chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Pt had anthrax #5 (according to MR, but number 8-10 per pt recollection) left arm on 1 May 08. Next day noted swelling, redness and lump which increased on 3 May and started to drain yellow syrupy drainage. Pt began to have numbness in left hand. Had fasciotomy on 3 May. On 5/20/08 had wound closed by a plastic surgeon. On 5/26 pt had redness and hardness at incision iste. Wound drained on 5/28. Pt had wound opened and I&D. Has been on IV and po antibiotics for MRSA and now has a wound vac.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Abscess
Clinical narrative: Pt had anthrax #5 (according to MR, but number 8-10 per pt recollection) left arm on 1 May 08. Next day noted swelling, redness and lump which increased on 3 May and started to drain yellow syrupy drainage. Pt began to have numbness in left hand. Had fasciotomy on 3 May. On 5/20/08 had wound closed by a plastic surgeon. On 5/26 pt had redness and hardness at incision iste. Wound drained on 5/28. Pt had wound opened and I&D. Has been on IV and po antibiotics for MRSA and now has a wound vac.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Culture wound positive, Erythema, Fasciotomy, Hypoaesthesia, Incision site erythema
Clinical narrative: Pt had anthrax #5 (according to MR, but number 8-10 per pt recollection) left arm on 1 May 08. Next day noted swelling, redness and lump which increased on 3 May and started to drain yellow syrupy drainage. Pt began to have numbness in left hand. Had fasciotomy on 3 May. On 5/20/08 had wound closed by a plastic surgeon. On 5/26 pt had redness and hardness at incision iste. Wound drained on 5/28. Pt had wound opened and I&D. Has been on IV and po antibiotics for MRSA and now has a wound vac.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Incisional drainage, Induration, Purulent discharge, Staphylococcal infection, Swelling
Clinical narrative: Pt had anthrax #5 (according to MR, but number 8-10 per pt recollection) left arm on 1 May 08. Next day noted swelling, redness and lump which increased on 3 May and started to drain yellow syrupy drainage. Pt began to have numbness in left hand. Had fasciotomy on 3 May. On 5/20/08 had wound closed by a plastic surgeon. On 5/26 pt had redness and hardness at incision iste. Wound drained on 5/28. Pt had wound opened and I&D. Has been on IV and po antibiotics for MRSA and now has a wound vac.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer (mother) concerning her 11 year old daughter who on an unspecified date was vaccinated with the first dose of GARDASIL.  On 18-MAR-2008 the patient was given the second dose of GARDASIL, (lot # not reported), IM.  One day after receiving the vaccination 19-MAR-2008 the daughter experienced a seizure.  She was taken to the emergency room where a CT scan and blood work were performed with normal results.  The patient was released that same day and reportedly recovered on an unspecified date.  Upon internal review, seizures were considered an other important medical event.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal
Clinical narrative: Information has been received from a consumer (mother) concerning her 11 year old daughter who on an unspecified date was vaccinated with the first dose of GARDASIL.  On 18-MAR-2008 the patient was given the second dose of GARDASIL, (lot # not reported), IM.  One day after receiving the vaccination 19-MAR-2008 the daughter experienced a seizure.  She was taken to the emergency room where a CT scan and blood work were performed with normal results.  The patient was released that same day and reportedly recovered on an unspecified date.  Upon internal review, seizures were considered an other important medical event.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood product transfusion, CSF immunoglobulin increased, CSF protein increased, Muscular weakness, Paraesthesia
Clinical narrative: This case was received from a health professional on 06 June 2008. A 56-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C2938AA) on 13 May 2008. The patient had a history of recurrent backache and left otitis, and was taking PREMARIN, CALCIUM, GLUCOSAMINE, FLEXORIL, and NASONEX concomitantly. On 27 May 2008, 14 days after vaccination, the patient began to complain of numbness and tingling in both hands "for a few days". On 29 May 2008, she developed lower extremity weakness and paresthesia of the left foot. She was admitted to the hospital on 31 May 2008, and diagnosed with Guillain-Barre Syndrome. At the time of the report, the event remained ongoing.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: This case was received from a health professional on 06 June 2008. A 56-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C2938AA) on 13 May 2008. The patient had a history of recurrent backache and left otitis, and was taking PREMARIN, CALCIUM, GLUCOSAMINE, FLEXORIL, and NASONEX concomitantly. On 27 May 2008, 14 days after vaccination, the patient began to complain of numbness and tingling in both hands "for a few days". On 29 May 2008, she developed lower extremity weakness and paresthesia of the left foot. She was admitted to the hospital on 31 May 2008, and diagnosed with Guillain-Barre Syndrome. At the time of the report, the event remained ongoing.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood amylase, Coagulation test, Coma, Computerised tomogram abnormal, Diarrhoea
