Page breadcrumb nav

VAERS Report 2115923

Case Report Section

Détails du rapport Vaer

Âge: 61 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 3001943


Date de réception du rapport
2022-02-16
Date à laquelle le formulaire est complèté
Date de vaccination
2021-05-07
Date d’apparition
190
Nombre de jours (date d’apparition – date de vaccination)
190
Description de l’événement indésirable

vaccination failure; sars-cov-2 infection; this case was received via regulatory authority (reference number: at-basgages-2022-004976) 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 vaccination failure (vaccination failure) and covid-19 (sars-cov-2 infection) in a 61-year-old female patient who received mrna-1273 (spikevax) (batch nos. 3003602 and 3001943) for covid-19 vaccination. no medical history information was reported. on 07-may-2021, the patient received first dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 20-jun-2021, received second dose of mrna-1273 (spikevax) (intramuscular) dosage was changed to 1 dosage form. on 13-nov-2021, the patient experienced vaccination failure (vaccination failure) (seriousness criterion medically significant) and covid-19 (sars-cov-2 infection) (seriousness criterion medically significant). at the time of the report, vaccination failure (vaccination failure) and covid-19 (sars-cov-2 infection) outcome was unknown. diagnostic results (normal ranges are provided in parenthesis if available): on 13-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 provided. no treatment information was provided. company comment : this regulatory authority case concerns a 61-year-old, female patient with no medical history reported, who experienced the unexpected serious aesi event of covid-19 (seriousness criterion medically significant) which occurred 4 months 24 days after second dose of mrna-1273. inappropriate schedule of product administration was also noted in the case (interval between dose 1 and dose 2 longer than 35 days), dose interval is 44 days therefore lack of efficacy cannot be concluded for this case. vaccination failure was captured as an event as per regulatory authority assessment. sars-cov-2 test was positive as on 13-nov-2021. ongoing pandemia remains as a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report. the events were assessed as serious as per regulatory authority�s report.; sender's comments: this regulatory authority case concerns a 61-year-old, female patient with no medical history reported, who experienced the unexpected serious aesi event of covid-19 (seriousness criterion medically significant) which occurred 4 months 24 days after second dose of mrna-1273. inappropriate schedule of product administration was also noted in the case (interval between dose 1 and dose 2 longer than 35 days), dose interval is 44 days therefore lack of efficacy cannot be concluded for this case. vaccination failure was captured as an event as per regulatory authority assessment. sars-cov-2 test was positive as on 13-nov-2021. ongoing pandemia remains as a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report. the events were assessed as serious as per regulatory authority�s report

Données de laboratoire
test date: 20211113; 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