chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Fatigue, Heart rate increased, Muscular weakness, Respiratory rate decreased
Clinical narrative: Patient became dizzy and hot on the way home in the car.  Pulse 120/Respiration 6.  Called 911, EMT stated glucose 88, pulse 80 doing better.  At ER was given script for Benadryl. Per 60 day follow up: Approx. 50% of strength recovered in legs; hands? Still in physical therapy 3 x/week. Extreme pain in knees-R>L instantly with standing ->walking -> movement. Neg evalaution with rheumatologist. MRI March 17, 07 pending appoint with orthopedic, MD. Continues to be on Medical leave from job. On egg free diet due to allergic rex to eggs in hospital, carries EPI-PEN. On daily medication for pain and stomach (ZANTAC) prevention. Multiple MD appts continue, as does pain, imability to sleep through the night, particpate in activities involving physicial movement/action/walking. Especially difficult being without any compensation due to medical leave from work.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Visual disturbance
Clinical narrative: Patient became dizzy and hot on the way home in the car.  Pulse 120/Respiration 6.  Called 911, EMT stated glucose 88, pulse 80 doing better.  At ER was given script for Benadryl. Per 60 day follow up: Approx. 50% of strength recovered in legs; hands? Still in physical therapy 3 x/week. Extreme pain in knees-R>L instantly with standing ->walking -> movement. Neg evalaution with rheumatologist. MRI March 17, 07 pending appoint with orthopedic, MD. Continues to be on Medical leave from job. On egg free diet due to allergic rex to eggs in hospital, carries EPI-PEN. On daily medication for pain and stomach (ZANTAC) prevention. Multiple MD appts continue, as does pain, imability to sleep through the night, particpate in activities involving physicial movement/action/walking. Especially difficult being without any compensation due to medical leave from work.
Age: 26.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Erythema, Pruritus, Skin irritation
Clinical narrative: My boyfriend and I both received the hepatitis A vaccine on 11/16/2006.  We both developed red, itchy, irritated skin one week following administration which has almost resolved.
Age: 52.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Back pain, Pain, Sleep disorder
Clinical narrative: On evening of vaccination, 11/22/06, client reports that she had so much pain in her Rt deltoid that she was unable to lie on Rt side. When awoke on 11/23/06 at 0400 hours, was unable to get out of bed due to body aches/stiffness and legs were numb. Could not get up w/o assistance; was helped to shower where she stood for a prolonged period in the hot water. Required assistance to dress and do any activity that required bending; unable to stand from a seated position without assistance.  Continues, 8 days later, to have pain in lower back that keeps her from bending over.
Age: 52.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Arthralgia, Pain, Respiratory failure
Clinical narrative: On evening of vaccination, 11/22/06, client reports that she had so much pain in her Rt deltoid that she was unable to lie on Rt side. When awoke on 11/23/06 at 0400 hours, was unable to get out of bed due to body aches/stiffness and legs were numb. Could not get up w/o assistance; was helped to shower where she stood for a prolonged period in the hot water. Required assistance to dress and do any activity that required bending; unable to stand from a seated position without assistance.  Continues, 8 days later, to have pain in lower back that keeps her from bending over.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: 4 x 2 1/4 inch redness at site, itching, and pain three days after injection.  Area circled and Benadryl given.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11-30-06, 3:45PM CHILD WAS C/O PAIN AT INJECTION SITE. MOM CHECKED AND FOUND AREA 5 CM X 3.5 CM. RIGHT UPPER ARM RED, HOT, TENDER, RAISED AT INJECTION SITE OF DTAP.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Called PH 3 days after getting flu vaccine. Stated that his arm was not sore, but did say that he had pain in the right side of his chest "if I move just right, or when I cough". Advised him to contact his doctor to have pain checked out. Stated that he wasn't sure if pain related to flu shot or not.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on torso and upper arms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 3" x 4" area of redness without induration on left upper arm. mom noticed redness start the evening of the vaccine. she was seen in clinic 3 days later.
Age: 99.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema, Speech disorder, Tongue oedema
Clinical narrative: Vaccine give 09:15, pt. noticed tongue swelling about 15:15 and reported to ward RN at 14:00 when swelling increased to lower lip then upper lip.  Unable to speak, lungs clear, no wheezing and maintained 02 Sat.  MD noticed - ordered 100mg Solumedrol IV and 25 mg Bendryl IM. Transferred to ER for monitoring.  Returned to ward same evening.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Eye oedema, Pruritus
Clinical narrative: Pt came back 3 hours after immunization and had a swollen left Eye and itching throughout the body which also included some tingling in the extremeties.  No Anaphylactic shock was noted upon observing the patient.  Pt stated that the eye swelling was beginning to decrease at the time of presentation to the pharmacy.
