chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Nausea, Tremor, Vomiting
Clinical narrative: 3 hours, post vax, pt developed trembling, abdominal pain which progressed to nausea, retching and vomiting which lasted 3-4 hours, then resolved. Not examined; this reported by the mother.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Warm to touch, tender, induration 1/2".
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Rash macular, Urticaria
Clinical narrative: Rash all over body-blotchy raised patches. Generalized urticaria, 12 hours later.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: 1cm X 3cm raised, reddened welt, warm to touch, sensitive to touch (not painful, not itchy).
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Drug ineffective, Infection, Pyrexia, Upper respiratory tract infection
Clinical narrative: Began on 10/8/00 with "pimples" on various body parts. Per mother temperature was 100F-102.4F (oral), dry cough (day and night). On 10/13/00, dx'd in office with URI and varicella zoster.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abasia, Herpes zoster, Infection
Clinical narrative: 2 year old female, developed vesiculopapular rash on right interior thigh/Tibia and feet, with refusal to walk. Presumed shingles was treated with acyclovir X 5 days. Rash resolved completely in about 1 week with restoration of walking. No history of chickenpox.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Generalized urticaria, post vax, (less than 24 hours later); resolved with Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pruritus, Tremor
Clinical narrative: 2 hours, post vax, pt had shakes, light-headedness, nausea and itchy skin on whole body.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Pt had swollen, red arm, increased temperature 102F-104F, extreme malaise and chills, post vax.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dizziness, Pallor
Clinical narrative: About 12 hours, post vax, pt coughing, pale and dizzy.
Age: 4.0
Sex: M
Vaccine: DT, IPV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Left leg swollen, mild redness on medial lower area, non-tender from hip to knee with limping noted. Treated with cold compresses and instructed to return if worsened or increased signs and symptoms. Was seen later in PM in clinic with increased swelling and partial blanching. Added Prelone 1 tsp X 2-3 days. Has an appointment for recheck.
Age: 56.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Pt states she developed inflammation on left upper arm, including redness, swelling, throbbing and itching within about 4-5 hours, post vax. Area also was warmer than surrounding portion of upper arm. Pt states these symptoms became more pronounced in the next 36 hours. States also has some soreness in left neck. Saw MD on 10/19/00. He advised ice pack application.
Age: 47.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Chills, Pain
Clinical narrative: Developed general body aching and chills approx. 36 hours, post vax, symptoms lasting approx. 48 hours.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site haemorrhage, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Extensive local reaction with purple, hot, indurated area surrounding injection site, over 10cm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Muscular weakness
Clinical narrative: Pt reported spells of difficulty raising and picking up fork, undoing clothes in arms and legs, lasting 15 minutes. Had to slide objects, multiple times a day on 9/29, 9/30 and 10/1 and only 3 times. On 10/2, had 1 episode. On 10/6, had normal exam.
Age: 49.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Unevaluable event
Clinical narrative: No data provided.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site, starting in the evening of the day the vaccination was given. Cellulitis/Abscess
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Rash, Throat tightness, Urticaria
Clinical narrative: Pt noted rash on arms and back at 22:30 on 10/12/00, post vax. Took Benadryl. On 10/13/00, after eating seafood at 20:30, developed numbness in his tongue, tightness of his throat and hives on his neck. Treated at ER and given Benadryl, epinephrine and prednisone.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, MMR, TYP, YF
Symptoms: Headache, Nausea, Tinnitus
Clinical narrative: Soldier complaining of ears ringing, headache and nausea. He stated he took a total of 8 Tylenol between 18:00 and 06:00 on 8/13/00. He was made aware that the headache and nausea are normal side effects after receiving vaccinations. Instructed him to consult physician in 2-3 days if symptoms do not subside. Client states "the symptoms are barely noticeable".
Age: 26.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Hypersensitivity, Hypoaesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Pt with complaint of numbness, tingling in right upper extremity. Noted onset at 19:00 on 8/12/00. Right upper extremity with swelling noted at bicep, and is warm to touch. He was instructed to take 2 Tylenol, avoid constricting garments to affected site and seek medical help in 3 days if swelling.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Pt developed dizziness, headache and muscle aches, immediately, post vax, lasting about 24 hours.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site oedema, Injury, Lymphoedema
Clinical narrative: Local erythema and edema at site of injection associated with supraclavicular adenopathy draining limb of injection site and animal bite.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Oedema
Clinical narrative: Severe local pain, redness, swelling; WBC 9.3/ ESR 31.
Age: 33.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Arthralgia, Fatigue, Headache, Joint swelling, Myalgia
Clinical narrative: Subsequent to receiving first dose of Lymerix the pt began to experience joint pain, swelling, stiffness, fatigue, muscle pain, hair loss, headaches, and tightness in her hands and feet. The symptoms continue. the pt stated that she has had various blood tests which are still ongoing. Physician stated that the pt was treated from 02/02/00 to 04/14/00 for routine medical exams. Medical documentation is illegible. The most recent information reports the event as unresolved.
