chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Back pain, Flank pain, Injection site haemorrhage, Injection site pain, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received PREVNAR 13; batch number unknown, intramuscular in right arm on 12Dec2018 at a single dose for immunization. Medical history was reported as none. Concomitant medication included Influenza Vaccine on 12Dec2018 for immunization. On 12Dec2018, the patient got the flu shot in his left arm and the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his right arm which bled a lot. He was fine the first few weeks but on 01Jan2019, patient developed pain in his lower back, side and lateral muscles, across his shoulders and underneath his clavicle. The injection site was sore initially and the muscle pain from an unknown date was getting a little better. The patient has been feeling muscle weakness on an unknown date, and on 01Jan2019, pain emanating from the injection site down through his back and sides of his chest wall and his core and it seems to be coming from injection site of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot not the Flu shot, though it has been going on for several weeks now. The outcome of the events injection site was sore initially / pain emanating from the injection site down through his back and sides of his chest wall and his core was not recovered, while outcome of the events got the flu shot in his left arm and the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his right arm which bled a lot, pain in his lower back, side and lateral muscles, across his shoulders and underneath his clavicle, and feeling muscle weakness was unknown.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Musculoskeletal pain, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received PREVNAR 13; batch number unknown, intramuscular in right arm on 12Dec2018 at a single dose for immunization. Medical history was reported as none. Concomitant medication included Influenza Vaccine on 12Dec2018 for immunization. On 12Dec2018, the patient got the flu shot in his left arm and the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his right arm which bled a lot. He was fine the first few weeks but on 01Jan2019, patient developed pain in his lower back, side and lateral muscles, across his shoulders and underneath his clavicle. The injection site was sore initially and the muscle pain from an unknown date was getting a little better. The patient has been feeling muscle weakness on an unknown date, and on 01Jan2019, pain emanating from the injection site down through his back and sides of his chest wall and his core and it seems to be coming from injection site of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot not the Flu shot, though it has been going on for several weeks now. The outcome of the events injection site was sore initially / pain emanating from the injection site down through his back and sides of his chest wall and his core was not recovered, while outcome of the events got the flu shot in his left arm and the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his right arm which bled a lot, pain in his lower back, side and lateral muscles, across his shoulders and underneath his clavicle, and feeling muscle weakness was unknown.
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is the 1st of 2 reports. A child of an unspecified age and gender started to receive TRUMENBA, NDC: 0005010001, Lot number: W95359, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the child had a severe headache and was taken to the emergency room. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2019059790 Same reporter/drugs/events, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Blepharospasm, Diarrhoea, Dyskinesia, Peripheral swelling, Seizure like phenomena
Clinical narrative: This is a spontaneous report from a contactable physician. A 26-month-old patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration, on 28Jan2019, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. One week after vaccination, in Feb2019, the patient experienced seizure like activities such as jerky movements and eye switching, diarrhea, swelling of the arm. Outcome of the events was unknown. Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that seizure like activities such as jerky movements and eye switching are related to PREVNAR 13 administration cannot be excluded.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age and gender started to receive PREVNAR 13, lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) stings going into the arm on an unspecified date. The outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Local reaction
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received the first dose of TRUMENBA, via an unspecified route of administration on 04Feb2019 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The reporter's daughter (patient) received her first dose of meningococcal group B rlp2086 on Monday, 04Feb2019, and she noticed yesterday afternoon (04Feb2019) she had a large red circle around the injection site. The reporter took the patient back to the doctor today (05Feb2019) and was told that it was a local reaction that can happen with any shot and not a reaction to the meningococcal group B rlp2086 vaccine itself. The outcome of the event was unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chest X-ray normal, Echocardiogram abnormal, Influenza virus test negative
Clinical narrative: Patient called and reported symptoms following morning that started during the night - vomiting, HR = 130, weakness, temp greater than 100. Pt. was advised to go to the ER.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus tachycardia, Supraventricular extrasystoles, Vomiting
Clinical narrative: Patient called and reported symptoms following morning that started during the night - vomiting, HR = 130, weakness, temp greater than 100. Pt. was advised to go to the ER.
