chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: One day post vax of an inadvertently intradermal injection of TD vaccine in the forearm, pt developed an injection site reaction characterized by redness, swelling and pain the next day. Pt recovered.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injury, Pyrexia
Clinical narrative: One week post vax, pt developed fever and an injection site reaction characterized by redness and swelling after sustaining "severe" cat scratches and symptoms of infection were noted. She also, had an injection of Rocephin at that time.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Hallucination, Pyrexia
Clinical narrative: A physician reported that a 63 year old female received tetanus toxoid 45 years ago and subsequently developed fever and hallucinations. No further information is available.
Age: 0.5
Sex: M
Vaccine: DT, HEP
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Within 24 hours post vax, pt developed injection site reaction characterized by redness, swelling and tenderness.  The redness and swelling resolved within 5 days.  A 'very hard small lump' developed and persisted as of 07/21/1999.
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site haemorrhage, Injection site infection, Injection site mass, Injection site oedema
Clinical narrative: Within 72 hours post vax, pt developed an injection site reaction characterized by a fairly large area of induration, swelling and heat.  The area would spontaneously bleed and ooze pus.  She treated the area by squeezing it and applying warm soaks.  This continued for approximately one month. One day while squeezing the site an "oily substance fell out". The site then stopped bleeding and oozing pus.
Age: 44.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site oedema, Pyrexia, White blood cell count increased
Clinical narrative: Within 36 to 48 hours the pt developed fever of 102 degrees and an injection site reaction on the Pnu-Imune administration site characterized by a 10 cm to 20 cm area of swelling and redness of his right arm.  His white blood cell count was 17,500/mL.  He was prescribed an oral antibiotic.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt developed an injection site reaction characterized by redness and swelling.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Pt developed an injection site reaction characterized by induration measuring 5 cm by 6 cm, redness and swelling.
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Rash pruritic
Clinical narrative: One day post vax, pt developed a red, itchy rash on his trunk, arms and legs.  He was treated with prednisone and recovered after 2 weeks.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Hypokinesia
Clinical narrative: Two days post vax, pt developed numbness in the fingertips of his left hand. The numbness progressed to involve his fingers and sometimes the entire left hand.  On 12/28/1999 he was seen by a physician who noted numbness mostly involving the fingertips of the left hand.  EMG and nerve conduction studies performed 02/02/2000 revealed borderline prolongation of median motor distal latency consistent with mild left carpal tunnel syndrome. The final dx was carpel tunnel syndrome due to repetitive work using the left hand.
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Injection site hypersensitivity, Injection site oedema, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Pt developed every joint aching, weakness in the knees, generalized muscle stiffness, malaise, and an injection site reaction characterized by redness and swelling.
Sex: U
Vaccine: TTOX
Symptoms: Lymphadenopathy, Neck pain, Pain in jaw
Clinical narrative: One day post vax pt developed aching all over noting the jaw, neck and shoulder areas and their lymph nodes were enlarged.  On 10/07/1999 they developed a headache and hives at the injection site.  As of 10/13/1999 the aches were gone but the headache persisted.
Age: 15.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Within a few days post vax, pt developed an injection site reaction characterized by a large brawny induration and swelling.  Pt was treated with Augmentin.  As of 11/11/1999 the symptoms were resolving.
Age: 16.0
Sex: U
Vaccine: TTOX
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Within a few days post vax, pt developed an injection site reaction characterized by a brawny induration and swelling.  Pt was treated with Augmentin and as of 11/11/1999 the symptoms were resolving.
Age: 17.0
Sex: U
Vaccine: TTOX
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Within a few days post vax, pt developed and injection site reaction characterized by a large brawny induration and swelling.  The pt was treated with Augmentin and as of 11/11/1999 the symptoms were resolving.
Sex: M
Vaccine: TTOX
Symptoms: Injection site nodule
Clinical narrative: Pt inadvertently received an intradermal injection of Tetanus Toxoid Adsorbed, Purogenated and subsequently developed a 2.5 X 2.5 cm granuloma at the injection site.
Age: 14.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema
Clinical narrative: Pharmacist reported that pt developed edema at the injection site and recovered.
Age: 57.0
Sex: F
Vaccine: LYME, TTOX
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Pt developed swelling and joint pain subsequent to receiving an injection of tetanus toxoids adsorbed and Lymerix.
Sex: F
Vaccine: TTOX
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Within 4 to 5 hours of inadvertently receiving an intradermal injection of Tetanus Toxoid Adsorbed, Purogenated pt developed an injection site reaction characterized by redness the size of nickels and experienced pain.  As of 01/05/2000 the redness persisted.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Arthritis, Injection site oedema, Injection site pain, Pain
Clinical narrative: Pt developed an arthritis reaction and an injection site reaction characterized by swelling, tightness and pain after receiving a tetanus toxoid injection in 1991.
