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VAERS Report 2136756

Case Report Section

Détails du rapport Vaer

Âge: 62 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 018j21abs


Date de réception du rapport
2022-02-24
Date à laquelle le formulaire est complèté
Date de vaccination
2021-12-31
Date d’apparition
2
Nombre de jours (date d’apparition – date de vaccination)
2
Description de l’événement indésirable

retinal center is occlusive os; this case was received via regulatory authority (reference number: nl-lrb-00780673) on 17-feb-2022 and was forwarded to moderna on 17-feb-2022. this regulatory authority case was reported by an other health care professional and describes the occurrence of retinal vein occlusion (retinal center is occlusive os) in a 62-year-old female patient who received mrna-1273 (spikevax) (batch no. 018j21abs) for covid-19 vaccination. previously administered products included for product used for unknown indication: astrazeneca vaccin (vaxzevria) covid-19 vaccin astrazeneca injvlstcovid-19 vaccin astrazeneca injvlst on 28-apr-2021 and astrazeneca vaccin (vaxzevria) covid-19 vaccin astrazeneca injvlstcovid-19 vaccin astrazeneca injvlst on 21-jul-2021. past adverse reactions to the above products included no adverse reaction with astrazeneca vaccin (vaxzevria) covid-19 vaccin astrazeneca injvlstcovid-19 vaccin astrazeneca injvlst and astrazeneca vaccin (vaxzevria) covid-19 vaccin astrazeneca injvlstcovid-19 vaccin astrazeneca injvlst. concomitant products included gabapentine and amitriptyline hydrochloride (amitriptyline hcl) for an unknown indication. on 31-dec-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 02-jan-2022, the patient experienced retinal vein occlusion (retinal center is occlusive os) (seriousness criterion medically significant). at the time of the report, retinal vein occlusion (retinal center is occlusive os) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, optical coherence tomography: retinal center is occlusive os (abnormal) retinal center is occlusive os. for mrna-1273 (spikevax) (unknown), the reporter did not provide any causality assessments. treatment information not provided. company comment: this is a regulatory case concerning a 62-year-old female patient with no relevant medical history, who experienced the serious unexpected aesi of retinal vein occlusion. the event occurred 3 days after the unreported dose of mrna-1273 vaccine administration. the optical coherence tomography revealed retinal center is occlusive os (left). no treatment information was reported, the event was not resolved at the time of this report. the event was assessed as related to the product administration per temporal association. the rechallenge was not applicable since the event occurred after most likely dose 3, ongoing and no further dosing was expected. the patient completed primary vaccination with a different authorized or approved covid-19 vaccine and was given 2 doses of astrazeneca covid-19 vaccine approximately 8 and 5 months prior to mrna-1273 vaccination. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this is a regulatory case concerning a 62-year-old female patient with no relevant medical history, who experienced the serious unexpected aesi of retinal vein occlusion. the event occurred 3 days after the unreported dose of mrna-1273 vaccine administration. the optical coherence tomography revealed retinal center is occlusive os (left). no treatment information was reported, the event was not resolved at the time of this report. the event was assessed as related to the product administration per temporal association. the rechallenge was not applicable since the event occurred after most likely dose 3, ongoing and no further dosing was expected. the patient completed primary vaccination with a different authorized or approved covid-19 vaccine and was given 2 doses of astrazeneca covid-19 vaccine approximately 8 and 5 months prior to mrna-1273 vaccination. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report

Données de laboratoire
test name: optical coherence tomography; result unstructured data: retinal center is occlusive os
Liste des symptômes
retinal vein occlusion optical coherence tomography
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