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VAERS Report 2156950

Case Report Section

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: fg6431


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-10-29
Date d’apparition
9
Nombre de jours (date d’apparition – date de vaccination)
9
Description de l’événement indésirable

diarrhoea; diarrhoea; card vaccine monitor this is a solicited report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority for a sponsored program. regulatory number: gb-mhra-ycvm-202101301448555150. other case identifier(s): gb-mhra-adr 25267350. a 80 year-old female patient received bnt162b2 (comirnaty), administration date 29oct2021 (lot number: fg6431) as dose 3 (booster) single for covid-19 immunisation. relevant medical history included: "systolic hypertension" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "generalised osteoarthritis" (unspecified if ongoing); "blood cholesterol" (unspecified if ongoing); "muscle cramp" (unspecified if ongoing). concomitant medication(s) included: candesartan taken for systolic hypertension; felodipine taken for hypertension; ibuprofen taken for osteoarthritis, osteoarthritis; omeprazole; paracetamol taken for osteoarthritis, osteoarthritis; rosuvastatin taken for blood cholesterol; quinine sulphate taken for muscle spasms. vaccination history included: bnt162b2 (dose 1, single, start date: 27apr2021, stop date: 29apr2021, outcome: recovered/resolved, lot: el0739), administration date: 29jan2021, for covid-19 immunization, reaction(s): "diarrhoea"; bnt162b2 (dose 2, single), for covid-19 immunization. the following information was reported: diarrhoea (medically significant) with onset 07nov2021, outcome "recovering", diarrhoea (medically significant), outcome "not recovered" and all described as "diarrhoea". additional information: patient has not had symptoms associated with covid-19. not had a covid-19 test. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. the reporters assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected. follow-up#2 (21feb2022): this is a solicited report from the regulatory authority card vaccine monitor program from a contactable consumer. this is a report received from the regulatory authority. updated information: dose description captured for 3rd dose and 2nd dose and also concomitant drug captured quinine sulphate, and event captured diarrhoea outcome not recovered /not resolved. no follow-up attempts are possible. no further information is expected.; sender's comments: based on temporal association, there is reasonable possibility of causal association between the reported events and the suspect drug bnt162b2. the impact of this report on the benefit/risk profile of the pfizer drug is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate

Données de laboratoire
na
Liste des symptômes
diarrhoea
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