chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Autism, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her approximately 16 month old daughter with no pertinent medical history of drug reactions or allergies who on 13-FEB-1995 was vaccinated with the first 0.5 ml dose of MMR II.  In approximately February 1995, "shortly after receiving the vaccination", the patient developed autism.  The patient's autism improved.  On approximately 1998, "when the patient was 5 years old", the patient was vaccinated with the second dose of MMR II.  On approximately 1998, "after receiving the booster of the vaccine", autism reappeared and had been "downhill ever since".  It was reported that the patient also received OPV-MERIEUX and DPT-HIB conj vaccine (unspecified carrier) on the same day.  The patient also received 5 other vaccines that same day however they were unknown.  Lab tests were done but no results provided.  At the time of this report, the patient's autism persisted.  Unspecified medical attention was sought.  Upon internal review, autisms were considered to be other important medical events.  No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her now 5 year old daughter with no drug reactions/allergies who on 22-MAR-2004 at the age of 12 months was vaccinated with MMR II. Concomitant therapy included VARIVAX, but the patient's mother did not know if the VARIVAX was (MSD) or not (manufacturer not reported). "Around when the patient turned 24 months old" in approximately March 2005, the patient developed autism. The patient had sought unspecified medical attention. The mother reported her son followed an autism program. At the time of reporting the patient was recovering from the autism. Upon internal review, the patient's autism was considered to be other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her now 22 year old son with an allergy to yeast who in "1988" at approximately 12 months old was vaccinated with MMR II. There was no concomitant medication. "Shortly after being vaccinated" in 1988 the patient experienced autism. The patient had sought unspecified medical attention. No lab test was performed. "Few years ago" the patient recovered from autism. The patient's autism was considered to be other important medical event. No further information is available.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Autism
Clinical narrative: Information has been received from a consumer concerning her approximately 24 month old son who on an unspecified date was vaccinated with the first dose of MMR II (lot # not provided) at the age to 24 months. The patient was diagnosed with autism after getting the first dose. The patient never received the booster dose. The consumer also mentioned that when her son was 5 years old he was administered with DTaP (unspecified) (+) DPT (manufacturer unspecified) he developed aggressive behavior. At the time of this report, the outcome was not provided. Unspecified medical attention was sought. Upon internal review, autism was considered to be other important medical event. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male patient who was vaccinated with a single dose of MMR II on an unspecified date. Subsequently the patient developed autism after receiving MMR II. At the time of this report, the patient had not recovered. No additional information was provided. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received form a nurse concerning a 23 year old female who on 21-NOV-2008 was vaccinated injection with the first dose of GARDASIL (lot # not reported). After received the first dose of GARDASIL, on 22-NOV-2008 the patient's face was red and she had redness at the site of where the band aid was. The patient recovered from adverse events after some time. The nurse reported that on 23-JAN-2009 they decided they were going to wait to give the second dose of GARDASIL. It was reported that the patient did not seek medical attention. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tremor in a 11-year-old subject of unspecified gender who was vaccinated with DTaP (unspecified manufacturer). On an unspecified date the subject received unspecified dose of DTaP. At an unspecified time after vaccination with DTaP, the subject experienced tremor and was hospitalized. At the time of reporting the outcome of the event was unspecified. No additional information was reported.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Cyanosis, Full blood count normal, Hypotonia, Pyrexia
Clinical narrative: 12 hours after 4 month vaccines given, pt with fever, multiple episodes of emesis and several cyanotic spells. 1 spell lasted 30-60 seconds - patient went limp, unresponsive, blue in color, other shorter episodes followed. Patient admitted to hospital overnight for observation. No treatment needed. Bright red streak in vomit.  6/10/09 ER record received for DOS 3/4/09 with dx: ALTE. vomiting, dehydration. Pt presented after several episodes of cyanosis, pallor, unresponsiveness and limpness after vomiting, lasting ~1 minute. Multiple vomiting events with one blood streaked emesis. No further events in hospital.  Observed o/n and d/c.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli, Vomiting, X-ray normal
Clinical narrative: 12 hours after 4 month vaccines given, pt with fever, multiple episodes of emesis and several cyanotic spells. 1 spell lasted 30-60 seconds - patient went limp, unresponsive, blue in color, other shorter episodes followed. Patient admitted to hospital overnight for observation. No treatment needed. Bright red streak in vomit.  6/10/09 ER record received for DOS 3/4/09 with dx: ALTE. vomiting, dehydration. Pt presented after several episodes of cyanosis, pallor, unresponsiveness and limpness after vomiting, lasting ~1 minute. Multiple vomiting events with one blood streaked emesis. No further events in hospital.  Observed o/n and d/c.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased
Clinical narrative: This non serious case was received on 27 February 2009 from a health care professional.  A child received PENTACEL (lot number not reported) on an unspecified date.  24 hours post vaccination the patient experienced a temperature of 100 degrees Fahrenheit.  The recovery status was not reported.  No further information was provided.  List of Documents held by Sender:  None.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, UNK
Symptoms: Injection site warmth
Clinical narrative: 9 X 9 cm irregular area to left delt.  Nt, slightly warm
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Blood culture, Culture urine, Full blood count, Pyrexia
Clinical narrative: Fever up to 105
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dry mouth, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Onset of fever to 102, hives under bilat axilla, pain and redness at injection site, perceived wheezing and dry mouth with nausea. Patient went to ER and was given fluids, mom denies patient receiving any meds. Pt advised by Dr to take BENADRYL 25 mg po q6h for 2-3 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: Onset of fever to 102, hives under bilat axilla, pain and redness at injection site, perceived wheezing and dry mouth with nausea. Patient went to ER and was given fluids, mom denies patient receiving any meds. Pt advised by Dr to take BENADRYL 25 mg po q6h for 2-3 days.
