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VAERS Report 2157394

Case Report Section

Vaer Report Details

Age: 58 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: unknown


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2022-02-08
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

following administration of the booster dose, diffuse skin rash and difficulty breathing appear.; following administration of the booster dose, diffuse skin rash and difficulty breathing appear.; this is a non-interventional study report from the regulatory authority-web. regulatory number: it-minisal02-844520. a 58 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 08feb2022 (batch/lot number: unknown) at the age of 58 years as dose 3 (booster), 0.3ml single for covid-19 immunisation. relevant medical history included: "allergies: beta-lactamines" (unknown if ongoing); "pulmonary arterial hypertension" (unknown if ongoing); "allergies: hymenoptera" (unspecified if ongoing). concomitant medication(s) included: esomeprazole sodium; acetylsalicylic acid; losartan potassium and hydrochlorothiazide. vaccination history included: covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation; covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. the following information was reported: rash (hospitalization), dyspnoea (hospitalization) all with onset 08feb2022, outcome "not recovered" and all described as "following administration of the booster dose, diffuse skin rash and difficulty breathing appear.". the event "following administration of the booster dose, diffuse skin rash and difficulty breathing appear." and "following administration of the booster dose, diffuse skin rash and difficulty breathing appear." was evaluated at the emergency room visit. the patient underwent the following laboratory tests and procedures: ear, nose and throat examination: performed with fiber optic execution, notes: which excludes hypopharyngolaryngeal edema and preserved air spasm. therapeutic measures were taken as a result of rash, dyspnoea included administration of flebocortid 500 mg intravenous, urbason 40 mg intravenous, trimeton 1 vial intravenos and adrenaline in aerosol. the reporter's assessment of the causal relationship of the "following administration of the booster dose, diffuse skin rash and difficulty breathing appear" 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. reporter comment: the patient was seen at the emergency room and it is not possible to trace the vaccine lot or the data relating to the first and second dose. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; reporter's comments: the patient was seen at the emergency room and it is not possible to trace the vaccine lot or the data relating to the first and second dose.; sender's comments: based on temporal association, the reported events rash and difficulty breathing are considered related to bnt162b2

Lab Data
test name: ent examination; result unstructured data: test result:performed with fiber optic execution; comments: which excludes hypopharyngolaryngeal edema and preserved air spasm
List of symptoms
rash dyspnoea ear, nose and throat examination
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