chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pain, Pruritus
Clinical narrative: Shingles vaccine administered 04/15/2009; 36 hrs. later I had 3.5 cm indurated, red, sore, warm vaccination site w/surrounding erythema accompanied by chills, aching, drowsiness and itching at site and up and down arm. By 48 hrs. post-injection a non-vesicular rash appeared on the injection site, about 3.5 cm circumference. I had no fever at any time. On days 4 and 5 post-injection symptoms began to receed. Day 5 only a painful, burning shingles-like itch and burning sensation extending to about three inches above the elbow and upwards into the armpit and a 3 cm. induration with erythema at injection site remained. Although symptoms continue to subside, I was seen by my physician today for examination. The injection site is less red, less painful and itching and burning are diminished. The rash lasted approx. 24 hrs. and dissipated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Shingles vaccine administered 04/15/2009; 36 hrs. later I had 3.5 cm indurated, red, sore, warm vaccination site w/surrounding erythema accompanied by chills, aching, drowsiness and itching at site and up and down arm. By 48 hrs. post-injection a non-vesicular rash appeared on the injection site, about 3.5 cm circumference. I had no fever at any time. On days 4 and 5 post-injection symptoms began to receed. Day 5 only a painful, burning shingles-like itch and burning sensation extending to about three inches above the elbow and upwards into the armpit and a 3 cm. induration with erythema at injection site remained. Although symptoms continue to subside, I was seen by my physician today for examination. The injection site is less red, less painful and itching and burning are diminished. The rash lasted approx. 24 hrs. and dissipated.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Haematoma, Head injury, Pyrexia, Rash
Clinical narrative: Child received PPD and Flu vaccine 4-15-09.Next day he developed fever.Red rashes developed on forehead.Mom gave a dose of benadryl elixir 1 tsp and rash seem to come down a little.That same morning he bumped his head on the bed railing and sustained a little hematoma on forehead.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 15 minutes following injection of varicella and mmr to left thigh mom returned with child and wanted us to see left thigh reddness and swelling.  2 3/4 inch in diameter reddness noted on left lateral thigh extending out around injection site of varicella.  MMR vaccine was also given in left thigh but 2 inches proximal to site of varicella injection.  No wheezing, SOB, no other skin reactions noted.  calm and drinking milk bottle.  Benadryl 6.25 mg given po.  instructed to apply cold compresses x10 minutes every 2-4 hrs for 24 hours and then warm compresses 4-5 times daily until swelling gone.  instructed mom to call clinic if he has further swelling, fever > 101 or change mental status.  instructed mom to call 911 with any sob, wheezing or decreased level consciousness.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Gaze palsy, Irritability, Musculoskeletal stiffness
Clinical narrative: On 4/15 and 4/16 baby was cranky and crying, no fever. On 4/18/09 "baby's eyes started rolling back" one time.  On 4/20/09 "everytime MOB put baby down mother noticed baby's eyes rolling back and entire body gets stiff for a few second (5-6 seconds)  Last episode at 0200. Seen in clinic this am by Dr., no seizure activity noted.  Voiding and stooling well, no seizures in family.  Advised to RTC if problems and caution/review with future immunizations.
Age: 58.0
Sex: F
Vaccine: DTAP, PPV, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Increase itching and rash on arm where vaccines were given. Benadryl cream prescribed by MD.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, swollen, hot area where vaccine given
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Autism, Pyrexia
Clinical narrative: About 12 days after getting Proquad VMMR vaccination and Pnem vaccination.  My son ran 105 F fever and I took him to the ER.  His temperature was measured again and it was 102.9 F after given tylenol.  He is now 31 months old and has just been diagnosed as moderately autistic.  He had reactions to every vaccination given to him before this, but I was told it was normal.  I was also told that this fever was not anything to worry about by Dr.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Troponin I increased
Clinical narrative: Unspecified disease of the pericardium. 5-000007  4/28/09 Received vaccine & clinic medical records of 3/20/09. FINAL DX: pericarditis Records reveal patient experienced chest pain which increased w/lying down.  Seen in ER 3/19 & had f/u clinic visit on 3/20.  ER had tx w/NSAID & inhaler.  Pts symptoms relieved.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Pericarditis, Troponin I increased
Clinical narrative: Unspecified disease of the pericardium. 5-000007  4/28/09 Received vaccine & clinic medical records of 3/20/09. FINAL DX: pericarditis Records reveal patient experienced chest pain which increased w/lying down.  Seen in ER 3/19 & had f/u clinic visit on 3/20.  ER had tx w/NSAID & inhaler.  Pts symptoms relieved.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, swollen, hot area around where vaccine was given
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza like illness, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: On day of administration, had flu-like symptoms including chills, aches, and vomited X1. Today (1 day after vaccine administration) she has a runny nose and a sore throat. Treatment for symptoms: Patient took tylenol every 4 to 6 hours.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: On day of administration, had flu-like symptoms including chills, aches, and vomited X1. Today (1 day after vaccine administration) she has a runny nose and a sore throat. Treatment for symptoms: Patient took tylenol every 4 to 6 hours.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: NO ADVERSE EVENT-MD ORDERED & PATIENT RECEIVED DTaP. THIS VACCINE IS NOT RECOMMENDED FOR CHILDREN PAST 6 YEARS OF AGE
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode fainted
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Head injury, Laceration, Loss of consciousness, Pain
Clinical narrative: Pt received Tdap and varicella and passed out. Hit forehead on wall and recieved a lacaration steri strips were applied Pt c/o dizziness and pain. Pt stayed in office 20 to 30 min and was ok to leave per Dr. After pt had no complaint of dizziness or pain. Mom is a nurse an made a f/u phone call the next day to report child is fine.
