chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.03
Sex: U
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt. received vaccines around 10:30am 12-16-10, pt went home ok. Next morning mom came back with pt and stated that pt developed fever at night and a generalized seizure lasting for a few minutes & subsiding when taken to the ER. Pt was given ROCEPHIN inj in the ER.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: 2 days after immunization, tender/erythematous left arm with tender axilla, treated with Doxycycline and ZYRTEC.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Expired drug administered, Feeling abnormal, Muscle twitching, Pyrexia
Clinical narrative: Initial report was received on 22 December 2010 from a health care provider which involved a case of misuse. An 11 year-old male patient who had no illnesses at the time of vaccination, had received on 21 December 2010 an expired intramuscular right deltoid first dose injection of MENACTRA, lot number U3068AA (expiration date 03 November 2010) and an intramuscular right deltoid injection of ADACEL, lot number U3049CA (sanofi pasteur Ltd. lot number C3258) and at 0200 (2AM) on 22 December 2010, he experienced a fever of 102.4. The patient was treated with TYLENOL and at 0400 (4AM) on 22 December 2010 his fever was 99-100 F. He then experienced a five to seven minute episode of uncontrollable muscle twitching of his arms, a feeling like his head was "going to pop off' and he had blurry vision. The reporter stated the patient was "okay" and his temperature was normal however he had an "upset stomach". No further information was available at the time of the report. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Initial report was received on 22 December 2010 from a health care provider which involved a case of misuse. An 11 year-old male patient who had no illnesses at the time of vaccination, had received on 21 December 2010 an expired intramuscular right deltoid first dose injection of MENACTRA, lot number U3068AA (expiration date 03 November 2010) and an intramuscular right deltoid injection of ADACEL, lot number U3049CA (sanofi pasteur Ltd. lot number C3258) and at 0200 (2AM) on 22 December 2010, he experienced a fever of 102.4. The patient was treated with TYLENOL and at 0400 (4AM) on 22 December 2010 his fever was 99-100 F. He then experienced a five to seven minute episode of uncontrollable muscle twitching of his arms, a feeling like his head was "going to pop off' and he had blurry vision. The reporter stated the patient was "okay" and his temperature was normal however he had an "upset stomach". No further information was available at the time of the report. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Joint swelling, Pyrexia, Rash erythematous
Clinical narrative: On 01-06-11 patient developed joint swelling in knees w/faint red rash on trunk, unable to walk. Then on 01-07-11 developed fever T 104 degrees w/o any symptoms. Fever persisted for 3 days.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Aspartate aminotransferase increased, Axillary pain, Blood albumin decreased, Blood amylase normal, Blood calcium decreased
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood culture negative, Blood lactate dehydrogenase increased, Blood thyroid stimulating hormone normal
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: C-reactive protein increased, CSF culture negative, CSF glucose increased, CSF protein increased, CSF white blood cell count negative
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Cardiac stress test normal, Chest X-ray normal, Chest pain, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Culture negative, Echocardiogram abnormal, Echocardiogram normal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Electrocardiogram abnormal, Fatigue, Feeling hot, Fibrin D dimer normal, Full blood count abnormal
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Gram stain, Gram stain negative, Haematocrit decreased, Headache, Injection site erythema
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Injection site induration, Lipase normal, Lumbar puncture, Lymphadenopathy, Lymphocyte count decreased
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin increased, Metabolic function test, Metabolic function test normal, Monocyte count increased
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Neutrophil count increased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Painful respiration, Prothrombin time normal
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Pyrexia, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red blood cells CSF positive, Sinus rhythm
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Troponin I increased, Urine analysis normal, Ventricular hypokinesia
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Pericarditis
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3, SMALL, FLUX, SMALL, FLUX, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: The patient received SPV (left arm; robust take) and Influenza TIV right deltoid on 8/28/10. The pt states that he was in his normal state of good health at the time. Around day 4 the pt noted an "annoying", low grade (2/10) headache (at the base of his neck). About day 6-7 the pt noted that he was fatigued and felt feverish. He also had pain in his left axilla and about 30mm of erythema and induration around the SPV site. Additionally, his headache had worsened (8/10) and he was having intermittent, "stabbing", substernal, non-radiating, non-positional chest pain. The pain did increase with deep inspiration. The pt denied SOB, palpitations, nausea or vomiting. The pt reported to medical on 9/7/10 (day 10) with complaints of a severe headache and chest pain (as described above). He was admitted to the ward. VS: 100.4, 110, 20, 100/60. CBC wnl (WBC 8.6-9.6; neutrophils: 76/2%-78.4%; lymphocytes: 16.1%-16.6%). EKG: ST with PR depression, ST elevation in lateral leads. The pt was medivaced on 9/8/10 for evaluation for possible encephalitis and myocarditis. The pt was seen in the ER. EKG: NSR with PR depression and ST segment elevation. CXR: wnl; CT (head: w/o) unremarkable. Labs: ESR, amylase, lipase, Pt, U/A, urine C&S wnl; CBC wnl except: lymphs 19.2L, monocytes 9.7H; CMP wnl except: albumin 3.0L, CA 7.8L, AST 38H; cardiac panel: CK 269.4H, Troponin I 2.05H, CKMB 4.6H; Blood culture: no growth. LP performed: CSF: colorless, clear, RBC 2, WBC 1, no cells, protein 53.6, glucose 71(H); GS no cells/organisms; culture no growth. The pt was transferred to a local hospital. He was released on 9/9/10 and followed on an outpatient basis. Labs 9/9/10: TSH and D-Dimer wnl; CRP: 17.1H, ESR 35H, CMP wnl except albumin 3.3L; cardiac panel wnl except: LDH 195H, Troponin I 1.15H; CBC wnl except: RBC 4.23L, HCT 38.4L, MCH 31.7H, monocytes 13.7H. EKG: NSR. Pt was started on INDOCIN. The pt had an echocardiogram on 9/14/10: EF 57%, no effusion. On 9/16/10 the pt had an MRI of the heart (w/wo): slight hypokinesia apical and middle lateral segments of the left ventricle; EF 59%, adenopathy left axilla. The last episode of chest pain was reported on 9/13/10. The pt stopped taking INDOCIN on 9/20/10. The pt was transferred and evaluated by Cardiology on 10/5/10. EKG: NSR; echo: EF 53%, no pericardial effusion, no wall motion abnormality. 