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From the 4/30/2021 release of VAERS data:

This is VAERS ID 864315



Case Details

VAERS ID: 864315 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-02
Onset:2019-11-15
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 259141B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood blister, Brain death, C-reactive protein increased, Circulatory collapse, Computerised tomogram head abnormal, Death, Haemoglobin normal, Immune thrombocytopenia, Intensive care, Life support, Neutrophil count decreased, Platelet count normal, Subarachnoid haemorrhage, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-18
   Days after onset: 3
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: IRON
Current Illness: Anaemia; Renal stone
Preexisting Conditions: Medical History/Concurrent Conditions: Hip replacement; Lithotripsy; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20191117; Test Name: CT scan of head; Result Unstructured Data: A fatal subarachnoid haemorrhage was identified.; Test Date: 20191117; Test Name: PLT
CDC Split Type: GBSEQIRUS202002300

Write-up: Fatal subarachnoid haemorrhage; Collapsed; ITP (Immuno thrombocytopenic purpura); This is a spontaneous case from, reported by other non-health professional to agency (reference number: 2020-0040501) on 03-Mar-2020, concerning a 70-year-old, male patient. The patient''s relevant medical history included recent lithotripsy for recurrent renal stones, mild anaemia, hip replacement in Aug-2019 and pneumonia in 2017. The patient''s concomitant medication included unspecified iron supplements for mild anaemia. On 02-Sep-2019, the patient''s haemoglobin (Hb) was at 103, white blood cell (WBC) count was at 4.4, neutrophils (N) were at 1.84, platelet (Plt) count was at 236 and C-reactive protein (CRP) was at 15.3. The units were not specified. There was concern over a suspected lower respiratory tract infection and subsequent suspicion of a pulmonary embolism, but both were ruled out. On 17-Sep-2019, the patient''s Hb was at 103, WBC count was at 5.2, N were at 2.88, Plt count was at 187 and CRP was at 21. The units were not specified. On 02-Oct-2019, the patient was administered Fluad (TIV) vaccine [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 259141B1A, expiration date: 31-May-2020, dose, route of administration and anatomical location: not reported] for an unknown indication. On 31-Oct-2019, the patient''s Hb was at 125, WBC count was at 5.4, N were at 3.28 and Plt count was at 213. The units were not specified. On 15-Nov-2019, on Friday, the patient developed blood filled blisters for which he sought medical attention. On 16-Nov-2019, on Saturday, the patient developed a purpura to his back. It was reported that at this point in time the patient otherwise did not feel unwell. On 17-Nov-2019, on Sunday morning, the patient collapsed at home and was taken to the hospital. A computed tomography (CT) scan of his head identified a fatal subarachnoid haemorrhage. The blood test results revealed a Plt count of 6, Hb was at 127, WBC was at 8.2, N were at 5.07 and CRP was at 18.9. The patient was diagnosed with immune thrombocytopenic purpura (ITP) and placed on organ support on the intensive care unit (ICU). On 18-Nov-2019, 24 hours after being placed on organ support, brainstem death was confirmed and the patient passed away. At the time of this report, the outcome for the events of ITP and circulatory collapse was not reported. The event of ?subarachnoid haemorrhage'' was considered as serious due to criterion of death, hospitalisation and medical significance, while the events of ?immune thrombocytopenic purpura'' and ?circulatory collapse'' were considered as serious due criterion of hospitalisation and medical significance, per company. The reporter stated that she believed there was a reasonable possibility that the flu vaccine may had caused the acute underlying ITP. The reporter did not provide causality assessment for the event of ?subarachnoid haemorrhage'' and ?circulatory collapse''. Company comment: The patient experienced immune thrombocytopenic purpura (ITP) one month and 13 days after receiving Fluad (TIV) vaccine. The patient also collapsed, developed subarachnoid haemorrhage and eventually died. Chronology is plausible. Causal role of the vaccine is assessed as possibly related for ITP, since research showed that influenza vaccinations increase the risk of ITP. Although circulatory collapse and subarachnoid haemorrhage were likely attributed to ITP, patient advanced age (70) may have contributed to development of the events, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender''s Comments: The patient experienced immune thrombocytopenic purpura (ITP) one month and 13 days after receiving Fluad (TIV) vaccine. The patient also collapsed, developed subarachnoid haemorrhage and eventually died. Chronology is plausible. Causal role of the vaccine is assessed as possibly related for ITP, since research showed that influenza vaccinations increase the risk of ITP. Although circulatory collapse and subarachnoid haemorrhage were likely attributed to ITP, patient advanced age (70) may have contributed to development of the events, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Reported Cause(s) of Death: Fatal subarachnoid haemorrhage


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