chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction left thigh with induration and 6x9 cm area of erythema.  No fever or systemic symptoms.  Symptoms first noted the morning after immunization.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pallor, Rash macular, Swelling face
Clinical narrative: Facial swelling and rash on face, trunk and upper extremities that is macular, blanchable and coalescing.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Redness, warmth, exquisitely tender to the touch.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient had DTaP administered in left arm/deltoid on 4/29/08.  Today 5/1/08 she developed redness and swelling along lateral border of her left arm.  No fever or pain.
Age: 1.3
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Convulsion, Pyrexia, Tremor
Clinical narrative: On 5/5/08 fever to 105 with ? seizure, shaking of arms and legs as well as blue around the mouth.  He did have a post ictal state for 30 minutes post episode.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: Shingles-rash and blisters, still have pain. Treatment- Valtrex, Gabapentin, Oxycodone
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pain in extremity, Swelling
Clinical narrative: Child had painful arm for 2 days 4/21-4/23 & noted (local) swelling - (local 10-15 cm right arm red) & erythema 4/22 - seen in clinic 4/23.  Mom gave BENADRYL, 4/22 PM.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Rash erythematous, Skin swelling
Clinical narrative: Immediately after vaccine given site was swelling with a red flare.  Red rash developed within 1 minute & skin swelling continued.  Gave BENADRYL 50 mg po.  No diff breathing or itchiness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 2nd Meningococcal given.  1st Meningococcal given 10/22/07.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling approx silver dollar size on Rt arm.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pain, Vaccination complication
Clinical narrative: Patient had a 8 1/2 cm by 12 cm size reaction to DTaP vaccine 2 days after given.  BENADRYL and MOTRIN for pain.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5-5-08 MENACTRA 3:30 pm.  5-6-08 awake with headache, sore left arm site of injection.  5-7-08 painful, red, warm to touch, swollen left deltoid site of injection.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Blood urea, Eosinophil count, Erythema, Full blood count, Liver function test
Clinical narrative: Pt awakened with total body pruritus - no urticaria. (Came to clinic on 5/5. Mild erythema of skin. Lungs - clear,  Heart - S1, S2, no murmur. Abd - soft, NT.  Given Loratadine 10mg po qd.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Red blood cell sedimentation rate, Skin nodule
Clinical narrative: Pt awakened with total body pruritus - no urticaria. (Came to clinic on 5/5. Mild erythema of skin. Lungs - clear,  Heart - S1, S2, no murmur. Abd - soft, NT.  Given Loratadine 10mg po qd.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Hives, swelling, and redness.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: 4x6 in. area of erythema/induration with central pinpoint water-filled vesicles L deltoid - seen ~48 hours after vaccine given (started at ~24 hours post-vaccine).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Balance disorder, Dizziness, Gastrooesophageal reflux disease, Headache
Clinical narrative: C/O dizziness, nausea, reflux, severe HA, can't stabilize self, had to be sent home from school, gave TYLENOL and laid down.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: C/O dizziness, nausea, reflux, severe HA, can't stabilize self, had to be sent home from school, gave TYLENOL and laid down.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pyrexia, Swelling, Tenderness
Clinical narrative: 5.6 cm local rxn with tenderness & swelling.  Onset fever 101-102 a few hrs after vaccine admin & persisting x48 hours at time of exam.  No other sign or sx of illness.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Body temperature increased, Cough, Febrile convulsion, Full blood count, Nasal congestion
Clinical narrative: Elevated temperature 102.2 7 days after MMR.  Had 1 febrile seizure, no sequelae.  Also had an URI at the time of seizure with cough and nasal congestion.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Nervousness
Clinical narrative: Hard to breathe, pounding heart & fast heart rate.  Bad headache, shaky.  Felt like throat was closing, dizzy.  Resolved after po BENADRYL.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Palpitations, Throat tightness
Clinical narrative: Hard to breathe, pounding heart & fast heart rate.  Bad headache, shaky.  Felt like throat was closing, dizzy.  Resolved after po BENADRYL.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Syncope, Vomiting
Clinical narrative: Patient was seen in office for sinus infection and allergies.  Patient was administered GARDASIL and when patient left the office, she vomited and had a syncope episode.  Mom took her to ER under direction of office.  Vomited again.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Moderate erythema to LD muscles 5-6" round.  No fever or other symptoms.  Mom did not administer any TYLENOL or ibuprofen.  Developed over course of 24 hours.  Recommended ice & TYLENOL & to contact primary M.D. if symptoms worsen.  TC on 5/7/08 to f/u message left.  Mother called back, swelling gone lasted another 2-3 days.  TYLENOL worked well.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hives at vaccine injection site within 5 minutes of receiving vaccine.  Vital signs were assessed after 5 minutes x 30 minutes and remained stable.  No meds given.  No additional hives noted.  No respiratory distress.
