Détails du rapport Vaer
Âge: N/A
Genre: Female
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: 000050a
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2022-02-20
- Date d’apparition
- 3
- Nombre de jours (date d’apparition – date de vaccination)
- 3
- Description de l’événement indésirable
-
idiopathic dizziness; this case was received via regulatory authority (reference number: gb-mhra-adr 26652354) on 27-feb-2022 and was forwarded to moderna on 27-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of dizziness (idiopathic dizziness) in a female patient of an unknown age who received mrna-1273 (moderna covid-19 vaccine) (batch no. 000050a) for an unknown indication. concomitant products included candesartan and furosemide for hypertension, covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) and elasomeran (covid-19 vaccine moderna) for vaccination, influenza vaccine (influenza virus) for an unknown indication. on 20-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 23-feb-2022, after starting mrna-1273 (moderna covid-19 vaccine), the patient experienced dizziness (idiopathic dizziness) (seriousness criterion medically significant). at the time of the report, dizziness (idiopathic dizziness) had not resolved. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. no treatment medication reported. patient had not symptoms associated with covid-19 and did not have an covid-19 test. patient had not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. this report was not related to possible inflammation of the heart (myocarditis or pericarditis). company comment: this regulatory authority case concerns a female patient of unknown age, with history of hypertension, who experienced the serious (medically significant) unexpected event of dizziness 3 days after receiving a dose of mrna-1273. patient previous vaccination schedule included one dose of chadox 1 ncov-19 vaccine and a dose of mrna-1273. patient's history of hypertension treated with candesartan and furosemide remains as a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report.; sender's comments: this regulatory authority case concerns a female patient of unknown age, with history of hypertension, who experienced the serious (medically significant) unexpected event of dizziness 3 days after receiving a dose of mrna-1273. patient previous vaccination schedule included one dose of chadox 1 ncov-19 vaccine and a dose of mrna-1273. patient's history of hypertension treated with candesartan and furosemide remains as a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report
- Données de laboratoire
-
na
- Liste des symptômes
-
dizziness
- 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