Age: 33.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Pain
Clinical narrative: Subsequent to receiving first dose of Lymerix the pt began to experience joint pain, swelling, stiffness, fatigue, muscle pain, hair loss, headaches, and tightness in her hands and feet. The symptoms continue. the pt stated that she has had various blood tests which are still ongoing. Physician stated that the pt was treated from 02/02/00 to 04/14/00 for routine medical exams. Medical documentation is illegible. The most recent information reports the event as unresolved.
Age: 33.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Alopecia, Arthralgia, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Subsequent to receiving first dose of Lymerix the pt began to experience joint pain, swelling, stiffness, fatigue, muscle pain, hair loss, headaches, and tightness in her hands and feet. The symptoms continue. the pt stated that she has had various blood tests which are still ongoing. Physician stated that the pt was treated from 02/02/00 to 04/14/00 for routine medical exams. Medical documentation is illegible. The most recent information reports the event as unresolved.
Age: 33.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Myalgia, Oedema
Clinical narrative: Subsequent to receiving first dose of Lymerix the pt began to experience joint pain, swelling, stiffness, fatigue, muscle pain, hair loss, headaches, and tightness in her hands and feet. The symptoms continue. the pt stated that she has had various blood tests which are still ongoing. Physician stated that the pt was treated from 02/02/00 to 04/14/00 for routine medical exams. Medical documentation is illegible. The most recent information reports the event as unresolved.
Age: 33.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Arthralgia, Fatigue, Headache, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Subsequent to receiving first dose of Lymerix the pt began to experience joint pain, swelling, stiffness, fatigue, muscle pain, hair loss, headaches, and tightness in her hands and feet. The symptoms continue. the pt stated that she has had various blood tests which are still ongoing. Physician stated that the pt was treated from 02/02/00 to 04/14/00 for routine medical exams. Medical documentation is illegible. The most recent information reports the event as unresolved.
Age: 33.0
Sex: F
Vaccine: LYME, LYME, LYME
Symptoms: Myalgia
Clinical narrative: Subsequent to receiving first dose of Lymerix the pt began to experience joint pain, swelling, stiffness, fatigue, muscle pain, hair loss, headaches, and tightness in her hands and feet. The symptoms continue. the pt stated that she has had various blood tests which are still ongoing. Physician stated that the pt was treated from 02/02/00 to 04/14/00 for routine medical exams. Medical documentation is illegible. The most recent information reports the event as unresolved.
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Injection site pain, Neck pain
Clinical narrative: Subsequent to receiving the first does of Lymerix, pts right arm was a little sore. One day post vax the pt was unable to get out of bed. Pt joints were aching and his neck was hurting like the flu. The most recent information reports the outcome of the event as ongoing.
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Hypokinesia, Influenza, Injection site pain, Neck pain
Clinical narrative: Subsequent to receiving the first does of Lymerix, pts right arm was a little sore. One day post vax the pt was unable to get out of bed. Pt joints were aching and his neck was hurting like the flu. The most recent information reports the outcome of the event as ongoing.
Sex: M
Vaccine: LYME, LYME
Symptoms: Pain
Clinical narrative: Subsequent to receiving the first does of Lymerix, pts right arm was a little sore. One day post vax the pt was unable to get out of bed. Pt joints were aching and his neck was hurting like the flu. The most recent information reports the outcome of the event as ongoing.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, DTP, HEP, HIBV, OPV
Symptoms: Agitation, Apnoea, Blood glucose increased, Cerebral haemorrhage, Cerebral ischaemia
Clinical narrative: 11 days post vax, the pt developed lethargy and a high pitched cry. 3 days later the baby became apneic. Death occurred 17 days post vax. It is believed that the baby died of vaccine-induced encephalitis.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, DTP, HEP, HIBV, OPV
Symptoms: Convulsion, Diarrhoea, Feeding disorder neonatal, Grunting, High-pitched crying
Clinical narrative: 11 days post vax, the pt developed lethargy and a high pitched cry. 3 days later the baby became apneic. Death occurred 17 days post vax. It is believed that the baby died of vaccine-induced encephalitis.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, DTP, HEP, HIBV, OPV
Symptoms: Hypoxia, Lethargy, Liver function test abnormal, Meningitis, Platelet count increased
Clinical narrative: 11 days post vax, the pt developed lethargy and a high pitched cry. 3 days later the baby became apneic. Death occurred 17 days post vax. It is believed that the baby died of vaccine-induced encephalitis.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, DTP, HEP, HIBV, OPV
Symptoms: Pneumonia, Pyrexia, Respiratory arrest
Clinical narrative: 11 days post vax, the pt developed lethargy and a high pitched cry. 3 days later the baby became apneic. Death occurred 17 days post vax. It is believed that the baby died of vaccine-induced encephalitis.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, DTP, HEP, HIBV, OPV
Symptoms: Agitation, Apnoea, Crying, Encephalitis, Lethargy
Clinical narrative: 11 days post vax, the pt developed lethargy and a high pitched cry. 3 days later the baby became apneic. Death occurred 17 days post vax. It is believed that the baby died of vaccine-induced encephalitis.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: On 8/29/00 at midnight the pt had one to two minute episodes of bilateral shoulder and arm jerking. A temp of 99.9 at the time was noted, eyes were open, alert throughout episode. On 8/30/00 early morning facial and neck twitching for 30-40 seconds, was alert throughout, no postictal state, no fever. Pt was then fine.