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dysphagia, Dyspnoea, Rash
Clinical narrative: Patient received a Tdap and 1st Hepatitis A and within 5 minutes, broke out in a rash and had trouble breathing and swallowing.  Patient reported he had a milk allergy.  We administered Benadryl 50 mg and monitored patient and he recovered well after approximately 1 hr and 45 minutes in the office.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: Two days following Twinrix vaccine on 4/15, client's upper lip began to swell. Swelling continued for several days. Client visited primary care physician on 4/20 and received prescription for hydroxyzine for allergic reaction. He is also scheduled to meet with allergist on 4/28. After two doses of hydroxyzine, swelling has reduced slightly but lip is still swollen one week later.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Blister, Body temperature increased, Irritability, Rash, Rash papular
Clinical narrative: 2 day h/o rash starting on face and spreading. Tactile temp, fussy.  Multiple papules, vesicles
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: fever  body aches HA  vomitng for 3 days
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Malaise
Clinical narrative: Given HPV injection approx. 8:20 a.m., Immediately felt sick and dizzy, thought she was going to vomit. There were two more incidents during day one; she said she felt more fatigued than usual and after waking up the second time after the vaccination had severe frontal head pain accompanied with dizziness. This is being reported on day two, patient says she continues to be dizzy and in general feels ill.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Given HPV injection approx. 8:20 a.m., Immediately felt sick and dizzy, thought she was going to vomit. There were two more incidents during day one; she said she felt more fatigued than usual and after waking up the second time after the vaccination had severe frontal head pain accompanied with dizziness. This is being reported on day two, patient says she continues to be dizzy and in general feels ill.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Akathisia, Anxiety, Asthenia, Blood test
Clinical narrative: Previous diagnosis to vaccine-Hypothyroidism, Hashimotos,Acid Reflux, Anxiety, Depression, OCD and had occassional eye tics. Exacerbation of previous symtoms such as reslessness, restless legs, fatigue, weakness, eye and neck tics, anxiety, OCD and depression escalated after receiving vaccines. At time of 1st vaccine, pt was on Zoloft for 2 yrs, Synthroid and Nexium. After vaccines, different meds were prescribed by psychiatrist to treat pts symptoms. Beg Oct, it seemed as if everything got worse. Attendance in school affected beg Nov 07 she was barely attending in Dec 07 and officialy diagnosed with mild Tourettes. Everything was atributed to medication/akathasia, as any medical professional who was asked said "no side effects" with the vaccine, since she has a hx of anxiety, everything's assumed to be anxiety,so she was treated purely psychologically. The discomfort was  unbearable for her leading to suicidal thoughts. Pt ended up in ER 2x, 1/22/08 admitted to adolescent inpt psych unit for almost 3 weeks, then partial hospitalization completed 4/11/08. After hospital-pt on 8 medications (6 psych). Never fully recovered, previous to vaccines, pt exercised daily for 2 hrs/day-still unable to exercise. Pt returned to school 9/08 with accommodations. Pt again experienced worsening of tics eye/neck and restlessness, muscle weakness and fatigue end of Feb 08. Attendance affected in school and unable to attend for 6 weeks beginning of March-home tutored. I believe that previous ailments were escalated by the vaccine. Still being treated for restlessness, muscle weakness, fatigue...gave #2 on 11-20-07 and #3 on 3-28-08.  5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. FINAL DIAGNOSIS: Bipolar Affective Disorder, Generalized Anxiety Disorder, Tourette's Disorder Records reveal restlessness, aggression, suicidal ideation, self-injurious behaviors. Neurological tics. Hashimoto's thyroiditis, esophageal reflux.  ICD9 codes: 296.30, 530.89, 244.9, 314.01, 307.23.  5/1/09 Received vaccine & PCP medical records of 11/07-1/09. FINAL DX: none provided Records reveal patient experienced torticollis 11/07, Tourette's, depression w/suicidal ideation & psych hospitalization 1/08.  Neuro consult done 11/07 & 12/07 for tics & inattention; final neuro dx Tourette's & OCD.   11/08Self mutilation 3/08 while in psych partial hospitalization & developed infection.  Sinusitis 8/08.  Fatigue & plantar warts 9/08.  Viral conjunctivitis 12/08.  Cough tic 1/09.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Depression, Discomfort, Electroencephalogram normal, Exercise tolerance decreased
