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From the 11/19/2021 release of VAERS data:

Found 22 cases where Vaccine targets Influenza or Pneumonia or Shingles (FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 or PNC or PNC10 or PNC13 or PPV or VARZOS) and Symptom is Arterial thrombosis or Arterial thrombosis limb or Axillary vein thrombosis or Blood fibrinogen increased or Complement factor C1 increased or Complement factor C3 increased or Complement factor C4 increased or Complement factor increased or Deep vein thrombosis or Platelet adhesiveness increased or Platelet dysfunction or Platelet function test abnormal or Pulmonary embolism or Secondary thrombocytosis or Thrombectomy or Thrombin-antithrombin III complex increased or Thrombin time abnormal or Thrombocytopenia or Thrombocytopenic purpura or Thrombolysis or Thrombophlebitis or Thrombosis or Thrombotic microangiopathy or Thrombotic stroke or Thrombotic thrombocytopenic purpura or Vena cava embolism or Vena cava thrombosis or Venous occlusion and Patient Died and Vaccination Date from '2005-01-01' to '2020-12-31'

Government Disclaimer on use of this data

Table

   
AgeVaccine/ManufacturerVaccine DoseYear of DeathCountPercent
< 3 Years6VAX-F / GLAXOSMITHKLINE BIOLOGICALS2201729.09%
6VAX-F / GLAXOSMITHKLINE BIOLOGICALS2total29.09%
6VAX-F / GLAXOSMITHKLINE BIOLOGICALSUNK201529.09%
6VAX-F / GLAXOSMITHKLINE BIOLOGICALSUNKtotal29.09%
6VAX-F / GLAXOSMITHKLINE BIOLOGICALStotal418.18%
DTAP / GLAXOSMITHKLINE BIOLOGICALS22005418.18%
DTAP / GLAXOSMITHKLINE BIOLOGICALS2total418.18%
DTAP / GLAXOSMITHKLINE BIOLOGICALStotal418.18%
FLUX(H1N1) / UNKNOWN MANUFACTURER1Unknown14.55%
FLUX(H1N1) / UNKNOWN MANUFACTURER1total14.55%
FLUX(H1N1) / UNKNOWN MANUFACTURERtotal14.55%
HEPA / GLAXOSMITHKLINE BIOLOGICALS1201329.09%
HEPA / GLAXOSMITHKLINE BIOLOGICALS1total29.09%
HEPA / GLAXOSMITHKLINE BIOLOGICALS4201329.09%
HEPA / GLAXOSMITHKLINE BIOLOGICALS4total29.09%
HEPA / GLAXOSMITHKLINE BIOLOGICALSUNK201314.55%
HEPA / GLAXOSMITHKLINE BIOLOGICALSUNKtotal14.55%
HEPA / GLAXOSMITHKLINE BIOLOGICALStotal522.73%
HEPA / MERCK & CO. INC.1201229.09%
HEPA / MERCK & CO. INC.1total29.09%
HEPA / MERCK & CO. INC.UNK201214.55%
HEPA / MERCK & CO. INC.UNKtotal14.55%
HEPA / MERCK & CO. INC.total313.64%
HIBV / MERCK & CO. INC.1201329.09%
HIBV / MERCK & CO. INC.1total29.09%
HIBV / MERCK & CO. INC.22005418.18%
HIBV / MERCK & CO. INC.2total418.18%
HIBV / MERCK & CO. INC.4201329.09%
HIBV / MERCK & CO. INC.4total29.09%
HIBV / MERCK & CO. INC.UNK201314.55%
HIBV / MERCK & CO. INC.UNKtotal14.55%
HIBV / MERCK & CO. INC.total940.91%
IPV / SANOFI PASTEUR22005418.18%
IPV / SANOFI PASTEUR2total418.18%
IPV / SANOFI PASTEURtotal418.18%
MEN / UNKNOWN MANUFACTURERUNKUnknown313.64%
MEN / UNKNOWN MANUFACTURERUNKtotal313.64%
MEN / UNKNOWN MANUFACTURERtotal313.64%
MMR / GLAXOSMITHKLINE BIOLOGICALS4201014.55%
MMR / GLAXOSMITHKLINE BIOLOGICALS4total14.55%
MMR / GLAXOSMITHKLINE BIOLOGICALSUNK201014.55%
MMR / GLAXOSMITHKLINE BIOLOGICALSUNKtotal14.55%
MMR / GLAXOSMITHKLINE BIOLOGICALStotal29.09%
MMR / MERCK & CO. INC.1201229.09%
MMR / MERCK & CO. INC.1201329.09%
MMR / MERCK & CO. INC.1total418.18%
MMR / MERCK & CO. INC.4201329.09%
MMR / MERCK & CO. INC.4total29.09%
MMR / MERCK & CO. INC.UNK201214.55%
MMR / MERCK & CO. INC.UNK201314.55%
MMR / MERCK & CO. INC.UNKtotal29.09%
MMR / MERCK & CO. INC.total836.36%
MMR / UNKNOWN MANUFACTURERUNKUnknown313.64%
MMR / UNKNOWN MANUFACTURERUNKtotal313.64%
MMR / UNKNOWN MANUFACTURERtotal313.64%
PNC / PFIZER/WYETH22005418.18%
PNC / PFIZER/WYETH2total418.18%
PNC / PFIZER/WYETH4201014.55%
PNC / PFIZER/WYETH4Unknown14.55%
PNC / PFIZER/WYETH4total29.09%
PNC / PFIZER/WYETHUNK200614.55%
PNC / PFIZER/WYETHUNK201014.55%
PNC / PFIZER/WYETHUNKtotal29.09%
PNC / PFIZER/WYETHtotal836.36%
PNC13 / PFIZER/WYETH1201229.09%
PNC13 / PFIZER/WYETH1201329.09%
PNC13 / PFIZER/WYETH1total418.18%
PNC13 / PFIZER/WYETH2201729.09%
PNC13 / PFIZER/WYETH2total29.09%
PNC13 / PFIZER/WYETH3Unknown14.55%
PNC13 / PFIZER/WYETH3total14.55%
PNC13 / PFIZER/WYETH4201329.09%
PNC13 / PFIZER/WYETH4total29.09%
PNC13 / PFIZER/WYETHUNK201214.55%