Sex: U
Vaccine: TTOX
Symptoms: Generalised oedema, Pruritus
Clinical narrative: Pt developed a systemic reaction characterized by generalized edema, itching and possibly wheezing.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Within 48 hours of inadvertently receiving improperly stored tetanus toxoid, pt developed an injection site reaction characterized by a small pink painful bump.  Pt went to the ER and was diagnosed with cellulitis. Pt was noted to for having a preexisting allergy to sulfa.
Sex: F
Vaccine: TTOX
Symptoms: Injection site nodule
Clinical narrative: Pt received a tetanus toxoid 28 years ago at age 7 and subsequently develop a nodule at the injection site which was resolved within several days.
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema
Clinical narrative: Pt developed swelling at the injection site which she attributed to a thimerosol allergy.
Age: 32.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Next day post vax, the pt reportedly awoke with joint aches and entire body ache, and a high fever. On 11/15/99, the pt was seen by the physician who noted that the pt did not take his temperature, but reported that it was high.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Pt developed a rapid heart beat and fever after receiving an influenza virus and pneumococcal vaccines on the same day.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Within days of receiving an injection of Flu Shield, pt developed a hypersensitivity reaction manifested by severe hives and itching.  Pt was treated with unspecified antihistamines and topical preparations and recovered in 7 to 10 days.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Pt developed sudden shaking, chills and myalgia with temperature of 101F approximately 27 hours post vax.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Within 24 hours post vax, pt developed an injection site reaction characterized by induration, redness, warmth and pain.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Muscle spasms, Pain
Clinical narrative: Post vax, the pt experienced arthralgias, achiness, and right hand spasms. No treatment was given.
Age: 62.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Difficulty in walking, Fall, Hypokinesia, Joint swelling
Clinical narrative: On 7/2/99, post vax, she experienced joint swelling and increased arthritic pain. Her knees and hands became swollen and she had difficulty walking due to pain. Also, she could not move her right hand which was very swollen. On 7/9/99, she misjudged a step and fell on a sidewalk skinning her hand, knees, and elbow.
Age: 62.0
Sex: F
Vaccine: LYME
Symptoms: Oedema peripheral, Pain
Clinical narrative: On 7/2/99, post vax, she experienced joint swelling and increased arthritic pain. Her knees and hands became swollen and she had difficulty walking due to pain. Also, she could not move her right hand which was very swollen. On 7/9/99, she misjudged a step and fell on a sidewalk skinning her hand, knees, and elbow.
Age: 70.0
Sex: M
Vaccine: LYME
Symptoms: Facial palsy, Pain
Clinical narrative: 34 days post vax, the pt was seen by a physician for facial pain and facial drooping. Physician initially thought that pt had a sinus infection and prescribed antibiotics. Pt returned to physician's office for follow-up because he still in pain. Physical exam revealed facial drooping and disconnected gaze. Dx with facial palsy. Physician stated that the pt's symptoms completely resolved approximately two weeks after they initiated.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Abdominal pain
Clinical narrative: Subsequently post vax, the pt experienced isolated left flank muscle pain. A doctor visit was required. He was treated with an anti-inflammatory, which did not improve his symptoms.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: One day post vax, the pt experienced pain at the injection site, fatigue, flu-like symptoms, and headaches which lasted two weeks.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Myalgia, Pyrexia, Rash
Clinical narrative: At the end of May 1999, post vax, she developed myalgias, low grade fever, and a rash. She saw a physician on 6/11/99 with myalgias and low grade fever. She was treated with doxycycline. The pt has been on doxycycline for 5 weeks and is still not feeling great.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Headache, Injection site pain, Pyrexia, Vision blurred
Clinical narrative: 24 hours post vax, he experienced headache (which lasted 10 days), fever, injection site pain (which lasted 2 days). No treatment was given. These symptoms resolved. On 6/15/99, the pt developed blurry vision. The pt's blurry vision is a bit better but is ongoing. He has been referred to a physician for an eye exam.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Subsequently post vax, the pt experienced polymyalgias and stiffness.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: On 5/17/99, post vax, he experienced injection site soreness. His arm stayed sore for approximately 60 hours then improved. On 5/20/99, he was able to play golf. He developed more generalized body aches and arthralgias. No fever or chills noted by the pt. These symptoms lasted for approximately 12-14 hours and then dissipated.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Facial palsy
Clinical narrative: On 04/01/1999, the pt received first dose of vax. Twelve days later, on 04/13, the pt developed right Bell's Palsy. Two months later, on 06/15, the pt developed left Bell's Palsy. An emergency room or doctors visit was required. The pt was treated with prednisone and Famvir. Symptoms resolved. The most recent information, received on 07/09, reports the condition of the pt is resolved. Reported on 10/06/2000: "The patient has a history of psoriasis, gastroesophageal reflux disease and pension prostatic hypertrophy.  Concomitant medications were not provided.  On 05/01/1999, the patient received his first 30 mcg dose of Lymerix for prevention of Lyme disease.  Twelve days later, on 04/13/1999, the patient developed right Bell's palsy.  On 05/20/1999, the patient received his second dose of Lymerix.    Twenty five days later, on 06/14/1998, the patient developed left Bell's Palsy with left sided facial numbness and (facial)weakness.  An emergency room or doctor visit was required.  The patient was treated with prednisone tapering dose and Famvir.  The information received by the manufacturer on 07/09/1999 reported the condition of the patient as resolved.  However, information indicated that as of 07/16/1999, the facial weakness of the patient was improving.  The events of left and right sided Bell's Palsy with facial weakness and numbness do not meet ICM serious criteria but are being submitted expeditously for informational purposes per FDA request.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Urticaria
Clinical narrative: The pt received his first and second doses of vax on 05/06 and 06/10/99, respectively. Following second dose of vax, he experienced a hive-like reaction. No treatment was given. The vax was discontinued. Per physician: the risk of type 1 hypersensitivity was stronger that the risk of Lyme disease. The most recent information, received on 07/15 reports the condition of the pt is resolved.
