chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Cardiac operation, Cardiac stress test, Catheterisation cardiac, Chest pain, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, headache, pain, fatigue, poor balance, gastrointestinal problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, activities of daily living impaired and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second doses of LYMERIX in August 1999 and September 1999. In August 1999 or September 1999, "days or weeks" following vaccination, the subject experienced joint pain in the wrists/ neck/ hip/ back, shooting pains in the leg (possible neuropathy), buttock pain, groin pain, fatigue, and paralysis. He attributed chronic fatigue to "debilitating" pain. He reported that he became paralyzed while walking down stairs and could not move, and one week later experienced a second episode of paralysis. In April 2002, he experienced chest pain (heart, with blocked arteries), and underwent a stress test, cardiac catheterization, and open heart surgery. Treatment included PREVASTATIN, CELEBREX, and VIOXX. The events, with the exception of paralysis and chest pain, were unresolved at the time of this report.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Decreased activity, Fatigue, Gastrointestinal disorder, Groin pain, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, headache, pain, fatigue, poor balance, gastrointestinal problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, activities of daily living impaired and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second doses of LYMERIX in August 1999 and September 1999. In August 1999 or September 1999, "days or weeks" following vaccination, the subject experienced joint pain in the wrists/ neck/ hip/ back, shooting pains in the leg (possible neuropathy), buttock pain, groin pain, fatigue, and paralysis. He attributed chronic fatigue to "debilitating" pain. He reported that he became paralyzed while walking down stairs and could not move, and one week later experienced a second episode of paralysis. In April 2002, he experienced chest pain (heart, with blocked arteries), and underwent a stress test, cardiac catheterization, and open heart surgery. Treatment included PREVASTATIN, CELEBREX, and VIOXX. The events, with the exception of paralysis and chest pain, were unresolved at the time of this report.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Musculoskeletal pain, Neck pain, Nervous system disorder, Pain, Pain in extremity
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, headache, pain, fatigue, poor balance, gastrointestinal problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, activities of daily living impaired and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second doses of LYMERIX in August 1999 and September 1999. In August 1999 or September 1999, "days or weeks" following vaccination, the subject experienced joint pain in the wrists/ neck/ hip/ back, shooting pains in the leg (possible neuropathy), buttock pain, groin pain, fatigue, and paralysis. He attributed chronic fatigue to "debilitating" pain. He reported that he became paralyzed while walking down stairs and could not move, and one week later experienced a second episode of paralysis. In April 2002, he experienced chest pain (heart, with blocked arteries), and underwent a stress test, cardiac catheterization, and open heart surgery. Treatment included PREVASTATIN, CELEBREX, and VIOXX. The events, with the exception of paralysis and chest pain, were unresolved at the time of this report.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Paralysis
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, headache, pain, fatigue, poor balance, gastrointestinal problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, activities of daily living impaired and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second doses of LYMERIX in August 1999 and September 1999. In August 1999 or September 1999, "days or weeks" following vaccination, the subject experienced joint pain in the wrists/ neck/ hip/ back, shooting pains in the leg (possible neuropathy), buttock pain, groin pain, fatigue, and paralysis. He attributed chronic fatigue to "debilitating" pain. He reported that he became paralyzed while walking down stairs and could not move, and one week later experienced a second episode of paralysis. In April 2002, he experienced chest pain (heart, with blocked arteries), and underwent a stress test, cardiac catheterization, and open heart surgery. Treatment included PREVASTATIN, CELEBREX, and VIOXX. The events, with the exception of paralysis and chest pain, were unresolved at the time of this report.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Autoimmune disorder, Borrelia burgdorferi serology
Clinical narrative: This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Borrelia burgdorferi serology positive, Cognitive disorder, Dactylitis, Dry eye, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Injection site pain, Joint swelling, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Nervous system disorder, Oedema peripheral, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Rash, Raynaud's phenomenon, Rheumatoid arthritis, Rheumatoid factor negative, Tendonitis
Clinical narrative: This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Tenosynovitis, Vision blurred
