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From the 1/14/2022 release of VAERS data:

Found 81 cases where Vaccine is RVX and Patient Died

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Case Details

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VAERS ID: 823574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apoptosis, Bronchitis, Death, Haemophagocytic lymphohistiocytosis, Hypopnoea, Influenza, Leukocytosis, Nasopharyngitis, Pneumonia, Pulmonary oedema, Pyrexia, Serum ferritin increased, Splenitis, Streptococcus test positive, Sudden infant death syndrome, Tracheitis, Upper respiratory tract infection, White blood cell count increased
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

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: ferritin level; Result Unstructured Data: increase; Test Name: a-hemolytic Streptococcus; Result Unstructured Data: a-hemolytic Streptococcus was detected in the lung section or in the blood; Test Name: white blood cell count; Result Unstructured Data: Leukocytosis
CDC Split Type: JPSA2019SA187260

Write-up: was died after 12 hours with little response to resuscitation; cold-like symptoms accompanied by fever; neutrophil infiltration in the spleen was evident, suggesting that the subjects were affected by hypercytokinemia deriving from an immunological reaction by some infection; extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes; cold-like symptoms accompanied by fever; interstitial pneumonia; upper respiratory infection; shallow breathing; partial patchy pulmonary edema; found limp in the evening; leukocytosis; acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen; lymphocyte apoptosis; mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis; mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis; Influenza Avirus was detected in our postmortem examination; Initial unsolicited valid serious case report received from the literature on 09-Jul-2019. This case is linked to cases 2019SA187262 and 2019SA187264 (same literature). The following is verbatim from the article: Introduction: Sudden infant deaths might be attributable to adverse reaction to vaccination, but separating them from coincidental occurrences is difficult. This study retrospectively investigated vaccination-related details and postmortem findings for 57 cases of sudden death in children 2 years or younger. Data were extracted from autopsy files at the Department of Forensic Medicine. Vaccination histories were available in 50 cases based on the maternity passbook. Of the 32 cases in which any vaccines were administered, 7 infants (21.9%) had received immunization within 7 days of death. The most frequent vaccine cited as the last immunization before death was Haemophilus influenzae B. Although a temporal association of vaccines with sudden death was present for two 3-month-old and one 14-month-old infants in whom death occurred within 3 days of receiving the H. influenzae type b and other vaccinations, a definitive relationship between the vaccine and death could not be identified. Histopathological examinations revealed pneumonia and upper respiratory infection as contributing to death in their cases. Moreover, all 3 cases showed hemophagocytosis in the spleen and lymph nodes, which are similar features to hemophagocytic lymphohistiocytosis. Judgment of the disorders as truly related to vaccination is difficult, but suspicious cases do exist. Forensic pathologists must devote more attention to vaccination in sudden infant death cases. This case involves a three months old female patient who experienced SIDS, cold symptoms, leukocytosis, shallow breathing, acute splenitis, infiltration of neutrophils and congestion within the red pulp of the spleen, macrophage activation syndrome, lymphocyte apoptosis, fever, pneumonia and upper respiratory infection, tracheitis and bronchitis, influenza A virus infection and limp while she received vaccines HAEMOPHILUS TYPE B (HIB) VACCINE, DTP IPV VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported. On an unknown date at the age of 63 days, the patient received first doses of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur and suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur, lot number not reported via unknown route in unknown administration site. On an unknown date at age of 91 days, the patient received a first dose of suspect DTP IPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date at age of 98 days, the patient received second doses of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur and suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur, lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed cold symptoms (nasopharyngitis) (the day after the second combined immunization) and in the evening found limp (gait disturbance) following the second dose administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and first dose following the administration of DTP IPV VACCINE. On an unknown date, the patient died (sudden infant death syndrome) within 3 days following the second dose administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and first dose following the administration of DTP IPV VACCINE. The patient was transported by ambulance. On an unknown date, the patient developed leukocytosis, shallow breathing (hypopnoea), acute splenitis, infiltration of neutrophils and congestion within the red pulp of the spleen (splenitis), extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes (haemophagocytic lymphohistiocytosis), lymphocyte apoptosis (apoptosis), fever (pyrexia), pneumonia and upper respiratory infection (upper respiratory tract infection) following the second dose administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and first dose following the administration of DTP IPV VACCINE. (latency not reported). shallow breathing (hypopnoea), limping pneumonia and upper respiratory infection (upper respiratory tract infection), cold symptoms with fever led to death of the patient. Laboratory test reveled mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis and whole lungs were congested, accompanied by partial patchy pulmonary edema (onset date and latency not reported). Neutrophil infiltration in the spleen was evident, suggesting that the subjects were affected by hypercytokinemia (onset and latency not reported) deriving from an immunological reaction by some infection. Hypercytokinemia and pulmonary edema were medically significant. for rest of the events seriousness not reported. The patient was died within 3 days after vaccination when she was 100 days old. Relevant laboratory test results included: Test: white blood cell count, result: 23,000/uL ( Leukocytosis) Test: ferritin level, result: 16,380 ng/mL (increased), a-hemolytic Streptococcus was detected in the lung section or in the blood. H. influenzae and S. pneumoniae were not detected in the bacterial culture. Final diagnosis was (fatal) upper respiratory infection, (fatal) pneumonia, (fatal) fever, (fatal) lymph nodes and bronchus-associated lymphoid tissue, (fatal) macrophage activation syndrome, (fatal) acute splenitis, infiltration of neutrophils and congestion within the red pulp of the spleen, (fatal) shallow breathing, (fatal) leukocytosis, (fatal) cold symptoms and (fatal) sids. It was not reported if the patient received any corrective treatment. An autopsy results shows the cause of death as Pneumonia or Upper respiratory tract infection. It was reported that the causal relationship of vaccination to the SID subjects was unknown. Outcome of shallow breathing (hypopnoea), limping pneumonia and upper respiratory infection (upper respiratory tract infection), cold symptoms with fever was fatal ad unknown for rest of the events. There will be no information available on the batch number for this case. List of documents held by sender: none.; Sender''s Comments: A 3-month-old female baby developed cold symptoms on the day after vaccination with HAEMOPHILUS TYPE B (HIB) VACCINE (unknown manufacturer), DTP IPV VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE. The infant was found limp in the evening and died despite resuscitative measures. The autopsy results show the cause of death as Pneumonia or Upper respiratory tract infection. Leukocytosis of 23,000/�L was also observed. Nasopharyngitis, leukocytosis (23,000/�L), hypopnea, splenitis, haemophagocytic lymphohistiocytosis (congenital), lymphadenopathy, fever and upper respiratory tract infection were also reported. However, the patient''s medical condition at the time of vaccination not reported and four different vaccinations preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed; Reported Cause(s) of Death: pneumonia; upper respiratory infection; was died after 12 hours with little response to resuscitation; sids


VAERS ID: 823712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Death, Haemophagocytic lymphohistiocytosis, Pneumonia, Splenitis, Tracheitis, Upper respiratory tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

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: Streptococcus; Result Unstructured Data: a-hemolytic Streptococcus was detected in the lung section or in the blood; Test Name: Tryptase; Test Result: 5.8 {DF}; Result Unstructured Data: 5.8 �g/L, indicating no anaphylactic reaction potentially related to the SID cases
CDC Split Type: JPSA2019SA187262

Write-up: Hewas found dead in sleep; pneumonia; bronchitis; tracheitis; upper respiratory infection; Cold like symptoms; extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes; acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen; Initial information received on 09-Jul-2019 regarding an unsolicited valid serious case issued from a literature article. This case is linked to case ID: 2019SA187260 and 2019SA187264. The following is verbatim from the article: Sudden infant deaths might be attributable to adverse reaction to vaccination, but separating them from coincidental occurrences is difficult. This study retrospectively investigated vaccination-related details and postmortem findings for 57 cases of sudden death in children 2 years or younger. Data were extracted from autopsy files at the Department of Forensic Medicine. Vaccination histories were available in 50 cases based on the maternity passbook. Of the 32 cases in which any vaccines were administered, 7 infants (21.9%) had received immunization within 7 days of death. The most frequent vaccine cited as the last immunization before death was Haemophilus influenzae B. Although a temporal association of vaccines with sudden death was present for two 3-month-old and one 14-month-old infants in whom death occurred within 3 days of receiving the H. influenzae type b and other vaccinations, a definitive relationship between the vaccine and death could not be identified. Histopathological examinations revealed pneumonia and upper respiratory infection as contributing to death in their cases. Moreover, all 3 cases showed hemophagocytosis in the spleen and lymph nodes, which are similar features to hemophagocytic lymphohistiocytosis. Judgment of the disorders as truly related to vaccination is difficult, but suspicious cases do exist. Forensic pathologists must devote more attention to vaccination in sudden infant death cases. Key Words: Hib, Streptococcus pneumoniae, forensic autopsy, histopathology, hemophagocytosis. This case involves a three months old male patient who died suddenly due to upper respiratory tract infection and pneumonia and had cold like symptoms, extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes and acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen while he received vaccines DTP IPV VACCINE, HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and HAEMOPHILUS TYPE B (HIB) VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (reported as 63 day after birth), the patient received a first dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, ROTAVIRUS VACCINE (not produced by Sanofi Pasteur), DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE inact;TETANUS VACCINE (not produced by Sanofi Pasteur, taken 107 days after birth), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (not produced by Sanofi Pasteur) and HEPATITIS B VACCINE (not produced by Sanofi Pasteur) lot number, route and administration site were not reported for all the vaccines. On an unknown date (reported as 107 day after birth), HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, ROTAVIRUS VACCINE (not produced by Sanofi Pasteur), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (not produced by Sanofi Pasteur) and HEPATITIS B VACCINE (not produced by Sanofi Pasteur) lot number, route and administration site were not reported for all the vaccines. On an unknown date, the patient developed a serious upper respiratory tract infection, pneumonia (unknown latency) following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), HEPATITIS B VACCINE and DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE inact;TETANUS VACCINE and ROTAVIRUS VACCINE.. On an unknown date, on third day the patient suddenly died (sudden infant death syndrome). This event was leading to death. On an unknown date, the patient developed a serious cold like symptoms (nasopharyngitis) (unknown latency, reported as continuously from the immunized day) following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), HEPATITIS B VACCINE and DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE inact;TETANUS VACCINE and ROTAVIRUS VACCINE. This event was leading to death. On an unknown date, (latency unknown) laboratory findings reveled that the patent showed acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen. Moreover, extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes (Haemophagocytic lymphohistiocytosis and splenitis). Relevant laboratory test results included: Streptococcus test positive - On an unknown date: [a-hemolytic Streptococcus was detected in the lung section or in the blood] Tryptase - On an unknown date: 5.8 [5.8 �g/L, indicating no anaphylactic reaction potentially related to the SID cases] Histopathological findings: Mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis, showed acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen and lymphocyte apoptosis and abundant nuclear debris were found in the lymph nodes and bronchus-associated lymphoid tissue. Hematoxylin and eosin stained sections of spleen showed hemophagocytosis, as erythrocytes, leukocytes, and platelets were engulfed by activated macrophages in tissues of the spleen and the lymph node. Final diagnosis was (fatal) sudden infant death and (fatal) cold like symptoms. It was not reported if the patient received a corrective treatment. On an unknown date, the patient died due to upper respiratory tract infection, pneumonia and sudden infant death. An autopsy was done. The cause of death was reported as upper respiratory tract infection, pneumonia and Sudden infant death syndrome. The outcome of the events was unknown for Haemophagocytic lymphohistiocytosis and splenitis and fatal for rest of the events. Causality statement: However, we concluded that the causal relationship of vaccination to the SID subjects was unknown in the reports because of the unclear mechanism how the 2 nonactive vaccines affect the mortality of infants and because of the difficulty to exclude potential coincidental occurrence. It is therefore necessary to consider it carefully at postmortem, along with the circumstances of death and autopsy findings, as many forensic pathologists may overlook this potential contributing factor. There will be no information available on the batch number for this case. List of documents held by sender: none.; Sender''s Comments: This case concerns a 3-month-old boy who died suddenly 3 days post-vaccination with HAEMOPHILUS TYPE B (HIB) (manufacturer unknown), HEPATITIS B , PNEUMOCOCCAL CONJ 13V (CRM197) , and DIPHTHERIA-TETANUS-PERTUSSIS-POLIO (DTaP-IPV) combined vaccines. The autopsy results revealed pneumonia and upper respiratory infection as a cause. The infant had presented cold like symptoms the day after vaccination. He was found dead in sleep in the early morning of the third day. Laboratory test included Streptococcus test positive and Tryptase was 5.8mcg/L, indicating no anaphylactic reaction potentially related to the SID cases, Histopathological findings showed tracheitis and bronchitis, showed acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen and lymphocyte. However, there is no information regarding patient''s medical condition at the time of vaccination, concomitant medications rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be individually assessed; Reported Cause(s) of Death: pneumonia; sudden infant death syndrome; Upper respiratory tract infection


