chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: RUB
Symptoms: Antinuclear antibody positive, Arthralgia, Erythema, Joint stiffness, Joint swelling
Clinical narrative: Pt had negative rubella titer 10 - 14 days post vax. Pt experienced achiness in lower body for 24 - 48 hours followed by pain, swelling and redness of joints in fingers and wrists. Pt treated with Feldene for 10 days and improved within 48 hours. Only slight stiffness remains in right index finger.
Age: 41.0
Sex: F
Vaccine: RUB
Symptoms: Pain
Clinical narrative: Pt had negative rubella titer 10 - 14 days post vax. Pt experienced achiness in lower body for 24 - 48 hours followed by pain, swelling and redness of joints in fingers and wrists. Pt treated with Feldene for 10 days and improved within 48 hours. Only slight stiffness remains in right index finger.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Platelet disorder
Clinical narrative: Platelet count 3000. Pt treated with prednisone.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Pt experienced severe itching and a slight red rash.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This 61-year-old pt was inadvertently administered a subcutaneous injection, instead of intra-muscular, of Flu-Shield on 10/01/1999. On 06/22/2000, the pt was hospitalized and neurologist made a dx of Guillain-Barre syndrome. While this is a labeled side effect, the reporter is not sure that the neurologist's dx is correct. Pt was treated with IV immunglobulin. Eight days later the pt had recovered and was discharged.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Pallor, Urticaria
Clinical narrative: Within 10 minutes post vax pt developed an allergic reaction characterized by hives and paleness. Pt treated with Benadryl.
Age: 5.0
Sex: F
Vaccine: DT, IPV, MMR
Symptoms: Pain, Pyrexia
Clinical narrative: Pt was given Tylenol for pain in left arm. Then every four hours during the day. Pt had temperature of 104, temperature range 100 - 101 through the night.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Pruritus, Pyrexia, Vasodilation procedure
Clinical narrative: Pt experienced a fever of 101F, induration, warmth, pruritus 6 " diameter.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Pt experienced localized erythema and edema approximately 2/3 of upper arm and fever. Rash described as pruritic. Temperature at time of recheck was 98.1
Age: 0.08
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Pt developed a fever and a tiny vesicular rash.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Pt experienced acute redness of face, itchy rash on arms and legs and one episode of vomiting. On exam, positive urticarial rash on arms and legs mildly on thorax.
Age: 7.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: This child received vax in the morning of 02/04/00, at noon he developed a fever of 103 F.  At 23:30 he had an episode of limb shaking (less than 5 minutes). On 02/05, he presented to the ER at 01:40 with fever, vomiting, and "shaking spells."  He was discharged home on acetaminophen or ibuprofen for fever.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Agitation, Insomnia, Pyrexia, Rash
Clinical narrative: Temperature of 103 within hours post vax, lasting 24 hours on and off. Numerous breakouts/rash over entire body, crying, sleeplessness. Rash lasting well over a week.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Screaming
Clinical narrative: Same day post vax, pt developed inconsolable, high-pitched crying lasting for 3 days.
Age: 21.0
Sex: F
Vaccine: HEP, YF
Symptoms: Laboratory test abnormal, Vomiting, Weight decreased
Clinical narrative: 07/19/2000 pt sought medical treatment. Complained of vomiting, weight loss since yellow fever vax. Was prescribed Reglan. 07/20 pt states Reglan not helping. Prescribed Compazine. At the time of this report she was still under treatment.
Age: 25.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Chills, Cough, Diarrhoea, Eye inflammation, Eye swelling
Clinical narrative: Pt complained of puffiness and redness underneath both eyes a day post vax. She also complained of chills, minimal cough and watery stool on the night of teh day of vax. Given cold compress, Tylenol PRN, and Benadryl.
Age: 27.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: In May 1999, the patient received her first injection with Lymerix with no untoward effects. In September 1999, she received the second dose.  The patient reported she became pregnant in February 2000. Her last menstrual period was January 30, 2000, and the estimated date of delivery is November 07, 2000.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Malaise
Clinical narrative: Not feeling well. The patient had his prescription for Lymerix filled on 05/06/200 which was kept unrefrigerated for approximately one week.  In March 2000, the patient received the first injection of Lymerix for prophylaxis. Sometime thereafter, he experienced not feeling well. No treatment was given. The information received on 4/11/2000 reported the patient received the second Lymerix dose. No further information was provided.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Muscular weakness
Clinical narrative: Generalized muscle weakness (back, shoulder, less). On 07/21/1999, the patient received his first injection of Lymerix, with no untoward effects.  On 07/23/1999, he received the second dose, and in the fall-winter of 1999 he experienced generalized muscle weakness of his back, muscle exercises to strengthen his muscles. The information received on 03/30/2000 reported the symptoms were ongoing.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Two hours post vax the patient experienced chills, fever, myalgia and sore arm at injection site.  The symptoms were treated with ibuprofen 600 mg. The information received on 30-March-2000 reported the symptoms resolved except for the sore arm.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Listless
Clinical narrative: At an unspecified time, the patient received her third injection of Lymerix. Sometime thereafter, probably in early 2000, she experienced feeling listless and run down. The information received on 04/04/2000 provides no further information.