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Eye swelling, Lip swelling, Pruritus, Rash
Clinical narrative: About 1540 pm MA had just finished giving pt IZZ's, when pt's foster mother asked if it was normal for pt to be all red MA turned to see pt and he was blotchy red all over trunk, face, neck, pt. scratching neck, eyes puffy, lips sl puffiness. No resp. distress, BENADRYL 12.5 mg given to R thigh and SOLUMEDROL 10mg given to L thigh IM. At 1600 rash resolving, child resting.
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Rash macular
Clinical narrative: About 1540 pm MA had just finished giving pt IZZ's, when pt's foster mother asked if it was normal for pt to be all red MA turned to see pt and he was blotchy red all over trunk, face, neck, pt. scratching neck, eyes puffy, lips sl puffiness. No resp. distress, BENADRYL 12.5 mg given to R thigh and SOLUMEDROL 10mg given to L thigh IM. At 1600 rash resolving, child resting.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 3" x 6" erythema at injection site noted several hours after receipt of vaccine - lasted 3 days and no c/o pain or discomfort.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: Pt had nonstop crying for 3 + hours
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: Non stated.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Reactive Lymphadenopathy, cervical, BIL.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Rash
Clinical narrative: Head to toe rash and headache. Reported by parent, did not see rash. Referred to family doctor. Unable to reach client for follow- up information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Herpes zoster ophthalmic, Ocular hyperaemia, Rash
Clinical narrative: Received Herpes Zoster Vaccine 5/8/2008 got rash on L eyebrow - forehead (slight) no blisters. Oct 11, 2008 - went to eye Dr - clear. Nov 23 2008 - L eye irritated, red. Dec 4 2008 herpes zoster in L cornea still going to Ophthalmologist.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Dyspnoea, Respiratory distress, Urticaria, Vomiting
Clinical narrative: Initial, hives, abdominal pain ( <5 min from getting shot). Within minutes, trouble breathing, emesis. PO BENADRYL given initially before resp distress, no affect IM epinephrine, resolution of symptoms after epinephrine.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: Extensive local swelling including entire arm and proximal forearm with localized pain and urticaria.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: The a.m. after vaccinations pt. noticed back of left arm sore & redness around injection site.  The redness continued to spread, was not to the touch.  It remained the next day also, pt. was seen in office.  Dx'd with cellulitis and was given anti-biotic Rx.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Mom states that eve after a shower noted area was red & swollen with a pinpoint flat rash that extended down from injection site 3 fingers width.  C/o being itchy & warm to touch.  Gave BENADRYL that evening and in AM with ice to area.  In AM, looked the same but improved over the day - It took a couple days to totally resolve.
