chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Immunodeficiency, Immunoglobulin therapy, Immunology test, Immunology test abnormal, Natural killer cell count
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 10-year-old patient of unknown gender. The patient's concurrent condition included ataxia telangiectasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 18 months, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin where the rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 3085 cells/uL, CD4 count 1091 cells/uL, CD19 count 0 cells/uL (post-rituximab) and natural killer (NK) cell count 560 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with abatacept and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. The patient have slowed in the progression of lesions but and lost rubella in skin on biopsy but subsequently bones were involved At the time of the report, the final outcome of the rubella was unknown but the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA003143 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA003143:
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Polymerase chain reaction positive, Pyoderma gangrenosum, Rubella, Rubivirus test positive, Skin lesion
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 10-year-old patient of unknown gender. The patient's concurrent condition included ataxia telangiectasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 18 months, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin where the rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 3085 cells/uL, CD4 count 1091 cells/uL, CD19 count 0 cells/uL (post-rituximab) and natural killer (NK) cell count 560 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with abatacept and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. The patient have slowed in the progression of lesions but and lost rubella in skin on biopsy but subsequently bones were involved At the time of the report, the final outcome of the rubella was unknown but the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA003143 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA003143:
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: T-lymphocyte count normal, Vaccination complication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 10-year-old patient of unknown gender. The patient's concurrent condition included ataxia telangiectasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 18 months, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin where the rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 3085 cells/uL, CD4 count 1091 cells/uL, CD19 count 0 cells/uL (post-rituximab) and natural killer (NK) cell count 560 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with abatacept and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. The patient have slowed in the progression of lesions but and lost rubella in skin on biopsy but subsequently bones were involved At the time of the report, the final outcome of the rubella was unknown but the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA003143 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA003143:
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes decreased, Condition aggravated, Death
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Sex: U
Vaccine: MMR
Symptoms: Dermatitis, Dermatitis psoriasiform, Finger amputation, Hepatitis, Immunodeficiency
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Sex: U
Vaccine: MMR
Symptoms: Immunoglobulin therapy, Immunohistochemistry, Immunology test, Immunology test abnormal, Natural killer cell count
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Sex: U
Vaccine: MMR
Symptoms: Polymerase chain reaction positive, Progressive multifocal leukoencephalopathy, Pyoderma gangrenosum, Rubella, Rubivirus test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Sex: U
Vaccine: MMR
Symptoms: T-lymphocyte count decreased, Vaccination complication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes decreased, Dermatitis, Dermatitis psoriasiform
Clinical narrative: This literature marketed report has been received from the authors of a published literature article,  and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included Coronin1A, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 3 years and 5.7 years, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin and underlying bone. The rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 464 cells/uL, CD4 count was 224 cells/uL, CD19 count was 24 cells/uL and natural killer (NK) cell count was 144 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient received antimicrobial treatment with cotrimoxazole, azithromycin, fluconazole, amoxicillin (+) clavulanic acid, ciprofloxacin; immune modulatory treatment with topical steroids and intravenous immunoglobulin (IVIG). There was no improvement after these treatments. Surgical excision was performed, but with local recurrence. Nitazoxanide was used for 4 months largely as salvage therapy in this extremely ill patient but with no improvement. At the time of this report, the outcome of the rubella was unknown and the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA003143, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Immunodeficiency, Immunoglobulin therapy, Immunology test, Immunology test abnormal, Natural killer cell count
Clinical narrative: This literature marketed report has been received from the authors of a published literature article,  and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included Coronin1A, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 3 years and 5.7 years, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin and underlying bone. The rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 464 cells/uL, CD4 count was 224 cells/uL, CD19 count was 24 cells/uL and natural killer (NK) cell count was 144 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient received antimicrobial treatment with cotrimoxazole, azithromycin, fluconazole, amoxicillin (+) clavulanic acid, ciprofloxacin; immune modulatory treatment with topical steroids and intravenous immunoglobulin (IVIG). There was no improvement after these treatments. Surgical excision was performed, but with local recurrence. Nitazoxanide was used for 4 months largely as salvage therapy in this extremely ill patient but with no improvement. At the time of this report, the outcome of the rubella was unknown and the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA003143, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Osteitis, Polymerase chain reaction positive, Pyoderma gangrenosum, Rubella, Rubivirus test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article,  and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included Coronin1A, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 3 years and 5.7 years, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin and underlying bone. The rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 464 cells/uL, CD4 count was 224 cells/uL, CD19 count was 