VAERS ID: 827791 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-07-12
Onset:2019-07-01
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Death, General physical health deterioration
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: UZ0095075131907UZB016699

Write-up: biological death; deterioration of the child�s condition; body temperature increased to 38 degrees; This spontaneous report was received from a reporter via Pfizer and refers to a 3-month-old patient. There was no information about the patient''s concurrent conditions, medical history or concomitant medication. On 12-JUL-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) orally, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT)) and with poliovirus vaccine (second generation) (POLIOVIRUS VACCINE (SECOND GENERATION)) for prophylaxis (strength, dosage schedule, route of administration, lot number and expiration date were not reported). Vaccination was carried out by a nurse. In July 2019, during two days after vaccination, the patient''s body temperature increased to 38 degrees (body temperature increased). After the deterioration of the child''s condition (condition aggravated) on 15-JUL-2019 at 3:00 - 5:00, the third day after the vaccination, baby died; an ambulance was called, when arrived they stated a biological death According to the preliminary conclusion of experts, vaccination was not the cause of death, a forensic medical examination was being carried out to determine the cause of death. It was unknown if an autopsy was done. According to the reporter, a temperature of 38 degrees was quite acceptable after vaccination and was not a critical and pathological temperature, which in rare cases can affect the central nervous system of a child. It was also noted that it was not known what actually happened to the child for 2-3 days at home, the conditions under which the child was taken care of and it was not yet established what additional side effects were observed with a child. The outcome of the events body temperature increased and condition aggravated, and the causal relationship between the events and the vaccines were not reported.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 845634 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

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:
CDC Split Type: BRGLAXOSMITHKLINEBR2019AM

Write-up: intussusception; This case was reported by a other health professional via sales rep and described the occurrence of intussusception in a child patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, unknown after receiving Rotavirus vaccine, the patient experienced intussusception (serious criteria death and GSK medically significant). On an unknown date, the outcome of the intussusception was fatal. The reported cause of death was intussusception. It was unknown if the reporter considered the intussusception to be related to Rotavirus vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was died, due to intussusception, after receiving the rotavirus vaccine. No additional information was provided.; Reported Cause(s) of Death: intussusception


VAERS ID: 846820 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adenovirus test, Apoptosis, Autopsy, Bed sharing, Brain oedema, Bronchitis, C-reactive protein normal, Cardio-respiratory arrest, Cough, Coxsackie virus test, Death, Haemophagocytic lymphohistiocytosis, Imaging procedure abnormal, Immunisation reaction, Influenza A virus test negative, Influenza B virus test, Influenza like illness, Influenza virus test negative, Interstitial lung disease, Laboratory test, Lymphadenopathy, Nasopharyngitis, Procalcitonin, Pulmonary congestion, Pulmonary oedema, Rhinorrhoea, Rotavirus test negative, Sneezing, Splenic infection, Splenitis, Splenomegaly, Streptococcus test negative, Sudden infant death syndrome, Tracheitis, Tryptase, Viral test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

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: Ad; Test Result: Negative ; Test Name: Autopsy findings; Result Unstructured Data: Main autopsy findings were as follows: Development was consistent with the patient''s age. No notable injury, critical disease or malformation was observed. Numerous ecchymoses were noted on the thymus gland and lung surface. Blood clotting in the heart was present. On the cut surface of lung, white turbidity around bronchi was seen. Summary of autopsy findings was as follows: Cold-like symptoms before death and marked splenomegaly and swollen lymph nodes on the autopsy suggested some infection; however, only mild tracheitis/bronchitis was found histologically. Neutrophil infiltration in spleen (acute splenitis/infected spleen) and haemophagocytosis imaing by macrophage in spleen, liver and lymph nodes were observed. Numerous instances of lymphocyte shedding/apoptosis imaging and abundant nuclear debris were found in the lymphoid tissue of the whole body, such as the lymph nodes, white pulp of the spleen, gut-associated lymphoid tissue, and BALT.; Test Name: Main histological findings; Result Unstructured Data: Main histological findings were as follows: Acute tracheitis/bronchitis, pulmonary congestion and oedema, leukomalacia in the cerebral cortex, acute splenitis (splenic infection), haemophagocytosis imaging, and lymphocyte shedding and apoptosis imaging in the lymph nodes and bronchus-associated lymphoid tissue (BALT).; Test Name: Severe pulmonary congestion; Result Unstructured Data: 91g/106g; Test Name: Spleen enlarged; Test Result: 27 g; Test Name: GAS; Test Result: Negative ; Test Name: Serum viral antibody level: Coxsackievirus group B type 3; Result Unstructured Data: 4-fold; Test Name: Serum viral antibody level: Coxsackievirus group B type 4; Result Unstructured Data: 8-fold; Test Name: CRP; Test Result: 0.45 {DF}; Test Name: hMP; Test Result: Negative ; Test Name: FluA; Test Result: Negative ; Test Name: FluB; Test Result: Negative ; Test Name: Serum IL-6; Test Result: 52.8 {DF}; Test Name: PCT; Result Unstructured Data: less than 0.02 ng/mL; Test Name: RS; Test Result: Negative ; Test Name: Rota; Test Result: Negative ; Test Name: Tryptase; Test Result: 5.8 {DF}
CDC Split Type: JPSA2018SA068932

