Détails du rapport Vaer
Âge: N/A
Genre: Female
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (PFIZER-BIONTECH))
Type : Coronavirus 2019 vaccine
Fabricant: PFIZER
Lot: 1f1008a
- Date de réception du rapport
- 2022-02-24
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-12-07
- Date d’apparition
- 0
- Nombre de jours (date d’apparition – date de vaccination)
- 0
- Description de l’événement indésirable
-
heavy menstruation after menopause (2 years no menstruation), heavy blood loss, heavier than ever before; off label use; interchange of vaccine products; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority-web. regulatory number: nl-lrb-00737336 (ra). a 51 year-old female patient received bnt162b2 (comirnaty), administration date 07dec2021 (lot number: 1f1008a) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "disease risk factor" (unspecified if ongoing); "menopause" (unspecified if ongoing), notes: (2 years no menstruation). previous covid-19 infection: no. the patient's concomitant medications were not reported. vaccination history included: spikevax (dose 1, 0.5 ml single; adrs: none), administration date: 12may2021, for covid-19 immunisation, reaction(s): "no adverse reaction"; spikevax (dose 2, 0.5 ml single; adverse events: fever, chills, etc), administration date: 09jun2021, for covid-19 immunisation, reaction(s): "fever", "chills". the following information was reported: off label use (medically significant) with onset 07dec2021, outcome "unknown", described as "off label use"; interchange of vaccine products (medically significant) with onset 07dec2021, outcome "unknown", described as "interchange of vaccine products"; postmenopausal haemorrhage (medically significant) with onset 23dec2021, outcome "not recovered", described as "heavy menstruation after menopause (2 years no menstruation), heavy blood loss, heavier than ever before". reporter comment: moderna vaccine (spikevax). past drug therapy moderna vaccine (spikevax): yes adrs: none date: 12may2021. past drug therapy moderna vaccine (spikevax): yes adrs: fever, chills, etc. date: 09jun2021. heavy menstruation after menopause (2 years of no menstruation) additional information adr: heavy blood loss, more than ever before. covid19 previous covid-19 infection: no. other diagnostic procedures: no no follow-up attempts are possible. no further information is expected.; reporter's comments: moderna vaccine (spikevax). past drug therapy moderna vaccine (spikevax): yes adrs: none date: 12may2021. past drug therapy moderna vaccine (spikevax): yes adrs: fever, chills, etc. date: 09jun2021. heavy menstruation after menopause (2 years of no menstruation) additional information adr: heavy blood loss, more than ever before. covid19 previous covid-19 infection: no. other diagnostic procedures: no
- Données de laboratoire
-
na
- Liste des symptômes
-
interchange of vaccine products off label use postmenopausal haemorrhage
- Patient décédé?
- Non
- Date de décès
- N/A
- Anomalie congénitale
- false
- Vaccin administré par :
- Other
- 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