chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, Influenza like illness, Loss of consciousness
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 (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). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain, stiffness, headaches, flu-like symptoms, fatigue, tingling in extremities, vision problems, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be 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 12 January 2009 via medical records. The subject received his first, second, and third doses of LYMERIX all in 2001. A few months after the second or third dose of LYMERIX. He developed skin rashes, shoulder pain, and tingling and numbness in the fingers and hands that subsequently progressed. In 2002 or 2003 he developed headaches. In 2003 or 2004 he developed leg cramps and deep vein thrombosis. In 2003, 2004, or 2005 he experienced fatigue and poor sleep. In 2005 or 2006 he experienced "black-outs". On an unknown date (possibly prior to LYMERIX vaccination), he developed an "intravenal occlusion of retina in both eyes". Treatment included anti-fungal/anti-bacterial creams and COUMADIN. With the exception of the skin rashes, headaches, and black-outs, the events were unresolved at the time of this report. The subject reported that "one eye has cleared up" and that the right eye was back to 20/20 vision, while the left eye remained blurry. The events of deep vein thrombosis and black-outs were assessed to be medically significant by GSK.
Sex: M
Vaccine: LYME
Symptoms: Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness, Nervous system disorder, 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 (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). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain, stiffness, headaches, flu-like symptoms, fatigue, tingling in extremities, vision problems, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be 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 12 January 2009 via medical records. The subject received his first, second, and third doses of LYMERIX all in 2001. A few months after the second or third dose of LYMERIX. He developed skin rashes, shoulder pain, and tingling and numbness in the fingers and hands that subsequently progressed. In 2002 or 2003 he developed headaches. In 2003 or 2004 he developed leg cramps and deep vein thrombosis. In 2003, 2004, or 2005 he experienced fatigue and poor sleep. In 2005 or 2006 he experienced "black-outs". On an unknown date (possibly prior to LYMERIX vaccination), he developed an "intravenal occlusion of retina in both eyes". Treatment included anti-fungal/anti-bacterial creams and COUMADIN. With the exception of the skin rashes, headaches, and black-outs, the events were unresolved at the time of this report. The subject reported that "one eye has cleared up" and that the right eye was back to 20/20 vision, while the left eye remained blurry. The events of deep vein thrombosis and black-outs were assessed to be medically significant by GSK.
Sex: M
Vaccine: LYME
Symptoms: Poor quality sleep, Rash, Retinal vein occlusion, Vision blurred, Visual impairment
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 (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). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain, stiffness, headaches, flu-like symptoms, fatigue, tingling in extremities, vision problems, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be 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 12 January 2009 via medical records. The subject received his first, second, and third doses of LYMERIX all in 2001. A few months after the second or third dose of LYMERIX. He developed skin rashes, shoulder pain, and tingling and numbness in the fingers and hands that subsequently progressed. In 2002 or 2003 he developed headaches. In 2003 or 2004 he developed leg cramps and deep vein thrombosis. In 2003, 2004, or 2005 he experienced fatigue and poor sleep. In 2005 or 2006 he experienced "black-outs". On an unknown date (possibly prior to LYMERIX vaccination), he developed an "intravenal occlusion of retina in both eyes". Treatment included anti-fungal/anti-bacterial creams and COUMADIN. With the exception of the skin rashes, headaches, and black-outs, the events were unresolved at the time of this report. The subject reported that "one eye has cleared up" and that the right eye was back to 20/20 vision, while the left eye remained blurry. The events of deep vein thrombosis and black-outs were assessed to be medically significant by GSK.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Autoimmune disorder, Borrelia burgdorferi serology positive
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 and swelling, fatigue, memory loss, tingling in extremities, headaches, visual problems, speech problems, cognitive problems, sleep difficulties, teeth and gum problems, 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. Very limited follow-up information was received on 26 October 2006. Follow-up indicated that the subject received LYMERIX twice in early 2000. Polyarthralgias were noted and a history of alcohol abuse. Follow-up information was received on 08 January 2009 via an interview between the subject and attorney(s). The subject received LYMERIX on 04 October 1999 and 28 October 1999. On the same day that he received each dose of LYMERIX, he developed arm soreness which resolved after approximately two weeks. A "couple of months" after the second dose of LYMERIX, he developed joint and muscle pain, fatigue, tingling, and sleep disturbance. In 2000 he developed memory loss and stuttering. In 2000 or 2001 he developed "sweating in bed". In 2001 he developed teeth grinding. In 2005 he developed headaches. In 2006 or 2007, he experienced "writing problems" described as his handwriting becoming progressively worse, and also reported difficulty using tools with his hands. Treatment included ADVIL and other unspecified medications including pain medications. With the exception of arm soreness, the events were unresolved at the time of reporting. The event of difficulty writing was assessed by GSK to be medically significant.