Clinical narrative: 21 y/o female seen in ER 13 May with C/O it hand & lt. foot numbness approximately 1 month post GARDASIL vaccine. She also C/O of nausea, vomiting and diarrhea. A heat CT demonstrated bilateral basal ganglion infarcts and a MRI showed with similar results with no acute process. She was admitted 20 May with left hemiballsmus. On 22 May her mental status declined. She received many doses of HALDOL and ATIVAN for agitation and was intubated on 28 May. She was transferred to medical center 28 may for w/u for encephalitis and has since become comatose. Symptoms: Nausea w/vomiting, Diarrhea, Nausea w/o vomiting, Numbness.  7/11/08 Reviewed hospital medical records for 6/11-6/23/2008. FINAL DX: aseptic meningo-encephalitis; choreoathetosis r/t meningo-encephalitis; paroxysmal autonomic instability w/dystonia; e. coli UTI. Records reveal pt transferred from military hospital.  Military deployment 1-3/2008.  On leave 5/2008 developed n/v/d, abd pain & bifrontal HA which continued to worsen.  Sought medical help but no dx given.  Developed left side weakness, flaccidity & several falls.  Found 5/12 unable to ambulate & incontinent of urine.  Taken to ER where MRI revealed possible basalganglia infarct.  To ICU where subsequent MRIs were WNL.  Ventilated & remains in persistent vegetative state.  LPs done.  PICC , trach & PEG tubes.  Intermittently febrile, labile BP, asystole x2.   Tx in multiple hospitals w/multiple meds including steroids, IVIG, antibiotics & antivirals.  12/11/08 Reviewed additional medical records of 5/08-7/08. FINAL DX:  Records reveal patient experienced nausea/vomiting/diarrhea, dizziness & HA, left hand/foot numbness x 4-5 days.  Seen in ER on 5/13 where labs were WNL but CT of brain revealed lacunar infarcts, bilateral basal ganglia & cavum verge.  Numbness continued & developed involuntary jerking of LEs & difficulty walking.  Admitted to MICU 6/08 w/encephalitis.  Tx w/IVIG & steroids.  Transferred to higher level of care & then to inpatient rehab program.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count, Hypoaesthesia, Laboratory test, Liver function test, Mental status changes
Clinical narrative: 21 y/o female seen in ER 13 May with C/O it hand & lt. foot numbness approximately 1 month post GARDASIL vaccine. She also C/O of nausea, vomiting and diarrhea. A heat CT demonstrated bilateral basal ganglion infarcts and a MRI showed with similar results with no acute process. She was admitted 20 May with left hemiballsmus. On 22 May her mental status declined. She received many doses of HALDOL and ATIVAN for agitation and was intubated on 28 May. She was transferred to medical center 28 may for w/u for encephalitis and has since become comatose. Symptoms: Nausea w/vomiting, Diarrhea, Nausea w/o vomiting, Numbness.  7/11/08 Reviewed hospital medical records for 6/11-6/23/2008. FINAL DX: aseptic meningo-encephalitis; choreoathetosis r/t meningo-encephalitis; paroxysmal autonomic instability w/dystonia; e. coli UTI. Records reveal pt transferred from military hospital.  Military deployment 1-3/2008.  On leave 5/2008 developed n/v/d, abd pain & bifrontal HA which continued to worsen.  Sought medical help but no dx given.  Developed left side weakness, flaccidity & several falls.  Found 5/12 unable to ambulate & incontinent of urine.  Taken to ER where MRI revealed possible basalganglia infarct.  To ICU where subsequent MRIs were WNL.  Ventilated & remains in persistent vegetative state.  LPs done.  PICC , trach & PEG tubes.  Intermittently febrile, labile BP, asystole x2.   Tx in multiple hospitals w/multiple meds including steroids, IVIG, antibiotics & antivirals.  12/11/08 Reviewed additional medical records of 5/08-7/08. FINAL DX:  Records reveal patient experienced nausea/vomiting/diarrhea, dizziness & HA, left hand/foot numbness x 4-5 days.  Seen in ER on 5/13 where labs were WNL but CT of brain revealed lacunar infarcts, bilateral basal ganglia & cavum verge.  Numbness continued & developed involuntary jerking of LEs & difficulty walking.  Admitted to MICU 6/08 w/encephalitis.  Tx w/IVIG & steroids.  Transferred to higher level of care & then to inpatient rehab program.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Urine analysis, Vomiting
Clinical narrative: 21 y/o female seen in ER 13 May with C/O it hand & lt. foot numbness approximately 1 month post GARDASIL vaccine. She also C/O of nausea, vomiting and diarrhea. A heat CT demonstrated bilateral basal ganglion infarcts and a MRI showed with similar results with no acute process. She was admitted 20 May with left hemiballsmus. On 22 May her mental status declined. She received many doses of HALDOL and ATIVAN for agitation and was intubated on 28 May. She was transferred to medical center 28 may for w/u for encephalitis and has since become comatose. Symptoms: Nausea w/vomiting, Diarrhea, Nausea w/o vomiting, Numbness.  7/11/08 Reviewed hospital medical records for 6/11-6/23/2008. FINAL DX: aseptic meningo-encephalitis; choreoathetosis r/t meningo-encephalitis; paroxysmal autonomic instability w/dystonia; e. coli UTI. Records reveal pt transferred from military hospital.  Military deployment 1-3/2008.  On leave 5/2008 developed n/v/d, abd pain & bifrontal HA which continued to worsen.  Sought medical help but no dx given.  Developed left side weakness, flaccidity & several falls.  Found 5/12 unable to ambulate & incontinent of urine.  Taken to ER where MRI revealed possible basalganglia infarct.  To ICU where subsequent MRIs were WNL.  Ventilated & remains in persistent vegetative state.  LPs done.  PICC , trach & PEG tubes.  Intermittently febrile, labile BP, asystole x2.   Tx in multiple hospitals w/multiple meds including steroids, IVIG, antibiotics & antivirals.  12/11/08 Reviewed additional medical records of 5/08-7/08. FINAL DX:  Records reveal patient experienced nausea/vomiting/diarrhea, dizziness & HA, left hand/foot numbness x 4-5 days.  Seen in ER on 5/13 where labs were WNL but CT of brain revealed lacunar infarcts, bilateral basal ganglia & cavum verge.  Numbness continued & developed involuntary jerking of LEs & difficulty walking.  Admitted to MICU 6/08 w/encephalitis.  Tx w/IVIG & steroids.  Transferred to higher level of care & then to inpatient rehab program.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Coma, Diagnostic procedure, Nuclear magnetic resonance imaging