PNC13 / PFIZER/WYETHUNK201314.55%
PNC13 / PFIZER/WYETHUNK201529.09%
PNC13 / PFIZER/WYETHUNKtotal418.18%
PNC13 / PFIZER/WYETHtotal1359.09%
PPV / UNKNOWN MANUFACTURERUNKUnknown313.64%
PPV / UNKNOWN MANUFACTURERUNKtotal313.64%
PPV / UNKNOWN MANUFACTURERtotal313.64%
VARCEL / MERCK & CO. INC.1201329.09%
VARCEL / MERCK & CO. INC.1total29.09%
VARCEL / MERCK & CO. INC.4201329.09%
VARCEL / MERCK & CO. INC.4total29.09%
VARCEL / MERCK & CO. INC.UNK201314.55%
VARCEL / MERCK & CO. INC.UNKtotal14.55%
VARCEL / MERCK & CO. INC.total522.73%
total75340.91%
44-65 YearsPPV / MERCK & CO. INC.UNK201314.55%
PPV / MERCK & CO. INC.UNKtotal14.55%
PPV / MERCK & CO. INC.total14.55%
total14.55%
75+ YearsFLU3 / EVANS VACCINESUNK200514.55%
FLU3 / EVANS VACCINESUNKtotal14.55%
FLU3 / EVANS VACCINEStotal14.55%
FLUX / NOVARTIS VACCINES AND DIAGNOSTICSUNK201514.55%
FLUX / NOVARTIS VACCINES AND DIAGNOSTICSUNKtotal14.55%
FLUX / NOVARTIS VACCINES AND DIAGNOSTICStotal14.55%
PNC13 / PFIZER/WYETH2201614.55%
PNC13 / PFIZER/WYETH2total14.55%
PNC13 / PFIZER/WYETHtotal14.55%
PPV / MERCK & CO. INC.UNK201214.55%
PPV / MERCK & CO. INC.UNKtotal14.55%
PPV / MERCK & CO. INC.total14.55%
VARZOS / MERCK & CO. INC.UNK201414.55%
VARZOS / MERCK & CO. INC.UNKtotal14.55%
VARZOS / MERCK & CO. INC.total14.55%
total522.73%
UnknownFLUX / UNKNOWN MANUFACTURERUNKUnknown418.18%
FLUX / UNKNOWN MANUFACTURERUNKtotal418.18%
FLUX / UNKNOWN MANUFACTURERtotal418.18%
HEP / MERCK & CO. INC.UNKUnknown29.09%
HEP / MERCK & CO. INC.UNKtotal29.09%
HEP / MERCK & CO. INC.total29.09%
HEP / UNKNOWN MANUFACTURERUNKUnknown29.09%
HEP / UNKNOWN MANUFACTURERUNKtotal29.09%
HEP / UNKNOWN MANUFACTURERtotal29.09%
VARZOS / GLAXOSMITHKLINE BIOLOGICALS1201814.55%
VARZOS / GLAXOSMITHKLINE BIOLOGICALS1201914.55%
VARZOS / GLAXOSMITHKLINE BIOLOGICALS1total29.09%
VARZOS / GLAXOSMITHKLINE BIOLOGICALS2202014.55%
VARZOS / GLAXOSMITHKLINE BIOLOGICALS2total14.55%
VARZOS / GLAXOSMITHKLINE BIOLOGICALStotal313.64%
total1150%
TOTAL† 92† 418.18%
† Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 22 (the number of cases found), and the Total Percentage is greater than 100.



Case Details

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VAERS ID: 237787 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Maryland  
Vaccinated:2005-03-31
Onset:2005-04-02
   Days after vaccination:2
Submitted: 2005-04-13
   Days after onset:10
Entered: 2005-05-23
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 616A2 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0070N / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1582 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494033 / 2 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Aspiration, Brain oedema, Cardio-respiratory arrest, Convulsion, Electrolyte imbalance, Haemolytic anaemia, Haemolytic uraemic syndrome, Nephritis, Pulmonary congestion, Pyrexia, Renal failure, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Renovascular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mefloquine 30mg q wk; Acetaminophen 80mg q 4h prn.
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Anemia, Electrolyte Imbalance
CDC Split Type:

Write-up: Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis. Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.


VAERS ID: 247278 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2005-11-02
Onset:2005-11-04
   Days after vaccination:2
Submitted: 2005-11-11
   Days after onset:7
Entered: 2005-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 61503 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Coma, Pain, Pulmonary embolism
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: had UTI diagnosed 11-1-05
Preexisting Conditions: Bactrim Augmentin Flagyl
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11-4-05 C/o pain rt side rt lower lobe crackles 11-5-05 rt rib pain in morning. 5pm clammy unresponsive went to ER died at hospital. Hospital reports died from pulmonary embolism. Have not received death certificate at this time. 11/18/05 Death certificate received which revealed COD as pulmonary emboli.


