Détails du rapport Vaer
Âge: 34 ans
Genre: Male
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: 000060asc04/0
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2022-02-06
- Date d’apparition
- 1
- Nombre de jours (date d’apparition – date de vaccination)
- 1
- Description de l’événement indésirable
-
hyperpyrexia throughout the day following vaccination, erythema at the injection site; hyperpyrexia throughout the day following vaccination, erythema at the injection site; this case was received (reference number: it-minisal02-842159) on 28-feb-2022 and was forwarded to moderna on 28-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of hyperpyrexia (hyperpyrexia throughout the day following vaccination, erythema at the injection site) and injection site joint erythema (hyperpyrexia throughout the day following vaccination, erythema at the injection site) in a 34-year-old male patient who received mrna-1273 (spikevax) (batch no. 000060a sc 04/05/22) for covid-19 vaccination. no medical history information was reported. on 06-feb-2022, the patient received dose of mrna-1273 (spikevax) (intramuscular) .25 milliliter. on 07-feb-2022, the patient experienced hyperpyrexia (hyperpyrexia throughout the day following vaccination, erythema at the injection site) (seriousness criterion medically significant) and injection site joint erythema (hyperpyrexia throughout the day following vaccination, erythema at the injection site) (seriousness criterion medically significant). at the time of the report, hyperpyrexia (hyperpyrexia throughout the day following vaccination, erythema at the injection site) and injection site joint erythema (hyperpyrexia throughout the day following vaccination, erythema at the injection site) was resolving. the action taken with mrna-1273 (spikevax) (intramuscular) was unknown. for mrna-1273 (spikevax) (intramuscular), the reporter did not provide any causality assessments. no concomitant medications were provided. no treatment medications were reported. company comment: this is a regulatory authority case concerning a 34-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant according to regulatory authority) events of hyperpyrexia and injection site erythema. the events occurred approximately 1 day after the unknown dose number of mrna-1273 vaccine administration. no reported treatment information. the outcome of the events were resolving from the time of last observation. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; reporter's comments: the severity is changed from 'non-serious' to 'severe' as' hyperpyrexia 'occurs, an event present in the ime list.; sender's comments: this is a regulatory authority case concerning a 34-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant according to regulatory authority) events of hyperpyrexia and injection site erythema. the events occurred approximately 1 day after the unknown dose number of mrna-1273 vaccine administration. no reported treatment information. the outcome of the events were resolving from the time of last observation. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report
- Données de laboratoire
-
na
- Liste des symptômes
-
injection site joint erythema hyperpyrexia
- 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