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: 1 wk after vaccine - fever 12 hours 100 degrees.  1 1/2 wk after intermittent swelling of digits.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Patient complained of feeling dizzy within 5 minutes of taking vaccine.  Developed two small itchy hives (1 on neck 1 on face area) within 20 minutes.  No respiratory symptoms - vital signs stable - BP 120/70 P 82 R 16.  Remained in Health Services.  BENADRYL given at 3:30 pm.  Driven home by family.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Malaise, Migraine, Vertigo
Clinical narrative: Fatigue that has been chronic and effecting quality of life.  Chronic arthralgias continuing to the present.  Chronic unrefreshing sleep, chronic post-exertional malaise after exercise.  New onset migraine headaches, now resolved.  Vertigo episodes - now resolved.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Rec. typhoid c/o cephalgia, arm pain, n/v and loose stools x 4 days.  Seen at facility.  Dx'd with adverse rx and given IV hydration with ZOFRAM.  Now asymptomatic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: At injection site patient described a spot about 2 inch by 1 1/2 inch oblong shaped that was red, warm to touch, and hard.  It was also itching her.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Chills, Diarrhoea, Injection site erythema, Physical examination, Pyrexia
Clinical narrative: Fever, shaking, chills.  Resolved within 48 hours without mild diarrhea, mild redness at injection site.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Tremor
Clinical narrative: Fever, shaking, chills.  Resolved within 48 hours without mild diarrhea, mild redness at injection site.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Pt received Varivax 4/30/08 & started with a local rxn the next day.  Seen in office 5/1/08.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 24 hrs after vaccine, small red bumps at vaccine site.  ? cellulitis.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Hives started at 9pm 5-1-08.  Varivax given at 5pm on 5-1-08.  Hives noted again on R thigh 6am 5-2-08-subsiding by 10:00am on 5-2-08.  (Hives were first on L elbow and R knee).
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Accidental overdose, Inappropriate schedule of drug administration
Clinical narrative: Pediarix & IPV immunizations given at same time, resulting in 2 doses of IPV being administered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 4cm x 3.5cm area of redness at site of Varivax vaccine, no treatment required.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Mother states 1-1 1/2 hrs after immunizations child had rash on face, hands, arms & abdomen.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Reports redness and swelling with itching at injection site day after immunization given.  Nothing applied to injection site-reports scratching the site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: G.M. brought child in 5/9/08 for us to evaluate R arm.  Upper arm is warm to touch; red; & swollen.  Pt. states that it is not painful.  GM states child has not complained.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure, Fall, Syncope
Clinical narrative: Syncope episode ~20 min after vaccine given-while pt in parking lot-fell to ground -> carried back to office VSS-got rest, elevate legs, fluids.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient complained of feeling lightheaded 5 minutes after receiving TdAp vaccine.Patient then fainted and had a loss of consiousness for 15 seconds. Patient alert and oriented and easily aroused after 15 seconds. Patient was asssited back into exam room and while sitting in the chair, fainted with a loss of consiousness for 10 seconds.  Paitent remained breathing throughout the incident.Patient placed on exam table in supine position.  Blood pressure 100/50, skin very plale and diaphoretic. EMS called and patient taken to Emergency Department.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient complained of feeling lightheaded 5 minutes after receiving TdAp vaccine.Patient then fainted and had a loss of consiousness for 15 seconds. Patient alert and oriented and easily aroused after 15 seconds. Patient was asssited back into exam room and while sitting in the chair, fainted with a loss of consiousness for 10 seconds.  Paitent remained breathing throughout the incident.Patient placed on exam table in supine position.  Blood pressure 100/50, skin very plale and diaphoretic. EMS called and patient taken to Emergency Department.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Injection site induration, Oedema peripheral, Skin warm
