chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Blood creatine phosphokinase increased, Chest pain, Cough, Fatigue
Clinical narrative: This report described the occurrence of flu-like symptoms in a 37 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received an injection of Lymerix on 4/13/01 and a second at a later time according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered flu-like symptoms, fatigue, vision problems, and memory loss. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Medical history included fatigue, insomnia, sore throat, dyspnea, asthmatic bronchitis, anxiety, depression, use of clenbutrol and ephedrine to build muscle, and cough. Between 1994 and 1995, the patient experienced chronic episodes of extreme fatigue and sluggishness. Medical records confirmed that the patient received Lymerix vaccine (lot number LY144B9) on 5/16/00. Approximately two and half months later, on 8/29/00, the patient complained of loss of muscle strength. At that time, the patient reported that he had been performing squats with 400 pounds and was running one mile three times weekly, but had to decrease his squat weight to 225 pounds which he performed with difficulty. On 2/13/01, the patient was examined for complaints including fatigue, nausea, and weight loss. Following the reported onset of flu-like symptoms, the patient experienced a left breast lump (suggestive of gynecomastia), gastritis, possible allergies characterized by cough, groin strain, elevated creatine kinase, and chest pain. The patient was evaluated to have a high cardiovascular risk, based upon cardio C-reactive protein values as well as an ongoing history of hypercholesterolemia and hypertriglyceridemia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide outcome to reported events.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Gastritis, Gynaecomastia, Hypersensitivity, Influenza like illness, Muscular weakness
Clinical narrative: This report described the occurrence of flu-like symptoms in a 37 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received an injection of Lymerix on 4/13/01 and a second at a later time according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered flu-like symptoms, fatigue, vision problems, and memory loss. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Medical history included fatigue, insomnia, sore throat, dyspnea, asthmatic bronchitis, anxiety, depression, use of clenbutrol and ephedrine to build muscle, and cough. Between 1994 and 1995, the patient experienced chronic episodes of extreme fatigue and sluggishness. Medical records confirmed that the patient received Lymerix vaccine (lot number LY144B9) on 5/16/00. Approximately two and half months later, on 8/29/00, the patient complained of loss of muscle strength. At that time, the patient reported that he had been performing squats with 400 pounds and was running one mile three times weekly, but had to decrease his squat weight to 225 pounds which he performed with difficulty. On 2/13/01, the patient was examined for complaints including fatigue, nausea, and weight loss. Following the reported onset of flu-like symptoms, the patient experienced a left breast lump (suggestive of gynecomastia), gastritis, possible allergies characterized by cough, groin strain, elevated creatine kinase, and chest pain. The patient was evaluated to have a high cardiovascular risk, based upon cardio C-reactive protein values as well as an ongoing history of hypercholesterolemia and hypertriglyceridemia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide outcome to reported events.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Nausea, Visual disturbance, Weight decreased
Clinical narrative: This report described the occurrence of flu-like symptoms in a 37 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received an injection of Lymerix on 4/13/01 and a second at a later time according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered flu-like symptoms, fatigue, vision problems, and memory loss. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Medical history included fatigue, insomnia, sore throat, dyspnea, asthmatic bronchitis, anxiety, depression, use of clenbutrol and ephedrine to build muscle, and cough. Between 1994 and 1995, the patient experienced chronic episodes of extreme fatigue and sluggishness. Medical records confirmed that the patient received Lymerix vaccine (lot number LY144B9) on 5/16/00. Approximately two and half months later, on 8/29/00, the patient complained of loss of muscle strength. At that time, the patient reported that he had been performing squats with 400 pounds and was running one mile three times weekly, but had to decrease his squat weight to 225 pounds which he performed with difficulty. On 2/13/01, the patient was examined for complaints including fatigue, nausea, and weight loss. Following the reported onset of flu-like symptoms, the patient experienced a left breast lump (suggestive of gynecomastia), gastritis, possible allergies characterized by cough, groin strain, elevated creatine kinase, and chest pain. The patient was evaluated to have a high cardiovascular risk, based upon cardio C-reactive protein values as well as an ongoing history of hypercholesterolemia and hypertriglyceridemia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide outcome to reported events.