Age: 0.7
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Anorexia, Induration, Mobility decreased, Pyrexia
Clinical narrative: Fever 102-103 degrees F wouldn't crawl or sleep or eat for 2 days very uncomfortable and just wanted to be held.  I get angry because I could have gotten DTAP by lying but felt that was wrong to do.  The leg it was administered in got a bit of a knot in it too.  Attention problems followed. Anger & frustration unusual to situations followed.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Dehydration, Full blood count, Metabolic function test, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever to 103 degrees. Fever was noted (rectal) 102.7 on admit to ER, uncontrollable vomiting. Dehydration. Neuro signs intact. Received IV fluids, ZOFRAN 1 mg IVP and TYLENOL 110mg.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Induration, Pruritus, Pyrexia, Tenderness
Clinical narrative: Client reports that she had a softball size knot on left arm the day after her last TWINRIX on 2/11/09. It "had local fever and I itched and was very sore. The local fever was reduced by 2/15; The size went down to a quarter (still is that size) by 2/17. Ibuprofen (600 mg) was taken 3x daily for 2-3 days. It was slightly helpful. The ice pack was slightly helpful. Recommended that her next injection be placed in Rt. deltoid.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Small pea-sized redness @ site of injection yesterday after school.  This morning pt c/o slight pain and site was itchy.  Mom noticed that redness had increased w/more itching and some pain when he came-home from school.  Mom gave BENADRYL to help.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Cold sweat, Culture urine negative, Dizziness, Pallor
Clinical narrative: Patient reports approximately 40 min after receiving vaccine became lightheaded, pale, clammy & then became semi unresponsive.  Co-workers called ambulance.  Patient taken to Medical Center.  ER evaluated & released at 5 pm.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Streptococcal identification test positive, Unresponsive to stimuli
Clinical narrative: Patient reports approximately 40 min after receiving vaccine became lightheaded, pale, clammy & then became semi unresponsive.  Co-workers called ambulance.  Patient taken to Medical Center.  ER evaluated & released at 5 pm.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site irritation, Oedema peripheral, Tenderness
Clinical narrative: The day after the vaccine was given, subject experienced tenderness, irritation, and swollenness in her left arm.  Tenderness and swelling has decreased substantially since.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt received shot 12/30/08 - Raised red area around shot site is still red - not swollen just red - pt. is not in pain just doesn't like mark on arm.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Pt received shot 12/30/08 - Raised red area around shot site is still red - not swollen just red - pt. is not in pain just doesn't like mark on arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abscess, Cellulitis, Inflammation, Pyrexia, Rash erythematous
Clinical narrative: Local inflammatory reaction. 7x7 warm erythematous area assoc w/ persist fever. DX cellulitis, secondary to sterile abscess from DTap vax.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Skin warm
Clinical narrative: Local inflammatory reaction. 7x7 warm erythematous area assoc w/ persist fever. DX cellulitis, secondary to sterile abscess from DTap vax.
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Stated developed raised red "bumps"  all over (L) arm 2 days after shot.  States area itching but better now.  Instructed to notify MD for further instructions & to not receive 2nd dose in 6 months.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Post vaccine VARICELLA.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: 3/14/09 Diagnosis of chickenpox Received VARICELLA vaccine 3/1/02.  Sibling had chickenpox - 2 wks prior had not received VARICELLA vaccine
Age: 76.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Discomfort, Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Pt received ZOSTER & TD BOOSTER vaccinations on 6Mar2009.  Pt received vaccines on R deltoid.  Zoster vaccine caused localized rxn to include redness, itchiness swelling, and discomfort.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Full blood count normal, Hypokinesia, Metabolic function test, Pain
Clinical narrative: Pain 24/7. Limited movement of right arm. Follow-up: R arm pain and weakness.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: 03/13/2009 pt. called to report "hive-like rash" appeared on face within 2-3 days of 1st Hep-B vaccine given on 3-03-09. Rash now itchy and spreading to trunk, arms. Relates mult. allergies - environmental incl. molds.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site abscess, Injection site warmth
Clinical narrative: Abscess on Rt thigh hard red lump, warm to touch, no fevers using BACTROBAN oint and warm compresses.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Patient presented to the clinic on the 19th of March complaining of a rash across his back and chest as well as behind his ears and some on his legs Follow-up: Patient was admitted to hospital on the evening of March 21, 2009 with complaint of chest pain and shortness of breath. He was diagnosed with Small Pox associated Myopericarditis. He previous to this was diagnosed with non viral pustulitis associated with the vaccine on the 18th. His cultures done at that time were negative.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Inflammation, Myopericarditis, Pain, Rash, Skin disorder
Clinical narrative: Patient presented to the clinic on the 19th of March complaining of a rash across his back and chest as well as behind his ears and some on his legs Follow-up: Patient was admitted to hospital on the evening of March 21, 2009 with complaint of chest pain and shortness of breath. He was diagnosed with Small Pox associated Myopericarditis. He previous to this was diagnosed with non viral pustulitis associated with the vaccine on the 18th. His cultures done at that time were negative.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin, Virus culture
Clinical narrative: Patient presented to the clinic on the 19th of March complaining of a rash across his back and chest as well as behind his ears and some on his legs Follow-up: Patient was admitted to hospital on the evening of March 21, 2009 with complaint of chest pain and shortness of breath. He was diagnosed with Small Pox associated Myopericarditis. He previous to this was diagnosed with non viral pustulitis associated with the vaccine on the 18th. His cultures done at that time were negative.
Age: 21.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Skin discolouration
Clinical narrative: Patient developed pain and redness at the injection site of Flu vaccine.  His entire right shoulder turned purple.
Age: 1.0
Sex: M
Vaccine: DPP, HEPA, HIBV, PPV
Symptoms: Crying
Clinical narrative: Crying nonstop from 1am-8am. Shots were given at 3:20pm the day before.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Seen on 3/13/09 for 10 year old well child visit.  Recieved varivax #2.  On 3/15/09 developed large area of redness, pai, and warmth on left arm.  Seen in our office and diagnosed with LUE cellulitis secondary to vaccination.  Treated with Augmentin.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, No adverse event
Clinical narrative: After 1 series of Hepatitis B vaccine(6/10/08, 7/15/08, and 11/25/08), the post-vaccine surface antibody on 3/10/2009 was negative.