Age: 28.0
Sex: F
Vaccine: LYME
Symptoms: Dizziness, Pain
Clinical narrative: On May 21, 1999, the pt received the first (IM-left deltoid) dose of Lymerix for prevention of Lyme disease.  Two days later on May 23, 1999, the pt experienced dizziness and aching.   The most recent information received on June 23, 1999 reports the condition of the pt as resolved.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Depression
Clinical narrative: On approximately 6/16/99, the pt received his first dose of Lymerix. subsequently, he experienced depression and arthralgias. The most information received on 7/16/99, reports the condition of the pt is unknown.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Pruritus, Rash, Vasodilation procedure
Clinical narrative: On May 18, 1999, the pt received her first (IM-Left Deltoid) dose of Lymerix.  She experienced soreness at the injection site which resolved the next day. Approximately 4 days later, she experienced an injection site rash consisting of several hard red lumps which were warm and itched. Her symptoms resolved in 3-4 days.  On 6/18/99, the pt received her second (IM-Left Deltoid) dose of Lymerix.   Approximately 4 days later on 6/22/99, she experienced the same reaction with additionally a red area which measured 6 in x 3 in. No treatment was given.  The pt states that her symptoms resolved on 6/29/99.  The most recent information received on 7/7/99, reports the condition of the pt as resolved.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Hyperhidrosis, Myalgia, Vomiting
Clinical narrative: On May 11, 1999, the pt received her first (IM-Right Arm) dose of Lymerix for prevention of Lyme disease. 1 - 1 1/2 hours later, on May 11, 1999, she experienced cold sweats, vomiting and severe pain over her entire body (muscles and joints). Her pain was so intense that she had difficulty driving. Her MD instructed her to go to the ER, but she did not get there. The vomiting and cold sweats subsided five hours later, leaving her with joint pains and muscle pains throughout her body. She was seen by he MD on 7/6/99 who ordered a rheumatoid test and sed rate. On 7/5/99 she was prescribed Trilisate which she took for a few days and then stopped because it was not helping her joint and muscle pain. She was seen by a different MD on 7/15/99. He prescribed prednisone which was started on 7/16/99. She was also prescribed Arthrotec. The most recent information received on 7/16/99, reports the condition of the pt is ongoing.
Age: 58.0
Sex: F
Vaccine: LYME
Symptoms: Musculoskeletal discomfort, Oedema peripheral, Pain
Clinical narrative: On 4/29/99, the pt received her first (IM-Left Deltoid) dose of Lymerix for prevention of Lyme disease.  One week later on 5/6/99, the pt experienced a muscle pull behind the knee. This adverse event resolved.  On 5/27/99, the pt received her second dose of Lymerix.  Approximately 3 days later, on 5/30/99, the pt experienced severe pain after walking. He left leg was swollen, she was seen by an orthopedist and Motrin was prescribed. Aching persists. The most recent information received on 6/23/99, reports the condition of the pt is ongoing.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: On an unspecified date, the pt received the first dose of Lymerix.  Subsequently, the pt experienced arthralgias.   The most recent information received on 7/16/99 reports the condition of the pt is unknown.
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Myalgia
Clinical narrative: On approximately 6/22/99, the pt received the first dose of Lymerix for prevention of Lyme disease.  Subsequently on 6/22/99, the pt experienced muscle pains and fatigue. These symptoms resolved after ten days.  The most recent information, received on 7/19/99 reports the condition of the pt is resolved.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a physician referring to a 40 year old main who, on 5/23/99, the pt received his 1st Lymerix dose in left deltoid, IM. Subsequently, he experienced nausea and muscle aches. Outcome; resolved. On 6/23/1999, the pt received his 2nd dose, IM, left deltoid. Within hours, on 6/23/1999, he experienced nausea, fatigue and muscle aches. Symptoms resolved spontaneously. The most recent information, received on 7/15/1999, reports the condition of the pt is resolved.
Age: 18.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Disorientation, Headache
Clinical narrative: On approximately 6/25/99, the pt received her first dose of Lymerix. Three hours later on 6/25/99, the pt experienced headache, disorientation, sore joints and she almost passed out. Her joints were sore for 1 1/2 weeks. She rested and took Tylenol.  The most recent information received on 7/26/99 reports the condition of the pt is recovered.
