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VAERS Report 2157115

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fe6208


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-11-09
Date of Onset
80
Number of days (onset date – vaccination date)
80
Adverse Event Description

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

Lab Data
na
List of symptoms
covid-19 vaccination failure
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
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.)