chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Lethargy, Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 8 weeks old male patient with none preexisting illness and a history of seizure, fell out swing evening before visit-cried about 30 seconds, behaving normal, who on 14-SEP-2011 was vaccinated by mouth with the first dose of ROTATEQ (Lot number 670242/0920AA). Concomitant vaccine included the first dose of PREVNAR (Lot number 90670) administered IM (site unknown), PENTACEL (Lot number C3966AA) administered IM (site unknown) and hepatitis virus vaccine (unspecified). On 26-SEP-2011, primary care provider records were received for date of service from 14-SEP-2011 to 26-SEP-2011. On 15-SEP-2011, the patient presented with lethargy, blood in stool, "not himself", not eating well after immunization. Lab diagnostic records received from EDOS revealed blood culture negative, red blood cell count 3.79 M/mm3 (N), whole blood hematocrit 31.7% (L), red cell distribution width 14.9% (h), blood platelet count 565 K/mm3 (H), white blood cell count 11.7 K/mm3 (N), blood neutrophil count 37% (L), blood lymphocyte count 52% (H), blood monocyte count 9% (H), serum blood urea nitrogen test 3 mg/dL (L). An x-ray abdomen was abnormal, x-ray with radiolucent ring showed potential "air in belly" and skull x-ray was unremarkable. The patient was diagnosed with intussusception. On 26-SEP-2011, the patient was seen in follow up after hospitalization for intussusception. Exam was unremarkable. Ring-like lucency over right mid abdomen on x-ray. At the time of the report, the outcome of the patient was unknown. The patient required an emergency room visit and the reporter considered the events were serious. "Not himself", blood in stool, poor feeding, no eating well, lethargy and intussusception were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 435102. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 670242/0920AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Red blood cell count decreased, Red cell distribution width increased, Skull X-ray normal, White blood cell count normal, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 8 weeks old male patient with none preexisting illness and a history of seizure, fell out swing evening before visit-cried about 30 seconds, behaving normal, who on 14-SEP-2011 was vaccinated by mouth with the first dose of ROTATEQ (Lot number 670242/0920AA). Concomitant vaccine included the first dose of PREVNAR (Lot number 90670) administered IM (site unknown), PENTACEL (Lot number C3966AA) administered IM (site unknown) and hepatitis virus vaccine (unspecified). On 26-SEP-2011, primary care provider records were received for date of service from 14-SEP-2011 to 26-SEP-2011. On 15-SEP-2011, the patient presented with lethargy, blood in stool, "not himself", not eating well after immunization. Lab diagnostic records received from EDOS revealed blood culture negative, red blood cell count 3.79 M/mm3 (N), whole blood hematocrit 31.7% (L), red cell distribution width 14.9% (h), blood platelet count 565 K/mm3 (H), white blood cell count 11.7 K/mm3 (N), blood neutrophil count 37% (L), blood lymphocyte count 52% (H), blood monocyte count 9% (H), serum blood urea nitrogen test 3 mg/dL (L). An x-ray abdomen was abnormal, x-ray with radiolucent ring showed potential "air in belly" and skull x-ray was unremarkable. The patient was diagnosed with intussusception. On 26-SEP-2011, the patient was seen in follow up after hospitalization for intussusception. Exam was unremarkable. Ring-like lucency over right mid abdomen on x-ray. At the time of the report, the outcome of the patient was unknown. The patient required an emergency room visit and the reporter considered the events were serious. "Not himself", blood in stool, poor feeding, no eating well, lethargy and intussusception were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 435102. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 670242/0920AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Obsessive-compulsive disorder
Clinical narrative: Information has been received from a nurse concerning a 5 year old male with a history of premature baby and speech delay who on 22-JAN-2007, was vaccinated the first dose of VARIVAX, on 23-APR-2007 was vaccinated the first dose of MMR II, and on January-2011 was vaccinated the second dose of MMR II, (Lot# 666244/1058Z). On the same day the patient also vaccinated the second dose of VARIVAX, (Lot# 668471/1197Z), KINRIX and intranasal FLUMIST (Medimmune). No adverse events were reported after the first dose. 1.5 hour later after the second dose, the patient experienced "OCD" type of behavior, he was washing his toy legos and taking his clothes off stating they were dirty and would not sit in his car seat claiming it had germs. The family thought this was very disabling and interfering with his daily life. The patient had improvement this past summer but the severity had increased again. The patient had sought medical attention by office visit. The patient has been to a number of specialists: neurology, immunology and psychiatry. The nurse stated a pediatric neurologist was consulted regarding the link with vaccinations. Lab diagnostics studies were performed: "electroencephalography (EEG)" was normal; immunology records were all normal; "Rapid Strep" was positive and PANDA test was negative. The patient was given steroids, ZOLOFT and RISPERDAL, but no improvement was noted. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Electroencephalogram normal, Immunology test normal, Laboratory test normal, Obsessive-compulsive disorder, Streptococcus test
