chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Inflammation, Platelet count increased, Red blood cell sedimentation rate increased
Clinical narrative: In March 2000, the pt was found to have a chronic inflammatory picture.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Diabetes insipidus, Pituitary tumour benign
Clinical narrative: Approximately one month post vax, the vaccinee developed diabetes insipidus and a tumor on his pituitary gland. The vaccinee is receiving replacement therapy for his pituitary tumor.
Age: 13.0
Sex: F
Vaccine: LYME
Symptoms: Drug ineffective
Clinical narrative: Post vax, it was determined that the child was a non responder.
Age: 10.0
Sex: M
Vaccine: LYME
Symptoms: Drug ineffective
Clinical narrative: Post vax, it was determined that the child was a non responder.
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Post vax, the pt experienced pain, redness, and swelling at the injection site.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Post vax, the pt experienced chills, arthralgia, fever, and headache.
Sex: F
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Alopecia
Clinical narrative: Pt had marked hair loss.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Hypokinesia, Injection site discolouration, Neck pain, Pain
Clinical narrative: Left arm pain, radiation to neck. Pain with motion. Blanching at site, resolving within 1 hour.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Bacterial infection, Diarrhoea, Pyrexia, Rash
Clinical narrative: MMR was given on 6/12/00 and within 12-24 hours, pt developed fever of 104F which continued for several days. Pt seen in ED on 6/16/00. Pt was placed on Amoxil. Pt seen again in ED on 6/20/00 with rash and Amoxil stopped. Diarrhea started on 6/17/00 and was (+) for C difficale. Pt fine now.
Age: 0.2
Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Small for dates baby, Sudden infant death syndrome
Clinical narrative: This infant died 24 hours following receipt of vaccines. Cause of death was reported as SIDS. At the time of immunization, the infant "did not look too healthy, appeared underweight for age". This report was received from the FDA (VAERS #92619). Additional information received from plaintiff's attorney on 7/20/2000, provided the infant's name, address and birth date; and the name of the facility where the infant was immunized.
Age: 1.6
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Febrile convulsion
Clinical narrative: A physician reported that a 19 month old male received an injection of Acel-Imune vaccine on 11/30/99. The next morning, the child developed a fever of up to 103F and subsequently, experienced a convulsion. He was hospitalized on the same day, 12/01/99, and treated with Tylenol and ibuprofen. No spinal tap was performed. The fever persisted in "stair step fashion" for the next 2 days. Follow-up information received from the physician on 1/17/00, indicated that the child's fever began approx. 16 hours, post vax. Generalized convulsions began approx. 20 hours, post vax and lasted approx. 3 minutes. The child was seen in ER and then hospitalized. The pt had been wheezing; no focal infiltrates were observed on a chest X-ray. The pt recovered and was discharged on 12/02/99.
Age: 1.6
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Asthma, Convulsion, Haematuria, Infection, Laboratory test abnormal
Clinical narrative: A physician reported that a 19 month old male received an injection of Acel-Imune vaccine on 11/30/99. The next morning, the child developed a fever of up to 103F and subsequently, experienced a convulsion. He was hospitalized on the same day, 12/01/99, and treated with Tylenol and ibuprofen. No spinal tap was performed. The fever persisted in "stair step fashion" for the next 2 days. Follow-up information received from the physician on 1/17/00, indicated that the child's fever began approx. 16 hours, post vax. Generalized convulsions began approx. 20 hours, post vax and lasted approx. 3 minutes. The child was seen in ER and then hospitalized. The pt had been wheezing; no focal infiltrates were observed on a chest X-ray. The pt recovered and was discharged on 12/02/99.
Age: 1.6
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Pyrexia
Clinical narrative: A physician reported that a 19 month old male received an injection of Acel-Imune vaccine on 11/30/99. The next morning, the child developed a fever of up to 103F and subsequently, experienced a convulsion. He was hospitalized on the same day, 12/01/99, and treated with Tylenol and ibuprofen. No spinal tap was performed. The fever persisted in "stair step fashion" for the next 2 days. Follow-up information received from the physician on 1/17/00, indicated that the child's fever began approx. 16 hours, post vax. Generalized convulsions began approx. 20 hours, post vax and lasted approx. 3 minutes. The child was seen in ER and then hospitalized. The pt had been wheezing; no focal infiltrates were observed on a chest X-ray. The pt recovered and was discharged on 12/02/99.
Age: 37.0
Sex: M
Vaccine: LYME, LYME, LYME
Symptoms: Arthralgia, Back pain, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Post vax, on the same day, the pt experienced soreness at the injection site which lasted to 5/25/00. He experienced flu-like illness with low-grade fever and muscle aches/joint discomfort. Most discomfort was in the back/spine area and began on 6/1/00. Additionally, he experienced discomfort throughout the thoracic cage.
Age: 37.0
Sex: M
Vaccine: LYME, LYME, LYME
Symptoms: Arthralgia, Influenza like illness, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Post vax, on the same day, the pt experienced soreness at the injection site which lasted to 5/25/00. He experienced flu-like illness with low-grade fever and muscle aches/joint discomfort. Most discomfort was in the back/spine area and began on 6/1/00. Additionally, he experienced discomfort throughout the thoracic cage.