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Chest pain, Laboratory test abnormal, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: This report described the occurrence of back pain in a 39 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and was subsequently medically confirmed via medical treatment records received through the litigation process. The patient received injections of Lymerix on 7/17/00, 8/17/00, and 8/7/01 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered back pain according to the client. The onset of his symptoms is not clear at this time. Treatment and outcome of the alleged event were not reported. The following information was received via medical records. The patient's medical history included a vertebral fracture when he was in the seventh grade, and Lyme Disease in 1999 with associated joint pain in the hip and shoulder. The patient's family history was significant for arthritis in the patient's mother. On 7/17/00 and 8/17/00, the patient received his first and second Lymerix vaccinations. Subsequent to receiving his third Lymerix vaccination sometime in 2001, in the summer of 2001, the patient developed throbbing pain in either his upper or lower back, which awakened him early morning. The patient also experienced morning stiffness. The symptoms were noted to be worse when lying down, performing intense yard work, or with prolonged and repetitive bending. The pain in the back did not radiate, and the patient retained an excellent range of motion of his back, without obvious structural deformities, negative straight leg raising, and no neurologic deficit. He experienced no peripheral joint symptoms, synovitis, effusions, nor focal tenderness of the spine. His pain was assessed to be fairly localized and neuropathic in origin, without evidence of acute inflammatory arthritic process. Neurontin was initiated, but was subsequently discontinued due to lack of efficacy. Treatment included ibuprofen, and the patient was advised to perform stretches. Diagnostic tests showed the patient to be HLA-B27 positive, and sacroiliac films were negative without sing of an inflammatory process. MRI of the lumbosacral spine showed mild degenerative disc bulging. A bone scan showed mild degenerative changes of the thoracic spine without pathologic lesion. On 1/2/02, back pain was described as muscular. A consult letter from a rheumatologist dated 2/3/03 indicated that the patient's symptoms improved following treatment with Vioxx. Following the reported onset of back pain, the patient experienced chest pain and possible ischemia. These were not reported as adverse events due to vaccination administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events.
Sex: M
Vaccine: LYME
Symptoms: Eye disorder, Eye pain, Fatigue, Hyperhidrosis, Muscle spasms
Clinical narrative: This report described the occurrence of muscle spasms in a male patient who received Lyme disease vaccine recombinant OspA for prophylaxis. This report was received as part of litigation proceedings. Medical records were subsequently provided. The patient's attorney reported that three vaccinations were given, the last in 2001 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered muscle spasms, fatigue eye pain and pressure, blurriness of vision, and diaphoresis. The onset of this symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was provided via medical records. The patient had a history of Lyme disease first diagnosed in 1991, and characterized by symptoms including severe arthritis of the lower extremities and neurological symptoms such as blurred vision, headaches, and occasional dizziness. Medical history also included palpitations, chest pressure on exertion, borderline mitral valve prolapse with mild mitral regurgitation, and trace pulmonic insufficiency. The most recent information received on 12/8/03 provided no information about the claimed events.
Sex: M
Vaccine: LYME
Symptoms: Vision blurred
Clinical narrative: This report described the occurrence of muscle spasms in a male patient who received Lyme disease vaccine recombinant OspA for prophylaxis. This report was received as part of litigation proceedings. Medical records were subsequently provided. The patient's attorney reported that three vaccinations were given, the last in 2001 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered muscle spasms, fatigue eye pain and pressure, blurriness of vision, and diaphoresis. The onset of this symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was provided via medical records. The patient had a history of Lyme disease first diagnosed in 1991, and characterized by symptoms including severe arthritis of the lower extremities and neurological symptoms such as blurred vision, headaches, and occasional dizziness. Medical history also included palpitations, chest pressure on exertion, borderline mitral valve prolapse with mild mitral regurgitation, and trace pulmonic insufficiency. The most recent information received on 12/8/03 provided no information about the claimed events.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Influenza like illness, Migraine, Paraesthesia
Clinical narrative: Back pain, Arthralgia, Influenza like illness, Paraesthesia, Migraine. This report described the occurrence of low back pain in a female patient who received Lyme disease vaccine recombinant OapA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patent received injections of LYMErix "between April and May of 2001 according to the client." On 03 September 2003. the patient's attorney alleged that the patient "suffered low back pain, right hip pain, flu-like symptoms, tingling of her fingers and toes, and migraine headaches beginning in September of 2001 according to the client." Treatment and outcomes of the alleged events were not reported.