Clinical narrative: 21 y/o female seen in ER 13 May with C/O it hand & lt. foot numbness approximately 1 month post GARDASIL vaccine. She also C/O of nausea, vomiting and diarrhea. A heat CT demonstrated bilateral basal ganglion infarcts and a MRI showed with similar results with no acute process. She was admitted 20 May with left hemiballsmus. On 22 May her mental status declined. She received many doses of HALDOL and ATIVAN for agitation and was intubated on 28 May. She was transferred to medical center 28 may for w/u for encephalitis and has since become comatose. Symptoms: Nausea w/vomiting, Diarrhea, Nausea w/o vomiting, Numbness.  7/11/08 Reviewed hospital medical records for 6/11-6/23/2008. FINAL DX: aseptic meningo-encephalitis; choreoathetosis r/t meningo-encephalitis; paroxysmal autonomic instability w/dystonia; e. coli UTI. Records reveal pt transferred from military hospital.  Military deployment 1-3/2008.  On leave 5/2008 developed n/v/d, abd pain & bifrontal HA which continued to worsen.  Sought medical help but no dx given.  Developed left side weakness, flaccidity & several falls.  Found 5/12 unable to ambulate & incontinent of urine.  Taken to ER where MRI revealed possible basalganglia infarct.  To ICU where subsequent MRIs were WNL.  Ventilated & remains in persistent vegetative state.  LPs done.  PICC , trach & PEG tubes.  Intermittently febrile, labile BP, asystole x2.   Tx in multiple hospitals w/multiple meds including steroids, IVIG, antibiotics & antivirals.  12/11/08 Reviewed additional medical records of 5/08-7/08. FINAL DX:  Records reveal patient experienced nausea/vomiting/diarrhea, dizziness & HA, left hand/foot numbness x 4-5 days.  Seen in ER on 5/13 where labs were WNL but CT of brain revealed lacunar infarcts, bilateral basal ganglia & cavum verge.  Numbness continued & developed involuntary jerking of LEs & difficulty walking.  Admitted to MICU 6/08 w/encephalitis.  Tx w/IVIG & steroids.  Transferred to higher level of care & then to inpatient rehab program.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chromosome analysis abnormal, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female with no pertinent medical history, no known allergies or adverse drug reactions and one prior pregnancy and child with no complication or problems.  On 14-FEB-2007, the patient was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot# 655619/1427F).  There were no concomitant medications reported.  The physician reported that after the administration, the patient reported that she was pregnant.  It was reported that the patient had a prenatal mid trimester sonogram performed and "slanted eyes" were noted.  At that time it was suggested to the patient that the baby might have Down's syndrome.  On 24-JUL-2007 the patient had a full term vaginal delivery.  Her baby was diagnosed with Down's syndrome confirmed by chromosome analysis.  The baby had been evaluated by a cardiologist for a patent ductus arteriosis  which has closed and a "tiny" patent foramen ovale.  The baby had an unspecified thyroid problem for which an endocrine follow-up was scheduled.  At the time of the report, the outcome of the atrial septal defect, thyroid disorder and trisomy 21 were unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Blood pressure, Injection site pain, Pruritus, Syncope
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who on 02-JUN-2008 was vaccinated with a first dose 0.5 mL of GARDASIL. Concomitant therapy included tuberculin purified protein derivative and meningococcal vaccine (manufacturer unknown). The mother reported that on 02-JUN-2008 her daughter fainted after she was vaccinated with her first dose of GARDASIL. She also developed itching on her hand and soreness at the injection site. The patient sought unspecified medical attention. The patient's blood pressure was obtained (results not reported). A telephone call was placed to the doctor's office to obtain more information. At this time no additional information was available. The patient was recovering. The reporter considered the events syncope, patient experienced itching on her hand and soreness at the injection site to be disabling. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 12 year old female with a history of an elbow injury and passing out, who on 02-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # 659962/1740U).  Concomitant therapy included a dose of MENACTRA and a dose of DTAP.  On 02-JUN-2008 the patient passed out after receiving the first dose of GARDASIL.  The patient was already in the clinic.  The physician also reported that the patient "might have experienced a minor seizure because her hands were kind of rigid and were tightened up."  No diagnostic laboratory testing was performed.  The physician noted that the patient had recovered.  No product quality complaint was involved.  Upon internal review, minor seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Induced labour, Laboratory test, Postpartum state