Age: 37.0
Sex: M
Vaccine: LYME, LYME, LYME
Symptoms: Arthralgia, Chest discomfort, Influenza like illness, Injection site pain, Joint swelling
Clinical narrative: Post vax, on the same day, the pt experienced soreness at the injection site which lasted to 5/25/00. He experienced flu-like illness with low-grade fever and muscle aches/joint discomfort. Most discomfort was in the back/spine area and began on 6/1/00. Additionally, he experienced discomfort throughout the thoracic cage.
Age: 37.0
Sex: M
Vaccine: LYME, LYME, LYME
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Post vax, on the same day, the pt experienced soreness at the injection site which lasted to 5/25/00. He experienced flu-like illness with low-grade fever and muscle aches/joint discomfort. Most discomfort was in the back/spine area and began on 6/1/00. Additionally, he experienced discomfort throughout the thoracic cage.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, DTAP, HEP, HIBV, IPV, RV
Symptoms: Abdominal pain upper, Intussusception, Irritability, Lethargy, Pallor
Clinical narrative: On 4/24/00, pt presented to the doctor's office with mid-abdominal pain, fussy, episodes of body stiffening, unusual fatige, trembling X 24 hours. Dx'd with intussusception. Pt was referred to pediactric surgeon.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, DTAP, HEP, HIBV, IPV, RV
Symptoms: Pyrexia, Somnolence
Clinical narrative: On 4/24/00, pt presented to the doctor's office with mid-abdominal pain, fussy, episodes of body stiffening, unusual fatige, trembling X 24 hours. Dx'd with intussusception. Pt was referred to pediactric surgeon.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, DTAP, HEP, HIBV, IPV, RV
Symptoms: Abdominal pain, Fatigue, Gastric outlet obstruction, Irritability, Musculoskeletal stiffness
Clinical narrative: On 4/24/00, pt presented to the doctor's office with mid-abdominal pain, fussy, episodes of body stiffening, unusual fatige, trembling X 24 hours. Dx'd with intussusception. Pt was referred to pediactric surgeon.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, DTAP, HEP, HIBV, IPV, RV
Symptoms: Tremor, White blood cell count increased
Clinical narrative: On 4/24/00, pt presented to the doctor's office with mid-abdominal pain, fussy, episodes of body stiffening, unusual fatige, trembling X 24 hours. Dx'd with intussusception. Pt was referred to pediactric surgeon.
Age: 52.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: In March 2000, the pt received her 1st injection of Lymerix. A few days later, the injection site was sore, hot and swollen for a couple of days (resolved without treatment). In April 2000, the pt had her 2nd dose and again injection site became sore, hot and swollen. On 6/9/00, the pt received her 3rd injection of Lymerix. Some time afterwards, the injection site became hot and swollen and a hard lump "the size of a tennis ball" developed which was very painful. On 6/10/00, there was redness around the site and then a second and third red area developed below the injection site which were itchy and hot to touch. The 3 red areas faded but did not decrease in size. On 6/11/00, the pt reported generalized body aches, and her elbows and fingers hurt. She also noted that her temperature was 98F (it is normally less than 97F) and that she felt very tired. She also added that her blood sugars were slightly elevated, although within normal range. The pt took Tylenol for the events and she started to feel better on 6/12/00. She also used a cold compress on the affected areas. The most recent information received on 6/13/00, reports that the areas were warm and the redness was almost completely gone. The outcome of the other events are unknown.
Age: 52.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: In March 2000, the pt received her 1st injection of Lymerix. A few days later, the injection site was sore, hot and swollen for a couple of days (resolved without treatment). In April 2000, the pt had her 2nd dose and again injection site became sore, hot and swollen. On 6/9/00, the pt received her 3rd injection of Lymerix. Some time afterwards, the injection site became hot and swollen and a hard lump "the size of a tennis ball" developed which was very painful. On 6/10/00, there was redness around the site and then a second and third red area developed below the injection site which were itchy and hot to touch. The 3 red areas faded but did not decrease in size. On 6/11/00, the pt reported generalized body aches, and her elbows and fingers hurt. She also noted that her temperature was 98F (it is normally less than 97F) and that she felt very tired. She also added that her blood sugars were slightly elevated, although within normal range. The pt took Tylenol for the events and she started to feel better on 6/12/00. She also used a cold compress on the affected areas. The most recent information received on 6/13/00, reports that the areas were warm and the redness was almost completely gone. The outcome of the other events are unknown.
Age: 52.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Fatigue, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: In March 2000, the pt received her 1st injection of Lymerix. A few days later, the injection site was sore, hot and swollen for a couple of days (resolved without treatment). In April 2000, the pt had her 2nd dose and again injection site became sore, hot and swollen. On 6/9/00, the pt received her 3rd injection of Lymerix. Some time afterwards, the injection site became hot and swollen and a hard lump "the size of a tennis ball" developed which was very painful. On 6/10/00, there was redness around the site and then a second and third red area developed below the injection site which were itchy and hot to touch. The 3 red areas faded but did not decrease in size. On 6/11/00, the pt reported generalized body aches, and her elbows and fingers hurt. She also noted that her temperature was 98F (it is normally less than 97F) and that she felt very tired. She also added that her blood sugars were slightly elevated, although within normal range. The pt took Tylenol for the events and she started to feel better on 6/12/00. She also used a cold compress on the affected areas. The most recent information received on 6/13/00, reports that the areas were warm and the redness was almost completely gone. The outcome of the other events are unknown.
Age: 52.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Injection site warmth, Pain, Pruritus, Vaccine positive rechallenge
Clinical narrative: In March 2000, the pt received her 1st injection of Lymerix. A few days later, the injection site was sore, hot and swollen for a couple of days (resolved without treatment). In April 2000, the pt had her 2nd dose and again injection site became sore, hot and swollen. On 6/9/00, the pt received her 3rd injection of Lymerix. Some time afterwards, the injection site became hot and swollen and a hard lump "the size of a tennis ball" developed which was very painful. On 6/10/00, there was redness around the site and then a second and third red area developed below the injection site which were itchy and hot to touch. The 3 red areas faded but did not decrease in size. On 6/11/00, the pt reported generalized body aches, and her elbows and fingers hurt. She also noted that her temperature was 98F (it is normally less than 97F) and that she felt very tired. She also added that her blood sugars were slightly elevated, although within normal range. The pt took Tylenol for the events and she started to feel better on 6/12/00. She also used a cold compress on the affected areas. The most recent information received on 6/13/00, reports that the areas were warm and the redness was almost completely gone. The outcome of the other events are unknown.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Mouth ulceration, Urticaria
Clinical narrative: Hives, mouth ulcers
Age: 0.7
Sex: M
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Same day post vax, the pt experienced an afebrile seizure.
Age: 33.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Fatigue, Pyrexia
Clinical narrative: This report describes the occurrence of joint pain. This pt received 2 injections of lyme vax. Pt experienced fatigue, joint pain, knee pain, weakness, fever, and chills post second vax. Pt reported missed 8 days of work and was referred to an infectious disease specialist. All symptoms are resolved except the fatigue. Please note that these events of joint and knee pain do not meet ICM serious criteria, but are being submitted expeditiously for informational purposes. FU information states the pt is a landscaper with frequent exposure to ticks.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Joint stiffness, Pain
Clinical narrative: One month post vax, the pt experienced joint stiffness, mild bilateral hand and heel pain, and mild right hip pain. He describes his mild pain as arthritic-like. He reports he had no joint swelling or warmth. Pt has been evaluated by a physician who has drawn lab work. Pt received no treatment for the events.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: Hospitalized for swelling to left upper and given IV antibiotics. Released from hospital 07/24/2000. Hospitalized X 2 days. Treated for cellulitis of injection site. D/C DGX is local reaction to tetanus toxoid w/ necrosis of fat.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt was found in his crib at daycare on 10/10/1997, having died from SIDS. Doctor spoke with other doctor on 10/15/1997, who said that the autopsy confirmed SIDS.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine
Clinical narrative: Post vax, the pt started getting severe migraine headaches, which have increased periodically over time. Pt states he has seen 3 doctors in reference to migraines.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Same day post vax, the pt developed a large reddened area that was very tender to the touch. Arm is very sore. Seen in a clinic and treated for reaction.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Arm became sore around 5 1/2 to 6 hours, post vax. There's slight redness in upper left arm.
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Arthritis, Joint stiffness, Polyarthritis
Clinical narrative: Post vax, this pt experienced stiffness in arm two days post vax 01/17. By 01/21, she experienced stiffness in neck. On 01/25, severe pain in arms wrists and knees. The pain continued to worsen and could not get relief from over the counter medications. Physician consulted and labs were conducted. Pt presented to the ER - pain caused difficulty breathing. The following day, she was seen by additional physicians who prescribed pain and inflammation reduction medication. Physicians thought there may be a causal relationship between vaxs and acute migratory polyarthritis.
Age: 1.08
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Before vaccinations were given, I questioned mother concerning the small amount of rashes noted on pt's arm and shoulder. Mother stated when the baby feels hot there will be rashes on her body. The child was active and had no temperature when the vaccines were given, but after 1 day of IZ's, mother called and said child had more rashes all over body and appears red and stated no temperature and no other problems, only the rashes.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: Pt with hard mass is SQ region of right thigh.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to left arm, face and chest; possible MS. (Please let me know if related).
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Left thigh became red from knee to upper thigh and back of thigh. Faded completely within 1/2 hour.
Age: 18.0
Sex: M
Vaccine: MMR, TD
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Had TD vaccine on 5/30/00. Symptoms began at 15:00 on 5/31/00. Pt complained of headache, fever, increased fatigue, pinkness and swelling at injection site and nausea. Referred to his MD on 6/1/00 for exam and antihistamine for swelling.
