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VAERS Report 2157215

Case Report Section

Détails du rapport Vaer

Âge: 21 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
2021-06-16
Date d’apparition
182
Nombre de jours (date d’apparition – date de vaccination)
182
Description de l’événement indésirable

pericardite; this case was received via regulatory authority(reference number: it-ra02-840728) on 24-feb-2022 and was forwarded to moderna on 24-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of pericarditis (pericardite) in a 21-year-old female patient who received mrna-1273 (spikevax) for covid-19 vaccination. the patient's past medical history included epilepsy (epilepsy). on 16-jun-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 15-dec-2021, the patient experienced pericarditis (pericardite) (seriousness criterion medically significant). at the time of the report, pericarditis (pericardite) had not resolved. the action taken with mrna-1273 (spikevax) (unknown) was unknown. patient's medical history included chromosome 7 long arm partial trisomy epilepsy the event was severe. no concomitant medication information was reported no treatment medication information was reported company comment: this regulatory case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced serious (medically significant) unexpected aesi event of pericarditis, 6 months after receiving a dose of mrna-1273 vaccine. at the time of the report, event had not resolved. the benefit-risk relationship of mrna-1273 is not affected by this report. event seriousness assessed as per regulatory authority reporting. most recent follow-up information incorporated above includes: on 25-feb-2022: significant follow-up contains, dose start date added. reporter's comments: chromosome 7 long arm partial trisomy epilepsy 08/02/2022 severity modified on the basis of the ime list from non-serious to 'severe-other clinically relevant condition; sender's comments: this regulatory case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced serious (medically significant) unexpected aesi event of pericarditis, 6 months after receiving a dose of mrna-1273 vaccine. at the time of the report, event had not resolved. the benefit-risk relationship of mrna-1273 is not affected by this report. event seriousness assessed as per regulatory authority reporting

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