Clinical narrative: Initial and follow-up information has been received through the pregnancy registry from a 25 year old female office manager with no pertinent medical history who on 07-DEC-2006 was vaccinated with a 0.5 ml dose of GARDASIL (lot #653938/0954F).  There was no concomitant medication.  On 29-DEC-2006 the patient learned that she was pregnant.  Unspecified medical attention was sought.  On an unspecified date the patient underwent "blood work" and an ultrasound.  There was no adverse experience.  At the time of the initial report, the patient was 9.5 weeks gestation.  It was reported that the patient was induced at 41 weeks estimated gestational age for a low amniotic fluid index.  The patient had a primary cesarean section due to a non-reassuring fetal heart rate and failure to descend with minimal cervical dilation.  She delivered a healthy normal female weighing 7 pounds and 2 ounces on 24-AUG-2007.  It was reported that the mother had some difficulty "mentally" postpartum.  At the time of the report, the mother and baby were "well."  Upon internal review, non-reassuring fetal heart rate and failure to descend with minimal cervical dilation were considered to be other important medical events.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Initial and follow-up information has been received through the pregnancy registry from a 25 year old female office manager with no pertinent medical history who on 07-DEC-2006 was vaccinated with a 0.5 ml dose of GARDASIL (lot #653938/0954F).  There was no concomitant medication.  On 29-DEC-2006 the patient learned that she was pregnant.  Unspecified medical attention was sought.  On an unspecified date the patient underwent "blood work" and an ultrasound.  There was no adverse experience.  At the time of the initial report, the patient was 9.5 weeks gestation.  It was reported that the patient was induced at 41 weeks estimated gestational age for a low amniotic fluid index.  The patient had a primary cesarean section due to a non-reassuring fetal heart rate and failure to descend with minimal cervical dilation.  She delivered a healthy normal female weighing 7 pounds and 2 ounces on 24-AUG-2007.  It was reported that the mother had some difficulty "mentally" postpartum.  At the time of the report, the mother and baby were "well."  Upon internal review, non-reassuring fetal heart rate and failure to descend with minimal cervical dilation were considered to be other important medical events.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a physician, who heard from another physician, that a female (age unreported) who was vaccinated with a dose of GARDASIL, became paralyzed.  The reporter considered the paralysis to be disabling.  It was reported that the patient has not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning an approximate 22 year old female who in December 2007, was vaccinated with the first dose of GARDASIL. Concomitant therapy included YAZ. Subsequently the patient experienced numbness and tingling in both feet. The second dose of GARDASIL, 0.5 ml, IM was given between January 2006 and May 2008. The patient was seen by a neurologist who recommended that the patient not receive the third dose. The reporter felt that numbness and tingling in both feet was considered to be an other important medical event. Additional information has been requested.7/18/08-record received for DOS 6/27/08-neurology consultation for C/O numbness involving lower part of body present since January 2008 possibly due to Gardasil. PE: free of any objective abnormality.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP
Symptoms: Asthenia, Convulsion, Dizziness, Paraesthesia, Syncope
Clinical narrative: Syncopal episode about 10 min after injection, possible seizure activity for 15-20 seconds. Then generalized weakness, tingling, and dizziness. The patient responded poorly to fluids, Benadryl, Epinephrine, and Decadron. 6/13/08-DC summary received for DOS 5/29-5/31/08. DC DX: Adverse reaction to vaccination. Day of vaccines developed swelling of right arm, felt dizzy and weak. Continued to feel weak for day or 2. Arm swelling and tingling continued as well as weakness of grip on right arm.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Allergy test negative, Aphasia, Autism, Childhood disintegrative disorder, Developmental delay
Clinical narrative: Twitching, ear infection, stimming. Loss of words and all verbal communication. Neurological and developmental delays. Autism from 18 mos - 22 mos onset. Low protein. Currently takes LEVOCARNITNINE and CO Q 10 for possible metabolic disorder. Follow-up 1/21/10 Seizures, tics, autism, developmental delays.   8/5/08 Reviewed psychologic examination report of 2/22/2008. FINAL DX: autism spectrum disorder Records reveal that patient experienced recurring otitis media abeginning at 15 mo that seemed to trigger a developmental regression beginning with his 1st ear infection but most apparent after 3rd ear infection approx 19 mo when he became very hyperactive.  Language loss began approx 22 mo & began stereotypical repetitive behaviors.  Had PE tubes placed & adenoids removed 10/2007 & ear infections resolved however found to have mild hearing loss.  