Sex: M
Vaccine: LYME
Symptoms: Bruxism, Cognitive disorder, Dysgraphia, Dysphemia, Fatigue
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 and swelling, fatigue, memory loss, tingling in extremities, headaches, visual problems, speech problems, cognitive problems, sleep difficulties, teeth and gum problems, 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. Very limited follow-up information was received on 26 October 2006. Follow-up indicated that the subject received LYMERIX twice in early 2000. Polyarthralgias were noted and a history of alcohol abuse. Follow-up information was received on 08 January 2009 via an interview between the subject and attorney(s). The subject received LYMERIX on 04 October 1999 and 28 October 1999. On the same day that he received each dose of LYMERIX, he developed arm soreness which resolved after approximately two weeks. A "couple of months" after the second dose of LYMERIX, he developed joint and muscle pain, fatigue, tingling, and sleep disturbance. In 2000 he developed memory loss and stuttering. In 2000 or 2001 he developed "sweating in bed". In 2001 he developed teeth grinding. In 2005 he developed headaches. In 2006 or 2007, he experienced "writing problems" described as his handwriting becoming progressively worse, and also reported difficulty using tools with his hands. Treatment included ADVIL and other unspecified medications including pain medications. With the exception of arm soreness, the events were unresolved at the time of reporting. The event of difficulty writing was assessed by GSK to be medically significant.
Sex: M
Vaccine: LYME
Symptoms: Gingival disorder, Headache, Hyperhidrosis, Insomnia, Joint swelling
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 and swelling, fatigue, memory loss, tingling in extremities, headaches, visual problems, speech problems, cognitive problems, sleep difficulties, teeth and gum problems, 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. Very limited follow-up information was received on 26 October 2006. Follow-up indicated that the subject received LYMERIX twice in early 2000. Polyarthralgias were noted and a history of alcohol abuse. Follow-up information was received on 08 January 2009 via an interview between the subject and attorney(s). The subject received LYMERIX on 04 October 1999 and 28 October 1999. On the same day that he received each dose of LYMERIX, he developed arm soreness which resolved after approximately two weeks. A "couple of months" after the second dose of LYMERIX, he developed joint and muscle pain, fatigue, tingling, and sleep disturbance. In 2000 he developed memory loss and stuttering. In 2000 or 2001 he developed "sweating in bed". In 2001 he developed teeth grinding. In 2005 he developed headaches. In 2006 or 2007, he experienced "writing problems" described as his handwriting becoming progressively worse, and also reported difficulty using tools with his hands. Treatment included ADVIL and other unspecified medications including pain medications. With the exception of arm soreness, the events were unresolved at the time of reporting. The event of difficulty writing was assessed by GSK to be medically significant.
Sex: M
Vaccine: LYME
Symptoms: Limb discomfort, Musculoskeletal pain, Myalgia, Nervous system disorder, 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 and swelling, fatigue, memory loss, tingling in extremities, headaches, visual problems, speech problems, cognitive problems, sleep difficulties, teeth and gum problems, 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. Very limited follow-up information was received on 26 October 2006. Follow-up indicated that the subject received LYMERIX twice in early 2000. Polyarthralgias were noted and a history of alcohol abuse. Follow-up information was received on 08 January 2009 via an interview between the subject and attorney(s). The subject received LYMERIX on 04 October 1999 and 28 October 1999. On the same day that he received each dose of LYMERIX, he developed arm soreness which resolved after approximately two weeks. A "couple of months" after the second dose of LYMERIX, he developed joint and muscle pain, fatigue, tingling, and sleep disturbance. In 2000 he developed memory loss and stuttering. In 2000 or 2001 he developed "sweating in bed". In 2001 he developed teeth grinding. In 2005 he developed headaches. In 2006 or 2007, he experienced "writing problems" described as his handwriting becoming progressively worse, and also reported difficulty using tools with his hands. Treatment included ADVIL and other unspecified medications including pain medications. With the exception of arm soreness, the events were unresolved at the time of reporting. The event of difficulty writing was assessed by GSK to be medically significant.
