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From the 5/7/2021 release of VAERS data:

This is VAERS ID 858439



Case Details

VAERS ID: 858439 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-03
Onset:2019-05-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2020-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Adenovirus test positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase, Blood bilirubin normal, Blood glucose normal, Blood thyroid stimulating hormone increased, Cough, Cytomegalovirus test negative, Dialysis efficacy test, Encephalitis cytomegalovirus, Encephalopathy, Eosinophil percentage, Epstein-Barr virus antibody positive, Fatigue, Gait disturbance, Gamma-glutamyltransferase increased, HIV antibody negative, HIV test negative, Haemoglobin urine present, Hepatitis, Herpes simplex test positive, Herpes virus infection, Increased bronchial secretion, International normalised ratio normal, Monocyte count, Mononucleosis heterophile test negative, Neutrophil percentage increased, Paresis, Platelet count normal, Polymerase chain reaction, Protein urine present, Thyroxine free normal, Urinary sediment present, Urine ketone body present, White blood cell count increased, White blood cells urine negative
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-10
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HPV VACCINE; BECLOMETHASONE [BECLOMETASONE]; PURAN T4; ACICLOVIR; IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190529; Test Name: ALT; Test Result: 1033 {DF}; Result Unstructured Data: 1033; Test Date: 20190529; Test Name: AST; Test Result: 1450 {DF}; Result Unstructured Data: 1450; Test Date: 20190605; Test Name: Alkaline phosphatase; Test Result: 343 {DF}; Result Unstructured Data: 343; Test Date: 20190529; Test Name: BILIRRUBINAS; Test Result: 0.38 {DF}; Result Unstructured Data: 0.38; Comments: Direct: 0,02 Indirect: 0,36; Test Date: 20190604; Test Name: BILIRRUBINAS; Result Unstructured Data: No changes Type; Test Date: 20190529; Test Name: Blood glucose; Test Result: 90 {DF}; Result Unstructured Data: 90; Test Date: 20190603; Test Name: TSH dosage; Test Result: 3.82 {DF}; Result Unstructured Data: 3.82; Test Date: 20190604; Test Name: Type Kt; Test Result: 75.8 {DF}; Result Unstructured Data: 75.8; Test Date: 20190529; Test Name: SEROLOGY FOR CITALOMEGALOVIRUS; Test Result: Negative ; Test Date: 20190529; Test Name: Eosinophils; Test Result: 0.5 %; Test Date: 20190529; Test Name: IgM Epstein Barr; Test Result: 14 {DF}; Result Unstructured Data: 14; Test Date: 20190529; Test Name: IgM Epstein Barr; Test Result: 12.9 {DF}; Result Unstructured Data: 12.9; Test Date: 20190529; Test Name: GAMMA/GT; Test Result: 17 {DF}; Result Unstructured Data: 17; Test Date: 20190605; Test Name: ANTI-HERPES IGG TYPE 2; Result Unstructured Data: Reagent greater than 2.47; Test Date: 20190605; Test Name: ANTI-HERPES IGG TYPE 2; Result Unstructured Data: Reagent greater than 30; Test Date: 20190605; Test Name: ANTI-HERPES IGM TYPE 1; Test Result: 2.47 {DF}; Result Unstructured Data: 2.47; Test Date: 20190605; Test Name: ANTI-HERPES IGM TYPE 1; Result Unstructured Data: Reagent greater than 30; Test Date: 20190529; Test Name: ANTI HVA; Test Result: Negative ; Test Date: 20190603; Test Name: HIV SEROLOGY; Result Unstructured Data: NORMAL; Test Date: 20190604; Test Name: Tipo INR; Test Result: 1.22 {DF}; Result Unstructured Data: 1.22; Test Date: 20190529; Test Name: Lymphocytes; Test Result: 15.1 %; Test Date: 20190529; Test Name: Monocytes; Test Result: 7.2 %; Test Date: 20190529; Test Name: Neutrophils; Test Result: 75.7 %; Test Date: 20190529; Test Name: Platelets; Test Result: 373 {DF}; Result Unstructured Data: 373; Test Date: 20190529; Test Name: PCR; Test Result: 10.10 {DF}; Result Unstructured Data: 10.10; Test Date: 20190603; Test Name: Free T4; Test Result: 1.18 {DF}; Result Unstructured Data: 1.18; Test Date: 20190529; Test Name: URINE TEST; Result Unstructured Data: KETONICAL BODIES ++, HEMOGLOBIN +++, SOME EPITHELIAL CELLS BY FIELD, LEUKOCYTES LESS THAN 1 P/C, RED BLOOD CELLS LESS THAN 1P/C, GRANULOSOS CYLINDERS 5 P/C;; Test Date: 20190603; Test Name: URINE TEST; Result Unstructured Data: HEMOGLOBIN +++, PROTEIN +.; Test Date: 20190529; Test Name: Leukocytes; Test Result: 16980 {DF}; Result Unstructured Data: 16980
CDC Split Type: BRSA2020SA020509