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Pain
Clinical narrative: On 7/16/99, the pt received his first IM-right deltoid dose of Lymerix. Four days later, on 7/20/99 at 1:00, he experienced pain radiating down right arm to elbow. He cannot lift his arm and he stayed home from work. He was treated with Tylenol. The most recent information received on 7/20/99, reports the condition of the pt persists.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Headache, Pain, Personality disorder
Clinical narrative: Within 5 hours post vax, the pt experienced an achy shoulder and one day later he had a headache and a foggy feeling.
Age: 72.0
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness
Clinical narrative: Post vax, the pt experienced flu-like symptoms.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Chills, Headache
Clinical narrative: On 07/15/1999, pt received first vax. One hour post vax, the pt experienced chills and a headache. The symptoms were treated with Tylenol. The most recent information received on 07/15/1999 reports approximately 2 hours later the chills went away and the headache lessened.
Age: 71.0
Sex: F
Vaccine: LYME
Symptoms: Bacterial infection, Influenza like illness, Laboratory test abnormal
Clinical narrative: The pt received her first and second doses of vax in February and March, 1999, respectively. In June 1999, she was found to have Lyme disease with flu-like symptoms. Two blood tests confirmed diagnosis. She was treated with Ceftin, and antibiotics (not specified). The most recent information, received 07/20/99, reported the condition of the pt is ongoing.
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Hypokinesia, Injection site pain, Pain
Clinical narrative: Pt received first and second doses of vax 05/99 and 07/01/99 respectively. Post 2nd vax (painful injection) pt experienced severe pain and then, 1/2 hour later, numbness in his left arm. His pain was so severe throughout the night that he could not sleep, and on the day that followed that he could not move his arm. This was initially reported as a paralysis, but it was later clarified that the impaired movement was actually due to excruciating pain of the left (injection) arm and shoulder. He took Extra Strength Tylenol to no avail. In the morning the pt was unable to dress himself. He experienced slight improvement 18 hours post vax. Treatment included hot packs. The symptoms began to slowly resolve after 10-14 days. As of the end of July each day is a little better, but the pain and impaired range of motion have not as yet resolved. On a scaled of 1-10 they are 3-4.
Age: 65.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint stiffness, Polymyalgia rheumatica
Clinical narrative: Ten days post second vax, on 05/23/99, pt experienced joint stiffness, arthralgias, and myalgias. He was diagnosed with polymyalgia rheumatica. The pt was first seen by physician on 07/01/99 and was treated with steroids (nos) and NSAIDS (nos). He was subsequently treated with prednisone (5 mg curretnly) and Vioxx (12.5 mg currently). Physician reported that the pt was doing better. The most recent information, received on 09/27/99, reports the condition of the pt is not yet resolved.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness
Clinical narrative: Pt received first vax on 05/24/1999. Approximately 2.5 weeks later, he experienced flu-like symptoms. No treatment was given. The most recent information received on 06/24/1999 reports the symptoms resolved in 36 hours.
Sex: U
Vaccine: LYME
Symptoms: Tremor
Clinical narrative: This is a spontaneous report from a licensed practical nurse. On an unspecified date, the pt received the 1st dose of Lymerix and a few hours later, the pt stated that he experienced convulsions. Physician stated in medical records that the pt had shakes. Convulsions were not mentioned. The pt took Advil and symptoms were reduced. The most recent information, received on 7/20/99, reports the condition of the pt is resolved.
Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: On 5/27/99, post vax, the pt experienced arm pain at injection site. The next day, the  pt experienced chills, body ache, headache, and nausea. Six days later, the pt was generally better but had an arm ache, and minor headache. No treatment was received.
Sex: F
Vaccine: LYME
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a female pt who on 5/16/99, received her 1st treatment with Lymerix, with no untoward effects. On 6/15/99, she received her 2nd dose and 46 hours later, experienced dizziness and lightheadedness, while walking. The most recent information received on 6/25/99, does not provide an outcome.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a physician referring to a male who received his 1st Lymerix on 5/22/99 and subsequently, he experienced a "tetanus -type reaction" of injection site pain. The pt received the 2nd dose of Lymerix on 6/22/99 and subsequently, he experienced joint pain, body aches and a worsening of the "tetanus-type" arm reaction. Symptoms resolved after 2 days. The most recent information, received on 7/22/99, reports the condition of the pt is resolved.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: On May 26, 1999, the pt received the first treatment with Lymerix. 48 hours later, he experienced a fever of 100.6, flu-like symptoms, and joint aches especially in the knees and elbows.  The most recent information received on 6/28/99, reports the symptoms as resolved. The joint aches resolved in 20 days.
Sex: U
Vaccine: LYME
Symptoms: Back pain, Feeling hot, Headache, Heart rate irregular, Neck pain
Clinical narrative: On 6/11/99, the pt received the first dose of Lymerix for prevention of Lyme disease.  18 days later,  on 6/29/99, she felt hot (facial), had a severe headache, sore neck and back, and dime-sized red spots on legs.  3 days later on 7/2/99, she was found to have an irregular heart beat at a clinic.  She was treated with Tylenol and aspirin.  The headache resolved, and the red spots have mostly resolved.  The most recent information, received on 7/22/99, reports the condition of the pt is ongoing.