10/6/10 stress test: (Bruce) for 10:01, PMHR 93% (181), METS 11.70, impression: wnl. Pt was placed in a non-deployable status for 6 months and scheduled for a follow-up mid-March 2011.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Feeling abnormal, Feeling hot, Pruritus
Clinical narrative: Pt arrived back in clinic approximately 4 hours after vaccine administered. Pt c/o feeling weird, itchy, warm, blotchy, hive over chest and neck, no SOB. BENADRYL 25 mg given po at 1:35pm - 2nd dose given at 2pm. Pt observed, improving, slept x 1 1/2 hours. Awoke c/o increased discomfort, itching, face redness, swelling. Taken to ER at 3:40 pm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Swelling face, Urticaria
Clinical narrative: Pt arrived back in clinic approximately 4 hours after vaccine administered. Pt c/o feeling weird, itchy, warm, blotchy, hive over chest and neck, no SOB. BENADRYL 25 mg given po at 1:35pm - 2nd dose given at 2pm. Pt observed, improving, slept x 1 1/2 hours. Awoke c/o increased discomfort, itching, face redness, swelling. Taken to ER at 3:40 pm.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Haematochezia, Intussusception, Laboratory test abnormal, Pallor, Vomiting
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 20 week old male with a history of gastrooesophageal reflux and vaccination with rotavirus (no brand or date reported) who on 28-SEP-2010 was vaccinated with the second dose of ROTATEQ (lot # 668124/0520Z, dose not reported) by mouth. Concomitant therapy included the second dose of PENTACEL (lot# 914265)/intramuscular injection and the second dose of PREVNAR (lot# 13529AA) intramuscular injection and no concomitant medicines. On 09-OCT-2010 the patient admitted to Emergency Room (ER) experienced pale, vomit, blood stools, transferred to hospital until 14-OCT-2010. On 09-NOV-2010 Primary Care Physician (PCP) records received for date of service (DOS) 28-SEP-2010 to 26-OCT-2010 with diagnosis (DX): status post (S/P) intussusception good weight gain. Patient to PCP after intussusception therapy (TX), originally lost weight but on 2nd visit gaining weight appropriately. PT on TX for reflux. Diagnosis laboratory test was performed for intussusception of bowels. There was no illness at time of vaccination. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 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 and was released. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. This was originally reported by a consumer. The VAERS ID# is 406786.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Weight decreased
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 20 week old male with a history of gastrooesophageal reflux and vaccination with rotavirus (no brand or date reported) who on 28-SEP-2010 was vaccinated with the second dose of ROTATEQ (lot # 668124/0520Z, dose not reported) by mouth. Concomitant therapy included the second dose of PENTACEL (lot# 914265)/intramuscular injection and the second dose of PREVNAR (lot# 13529AA) intramuscular injection and no concomitant medicines. On 09-OCT-2010 the patient admitted to Emergency Room (ER) experienced pale, vomit, blood stools, transferred to hospital until 14-OCT-2010. On 09-NOV-2010 Primary Care Physician (PCP) records received for date of service (DOS) 28-SEP-2010 to 26-OCT-2010 with diagnosis (DX): status post (S/P) intussusception good weight gain. Patient to PCP after intussusception therapy (TX), originally lost weight but on 2nd visit gaining weight appropriately. PT on TX for reflux. Diagnosis laboratory test was performed for intussusception of bowels. There was no illness at time of vaccination. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 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 and was released. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. This was originally reported by a consumer. The VAERS ID# is 406786.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Mobility decreased, Pain in extremity
Clinical narrative: Received flu shot and next day had pain in arm. No redness or swelling at site. Pain is a deep pain, can't move arm certain ways, can't sleep on arm. Doctor stated that injection was given into the nerve. Pt explained that he could not remember where shot was given.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Laboratory test, Multiple sclerosis, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: 12-23-10 Patient phoned the health dept to inquire the date of the H1N1 vaccine that we administered last year. It was 12-15-09. This year her personal physician administered flu vaccine on 12-3-10. Within a couple of weeks after each of the 2 doses experienced numbness & weakness in her legs. Consulted a chiropractor who referred her to a neurologist - has initial consult today. 1-3-11 I followed up w/patient today. The neurologist did an MRI & other diagnostic tests & has diagnosed patient w/Multiple Sclerosis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, soreness, swelling, itching, hot skin at site, large raised round area, fast heart beat, elevated blood pressure (as much as 151/99)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, soreness, swelling, itching, hot skin at site, large raised round area, fast heart beat, elevated blood pressure (as much as 151/99)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Nasopharyngitis, Pain, Paraesthesia, Pyrexia
Clinical narrative: Felt "tingling" right away at injection site. That night felt like a cold was coming on - felt achy like she may have had a low grade fever - felt chest "congestion" - no cough - resolved completely in 2 days. (two days)