Clinical narrative: Information has been received from a nurse concerning a 5 year old male with a history of premature baby and speech delay who on 22-JAN-2007, was vaccinated the first dose of VARIVAX, on 23-APR-2007 was vaccinated the first dose of MMR II, and on January-2011 was vaccinated the second dose of MMR II, (Lot# 666244/1058Z). On the same day the patient also vaccinated the second dose of VARIVAX, (Lot# 668471/1197Z), KINRIX and intranasal FLUMIST (Medimmune). No adverse events were reported after the first dose. 1.5 hour later after the second dose, the patient experienced "OCD" type of behavior, he was washing his toy legos and taking his clothes off stating they were dirty and would not sit in his car seat claiming it had germs. The family thought this was very disabling and interfering with his daily life. The patient had improvement this past summer but the severity had increased again. The patient had sought medical attention by office visit. The patient has been to a number of specialists: neurology, immunology and psychiatry. The nurse stated a pediatric neurologist was consulted regarding the link with vaccinations. Lab diagnostics studies were performed: "electroencephalography (EEG)" was normal; immunology records were all normal; "Rapid Strep" was positive and PANDA test was negative. The patient was given steroids, ZOLOFT and RISPERDAL, but no improvement was noted. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Streptococcus test positive
Clinical narrative: Information has been received from a nurse concerning a 5 year old male with a history of premature baby and speech delay who on 22-JAN-2007, was vaccinated the first dose of VARIVAX, on 23-APR-2007 was vaccinated the first dose of MMR II, and on January-2011 was vaccinated the second dose of MMR II, (Lot# 666244/1058Z). On the same day the patient also vaccinated the second dose of VARIVAX, (Lot# 668471/1197Z), KINRIX and intranasal FLUMIST (Medimmune). No adverse events were reported after the first dose. 1.5 hour later after the second dose, the patient experienced "OCD" type of behavior, he was washing his toy legos and taking his clothes off stating they were dirty and would not sit in his car seat claiming it had germs. The family thought this was very disabling and interfering with his daily life. The patient had improvement this past summer but the severity had increased again. The patient had sought medical attention by office visit. The patient has been to a number of specialists: neurology, immunology and psychiatry. The nurse stated a pediatric neurologist was consulted regarding the link with vaccinations. Lab diagnostics studies were performed: "electroencephalography (EEG)" was normal; immunology records were all normal; "Rapid Strep" was positive and PANDA test was negative. The patient was given steroids, ZOLOFT and RISPERDAL, but no improvement was noted. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL, MMR, VARCEL, DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Abnormal behaviour, Blood immunoglobulin G normal, Cardiac murmur, Obsessive-compulsive disorder, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 5 year old male with a history of premature baby and speech delay who on 22-JAN-2007, was vaccinated the first dose of VARIVAX, on 23-APR-2007 was vaccinated the first dose of MMR II, and on January-2011 was vaccinated the second dose of MMR II, (Lot# 666244/1058Z). On the same day the patient also vaccinated the second dose of VARIVAX, (Lot# 668471/1197Z), KINRIX and intranasal FLUMIST (Medimmune). No adverse events were reported after the first dose. 1.5 hour later after the second dose, the patient experienced "OCD" type of behavior, he was washing his toy legos and taking his clothes off stating they were dirty and would not sit in his car seat claiming it had germs. The family thought this was very disabling and interfering with his daily life. The patient had improvement this past summer but the severity had increased again. The patient had sought medical attention by office visit. The patient has been to a number of specialists: neurology, immunology and psychiatry. The nurse stated a pediatric neurologist was consulted regarding the link with vaccinations. Lab diagnostics studies were performed: "electroencephalography (EEG)" was normal; immunology records were all normal; "Rapid Strep" was positive and PANDA test was negative. The patient was given steroids, ZOLOFT and RISPERDAL, but no improvement was noted. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Intra-uterine death, Maternal exposure during pregnancy, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of fetal demise in a 41-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) while pregnant. There were no concurrent medications. On 12 October 2011 at 13:00 the pregnant subject received a dose of FLUARIX at 0.5 ml in the left arm. The subject experienced vaccine exposure during pregnancy. On 20 October 2011, 8 days after vaccination with FLUARIX and at 19 weeks gestation (almost 5 months of pregnancy) the subject was at her regular obstetrician appointment and no fetal heartbeat was detected. Fetal demise was reported. The healthcare professional considered the events were clinically significant (or requiring intervention). Causality was not known. The reporter indicated that she believed there were procedures done at the hospital, but she did not know if the patient had to spend the night.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intra-uterine death, Maternal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of fetal demise in a 41-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) while pregnant. There were no concurrent medications. On 12 October 2011 at 13:00 the pregnant subject received a dose of FLUARIX at 0.5 ml in the left arm. The subject experienced vaccine exposure during pregnancy. On 20 October 2011, 8 days after vaccination with FLUARIX and at 19 weeks gestation (almost 5 months of pregnancy) the subject was at her regular obstetrician appointment and no fetal heartbeat was detected. Fetal demise was reported. The healthcare professional considered the events were clinically significant (or requiring intervention). Causality was not known. The reporter indicated that she believed there were procedures done at the hospital, but she did not know if the patient had to spend the night.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Fatigue
Clinical narrative: Deep, severe aching of most body joints, esp. legs - started day after shot in pm and increased to severe by following morning, peaking on days 3-5, then begining to decrease every day thereafter up to this date; still some mild discomfort in knees; Weakness/fatigue:  peaking as aching on days 3-5, then continues till this date to experience unusual weakness and fatigue.
Age: 37.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Activities of daily living impaired, Herpes zoster, Insomnia, Pain, Pruritus
Clinical narrative: Seasonal Flu Vaccine Administered in Left Arm.  Developed shingles rash with T6 dermatome with severe pain itchiness and inability to function due to pain, was started on Famvir by on call emergency doctor.  Rash extended and Neurontin 300 mg tid and Famvir continued for another 7 days.  Has severe shingles pain interfering with sleep and functioning.  Seen by PCP.
Age: 37.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Herpes zoster
Clinical narrative: Seasonal Flu Vaccine Administered in Left Arm.  Developed shingles rash with T6 dermatome with severe pain itchiness and inability to function due to pain, was started on Famvir by on call emergency doctor.  Rash extended and Neurontin 300 mg tid and Famvir continued for another 7 days.  Has severe shingles pain interfering with sleep and functioning.  Seen by PCP.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Asthenia, Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting for days, weakness, fever stomach pain, headaches.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Adenovirus test, Alanine aminotransferase increased, Antibody test negative, Aspartate aminotransferase increased
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood pH increased
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Blood phosphorus increased, Borrelia test negative, Brain natriuretic peptide increased, C-reactive protein increased, Carbon dioxide decreased
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac failure, Cardiomegaly, Chest X-ray abnormal, Chills, Cytomegalovirus test
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Cytomegalovirus test negative, Death, Dialysis, Dyspnoea, Echocardiogram abnormal
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Ejection fraction decreased, Epstein-Barr virus antibody positive, Extracorporeal membrane oxygenation, Fatigue, Feeling abnormal
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Fibrin D dimer, General physical health deterioration, HIV test negative, Headache, Hepatitis B core antibody negative
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Influenza, Influenza A virus test negative
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test, Intensive care, Jaundice, Left ventricular dysfunction, Lung consolidation
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Myocarditis, Neutrophil percentage increased, PO2 decreased, Pericardial effusion
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pleural effusion, Protein urine present, Pulmonary arterial pressure normal, Pulmonary hypertension, Pulmonary oedema
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Renal impairment, Respiratory syncytial virus test negative, Streptococcus test negative, Toxoplasma serology
Clinical narrative: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.