Write-up: Sudden death/found dead while sleeping; Suspected abnormal immunisation reaction; Mild cold-like symptoms; severe interstitial pneumonia; Acute tracheitis/bronchitis; Acute tracheitis/bronchitis; Pulmonary congestion and oedema; Pulmonary congestion and oedema; Brain oedema; Acute splenitis; Haemophagocytosis imaging; Apoptosis imaging; Splenic infection; splenomegaly; severe interstitial pneumonia with neck and peritoneal lymph node swelling; Nasal discharge; Cough; Sneezing; Initial information received on 07-Mar-2018 regarding an unsolicited valid serious case issued from the literature articles: This case was issued in publication in which another related case was reported: 2018SA068930 (Cluster). This case involves a 3 months old male patient who experienced sudden death/found dead while sleeping, suspected abnormal immunisation reaction, mild cold-like symptoms, severe interstitial pneumonia, acute tracheitis/bronchitis, pulmonary congestion and oedema, brain oedema, acute splenitis, haemophagocytosis imaging, apoptosis imaging and splenic infection, while he received vaccine HIB (PRP/T) VACCINE [ActHIB] and while treated with DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE;TETANUS VACCINE, PNEUMOCOCCAL VACCINE CONJ, HEPATITIS B VACCINE and ROTAVIRUS VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (3 days before death), the patient simultaneously received ActHIB (2nd dose, unknown dosage), PNEUMOCOCCAL VACCINE (2nd dose, unknown dosage), HEPATITIS B VACCINE (2nd dose, unknown dosage), ROTAVIRUS VACCINE (2nd dose, unknown dosage) and SQUAREKIDS (1st dose, unknown dosage) as prophylactic vaccination. After the vaccination, the patient was noted to have mild cold-like symptoms such as sneezing, cough and nasal discharge. As having no pyrexia, the patient was followed at home. On an unknown date, 3 days after the vaccination, the patient was found dead (sudden death) while sleeping: the patient was sleeping with his parents on the same bed and was found lying on the left side and not breathing. The ambulance was called. Upon arrival of the ambulance and in the hospital, the patient was already in cardiopulmonary arrest. Subsequently, the patient had no return of spontaneous circulation and confirmed to die. The patient was found to have acute deterioration while sleeping, and the death situation was similar to those of general SIDS cases. On an unknown date, autopsy findings included severe interstitial pneumonia with neck and peritoneal lymph node swelling and splenomegaly. Acute tracheitis/bronchitis, pulmonary congestion and oedema, brain oedema, acute splenitis (splenic infection) and haemophagocytosis imaging were noted. Abnormal immunisation reaction was suspected. Apoptosis imaging was noted. Main autopsy findings were as follows: Development was consistent with the patient''s age. No notable injury, critical disease or malformation was observed. Numerous ecchymoses were noted on the thymus gland and lung surface. Blood clotting in the heart was present. On the cut surface of lung, white turbidity around bronchi was seen. Severe pulmonary congestion (91 g/106 g) and enlarged spleen (27 g) were observed. Main histological findings were as follows: Acute tracheitis/bronchitis, pulmonary congestion and oedema, leukomalacia in the cerebral cortex, acute splenitis (splenic infection), haemophagocytosis imaging, and lymphocyte shedding and apoptosis imaging in the lymph nodes and bronchus-associated lymphoid tissue (BALT). Summary of autopsy findings was as follows: Cold-like symptoms before death and marked splenomegaly and swollen lymph nodes on the autopsy suggested some infection; however, only mild tracheitis/bronchitis was found histologically. Neutrophil infiltration in spleen (acute splenitis/infected spleen) and haemophagocytosis imaing by macrophage in spleen, liver and lymph nodes were observed. Numerous instances of lymphocyte shedding/apoptosis imaging and abundant nuclear debris were found in the lymphoid tissue of the whole body, such as the lymph nodes, white pulp of the spleen, gut-associated lymphoid tissue, and BALT. The patient developed a serious sudden death/found dead while sleeping (sudden death). This event was assessed as medically significant and was leading to death. The patient developed a serious suspected abnormal immunisation reaction (immunisation reaction). This event was leading to death. The patient developed a serious mild cold-like symptoms (nasopharyngitis). This event was leading to death. The patient developed a serious severe interstitial pneumonia (interstitial lung disease). This event was assessed as medically significant and was leading to death. The patient developed a serious acute tracheitis/bronchitis (bronchitis). This event was leading to death. The patient developed a serious acute tracheitis/bronchitis (tracheitis). This event was leading to death. The patient developed a serious pulmonary congestion and oedema (pulmonary congestion). This event was assessed as medically significant and was leading to death. The patient developed a serious pulmonary congestion and oedema (pulmonary oedema). This event was assessed as medically significant and was leading to death. The patient developed a serious brain oedema. This event was assessed as medically significant and was leading to death. The patient developed a serious acute splenitis (splenitis). This event was leading to death. The patient developed a serious haemophagocytosis imaging (haemophagocytic lymphohistiocytosis). This event was assessed as medically significant and was leading to death. The patient developed a serious apoptosis imaging (apoptosis). This event was leading to death. The patient developed a serious splenic infection. This event was assessed as medically significant and was leading to death. The patient developed a serious splenomegaly. This event was leading to death. The patient developed a serious severe interstitial pneumonia with neck and peritoneal lymph node swelling (lymphadenopathy). This event was assessed as medically significant and was leading to death. The patient developed a serious nasal discharge (rhinorrhoea). This event was leading to death. The patient developed a serious cough. This event was leading to death. The patient developed a serious sneezing. This event was leading to death. Relevant laboratory test results included: Adenovirus test - On an unknown date: Negative Autopsy - On an unknown date: [Main autopsy findings were as follows: Development was consistent with the patient''s age. No notable injury, critical disease or malformation was observed. Numerous ecchymoses were noted on the thymus gland and lung surface. Blood clotting in the heart was present. On the cut surface of lung, white turbidity around bronchi was seen. Summary of autopsy findings was as follows: Cold-like symptoms before death and marked splenomegaly and swollen lymph nodes on the autopsy suggested some infection; however, only mild tracheitis/bronchitis was found histologically. Neutrophil infiltration in spleen (acute splenitis/infected spleen) and haemophagocytosis imaing by macrophage in spleen, liver and lymph nodes were observed. Numerous instances of lymphocyte shedding/apoptosis imaging and abundant nuclear debris were found in the lymphoid tissue of the whole body, such as the lymph nodes, white pulp of the spleen, gut-associated lymphoid tissue, and BALT.]; on an unknown date: [Main histological findings were as follows: Acute tracheitis/bronchitis, pulmonary congestion and oedema, leukomalacia in the cerebral cortex, acute splenitis (splenic infection), haemophagocytosis imaging, and lymphocyte shedding and apoptosis imaging in the lymph nodes and bronchus-associated lymphoid tissue (BALT).]; on an unknown date: [91g/106g]; on an unknown date: 27 g Beta haemolytic streptococcal infection - On an unknown date: Negative C-reactive protein - On an unknown date: 0.45 mg/dL Coxsackie virus test - On an unknown date: [4-fold]; on an unknown date: [8-fold] Human metapneumovirus test - On an unknown date: Negative Influenza A virus test - On an unknown date: Negative Influenza B virus test - On an unknown date: Negative Interleukin level - On an unknown date: 52.8 pg/mL Procalcitonin - On an unknown date: [less than 0.02 ng/mL] Respiratory syncytial virus test - On an unknown date: Negative Rotavirus test - On an unknown date: Negative Tryptase - On an unknown date: 5.8 ug/L Final diagnosis was (fatal) splenic infection, (fatal) apoptosis imaging, (fatal) haemophagocytosis imaging, (fatal) acute splenitis, (fatal) brain oedema, (fatal) pulmonary congestion and oedema, (fatal) acute tracheitis/bronchitis, (fatal) severe interstitial pneumonia, (fatal) mild cold-like symptoms, (fatal) suspected abnormal immunisation reaction and (fatal) sudden death/found dead while sleeping. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for sudden death/found dead while sleeping, as Fatal on an unknown date for mild cold-like symptoms, as Fatal on an unknown date for severe interstitial pneumonia, as Fatal on an unknown date for severe interstitial pneumonia with neck and peritoneal lymph node swelling, as Fatal on an unknown date for splenomegaly, as Fatal on an unknown date for cough, as Fatal on an unknown date for nasal discharge, as Fatal on an unknown date for acute tracheitis/bronchitis, as Fatal on an unknown date for acute tracheitis/bronchitis, as Fatal on an unknown date for pulmonary congestion and oedema, as Fatal on an unknown date for pulmonary congestion and oedema, as Fatal on an unknown date for brain oedema, as Fatal on an unknown date for acute splenitis, as Fatal on an unknown date for haemophagocytosis imaging, as Fatal on an unknown date for suspected abnormal immunisation reaction, as Fatal on an unknown date for sneezing, as Fatal on an unknown date for apoptosis imaging and as Fatal on an unknown date for splenic infection. An autopsy was done. The cause of death was reported as Sudden death, Nasopharyngitis, Interstitial lung disease, Tracheitis, Bronchitis, Pulmonary congestion, Pulmonary oedema, Splenitis, Brain oedema, Haemophagocytic lymphohistiocytosis, Immunisation reaction, Apoptosis and Splenic infection. Reporter comment: Regarding all events: The patient was suspected to have some infection as having cold-like symptoms before death and marked splenomegaly and lymph node swelling at autopsy. It was assumed that the infection triggered an abnormal immunological reaction, which induced hypercytokinemia. In an infant with some predisposition for immune abnormality, cellular immunity can be induced by vaccination and trigger abnormal immunisation reaction, which might led to an abrupt change in the course followed by sudden death. The action mechanism of 2 kinds of inactive vaccines affecting the infant death is unknown, and the simultaneous onset with vaccination cannot be denied. Thus, the causality between SID and vaccines are concluded as unknown, but needs to be suspected. The disorders developing after the multiple vaccinations on the second immunization can be anaphylaxis. Common features such as splenitis and hemophagocytosis were also evident. The uncontrollable immune overreaction mainly caused by the activated lymphocytes and histiocyte/macrophages might have led to hemophagocytic lymphohistiocytosis, which is clinically similar to macrophage activation syndrome. The finding of apoptosis in the lymphoid tissue of the whole body was considered to demonstrate abnormal immunological reaction. Follow-up information received from the forensic medicine specialist on 20-Mar-2018. It was reported that the continuation of the investigation was impossible as the patient was unable to be identified. Additional information was received on 31-Oct-2019 from the physician: Updated information in the fields of general, patient, products, events and analysis.; Sender''s Comments: Followup received on 20-MAR-2018 does not change the previous assessment. This case concerns a literature article in which a 3 month old infant died in sleep 3 days after vaccination (Act-HIB and pneumococcal, hepatitis B, DPT-IPV and rotavirus vaccines) . The infant had mild Flu like symptoms. Autopsy results indicated severe interstitial pneumonia with lymph node swelling and splenomegaly which indicate towards an underlying infection. However, the age and clinical details correspond closely with the general Sudden Infant Death Syndrome (SIDS) cases. Further information regarding patient medical history, details regarding whether it was a premature birth or not, recent infectious history especially upper respiratory, allergic history, past vaccination history and its tolerance are needed to further assess the case. Moreover, multiple vaccinations preceded the event. Based upon the reported information, the role of the vaccines cannot be assessed individually. JP-SA-2018SA068930:CLUSTER; Reported Cause(s) of Death: Sudden death/found dead while sleeping; Mild cold-like symptoms; Severe interstitial pneumonia; Acute tracheitis/bronchitis; Acute tracheitis/bronchitis; Pulmonary congestion and oedema; Pulmonary congestion and oedema; Acute splenitis; Brain oedema;


VAERS ID: 861792 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2020-02-10
Onset:2020-02-01
Submitted: 0000-00-00
Entered: 2020-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Cyanosis, Death, Endotracheal intubation, Eye oedema, Lip oedema, Mechanical ventilation, Pulse absent, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-11
   Days after onset: 10
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200210; Test Name: Pulse rate; Result Unstructured Data: Test Result: no pulse, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2020GS

