chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Local reaction with redness and swelling to Pentacel. Also, about 3 hours of inconsoleable crying. Fussiness over next three days. Site of other vaccines WNL.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Acute myeloid leukaemia, Injection site swelling, Neutropenia, Pyrexia
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Impaired healing, Myeloid leukaemia, Neutropenia, Vaccinia
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Biopsy bone marrow abnormal, Blood product transfusion, Blood test abnormal, Chemotherapy, Clostridial infection
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cow pox, Culture positive, Endotracheal intubation, Gangrene, Haemodialysis
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Impaired healing, Injection site erythema, Injection site induration, Injection site scab, Intensive care
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Leg amputation, Lung infection pseudomonal, Multi-organ failure, Myeloid leukaemia, Neutropenia
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Perirectal abscess, Polymerase chain reaction, Pseudomonal sepsis, Staphylococcal infection, Vaccination complication
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Vaccinia
Clinical narrative: **Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site mass, Rash
Clinical narrative: Severe raised and hot rash on torso. Raised hard bump at site of shot all occurred two weeks after shot.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bacteraemia, Blood creatinine increased, Body temperature increased, C-reactive protein normal
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Gait disturbance, Headache, Incisional drainage, Joint swelling
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Nausea, Osteomyelitis, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin warm, Staphylococcal infection, Tenderness, Weight bearing difficulty
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood creatinine increased, Body temperature increased, C-reactive protein normal, Dizziness
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Headache, Incisional drainage, Joint injury, Joint swelling
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb injury, Lumbar puncture, Nausea, Osteomyelitis, Pain
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Skin warm, Staphylococcal bacteraemia, Tenderness
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abnormal behaviour, Affective disorder, Aggression, Anxiety disorder, Educational problem
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study for which Sanofi Pasteur is not a sponsor. "The patient is a 10 year old female patient in the fifth grade. She reports having lots of trouble controlling her temper. She was arguing with her mother and grandmother and did not believe them when they said that they couldn't go to church because their ride was sick and could not drive them and so the patient threw a fit, barricaded herself in her room and broke a lot of mirrors and windows. The patient also hit her grandmother repeatedly and scratched her mother drawing blood. They report that the patient has been having fits and tantrums every week and it has been escalating. The patient has been hitting walls, getting very argumentative, they do report that the patient gets bullied a lot at school and she is made fun of because of how she looks and pushed into walls. As a result, the patient has tried to have friendship with teachers. She used to be on the honor roll, but she is failing all the classes this year. They report that ADHD is improved on CONCERTA, but again her school performance has worsened quite a bit. The patient lives with her mother and 6 year old brother. The patient's parents divorced when the patient was 6 and then the mother remarried and just divorced the step dad year ago, the patient apparently is very resentful about this and blames her mother and says that she should remarry any guy. They do report that the stepfather was very strict and punished the patient with a belt leaving red marks, but no bruises and the patient was never sexually abused. The patient was admitted to a child psychiatry unit from November 12 to November 19, 2008. Final diagnosis: Behavioral problems with mood and anxiety disorders." Past medical history included ADHD and asthma. The patient was taking CONCERTA, Clonidine, RISPERDAL and ZOLOFT. The patient had received FLUZONE on 03 October 2008. The date of the SAE was reported as 12 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number: 2009-00622.