Age: 26.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Pruritus
Clinical narrative: Member developed erythema swelling and lymphedema on the upper arm at the injection site. He had severe pruritis. Symptoms started on 11 Mar. He was told to go home and take benedryl and motrin. He returned with worsening symptoms on the 12th. He was told to continue the benedryl and motrin. On recheck on Mar 19, 2009. He had total resolution of his symptoms
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, No adverse event
Clinical narrative: After 1 series of Hep B vaccine (4/20/07, 12/21/2007 and 02/15/2008) post-vaccine HBsab was negative (titer on 3/10/09). Follow-up Information 23-MAR-2009: I am requesting that this VAERS record be either deleted or corrected to reflect the following information: This record was initiated because the submitter understood that a VAERS Report was to be filed when a client received the 3-dose adult series of Hepatitis B vaccine and then was found (by immunity titer) to be a "non-responder", but the client in fact did not have a titer drawn at all. The VAERS report states in Question #7 that the client had a post-vaccine Hep. B Surface ANtibody (titer) drawn on 3/10/09 when in fact it was a Hep B Surface Antigen which, of course, does not check for antibodies in response to vaccine. Therefore, this VAERS report was completed in error.
Age: 12.0
Sex: F
Vaccine: DTAP, HPVX, MEN
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: fever to 103.4, muscle spasm, r thumb-treated with anti-pyretics, time
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Pt received adacel vaccine on 3/18/09. Today 3/20/09 noticed rash on left forearm that is itchy, raised, were 9 bumps initially, now only 3.   No other meds, no difficulty breathing , no new lotions,soaps or detergents.3 raised discrete bumps on left forearm, with tops scratched off, site of Tdap looks nl skin over deltoid, no erythema or tenderness or skin lesions of any kind, does have another lesion right hand, dorsum-predated this rash by a few days and is a fixed lesion, not itchy, lungs clear no angioedema
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site mass, Injection site pain
Clinical narrative: After receiving the second dose of the Gardasil vaccine, I had a large lump under the skin at the injection site that felt almost like a marble. The skin was not hotter than usual or red, it was just a lump. It does not hurt all the time, only when bumped or touched. The bump decreases in size, but it is 8 days after the injection and it is still present.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Rash erythematous, Skin warm, Urticaria
Clinical narrative: MMR given at 0930am, developed erythematous wheal, 4 cm & warm, almost immeditely and small hives down both arms and face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Rash
Clinical narrative: Pt noted an ugly looking rash, which she describes as bright red and a lengthwise oval that is about 2-3" long.  She notes that it may be slightly raised, but does not itch.   She noted her temperature is 100, but she is also getting over a cold.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt noted a faint red rash around the injection site.  It was about 1/2" X 1&1/2" in the shape of a lenthwise oval.   It does not itch.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Mobility decreased
Clinical narrative: Mother reported to Health Dept. that pt. woke up on the morning of 3-19-09 complaining of being dizzy and unable to get out of bed.  He followed up with a private physician the same day.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Chills, Malaise, Nausea, Vomiting
Clinical narrative: 12 hours after receivng vaccines patient had temp (102F), n/v, chills and malaise.  Mom treating with tylenol and fluids.
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Burning sensation, Erythema
Clinical narrative: PT RECIEVED ANTHRAX VACCINATION AS A TUBERCULOSIS TEST ON HIS LEFT FOREARM.  HE HAD THE NORMAL SIDE EFFECTS OF THE ANTHRAX VACCINE; REDNESS, AND BURNING.  AT 3:00 PM ON 30 MARCH 2009.
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: PT RECIEVED ANTHRAX VACCINATION AS A TUBERCULOSIS TEST ON HIS LEFT FOREARM.  HE HAD THE NORMAL SIDE EFFECTS OF THE ANTHRAX VACCINE; REDNESS, AND BURNING.  AT 3:00 PM ON 30 MARCH 2009.
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Wrong drug administered
Clinical narrative: PT RECIEVED ANTHRAX VACCINATION AS A TUBERCULOSIS TEST ON HIS LEFT FOREARM.  HE HAD THE NORMAL SIDE EFFECTS OF THE ANTHRAX VACCINE; REDNESS, AND BURNING.  AT 3:00 PM ON 30 MARCH 2009.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Injection site vesicles, Urticaria
Clinical narrative: Hives appeared on 3/19/09 and a vesicular rash around injection site.  Treated with benadryl
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Injection site pain, Oropharyngeal pain
Clinical narrative: Localized soreness/tenderness in upper arm near site of injection.  Mild sore throat and diarrhea.
