chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening 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 on 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 come 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 urgent care clinic for worsening of left knee pain. The pain was sharp, locate 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 been 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 persistent 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 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. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening 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 on 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 come 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 urgent care clinic for worsening of left knee pain. The pain was sharp, locate 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 been 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 persistent 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 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. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening 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 on 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 come 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 urgent care clinic for worsening of left knee pain. The pain was sharp, locate 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 been 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 persistent 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 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. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening 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 on 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 come 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 urgent care clinic for worsening of left knee pain. The pain was sharp, locate 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 been 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 persistent 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 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 the 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 vaccines. The reporter for this case is the same as in case number: 2009-00622.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase increased, Basophil count decreased, Blood albumin normal
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood alkaline phosphatase increased, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase increased, Blood creatinine increased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood glucose normal, Blood osmolarity decreased, Blood potassium decreased, Blood sodium normal, Blood urea normal
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Carbon dioxide increased, Chest discomfort, Chest pain, Eosinophil count increased, Haematocrit normal
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Haemoglobin normal, Lymphocyte count normal, Mean cell haemoglobin concentration, Mean cell haemoglobin normal, Mean cell volume
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Mean platelet volume normal, Monocyte count increased, Neutrophil count normal, Platelet count normal, Protein total normal
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Red blood cell abnormality, Red cell distribution width, Troponin increased, White blood cell count increased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Anion gap normal, Axillary pain, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB increased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Blood glucose normal, Blood osmolarity decreased, Blood potassium normal
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chest discomfort, Chest pain
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Injection site pain, Myopericarditis, Troponin I increased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Anion gap increased, Axillary pain, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB increased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Blood glucose normal, Blood osmolarity decreased, Blood potassium decreased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Chest discomfort
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU3, SMALL, TYP, FLU3, SMALL, TYP, FLU3, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram abnormal, Injection site pain, Myopericarditis, Troponin I increased
Clinical narrative: This case was received on 26 June 2009 via QScan search, under reference number 342176. A 22-year-old male received ACAM2000, lot number W04003A, TYPHIM VI, lot number B04242, and FLUZONE, U2941AA on 04 March 2009. Eleven days later, the patient developed tightness and intermittent pain in his chest. He was hospitalized and diagnosed with myopericarditis. He also experienced increased tenderness at the injection site and left axilla pain. Records from the patient's two-day hospital stay include the following test results: an abnormal electrocardiogram; CK, 450; CK MMB, 14.9; Troponin I, 6.14; Glucose, 96; Urea nitrogen, 10; CREAT, 1.3; BUN/CREATININE, 7.7; Sodium, 140; Potassium, 3.4; Chloride, 99; Carbon dioxide, 29; anion GAP 4, 15; Osmolality, Cal, 269; and Calcium, 9.6. The patient was treated with aspirin (ASA). He remained stable and his pain decreased. The patient was discharged to home with a recommendation for cardiac follow-up. The patient was reported to have recovered from the event. The reports states that the patient went to the hospital on 15 March 2009. However, the medical records referenced in the report are for a hospitalization on 16 March 2009 and 17 March 2009. List of Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal disorder, Gestational diabetes, Glucose tolerance test abnormal
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis. There were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as Case number 2009-01355.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ultrasound scan
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis. There were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as Case number 2009-01355.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal non-stress test, Gestational diabetes, Glucose tolerance test abnormal
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis. There were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as Case number 2009-01355.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neonatal disorder, Ultrasound scan
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis. There were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as Case number 2009-01355.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Computerised tomogram abnormal, Fat necrosis
Clinical narrative: This report was received from a health care professional on 16 April 2009, and refers to a serious adverse event experienced by a subject participating in a study. Subject identification number: 10808351. A previously healthy 18-year-old male subject received study product FLUZONE SV 2008-2009 (lot not reported) on 03 November 2008. On 01 December 2008, 28 days post-vaccination, he presented to the emergency room with right lower quadrant pain and nausea. A CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. The subject underwent an appendectomy, and histopathology diagnosis was follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis. He was discharged from the hospital on 02 December 2008 and prescribed VICODIN as needed for pain. Outcome was not reported. According to study investigator, the event was unrelated to FLUZONE.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Infarction, Lymphoid hyperplasia of appendix, Nausea
Clinical narrative: This report was received from a health care professional on 16 April 2009, and refers to a serious adverse event experienced by a subject participating in a study. Subject identification number: 10808351. A previously healthy 18-year-old male subject received study product FLUZONE SV 2008-2009 (lot not reported) on 03 November 2008. On 01 December 2008, 28 days post-vaccination, he presented to the emergency room with right lower quadrant pain and nausea. A CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. The subject underwent an appendectomy, and histopathology diagnosis was follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis. He was discharged from the hospital on 02 December 2008 and prescribed VICODIN as needed for pain. Outcome was not reported. According to study investigator, the event was unrelated to FLUZONE.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood amylase normal, Culture throat negative, Epstein-Barr virus test negative, Eye pain, Facial pain
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Bar virus (EBV) and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A &-haemolytic streptococci (GAS) throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous ROCEPHIN and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and TYLENOL # for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE, and the SAE was not going to be reported to VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymphadenitis, Neck pain, Photophobia, Salivary gland pain, Swelling face
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Bar virus (EBV) and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A &-haemolytic streptococci (GAS) throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous ROCEPHIN and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and TYLENOL # for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE, and the SAE was not going to be reported to VAERS. Documents held by sender: None.