chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological symptom
Clinical narrative: Information has been received from a physician via a company representative concerning a 17 year old who on an unspecified date was vaccinated with Gardasil IM.  On approx 07-FEB-2008, "about 3 weeks ago" the patient developed neurological symptoms and was hospitalized for one week.  The neurologist at the hospital diagnosed her with Miller Fisher variance of Guillain-Barre syndrome.  At the time of reporting the patient "improved but she's undergoing therapy" and has not recovered.  No further information was provided.  The reporter felt that Miller Fisher variance of Guillain-Barre syndrome was disabling and required hospitalization.  Additional information has been requested. 4/8/08-records received for DOS 2/6-2/12/08- DC DX: Guillain-Barre variant.  Developed cough and diarrhea week prior to admission. Also had vomiting and fevers. On morning of admission developed tingling in hands and feet and dysarthric speech, blurry vision and difficulty with walking. Treated with IVIG with improvement of ataxia and dysarthria.  CDC's CISA staff has reviewed this case and concluded that this case is not GBS.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Decreased appetite, Delivery, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 26-JUN-2007 was vaccinated with a first dose of GARDASIL (lot# 656050/0245U) IM and on 22-SEP-2007 was vaccinated with a second dose of GARDASIL (lot# 657006/0188U) IM while being pregnant. The patient came into the physician's office on 27-FEB-2008 the patient experienced complaints of abdominal pain, felt weak, feeling hot and a poor appetite. The patient was sent home and delivered a full term 6 pound baby in the bathroom on 27-FEB-2008. The patient and the baby are currently in the hospital on 28-FEB-2008. (It was unknown when the patient admitted to the hospital). The baby was a little anemic otherwise healthy. No additional information was provided. The reporter felt that complaints of abdominal pain, felt weak, feeling hot and a poor appetite required hospitalization. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 26-JUN-2007 was vaccinated with a first dose of GARDASIL (lot# 656050/0245U) IM and on 22-SEP-2007 was vaccinated with a second dose of GARDASIL (lot# 657006/0188U) IM while being pregnant. The patient came into the physician's office on 27-FEB-2008 the patient experienced complaints of abdominal pain, felt weak, feeling hot and a poor appetite. The patient was sent home and delivered a full term 6 pound baby in the bathroom on 27-FEB-2008. The patient and the baby are currently in the hospital on 28-FEB-2008. (It was unknown when the patient admitted to the hospital). The baby was a little anemic otherwise healthy. No additional information was provided. The reporter felt that complaints of abdominal pain, felt weak, feeling hot and a poor appetite required hospitalization. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from an office manager at a physician's office, via a company representative, concerning a female (age not specified), who on an unknown date was vaccinated with a dose of Gardasil (site, route and lot # not reported).  After receiving the vaccination, the patient had a seizure.  The details and outcome of the event were not specified.  No other information was available.  The patient sought unspecified medical attention.  Upon internal review, "had a seizure after receiving a dose of Gardasil" was considered to be serious as an other important medical event.  Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: PNC, RV5
Symptoms: Aspiration, Cardiomegaly, Chest X-ray abnormal, Lung infiltration
Clinical narrative: Information has been received from a pharmacist and nurse in a pediatrician's office concerning a 6 month old male with Down's syndrome, reflux, trial septal defect, recurrent pulmonary infections and congenital heart defect (type unknown no corrective surgery) and no drug allergies who on 18-SEP-2007, 29-NOV-2007 and 26-FEB-2008 was vaccinated PO with a dose of Rotateq (lot# 657670/0901U, 657672/0903U, 657989/1838U).  Concomitant drug therapy included PREVACID.  In February 2008, a few weeks ago, the patient had a previous hospital admission for aspiration.  The nurse mentioned that the patient had aspirated before, but not after the first and second doses of Rotateq.  The nurse did not have specifics on interventions, but said that the pediatrician would have the information.  On 16-FEB-2008 a chest X-ray revealed interstitial infiltrates and cardiomegaly.  