Clinical narrative: This case was reported by a lawyer and described the occurrence of swelling and pain in the joints in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced swelling and pain in her joints, muscle pain, headaches, flu-like symptoms, rashes, tingling in extremities. Raynaud's phenomenon, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. On 14 September 1999 and 15 October 1999, the subject received the first and second doses of LYMERIX. At the time of her first vaccination she reported that she had recently been bitten by a tick or other insect, and was placed on prophylactic doxycycline. The subject received the third dose of LYMERIX on 14 September 2000. On 03 October 2000, she reported her arm hurt at the injection site. On 06 September 2001, she was diagnosed with acute flexor tenosynovitis, right index finger. On 12 September 2001 she was evaluated for possible Lyme disease, with right hand lump and soreness. Impression included possible tendonitis versus arthritis of the second right metacarpal phalangeal joint. A Lyme titer was positive on an unspecified date. On unspecified dates, she developed memory loss, blurred vision, dry eyes, swelling of the feet and hands, and joint complaints. She was seen by an orthopaedist between 18 September 2001 and 03 June 2004, for wrist pain and swelling/polyarthralgia of the wrists, flexor tenosynovitis of the right finger, and flare-ups of dactylitis in both hands. Assessment included probable rheumatoid arthritis. Treatment included CELEBREX. According to a patient summary, subsequent to receiving LYMERIX she developed an "extremely sore shoulder after the shot", tendonitis of the right hand, body aches (knee, feet, elbow, and shoulder), left and right had swelling, suspected clinical rheumatoid arthritis, and general body aches. Medications included NAPROXEN and MOTRIN. The event of probable rheumatoid arthritis was assessed to be medically significant by GSK.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Arthritis, Asthenia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Autoimmune disorder, Back pain, Borrelia burgdorferi serology, Borrelia burgdorferi serology positive, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Gait disturbance, Grip strength decreased, HLA marker study, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Immune system disorder, Immunology test, Influenza like illness
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Lethargy, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder, Neurological examination normal, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid arthritis, Rheumatoid factor negative
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Bronchitis
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of acute bronchitis in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). In September 2008 the subject received 1st dose of KINRIX at 0.5 ml in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced severe acute bronchitis. The subject was hospitalised for 3 days and the healthcare professional considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with KINRIX.
Age: 31.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: None. Patient was inadvertently given DTaP instead of Tdap.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperaesthesia, Influenza serology negative, Oedema, Pain
Clinical narrative: Fever 100.9, chills. Generalized body aches, severe edema, sensitivity to touch.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 100.9, chills. Generalized body aches, severe edema, sensitivity to touch.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Physical examination, Wheezing
Clinical narrative: Wheezing, sore throat
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Red, inflammed, warm to touch at injection site noted by parent day after administered. Advised cool pack, anti-inflammatory.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Anxiety, Dyspnoea, Oropharyngeal pain, Palpitations, Paraesthesia oral
Clinical narrative: Patient received anthrax and typhoid in the Rt deltoid.  Patient has a really bad anxiety of receiving shots but tolerated them well.  Had nurse in the room in case of vasovagel reaction.  During her 20 minute wait time patient was talking with me and was doing fine.  Patient started to complain of a sore throat.   Started to call nurse back into the office when the patient started to say her tongue felt funny and she was having difficulty breathing.  Applied O2 at 6L with NC and hit code blue alarm.  Received provider's order to administer Epi Pen, administered Epi Pen in Rt thigh.  Patient asked if her heart was supposed to be racing after that and was reassured that it was a side effect of the Epi Pen.   Her symptoms started to go away shortly after receiving the Epi Pen.  Monitored patient for 1 hour after event and the provider sent her home on quarter for the rest of the day.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Hyperhidrosis, Pallor
Clinical narrative: patient became pale and swety after receiving shot sat down and had a couple of small jerky movements
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: Pain in right shoulder starting 11/12/2008.  Initial visit to orthopedic surgeon.  He felt pain was from inflammation of the shoulder and prescribed naproxen.  Pain did not go away and by 11/14/2008 a rash appeared.  I visited my Internist and he thought the rash was some type of allergic reaction.  On 11/17/2008 I went back to my internist and he confirmed a diagnosis of shingles.  He then prscribed an antiviral med.