Sex: F
Vaccine: LYME
Symptoms: Dizziness, Headache
Clinical narrative: On 03/20/2000, the patient received her first injection with Lymerix 30 mg for prophylaxis. Two days later, on 03/22/2000, she experienced a headache and dizziness. The information received on 04/05/2000 reported the symptoms resolved.
Sex: F
Vaccine: LYME
Symptoms: Oligomenorrhoea
Clinical narrative: At and unspecified time, the patient received her second injection site with Lymerix. Sometime thereafter, she experienced a delayed menstrual period.  The information received on 4/5/00 provides no further information.
Sex: F
Vaccine: LYME
Symptoms: Difficulty in walking, Feeling cold, Tremor
Clinical narrative: The patient received her third injection of Lymerix and 3.5 hours later experienced feeling cold, shaking, and could not walk. The information received on 04/14/2000 reports the symptoms resolved after 1.5 hours.
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis
Clinical narrative: The patient had Lyme Disease that went undetected 8-12 months ago. She stated she had excellent treatment and did fine. June 1999, she received her first vax. Sometime post vax she experienced arthritic symptoms that were bothersome. In July 1999 while the arthritic symptoms were ongoing, she received the second dose, she said she really had Lyme  arthritic  problems, the same as when she had Lyme Disease. Laboratory studies were not performed, and the third shot was not given.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Injection site swelling
Clinical narrative: At unspecified time, the patient received her first two injections with Lymerix for prophylaxis, with no untoward effects.  On 04/01/00, she received the third dose  and the next day experienced a bull's eye red mark the size of a softball and arm swelling on her injected arm. Approximately two days after the injection, she experienced joint pain in her knees and ankles so bad she could not walk. Three days afterward, she had back pain. No treatment given, the information received on 04/06/00 reported the arm swelling went down and the joint pain continued but was improved.
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Back pain
Clinical narrative: At unspecified times, the patient received the first two injections of Lymerix for prophylaxis, with no untoward effects. On 04/01/2000 he received the third dose, and two days later, 04/03/2000 experienced back pain. No treatment was given. The information received on 04/08/2000 does not provide an outcome.
Age: 31.0
Sex: M
Vaccine: LYME
Symptoms: Joint swelling
Clinical narrative: On 02-Feb-2000, the patient received his first injection with Lymerix 30 mg for prophylaxis. Sometime thereafter, he experienced a swollen knee which he was unable to bend or use for one week. The second dose of Lymerix was not given. The information on 07-Apr-2000 reported the symptoms resolved.
Age: 63.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Infection, Joint swelling, Monarthritis, Red blood cell sedimentation rate increased
Clinical narrative: The patient received the first two doses of injection, with no apparent untoward effects. On 04/05/2000, he received the third dose and approximately one week later tested positive for rheumatoid factor and had an elevated erythrocyte sedimentation rate and and elevated Lyme titer blot for Lyme antibody. Upon physical exam, the patient had a diffusely swollen tender wrist with decreased range of motion in all planes. The exam was not consistent with isolated ligament tear or cartilage injury, but appeared to be an acute monarticular inflammatory arthropathy. Treatment included Medrol intrarticular injection of cortisone. The information received on 05/06/2000 reported after the cortisone injection the symptoms almost completely resolved.
Age: 63.0
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid factor
Clinical narrative: The patient received the first two doses of injection, with no apparent untoward effects. On 04/05/2000, he received the third dose and approximately one week later tested positive for rheumatoid factor and had an elevated erythrocyte sedimentation rate and and elevated Lyme titer blot for Lyme antibody. Upon physical exam, the patient had a diffusely swollen tender wrist with decreased range of motion in all planes. The exam was not consistent with isolated ligament tear or cartilage injury, but appeared to be an acute monarticular inflammatory arthropathy. Treatment included Medrol intrarticular injection of cortisone. The information received on 05/06/2000 reported after the cortisone injection the symptoms almost completely resolved.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site swelling, Vasodilation procedure
Clinical narrative: On 9/17/1999 and 10/25/1999, the patient received her first two injections with Lymerix for prophylaxis, with no untoward effects. On 03/29/2000, she received the third dose and approximately one day later, 03/30/2000, experienced redness, heat, swelling, pain, and a raised area 10cm x 10cm at the injection site.
Age: 18.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: Post first vax pt had no untoward effects. Post second vax he experienced a fever, chills, and joint aches. By 04/14/00 the aches and fever had improved, on 04/15/00, he experienced a rash allover his body that was described as raised.  The pt was treated with ibuprofen, and Lymerix was discontinued.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Post first vax no untoward effects. Post second dose, one week later, experienced bilateral knee pain. Treatment included ibuprofen, and Lymerix was discontinued.