Age: 0.8
Sex: F
Vaccine: IPV, PNC
Symptoms: Pyrexia
Clinical narrative: The pt received the vaccines in the morning and by the afternoon, the pt had a fever of 103.4. The Mom was instructed to give the pt Ibuprofen and when given the fever was up to 104.3 within 45 minutes was reduced to 102.3. Was told to call if there are any concerns.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Dyspnoea, Leukocytosis, Pyrexia, Vomiting
Clinical narrative: 5 hours post vax, the pt experienced emesis and trouble breathing. The pt stopped breathing, mouth to mouth resuscitation was performed and was done when 911 came the pt was breathing. The pt had a fever of 102 and was given IV fluids and antibiotics and was discharged.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying, Hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Mom states that baby had a fever of 100 - 103 last night and today. States baby screamed for 35 minutes up to 1 hour. The left leg is slightly swollen and the baby was given Tylenol. MD advised to give pediatric DT only. Diagnosed as a pertussis reaction.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Gait disturbance, Hypoaesthesia, Hypokinesia, Pain
Clinical narrative: Immediately following vax, the pt did not walk, he could move his foot, but would not move his leg, he would not put any weight on his leg. Possibly some numbness was experienced. At approximately 36 hours post vax, the pt began testing his leg and within 48 hours walked with slight limp.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: The pt experienced a local reaction measuring 2.5 x 1.25" on the left leg. Reaction not noted until approximately 14 hours post vax. The pt also experienced a fever of 99.6 up to 101. Pt was treated with Keflex.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Malaise
Clinical narrative: The pt experienced malaise, swelling, erythema, and an injection site reaction.
Age: 50.0
Sex: F
Vaccine: HEPA, TD, HEPA, TD
Symptoms: Asthenia, Erythema, Lethargy, Muscle spasms, Pain
Clinical narrative: 12 hours post vax, the pt developed pain in left arm, redness, muscle spasm, lethargy, and weakness. Went to ER and received IV epinephrine, Prednisone, and Benadryl.
Age: 50.0
Sex: F
Vaccine: HEPA, TD, HEPA, TD
Symptoms: Asthenia, Injection site erythema, Injection site pain, Lethargy, Muscle spasms
Clinical narrative: 12 hours post vax, the pt developed pain in left arm, redness, muscle spasm, lethargy, and weakness. Went to ER and received IV epinephrine, Prednisone, and Benadryl.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Haematemesis, Myalgia, Nausea, Vomiting
Clinical narrative: 24 hours post vax, the pt developed nausea and vomiting. He also had myalgias. No fever, no URI, no diarrhea. Self treated after 24 hours. Bood in emesis. He will undergo endoscopy next week.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pain, Urticaria
Clinical narrative: Post vax, the pt developed erythema, edema-a localized reaction. It looked like hives around the injection site. Also, pain in arm.
Age: 1.4
Sex: M
Vaccine: HIBV, IPV, MMR
Symptoms: Rash macular, Upper respiratory tract infection
Clinical narrative: Post vax, the pt developed URI symptoms, macular rash on trunk, extremities, and face.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Eye movement disorder, Listless, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: Post vax, the pt developed high fever, listless, quiet. Child started vomiting, eyes rolled back. Mom took child to ER and gave Motrin and a dose of Tylenol. Observed in ER for 2 hours. Instructed to give Motrin and Tylenol.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Large erythema on leg where DTAP was administered.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Mom advised physician that pt broke out in hives approximately 45 minutes to one hour after receiving vax.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pain, Pruritus, Pyrexia
Clinical narrative: Next morning post vax, the pt awoke with a fever of 101. Also, erythema and edema on right arm extending from sternum down to right arm to antecubital space. Pruritic in nature with slight tenderness to the touch.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Rash papular
Clinical narrative: 48 hours post vax, the pt developed a diffuse papular rash on arms and abdomen. Relief with Benadryl. Full resolution.
Age: 1.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site mass
Clinical narrative: Post vax, the pt developed local induration at injection site, hard 8mm diameter area on left thigh at site of Hib vax.
Age: 8.0
Sex: F
Vaccine: PNC
Symptoms: Pain, Rash, Urticaria
Clinical narrative: Rash diffuse on thigh, hive-like and tender to touch.
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Vasodilation procedure
Clinical narrative: Local reaction at injection site characterized by erythema, warmth, tender to touch, pain, and swelling.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt broke out in a vesicular rash which was very painful over the right anterior thigh to the knee with a strip up the outer surface of the buttock. It was treated with Zuvirax and cleared.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Gait disturbance, Infection, Irritability
Clinical narrative: On 9/28, the pt developed diffuse varicella. She also developed clumsy gait, and extreme fussiness.