Clinical narrative: Previous diagnosis to vaccine-Hypothyroidism, Hashimotos,Acid Reflux, Anxiety, Depression, OCD and had occassional eye tics. Exacerbation of previous symtoms such as reslessness, restless legs, fatigue, weakness, eye and neck tics, anxiety, OCD and depression escalated after receiving vaccines. At time of 1st vaccine, pt was on Zoloft for 2 yrs, Synthroid and Nexium. After vaccines, different meds were prescribed by psychiatrist to treat pts symptoms. Beg Oct, it seemed as if everything got worse. Attendance in school affected beg Nov 07 she was barely attending in Dec 07 and officialy diagnosed with mild Tourettes. Everything was atributed to medication/akathasia, as any medical professional who was asked said "no side effects" with the vaccine, since she has a hx of anxiety, everything's assumed to be anxiety,so she was treated purely psychologically. The discomfort was  unbearable for her leading to suicidal thoughts. Pt ended up in ER 2x, 1/22/08 admitted to adolescent inpt psych unit for almost 3 weeks, then partial hospitalization completed 4/11/08. After hospital-pt on 8 medications (6 psych). Never fully recovered, previous to vaccines, pt exercised daily for 2 hrs/day-still unable to exercise. Pt returned to school 9/08 with accommodations. Pt again experienced worsening of tics eye/neck and restlessness, muscle weakness and fatigue end of Feb 08. Attendance affected in school and unable to attend for 6 weeks beginning of March-home tutored. I believe that previous ailments were escalated by the vaccine. Still being treated for restlessness, muscle weakness, fatigue...gave #2 on 11-20-07 and #3 on 3-28-08.  5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. FINAL DIAGNOSIS: Bipolar Affective Disorder, Generalized Anxiety Disorder, Tourette's Disorder Records reveal restlessness, aggression, suicidal ideation, self-injurious behaviors. Neurological tics. Hashimoto's thyroiditis, esophageal reflux.  ICD9 codes: 296.30, 530.89, 244.9, 314.01, 307.23.  5/1/09 Received vaccine & PCP medical records of 11/07-1/09. FINAL DX: none provided Records reveal patient experienced torticollis 11/07, Tourette's, depression w/suicidal ideation & psych hospitalization 1/08.  Neuro consult done 11/07 & 12/07 for tics & inattention; final neuro dx Tourette's & OCD.   11/08Self mutilation 3/08 while in psych partial hospitalization & developed infection.  Sinusitis 8/08.  Fatigue & plantar warts 9/08.  Viral conjunctivitis 12/08.  Cough tic 1/09.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Muscular weakness, Nuclear magnetic resonance imaging brain, Obsessive-compulsive disorder, Restless legs syndrome
Clinical narrative: Previous diagnosis to vaccine-Hypothyroidism, Hashimotos,Acid Reflux, Anxiety, Depression, OCD and had occassional eye tics. Exacerbation of previous symtoms such as reslessness, restless legs, fatigue, weakness, eye and neck tics, anxiety, OCD and depression escalated after receiving vaccines. At time of 1st vaccine, pt was on Zoloft for 2 yrs, Synthroid and Nexium. After vaccines, different meds were prescribed by psychiatrist to treat pts symptoms. Beg Oct, it seemed as if everything got worse. Attendance in school affected beg Nov 07 she was barely attending in Dec 07 and officialy diagnosed with mild Tourettes. Everything was atributed to medication/akathasia, as any medical professional who was asked said "no side effects" with the vaccine, since she has a hx of anxiety, everything's assumed to be anxiety,so she was treated purely psychologically. The discomfort was  unbearable for her leading to suicidal thoughts. Pt ended up in ER 2x, 1/22/08 admitted to adolescent inpt psych unit for almost 3 weeks, then partial hospitalization completed 4/11/08. After hospital-pt on 8 medications (6 psych). Never fully recovered, previous to vaccines, pt exercised daily for 2 hrs/day-still unable to exercise. Pt returned to school 9/08 with accommodations. Pt again experienced worsening of tics eye/neck and restlessness, muscle weakness and fatigue end of Feb 08. Attendance affected in school and unable to attend for 6 weeks beginning of March-home tutored. I believe that previous ailments were escalated by the vaccine. Still being treated for restlessness, muscle weakness, fatigue...gave #2 on 11-20-07 and #3 on 3-28-08.  5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. FINAL DIAGNOSIS: Bipolar Affective Disorder, Generalized Anxiety Disorder, Tourette's Disorder Records reveal restlessness, aggression, suicidal ideation, self-injurious behaviors. Neurological tics. Hashimoto's thyroiditis, esophageal reflux.  ICD9 codes: 296.30, 530.89, 244.9, 314.01, 307.23.  5/1/09 Received vaccine & PCP medical records of 11/07-1/09. FINAL DX: none provided Records reveal patient experienced torticollis 11/07, Tourette's, depression w/suicidal ideation & psych hospitalization 1/08.  Neuro consult done 11/07 & 12/07 for tics & inattention; final neuro dx Tourette's & OCD.   11/08Self mutilation 3/08 while in psych partial hospitalization & developed infection.  Sinusitis 8/08.  Fatigue & plantar warts 9/08.  Viral conjunctivitis 12/08.  Cough tic 1/09.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Restlessness, Suicidal ideation, Tic, Tourette's disorder