Sex: U
Vaccine: LYME
Symptoms: Rash
Clinical narrative: On 6/11/99, the pt received the first dose of Lymerix for prevention of Lyme disease.  18 days later,  on 6/29/99, she felt hot (facial), had a severe headache, sore neck and back, and dime-sized red spots on legs.  3 days later on 7/2/99, she was found to have an irregular heart beat at a clinic.  She was treated with Tylenol and aspirin.  The headache resolved, and the red spots have mostly resolved.  The most recent information, received on 7/22/99, reports the condition of the pt is ongoing.
Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Skin burning sensation
Clinical narrative: On June 26, 1999, the pt received his first treatment with Lymerix. Two weeks later he experienced pain in his left knee "gimpy knee" and a burning sensation in his left calf.  The most recent information received on 6/28/99, reports the knee pain resolved, and the burning calf sensation resolved. The pt received the second Lymerix dose and he did not report any adverse events, "all ok".
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Erythema, Injection site swelling, Urticaria
Clinical narrative: On 4/8/99, the pt received the first IM dose of Lymerix.   One day later, on 4/9/99, the pt developed a two inch red slightly raised wheal and flare at the injection site. Outcome resolved in a few days.  On 5/13/99, the pt received her second IM dose of Lymerix.  One day later, on 5/14/99, she developed a six inch red raised wheal and flare at the injection site. Resolved in a few days. The pt received no treatment.  The most recent information, received on 7/22/99, reports the condition of the pt as resolved.
Age: 45.0
Sex: M
Vaccine: LYME
Symptoms: Photosensitivity reaction
Clinical narrative: The pt received the first and second IM doses of Lymerix to prevent Lyme disease.  Nine days post 2nd dose and 79 days post receiving 1st dose, the pt experienced photosensitivity type rash on his neck, shoulders, chest, and lower extremities. A MD visit or ER visit was required. He was treated with prednisone and Claritin.  The most recent information, received on 8/18/99, reports the condition of the pt is resolving.
Sex: F
Vaccine: LYME
Symptoms: Pyrexia, Tremor
Clinical narrative: On 6/8/99, the pt received her first treatment with Lymerix.  Four hours later, the pt experienced a fever of 102, chills, and shaking.  Lymerix was discontinued. The most recent information received on 6/29/99 reports the chills and shaking lasted 1.5 hours.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Myalgia
Clinical narrative: On 6/23/99, the pt received his first dose of Lymerix. Two weeks later, on 7/7/99, he experienced arthralgia and myalgia in his arms. He could ot lift both arms above his chest. An ER physician visit was required. He was treated with NSAIDs and prednisone.   The most recent information received on 7/23/99, reports the condition of the pt is ongoing.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Condition aggravated, Difficulty in walking, Injection site erythema
Clinical narrative: In mid May, 1999, the pt received her first treatment with Lymerix. Sometime thereafter, she experienced a slight redness at the injection site which resolved. In mid June 1999, she received the second dose of Lymerix and one day later she was bitten by a tick. Approximately one week after the second dose, she experienced an arthritis attack, with joint pain, stiffness, and difficulty walking.  No treatment was given. The most recent information received on 6/29/99 reports the symptoms are ongoing.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Musculoskeletal stiffness
Clinical narrative: In mid May, 1999, the pt received her first treatment with Lymerix. Sometime thereafter, she experienced a slight redness at the injection site which resolved. In mid June 1999, she received the second dose of Lymerix and one day later she was bitten by a tick. Approximately one week after the second dose, she experienced an arthritis attack, with joint pain, stiffness, and difficulty walking.  No treatment was given. The most recent information received on 6/29/99 reports the symptoms are ongoing.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Face oedema, Pruritus, Rash
Clinical narrative: 27 days post 2nd and two months post 1st dose of vaccine, the pt experienced itching and rash of the hands (a glove-like effect to wrist) and swelling of lips. He was treated with Allegra and Hydrocortisone.  The most recent information received on 8/20/99 reports the condition of the pt is ongoing.
Age: 41.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: On 7/7/99, the pt received his first IM-left deltoid dose of Lymerix.  Subsequently, he experienced discomfort and the sensation of heat at the injection site. These symptoms resolved after three weeks.  The most recent information received on 7/27/99, reports the condition of the pt is resolved.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Cold sweat, Nausea, Pain, Pyrexia
Clinical narrative: On 6/29/99, the pt received her first treatment with Lymerix at an unspecified dose. Approximately one hour later, she experienced feeling cold and clammy, nausea, achiness, fever, and freezing. The pt went to the ER.  The most information received on 6/29/99, reports the events resolved and the pt left the ER.  The reporter from the Department of Natural Resources stated the pt had a pre-existing condition, and the symptoms were not related to Lymerix.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: On an unspecified date, the pt received the unspecified dose of Lymerix.  Subsequently, the pt experienced arthralgias and myalgias.  The most recent information, received on 7/27/99, reports the condition of the pt is unknown.
