Adverse Event Reporting

VAERS ID	1121390
Gender	Female
Age
StateCode	FR
Pharmaceutical Company	PFIZER\BIONTECH
Lot Number	EJ6788
Number of vaccinations	1
Vaccinated	2021-01-29
Onset	2021-02-01
Condition	Died

Symptoms

Pyrexia
Chills
Asthenia
Cough
Oedema peripheral
SARS-CoV-2 test
Computerised tomogram
Urine analysis
COVID-19
Culture urine
C-reactive protein
Liver function test
COVID-19 pneumonia
Sepsis
Blood creatinine
Physical examination
General physical health deterioration
Platelet count
Alanine aminotransferase
Aspartate aminotransferase
Blood potassium
Haemoglobin
White blood cell count
Microscopy
Klebsiella infection
Coma scale
Blood sodium
Blood bicarbonate
Bacterial pyelonephritis

Current Illness

Chronic renal failure

Preexisting Conditions

Medical History/Concurrent Conditions: Anaemia; Arterial hypertension; Atrioventricular block; Bipolar disorder; Cardiorenal syndrome; Congestive heart failure; Diabetic nephropathy; Heart block atrioventricular; Heart disease, unspecified (with conserved fraction of ejection); Hemodialysis; Hyperparathyroidism secondary; Hyperuricemia; Nephroangiosclerosis; Obesity; Sleep apnea syndrome; Type 2 diabetes mellitus

Other Medications

BISOPROLOL; ATORVASTATIN; DEPAKOTE; RISPERIDONE; FUROSEMIDE; CANDESARTAN CILEXETIL; RENVELA; LYRIC [PREGABALIN]; MELAXOSE; MIMPARA; LAMALINE [CAFFEINE;PAPAVER SOMNIFERUM LATEX;PARACETAMOL]; NOVORAPID; ABASAGLAR; KARDEGIC; PANTOPRAZOLE; CALC

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 20210211; Test Name: ALT; Result Unstructured Data: Test Result:195; Comments: increased; Test Date: 20210211; Test Name: AST; Result Unstructured Data: Test Result:250; Comments: increased; Test Date: 20210205; Test Name: bicarbonates; Result Unstructured Data: Test Result:28 mmol/L; Test Date: 20210205; Test Name: creatinine; Result Unstructured Data: Test Result:194 umol/l; Test Date: 20210211; Test Name: creatinine; Result Unstructured Data: Test Result:544 umol/l; Test Date: 20210205; Test Name: potassium; Result Unstructured Data: Test Result:3.
2 mmol/L; Test Date: 20210205; Test Name: sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 202102; Test Name: Glasgow score; Result Unstructured Data: Test Result:15; Test Date: 202102; Test Name: thoracic CT; Result Unstructured Data: Test Result:compatible aspect with SARS-cov-2 pneumonia; Comments: with multiple focus of superinfection of pneumonic appearance; Test Date: 20210205; Test Name: C-reactive protein; Result Unstructured Data: Test Result:27 mg/l; Test Date: 202102; Test Name: culture of urine; Result Unstructured Data: Test Result:disclosed infection to Klebsiella Pneumoniae exten; Comments: disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; Test Date: 20210205; Test Name: hemoglobin; Result Unstructured Data: Test Result:100 g/l; Test Date: 20210211; Test Name: hemoglobin; Result Unstructured Data: Test Result:87 g/l; Test Date: 20210205; Test Name: liver function; Result Unstructured Data: Test Result:normal; Test Date: 202102; Test Name: microscopy; Result Unstructured Data: Test Result:disclosed infection to Klebsiella Pneumoniae exten; Comments: disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; Test Date: 202102; Test Name: cardiac examination; Result Unstructured Data: Test Result:no unusual sign; Test Date: 20210205; Test Name: platelets; Result Unstructured Data: Test Result:152 x10 9/l; Test Date: 20210211; Test Name: platelets; Result Unstructured Data: Test Result:132 x10 9/l; Test Date: 20210206; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 202102; Test Name: culture of urine; Result Unstructured Data: Test Result:infection to Klebsielle Pneumoniae; Test Date: 20210205; Test Name: white blood cells; Result Unstructured Data: Test Result:6 x10 9/l; Test Date: 20210211; Test Name: white blood cells; Result Unstructured Data: Test Result:5.
2 x10 9/l

