
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: MENINGOCOCCAL (NO BRAND NAME)
Type : Meningococcal polysaccharide vaccine
Fabricant: UNKNOWN
Lot: abxb82aa
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-08-19
- Date d’apparition
- 0
- Nombre de jours (date d’apparition – date de vaccination)
- 0
- Description de l’événement indésirable
-
fever 37.5 over 12 hours and day 1, irritability and nervousism day 3; fever 37.5 over 12 hours and day 1, irritability and nervousism day 3; fever 37.5 over 12 hours and day 1, irritability and nervousism day 3; this case was reported by a physician via regulatory authority and described the occurrence of fever in a 3-month-old female patient who received men b nvs (bexsero) (batch number abxb82aa, 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 19th august 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 19th august 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), irritability (serious criteria other: serious as per reporter) and nervousness (serious criteria other: serious as per reporter). on 23rd august 2021, the outcome of the fever, irritability and nervousness were recovered/resolved. it was unknown if the reporter considered the fever, irritability and nervousness to be related to bexsero and meningococcal b vaccine pre-filled syringe device. this report is made without prejudice and does not imply any admission or liability for the incident or its consequences. additional details were reported as follows: on 19th august 2021, the body temperature of patient was recorded as 37.5 degree celsius. the duration for events fever, irritability and nervousness was 4 days. as per verbatim, nervousness occurred on day 3 but time to onset was captured as less than a day as per reported dates. initial information was received from a physician via regulatory authority on 28th february 2022: fever 37.5 over 12 hours and day 1, irritability and nervousism day 3
- Données de laboratoire
-
test date: 20210819; test name: body temperature; result unstructured data: (test result:37.5,unit:degree c,normal low:,normal high:)
- Liste des symptômes
-
nervousness irritability 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