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Laboratory test abnormal, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis, Arthralgia, Back Pain. This report described the occurrence of a burning sensation in a male patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. Medical records were subsequently provided. The patients medical history included trauma to different joints and rotator cuff problems, atypical chest pain on exertion (first reported on 08 march 2001 and noted to be "Resolved" on 03 may 2001), dyspnea on exertion (first reported on 08 March 2001). Concurrent medications included atorvastatin (Lipitor). The patient received injections of LYMErix on 04 April 2001, 07 May 2001, and 04 April 2002. On 04 April 2001, the patient also received his first dose of hepatitis B vaccine (manufacturer unknown). His second dose was received on 04 May 2001 and his third dose on 04 October 2001. On 03 September 2003, the patient's attorney alleged that the patient "suffered burning of the forearms, swelling of his wrist, hand, fingers and ankles, pain in his shoulders, legs, back and feet beginning one to two weeks after his second (LYMErix) vaccination according to the client." Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. The patient was evaluated by a rheumatologist on 26 march 2002, for intermittent joint pain and swelling primarily of the wrists and hands. The pain was described as a burning sensation that lasts approximately one week. The patient had diffuse swelling of both hands (including digits) and had decreased range of motion in wrist with flexion and extension. There was no warmth or erythema noted. The clinical impression was that the patient either had arthralgia possibly due to an inflammatory process, or that he had an auto-immune disorder, or possibl a "Lyme vaccine induced syndrome". He was placed on Celebrex. The joint swelling subsided but he continued to have aches and pains and morning stiffness. The patient was subsequently diagnosed with rheumatoid arthritis on the basis of red, hot, swollen and painful fingers, hands, painful knees and painful feet. His rheumatoid factor was "extremely high" manifested by value of 1410 IU/L (upper limits normal 20), his HLA B27 was negative, antinuclear antibody was negative, C-reactive protein was normal, sed rate was normal, and he had a negative Lyme titer. X-ray of hands was normal and he was placed on methorexate. Within five weeks, he improved significantly and has been maintained on 15 mg of methotrexate weekly.
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Sensory disturbance, Swelling
Clinical narrative: Rheumatoid Arthritis, Arthralgia, Back Pain. This report described the occurrence of a burning sensation in a male patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. Medical records were subsequently provided. The patients medical history included trauma to different joints and rotator cuff problems, atypical chest pain on exertion (first reported on 08 march 2001 and noted to be "Resolved" on 03 may 2001), dyspnea on exertion (first reported on 08 March 2001). Concurrent medications included atorvastatin (Lipitor). The patient received injections of LYMErix on 04 April 2001, 07 May 2001, and 04 April 2002. On 04 April 2001, the patient also received his first dose of hepatitis B vaccine (manufacturer unknown). His second dose was received on 04 May 2001 and his third dose on 04 October 2001. On 03 September 2003, the patient's attorney alleged that the patient "suffered burning of the forearms, swelling of his wrist, hand, fingers and ankles, pain in his shoulders, legs, back and feet beginning one to two weeks after his second (LYMErix) vaccination according to the client." Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. The patient was evaluated by a rheumatologist on 26 march 2002, for intermittent joint pain and swelling primarily of the wrists and hands. The pain was described as a burning sensation that lasts approximately one week. The patient had diffuse swelling of both hands (including digits) and had decreased range of motion in wrist with flexion and extension. There was no warmth or erythema noted. The clinical impression was that the patient either had arthralgia possibly due to an inflammatory process, or that he had an auto-immune disorder, or possibl a "Lyme vaccine induced syndrome". He was placed on Celebrex. The joint swelling subsided but he continued to have aches and pains and morning stiffness. The patient was subsequently diagnosed with rheumatoid arthritis on the basis of red, hot, swollen and painful fingers, hands, painful knees and painful feet. His rheumatoid factor was "extremely high" manifested by value of 1410 IU/L (upper limits normal 20), his HLA B27 was negative, antinuclear antibody was negative, C-reactive protein was normal, sed rate was normal, and he had a negative Lyme titer. X-ray of hands was normal and he was placed on methorexate. Within five weeks, he improved significantly and has been maintained on 15 mg of methotrexate weekly.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Fatigue, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Arthralgia, Fatigue, Musculoskeletal stiffness, Arthritis, Myalgia, Muscle tightness. This report described the occurrence of joint pain in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient reportedly received an injection of LYMErix on 28 May 2000. On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pain, fatigue, generalized stiffness, right knee inflamation, bilateral hip pain, malgias, tightening (sic) of her calf muscles and right kneee pain. The onset of her symptoms is not clear at this time."  Treatment and outcomes of the alleged events were not reported.
