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VAERS Report 2157398

Case Report Section

Détails du rapport Vaer

Âge: N/A

Genre: Male

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: fn1448


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-01-23
Date d’apparition
2
Nombre de jours (date d’apparition – date de vaccination)
2
Description de l’événement indésirable

difficulties in sight; difficulties in chewing; temporary paralysis of one side of the face; this is a pfizer-sponsored expanded access program report received from a contactable reporter(s) (consumer or other non hcp) from the medicines agency () -web. the reporter is the patient. regulatory number: it-minisal02-844908 (minisal02). a 38-year-old male patient received bnt162b2 (comirnaty), intramuscular, administered in deltoid left, administration date 23jan2022 12:36 (lot number: fn1448) as dose 2 (booster), single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: janssen vaccine (0.5 ml, intramuscular, dose 1), administration date: 06jun2021, for sars-cov-2 vaccination. the following information was reported: facial paralysis (medically significant) with onset 25jan2022, outcome "not recovered", described as "temporary paralysis of one side of the face"; visual impairment (non-serious), outcome "unknown", described as "difficulties in sight"; mastication disorder (non-serious), outcome "unknown", described as "difficulties in chewing". the events "temporary paralysis of one side of the face", "difficulties in sight" and "difficulties in chewing" were evaluated at the emergency room visit. the reporter's assessment of the causal relationship of the "temporary paralysis of one side of the face", "difficulties in sight" and "difficulties in chewing" 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 the limited available information, plausible temporal association and known drug safety profile, the events are assessed as 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 regulatory authorities, ethics committees, and investigators, as appropriate

Données de laboratoire
na
Liste des symptômes
visual impairment facial paralysis mastication disorder
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