Age: 24.0
Sex: M
Vaccine: DTP
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on my arms and torso in small to large patches, that itch. I've had no treatment for it yet.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever, chills, muscle aches, headache, upset stomach, sore throat, shortness of breath, extreme fatigue, odd taste in mouth.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Taste disorder
Clinical narrative: Fever, chills, muscle aches, headache, upset stomach, sore throat, shortness of breath, extreme fatigue, odd taste in mouth.
Age: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Fatigue, Influenza virus test negative, Loss of consciousness
Clinical narrative: Extreme fatigue, my daughter passed completely out and her lips turned blue within a couple seconds. Took her to the doctor, they said she tested positive for the flu.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Please question employee.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Dyspnoea, Erythema, Hyperhidrosis
Clinical narrative: Patient describes reaction: Red swollen knot about the size of the circle on a coffee cup. She stated other side effects: bones hurt, feels flu like, left side of face red and swollen, body hurts, chills, sweating, runny nose, and having a hard time breathing. Talked to her about monitoring and putting a cool pack on the area. If it gets worse to contact her doctor or if have any major reactions to go the the doctor or ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nodule, Pain, Rhinorrhoea, Swelling
Clinical narrative: Patient describes reaction: Red swollen knot about the size of the circle on a coffee cup. She stated other side effects: bones hurt, feels flu like, left side of face red and swollen, body hurts, chills, sweating, runny nose, and having a hard time breathing. Talked to her about monitoring and putting a cool pack on the area. If it gets worse to contact her doctor or if have any major reactions to go the the doctor or ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Patient describes reaction: Red swollen knot about the size of the circle on a coffee cup. She stated other side effects: bones hurt, feels flu like, left side of face red and swollen, body hurts, chills, sweating, runny nose, and having a hard time breathing. Talked to her about monitoring and putting a cool pack on the area. If it gets worse to contact her doctor or if have any major reactions to go the the doctor or ER.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Red, painful hard lump at Injection site.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Projectile Vomit and runny diarrhea, lasted 3 days. Hospitalized.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Awoke day after vaccine with small bumps near inj. site. 2 days after vaccine developed whole body rash that came and went. No fevers.
Age: 4.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Information has been received from a nurse referring to 4 years old patient of unknown gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 18-JAN-2019, the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot # R022249 and expiration date 16-APR-2020; frequency and route were not provided) for prophylaxis instead of PREVNAR 13 (wrong product administered). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In 2006, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated at a skin institute for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is not recovered/not resolved. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In 2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a community care facility as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated by a physician at a community care facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is not recovered/not resolved. The causality of the events is related. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes decreased, Death, Dermatitis
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-month-old patient of unknown gender. The patient's concurrent condition included DNA Ligase IV syndrome, 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 12 months, 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 and intestine but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) only in skin and liver. 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 380 cells/uL, CD4 count 73 cells/uL, CD19 count 21 cells/uL and natural killer (NK) cell count 432 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with topical steroids and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Nitazoxanide was given for weeks with no improvement in skin lesions. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions, but on an unknown date the patient died. The patient's death was related to HSCT. 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 the HSCT procedure. This is one of seven reports derived from the same literature article (linked mars cases 1902USA004783, 1902USA004784, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA004783: US-009507513-1902USA004784: US-009507513-1902USA004785: US-009507513-1902USA004786: US-009507513-1902USA004787: US-009507513-1902USA004788:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Dermatitis psoriasiform, Gastrointestinal inflammation, 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-month-old patient of unknown gender. The patient's concurrent condition included DNA Ligase IV syndrome, 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 12 months, 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 and intestine but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) only in skin and liver. 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 380 cells/uL, CD4 count 73 cells/uL, CD19 count 21 cells/uL and natural killer (NK) cell count 432 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with topical steroids and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Nitazoxanide was given for weeks with no improvement in skin lesions. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions, but on an unknown date the patient died. The patient's death was related to HSCT. 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 the HSCT procedure. This is one of seven reports derived from the same literature article (linked mars cases 1902USA004783, 1902USA004784, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA004783: US-009507513-1902USA004784: US-009507513-1902USA004785: US-009507513-1902USA004786: US-009507513-1902USA004787: US-009507513-1902USA004788:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Immunology test, Immunology test abnormal, Natural killer cell count, Polymerase chain reaction positive, Pyoderma gangrenosum