Sex: F
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: Arthralgia, Fatigue, Musculoskeletal stiffness, Arthritis, Myalgia, Muscle tightness. This report described the occurrence of joint pain in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient reportedly received an injection of LYMErix on 28 May 2000. On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pain, fatigue, generalized stiffness, right knee inflamation, bilateral hip pain, malgias, tightening (sic) of her calf muscles and right kneee pain. The onset of her symptoms is not clear at this time."  Treatment and outcomes of the alleged events were not reported.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Depression, Fatigue, Headache
Clinical narrative: Depression, Headache, Back pain, Neck pain, Paraesthesia, Arthralgia, Influenza like illness, Fatigue, Visual disturbance, Medication error. This report described the occurrence of depression in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of LYMErix on 29 June 1999, 30 July 1999 and 26 July 2001 "according to the client." This represents a 0,1, and 25 months schedule rather than the reccomended schedule of 0,1, and 12 months. On 03 September 2003, the patient's attorney alleged that the patient "suffered headaches, soreness of her back and neck, tingling, joint pain, flu-like symptoms, fatigue, vision problems and depression. The onset of her symptoms is not clear at this time." Treatment and outcomes of the alleged events were not reported.
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Medication error, Neck pain, Paraesthesia, Visual disturbance
Clinical narrative: Depression, Headache, Back pain, Neck pain, Paraesthesia, Arthralgia, Influenza like illness, Fatigue, Visual disturbance, Medication error. This report described the occurrence of depression in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of LYMErix on 29 June 1999, 30 July 1999 and 26 July 2001 "according to the client." This represents a 0,1, and 25 months schedule rather than the reccomended schedule of 0,1, and 12 months. On 03 September 2003, the patient's attorney alleged that the patient "suffered headaches, soreness of her back and neck, tingling, joint pain, flu-like symptoms, fatigue, vision problems and depression. The onset of her symptoms is not clear at this time." Treatment and outcomes of the alleged events were not reported.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Hypokinesia, Shoulder pain
Clinical narrative: This report described the occurrence of joint pain in a male pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix "on 6/14/99, 5/13/99, and a later dose, the date of administration is not know to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered shoulder pain, restriction of movement, low back pain and knee pain. The onset of her symptoms is not clear at this time."  Treatment and outcome of the alleged events were not reported.
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Laboratory test abnormal, Pain, Sensation of heaviness
Clinical narrative: This report described the occurrence of heaviness of the leg of a female pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received as part of litigation proceedings.  The pt received injections of Lymerix on 04/22/1999 and 05/20/1999 "according to the client".  On 09/03/03, the pt's attorney alleged that the pt "suffered heaviness of her leg and severe right hip pain beginning within several weeks of her second vaccination according to the client".  Treatment and outcome of the alleged events were not reported.  The following information was obtained from medical records forwarded by the attorney on 12/03/03.  This 46 year old female was an avid runner.  She developed right hip and thigh myofascial pain and lower back pain for the first time while running on 05/09/1999.  The pt reported to her physician that the pain worsened after she received her second vaccination of Lymerix.  She underwent chiropractic treatment and massage therapy to treat the ongoing pain.  She saw her physician on 05/03/02 and, since the pain was continuing, was referred for physical therapy.  After sixteen physical therapy visits from 05/09/02 to 06/20/02 she made good progress in controlling the pain, though for two to three weeks during the therapy she did not run at all.  Her rehabilitation physician noted that her symptoms were consistent with osteoarthritis of the spine and hip.  He recommended increased cushioning of her footwear and decreased frequency of running sessions. At a follow up visit to her physician on 06/28/02 she was doing better and had continued her running activities.  During the period after she received Lymerix she sought treatment for recurrent attacks of epigastric pain.  She had a long history of heartburn and, on 11/05/01, was in the process of being worked up for these episodes.  The epigastric pain was not reported as an adverse event due to Lymerix administration and is not coded as such.