Clinical narrative: Previous diagnosis to vaccine-Hypothyroidism, Hashimotos,Acid Reflux, Anxiety, Depression, OCD and had occassional eye tics. Exacerbation of previous symtoms such as reslessness, restless legs, fatigue, weakness, eye and neck tics, anxiety, OCD and depression escalated after receiving vaccines. At time of 1st vaccine, pt was on Zoloft for 2 yrs, Synthroid and Nexium. After vaccines, different meds were prescribed by psychiatrist to treat pts symptoms. Beg Oct, it seemed as if everything got worse. Attendance in school affected beg Nov 07 she was barely attending in Dec 07 and officialy diagnosed with mild Tourettes. Everything was atributed to medication/akathasia, as any medical professional who was asked said "no side effects" with the vaccine, since she has a hx of anxiety, everything's assumed to be anxiety,so she was treated purely psychologically. The discomfort was  unbearable for her leading to suicidal thoughts. Pt ended up in ER 2x, 1/22/08 admitted to adolescent inpt psych unit for almost 3 weeks, then partial hospitalization completed 4/11/08. After hospital-pt on 8 medications (6 psych). Never fully recovered, previous to vaccines, pt exercised daily for 2 hrs/day-still unable to exercise. Pt returned to school 9/08 with accommodations. Pt again experienced worsening of tics eye/neck and restlessness, muscle weakness and fatigue end of Feb 08. Attendance affected in school and unable to attend for 6 weeks beginning of March-home tutored. I believe that previous ailments were escalated by the vaccine. Still being treated for restlessness, muscle weakness, fatigue...gave #2 on 11-20-07 and #3 on 3-28-08.  5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. FINAL DIAGNOSIS: Bipolar Affective Disorder, Generalized Anxiety Disorder, Tourette's Disorder Records reveal restlessness, aggression, suicidal ideation, self-injurious behaviors. Neurological tics. Hashimoto's thyroiditis, esophageal reflux.  ICD9 codes: 296.30, 530.89, 244.9, 314.01, 307.23.  5/1/09 Received vaccine & PCP medical records of 11/07-1/09. FINAL DX: none provided Records reveal patient experienced torticollis 11/07, Tourette's, depression w/suicidal ideation & psych hospitalization 1/08.  Neuro consult done 11/07 & 12/07 for tics & inattention; final neuro dx Tourette's & OCD.   11/08Self mutilation 3/08 while in psych partial hospitalization & developed infection.  Sinusitis 8/08.  Fatigue & plantar warts 9/08.  Viral conjunctivitis 12/08.  Cough tic 1/09.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Back pain, Cervical spinal stenosis, Diabetes mellitus
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthritis in a male subject in his forties who was vaccinated with LYMERIX (GlaxoSmithKline). The reporting lawyer did not specify the adverse events experienced by the subject. The following information was received on 08 April 2009 via medical records. The subject reported that he was vaccinated with LYMERIX in 2001. In November 2001, the subject was evaluated for neck pain, right arm numbness, and low back pain, and magnetic resonance imaging showed mild degenerative disc disease. On 30 January 2002, he was complained of chronic neck and back pain. On 14 May 2003, he was evaluated for polyarthralgias, intermittent numbness of the hands and toes, as well as diabetes, hypertension, reflux and hyperlipidemia. The subject reported that he had been evaluated by a neurologist and diagnosed with mild diabetic neuropathy and numbness related to a remote injury. Magnetic resonance imaging of the brain was unremarkable and of the neck was significant for stenosis and possible disc protrusion. The subject believed that he had Lyme arthritis, and noted that he had received LYMERIX in 2001. Assessment included polyarthralgias of unclear etiology. Upon follow up on 04 January 2005, the subject continued to be followed by pain management for neck and lower back pain. Treatment included ULTRACET. Assessment on 18 July 2005 included cervical spine pain and spurring, left shoulder pain, headache, and bilateral arm numbness. He was receiving ULTRAM "six per day" for increasing pain due to the bone spur in his neck". Between 03 January 2002 and 05 September 2007, the subject was followed regularly for shoulder joint pain, neck pain, cervical spondylosis with disc spur complex at C5/6, low back pain, buttock pain, neck pain, numbness and tingling of the fingers. Diagnoses included herniated nucleus pulposus (cervical), axial pain, lumbar degenerative disc disease, lumbar radiculopathy, right side sciatica, degenerative disc disease, cervical degenerative disc disease, and cervicalgia. Treatment included medications (KETOPROFEN, VIOXX, BACLOFEN, LIDOCAINE cream, MOBIC, TRAMADOL, FLEXERIL, NEURONTIN, VICOPROFEN, ZYDONE, TYLENOL, ULTRAM) and facet joint injections/ cervical epidural block. He was seen on 15 May 2008 with a flare of low back and coccyx pain, and assessment included lumbar degenerative disc disease, lumbar radiculopathy (resolved), cervical degenerative disc disease, and cervicalgia. Treatment included TRAMADOL, FLEXERIL, NEURONTIN, MOBIC, and VICOPROFEN, and he received a lumbar neuroforaminal injection. Neck pain persisted as recently as January 2009. On 10 February 2009, he presented with a three week history of severe left calf pain after going hunting, and assessment included myalgias of the left calf "suspect torn muscle". Treatment included LORTAB. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Diabetic neuropathy, Exostosis, Headache, Hyperlipidaemia, Hypertension