Age: 0.93
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Leukocytosis, Oedema peripheral, Pericardial effusion, Pyrexia
Clinical narrative: Developed Low grade fever 7 days post vaccination. Developed swollen hands and feet (right sided hands first then developed into bilateral swelling of both hands and feet). She was crawling and cruising furniture which ceased 10 days post injection. She was admitted and diagnosed with vasculitis of an unknown origin. She is pending a bone marrow biopsy to R/O Leukemia, but it is not probable.  Final result on duration, tx, outcome still pending. 12/12/06 Received medical records from hospital which reveal patient transferred from outlying hospital on 11/27/06 for bilateral swelling of hands & feet along with fever & decreased oral intake.  Temp on transfer was 102.2  D/C home on 12/1/06 to be f/u by rheumatolody & hematology.  D/C on tapering steroids Final DX: systemic inflammation; secondary dx included lupus anticoagulant & possible hereditary spherocytosis. Records did not include rheum or heme consults & requested again. 12/18/06 Received medical records from PCP which reveal patient was in good health but fussy/cranky with frequent spitting up from birth.  Well child on day of vax.  Next visit 11/25 had low grade fever, cranky & not sleeping or eating well for 2-3 days.  Exam revealed only that patient was teething & had an ulcer on the tip of her tongue.  Next note is from 12/4 after hospitalization & indicates resolving arthralgia & viral syndrome.  To be followed by rheum/heme as outpatient. 12/22/06 Received consults as requested & case closed. Final DX: Systemic inflammation; secondary dx: lupus anticoagulant; possible hereitary spherocytosis.
Age: 0.93
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Spherocytic anaemia, Systemic lupus erythematosus, Vasculitis
Clinical narrative: Developed Low grade fever 7 days post vaccination. Developed swollen hands and feet (right sided hands first then developed into bilateral swelling of both hands and feet). She was crawling and cruising furniture which ceased 10 days post injection. She was admitted and diagnosed with vasculitis of an unknown origin. She is pending a bone marrow biopsy to R/O Leukemia, but it is not probable.  Final result on duration, tx, outcome still pending. 12/12/06 Received medical records from hospital which reveal patient transferred from outlying hospital on 11/27/06 for bilateral swelling of hands & feet along with fever & decreased oral intake.  Temp on transfer was 102.2  D/C home on 12/1/06 to be f/u by rheumatolody & hematology.  D/C on tapering steroids Final DX: systemic inflammation; secondary dx included lupus anticoagulant & possible hereditary spherocytosis. Records did not include rheum or heme consults & requested again. 12/18/06 Received medical records from PCP which reveal patient was in good health but fussy/cranky with frequent spitting up from birth.  Well child on day of vax.  Next visit 11/25 had low grade fever, cranky & not sleeping or eating well for 2-3 days.  Exam revealed only that patient was teething & had an ulcer on the tip of her tongue.  Next note is from 12/4 after hospitalization & indicates resolving arthralgia & viral syndrome.  To be followed by rheum/heme as outpatient. 12/22/06 Received consults as requested & case closed. Final DX: Systemic inflammation; secondary dx: lupus anticoagulant; possible hereitary spherocytosis.
Age: 0.93
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Irritability, Oedema peripheral, Pyrexia, Red blood cell sedimentation rate increased, Sleep disorder
Clinical narrative: Developed Low grade fever 7 days post vaccination. Developed swollen hands and feet (right sided hands first then developed into bilateral swelling of both hands and feet). She was crawling and cruising furniture which ceased 10 days post injection. She was admitted and diagnosed with vasculitis of an unknown origin. She is pending a bone marrow biopsy to R/O Leukemia, but it is not probable.  Final result on duration, tx, outcome still pending. 12/12/06 Received medical records from hospital which reveal patient transferred from outlying hospital on 11/27/06 for bilateral swelling of hands & feet along with fever & decreased oral intake.  Temp on transfer was 102.2  D/C home on 12/1/06 to be f/u by rheumatolody & hematology.  D/C on tapering steroids Final DX: systemic inflammation; secondary dx included lupus anticoagulant & possible hereditary spherocytosis. Records did not include rheum or heme consults & requested again. 12/18/06 Received medical records from PCP which reveal patient was in good health but fussy/cranky with frequent spitting up from birth.  Well child on day of vax.  Next visit 11/25 had low grade fever, cranky & not sleeping or eating well for 2-3 days.  Exam revealed only that patient was teething & had an ulcer on the tip of her tongue.  Next note is from 12/4 after hospitalization & indicates resolving arthralgia & viral syndrome.  To be followed by rheum/heme as outpatient. 12/22/06 Received consults as requested & case closed. Final DX: Systemic inflammation; secondary dx: lupus anticoagulant; possible hereitary spherocytosis.
