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VAERS Report 2157401

Case Report Section

Vaer Report Details

Age: 80 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fd7959


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-08-25
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

approximately 30 minutes after administration of the first vaccine dose, constriction in the jugule occurs; this is a non-interventional study report from the agency regulatory authority-web. regulatory number: it-minisal02-845176. an 80 year-old female subject received bnt162b2 (comirnaty), intramuscular, administration date 25aug2021 13:30 (lot number: fd7959, expiration date: 31oct2021) at the age of 80 years as dose 1, 0.3 ml single for covid-19 immunisation. relevant medical history included: "osteoporosis" (unknown if ongoing); "hysterectomy" (unknown if ongoing); "hypertension arterial" (unknown if ongoing); "drug hypersensitivity" (unknown if ongoing), notes: multiple drug allergies; "polyallergic patient" (unspecified if ongoing). concomitant medication(s) included: losartan. past drug history included: arimidex, reaction(s): "anaphylactic shock". the following information was reported: throat tightness (hospitalization) with onset 25aug2021 14:00, outcome "recovered" (25aug2021), described as "approximately 30 minutes after administration of the first vaccine dose, constriction in the jugule occurs". therapeutic measures were taken as a result of throat tightness, the action taken was reported as administration of trimeton 1 fl iv with complete regression of symptoms. the reporter's assessment of the causal relationship of the "approximately 30 minutes after administration of the first vaccine dose, constriction in the jugule occurs" with the suspect product(s) bnt162b2 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.; sender's comments: based on temporal association, he event throat tightness is possibly related to bnt162b2 (comirnaty). the impact of this report on the benefit/risk profile of the pfizer product 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 ras, ethics committees, and investigators, as appropriate

Lab Data
na
List of symptoms
throat tightness
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
Yes
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na