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site induration
Clinical narrative: One inch area of inderation at the site of the chicken pox injection. No rash in the area. I felt it was an uncommon reaction.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Choking, Dysstasia, Fall, Influenza
Clinical narrative: Had cold symptoms in Nov - Dec. Flu symptoms 1st Jan. Saw P.C. 1/5/09, showed signs of choking often, called paramedics 1/18/09 - could not stand after a fall. Hospitalized that night 21 or 22nd Spinal tap done, treatment started.   4/3/09 MR received for DOS 1/27-2/23/2009 with D/C DX:  Dysphagia. Guillain-Barre Syndrome.  Hx of alcoholism and dementia.  Respiratory insufficiency.  Pt initially presented to local hospital 1/19/09 with profound progressive weakness and dx with GBS.  Intubated following a choking episode which resulted in acute respiratory distress. Developed LLL pneumonia and a small PE. TX with IVIG.  Transferred to current facility for vent mgmt 2' to increasing hypoxia and O2 requirements. Trach, IVC filter and PEG placed. Transferred to long term rehab 2/23/09
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nasopharyngitis
Clinical narrative: Had cold symptoms in Nov - Dec. Flu symptoms 1st Jan. Saw P.C. 1/5/09, showed signs of choking often, called paramedics 1/18/09 - could not stand after a fall. Hospitalized that night 21 or 22nd Spinal tap done, treatment started.   4/3/09 MR received for DOS 1/27-2/23/2009 with D/C DX:  Dysphagia. Guillain-Barre Syndrome.  Hx of alcoholism and dementia.  Respiratory insufficiency.  Pt initially presented to local hospital 1/19/09 with profound progressive weakness and dx with GBS.  Intubated following a choking episode which resulted in acute respiratory distress. Developed LLL pneumonia and a small PE. TX with IVIG.  Transferred to current facility for vent mgmt 2' to increasing hypoxia and O2 requirements. Trach, IVC filter and PEG placed. Transferred to long term rehab 2/23/09
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Lip swelling, Oropharyngeal pain, Swollen tongue
Clinical narrative: 3-4 hours after vaccines (and after dinner + dessert), developed hives, lip/tongue swelling, throat and chest discomfort and dyspnea;  then syncope.  Resolved after EPINEPHRINE, SOLUMEDROL, BENADRYL. 4/6/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: anaphylaxis Records reveal patient experienced facial swelling, bilateral pinna edema, rash, nausea, pallor, difficulty speaking, shortness of breath, chest discomfort & lightheadedness approx 2.5 hr s/p vaccinations.  Had eaten ice cream w/peanut butter.  Had syncopal episode & became obtunded while in ER.  Eats nuts/PB regularly.  Tx w/epi, IV steroids.  Rash resolved, swelling decreased.  Admitted overnight for observation.  No rebound & d/c to home w/epipen.  Already had allergist appt for coming mo.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Syncope, Urticaria
Clinical narrative: 3-4 hours after vaccines (and after dinner + dessert), developed hives, lip/tongue swelling, throat and chest discomfort and dyspnea;  then syncope.  Resolved after EPINEPHRINE, SOLUMEDROL, BENADRYL. 4/6/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: anaphylaxis Records reveal patient experienced facial swelling, bilateral pinna edema, rash, nausea, pallor, difficulty speaking, shortness of breath, chest discomfort & lightheadedness approx 2.5 hr s/p vaccinations.  Had eaten ice cream w/peanut butter.  Had syncopal episode & became obtunded while in ER.  Eats nuts/PB regularly.  Tx w/epi, IV steroids.  Rash resolved, swelling decreased.  Admitted overnight for observation.  No rebound & d/c to home w/epipen.  Already had allergist appt for coming mo.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Anaphylactic reaction, Skin test positive
Clinical narrative: 3-4 hours after vaccines (and after dinner + dessert), developed hives, lip/tongue swelling, throat and chest discomfort and dyspnea;  then syncope.  Resolved after EPINEPHRINE, SOLUMEDROL, BENADRYL. 4/6/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: anaphylaxis Records reveal patient experienced facial swelling, bilateral pinna edema, rash, nausea, pallor, difficulty speaking, shortness of breath, chest discomfort & lightheadedness approx 2.5 hr s/p vaccinations.  Had eaten ice cream w/peanut butter.  Had syncopal episode & became obtunded while in ER.  Eats nuts/PB regularly.  Tx w/epi, IV steroids.  Rash resolved, swelling decreased.  Admitted overnight for observation.  No rebound & d/c to home w/epipen.  Already had allergist appt for coming mo.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Pruritus
Clinical narrative: Redness, itching and shortness of breath.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Pyrexia, Tenderness
Clinical narrative: Fever, left arm swelling, redness and tenderness.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash macular, Rash papular
Clinical narrative: Within 5 minutes of receiving 3 vaccines - MENACTRA, ADACEL, and GARDASIL, pt developed a macular/papular rash L arm and trunk. BENADRYL dispensed - rash resolving within about 15-20 min. No wheeze. No h/o latex allergy.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Nausea, Vision blurred, Vomiting
Clinical narrative: Blurred vision, Nausea.  Vomiting 20-25 mins.  Prior to EMS being called.  Treated with a cold compress until EMS arrived.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Erythema multiforme, Upper respiratory tract infection
Clinical narrative: Child noted to have Erythema Multiforme 7 days after receiving vaccines. Also had mild URI, so E. Multiforme could be due to viral etiology. ? Possible reaction to MMR ?