Age: 41.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Angiogram, Asthenia, Blood creatine phosphokinase, Condition aggravated, Coordination abnormal
Clinical narrative: The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.
Age: 41.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Diplopia, Dysarthria, Dysphagia, Dysphasia, Dysuria
Clinical narrative: The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.
Age: 41.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Gait disturbance, Gaze palsy, Hypertension, Hypoaesthesia, Influenza like illness
Clinical narrative: The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.
Age: 41.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Laboratory test abnormal, Miller Fisher syndrome, Nuclear magnetic resonance imaging brain, Pain, Paraesthesia
Clinical narrative: The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.
Age: 41.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Paraesthesia, Scan brain, Sensory disturbance, Speech disorder, Ultrasound Doppler
Clinical narrative: The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.
Age: 41.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: White blood cell count increased
Clinical narrative: The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site nodule, Pyrexia
Clinical narrative: Mom states got vaccines at 2pm. At 5-6pm started crying loudly, high pitched screaming and cried for 3-3.5hrs. Fever 101-102 orally. Leg no redness or swelling but knots. Did not got pediatrician or emergency room but notified at next visit.
Age: 1.05
Sex: F
Vaccine: HIBV, IPV, MMRV, PNC
Symptoms: Rash
Clinical narrative: Patient developed total body rash within 24 hours of receiving 12 month immunizations.  Rash worse at left leg site when ProQuad was given.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Right arm pain following injection, next day arm pain, swelling redness.  Recommended treatment ice and NSAIDS.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: One hour after inoculation, I experienced swelling in right neck area - gland, tender and swollen walnut size - diminished next day but still swollen and tender.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysphagia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt noticed redness, swelling and warmth at left deltoid injection site 48 hours after shot with some mild difficulty swallowing. Placed cold packs; cannot take oral Benadryl; will try topical.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 24 hours, 103 F. No specific treated with Tylenol.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Blister like rash over body.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Bone disorder, Eye pain, Gastrointestinal disorder, Haematochezia, Incorrect route of drug administration
Clinical narrative: Seriousness Criteria Other medically significant (OMIC). Initial report received on 11/15/06 from the pt. A 44 year old male pt, who had cold symptoms, received a booster dose of TD ADS adult vaccine, lot number U0818AA, administered in the right gluteal muscle on 11/19/02. Per the pt, he was asked several times if he wanted to get his tetanus booster, and he finally agreed. He stated that it was documented in his chart that the vaccine was administered in the left deltoid, but he received the vaccine in the right gluteal muscle. The pt feels that it was possible that he was administered other substances other than the TD ADS adult vaccine. According to the pt the vaccine administrator hid the vaccine view prior to injection, left the room abruptly after the injection and then documented the immunization site differently in the chart from where it was actually administered. On day post immunization the pt developed steady, severe aching pain in the center to upper right shoulder, and pain into the right upper arm. The pt had unaccounted weight loss from 210 lbs to 158 lbs over 8 months. He had blood stools, chronic neurologic and gastro problems and had been diagnosed with reactive neuritis. Reportedly, the pt had a walnut size hole (2.8 x 1.9 x 3.6cm) in the right hip bone. He reported lesions at the injection site per MRI of the pelvis, done on 4/28/03. A CT scan of the pelvis was performed on 5/1/03. The pt was re evaluated on 5/6/03, and a bone scan (nuclear med) was performed on 5/1/03. The diagnosis, investigation performed, and treatment received during an ER visit approx 2 weeks later, were not reported. C reactive protein test was abnormal on 5/29/03 3.53 mg/l. The following diagnostic tests were also performed CT of the abdomen and pelvis on 6/10/03, colonoscopy with biopsy on 6/20/03, and CT guided bone biopsy on 6/30/03. The pt was again in the ER in July 2003 diagnostics performed and treatment received were not reported. On 8/4/03 gastroscopic examination was done. On 3/15/04 the pt had a follow up CT scan of the pelvis. Reportedly on 1/5/05 the pelvis was resolving due to trauma. No results were reported for any of the diagnostic tests reported. At the time of this report, the pt was continuing to have persistent pain in his arms and legs, and pain in his left eye.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Injection site reaction, Nervous system disorder, Neuritis, Pain, Shoulder pain
