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This is VAERS ID 610282

History of Changes from the VAERS Wayback Machine

First Appeared on 12/14/2015

VAERS ID: 610282
VAERS Form:
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 0 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA00746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 1/14/2016

VAERS ID: 610282 Before After
VAERS Form:
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 0 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA00746 WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 9/14/2017

VAERS ID: 610282 Before After
VAERS Form:(blank) 1
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 0 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 0 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 2/14/2018

VAERS ID: 610282 Before After
VAERS Form:1
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 6/14/2018

VAERS ID: 610282 Before After
VAERS Form:1
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 8/14/2018

VAERS ID: 610282 Before After
VAERS Form:1
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 9/14/2018

VAERS ID: 610282 Before After
VAERS Form:1
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


Changed on 10/14/2018

VAERS ID: 610282 Before After
VAERS Form:1
Age:1.1
Sex:Female
Location:Unknown
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2015-11-17
Entered:2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Biopsy skin abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Hepatic failure, Herpes virus infection, Jaundice, Leukocytosis, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Platelet count decreased, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Skin lesion, White blood cell count increased, General physical health deterioration, Autopsy, Eschar, Ophthalmological examination abnormal, Lymphoblast count, Immunohistochemistry, Blood test abnormal, Viral test negative, Rotavirus test negative, Transfusion, Immunoglobulin therapy, Varicella virus test positive, Rubivirus test positive, Rubulavirus test positive, Autoimmune haemolytic anaemia, Immune thrombocytopenic purpura, Varicella zoster virus infection, Polymerase chain reaction positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC 'Split Type': WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.

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