Détails du rapport Vaer
Âge: 44 ans
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
- 2022-02-26
- Date d’apparition
- 0
- Nombre de jours (date d’apparition – date de vaccination)
- 0
- Description de l’événement indésirable
-
general body pain; throbbing headache; skin pain; feverish; fatigue; fuzzy head; this case was received reference number: gb-mhra-adr 26657155) 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 pain (general body pain), headache (throbbing headache), pain of skin (skin pain), pyrexia (feverish), fatigue (fatigue) and feeling abnormal (fuzzy head) in a 44-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. concurrent medical conditions included wegeners granulomatosis and immunodeficiency (has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). on 26-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 26-feb-2022, the patient experienced pain (general body pain) (seriousness criterion medically significant), headache (throbbing headache) (seriousness criterion medically significant), pain of skin (skin pain) (seriousness criterion medically significant), pyrexia (feverish) (seriousness criterion medically significant), fatigue (fatigue) (seriousness criterion medically significant) and feeling abnormal (fuzzy head) (seriousness criterion medically significant). at the time of the report, pain (general body pain), headache (throbbing headache), pain of skin (skin pain), fatigue (fatigue) and feeling abnormal (fuzzy head) had not resolved and pyrexia (feverish) was resolving. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, sars-cov-2 test: negative (negative) no - negative covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. no concomitant medications were provided. patient did not tested positive for covid-19 after taking the vaccine. she did not had symptoms associated with covid-19. she was not pregnant. she was not enrolled in clinical trial. it was reported that, her report was not related to possible inflammation of the heart (myocarditis or pericarditis). no treatment medications were provided. company comment: this is a regulatory authority case concerning a 44-year-old female patient with medical history of granulomatosis with polyangiitis and immunodeficiency, who experienced the unexpected and serious (medically significant) events of fatigue, pain, headache, pain of skin, pyrexia, and feeling abnormal that occurred the same day after a dose of mrna-1273 vaccine (given as a third dose) was administered. medical history of granulomatosis with polyangiitis and immunodeficiency remain as confounders. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this is a regulatory authority case concerning a 44-year-old female patient with medical history of granulomatosis with polyangiitis and immunodeficiency, who experienced the unexpected and serious (medically significant) events of fatigue, pain, headache, pain of skin, pyrexia, and feeling abnormal that occurred the same day after a dose of mrna-1273 vaccine (given as a third dose) was administered. medical history of granulomatosis with polyangiitis and immunodeficiency remain as confounders. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report
- Données de laboratoire
-
test name: covid-19 virus test; test result: negative ; result unstructured data: no - negative covid-19 test
- Liste des symptômes
-
fatigue feeling abnormal headache pain pyrexia sars-cov-2 test pain of skin
- 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
-
immunodeficiency (has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); wegeners granulomatosis