Write-up: Hepatitis; Encephalopathy; Secretion; Cough; Positive adenovirus; Herpes positive / Herpes virus infection; Abdominal pain; Prostration; Change of gait and difficulty walking; Paresis; Initial information regarding an unsolicited valid serious case received from a nurse via physician and other health Care Professional via agency (under the reference number: IBFV-2020-1751) on 23-Jan-2020 and transmitted to sanofi on 23-Jan-2020. This case involves a 12 years old male patient who experienced abdominal pain (abdominal pain), paresis (paresis), prostration (fatigue), change of gait and difficulty walking (gait disturbance), secretion (increased bronchial secretion), cough (cough), positive adenovirus (adenovirus test positive), herpes positive / herpes virus infection (herpes virus infection), hepatitis (hepatitis) and encephalopathy (encephalopathy), while he received INFLUENZA VACCINE (TRIVALENT). Medical history, medical treatment, vaccination and family history were not provided. On 03-May-2019, Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; On 18-MAR-2007, BECLOMETHASONE [BECLOMETASONE] (BECLOMETHASONE [BECLOMETASONE]) for Asthma and LEVOTHYROXINE SODIUM (PURAN T4) for Hypothyroidism; On 06-Jun-2019, ACICLOVIR (ACICLOVIR) for Herpes virus infection; and On 10-Jun-2019, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]). On 03-May-2019, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number not reported) via an intramuscular route in the right deltoid. On 09-May-2019, the patient developed a serious paresis (paresis) 6 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 27-May-2019, the patient developed a serious change of gait and difficulty walking (gait disturbance) 24 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 29-May-2019, the patient developed a serious abdominal pain (abdominal pain) and prostration (fatigue) 26 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 03-Jun-2019, the patient developed a serious secretion (increased bronchial secretion), cough (cough), positive adenovirus (adenovirus test positive) and herpes positive / herpes virus infection (herpes virus infection) 1 month following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On an unknown date, the patient developed a serious hepatitis (hepatitis) and encephalopathy (encephalopathy) (unknown latency) following the administration of INFLUENZA VACCINE (TRIVALENT). These events were assessed as medically significant and was leading to death. Relevant laboratory test results included: Alanine aminotransferase - On 29-May-2019: 1033 [1033] Aspartate aminotransferase - On 29-May-2019: 1450 [1450] Blood alkaline phosphatase - On 05-Jun-2019: 343 [343] Blood bilirubin - On 29-May-2019: 0.38 [0.38]; on 04-Jun-2019: No changes Type [No changes Type] Blood glucose - On 29-May-2019: 90 [90] Blood thyroid stimulating hormone - On 03-Jun-2019: 3.82 [3.82] Dialysis efficacy test - On 04-Jun-2019: 75.8 [75.8] Encephalitis cytomegalovirus - On 29-May-2019: Negative Eosinophil count - On 29-May-2019: 0.5 % Epstein-Barr virus antibody - On 29-May-2019: 14 [14] then 12.9 [12.9] Gamma-glutamyltransferase - On 29-May-2019: 17 [17] HIV antibody - On 29-May-2019: Negative HIV test - On 03-Jun-2019: NORMAL [NORMAL] Herpes simplex - On 05-Jun-2019: Reagent greater than 2.47 [Reagent greater than 2.47] then Reagent greater than 30 [Reagent greater than 30] then 2.47 [2.47] then Reagent greater than 30 [Reagent greater than 30] International normalised ratio - On 04-Jun-2019: 1.22 [1.22] Lymphocyte count - On 29-May-2019: 15.1 % Monocyte count - On 29-May-2019: 7.2 % Neutrophil count - On 29-May-2019: 75.7 % Platelet count - On 29-May-2019: 373 [373] Polymerase chain reaction - On 29-May-2019: 10.10 [10.10] Thyroxine free - On 03-Jun-2019: 1.18 [1.18] Urine analysis - On 29-May-2019: KETONICAL BODIES ++, HEMOGLOBIN +++, SOME [KETONICAL BODIES ++, HEMOGLOBIN +++, SOME EPITHELIAL CELLS BY FIELD, LEUKOCYTES LESS THAN 1 P/C, RED BLOOD CELLS LESS THAN 1P/C, GRANULOSOS CYLINDERS 5 P/C;]; on 03-Jun-2019: HEMOGLOBIN +++, PROTEIN +. [HEMOGLOBIN +++, PROTEIN +.] White blood cell count - On 29-May-2019: 16980 [16980] (Other relevant tests included Bast: 1%. monoteste: negative. Type KTTP: 27.6. Ctrl: 31.1) Final diagnosis were (fatal) paresis, (fatal) change of gait and difficulty walking, (fatal) prostration, (fatal) abdominal pain, (fatal) herpes positive / herpes virus infection, (fatal) positive adenovirus, (fatal) cough, (fatal) secretion, (fatal) encephalopathy and (fatal) hepatitis. It was not reported if the patient received any corrective treatment. On 10-JUN-2019, the patient outcome was reported as Fatal from the all events. It is unknown if an autopsy was done. The cause of death was reported as Abdominal pain, Paresis, Fatigue, Gait disturbance, Cough, Increased bronchial secretion, Adenovirus test positive, Herpes virus infection, Hepatitis and Encephalopathy.; Sender''s Comments: This case concerns an 12 year old male patient who presented with abdominal pain, paresis, fatigue, gait disturbance, increased bronchial secretion, cough, adenovirus test positive, herpes virus infection, hepatitis and encephalopathy, after vaccination with INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer). The time to onset is compatible with the role of vaccine. Laboratory data were reported. The event is most likely the infectious origin. However, patient''s past medical history, medical condition at time of vaccination ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Abdominal pain; Paresis; Prostration; Walking difficulty; Cough; Tracheo-bronchial secretion excess; Adenovirus serology test positive; Herpes viral infection NOS; Hepatitis; Encephalopathy


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