Détails du rapport Vaer
Âge: N/A
Genre: Female
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: unknown
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2022-01-25
- Date d’apparition
- 0
- Nombre de jours (date d’apparition – date de vaccination)
- 0
- Description de l’événement indésirable
-
fever; joint ache; chills; headache; this case was received via regulatory authority. this regulatory authority case was reported by a consumer and describes the occurrence of pyrexia (fever), arthralgia (joint ache), chills (chills) and headache (headache) in a female patient of an unknown age who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. no medical history information was reported. on 25-jan-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 25-jan-2022, the patient experienced pyrexia (fever) (seriousness criterion medically significant), arthralgia (joint ache) (seriousness criterion medically significant), chills (chills) (seriousness criterion medically significant) and headache (headache) (seriousness criterion medically significant). on 27-jan-2022, pyrexia (fever) had resolved. on 29-jan-2022, chills (chills) had resolved. at the time of the report, arthralgia (joint ache) and headache (headache) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, sars-cov-2 test: no - negative covid-19 test (negative) no - negative covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. concomitant product use was not provided by the reporter. on 25-jan-2022, the patient received dose 3a of mrna-1273 (spikevax). patient received moderna 3rd shot/booster on the aforementioned date and experienced headaches almost everyday since then. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. report not related to possible inflammation of the heart (myocarditis or pericarditis). treatment information was not provided. company comment: this is a regulatory case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected events of pyrexia, arthralgia, headache and chills the same day a dose of mrna-1273 vaccine, given as a booster dose, was administered. patient reported she experienced headaches almost every day since vaccination. no further details were provided for medical reviewing. the benefit-risk relationship of the mrna-1273 vaccine is not affected by this report. event seriousness was captured as reported.; sender's comments: this is a regulatory case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected events of pyrexia, arthralgia, headache and chills the same day a dose of mrna-1273 vaccine, given as a booster dose, was administered. patient reported she experienced headaches almost every day since vaccination. no further details were provided for medical reviewing. the benefit-risk relationship of the mrna-1273 vaccine is not affected by this report. event seriousness was captured as reported
- Données de laboratoire
-
test name: covid-19 virus test; test result: negative ; result unstructured data: no - negative covid-19 test
- Liste des symptômes
-
chills headache arthralgia pyrexia sars-cov-2 test
- 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