Détails du rapport Vaer
Région : Outside US
- Patient décédé?
- Renseignements sur les vaccins
Nom: COVID19 (COVID19 (PFIZER-BIONTECH))
Type : Coronavirus 2019 vaccine
- Date de réception du rapport
- Date à laquelle le formulaire est complèté
- Date de vaccination
- Date d’apparition
- Nombre de jours (date d’apparition – date de vaccination)
- Description de l’événement indésirable
severe period pains; heavy clotted periods/heavy periods; this is a spontaneous report received from a contactable reporter (consumer or other non hcp) from the medicines and healthcare products regulatory agency (uk-mhra). regulatory number: gb-mhra-webcovid-202202191820434860-8uwxh (mhra). other case identifier: gb-mhra-adr 26625948 (mhra). a 35-year-old female patient (not pregnant) received bnt162b2 (comirnaty), administration date 10mar2021 (batch/lot number: unknown) as dose 1, single, administration date 05may2021 (batch/lot number: unknown) as dose 2, single and administration date 05nov2021 (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "anaemia" (unspecified if ongoing); "heavy periods" (unspecified if ongoing); "pain" (unspecified if ongoing); "anxiety depression" (unspecified if ongoing). concomitant medications included: ferrous fumarate taken for anaemia; norethisterone taken for heavy menstrual bleeding; nurofen express [ibuprofen lysinate] taken for pain; paracetamol taken for pain; sertraline taken for depression. vaccination history included: bnt162b2 (dose 1), administration date: 10mar2021, for covid-19 immunisation; bnt162b2 (dose 2), administration date: 05may2021, for covid-19 immunisation, reaction: "inappropriate schedule of vaccine administered". unsure if patient has had symptoms associated with covid-19. patient is not currently breastfeeding. the following information was reported: dysmenorrhoea (disability, medically significant), outcome "recovered", described as "severe period pains"; heavy menstrual bleeding (disability, medically significant), outcome "not recovered", described as "heavy clotted periods/heavy periods". the events "severe period pains" and "heavy clotted periods/heavy periods" were evaluated at the emergency room visit. the patient underwent the following laboratory tests and procedures: gynaecological examination: normal, notes: normal; sars-cov-2 test: negative, notes: no - negative covid-19 test; ultrasound pelvis: normal, notes: normal. therapeutic measures were taken as a result of dysmenorrhoea, heavy menstrual bleeding. additional information: heavy clotted periods, flooding every hour. attended a and e. tranexamic acid taken. did not help. norethisterone taken for 10 day stopped period for one week. heavy clotted period started again. severe period pains present. no history of pain. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. the events were not related to a possible inflammation of the heart (myocarditis or pericarditis). no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; sender's comments: linked report(s) : gb-pfizer inc-202200319242 same patient,product,different dose/event
- Données de laboratoire
test name: internal examination; result unstructured data: test result:normal; comments: normal; test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test; test name: pelvis ultrasound; result unstructured data: test result:normal; comments: normal
- Liste des symptômes
heavy menstrual bleeding dysmenorrhoea sars-cov-2 test ultrasound pelvis gynaecological examination
- Patient décédé?
- Date de décès
- Anomalie congénitale
- Vaccin administré par :
- Vaccin acheté par :
- Visite d’un patient à l’urgence?
- Patient hospitalisé?
- Séjour à l’hôpital
- Nombre de jours à l’hôpital
- Non spécifié
- Invalidité permanente?
- Maladie actuelle