VAERS ID: 460432 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Female  
Location: New Jersey  
Vaccinated:2012-07-16
Onset:2012-07-22
   Days after vaccination:6
Submitted: 2012-07-27
   Days after onset:5
Entered: 2012-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 02771AE / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1577 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E56178 / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Acidosis, Acute myeloid leukaemia, Anaemia, Aspiration bone marrow abnormal, Bacterial test negative, Bilevel positive airway pressure, Blast cells present, Blood culture, Central venous catheterisation, Culture urine, Death, Diarrhoea, Endotracheal intubation, Full blood count abnormal, Hypercapnia, Leukocytosis, Mechanical ventilation, Oxygen saturation decreased, Postoperative respiratory distress, Pyrexia, Tachycardia, Tachypnoea, Thrombocytopenia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Blood premalignant disorders (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Malignant lymphomas (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: (all medications received between admission 7/17/12 and death 7/22/12); Aluminum hydroxide suspension; Diphenhydramine; Acetaminophen; Propofol; Allopurinol; Cefepime; Ondansetron; Cytarabine; Morphine; Dexamethasone; Albuterol (inhaled); D
Current Illness: AML
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy is pending
CDC Split Type:

Write-up: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.


VAERS ID: 503021 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: New Mexico  
Vaccinated:2013-07-10
Onset:2013-07-30
   Days after vaccination:20
Submitted: 2013-09-18
   Days after onset:50
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB692AA / 1 UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J000564 / 4 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. H009578 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G45476 / 4 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H017132 / UNK UN / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Adenovirus infection, Alpha 1 foetoprotein normal, Amino acid level, Ammonia decreased, Anaemia, Anti-NMDA antibody negative, Antibody test, Antibody test negative, Antinuclear antibody negative, Aspergillus test, Asthenia, B-lymphocyte count, B-lymphocyte count decreased, Bacterial infection, Biopsy skin abnormal, Blood creatine phosphokinase decreased, Blood culture negative, Blood fibrinogen increased, Blood fibrinogen normal, Blood homocysteine normal, Blood immunoglobulin A normal, Blood immunoglobulin E, Blood immunoglobulin G normal, Blood immunoglobulin M increased, Blood lactate dehydrogenase increased, Blood lactic acid decreased, Blood lactic acid normal, Blood pyruvic acid, Blood pyruvic acid increased, Blood triglycerides increased, Blood urea, Bordetella test negative, Bronchial secretion retention, CD4 lymphocytes decreased, CD4/CD8 ratio, CD8 lymphocytes decreased, CSF culture negative, CSF oligoclonal band absent, CSF test abnormal, CSF test normal, Carnitine decreased, Cell marker, Cerebral atrophy, Ceruloplasmin, Chlamydia test negative, Clostridium test, Clostridium test negative, Complement factor, Corynebacterium test, Culture negative, Culture urine negative, Culture wound negative, Culture wound positive, Cytomegalovirus test, Cytomegalovirus test negative, Diarrhoea, Encephalopathy, Endotracheal intubation, Enterovirus test negative, Enzyme level test, Epstein-Barr virus test negative, Free fatty acids, Fungal test, Fungal test negative, General physical health deterioration, Gram stain positive, HIV test negative, Herpes simplex serology negative, Herpes virus infection, Human herpes virus 6 serology negative, Human rhinovirus test positive, Immunoglobulin therapy, Influenza B virus test, Influenza virus test negative, Intensive care, Jaundice, Klebsiella infection, Klebsiella test positive, Legionella test, Lipids, Lumbar puncture abnormal, Lymphocyte stimulation test, Measles antibody negative, Mumps antibody test, Muscular weakness, Mycoplasma test, Natural killer cell count, Nervous system disorder, Neurological decompensation, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Organic acid analysis, Parasite stool test negative, Polymerase chain reaction, Pseudomonas infection, Rash papular, Rhinovirus infection, Rubella antibody test, Scab, Serum ferritin increased, Stool analysis normal, T-lymphocyte count decreased, Thyroxine decreased, Transfusion, Tuberculin test negative, Urine analysis normal, Varicella virus test positive, Viral test negative, Vitamin B12, Warm type haemolytic anaemia, White matter lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Angioedema (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Lipodystrophy (broad), Normal pregnancy conditions and outcomes (broad), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-10-03
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 48 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Surface Marker T&B panel CD3 (T3): 18% (low) CD3 ABS: 58 (low) Surface marker CD4 (T4): 12% (low) Surface Marker T4 ABs: 40 (low) CD8 (T8): 5% (low) T8 ABS: 16 (low) CD4/CD8 ratio: 2.54 (nl) CD19 (B4): 68% (high) CD19 Abs: 225 (low) CD16/CD56 NK cells 15% (high nl) CD16/CD56 Absolute count 49 (low) IgA: 32 IgG 505 IgM 309 (high) IgE: 49.9 (nl 0-49) CH50: 25 (reference values have not been established for patients <16 yo) AH50: not done LDH: 2586 Ferritin: 1310 Fibrinogen: 337 Triglycerides: 150 Ammonia: 15 Lactate: 1.39 CK: <20 Stool reducing substances negative ANA profile negative Carnitine profile: total carnitine low (30) otherwise normal Pyruvic acid, B: 0.17 (high; nl 0.08-0.16) Pyruvic acid (mg/dL): 1.5 (high, nl 0.7-1.4) Homocysteine: 4.8 (nl 4.7-12.6) Alpha-fetoprotein: 2.1 Ceruloplasmin: 19.4 CSF and serum paraneoplastic lab: negative CSF and serum NMDA receptor antibody: negative Oligoclonal bands (CSF): negative 3 Methylglutaconic acid: normal Organic acid (urine): "slight 3-hydroxyisovaleric without 3-methylcrotonylglycine; rule out biotin deficiency or combined carboxylase deficiency" Total lipids: 680 Pending labs: Very long chain fatty acid Complete MTDNA analysis Lysosomal enzyme panel Plasmalogen Urine organic acid Plasma amino acids Acylcarnitine profile Vitamin B12 metabolites UPGC (testing for congenital porphyria) Lymphocyte stimulation CD31 recent thymic emigrants cytochip 5 cell (CGL) Pyridoxal 5-phosphate Folate/5MTHF (CSF) BH4/Neopterin profile (CSF) Amino acid (CSF) Toll-like receptor assay B-cell line immortalized with EBV Comprehensive SCID panel, 18 genes Vaccine antibodies: Rubeola virus IgM and IgG: negative S. Pneumoniae IgG Ab: All 23 serotype IgG levels low Diphtheria IgG: 0.020 (minimum level of protective antibody is 0.01-0.1; majority should demonstrate $g0.1) Tetanus IgG: 0.11 (minimum level of protective antibody 0.01-0.15; majority should demonstrate $g0.15) H. Influenzae B Ab IgG: 0.56 (reference .0.15; optimum antibody level is $g1.0 post vaccine) Microbiology: BAL studies: Pneumocystis stain: negative Gram stain: gram positive organism identified HSV and CMV negative Pertussis negative Mycoplasma negative Fungal culture negative Chlamydia trachomatis negative Mycoplasma negative Legionella negative Pending: M. Hominis and ureaplasma VZV studies: 9/4 CSF VZV PCR: positive; 723 copies/ml 9/12 CSF VZV PCR: pending VZV PCR (wound swab 9/12): positive, 137,156 copies/ml VZV PCR (2nd skin wound 9/12): in-process VZV PCR from BAL fluid: pending VZV PCR from serum:negative VZV IgM (serum): negative VZV IgG (serum): positive VZV IgM and IgG from CSF and serum: negative Other micro: Viral PCR: adenovirus, rhino/entero Urine culture (9/4): $g100,000 colonies Klebsiella Urine culture (9/11): no growth CSF studies: culture NGTD, EBV, CMV, HSV negative Blood cultures (9/4): NGTD Blood fungus culture (9/5): negative Stool wet mount: negative C diff: negative Stool O&P: negative Stool viral EM: negative Wound culture (9/6): rare normal skin flora isolated HHV6 PCR (serum): negative HHV-6 PCR (CSF): not done CMV (urine): negative Measles PCR (throat) negative Mumps PCR (thorat) in-process Rubella PCR (throat) in-process Parvo PCR (CSF): not done Aspergillus antigen: pending Enterovirus PCR (CSF): negative Enterovirus PCR (throat, rectum): negative HIV-1 DNA PCR: negative PPD skin test: negative
CDC Split Type:

Write-up: Patient presented to urgent care on 8/1/13 with 2 day history of diarrhea, possible fever, decreased energy, and jaundice. She also developed a disseminated flesh colored papular rash which would rapidly scab over. She was found to be profoundly anemic to 5.4 and was admitted to hospital. She required nearly daily transfusions due to new onset warm Ab hemolytic anemia which only improved slightly with a burst of high dose steroids as well as two treatments with IVIG. She also developed three other rashes during this hospital course. She had a massive diagnostic workup at Hospital, and had a skin biopsy of a lesion that appeared to be consistent with a herpes virus infection but was negative for HSV1 or HSV2. She was treated with IV acyclovir at meningitic dosing for 14 days. She also developed worsening encephalopathy with decreased ability to clear her own secretions. It was determined that she was deteriorating clinically and required further diagnostic workup at a tertiary care center. She was transferred to another hospital on 9/4/13. She was admitted to the PICU due to worsening neurologic status and has required prolonged intubation due to concern for neuromuscular weakness. LP on admission and subsequent skin lesion sample was positive for VZV DNA by PCR, and MRI brain and neck has shown diffuse cerebral atrophy and hyperintensity of basal ganglia, medulla, and cervical spine. She was treated with a burst of high dose steroids and 3 back-to-back doses of IVIG with improvement in her transfusion requirements. She was also treated with acyclovir and subsequently foscarnet with improvement in symptoms. Of note, she has had multiple infections during her hospital courses including rhinovirus, adenovirus, Pseudomonas, Ambiotrophia, and Klebsiella.


VAERS ID: 640247 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Iowa  
Vaccinated:2016-06-21
Onset:2016-06-21
   Days after vaccination:0
Submitted: 2016-06-21
   Days after onset:0
Entered: 2016-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M79320 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Fall, Head injury, Pulmonary embolism, Resuscitation
SMQs:, Embolic and thrombotic events, venous (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tramadol; simvastatin 20 daily; nifedipine 60 daily
Current Illness: No illness, patient said no know allergies or previous reactions to IMZ
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient dropped to the floor and hit her head shortly after being immunized with Prevnar. CPR administered on site. Patient later died at hospital. Dr./coroner believes it was not related to the shot but rather a pulmonary embolism.


