Détails du rapport Vaer
Âge: 52 ans
Genre: Male
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: xku2xzast5dknnn
- Date de réception du rapport
- 2022-02-24
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2022-01-04
- Date d’apparition
- 14
- Nombre de jours (date d’apparition – date de vaccination)
- 14
- Description de l’événement indésirable
-
longembolieen; headache; don't feel good; fatigue; stuffiness led to stabbing pain.; this case was received via regulatory authority (reference number: nl-lrb-00780910) on 17-feb-2022 and was forwarded to moderna on 17-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of pulmonary embolism (longembolieen) in a 52-year-old male patient who received mrna-1273 (spikevax) (batch no. xku2xzast5dknnnpgnrj42#0) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. the patient's past medical history included covid-19 on 11-dec-2020. previously administered products included for product used for unknown indication: biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3mlcovid-19 vaccin pfizer injvlst on 10-jun-2021, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3mlcovid-19 vaccin pfizer injvlst on 19-aug-2021. past adverse reactions to the above products included no adverse reaction with biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3mlcovid-19 vaccin pfizer injvlst, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3mlcovid-19 vaccin pfizer injvlst. concomitant products included apixaban and oxycodone hydrochloride (oxycodon) for an unknown indication. on 04-jan-2022, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 18-jan-2022, the patient experienced dyspnoea (stuffiness led to stabbing pain.) and pulmonary embolism (longembolieen) (seriousness criteria hospitalization, medically significant and life threatening). on an unknown date, the patient experienced malaise (don't feel good), fatigue (fatigue) and headache (headache). at the time of the report, dyspnoea (stuffiness led to stabbing pain.) and pulmonary embolism (longembolieen) was resolving and malaise (don't feel good), fatigue (fatigue) and headache (headache) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 11-dec-2020, sars-cov-2 test positive: positive (positive) positive. on 08-jan-2022, sars-cov-2 test false positive: positive (positive) positive. on an unknown date, computerised tomogram: results not reported unknown. on an unknown date, electrocardiogram: results not reported unknown. on an unknown date, ultrasound scan: results not reported unknown. no treatment details were reported. this is a regulatory case concerning a 52-year-old male patient with a medical history of covid-19, who experienced the unexpected serious event of pulmonary embolism and non serious events of dyspnea, malaise, fatigue and headache. a concomitant product in this case pfizer covid-19 vaccine. the event pulmonary embolism (aesi) occurred approximately 2 weeks after the received dose of mrna � 1273 vaccine. pulmonary embolism was reported as life threatening and caused hospitalization and at the time of report the event had not resolved. the reporter's assessment was not provided. the benefit-risk relationship of the vaccine is not affected by this report.; sender's comments: this is a regulatory case concerning a 52-year-old male patient with a medical history of covid-19, who experienced the unexpected serious event of pulmonary embolism and non serious events of dyspnea, malaise, fatigue and headache. a concomitant product in this case pfizer covid-19 vaccine. the event pulmonary embolism (aesi) occurred approximately 2 weeks after the received dose of mrna � 1273 vaccine. pulmonary embolism was reported as life threatening and caused hospitalization and at the time of report the event had not resolved. the reporter's assessment was not provided. the benefit-risk relationship of the vaccine is not affected by this report
- Données de laboratoire
-
test name: ct scan; result unstructured data: unknown; test name: ecg; result unstructured data: unknown; test date: 20220108; test name: corona, bevestigd met test; test result: positive ; result unstructured data: positive; test date: 20201211; test name: corona, bevestigd met test; test result: positive ; result unstructured data: positive; test name: ultrasound; result unstructured data: unknown
- Liste des symptômes
-
malaise fatigue headache dyspnoea pulmonary embolism electrocardiogram computerised tomogram sars-cov-2 test positive ultrasound scan sars-cov-2 test false positive
- 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