Adverse Event Reporting

VAERS ID	1471636
Gender	Male
Age	87
StateCode	FR
Pharmaceutical Company	PFIZER\BIONTECH
Lot Number	EK9788
Number of vaccinations	2
Vaccinated	2021-01-30
Onset	2021-02-02
Condition	Hospitalized Died

Symptoms

Pyrexia
SARS-CoV-2 test
Chest X-ray
Fibrin D dimer
Full blood count
Troponin I
Blood glucose
SARS-CoV-2 antibody test
Activated partial thromboplastin time
Glomerular filtration rate
C-reactive protein
Blood albumin
Blood creatine phosphokinase
Blood lactate dehydrogenase
Blood phosphorus
Acute kidney injury
COVID-19 pneumonia
Blood urea
Respiratory failure
Body temperature
Antipsychotic drug level
Oxygen saturation
Respiratory rate
Platelet count
Drug ineffective
Body mass index
Alanine aminotransferase
Aspartate aminotransferase
Blood potassium
Haemoglobin
White blood cell count
Haematocrit
Blood alkaline phosphatase
Gamma-glutamyltransferase
Blood creatine
Serum ferritin
Blood 25-hydroxycholecalciferol
Hepatitis B surface antigen
Blood sodium
Mean cell volume
Blood parathyroid hormone
PO2
Hepatitis B surface antibody
Hepatitis B core antibody
Blood bromide

Current Illness

Preexisting Conditions

Medical History/Concurrent Conditions: Acute myocardial infarction; Acute pericarditis (secondary to giant cell arteritis on corticoid treatment); Benign prostatic hyperplasia; Bipolar disorder; Dementia; Ischaemic cardiomyopathy; Obesity; Parkinson's syndrome (on Sinemet treatment)

Other Medications

TAMSULOSINE HCL; PREDNISONE; SINEMET PLUS; LITHIUM CARBONATE

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 20210209; Test Name: aTTP; Result Unstructured Data: Test Result:1.
02; Test Date: 20210209; Test Name: ALT; Result Unstructured Data: Test Result:9; Test Date: 20210208; Test Name: Litemia; Result Unstructured Data: Test Result:05; Test Date: 20210209; Test Name: AST; Result Unstructured Data: Test Result:34; Test Date: 20210209; Test Name: Calcidiol; Result Unstructured Data: Test Result:70.
7; Test Date: 20210209; Test Name: Albumin; Result Unstructured Data: Test Result:38; Test Date: 20210209; Test Name: FA; Result Unstructured Data: Test Result:86; Test Date: 20210209; Test Name: Br; Result Unstructured Data: Test Result:10; Test Date: 20210207; Test Name: Cr; Result Unstructured Data: Test Result:109; Test Date: 20210209; Test Name: Cr; Result Unstructured Data: Test Result:229; Test Date: 20210211; Test Name: Cr; Result Unstructured Data: Test Result:242; Test Date: 20210209; Test Name: Cr-kinase; Result Unstructured Data: Test Result:80; Test Date: 20210209; Test Name: Gluco; Result Unstructured Data: Test Result:11.
9; Test Date: 20210207; Test Name: LDH; Result Unstructured Data: Test Result:453; Test Date: 20210209; Test Name: LDH; Result Unstructured Data: Test Result:457; Test Date: 20210209; Test Name: Parathyrin; Result Unstructured Data: Test Result:15.
9; Test Date: 20210209; Test Name: Phosphate; Result Unstructured Data: Test Result:1.
45; Test Date: 20210207; Test Name: K; Result Unstructured Data: Test Result:4.
25; Test Date: 20210209; Test Name: K; Result Unstructured Data: Test Result:4.
12; Test Date: 20210211; Test Name: K; Result Unstructured Data: Test Result:3.
51; Test Date: 20210207; Test Name: Na; Result Unstructured Data: Test Result:144; Test Date: 20210209; Test Name: Na; Result Unstructured Data: Test Result:146; Test Date: 20210211; Test Name: Na; Result Unstructured Data: Test Result:156; Test Date: 20210209; Test Name: Urea; Result Unstructured Data: Test Result:33.
1; Test Name: BMI; Result Unstructured Data: Test Result:30-40; Test Date: 20210207; Test Name: temperature; Result Unstructured Data: Test Result:36.
5 Centigrade; Test Date: 20210207; Test Name: Chest X-ray; Result Unstructured Data: Test Result:diffuse bilateral infiltrates; Comments: diffuse bilateral infiltrates; Test Date: 20210207; Test Name: CRP; Result Unstructured Data: Test Result:187; Test Date: 20210209; Test Name: CRP; Result Unstructured Data: Test Result:137.
2; Test Date: 20210209; Test Name: lower D-dimer; Result Unstructured Data: Test Result:250; Test Date: 20210207; Test Name: haemogram; Result Unstructured Data: Test Result:lymphopenia 0.
79; Comments: without leukocytosis with lymphopenia 0.
79.
; Test Date: 20210209; Test Name: GGT; Result Unstructured Data: Test Result:74; Test Date: 20210209; Test Name: glomerular filtration; Result Unstructured Data: Test Result:21; Test Date: 20210211; Test Name: glomerular filtration; Result Unstructured Data: Test Result:20; Test Date: 20210209; Test Name: Hematocrit; Test Result: 48 %; Test Date: 20210209; Test Name: Hb; Result Unstructured Data: Test Result:160; Test Date: 20210209; Test Name: Hep B Ac IgG; Result Unstructured Data: Test Result:-; Test Date: 20210209; Test Name: Ac (anti surface); Result Unstructured Data: Test Result:-; Test Date: 20210209; Test Name: HbsAg; Result Unstructured Data: Test Result:-; Test Date: 20210209; Test Name: medium corpuscular volume; Result Unstructured Data: Test Result:92; Test Date: 20210207; Test Name: O2 Sat; Test Result: 94 %; Test Date: 20210209; Test Name: platelets; Result Unstructured Data: Test Result:259.
000; Test Date: 20210207; Test Name: pO2; Result Unstructured Data: Test Result:54; Test Name: RR; Result Unstructured Data: Test Result:50; Comments: breaths per minute; Test Date: 20210207; Test Name: RR; Result Unstructured Data: Test Result:50; Comments: breaths per minute; Test Date: 20210209; Test Name: Coronavirus SARS-CoV-2; total Antibodies; Result Unstructured Data: Test Result:-; Test Date: 20210205; Test Name: PCR SARS CoV2; Result Unstructured Data: Test Result:+; Comments: PCR SARS CoV2 +.
; Test Date: 20210205; Test Name: rapid antigen test; Result Unstructured Data: Test Result:+; Test Date: 20210207; Test Name: ferritin; Result Unstructured Data: Test Result:1115.
6; Test Date: 20210209; Test Name: ferritin; Result Unstructured Data: Test Result:1448.
5; Test Date: 20210209; Test Name: TP I; Result Unstructured Data: Test Result:1.
12; Test Date: 20210209; Test Name: leucocytes; Result Unstructured Data: Test Result:13.
100; Comments: N 11.
640; L 910; N 88.
7%, L 6.
9%