VAERS ID: 857290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2019-05-15
Onset:2019-05-01
Submitted: 0000-00-00
Entered: 2020-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4257F / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Death, Deep vein thrombosis, Erythema, Eyelid margin crusting, Ophthalmic herpes zoster, Pneumonia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Ocular infections (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-15
   Days after onset: 228
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ERYTHROMYCIN OINTMENT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202000

Write-up: DVT; Pneumonia; Pharmacist states the patient''s death; forehead redness; forehead; crusting of the eyes; Ocular shingles; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis. Co-suspect products included erythromycin (Erythromycin Ointment) for prophylaxis. On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Erythromycin Ointment at an unknown dose and frequency. In May 2019, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On 22nd May 2019, the patient experienced erythema, blister and eye crusting. On 15th December 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and pneumonia (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and artificial tears nos (Artificial Tears). Erythromycin Ointment was discontinued. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting were unknown. The patient died on 15th December 2019. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting to be related to Shingrix. Additional details were provided as follows: The patient was received Shingrix developed ocular shingles within one week. The medical team were unsure if it was herpes, but the chart notes not clearly bacterial or viral. Patient was prescribed erythromycin ointment for prophylaxis, then on 22nd May 2019 started getting forehead redness and blisters, crusting of the eyes, and she stopped erythromycin.The treatment was changed to artificial tears and started Valcyclovir 1g, 1 BID for 10 days. Patient had consult with ophthalmology and was treated with artificial tears. The consult noted "no evidence of herpetic uvelitis, keratitis, or retinitis in right eye and a treatment with antiviral medication was continue. On 15th December 2019, the patient died exact cause of death unknown. The patient had multiple issues including DVT and pneumonia, and patient elected for comfort care instead of treatment. Pharmacist states the patient''s death does not appear to be related to Shingrix.; Reported Cause(s) of Death: Death


VAERS ID: 1261110 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: South Carolina  
Vaccinated:2018-05-22
Onset:2018-05-01
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Anoxia, Autopsy, Blood creatinine increased, Blood sodium decreased, Blood urea increased, Bronchitis chronic, Cardiac arrest, Cardiogenic shock, Central venous catheterisation, Condition aggravated, Death, Endotracheal intubation, Feeding disorder, Fluid intake reduced, Glomerulonephritis membranous, Hyponatraemia, Hypotension, Hypovolaemia, Hypoxia, Influenza like illness, Malaise, Metabolic encephalopathy, Multiple organ dysfunction syndrome, Muscle contractions involuntary, Myalgia, Myocardial infarction, Pyrexia, Rash, Renal disorder, Renal tubular necrosis, Respiratory failure, Seizure, Shock, Tachycardia, Thrombocytopenia, Transaminases increased, Viral infection, Viral test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RITUXIMAB
Current Illness: Glomerulonephritis membranous (diagnosed with membranous glomerulonephritis); Renal disorder (had long standing kidney problems)
Preexisting Conditions: Medical History/Concurrent Conditions: Biopsy (had a biopsy on February 2018.)
Allergies:
Diagnostic Lab Data: Test Date: 20180526; Test Name: Creatinine increased; Result Unstructured Data: (Test Result:value not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180526; Test Name: Hyponatremia; Result Unstructured Data: (Test Result:value not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180526; Test Name: Blood urea nitrogen increased; Result Unstructured Data: (Test Result:value not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180526; Test Name: body temperature; Result Unstructured Data: (Test Result:103.9,Unit:degree F,Normal Low:,Normal High:); Test Date: 201805; Test Name: lab test; Test Result: Negative ; Test Date: 20180526; Test Name: Transaminitis; Result Unstructured Data: (Test Result:value not reported,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: USGLAXOSMITHKLINEUS202109

