chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Blindness unilateral, Blood test normal, Computerised tomogram normal
Clinical narrative: We have tract patient's symptoms back to early part of December.  She complained on and off of achy joints and just not feeling right.  In February one of her track coach's approched me with concern and asked if patient had told me about her knees hurting and the lower part of her legs going numb on several different occasions.  The trainer had looked at her and suggested a knee brace.    The sparactic numbness continued though.  On 4-14-08 patient received the 3rd HPV vaccine.  On 4-18-08 I received a phone call that patient  had experience and ice pick type pain in the back of her head and could not see out of her right eye and was complaining that the  right side of face and arm were completely numb.  We went straight to Dr. who sent us to hospital for a cat scan and then to Emergency for and MRI. Diagnosis: Sphrenoid Sinusitis.  She was given a prescription for a Z-pack and Naprolan. Patient's symptoms seem to improve but still complained of achy joints especially in her lower back and hips and now experiencing twitching on the right side of face and arm.  On 5-7-08 we took patient to the emergency room again because her lower back, hips, knees and ankles were hurting and numb. She complained that the pain felt like it was coming from the inside of the bone.  Diagnosis:  Possible pinch nerve, ice and heat along with Advil were to be implemented  5-8-08 I called Dr. because patient's symptoms had worsened overnight and now was having trouble walking.  He called an nueroligist and set up for him to see her 5-9-08 the very next morning at 6:30a.m..  Dr. examined patient and told us he was admitting her into the hospital with the suspicions of MS.  He treated her symptons as and MS patient.  A spinal tap, MRI, and blood work was ordered along with and IV for a steroid treatment to be given every 6 hrs. for 30 mins each time.  Patient was discharged on 5-13-08 and to take Predizone for 5 days along with Aleeve.  On 5-20 Dr. did and EmG and found  left lumzosacarl radiculopathy.  Dr. referred us to Pediactric neorologist.  6-17 Dr. examined and order an Evoke Potential findings were normal.  Patient continues to have sparatic numbness, achy joints especially hips and knees, and lower back pain.  From November to May patient's symptons gradually escalated.  As of today, patient is still experiencing sparactic espisodes and is taking Aleeve everyday to manage her pain.  We are still in the process of finding out how to help her and the actual cause. A Pediactric Rhumatologist from Hospital is reviewing her reports.  We are waiting to here back from them. 8/15/08-records received for DOS 5/9-5/13/08- presented with C/O progressive weakness of left lower extremity with some back pain radiating down into lower extremity. Hip and joint pain. Rheumatoid arthritis ruled out. Admitted with presumed myelitis. Treated with IV Solu-Medrol and improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diagnostic procedure, Electromyogram abnormal, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: We have tract patient's symptoms back to early part of December.  She complained on and off of achy joints and just not feeling right.  In February one of her track coach's approched me with concern and asked if patient had told me about her knees hurting and the lower part of her legs going numb on several different occasions.  The trainer had looked at her and suggested a knee brace.    The sparactic numbness continued though.  On 4-14-08 patient received the 3rd HPV vaccine.  On 4-18-08 I received a phone call that patient  had experience and ice pick type pain in the back of her head and could not see out of her right eye and was complaining that the  right side of face and arm were completely numb.  We went straight to Dr. who sent us to hospital for a cat scan and then to Emergency for and MRI. Diagnosis: Sphrenoid Sinusitis.  She was given a prescription for a Z-pack and Naprolan. Patient's symptoms seem to improve but still complained of achy joints especially in her lower back and hips and now experiencing twitching on the right side of face and arm.  On 5-7-08 we took patient to the emergency room again because her lower back, hips, knees and ankles were hurting and numb. She complained that the pain felt like it was coming from the inside of the bone.  Diagnosis:  Possible pinch nerve, ice and heat along with Advil were to be implemented  5-8-08 I called Dr. because patient's symptoms had worsened overnight and now was having trouble walking.  He called an nueroligist and set up for him to see her 5-9-08 the very next morning at 6:30a.m..  