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VAERS ID: 1000430

AGE: 36| SEX: M|State: FR

Description

afebrile convulsive crisis; syncope; disorientation; nausea; abdominal pain; diarrhea; tachycardia; rhinorrhea; dyspnea; Diaphoresis; peripheric cyanosis; febricula; vomit; respiratory distress; Headache; Asthenia/fatigue; Asthenia/fatigue; chills; pain/sensitivity; dizziness; This is a spontaneous report from a non-contactable other HCP via e-mail. A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4241, Expiration date 01Apr2021) intramuscular on 30Dec2020 at single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergy. The patient experienced afebrile convulsive crisis on an unspecified date, respiratory distress on 30Dec2020, syncope on an unspecified date, headache on 30Dec2020, asthenia/fatigue on 30Dec2020, chills on 30Dec2020, pain/sensitivity on 30Dec2020, dizziness on 30Dec2020, nausea on 01Jan2021, vomit on 30Dec2020, abdominal pain on 01Jan2021, diarrhea on 01Jan2021, tachycardia on 30Dec2020, rhinorrhea on 30Dec2020, dyspnea on 30Dec2020, diaphoresis on 30Dec2020, peripheric cyanosis on 30Dec2020, febricula on 30Dec2020. Timeframe between vaccination and starting of symptoms was reported 10 hours. The event afebrile convulsive crisis requires hospitalization. Clinical course was reported that it began the same day of the vaccination against COVID-19 with febricula 37.6 without drug management, the following day without apparent signs. Later on Saturday, 01Jan2021, he presented abdominal pain with diarrhea with presence of mucus, the patient self-medicated with loperamide one doses presenting improvement, intermittent nausea is added later, continuing with chills, without fever evidenced with thermometer, with oximetry's above 95%. Today morning the patient presented a syncope sensation, after his presented convulsion, for approximately 3 minutes, without loss of control of the sphincters, later recovered a state of alert with disorientation, partial, and returning to convulsion in the same way, as well as a total 4 convulsive events, reasoning for what he consulted. The patient underwent lab tests and procedures which included body temperature: 37.6 centigrade on 30Dec2020 febricula, oxygen saturation: 95 % on 30Dec2020. Therapeutic measures were taken as a result of diarrhea. The patient recovered from diarrhea and febricula. The outcome of other events was unknown. No follow up attempts possible. No further information expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events seizure, respiratory distress and syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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

Abdominal pain, Diarrhoea, Headache, Pyrexia, Tachycardia, Asthenia, Disorientation, Hyperhidrosis, Respiratory distress, Vomiting, Body temperature, Dizziness, Nausea, Rhinorrhoea, Chills, Dyspnoea, Oxygen saturation, Seizure, Cyanosis, Fatigue, Pain, Syncope

Vaccines

VAX DATE: 29 December 2020 | ONSET DATE: 29 December 2020 | DAYS TO ONSET: 0
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • LA
  • EK4241

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
Y
LAB_DATA:
Test Date: 20201230; Test Name: Body Temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: febricula.; Test Date: 20210101; Test Name: Body Temperature; Result Unstructured Data: Test Result:without fever Centigrade; Test Date: 20201230; Test Name: oximetry; Result Unstructured Data: Test Result:above 95 %
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:
MXPFIZER INC2021069198
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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