Sex: M
Vaccine: LYME
Symptoms: Diarrhoea
Clinical narrative: In approximately March, 1999, the pt received a treatment with Lymerix at an unspecified dose. Sometime thereafter, he experienced diarrhea.  The most recent information received on 6/30/99 reports the symptoms are ongoing.
Age: 58.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Influenza like illness, Pain
Clinical narrative: On approximately 6/3/99, the pt received her first dose of Lymerix.  On 7/1/99, the pt received her second dose of Lymerix. The following day, on 7/2/99, she felt as if she had a 24-hour flu. She experienced achiness and soreness in hips/legs that felt like arthritis. An MD visit was required. The pt was treated with Medrol.  FU states she experienced extremem joint and muscle pain all over her body. She stated she felt like she had "went from 58 to 85". In Sept 1999 she was hospitalized as she could not move her legs.
Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: The pt has a history of Lyme disease on two occasions.  On 4/23/99, the pt received her first treatment with Lymerix, with no adverse effects. On 5/26/99, she received the second dose and two weeks later, experienced tenderness and a prickly feeling (migratory) at the injection site which resolved in 3 days. On 6/28/99, she received the third dose, and two hours later the prickly feeling returned.  The most recent information received on 1/30/99 reports the symptoms are ongoing.
Age: 21.0
Sex: M
Vaccine: LYME
Symptoms: Erythema, Injection site pain, Movement disorder, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: On 6/28/99, at 10:00 AM, the pt began to experienced pain at the injection site, stiffness, swelling, erythema, arm spasm, mild tingling into the tips of the fingers and the inability to raise arm. Outpatient treatment was required. He was treated with Darvocet, Motrin, and war soaks. He was to rest and elevate the right arm. He was to support the right arm with pillow under the arm when he sleeps tonight. He was taken off work today.  He was advised that if he chose to continue with the Lymerix series, he may experience similar muscular difficulties with the next injection, but that may be able to subdue some the the muscle difficulties by pre treating himself with some Motrin, and Tylenol prior to his injection and then following the injection with warm soaks within a few hours of injection.  7/28/9, the diagnosis is a localized reaction to Lymerix injection to the mid right deltoid.  As of 7/29/99, an MD observed that the pt still had some minimal tenderness localized at the injection site. There was no swelling, no erythema, no ecchymosis, no increase in warmth. He showed full range of motion in the shoulder, neck and elbow. Good grip strength. He showed some very minimal tenderness for forceful humeral abduction and humeral flexion. The remainder of humeral range of motion was without difficulty and within normal limits.  The reaction resolved in less than two days.  The most recent information received on 9/9/99 reports the condition of the pt is resolved.
Age: 21.0
Sex: M
Vaccine: LYME
Symptoms: Oedema, Paraesthesia
Clinical narrative: On 6/28/99, at 10:00 AM, the pt began to experienced pain at the injection site, stiffness, swelling, erythema, arm spasm, mild tingling into the tips of the fingers and the inability to raise arm. Outpatient treatment was required. He was treated with Darvocet, Motrin, and war soaks. He was to rest and elevate the right arm. He was to support the right arm with pillow under the arm when he sleeps tonight. He was taken off work today.  He was advised that if he chose to continue with the Lymerix series, he may experience similar muscular difficulties with the next injection, but that may be able to subdue some the the muscle difficulties by pre treating himself with some Motrin, and Tylenol prior to his injection and then following the injection with warm soaks within a few hours of injection.  7/28/9, the diagnosis is a localized reaction to Lymerix injection to the mid right deltoid.  As of 7/29/99, an MD observed that the pt still had some minimal tenderness localized at the injection site. There was no swelling, no erythema, no ecchymosis, no increase in warmth. He showed full range of motion in the shoulder, neck and elbow. Good grip strength. He showed some very minimal tenderness for forceful humeral abduction and humeral flexion. The remainder of humeral range of motion was without difficulty and within normal limits.  The reaction resolved in less than two days.  The most recent information received on 9/9/99 reports the condition of the pt is resolved.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Myopia, Retinal disorder, Vaccine positive rechallenge, Visual disturbance
Clinical narrative: This is a spontaneous report from a 46 year old physician referring to himself and follow-up from his opthalmologist. In April, 1999, the pt received his 1st treatment with Lymerix at an unspecified dose. Sometime thereafter, he experienced arm soreness, which resolved. In May, 1999, he received he 2nd dose of Lymerix and sometime afterward he again had arm soreness and visual disturbances with floaters and shadows. Two ophthalmologists were consulted and he was dx'd with asteroid hyalosis, myopia, presbyopia and possible pars planitis. No treatment was given. The most recent information received on 7/29/1999, reports the outcome is good and the prognosis is good. The information received on 4/4/00 by the pt reported the symptoms are permanent and ongoing.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Vitreous disorder, Vitreous floaters