Age: 18.0
Sex: M
Vaccine: MMR, TD
Symptoms: Pyrexia
Clinical narrative: Had TD vaccine on 5/30/00. Symptoms began at 15:00 on 5/31/00. Pt complained of headache, fever, increased fatigue, pinkness and swelling at injection site and nausea. Referred to his MD on 6/1/00 for exam and antihistamine for swelling.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash vesicular
Clinical narrative: Approximately 7-8 days, post vax, child developed a bleb-like rash which worsened for 1-2 days, then began to fade, and was gone in a matter of 3-4 days. Child also ran a low-grade (less than 101F) fever and developed diarrhea for which she saw a physician and was treated with Pedialyte.
Age: 12.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Pruritus, Rash macular
Clinical narrative: Mom states she had "blotches from head to toe", severe itching but normal temperature of 97.9F. She was given Celestone in ER and oral medicine (she thinks it was Benadryl) to take prn.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site swelling, Irritability
Clinical narrative: That same evening, post vax, leg had swelling from knee to hip. No temperature, only fussy. No nodule at site. Injection in proper site.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site swelling
Clinical narrative: Comvax given on 7/17/00, leg swollen, went to ER on 7/19/00 evening and mother states nothing was done. Pt checked by MD on 7/20/2000 an had swollen right outer thigh. Treated with warm packs. To recheck in 2 months for well baby check.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Ear pain, Feeling hot, Malaise, Myalgia
Clinical narrative: Woke up early Sunday very hot to touch, not feeling good, complaining of muscle aches, tired and ears painful. Gave Tylenol on 7/16, FNP. No ear infection found and instructed to continue Tylenol or Advil. On 7/18, mom states child is acting fine.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Rash maculo-papular
Clinical narrative: 8cm X 5cm splotchy, erythema, mostly medial to injection site of DTAP.
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling, itching; large area approximately 6" X 6" to left deltoid. Pt was given Sterapred, Cipro and Atarax.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Injection site swelling
Clinical narrative: Six days, post vax, he had arm swelling and weakness. Resolved with ibuprofen and warm soaks.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Injection site swelling, Rash
Clinical narrative: Five days, post vax, he had a mild rash and minimal swelling at the injection site. Resolved with ibuprofen and warm soaks.
Age: 65.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Pyrexia
Clinical narrative: On 5/14/99 and 6/11/99, the pt received his 1st and 2nd Lymerix vaccines. On 5/15/00, he received his 3rd dose and within 45 minutes later, he experienced chills, fever and a mild headache. Pt was evaluated in an ER but was not treated. The information received on 5/19/00, reported the symptoms resolved after 48 hours.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia, Paraesthesia
Clinical narrative: On 3/19/99, the pt received her 1st Lymerix. 24 hours later, she experienced a paresthesia of her hand and myalgias. No treatment was given. The information received on 5/19/2000, reported the symptons resolved after 24 hours.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Pruritus, Swelling
Clinical narrative: On 5/28/99 and 7/1/99, the pt received his 1st and 2nd doses of Lymerix, respectively. During 2000, the vaccinee had 2 wood tick bites: one on his head and one next to his navel. In both instances, he experienced swelling the size of a dime and severe itching at the site of the bites which lasted for 2 weeks. He is an outdoor person and has never had such a reaction to a wood tick bite prior to receiving Lymerix. However, he has had this type of reaction to black fly bites. On 5/30/00, the pt received his 3rd dose of Lymerix. The most recent information, received on 5/30/00, reports the condition of the vaccinee as resolved.
Age: 16.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Malaise, Pain, Rash
Clinical narrative: In 4/99, the pt received his 1st dose of Lymerix. 24 hours, post vax, he experienced pain at the injection site, then flu-like symptoms. He had a low-grade fever which lasted 3 days. Outcome:resolved. In 5/99, the pt received his 2nd dose of Lymerix. 24 hours, post vax, he experienced pain at the injection site and flu-like symptoms. Symptoms lasted 24 hours and then resolved. On 5/24/00, the pt received his 3rd dose of Lymerix. 3 days later, on 5/27/00, he experienced pain at the injection site, and did not feel well. The pt felt "achey". Additionally, he developed a tiny, red, flat rash behind one ear. On 5/29/00, the rash spread around his back, behind both ears, and down his back and chest. No treatment was given. Outcome: unresolved. The most recent information, received on 5/30/00, reports the condition of the vaccinee as unresolved.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: In May, 1999, on an unspecified date, and on 5/26/00, the pt received her 1st, 2nd and 3rd doses of Lymerix, respectively. On 5/26/00, the pt notified her physician that she was approximately 6 weeks pregnant. Her last menstrual period was in April, 2000, the date of the positive pregnancy test was in May, 2000, and the estimated delivery date is January, 2001. The most recent information, received on 5/31/00, reports the condition of the vaccinee as ongoing.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: On 5/18/2000, the pt received her 1st Lymerix. 4 1/2 hours later, she experienced flu-like symptoms, chills and fever. Treatment included Aleve. The information received on 5/23/00, reported the symptoms resolved after 2 hours.
