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