Write-up: labial edema; Eye edema; Pulse absent; abdominal distension; cyanosis; Unresponsive to stimulus; Unknown cause of death; This case was reported by a other health professional via licensee and described the occurrence of unknown cause of death in a 2-month-old male patient who received Rotavirus vaccine for prophylaxis. On 10th February 2020 10:30, the patient received Rotavirus vaccine (oral). On 10th February 2020 10:35, 5 min after receiving Rotavirus vaccine, the patient experienced lip edema (serious criteria hospitalization), eye edema (serious criteria hospitalization), pulse absent (serious criteria hospitalization), abdominal distension (serious criteria hospitalization), cyanosis (serious criteria hospitalization) and unresponsive to stimuli (serious criteria hospitalization and GSK medically significant). In February 2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The patient was treated with oxygen (Ventilatory Support (Oxygen)). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the lip edema, eye edema, pulse absent, abdominal distension, cyanosis and unresponsive to stimuli were unknown. The patient died on 11th February 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, lip edema, eye edema, pulse absent, abdominal distension, cyanosis and unresponsive to stimuli to be related to Rotavirus vaccine. Additional case details were reported as follows: The patient presented with labial and eye edema, no pulse, abdominal distension and cyanosis and was unresponsive to stimulus. The patient did not have cough and neither vomited or cried. Life support measures were performed by the local health team with CPR (cardio pulmonary resuscitation), ventilatory support and airway disobstruction. The patient was admitted to hospital, orotracheal intubation was performed. On 11th February at 6:45 pm, 1 day 8 hours and 15 minutes after vaccination, the patient died.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 862731 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2010-06-03
Onset:2010-06-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA672A / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D02112 / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asphyxia, Autopsy, Brain injury, Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-07
   Days after onset: 1
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:
Current Illness: Immunisation; Immunization
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075132002AUS006931

Write-up: Hypoxic brain damage consistent with positional asphyxia; cardiac arrest; Information has been downloaded from authority (AU-PFIZER INC-2011119149). This literature marketed report has been received from author of the literature article entitled as stated below refers to a 6 week old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2010, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (lot # AROLA09 (invalid lot) and expiration date was not provided) 1 dosage form, single, orally for immunisation. On the same day, the patient also administered with other co-suspect therapies which included, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) solution for injection in pre-filled syringe (lot# D02112 and expiration date reported as February 2013) 1 dosage form, single for immunization and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX HEXA) (lot# A21CA672A and expiration date was not provided) 1 dosage form for immunization. On 06-JUN-2010, 4 days after onset of therapy the patient experienced hypoxic brain damage consistent with positional asphyxia (brain injury) and cardiac arrest. Approximately on an unknown date in June 2010, the patient was hospitalized due to the events. On 07-JUN-2010, the patient died of cardiac arrest and brain injury. An Autopsy was performed. The outcome of brain injury and cardiac arrest was reported as fatal. Causality assessment was not provided. A copy of the published article is attached as further documentation of the patient''s experience. Literature Report: Investigation of Prevenar and deaths in children in this country: what does it mean for other countries?. prescriber. Sender''s Comments: AU-PFIZER INC-HQWYE904905AUG03: AU-PFIZER INC-AUWYE355224SEP07: AU-PFIZER INC-AU-WYE-G06183310: AU-PFIZER INC-2011119243:; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Hypoxic brain damage


VAERS ID: 867878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Brain death, Brain herniation, Brain oedema, Cardio-respiratory arrest, Computerised tomogram head abnormal, Diabetes insipidus, Electroencephalogram abnormal, Enterovirus infection, Enterovirus test positive, Febrile convulsion, Hyperglycaemia, Hypertension, Hyperthermia, Hypoxic-ischaemic encephalopathy, Magnetic resonance imaging brain abnormal, Pneumonia, Pulmonary oedema, Pyrexia, Rhinorrhoea, Staring, Status epilepticus, Tardive dyskinesia, Tonic clonic movements, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (patient mother had from infancy); Febrile seizure (patient mother had before 12 months old); Omphalitis; Tonic-clonic seizures (patient mother managed it with sodium valproate only)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: degree C; Test Name: Electroencephalogram; Result Unstructured Data: Test Result: showed electrocerebral silence; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result: see text; Test Name: Viral swab; Result Unstructured Data: Test Result: Enterovirus 71 was found
CDC Split Type: AUGLAXOSMITHKLINEAU2020GS

Write-up: Seizure; cardiopulmonary arrest during intubation; pulmonary oedema; Staring; unresponsive with lip smacking; unresponsive with lip smacking; bilateral tonic clonic movements; Status epilepticus; secondary pneumonia/extensive bronchopneumonia; Enterovirus 71; hyperglycaemia; hyperthermia; hypertension; fever/mild febrile illness; diabetes insipidus; Brain death; severe cerebral oedema; diffuse hypoxic ischemic encephalopathy; extensive changes with cerebellar tonsillar herniation; rhinorrhea; This case was reported in a literature article and described the occurrence of brain death in a 12-month-old male patient who received DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) for prophylaxis, DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) for prophylaxis, Rotavirus vaccine for prophylaxis, Rotavirus vaccine for prophylaxis, Hib-MenC-TT (HIB and Meningitis C vaccine) for prophylaxis, MMR (MMR vaccine) for prophylaxis, 13-VALENT PNEUMOCOCCAL CONJUGATE for prophylaxis, 13-VALENT PNEUMOCOCCAL CONJUGATE for prophylaxis and 13-VALENT PNEUMOCOCCAL CONJUGATE for prophylaxis. The patient''s past medical history included omphalitis. The patient had a Family History of epilepsy (patient mother had from infancy), febrile seizure (patient mother had before 12 months old) and tonic-clonic seizures (patient mother managed it with sodium valproate only). On an unknown date, the patient received the 1st dose of DTPa-HBV-IPV-HIB, the 2nd dose of DTPa-HBV-IPV-HIB, the 3rd dose of DTPa-HBV-IPV-HIB, the 1st dose of Rotavirus vaccine, the 2nd dose of Rotavirus vaccine, HIB and Meningitis C vaccine at an unknown dose, MMR vaccine, the 1st dose of 13-VALENT PNEUMOCOCCAL CONJUGATE, the 2nd dose of 13-VALENT PNEUMOCOCCAL CONJUGATE and the 3rd dose of 13-VALENT PNEUMOCOCCAL CONJUGATE. On an unknown date, between 10 and 11 months after receiving DTPa-HBV-IPV-HIB and Rotavirus vaccine, 8 months after receiving DTPa-HBV-IPV-HIB and Rotavirus vaccine, 6 months after receiving DTPa-HBV-IPV-HIB, 27 hrs after receiving HIB and Meningitis C vaccine and MMR vaccine and an unknown time after starting levetiracetam, the patient experienced brain death (serious criteria death and GSK medically significant), cerebral edema (serious criteria death and GSK medically significant), hypoxic-ischemic encephalopathy (serious criteria death and GSK medically significant), brain herniation (serious criteria death and GSK medically significant), pneumonia (serious criteria death, hospitalization and GSK medically significant), enterovirus infection (serious criteria death and GSK medically significant), febrile seizure (serious criteria hospitalization and GSK medically significant), cardiopulmonary arrest (serious criteria hospitalization and GSK medically significant), pulmonary edema (serious criteria hospitalization and GSK medically significant), diabetes insipidus (serious criteria GSK medically significant), staring (serious criteria hospitalization), unresponsive to verbal stimuli (serious criteria hospitalization and GSK medically significant), lip smacking (serious criteria hospitalization and GSK medically significant), tonic clonic movements (serious criteria hospitalization and GSK medically significant), status epilepticus (serious criteria hospitalization and GSK medically significant), hyperglycemia, hyperthermia, hypertension, fever and rhinorrhea. The patient was treated with levetiracetam, midazolam, epinephrine (Adrenalin), morphine and antibiotics nos. On an unknown date, the outcome of the brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia and enterovirus infection were fatal and the outcome of the febrile seizure, cardiopulmonary arrest, pulmonary edema, diabetes insipidus, staring, unresponsive to verbal stimuli, lip smacking, tonic clonic movements, status epilepticus, hyperglycemia, hyperthermia, hypertension and fever were unknown and the outcome of the rhinorrhea was recovered/resolved. The reported cause of death was brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia and enterovirus infection. An autopsy was performed. The reporter considered the brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia, enterovirus infection, febrile seizure, cardiopulmonary arrest, pulmonary edema, diabetes insipidus, staring, unresponsive to verbal stimuli, lip smacking, tonic clonic movements, status epilepticus, hyperglycemia, hyperthermia, hypertension, fever and rhinorrhea to be related to DTPa-HBV-IPV-HIB, DTPa-HBV-IPV-HIB, DTPa-HBV-IPV-HIB, Rotavirus vaccine and Rotavirus vaccine. The reporter considered the brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia, enterovirus infection, febrile seizure, cardiopulmonary arrest, pulmonary edema, diabetes insipidus, staring, unresponsive to verbal stimuli, lip smacking, tonic clonic movements, status epilepticus, hyperglycemia, hyperthermia and hypertension to be related to HIB and Meningitis C vaccine and MMR vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of seizure in a 12-month-old male patient, who was vaccinated with unspecified diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type b, hepatitis B and inactivated polio combination vaccine (DTPa-Hib-HepB-IPV), unspecified rotavirus vaccine, unspecified Haemophilus influenzae type b and meningococcal C conjugate vaccine (Hib-MenC), unspecified measles-mumps-rubella vaccine (MMR) (manufacturer unknown) for prophylaxis. The patient born at full-term via spontaneous vaginal delivery to non-consanguineous parents (first pregnancy via in-vitro fertilisation). The patient was a healthy infant with normal growth and development and no significant medical history aside from omphalitis as a neonate. The patient''s mother had epilepsy from infancy, with her first febrile seizure (FS) before 12 months old. The patient''s mother progressed to have both febrile and afebrile bilateral tonic clonic seizures, but no focal seizures or status epilepticus. Seizures of patient''s mother were managed with sodium valproate only. Seizure frequency decreased from once every two months from infancy to puberty, to being seizure free for 4 years before ceasing medication for 5 years before the patient''s birth. There was no significant neurodevelopmental impact from the seizures, and completed high school studies with no assistance. There was a history of epilepsy in sister of patient''s mother and father of patient''s mother. No family members had prolonged seizures or developmental concerns. No information on patient''s concurrent condition or concomitant medication was provided. On an unspecified date, at the age of 6 weeks and at the age of 4 months, the patient received 1st and 2nd dose of unspecified diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type b, hepatitis B and inactivated polio combination vaccine (DTPa-Hib-HepB-IPV) (administration route and site unspecified; batch number not provided), unspecified rotavirus vaccine (batch number not provided) and unspecified 13-valent pneumococcal conjugate vaccine (PCV13) (administration route and site unspecified; batch number not provided) respectively. On an unspecified date, at the age of 6 months, the patient received 3rd dose of unspecified diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type b, hepatitis B and inactivated polio combination vaccine (DTPa-Hib-HepB-IPV) (administration route and site unspecified; batch number not provided), and unspecified 13-valent pneumococcal conjugate vaccine (PCV13) (administration route and site unspecified; batch number not provided) respectively. The patient had no adverse events following immunisation. On an unspecified date, at the age of 12 months, the patient received unspecified Haemophilus influenzae type b and meningococcal C conjugate vaccine (Hib-MenC), and unspecified measles-mumps-rubella vaccine (MMR). On an unspecified date, at the age of 12 months, an unknown period after the vaccination, the patient had a mild febrile illness with rhinorrhea lasting 1-2 weeks and had been afebrile for 3-4 days at the time of Hib-MenC and MMR vaccinations. Approximately 27 hours later, first seizure occurred. The patient''s mother saw him sitting up in bed on the baby video monitor, and went into the room to find him staring, unresponsive with lip smacking, followed by bilateral tonic clonic movements. Fever to 38.5 degree C was recorded on arrival to emergency. 4 doses of midazolam were given before status epilepticus terminated at approximately 40 min. The patient went into cardiopulmonary arrest during intubation and had 40 min of down time before return of spontaneous circulation on an adrenalin infusion. A loading dose of levetiracetam (30 mg/kg) was given and the patient was transferred to paediatric intensive care unit on morphine and adrenaline infusion. Antibiotics were commenced, cerebrospinal Fluid (CSF) collection was deferred. Computer tomography (CT) brain showed severe global hypoxic ischemic brain injury with cerebral oedema. The admission was complicated by pulmonary oedema, secondary pneumonia, diabetes insipidus, hyperglycaemia, hyperthermia and hypertension. Electroencephalography (EEG) showed electrocerebral silence, and magnetic resonance imaging (MRI) re-demonstrated extensive changes with cerebellar tonsillar herniation and absence of flow in the intracranial arteries on magnetic resonance angiogram (MRA) consistent with brain death; medical support was withdrawn, and the patient died. Autopsy found severe cerebral oedema with diffuse hypoxic ischemic encephalopathy changes and cerebellar tonsillar herniation. There was also extensive bronchopneumonia. Enterovirus 71 was found on tracheal and rectal swab. There were no signs of meningitis or encephalitis on neuropathological exam of brain and spinal cord. Genomic testing was not performed at the time of autopsy. Instead, the patient''s mother was referred for genetic review during her subsequent pregnancy. Whole exome sequencing was arranged on a stored liver-derived DNA sample from the Case, focussing on a panel of SUDEP (sudden unexpected death in epilepsy), long QT syndrome and hypoventilation-associated genes. The detected heterozygous missense variant in SCN1A (NM001165963.1: c.2866AG;p.(Met956Val)) was novel and classified as likely pathogenic by Regulatory Authority guidelines (Class 4: PM2, PM5, PP2, PP3). This variant was also subsequently found in the patient''s mother. This case has been considered serious due to death and hospitalization. The author commented, "SCN1A variants cause a spectrum of epilepsy syndromes from Dravet Syndrome, a severe epileptic encephalopathy of early infancy to the milder disorder of genetic epilepsy with febrile seizures plus (GEFS+). These genetic epilepsies are associated with increased risk of poor outcome including complications of status epilepticus and early mortality. Individualised management of young children known to be at increased risk should be considered, such as around vaccination management. Vaccinations have been implicated in triggering an earlier onset of seizures in children with underlying genetic epilepsy, including SCN1Arelated Dravet syndrome. While this was a novel amino acid change, other pathogenic missense changes affecting the same residue, including p.Met956Thr, have been reported where in vitro studies demonstrate reduced cell surface SCN1A expression, highlighting the functional importance of this particular highly conserved methionine. The absence of variants in this position in population databases including Genome Aggregation Database (gnomAD) and in silico predictions support this missense variant as being likely pathogenic. We report a novel missense SCN1A variant in a 12-month-old child who suffered a catastrophic outcome from status epilepticus with cardiac arrest following vaccination, in the context of recent febrile illness likely associated with enterovirus 71. Multiple factors may have contributed to the death of this Case including vaccination, status epilepticus, pathogenic SCN1A variant and enterovirus infection. Although it is not possible to predict an individual''s phenotype based on their genotype alone, the pattern in this family is more consistent with GEFS plussyndrome, and missense variants more commonly occur with the milder GEFS plus phenotype. Post-vaccination seizures occur in a small number of individuals and are well documented in children with Dravet syndrome. SCN1A variants predispose individuals, particularly those with Dravet syndrome, to status epilepticus and to an increased risk of SUDEP. Enterovirus 71 infection can cause FSs, aseptic meningitis, and encephalitis following a prodromal illness as in this Case and does not typically have evidence of cerebritis at autopsy. The presence of CNS infection was unclear due to lack of CSF sampling in this acutely ill infant. In this case, where cardiac arrest followed status epilepticus, enterovirus 71 also predisposes to pulmonary oedema and myocarditis, with young children more severely affected. Pre-symptomatic treatment is not our standard management of FSs or risk of seizures in families with genetic epilepsy, as antiepileptic medications may be associated with side effects including on neurodevelopment and cognition." The author concluded, "This is the first report of this novel pathogenic SCN1A variant associated with status epilepticus, viral infection and infant death following vaccination. We have described an approach to personalized management around vaccination of an asymptomatic younger sibling with the same variant. Establishing genetic aetiology as early as possible in familial epilepsies has the potential to change management and outcomes for affected children. In future, through cooperative international efforts using well-designed natural history and treatment trials, it should be possible to predict risks and benefits of pre-symptomatic treatment with greater certainty in similar cases, with a view to optimising personalised management of vaccination for children with genetic epilepsies." Lab Comments: Lab test done on an unknown date. Cerebrospinal Fluid (CSF) collection was deferred. Computer tomography (CT) brain showed severe global hypoxic ischemic brain injury with cerebral oedema. Electroencephalography (EEG) showed electrocerebral silence, and magnetic resonance imaging (MRI) re-demonstrated extensive changes with cerebellar tonsillar herniation and absence of flow in the intracranial arteries on magnetic resonance angiogram (MRA) consistent with brain death. Enterovirus 71 was found on tracheal and rectal swab.; Reported Cause(s) of Death: Brain death; Cerebral oedema; Hypoxic-ischemic encephalopathy; Brain herniation; Pneumonia; Enterovirus infection