Sex: M
Vaccine: LYME
Symptoms: Hypokinesia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 5/28/00, the pt received his 1st dose of Lymerix. Subsequently, he experienced severe swelling and pain at the injection site, which was warm to the touch. Additionally, he experienced pain when lifting the injection site arm. The most recent information, received on 6/13/00, reports the condition of the vaccinee as ongoing.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Joint effusion
Clinical narrative: On 05/27/2000, this male pt received first dose of vax. Reportedly since receiving the vax, the pt has had his left knee aspirated three times.
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Malaise, Pyrexia
Clinical narrative: This pt received his first vax on 04/27/00. One day post vax, he experienced lightheadedness, malaise and a slight fever. No outcome was provided.
Age: 63.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Injection site rash
Clinical narrative: On 6/2/00, the pt received her 1st dose of Lymerix. Six hours later, on 6/2/00, the pt experienced generalized arthralgias and a bullseye rash at the injection site. The vaccinee had no fever, rash or pruritus. She was treated that day with NSAIDS (NOS). The most recent information, received on 6/5/00, reports the condition of the vaccinee is resolving.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: On 5/7/00, the pt received his 1st dose of Lymerix. One week later, on 5/14/00, he experienced shoulder joint soreness which resolved in 2-3 days. Three days later, on 5/17/00, he experienced knee joint pain. No treatment was given. The most recent information received on 6/7/00, reports the condition of the vaccinee is "almost resolved".
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: On 5/12/00, the pt received his 1st injection with Lymerix. Sometime thereafter, he experienced pain at the injection site. The information received on 5/23/2000, did not provide an outcome.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Chills, Tremor
Clinical narrative: In May, 2000, the pt received his 1st dose of Lymerix and within 1 hour, post vax, the vaccinee felt queazy. His queasiness lasted for 1-2 days and resolved. On 6/9/00 at 12:30, the pt received his 2nd Lymerix and within 40 minutes, post vax, he experienced chills and shaking. These symptoms seemed to be lessening but were unresolved. The most recent information, received on 6/9/00, reports the condition of the vaccinee as unresolved.
Sex: F
Vaccine: HEP, LYME
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: In March, 2000, the pt received her 1st dose of Lymerix. Initially, she reported experiencing pain in her hips. She also reported pain and stiffness in her other joints when sedentary which lessens when mobile. A genetic marker test (NOS) was performed. The physician reported she experienced 'generalized arthritis', but he was not the prescribing physician. He stated no testing was done to rule out arthritis versus arthralgia, but "concurs it is probably arthralgia". Treatment included ibuprofen. The pt reported the symptoms lasted 1.3 months which became intermittent and are now occasional. A few days ago in June, 2000, the pt reported her shoulders, wrists and elbows ached and then resolved.
Sex: M
Vaccine: LYME
Symptoms: Arthritis
Clinical narrative: On an unspecified date, the pt received a dose of Lymerix. The nurse reported that she had heard that the pt claimed he developed autoimmune arthritis. The most recent information received on 6/13/00, reports the outcome of the event as unknown. Additional information has been requested.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: At an unspecified time, the pt received his 1st dose of Lymerix, with no untoward effects. The physician reported the pt received the 2nd dose, and the pt reported to his physician he experienced joint pain. The most recent information received on 6/13/00, reported the joint pain resolved.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: On 8/23/99 and 9/27/99, the pt received his 1st and 2nd Lymerix. Subsequent to his 2nd Lymerix, the pt experienced joint pain. A doctor visit was required. The most recent information, received on 5/26/00, reports the condition of the pt is unknown.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: "Approximately 1 year ago", the pt received his 1st, 2nd and 3rd doses of Lymerix. About 4-5 months ago, he experienced muscle and joint pain. This included right shoulder bursitis-type pain, pain in the back of his legs from his heels up to middle upper calf, and aching feet from time to time. A doctor visit was required. Physician told the pt that he "did not have arthritis". The most recent information, received on 6/5/00, reports the condition of the vaccinee is ongoing.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Myalgia, Paraesthesia
Clinical narrative: On unspecified dates, the pt received his 1st, 2nd and 3rd doses of Lymerix. Subsequent to his 3rd dose, he experienced paresthesia, arthralgias and myalgias. The most recent information, received on 6/6/00, reports the condition of the vaccinee is unknown.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Myalgia, Nausea
Clinical narrative: In early May, 2000, the pt received his 1st dose of Lymerix. On approximately 6/1/2000, he began experiencing pain in both elbows (like muscle pain), right wrist, and both knees. He stated it was like a constant, annoying ache in these areas. The pain was getting worse all over. "He didn't know what to do". Additionally, he has a "strange pain" in his back, is intermittently nauseous and his "skin burns" (not constant). The vaccinee stated that the pain he is now experiencing is "different" from that which he has experienced before with tennis elbow and back "problems". The most recent information, received on 6/7/00, reports the condition of the vaccinee as ongoing.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Drug ineffective
Clinical narrative: On  unspecified dates, the pt received 3 injections of Lymerix. The physician reported that he had a negative titer after receiving the 3 injections. The most recent information received on 5/18/2000, reports the outcome of the event as unknown.