Also medically found to have metabolic disorder & eczema, picky eater, loose stools, hyperactive, difficulty falling asleep, loss of speech.  Had been receiving ST/OT.  6/20/08 Reviewed PCP medical records for 12/18/06-8/2/2007. FINAL DX: Records reveal patient experienced recent URI & was teething on day of vaccination otherwise in good health.  Returned to clinic 12/28/06 w/vomiting, diarrhea, fever, cough, congestion, lethargic & decreased appetite. Dx w/URI & ROM, treated w/antibiotics.  Returned 2/23/07 w/runny nose, cough, congestion, fever, decreased sleep.  Dx wLOM & URI, treated w/antibiotics.  Returned 3/9/07 w/questionable seizure night before with shaking while in highchair.  Exam revealed resolved OM & neuro eval WNL.  Referred to neurology for EEG.  Had additional OM & URI, loss of speech.  Referred to ENT for hearing test.  Neuro did not feel had seizures.  No documentation of autism in PCP records received.   7/4/08 Reviewed developmental peds medical records of 8/23-9/26/2007. FINAL DX: autistic disorder Records reveal patient experienced hyperactivity, paroxysmal twitching behaviors, abnormal repetitive play, toe walking, not responsive to name, sleep difficulties, toy/activity fixations, finicky eating, stereotypical repetitive behaviors, Receiving ST/PT/OT from early intervention program at time of evaluation.  An addendum of 2/2008 notes that parents reported regression to the point of having no recognizable words.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Ear infection, Metabolic disorder, Metabolic function test abnormal, Muscle twitching, Nervous system disorder
Clinical narrative: Twitching, ear infection, stimming. Loss of words and all verbal communication. Neurological and developmental delays. Autism from 18 mos - 22 mos onset. Low protein. Currently takes LEVOCARNITNINE and CO Q 10 for possible metabolic disorder. Follow-up 1/21/10 Seizures, tics, autism, developmental delays.   8/5/08 Reviewed psychologic examination report of 2/22/2008. FINAL DX: autism spectrum disorder Records reveal that patient experienced recurring otitis media abeginning at 15 mo that seemed to trigger a developmental regression beginning with his 1st ear infection but most apparent after 3rd ear infection approx 19 mo when he became very hyperactive.  Language loss began approx 22 mo & began stereotypical repetitive behaviors.  Had PE tubes placed & adenoids removed 10/2007 & ear infections resolved however found to have mild hearing loss.  Also medically found to have metabolic disorder & eczema, picky eater, loose stools, hyperactive, difficulty falling asleep, loss of speech.  Had been receiving ST/OT.  6/20/08 Reviewed PCP medical records for 12/18/06-8/2/2007. FINAL DX: Records reveal patient experienced recent URI & was teething on day of vaccination otherwise in good health.  Returned to clinic 12/28/06 w/vomiting, diarrhea, fever, cough, congestion, lethargic & decreased appetite. Dx w/URI & ROM, treated w/antibiotics.  Returned 2/23/07 w/runny nose, cough, congestion, fever, decreased sleep.  Dx wLOM & URI, treated w/antibiotics.  Returned 3/9/07 w/questionable seizure night before with shaking while in highchair.  Exam revealed resolved OM & neuro eval WNL.  Referred to neurology for EEG.  Had additional OM & URI, loss of speech.  Referred to ENT for hearing test.  Neuro did not feel had seizures.  No documentation of autism in PCP records received.   7/4/08 Reviewed developmental peds medical records of 8/23-9/26/2007. FINAL DX: autistic disorder Records reveal patient experienced hyperactivity, paroxysmal twitching behaviors, abnormal repetitive play, toe walking, not responsive to name, sleep difficulties, toy/activity fixations, finicky eating, stereotypical repetitive behaviors, Receiving ST/PT/OT from early intervention program at time of evaluation.  An addendum of 2/2008 notes that parents reported regression to the point of having no recognizable words.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Protein total decreased
Clinical narrative: Twitching, ear infection, stimming. Loss of words and all verbal communication. Neurological and developmental delays. Autism from 18 mos - 22 mos onset. Low protein. Currently takes LEVOCARNITNINE and CO Q 10 for possible metabolic disorder. Follow-up 1/21/10 Seizures, tics, autism, developmental delays.   8/5/08 Reviewed psychologic examination report of 2/22/2008. FINAL DX: autism spectrum disorder Records reveal that patient experienced recurring otitis media abeginning at 15 mo that seemed to trigger a developmental regression beginning with his 1st ear infection but most apparent after 3rd ear infection approx 19 mo when he became very hyperactive.  Language loss began approx 22 mo & began stereotypical repetitive behaviors.  Had PE tubes placed & adenoids removed 10/2007 & ear infections resolved however found to have mild hearing loss.  Also medically found to have metabolic disorder & eczema, picky eater, loose stools, hyperactive, difficulty falling asleep, loss of speech.  Had been receiving ST/OT.  6/20/08 Reviewed PCP medical records for 12/18/06-8/2/2007. FINAL DX: Records reveal patient experienced recent URI & was teething on day of vaccination otherwise in good health.  Returned to clinic 12/28/06 w/vomiting, diarrhea, fever, cough, congestion, lethargic & decreased appetite. Dx w/URI & ROM, treated w/antibiotics.  Returned 2/23/07 w/runny nose, cough, congestion, fever, decreased sleep.  Dx wLOM & URI, treated w/antibiotics.  Returned 3/9/07 w/questionable seizure night before with shaking while in highchair.  