Détails du rapport Vaer
Âge: 53 ans
Genre: Female
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: 3004737
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-12-01
- Date d’apparition
- 6
- Nombre de jours (date d’apparition – date de vaccination)
- 6
- Description de l’événement indésirable
-
left leg pain from left buttock and left back of thigh, numbness in foot; left leg pain from left buttock and left back of thigh, numbness in foot; left leg pain from left buttock and left back of thigh, numbness in foot; this case was received via ra (reference number: gb-mhra-adr 26617841) on 23-feb-2022 and was forwarded to moderna on 23-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of pain in extremity (left leg pain from left buttock and left back of thigh, numbness in foot), musculoskeletal pain (left leg pain from left buttock and left back of thigh, numbness in foot) and hypoaesthesia (left leg pain from left buttock and left back of thigh, numbness in foot) in a 53-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 3004737) for covid-19 vaccination. patient is not currently breastfeeding. on 01-dec-2021, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 07-dec-2021, the patient experienced pain in extremity (left leg pain from left buttock and left back of thigh, numbness in foot) (seriousness criteria disability and medically significant), musculoskeletal pain (left leg pain from left buttock and left back of thigh, numbness in foot) (seriousness criteria disability and medically significant) and hypoaesthesia (left leg pain from left buttock and left back of thigh, numbness in foot) (seriousness criteria disability and medically significant). at the time of the report, pain in extremity (left leg pain from left buttock and left back of thigh, numbness in foot), musculoskeletal pain (left leg pain from left buttock and left back of thigh, numbness in foot) and hypoaesthesia (left leg pain from left buttock and left back of thigh, numbness in foot) had not resolved. patient was not breastfeeding at the time of report. relevant concomitant medications were not reported. the dosage text for the suspect product was reported as dose 3c. treatment information was not provided. company comment: this regulatory case concerns a 53-year-old, female patient with no relevant medical history reported, who experienced the serious (seriousness criteria disability and medically significant) unexpected events of pain in extremity, musculoskeletal pain and hypoaesthesia. the events occurred 6 days after the third dose of mrna-1273. at the time of the report, the events had not resolved. the benefit-risk relationship of mrna-1273 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 53-year-old, female patient with no relevant medical history reported, who experienced the serious (seriousness criteria disability and medically significant) unexpected events of pain in extremity, musculoskeletal pain and hypoaesthesia. the events occurred 6 days after the third dose of mrna-1273. at the time of the report, the events had not resolved. the benefit-risk relationship of mrna-1273 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
-
pain in extremity hypoaesthesia musculoskeletal pain
- 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