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VAERS Report 2156739

Case Report Section

Détails du rapport Vaer

Âge: 54 ans

Genre: Male

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 3005686


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-12-17
Date d’apparition
1
Nombre de jours (date d’apparition – date de vaccination)
1
Description de l’événement indésirable

pain; muscle fatigue; this case was received via regulatory authority (reference number: gb-mhra-adr 26620845) 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 (pain) and muscle fatigue (muscle fatigue) in a 54-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 3005686) for covid-19 vaccination. the patient's past medical history included suspected covid-19 from 13-sep-2021 to 24-sep-2021. previously administered products included for covid-19 vaccination: sars-cov-2 vaccine on 23-apr-2021 and sars-cov-2 vaccine on 14-may-2021. past adverse reactions to the above products included no adverse event with sars-cov-2 vaccine and sars-cov-2 vaccine. concomitant products included beclometasone dipropionate, formoterol fumarate (fostair) for asthma, tamsulosin for enlarged prostate (benign), levothyroxine for hypothyroidism, pramipexole for restless legs, lansoprazole and mebeverine for an unknown indication. on 17-dec-2021, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 18-dec-2021, the patient experienced pain (pain) (seriousness criterion medically significant) and muscle fatigue (muscle fatigue) (seriousness criterion medically significant). on 24-dec-2021, muscle fatigue (muscle fatigue) had resolved. at the time of the report, pain (pain) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 14-sep-2021, sars-cov-2 test: positive (positive) yes - positive covid-19 test. patient has not tested positive for covid-19 since having the vaccine and patient was not enrolled in clinical trial. concomitant medication reported as unknown medication. the patient had muscle fatigue and pain. report not related to possible inflammation of the heart (myocarditis or pericarditis). no treatment medication information provided company comment: this is a regulatory authority case concerning a 54-year-old, male patient with relevant concurrent medical conditions of hypothyroidism (under medication with levothyroxine) and restless legs (under medication with pramipexole), who experienced the unexpected serious (medically significant according to regulatory authority) events of pain and muscle fatigue. the events occurred 1 day after the third dose of mrna-1273 vaccine administration in covid-19 vaccine in series. no reported treatment information. the outcome of the event pain was not resolved while the event muscle fatigue the outcome was resolved from the time of last observation. the concurrent medical conditions of hypothyroidism and restless legs remain confounders. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this is a regulatory authority case concerning a 54-year-old, male patient with relevant concurrent medical conditions of hypothyroidism (under medication with levothyroxine) and restless legs (under medication with pramipexole), who experienced the unexpected serious (medically significant according to regulatory authority) events of pain and muscle fatigue. the events occurred 1 day after the third dose of mrna-1273 vaccine administration in covid-19 vaccine in series. no reported treatment information. the outcome of the event pain was not resolved while the event muscle fatigue the outcome was resolved from the time of last observation. the concurrent medical conditions of hypothyroidism and restless legs remain confounders. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report

Données de laboratoire
test date: 20210914; test name: covid-19 virus test; test result: positive ; result unstructured data: yes - positive covid-19 test
Liste des symptômes
pain sars-cov-2 test muscle fatigue
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