Age: 31.0
Sex: M
Vaccine: LYME
Symptoms: Malaise, Pyrexia
Clinical narrative: On an unspecified date, the pt received the 1st dose of Lymerix and 1 day later, he experienced generalized muscle aches. Outcome: resolved. On an unspecified date, the pt received his 2nd dose of Lymerix and 1 day later, he experienced muscle pain in his arms and back. Outcome: resolved. On an unspecified date, th pt received his 3rd dose of Lymerix and 1 day later, he experienced a high fever. The reporter stated that since her husband had received Lymerix, he has had intermittent "illnesses" (NOS). No treatment was given. The most recent information, received on 6/8/00, reports the condition of the pt as unknown.
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: On 5/5/00, the pt received her 1st dose of Lymerix. She received her 2nd dose on 6/6/00 and 4 days, post vax of 2nd dose, on 6/11/00, she had a positive home pregnancy test. Date of LMP and expected date of delivery were not specified. The most recent information received on 6/12/00, reports the outcome of the pregnancy as unknown.
Age: 18.0
Sex: M
Vaccine: LYME
Symptoms: Facial palsy
Clinical narrative: On 6/6/00, the pt received his 1st dose of Lymerix. Nine days later, on 6/15/00, the pt presented with right-sided Bell's palsy. The most recent information, received on 6/15/00, reports the outcome of the event as unresolved.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Hypoaesthesia, Joint effusion, Joint range of motion decreased
Clinical narrative: In May, 1999 and June, 1999, the pt received the 1st and 2nd doses of Lymerix. Rheumatologist reports that subsequently, the pt experienced pain in all of his joints except the distal interphalangeal joints. The metacarpophalangeal joints were a little tender on exam. The exam was mostly unremarkable. There was no swelling. The pt claimed he had intermittent swelling and pain but none were found. There were no warm joints on exam. There was a small effusion in the right knee, too small to tap. The rheumatologist stated that this effusion could be due to degenerative joint disease and he noted some loss of range of motion to the right knee. The pt also complained of abnormal sensations in his legs which started as pain but was now a numbness. He could not identify when this started. He was referred to a neurologist. No treatment was given. The rhematologist saw no joint changes indicating arthritis. There were no erosions and no inflammatory changes. The most recent information, received on 6/14/00, reports the outcome of the event as unresolved.
Sex: M
Vaccine: LYME
Symptoms: Injection site rash
Clinical narrative: At unspecified times, the pt received his first 2 injections with Lymerix, with no untoward effects. Sometime after receiving the 3rd dose of Lymerix, he experienced a rash around the injection site. The information received on 6/14/2000, reported the symptoms were ongoing.
Age: 18.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Influenza like illness
Clinical narrative: On 5/27/00, the pt received her 1st dose of Lymerix. Within days of the injection, she experienced mild flu symptoms, back pain, and "bad" joint pain. The reporter noted that the pt needed treatment by a chiropractor 5 times in 2 weeks due to severe back pain. The most recent information received on 6/12/2000, reported the outcome of the events as resolving.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Diarrhoea, Dizziness, Injection site pain, Nausea, Vomiting
Clinical narrative: On 4/16/00, the pt received his 1st dose of Lymerix and within the 1st hour, post vax, the pt experienced right arm numbness for 15 hours, arm soreness for 24 hours and tingling in the arm for 6 hours. The events resolved after 24 hours. On 5/19/00, the pt received his 2nd dose of Lymerix and within 18 hours, he experienced nausea, vomiting, diarrhea, dizziness and some arm soreness. It was noted that the pt was sick for 3 days. The most recent information received on 5/26/00, reports the outcome of the events as resolved.
Sex: F
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: On unspecified dates, the pt received her 1st and 2nd doses of Lymerix. The pt reported that her arm hurt and felt heavy for 2 days, post vax. Within 24 to 48 hours, post vax of the 2nd vax, the pt developed a fever of 102 to 102. The most recent information received on 5/26/00, reports the outcome of the events as resolved.
Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Abdominal pain, Arthralgia, Headache, Influenza like illness, Menstruation irregular
Clinical narrative: On 5/27/00, the pt received her 1st dose of Lymerix and within 1 1/2 hours, post vax, the pt experienced flu symptoms, headache, joint pain, and severe abdominal pain (in the ovary area). She also reported her menstrual period lasted 12 days. The most recent information received on 6/12/00 reports the outcome of the events as not yet recovered but resolving slowly.