24 cells/uL and natural killer (NK) cell count was 144 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient received antimicrobial treatment with cotrimoxazole, azithromycin, fluconazole, amoxicillin (+) clavulanic acid, ciprofloxacin; immune modulatory treatment with topical steroids and intravenous immunoglobulin (IVIG). There was no improvement after these treatments. Surgical excision was performed, but with local recurrence. Nitazoxanide was used for 4 months largely as salvage therapy in this extremely ill patient but with no improvement. At the time of this report, the outcome of the rubella was unknown and the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA003143, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Surgery, T-lymphocyte count decreased, Vaccination complication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article,  and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included Coronin1A, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 3 years and 5.7 years, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin and underlying bone. The rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 464 cells/uL, CD4 count was 224 cells/uL, CD19 count was 24 cells/uL and natural killer (NK) cell count was 144 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient received antimicrobial treatment with cotrimoxazole, azithromycin, fluconazole, amoxicillin (+) clavulanic acid, ciprofloxacin; immune modulatory treatment with topical steroids and intravenous immunoglobulin (IVIG). There was no improvement after these treatments. Surgical excision was performed, but with local recurrence. Nitazoxanide was used for 4 months largely as salvage therapy in this extremely ill patient but with no improvement. At the time of this report, the outcome of the rubella was unknown and the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA003143, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, Bone marrow disorder, CD4 lymphocytes decreased, Death
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient's death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender's Comments: US-009507513-1902USA003143.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Dermatitis, Dermatitis psoriasiform, Hepatitis, Immunodeficiency, Immunoglobulin therapy
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient's death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender's Comments: US-009507513-1902USA003143.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Immunology test, Immunology test abnormal, Inflammation, Laryngeal inflammation, Natural killer cell count
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient's death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender's Comments: US-009507513-1902USA003143.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Nephritis, Polymerase chain reaction positive, Progressive multifocal leukoencephalopathy, Pyoderma gangrenosum, Rubella
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient's death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender's Comments: US-009507513-1902USA003143.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Rubivirus test positive, Skin lesion, Stomatitis, T-lymphocyte count decreased, Vaccination complication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient's death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender's Comments: US-009507513-1902USA003143.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 11-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously, lot# R008393, expiration date 20-MAR-2020 (exact dose, frequency and site of administration were not reported) for prophylaxis. Vaccine was diluted with properly stored sterile diluent. Temperature excursion was detected by digital data logger. No details were provided. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA005484.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 11-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously, lot # R008393, expiration date 20-MAR-2020 (exact dose, frequency and site of administration were not reported) for prophylaxis. Vaccine was diluted with properly stored sterile diluent. Temperature excursion was detected by digital data logger. No details were provided. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA005350.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Somnolence, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for 1st dose refer case US2019023148). On 30th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, fatigue and sleepiness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, fatigue and sleepiness were recovered/resolved. It was unknown if the reporter considered the pain in arm, fatigue and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The patient received SHINGRIX on an unknown arm. The patient experienced some fatigue, was sleepy and arm soreness.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in bed for a day. This case has been linked with US2019GSK022776 and US2019GSK022778, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 9 hrs after receiving SHINGRIX, the patient experienced shivering. The patient was treated with ADVIL. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced extreme shivering during night approximately 9 to 10 hours after receiving SHINGRIX vaccine. The shivering was subsided after taking ADVIL. (Approx 45 min. after taking the ADVIL). The shivering was lasted approximately 2 hours from 1:30 to 3:30 am. The reporter was asking could the drug be the cause. The reporter said should they expect a similar reaction after taking the 2nd shot. The reporter asked was it safe to take the 2nd shot if the 1st causes the shivering.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, nausea, fatigue and injection site pain post vaccination. All the symptoms listed, required the patient to take 2 days of sick leave from work. The patient fully recovered after 3 to 4 days with no prolonged symptoms. This case has been linked to case US2019GSK023610, US2019GSK023609, US2019GSK023611 and US2019GSK023600, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received few years back before the date of reporting). Concurrent medical conditions included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced shingles and condition aggravated. On an unknown date, the outcome of the shingles and condition aggravated were unknown. It was unknown if the reporter considered the shingles and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's information, batch number, expiration date were unavailable. The patient had ZOSTAVAX a few years back, and recently had a shingles outbreak. The patient still had signs and symptoms of it, when she was given dose of SHINGRIX. After a couple weeks, she had a further outbreak. The patient asked reporter if she should have had that new dose. The reporter told her that he did not think she should have. The reporter felt it should have been put off awhile. No phone number was available, agent was unable to contact for additional details.