Age: 30.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Face oedema, Feeling hot, Oedema, Rheumatoid arthritis
Clinical narrative: This report described the occurrence of joint pain and swelling in the face in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received her first dose of LYMErix "in June of 2000. Subsequent vaccination dates are not known by the client." On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pains, swelling of her ankles, knees, hips, shoulders, elbows, wrists, fingers and jaw. The onset of her symptoms is unclear at this time." Treatment and outcomes of the alleged events were not reported. The following information was provided via medical records. The patient's medical history included a tick bite in June 2000. The patient's grandmother had arthritis. The patient received her initial LYMErix vaccination on 26 June 2000, and her second LYMErix vaccination on 28 July 2000. In December 2000, the patient presented with complaints of ankle and foot pain; however, x-rays revealed normal findings. On 12 October 2002, the patient presented with left knee inflammation that was hot to touch, and right thumb pain and swelling. Diagnostic tests on that date revealed an elevated rheumatoid factor. Between 05 November 2002 and 19 June 2003, the patient was evaluated by an arthritis specialist for chronic arthralgias that occurred intermittently, usually in just one or two joints at a time, with most of the peripheral joints involved at one time or another. The patient complained of joint swelling in the wrists, fingers, and knees, with episodes lasting one to two days at a time. Impressions included intermittent arthralgias/arthritis assessed to be probable palindromic rheumatism, with antinuclear antibody negative lupus less likely a possibility. Treatment included Naprosyn. In January 2003 Plaquenil was prescribed although the patient did not initiate the medication. On 22 December 2002 the patient injured her left angle and was diagnosed with an acute ankle sprain accompanied by swelling and tenderness. Following the reported onset of joint pain and swelling, the patient experienced left ear erythema, and elevated platelet count, blood glucose, and total bilirubin. The patient had no history of chicken pox, and on 08 July 2003, diagnostic tests were positive for varicella zoster virus antibody (IgM). These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 08 December 2003 did not provide the outcome of joint pain/ joint swelling.
Age: 30.0
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid factor
Clinical narrative: This report described the occurrence of joint pain and swelling in the face in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received her first dose of LYMErix "in June of 2000. Subsequent vaccination dates are not known by the client." On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pains, swelling of her ankles, knees, hips, shoulders, elbows, wrists, fingers and jaw. The onset of her symptoms is unclear at this time." Treatment and outcomes of the alleged events were not reported. The following information was provided via medical records. The patient's medical history included a tick bite in June 2000. The patient's grandmother had arthritis. The patient received her initial LYMErix vaccination on 26 June 2000, and her second LYMErix vaccination on 28 July 2000. In December 2000, the patient presented with complaints of ankle and foot pain; however, x-rays revealed normal findings. On 12 October 2002, the patient presented with left knee inflammation that was hot to touch, and right thumb pain and swelling. Diagnostic tests on that date revealed an elevated rheumatoid factor. Between 05 November 2002 and 19 June 2003, the patient was evaluated by an arthritis specialist for chronic arthralgias that occurred intermittently, usually in just one or two joints at a time, with most of the peripheral joints involved at one time or another. The patient complained of joint swelling in the wrists, fingers, and knees, with episodes lasting one to two days at a time. Impressions included intermittent arthralgias/arthritis assessed to be probable palindromic rheumatism, with antinuclear antibody negative lupus less likely a possibility. Treatment included Naprosyn. In January 2003 Plaquenil was prescribed although the patient did not initiate the medication. On 22 December 2002 the patient injured her left angle and was diagnosed with an acute ankle sprain accompanied by swelling and tenderness. Following the reported onset of joint pain and swelling, the patient experienced left ear erythema, and elevated platelet count, blood glucose, and total bilirubin. The patient had no history of chicken pox, and on 08 July 2003, diagnostic tests were positive for varicella zoster virus antibody (IgM). These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 08 December 2003 did not provide the outcome of joint pain/ joint swelling.
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal
Clinical narrative: This report described the occurrence of a positive Lyme test in a 64 year old female pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. This report was received from the pt and has not been verified by a physician or other health care professional. The pt received a series of three doses of LYMErix "in 2000." In September 2003, an unspecified test for Lyme disease had a "positive titer."
Sex: U
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in an adult female pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. A physician or other health care professional has not verified this report. The pt received her second injection of LYMErix on 4/9/99. The initial injection of LYMErix was administered on an unknown date. After receiving LYMErix, the pt experienced arm pain at injection site and entire upper arm which resolved after a few days.
