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VAERS Report 2136760

Case Report Section

Détails du rapport Vaer

Âge: 50 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: 000121abs


Date de réception du rapport
2022-02-24
Date à laquelle le formulaire est complèté
Date de vaccination
2022-01-04
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

pain under 1 chest,; 1x dizzy; sore lump under armpit; flutter; remitting; fatigue; don't feel good; fever: 37.5 to 38 degrees celcius; cold shivers; this case was received via ra (reference number: nl-lrb-00780950) on 17-feb-2022 and was forwarded to moderna on 17-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of chest pain (pain under 1 chest,), dizziness (1x dizzy), lymphadenopathy (sore lump under armpit), cardiac flutter (flutter) and vomiting (remitting) in a 50-year-old female patient who received mrna-1273 (spikevax) (batch no. 000121abs) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. the patient's past medical history included pacemaker insertion (cardiac) (no family history), heart valve replacement (no family history) and cardiac flutter (no family history). previously administered products included for product used for unknown indication: biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3mlcovid-19 vaccin pfizer injvlst on 14-may-2021, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3mlcovid-19 vaccin pfizer injvlst on 18-jun-2021. past adverse reactions to the above products included no adverse reaction with biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3mlcovid-19 vaccin pfizer injvlst, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3mlcovid-19 vaccin pfizer injvlst. concomitant products included phenprocoumon (fenprocoumon) and sotalol hydrochloride (sotalol rph) for an unknown indication. on 04-jan-2022, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on an unknown date, the patient experienced malaise (don't feel good), chest pain (pain under 1 chest,) (seriousness criterion hospitalization), dizziness (1x dizzy) (seriousness criterion hospitalization), lymphadenopathy (sore lump under armpit) (seriousness criterion hospitalization), cardiac flutter (flutter) (seriousness criterion hospitalization), vomiting (remitting) (seriousness criterion hospitalization) and fatigue (fatigue). an unknown date, the patient experienced body temperature increased (fever: 37.5 to 38 degrees celcius). an unknown date, the patient experienced chills (cold shivers). at the time of the report, malaise (don't feel good), body temperature increased (fever: 37.5 to 38 degrees celcius), chest pain (pain under 1 chest,), dizziness (1x dizzy), lymphadenopathy (sore lump under armpit), chills (cold shivers), cardiac flutter (flutter), vomiting (remitting) and fatigue (fatigue) had resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 06-jan-2022, body temperature: 37.5 to 38 (high) fever: 37.5 to 38 degrees celcius. no treatment information was provided. company comment: this regulatory case concerns a 50-year-old, female patient with relevant medical history of cardiac flutter status post cardiac pacemaker insertion (unspecified date) and heart valve replacement (unspecified date), and past drug history of administration of two doses of comirnaty (pfizer/biontech covid-19 mrna vaccine), who experienced the unexpected, serious (hospitalization) aesi of cardiac flutter; the unexpected, serious (hospitalization) events of chest pain, dizziness, lymphadenopathy and vomiting; and other associated unexpected and expected, non-serious events. the events occurred beginning 3 hours and up to 12 hours after administration of an unspecified dose of the moderna mrna-1273 vaccine. treatment information was not provided. however, the events had resolved at the time of the report. the medical history of cardiac flutter status post cardiac pacemaker insertion and heart valve replacement remains a confounder for the events cardiac flutter, chest pain and dizziness. the benefit-risk relationship of the moderna mrna-1273 vaccine is not affected by this report.; sender's comments: this regulatory case concerns a 50-year-old, female patient with relevant medical history of cardiac flutter status post cardiac pacemaker insertion (unspecified date) and heart valve replacement (unspecified date), and past drug history of administration of two doses of comirnaty (pfizer/biontech covid-19 mrna vaccine), who experienced the unexpected, serious (hospitalization) aesi of cardiac flutter; the unexpected, serious (hospitalization) events of chest pain, dizziness, lymphadenopathy and vomiting; and other associated unexpected and expected, non-serious events. the events occurred beginning 3 hours and up to 12 hours after administration of an unspecified dose of the moderna mrna-1273 vaccine. treatment information was not provided. however, the events had resolved at the time of the report. the medical history of cardiac flutter status post cardiac pacemaker insertion and heart valve replacement remains a confounder for the events cardiac flutter, chest pain and dizziness. the benefit-risk relationship of the moderna mrna-1273 vaccine is not affected by this report

Données de laboratoire
test date: 20220106; test name: body temperature increased; result unstructured data: fever: 37.5 to 38 degrees celcius
Liste des symptômes
chills malaise fatigue vomiting chest pain dizziness lymphadenopathy body temperature body temperature increased cardiac flutter
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?
Oui
Séjour à l’hôpital
Non
Nombre de jours à l’hôpital
Non spécifié
Invalidité permanente?
Non
Allergies:
na
Maladie actuelle
na