Dr. examined patient and told us he was admitting her into the hospital with the suspicions of MS.  He treated her symptons as and MS patient.  A spinal tap, MRI, and blood work was ordered along with and IV for a steroid treatment to be given every 6 hrs. for 30 mins each time.  Patient was discharged on 5-13-08 and to take Predizone for 5 days along with Aleeve.  On 5-20 Dr. did and EmG and found  left lumzosacarl radiculopathy.  Dr. referred us to Pediactric neorologist.  6-17 Dr. examined and order an Evoke Potential findings were normal.  Patient continues to have sparatic numbness, achy joints especially hips and knees, and lower back pain.  From November to May patient's symptons gradually escalated.  As of today, patient is still experiencing sparactic espisodes and is taking Aleeve everyday to manage her pain.  We are still in the process of finding out how to help her and the actual cause. A Pediactric Rhumatologist from Hospital is reviewing her reports.  We are waiting to here back from them. 8/15/08-records received for DOS 5/9-5/13/08- presented with C/O progressive weakness of left lower extremity with some back pain radiating down into lower extremity. Hip and joint pain. Rheumatoid arthritis ruled out. Admitted with presumed myelitis. Treated with IV Solu-Medrol and improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Lumbar puncture normal, Malaise, Muscle twitching
Clinical narrative: We have tract patient's symptoms back to early part of December.  She complained on and off of achy joints and just not feeling right.  In February one of her track coach's approched me with concern and asked if patient had told me about her knees hurting and the lower part of her legs going numb on several different occasions.  The trainer had looked at her and suggested a knee brace.    The sparactic numbness continued though.  On 4-14-08 patient received the 3rd HPV vaccine.  On 4-18-08 I received a phone call that patient  had experience and ice pick type pain in the back of her head and could not see out of her right eye and was complaining that the  right side of face and arm were completely numb.  We went straight to Dr. who sent us to hospital for a cat scan and then to Emergency for and MRI. Diagnosis: Sphrenoid Sinusitis.  She was given a prescription for a Z-pack and Naprolan. Patient's symptoms seem to improve but still complained of achy joints especially in her lower back and hips and now experiencing twitching on the right side of face and arm.  On 5-7-08 we took patient to the emergency room again because her lower back, hips, knees and ankles were hurting and numb. She complained that the pain felt like it was coming from the inside of the bone.  Diagnosis:  Possible pinch nerve, ice and heat along with Advil were to be implemented  5-8-08 I called Dr. because patient's symptoms had worsened overnight and now was having trouble walking.  He called an nueroligist and set up for him to see her 5-9-08 the very next morning at 6:30a.m..  Dr. examined patient and told us he was admitting her into the hospital with the suspicions of MS.  He treated her symptons as and MS patient.  A spinal tap, MRI, and blood work was ordered along with and IV for a steroid treatment to be given every 6 hrs. for 30 mins each time.  Patient was discharged on 5-13-08 and to take Predizone for 5 days along with Aleeve.  On 5-20 Dr. did and EmG and found  left lumzosacarl radiculopathy.  Dr. referred us to Pediactric neorologist.  6-17 Dr. examined and order an Evoke Potential findings were normal.  Patient continues to have sparatic numbness, achy joints especially hips and knees, and lower back pain.  From November to May patient's symptons gradually escalated.  As of today, patient is still experiencing sparactic espisodes and is taking Aleeve everyday to manage her pain.  We are still in the process of finding out how to help her and the actual cause. A Pediactric Rhumatologist from Hospital is reviewing her reports.  We are waiting to here back from them. 8/15/08-records received for DOS 5/9-5/13/08- presented with C/O progressive weakness of left lower extremity with some back pain radiating down into lower extremity. Hip and joint pain. Rheumatoid arthritis ruled out. Admitted with presumed myelitis. Treated with IV Solu-Medrol and improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve conduction studies normal, Nerve injury, Nuclear magnetic resonance imaging normal, Pain, Radiculopathy