Clinical narrative: This is a spontaneous report from a 46 year old physician referring to himself and follow-up from his opthalmologist. In April, 1999, the pt received his 1st treatment with Lymerix at an unspecified dose. Sometime thereafter, he experienced arm soreness, which resolved. In May, 1999, he received he 2nd dose of Lymerix and sometime afterward he again had arm soreness and visual disturbances with floaters and shadows. Two ophthalmologists were consulted and he was dx'd with asteroid hyalosis, myopia, presbyopia and possible pars planitis. No treatment was given. The most recent information received on 7/29/1999, reports the outcome is good and the prognosis is good. The information received on 4/4/00 by the pt reported the symptoms are permanent and ongoing.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Dizziness, Headache, Influenza like illness, Nausea
Clinical narrative: This is a spontaneous report from a nurse referring to a 44 year old male pt who on 5/27/99, received his 1st Lymerix, with no ill effects. On 6/24/1999, he received the 2nd dose and 1 day later, experienced nausea, dizziness, headache, aching joints, flu-like symptoms and a tingling left arm at injection site. The pt was advised to take Tylenol or ibuprofen as treatment, and the pt has not decided to receive the 3rd Lymerix injection. The most recent information received on 8/5/99, reports the symptoms resolved, 3 days later on 6/28/1999.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a nurse referring to a 44 year old male pt who on 5/27/99, received his 1st Lymerix, with no ill effects. On 6/24/1999, he received the 2nd dose and 1 day later, experienced nausea, dizziness, headache, aching joints, flu-like symptoms and a tingling left arm at injection site. The pt was advised to take Tylenol or ibuprofen as treatment, and the pt has not decided to receive the 3rd Lymerix injection. The most recent information received on 8/5/99, reports the symptoms resolved, 3 days later on 6/28/1999.
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Joint swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a RN referring to a 51 year old male. On 7/14/99, the pt received the second dose of Lymerix. Nine days later, 07 7/23/99, be experienced fatigue, fever, aching joints, chills and swollen joints. He was seen by a physician on 7/23/99. Outcome: fatigue remains. The most recent information, received on 8/3/99, reports the condition of the pt is ongoing.
Age: 69.0
Sex: F
Vaccine: LYME
Symptoms: Cranial nerve disorder, Facial palsy, Headache
Clinical narrative: On 4/26/99, the pt received her 1st Lymerix and her ongoing headaches persisted. A neurologist evaluated these headaches and he felt they were tension type with exacerbations of migraines. The radiologist felt the differential dx of such lesions included:deep white matter ischemic disease, MS, Lyme disease, and migraine headaches. She was treated with nortriptyline and Naprosyn. On 6/10/99, the pt received her 2nd dose of Lymerix and 6 days later, 6/16/99, she began to have left-sided facial weakness. Further evaluation revealed left-sided palsy. The physician stated this would be consistent with minimally elevated Lyme antibody from the recent vaccine. She was examined by an ophthalmologist, and he found the pt had palsies of the left IV, VI and VII cranial nerves. The most recent information received on 7/29/99 reports the symptoms are ongoing. The reporting physician stated it highly unlikely that Lyme disease is the cause of the pt's cranial neurapathies. She is seronegative, and her spinal fluid analysis are normal. "It has been postulated that she may have the cranial neuropathy secondary to the Lyme vaccine. It does seem temporally related." The etiology of the pt's cranial nerve palsies is uncertain. "The fact that the headaches began prior to her ever receiving the vaccine makes me think it is unlikely secondary to the vaccine and that she has some other underlying illness. MS would still be a possibility." However, the neurologist and ophthalmalogist feel that it is unlikely. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: This is a spontaneous report from a 40 year old male pt who on 6/1/99, the pt received his first treatment with Lymerix. Sometime, thereafter, he experienced a sore arm, headache, fatigue and flu-like symptoms. On 6/30/99, while the symptoms were ongoing, the pt received the 2nd dose of Lymerix. The pt was treated with Tylenol. The most recent information received on 7/1/99, reports the symptoms are ongoing.
Age: 53.0
Sex: F
Vaccine: LYME, LYME, LYME, LYME
Symptoms: Arthralgia, Joint swelling, Vasodilation procedure
Clinical narrative: Two days post vax, the pt stated her left hand felt scalded. The joints of both hands, then feet, shoulders and knees were painful and swollen. She was seen by a physician who prescribed anti-inflammatories, then Vioxx, and doxycycline for one month.
Age: 53.0
Sex: F
Vaccine: LYME, LYME, LYME, LYME
Symptoms: Headache, Hypokinesia, Infection, Nausea, Oedema peripheral
Clinical narrative: Two days post vax, the pt stated her left hand felt scalded. The joints of both hands, then feet, shoulders and knees were painful and swollen. She was seen by a physician who prescribed anti-inflammatories, then Vioxx, and doxycycline for one month.
Age: 53.0
Sex: F
Vaccine: LYME, LYME, LYME, LYME
Symptoms: Pain
Clinical narrative: Two days post vax, the pt stated her left hand felt scalded. The joints of both hands, then feet, shoulders and knees were painful and swollen. She was seen by a physician who prescribed anti-inflammatories, then Vioxx, and doxycycline for one month.
