chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm, at site of injection, with 3" X 3" reddened area, hot to touch, non-tender. No other symptoms or complaints stated. Event began 1 day, post vax. Referred client to PMD. Client was to see MD that afternoon.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pneumonia
Clinical narrative: Post vax, the pt developed soreness, tenderness to the touch, redness, and swelling on the left arm where the shot was given. Pt went to private doctor and was told she had a reaction to the shot and a touch of pneumonia.
Age: 16.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Infection
Clinical narrative: Post vax, the pt developed a mild case of varicella.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: On 11/15/00, the pt began swelling from shoulder blade around arm, down to bend of elbow.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Headache
Clinical narrative: Child developed a headache for 3 weeks after a dose of Hepatitis B and had a seizure 3 weeks after shot. Has not been able to control hyperactivity with Adderall  15 mg Bid since.
Age: 9.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site mass, Injection site pain, Pruritus
Clinical narrative: On 11/18/00, the pt developed mild pain, itching, and a red mosquito type bump on left upper arm. Red bump has disappeared but pain and itching continues. Pain has continued since administration of injection.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Post vax, the pt developed breakthrough varicella.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: 6 hours, post vax, the right deltoid became sore and was unable to lift arm. Applied ice, heat and took ibuprofen with some relief but states "it is better today".
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Macular-papular rash only on legs and forearms. States some itchiness approx. 36 hours, post vax. Denied any other signs or symptoms of illness or problems.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain 30 minutes, post vax, with swelling and redness to site that night; worsening 2 days later. States she took Tylenol for pain and temperature of 99.9F. Also states she noted lumps on inside of bicep area. States feels better today (12/4/0) but symptoms are still there.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Widespread hives which lasted almost 10 days. Began approx. 3 hours, post vax. Treated with Benadryl and cool compresses.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Approx. 14 hours, post vax of TD vaccine, left deltoid area was swollen and painful. Area of induration noted by this writer on 11/30/00, approx. 50mm in diameter. Pt instructed to apply warm soaks to area. States last TD over 10 years ago without problem.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: I received my shot Monday in 11/27/00 at 13:30. I started with chills about 19:00 Monday night and I woke up about 03:00 vomiting and had diarrhea. I couldn't hold anything down until this afternoon. I had a little ginger ale. I called the doctor and he sent my promethazine which helped some. I still can't eat some food yet.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Nausea, Oedema, Pruritus, Vasodilation procedure
Clinical narrative: 72 hours post vax, the pt had warmth, redness, swelling, itching and nausea/vomiting.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: 72 hours post vax, the pt had warmth, redness, swelling, itching and nausea/vomiting.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Cellulitis, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Client states that on the evening of 11/14/00, around 17:30, she "felt sick"; about midnight she complained of backache, neck and arm aching. Called nurse "hotline" and was advised to take Tylenol, which she did. On 11/16/00, client states she felt light-headed and called her doctor, who was not in. She returned to the health dept where she got her shot. Examination of the right arm, indicated swelling, redness and warm to the touch from the middle of the upper arm to the elbow; and a small raised blister on the anterior right arm about 2" above the elbow which appeared to be an insect bite. IZ records indicate pneumococcal vaccine was administered in right deltoid. Health dept placed a call to client's doctor who was on vacation and was advised by their office to send client to walk-in clinic or the ER for follow-up. Client chose to go to walk-in clinic and was dx'd with "cellulitis". On 11/20/00, client reports she received antibiotic shot on 11/16 and 11/17 and her arm is better although her right arm to the middle of her chest is "still sensitive to touch".
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Malaise, Neck pain
Clinical narrative: Client states that on the evening of 11/14/00, around 17:30, she "felt sick"; about midnight she complained of backache, neck and arm aching. Called nurse "hotline" and was advised to take Tylenol, which she did. On 11/16/00, client states she felt light-headed and called her doctor, who was not in. She returned to the health dept where she got her shot. Examination of the right arm, indicated swelling, redness and warm to the touch from the middle of the upper arm to the elbow; and a small raised blister on the anterior right arm about 2" above the elbow which appeared to be an insect bite. IZ records indicate pneumococcal vaccine was administered in right deltoid. Health dept placed a call to client's doctor who was on vacation and was advised by their office to send client to walk-in clinic or the ER for follow-up. Client chose to go to walk-in clinic and was dx'd with "cellulitis". On 11/20/00, client reports she received antibiotic shot on 11/16 and 11/17 and her arm is better although her right arm to the middle of her chest is "still sensitive to touch".