Sex: M
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in an adult male pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. The reporter is the pt's wife. A physician or other health care professional has not verified this report. The pt received the first injection of LYMErix on 4/9/99. The reporter stated that she did not believe her husband received the second vaccination. At an unknown time after receiving LYMErix, the pt experienced arm pain at the injection site. The outcome of the event is unknown.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Injection site hypersensitivity, Paraesthesia, Pruritus
Clinical narrative: about 5 minutes after receiving MMR, patient got tingling in just left arm and then spread  to whole body followed by numbness.  Denied feeling of touch or awareness of heat or cold.  Also tongue feels tingling. Also had itching around injection site 30 minutes later.Patient left clinic after about 1 hour and 45 minutes after injection.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Dysphagia, Dysphonia, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: Within 2 hours, felt like throat swollen, difficulty breathing.  Could not swallow, low grade fever (99.7) Body aches, hoarseness.  Felt a little like flu.  Extreme fatigue.  Was seen following day by Dr.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Within 2 hours, felt like throat swollen, difficulty breathing.  Could not swallow, low grade fever (99.7) Body aches, hoarseness.  Felt a little like flu.  Extreme fatigue.  Was seen following day by Dr.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Hypersensitivity, Pruritus, Rash erythematous, Urticaria
Clinical narrative: 01/17/04   red fine rash, raised on shoulders and flank (went away with Benedryl) 02/04/04 generalized itchy skin rash (treated with epi, benedryl, and prednisone) 02/07/04  Admitted to hospital - scattered red rash, itchy over entire body (treated with epi, decadron, solumedrol, pepsid, benedryl) diagnosed as urticaria  02/10/04 referred to dermatologist - diagnosis made was urticaria secondary to smallpox vaccination. The hospital discharge summary received on 3/3/04 states an allergic reaction.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Rash
Clinical narrative: Rash to lower torso and thighs
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Feeling hot, Oedema peripheral, Pyrexia, Tenderness
Clinical narrative: Right upper arm swelling with warmth and soreness stated on 8/8/03 in the A.M.  It also c/o n/a this A.M., mom stated pt. felt warm last night but did not take his temp. denes any vomiting, dizzness or stiff neck.  PHN too temp on 8/8/03 at 3:45 P.M. - 99.2 via ear.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Immunocompromised 5 yr old received DTaP and IPV Rt thigh and MMR left thigh to complete childhood series.  Rt thigh 2nd day red with golfball size swelling (used ice and tylenol) 3rd day temperature, swelling size of baseball, red and hard.  Family physician dizgnosed cellulitis and prescribed oral antibiotics.  Mother reported to clinic on 8/5/03 AM, stating was improvement with medication.  Appears to be cellulitis.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Nausea, Rash
Clinical narrative: Pt. received Enegix-B Hepatitis B vaccination #1 on 01/09/04.  When asked if he had any problem with initial vaccination on return visit on 02/23/2004 pt. stated he had nausea, dizziness, and slight SOB several hours after receiving vaccine.  Also pt. states he broke out in a "bumpy rash" on face only, 1-2 days after starting doxycline; did not seek treatment; dis not contact.
Age: 1.16
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Vomiting
Clinical narrative: Vomiting within 1 hour after receiving vaccination.  Vomiting occurred off and on for 5 days.  Some mild lethargy for about 24 hours after vaccination.  (None of my other children were sick and none of them showed signs of being sick after.)
Age: 1.59
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR
Symptoms: Anorexia, Pyrexia, Rash macular, Rhinorrhoea, Viral infection
Clinical narrative: Running nose started at 12 noon 8/6/03.  Fever 102 x2 days, 8/7/03, flat red marks developed over total body x4-5 days, 8/8/03 no appetite x4 days.  Went to Hospital on 8/8/03, diagnosis viral rash.  No treatment required.
Age: 1.59
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR
Symptoms: Erythema, Pyrexia, Rash, Viral infection
Clinical narrative: Running nose started at 12 noon 8/6/03.  Fever 102 x2 days, 8/7/03, flat red marks developed over total body x4-5 days, 8/8/03 no appetite x4 days.  Went to Hospital on 8/8/03, diagnosis viral rash.  No treatment required.
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Agitation, Crying, Pyrexia, Urticaria
Clinical narrative: The immunizations were administered in the afternoon of 2/24/04 and the parents noticed that the child developed hives on her extremities and torso on 2/25/04 at approximately 5pm. At that time she was extremely upset and screamed for quite some time and was found to have a fever, also.  (The time frame was not discussed in detail.) She was taken to urgent care and was treated with Benadryl.  Hives reappeared on 2/26/04 at 10 a.m.  She will subsequently be seen by an allergist.
Age: 3.0
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Erythema, Feeling hot, Oedema peripheral, Tenderness
Clinical narrative: On 2/25/2004 mother brough her child in for immunizations. On 2/26/2003 mother brought the child back stating that his arm was swollen. She states that she noticed it last night; she was not sure of the time. Upon examination the right deltoid was noticeably red,swollen, and feverish. Mother states that the child has no other complaints other than a sore right arm. Mother was encouraged to give the child an inti-inflammatory (Motrin)to help reduce the swelling. Was also told that if the swelling became worse and she was concerned to visit the ER if after hours. Will contact mother in the am to see if there has been any improvement in the child's condition.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Received her IM typhoid vaccination on February 4, 2004. The following day she developed whole body muscle pain that she rated 8/10. She also experienced chills and felt as if she had a fever(subjective) . She took Tylenol 1 gram but it was not effective. The next day she awoke with severe abdominal cramps (rated 8/10).  The myalgias continued and she also felt nauseated and vomited twice. The following day (day 3), she felt worse and reported to the emergency room. During her four-hour length of stay, she received IV fluids, Zofran 4MG and Toradol 30MG by IV, and Motrin 800MG by mouth. Urine analysis done: ketones 80, sp grav 1.031 otherwise normal UA. Symptoms resolved after 6 days.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Received her IM typhoid vaccination on February 4, 2004. The following day she developed whole body muscle pain that she rated 8/10. She also experienced chills and felt as if she had a fever(subjective) . She took Tylenol 1 gram but it was not effective. The next day she awoke with severe abdominal cramps (rated 8/10).  The myalgias continued and she also felt nauseated and vomited twice. The following day (day 3), she felt worse and reported to the emergency room. During her four-hour length of stay, she received IV fluids, Zofran 4MG and Toradol 30MG by IV, and Motrin 800MG by mouth. Urine analysis done: ketones 80, sp grav 1.031 otherwise normal UA. Symptoms resolved after 6 days.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: On 2/25/2004 mother brought her child in for immunizations. On 2/26/2004 mother brought the child back to the office stating that his arm was swollen. She stated that she notice it last night; she was not sure of the time. Upon examination the left deltoid was noticeably red, sollen, and feverish. Mother stated that the child had not other complaints other than his left arm. She was encouraged to give the child an inti-inflammatory (Motrin)to help with the swelling. Mother was also told that if the pain or swelling became worse that she should she should contact her family physician or if after hours go to the ER. Provider will contact patient in AM to see if there has been any improvement.
Sex: M
Vaccine: FLU3
Symptoms: Thyrotoxic crisis, Vaccine positive rechallenge
Clinical narrative: A report was received from a health care professional on 11/18/03 concerning a vaccinee of unspecified demography who experienced thyroid storm, which was considered medically significant (OMIC) in the same month as receiving influenza vaccine (brand unspecified) in November 2003. The vaccinee has a history of hyperthyroidism. On an unspecified date in November 2003, the vaccinee experienced thyroid storm. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1 2/16/04: A follow up report was received from a health care professional indicating that the vaccinee had received a shot of Fluvirin several years previously and subsequently developed thyroid storm (date of onset and vaccination not known). The vaccinee has received several vaccinations since then including Fluvirin in November 2003 without reaction.