Exam revealed resolved OM & neuro eval WNL.  Referred to neurology for EEG.  Had additional OM & URI, loss of speech.  Referred to ENT for hearing test.  Neuro did not feel had seizures.  No documentation of autism in PCP records received.   7/4/08 Reviewed developmental peds medical records of 8/23-9/26/2007. FINAL DX: autistic disorder Records reveal patient experienced hyperactivity, paroxysmal twitching behaviors, abnormal repetitive play, toe walking, not responsive to name, sleep difficulties, toy/activity fixations, finicky eating, stereotypical repetitive behaviors, Receiving ST/PT/OT from early intervention program at time of evaluation.  An addendum of 2/2008 notes that parents reported regression to the point of having no recognizable words.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood test normal, Culture stool negative, Diarrhoea, Inappropriate schedule of drug administration, Occult blood positive
Clinical narrative: 2 days after vaccination, developed diarrhea, mucosy, heme positive, then fever (102.5). All cultures negative. Lasted several weeks. Now on Neolate
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: 2 days after vaccination, developed diarrhea, mucosy, heme positive, then fever (102.5). All cultures negative. Lasted several weeks. Now on Neolate
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Approximately 5 min. after receiving the HPV vaccine client complained of pain at the injection site followed by tingling & numbness of her right hand & fingers.  This continued for the next 24 hours.  Client has since recovered.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Electrocardiogram normal, Lethargy, Pyrexia, Somnolence
Clinical narrative: On Wednesday, 5/28/08, at 6pm, patient began running fever of 99 degrees F.  Parents began giving TYLENOL (Infant's).  Fever gradually increased to 101 degrees F by Friday (5-30-08) and patient was lethargic, difficult to awaken & not eating.  Went to ER.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills
Clinical narrative: PNEUMOVAX 0.5 cc administered SQ L arm and 45-60 minutes later developed temperature 102.7 oral and chills - TYLENOL given and symptoms gone in 3 hours.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Oxygen saturation decreased, Throat irritation
Clinical narrative: Client was seen at Urgent Care Center with itching to throat and S.O.B.  They gave BENADRYL 50 mg & KENALOG 40 mg - then sent client to ER.  I called 6/10/08-at home-client states doing fine.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: 8 days after MMR, VARIVAX and PREVNAR vaccines had a simple, febrile seizure - seen in ER - no physical findings.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Drug hypersensitivity, Erythema, Skin warm, Tenderness
Clinical narrative: (R) thigh 3x4 in erythema, tender, warm. (L) (-), A/P (R) thigh cellulitis vs reaction, PCN allergy, Zithromax rx started heat recent.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Full body rash, started 2nd
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Called guardian left message for her to contact our office.  At this time we are not aware of any adverse reactions or concerns.
Age: 51.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Blood pressure, Erythema, Heart rate normal, Local reaction, Lymphadenopathy
Clinical narrative: 50-year-old male with history of asthma.  He was seen in the office 4 days ago and as part of preventative medicine assessment was given ADACEL in the left shoulder.  He was also given hepatitis A in the right shoulder and that he has traveled abroad where there is potential for hepatitis A exposure.  He has had a very substantial localized reaction in the left shoulder, nothing in the right shoulder, and accompanying systemic symptoms.  He notes that he felt low-grade fever and achy following the vaccination.  From that aspect, the systemic effects have diminished, but he has had increased localized reaction with erythema, warmth, and some tenderness in the axillary area.  He has not had such a reaction before.  He has not had any breathing difficulties.  No acute distress.  Blood pressure 108/78, pulse 80 and regular, afebrile.  Neck is soft and supple.  There is no angioedema.  No stridor.  Lungs are clear without wheeze.  He does have substantial erythema draping via left shoulder.  He does have good range of motion.  There is no suggestion of any septic arthritis.  He does have a little bit of axillary discomfort and perhaps some low grade axillary palpable adenopathy.  The erythema is pretty confluent.  It is warmth to touch.  There is no petechiae or purpura.  No bullous formation.  Neurovascularly intact.  Substantial localized reaction to ADADEL vaccination.  It may possible by the acellular pertussis component, although it may be the tetanus component.  Patient is systemically improved.  He is using ibuprofen on a p.r.n. basis.  I did suggest a brief course of prednisone 40 mg daily for 5 days, which he declined.  I also recommended to cover the potential cellulitis given the erythematous nature and the axillary adenopathy with KEFLEX 500 mg 1 p.o. t.i.d. x10 days, #30, with no refills, discontinue for rash or GI intolerance.  We will make reports of vaccine adverse event.  Would advise that in future unless necessary, patient hold on ADACEL vaccination, could consider Td vaccination.  He certainly would be okay to get a second hepatitis A in 6 months.  Follow up for this matter at this point will be p.r.n.