Clinical narrative: Received Varivax #2 on 5-7-2008.  On 5-9-2008 mom called the afterhours triage nurse, was told to take patient to ER.  Mom took him to ER since his Right arm was red, raised, swollen, hot to touch. At the ER mom states she was told it was an allegic reaction to the varivax immunization.  Pt given benedryl 25mg and told to repeat every 6 hours as needed.  Also told to apply cold or hot compresses. Told to return to ER is arm gets a red streak. Per mom, on %-12-2008 when she call the office, she stated the redness is gone.  what is left is the hard area where the injection was given.  the hard area is "less hard" than it was.  It is now only quarter size. Presently mom has stopped benedryl, had been giving at night only.  suggest continue few more nights, and call prn.Agreed to make a vaers report.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Had Hives X 5 days covered body except for face and neck.  Hives did come and go with Benadryl.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood pressure, Dizziness, Heart rate normal, Immediate post-injection reaction
Clinical narrative: Received first dose of Engerix-B 1 mL IM, Lt deltoid.  Immediately became weak and lightheaded.  No LOC.  Placed head between knees, BP 110/69.  Placed in supine position, 86/55 P 60 bpm, 90/50, 109/62.  Entire episode lasted approx 10 minutes.  No further side effects. Contributed to having not eaten that day.
Age: 52.0
Sex: U
Vaccine: PNC
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for shortness of breath and chest pain. Vaccination took place on 10/22/2007 and hospital admission was on 2/25/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Fontanelle bulging, Pyrexia
Clinical narrative: Transient bulging anterior fontanelle for 3 days, fever for 3 days.  Underwent full sepsis workup and received IV antibiotics for 48 hours, pending negative cultures.  Admitted to Hospital 5/14/08-records received for DOS 5/9-5/10/08-DC DX: Bulging fontanelle, R/O meningitis. Presented to ED wtih noticeable fontanel bulging out. PE:anterior fontanel bulging. Temp 100.4 tympanic.
Age: 78.0
Sex: U
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for COPD exacerbation. Vaccination took place on 1/7/2008 and hospital admission was on 2/5/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  5/19/2008 MR received for DOS 2/5-10/2008 with D/C DX:  Non-ST segment elevation Myocardial Infarction.  Acute on chronic respiratory failure.  Acute on chronic renal failure.  Atrial Fibrillation with rapid ventricular response.  Acute Bronchitis.  COPD.  Gastrointestinal bleeding.  Anemia.  Hyperlipidemia. Pt presented to ER with 2 day hx of cough and fever with worsening shortness of breath with diaphoresis. Pt also had diarrhea 1 day prior to ER visit. On admission, troponin was (+).  PE (+) for I&E wheezing and decreased breath sounds.  Pt developed atrial fib, GI bleeding, and acute on chronic renal failure during hospitalization: multi-system organ failure. Transferred to hospice on 2/10/08 per pt request. Pt expired on 2/11/08.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Chills, Night sweats, Pyrexia, Vaccine positive rechallenge
Clinical narrative: She was also vaccinated with varicella on 10/25/07, She is very healthy and each occurrence happened after the vaccinations. First vaccine high fevers after about 2-3wks after vaccine of 102 to 104.0 no other symptoms lasted about 2weeks. Taken to MD and evaluated.  This second vaccine again a reaction at about 2weeks starting May 11th high fevers again ranging from 102.5 to 103.4 as of date but with chills,weakness when fever rises, and night sweats. This time fevers were better controlled with alt tynenol q6hs and ibuprofen q6hs. If this fevers are this high, it is a concern of mine for children that may be immunosuppressed or younger to get this vaccine due to the reaction. I'm sure it was the vaccine, it was the only common thing that she received at the time. Please evaluate and do more research regarding this fevers. No rash, no blisters. I'm a nurse and will continue to monitor my daughter for further symptoms. thank you.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Injection site red, swollen, warm.  Pt did not feel well
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomitting (1x), fever for 2 days which fluctuated between 100 and 101, 3 episodes diarrhea.  I do not believe this was a stomach virus because no one else in my family caught it, including my other child.