Age: 0.33
Sex: F
Vaccine: DTAP, IPV
Symptoms: Apnoea, Crying, Lethargy
Clinical narrative: Immediately after administering DTAP and IPV in same thigh and rubbing injection site, patient stopped breathing. She had not cried long. She was immediately picked up and stimulated verbally and physically. The episode lasted approx. 15 seconds. Upon coming to, she appeared lethargic for approx. 5 mins.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Skin warm, Swelling
Clinical narrative: 2-17-04 At 9:25 am was given shots DTaP and IPV right leg and MMR left leg. 8:30 pm on 2-18-04 as mother was getting child ready for bed right leg swollen from hip to knee (whole leg) Tight and hot was put on Cephalexin that night and started on Benadryl 2-19-04. Swelling gone on 2-24-04.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection, Injection site erythema, Injection site vesicles
Clinical narrative: Vesicle in erythematous base at site of injection. Most likely varicella 2 hours to injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Client came to clinic at 11:45 am at 2/25/04 complained of affected arm 2 prime vaccination of flu vaccine in 11/03. Asked client why she waited to Follow up arm pain and loss of range of motion- client had no response. Referred to Private medical doctor to determine cause and treatment.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Patient presented into our clinic, on 02-20-04, with sibling. Seven month old sibling received immunizations. Mom asked of safety because of older brother had chicken pox, diagnosed by their family physician. Upon further questioning and observation of patient, he had break-through pox since 02-18-04 and more had since erupted since the initial doctor visit.  Patient had approximately 80 pox on trunk and two on right femur.  Some were crusted but none appeared to be blistered.  Other than itching, patient had no other symptoms.  Mother stated that child returned to school on 02/24/04 per doctors release.  Child was previously immunized as stated above.
Age: 26.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Headache, Nausea
Clinical narrative: Client came in for a travel vaccines.  Was given oral Typhoid Fever on 2/17/04. He took his first pill on 2/18/04 at 7 am on an empty stomach. At 7:30 am, he started to have a headache. Took some Advil and it started to get worse. At 8 am, he ate something and no relief of his headache. At 8:30, drank some coffee thinking the caffine would help, but it didn't.  Took some more Advil.  Had some nausea around 1-1:30 pm.  Finally headache started to subside around 3:30-4 pm. By the next day, he stated he was about 90% better.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abscess
Clinical narrative: Sterile Abscess in Right thigh; symptomatic treatment
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme, onset 14 days after smallpox and anthrax #1 vaccination.  Involving arms, legs, hands and feet.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Tinnitus, Vertigo
Clinical narrative: Still has tinnitus, driving me crazy. Some times it get so loud that I can not hear well. Sometimes it even sounds two-toned. Sometimes when I am riding my motorcycle I can't hear the motor over the tinnitus, it's that loud. I don't tolerate flying very well. The sensation of flying really gets me going. I still have vertigo, but mostly in low light, etc.. Otherwise I am in good shape.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin increased
Clinical narrative: This case was reported by a nurse and described the occurrence of elevated bilirubin in a 2 day old female patient who had received hepatitis B vaccine recombinant for prophylaxis. On 2/20/04, the patient received a pediatric dose of Engerix B. According to the reporter, the hospital was uncertain whether the neonate had received an initial dose of Engerix B, and administered the dose on 2/20/04 due to this uncertainty. On the same day that the patient received Engerix B vaccination, she experienced elevated bilirubin and was hospitalized. The event was unresolved at the time of reporting. The nurse considered the event was possibly related to vaccination with Engerix B.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Oedema, Pain, Post vaccination autoinoculation, Rash erythematous
Clinical narrative: Information regarding smallpox vaccine, dried calf lymph type injection was received from a published literature article. Autoinoculation vaccinia. In light of the anthrax attacks in 2001 and the threat of further bioterrorism, this article discusses the issues of smallpox vaccination within the current dermatologic environment, presenting the case of a 19 year old male pt who developed autoinoculation vaccinia. Four to five days post-immunization, the pt developed a "major reaction" at the site of vaccination. A few days later, he noticed the onset of a painful, erythematous, edematous eruption on his upper thighs and scrotum. Small papules develped into umbilicated pustules. The pt admitted to scratching the vaccination site. After he was seen during the second week of his illness, he was admitted to the hospital. Viral culture results were positive for vaccinia. Tzanck smear was negative for multinucleated giant cells, and no Guarnieri bodies were seen. He was treated with compresses, and the eruption resolved in two days without scarring. The authors concluded that "smallpox vaccination complications were relatively common when it was a routine inoculation in the 1950s and 1960s. The most common complication, occurring at a rate of 1 in 1000 vaccinations, was accidental inoculation. Accidental inoculation can be due to either autoinoculation, as in the case presented, or to contact with a vaccinated person, often a sibling or a close contact." The common and occasionally severe complications must be taken into account when shaping our national strategy.