Clinical narrative: We have tract patient's symptoms back to early part of December.  She complained on and off of achy joints and just not feeling right.  In February one of her track coach's approched me with concern and asked if patient had told me about her knees hurting and the lower part of her legs going numb on several different occasions.  The trainer had looked at her and suggested a knee brace.    The sparactic numbness continued though.  On 4-14-08 patient received the 3rd HPV vaccine.  On 4-18-08 I received a phone call that patient  had experience and ice pick type pain in the back of her head and could not see out of her right eye and was complaining that the  right side of face and arm were completely numb.  We went straight to Dr. who sent us to hospital for a cat scan and then to Emergency for and MRI. Diagnosis: Sphrenoid Sinusitis.  She was given a prescription for a Z-pack and Naprolan. Patient's symptoms seem to improve but still complained of achy joints especially in her lower back and hips and now experiencing twitching on the right side of face and arm.  On 5-7-08 we took patient to the emergency room again because her lower back, hips, knees and ankles were hurting and numb. She complained that the pain felt like it was coming from the inside of the bone.  Diagnosis:  Possible pinch nerve, ice and heat along with Advil were to be implemented  5-8-08 I called Dr. because patient's symptoms had worsened overnight and now was having trouble walking.  He called an nueroligist and set up for him to see her 5-9-08 the very next morning at 6:30a.m..  Dr. examined patient and told us he was admitting her into the hospital with the suspicions of MS.  He treated her symptons as and MS patient.  A spinal tap, MRI, and blood work was ordered along with and IV for a steroid treatment to be given every 6 hrs. for 30 mins each time.  Patient was discharged on 5-13-08 and to take Predizone for 5 days along with Aleeve.  On 5-20 Dr. did and EmG and found  left lumzosacarl radiculopathy.  Dr. referred us to Pediactric neorologist.  6-17 Dr. examined and order an Evoke Potential findings were normal.  Patient continues to have sparatic numbness, achy joints especially hips and knees, and lower back pain.  From November to May patient's symptons gradually escalated.  As of today, patient is still experiencing sparactic espisodes and is taking Aleeve everyday to manage her pain.  We are still in the process of finding out how to help her and the actual cause. A Pediactric Rhumatologist from Hospital is reviewing her reports.  We are waiting to here back from them. 8/15/08-records received for DOS 5/9-5/13/08- presented with C/O progressive weakness of left lower extremity with some back pain radiating down into lower extremity. Hip and joint pain. Rheumatoid arthritis ruled out. Admitted with presumed myelitis. Treated with IV Solu-Medrol and improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Reflex test normal, Sinusitis
Clinical narrative: We have tract patient's symptoms back to early part of December.  She complained on and off of achy joints and just not feeling right.  In February one of her track coach's approched me with concern and asked if patient had told me about her knees hurting and the lower part of her legs going numb on several different occasions.  The trainer had looked at her and suggested a knee brace.    The sparactic numbness continued though.  On 4-14-08 patient received the 3rd HPV vaccine.  On 4-18-08 I received a phone call that patient  had experience and ice pick type pain in the back of her head and could not see out of her right eye and was complaining that the  right side of face and arm were completely numb.  We went straight to Dr. who sent us to hospital for a cat scan and then to Emergency for and MRI. Diagnosis: Sphrenoid Sinusitis.  She was given a prescription for a Z-pack and Naprolan. Patient's symptoms seem to improve but still complained of achy joints especially in her lower back and hips and now experiencing twitching on the right side of face and arm.  On 5-7-08 we took patient to the emergency room again because her lower back, hips, knees and ankles were hurting and numb. She complained that the pain felt like it was coming from the inside of the bone.  Diagnosis:  Possible pinch nerve, ice and heat along with Advil were to be implemented  5-8-08 I called Dr. because patient's symptoms had worsened overnight and now was having trouble walking.  He called an nueroligist and set up for him to see her 5-9-08 the very next morning at 6:30a.m..  Dr. examined patient and told us he was admitting her into the hospital with the suspicions of MS.  He treated her symptons as and MS patient.  A spinal tap, MRI, and blood work was ordered along with and IV for a steroid treatment to be given every 6 hrs. for 30 mins each time.  Patient was discharged on 5-13-08 and to take Predizone for 5 days along with Aleeve.  