Age: 38.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site erythema, Pruritus, Vasodilation procedure
Clinical narrative: Left deltoid with erythema, warmth, and pruritus. Treated with Claritin, Topicort cream, and cool compresses.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nausea, Pruritus, Rash papular
Clinical narrative: 12 hours post vax, the pt developed severe nausea, itching, and redness with a papular rash. Self treated with Benadryl.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on back, stomach, scratching arms. Given Benadryl to relieve symptoms.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Contusion, Oedema peripheral
Clinical narrative: 24 hours post vax, the pt developed leg swelling and bruising.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Cholelithiasis, Laboratory test abnormal, Malaise
Clinical narrative: Post vax, the physician reported that on 10/10/00, the pt just wasn't himself. Pt claimed it was the Flu shot that made him ill, however, the doctor believes pt was passing a gallstone. The pt was hospitalized on 10/11/00, for acute hepatic injury, gallstones is the dx. Additional information received on 10/16/00, states that the reporting physician reaffirmed his belief that pt's symptoms were secondary to passage of a gallstone.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: The pt experienced vomiting episodes, multiple within 24 hours of vaccination.
Age: 42.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site pain
Clinical narrative: Post vax, the pt developed severe left arm pain and tenderness at injection site on left deltoid.
Age: 61.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: A few days post vax (1st dose), the pt developed left axillary lymphadenopathy. No treatment was given. Following the 2nd dose, the pt experienced injection site soreness. Symptoms resolved 3 1/2 weeks post vax. The most recent information received on 8/8/00 reports the outcome of the pt as resolved.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthropathy, Musculoskeletal stiffness
Clinical narrative: One week post vax, the pt developed a "severe stiff neck" which resolved after 4-5 days. Following the 2nd dose, she developed a "frozen left shoulder". An MD visit was required and the physician recommended physical therapy. The "frozen shoulder resolved 5/00. The most recent information received on 6/22/00 reports the outcome of the event as resolved.
Age: 16.0
Sex: M
Vaccine: LYME
Symptoms: Lymphadenopathy, Skin nodule
Clinical narrative: Six days post vax, the pt developed a nodule on his chin above his adam's apple. Outpatient treatment was required. The physician diagnosed the pt with adenitis and treated him with antibiotics. He stated that he has no reason to believed the pt's adenitis was due to the Lymerix vaccine. The most recent information received on 7/20/00 reports the outcome of the event as unknown.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Erythema, Insomnia, Myalgia, Pain
Clinical narrative: 19 days post vax the pt experienced a fever of 102. She took ibuprofen and the fever was gone four hours later. She later experienced joint pain that started in her left wrist and right index finger. She also experience muscle pain in the right side of her neck. She reported that the muscle and joint pain moved around. She also experienced right great toe pain. The pt then developed erythema migrans on her back and received 21 days of treatment of Doxycycline at half dose. She also experienced generalized back muscle pain, bilateral knee joint pain and left arm to shoulder muscle pain. She also had difficulty sleeping due to the symptoms. The most recent information reports the rash and fever have resolved but the joint pain remains.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: 19 days post vax the pt experienced a fever of 102. She took ibuprofen and the fever was gone four hours later. She later experienced joint pain that started in her left wrist and right index finger. She also experience muscle pain in the right side of her neck. She reported that the muscle and joint pain moved around. She also experienced right great toe pain. The pt then developed erythema migrans on her back and received 21 days of treatment of Doxycycline at half dose. She also experienced generalized back muscle pain, bilateral knee joint pain and left arm to shoulder muscle pain. She also had difficulty sleeping due to the symptoms. The most recent information reports the rash and fever have resolved but the joint pain remains.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: The pt experienced a high fever, flu-like symptoms, and severe joint pain. The pt was seen by an orthopedist and a neurologist. Two MRI's have been done which reveal no degenerative changes or arthritis. The most recent information received on 6/27/00 reports the outcome of the event as unresolved.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Joint stiffness, Lethargy, Myalgia
Clinical narrative: Within 24 hours post vax, the pt experienced stiff shoulders, which resolved in one week. In 5/99, the pt received his 2nd dose, within 24 hours post vax, he experienced right arm stiffness and muscle pain the right deltoid, this also resolved in one week. In 4/00 the pt received his 3rd dose, 24-48 hours post vax, the pt experienced joint stiffness, right deltoid pain, joint pain, fever, sore throat, lethargy, tiredness, and generalized muscle pain. The fever, right deltoid pain and sore throat resolved in a few days. The remaining symptoms are ongoing. The most recent information received on 6/27/00 report the outcome of the event is ongoing.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Within 24 hours post vax, the pt experienced stiff shoulders, which resolved in one week. In 5/99, the pt received his 2nd dose, within 24 hours post vax, he experienced right arm stiffness and muscle pain the right deltoid, this also resolved in one week. In 4/00 the pt received his 3rd dose, 24-48 hours post vax, the pt experienced joint stiffness, right deltoid pain, joint pain, fever, sore throat, lethargy, tiredness, and generalized muscle pain. The fever, right deltoid pain and sore throat resolved in a few days. The remaining symptoms are ongoing. The most recent information received on 6/27/00 report the outcome of the event is ongoing.