Clinical narrative: Seriousness Criteria Other medically significant (OMIC). Initial report received on 11/15/06 from the pt. A 44 year old male pt, who had cold symptoms, received a booster dose of TD ADS adult vaccine, lot number U0818AA, administered in the right gluteal muscle on 11/19/02. Per the pt, he was asked several times if he wanted to get his tetanus booster, and he finally agreed. He stated that it was documented in his chart that the vaccine was administered in the left deltoid, but he received the vaccine in the right gluteal muscle. The pt feels that it was possible that he was administered other substances other than the TD ADS adult vaccine. According to the pt the vaccine administrator hid the vaccine view prior to injection, left the room abruptly after the injection and then documented the immunization site differently in the chart from where it was actually administered. On day post immunization the pt developed steady, severe aching pain in the center to upper right shoulder, and pain into the right upper arm. The pt had unaccounted weight loss from 210 lbs to 158 lbs over 8 months. He had blood stools, chronic neurologic and gastro problems and had been diagnosed with reactive neuritis. Reportedly, the pt had a walnut size hole (2.8 x 1.9 x 3.6cm) in the right hip bone. He reported lesions at the injection site per MRI of the pelvis, done on 4/28/03. A CT scan of the pelvis was performed on 5/1/03. The pt was re evaluated on 5/6/03, and a bone scan (nuclear med) was performed on 5/1/03. The diagnosis, investigation performed, and treatment received during an ER visit approx 2 weeks later, were not reported. C reactive protein test was abnormal on 5/29/03 3.53 mg/l. The following diagnostic tests were also performed CT of the abdomen and pelvis on 6/10/03, colonoscopy with biopsy on 6/20/03, and CT guided bone biopsy on 6/30/03. The pt was again in the ER in July 2003 diagnostics performed and treatment received were not reported. On 8/4/03 gastroscopic examination was done. On 3/15/04 the pt had a follow up CT scan of the pelvis. Reportedly on 1/5/05 the pelvis was resolving due to trauma. No results were reported for any of the diagnostic tests reported. At the time of this report, the pt was continuing to have persistent pain in his arms and legs, and pain in his left eye.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Skin ulcer, Weight decreased
Clinical narrative: Seriousness Criteria Other medically significant (OMIC). Initial report received on 11/15/06 from the pt. A 44 year old male pt, who had cold symptoms, received a booster dose of TD ADS adult vaccine, lot number U0818AA, administered in the right gluteal muscle on 11/19/02. Per the pt, he was asked several times if he wanted to get his tetanus booster, and he finally agreed. He stated that it was documented in his chart that the vaccine was administered in the left deltoid, but he received the vaccine in the right gluteal muscle. The pt feels that it was possible that he was administered other substances other than the TD ADS adult vaccine. According to the pt the vaccine administrator hid the vaccine view prior to injection, left the room abruptly after the injection and then documented the immunization site differently in the chart from where it was actually administered. On day post immunization the pt developed steady, severe aching pain in the center to upper right shoulder, and pain into the right upper arm. The pt had unaccounted weight loss from 210 lbs to 158 lbs over 8 months. He had blood stools, chronic neurologic and gastro problems and had been diagnosed with reactive neuritis. Reportedly, the pt had a walnut size hole (2.8 x 1.9 x 3.6cm) in the right hip bone. He reported lesions at the injection site per MRI of the pelvis, done on 4/28/03. A CT scan of the pelvis was performed on 5/1/03. The pt was re evaluated on 5/6/03, and a bone scan (nuclear med) was performed on 5/1/03. The diagnosis, investigation performed, and treatment received during an ER visit approx 2 weeks later, were not reported. C reactive protein test was abnormal on 5/29/03 3.53 mg/l. The following diagnostic tests were also performed CT of the abdomen and pelvis on 6/10/03, colonoscopy with biopsy on 6/20/03, and CT guided bone biopsy on 6/30/03. The pt was again in the ER in July 2003 diagnostics performed and treatment received were not reported. On 8/4/03 gastroscopic examination was done. On 3/15/04 the pt had a follow up CT scan of the pelvis. Reportedly on 1/5/05 the pelvis was resolving due to trauma. No results were reported for any of the diagnostic tests reported. At the time of this report, the pt was continuing to have persistent pain in his arms and legs, and pain in his left eye.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anaphylactic reaction, Bronchial obstruction, Face oedema, Flushing, Hypersensitivity
Clinical narrative: SOB, red face, lightheaded. Given Benadryl 50 mg, oxygen given, Xopenex treatment.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Respiratory distress, Shock, Tachycardia, Tongue oedema
Clinical narrative: SOB, red face, lightheaded. Given Benadryl 50 mg, oxygen given, Xopenex treatment.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Dyspnoea, Erythema, Hypoxia
Clinical narrative: SOB, red face, lightheaded. Given Benadryl 50 mg, oxygen given, Xopenex treatment.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Rash pruritic