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Paraesthesia
Clinical narrative: In May, 1999, the pt received the 1st dose of Lymerix, with no untoward effects. In June, 1999, he received the 2nd dose of Lymerix and during June, he reported experiencing pinpoint injection site pain which spread to his entire arm. He reported the pain sometimes feels like an "electrical shock" which settled in his shoulder. He reported decreased range of motion and decreased strength in the affected arm and shoulder. No treatment was given. The most recent information received on 6/14/00, reported the symptoms were ongoing.  Received on 09/21/2000: "Follow up from his physician reported "patient has bursitis of the shoulder.  No correlation with Lymerix."  The most recent information received on 09/19/2000 did not provide an outcome.  The events bursitis, shock-like feeling in arm, and decreased range of motion do not meet ICM serious criteria, but are being submitted expeditiously per FDA request.
Sex: F
Vaccine: LYME
Symptoms: Erythema, Infection parasitic
Clinical narrative: On an unspecified date, the pt received 3 injections of Lymerix. It was noted that the pt received the injections on an accelerated schedule (all 1 month apart). Some time later, the pt developed 2 areas of erythema migrans, requiring either an ER or doctor's visit. She received unspecified treatment for Lyme disease. The most recent information received on 6/13/2000, reports the outcome of the event as unknown.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Influenza like illness, Nausea
Clinical narrative: On 6/6/00, the pt received her 1st dose of Lymerix and 1 week later, on 6/13/00, she experienced flu-like symptoms, nausea and weakness which lasted 2 days. No treatment was given. The most recent information, received on 6/16/2000, reports the outcome of the event is resolved.
Age: 27.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Chills, Influenza like illness, Injection site erythema, Pain
Clinical narrative: On 6/19/00 at 16:00, the pt received her 1st dose of Lymerix and at 18:00, her left arm felt "like she got hit with a sledge hammer". Subsequently, she had "no energy", and experienced flu-like symptoms, chills and redness at the injection site. She was treated with ice and ibuprofen. The most recent information, received on 6/20/00, reports the chills as having resolved on 6/20/00 and the other events as being unresolved.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: On 6/14/00, the pt received his 3rd dose of Lymerix and 5 days later, on 6/19/00, he developed a headache and fatigue. On 6/20/00, he developed a low-grade fever, sweating, sinus congestion and nasal stuffiness which, the vaccinee stated, made it "harder for him to breathe". The most recent information received on 6/20/00, reports the outcome of the event as unresolved.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Sinus congestion
Clinical narrative: On 6/14/00, the pt received his 3rd dose of Lymerix and 5 days later, on 6/19/00, he developed a headache and fatigue. On 6/20/00, he developed a low-grade fever, sweating, sinus congestion and nasal stuffiness which, the vaccinee stated, made it "harder for him to breathe". The most recent information received on 6/20/00, reports the outcome of the event as unresolved.
Age: 18.0
Sex: F
Vaccine: LYME
Symptoms: Rash
Clinical narrative: On an unspecified date, the pt received an injection of Lymerix and within 30 minutes of the injection, the pt developed a full body rash. The most recent information received on 6/20/2000, reports the outcome of the event as unknown.
Age: 28.0
Sex: M
Vaccine: LYME
Symptoms: Rash
Clinical narrative: In May, 2000, the pt received his 3rd dose of Lymerix and 24 hours, post vax, the vaccinee developed an upper body rash. The rash lasted 5 days. No treatment was given. The most recent information received on 6/20/00, reports the outcome of the event as resolved without sequelae.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Pain
Clinical narrative: On 4/20/00, the pt received his 3rd dose of Lymerix and subsequently, he experienced bilateral biceps and shoulder pain. No treatment was given. The most recent information, received on 6/21/00, reports the outcome of the event as unresolved.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: On an unspecified date, the vaccinee received her first dose of Lymerix and subsequently, she experienced general muscle pain and joint pain. Outcome: unresolved. On an unspecified date, the pt received her second dose of Lymerix and subsequently, she experienced mid-line back pain at the waist. No treatment was given. Outcome: unresolved. The most recent information, received on 6/21/2000, reports the outcome of the event as unresolved.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Back pain
Clinical narrative: In 2/99 and 5/99, the pt received his 1st and 2nd dose of Lymerix and after the 2nd dose, he experienced low back pain. No treatment was given. The most recent information received on 6/22/00, reports the outcome of the event as unresolved.