Age: 77.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Myalgia, Neck pain, Pain
Clinical narrative: Following her vax in 2/00 the pt experienced pains, backaches, muscle aches, neck pain, and joint pain, which reportedly she described as very similar to her symptoms from Lyme disease. She was seen by her physician on 5/22/00. He performed several blood tests, the results of which are pending. The most recent information received on 1/26/00 reports the outcome of the event is unknown.
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Following vaccinations, the pt experienced a "burning sensation" in "all of her joints". the pt believed that she had pre-existing Lyme disease which was exacerbated by the vaccine. Reportedly, prior to vaccination she was absolutely symptomatic and believed herself to be Lyme disease free. The most recent information received on 6/26/00 reports the outcome of the event as unknown.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Laboratory test abnormal, Tendonitis
Clinical narrative: Subsequent to receiving two doses of Lymerix, the pt was referred by his family physician to an orthopedist for a complaint of ulnar sided left wrist pain not precipitated by any traumatic events or episodes. At that time upon a physical exam the orthopedist diagnosed extensor carpi ulnaris tendinitis and prescribed a splint and anti-inflammatory treatment as needed (Vioxx). The pt received the third dose of Lymerix. The most recent information reports the outcome of the event as unknown.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Antinuclear antibody positive, Arthralgia, Laboratory test abnormal, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: 3 - 4 days subsequent to receiving first and second doses of Lymerix pts upper arms starting aching, and joints in her hands started tingling. Physician concluded that the pt was experiencing a possible Lyme vax reaction and referred her to a rheumatologist. Approximately 2 months post vax the rheumatologist stated that four days after second dose the pt developed severe pain and swelling in the hands and wrists along with an aching in the upper arms and thighs.  The pt felt very stiff in the morning and described difficulty bending her hands. Pt stated that her neck was slightly stiff and she has some aching in the lower back. She denied rash, dry eyes, dry mouth, fevers, or fatigue.  She stated her appetite was good. She denied eye symptoms. The rheumatologist stated that he believed that this pts myalgias and arthralgias were related to the Lyme vaccine. He did not believed that the pts symptoms were related to the ulcerative colitis. Despite a low-positive ANA he did not believe that the pt had lupus or Sjorgen's syndrome. Pt was treated with Vioxx 12.5 mg daily and the rheumatologist concluded that he expected her to improve rapidly without any other treatment. The pt continued to report joint pain in both hands although not as severe as it was immediately after vax. The most recent information reports the outcome of the event as unknown.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Pain, Paraesthesia
Clinical narrative: 3 - 4 days subsequent to receiving first and second doses of Lymerix pts upper arms starting aching, and joints in her hands started tingling. Physician concluded that the pt was experiencing a possible Lyme vax reaction and referred her to a rheumatologist. Approximately 2 months post vax the rheumatologist stated that four days after second dose the pt developed severe pain and swelling in the hands and wrists along with an aching in the upper arms and thighs.  The pt felt very stiff in the morning and described difficulty bending her hands. Pt stated that her neck was slightly stiff and she has some aching in the lower back. She denied rash, dry eyes, dry mouth, fevers, or fatigue.  She stated her appetite was good. She denied eye symptoms. The rheumatologist stated that he believed that this pts myalgias and arthralgias were related to the Lyme vaccine. He did not believed that the pts symptoms were related to the ulcerative colitis. Despite a low-positive ANA he did not believe that the pt had lupus or Sjorgen's syndrome. Pt was treated with Vioxx 12.5 mg daily and the rheumatologist concluded that he expected her to improve rapidly without any other treatment. The pt continued to report joint pain in both hands although not as severe as it was immediately after vax. The most recent information reports the outcome of the event as unknown.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Abdominal pain, Arthralgia, Arthritis, Asthenia, Cold sweat
Clinical narrative: Subsequent to receiving first and second doses of Lymerix the pt began experiencing joint pain and fatigue. She was prescribed antibiotics for a presumed flu. Physician stated that he had treated the pt from 11/02/99 to 03/15/00 for joint pain, sore throat, post nasal drip, and abdominal pain. In addition the pt had head and chest congestion. Pt was clammy with activity. Pt was treated with Entex during November. 12/3/99 assessment and plan: Pt with osteoarthritis of her hand, no evidence of inflammatory arthritis or connective tissue disease. Physician stated that he believed the pt had fibromyalgia and referred the pt to physical therapy. The pt denied joint swelling. The pt indicated that she experienced pain, clicking, weakness and loss of motion. Pt was treated from 12/3/99 to 02/4/00 for osteoarthritis and fibromyalgia. On 12/16/99 an elevated sed rate was found and attributed to a sinus infection. On 01/02/99 pt complained of having achy joints for a few weeks. on 01/23/99 pt was treated with Amoxil 500 mg tid for ongoing sinus pain and increased post nasal drip. Physician prescribed Celebrex 100mg bid as needed. Celebrex bothered pts stomach so she was switched to Vioxx 12.5mg gd as needed. 