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthritis in a male subject in his forties who was vaccinated with LYMERIX (GlaxoSmithKline). The reporting lawyer did not specify the adverse events experienced by the subject. The following information was received on 08 April 2009 via medical records. The subject reported that he was vaccinated with LYMERIX in 2001. In November 2001, the subject was evaluated for neck pain, right arm numbness, and low back pain, and magnetic resonance imaging showed mild degenerative disc disease. On 30 January 2002, he was complained of chronic neck and back pain. On 14 May 2003, he was evaluated for polyarthralgias, intermittent numbness of the hands and toes, as well as diabetes, hypertension, reflux and hyperlipidemia. The subject reported that he had been evaluated by a neurologist and diagnosed with mild diabetic neuropathy and numbness related to a remote injury. Magnetic resonance imaging of the brain was unremarkable and of the neck was significant for stenosis and possible disc protrusion. The subject believed that he had Lyme arthritis, and noted that he had received LYMERIX in 2001. Assessment included polyarthralgias of unclear etiology. Upon follow up on 04 January 2005, the subject continued to be followed by pain management for neck and lower back pain. Treatment included ULTRACET. Assessment on 18 July 2005 included cervical spine pain and spurring, left shoulder pain, headache, and bilateral arm numbness. He was receiving ULTRAM "six per day" for increasing pain due to the bone spur in his neck". Between 03 January 2002 and 05 September 2007, the subject was followed regularly for shoulder joint pain, neck pain, cervical spondylosis with disc spur complex at C5/6, low back pain, buttock pain, neck pain, numbness and tingling of the fingers. Diagnoses included herniated nucleus pulposus (cervical), axial pain, lumbar degenerative disc disease, lumbar radiculopathy, right side sciatica, degenerative disc disease, cervical degenerative disc disease, and cervicalgia. Treatment included medications (KETOPROFEN, VIOXX, BACLOFEN, LIDOCAINE cream, MOBIC, TRAMADOL, FLEXERIL, NEURONTIN, VICOPROFEN, ZYDONE, TYLENOL, ULTRAM) and facet joint injections/ cervical epidural block. He was seen on 15 May 2008 with a flare of low back and coccyx pain, and assessment included lumbar degenerative disc disease, lumbar radiculopathy (resolved), cervical degenerative disc disease, and cervicalgia. Treatment included TRAMADOL, FLEXERIL, NEURONTIN, MOBIC, and VICOPROFEN, and he received a lumbar neuroforaminal injection. Neck pain persisted as recently as January 2009. On 10 February 2009, he presented with a three week history of severe left calf pain after going hunting, and assessment included myalgias of the left calf "suspect torn muscle". Treatment included LORTAB. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Intervertebral disc degeneration, Intervertebral disc protrusion, Lumbar radiculopathy, Musculoskeletal pain
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthritis in a male subject in his forties who was vaccinated with LYMERIX (GlaxoSmithKline). The reporting lawyer did not specify the adverse events experienced by the subject. The following information was received on 08 April 2009 via medical records. The subject reported that he was vaccinated with LYMERIX in 2001. In November 2001, the subject was evaluated for neck pain, right arm numbness, and low back pain, and magnetic resonance imaging showed mild degenerative disc disease. On 30 January 2002, he was complained of chronic neck and back pain. On 14 May 2003, he was evaluated for polyarthralgias, intermittent numbness of the hands and toes, as well as diabetes, hypertension, reflux and hyperlipidemia. The subject reported that he had been evaluated by a neurologist and diagnosed with mild diabetic neuropathy and numbness related to a remote injury. Magnetic resonance imaging of the brain was unremarkable and of the neck was significant for stenosis and possible disc protrusion. The subject believed that he had Lyme arthritis, and noted that he had received LYMERIX in 2001. Assessment included polyarthralgias of unclear etiology. Upon follow up on 04 January 2005, the subject continued to be followed by pain management for neck and lower back pain. Treatment included ULTRACET. Assessment on 18 July 2005 included cervical spine pain and spurring, left shoulder pain, headache, and bilateral arm numbness. He was receiving ULTRAM "six per day" for increasing pain due to the bone spur in his neck". Between 03 January 2002 and 05 September 2007, the subject was followed regularly for shoulder joint pain, neck pain, cervical spondylosis with disc spur complex at C5/6, low back pain, buttock pain, neck pain, numbness and tingling of the fingers. Diagnoses included herniated nucleus pulposus (cervical), axial pain, lumbar degenerative disc disease, lumbar radiculopathy, right side sciatica, degenerative disc disease, cervical degenerative disc disease, and cervicalgia. Treatment included medications (KETOPROFEN, VIOXX, BACLOFEN, LIDOCAINE cream, MOBIC, TRAMADOL, FLEXERIL, NEURONTIN, VICOPROFEN, ZYDONE, TYLENOL, ULTRAM) and facet joint injections/ cervical epidural block. He was seen on 15 May 2008 with a flare of low back and coccyx pain, and assessment included lumbar degenerative disc disease, lumbar radiculopathy (resolved), cervical degenerative disc disease, and cervicalgia. Treatment included TRAMADOL, FLEXERIL, NEURONTIN, MOBIC, and VICOPROFEN, and he received a lumbar neuroforaminal injection. Neck pain persisted as recently as January 2009. On 10 February 2009, he presented with a three week history of severe left calf pain after going hunting, and assessment included myalgias of the left calf "suspect torn muscle". Treatment included LORTAB. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Myalgia, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthritis in a male subject in his forties who was vaccinated with LYMERIX (GlaxoSmithKline). The reporting lawyer did not specify the adverse events experienced by the subject. The following information was received on 08 April 2009 via medical records. The subject reported that he was vaccinated with LYMERIX in 2001. In November 2001, the subject was evaluated for neck pain, right arm numbness, and low back pain, and magnetic resonance imaging showed mild degenerative disc disease. On 30 January 2002, he was complained of chronic neck and back pain. On 14 May 2003, he was evaluated for polyarthralgias, intermittent numbness of the hands and toes, as well as diabetes, hypertension, reflux and hyperlipidemia. The subject reported that he had been evaluated by a neurologist and diagnosed with mild diabetic neuropathy and numbness related to a remote injury. Magnetic resonance imaging of the brain was unremarkable and of the neck was significant for stenosis and possible disc protrusion. The subject believed that he had Lyme arthritis, and noted that he had received LYMERIX in 2001. Assessment included polyarthralgias of unclear etiology. Upon follow up on 04 January 2005, the subject continued to be followed by pain management for neck and lower back pain. Treatment included ULTRACET. Assessment on 18 July 2005 included cervical spine pain and spurring, left shoulder pain, headache, and bilateral arm numbness. He was receiving ULTRAM "six per day" for increasing pain due to the bone spur in his neck". Between 03 January 2002 and 05 September 2007, the subject was followed regularly for shoulder joint pain, neck pain, cervical spondylosis with disc spur complex at C5/6, low back pain, buttock pain, neck pain, numbness and tingling of the fingers. Diagnoses included herniated nucleus pulposus (cervical), axial pain, lumbar degenerative disc disease, lumbar radiculopathy, right side sciatica, degenerative disc disease, cervical degenerative disc disease, and cervicalgia. Treatment included medications (KETOPROFEN, VIOXX, BACLOFEN, LIDOCAINE cream, MOBIC, TRAMADOL, FLEXERIL, NEURONTIN, VICOPROFEN, ZYDONE, TYLENOL, ULTRAM) and facet joint injections/ cervical epidural block. He was seen on 15 May 2008 with a flare of low back and coccyx pain, and assessment included lumbar degenerative disc disease, lumbar radiculopathy (resolved), cervical degenerative disc disease, and cervicalgia. Treatment included TRAMADOL, FLEXERIL, NEURONTIN, MOBIC, and VICOPROFEN, and he received a lumbar neuroforaminal injection. Neck pain persisted as recently as January 2009. On 10 February 2009, he presented with a three week history of severe left calf pain after going hunting, and assessment included myalgias of the left calf "suspect torn muscle". Treatment included LORTAB. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Sciatica, Spinal osteoarthritis
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthritis in a male subject in his forties who was vaccinated with LYMERIX (GlaxoSmithKline). The reporting lawyer did not specify the adverse events experienced by the subject. The following information was received on 08 April 2009 via medical records. The subject reported that he was vaccinated with LYMERIX in 2001. In November 2001, the subject was evaluated for neck pain, right arm numbness, and low back pain, and magnetic resonance imaging showed mild degenerative disc disease. On 30 January 2002, he was complained of chronic neck and back pain. On 14 May 2003, he was evaluated for polyarthralgias, intermittent numbness of the hands and toes, as well as diabetes, hypertension, reflux and hyperlipidemia. The subject reported that he had been evaluated by a neurologist and diagnosed with mild diabetic neuropathy and numbness related to a remote injury. Magnetic resonance imaging of the brain was unremarkable and of the neck was significant for stenosis and possible disc protrusion. The subject believed that he had Lyme arthritis, and noted that he had received LYMERIX in 2001. Assessment included polyarthralgias of unclear etiology. Upon follow up on 04 January 2005, the subject continued to be followed by pain management for neck and lower back pain. Treatment included ULTRACET. Assessment on 18 July 2005 included cervical spine pain and spurring, left shoulder pain, headache, and bilateral arm numbness. He was receiving ULTRAM "six per day" for increasing pain due to the bone spur in his neck". Between 03 January 2002 and 05 September 2007, the subject was followed regularly for shoulder joint pain, neck pain, cervical spondylosis with disc spur complex at C5/6, low back pain, buttock pain, neck pain, numbness and tingling of the fingers. Diagnoses included herniated nucleus pulposus (cervical), axial pain, lumbar degenerative disc disease, lumbar radiculopathy, right side sciatica, degenerative disc disease, cervical degenerative disc disease, and cervicalgia. Treatment included medications (KETOPROFEN, VIOXX, BACLOFEN, LIDOCAINE cream, MOBIC, TRAMADOL, FLEXERIL, NEURONTIN, VICOPROFEN, ZYDONE, TYLENOL, ULTRAM) and facet joint injections/ cervical epidural block. He was seen on 15 May 2008 with a flare of low back and coccyx pain, and assessment included lumbar degenerative disc disease, lumbar radiculopathy (resolved), cervical degenerative disc disease, and cervicalgia. Treatment included TRAMADOL, FLEXERIL, NEURONTIN, MOBIC, and VICOPROFEN, and he received a lumbar neuroforaminal injection. Neck pain persisted as recently as January 2009. On 10 February 2009, he presented with a three week history of severe left calf pain after going hunting, and assessment included myalgias of the left calf "suspect torn muscle". Treatment included LORTAB. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 21.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Brain oedema, Encephalitis, Oropharyngeal pain, Pyrexia, Unresponsive to stimuli