Write-up: suffered spontaneous contractions / had a central line placed; tachycardic / (intubation removed after) and hypotensive; hypoxemia; Chronic bronquitis; never recovered pulmonary activity and died / Respiratory failure with hypoxemia; Elevated MI and shock; Elevated MI and shock; kidney problem / Diagnosed with membranous glomerulonephritis / worsened /hospitalized after getting worse; kidney problem / Diagnosed with membranous glomerulonephritis / worsened /hospitalized after getting worse; extremely ill kidneys shut down / developed acute renal failure; tubular necrosis; Metabolic encephalopathy (due to hyponatremia and anoxia); anoxia; Thrombocytopenia; hypotension (secondary to hypovolemia). /hypotensive; secondary to hypovolemia; Rash on the lower extremities; Decreased fluid and nourishment intake due to inability to eat and drink; Decreased fluid / due to inability to eat and drink; Hyponatremia; Transaminitis; Increased /creatinine; Increased BUN and creatinine; malaise; flu like symptoms / flu like illness; viral-like symptoms; myalgia; fever / Fever 103.9?F; multiorgan failure; rapidly decompensated with seizure; This case was reported by a physician via call center representative and described the occurrence of respiratory failure in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient''s past medical history included biopsy (had a biopsy on February 2018.). Previously administered products included prednisone, ciclosporin, immunosuppressive therapy (had exacerbation of the problem and was treated with immunosuppressive therapy using rituximab twice) and rituximab. Concurrent medical conditions included renal disorder (had long standing kidney problems) and glomerulonephritis membranous (diagnosed with membranous glomerulonephritis). Concomitant products included rituximab. On 22nd May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than 2 weeks after receiving Shingrix, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and multi-organ failure (serious criteria hospitalization and GSK medically significant). On 22nd May 2018, the patient experienced influenza like illness (serious criteria hospitalization), viral infection (serious criteria hospitalization), myalgia (serious criteria hospitalization), fever (serious criteria hospitalization) and malaise (serious criteria hospitalization). On 26th May 2018, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant), hypotension (serious criteria hospitalization), hypovolemia (serious criteria hospitalization), rash (serious criteria hospitalization), unable to eat (serious criteria hospitalization), fluid intake reduced (serious criteria hospitalization), hyponatremia (serious criteria hospitalization), transaminitis (serious criteria hospitalization), creatinine increased (serious criteria hospitalization) and blood urea nitrogen increased (serious criteria hospitalization). On 29th May 2018, the patient experienced respiratory failure (serious criteria death, hospitalization and GSK medically significant), myocardial infarction (serious criteria hospitalization and GSK medically significant), cardiogenic shock (serious criteria hospitalization and GSK medically significant), glomerulonephritis membranous (serious criteria hospitalization and GSK medically significant), condition aggravated (serious criteria hospitalization), acute renal failure (serious criteria hospitalization and GSK medically significant), tubular necrosis (serious criteria hospitalization and GSK medically significant), metabolic encephalopathy (serious criteria hospitalization and GSK medically significant), anoxia (serious criteria hospitalization and GSK medically significant), hypoxemia (serious criteria hospitalization and GSK medically significant) and chronic bronchitis (serious criteria hospitalization). On 30th May 2018, the patient experienced tachycardia (serious criteria hospitalization) and muscle contractions involuntary (serious criteria hospitalization). On 30th May 2018, the outcome of the respiratory failure was fatal. On an unknown date, the outcome of the myocardial infarction, cardiogenic shock, glomerulonephritis membranous, condition aggravated, acute renal failure, thrombocytopenia, tubular necrosis, metabolic encephalopathy, anoxia, seizure, hypoxemia, multi-organ failure, chronic bronchitis, hypotension, tachycardia, hypovolemia, muscle contractions involuntary, influenza like illness, viral infection, myalgia, fever, rash, malaise, unable to eat, fluid intake reduced, hyponatremia, transaminitis, creatinine increased and blood urea nitrogen increased were unknown. The patient died on 30th May 2018. The reported cause of death was respiratory failure. An autopsy was performed. It was unknown if the reporter considered the respiratory failure, myocardial infarction, cardiogenic shock, glomerulonephritis membranous, condition aggravated, acute renal failure, thrombocytopenia, tubular necrosis, metabolic encephalopathy, anoxia, seizure, hypoxemia, multi-organ failure, chronic bronchitis, hypotension, tachycardia, hypovolemia, muscle contractions involuntary, influenza like illness, viral infection, myalgia, fever, rash, malaise, unable to eat, fluid intake reduced, hyponatremia, transaminitis, creatinine increased and blood urea nitrogen increased to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had long standing kidney problems and was various drugs for the past 20 years. The patient had last Rituximab treatment on 16th May 2018. As per MD (Doctor of Medicine) insistence patient got Shingrix vaccine. The patient experienced flu like symptoms, myalgia, fever and malaise and his condition worsened. On 26th May 2018, the patient was hospitalized after getting worse. The patient got extremely ill, kidneys shut down, there was hypotension (secondary to hypovolemia), decreased fluid and nourishment intake due to inability to eat and drink, fever 103.9 degree Fahrenheit, rash on the lower extremities, thrombocytopenia, hyponatremia decreased sodium, blood urea nitrogen increased and creatinine increased and transaminitis. Initial hospital could not do dialysis due to lack of equipment and was transferred to reporters hospital with a diagnose of membranous glomerulonephritis. On 29th May 2018, the patient was transferred to reporter''s hospital and patient died in less than 24 hours. The patient developed acute renal failure with tubular necrosis, respiratory failure with hypoxemia, chronic bronchitis (found in reporter''s hospital), metabolic encephalopathy (due to hyponatremia and anoxia), elevated MI (myocardial infarction) and shock. The patient had viral-like symptoms, tests for several common viruses came negative. As per physician notes patient rapidly decompensated with seizure and multiorgan failure, questionable meningitis versus immune response; pathologist (reporter) confirms patient did not have meningitis. On 30th May 2018, the patient was declared DNR (do-not-resuscitate) by family and later became asystolic, suffered spontaneous contractions and had a central line placed. The patient became tachycardic and hypotensive and was removed from intubation and 2 minutes later never recovered pulmonary activity and died. The health care professional was performing autopsy on a patient. No vaccine administration information available to reporter. The reporter consented to follow-up. This case had been linked with US2021090816, reported by the same reporter.; Sender''s Comments: US-GLAXOSMITHKLINE-US2021090816:same reporter (wife?s case); Reported Cause(s) of Death: Respiratory failure