VAERS ID: 889383 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 2 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 1 - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 1 - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Agitation, Anaemia, Bacterial sepsis, Condition aggravated, Congenital absence of bile ducts, Death, Encephalopathy, Food aversion, Hepatic failure, Hepatitis B, Hyperthermia, Hypoglycaemia, Hypoproteinaemia, Infection, Interstitial lung disease, Jaundice, Leukocyturia, Myocarditis, Nephritis, Pancreatitis, Pulmonary congestion, Pulmonary haemorrhage, Respiratory tract infection, Sepsis, Toxicity to various agents, Tracheobronchitis, Viral infection
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Congenital, familial, neonatal and genetic disorders of the liver (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Drug abuse and dependence (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Intrauterine infection (detection of anti-Toxoplasma gondi IgG +, anti-HSV type 1 and 2 IgG +, anti-CMV IgG); Tricuspid insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis B (mother carrier of hepatitis B surface antigen)
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: (Test Result:increased at age of 5 month,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:1850 at day 2,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:2988 and 1488 day 3,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:1820 day 4,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:2604 day 7,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:2260 day 8,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:1338 day 9,Unit:IU/L); Test Name: ALT; Result Unstructured Data: (Test Result:686 day 10,Unit:IU/L); Test Name: amylase; Result Unstructured Data: (Test Result:37.6 day 2,Unit:g/L); Test Name: amylase; Result Unstructured Data: (Test Result:85 day 8,Unit:g/L); Test Name: amylase; Result Unstructured Data: (Test Result:30 day 9,Unit:g/L); Test Name: AST; Result Unstructured Data: (Test Result:at age of 5 month,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:1650 at day 2,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:769.9 and 950 day 3,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:440 day 4,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:258 day 7,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:1788 day 8,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:860 day 9,Unit:IU/L); Test Name: AST; Result Unstructured Data: (Test Result:277 day 10,Unit:IU/L); Test Name: conjugated bilirubin; Result Unstructured Data: (Test Result:50.7 at day 2,Unit:mcmol/L); Test Name: conjugated bilirubin; Result Unstructured Data: (Test Result:43 day 3,Unit:mcmol/L); Test Name: conjugated bilirubin; Result Unstructured Data: (Test Result:65 day 4,Unit:mcmol/L); Test Name: conjugated bilirubin; Result Unstructured Data: (Test Result:107 day 8,Unit:mcmol/L); Test Name: conjugated bilirubin; Result Unstructured Data: (Test Result:93 day 9,Unit:mcmol/L); Test Name: conjugated bilirubin; Result Unstructured Data: (Test Result:98.2 day 10,Unit:mcmol/L); Test Name: bleeding time; Result Unstructured Data: (Test Result:5.3-5.45,Unit:/min); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:197.8 without cytolysis,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:92.4 day 2,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:99.37and 89 day 3,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:78 day 4,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:220.8 day 7,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:223.9 day 8,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:244 day 10,Unit:mcmol/L); Test Name: total bilirubin from the indirect fraction; Result Unstructured Data: (Test Result:hyperbilirubinemia 92.4-223-224-204.9,Unit:mcmol/L); Test Name: calcium; Result Unstructured Data: (Test Result:2.49 day 2,Unit:IU/L); Test Name: calcium; Result Unstructured Data: (Test Result:1.94 day 3,Unit:IU/L); Test Name: calcium; Result Unstructured Data: (Test Result:2.48 day 8,Unit:IU/L); Test Name: calcium; Result Unstructured Data: (Test Result:2.16 day 9,Unit:IU/L); Test Name: creatinine; Result Unstructured Data: (Test Result:58 day2,Unit:unknown); Test Name: creatinine; Result Unstructured Data: (Test Result:271 day 8,Unit:unknown); Test Name: creatinine; Result Unstructured Data: (Test Result:159 day9,Unit:unknown); Test Name: creatinine; Result Unstructured Data: (Test Result:50 day 10,Unit:unknown); Test Name: Fibrinogen; Result Unstructured Data: (Test Result:1.11 day 2,Unit:g/L); Test Name: Fibrinogen; Result Unstructured Data: (Test Result:3.11 day 3,Unit:g/L); Test Name: Fibrinogen; Result Unstructured Data: (Test Result:1.78 day day 8,Unit:g/L); Test Name: Fibrinogen; Result Unstructured Data: (Test Result:1.78 day 9,Unit:g/L); Test Name: glucose; Result Unstructured Data: (Test Result:4.11 day 2,Unit:mmol/L); Test Name: glucose; Result Unstructured Data: (Test Result:2.27 day 8,Unit:mmol/L); Test Name: glucose; Result Unstructured Data: (Test Result:2.16 day 9,Unit:mmol/L); Test Name: venous blood pH; Result Unstructured Data: (Test Result:7.43-7.54,Unit:unknown); Test Name: potassium; Result Unstructured Data: (Test Result:4.8,Unit:unknown); Test Name: potassium; Result Unstructured Data: (Test Result:3.98 day 3,Unit:unknown); Test Name: potassium; Result Unstructured Data: (Test Result:5.44 day 8,Unit:unknown); Test Name: potassium; Result Unstructured Data: (Test Result:5.39 day 9,Unit:unknown); Test Name: sodium; Result Unstructured Data: (Test Result:140 day 2,Unit:unknown); Test Name: sodium; Result Unstructured Data: (Test Result:137 day 3,Unit:unknown); Test Name: sodium; Result Unstructured Data: (Test Result:137 day 8,Unit:unknown); Test Name: sodium; Result Unstructured Data: (Test Result:134 day 9,Unit:unknown); Test Name: urea; Result Unstructured Data: (Test Result:2.42 day 2,Unit:mmol/L); Test Name: urea; Result Unstructured Data: (Test Result:3.42 day 3,Unit:mmol/L); Test Name: urea; Result Unstructured Data: (Test Result:17.1 day 8,Unit:mmol/L); Test Name: urea; Result Unstructured Data: (Test Result:17.8 day 9,Unit:mmol/L); Test Name: urea; Result Unstructured Data: (Test Result:1.6 day 10,Unit:mmol/L); Test Name: body mass index; Result Unstructured Data: (Test Result:17.3,Unit:unknown); Test Name: chest X-ray; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Name: Cytomegalovirus test; Result Unstructured Data: (Test Result:with anti-CMV IgG negative,Unit:unknown); Test Name: echocardiographs; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Name: hematocrit; Result Unstructured Data: (Test Result:25-28,Unit:%); Test Name: Hb; Result Unstructured Data: (Test Result:93-95,Unit:g/L); Test Name: Hepatitis B core antibody; Result Unstructured Data: (Test Result:anti-HBc positive,Unit:unknown); Test Name: HBV DNA assay; Result Unstructured Data: (Test Result:could not be determined,Unit:unknown); Test Name: anti-HBs; Result Unstructured Data: (Test Result:negative,Unit:unknown); Test Name: HbsAg; Result Unstructured Data: (Test Result:detected at 3 month of age,Unit:unknown); Test Name: HbsAg; Test Result: Positive ; Test Name: lymphocyte count; Test Result: 71 %; Test Name: lymphocyte count; Test Result: 46 %; Test Name: mycoplasma test; Result Unstructured Data: (Test Result:mycoplasma infection with anti-Mycoplasma pneumoni,Unit:unknown); Test Name: neutrophill count; Result Unstructured Data: (Test Result:19-38 with with toxic granulocytosis,Unit:%); Test Name: PI (perfusion index proximal oximetry); Result Unstructured Data: (Test Result:74 day 2,Unit:%); Test Name: PI (perfusion index proximal oximetry); Result Unstructured Data: (Test Result:85 day 3,Unit:%); Test Name: PI (perfusion index proximal oximetry); Result Unstructured Data: (Test Result:78 day 8,Unit:%); Test Name: PI (perfusion index proximal oximetry); Result Unstructured Data: (Test Result:82 day 9,Unit:%); Test Name: pCO2; Result Unstructured Data: (Test Result:decreased 29.4-22,Unit:unknown); Test Name: physical examination; Result Unstructured Data: (Test Result:See text,Unit:unknown); Test Name: Platelet count; Result Unstructured Data: (Test Result:149-153,Unit:x10e9/L); Test Name: pO2; Result Unstructured Data: (Test Result:80.5-88,Unit:unknown); Test Name: total proteins; Result Unstructured Data: (Test Result:43 day 2,Unit:g/L); Test Name: total proteins; Result Unstructured Data: (Test Result:53.9 and 59 day 3,Unit:g/L); Test Name: total proteins; Result Unstructured Data: (Test Result:57 day 4,Unit:g/L); Test Name: total proteins; Result Unstructured Data: (Test Result:220.8 day 7,Unit:g/L); Test Name: total proteins; Result Unstructured Data: (Test Result:52.5 day 8,Unit:g/L); Test Name: total proteins; Result Unstructured Data: (Test Result:56 day 9,Unit:g/L); Test Name: total proteins; Result Unstructured Data: (Test Result:53.5 hypoproteinemia,Unit:g/L); Test Name: erythrocytes; Result Unstructured Data: (Test Result:2.9-3.1,Unit:X10E12/L); Test Name: erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:5-2,Unit:mm/h); Test Name: abdomen sonography; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Name: leukocyte count; Result Unstructured Data: (Test Result:6.9-15.9,Unit:x10E6/L); Comments: On an unspecified date, Lab test were performed. The patient corresponding to age, afebrile status, the presence of intense and diffuse mucocutaneous jaundice, fr-32 r/min, ps- 143 b/min., body G of 8,500 g, length 69 cm, IP = 1.02; abdomen enlarged in volume, flatulence, hepatomegaly + 2.5 +3 cm below the right costal rim, with round edge, insensitive; absence of splenomegaly, absence of peripheral edema and ascites, presence of discolored stool 4/day, pasty, light yellow urine, periodically brown.Biochemical examination of the blood caused severe disorders of basic liver function.Additional instrumental examination by chest X-ray determined characteristic of acute viral respiratory infection imaging signs with hyper-aeration and accentuated bilateral contour of the lungs, presence of grade I thymomegaly, reaction of the interlobar pleura. The sonographic results of the abdominal organs were suggestive of a diffuse inflammatory process in both the pancreas with multiple linear echoes, contracted gallbladder, with dimensions difficult to appreciate, with 4 mm thick walls, dilation of the choledochus, portal vein with diameter = 2 mm, pancreas with dimensions 7x7x7 mm, with increased echogenicity; absence of changes in the bilateral kidney parenchyma. Neurosonographs found dilation of ventricle III, with the lateral ventricle at the location of the anterior horns dilated on the left; echocardiographs confirm the preserved left ventricular (LV) pump function, the presence of false cord in the LV, signs of gr. I tricuspid valve insufficiency. Morpho histological examination (post-mortem) of the liver tissue confirmed the presence of foamy cytoplasm of hepatocytes with bile accumulations, development of interlobular septa, the presence of hepatocyte necrosis, sinusoidal congestion, lymphocyte infiltration in the portal tracts, a reduction in cholangiol proliferation.
CDC Split Type: MDGLAXOSMITHKLINEMD2020EM

