Page breadcrumb nav

VAERS Report 2136763

Case Report Section

Détails du rapport Vaer

Âge: 57 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (MODERNA))

Type : Coronavirus 2019 vaccine

Fabricant: MODERNA

Lot: injvlst


Date de réception du rapport
2022-02-24
Date à laquelle le formulaire est complèté
Date de vaccination
2021-06-15
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

cysts on both ovaries; fatigue; cold shivers; headache; don't feel good; inflammatory reaction at the reaction site: pain, swelling, arising within a week of vaccination; response to or around the injection site: swelling, occurring within a week of vaccination; response to or around the injection site: pain; this case was received via regulatory authority (reference number: nl-lrb-00782626) 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 ovarian cyst (cysts on both ovaries) in a 57-year-old female patient who received mrna-1273 (spikevax) (batch no. moderna injvlst 0.5ml 3002917) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. no medical history information was reported. on 15-jun-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 15-jun-2021, the patient experienced injection site swelling (response to or around the injection site: swelling, occurring within a week of vaccination), injection site pain (response to or around the injection site: pain) and injection site inflammation (inflammatory reaction at the reaction site: pain, swelling, arising within a week of vaccination). on 16-jun-2021, the patient experienced headache (headache), malaise (don't feel good), fatigue (fatigue) and chills (cold shivers). on an unknown date, the patient experienced ovarian cyst (cysts on both ovaries) (seriousness criterion hospitalization). on 17-jun-2021, headache (headache), malaise (don't feel good), fatigue (fatigue) and chills (cold shivers) had resolved. at the time of the report, injection site swelling (response to or around the injection site: swelling, occurring within a week of vaccination), injection site pain (response to or around the injection site: pain) and injection site inflammation (inflammatory reaction at the reaction site: pain, swelling, arising within a week of vaccination) had resolved and ovarian cyst (cysts on both ovaries) was resolving. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, computerised tomogram: ovarian cysts ovarian cysts. on an unknown date, ultrasound scan: ovarian cysts ovarian cysts. concomitant medication and treatment details were not reported. company comment: this is a regulatory authority case concerning a 57-year-old female patient, with no medical history reported in this case, who experienced the serious unexpected adverse event of ovarian cyst (serious criteria hospitalized) confirmed by echography and ct scan, in an unknown day in the context of the administration of a dose of the mrna-1273 vaccine of an unknown dose number and schedule of vaccination. additionally, other non-serious events were reported. the benefit-risk relationship of the mrna-1273 vaccine is not affected by this report. event seriousness assessed as per regulatory authority reporting.; sender's comments: this is a regulatory authority case concerning a 57-year-old female patient, with no medical history reported in this case, who experienced the serious unexpected adverse event of ovarian cyst (serious criteria hospitalized) confirmed by echography and ct scan, in an unknown day in the context of the administration of a dose of the mrna-1273 vaccine of an unknown dose number and schedule of vaccination. additionally, other non-serious events were reported. the benefit-risk relationship of the mrna-1273 vaccine is not affected by this report. event seriousness assessed as per regulatory authority reporting

Données de laboratoire
test name: ct scan; result unstructured data: ovarian cysts; test name: echography; result unstructured data: ovarian cysts
Liste des symptômes
injection site inflammation chills malaise fatigue headache injection site pain injection site swelling computerised tomogram ultrasound scan ovarian cyst
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