On 17-FEB-2008 the chest X-ray showed persistent infiltrates.  On 26-FEB-2008 from the nurse's understanding, he "just aspirated on the Rotateq and it was not necessarily an allergic reaction.  On 27-FEB-2008 another chest X-ray showed left lower base infiltrates and cardiomegaly.  On 29-FEB-2008 early in the morning the patient was admitted to the hospital with a diagnosis of pneumonia.  Prior to admission the chest X-ray that was performed at 02:30 showed cardiomegaly, severe and persistent bilateral infiltrates.  At the time of this report, the patient remained hospitalized according to the pharmacist and pediatrician's and pulmonologist's offices.  The patient was recovering noted to be doing better but still had a lot of infiltrates.  There was no product quality complaint.  Additional information has been requested.  3/19/08 Reviewed hospital medical records of 2/29-3/7/2008. FINAL DX: Down's syndrome; aspiration pneumonia; bronchomalacia; atrioseptal defect; GERD; dysfunctional swallow. Records reveal patient experienced gag, cough & choking s/p rotavirus vax.  That night was febrile & had decreased O2 sats.  Seen by pcp.  Tx w/oral antibiotics.  Worsened & taken to ER where noted to have severely decreased O2 sats.  Admitted to PICU.  Tx w/IV antibiotics.  Improved very slowly.  Feedings changed from oral to transpyloric to minimize further risk of aspiration.   Developed bilateral interstitial infiltrates.  Tx w/diuretics.  Bronchoscopy done 3/7/08 revealed bilaterally large airway bronchomalacia & thick mucuous plugs.  Improved to room air by d/c & was able to tolerate thickened formula.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Haematemesis, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 4 month old female with a history of reflux who was vaccinated with her second dose of Rotateq (lot# not provided).  About 2 or 3 weeks vaccination, the patient experienced bloody vomit and bloody feces and was subsequently hospitalized.  Therapy with Rotateq was discontinued.  Subsequently, the patient recovered.  There was no product quality complaint.  The physician considered bloody feces to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning 2 patients who were vaccinated with their third doses of Rotateq.  Subsequently the patients were hospitalized with rotavirus.  The patients sought unspecified medical attention.  Lab diagnostic studies performed included positive tests for rotavirus.  The outcomes were unknown.  There were no product quality complaints.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood bilirubin
Clinical narrative: Sudden death on school playground.  3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent's vehicle & collapsed over the car.  Parent & other bystanders witnessed event & called 911.  Parent told ER patient was gurgling, color drained from face & eyes glassed over.  Transported to ER where resuscitation unsuccessful.    3/25/08 Reviewed pcp medical records of 12/31/07.  Only complaint was of slight pain right knee s/p bike crash.  Pt wt 148 lbs, ht 63.5 in, BMI 25.8.  BP 100/60.  Vax record supplies lot #. Family hx: parent w/HTN.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood creatine phosphokinase normal, Cardiac arrest, Globulin, Hypertrophic cardiomyopathy, Inappropriate schedule of drug administration
Clinical narrative: Sudden death on school playground.  3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent's vehicle & collapsed over the car.  Parent & other bystanders witnessed event & called 911.  Parent told ER patient was gurgling, color drained from face & eyes glassed over.  Transported to ER where resuscitation unsuccessful.    3/25/08 Reviewed pcp medical records of 12/31/07.  Only complaint was of slight pain right knee s/p bike crash.  Pt wt 148 lbs, ht 63.5 in, BMI 25.8.  BP 100/60.  Vax record supplies lot #. Family hx: parent w/HTN.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Myoglobin blood increased, Sudden death, Troponin, Ventricular fibrillation
Clinical narrative: Sudden death on school playground.  3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent's vehicle & collapsed over the car.  Parent & other bystanders witnessed event & called 911.  Parent told ER patient was gurgling, color drained from face & eyes glassed over.  Transported to ER where resuscitation unsuccessful.    3/25/08 Reviewed pcp medical records of 12/31/07.  Only complaint was of slight pain right knee s/p bike crash.  Pt wt 148 lbs, ht 63.5 in, BMI 25.8.  BP 100/60.  Vax record supplies lot #. Family hx: parent w/HTN.
