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VAERS ID: 2272639

AGE: UNK| SEX: F|State: FR

Description

Vaccination failure; COVID-19; Aggravation of the urticaria; Dose 1: unbearable urticaria - Booster Dose 1: generalised urticaria: neck, thighs, entire thorax, arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. The reporter is the patient. Regulatory number: FR-AFSSAPS-ST20221143. A 54-year-old female patient received BNT162b2 (COMIRNATY), on 24May2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown), on 23Jun2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) and on 28Nov2021 as dose 3 (booster), single (Lot number: FG7911), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Jun2021, outcome "unknown", described as "Aggravation of the urticaria"; URTICARIA (non-serious) with onset Jun2021, outcome "not recovered", described as "Dose 1: unbearable urticaria - Booster Dose 1: generalised urticaria: neck, thighs, entire thorax, arms"; COVID-19 (medically significant) with onset 19Jan2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 19Jan2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Unknown results; SARS-CoV-2 test: (19Jan2022) Positive; Specialist consultation: (unspecified date) Unknown results. Therapeutic measures were taken as a result of urticaria. Clinical course: Early June, a few days after Dose 1: unbearable urticaria from the lower calves to the ankles, unresolved between Dose 1 and Dose 2; no medical consultation. Aggravation of the urticaria after Dose 2. Adverse effects lasted for 2 months. 3 weeks after Booster Dose 1: generalised urticaria: neck, thighs, entire thorax, arms. medical prescription: no improvement on antihistamine. Dermatologist consultation: a biopsy was reportedly done. File pending additional information. Medical consultation and biopsy report requested. Treatment: Antihistamine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Symptoms

Biopsy, Vaccination failure, COVID-19, SARS-CoV-2 test, Specialist consultation, Urticaria

Vaccines

VAX DATE: 27 November 2021 | ONSET DATE: 31 May 2021 | DAYS TO ONSET:
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 3
  • OT
  • FG7911

RECVDATE:11 May 2022
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:N
LAB_DATA:Test Name: Biopsy; Result Unstructured Data: Test Result:Unknown results; Test Date: 20220119; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: Dermatologist consultation; Result Unstructured Data: Test Result:Unknown results
V_ADMINBY:OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:FRPFIZER INC202200656815
FORM_VERS:2
TODAYS_DATE:10 May 2022
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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