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VAERS Report 2157190

Case Report Section

Détails du rapport Vaer

Âge: 52 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 030g21a


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-01-07
Date d’apparition
1
Nombre de jours (date d’apparition – date de vaccination)
1
Description de l’événement indésirable

sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset; sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset; sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset; sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset; sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset; sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset; this case was initially received via regulatory authority(reference number: it-ra02-830576) on 28-jan-2022. the most recent information was received 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 fatigue (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), loss of consciousness (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), vomiting (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), nausea (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), headache (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) and pyrexia (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) in a 52-year-old female patient who received mrna-1273 (spikevax) (batch no. 030g21a) for covid-19 vaccination. the patient's past medical history included epistaxis and headache. concurrent medical conditions included seasonal allergy and allergy. concomitant products included alprazolam (xanax) for an unknown indication. on 07-jan-2022, the patient received dose of mrna-1273 (spikevax) (intramuscular) .25 milliliter. on 08-jan-2022, the patient experienced fatigue (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) (seriousness criterion medically significant), loss of consciousness (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) (seriousness criterion medically significant), vomiting (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) (seriousness criterion medically significant), nausea (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) (seriousness criterion medically significant), headache (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) (seriousness criterion medically significant) and pyrexia (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) (seriousness criterion medically significant). at the time of the report, fatigue (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), loss of consciousness (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), vomiting (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), nausea (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset), headache (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) and pyrexia (sense of nausea and vomiting, fainting (3 times), severe headache, fever 38, fatigue, gastrointestinal upset) was resolving. the action taken with mrna-1273 (spikevax) (intramuscular) was unknown. no treatment medication was provided. senders comment: severity criterion added: serious other clinically relevant condition, following evaluation of the presence of "loss of consciousness" in the ime list, an event reported together with others and which the reporter indicates as having a great impact on the quality of life. company comment: this regulatory authority case concerns a 52-year-old female with a medical history of headaches who experienced the serious (medically significant) unexpected events of fatigue, loss of consciousness, vomiting, nausea, headache and pyrexia 1 day after an unknown dose of mrna-1273. testing and treatment are not reported. the outcome is resolving. the history of headache is a confounder as the patient had these before the reported event. the risk-benefit relationship of mrna-1273 vaccine is not affected by this report. most recent follow-up information incorporated above includes: on 28-feb-2022: significant follow up added. seriousness upgraded for all events and case. senders comment added. reporter's comments: severity criterion added: serious other clinically relevant condition, following evaluation of the presence of "loss of consciousness" in the ime list, an event reported together with others and which the reporter indicates as having a great impact on the quality of life.; sender's comments: this regulatory authority case concerns a 52-year-old female with a medical history of headaches who experienced the serious (medically significant) unexpected events of fatigue, loss of consciousness, vomiting, nausea, headache and pyrexia 1 day after an unknown dose of mrna-1273. testing and treatment are not reported. the outcome is resolving. the history of headache is a confounder as the patient had these before the reported event. the risk-benefit relationship of mrna-1273 vaccine is not affected by this report

Données de laboratoire
na
Liste des symptômes
fatigue vomiting nausea headache pyrexia loss of consciousness
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