Sex: M
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: My wife and I believe that the vaccine (ZOSTAVAX) can give a person genital herpes! We received our injections on 03-05-07 and we both developed herpes within a few months.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Per MD report, patient began experiencing arthritic symptoms in both wrists which started in the weeks after flu shot. MD states that patient now has early rheumatoid arthritis in both wrists. MD to contact physician at another hospital.  Dosage administered by medical center.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: Per MD report, patient began experiencing arthritic symptoms in both wrists which started in the weeks after flu shot. MD states that patient now has early rheumatoid arthritis in both wrists. MD to contact physician at another hospital.  Dosage administered by medical center.
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTaP instead of tdap.  Mother says patient is fine, no adverse effects.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion
Clinical narrative: Seen in office, seizure after immunizations.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Antibody test negative, Antinuclear antibody negative, Arthralgia, Autoimmune disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Cervical spinal stenosis, Cervicobrachial syndrome, Cognitive disorder, Compartment syndrome
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Ehrlichia serology, Fatigue, Hypoaesthesia, Immunology test, Intervertebral disc degeneration
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Intervertebral disc disorder, Intervertebral disc protrusion, Joint swelling, Lumbar spinal stenosis, Mobility decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Muscle contractions involuntary, Muscle spasms, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Pain in extremity
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Paraesthesia, Parasitic blood test negative, Radiculitis, Rash, Red blood cell sedimentation rate normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid factor negative, Rocky mountain spotted fever, Scoliosis, Sleep disorder, Spinal X-ray
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Spinal X-ray abnormal, Spinal osteoarthritis, Tenosynovitis, X-ray abnormal, X-ray limb abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: X-ray of pelvis and hip abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias an in adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix.  On an unspecified date after vaccination with LYMErix, the subject experienced arthralgias, myalgias, sleep problems, fatigue and rashes.  In addition, he suffers from rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  The subject also has decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Upon follow up information received via medical records on 16 January 2008, the subject was identified as being in his fifties with a history of basal cell skin cancer.  No other information was provided at that time.  Follow up information was received on 28 February 2008 via medical records.  The subject reportedly had a history of hepatitis, cervical spine stenosis at C2 and C3, sciatica, and "insignificant" cardiac arrhythmia, each of which were diagnosed on an unspecified date.  He also had a history of Bell's palsy in approximately 1997.  On 01 August 2002, diagnostic findings included discogenic disease and degenerative arthritis from L4 to L5 and at T11 to T12, slight scoliosis, and limited flexion and extension consistent with muscle spasm.  On 04 September 2003, he was evaluated for a history of lower back pain and bilateral leg pain with numbness, with findings including diffuse osteoarthritis with degenerative disc disease, spinal canal stenosis associated with disc herniation, and mild dextroscoliosis.  On 26 April 2004, an X-ray revealed mild degenerative arthritis of the right knee.  Between August 2002 and July 2005, the subject was evaluated for multiple complaints including lumbar radiculitis and hip tenosynovitis (01 August 2002), multi-site joint pain (31 July 2003), lumbar degenerative joint disease (21 August 2003), lumbar spinal stenosis and disc osteophyte complex (23 September 2003), swollen and sore knees (26 April 2004), leg cramps and myalgias (09 August 2004), cervical radiculitis (15 September 2004), joint swelling in the legs and knees and muscle spasms, cervical stenosis, and medical compartment syndrome associated with bilateral knee pain (31 May 2005), muscle spasms (18 July 2005), muscle cramps and fasciculations of the left lower extremity (11 August 2005), and cervical pain with numbness and tingling of the shoulder and arm (05 September 2006).  Treatment included Bextra, Flexeril, and Percocet.  Based upon follow up information, this report was assessed to be medically significant by GSK.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Convulsion
Clinical narrative: Generalized seizures x 2 on 2/29/08 lasting 2-5 minutes after DTaP. Better on the same day.  03/11/2008 MR received for 2 ERvisits 2/29 and admission 3/1-2/2008 with DX: Grand Mal Seizure. 2' DX:  otitis media. New onset seizure (afebrile). ???vaccine reaction.  Two hour after receiving vax pt was noted to have become unconscious while clenching fists and arms.  Brought to Er and d/c after (-) sepsis w/u.  Several hours after d/c pt had another witnessed sizure which included clenching of arms and wrists, eyes rolled back, and pt became unconscious x 2 minutes. Pt had 3 day hx of diarrhea prior to vaccines.   Admitted with Impression: seizure and dehydration after 2nd episode.
