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VAERS Report 2136767

Case Report Section

Détails du rapport Vaer

Âge: 29 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 3004493


Date de réception du rapport
2022-02-24
Date à laquelle le formulaire est complèté
Date de vaccination
2021-08-11
Date d’apparition
43
Nombre de jours (date d’apparition – date de vaccination)
43
Description de l’événement indésirable

about pregnancy; trombosebeen; this case was received via ra (reference number: nl-lrb-00783051) on 18-feb-2022 and was forwarded to moderna on 18-feb-2022. this regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of deep vein thrombosis (trombosebeen) in a 29-year-old female patient who received mrna-1273 (spikevax) (batch no. 3004493) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. previously administered products included for product used for unknown indication: spikevax (moderna vaccin (spikevax) covid-19 vaccin moderna injvlst 0 and5mlcovid-19 vaccin moderna injvlst) on 07-jul-2021. past adverse reactions to the above products included no adverse reaction with spikevax. concurrent medical conditions included maternal vaccine exposure (vaccine exposure during pregnancy week: 2). on 11-aug-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. last menstrual period and estimated date of delivery were not provided. on 23-sep-2021, the patient experienced deep vein thrombosis (trombosebeen) (seriousness criterion life threatening). on an unknown date, the patient experienced maternal exposure during pregnancy (about pregnancy). on 10-jan-2022, deep vein thrombosis (trombosebeen) had resolved. at the time of the report, maternal exposure during pregnancy (about pregnancy) had resolved. concomitant and treatment medication information were not provided. company comment: this regulatory case concerns a 29-year-old pregnant female patient with relevant medical history of maternal vaccine exposure, who experienced the unexpected serious event of deep vein thrombosis leg (seriousness criteria- life threatening), 1 month and 13 days after receiving the mrna-1273 vaccine. non serious event of maternal exposure during pregnancy has also been reported. vaccine was administered at 2 weeks of gestation. current condition of pregnancy can be a risk factor for developing deep vein thrombosis. the benefit-risk relationship of mrna-1273 is not affected by this report. seriousness of the event retained as per regulatory authority reporting.; sender's comments: this regulatory case concerns a 29-year-old pregnant female patient with relevant medical history of maternal vaccine exposure, who experienced the unexpected serious event of deep vein thrombosis leg (seriousness criteria- life threatening), 1 month and 13 days after receiving the mrna-1273 vaccine. non serious event of maternal exposure during pregnancy has also been reported. vaccine was administered at 2 weeks of gestation. current condition of pregnancy can be a risk factor for developing deep vein thrombosis. the benefit-risk relationship of mrna-1273 is not affected by this report. seriousness of the event retained as per regulatory authority reporting

Données de laboratoire
na
Liste des symptômes
deep vein thrombosis maternal exposure during pregnancy
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