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This is VAERS ID 835593

History of Changes from the VAERS Wayback Machine

First Appeared on 1/14/2020

VAERS ID: 835593
VAERS Form:2
Age:
Sex:Female
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:0000-00-00
Entered:2019-09-24
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: Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M increased, CD4 lymphocytes decreased, Condition aggravated, Cytomegalovirus infection, Death, Dyspnoea, Intensive care, Lymphopenia, Pneumonia, Polymerase chain reaction, Complement factor C3 decreased, Cytomegalovirus test positive, Mechanical ventilation

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphopenia; Primary immunodeficiency syndrome; Rubella; Thrombocytopenia (at the age of 7 days old and was referred to neonatology unit from other hospital)
Allergies:
Diagnostic Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: increased, Test Result Unit: unknown; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: increased, Test Result Unit: unknown; Test Name: Blood immunoglobulin A; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Blood immunoglobulin E; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result: antibodies to rubella increased, Test Result Unit: unknown; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result: increased, Test Result Unit: unknown; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result: positive IgM CMV, Test Result Unit: unknown; Test Name: CD4 lymphocytes; Result Unstructured Data: Test Result: decreased, Test Result Unit: unknown; Test Name: Complement factor C3; Result Unstructured Data: Test Result: decreased, Test Result Unit: unknown; Test Name: Lymphocyte count; Result Unstructured Data: Test Result: ranged between 35.6 and 66, Test Result Unit: %; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result: ranged between 2760 and 3830, Test Result Unit: /uL; Test Name: Neutrophil count; Result Unstructured Data: Test Result: within normal limits, Test Result Unit: unknown; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown
CDC 'Split Type': IDGLAXOSMITHKLINEID2019GS

Write-up: Pneumonia; Dyspnea; Cytomegalovirus (CMV) infection; Lymphopenia; Death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included BCG VACCINE for prophylaxis. The patient''s past medical history included thrombocytopenia (at the age of 7 days old and was referred to neonatology unit from other hospital), rubella, lymphopenia and primary immunodeficiency syndrome. Previously administered products included IVIG (received intravenously for 3 days in the previous hospital). 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 4 months after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), pneumonia (serious criteria hospitalization and GSK medically significant), dyspnea (serious criteria hospitalization), cytomegalovirus infection (serious criteria GSK medically significant) and lymphopenia. The patient was treated with ganciclovir. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pneumonia, dyspnea, cytomegalovirus infection and lymphopenia were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, pneumonia, dyspnea, cytomegalovirus infection and lymphopenia to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the death NOS, pneumonia, lymphopenia, cytomegalovirus (CMV) infection in a 3-month-old female patient who was vaccinated with unspecified hepatitis B virus (HBV) vaccine; unspecified Bacillus Calmette Guerin (BCG) vaccine (manufacturer unknown for both) for prophylaxis. The patient, at the age of 7 days old, was referred to neonatology unit from other hospital due to thrombocytopenia with mark increased in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). The patient had received intravenous immunoglobulin (IVIG) for 3 days in the previous hospital. The patient''s laboratory tests showed the percentage of lymphocytes ranged between 35.6 % and 66 %. Retrospective calculation revealed total lymphocyte count ranged between 2760 and 3830/microL (normal value more than 3400/microL). Neutrophil count was within normal limits. Levels of immunoglobulin M (IgM) and IgG antibodies to rubella increased, accompanied by increased levels of IgG antibodies to toxoplasma, CMV and herpes simplex virus 1 (HSV1). The patient received packed red cell (PRC) and TC transfusions. The patient was diagnosed as having rubella infection. After 24 days of treatment, the patient was discharged in good condition. The patient had lymphopenia and primary immunodeficiency. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 31 days and 3 months of age , the patient received unspecified hepatitis B virus vaccine (administration route and site unspecified, dosages unknown, batch number not provided) and BCG vaccine (administration route and site unspecified, dosages unknown, batch number not provided) in outpatient clinic. The age at vaccination was not provided. On an unspecified date at age 3 months, an unknown period after vaccination, the patient experienced dyspnea. Subsequently, the patient was admitted to pediatric intensive care unit (PICU) for pneumonia that needed ventilator support. The patient''s laboratory tests again showed lymphopenia. Further exploration found increased levels of IgM, with normal level of IgG, IgA and IgE, also decreased CD4 (cluster of differentiation 4) and C3 levels. Human immunodeficiency virus polymerase chain reaction (HIV PCR) was negative. IgM CMV was positive. The patient was treated with gancyclovir. On an unspecified date, the patient died after 30 days of hospitalization. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as serious due to death/hospitalization. The author stated "Complete blood count (CBC) test result does not automatically include the value of total lymphocytes; it included only the percentage of lymphocytes. Because the lymphocytes percentage were always within normal limits, the treating physicians were not concerned with the low value of total lymphocytes, reflecting the low levels of T and/or B lymphocytes. Unfortunately, the patient then underwent severe infection and further tests found low CD4 lymphocyte levels with increased levels of IgM. There should be an opportunity to explore PID, especially in this case the possibility of Severe Combined Immune Deficiency (SCID), in the first hospitalization during newborn period. If we were aware of PID, this patient could be treated and prevented for possible severe infections". The author concluded "Simple tests such as CBC needs to be interpreted in more detailed of the presence of lymphopenia or neutropenia to be indicative of primary immunodeficiency". This article is not available for regulatory submission due to copyright restriction. Lab Comments: Lab test done on an unknown date. Before vaccination, at the age of 7 days old, the patient was referred to neonatology unit from other hospital due to thrombocytopenia with mark increased in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). The patient''s laboratory tests showed the percentage of lymphocytes ranged between 35.6 % and 66 %. The patient''s laboratory tests showed the percentage of lymphocytes ranged between 35.6 % and 66 %. Retrospective calculation revealed total lymphocyte count ranged between 2760 and 3830/microL (normal value more than 3400/microL). Neutrophil count was within normal limits. Levels of immunoglobulin M (IgM) and IgG antibodies to rubella increased, accompanied by increased levels of IgG antibodies to toxoplasma, CMV and herpes simplex virus 1 (HSV1). After vaccination, the patient''s laboratory tests again showed lymphopenia. Further exploration found increased levels of IgM, with normal level of IgG, IgA and IgE, also decreased CD4 (cluster of differentiation 4) and C3 levels. Human immunodeficiency virus polymerase chain reaction (HIV PCR) was negative. IgM CMV was positive.; Reported Cause(s) of Death: Death NOS

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