Age: 13.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Body temperature increased, Headache, Malaise, Vomiting
Clinical narrative: Received call from School Nurse @ 8:30 a.m. on 5/13/08 stating Mom called her this morning that child was ill had Headache, Emesis and Temperature.  Reviewed shot records and contacted Mom @ approximately 9:00 a.m on 5/13/08 and questioned how son was feeling.  Mom was at work and stated that he called her complaining he didn't feel good, had headache all night, and vomited this morning.  Mom asked him to take his temperature with a digital thermometer and he told her it was 101.0 degrees.  She told him to take Ibuprofen and go back to bed.  I asked her if he had any stiffness in the neck, how many times he vomited and if he normally runs temperatures easily?  She stated he was sick with a stomach virus on 5/8/08 and 5/09/08 but seemed to be fine on 5/10/08 and 5/11/08.  She stated he did have a temperature of approx. 100.0 degrees during the stomach virus.  He had one emesis in the am per Mom.  She was not there with the child and he reported it to her over the phone.  I asked Mom if he was home alone and she said yes, " I think he will be fine and I am not sure this is even related to the vaccines".  I requested she continue to check on him hourly, contact her physician and to contact me with updates regularly.  Advised to go to ER if symptoms get worse.   I contacted Mom @ noon to get update.  She stated his temperature was 100.0 degrees, no further emesis, slight headache but feeling much better.  She is going to make him a doctors appt. if he continues to feel ill. She will leave work in the afternoon and take him to the doctor if she feels it is necessary.  I requested she contact me with update at end of day.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash erythematous, Vaccine positive rechallenge
Clinical narrative: S/P first set of immunizations deveolped fever and fine red rash x2 days.S/P second set of immunizations began to develope fine red rash within 20 mins. of immunizations. Given Benadryl 1/4 tsp in office with resolution of rash. Rash didnot return but had fever x48 hours again, peaked @102.0 with Tylenol
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site urticaria
Clinical narrative: Pt developed a golf ball sized, red welt at injection site, with a smaller, hard knot under the skin, about 24 hours after injection. Area itched for 3-4 days. Today (7 days after injection), skin is still red, but no knot or itching reported by patient.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Ear discomfort, Facial palsy, Headache, Hypoaesthesia facial, Insomnia
Clinical narrative: After receiving the HBV vaccine on 4/25/08 he noticed having a headache that afternoon. That night he hardly slept and was real restless.  Saturday morning he felt like he had water in his ear, jaw was numb.  Then he noticed the left side of his face also got numb and his left eye would not blink.  He went to the hospital Saturday evening and was diagnoses with Bells Palsey.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Ophthalmoplegia, Restlessness
Clinical narrative: After receiving the HBV vaccine on 4/25/08 he noticed having a headache that afternoon. That night he hardly slept and was real restless.  Saturday morning he felt like he had water in his ear, jaw was numb.  Then he noticed the left side of his face also got numb and his left eye would not blink.  He went to the hospital Saturday evening and was diagnoses with Bells Palsey.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swollen red pruritic area at the site of vaccine
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Rash
Clinical narrative: Patient had a rash after immunization, but lingering wart-like bump at site of injection after 5 months.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: CHILD EXPERIENCED VOMITING AND DIARRHEA FOR 2 WEEKS FOLLOWING ADMININISTRATION OF ROTATEQ. CHILDS MOTHER DID NOT CONTACT OUR FACILITY BUT MADE US AWARE OF REACTION IN CLINIC TODAY.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, TYP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Pt reports symptoms began 10 min after vaccines given of headache, dizziness, nausea.  Pt was seen at clinic at 1400 pm on 5/12/08 and given Motrin.  Pt states no relief from Motrin.  Pt returned to clinic Immunizations today c/o of worsening of headache, dizziness, nausea.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cough, Throat irritation
Clinical narrative: Vaccine given on 4/28/08 at 3:45pm.  A couple days later, she developed a dry, non-productive cough.  No fever.  States, "It feels like something is stuck in my throat."