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-month-old patient of unknown gender. The patient's concurrent condition included DNA Ligase IV syndrome, 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 12 months, 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 and intestine but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) only in skin and liver. 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 380 cells/uL, CD4 count 73 cells/uL, CD19 count 21 cells/uL and natural killer (NK) cell count 432 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with topical steroids and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Nitazoxanide was given for weeks with no improvement in skin lesions. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions, but on an unknown date the patient died. The patient's death was related to HSCT. 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 the HSCT procedure. This is one of seven reports derived from the same literature article (linked mars cases 1902USA004783, 1902USA004784, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA004783: US-009507513-1902USA004784: US-009507513-1902USA004785: US-009507513-1902USA004786: US-009507513-1902USA004787: US-009507513-1902USA004788:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Rubella, Rubivirus test positive, Skin lesion, Stem cell transplant, T-lymphocyte count decreased
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-month-old patient of unknown gender. The patient's concurrent condition included DNA Ligase IV syndrome, 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 12 months, 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 and intestine but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) only in skin and liver. 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 380 cells/uL, CD4 count 73 cells/uL, CD19 count 21 cells/uL and natural killer (NK) cell count 432 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with topical steroids and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Nitazoxanide was given for weeks with no improvement in skin lesions. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions, but on an unknown date the patient died. The patient's death was related to HSCT. 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 the HSCT procedure. This is one of seven reports derived from the same literature article (linked mars cases 1902USA004783, 1902USA004784, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA004783: US-009507513-1902USA004784: US-009507513-1902USA004785: US-009507513-1902USA004786: US-009507513-1902USA004787: US-009507513-1902USA004788:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-month-old patient of unknown gender. The patient's concurrent condition included DNA Ligase IV syndrome, 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 12 months, 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 and intestine but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) only in skin and liver. 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 380 cells/uL, CD4 count 73 cells/uL, CD19 count 21 cells/uL and natural killer (NK) cell count 432 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with topical steroids and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Nitazoxanide was given for weeks with no improvement in skin lesions. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions, but on an unknown date the patient died. The patient's death was related to HSCT. 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 the HSCT procedure. This is one of seven reports derived from the same literature article (linked mars cases 1902USA004783, 1902USA004784, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA004783: US-009507513-1902USA004784: US-009507513-1902USA004785: US-009507513-1902USA004786: US-009507513-1902USA004787: US-009507513-1902USA004788:
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes decreased, Cryotherapy, Dermatitis
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 30-month-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 medicines were not reported. On an unknown date at age of 24 months, the patient was vaccinated with a dose of M-M-R II (exact 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 genome. The patient's CD3 count was 240 cells/uL, CD4 count 153 cells/uL, CD19 count 77 cells/uL and natural killer (NK) cell count 184 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient underwent antimicrobial treatment (cryotherapy, erythromycin, imiquimod) and immune modulatory treatment (tacrolimus cream, hydroxychloroquine, topical steroids). Both treatments were unsuccessful, but prednisone given orally led to some improvement. The patient was additionally treated with intravenous immunoglobulin (IVIG) still without improvement. Nitazoxanide was used for one year, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Granulomas progressed with persistent rubella on repeated biopsy. At the time of the report, the patient did not recover from the rubella. 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 intravenous immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked 902USA003143, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Dermatitis psoriasiform, Immunodeficiency, Immunoglobulin therapy, Immunology test, Immunology test abnormal