02/04/00: pt felt better with physical therapy, with less fatigue, less insomnia and less pain. She experienced weight gain. After shoveling snow pt felt a recurrence of symptoms, but felt well overall. Pts ASO titer and rheumatoid factor were negative. On 02/24/00 physician noted a bad stiff neck associated with headache, tennis elbow, and myalgias. 03/15/00: Left elbow symptoms responded well to physical therapy. The most recent information reports the outcome as unknown.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Fibromyalgia, Joint range of motion decreased, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: Subsequent to receiving first and second doses of Lymerix the pt began experiencing joint pain and fatigue. She was prescribed antibiotics for a presumed flu. Physician stated that he had treated the pt from 11/02/99 to 03/15/00 for joint pain, sore throat, post nasal drip, and abdominal pain. In addition the pt had head and chest congestion. Pt was clammy with activity. Pt was treated with Entex during November. 12/3/99 assessment and plan: Pt with osteoarthritis of her hand, no evidence of inflammatory arthritis or connective tissue disease. Physician stated that he believed the pt had fibromyalgia and referred the pt to physical therapy. The pt denied joint swelling. The pt indicated that she experienced pain, clicking, weakness and loss of motion. Pt was treated from 12/3/99 to 02/4/00 for osteoarthritis and fibromyalgia. On 12/16/99 an elevated sed rate was found and attributed to a sinus infection. On 01/02/99 pt complained of having achy joints for a few weeks. on 01/23/99 pt was treated with Amoxil 500 mg tid for ongoing sinus pain and increased post nasal drip. Physician prescribed Celebrex 100mg bid as needed. Celebrex bothered pts stomach so she was switched to Vioxx 12.5mg gd as needed. 02/04/00: pt felt better with physical therapy, with less fatigue, less insomnia and less pain. She experienced weight gain. After shoveling snow pt felt a recurrence of symptoms, but felt well overall. Pts ASO titer and rheumatoid factor were negative. On 02/24/00 physician noted a bad stiff neck associated with headache, tennis elbow, and myalgias. 03/15/00: Left elbow symptoms responded well to physical therapy. The most recent information reports the outcome as unknown.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Rhinorrhoea, Weight increased
Clinical narrative: Subsequent to receiving first and second doses of Lymerix the pt began experiencing joint pain and fatigue. She was prescribed antibiotics for a presumed flu. Physician stated that he had treated the pt from 11/02/99 to 03/15/00 for joint pain, sore throat, post nasal drip, and abdominal pain. In addition the pt had head and chest congestion. Pt was clammy with activity. Pt was treated with Entex during November. 12/3/99 assessment and plan: Pt with osteoarthritis of her hand, no evidence of inflammatory arthritis or connective tissue disease. Physician stated that he believed the pt had fibromyalgia and referred the pt to physical therapy. The pt denied joint swelling. The pt indicated that she experienced pain, clicking, weakness and loss of motion. Pt was treated from 12/3/99 to 02/4/00 for osteoarthritis and fibromyalgia. On 12/16/99 an elevated sed rate was found and attributed to a sinus infection. On 01/02/99 pt complained of having achy joints for a few weeks. on 01/23/99 pt was treated with Amoxil 500 mg tid for ongoing sinus pain and increased post nasal drip. Physician prescribed Celebrex 100mg bid as needed. Celebrex bothered pts stomach so she was switched to Vioxx 12.5mg gd as needed. 02/04/00: pt felt better with physical therapy, with less fatigue, less insomnia and less pain. She experienced weight gain. After shoveling snow pt felt a recurrence of symptoms, but felt well overall. Pts ASO titer and rheumatoid factor were negative. On 02/24/00 physician noted a bad stiff neck associated with headache, tennis elbow, and myalgias. 03/15/00: Left elbow symptoms responded well to physical therapy. The most recent information reports the outcome as unknown.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Groin pain, Headache, Pain
Clinical narrative: Subsequent to receiving first and second doses of Lymerix, the pt experienced joint pain and soreness. Pts pain seemed to be located differently at times; in his neck, groin, knees and ankles. Recently his hands have hurt and he had difficulty grasping things, opening jars, etc. Most recently pt has had mild headaches at times, groin pain and could not stand on his feet for long periods. Physician prescribed doxycycline 100mg bid for 21 days. The most recent information reports the outcome of the event as unknown.
Age: 32.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Within two weeks post vax the pt experienced joint pain including ankle pain. No treatment was given. The most recent information reports the outcome of the event as resolved.
Sex: M
Vaccine: LYME
Symptoms: Injection site reaction
Clinical narrative: Subsequent to receiving an unspecified dose of Lymerix the pt had a localized skin reaction to a tick bite at the bite site. The most recent information reports the outcome of the event as unknown.