Age: 53.0
Sex: F
Vaccine: LYME, LYME, LYME, LYME
Symptoms: Headache, Hypokinesia, Laboratory test abnormal, Nausea, Oedema peripheral
Clinical narrative: Two days post vax, the pt stated her left hand felt scalded. The joints of both hands, then feet, shoulders and knees were painful and swollen. She was seen by a physician who prescribed anti-inflammatories, then Vioxx, and doxycycline for one month.
Age: 53.0
Sex: F
Vaccine: LYME, LYME, LYME, LYME
Symptoms: Pain, Skin burning sensation
Clinical narrative: Two days post vax, the pt stated her left hand felt scalded. The joints of both hands, then feet, shoulders and knees were painful and swollen. She was seen by a physician who prescribed anti-inflammatories, then Vioxx, and doxycycline for one month.
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue
Clinical narrative: One and a half weeks post vax, the pt experienced shoulder joint achiness and extreme fatigue. No treatment was given, and he is currently being tested for Lyme disease and rheumatoid arthritis.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Joint swelling, Myalgia
Clinical narrative: 24 hours post vax, the pt experienced severe myalgias, arthralgias, and swelling of her ankles, knees, and other joints.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Injection site pain, Myalgia, Rash
Clinical narrative: Within a few days post vax, she experienced injection site pain, large bullseye rash, myalgia, and arthralgia. No treatment was given. Symptoms resolved after one month.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Pruritus, Rash
Clinical narrative: Approximately two weeks post vax, the pt experienced a generalized itchy rash on face and all over her body. The symptoms were treated with Benadryl, hydrocortisone lotion, and Claritin.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Nausea, Stomach discomfort
Clinical narrative: Post vax, the pt experienced an increase in stomach upset and nausea. It feels like a ball in his stomach. No treatment was given.
Age: 66.0
Sex: F
Vaccine: LYME
Symptoms: Eye oedema, Ocular hyperaemia
Clinical narrative: A spontaneous report from a 66 year old female pt who, ten days post vax, she experienced puffy and red eyes, which resolved in 3 days. On 7/20/99, the pt received the 2nd dose (1st dose on 6/15/99) and 10 days later re-experienced these same symptoms. The symptoms were treated with Claritin and Benadryl cream around the outer eye. The most recent information reports the symptoms resolved in 3 days.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a physician referring to his 48 year old wife. Approximately 2.5 hours, post vax, she experienced shakiness, chills and fever of 99F. The symptoms were treated with 1 gram of Tylenol, and Lymerix was discontinued. The most recent information received on 7/5/99, reports the symptoms resolved in 5-6 hours.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Pain
Clinical narrative: This is a spontaneous report from a 46 year old nurse referring to himself. On 7/16/99, he experienced fatigue with decreased vigor. On 7/22/99, he developed pain in his heels, the right more so than the left heel. The recent information received on 8/2/99, reports the fatigue is slowly improving and the heel soreness lasted 5-6 days.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Neck pain, Nervousness, Paraesthesia, Tremor
Clinical narrative: This is a spontaneous report from a 55 year old female pt who, approximately 3 hours post vax, experienced sudden body tremors, hands shaking and her insides shaking. Also, she developed a sharp pain in the injected left arm. The next morning, the body tremors ceased but the arm pain persisted another 3 days. Approximately 2 weeks after the injection, she experienced a dull pain which was intermittent and tingling of her neck which radiated down her left arm. The symptoms were treated with Benadryl. The most recent information received on 7/2/99, reports the pain in arm and neck appears to be ongoing. Her doctor suggested she take cortisone but she does not want to. The physician attributes the arm pain to the arthritis, but the pt does not believe this because she never had pain there before.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a RN referring to a 50 year old female who, 5 days post vax, on 7/28/1999, she experienced a 3cm X 4cm area of hives at the injection site. On 7/30/1999, the hives resolved. Some itching and redness remained. On 8/1/1999, symptoms were completely resolved. The most recent information, received on 8/5/1999, reports the condition of the pt is resolved.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Chest pain, Fatigue, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a physician referring to a female pt who on 4/13/99, received her 1st dose of Lymerix and on 5/13/99, she received her 2nd dose. Two weeks later, she experienced a diffuse myalgia, fatigue, polyarthralgias, fever of 101F, chest wall pain and a mild to moderate elevation in her sedimentation rate of 40. No treatment was given. The most recent information received on 8/2/99, reports the chest wall pain persisted but has improved. The pt still has pain in her hands, feet and lumbar spine.
Sex: F
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: This is a spontaneous report from a physician referring to a female pt who on 4/13/99, received her 1st dose of Lymerix and on 5/13/99, she received her 2nd dose. Two weeks later, she experienced a diffuse myalgia, fatigue, polyarthralgias, fever of 101F, chest wall pain and a mild to moderate elevation in her sedimentation rate of 40. No treatment was given. The most recent information received on 8/2/99, reports the chest wall pain persisted but has improved. The pt still has pain in her hands, feet and lumbar spine.