Write-up: acholic stools; agitation/increased agitation; acute respiratory infection/acute viral respiratory infection; hyperthermic syndrome; abdominal bloating/volume increase of the abdomen; refusal of food; intensification of mucocutaneous jaundice; volume increase of the abdomen; physiological jaundice; toxic encephalopathy; worsening of the general condition; microfocal interstitial pneumonia; volume increase of the abdomen; Pulmonary congestion; intrapulmonary hemorrhage; Positive viral infection with the HBsAg virus (titer more than 3000 IU): viral hepatitis B with cellular polymorphs; Toxic pancreatitis; liver failure; Acute renal failure; Virotic-bacterial sepsis; Acute necrotic pancreatitis; tracheobronchitis; hepato-reno-pulmonary failure; leukocyturia; macrohematuria; fibroadenomatosis; hypercreatininemia; anemia; hypoproteinemia; hypoglycemia; hyperglycemia; vertical infection transmission; This case was reported in a literature article and described the occurrence of hepatitis b in a 3-day-old male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine (batch number UNK, expiry date unknown) for prophylaxis, Polio Bivalent T1 T3 oral (Oral polio vaccine) (batch number UNK, expiry date unknown) for prophylaxis, Rotavirus vaccine (batch number UNK, expiry date unknown) for prophylaxis, Hib UNK (Hib vaccine) (batch number UNK, expiry date unknown) for prophylaxis, 10PN-PD-Dit (Pneumococcal vaccine) (batch number UNK, expiry date unknown) for prophylaxis, DTP (A or W not known) (DTP vaccine) (batch number UNK, expiry date unknown) for prophylaxis and BCG (BACILLUS CALMETTE GUERIN) (batch number UNK, expiry date unknown) for prophylaxis. Concurrent medical conditions included intrauterine infection (detection of anti-Toxoplasma gondi IgG +, anti-HSV type 1 and 2 IgG +, anti-CMV IgG) and tricuspid insufficiency. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 1st dose of Oral polio vaccine (oral), the 1st dose of Rotavirus vaccine (oral), the 1st dose of Hib vaccine, the 1st dose of Pneumococcal vaccine, the 1st dose of DTP vaccine and BCG (BACILLUS CALMETTE GUERIN). On an unknown date, not applicable after receiving Hepatitis B vaccine and less than 4 months after receiving Hepatitis B vaccine, Oral polio vaccine, Rotavirus vaccine, Hib vaccine, Pneumococcal vaccine and DTP vaccine, the patient experienced hepatitis b (serious criteria death and GSK medically significant), jaundice (serious criteria death and hospitalization), necrotizing pancreatitis (serious criteria death and GSK medically significant), tracheobronchitis (serious criteria death), abdomen enlarged (serious criteria hospitalization), bacterial sepsis (serious criteria death and GSK medically significant), general physical health deterioration (serious criteria death and hospitalization), pneumonia (serious criteria death, hospitalization and GSK medically significant), pulmonary hemorrhage (serious criteria death and GSK medically significant), jaundice (serious criteria hospitalization), toxic encephalopathy (serious criteria hospitalization and GSK medically significant), toxic pancreatitis (serious criteria GSK medically significant), liver failure (serious criteria GSK medically significant), acute renal failure (serious criteria GSK medically significant), cytolysis (serious criteria hospitalization), lung congestion (serious criteria GSK medically significant), acholic stool (serious criteria hospitalization), agitation (serious criteria hospitalization), acute respiratory tract infection (serious criteria hospitalization and GSK medically significant), hyperthermia (serious criteria hospitalization), abdominal distension (serious criteria hospitalization), appetite absent (serious criteria hospitalization), respiratory failure (serious criteria GSK medically significant), leukocyturia, macroscopic hematuria, fibroadenoma, hypercreatininemia, anemia, hypoproteinemia, hypoglycemia, hyperglycemia and vertical infection transmission. The patient was treated with antibiotics nos (Antibacterial Medication (Nos)), non-drug therapy (Phototherapy) and paracetamol (Panadol Baby). On an unknown date, the outcome of the hepatitis b, jaundice, necrotizing pancreatitis, tracheobronchitis, bacterial sepsis, general physical health deterioration, pneumonia and pulmonary hemorrhage were fatal and the outcome of the abdomen enlarged, jaundice, toxic encephalopathy, cytolysis and acholic stool were recovered/resolved and the outcome of the toxic pancreatitis, liver failure, acute renal failure, lung congestion, agitation, acute respiratory tract infection, hyperthermia, abdominal distension, appetite absent, respiratory failure, leukocyturia, macroscopic hematuria, fibroadenoma, hypercreatininemia, anemia, hypoproteinemia, hypoglycemia, hyperglycemia and vertical infection transmission were unknown. The reported cause of death was jaundice, hepatitis b, biliary atresia, necrotizing pancreatitis, bacterial sepsis, tracheobronchitis, myocarditis, pneumonia, nephritis and pulmonary hemorrhage. An autopsy was performed. It was unknown if the reporter considered the abdomen enlarged, jaundice, toxic encephalopathy, cytolysis, acholic stool and vertical infection transmission to be related to Hepatitis B vaccine. It was unknown if the reporter considered the hepatitis b, jaundice, necrotizing pancreatitis, tracheobronchitis, bacterial sepsis, general physical health deterioration, pneumonia, pulmonary hemorrhage, toxic pancreatitis, liver failure, acute renal failure, lung congestion, acute respiratory tract infection, hyperthermia, abdominal distension, appetite absent, respiratory failure, leukocyturia, macroscopic hematuria, fibroadenoma, hypercreatininemia, anemia, hypoproteinemia, hypoglycemia, hyperglycemia and vertical infection transmission to be related to Hepatitis B vaccine. The reporter considered the agitation to be related to Hepatitis B vaccine, Oral polio vaccine, Rotavirus vaccine, Hib vaccine, Pneumococcal vaccine and DTP vaccine. It was unknown if the reporter considered the hepatitis b, jaundice, necrotizing pancreatitis, tracheobronchitis, bacterial sepsis, general physical health deterioration, pneumonia, pulmonary hemorrhage, toxic pancreatitis, liver failure, acute renal failure, lung congestion, acute respiratory tract infection, hyperthermia, abdominal distension, appetite absent, respiratory failure, leukocyturia, macroscopic hematuria, fibroadenoma, hypercreatininemia, anemia, hypoproteinemia, hypoglycemia and hyperglycemia to be related to Oral polio vaccine, Rotavirus vaccine, Hib vaccine, Pneumococcal vaccine and DTP vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Viral Hepatitis B and death NOS in a 3-day-old male PT, who was vaccinated with Unspecified hepatitis B virus vaccine; Unspecified OPV vaccine ; Unspecified rotavirus vaccine; Unspecified Haemophilus influenzae type b vaccine ; Unspecified Pneumococcal vaccine; Unspecified DTP (manufacturer unknown for all) for prophylaxis. The patient (PT) was born from a second pregnancy which evolved with signs of toxicosis throughout the period and intrauterine infection of the fetus with the detection of anti-Toxoplasma gondi immunoglobulin G (IgG) plus (positive), anti-herpes simplex virus (HSV) type 1 and 2 IgG positive anti cytomegalo virus (CMV) IgG positive in the PT mother. The PT was born at 36-37 weeks, with an Apgar score of 7/8 points, weight 3,170 g., length L 51 cm. Careful collection of the family epidemiological history revealed that the PT mother, from the age of 9, was suffering from HVBC. In the PT mother''s case history, 2 years before the current pregnancy, a surgery for bilateral broadenomatosis of the mammary glands was stated. The first pregnancy ended in a miscarriage within 9 weeks. The researched PT was born from the second pregnancy, with pathological evolution. The PT was breastfed in the first hours after birth and fed naturally for 2 months. No information on PT concomitant medication was reported. On an unspecified date, after birth, at 24 hours, the PT was vaccinated with an anti-HVB1 vaccine (administration route and site unspecified, batch number not provided). On an unknown date at 3rd day after birth, an unspecified time after vaccination, the PT was noted with physiological jaundice and discharged in a satisfactory state from the maternity ward. At 8 days after birth, the PT was vaccinated with unspecified bacilli Calmette-guerin (BCG) vaccine. The first hospitalization took place at the age of 2 weeks for persistent neonatal jaundice, toxic encephalopathy. The PT was hospitalized repeatedly for the persistence of jaundice at birth, volume increase of the abdomen and the association of cytolysis syndrome found on an out PT service. It persisted until the current hospitalization, with recurrent episodes, associated with acholic stools, from birth. Treatment with antibacterial, symptomatic remedies, phototherapy was performed for 8 days, after which the PT was discharged at home. Body weight at discharge was 2,970 g, total bilirubin 197.8 mcmol/L from the indirect fraction, without cytolysis. The PT physical development and psycho-emotional status were considered age appropriate. At the age of 2 months, the PT was concomitantly vaccinated with anti HVB2, VPO1, RV1, Hib1, PC1, DTP1. These vaccines were accompanied by a post-vaccination reaction manifested by agitation, perioral cyanosis, fever. At 3 months of age, HbsAg was detected. At the age of 5 months, the PT suffered from an episode of acute respiratory infection, with hyperthermic syndrome, for which he received symptomatic treatment at home (PO Panadol Baby 240 mg/24 h for 3 consecutive days). On the 5th day of treatment there was a worsening of the general condition with the appearance of symptoms: increased agitation, expressed abdominal bloating, refusal of food, intensification of mucocutaneous jaundice, volume increase of the abdomen, increase