Age: 41.0
Sex: M
Vaccine: LYME
Symptoms: Difficulty in walking, Hypoaesthesia, Joint swelling
Clinical narrative: Post first vax no untoward effects. Post second dose flu-like illness, which lasted a few days and resolved. Post third dose left sided numbness, swelling of hands, wrist, and shoulder, flu-like illness, and could not walk. Treatment included an over the counter non-steroidal. Information received on 4/13/00 reported the patient is now walking and was 80% better. Gets better each day.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Oedema peripheral, Pain
Clinical narrative: Post first vax, one week later, he experienced feeling achy all over his body and swelling of his right index and right ring finger and swelling left index and middle finger. The pt was treated with aspirin.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Depression, Fatigue
Clinical narrative: 05/13/1999, shortly post onset of symptoms, this 45-year-old female received second dose received Indocin ER 75 mg 1-2 qd for pain. Her heels have been as painful as her right arm and wrist. She has felt quite tired and is sleeping very poorly. She has been depressed but not suicidal.  06/27/1999 urgent care visit pt with left arm pain for several days. There was no history of trauma. She is right-handed. Pain is worst at elbow but radiated to wrist and shoulder. The area was very tender and slightly swollen. She denied that deep tan/burn is recent. The patient's only medication was Meridia. Impression: left lateral epicondylitis with probable extensor tendonitis at wrist also. Prescribed: sling, elevation and Indocin 25mg, two capsules PO tid for two days then one capsule tid. Diagnosis: tendonitis/capsulitis/periarthritis left elbow. 05/09/2000 Diagnosis: chronic lateral humeral epicondylitis. The patient had debridement of her left lateral humerus epicondyle performed three days ago. At the time of her surgery, her conjoint tendon was reflected and holes were drilled lateral humerus epicondyle. She did well post-operatively but had some problems with post-operative pain. The surgery helped relieve her pre-operative pain.  April 21, 2000 office visit: Assessment: the patient had sleep deprivation, wide spread aches and pains, and an element of depression. There was no evidence of synovitis on examination. To the physician, her symptoms were strongly suggestive of fibromyalgia. The patient was prescibed trazodone.  Lymerix was discontinued.  The most recent information received 06/12 reports the condition of the vaccinee as ongoing.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Inflammation, Muscle disorder, Oedema peripheral, Pain, Sleep disorder
Clinical narrative: 05/13/1999, shortly post onset of symptoms, this 45-year-old female received second dose received Indocin ER 75 mg 1-2 qd for pain. Her heels have been as painful as her right arm and wrist. She has felt quite tired and is sleeping very poorly. She has been depressed but not suicidal.  06/27/1999 urgent care visit pt with left arm pain for several days. There was no history of trauma. She is right-handed. Pain is worst at elbow but radiated to wrist and shoulder. The area was very tender and slightly swollen. She denied that deep tan/burn is recent. The patient's only medication was Meridia. Impression: left lateral epicondylitis with probable extensor tendonitis at wrist also. Prescribed: sling, elevation and Indocin 25mg, two capsules PO tid for two days then one capsule tid. Diagnosis: tendonitis/capsulitis/periarthritis left elbow. 05/09/2000 Diagnosis: chronic lateral humeral epicondylitis. The patient had debridement of her left lateral humerus epicondyle performed three days ago. At the time of her surgery, her conjoint tendon was reflected and holes were drilled lateral humerus epicondyle. She did well post-operatively but had some problems with post-operative pain. The surgery helped relieve her pre-operative pain.  April 21, 2000 office visit: Assessment: the patient had sleep deprivation, wide spread aches and pains, and an element of depression. There was no evidence of synovitis on examination. To the physician, her symptoms were strongly suggestive of fibromyalgia. The patient was prescibed trazodone.  Lymerix was discontinued.  The most recent information received 06/12 reports the condition of the vaccinee as ongoing.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Tendonitis, Vitamin D deficiency
Clinical narrative: 05/13/1999, shortly post onset of symptoms, this 45-year-old female received second dose received Indocin ER 75 mg 1-2 qd for pain. Her heels have been as painful as her right arm and wrist. She has felt quite tired and is sleeping very poorly. She has been depressed but not suicidal.  06/27/1999 urgent care visit pt with left arm pain for several days. There was no history of trauma. She is right-handed. Pain is worst at elbow but radiated to wrist and shoulder. The area was very tender and slightly swollen. She denied that deep tan/burn is recent. The patient's only medication was Meridia. Impression: left lateral epicondylitis with probable extensor tendonitis at wrist also. Prescribed: sling, elevation and Indocin 25mg, two capsules PO tid for two days then one capsule tid. Diagnosis: tendonitis/capsulitis/periarthritis left elbow. 05/09/2000 Diagnosis: chronic lateral humeral epicondylitis. The patient had debridement of her left lateral humerus epicondyle performed three days ago. At the time of her surgery, her conjoint tendon was reflected and holes were drilled lateral humerus epicondyle. She did well post-operatively but had some problems with post-operative pain. The surgery helped relieve her pre-operative pain.  April 21, 2000 office visit: Assessment: the patient had sleep deprivation, wide spread aches and pains, and an element of depression. There was no evidence of synovitis on examination. To the physician, her symptoms were strongly suggestive of fibromyalgia. The patient was prescibed trazodone.  Lymerix was discontinued.  The most recent information received 06/12 reports the condition of the vaccinee as ongoing.
Age: 66.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Headache, Influenza like illness, Pyrexia
Clinical narrative: A few hours later post first vax, on 04/18, this female pt experienced fever, chills, joint pain, headache, flu-like symptoms.
Age: 38.0
Sex: M
Vaccine: LYME
Symptoms: Antinuclear antibody positive, Arthritis, Condition aggravated, Feeling hot, Laboratory test abnormal
Clinical narrative: Post second dose this pts previous symptoms that were experienced with first vax worsended, ie., arthritis symptoms (swelling and warmth) in his fingers and wrists. He was treated with Medrol Dosepak and Vioxx. The most recent information received 04/26/00 reports the condition of the vaccinee is unknown.
Age: 38.0
Sex: M
Vaccine: LYME
Symptoms: Swelling
Clinical narrative: Post second dose this pts previous symptoms that were experienced with first vax worsended, ie., arthritis symptoms (swelling and warmth) in his fingers and wrists. He was treated with Medrol Dosepak and Vioxx. The most recent information received 04/26/00 reports the condition of the vaccinee is unknown.
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Ear discomfort, Inflammation
Clinical narrative: Post second dose this pt's right ear became plugged and remained plugged for six weeks. His family physician said it was a cold. A specialist said that his ear was inflamed and prescribed antibiotics(nos) and decongestant(nos) which did not help. Since then, his ear became plugged from time to time and was relieved by blowing air through his nose. The most recent information received 04/26 reports the condition as ongoing.
Age: 76.0
Sex: M
Vaccine: LYME
Symptoms: Arrhythmia, Hypokinesia, Injection site pain, Pain, Sensation of heaviness
Clinical narrative: One week post third vax, this pt had trouble getting up (ached), experienced the sensation of heavy limbs, could not shave (NOS), felt pain at the injection site radiating to his fingertips, and had irregular heartbeat. He was unable to do his normal activities, but was able to drive some days and his symptoms were better on some days than others. Treated with Vioxx, which was ineffective.  The most recent information received on 04/28/2000 reports that the condition of the pt is slightly improved.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Myalgia, Platelet count decreased, White blood cell count decreased
Clinical narrative: On 04/01/1999 and 05/01/1999, the patient received her first two injections with no untoward effects. On 04/01/2000, she received the third dose and sometime afterward experienced arthralgias and myalgias.
Sex: M
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: Post third vax, vaccinee experienced itching and pain at injection site which progressed to generalized itching. The most recent information reports the conditionn of the pt as unknown.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Blood creatinine increased, Feeling hot, Hypokinesia, Joint stiffness
Clinical narrative: Post first vax, no untoward effects. Post second vax, received on 01/11/2000, he experienced arthritis symptoms, pain in his shoulder, neck, and elbow with tingling and stiffness. He also had decreased range of motion due to pain in his left shoulder. The patient had left shoulder mild warmth on physical exam on 4/20/00. Treatment included Vioxx. The information received on 04/26/00 reported the symptoms as ongoing.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Paraesthesia
Clinical narrative: Post first vax, no untoward effects. Post second vax, received on 01/11/2000, he experienced arthritis symptoms, pain in his shoulder, neck, and elbow with tingling and stiffness. He also had decreased range of motion due to pain in his left shoulder. The patient had left shoulder mild warmth on physical exam on 4/20/00. Treatment included Vioxx. The information received on 04/26/00 reported the symptoms as ongoing.
Age: 23.0
Sex: M
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Rash pruritic
Clinical narrative: Post first vax, 5-7 days later, reportedly, he developed a raised red, itchy rash at the injection site. He was treated with Benadryl and cortisone cream at the reaction site and it disappeared in 2-3 days. The most recent information reports the condition as resolved.
Age: 41.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Erectile dysfunction, Headache, Hernia, Pain
Clinical narrative: Post first vax, no untoward effects. Approximately 4 months post second vax in mid-August, pt experienced a headache, testicular pain, and joint pain. The symptoms were treated with Celebrex, tetracycline, Ceftin and IV Rocephin, the headache has improved since Celebrex, and the joint pain is ongoing but better. Information received on 05/05/00 reports the testicular pain resolved, the headache has improved, and the joint pain is ongoing but better. Follow-up states that the pt feels the testicular pain is realted to his long history of Lyme disease. He did report decreased erectile function with decreased nocturnal erections. The pt also reported headaches. The physician reported a small inguinal hernia.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Influenza like illness, Myalgia
Clinical narrative: Two days post first vax, he experienced flu-like symptoms, muscle pain and joint pain. No treatment given. The most recent information, received on 05/01/2000 reports that flu-like symptoms resolved and the joint and muscle pain are ongoing. The follow up describes the occurrence of joint pain in a 55 year old male who received the first injection of LYMErix for prophylaxis. Follow up has been received from the responsible physician; however, he was not able to verify the adverse events reported. The pt has no known drug allergies. Concurrent clinical condtiions includes elevated cholesterol and stomach problems NOS. Concurrent medications include Pravachol and Prilosec. On 4/6/00, the pt received his first dose of LYMErix. According to the pt, two days later he experienced flu-like symptoms, muscle pain and joint pain. No treatment was given. Per the pt on 5/1/00, the flu-like symptoms resolved and the joint and muscle pain were ongoing. According to the physician's office, there was "no notation that the pt complained of anything at all, including any vaccine related problems" on 5/8/00. The pt received the second injection of LYMErix on 5/8/00 and has subsequently not reported any events to the physician. The event of 'joint pain' does not meet serious criteria, but is being submitted expeditiously for informational purposes.
Age: 15.0
Sex: M
Vaccine: LYME
Symptoms: Cough, Pharyngitis, Rhinorrhoea
Clinical narrative: Post second vax, four days later, he again experienced cold symptoms with a runny nose and a cough. Treatment included Triaminic.  The information received on 05/16 reported the pt still has some cold symptoms.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: "Shortly after" the first vax, he has experienced fatique, headache, myalgias and arthralgias. Reportedly there was no tenderness, swelling, effusions or tenosynovitis. There was no neurological problems or Lyme arthritis. No treatment was given. Lymerix was discontinued. Most recent information reports the condition as ongoing. On 3/20/00, the pt received his first Im injection of LYMErix. He also developed right shoulder pain. Initially, the pt had no neurological problems; however, on follow up, the physician indicated that the pt was experiencing neuropsychiatric symptoms consisting of difficulty with memory, thinking, concentration, and calculation. Relevant lab tests included a sed rate of 33mm/h, rheumatoid factor <20, negative antinuclear antibody, and a negative HLA-H27 antigen. Joint fluid was not obtained. Reportedly, the pt is going to bee seen by an orthpopedic physician. The events of headache, shoulder pain, arthralgias, and neuropsychiatric symptos do not meet serious criteria but are being submitted expeditiously for informational purposes.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Pain, Shoulder pain
Clinical narrative: Post third vax, he experienced knee pain, and pain in arm and shoulder.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Injury
Clinical narrative: On 06/1/1999 and 07/06/1999, the vaccinee received his first and second injections. On 07/20/1999 the pt stated that he began to experience chronic arrhralgia and arthritis. He was treated with Naproxen, Vioxx, and ibuprofen. Physician stated that on two unspecified dates subsequent to 05/04/1999 no knee effusion or swelling was ever detected.  In December, 1999, MRI of the right knee reportedly revealed a posterior tear of the lateral meniscus, calcification of the lateral meniscus, and chondromalacia of the patella, but no finding that he would consider to be consistent with a vaccine-associated arthritis. The vaccinee received his third dose of Lymerix during the summer of 2000. Vaccinee reported that the pain in his knees persists but was not aggravated by the third dose. The most recent info, received on 8/10/00, reports the outcome of the event as ongoing. The adverse event of "chronic arthralgia" does  not meet serious criteria but is being submitted expeditiously for informational purposes. The pt has no history of Lyme disease, gout, psoriasis or Crohn's disease. He has no family history of rheumatoid arthritis or lupus. The following labs were provided by rheumatologist: erythrocyte sed rate was 2mm/hr, rheumatoid factor was negative, and antinuclear antibody was negative. A c-reactive protein was not done. The most recent info, received on 9/1/00, reports the outcome of the event as unknown.
Age: 58.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Post first vax, two hours later, pt experienced flu like symptoms with chills, weakness, dizziness, and tiredness. She also had severe injection site upper arm pain. Psot second dose same day her entire arm was hurting and muscle hurting. She was treated with Advil.
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness
Clinical narrative: One month post second vax, on 07/08/1999, pt began to experience severe flu symptoms. In September, she reportedly experienced similar flu symptoms. She was advised by unspecified individual to forego third dose. The most recent information received 05/15/2000 reports the condition of the vaccinee as unk.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Hypertonia, Hypotonia, Injection site pain
Clinical narrative: Post first vax, no untoward effects. Post second vax, and sometime thereafter, he experienced acute pain at the injection site. He also experienced involuntary muscle twitching at the injection site in his upper left arm and shoulder. His neurologist characterized these as myoclonic nature although he had not been witness to or been able to elicit such contractions. The involuntary muscle twitching has lasted for almost one year and has awakened the patient at night. Pt declined any drug intervention.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Pain
Clinical narrative: Post first vax with no untoward effects. Post second dose sometime thereafter, experienced arthritic pain in his lower back, spine, hands, and shoulder. Treatment included Advil.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: Post first and second vax, no untoward effects. Post third vax, he experienced myalgias.