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyspnoea, Full blood count normal, Gaze palsy, Metabolic function test normal, Moaning
Clinical narrative: Patient received 2 month vaccines (Pediarix, HIB, Prevnar, Rotateq) on 5/9/08. That evening, he developed fever up to 101.6, had emesis x 1, had eye deviation and became unresponsive with fixed gaze and moaning for 30 min- 1 hr. Parents brought patient to ED, where patient was responsive and exam was normal.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Staring, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient received 2 month vaccines (Pediarix, HIB, Prevnar, Rotateq) on 5/9/08. That evening, he developed fever up to 101.6, had emesis x 1, had eye deviation and became unresponsive with fixed gaze and moaning for 30 min- 1 hr. Parents brought patient to ED, where patient was responsive and exam was normal.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Choking, Decreased appetite, Diet refusal, Disturbance in attention
Clinical narrative: Since the vaccine, patient has been sleeping about 50% more of the time or is drowsy, his appetite has decreased about 30%, he is much less alert, chokes while he is eating, eye contact has decreased significantly, he no longer want to take a bottle at all, he has moments where it seems he isn't there (spaced out), and he has for the most part stopped coo'ing.  These symptoms started the evening after the vaccine and have persisted to now.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Hypersomnia, Somnolence
Clinical narrative: Since the vaccine, patient has been sleeping about 50% more of the time or is drowsy, his appetite has decreased about 30%, he is much less alert, chokes while he is eating, eye contact has decreased significantly, he no longer want to take a bottle at all, he has moments where it seems he isn't there (spaced out), and he has for the most part stopped coo'ing.  These symptoms started the evening after the vaccine and have persisted to now.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dysarthria, Dyspnoea, Hyperhidrosis, Hypoaesthesia facial, Immediate post-injection reaction
Clinical narrative: Immediately after receiving  2nd dose  os Hepatitis Be vaccine (Energix-B) employee complained of diminished vision, ringing in ears, facial numbness, SOB, and slurred speech and sweaty hands. Employee was sent to the ER for evaluation and was released with in two hours. Symptomolgy continued.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Tinnitus, Visual acuity reduced
Clinical narrative: Immediately after receiving  2nd dose  os Hepatitis Be vaccine (Energix-B) employee complained of diminished vision, ringing in ears, facial numbness, SOB, and slurred speech and sweaty hands. Employee was sent to the ER for evaluation and was released with in two hours. Symptomolgy continued.
Age: 65.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Dermographism, Rash pruritic
Clinical narrative: He received zostavax vaccine and tetanus-diphtheria (Td) on 5-12-08. Several hours later he noted itchy rash. Was seen in clinic today for evaluation. The rash is dermatographism on upper chest, upper back, lower legs. No prior history of this. Otherwise well. Dr. and myself (reporter) work in our allergy dept. and feel this is NOT a true allergic reaction, but wanted to report this. Treating with antihistamines and observation. We expect full recovery.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Autism
Clinical narrative: This case was reported by a pharmacist on behalf of a physician and described the occurrence of autism in a subject of unspecified age and gender who was vaccinated with Pediarix (GlaxoSmithKline).  On unspecified dates in 2006, the subject received unspecified number of doses of Pediarix vaccine.  At an unspecified time recently, the subject was diagnosed with autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Back injury, Back pain
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Blood immunoglobulin G normal, Borrelia burgdorferi serology negative, Chills, Cognitive disorder, Condition aggravated
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Deafness unilateral, Ear disorder, Ehrlichia serology, Eye disorder, Fatigue
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Full blood count normal, Headache, Human ehrlichiosis, Hyperhidrosis, Influenza like illness
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Insomnia, Joint injury, Joint swelling, Lyme disease, Metabolic function test normal
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Migraine, Musculoskeletal pain, Myalgia, Neck pain, Nervous system disorder
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia, Rash, Red blood cell sedimentation rate
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
Sex: M
Vaccine: LYME
Symptoms: Rickettsia antibody, Serology negative, Visual disturbance
Clinical narrative: This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.