Sex: M
Vaccine: LYME
Symptoms: Visual impairment
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 and swelling, fatigue, memory loss, tingling in extremities, headaches, visual problems, speech problems, cognitive problems, sleep difficulties, teeth and gum problems, 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. Very limited follow-up information was received on 26 October 2006. Follow-up indicated that the subject received LYMERIX twice in early 2000. Polyarthralgias were noted and a history of alcohol abuse. Follow-up information was received on 08 January 2009 via an interview between the subject and attorney(s). The subject received LYMERIX on 04 October 1999 and 28 October 1999. On the same day that he received each dose of LYMERIX, he developed arm soreness which resolved after approximately two weeks. A "couple of months" after the second dose of LYMERIX, he developed joint and muscle pain, fatigue, tingling, and sleep disturbance. In 2000 he developed memory loss and stuttering. In 2000 or 2001 he developed "sweating in bed". In 2001 he developed teeth grinding. In 2005 he developed headaches. In 2006 or 2007, he experienced "writing problems" described as his handwriting becoming progressively worse, and also reported difficulty using tools with his hands. Treatment included ADVIL and other unspecified medications including pain medications. With the exception of arm soreness, the events were unresolved at the time of reporting. The event of difficulty writing was assessed by GSK to be medically significant.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Arthritis, Autoimmune 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 (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). An unknown amount of time after vaccination with LYMERIX, the subject experienced joint pain, flu-like symptoms, fatigue, autoimmune disease, activities of daily living impaired, memory loss, headache, joint inflammation, stiffness, numbness, rheumatological symptoms, neurological impairment and cognitive impairment. 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 05 January 2009 via medical records. The subject's medical history included recurrent synovitis and symptoms consistent with gouty arthropathy/arthritis. The subject received his first and second doses of LYMERIX on 16 March 1999 and 27 April 1999. A progress note dated 20 April 1999 indicated that the subject had had "no recurrent attacks of acute arthropathy." On 23 February 2000, the subject received his third LYMERIX, and also reported a three week history of fatigue. Between 05 February 2001 and May 2001, the subject presented with complaints of neck stiffness and headaches. On 26 January 2002 and 02 May 2002, the subject was evaluated by an orthopedist for elbow swelling, and was diagnosed with chronic left elbow bursitis.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Borrelia burgdorferi serology, Borrelia burgdorferi serology positive, Bursitis, Cognitive disorder, Condition aggravated
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 (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). An unknown amount of time after vaccination with LYMERIX, the subject experienced joint pain, flu-like symptoms, fatigue, autoimmune disease, activities of daily living impaired, memory loss, headache, joint inflammation, stiffness, numbness, rheumatological symptoms, neurological impairment and cognitive impairment. 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 05 January 2009 via medical records. The subject's medical history included recurrent synovitis and symptoms consistent with gouty arthropathy/arthritis. The subject received his first and second doses of LYMERIX on 16 March 1999 and 27 April 1999. A progress note dated 20 April 1999 indicated that the subject had had "no recurrent attacks of acute arthropathy." On 23 February 2000, the subject received his third LYMERIX, and also reported a three week history of fatigue. Between 05 February 2001 and May 2001, the subject presented with complaints of neck stiffness and headaches. On 26 January 2002 and 02 May 2002, the subject was evaluated by an orthopedist for elbow swelling, and was diagnosed with chronic left elbow bursitis.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, 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 (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). An unknown amount of time after vaccination with LYMERIX, the subject experienced joint pain, flu-like symptoms, fatigue, autoimmune disease, activities of daily living impaired, memory loss, headache, joint inflammation, stiffness, numbness, rheumatological symptoms, neurological impairment and cognitive impairment. 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 05 January 2009 via medical records. The subject's medical history included recurrent synovitis and symptoms consistent with gouty arthropathy/arthritis. The subject received his first and second doses of LYMERIX on 16 March 1999 and 27 April 1999. A progress note dated 20 April 1999 indicated that the subject had had "no recurrent attacks of acute arthropathy." On 23 February 2000, the subject received his third LYMERIX, and also reported a three week history of fatigue. Between 05 February 2001 and May 2001, the subject presented with complaints of neck stiffness and headaches. On 26 January 2002 and 02 May 2002, the subject was evaluated by an orthopedist for elbow swelling, and was diagnosed with chronic left elbow bursitis.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Joint swelling, Musculoskeletal pain, Musculoskeletal stiffness, Nervous system 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 (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). An unknown amount of time after vaccination with LYMERIX, the subject experienced joint pain, flu-like symptoms, fatigue, autoimmune disease, activities of daily living impaired, memory loss, headache, joint inflammation, stiffness, numbness, rheumatological symptoms, neurological impairment and cognitive impairment. 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 05 January 2009 via medical records. The subject's medical history included recurrent synovitis and symptoms consistent with gouty arthropathy/arthritis. The subject received his first and second doses of LYMERIX on 16 March 1999 and 27 April 1999. A progress note dated 20 April 1999 indicated that the subject had had "no recurrent attacks of acute arthropathy." On 23 February 2000, the subject received his third LYMERIX, and also reported a three week history of fatigue. Between 05 February 2001 and May 2001, the subject presented with complaints of neck stiffness and headaches. On 26 January 2002 and 02 May 2002, the subject was evaluated by an orthopedist for elbow swelling, and was diagnosed with chronic left elbow bursitis.
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Back pain, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain 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 joint pain and swelling, tingling in extremities, headaches, flu-like symptoms, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated 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 12 January 2009 via medical records. The subject received the first and second dose of LYMERIX both in 1998. A few months after vaccination with LYMERIX, she developed left hip pain, knee pain and swelling, and right hand pain and swelling. She also indicated that she experienced hip and back pain, and she was reportedly advised that she might have rheumatoid arthritis. Treatment included VIOXX and CELEBREX. The events were unresolved at the time of this report. The event of possible rheumatoid arthritis was assessed by GSK to be medically significant.
Sex: F
Vaccine: LYME
Symptoms: Headache, Influenza like illness, Joint swelling, Musculoskeletal pain, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain 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 joint pain and swelling, tingling in extremities, headaches, flu-like symptoms, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated 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 12 January 2009 via medical records. The subject received the first and second dose of LYMERIX both in 1998. A few months after vaccination with LYMERIX, she developed left hip pain, knee pain and swelling, and right hand pain and swelling. She also indicated that she experienced hip and back pain, and she was reportedly advised that she might have rheumatoid arthritis. Treatment included VIOXX and CELEBREX. The events were unresolved at the time of this report. The event of possible rheumatoid arthritis was assessed by GSK to be medically significant.
Sex: F
Vaccine: LYME
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain 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 joint pain and swelling, tingling in extremities, headaches, flu-like symptoms, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated 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 12 January 2009 via medical records. The subject received the first and second dose of LYMERIX both in 1998. A few months after vaccination with LYMERIX, she developed left hip pain, knee pain and swelling, and right hand pain and swelling. She also indicated that she experienced hip and back pain, and she was reportedly advised that she might have rheumatoid arthritis. Treatment included VIOXX and CELEBREX. The events were unresolved at the time of this report. The event of possible rheumatoid arthritis was assessed by GSK to be medically significant.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Asthenia, Fatigue, Headache, Hypoaesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of muscle weakness 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 unspecified time after vaccination with LYMERIX, the subject experienced weakness, fatigue, possible autoimmune disease, activities of daily living impaired, tingling, numbness, flu-like symptoms, headaches, possible memory loss and possible neurological problems. 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 12 January 2009 via medical records. The subject was vaccinated with LYMERIX on 06 April 1999, 11 May 1999, and 25 May 2000. Between his second and third doses of LYMERIX, he developed "extreme" leg fatigue and muscle aches in his legs. In 2001 or 2002, he developed numbness in his left foot. he was reportedly advised that he might require intravenous immunoglobulin (IVIG) in the event that neuropathy progressed. The events were unresolved at the time of this report. The event of neuropathy was assessed by GSK to be medically significant.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness, Muscular weakness, Myalgia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of muscle weakness 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 unspecified time after vaccination with LYMERIX, the subject experienced weakness, fatigue, possible autoimmune disease, activities of daily living impaired, tingling, numbness, flu-like symptoms, headaches, possible memory loss and possible neurological problems. 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 12 January 2009 via medical records. The subject was vaccinated with LYMERIX on 06 April 1999, 11 May 1999, and 25 May 2000. Between his second and third doses of LYMERIX, he developed "extreme" leg fatigue and muscle aches in his legs. In 2001 or 2002, he developed numbness in his left foot. he was reportedly advised that he might require intravenous immunoglobulin (IVIG) in the event that neuropathy progressed. The events were unresolved at the time of this report. The event of neuropathy was assessed by GSK to be medically significant.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Respiratory arrest
Clinical narrative: Found by father not breathing approximately 0500 on 1/10.  Attempted resuscitation at home via police then EMS.  To hospital with resuscitation efforts for approximately 1 hr with no results.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Death
Clinical narrative: Pt was administered vaccines on 013109.  Pt was found deceased on 011409. 10/28/09 Autopsy report received. DOD 11/14/09 Cause of Death: Sudden Unexplained Infant Death. Additional information extracted: Suddent Infant Death Syndrome.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Developed hives/facial swelling, local itching within 5 minutes of vaccine. Required EpiPen administration.