Clinical narrative: Received vaccines 4/2, on 4/9 developed fevers, sore throat - unresponsiveness and encephalitis with brain edema by 4/11. Suspect viral encephalitis - multiple studies pending.  4/23/09 Received hospital medical records of 4/12-4/21/2009. FINAL DX: encephalitis Records reveal patient experienced fever, chills, HA, sore throat on 4/8/09.  Seen in student health 4/9 where strep neg.  Tx w/antipyretics.  Later on 4/9, developed altered mental status, unintelligible speech, vomiting x 1 & shaking.  Admitted to local hospital.  LP done.  Admitted to ICU, tx w/IV antibiotics/antivirals, intracranial bolt place to reduce ICP.  Condition deterorated, remained febrile, intubated & transferred to higher level of care.  Neuro, ID, Optho consults done.  Tx w/antibiotics, antivirals, IVIG x 3.  Improved slowly but febrile throughout, failed extubation, trached, feeding tube placement & transferred to rehab.  At d/c pt could open eyes & tracks but unable to follow commands.  6/10/09 Hospital records and DC summary received DOS 4/10/09 to 4/12/09. ASSESSMENT: Encephalitis, unknown etiology. Post vaccination sore throat, headaches, fever, irritable, confused. Not very responsive. Shaking rigors. On ventilator. Pupils assymmetric.  Spontaneous eye movements, posturing of upper extremities on stimulation, hiccups, diffuse erythema. Withdrawal response of lower extremities to painful stimulation. Transferred to another facility. ICD-9 Codes: 780.97 Altered Mental Status. 323.9 UNSP Causes of Encephalitis, Myelitis & Encephalitis. 348.5 Cerebral Edema. 780.60 Fever unspecified. 573.3 Hepatitis NOS. 305.1 Tobacco use disorder.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Full blood count, Pyrexia, Screaming
Clinical narrative: Child ran a fever up to 104 with last vaccines and screamed for ten hours nonstop.
Age: 1.7
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient received DTap and VARIVAX vaccines on 3/18/09 in right thigh. Patient returned to office 3/20/09 with large red circular area around injection site with slight induration at the injection site. Patient was treated with KEFLEX.
Age: 1.3
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received DTap vaccine in left thigh on 3/16/09. Parent reported large red swollen area around injection site 1 day after injection. Redness and swelling resolved after 2 days. Patient was not treated.
Age: 12.0
Sex: M
Vaccine: TYP
Symptoms: Culture throat, Dysphagia, Dysphonia, Laryngitis, Oropharyngeal pain
Clinical narrative: Sore throat, difficulty swallowing, hoarseness and laryngitis. Told to stop VIVOTIF and use ADVIL. Throat culture pending.
Age: 12.0
Sex: M
Vaccine: TYP
Symptoms: Streptococcal identification test negative
Clinical narrative: Sore throat, difficulty swallowing, hoarseness and laryngitis. Told to stop VIVOTIF and use ADVIL. Throat culture pending.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large target lesion (7cm x 5 cm) with central clearing. Raised, red and warm, but no pain or itching.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt c/o mild pain at left upper arm at previous injection site with redness and tenderness (2" x 5" of size). Pt stated scratching area after 4 days of injection.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Cold sweat, Musculoskeletal discomfort, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever and cold sweats and chills 4-20-09 that evening after the vaccine was administered. Pt also c/o difficult with forward flexion of neck - "mild discomfort. NOTE GCND notified 4/21/09 and Pt's father given VAERS forms also. Fever, headache, stiffness in back and neck.  102 degreees when highest.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Varicella
Clinical narrative: Erythema on L thigh with chicken pox looking lesions warm compresses + Augmentin x 5 days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Dermatitis, Pruritus, Rash, Rash erythematous
Clinical narrative: Erythematous papular and plaque like lesions - very pruritic on extensor surface of upper and lower extremities. This rash developed 2 weeks after 2nd and 3rd GARDASIL vaccine
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular, Skin plaque, Vaccine positive rechallenge
Clinical narrative: Erythematous papular and plaque like lesions - very pruritic on extensor surface of upper and lower extremities. This rash developed 2 weeks after 2nd and 3rd GARDASIL vaccine
Age: 20.0
Sex: F
Vaccine: ANTH, HPV4, SMALL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Received smallpox 31 Mar 09 Lt upper arm, which was followed by swelling, redness, and increasing tenderness, no fever, Pt stated she was vaccinated with Smallpox previously on 28 Nov 2007, but no desired effect and it did not take.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Depression, Fatigue, Memory impairment, Mental disorder
Clinical narrative: This is a follow-up to a previously submitted VAERS report this 47 year old patient received 4 BIOTHRAX prior to and during his deployment in 2003. His concerns centered on whether the BIOTHRAX contributed to mental (depression, memory, fatigue) and physical disorders (joint pain, skin discoloration, rash) that "began in 2003".
