Détails du rapport Vaer
Âge: N/A
Genre: Male
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: 0.1mg/0.5ml
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-12-14
- Date d’apparition
- 3
- Nombre de jours (date d’apparition – date de vaccination)
- 3
- Description de l’événement indésirable
-
cytomegalovirus infection; hyperparathyroidism; this case was received via a regulatory authority (reference number: gb-mhra-adr 26635342) on 23-feb-2022 and was forwarded to moderna on 23-feb-2022. this regulatory authority case was reported by an other health care professional and describes the occurrence of cytomegalovirus infection (cytomegalovirus infection) and hyperparathyroidism (hyperparathyroidism) in a male patient of an unknown age who received mrna-1273 (moderna covid-19 vaccine) (batch no. 0.1mg/ 0.5ml) for an unknown indication. anxiety with depression. sciatica. on 14-dec-2021, the patient received dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 17-dec-2021, the patient experienced cytomegalovirus infection (cytomegalovirus infection) (seriousness criterion medically significant) and hyperparathyroidism (hyperparathyroidism) (seriousness criterion medically significant). at the time of the report, cytomegalovirus infection (cytomegalovirus infection) and hyperparathyroidism (hyperparathyroidism) had not resolved. for mrna-1273 (moderna covid-19 vaccine) (unknown), the reporter did not provide any causality assessments. concomitant medication list was not provided. treatment information was not provided. dosage text included: 0.1mg/ 0.5ml. reporter reported that patient had anxiety with depression and sciatica as medical history and concurrent condition. severe sore throat that he was unable to eat or drink properly. he has lost 7.4 kg in weight in 2 months. his tsh was undetectable with t3 of 8.7 but normal thyroid stimulating receptor antibodies. he was still unwell. no, this reaction did not occurred as a result of a mistake made in the administration of the vaccine. company comment: this regulatory authority case concerns a male patient of unknown age with no relevant medical history reported, who experienced the unexpected events of cytomegalovirus infection and hyperparathyroidism, which were considered as medically significant. the events occurred approximately 3 days after a dose of mrna-1273. no information about dose number or vaccination schedule was provided. as reported, the patient had severe sore throat that he was unable to eat or drink properly. he has lost 7.4 kg in weight in 2 months. reportedly, his tsh was undetectable with t3 of 8.7 but normal thyroid stimulating receptor antibodies. no further laboratory or diagnostic findings were described. the benefit-risk relationship of mrna-1273 is not affected by this report. event seriousness was assessed as per regulatory authority reporting.; sender's comments: this regulatory authority case concerns a male patient of unknown age with no relevant medical history reported, who experienced the unexpected events of cytomegalovirus infection and hyperparathyroidism, which were considered as medically significant. the events occurred approximately 3 days after a dose of mrna-1273. no information about dose number or vaccination schedule was provided. as reported, the patient had severe sore throat that he was unable to eat or drink properly. he has lost 7.4 kg in weight in 2 months. reportedly, his tsh was undetectable with t3 of 8.7 but normal thyroid stimulating receptor antibodies. no further laboratory or diagnostic findings were described. the benefit-risk relationship of mrna-1273 is not affected by this report. event seriousness was assessed as per regulatory authority reporting
- Données de laboratoire
-
na
- Liste des symptômes
-
hyperparathyroidism cytomegalovirus infection
- 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