On 5-20 Dr. did and EmG and found  left lumzosacarl radiculopathy.  Dr. referred us to Pediactric neorologist.  6-17 Dr. examined and order an Evoke Potential findings were normal.  Patient continues to have sparatic numbness, achy joints especially hips and knees, and lower back pain.  From November to May patient's symptons gradually escalated.  As of today, patient is still experiencing sparactic espisodes and is taking Aleeve everyday to manage her pain.  We are still in the process of finding out how to help her and the actual cause. A Pediactric Rhumatologist from Hospital is reviewing her reports.  We are waiting to here back from them. 8/15/08-records received for DOS 5/9-5/13/08- presented with C/O progressive weakness of left lower extremity with some back pain radiating down into lower extremity. Hip and joint pain. Rheumatoid arthritis ruled out. Admitted with presumed myelitis. Treated with IV Solu-Medrol and improved.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Pyrexia, White blood cell count abnormal
Clinical narrative: This case was reported by a physician, via a GSK representative, that described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline).  Concurrent vaccinations given on the same date (unspecified) as PEDIARIX included ACTHIB (Sanofi Pasteur); unknown; ROTATEQ (Merck); oral; and PREVNAR (Wyeth); unknown.  On an unspecified date, the subject received the 2nd dose of PEDIARIX (.5 ml, unknown).  At an unspecified time after vaccination with PEDIARIX, the subject experienced a high fever, reported to be in the 103 degree Fahrenheit range.  At an unspecified time after vaccination with PEDIARIX, blood was drawn from the subject and the test results showed a white blood count "shift to the left", but no bacteria was detected.  The subject was hospitalized (dates and duration unspecified).  The subject was treated with at least one dose of ROCEPHIN.  The fever was reported to be resolved within 24 hours, but the outcome of the abnormal white blood cell count was not reported.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Heart rate increased, Pallor, Pulse abnormal, Syncope
Clinical narrative: Client received MENACTRA (RD) HPV #1 (LD) fainted.  Patient airway maintained-lowered to floor mat-pallor.  Thready fast pulse-cold compresses to head-raised feet-monitored for adverse reactions.  Color returned-normal pulse returned.  Faint: 30 second-monitored 30 min.  Release to mother.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood creatine phosphokinase, Borrelia burgdorferi serology negative, Full blood count, Gait disturbance, Headache
Clinical narrative: Fever 101-103 associated with headache & body aches.  Intense muscle aches lower extrem > upper extrem to the point of difficulty walking, getting out of chair, etc.  Duration 5-6d.  Rx ibuprofen 600mg q 6 hr.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Myalgia, Pain, Parvovirus B19 serology positive, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Fever 101-103 associated with headache & body aches.  Intense muscle aches lower extrem > upper extrem to the point of difficulty walking, getting out of chair, etc.  Duration 5-6d.  Rx ibuprofen 600mg q 6 hr.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on bottom - 3 large red round areas & several small pimply marks.  The area is uncomfortable - it is hard to lay down or sit.  MD diagnosed as shingles.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: R arm pain/ ? vaccine reaction.  C/O itching & headache x2 days.  Rx MOTRIN/observe.
Age: 21.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Developed dizziness, chills, fever, nausea & vomiting w/ diarrhea.  PHENERGAN on hand for nausea.
Age: 21.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Vomiting
Clinical narrative: Developed dizziness, chills, fever, nausea & vomiting w/ diarrhea.  PHENERGAN on hand for nausea.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Blurred vision in left eye unable to focus.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy, Muscle twitching
Clinical narrative: Received ZOSTAVAX 7-11-2008; 7-18-2008 client experienced facial droop (L) side x 1 minute.  Seen by PP.  Dr. (diagnosis Bell's palsy) on 7-23-2008.  Continues to experience (L) sided facial droop lasting 1 minute when fatigued.  (L) eye twitching prior 1 month to vaccine June 2008.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncope ~3 min - cold cloths to forehead, juice.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Injection site pruritus
Clinical narrative: Approximately 30 minutes after immunization, donor had itching at site of shot.  Denies all other symptoms.  Resolved within 2 hours of start.  No further problems.