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Skin discolouration
Clinical narrative: This is a follow-up to a previously submitted VAERS report this 47 year old patient received 4 BIOTHRAX prior to and during his deployment in 2003. His concerns centered on whether the BIOTHRAX contributed to mental (depression, memory, fatigue) and physical disorders (joint pain, skin discoloration, rash) that "began in 2003".
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Diarrhoea, Injection site haematoma, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting and diarrhea, subjective fever and hematoma to site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site mass
Clinical narrative: Knot upper (R) leg.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Decreased appetite, Pyrexia, Rash, Tremor, Vomiting
Clinical narrative: Fever, decreased appetite, rash, shaky, vomiting in the 24 hours to 48 hours with the vaccine administration on 4/15/09
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Anger, Blood pressure normal, Cyanosis, Fall, Fear
Clinical narrative: After vaccines were given the patient hopped off the exam table (she was sitting on it) & fell to the floor and became rigid and looked blue and unresponsive but not flaccid with then tonic - clonic movements upon awakening after about 1-1 1/2 minutes and felt scared and angry after episode. HR/BP okay X
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Heart rate normal, Muscle rigidity, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: After vaccines were given the patient hopped off the exam table (she was sitting on it) & fell to the floor and became rigid and looked blue and unresponsive but not flaccid with then tonic - clonic movements upon awakening after about 1-1 1/2 minutes and felt scared and angry after episode. HR/BP okay X
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Swelling face
Clinical narrative: Sudden (<15min) onset of facial swelling after vaccine delivery.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Erythema multiforme, Swelling, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male patient who on 16-MAR-2005 was vaccinated with MMR II. The patient's entire body and face swollen after receiving the vaccine. The registered nurse was not sure if the patient received a second dose of MMR II. The patient was hospitalized on 15-AUG-2008 for erythema multi-form caused by an unknown allergen. The registered nurse did not feel it was related to MMR II. The patient was treated with SOLU-MEDROL. On an unknown date the patient recovered from entire body and face swollen and erythema multi-form caused by an unknown allergen. The registered nurse did not know when the patient was released from the hospital. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: hives on face, neck, groin area, back, and torso
Age: 35.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Flow cytometry, Lymph node pain, Lymphadenectomy, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning another 35 year old female physician with no allergies. No adverse events following prior vaccination or illness at time of vaccination or other medical conditions who on 28-JAN-2009 was vaccinated with the first dose of GARDASIL (lot # 661841/0653X) into the left deltoid. On 02-FEB-2009 the patient developed lymphadenopathy in the left axilla in a few days after injection given at the same side. The patient had a biopsy and surgical excision by Breast specialist about one week later (result not reported). It was reported that the patient recovered on an unspecified date. The reporter considered lymphadenopathy in left axilla to be other important medical event. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mammogram, Pathology test, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning another 35 year old female physician with no allergies. No adverse events following prior vaccination or illness at time of vaccination or other medical conditions who on 28-JAN-2009 was vaccinated with the first dose of GARDASIL (lot # 661841/0653X) into the left deltoid. On 02-FEB-2009 the patient developed lymphadenopathy in the left axilla in a few days after injection given at the same side. The patient had a biopsy and surgical excision by Breast specialist about one week later (result not reported). It was reported that the patient recovered on an unspecified date. The reporter considered lymphadenopathy in left axilla to be other important medical event. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Lymphadenopathy, No reaction on previous exposure to drug, Surgery
Clinical narrative: Information has been received from a physician concerning another 35 year old female physician with no allergies. No adverse events following prior vaccination or illness at time of vaccination or other medical conditions who on 28-JAN-2009 was vaccinated with the first dose of GARDASIL (lot # 661841/0653X) into the left deltoid. On 02-FEB-2009 the patient developed lymphadenopathy in the left axilla in a few days after injection given at the same side. The patient had a biopsy and surgical excision by Breast specialist about one week later (result not reported). It was reported that the patient recovered on an unspecified date. The reporter considered lymphadenopathy in left axilla to be other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Activities of daily living impaired, Convulsion, Hepatobiliary scan, Irritable bowel syndrome, Laboratory test
Clinical narrative: Information has been received from a school nurse (registered nurse) concerning a middle school aged female who was vaccinated with a dose of GARDASIL. On an unspecified date, after receiving GARDASIL, the patient developed aluminum poisoning. The patient sought unspecified medical attention. Additional information was received from the school nurse and an office manager concerning the 13 year old middle school female who on 4-FEB-2008 was vaccinated with the first dose of GARDASIL, on 16-APR-2008 was vaccinated with the second dose and on 16-AUG-2008 was vaccinated with the third dose (lot #: 660393/0067X). On an unspecified date, after administration of GARDASIL, the patient developed aluminum poisoning. This is one of several reports received from the same source. Additional information has been requested.