VAERS ID: 267939 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-03
Onset:2006-11-06
   Days after vaccination:3
Submitted: 2006-11-29
   Days after onset:23
Entered: 2006-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blood potassium increased, HIV infection, Haemoglobin decreased, Neutropenia, Platelet count decreased, Pyrexia, Sepsis, Thrombocytopenia
SMQs:, Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Co-trimoxazole
Current Illness: Fever; Thrombocytopenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 10/26/06, all laboratory test results were either within normal limits or not clinically significant except absolute neutrophils and potassium which measured 0.51x10^9/l (Grade III, normal rage = 2.00 - 8.00) and 6.1 mmol/l (Grade II, normal range = 4.1 - 5.3) respectively. On 10/31/06, hemoglobin was grade I and measured 9.9 g/dl (normal range = 10.0 - 15.0), platelet count was grade II at 46X 10^9/l (normal range = 140 - 350) and neutrophil count was grade I at 1.47X10^9/l (normal range = 2.00 - 8.00). All other tests performed on 10/31/06 were either within normal limits or considered not clinically significant. On 11/3/06, platelet count was grade III at 25 X 10^9/l and neutrophil count was grade II at 1.17 X 10^9/l. All other laboratory tests performed on 11/3/06 were either within normal limits or considered not clinically significant.
CDC Split Type: B0446409A

Write-up: This six week old female subject was enrolled in an open label collaborative study comparing three treatment strategies in infants with perinatally acquired HIV-1 infection diagnosed between 6 and 12 weeks of age. The subject received oral zidovudine at 65 mg twice per day from 11/3/06 to 11/6/06, oral lamivudine at 18 mg twice per day from 11/3/06 to 11/6/06 and oral Kaletra at 1 ml twice per day from 11/3/06 to 11/6/06. Co-suspect medication included the pneumococcal vaccine, Prevnar, which was also administered on 11/3/06 at dose 0.5 ml, diphtheria vaccine and tetanus vaccine and pertussis vaccine. Concomitant medications included Co-trimoxazole. On 11/6/06, three days after the start of zidovudine, lamivudine and Kaletra, the subject died. The cause of death was unknown. Treatment with zidovudine, lamivudine, Kaletra was discontinued on the same day. It was unknown whether an autopsy was performed. The site was informed of the subject''s death on 11/9/06. At the time of reporting no details of the subject''s condition prior to death was available; however, the mother of the subject was due to visit the site on 11/13/06 to provide further details. The investigator reported the death as possibly related to treatment with zidovudine, lamivudine, and Kaletra. The investigator also reported the death as possibly related to the pneumococcal vaccine, Prevnar. The investigator commented that details of the subject''s clinical condition was unknown and that this was a temporary association. The investigator further commented that the subject had also received diphtheria, tetanus and pertussis vaccines on 11/3/06 which are known to cause neurological sequelae. Follow up received on 11/16/06: The child was not taken to any health care facility. The death occurred at home. The mother had put the subject to sleep at 00:00 on 11/6/06 and when she went to check up on the child five hours later, the child had passed away. An autopsy was not performed. The site was aware of the death after the funeral had taken place. Treatment with the study medication was continued until the subject''s death. The subject did not have any pre-existing conditions. A blood test which was performed revealed a grade 3 thrombocytopenia which was not related to study medication (date performed unspecified). The subject had experienced fever with a body temperature of 38.1 degrees C on 11/4/06 and 38.7 degrees C on 11/5/06. The investigator reported that the cause of death was unknown and the association with the study drug was a temporal one. Therefore underlying sepsis could not be ruled out. The investigator further stated that diphtheria, tetanus and pertussis vaccines were administered which have neurological sequelae as part of their side effect profile and are considered co-suspect. Follow up received on 11/23/06: On 10/26/06, all laboratory test results were either within normal limits or not clinically significant except absolute neutrophils and potassium which measured 0.51x10^9/l (Grade III, normal rage = 2.00 - 8.00) and 6.1 mmol/l (Grade II, normal range = 4.1 - 5.3) respectively. On 10/31/06, hemoglobin was grade I and measured 9.9 g/dl (normal range = 10.0 - 15.0), platelet count was grade II at 46X 10^9/l (normal range = 140 - 350) and neutrophil count was grade I at 1.47X10^9/l (normal range = 2.00 - 8.00). All other tests performed on 10/31/06 were either within normal limits or considered not clinically significant. On 11/3/06, platelet count was grade III at 25 X 10^9/l and neutrophil count was grade II at 1.17 X 10^9/l. All other laboratory tests performed on 11/3/06 were either within normal limits or considered not clinically significant. The thrombocytopenia was considered clinically significant; however, onset was prior to the start of treatment with study medication. The investigator was unsure as to whether there was an underlying sepsis - no investigations or clinical examinations were undertaken that revealed sepsis. The subject''s temperature indicated pyrexia, however, the cause was unknown. The investigator further commented that it was not known whether there was a definite relationship between the event and the study drugs. The investigator stated that it was difficult to assess whether a relationship existed between the event and the anti-retrovirals, and the vaccine. The investigator went on to state that the time of initiation of the study drugs was the same, and this may be the only association.