Age: 8.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: 11/4 had varicella shot R arm.  11/5 developed redness & blisters on R arm below injection site- pt here 11/6/09
Age: 32.0
Sex: U
Vaccine: HEP, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Lt deltoid became red, swollen, warm the evening of 12/30/08.  Symptoms worsened next day.  She was seen at clinic on 11/1/09- They referred her to E.R. They prescribed KEFLEX  TID x 10 days which she is still taking.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Viral DNA test positive
Clinical narrative: VARICELLA- like rash
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Musculoskeletal stiffness, Nightmare
Clinical narrative: Chills, fever of 101.9, aches, stiffness - around 6:30 pm.  Around 1 am next am0 headache, sweating, nightmares, few hives on hands.  Symptoms improved 1-14-09, resolved 1-15-09.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Chills, fever of 101.9, aches, stiffness - around 6:30 pm.  Around 1 am next am0 headache, sweating, nightmares, few hives on hands.  Symptoms improved 1-14-09, resolved 1-15-09.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: My left shoulder started pinching.  The pain progressed to point of doctor visit.  Am currently doing physical therapy for left shoulder.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Malaise, Pain, Pain in extremity
Clinical narrative: Worst shot ever given- hurt immediately and for approx 4 to 5 days after.  Got really sick after for 4 days - puking etc.  Started noticing that arm aches all the time/area given is sore to touch-hard to lift above a certain height for last 2 months
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Worst shot ever given- hurt immediately and for approx 4 to 5 days after.  Got really sick after for 4 days - puking etc.  Started noticing that arm aches all the time/area given is sore to touch-hard to lift above a certain height for last 2 months
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage, Blood albumin normal
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine decreased
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea decreased, Carbon dioxide normal
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Culture wound positive, Eosinophil count normal, Eosinophil percentage, Gram stain positive, Haematocrit decreased
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Haemoglobin decreased, Injection site abscess, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage decreased
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Platelet count normal, Protein total normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Vaccine positive rechallenge, White blood cell count normal
Clinical narrative: Redness, induration, swelling on R thigh where Hib and PREVNAR were given.  Later developed into a localized abcess.  Had recurrence of similar symptoms with 12 mo shots in Aug of 2006.  Abscess in L leg with 12 month shots where Hib & MMR were given.  Symptom: Erythema Start: 04/2006; Swelling Start 04/2006; Tenderness Start: 04/2006
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episode following GARDASIL administration. Held in clinic for 15 min following incident, with BP initially 122/64 and 126/76 15 min later.  Given 12oz apple juice while reclining.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Dysgeusia, Erythema, Induration, Similar reaction on previous exposure to drug, Skin warm
Clinical narrative: Redness, firm, warm to touch 6.0cm X4.5cm, chemical taste in mouth approximately 20min after administration patient normally has chemical taste with vaccines.
Age: 1.4
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area is swollen, hot red to left thigh. Treatment CLENDA 75/5 1 top po tid x 10 days.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Hypersensitivity
Clinical narrative: 1. Inconsolable, crying within 6 hrs. 2. Not having lower extremities 3. Hypersensitive below waste line
Age: 12.0
Sex: M
Vaccine: DTP, VARCEL
Symptoms: Confusional state, Full blood count normal, Headache, Nausea, Urine analysis normal
Clinical narrative: Confused/blurriness/head pain/nausea.  Another student at his school had immunizations yesterday also, and was sent home from school with similar symptoms.
Age: 12.0
Sex: M
Vaccine: DTP, VARCEL
Symptoms: Vision blurred
Clinical narrative: Confused/blurriness/head pain/nausea.  Another student at his school had immunizations yesterday also, and was sent home from school with similar symptoms.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SM developed redness, swelling and pain at injection site within 24 hrs of receiving his second ANTHRAX shot.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed redness, pain and swelling at site of anthrax vaccine within a few hours after receiving the shot.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine at our office on 1/5/09.  On 1/6/09 pt started with redness, swelling, hot to touch with pain, some itching at the vaccine site.  Went to urgent care on 1/7/09 - was prescribed Cefalaxen 250 mg qid x 10 days.  Pt here today 1/9/09 - doing better.