of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). This was followed by re-hospitalization in the intensive care and pediatric resuscitation subdivision. Objective clinical examination found: physical development of the PT corresponding to age, afebrile status, the presence of intense and diffuse mucocutaneous jaundice, fr-32 r/min, ps- 143 b/min., body G of 8,500 g, length 69 cm, IP = 1.02; body mass index (BMI) = 17.3, abdomen enlarged in volume, flatulence, hepatomegaly + 2.5 +3 cm below the right costal rim, with round edge, insensitive; absence of splenomegaly, absence of peripheral edema and ascites, presence of discolored stool 4/day, pasty, light yellow urine, periodically brown The laboratory examination determined the following: On 2nd May laboratory tests showed, ALT: 1850 IU/L, AST: 1650 IU/L, total bilirubin: 92.4 mcmol/L, conjugated bilirubin: 50.7 mcmol/L, amylase: 37.6 g/h/L, Fibrinogen: 1.11 g/L, calcium: 2.49 IU/L, glucose: 4.11 mmol/L, PI 74 percentage, total proteins: 43 g/L, urea 2.42 mmol/L, creatinine: 58 (units not reported), sodium: 140 (units not reported) and potassium: 4.8 (unit not reported). On 3rd May laboratory tests showed, ALT: 2988 IU/L and 1488 IU/L, AST: 769.9 IU/L and 950 IU/L, total bilirubin: 99.37 mcmol/L and 89 mcmol/L, conjugated bilirubin: 43 mcmol/L, Fibrinogen: 3.11 g/L, calcium: 1.94 IU/L, PI 85 percentage, total proteins: 53.9 g/L and 59 g/L, urea 3.42 mmol/L, sodium: 137 (units not reported) and potassium: 3.98 (unit not reported). On 4th May laboratory tests showed, ALT: 1820 IU/L, AST: 440 IU/L, total bilirubin: 78 mcmol/L, conjugated bilirubin: 65 mcmol/L and total proteins: 57 g/L. On 7th May laboratory tests showed, ALT: 2604 IU/L, AST: 258 IU/L and total bilirubin: 220.8 mcmol/L. On 8th May laboratory tests showed, ALT: 2260 IU/L, AST: 1788 IU/L, total bilirubin: 223.9 mcmol/L, conjugated bilirubin: 107 mcmol/L, amylase: 85 g/h/L, Fibrinogen: 1.78 g/L, calcium: 2.48 IU/L, glucose: 2.27 mmol/L, PI 78%, total proteins: 52.5 g/L, urea 17.1 mmol/L, creatinine: 271 (units not reported), sodium: 137 (units not reported) and potassium: 5.44 (unit not reported). On 9th May laboratory tests showed, ALT: 1338 IU/L, AST: 860 IU/L, total bilirubin: 244 mcmol/L, conjugated bilirubin: 93 mcmol/L, amylase: 30 g/h/L, Fibrinogen: 1.78 g/L, calcium: 2.16 IU/L, glucose: 7.7 mmol/L, PI 82%, total proteins: 56 g/L, urea 17.8 mmol/L, creatinine: 159 (units not reported), sodium: 134 (units not reported) and potassium: 5.39 (unit not reported). On 10th May laboratory tests showed, ALT: 686 IU/L, AST: 277 IU/L, total bilirubin: 204.9 mcmol/L, conjugated bilirubin: 98.2 mcmol/L, urea 1.6 mmol/L and creatinine: 50 (units not reported). On unknown dates, lab tests showed anemia of gr. II with Hb 93-95 g/L; erythrocytes 2.9-3.1X10E12/L; decreased hematocrit - 25-28%, thrombocytopenia 149-153X10E9/L; leukocytosis 6.9-15.9X10E6/L, neutropenia 19-38% with toxic granulocytosis; lymphocytosis 71%, lymphopenia 46%, erythrocyte sedimentation rate (ESR) 5-2 mm/h, increased bleeding time: 5.3-5.45 minutes. Biochemical examination of the blood caused severe disorders of basic liver function: hypoproteinemia 53.5 g/L; hyperbilirubinemia 92.4-223-224-204.9 mcmol/L (results based on lab tests performed earlier) from the conjugate fraction (direct), hypophilia brinogenemia, episodes of hypoglycemia or hyperglycemia, hypercreatininemia, decreased urea secretion. In order to determine the immunoserological status of the PT on the most common infections, especially HBV and HCV, blood tests were performed on HBsAg with a positive result in a high titer of 3000 IU; total anti-HBc +, negative anti-HBs were detected, and HBV deoxyribonucleic acid (DNA) could not be determined. Cytomegalovirus infection with anti-CMV IgG negative and mycoplasma infection with anti-Mycoplasma pneumonia negative IgM were excluded. General examination of urine showed leukocyturia 28-30 cells in the field of view, macrohematuria with 50-60 erythrocytes in the field of view. Estimation of electrolytic and acid-base blood metabolism found the presence of metabolic acidosis with a slight increase in venous blood pH - 7.43-7.54; partial pressure of carbon dioxide (pCO2) decreased 29.4-22; partial pressure of oxygen (pO2) = 80.5-88; lactic acidosis, base excess (BE) minus 4.3. Additional instrumental examination by chest X-ray determined characteristic of acute viral respiratory infection imaging signs with hyper-aeration and accentuated bilateral contour of the lungs, presence of grade I thymomegaly, reaction of the interlobar pleura. The sonographic results of the abdominal organs were suggestive of a diffuse inflammatory process in both the pancreas with multiple linear echoes, contracted gallbladder, with dimensions difficult to appreciate, with 4 mm thick walls, dilation of the choledochus, portal vein with diameter = 2 mm, pancreas with dimensions 7x7x7 mm, with increased echogenicity; absence of changes in the bilateral kidney parenchyma. Neurosonographs found dilation of ventricle III, with the lateral ventricle at the location of the anterior horns dilated on the left; echocardiographs confirm the preserved left ventricular (LV) pump function, the presence of false cord in the LV, signs of gr. I tricuspid valve insufficiency. The PT was consulted by the multidisciplinary team: the surgeon, who assumed the presence of mechanical jaundice and the need for diagnostic esophagogastroduodenoscopy, the infectious disease physician who suspected the presence of nonspecific acute viral hepatitis and the pediatric gastroenterologist-hepatologist. During the hospitalization period, the diagnosis of perinatal viral hepatitis type B (HBsAg positive) was established, with cholestasis syndrome, cytolysis, progressive liver failure, the PT condition worsened with a negative dynamic by the installation of hepato-reno-pulmonary failure. Complications: Acute toxic hepatic encephalopathy, Acute renal failure, anuria, hepato-pulmonaryrenal syndrome, Pulmonary congestion with interlobar pleurisy, Thymomegaly, Toxic pancreatitis, toxic biliary sludge and Metabolic acidosis. Throughout the hospitalization, the PT received intensive symptomatic treatment and resuscitation, provided by the national and international pediatric protocols and medical standards, which however were ineffective, resulting in death on the 9th day of hospitalization. Morpho histological examination of the liver tissue confirmed the presence of foamy cytoplasm of hepatocytes with bile accumulations, development of interlobular septa, the presence of hepatocyte necrosis, sinusoidal congestion, lymphocyte infiltration in the portal tracts, a reduction in cholangiol proliferation. The morpho-pathological diagnosis was found to be bicausal, combined from two simultaneously associated pathologies: Main disease: primary diagnosis: Positive viral infection with the HBsAg virus (titer more than 3000 IU): viral hepatitis B with cellular polymorphs, gigantocellular metamorphosis of hepatocytes, foamy and microvesicular vacuolar dystrophies with subtotal centrolobular alterative-necrolithic changes, polymorphocellular infiltration, with the presence of coliform proliferation, focar liver steatosis. Second disease: Small malformations: Bile duct atresia with intrahepatic cholestasis syndrome, pseudoadenomatous restructuring of the trabecular component; Parieto-tricuspid oblique intratrial cleft with focal brooch of the right atrium endocardium. Complications. Immunological distress - reactive thymomegaly, thymus weight 32 g (normal 12 g), active macrophage phagocytosis in the thymus with aspects of class II accidental thymus transformation (TAT), reactive changes of the mesenteric lymph nodes, of the gastrointestinal lymphoid-follicular system, of the paratrachial ones, spleen lymphocyte depletion. Acute necrotic pancreatitis subtotal with steatonecrosis of the capsule and perifocal-mesenteric celladipose tissues. Vomiting syndrome focal necrotic-leukocyte erosive esophagitis with bacterial microcolonization. Viroticbacterial sepsis erosive segmental tracheobronchitis with bacterial microcolonization, myocarditis, microfocal interstitial pneumonia, focal nephritis, reactive spleen myelosis, reactive intravascular polymorphocellular cytosis CID Syndrome phenomenon of erythrocyte aggregation, modified gastrointestinal and intrapulmonary hemorrhage. Decompensated hepato-renal failure: bilirubinemia - marked polyorganic jaundice, of the mucous membranes, of the skin; renal nephronecrosis. Moderate polyorganic anemia. Toxiccirculatory encephalopathy edema and focal ischemia. Toxicdystrophy and polyorganic syndrome. This case was considered as serious due to death and hospitalization. The authors commented "According to the morphopathological peculiarities attested macroscopically and microscopically, it was found that the morbid status that caused the death of the child was determined by a main disease combined with 2 pathologies characterized by malformations of the hepatobiliary system, with infection caused by hepatitis B virus (HBV - HBsAg positive more than 3000 IU), manifested by hepatocellular sm polymorphs and subtotal and advanced acute alterative-necrotic changes of the liver, and by small malformations of the bile ducts - atresia of the bile duct, complicated by severe secondary syndrome of intrahepatic cholestasis, aggravated by infection hepatic viral B. Subsequently, the disease was complicated by subtotal acute necrotic pancreatitis, immunological distress, and virotic-bacterial sepsis seconded by SCID with the onset of hepato-renal-pulmonary failure syndrome and toxic-circulatory encephalopathy, which resulted in death". This article is not available for regulatory submission due to copyright restriction.; Reported Cause(s) of Death: jaundice; hepatitis B; Bile duct atresia; Acute necrotic pancreatitis; bacterial sepsis; tracheobronchitis; myocarditis; pneumonia; focal nephritis; pulmonary hemorrhage