VAERS ID: 351178 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-22
Onset:2007-12-06
   Days after vaccination:198
Submitted: 2009-07-10
   Days after onset:581
Entered: 2009-07-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 24359 / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Anuria, Bacterial test positive, Blood culture positive, Blood gases normal, Blood pressure decreased, Blood sodium decreased, Body temperature increased, C-reactive protein increased, Chest X-ray abnormal, Constipation, Crepitations, Death, Dyspnoea, Endotracheal intubation, Enema administration, Febrile convulsion, General physical health deterioration, Hyponatraemia, Intensive care, Lymphocytosis, Mechanical ventilation, Neutropenia, Oxygen saturation decreased, Pleural effusion, Pneumonia pneumococcal, Pyrexia, Renal failure, Respiratory distress, Respiratory syncytial virus test negative, Septic shock, Tachycardia, Thrombocytopenia, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Past therapies included three doses of INFANRIX-QUINTA received on 18-Jun-2006, 18-Sep-2006 and 24-Oct-2006 and one dose of PRIORIX received on 22-May-2007. The patient had no relevant medical history.
Allergies:
Diagnostic Lab Data: On 07-Dec-2007 test results were: body temperature (results: 36.4 deg. C.); oxygen saturation (results: Decreased); body temperature (results: 39.3 deg. C.); chest X-ray (results: On admission, showed nearly complete opacity of the lung on the right side and moderate pleural effusion. The left side of the lung was almost free of lesion except a few left retrocardiac opacities.); c-reactive protein (results: 354 mg/L); blood sodium (results: 131 mmol/L); chest X-ray (results: Later on 07-Dec-2007, showed spread of opacities on the right side of the lung); respiratory syncytial virus test (results: Negative); urine analysis (results: Positive pneumococcal antigen in urine); blood culture (results: Positive to pneumococcus, multi-sensitive, serotype 19A); body temperature (results: 41.1 deg. C.); blood pressure (results: Decreased); and blood gases (results: Normal).
CDC Split Type: FRWYEG03981909

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding an 18-month-old female patient who experienced absence of micturition, right pneumococcal pleuropneumonia and positive blood culture to pneumococcus serotype 19A, respiratory distress, febrile convulsion, renal failure and septic shock. The patient received the fourth dose on 22-May-2007. On 06-Dec-2007 at 06:00 p.m. the patient started to experience absence of micturition. On 07-Dec-2007 at 11:00 a.m., she was admitted in the emergency unit for abdominal pain and persistent anuria. Body temperature was at 36.4 C but the patient had taken an antipyretic drug. Physical examination was normal. She was diagnosed with constipation and was prescribed an enema. At 01:00 p.m., on 07-Dec-2007, while the patient was about to come back home, the patient''s general condition reduced as well as respiratory condition: the patient developed dyspnea, fever at 39.3, oxygen saturation decreased and crepitations were heard at auscultation. Chest X-ray revealed nearly complete opacity of the lung on the right side and moderate pleural effusion. The left side of the lung was almost free of lesion except a few left retrocardiac opacities. The patient was hospitalized in a pediatric intensive care unit with respiratory distress. Lab tests revealed neutropenia, lymphocytosis, thrombocytopenia, CRP at 354 mg/L and hyponatremia at 131 mmol/L. Blood gases were normal. Respiratory syncytial virus test was negative, but pneumococcal antigens were found in urine and blood culture was positive for pneumococcus later identified serotype 19A. There was no neurological disorder. A vesicular murmur was heard on the right basis. Antibiotic therapy with CLAFORAN and VANCOMYCIN was introduced. On 07-Dec-2007, 3 hours after admission, body temperature was 41.1 C, blood pressure had decreased, the patient had developed tachycardia and febrile convulsion treated by VALIUM and GARDENAL. She was intubated for ventilation. Repeat chest X-ray revealed spread of right opacities. The patient finally died on 08-Dec-2007 as a result of septic shock with right pneumococcal pleuropneumonia due to serotype 19A and renal failure. The cause of death was reported as pneumonia pneumococcal, septic shock and renal failure. See related case(s): FR-WYE-G03982009 regarding pneumococcal pneumonia in the patient''s brother.


VAERS ID: 391943 (history)  
Form: Version 1.0  
Age: 1.04  
Sex: Male  
Location: Foreign  
Vaccinated:2008-12-02
Onset:2010-03-30
   Days after vaccination:483
Submitted: 2010-06-30
   Days after onset:92
Entered: 2010-07-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 33718 / 4 LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, CSF test abnormal, Death, Intensive care, Meningitis pneumococcal, Thrombotic microangiopathy
SMQs:, Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Renovascular disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-17
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant therapy included three doses of Infanrix-Quinta administered concomitantly to Prevenar on 26-Feb-2008, 01-Apr-2008 and 02-May-2008 and Priorix Vaccine concomitantly to Prevenar on 02-Dec-2008.
Current Illness: The patient''s concurrent illness includes tonsillitis, occurred 4 days before the hospitalization (estimated on 26-Mar-2010) treated with Amoxicillin.
Preexisting Conditions: The patient had no other relevant medical history.
Allergies:
Diagnostic Lab Data: Bacterial test (results: Pneumococcus soluble antigen was found in the CSF but no germ was isolated and serotype identification was not possible) was done in Apr-2010.
CDC Split Type: FRWYEG06318410

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 28-month-old male patient who experienced pneumococcal meningitis and thrombotic microangiopathy. The patient received the fourth dose on 01-Dec-2008. Concomitant therapy included PRIORIX Vaccine concomitantly to PREVENAR on 02-Dec-2008. The patient was hospitalized in intensive care unit from 30-Mar-2010 to 17-Apr-2010 due to pneumococcal meningitis. The diagnosis was based on pneumococcus soluble antigen found in the CSF. However, no germ was isolated and consequently the serotype identification was not possible. The patient died on 17-Apr-2010. The cause of death was reported as pneumococcal meningitis complicated with thrombotic microangiopathy. No additional information was available at the time of this report.


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