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VAERS Report 2115849

Case Report Section

Détails du rapport Vaer

Âge: N/A

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: fc2473


Date de réception du rapport
2022-02-16
Date à laquelle le formulaire est complèté
Date de vaccination
2021-07-14
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

above all autoimmune hepatitis; increase transaminases; vomiting; liver-kidney microsomal antibody positive; nausea; inappropriate schedule of vaccine administered; this is a spontaneous report received from a contactable reporter(s) (physician) from the regulatory authority. regulatory number: at-basgages-2021-063454 (agency). a 43 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 14jul2021 (batch/lot number: fc2473) as dose 2, single for covid-19 immunisation. relevant medical history included: "substitute addiction in opiate", start date: 22oct2014 (ongoing), notes: good, stable, in therapy. the patient's concomitant medications were not reported. vaccination history included: comirnaty (dose 1), administration date: 02jun2021, for covid-19 immunisation. the following information was reported: autoimmune hepatitis (medically significant) with onset 05nov2021, outcome "not recovered", described as "above all autoimmune hepatitis"; transaminases increased (medically significant) with onset 05nov2021, outcome "not recovered", described as "increase transaminases"; vomiting (medically significant) with onset 05nov2021, outcome "not recovered", described as "vomiting"; autoantibody positive (medically significant) with onset 05nov2021, outcome "not recovered", described as "liver-kidney microsomal antibody positive"; nausea (medically significant) with onset 05nov2021, outcome "not recovered", described as "nausea"; inappropriate schedule of product administration (non-serious) with onset 14jul2021, outcome "unknown", described as "inappropriate schedule of vaccine administered". the patient underwent the following laboratory tests and procedures: autoantibody test: (05nov2021) positive; transaminases: (05nov2021) increased. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; sender's comments: linked report(s) : at-pfizer inc-202200245429 invalid case

Données de laboratoire
test date: 20211105; test name: liver-kidney microsomal antibody positive; test result: positive ; test date: 20211105; test name: serum transaminase increased; result unstructured data: test result:increased
Liste des symptômes
vomiting nausea inappropriate schedule of product administration autoantibody positive transaminases increased autoimmune hepatitis transaminases autoantibody test
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
drug addiction (good, stable, in therapy)