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hyperhidrosis, Joint swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Sensation of swelling in legs, knees, elbows and hands. Mild pain in quads, sweating, sensation of dyspnea. Treated 2 weeks prior for hives due to ibuprofen (took BENADRYL). Multiple sensitivities, told she had "hereditary angioedema type 2 protein", unconfirmed record. No rxn at injection site. Started on PREDNISONE 3/20. Unremarkable exam.
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: L arm swollen around site.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP
Age: 38.0
Sex: M
Vaccine: MMR, TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP.
Sex: F
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP.
Age: 26.0
Sex: F
Vaccine: HEP, TD
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of TDAP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Urticaria = Legs and arms. No other symptoms. Occurred after shot. Disappeared after Benadryl.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Swelling @ site of injection. Post 12-12 hours later redness, hot to touch and swelling.
Age: 4.0
Sex: F
Vaccine: DPP, MMR, TD
Symptoms: Blood test abnormal, Oliguria, Pyrexia
Clinical narrative: My daughter had her 4yr old injections, she has always had a slight fever with each vaccination. This time however she hasn't been producing much urine at all. On the thurs she had 10ml of urine in her bladder whilst we were at the hosp. She hasn't been going to the tiolet nearly as often. All kidney tests were carried out & results were fine. Just curious if this is related, as it only started the same day we had the injection.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Dizziness, Muscular weakness
Clinical narrative: Shortly after first shot, daughter started having weakness/tingling in left arm. Also, dizziness.  Within a week after second shot, she began to have more weakness in both legs, tingling in both legs and left arm.  Dizziness is worse. She feels very weak all over and doesnt feel like doing much.  3/23/09 Received PCP medical records of 1/9-3/9/2009. FINAL DX: migraine classical Records reveal patient was new patient on 1/9/09 & reported chronic vaginal infection x 2 yrs & HAw/photophobia & nausea.  Examination revealed condyloma.  Received HPV #1 & Menactra.  Also tx w/oral BCP & verapamil for HA.  RTC 3/9/09 for HPV #2.   5/12/09 Case closed as incomplete.  Will reopen should additional information documenting high ASO titre & diagnosis of rheumatic fever as verbally reported by PCP become available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Shortly after first shot, daughter started having weakness/tingling in left arm. Also, dizziness.  Within a week after second shot, she began to have more weakness in both legs, tingling in both legs and left arm.  Dizziness is worse. She feels very weak all over and doesnt feel like doing much.  3/23/09 Received PCP medical records of 1/9-3/9/2009. FINAL DX: migraine classical Records reveal patient was new patient on 1/9/09 & reported chronic vaginal infection x 2 yrs & HAw/photophobia & nausea.  Examination revealed condyloma.  Received HPV #1 & Menactra.  Also tx w/oral BCP & verapamil for HA.  RTC 3/9/09 for HPV #2.   5/12/09 Case closed as incomplete.  Will reopen should additional information documenting high ASO titre & diagnosis of rheumatic fever as verbally reported by PCP become available.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Inflammation
Clinical narrative: Sudden onset of fever accompanied with febrile seizures approxmitatly 9 days after vaccinations were recieved. visited ER after first seizure on 3/19/09 and follow up visit with pediatriction on 3/20/09 and at approx 4pm on 3/20/09 was taken back to local ER with high fever and  2 small seizures . Upon arrival to ER he had another seizure and was hospitalized overnight. several tests were run to determine the origin of fever and the only thing that was found was a very slight ear inflamation and the ER physican said that there was a possibility that it could be an adverse reaction to his vaccinations received 9 days prior to this event.  3/27/09 Received hospital medical records of 3/19-3/20/2009. FINAL DX: febrile seizures, resolved; middle ear effusions Records reveal patient experienced several episodes of febrile seizure w/generalized shaking of arms & legs, eyes rolled back in head.  Seen in ER & dx w/acute otitis media & started on oral antibiotics.  Seen by PCP who concurred w/dx.  Recurrent febrile seizures & admitted.  Temp max in hospital 102.2.  No further seizure activity & d/c to home on continued oral antibiotics.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Urticaria
Clinical narrative: TDAP ADMINISTERED (L) DELTOID 3/6/9 @ 1045.  PT NOTED HIVES & ITCH @ SITE 3/11/9.  PT CONTACTED DR 3/12/9 & WAS BROUGHT IN FOR EVAL.  EXAM REVEALED 6cmX6cm SUPERFICIAL, SLIGHTLY RAISED, RED AREA @ INJ SITE.  PT DENIED MUSCLE TENDERNESS. NO NOTED MUSCLE INVOLVEMENT.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Amyotrophic lateral sclerosis, Muscle atrophy
Clinical narrative: In 2002 patient started to loose muscle and in May 2003, was diagnosed with ALS.  4/22/09 MR received from neuro 2/7/05 to 4/6/09 with DX:  Probable ALS, mostly lower motor neurons. Pt first noted sx of weight loss, leg cramps, dizziness and H/A and worsening dyspnea with exertion in 2002. Dx with probable ALS in 2003.  Over the years, progressively weaker with some absent and some decreased reflexes and strength. Dx changed to PMA (progressive muscular atrophy) by 11/2005. Still probable ALS.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neuralgia
Clinical narrative: Patient received both a pneumovax and influenza injection on 10/21/08, The influenza vaccination was given in patient's right arm, and the pneumovax in the left. Patient is now reporting that since the pneumovax injection in her left arm, some 5 months ago,she has been experiencing persistant neural pain.