Age: 51.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pain, Pyrexia, Skin warm, Tenderness
Clinical narrative: 50-year-old male with history of asthma.  He was seen in the office 4 days ago and as part of preventative medicine assessment was given ADACEL in the left shoulder.  He was also given hepatitis A in the right shoulder and that he has traveled abroad where there is potential for hepatitis A exposure.  He has had a very substantial localized reaction in the left shoulder, nothing in the right shoulder, and accompanying systemic symptoms.  He notes that he felt low-grade fever and achy following the vaccination.  From that aspect, the systemic effects have diminished, but he has had increased localized reaction with erythema, warmth, and some tenderness in the axillary area.  He has not had such a reaction before.  He has not had any breathing difficulties.  No acute distress.  Blood pressure 108/78, pulse 80 and regular, afebrile.  Neck is soft and supple.  There is no angioedema.  No stridor.  Lungs are clear without wheeze.  He does have substantial erythema draping via left shoulder.  He does have good range of motion.  There is no suggestion of any septic arthritis.  He does have a little bit of axillary discomfort and perhaps some low grade axillary palpable adenopathy.  The erythema is pretty confluent.  It is warmth to touch.  There is no petechiae or purpura.  No bullous formation.  Neurovascularly intact.  Substantial localized reaction to ADADEL vaccination.  It may possible by the acellular pertussis component, although it may be the tetanus component.  Patient is systemically improved.  He is using ibuprofen on a p.r.n. basis.  I did suggest a brief course of prednisone 40 mg daily for 5 days, which he declined.  I also recommended to cover the potential cellulitis given the erythematous nature and the axillary adenopathy with KEFLEX 500 mg 1 p.o. t.i.d. x10 days, #30, with no refills, discontinue for rash or GI intolerance.  We will make reports of vaccine adverse event.  Would advise that in future unless necessary, patient hold on ADACEL vaccination, could consider Td vaccination.  He certainly would be okay to get a second hepatitis A in 6 months.  Follow up for this matter at this point will be p.r.n.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after injection noticed swelling & warmth at injection site.  Came into office 3 days later still with pain, swelling & redness at injection site.  1 1/4" x 3" edematous area.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient presents to office with left upper arm pain and decreased ROM due to pain with abduction.
Age: 15.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Fatigue, Injection site discolouration, Injection site swelling, Urticaria
Clinical narrative: Patient developed hives, fatigue, swelling and black and blue discoloration at site of Tdap injection.
Age: 27.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Headache, Injection site nodule, Migraine, Skin warm
Clinical narrative: Stated that  morning OP 06/07/08, noticed a large nodule at the injection site with a large red raised area roughly 4-5" in diameter around the injection site. Red area is warm to touch, and raised' Red as of 06/11/08. Also reports having migraine headaches since 6/6/08. No sent to clinic for evaluation at 6/11/08
Age: 64.0
Sex: M
Vaccine: TTOX
Symptoms: Asthenia, Feeling abnormal, Localised infection, Somnolence
Clinical narrative: Infection of finger-swollen-puss under skin-before after-within 20 minute of shot in the sun, felt very weak-just funny feeling-out of sun ok-later 10 min in sun again, sick again-been weak-sleepy-since.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: 6/3 tenderness at site later in day and then redness later on.  6/4 pain decreased to elbow and that night redness 1 1/2" x 3" around site.  6/5 pain and tenderness into shoulders and neck - antibiotic given (Levaquin 500 mg x 5 d).  6/6 painful muscles right side chest - Prednisone dose pak given (redness resolving).  6/8 tenderness gone, symptoms resolved.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: 6/3 tenderness at site later in day and then redness later on.  6/4 pain decreased to elbow and that night redness 1 1/2" x 3" around site.  6/5 pain and tenderness into shoulders and neck - antibiotic given (Levaquin 500 mg x 5 d).  6/6 painful muscles right side chest - Prednisone dose pak given (redness resolving).  6/8 tenderness gone, symptoms resolved.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm, Tenderness
Clinical narrative: At VARIVAX injection site left posterior arm - red raised area at 2inch long. Warm and tender to touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Induration, Pruritus, Swelling, Type IV hypersensitivity reaction
Clinical narrative: Left arm after 2 days with TDAP and VARIVAX. Noted to have swelling, hardness and itching. Deltoid area with ill defined bordered swelling, redness and induration centered around. TDAP site. Not tender with pressure. No fluctuant, no pointing. Type 4 hypersensitivity to TDAP. Treatment - Triamcinolone, ice and Zyrtec.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Dysphonia, Musculoskeletal stiffness
Clinical narrative: STIFFNESSS ALL OVER BODY,JOINT PAIN , HOARSENESS
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Wound drainage
Clinical narrative: Patient received Zostavax on 4/28/08 in left arm.  On 4/29/08, patient developed rash.  Rash first developed in the left innter arm by the elbow bend, and later developed on the left abdomen to a lesser degree.  The area on the arm was seeping.  Patient denied pain. Rash only developed on the left side.  Patient was advised to use calamine lotion to the rash.  Patient stated the calamine did not seem to help, and that the reaction "needed to run its course".  States it took several weeks to resolve.