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC, DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Crying, Lethargy, Pyrexia
Clinical narrative: High fever, lethargy, uncontrolled crying for short periods of time. See attached hospital records.  5/9/08 Reviewed hospital medical records of 2/28-3/3/2008. FINAL DX: atypical Kawasaki's disease w/o evidence of cardiac lesions Records reveal patient expereinced febrile illness x 7 days w/URI s/s, pale, rash, conjunctivitis, acute OM, emesis, fall, irritability, poor appetite, red lips, swelling of hands/feet w/peeling skin on feet.  Cardiology consult done.  Tx w/IVIG & ASA.  Improved & d/c to home on continued ASA w/cardio f/u & serial echocardiograms.   3/11/08 Reviewed ER medical records of 2/21/08. FINAL DX: possible viral syndrome; r/o Kawasaki disease; & prolonged fever.  Records reveal patient w/fever day s/p vaccines w/fall that day hitting back of head & becoming sleepy.  Returned to ER on 2/22/08 for continued fever, cough, post tussive emesis & irritability.  Temp in ER was 103.1  Sick sibling in home.  TX w/IV antibiotics & antipyretics.  Dx at that time Fever & URI on continued oral antibiotics. No improvement & admitted  2/23-2/28/2008.  Hospital medical records reveal patient experienced cold s/s of low grade fever, cough, runny nose, respiratory congestion, wheezing, intercostal retractions x 2 days.  Seen by PCP & sent to ER.  Temp in ER was 104.  Tx w/breathing treatments & IV antibiotics.  Developed diffuse urticarial rash & inflammed conjunctiva.  Continued to run fever as high as 106.  Transferred to higher level of care. Linked w/307191 Follow-up: Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC, DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Blood culture negative, Bronchiolitis, CSF culture negative, Chest X-ray abnormal, Crying
Clinical narrative: High fever, lethargy, uncontrolled crying for short periods of time. See attached hospital records.  5/9/08 Reviewed hospital medical records of 2/28-3/3/2008. FINAL DX: atypical Kawasaki's disease w/o evidence of cardiac lesions Records reveal patient expereinced febrile illness x 7 days w/URI s/s, pale, rash, conjunctivitis, acute OM, emesis, fall, irritability, poor appetite, red lips, swelling of hands/feet w/peeling skin on feet.  Cardiology consult done.  Tx w/IVIG & ASA.  Improved & d/c to home on continued ASA w/cardio f/u & serial echocardiograms.   3/11/08 Reviewed ER medical records of 2/21/08. FINAL DX: possible viral syndrome; r/o Kawasaki disease; & prolonged fever.  Records reveal patient w/fever day s/p vaccines w/fall that day hitting back of head & becoming sleepy.  Returned to ER on 2/22/08 for continued fever, cough, post tussive emesis & irritability.  Temp in ER was 103.1  Sick sibling in home.  TX w/IV antibiotics & antipyretics.  Dx at that time Fever & URI on continued oral antibiotics. No improvement & admitted  2/23-2/28/2008.  Hospital medical records reveal patient experienced cold s/s of low grade fever, cough, runny nose, respiratory congestion, wheezing, intercostal retractions x 2 days.  Seen by PCP & sent to ER.  Temp in ER was 104.  Tx w/breathing treatments & IV antibiotics.  Developed diffuse urticarial rash & inflammed conjunctiva.  Continued to run fever as high as 106.  Transferred to higher level of care. Linked w/307191 Follow-up: Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.