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: We left the clinic and within 1-2 hours had 103-104 temp and is still having extremely high fever and chills today.
Age: 1.83
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Ataxia, Computerised tomogram normal, Encephalitis, Fall, Gait disturbance
Clinical narrative: This previously healthy 22-month-old male had the following vaccinations on 1/20: 4th HIB, 1st hepatitis A, and 1st varicella. The following day, he developed an unsteady gait with walking. The symptoms progressively worsened and he also developed some upper extremity and truncal "shakiness". He presented to the ED on 2/18, where it was noted that he was able to ambulate but had a wobbly, unsteady gait and had intermittent falls. There was no seizure activity and no history of head trauma or other prior medical conditions. He began walking at age 1 year and, prior to the vaccinations, was ambulating without any difficulty, running, and had a normal and steady gait. A CT scan of the head without contrast was negative. The case was discussed with the on-call ID physician, who reported that ataxia is a rare complication of varicella vaccination. The patient was admitted to the hospital, had an MRI of the head and spine was read as normal, and discharged after 1 day. The discharge diagnosis was acute onset of truncal ataxia that was most likely post-infectious/vaccine cerebritis.  Summary: probable cerebritis secondary to varicella vaccination.  3/27/09 Received vaccine & PCP medical records of 1/19-3/17/2009. FINAL DX: ataxia Records reveal patient experienced cold w/cough, nasal discharge, no fever, dx w/URI on 1/19/09.  RTC 2/10 f/r anemia f/u.  RTC 2/24 s/p hospitalization for weakness of legs & ataxia.  Neuro f/u.  RTC 3/3 & 3/17 continued to improve.  4/6/09 Received hospital medical records of 2/18-2/19/2009. FINAL DX: ataxia Records reveal patient experienced progressively worsening ataxia x 1 day.  Had unsteady gait day after vaccines & seen by PCP then some improvement & then worsening s/s x 1 day.  Wobbly unsteady gait w/frequent falls, upper extremity & truncal shakiness.  Cast discussed w/ID & Neuro.  Admitted overnight for observation.  D/C to home next day when labs & scans all WNL.
Age: 1.83
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Tremor, Vaccination complication
Clinical narrative: This previously healthy 22-month-old male had the following vaccinations on 1/20: 4th HIB, 1st hepatitis A, and 1st varicella. The following day, he developed an unsteady gait with walking. The symptoms progressively worsened and he also developed some upper extremity and truncal "shakiness". He presented to the ED on 2/18, where it was noted that he was able to ambulate but had a wobbly, unsteady gait and had intermittent falls. There was no seizure activity and no history of head trauma or other prior medical conditions. He began walking at age 1 year and, prior to the vaccinations, was ambulating without any difficulty, running, and had a normal and steady gait. A CT scan of the head without contrast was negative. The case was discussed with the on-call ID physician, who reported that ataxia is a rare complication of varicella vaccination. The patient was admitted to the hospital, had an MRI of the head and spine was read as normal, and discharged after 1 day. The discharge diagnosis was acute onset of truncal ataxia that was most likely post-infectious/vaccine cerebritis.  Summary: probable cerebritis secondary to varicella vaccination.  3/27/09 Received vaccine & PCP medical records of 1/19-3/17/2009. FINAL DX: ataxia Records reveal patient experienced cold w/cough, nasal discharge, no fever, dx w/URI on 1/19/09.  RTC 2/10 f/r anemia f/u.  RTC 2/24 s/p hospitalization for weakness of legs & ataxia.  Neuro f/u.  RTC 3/3 & 3/17 continued to improve.  4/6/09 Received hospital medical records of 2/18-2/19/2009. FINAL DX: ataxia Records reveal patient experienced progressively worsening ataxia x 1 day.  Had unsteady gait day after vaccines & seen by PCP then some improvement & then worsening s/s x 1 day.  Wobbly unsteady gait w/frequent falls, upper extremity & truncal shakiness.  Cast discussed w/ID & Neuro.  Admitted overnight for observation.  D/C to home next day when labs & scans all WNL.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Blood calcium normal, Blood electrolytes normal, Computerised tomogram normal, Dysphonia, Febrile convulsion
Clinical narrative: Complex febrile seizure (15-20 min of generalized T-C seizure but with eye deviation to the right). Fever 39. Hoarseness. RSV antigen positive. Rec'd 0.75 mg Lorazepam in ER. Hospitalized for observation overnight.  4/13/09 MR received for DOS 3/22/09 with final dx:  Complex febrile seizure.  RSV infection. Pt presented to ER following an episode of seizure and fever.  Recently pt had some hoarseness, loose stools, 1 episode of vomiting and irritability.  Pt found unresponsive with jerking extremities, eye deviation to the right and gurgling. Still seizing on arrival to ED for a totoal of 15-20 minutes. Somnolent after. Tx with lorazepam with improvement and d/c same day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Full blood count, Gaze palsy, Grand mal convulsion, Influenza serology negative, Pyrexia
