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VAERS Report 2156930

Case Report Section

Détails du rapport Vaer

Âge: 62 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 3005889


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-02-24
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

lethargy; headache; nauseous; inflammation injection site; this case was received via regulatory authority (reference number: gb-mhra-adr 26657119) on 28-feb-2022 and was forwarded to moderna on 28-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of lethargy (lethargy), headache (headache), nausea (nauseous) and injection site inflammation (inflammation injection site) in a 62-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 3005889) for an unknown indication. concomitant products included covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) from 15-mar-2021 to an unknown date and covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) for an unknown indication. on 24-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 24-feb-2022, the patient experienced lethargy (lethargy) (seriousness criterion medically significant), headache (headache) (seriousness criterion medically significant), nausea (nauseous) (seriousness criterion medically significant) and injection site inflammation (inflammation injection site) (seriousness criterion medically significant). at the time of the report, lethargy (lethargy), nausea (nauseous) and injection site inflammation (inflammation injection site) had not resolved and headache (headache) was resolving. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. patient was otherwise fit and well. patient did not had symptoms associated with covid-19 and did not had a covid-19 test. patient had not tested positive for covid-19 since she had received the vaccine. this report was not related to possible inflammation of the heart (myocarditis or pericarditis). no treatment medication reported. company comment: this case concerns a 62-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of lethargy, headache, and nausea the same day after the third dose of mrna-1273. information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. seriousness assessment has been retained as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. the benefit-risk relationship of mrna-1273 is not affected by this report.; sender's comments: this case concerns a 62-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of lethargy, headache, and nausea the same day after the third dose of mrna-1273. information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. seriousness assessment has been retained as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. the benefit-risk relationship of mrna-1273 is not affected by this report

Données de laboratoire
na
Liste des symptômes
injection site inflammation nausea headache lethargy
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