VAERS ID: 896971 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-10-06
Onset:2020-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UNK / UNK - / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH UNK / UNK - / SC
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Condition aggravated, Death, Mood altered, Oxygen saturation decreased, Paroxysmal arrhythmia, Respiratory failure, Supraventricular tachycardia
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), 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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-10-11
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201010; Test Name: Oxygen concentration; Result Unstructured Data: (Test Result:Depressed value,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: JPGLAXOSMITHKLINEJP2020JP

Write-up: Supraventricular tachycardia; Paroxysmal arrhythmia; Respiratory failure/ Acute respiratory failure; Condition aggravated; Bad mood; This case was reported by a physician via regulatory authority and described the occurrence of acute respiratory failure in a infant patient who received Rotavirus vaccine for prophylaxis. Co-suspect products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) for prophylaxis and HEPATITIS B VACCINE (BIMMUGEN) for prophylaxis. On 6th October 2020, the patient received Rotavirus vaccine (oral), ACTHIB (subcutaneous), PREVENAR 13 (subcutaneous) and BIMMUGEN (subcutaneous). On 6th October 2020, less than a day after receiving Rotavirus vaccine, the patient experienced bad mood, paroxysmal supraventricular tachycardia (serious criteria hospitalization and life threatening), and paroxysmal arrhythmia (serious criteria hospitalization and GSK medically significant). On 10th October 2020, the patient experienced acute respiratory failure (serious criteria death and GSK medically significant) and condition aggravated. On an unknown date, the outcome of the acute respiratory failure was fatal and the outcome of the paroxysmal supraventricular tachycardia was not recovered/not resolved and the outcome of the paroxysmal arrhythmia was recovered/resolved and the outcome of the bad mood was recovering/resolving and the outcome of the condition aggravated was unknown. The patient died on 11th October 2020. The reported cause of death was acute respiratory failure. It was unknown if the reporter considered the acute respiratory failure, paroxysmal supraventricular tachycardia, paroxysmal arrhythmia, bad mood and condition aggravated to be related to Rotavirus vaccine. Additional details: The patient''s age and gender were unknown. Age group was not reported but selected as infant as per vaccine indication. Age at vaccination was not reported. The patient had no concurrent disease or past medical history. The patient had no past drug adverse reaction history. No special notes of allergy. Suspect drugs included rotavirus vaccine (1 tube, route: oral), ACTHIB (1 vial, route: subcutaneous injection), PREVENAR 13 (1 syringe, route: subcutaneous injection), and BIMMUGEN (1 vial route: subcutaneous injection). The lot number of rotavirus vaccine was unknown. These four vaccines were given on 6 October 2020, and after the patient returned home, the patient got into a bad mood. At night on the same day, the patient developed supraventricular tachycardia. After being brought to the emergency outpatient section of another hospital, the patient was transferred and emergently admitted to the reporting hospital. On 7 October 2020, arrhythmia attack occurred again during the night but did not occur thereafter. Arrhythmia attack was controlled with oral medications, and improvement in the condition of bad mood and the laboratory data was noted. On 10 October 2020, a decrease in oxygen concentration and respiratory failure suddenly occurred. Emergency procedures and intensive care management were conducted, but the patient''s condition was aggravated. On 11 October 2020, the patient passed away. Other procedures or diagnoses that could have an influence on onset of adverse reaction and others: No The reporter considered the tachycardia attack to be serious (criteria: life-threatening) and the respiratory failure to be serious (death). The outcome of the tachycardia attack was not recovered/not resolved as of 11 October 2020. The outcome of the respiratory failures was death on 11 October 2020. According to the physician, the causal relationship between the death and rotavirus vaccine, ACTHIB, PREVENAR 13, and BIMMUGEN was unknown. The physician stated that the patient had no past medical history, and after receiving vaccination, the patient got into a bad mood and developed arrhythmia attack. After the admittance to the reporting hospital, the patient''s condition was stable, and improvement in the arrhythmia attack and the condition of bad mood was noted. The causality of the acute respiratory failure and the death with the vaccination (rotavirus vaccine, ACTHIB, PREVENAR 13, and BIMMUGEN) was unknown because the events occurred four days after the vaccination was performed, and other relevant causes were also unknown.; Reported Cause(s) of Death: Respiratory failure/ Acute respiratory failure


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