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VAERS Report 2156657

Case Report Section

Détails du rapport Vaer

Âge: 36 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: unknown


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-01-06
Date d’apparition
1
Nombre de jours (date d’apparition – date de vaccination)
1
Description de l’événement indésirable

medication error; myopericarditis; this case was received via the regulatory authority ra (reference number: gb-mhra-adr 26647897) on 27-feb-2022 and was forwarded to moderna on 27-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of medication error (medication error) and myocarditis (myopericarditis) in a 36-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. no medical history information was reported. on 06-jan-2022, the patient received dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 07-jan-2022, after starting mrna-1273 (moderna covid-19 vaccine), the patient experienced myocarditis (myopericarditis) (seriousness criteria hospitalization and medically significant). on an unknown date, the patient experienced medication error (medication error) (seriousness criteria hospitalization and medically significant). at the time of the report, medication error (medication error) outcome was unknown and myocarditis (myopericarditis) was resolving. for mrna-1273 (moderna covid-19 vaccine) (unknown), the reporter did not provide any causality assessments. concomitant medications were not reported. it was reported that reaction occurred as a result of a mistake made in the administration of the vaccine. event had occurred within 12 hours of vaccination. treatment medications were not reported. company comment: this is a regulatory authority case concerning a 36-year-old, female patient with no reported medical history, who experienced the expected serious (hospitalization and medically significant according to regulatory authority) adr event of myopericarditis. unspecified medication error was also reported. the event myopericarditis occurred approximately 1 day after the unknown dose number of mrna-1273 vaccine administration which resulted to hospitalization. the events were described as, the event occurred as a result of a mistake made in the administration of the vaccine. no reported treatment information. the outcome of the event myopericarditis was resolving. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. most recent follow-up information incorporated above includes: on 27-feb-2022: follow-up received contains updated information on events: event medication error was added.; sender's comments: this is a regulatory authority case concerning a 36-year-old, female patient with no reported medical history, who experienced the expected serious (hospitalization and medically significant according to regulatory authority) adr event of myopericarditis. unspecified medication error was also reported. the event myopericarditis occurred approximately 1 day after the unknown dose number of mrna-1273 vaccine administration which resulted to hospitalization. the events were described as, the event occurred as a result of a mistake made in the administration of the vaccine. no reported treatment information. the outcome of the event myopericarditis was resolving. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report

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