Clinical narrative: A report was received from a healthcare professional on 15/Nov/2006 concerning a  unidentified vaccinee.  No other details were provided at this time.  Further information was received on 28/Nov/2006 from the same healthcare professional concerning a 69-year-old female vaccinee. The vaccinee has a history of diabetes, no details concerning concomitant medications were provided.  On 03/Nov/2006 the vaccinee received Fluvirin in the left deltoid.  Eight days later she awoke in the night with severe left arm pain which did not resolve. The following day 11/Nov/2006, the vaccinee attended the emergency room where investigations were carried out to elicit the cause of the pain, a treadmill stress test, cardiac enzymes, glucose reading, X-ray of the C-spine and CT scan were performed and were all reported with TYLENOL #3 with codeine which had no effect, and Morphine which resulted in an itchy rash, but no pain relief.  TORADOL was then administered with pain relief 1 hour, and was repeated a number of times.  On 13/Nov/2006 the vaccinee pain resolved, the itching and rash had also resolved, and she was discharged from hospital.  No cause was found for the left arm pain, and the vaccinee has had no recurrence.  A copy of the hospital discharge summary has been requested.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC
Symptoms: Erythema, Injection site induration, Pyrexia, Tenderness
Clinical narrative: Left upper thigh redness with increased induration. Minimally tender- no swelling. Low grade fever 100.3. Treatment antipyretine
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: generalized rash
Age: 2.0
Sex: F
Vaccine: TD
Symptoms: Medication error
Clinical narrative: Patient received Td instead of Flu shot.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with seasonal allergies to clindamycin and Penicillin, who on 11/15/06 was vaccinated SC in the back of her left arm with a second dose of MMR II (lot 654820/1027F). There was no concomitant medication. The pt went home, and 45 minutes after vaccination she experienced breathing difficulty. The pts parents immediately took her to the ER and she was treated with epinephrine, prednisone and oral Benadryl. The pt was given Epi Pen to take home with her. It was reported that the pt was in the ER for hours but was not hospitalized, and she was told to follow up with an allergist. The pt received her first dose of MMR II in 1989 and to the nurses knowledge, did not have nay adverse effects after that vaccination. Subsequently, the pt came in for an office visit and is better now and has recovered. There was no product quality complaint involved. The reporter considered the pts breathing difficulty to be an other important medical event (OMIC), disabling and life threatening. A lot check was requested.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt ran high fever of 103 for 3 days following influenza injection (1st dose received, fever started following day).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Dizziness, Dyspnoea, Malaise, Oedema peripheral
Clinical narrative: Patient called today describing not feeling well right after she left our store. She had some breathing difficulty, hand swelling, heart irregularities and dizziness. She said that today 11-22-06 she is feeling better. I recommended that she see a physician if needed. Symptoms ended.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Arm swollen from shoulder to below elbow. Fever in arm, painful and sore to touch. I felt sick for two days after shot.
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Varicella 11-27-06 O visit
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: Tdap was given instead of DTaP, pt had no adverse reaction.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Lethargy, Pyrexia, Viral infection
Clinical narrative: Mother reports patient had a little fever Sat. 10/19 in the AM, gave her Motrin, sent to babysitter above she developed temp 105 degrees, was lethargic. Mother took her ER where she was given Tylenol and Motrin, temp down, told patient had probable viral infection. No further high temps that day, well now.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: One day after received hepatitis A 0.5 a IM. Pt got rash diffuse x 2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Client received Dtap, MMR, Polio at 11am on 7/20/06. Developed fever of 102 seven hours later fever spiked to 105 despite Motrin x2. Fever then decreased to 99 but spiked again to 105 with stomach cramping lasting 1.5 hours. Woke the next morning without further similiar symptoms.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: 1 pox on his buttocks
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: DTaP, IPV given in left leg 11/22/06. Left upper leg red, edematous, tender, warm to touch. Tx: Benadryl and warm compresses
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Medication error, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in an 18-year-old male subject who was vaccinated with Boostrix for prophylaxis. The subject had no significant medical history or concurrent conditions. Concurrent vaccination received the same day as 2nd dose of Boostrix, 21 August 2006 included Menactra in the right deltoid (lot number and expiration not provided). On an unspecified date in March 2006 the subject received a dose of Boostrix at 0.5 ml. On 21 August 2006 the subject inadvertently received a second dose of Boostrix (lot AC52B005AA) intramuscularly in the left arm. This was considered to be a medication error as the interval between doses of Boostrix was too short. The recommended interval is 10 years. Following the inadvertent administration of the 2nd dose of Boostrix, 21 August 2006, the subject developed achiness and fever. The events resolved on 25 August 2006. The healthcare professional considered the events were possibly related to vaccination with Boostrix.
