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VAERS Report 2115891

Case Report Section

Détails du rapport Vaer

Âge: 68 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 3001531


Date de réception du rapport
2022-02-16
Date à laquelle le formulaire est complèté
Date de vaccination
2021-05-04
Date d’apparition
192
Nombre de jours (date d’apparition – date de vaccination)
192
Description de l’événement indésirable

sars-cov-2 infection; vaccination failure; this case was received (reference number: at-basgages-2022-004859) on 09-feb-2022 and was forwarded to moderna on 09-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of covid-19 (sars-cov-2 infection) and vaccination failure (vaccination failure) in a 68-year-old female patient who received mrna-1273 (spikevax) (batch nos. 3001531 and 3002916) for covid-19 vaccination. no medical history information was reported. on 04-may-2021, the patient received first dose of mrna-1273 (spikevax) (intramuscular) 1 dosage form. on 11-jun-2021, received second dose of mrna-1273 (spikevax) (intramuscular) dosage was changed to 1 dosage form. on 12-nov-2021, the patient experienced covid-19 (sars-cov-2 infection) (seriousness criterion medically significant) and vaccination failure (vaccination failure) (seriousness criterion medically significant). at the time of the report, covid-19 (sars-cov-2 infection) and vaccination failure (vaccination failure) outcome was unknown. diagnostic results (normal ranges are provided in parenthesis if available): on 12-nov-2021, sars-cov-2 test: positive (positive) positive. for mrna-1273 (spikevax) (intramuscular), the reporter did not provide any causality assessments. no concomitant medications were reported. no treatment information was provided. company comment: this is a regulatory authority case concerning a 68-year-old female patient, with no medical history reported, who experienced the serious unexpected aesi of covid-19. also, the special situation of vaccination failure was reported. the event occurred approximately 5 months and 2 days after the administration of the second dose of the mrna-1273 vaccine of an inappropriate schedule of vaccination (time between doses: 39 days). the benefit-risk relationship of the mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority's report due to medically significant.; sender's comments: this is a regulatory authority case concerning a 68-year-old female patient, with no medical history reported, who experienced the serious unexpected of covid-19. also, the special situation of vaccination failure was reported. the event occurred approximately 5 months and 2 days after the administration of the second dose of the mrna-1273 vaccine of an inappropriate schedule of vaccination (time between doses: 39 days). the benefit-risk relationship of the mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority's report due to medically significant

Données de laboratoire
test date: 20211112; test name: covid-19 pcr test; test result: positive ; result unstructured data: positive
Liste des symptômes
covid-19 sars-cov-2 test vaccination failure
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