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VAERS ID: 1000290

AGE: UNK| SEX: F|State: FR

Description

medication error; Anaphylactic reaction; Pulmonary edema; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-EYC 00237518, Safety Report Unique Identifier: GB-MHRA-ADR 24581820. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/Batch: EE8493), parenteral on 11Jan2021 at single dose for COVID-19 vaccination. Medical history included ongoing multiple allergies. Concomitant medication included fexofenadine hydrochloride (unknown manufacturer). The patient experienced anaphylactic reaction on 11Jan2021 and medication error (Contraindicated product administered) on an unspecified date. The patient reported that she was advised to have the jab even though she carried epi pen and had multiple allergies. This was stated on patient forms. Upon recent follow-up, the patient had been seen by the general practitioner (GP) again and had prescribed antibiotics and more steroids as she had pulmonary edema described as fluid on her left lung (same side of vaccination) (started in Jan2021) and still suffering symptoms of anaphylaxis. The outcome of event anaphylactic reaction was not recovered; and outcome of the event pulmonary edema was unknown. The reported events were considered serious requiring hospitalization. No follow-up attempts are possible. No further information is expected. Follow-up (21Jan2021): New information received from the same contactable consumer (patient) included: event details (outcome of the event anaphylactic reaction updated from recovered with sequelae to 'not recovered'; new event: pulmonary edema). No follow-up attempts are possible. No further information is expected.

Symptoms

Anaphylactic reaction, Contraindicated product administered, Pulmonary oedema

Vaccines

VAX DATE: 10 January 2021 | ONSET DATE: 31 December 2020 | DAYS TO ONSET:
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • UNK
  • OT
  • EE8493

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
Fexofenadine Hydrochloride
CUR_ILL:
Multiple allergies (she carried EpiPen)
HISTORY:
PRIOR_VAX:
SPLTTYPE:
GBPFIZER INC2021031565
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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