Age: 3.0
Sex: M
Vaccine: DT
Symptoms: Rash erythematous
Clinical narrative: Within 5 minutes of receiving the dt shot in his thigh, the patient broke out is a red rash that started on his neck.  Over the next 10 minutes the rash spread to his face, went down his arms to his hands, and started down his back.  It stopped spreading after about 20 minutes.  The rash stayed on the patient for about 2 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: HIV test, Injection site rash, Injection site vesicles, Musculoskeletal pain, Neck pain
Clinical narrative: Pt. received the Zostavax on June 5 and then dev. left arm pain and shoulder and neck pain on the left on 6/8. Then noticed rash on 6/12 with red scattered lesions on upper left arm around the injection site with a small amount of vesciculation noted. Has pain and took Darvocet she had.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. received the Zostavax on June 5 and then dev. left arm pain and shoulder and neck pain on the left on 6/8. Then noticed rash on 6/12 with red scattered lesions on upper left arm around the injection site with a small amount of vesciculation noted. Has pain and took Darvocet she had.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Intense soreness and swelling around injection site for anthrax shot
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Mass, Pyrexia, Rash erythematous
Clinical narrative: STARTED OFF WITH DISCOLORATION OF SKIN AND REDNEDDNESS AND A RAISED BUMP THE SIZE OF A GOLFBALL 40 MIN AFTER THE SHOT. 5 DAYS LATER A REDDISH RASH (RASH DOES NOT ITCH) ON RIGHT SHOULDER AND BOTH FOREARMS APPEARED. ALSO KNEES HAVE SOME ARTHRITIC PAIN. ALSO HAD SLIGHT FEVER ON DAY 4 AFTER THE SHOT.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Skin discolouration, Swelling
Clinical narrative: STARTED OFF WITH DISCOLORATION OF SKIN AND REDNEDDNESS AND A RAISED BUMP THE SIZE OF A GOLFBALL 40 MIN AFTER THE SHOT. 5 DAYS LATER A REDDISH RASH (RASH DOES NOT ITCH) ON RIGHT SHOULDER AND BOTH FOREARMS APPEARED. ALSO KNEES HAVE SOME ARTHRITIC PAIN. ALSO HAD SLIGHT FEVER ON DAY 4 AFTER THE SHOT.
Age: 1.08
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face and shoulder
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Seen in ER 4-25-08 for left thigh cellulitis, started on augmentin.  Returned to clinic 4-26-08 after one dose of antibiotic as erythema had slight extension very subtly outside skin marking. ENC to cont augmentin
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 3rd vaccine given even though he had already had two previous, no adverse effects
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Dry skin, Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Mother informs that the child's upper left limb became edematous, red and hot. The patient was evaluated by Dr. who ordered Benadryl. Fever started the second day. At the moment the area is free of edema but is a little rough to the touch than the rest of the skin.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Syncope
Clinical narrative: Syncope
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Satelite infection left shoulder 1 cm below vacination site, right shoulder, right upper back, and 2 on left upper back.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Satelite infection on left shoulder 1 cm  below vacination site and two on left upper back.
Age: 23.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Hyperhidrosis, Syncope
Clinical narrative: SEVERE DIARRHEA, FAIINT FEELING AND SWAETING WITHIN 12 HOURS OF IMMUNIZATION
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient presented to the office on the A.M. of 06/12/2008 with redness, swelling and warmth to the back of left arm.  The area measured 10cmx12cm. Mom stated that it started last pm 06/11/2008.  Mom had circled the area with a marker last pm it measured approximately 8cmx10cm.  Patient was seen by Dr.  at 11:50am on 6/12/2008 and treated for cellulitis d/t vaccine reaction with Cleocin 300mg by mouth every 8 hrs for 7 days.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Diarrhoea, Hyperhidrosis, Syncope
Clinical narrative: SEVERE DIARRHEA, FAINT FEELING, AND SWEATING WITHIN 12 HOURS OF VACCINATION
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Broke out in hives the same day she took the first dosage. She broke out all over her chest and around her hips. She did not finish the pills.
Age: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: Mother reports rash over daughter's entire body on 6-12-08 at 2:30 p.m. No breathing problems, fever. Instructed to administer Children's Benadryl and if symptoms persist then Dr. Appt
Age: 52.0
Sex: M
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness, swelling, warmth from shoulder to elbow.
Age: 52.0
Sex: M
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Redness, swelling, warmth from shoulder to elbow.
Age: 52.0
Sex: M
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Nausea, Pyrexia, Tenderness
Clinical narrative: Redness, swelling, warmth from shoulder to elbow.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: patient complaining of arm soreness after receiving the flu vaccination on 11/07/2007. Patient made pharmacy aware on 6/9/08.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Oxygen saturation normal, Wheezing
Clinical narrative: Client went to emergency room approximately 24 hours after receiving first dose of HPV vaccine with complaints of difficulty breathing (wheezing).  Denied itching, rashes or history of asthma.  Denied sensation of throat closing. Pulse ox was 99%. Client was treated at the ER with Prednisone PO 60 mg; Pepcid PO 20 mg and Benadryl PO 50 mg with good results.  Discharged to home with instructions to follow up at Health Dept in 2-4 days.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, TTOX
Symptoms: Apnoea, Chest X-ray normal, Crying, Full blood count normal, Livedo reticularis
Clinical narrative: After vaccination on 6/5/08 during routine WCC the patient had inconsolable crying for approximately 24 hours.  On D#5 post vaccine after a second crying bout the mother tried to soothe the child with a warm bath.  The child appeared dusky shortly thereafter and within 10-15minutes became apneic, mottled, and gray.  9-1-1 was called and EMS arrived within 5 minutes.   The child recevied oxygen and stimulation. The patient vomited x2 in the ambulance. Within a few minutes of arrival the patient color returned and the patient perked up.  The patient was obsrved for 48 hours in the hospital with an unknown eitiology for the ALTE. 6/20/08-records received for DOS 6/10/08-overnight stay uneventful. History of several weeks C/O cough worse at night. DX:ALTE.