Age: 1.0
Sex: M
Vaccine: MEA, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: 2/20/2008-vaccines: varicella, measles, PCV7 given.  2/21/08-fever 102.2 2/22/08-fever 105 per phone calls to advise RN at clinic.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Arthralgia, Fatigue, Muscle spasms, Muscle twitching
Clinical narrative: Muscle twitch under left eye.  Muscle aches, joint aches - progressing thru body.  Fingers slight swelling, muscle ache back of neck into back of head.  Fatigue in afternoons.  Slight agitation after taking thyroid med in a.m.  Muscle spasm in abdomen for +/- 5 mins on day of vac.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Oedema peripheral
Clinical narrative: Muscle twitch under left eye.  Muscle aches, joint aches - progressing thru body.  Fingers slight swelling, muscle ache back of neck into back of head.  Fatigue in afternoons.  Slight agitation after taking thyroid med in a.m.  Muscle spasm in abdomen for +/- 5 mins on day of vac.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Nausea, Sneezing
Clinical narrative: 5min after receiving VARIVAX, pt c/o ST, nausea, sneezing.  No rash.  BP 98/70.  No SOB.  R eye puffy.  1 1/2 tsp oral BENADRYL given with no imp. pt.  Transported to ER via paramedics.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Antinuclear antibody negative, Asthma, Biopsy, Bronchoscopy normal, C-reactive protein normal
Clinical narrative: SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Catheterisation cardiac normal, Computerised tomogram normal, Culture negative, Echocardiogram normal, Electroencephalogram normal
Clinical narrative: SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count normal, Gastric emptying study, Gastrooesophageal reflux disease, HIV test negative, Metabolic function test
Clinical narrative: SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging normal, Patellofemoral pain syndrome, Post-traumatic amnestic disorder, Pulmonary function test normal, Rheumatoid factor negative
Clinical narrative: SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Spirometry normal, Syphilis test negative, Thyroid function test normal, Ultrasound abdomen normal, X-ray normal
Clinical narrative: SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Married 10/13/07.  11/5/07 menstrual cycle 3-4 days vs 5-6 but has irregular cycles since off BCP x several months.  AVA vaccine #1 9/7/07 with 2nd about 2 wks later (estimated 9/21/07 as not in DEERS).  Third AVA, primary ACAM SMPX, flumist given 11/7/07.  No adverse events and normal take for SMPX with foreation at left arm site.  Missed menstrual cycle in Dec with pregnancy test positive 12/20/07.  Normal pregnancy w/o complications, normal vag delivery.  Healthy newborn female born 7/15/08 - needs trensturn released, scheduled for 7/17/08.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Erythema, Joint swelling
Clinical narrative: Woke from nap, inconsolable (~1230pm) L thigh red & swollen to knee.  Came to office at 100pm.  Ice applied ibuprofen given (had TYLENOL 3 hours prior).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Malaise, Nausea, Pyrexia, Swelling
Clinical narrative: Severe red swollen area nausea malaise fever to 102 for 5 days.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Rash
Clinical narrative: Mom states patient is running a low grade temp, and broken out in a rash.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Skin lesion, Urticaria
Clinical narrative: 7 cm x 5 cm area of erythema and induration left arm at shot site.  7-8 urticarial lesions on chest and abdomen.  1 urticarial lesion left forearm.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Lumbar puncture, Neuropathy peripheral
Clinical narrative: Bilateral neuropathy.  Numbing & tingling in hands & feet.  Started approximately weeks after vaccination.  Sensitivity to cold & heat in both hands.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Temperature intolerance, X-ray
Clinical narrative: Bilateral neuropathy.  Numbing & tingling in hands & feet.  Started approximately weeks after vaccination.  Sensitivity to cold & heat in both hands.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Received Hep A vaccine on 8-4-08, developed rash at site of inoculation - erythematous, not painful or itchy but 5"x5 1/2" in diameter.  Treatment: BENADRYL, ice/cold compress, f/u in 1 day.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Had shot on AM of 31st.  First symptoms on Aug 3 in evening.  Noticed itching & rash on chest-back-legs.  No other symptoms.  Has been treating with BENADRYL & topical CALADRYL with some.  Client has recently returned from a 1 week vacation (family reunion). Her rash is diffuse and reddish-very itchy.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: As per mom irritation and swelling to vaccine site.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient developed a large area (12cm x 13cm) of erythema, firmness, tenderness & increased warmth on her left thigh.  The center was hard & yellowish = 4.0cm x 2.4cm.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Abscess, Cellulitis, Erythema, Induration, Pruritus
Clinical narrative: Very red, swollen, hot, itchy, discharge.  7cm oval light red right upper arm.  Central area very hot, red, tender, firm.  Appears to be forming a abscess.  Diagnosis: Cellulitis.  Medi Keflex.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Very red, swollen, hot, itchy, discharge.  7cm oval light red right upper arm.  Central area very hot, red, tender, firm.  Appears to be forming a abscess.  Diagnosis: Cellulitis.  Medi Keflex.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt developed swelling at injection site that increased over 24 hours to her upper arm down to her elbow.  Area became firm and painful.  Symptom resolved with ice to area.
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: I gave her combination vaccine DTaP + Hep B + IPV.  She didn't need Hep B + IPV.