Clinical narrative: Complex febrile seizure (15-20 min of generalized T-C seizure but with eye deviation to the right). Fever 39. Hoarseness. RSV antigen positive. Rec'd 0.75 mg Lorazepam in ER. Hospitalized for observation overnight.  4/13/09 MR received for DOS 3/22/09 with final dx:  Complex febrile seizure.  RSV infection. Pt presented to ER following an episode of seizure and fever.  Recently pt had some hoarseness, loose stools, 1 episode of vomiting and irritability.  Pt found unresponsive with jerking extremities, eye deviation to the right and gurgling. Still seizing on arrival to ED for a totoal of 15-20 minutes. Somnolent after. Tx with lorazepam with improvement and d/c same day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Respiratory syncytial virus test positive, Urine analysis normal, White blood cell count increased
Clinical narrative: Complex febrile seizure (15-20 min of generalized T-C seizure but with eye deviation to the right). Fever 39. Hoarseness. RSV antigen positive. Rec'd 0.75 mg Lorazepam in ER. Hospitalized for observation overnight.  4/13/09 MR received for DOS 3/22/09 with final dx:  Complex febrile seizure.  RSV infection. Pt presented to ER following an episode of seizure and fever.  Recently pt had some hoarseness, loose stools, 1 episode of vomiting and irritability.  Pt found unresponsive with jerking extremities, eye deviation to the right and gurgling. Still seizing on arrival to ED for a totoal of 15-20 minutes. Somnolent after. Tx with lorazepam with improvement and d/c same day.
Sex: F
Vaccine: MMR
Symptoms: Death
Clinical narrative: Information has been received from a registered nurse who reported what read an article. In the article was reported that a female patient died because of the serious adverse event due to GARDASIL. The patient was not the reporting nurse's patient and she did not have a copy of the article. This is a unconfirmed report. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Death, Demyelination, Intraocular pressure test, Multiple sclerosis, Neuromyelitis optica
Clinical narrative: Information has been received form a lawyer regarding a case in litigation which was reported in a literature article concerning a 47 year old female patient who on 20-MAY-1998 was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medication was not reported. The special master reported that there was a logical sequence of cause and effect in patient's having received the vaccination and then experiencing optic neuritis, the first symptom of her Devic's disease of variant of multiple sclerosis (MS). It was reported that two months after getting the second dose of the vaccine the patient noted retro-orbital pressure in her left eye followed by decreased visual function. On July 27, 1998, she noted a curtain over the superior visual field in her left eye. On 25-JAN-2009 she had an magnetic resonance imaging (MRI) scan of brain which was negative, although there was an abnormal signal in the upper cervical spinal cord. The physician diagnosed neurologic syndrome involving her optic nerves and spinal cord. The medical records during the patient's final hospitalization reflected that she died from demyelinating disease. It was reported that patient had a vaccine injury and her death was also vaccine related. The patient died in May (Year not reported) at age of 47. The reporter felt that Devic's disease and demyelinating disease were related to the therapy with RECOMBIVAX HB. No other information is available.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Optic neuritis, Vaccination complication, Visual field defect
Clinical narrative: Information has been received form a lawyer regarding a case in litigation which was reported in a literature article concerning a 47 year old female patient who on 20-MAY-1998 was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medication was not reported. The special master reported that there was a logical sequence of cause and effect in patient's having received the vaccination and then experiencing optic neuritis, the first symptom of her Devic's disease of variant of multiple sclerosis (MS). It was reported that two months after getting the second dose of the vaccine the patient noted retro-orbital pressure in her left eye followed by decreased visual function. On July 27, 1998, she noted a curtain over the superior visual field in her left eye. On 25-JAN-2009 she had an magnetic resonance imaging (MRI) scan of brain which was negative, although there was an abnormal signal in the upper cervical spinal cord. The physician diagnosed neurologic syndrome involving her optic nerves and spinal cord. The medical records during the patient's final hospitalization reflected that she died from demyelinating disease. It was reported that patient had a vaccine injury and her death was also vaccine related. The patient died in May (Year not reported) at age of 47. The reporter felt that Devic's disease and demyelinating disease were related to the therapy with RECOMBIVAX HB. No other information is available.