Age: 69.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Oedema peripheral, Pain, Rheumatoid arthritis
Clinical narrative: Subsequent to receiving first and second doses of Lymerix the pt experienced pain in her hands and fingers. Outcome unresolved. Pt was treated with NSAIDS in June of 1999. In May, 2000 the pt received third dose of Lymerix. Subsequently the pain in her hands worsened. Physician evaluated her joint complaints and swollen fingers were documented on the exam. Reporter was unsure whether or not warm joints were documented. Lab work was done for arthritis (results unknown). Approximately 6/18/00, pts was diagnosed with rheumatoid arthritis. Pt was treated with Relafen and Plaquenil. The most recent information reports the outcome as ongoing.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Back pain, Liver function test abnormal
Clinical narrative: Four days subsequent to first dose of Lymerix, pt experienced fever of 103 degrees and lower back pain. The symptoms lasted for four days and resolved. Two days  subsequent to receiving second dose of Lymerix, the pt experienced fever of 102.5 degrees, muscle and joint pain. The outcome is unresolved. Subsequent to an unspecified dose of Lymerix pt experienced elevated liver function tests with AST = 45 and ALT= 96. Pt will be worked up for hepatitis. No risk factors for pt were identified. The most recent information reports the outcome of the event as ongoing.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia, Pyrexia
Clinical narrative: Four days subsequent to first dose of Lymerix, pt experienced fever of 103 degrees and lower back pain. The symptoms lasted for four days and resolved. Two days  subsequent to receiving second dose of Lymerix, the pt experienced fever of 102.5 degrees, muscle and joint pain. The outcome is unresolved. Subsequent to an unspecified dose of Lymerix pt experienced elevated liver function tests with AST = 45 and ALT= 96. Pt will be worked up for hepatitis. No risk factors for pt were identified. The most recent information reports the outcome of the event as ongoing.
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: 16 days post vax, the pt tested positive for pregnancy. A doctor visit was required and no treatment was given. Pt reported that this was an unexpected pregnancy. The most recent information reports the outcome of the event as ongoing.
Sex: F
Vaccine: LYME
Symptoms: Pruritus, Rash
Clinical narrative: Subsequent to receiving first and second doses of Lymerix, pt experienced itching and blemishes. The most recent information reports the outcome of the event as unknown.
Age: 30.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: One hour subsequent to receiving third dose of Lymerix pt experienced fever of 100 degrees and chills. Pt was seen in the ER, treated with Tylenol and discharged. The most recent information reports the outcome of the event as resolved.
Age: 38.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Injection site oedema, Myalgia
Clinical narrative: Within a few hours post vax the pt experienced injection site swelling. Additionally pt felt as if he had Lyme disease again and experienced joint pain in every joint and muscle aches. He was unable to work for four days. Pt was treated with over the counter NSAIDS and rest. Symptoms resolved in 4-5 days. Joint complaints were not evaluated by a physician. The most recent information reports the outcome of the event is resolved.
Age: 28.0
Sex: F
Vaccine: LYME
Symptoms: Dermal cyst, Laboratory test abnormal, Pain
Clinical narrative: Subsequent to receiving the first dose of Lymerix the pt developed tennis ball size sebaceous cysts which were cut and drained on the genital area. The cyst on her nose was very painful and the pt refused for it to be drained. It was treated with Augmentin for 10 days. The cysts resolved. The following month the genital cysts returned. It was treated with Augmentin and the cyst resolved. Physician did not feel that the cysts were related to Lymerix.  Pt was found to be pregnant subsequent to receiving the second dose of Lymerix. The most recent information reports that the cysts resolved and that the pregnancy is ongoing.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Dysgeusia
Clinical narrative: 14 days post vax the pt reported that she developed a metallic taste in her mouth which did not affect the taste of food. No treatment was given. Physician was uncertain as to the onset date of the adverse event. Approximately 2 weeks later the pt received the second dose of Lymerix. The most recent information reports the outcome of the event as uncertain per the physician.
Age: 70.0
Sex: M
Vaccine: LYME
Symptoms: Erythema, Infection, Skin ulcer
Clinical narrative: Subsequent to receiving third dose of Lymerix, the pt developed a bulls-eye lesion on the right leg 1.25 inches. Per the Merck manual the pt started amoxicillin 500 mg tid for 10 days and applied triple antibiotic ointment to the lesion. The pt was seen by a physician and was found to have erythema on the hip and an 8 cm lesion with clear center and elevated edges which suggested Lyme disease to the physician. The pt was treated with Ceftin 500 mg bid PO for 20 days. The most recent information reports the outcome of the event as unknown.
Age: 63.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: One day post vax the pt developed a four inch, red, raised band around the entire circumference of the right upper arm, which ached dully. There was no pruritus. Symptoms resolved after a few days. The most recent information reports the outcome of the event as resolved.