Sex: M
Vaccine: HEP
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: Information has been received from a lawyer regarding a case in litigation, which was reported in an article concerning a male who on 27-SEP-2000 was vaccinated with a second dose of RECOMBIVAX HB (lot # not reported). The patient alleged that within hours of the vaccination, it caused Guillain-Barre Syndrome (GBS). On 06-DEC-2000 the patient was diagnosed with Guillain-Barre Syndrome and was ultimately diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). The patient alleged that the RECOMBIVAX HB caused chronic inflammatory demyelinating polyneuropathy. It was concluded that "based on the prior holdings relating causally hepatitis B virus vaccine and demyelinating diseases, in particular CIDP, and respondent's expert's agreement that, if biological plausibility and logical sequence of cause and effect were persuasive in this case, the temporal interval between petitioner's vaccination and onset of CIDP is within the range of statistically significant increase incidence, and ruled that the petitioner has made a prima facie case of causation in fact." The patient's outcome was not reported. Upon internal review, the patient's Guillain-Barre Syndrome was considered to be an other important medical event. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Blood pressure increased, Blood test normal, Erythema
Clinical narrative: Information has been received from a 68 year old female with no known drug allergies and no pertinent medical history, who on 17-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Starting on 17-FEB-2007 through 24-FEB-2007, the patient experienced injection site pain, hip pain, ankle pain, knee pain and exhaustion.  Then starting on 25-FEB-2007 through 03-MAR-2007, the patient had ringing of the ears, hot flashes, hard red spots on her body, exhaustion, headache and increased blood pressure.  The symptoms she had left were the hard red spots on her body, ear ringing, and pain in her hips, knee, ankle, and front and the back of the thighs and up to her rib cage.  From October 2007 until the report date of 01-AUG-2008, the patient still had terrible pain from her ankles to her rib cage, but the symptoms of injection site pain, increased blood pressure, hot flashes, and the red spots had gone away.  The consumer also reported that from the experience she took a year off from work, and she had trouble getting up and down the stairs.  She saw a couple of physicians regarding the experience she had.  Blood work was done and "needles were stuck in to check her nerves".  Blood work came back O.K.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hot flush, Impaired work ability, Induration
Clinical narrative: Information has been received from a 68 year old female with no known drug allergies and no pertinent medical history, who on 17-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Starting on 17-FEB-2007 through 24-FEB-2007, the patient experienced injection site pain, hip pain, ankle pain, knee pain and exhaustion.  Then starting on 25-FEB-2007 through 03-MAR-2007, the patient had ringing of the ears, hot flashes, hard red spots on her body, exhaustion, headache and increased blood pressure.  The symptoms she had left were the hard red spots on her body, ear ringing, and pain in her hips, knee, ankle, and front and the back of the thighs and up to her rib cage.  From October 2007 until the report date of 01-AUG-2008, the patient still had terrible pain from her ankles to her rib cage, but the symptoms of injection site pain, increased blood pressure, hot flashes, and the red spots had gone away.  The consumer also reported that from the experience she took a year off from work, and she had trouble getting up and down the stairs.  She saw a couple of physicians regarding the experience she had.  Blood work was done and "needles were stuck in to check her nerves".  Blood work came back O.K.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Nerve conduction studies, Pain in extremity, Rash erythematous
Clinical narrative: Information has been received from a 68 year old female with no known drug allergies and no pertinent medical history, who on 17-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Starting on 17-FEB-2007 through 24-FEB-2007, the patient experienced injection site pain, hip pain, ankle pain, knee pain and exhaustion.  Then starting on 25-FEB-2007 through 03-MAR-2007, the patient had ringing of the ears, hot flashes, hard red spots on her body, exhaustion, headache and increased blood pressure.  The symptoms she had left were the hard red spots on her body, ear ringing, and pain in her hips, knee, ankle, and front and the back of the thighs and up to her rib cage.  From October 2007 until the report date of 01-AUG-2008, the patient still had terrible pain from her ankles to her rib cage, but the symptoms of injection site pain, increased blood pressure, hot flashes, and the red spots had gone away.  The consumer also reported that from the experience she took a year off from work, and she had trouble getting up and down the stairs.  She saw a couple of physicians regarding the experience she had.  Blood work was done and "needles were stuck in to check her nerves".  Blood work came back O.K.