Sex: U
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of insufficient dosage in subjects of unspecified age and gender who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (BOOSTRIX) for prophylaxis. The subjects' medical history, concurrent conditions and concurrent medications were not provided. On an unspecified date in July, August and September 2006, subjects received an unspecified dose of BOOSTRIX. A nurse reported that she had approximately 160 immunizations where the BOOSTRIC vaccine potentially had one tenth of a cc less in each vial.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: Infant Died within 24 hours of receiving routine child hood immunizations.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Crohn's disease, Diarrhoea, Hypokalaemia, Laboratory test abnormal
Clinical narrative: Initial report received on 22 November 2006 from an investigator participating in the above-mentioned trial. A 72-year-old female subject with history of Crohn's disease was diagnosed with exacerbation of Crohn's disease, 9 days after she had received a first dose, right arm, intramuscular injection of Influenza Virus Vaccine USP Trival A & B, High dose, Subvirion-U, lot number not reported, on 25 October 2006. Her medical history also included: osteoarthritis, glaucoma, vascular headaches, vasomotor rhinitis, labile blood pressure, asthma, nephrolithiasis, hyperglycemia, gastroesophageal reflux and dyspepsia, cholecystectomy. Concomitant treatments were Combivent, Advair, Prilosec, Potassium, timolol. On 27 November 2006, two days post-vaccination, the subject experienced diarrhea and nausea that lasted 9 days, until 06 November 2006. On 03 November 2006 the subject experienced hypokalemia that lasted a day, until 04 November 2006. The subject was admitted to the hospital on 03 November 2006 and discharged on 06 November 2006. The subject was treated with Prednisone 40 mg daily, mesalamine 1200mg 4 times a day and IV fluids with potassium chloride. The subject had recovered. Important laboratories results done at the hospital: C-Diff toxin-negative; feces culture- no E.coli or salmonella; stool for WBC's-negative; chemistry panel-normal, Hemogram + PLT + Autodif + WBC-High; Lactate-normal. The subject continued in the study trial. According to the investigator, the event was related to the study vaccine. Documents held by sender: hospital admission and discharge summaries and laboratory results.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Initial report received on 22 November 2006 from an investigator participating in the above-mentioned trial. A 72-year-old female subject with history of Crohn's disease was diagnosed with exacerbation of Crohn's disease, 9 days after she had received a first dose, right arm, intramuscular injection of Influenza Virus Vaccine USP Trival A & B, High dose, Subvirion-U, lot number not reported, on 25 October 2006. Her medical history also included: osteoarthritis, glaucoma, vascular headaches, vasomotor rhinitis, labile blood pressure, asthma, nephrolithiasis, hyperglycemia, gastroesophageal reflux and dyspepsia, cholecystectomy. Concomitant treatments were Combivent, Advair, Prilosec, Potassium, timolol. On 27 November 2006, two days post-vaccination, the subject experienced diarrhea and nausea that lasted 9 days, until 06 November 2006. On 03 November 2006 the subject experienced hypokalemia that lasted a day, until 04 November 2006. The subject was admitted to the hospital on 03 November 2006 and discharged on 06 November 2006. The subject was treated with Prednisone 40 mg daily, mesalamine 1200mg 4 times a day and IV fluids with potassium chloride. The subject had recovered. Important laboratories results done at the hospital: C-Diff toxin-negative; feces culture- no E.coli or salmonella; stool for WBC's-negative; chemistry panel-normal, Hemogram + PLT + Autodif + WBC-High; Lactate-normal. The subject continued in the study trial. According to the investigator, the event was related to the study vaccine. Documents held by sender: hospital admission and discharge summaries and laboratory results.