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: On 5/3/99, the pt received her 1st dose of Lymerix with no untoward effects. On 6/3/99, she received the 2nd dose and became pregnant. The pt's LMP was 6/1/99 and her estimated date of delivery is 3/1/00. The pt's physician stated the pt has not been seen since 8/13/99. The most recent information received on 4/25/00 does not provide an outcome.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Placental disorder
Clinical narrative: On 4/16/99, the pt received the 1st dose of Lymerix. The pt was found to be pregnant. The date LMP is 03/17/99. The date of the positive pregnancy test is 5/4/99 and the estimated delivery date is late December, 1999. The pt delivered a 4 lb 8.5 oz female on 12/9/99 after a 37 1/2 week gestation. The mother experienced retained placenta. The most recent information received on 5/11/00, reports the condition of the pt as unknown. Physician has sent a letter to pt requesting follow-up information and it will be available as soon as he receives it.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Crying, Otitis media, Pyrexia, Screaming, Speech disorder
Clinical narrative: Pt had his 1st set of shots at 13:00 on 10/10/1992. At about 16:00, he became fussy, screaming, crying and running a fever. When I looked at his legs, his right leg was swollen, red and very hot. We took him to the ER, where he was seen by a doctor. The doctor told me to give him Tylenol and Benadryl.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Pt had his 1st set of shots at 13:00 on 10/10/1992. At about 16:00, he became fussy, screaming, crying and running a fever. When I looked at his legs, his right leg was swollen, red and very hot. We took him to the ER, where he was seen by a doctor. The doctor told me to give him Tylenol and Benadryl.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Screaming
Clinical narrative: Pt had his 1st set of shots at 13:00 on 10/10/1992. At about 16:00, he became fussy, screaming, crying and running a fever. When I looked at his legs, his right leg was swollen, red and very hot. We took him to the ER, where he was seen by a doctor. The doctor told me to give him Tylenol and Benadryl.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Coma, Convulsion, Dyspnoea, Flushing
Clinical narrative: It was reported that the pt cried immediately and had very impressive erythema from lower abdomen to legs. Decreased responsiveness and stiffening of the extremities were noted. The physician reported that it was most likely a seizure that lasted 5 minutes total and vital signs were stable during the time. After 5 minutes the pt improved. The pt was taken to the ER and a complete work-up was done. Within 1 hour, it was reported that the pt was pretty close to baseline and the next day was fine. The pt was admitted to the hospital and released the next day.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Coma, Erythema, Musculoskeletal stiffness
Clinical narrative: It was reported that the pt cried immediately and had very impressive erythema from lower abdomen to legs. Decreased responsiveness and stiffening of the extremities were noted. The physician reported that it was most likely a seizure that lasted 5 minutes total and vital signs were stable during the time. After 5 minutes the pt improved. The pt was taken to the ER and a complete work-up was done. Within 1 hour, it was reported that the pt was pretty close to baseline and the next day was fine. The pt was admitted to the hospital and released the next day.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Convulsion, Crying, Depressed level of consciousness, Erythema, Musculoskeletal stiffness
Clinical narrative: It was reported that the pt cried immediately and had very impressive erythema from lower abdomen to legs. Decreased responsiveness and stiffening of the extremities were noted. The physician reported that it was most likely a seizure that lasted 5 minutes total and vital signs were stable during the time. After 5 minutes the pt improved. The pt was taken to the ER and a complete work-up was done. Within 1 hour, it was reported that the pt was pretty close to baseline and the next day was fine. The pt was admitted to the hospital and released the next day.
Age: 25.0
Sex: F
Vaccine: HEP, TD
Symptoms: Asthenia, Blood pressure decreased, Cough, Dyspnoea, Fatigue
Clinical narrative: Pt developed shortness of breath, extreme fatigue, low blood pressure, episodic low grade fever, hypoxia, quickening of the heart (up to 90), tremors, pale, clamminess, cold, sweating, weakness, and cough. Doc 198136 states the following: Hypersensitivity to environmental allergens, developed food allergies. A follow up report received 8/1/2000 adds: Pt states that symptoms had sudden onset. She was seen that day (5/19/2000) by her physician who ordered several tests all of which were WNL. In late June-early July, she was hospitalized as symptoms worsened. More tests were performed including CXR, echocardiogram and blood tests for oxygen content of her blood. Admitting diagnosis was hypoxia. She consulted with a pulmonary-critical care specialist after discharge from the hospital. Again, all tests were negative or WNL. Pt states she obtained a copy of the package insert from SmithKline and that "all my symptoms are there." She plans follow-up with PCP later this week to discuss this. Currently her health status is slowly improving. Her breathing has become easier and she is able to cook for herself. She continues to sleep a lot and feel fatigued.
Age: 25.0
Sex: F
Vaccine: HEP, TD
Symptoms: Heart rate increased, Hyperhidrosis, Hypoxia, Pallor, Pyrexia
Clinical narrative: Pt developed shortness of breath, extreme fatigue, low blood pressure, episodic low grade fever, hypoxia, quickening of the heart (up to 90), tremors, pale, clamminess, cold, sweating, weakness, and cough. Doc 198136 states the following: Hypersensitivity to environmental allergens, developed food allergies. A follow up report received 8/1/2000 adds: Pt states that symptoms had sudden onset. She was seen that day (5/19/2000) by her physician who ordered several tests all of which were WNL. In late June-early July, she was hospitalized as symptoms worsened. More tests were performed including CXR, echocardiogram and blood tests for oxygen content of her blood. Admitting diagnosis was hypoxia. She consulted with a pulmonary-critical care specialist after discharge from the hospital. Again, all tests were negative or WNL. Pt states she obtained a copy of the package insert from SmithKline and that "all my symptoms are there." She plans follow-up with PCP later this week to discuss this. Currently her health status is slowly improving. Her breathing has become easier and she is able to cook for herself. She continues to sleep a lot and feel fatigued.