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 30-month-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 medicines were not reported. On an unknown date at age of 24 months, the patient was vaccinated with a dose of M-M-R II (exact 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 genome. The patient's CD3 count was 240 cells/uL, CD4 count 153 cells/uL, CD19 count 77 cells/uL and natural killer (NK) cell count 184 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient underwent antimicrobial treatment (cryotherapy, erythromycin, imiquimod) and immune modulatory treatment (tacrolimus cream, hydroxychloroquine, topical steroids). Both treatments were unsuccessful, but prednisone given orally led to some improvement. The patient was additionally treated with intravenous immunoglobulin (IVIG) still without improvement. Nitazoxanide was used for one year, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Granulomas progressed with persistent rubella on repeated biopsy. At the time of the report, the patient did not recover from the rubella. 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 intravenous immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked 902USA003143, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Natural killer cell count, 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 30-month-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 medicines were not reported. On an unknown date at age of 24 months, the patient was vaccinated with a dose of M-M-R II (exact 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 genome. The patient's CD3 count was 240 cells/uL, CD4 count 153 cells/uL, CD19 count 77 cells/uL and natural killer (NK) cell count 184 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient underwent antimicrobial treatment (cryotherapy, erythromycin, imiquimod) and immune modulatory treatment (tacrolimus cream, hydroxychloroquine, topical steroids). Both treatments were unsuccessful, but prednisone given orally led to some improvement. The patient was additionally treated with intravenous immunoglobulin (IVIG) still without improvement. Nitazoxanide was used for one year, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Granulomas progressed with persistent rubella on repeated biopsy. At the time of the report, the patient did not recover from the rubella. 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 intravenous immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked 902USA003143, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Age: 2.0
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 30-month-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 medicines were not reported. On an unknown date at age of 24 months, the patient was vaccinated with a dose of M-M-R II (exact 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 genome. The patient's CD3 count was 240 cells/uL, CD4 count 153 cells/uL, CD19 count 77 cells/uL and natural killer (NK) cell count 184 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient underwent antimicrobial treatment (cryotherapy, erythromycin, imiquimod) and immune modulatory treatment (tacrolimus cream, hydroxychloroquine, topical steroids). Both treatments were unsuccessful, but prednisone given orally led to some improvement. The patient was additionally treated with intravenous immunoglobulin (IVIG) still without improvement. Nitazoxanide was used for one year, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Granulomas progressed with persistent rubella on repeated biopsy. At the time of the report, the patient did not recover from the rubella. 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 intravenous immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked 902USA003143, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes normal, Dermatitis, Dermatitis psoriasiform
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 39-month-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 unknown dates at age of 12 and 17 months, 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 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 3074 cells/uL, CD4 count 2450 cells/uL, CD19 count 178 cells/uL and natural killer (NK) cell count 1158 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with topical steroids, non-steroid anti-inflammatory drugs (NSAID) and intravenous immunoglobulin (IVIG) with no improvement. Nitazoxanide was used for 5 months, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions. 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 the HSCT. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA003143, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 1.0
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 39-month-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 unknown dates at age of 12 and 17 months, 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 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 3074 cells/uL, CD4 count 2450 cells/uL, CD19 count 178 cells/uL and natural killer (NK) cell count 1158 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with topical steroids, non-steroid anti-inflammatory drugs (NSAID) and intravenous immunoglobulin (IVIG) with no improvement. Nitazoxanide was used for 5 months, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions. 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 the HSCT. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA003143, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 1.0
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 39-month-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 unknown dates at age of 12 and 17 months, 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 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 3074 cells/uL, CD4 count 2450 cells/uL, CD19 count 178 cells/uL and natural killer (NK) cell count 1158 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with topical steroids, non-steroid anti-inflammatory drugs (NSAID) and intravenous immunoglobulin (IVIG) with no improvement. Nitazoxanide was used for 5 months, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions. 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 the HSCT. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA003143, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Stem cell transplant, 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 39-month-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 unknown dates at age of 12 and 17 months, 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 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 3074 cells/uL, CD4 count 2450 cells/uL, CD19 count 178 cells/uL and natural killer (NK) cell count 1158 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with topical steroids, non-steroid anti-inflammatory drugs (NSAID) and intravenous immunoglobulin (IVIG) with no improvement. Nitazoxanide was used for 5 months, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions. 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 the HSCT. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA003143, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes normal, Dermatitis, Dermatitis psoriasiform
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: