chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: LYME
Symptoms: Medication error, Muscular weakness, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of muscle weakness in a male patient who received Lyme disease vaccine recombinant for prophylaxis. On unspecified dates several years ago, the patient received an unspecified number of injections of Lymerix. The injections were administered in the right thigh, instead of the recommended deltoid muscle. At an unspecified time post immunization, the patient experienced muscle weakness and muscle pain. As of 7/8/03, the outcomes of the events were unknown.
Age: 23.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Laboratory test abnormal, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fatigue in a 23 year old male pt who received Lyme disease vaccine recombinant OsaA (Lymerix) for prophylaxis.  Concurrent medications included loratadine (Claritin).  On unspecified dates in 1999, the pt received an unspecified number of injections of Lymerix.  Approximately 4 years post-immunization, "several weeks" prior to 08/01/03, the pt presented to the physician with complaints of fatigue and fever.  Total Lyme antibody screen was positive.  The events were unresolved as of 08/01/03.
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis
Clinical narrative: This case described the occurrence of arthritis in a 62 year old male pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other health care professional.  On unspecified dates in 1999, the pt received an unspecified number of injections of Lymerix.  Approximately 3 years post-immunization, in "late summer of 2002", the pt experienced arthritis.  The event was unresolved as of 08/07/03.  As of that date, the pt had not sought medical attention.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Condition aggravated, Oedema peripheral
Clinical narrative: This case described the occurrence of exacerbation of arthritis and fibromyalgia in a 47 year old female who received Lyme disease vaccine recombinant OsaA (Lymerix) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other healthcare professional.  The medical history reportedly included allergy to sulfa-containing medications, fibromyalgia and arthritis. Concurrent medications included naproxen (Naproxyn) and fluoxetine hydrochloride (Prozac). The pt stated that she was bitten by a tick in October 2001.  Reportedly, a physician removed the tick and recommended that she receive the first injection of Lymerix, which was administered on 10/05/01.  The pt stated that on 10/06/01, one day post-immunization, she developed swelling in her arms and pain "in her body", which she attributed to worsening of the pre-existing fibromyalgia and arthritis.  The pt stated that "the pain has never let up.  My body is deteriorating, and they tell me if the rate of acceleration does not slow, my bones will eventually fuse together."  The pt stated that due to the swelling of her arms that she experienced post-immunization the Lymerix immunization series was discontinued.  As of 08/11/03, the arm swelling had reportedly resolved.  The worsening of pre-existing fibromyalgia and arthritis was "worse".
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of knee pain in a 43 year old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  On unspecified dates, the pt received an unspecified number of doses of Lymerix.  The pt presented to the reporter on 08/06/03 with a complaint of knee pain that had been present for approximately one month.  As of 08/18/03, the knee pain persisted.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Anorexia, Arthralgia, Chills, Fatigue
Clinical narrative: This case described a 40 year old female pt who believe she contracted Lyme disease following receipt of Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. This report was received from the pt and has been verified by a physician.  The pt received Lymerix on 03/07/00, 04/07/00 and 04/10/01. The pt stated that in August 2003, she began to experienced a leg rash, memory loss, "severe" fatigue, chills, joint achiness, and loss of appetite. The pt believed that she had Lyme disease.  Additional information was received from the treating physician on 10/31/03.  The pt presented to him on 08/19/03 with rash, fatigue and diffuse joint pain of approximately two weeks duration.  A presumptive diagnosis of Lyme disease was made and the physician prescribed a 21 day course of doxycycline.  Subsequently, Lyme Western blots were negative.  As of 10/21/03, the "symptoms were improving with therapy."
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Rash
Clinical narrative: This case described a 40 year old female pt who believe she contracted Lyme disease following receipt of Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. This report was received from the pt and has been verified by a physician.  The pt received Lymerix on 03/07/00, 04/07/00 and 04/10/01. The pt stated that in August 2003, she began to experienced a leg rash, memory loss, "severe" fatigue, chills, joint achiness, and loss of appetite. The pt believed that she had Lyme disease.  Additional information was received from the treating physician on 10/31/03.  The pt presented to him on 08/19/03 with rash, fatigue and diffuse joint pain of approximately two weeks duration.  A presumptive diagnosis of Lyme disease was made and the physician prescribed a 21 day course of doxycycline.  Subsequently, Lyme Western blots were negative.  As of 10/21/03, the "symptoms were improving with therapy."
Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of joint pain in an approximately 52 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  On unspecified dates "several years ago" the pt received an unspecified number of doses of Lymerix.  In approximately 1999, the pt began to experience joint pain and muscle pain and was referred to the reporting orthopedist.  As of 08/29/03, the events persisted.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This case described the occurrence of arthralgia in an adult female pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received from the pt, who is a nurse.  The pt's medical history included two episodes of Lyme disease.  On unspecified dates, the pt received an unspecified number of doses of Lymerix.  At an unknown time post-immunization, the pt began to experience arthralgia.  The pt was seen by a physician, who prescribed unspecified IV antibiotics.  The outcome of the event is unknown.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Dizziness, Laboratory test abnormal, Vertigo
Clinical narrative: This case was reported by a nurse practitioner and describes the occurrence of vertigo in a 43 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  The pt received a series of three doses of Lymerix on 05/23/00, 06/20/00 and 07/18/00.  The fourth dose of Lymerix (Lot # LY145A9) was received on 08/31/01.  This represents a schedule of 0,1,2 and 15 months, rather than the recommended schedule of 0,1 and 12 months.  ON 03/31/03 approximately 57 days after the fourth injection of Lymerix, the pt experienced vertigo and dizziness which required the pt to consult a physician.  The outcome of the events is unknown.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: This report described the occurrence of joint pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 6/11/99, 7/8/99, and unspecified date in July 2000 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint and muscle pain. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Erythema, Fatigue, Joint range of motion decreased
Clinical narrative: This report described the occurrence of joint pain and arthritis in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was initially received as part of litigation proceedings and was subsequently medically confirmed through receipt of medical treatment records via the litigation process. The patient received injections of Lymerix on 8/14/01 and 9/14/01 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint pain, arthritis, fatigue, and rashes. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient stepped on a rusty nail on 8/13/01. He saw his family practice physician on 8/14/01 after he began to develop pain and erythema at the puncture wound site. His physician ordered he receive a tetanus vaccine that day. He was sent to another facility since the physician did not have the vaccine available at his office. It is not indicated in the records whether he had the vaccine. There is also no evidence in the available medical records of him receiving Lymerix that day. On 2/19/02, the patient saw his physician for a one to two week history of pain in the right shoulder over the AC junction which developed when he was pulling an object and increased with internal rotation. He also complained of pain over the abductor tendons in the right hip. His physician attributed the pain to tendonitis and he was started on ibuprofen. By 5/30/02 the shoulder pain had worsened. A shoulder x-ray was negative. He was treated for subacromial bursitis with naprosyn. This did not control the pain. On 6/20/02 he received an injection into the bursa of kenalog plus xylocaine.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Rash, Tendonitis
Clinical narrative: This report described the occurrence of joint pain and arthritis in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was initially received as part of litigation proceedings and was subsequently medically confirmed through receipt of medical treatment records via the litigation process. The patient received injections of Lymerix on 8/14/01 and 9/14/01 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint pain, arthritis, fatigue, and rashes. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient stepped on a rusty nail on 8/13/01. He saw his family practice physician on 8/14/01 after he began to develop pain and erythema at the puncture wound site. His physician ordered he receive a tetanus vaccine that day. He was sent to another facility since the physician did not have the vaccine available at his office. It is not indicated in the records whether he had the vaccine. There is also no evidence in the available medical records of him receiving Lymerix that day. On 2/19/02, the patient saw his physician for a one to two week history of pain in the right shoulder over the AC junction which developed when he was pulling an object and increased with internal rotation. He also complained of pain over the abductor tendons in the right hip. His physician attributed the pain to tendonitis and he was started on ibuprofen. By 5/30/02 the shoulder pain had worsened. A shoulder x-ray was negative. He was treated for subacromial bursitis with naprosyn. This did not control the pain. On 6/20/02 he received an injection into the bursa of kenalog plus xylocaine.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Fatigue, Insomnia, Irritability
Clinical narrative: This report described the occurrence of back pain in a 51 year old female patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient submitted a report directly to VAERS. The patient's medical history included heel spurs and under active thyroid. Concurrent medications included nabumetone, ibuprofen, levothyroxine, and estradiol. On a VAERS form completed by the patient on 3/14/03, she indicated that she received SC injections of Lymerix on 6/4/99, 7/8/99, and 7/8/00. Lymerix is not recommended for SC administration. The patient indicated that her adverse experience began in Fall 2001. For the description of the event, she wrote, "Fatigue, muscle and joint pain, problems sleeping, memory problems." She indicated that the outcome of these events was unknown. On 9/3/03, the patient's attorney stated, "Vaccinations occurred on 7/3/99, 7/8/99, and 7/8/00 according to the client." The attorney alleged that the patient's symptoms were masked by Relafen and Motrin which she was taking for heel [sic] spurs. She recognized her symptoms in the fall of 2001. She suffered back, shoulder, elbow and neck pain, memory problems and insomnia. The patient is HLA DR4 positive. The following information was provided via medical records. Medical history included joint pain, neck pain, and fatigue, in addition to Lyme disease versus fibromyalgia versus chronic fatigue syndrome (documented as past medical history upon evaluation on 7/22/02). Dates of onset for these medical history events were not provided. According to records, the patient received Lymerix vaccinations on 6/3/99, 7/8/99, and 6/8/00 (the patient's attorney reported that the third Lymerix vaccination had been administered on 7/8/00). On 6/24/99, three weeks after the initial Lymerix vaccination, the patient presented with complaints of fatigue. The patient developed joint pain in multiple joints, and was evaluated for these complaints on 8/27/01, 7/29/02, and 1/30/03. As recently as 1/30/03, the patient continued to experience multiple joint pain. Medical records dated 5/5/03 indicated that the patient had experienced a Lyme vaccine reaction. Following the reported onset of back pain, the patient experienced upper respiratory infection, colon polyp, and pharyngitis. She also complained of moodiness/irritability and a fluttery feeling in her chest on 6/24/99, the same date she was evaluated for fatigue. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide the outcome of the reported events.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Memory impairment, Mood swings, Myalgia, Neck pain, Pharyngitis
Clinical narrative: This report described the occurrence of back pain in a 51 year old female patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient submitted a report directly to VAERS. The patient's medical history included heel spurs and under active thyroid. Concurrent medications included nabumetone, ibuprofen, levothyroxine, and estradiol. On a VAERS form completed by the patient on 3/14/03, she indicated that she received SC injections of Lymerix on 6/4/99, 7/8/99, and 7/8/00. Lymerix is not recommended for SC administration. The patient indicated that her adverse experience began in Fall 2001. For the description of the event, she wrote, "Fatigue, muscle and joint pain, problems sleeping, memory problems." She indicated that the outcome of these events was unknown. On 9/3/03, the patient's attorney stated, "Vaccinations occurred on 7/3/99, 7/8/99, and 7/8/00 according to the client." The attorney alleged that the patient's symptoms were masked by Relafen and Motrin which she was taking for heel [sic] spurs. She recognized her symptoms in the fall of 2001. She suffered back, shoulder, elbow and neck pain, memory problems and insomnia. The patient is HLA DR4 positive. The following information was provided via medical records. Medical history included joint pain, neck pain, and fatigue, in addition to Lyme disease versus fibromyalgia versus chronic fatigue syndrome (documented as past medical history upon evaluation on 7/22/02). Dates of onset for these medical history events were not provided. According to records, the patient received Lymerix vaccinations on 6/3/99, 7/8/99, and 6/8/00 (the patient's attorney reported that the third Lymerix vaccination had been administered on 7/8/00). On 6/24/99, three weeks after the initial Lymerix vaccination, the patient presented with complaints of fatigue. The patient developed joint pain in multiple joints, and was evaluated for these complaints on 8/27/01, 7/29/02, and 1/30/03. As recently as 1/30/03, the patient continued to experience multiple joint pain. Medical records dated 5/5/03 indicated that the patient had experienced a Lyme vaccine reaction. Following the reported onset of back pain, the patient experienced upper respiratory infection, colon polyp, and pharyngitis. She also complained of moodiness/irritability and a fluttery feeling in her chest on 6/24/99, the same date she was evaluated for fatigue. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide the outcome of the reported events.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Polyp, Upper respiratory tract infection
Clinical narrative: This report described the occurrence of back pain in a 51 year old female patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient submitted a report directly to VAERS. The patient's medical history included heel spurs and under active thyroid. Concurrent medications included nabumetone, ibuprofen, levothyroxine, and estradiol. On a VAERS form completed by the patient on 3/14/03, she indicated that she received SC injections of Lymerix on 6/4/99, 7/8/99, and 7/8/00. Lymerix is not recommended for SC administration. The patient indicated that her adverse experience began in Fall 2001. For the description of the event, she wrote, "Fatigue, muscle and joint pain, problems sleeping, memory problems." She indicated that the outcome of these events was unknown. On 9/3/03, the patient's attorney stated, "Vaccinations occurred on 7/3/99, 7/8/99, and 7/8/00 according to the client." The attorney alleged that the patient's symptoms were masked by Relafen and Motrin which she was taking for heel [sic] spurs. She recognized her symptoms in the fall of 2001. She suffered back, shoulder, elbow and neck pain, memory problems and insomnia. The patient is HLA DR4 positive. The following information was provided via medical records. Medical history included joint pain, neck pain, and fatigue, in addition to Lyme disease versus fibromyalgia versus chronic fatigue syndrome (documented as past medical history upon evaluation on 7/22/02). Dates of onset for these medical history events were not provided. According to records, the patient received Lymerix vaccinations on 6/3/99, 7/8/99, and 6/8/00 (the patient's attorney reported that the third Lymerix vaccination had been administered on 7/8/00). On 6/24/99, three weeks after the initial Lymerix vaccination, the patient presented with complaints of fatigue. The patient developed joint pain in multiple joints, and was evaluated for these complaints on 8/27/01, 7/29/02, and 1/30/03. As recently as 1/30/03, the patient continued to experience multiple joint pain. Medical records dated 5/5/03 indicated that the patient had experienced a Lyme vaccine reaction. Following the reported onset of back pain, the patient experienced upper respiratory infection, colon polyp, and pharyngitis. She also complained of moodiness/irritability and a fluttery feeling in her chest on 6/24/99, the same date she was evaluated for fatigue. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide the outcome of the reported events.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Chest pain
Clinical narrative: This report described the occurrence of chest pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 6/3/99, 7/7/99, and 5/25/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered chest pain, aching knees, hands, elbows, and shoulders within one month of his first vaccination. Treatment and outcomes of the alleged events were not reported.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Rash
Clinical narrative: This report described the occurrence of arthritis like symptoms in a 58 year old male patient who stated that he received Lyme disease vaccine recombinant as part of a clinical trial of compound 215274. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 2/8/95, 4/13/95, and 2/28/96 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint pain, rashes and arthritis like symptoms. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Following the reported administration of Lymerix vaccines, on 7/28/97, the patient presented with an injury to the right shoulder after attempting to lift his car, and was diagnosed with impingment syndrome of the right rotator cuff. This was not reported as an adverse event due to vaccine administration, but was found during the course of review of the patient's medical records. Therefore, this is not listed as an adverse event. The most recent information received on 12/9/03 provided no information about the claimed events.
Sex: M
Vaccine: LYME
Symptoms: Headache, Medication error, Migraine, Neck pain
Clinical narrative: This report described the occurrence of migraine headaches in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 3/24/00 (lot LY128A2), 4/20/00 (lot LY136B9), and 9/27/00 (lot LY128A2). The vaccine was administered on a 0, 1, and 6 month schedule rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered neck pain after his third vaccination along with migraine headaches. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Medication error, Swelling
Clinical narrative: This report described the occurrence of knee and leg pain and swelling in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 7/3/01, 8/6/01, and 1/22/02 according to the client. This represents a schedule of 0, 1, and 6 months rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered right knee and leg swelling and pain. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: This report described the occurrence of chest pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received injections of Lymerix on 5/26/99, 6/28/99, and 5/9/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered foot swelling, joint pain, tingling, headaches, chest tightness with pain, stiff neck and memory loss beginning three days after first and second vaccinations. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient, a 43 year old male, had a history of hypertension and hypercholesterolemia and was in relatively good health, with good control of his hypertension. He worked and had frequent exposure to the woods. In approximately May 2000, he developed severe acute headaches, associated with chest pain. The chest pain was pleuritic and non-exertional and resolved after taking about ten deep breaths. He saw a cardiologist regarding the chest pain in June 2000. An electrocardiogram and echocardiogram were normal. He also underwent a hematology consult on 6/26/00 because of complaints of extreme fatigue, malaise and shortness of breath, which also started intermittently in May 2000. These symptoms occurred with a stiff neck and the other symptoms of chest pain and headache. He reported to the hematologist that he had received Lymerix in May and June of 1999 and May 2000 and that he had several gout-like left foot pain shortly after the first two doses. The other symptoms occurred several weeks after receiving the third Lyme vaccine. From May, 2000 to June 2000 his hemoglobin began to decrease from 13.9g/dl to 10.9g/dl while his erythrocyte sedimentation rate also rose form 29 to 122 mm/hr. During this time his white blood cell count, platelets and liver function tests were normal. In addition the patient complained of tachycardia. The hematologist did not suspect a hematologic problem but thought the anemia was due to another underlying cause. In view of the patient's occupation, he felt the patient's multiple symptoms were most likely related to a tick related disease or possibly secondary to Lymerix. He was started on doxycycline. Two months later, on 8/17/00, his hemoglobin and sedimentation rate had improved, though he was still anemic. He underwent a bone marrow biopsy that day which was normal. He had a slightly low iron, with a normal ferritin and iron biding capacity. At that time he continued to complain of fatigue with myalgia and arthralgia. Additional lab values are available upon request. On 8/15/00 CTR scan of chest revealed a small 1-2 millimeter-sized pleural nodule in the right mid/lower lung anteriorly and posteriorly. This was followed by CT scan over the next year. It was unchanged suggesting a benign etiology.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Laboratory test abnormal, Malaise, Musculoskeletal stiffness
Clinical narrative: This report described the occurrence of chest pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received injections of Lymerix on 5/26/99, 6/28/99, and 5/9/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered foot swelling, joint pain, tingling, headaches, chest tightness with pain, stiff neck and memory loss beginning three days after first and second vaccinations. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient, a 43 year old male, had a history of hypertension and hypercholesterolemia and was in relatively good health, with good control of his hypertension. He worked and had frequent exposure to the woods. In approximately May 2000, he developed severe acute headaches, associated with chest pain. The chest pain was pleuritic and non-exertional and resolved after taking about ten deep breaths. He saw a cardiologist regarding the chest pain in June 2000. An electrocardiogram and echocardiogram were normal. He also underwent a hematology consult on 6/26/00 because of complaints of extreme fatigue, malaise and shortness of breath, which also started intermittently in May 2000. These symptoms occurred with a stiff neck and the other symptoms of chest pain and headache. He reported to the hematologist that he had received Lymerix in May and June of 1999 and May 2000 and that he had several gout-like left foot pain shortly after the first two doses. The other symptoms occurred several weeks after receiving the third Lyme vaccine. From May, 2000 to June 2000 his hemoglobin began to decrease from 13.9g/dl to 10.9g/dl while his erythrocyte sedimentation rate also rose form 29 to 122 mm/hr. During this time his white blood cell count, platelets and liver function tests were normal. In addition the patient complained of tachycardia. The hematologist did not suspect a hematologic problem but thought the anemia was due to another underlying cause. In view of the patient's occupation, he felt the patient's multiple symptoms were most likely related to a tick related disease or possibly secondary to Lymerix. He was started on doxycycline. Two months later, on 8/17/00, his hemoglobin and sedimentation rate had improved, though he was still anemic. He underwent a bone marrow biopsy that day which was normal. He had a slightly low iron, with a normal ferritin and iron biding capacity. At that time he continued to complain of fatigue with myalgia and arthralgia. Additional lab values are available upon request. On 8/15/00 CTR scan of chest revealed a small 1-2 millimeter-sized pleural nodule in the right mid/lower lung anteriorly and posteriorly. This was followed by CT scan over the next year. It was unchanged suggesting a benign etiology.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Oedema peripheral, Paraesthesia
Clinical narrative: This report described the occurrence of chest pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received injections of Lymerix on 5/26/99, 6/28/99, and 5/9/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered foot swelling, joint pain, tingling, headaches, chest tightness with pain, stiff neck and memory loss beginning three days after first and second vaccinations. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient, a 43 year old male, had a history of hypertension and hypercholesterolemia and was in relatively good health, with good control of his hypertension. He worked and had frequent exposure to the woods. In approximately May 2000, he developed severe acute headaches, associated with chest pain. The chest pain was pleuritic and non-exertional and resolved after taking about ten deep breaths. He saw a cardiologist regarding the chest pain in June 2000. An electrocardiogram and echocardiogram were normal. He also underwent a hematology consult on 6/26/00 because of complaints of extreme fatigue, malaise and shortness of breath, which also started intermittently in May 2000. These symptoms occurred with a stiff neck and the other symptoms of chest pain and headache. He reported to the hematologist that he had received Lymerix in May and June of 1999 and May 2000 and that he had several gout-like left foot pain shortly after the first two doses. The other symptoms occurred several weeks after receiving the third Lyme vaccine. From May, 2000 to June 2000 his hemoglobin began to decrease from 13.9g/dl to 10.9g/dl while his erythrocyte sedimentation rate also rose form 29 to 122 mm/hr. During this time his white blood cell count, platelets and liver function tests were normal. In addition the patient complained of tachycardia. The hematologist did not suspect a hematologic problem but thought the anemia was due to another underlying cause. In view of the patient's occupation, he felt the patient's multiple symptoms were most likely related to a tick related disease or possibly secondary to Lymerix. He was started on doxycycline. Two months later, on 8/17/00, his hemoglobin and sedimentation rate had improved, though he was still anemic. He underwent a bone marrow biopsy that day which was normal. He had a slightly low iron, with a normal ferritin and iron biding capacity. At that time he continued to complain of fatigue with myalgia and arthralgia. Additional lab values are available upon request. On 8/15/00 CTR scan of chest revealed a small 1-2 millimeter-sized pleural nodule in the right mid/lower lung anteriorly and posteriorly. This was followed by CT scan over the next year. It was unchanged suggesting a benign etiology.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Shoulder pain
Clinical narrative: This report described the occurrence of joint pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient's attorney stated that the patient received an unspecified number of injections of Lymerix in the time period between 1998 and 1999 according to the client. Most likely, the vaccinations were administered in 1999. On 9/3/03, the patient's attorney alleged that the patient suffered severe pain of the knees, shoulder, and elbows. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Age: 8.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Disturbance in attention, Dizziness, Fatigue, Headache
Clinical narrative: This report described the occurrence of headaches in a female pt who reportedly received Lyme disease vaccine recombinant as part of a clinical trial of compound 215274. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 6/8/98, 7/6/98 and 6/3/99 "according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered from headaches, fatigue, flu-like symptoms, tingling, difficulty concentrating, stomach upset, swollen lymph nodes, muscle and joint pain, and dizziness according to the client." Time to onset from immunization was not reported.
Age: 8.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Lymphadenopathy, Myalgia, Paraesthesia, Stomach discomfort
Clinical narrative: This report described the occurrence of headaches in a female pt who reportedly received Lyme disease vaccine recombinant as part of a clinical trial of compound 215274. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 6/8/98, 7/6/98 and 6/3/99 "according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered from headaches, fatigue, flu-like symptoms, tingling, difficulty concentrating, stomach upset, swollen lymph nodes, muscle and joint pain, and dizziness according to the client." Time to onset from immunization was not reported.
Age: 6.0
Sex: M
Vaccine: LYME
Symptoms: Chills, Pyrexia
Clinical narrative: This report described the occurrence of fever in a male pt who reportedly received Lyme disease vaccine recombinant as part of a clinical trial of compound 215274. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on5/13/98, 6/8/98 and 5/5/99 "according to his medical records." On 9/3/03, the pt's attorney alleged that the pt "has complaint of fever and chills according to his medical records." Time to onset from immunization was not reported. Limited medical records Limited medical records supplied by the attorney indicated that the pt was treated with amoxicillin on 9/17/02, Zithromax on 9/17/02 and Mepron on an unspecified date. Outcomes of the alleged events were not reported.
Sex: M
Vaccine: LYME
Symptoms: Headache, Musculoskeletal stiffness, Paraesthesia, Tenderness, Visual disturbance
Clinical narrative: This report described the occurrence of soreness in a male pt who received Lyme disease vaccine (LYMErix) for prophylaxos. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received three injections of LYMErix "with the last in June of 2000 according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered soreness, stiffness of his foot and knuckles, tingling, headaches, and vision problems. The onset of his symptoms is not clear at this time." Treatment and outcomes of the alleged events were not reported.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Joint swelling, Paraesthesia, Visual disturbance
Clinical narrative: This report described the occurrence of joint pain and swelling in a female pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt reportedly received an unspecified number of injections of LYMErix. The pt's attorney stated, "Dates of vaccination are not available at this time." On 9/3/03, the pt's attorney alleged that the pt "suffered joint pain and swelling, tingling of her hand, and vision problems. The onset of her symptoms is not clear at this time." Treatment and outcomes of the alleged events were not reported.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Joint swelling, Laboratory test abnormal, Neck pain
Clinical narrative: This report described the occurrence of joint pain and swelling in a forty year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. Medical records were subsequently provided. The patient received an injection of Lymerix on 6/17/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint pain and swelling within one week of vaccination according to the client. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Medical history included lowe back pain for years. On 8/14/00, the patient presented with back pain and described being totally out of joint. On 2/14/03, the patient presented for orthopedic evaluation with complaints of right shoulder pain that began in approximately August 2002 following manual labor. X-rays revealed degenerative changes at the acromioclavicular joint with mild osteolysis at the distal clavicle. At that time, he was diagnosed with work-related shoulder pain, shoulder region impingement syndrome, and localized osteoarthritis, shoulder-acromioclavicular joint. He also complained of acute right neck pain which he felt was related to problems stemming from the unopposed action of the left upper trapezius impingement and atrophy of the right shoulder girdle, and reported inability to lift his arm without pain. Treatment included physical therapy. On 8/28/03, the patient underwent arthroscopy of the right shoulder including arthroscopic subacromial decompression and right distal clavulectomy for treatment of right shoulder impingement syndrome and acromioclavicular joint pain. Post operative diagnosis included right shoulder impingement syndrome and degenerative joint disease of the right acromioclavicular joint. Treatment included Tylenol+ codeine. Following the reported onset of joint pain and swelling, the patient experienced back and neck pain attributed to exertion, a disc bulge and lumbosacral strain while lifting with left leg/foot paresthesia. On 10/10/01, the patient reported that he bent over at work and his back went out. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide information about the outcome of joint pain and joint swelling.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Osteolysis, Paraesthesia