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Information has been received from a 68 year old female with no known drug allergies and no pertinent medical history, who on 17-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Starting on 17-FEB-2007 through 24-FEB-2007, the patient experienced injection site pain, hip pain, ankle pain, knee pain and exhaustion.  Then starting on 25-FEB-2007 through 03-MAR-2007, the patient had ringing of the ears, hot flashes, hard red spots on her body, exhaustion, headache and increased blood pressure.  The symptoms she had left were the hard red spots on her body, ear ringing, and pain in her hips, knee, ankle, and front and the back of the thighs and up to her rib cage.  From October 2007 until the report date of 01-AUG-2008, the patient still had terrible pain from her ankles to her rib cage, but the symptoms of injection site pain, increased blood pressure, hot flashes, and the red spots had gone away.  The consumer also reported that from the experience she took a year off from work, and she had trouble getting up and down the stairs.  She saw a couple of physicians regarding the experience she had.  Blood work was done and "needles were stuck in to check her nerves".  Blood work came back O.K.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Epilepsy, Grand mal convulsion
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 20-JUN-2007 was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  On 27-DEC-2007 the patient was vaccinated with a second dose of GARDASIL by intramuscular injection (injection route not reported).  On 08-JAN-2008, also reported as 11 days post-second dose, the patient experienced generalized seizure.  On 08-JAN-2008, the patient went to emergency room.  While at ER, an EEG was scheduled, a CT scan was actually performed and the results were unspecified.  The physician reported that the patient's seizures were currently being controlled by a combination of medications, KEPPRA and other unspecified medication.  The physician reported that the patient's last seizure was on 30-MAY-2008.  The patient's outcome was not specified.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 20-JUN-2007 was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  On 27-DEC-2007 the patient was vaccinated with a second dose of GARDASIL by intramuscular injection (injection route not reported).  On 08-JAN-2008, also reported as 11 days post-second dose, the patient experienced generalized seizure.  On 08-JAN-2008, the patient went to emergency room.  While at ER, an EEG was scheduled, a CT scan was actually performed and the results were unspecified.  The physician reported that the patient's seizures were currently being controlled by a combination of medications, KEPPRA and other unspecified medication.  The physician reported that the patient's last seizure was on 30-MAY-2008.  The patient's outcome was not specified.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Bacteria stool identified, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a company representative concerning a 6-8 month old female who was vaccinated with ROTATEQ.  It was reported that the patient had diarrhea and vomiting after ROTATEQ.  The office was not sure if it was the second or third dose.  "The child was off schedule a little bit."  The patient was hospitalized for an unspecified duration and tested positive for C. difficile.  The mother has an unspecified immunodeficiency disorder and doctors are unsure if the child has it as well.  At this time, it was reported that the patient has not recovered from the events.  No product quality complaint.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Gaze palsy, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter with questionable allergies to penicillin and a history of Bell's Palsy who in December 2007 or January 2008, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  In February 2008, the patient was vaccinated with a second dose of GARDASIL intramuscularly (injection site and lot number not reported).  There was no concomitant medication.  On 25-JUN-2008 or 26-JUN-2008, the patient had a relatively high fever of 101.9 F.  She was put on ZITHROMAX from 26-JUN-2008 to 30-JUN-2008.  On 02-JUL-2008 the patient had a seizure, her eyes rolled to the back of her head and she had a loss of memory.  The patient was taken to the emergency room and the following tests were done: CT scan, EEG and MRI which were all normal.  The ER did not find the cause of the seizure.  Subsequently the patient recovered from the events.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested. 8/13/08-records received for DOS 7/2/08-presented to ED after loss of consciousness while eating lunch. Coherent and confused enroute to ED. In ED awake, alert oriented with no specific complaints. Unaware of any antecedent symptoms prior to episode. DX: Syncope, probably seizure.  8/15/08-records received-1st Gardasil received 12/26/07-2nd Gardasil received 3/6/08. On 7/10/08-Parent contacted PCP office concerned about seizure after 2nd vaccination. Seizure occurred 1 week ago.  8/13/08-experienced second seizure. Will continue to follow in office.