Détails du rapport Vaer
Âge: 41 ans
Genre: Male
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: unknown
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2022-01-09
- Date d’apparition
- 17
- Nombre de jours (date d’apparition – date de vaccination)
- 17
- Description de l’événement indésirable
-
pulmonary embolism; this case was received (reference number: gr-greof-202200751) on 25-feb-2022 and was forwarded to moderna on 25-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of pulmonary embolism (pulmonary embolism) in a 41-year-old male patient who received mrna-1273 (spikevax) for covid-19 vaccination. the patient's past medical history included smoker (10 p/y). concomitant products included levothyroxine sodium (thyrohormone) for an unknown indication. on 09-jan-2022, the patient received third dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 26-jan-2022, the patient experienced pulmonary embolism (pulmonary embolism) (seriousness criteria hospitalization, medically significant and life threatening). at the time of the report, pulmonary embolism (pulmonary embolism) was resolving. for mrna-1273 (spikevax) (unknown), the reporter did not provide any causality assessments. additional information on concomitant product was reported as thyrohormone levothyroxine sodium. treatment details was not reported by the reporter. company comment: this regulatory case concerns a 41-year-old, male patient with no relevant medical history, who experienced the unexpected, serious (seriousness criteria life-threatening, hospitalization and medically significant), aesi of pulmonary embolism 17 days after the third dose of mrna-1273. at the time of report, outcome of the event was resolving. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority report.; sender's comments: this regulatory case concerns a 41-year-old, male patient with no relevant medical history, who experienced the unexpected, serious (seriousness criteria life-threatening, hospitalization and medically significant), aesi of pulmonary embolism 17 days after the third dose of mrna-1273. at the time of report, outcome of the event was resolving. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority report
- Données de laboratoire
-
na
- Liste des symptômes
-
pulmonary embolism
- 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?
- Oui
- Séjour à l’hôpital
- Non
- Nombre de jours à l’hôpital
- Non spécifié
- Invalidité permanente?
- Non
- Allergies:
-
na
- Maladie actuelle
-
na