Détails du rapport Vaer
Âge: 42 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
- Date d’apparition
- 0
- Nombre de jours (date d’apparition – date de vaccination)
- 0
- Description de l’événement indésirable
-
exhaustion; lymph nodes cervical swollen; this case was received via regulatory authority (reference number: gr-greof-20217507) on 01-mar-2022 and was forwarded to moderna on 01-mar-2022. this regulatory authority case was reported by a consumer and describes the occurrence of lymphadenopathy (lymph nodes cervical swollen) in a 42-year-old male patient who received mrna-1273 (spikevax) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. no medical history information was reported. on an unknown date, the patient received dose of mrna-1273 (spikevax) (intramuscular) 1 dosage form. on 01-sep-2021, the patient experienced fatigue (exhaustion) and lymphadenopathy (lymph nodes cervical swollen) (seriousness criterion disability). at the time of the report, fatigue (exhaustion) and lymphadenopathy (lymph nodes cervical swollen) had not resolved. the action taken with mrna-1273 (spikevax) (intramuscular) was unknown. no concomitant drug details were reported. no treatment details were reported. company comment: this regulatory case concerns a 42-year-old, male patient with no medical history reported, who experienced the unexpected, serious (seriousness criteria disability) event of lymphadenopathy an unknown duration after the unknown dose of mrna-1273. no relevant lab data or details regarding clinical course and treatment received were reported. at the time of report, outcome of the event was not resolved. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. event seriousness assessed as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; sender's comments: this regulatory case concerns a 42-year-old, male patient with no medical history reported, who experienced the unexpected, serious (seriousness criteria disability) event of lymphadenopathy an unknown duration after the unknown dose of mrna-1273. no relevant lab data or details regarding clinical course and treatment received were reported. at the time of report, outcome of the event was not resolved. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. event seriousness assessed as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity
- Données de laboratoire
-
na
- Liste des symptômes
-
fatigue lymphadenopathy
- 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?
- Oui
- Allergies:
-
na
- Maladie actuelle
-
na