Clinical narrative: This report described the occurrence of joint pain and swelling in a forty year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. Medical records were subsequently provided. The patient received an injection of Lymerix on 6/17/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint pain and swelling within one week of vaccination according to the client. Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. Medical history included lowe back pain for years. On 8/14/00, the patient presented with back pain and described being totally out of joint. On 2/14/03, the patient presented for orthopedic evaluation with complaints of right shoulder pain that began in approximately August 2002 following manual labor. X-rays revealed degenerative changes at the acromioclavicular joint with mild osteolysis at the distal clavicle. At that time, he was diagnosed with work-related shoulder pain, shoulder region impingement syndrome, and localized osteoarthritis, shoulder-acromioclavicular joint. He also complained of acute right neck pain which he felt was related to problems stemming from the unopposed action of the left upper trapezius impingement and atrophy of the right shoulder girdle, and reported inability to lift his arm without pain. Treatment included physical therapy. On 8/28/03, the patient underwent arthroscopy of the right shoulder including arthroscopic subacromial decompression and right distal clavulectomy for treatment of right shoulder impingement syndrome and acromioclavicular joint pain. Post operative diagnosis included right shoulder impingement syndrome and degenerative joint disease of the right acromioclavicular joint. Treatment included Tylenol+ codeine. Following the reported onset of joint pain and swelling, the patient experienced back and neck pain attributed to exertion, a disc bulge and lumbosacral strain while lifting with left leg/foot paresthesia. On 10/10/01, the patient reported that he bent over at work and his back went out. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. The most recent information received on 12/8/03 did not provide information about the outcome of joint pain and joint swelling.
Sex: F
Vaccine: LYME
Symptoms: Joint swelling
Clinical narrative: This report described the occurrence of joint swelling in a female patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received an unspecified number of injections of Lymerix between 1998 and 2000 with the last dose in May of 2000 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered swelling of her elbow, thumbs, and knees since 2000. Time to onset from immunization, treatment, and outcomes of the alleged events were not reported.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Fatigue, Influenza like illness, Paraesthesia
Clinical narrative: This report described the occurrence of flu-like symptoms in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 7/8/99, 8/6/99, and 9/9/99 according to the client. This represents a 0, 1, and 2 month schedule rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered flu like symptoms, fatigue, back pain, knee, shoulder, hip pain, burning and tingling of his hands and arms. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Headache, Influenza like illness, Medication error, Tinnitus
Clinical narrative: This report described the occurrence of flu-like symptoms in a female patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 6/1/99, 7/1/99, and 7/29/99 according to the client. This represents a 0, 1, and 2 month schedule rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered flu-like symptoms, ear popping, joint pain and headaches. The onset of her symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, Joint swelling, Myalgia
Clinical narrative: This report described the occurrence of myalgias in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient's attorney reported that the patient received injections of Lymerix on 12/9/99, 2/28/00 and 5/10/01 according to the client and medical records. However, an immunization record supplied by the attorney indicated that the dates of immunization were 12/9/99, 2/17/00, and 8/10/01. This represents a schedule of 0, 2, and 20 months rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered myalgia, aching hands, feet and legs, fatigue, joint swelling, night sweats, numbness and headaches. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Sex: M
Vaccine: LYME
Symptoms: Night sweats, Pain
Clinical narrative: This report described the occurrence of myalgias in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient's attorney reported that the patient received injections of Lymerix on 12/9/99, 2/28/00 and 5/10/01 according to the client and medical records. However, an immunization record supplied by the attorney indicated that the dates of immunization were 12/9/99, 2/17/00, and 8/10/01. This represents a schedule of 0, 2, and 20 months rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered myalgia, aching hands, feet and legs, fatigue, joint swelling, night sweats, numbness and headaches. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.