Write-up

general and respiratory condition deterioration; SARS-CoV-2 (RT-PCR) was positive/COVID-19 aggravated; discreet edema of lower limbs; chills; light dry cough; fever; pneumonia to SARS-Cov-2; bacterial pyelonephritis; infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; important septic state; important asthenia; This is a spontaneous report from a contactable pharmacist downloaded from the WEB FR-AFSSAPS-LY20211184.
A 73-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 29Jan2021 (Batch/Lot Number: EJ6788) at single dose for COVID-19 vaccination.
Medical history included heart block atrioventricular, anemia, arterial hypertension, type 2 diabetes mellitus, hyperparathyroidism secondary, ongoing chronic renal failure associated with diabetic nephropathy, obesity, bipolar disorder, sleep apnea syndrome, hyperuricemia, nephroangiosclerosis, cardio-renal syndrome, with hemodialysis initiated on 10Apr2019, heart disease with conserved fraction of ejection with multiple episodes of congestive heart failure, atrioventricular block with pacemaker.
SARS-Cov-2 history was unknown.
Concomitant medications included bisoprolol, atorvastatin, valproate semisodium (DEPAKOTE), risperidone, furosemide, candesartan cilexetil, sevelamer carbonate (RENVELA), pregabalin (LYRIC), lactulose, paraffin, liquid (MELAXOSE), cinacalcet hydrochloride (MIMPARA), caffeine, papaver somniferum latex, paracetamol (LAMALINE), insulin aspart (NOVORAPID), insulin glargine (ABASAGLAR), acetylsalicylate lysine (KARDEGIC), pantoprazole, calcium carbonate (CALCIDOSE), zopiclone (IMOVANE), sodium polystyrene sulfonate (KAYEXALATE).
On 29Jan2021 patient received a first injection of COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY) for vaccination against SARS-COV-2.
On 03Feb2021 patient felt after dialysis.
On 05Feb2021 patient experienced chills, but no fever, with light dry cough not noticed before.
Hemodynamic state was stable.
No clinical evidence of infection was observed, no dysuria, no bowel disorder.
No unusual sign on cardiac examination, but discreet edema of lower limbs.
No clinical evidence of pneumonia.
No bowel disorder.
The patient presented with important asthenia, but Glasgow score was 15.
Antibiotics by ceftriaxone sodium (unspecified trade name) and gentamicin (unspecified trade name) were started.
On 06Feb2021 SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) was positive.
Later, pulmonary condition decreased with wheezing and crackles in bases, requiring oxygen therapy.
Direct microscopy and culture of urine disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases, requiring a treatment by imipenem (unspecified trade name) 500mg twice daily.
In Feb2021, the patient presented with important septic state with unwell tolerated fever, and covid-19 aggravated.
On 16Feb2021 due to general and respiratory condition deterioration it was decided to stop active treatments and to continue comfort care.
Patient died on 17Feb2021.
In total: complications of pneumonia to SARS-Cov-2 with (bacterial) pyelonephritis to Klebsielle Pneumoniae extended-spectrum beta-lactamases.
Laboratory work-up: On 05Feb2021: white blood cells 6 x10^9/L, heamoglobin 100 g/L, platelets 152 x10^9/L, sodium 139 mmol/L, potassium 3.
2 mmol/L, bicarbonates 28 mmol/L, creatinine 194 umol/L (usual range not known), liver function was normal, C-reactive-protein 27 mg/L.
On 11Feb2021: white blood cells 5.
2 x10^9/L, hemoglobin 87 g/L, platelets 132 x10^9/L, creatinine 544 umol/L (usual range not known), increased transaminases (Aspartate aminotransferase 250 and alanine aminotransferase 195 normal ranges not available).
Additional examination: In Feb2021 thoracic computed tomography disclosed compatible aspect with SARS-cov-2 pneumonia, with multiple focus of superinfection of pneumonic appearance.
The patient died on 17Feb2021.
Cause of death was bacterial pyelonephritis and COVID-19 pneumonitis, covid-19, infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases and general and respiratory condition deterioration.
It was not reported if an autopsy was performed.
No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; general and respiratory condition deterioration; SARS-CoV-2 (RT-PCR) was positive/COVID-19 aggravated; Bacterial pyelonephritis; COVID-19 pneumonitis