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VAERS Report 2157401

Case Report Section

Détails du rapport Vaer

Âge: 80 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: fd7959


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-08-25
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

approximately 30 minutes after administration of the first vaccine dose, constriction in the jugule occurs; this is a non-interventional study report from the agency regulatory authority-web. regulatory number: it-minisal02-845176. an 80 year-old female subject received bnt162b2 (comirnaty), intramuscular, administration date 25aug2021 13:30 (lot number: fd7959, expiration date: 31oct2021) at the age of 80 years as dose 1, 0.3 ml single for covid-19 immunisation. relevant medical history included: "osteoporosis" (unknown if ongoing); "hysterectomy" (unknown if ongoing); "hypertension arterial" (unknown if ongoing); "drug hypersensitivity" (unknown if ongoing), notes: multiple drug allergies; "polyallergic patient" (unspecified if ongoing). concomitant medication(s) included: losartan. past drug history included: arimidex, reaction(s): "anaphylactic shock". the following information was reported: throat tightness (hospitalization) with onset 25aug2021 14:00, outcome "recovered" (25aug2021), described as "approximately 30 minutes after administration of the first vaccine dose, constriction in the jugule occurs". therapeutic measures were taken as a result of throat tightness, the action taken was reported as administration of trimeton 1 fl iv with complete regression of symptoms. the reporter's assessment of the causal relationship of the "approximately 30 minutes after administration of the first vaccine dose, constriction in the jugule occurs" 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 temporal association, he event throat tightness is possibly related to bnt162b2 (comirnaty). the impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to ras, ethics committees, and investigators, as appropriate

Données de laboratoire
na
Liste des symptômes
throat tightness
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?
Oui
Séjour à l’hôpital
Non
Nombre de jours à l’hôpital
Non spécifié
Invalidité permanente?
Non
Allergies:
na
Maladie actuelle
na