Sex: M
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Prior to first vax, pt had mild arthritis symptoms of joint pain and stiffness. On 4/23/1999 post third vax,  one morning in early May, 2000 pt awoke reportedly experiencing severe pain and stiffness in his legs and feet (nos). No treatment was given.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Pain
Clinical narrative: Post first and second vax, sometime thereafter she experienced arthritic like joint pain. Treatment included Celecoxib.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Feeling hot
Clinical narrative: Approximately one hour post vax, the pt experienced general muscle aches, headaches and exhaustion. These symptoms resolved after 4 days. On 5/8/00, the pt received her second dose of Lymerix and approximately 45 minutes later felt severe pain in both knees, neck and "finger bones". Her hands became numb and she experienced lightheadedness, "wooziness", a little nausea and could barely drive her car home. That night she needed assistance to get into bed. She could not lift herself into bed. On 5/9/00 she felt tired and her knees, elbows, and neck still hurt but not like the previous day. On 5/16/00 she felt numbness from her waist up to her neck including her arms. He heart was racing and she "felt as if to pass out". She also felt feverish and sweaty. She saw her doctor and had blood work and an electrocardiogram. All tests were normal. Her physician felt she had a hypersensitivity reaction to Lymerix. No treatment was given. The information received on 5/17/00 reported she still had bilateral knee pain, lightheadedness, nausea and some diarrhea.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Hyperhidrosis, Hypoaesthesia, Loss of consciousness, Nausea, Neck pain
Clinical narrative: Approximately one hour post vax, the pt experienced general muscle aches, headaches and exhaustion. These symptoms resolved after 4 days. On 5/8/00, the pt received her second dose of Lymerix and approximately 45 minutes later felt severe pain in both knees, neck and "finger bones". Her hands became numb and she experienced lightheadedness, "wooziness", a little nausea and could barely drive her car home. That night she needed assistance to get into bed. She could not lift herself into bed. On 5/9/00 she felt tired and her knees, elbows, and neck still hurt but not like the previous day. On 5/16/00 she felt numbness from her waist up to her neck including her arms. He heart was racing and she "felt as if to pass out". She also felt feverish and sweaty. She saw her doctor and had blood work and an electrocardiogram. All tests were normal. Her physician felt she had a hypersensitivity reaction to Lymerix. No treatment was given. The information received on 5/17/00 reported she still had bilateral knee pain, lightheadedness, nausea and some diarrhea.
Sex: M
Vaccine: LYME
Symptoms: Joint stiffness
Clinical narrative: Post third vax, pt experienced his right knee feeling stiff and tight. No treatment was given. The follow up received on 8/4/00 states that the pt has a medical history that includes two cases of Lyme disaese. The first episode occurred a few years ago, maked by erythema chronicum migrane. The last episode occurred in early 1999 manifested by a bull's eye rash, followed by Bell's palsy. The bell's palsy was treated with antibiotics and resolved in 3 weeks. In July 2000 he developed a red swollen itchysite that was thought to be a bug bite. In May 1999 and later in May 1999, the pt received his first two injections with Lymerix for prophylaxis. Approximately 2 months after the first injection, in June 1999 he received the third dose of Lymeris. Approximately 9 monthsafter the third dose of Lymerix, the pt experienced his right knee feeling stiff and tight. No treatment was given. In approximately mid July 2000, the pt received a booster injection of Lymerix (4th) dose and within two weeks he experienced a bull's eye rash from his naval across his back. He saw a physician at an "urgent care center" and was treated with Doxycycline 100mg 2x day fofr 30 days. A Western blot for Lyme antibody was performed and was negative. The info received on 7/7/00 reported the stiffness resolved after a few weeks. The pt has had "no further problems." The most recent info received on 8/4/00 reported the rash resolved. The events of tightness and stiffness in right knee do not meet serious criteria but are being submitted expeditiously for informational purposes.
Sex: M
Vaccine: LYME
Symptoms: Sensation of heaviness
Clinical narrative: Post first vax, sometime thereafter pt experienced a dull heaviness in the affected arm. This resolved after one week. Post second vax, he experienced the same symptoms.
Age: 25.0
Sex: F
Vaccine: LYME
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Post first vax, twenty minutes later, she experienced pain at the base of her head which worsened and went to the top of her head. She developed a severe headache and also chills. She vomited after taking an Advil as treatment. The information received on May 5, 2000 reported by 7:00 pm on date of vax she had a slight headache without a fever, and chills and vomiting had resolved.
Sex: F
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: Post first vax, seven days later she experienced a chronic muscle ache at the injection site. There was no treatment.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Palpitations
Clinical narrative: Post first vax, one hour later she experienced diffuse joint pain and palpitations.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Post first vax no untoward effects. Post second vax early May experienced right knee joint pain. 05/22/2000 he experienced left knee joint pain. No treatment was given.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Infection, Laboratory test abnormal, Pain
Clinical narrative: Post first and second vax, litigation alleges the pt experienced arthritic-like symptoms in various joints of his body. The newspaper article quotes the pt as developing the same form of arthritis that afflicts his wife after getting vax. Pt has test HLA-DR4 positive and is positive for Lyme disease. He is being treated by MD for these events. The litigation states that the pt has suffered great pain, discomfort and emotional distress as well as the events have severely limited his employment options and opportunities. The litigation alleges that pt Lyme disease and arthritic symptoms associated with his HLA-DR4 positive status were triggered by his vax with Lymerix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Subseqeuntly post vax, the vaccinee experienced tenderness at the injection site.