Age: 34.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: Subsequent to receiving vax pt was found to be in early part of pregnancy at the time of administration. The most recent information reports the outcome of the event is unknown. The vacinee was a thalassemia carrier and a beta streptoccus carrier, for which she was treated with ampicillin (treatment was complete approximately one week priori to admission to the hospital) The vaccinee had delivered two full term children previously by ceserean action. In April 1999, in May 1999, and on May 04, 2000, the vacinee received her first, secondm and thrid dose of Lymerix, respectively. She became pregnant at the end of May 2000. The date of her last menstrual period was April 27, 2000, and the esimated date of confinement was Feb 01, 2001. On Dec 05, 2000, the vaccinee delivered twins by cesarean section at 31 weeks gestational age due to premature spontaneous onset of labor and prior cesarean section. Twin A was a female weighting 4 lbs 5 ounces at birth. Her Apgar scores were 9 and 9. Twin B was a male weighing 3 lbs 10 ounces at birth. His Apgar scores were 9 and 8. Both babies were deliverd by total breech extraction, even though twin B presented as a vertex presentation. The reporter stated that the neonatal status was normal, the twins were viable, no problems were noted, and the delivery was tolerated well. At the time of the cesarean section, the patient underwent a tubal litigation. The vaccinee's post operative course was additionally complicated by upper respiratory congestion and some difficulty breathing. She was seen by an ENT (ear, nose, and throat) specialist, who made a diagnosis of vocal cord polyps. These were removed by microlaryngoscopy on Dec 07, 2000. The remainder of the patient's post operative coure was uneventful. The mother was discharged from the hospital on Dec 09, 2000 and the infants were sent home at an unknown later date. Discharge diagnosis (mother) 1 pregnacy, 31 weeks, twin gestation: multiperity 2 Anemia 3 Vocal cord polys. As of May 14, 2001 mother and infants were doing well.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Unevaluable event
Clinical narrative: Immediately after receiving first dose of Lymerix, the pt experienced injection site pain which resolved. Immediately after receiving second dose of Lymerix, pt experienced pain at injection which resolved. Immediately after receiving third dose of Lymerix pt experienced injection site pain which resolved. The most recent information reports the outcome of the event as resolved.
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Arthropathy, Feeling hot, Joint swelling
Clinical narrative: 3-4 weeks after receiving first dose of Lymerix, pt developed pain and swelling of the right knee.  The right knee pain continued. Subsequent to receiving second dose of Lymerix, the pt developed pain and swelling of the left knee and the right knee pain increased. At the time of evaluation the swelling of his joints was down. The right knee was initially warm but resolved prior to evaluation. Pts wife stated that she thought that the pt was diagnosed with arthritis. Pt was treated with diclofenac sodium/misoprostol. The most recent information, reports the outcome of the event is ongoing.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Approximately 24 hours post vax, pt developed a lump at injection site .5 inch in diameter, then redness and tenderness. The redness and tenderness resolved after 3 days. A soft lump .25 inch in diameter remains. The most recent information reports the outcome of the event is ongoing.
Age: 33.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Depression, Drug ineffective, Dyspnoea, Fatigue
Clinical narrative: Two days post vax, the pt developed joint pain, fever, night sweats, rash, fatigue, shortness of breath, numbness and tingling, and twitching facial muscles. A doctor visit was required. The pt was diagnosed with Lyme disease. Pt was treated with a 21 day regimen of doxycycline. Pt was tested positive for babesiosis. Pt was treated with amoxicillin, Lariam, Zithromax, and probenecid. Doxycycline was not started as consumer works outside. The most recent information reports the outcome of the event as unresolved. A 15-day follow up report received 12/26/2001 adds: Report number 2000021964-1 describes babesiosis and Lyme disease in a 34-year-old male who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received from a medical office worker on behalf of the treating physician. Medical history included multiple tick bites before and after Lymerix administration. The pt had no known allergies. Concurrent conditions were not specified. There were no concurrent medications. The pt received his 1st injectin of Lymerix on an unspecified date. He received his 2nd injection of Lymerix in June 2000 (exact date not provided). Two days following the 2nd Lymerix injection, the pt experienced joint pain, fever of 104 degrees F, night sweats, five areas of bull's eye rash, fatigue, shortness of breath, numbness, tingling and twitching facial muscles. the pt reported that he "could not move from his hips down". The pt was seen by a physician. On 06/16/2000, the physician made a diagnosis of Lyme disease and prescribed a 21-day course of doxycycline. On 07/14/2000 the pt saw the physician for follow-up, at that time, he "tested positive for babesiosis." He was treated with amoxicillin, mefloquine (Lariam), azithromycin (Zithromax) and probenecid. Additional info was received from the pt on 12/17/2001. He reported that, prior to Lymerix administration, he "was tested for Lyme and it was negative." He reported that he has "been diagnosed with 2 different types of Lyme and also babesiosis." He also stated, "since then I've been depressed and on numerous medications. I was put out of work and collected for workers comp...I had meds and home IV (intravenous) Rocephin (coftriaxoac) which didn't help. I'm still receiving treatments of biocillin once a week. I have seen other doctors who also say I will have chronic Lyme the rest of my life." The Lyme disease, babesiosis, and depression were considered to be disabling because the pt was unable to work. Therefore, this report has been reclassified as serious, unexpected.