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This is VAERS ID 840522

Case Details

VAERS ID: 840522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Chest X-ray abnormal, Death, Diarrhoea, Haematology test abnormal, Haemoglobin normal, Lung infiltration, Lymphocyte percentage decreased, Lymphopenia, Nasal flaring, Neutrophilia, PO2 normal, Pneumonia, Procalcitonin increased, Rash, Rhonchi, Use of accessory respiratory muscles, Wheezing, White blood cell count, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 37.6, Test Result Unit: degree C; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 175.3, Test Result Unit: unknown; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 10.5, Test Result Unit: unknown; Test Name: Heart rate; Result Unstructured Data: Test Result: 194, Test Result Unit: /min; Test Name: Lymphocyte count; Result Unstructured Data: Test Result: 19, Test Result Unit: unknown; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: 70.3, Test Result Unit: unknown; Test Name: PO2; Result Unstructured Data: Test Result: 94, Test Result Unit: unknown; Test Name: Procalcitonin; Result Unstructured Data: Test Result: 6.9, Test Result Unit: unknown; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 63, Test Result Unit: /min; Test Name: Leukocyte count; Result Unstructured Data: Test Result: 13600 (normal), Test Result Unit: unknown; Test Name: Polymorphonuclear count; Result Unstructured Data: Test Result: 75, Test Result Unit: unknown; Test Name: X-ray; Result Unstructured Data: Test Result: showed infiltrate and cavity, Test Result Unit: unknown; Test Name: Hematology test
CDC Split Type: IDGLAXOSMITHKLINEID2019GS

Write-up: Pneumonia; Skin rash; Diarrhea; Nasal flaring; symptoms of wheezing; Rhonchi; Retraction/chest indrawing was positive and severe; Lymphopenia; Neutrophilia; Lung infiltration; This case was reported in a literature article and described the occurrence of pneumonia in a 2-month-old male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included BCG VACCINE for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and BCG VACCINE at an unknown dose. On an unknown date, less than 3 months after receiving Hepatitis B vaccine, the patient experienced pneumonia (serious criteria death and GSK medically significant), rash, diarrhea, nasal flaring, wheezing, rhonchi, retractive breathing, lymphopenia, neutrophilia and lung infiltration. On an unknown date, the outcome of the pneumonia was fatal and the outcome of the rash, diarrhea, nasal flaring, wheezing, rhonchi, retractive breathing, lymphopenia, neutrophilia and lung infiltration were unknown. The reported cause of death was pneumonia. The reporter considered the pneumonia, rash, diarrhea, nasal flaring, wheezing, rhonchi, retractive breathing, lymphopenia, neutrophilia and lung infiltration to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of pneumonia in a 2-month-old male patient, who was vaccinated with unspecified hepatitis B virus vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was a part of multicenter cohort study that aimed to describe the causes of pneumonia that may change after the introduction of vaccines and to identify biomarkers to differentiate between bacterial and viral infection. The 2-year multicenter cohort study was conducted in children between 2-month and 5-year old with pneumonia in three hospitals since July 2017. The patient had no breast-feeding history of more than or equal to 6 months. The patient had no underlying disease of development delay, congenital heart diseases, asthma and recurrent pneumonia. The patient had no vaccine history of diphtheria, pertussis, and tetanus vaccine (DPT) and Haemophilus influenzae type B (HIB) vaccine. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified hepatitis B virus vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The age of vaccination was not provided. On an unspecified date since July 2017, at the age of 2-months, an unknown period after the vaccination, the patient developed skin rash and had symptoms of diarrhea and had nasal flaring and had symptoms of retraction, ronchi and wheezing. The patient''s oxygen saturation (sat O2) was 70.3 and partial pressure of oxygen (Pa O2) was 94. During examination, the he patient''s vital sign showed: body temperature 37.6 deg. C, pulse 194 times/minute, and respiratory rate was 63 times/minute. The patient chest indrawing was positive and severe. The radiology examination showed infiltrate and cavity. Subsequently the patient was diagnosed with pneumonia with unknown etiology. The patient''s laboratory blood tests showed: hemoglobin (Hb) was 10.5, leucocyte was 13600, lymphocyte was 19, polymorphonuclear leukocytes (PMN) was 75. The patient''s hematology showed lymphopenia, and neutrophilia. The patient had normal leucocyte count. The patient had no leukopenia, no leukocytosis, no neutropenia and no normal lymphocyte count. Biomarker result showed C- reactive protein (CRP) was 175.3 and procalcitonin was 6.9. On an unspecified date, the patient had died. The cause of death was pneumonia. It was unknown if an autopsy was performed. This case has been considered serious due to due to death. The author did not comment on the relationship between the event of pneumonia and unspecified hepatitis B virus vaccine, and unspecified Bacillus Calmette-Guerin (BCG) vaccine. The authors concluded, "Mixed viral and bacterial infection were predominant. Several atypical pathogens were identified. No significant different in biomarkers between viral, bacterial and mixed infection groups was found. This finding highlights the need to improve diagnostic capacity to aid clinicians in pneumonia management." This article corresponding to this case is not available for regulatory submission due to copyright restriction. Lab Comments: Lab test done on an unknown date. The patient chest indrawing was positive and severe. The patient''s hematology showed lymphopenia, and neutrophilia. The patient had no leukopenia, no leukocytosis, no neutropenia and no normal lymphocyte count.; Reported Cause(s) of Death: Pneumonia


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