Age: 72.0
Sex: M
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Pruritus, Rash
Clinical narrative: Three weeks post 3rd dose of vax, the pt experienced an itching red rash which started on the insides of his thighs and progressed to his chest and arms. A doctor visit was required. He was treated with hydroxyzine. The vaccinee is allergic to silicone, poison ivy, doxycycline, pollen and sumac. He has a history of arthritis (bilateral knee and cervical spine)for "many years." In 1997 he had a tick bite and developed a bull's eye rash. He was treated with antibiotics and events resolved without sequelae. The vaccinee was not sure whether he was tested for Lyme disease. Concomitant medications included Claritin and Allegra. The vaccinee felt that he experienced as allergic reaction to the silicon based additive to Lymeri. The vaccinee received his first and second IM doses of Lymerix for prevention of Lyme disease on 3/10/99 and 4/12/00, respectively. After the first and second dose of Lymerix, he experienced having more stiffness in his knees and neck. Symptoms resolved without treatment. The vaccinee received his third IM left deltoid dose of Lymerix on 3/13/00. Three weeks later, on 4/1/00 he experienced an itching red rash which started on the insides of his thighs and progressed to his chest and arms. A doctor visit was required. He was treated with hydroxyzine 25mg qid prn. The dermatologist stated that the rash and aching had nothing at all to do with the Lymerix and that the vaccinee had something more consistent with eczema. He did not feel that the rash was either allergic, immunologic or exanthematous in nature. The most recent info, received on 8/31/00, reports the condition of the vaccinee is unknown. The event of "stiffness" does not meet serious criteria but is being submitted expeditiously per FDA request.
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Cough, Dyspnoea, Fatigue, Head discomfort, Hypoaesthesia
Clinical narrative: Two days post vax, the pt's head felt sloshy, like cotton, she had sore throat, chest congestion, a cough, and difficulty breathing. She could not seem to take in a deep breath. The difficulty breathing felt worse with activity. Additionally, she had a little bit of numbness in the ball of her left foot, and extreme fatigue. She described her legs as feeling like lead. No treatment given.
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Pharyngolaryngeal pain, Sensation of heaviness
Clinical narrative: Two days post vax, the pt's head felt sloshy, like cotton, she had sore throat, chest congestion, a cough, and difficulty breathing. She could not seem to take in a deep breath. The difficulty breathing felt worse with activity. Additionally, she had a little bit of numbness in the ball of her left foot, and extreme fatigue. She described her legs as feeling like lead. No treatment given.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: 24 hours post vax, the pt experienced a 6 " diameter area of redness and hardness at the injection site. The consumer stated that the injection site was as hard as a rock. No treatment was given.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Injection site atrophy, Injection site pain, Injection site swelling, Myalgia, Paraesthesia
Clinical narrative: Two hours post vax, the pt experienced intense injection site pain that radiated down her arm to her hand, and the pt returned to the physician's office. The pain worsened and the fingers of her left hand began to tingle. Her left hand became numb. After 12 hours, she experienced a deep aching muscle pain that extended from her shoulder to her wrist. Treatment included codeine. After 2 days the numbness and tingling resolved and the pain was slowly getting better, if she avoided sleeping on her arm. On 5/16/00, the pt was seen for follow-up and it was noted she had atrophy of the left deltoid and heat and a circular swell like smallpox vaccine leaves after injection.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Vasodilation procedure
Clinical narrative: Two hours post vax, the pt experienced intense injection site pain that radiated down her arm to her hand, and the pt returned to the physician's office. The pain worsened and the fingers of her left hand began to tingle. Her left hand became numb. After 12 hours, she experienced a deep aching muscle pain that extended from her shoulder to her wrist. Treatment included codeine. After 2 days the numbness and tingling resolved and the pain was slowly getting better, if she avoided sleeping on her arm. On 5/16/00, the pt was seen for follow-up and it was noted she had atrophy of the left deltoid and heat and a circular swell like smallpox vaccine leaves after injection.
Age: 60.0
Sex: F
Vaccine: LYME
Symptoms: Blister, Injection site hypersensitivity, Injection site mass, Injection site pain, Injury
Clinical narrative: Subsequently post vax, the vaccinee experienced a very sore arm that became red and which formed a hard area. The vaccinee reported receiving a deer tick bite around 4/28/00 on her right flank. She was treated with doxycycline and the event resolved. She reported another deer tick bite on 5/11/00 between her great toe and second toe. On 5/13/00, she developed a red blister with white center, about 1/4 " in diameter that swelled and itched severely. She continued to take Benadryl to manage the itch.
Age: 60.0
Sex: F
Vaccine: LYME
Symptoms: Pruritus, Swelling
Clinical narrative: Subsequently post vax, the vaccinee experienced a very sore arm that became red and which formed a hard area. The vaccinee reported receiving a deer tick bite around 4/28/00 on her right flank. She was treated with doxycycline and the event resolved. She reported another deer tick bite on 5/11/00 between her great toe and second toe. On 5/13/00, she developed a red blister with white center, about 1/4 " in diameter that swelled and itched severely. She continued to take Benadryl to manage the itch.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: 5-10 minutes post vax, the pt experienced tingling sensation in two fingers on his injection arm. Additionally, two hours post vax, he experienced more severe pain at the injection site. He was seen by a physician on 5/13/00. No treatment was given.
Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Hypokinesia, Joint stiffness, Myalgia, Pain
Clinical narrative: On 6/1/99 and 7/9/99, the pt had his 1st and 2nd .5 cc dose of Lymerix. About 4 months later, in November 1999, he developed sore muscles and stiff joints which became progressively worse. He went to a physician who used "ultrasound" to dx "inflammation". The pt was treated with an unknown NSAID. By April, 2000, he could "hardly get out of bed". On 4/3/00, he was seen be a physician who did tests. He was dx'd with polymyalgia rheumatica. He was found to have a very stiff hip and shoulder. On 4/5/00, he started on prednisone and after the 1st dose, his symptoms resolved. The physician did not think that the dx was related to Lymerix. The most recent information, received on 6/16/00, reports the condition of the vaccinee as completely resolved.
Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: On 6/1/99 and 7/9/99, the pt had his 1st and 2nd .5 cc dose of Lymerix. About 4 months later, in November 1999, he developed sore muscles and stiff joints which became progressively worse. He went to a physician who used "ultrasound" to dx "inflammation". The pt was treated with an unknown NSAID. By April, 2000, he could "hardly get out of bed". On 4/3/00, he was seen be a physician who did tests. He was dx'd with polymyalgia rheumatica. He was found to have a very stiff hip and shoulder. On 4/5/00, he started on prednisone and after the 1st dose, his symptoms resolved. The physician did not think that the dx was related to Lymerix. The most recent information, received on 6/16/00, reports the condition of the vaccinee as completely resolved.
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Feeling abnormal, Feeling hot, Pain, Pyrexia
Clinical narrative: In April 1999, IM/RA, May 1999, IM/RA, and on 5/15/00 IM/LA, the pt received his 1st, 2nd and 3rd doses of Lymerix. The pt experienced a "funny sensation" throughout his body while walking to his car. He reported that his "whole skeleton hurt". He reported that it took 2 hands to unlock the car and start the engine due to his entire body shaking. He drove for 10 minutes and when he arrived home, his body was still shaking and his "hair felt hot". His wife called the ER and they told her to bring him there immediately. When they arrived, he had a fever of 105F. His fever went down to 101 and he was sent home. He received no treatment in the ER. At 23:00, he felt weak and his "hair was hurting". He went to bed and when he awoke on 5/16/00, all his symptoms were gone. The most recent information, received on 5/16/00, reports that the condition of the pt is resolved.
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Tremor
Clinical narrative: In April 1999, IM/RA, May 1999, IM/RA, and on 5/15/00 IM/LA, the pt received his 1st, 2nd and 3rd doses of Lymerix. The pt experienced a "funny sensation" throughout his body while walking to his car. He reported that his "whole skeleton hurt". He reported that it took 2 hands to unlock the car and start the engine due to his entire body shaking. He drove for 10 minutes and when he arrived home, his body was still shaking and his "hair felt hot". His wife called the ER and they told her to bring him there immediately. When they arrived, he had a fever of 105F. His fever went down to 101 and he was sent home. He received no treatment in the ER. At 23:00, he felt weak and his "hair was hurting". He went to bed and when he awoke on 5/16/00, all his symptoms were gone. The most recent information, received on 5/16/00, reports that the condition of the pt is resolved.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Oedema peripheral
Clinical narrative: In 1999, the vaccinee received his 1st dose of Lymerix. The day of the vaccination, he had injection arm soreness which lasted a few days and then resolved. In about May, 1999, the vaccinee received his 2nd dose of Lymerix and he had bilateral knuckle swelling which resolved after 1 month. On 5/11/00, the pt received his 3rd dose of Lymerix and he had redness at the injection site, about 6" in diameter and the injection site was hot to touch. These symptoms resolved on 5/16/00. The pt's symptoms were treated with ice packs to the site. The most recent information, received on 5/16/00 reports the condition of the vaccinee as resolved. THe pt was not sure if he had a fever as he did not take his temperature. The vaccinee's symptoms were treated with ice packs to the site. The most recent info, received on 8/20/00 reports that the events resolved. Please note that the event of "knuckle swelling" does not meet serious criteria, but is being sumbitted expeditiously for informational purposes.
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Malaise, Palpitations
Clinical narrative: Post vax, the pt experienced a sick feeling, flu-like symptoms, and had heart palpitations.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Pain, Pyrexia, Rash maculo-papular
Clinical narrative: One day post vax, the pt experienced a low grade fever, headache, maculo-papular rash and generalized aches. No treatment was given. The information received on 5/17/00 reported the symptoms resolved.
Sex: M
Vaccine: LYME
Symptoms: Rash
Clinical narrative: Some time post vax, the pt developed a rash.
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Some time later post vax, the pt developed flu-like symptoms including fever and chills.
Sex: F
Vaccine: LYME
Symptoms: Drug ineffective
Clinical narrative: Post vax, it was determined that the pt was a nonresponder.
Sex: F
Vaccine: LYME
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: On 5/18/00, the pt experienced rigors, a frontal headache, muscle aches, and flu-like symptoms.