Age: 65.0
Sex: F
Vaccine: IPV, PPV, TYP
Symptoms: Injection site swelling
Clinical narrative: Vaccines given  1/14/09. Left arm swelling.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Lip swelling, Swollen tongue, Urticaria, Wheezing
Clinical narrative: Patient developed hives within 2 hrs of vaccines being given. Rx BENADRYL PO. No tongue/lip swelling/wheezing.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Red raised rash over torso, about 30 lesions.  No open areas, no s/s infection, no crusting.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: On unspecified dates, the subjects received unspecified doses of HEPATITIS B vaccine (unknown).  At an unspecified time after vaccination with HEATITIS B vaccines, the subjects experienced not responding to therapy.  The sales representative reported that she "heard through hearsay that some college clinics  in her sales territory are testing all their nursing students and if their HEPATITIS B antibody titers are below 10, 000 mIU, they are revaccination them with on e or more doses of HEPATITITS B vaccine.  An unknown number of subjects have shown non-protective Hepatitis B antibody titers when tested anywhere from greater than two months to years after completing their last HEPATITIS vaccine series".  The sales representative did not have any further subject data at this time.  She did not know what brand of HEPATITIS B vaccine had been used in these subjects in the past.  The sales representative will attempt to get further information.  At the time of reporting, the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Therapeutic response decreased
Clinical narrative: This case was reported by a sales representative and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). On unspecified dates, the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced decreased therapeutic response. The sales representative reported that she "heard through hearsay", at least one subject had a titer of 7,000 mIU when a protective titer is considered 10,000 mIU, after completing the hepatitis B vaccine series in the past. The timing of this subject's previous vaccine series was not known. The sales representative did not have any further subject data at this time. She did not know what brand of hepatitis B vaccine had been used in the subject in the past. The sales representative will attempt to get further information. Relevant test results included hepatitis B antibody titer of 7,000 mIU. At the time of reporting the outcome of the event was unspecified.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  On 21 October 2008, the subject received 1st dose of ENGERIX B (20 mcg, unknown, left arm).  On 23 October 2008, 2 days  after vaccination with ENGERIX B, the subject experienced hives.  The subject, who is also a hospital employee, was given her first dose  of ENGERIX B and developed hives all over her body 48 hours after.  She was seen back at employee health and advised to take CLARITIN and BENADRYL.  At the time of reporting the outcome of the event was unspecified.
Age: 45.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Blister, Hepatitis B antibody negative, Inappropriate schedule of drug administration, No therapeutic response, Skin disorder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HEPTAVAX, ENGERIX B.  The subject's medical history included skin problem.   Concurrent medications included RAPTIVAL.  ON 2 November 2006, the subject received 1st dose of Hepatitis B vaccine (unknown, left deltoid), On 5 December 2006, 3 April 2007, the subject received 2nd dose and 3rd dose of ENGERIX (1ml, unknown, left deltoid) and experienced not responding to therapy and drug dose administration interval too short.  On 19 March 2008, 8 May 2008 and 17 July 2008 the subject received 1st dose 2nd dose, and 3rd dose of ENGERIX B(1 ml, unknown, right deltoid) and experienced not responding to therapy and drug dose administration interval too short.  Relevant test results included negative titers. The healthcare professional reported the subject received two separate series of Hepatitis B vaccines and still has a negative titer.  The first series was a mixture of GSK and Merck product.  The subject told the nurse on 08 May 2007, that he had a negative titer.  The second series of hepatitis B vaccines were all GSK products.  The reporting healthcare professional did not know when the titer was drawn.  At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 15 December 2008.   The subject's skin problem was further described as small blisters on hands and feet.  Additional concomitant medications included ATENOLOL, TRICOR and NEXIUM.  The reporter stated RAPTIVA was preventing the subject from building titers with the Hepatitis B vaccine.  The subject started therapy with RAPTIVA in 2007, 125ml per week and continues.  At the time of the report, the events were unresolved.
Sex: M
Vaccine: HEP
Symptoms: Hypoacusis, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of hearing deficit in a male subject of unspecified age who was vaccinated with HepB vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of HepB (unknown).  A few days after he reported getting HepB, the subject developed unilateral acute hearing deficit.  His hearing got better with time and a course of steroids.  It was reported that the subject has had three hepatitis B vaccines and did not seroconvert.  The subject was not responding to therapy.