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VAERS ID: 1000428

AGE: 31| SEX: F|State: FR

Description

oxygen saturation between 80-85%; Fever greater or equal to 38 grades Celsius; headache; myalgia; arthralgia; respiratory distress; pharyngeal pain; cough; dyspnea; This is a spontaneous report from a non-contactable other hcp via e-mail. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm at first single dose on 24Dec2020 for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Starting a clinical course on 01Jan2021, at the start of the watch at 08:00 hours, patient referred headache, myalgias and arthralgias, pharyngeal pain, cough, dyspnea respiratory distress, leaving home. Later, on 02Jan2021 in the morning, patient also referred to fever greater or equal to 38 grades Celsius, headache, myalgias and arthralgias, oxygen saturation between 80-85%; Hospitalization is decided, CT with CORADS 3. Later, on Sunday (03Jan2021), she presented with 95% saturation without oxygen, asymptomatic and afebrile, for which she was discharged home. Outcome of the event was recovered on 03Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Symptoms

Arthralgia, Headache, Pyrexia, Body temperature, Myalgia, Respiratory distress, Computerised tomogram, Oropharyngeal pain, Cough, Oxygen saturation, Dyspnoea, Oxygen saturation decreased

Vaccines

VAX DATE: 23 December 2020 | ONSET DATE: 31 December 2020 | DAYS TO ONSET: 8
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • LA

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
1
X_STAY:
DISABLE:
RECOVD:
Y
LAB_DATA:
Test Date: 20210102; Test Name: Body Temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: Fever greater or equal to 38 grades Celsius; Test Date: 20210102; Test Name: CT scan; Result Unstructured Data: Test Result:CORADS 3; Test Date: 20210102; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:between 80-85 %; Test Date: 20210103; Test Name: Oxygen saturation; Test Result: 95 %
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:
MXPFIZER INC2021069196
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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