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter with questionable allergies to penicillin and a history of Bell's Palsy who in December 2007 or January 2008, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  In February 2008, the patient was vaccinated with a second dose of GARDASIL intramuscularly (injection site and lot number not reported).  There was no concomitant medication.  On 25-JUN-2008 or 26-JUN-2008, the patient had a relatively high fever of 101.9 F.  She was put on ZITHROMAX from 26-JUN-2008 to 30-JUN-2008.  On 02-JUL-2008 the patient had a seizure, her eyes rolled to the back of her head and she had a loss of memory.  The patient was taken to the emergency room and the following tests were done: CT scan, EEG and MRI which were all normal.  The ER did not find the cause of the seizure.  Subsequently the patient recovered from the events.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested. 8/13/08-records received for DOS 7/2/08-presented to ED after loss of consciousness while eating lunch. Coherent and confused enroute to ED. In ED awake, alert oriented with no specific complaints. Unaware of any antecedent symptoms prior to episode. DX: Syncope, probably seizure.  8/15/08-records received-1st Gardasil received 12/26/07-2nd Gardasil received 3/6/08. On 7/10/08-Parent contacted PCP office concerned about seizure after 2nd vaccination. Seizure occurred 1 week ago.  8/13/08-experienced second seizure. Will continue to follow in office.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  There was no concomitant medication.  Within 10 minutes after the vaccination, the patient developed a seizure.  The patient stayed in the office and recovered prior to leaving the office.  The duration of the seizure was unspecified.  The physician reported that no hospitalization or laboratory work up was required for the patient.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL.  The physician reported that a patient experienced on 01-AUG-2008 after having at some point previously received a GARDASIL injection.  Upon internal review seizure was considered an other important medical event.  Additional information has been requested. 8/22/08 Reviewed PCP office records which included ER contact info, labs & vax records. FINAL DX: vasovagal syncope; possible idiopathic seizure Records reveal patient immediately after 1st HPV injection 2/13/08 felt dizzy fainted & had tremors lasting less than 30 second, awoke alert but tired.  Recovered completely & d/c to home.  Parent informed MD of fainting & tremors while vacationing out of state, woke up confused & had HA x 2 days.  Seen in ER where CT scan & labs were WNL.  8/26/08 Reviewed ER medical records of 8/1/2008. FINAL DX: syncopal episode, probable vasovagal  Records reveal patient experienced trip & fall into a few inches of water at beach.  Got up & walked a few steps then fell forward & had seizure lasting 10-20 sec.  Patient had no memory of event.   Had HA & sore neck in ER.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Grand mal convulsion, Laboratory test, Scan, Syncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL.  The physician reported that a patient experienced on 01-AUG-2008 after having at some point previously received a GARDASIL injection.  Upon internal review seizure was considered an other important medical event.  Additional information has been requested. 8/22/08 Reviewed PCP office records which included ER contact info, labs & vax records. FINAL DX: vasovagal syncope; possible idiopathic seizure Records reveal patient immediately after 1st HPV injection 2/13/08 felt dizzy fainted & had tremors lasting less than 30 second, awoke alert but tired.  Recovered completely & d/c to home.  Parent informed MD of fainting & tremors while vacationing out of state, woke up confused & had HA x 2 days.  Seen in ER where CT scan & labs were WNL.  8/26/08 Reviewed ER medical records of 8/1/2008. FINAL DX: syncopal episode, probable vasovagal  Records reveal patient experienced trip & fall into a few inches of water at beach.  Got up & walked a few steps then fell forward & had seizure lasting 10-20 sec.  Patient had no memory of event.   Had HA & sore neck in ER.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal cardiac disorder, Pregnancy test negative
Clinical narrative: Information has been received from a 21 year old female with no medical history or no drug allergies, for the Pregnancy Registry for GARDASIL, who on an unknown date was vaccinated with the first dose of GARDASIL, on 02-JUL-2007 was vaccinated with the second dose of GARDASIL and in October 2007, was vaccinated with the third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified) and progesterone.  In November 2007, the patient found out she was pregnant.  The patient stated that she was given a pregnancy test each time and they came back negative, but it was assumed that the patient became pregnant around July 16, 2007.  The patient reported that she had her baby on 11-APR-2008, and her son was born with heart defects.  The patient stated that her son went to his physician every month too two months and had an electrocardiogram (EKG and ultrasound done), and he would have surgery when his heart gets bigger.  The patient stated that her son's surgery around will be when he is a year old.  No product quality complaint was involved.  Upon internal review, heart defect was considered to be a congenital anomaly.  Additional information has been requested.