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VAERS Report 2157115

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: fe6208


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-11-09
Date d’apparition
80
Nombre de jours (date d’apparition – date de vaccination)
80
Description de l’événement indésirable

she is now ill with covid-19; vaccinated with both doses; she is now suffering from covid-19; this is a spontaneous report received from a contactable reporter(s) (physician) from the regulatory authority and product quality group. a 44 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 09nov2021 (lot number: fe6208) as dose 2, single and intramuscular, administration date 10may2021 (lot number: ex6537) as dose 1, single for covid-19 immunisation. relevant medical history included: "ulcus cruris" (unknown if ongoing), notes: in the last two years she also had ulcus cruris l. sin.; "chronic venous insufficiency" (ongoing), notes: patient suffers from sy varicosum ceap in extremitas inf. l. sin et ceap iii l. dex.; "varicose vein" (ongoing), notes: patient suffers from sy varicosum ceap in extremitas inf. l. sin et ceap iii l. dex. the patient's concomitant medications were not reported. vaccination history included: comirnaty (dose 1, batch/lot ex6537, intramuscular), administration date: 30may2021, for covid-19 immunisation, reaction(s): "varicose inflammation", "thrombophlebitis of the leg", "leg edema"; comirnaty (dose 2, batch/lot fe6208, intramuscular), administration date: 25nov2021, for covid-19 immunisation, reaction(s): "thrombophlebitis". the following information was reported: drug ineffective (medically significant) with onset 28jan2022, outcome "recovering", described as "she is now ill with covid-19; vaccinated with both doses"; covid-19 (medically significant) with onset 28jan2022, outcome "recovering", described as "she is now suffering from covid-19". [2:23 pm] this is a spontaneous report received from a contactable reporter(s) (physician) from the regulatory authority and product quality group.a 44 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 09nov2021 (lot number: fe6208) as dose 2, single and intramuscular, administration date 10may2021 (lot number: ex6537) as dose 1, single for covid-19 immunisation. relevant medical history included: "ulcus cruris" (unknown if ongoing), notes: in the last two years she also had ulcus cruris l. sin.; "chronic venous insufficiency" (ongoing), notes: patient suffers from sy varicosum ceap in extremitas inf. l. sin et ceap iii l. dex.; "varicose vein" (ongoing), notes: patient suffers from sy varicosum ceap in extremitas inf. l. sin et ceap iii l. dex. the patient's concomitant medications were not reported. vaccination history included: comirnaty (dose 1, batch/lot ex6537, intramuscular), administration date: 30may2021, for covid-19 immunisation, reaction(s): "varicose inflammation", "thrombophlebitis of the leg", "leg edema"; comirnaty (dose 2, batch/lot fe6208, intramuscular), administration date: 25nov2021, for covid-19 immunisation, reaction(s): "thrombophlebitis". the following information was reported: drug ineffective (medically significant) with onset 28jan2022, outcome "recovering", described as "she is now ill with covid-19; vaccinated with both doses"; covid-19 (medically significant) with onset 28jan2022, outcome "recovering", described as "she is now suffering from covid-19". product quality group providing investigation results: conclusion (fe6208): the investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. the final scope was determined to be the associated lot(s) of the reported lot fe6208. a complaint sample was not returned. no 6192984 6159789 related quality issues were identified during the investigation. there is no impact on product quality, regulatory, validation and stability. pgs puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. the ra process determined that no regulatory notification was required. the reported defect could not be confirmed. no root cause or capa were identified as the complaint was not confirmed. conclusion (ex6537): the investigation of the referenced pr id resulted in the following conclusion: reference pr id 6004595 (see file attachment in this investigation record) the complaint for 'pfizerbiontech covid-19 vaccine' was investigated. the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. the final scope was determined to be the associated lot(s) of the reported lot ex6537. a complaint sample was not returned. no related quality issues were identified during the investigation. there is no impact on product quality. sender's comments: linked report(s) : hr-pfizer inc-202200307134 same patient, different events;hr-pfizer inc-202200340455 the same patient, different dose

Données de laboratoire
na
Liste des symptômes
covid-19 vaccination failure
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
chronic venous insufficiency (patient suffers from sy varicosum ceap in extremitas inf. l. sin et ceap iii l. dex.); varicose vein (patient suffers from sy varicosum ceap in extremitas inf. l. sin et ceap iii l. dex.)