Write-up

respiratory failure; acute renal failure; COVID-19 pneumonia; Drug ineffective; she began to have febrile peaks on 02Feb; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-926787.
A 87-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 30Jan2021 (Batch/Lot Number: EK9788) as 0.
3ml single dose for COVID-19 immunization.
Patient received first dose of bnt162b2 (COMIRNATY, Solution for injection) dose 1 intramuscular on 09Jan2021 (Batch/Lot Number: EJ6796) as 0.
3ml single dose for COVID-19 immunization.
Medical history included ischaemic cardiomyopathy from an unknown date and unknown if ongoing, acute myocardial infarction from 2002 to an unknown date, parkinsonism from an unknown date and unknown if ongoing on Sinemet treatment, bipolar disorder, benign prostatic hyperplasia, dementia, pericarditis from an unknown date and unknown if ongoing, secondary to giant cell arteritis on corticoid treatment, obesity from an unknown date and unknown if ongoing.
Concomitant medications included tamsulosine HCL taken for benign prostatic hyperplasia from Mar2012 to 07Feb2021; prednisone taken for giant cell arteritis from Aug2019 to 07Feb2021; carbidopa monohydrate, levodopa (SINEMET PLUS) taken for Parkinson's disease from an unspecified start date to 07Feb2021; lithium carbonate taken for bipolar disorder from Jan2013 to 07Feb2021.
The patient experienced respiratory failure and acute renal failure on an unspecified date which leads to hospitalization.
The patient experienced drug ineffective on an unspecified date.
She began to have febrile peaks on 02feb on 02Feb2021.
The patient experienced COVID-19 pneumonia on 02Feb2021 which leads to hospitalization.
Therapeutic measures were taken as result of COVID-19 pneumonia, respiratory failure, acute renal failure and she began to have febrile peaks on 02feb (pyrexia).
Evolution and treatment: Hospital stay of patient was marked by progressive respiratory failure with marked radiological worsening.
Anal progressive elevation of acute phase reactants and onset of acute renal failure AKIN (Acute Kidney injury classification) 3 (dehydration and retention).
Intravenous hydration + SV did not improve renal function.
The patient underwent lab tests with blood creatine: 109 and blood lactate dehydrogenase: 453 on 07Feb2021.
Physician Suspend Remdesivir (200mg) on 07Feb2021.
Physician Suspend Remdesivir (100mg) on 08Feb2021 due to renal failure and respiratory worsening, escalated SARS CoV2 treatment with 1 bolus of dexamethasone 20mg.
Patient Respiratory discomfort persisted and RR over 50 breaths per minute.
The patient underwent lab tests with antipsychotic drug level: 05 on 08Feb2021.
The patient underwent lab tests and procedures which included activated partial thromboplastin time: 1.
02, alanine aminotransferase: 9, aspartate aminotransferase: 34, blood 25-hydroxycholecalciferol: 70.
7, blood albumin: 38, blood alkaline phosphatase: 86, blood bromide: 10, blood creatine: 229, blood creatine phosphokinase: 80, blood glucose: 11.
9 and blood lactate dehydrogenase: 457 on 09Feb2021.
The patient underwent lab tests with blood creatine: 242 on 11Feb2021.
Comfort measures since 12Feb2021, Patient died on 17Feb2021.
The outcome of respiratory failure, acute renal failure and she began to have febrile peaks on 02feb was unknown.
The patient died on 17Feb2021.
It was not reported if an autopsy was performed.
No follow-up attempts possible.
No further information expected.
; Reporter's Comments: Summary of Reporter's Comments text: Patient 81 years old with history: Ischaemic cardiomyopathy, Acute myocardial infarction 2002, idiopathic versus pharmacological parkinsonian syndrome on Sinemet treatment, bipolar disorder (lithemia N, last controls), benign prostatic hyperplasia, probable dementia.
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; Reported Cause(s) of Death: COVID-19 pneumonia