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VAERS Report 2157361

Case Report Section

Détails du rapport Vaer

Âge: 59 ans

Genre: Male

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)

Type : Influenza virus vaccine, quadrivalent, cell-culture-derived

Fabricant: SEQIRUS

Lot: unknown


Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: ff2382


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-10-18
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

patient received both comirnaty and flucelvax tetra on 18oct2021; pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees; pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees; active surveillance co-administration this is a non-interventional study report from the regulatory authority-web. regulatory number: it-minisal02-843292. a 59 year-old male patient received bnt162b2 (comirnaty), intramuscular, administration date 18oct2021 (lot number: ff2382, expiration date: 31mar2022) at the age of 59 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation; influenza vaccine inact sag 4v (flucelvax tetra [influenza vaccine inact sag 4v]), intramuscular, administration date 18oct2021 (lot number: unknown) for immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation; covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. the following information was reported: product use issue (medically significant) with onset 18oct2021, outcome "unknown", described as "patient received both comirnaty and flucelvax tetra on 18oct2021"; vaccination site pain (medically significant), pyrexia (medically significant) all with onset 18oct2021, outcome "recovered" (20oct2021) and all described as "pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees". the patient underwent the following laboratory tests and procedures: body temperature: (18oct2021) above 37 degrees. therapeutic measures were taken as a result of vaccination site pain, pyrexia and treatment included simultaneous intake of tachipirina. the reporter's assessment of the causal relationship of the "patient received both comirnaty and flucelvax tetra on 18oct2021" and "pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees" with the suspect product(s) bnt162b2 was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on currently known drug safety profile, a causal association between the reported events pyrexia and vaccination site pain and bnt162b2 cannot be excluded

Données de laboratoire
test date: 20211018; test name: body temperature; result unstructured data: test result:above 37 degrees
Liste des symptômes
pyrexia body temperature vaccination site pain product use issue
Patient décédé?
Non
Date de décès
N/A
Anomalie congénitale
false
Vaccin administré par :
Other
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