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Eye swelling, Rash macular
Clinical narrative: Post vax, the pt developed swelling of eyes and blotching of skin.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Client states that on Wednesday evening on 10/4/00, post vax, he noticed that his left arm was hurting. He rolled up the sleeve of his shirt and saw that his arm was swollen at the site of injection. After 2 days, the site remained swollen and began to turn dark down to his elbow. On Monday, 10/9/00, he saw a doctor who informed him that the blood thinner that he is currently taking could have caused him to have a reaction to the flu shot and that it may take up to 2 weeks to clear up. No treatment was given at the time of doctor's visit. On 10/13/00, 17:30, called client to determine status. He states he did not think his MD would call him. Called his MD's answering service and was assured the doctor, on call, would call MD. On 10/16/00, 17:30, pt states doctor never called on Friday, but he did see a doctor today. He was told by this doctor, that the bleeding will stop and he agreed that the bruise had not gotten any larger. Pt states he is just fine."
Age: 0.75
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site mass
Clinical narrative: Next day post vax, the pt developed a knot in right leg.
Age: 1.75
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site hypersensitivity, Vasodilation procedure
Clinical narrative: On 11/1/00, the pt noticed arm was red and warm to the touch. Pt was recommended treating area with cool compresses and Tylenol.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Injection site pain, Pyrexia
Clinical narrative: 4 hours post vax, the pt developed pain at injection site, fever, and shortness of breath.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Post vax, the pt developed facial nerve palsy-Bell's on left side of face.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Difficulty in walking, Erythema, Orchitis, Scrotal oedema
Clinical narrative: Information has been received from a health professional concerning a 5 year old male pt who on 8/7/00 was vaccinated with the 2nd dose of MMR II, a 1st dose of DPT (Infanrix), a 1st dose polio virus vaccine (IPOL) and the 1st dose of varicella virus vaccine. On 8/10/00, the pt experienced left testicular swelling, mild erythema of the left scrotum with generalized tenderness and swelling. The pt also walks with legs slightly abducted. The pt's dx was orchitis. The pt's mother stated that "we can only conclude that it was a reaction to the vaccine". He was seen by a pediatric urologist who reported "that there had not been a documented case of this type of reaction in a juvenile in over 17 years". The reporter considered the pt's experiences to have resulted in a significant disability. Follow-up information from a nurse stated "she vaguely recalled this child's experience, and believed he had seen a pediatric urologist who was the primary physician treating the pt for this experience". The nurse also stated "she thought it was the urologist who felt the child's orchitis was related to MMR II vaccination, though she was not certain of this". She also stated "that she believed the child walked with his legs abducted due to the testicular swelling and orchitis and this was not a separate adverse experience, but again she could not definitively state this without checking th pt's chart". She also stated "she would obtain the pt's chart and call back to clarify the information discussed". Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Gait disturbance, Genitalia external painful, Oedema genital, Orchitis
Clinical narrative: Information has been received from a health professional concerning a 5 year old male pt who on 8/7/00 was vaccinated with the 2nd dose of MMR II, a 1st dose of DPT (Infanrix), a 1st dose polio virus vaccine (IPOL) and the 1st dose of varicella virus vaccine. On 8/10/00, the pt experienced left testicular swelling, mild erythema of the left scrotum with generalized tenderness and swelling. The pt also walks with legs slightly abducted. The pt's dx was orchitis. The pt's mother stated that "we can only conclude that it was a reaction to the vaccine". He was seen by a pediatric urologist who reported "that there had not been a documented case of this type of reaction in a juvenile in over 17 years". The reporter considered the pt's experiences to have resulted in a significant disability. Follow-up information from a nurse stated "she vaguely recalled this child's experience, and believed he had seen a pediatric urologist who was the primary physician treating the pt for this experience". The nurse also stated "she thought it was the urologist who felt the child's orchitis was related to MMR II vaccination, though she was not certain of this". She also stated "that she believed the child walked with his legs abducted due to the testicular swelling and orchitis and this was not a separate adverse experience, but again she could not definitively state this without checking th pt's chart". She also stated "she would obtain the pt's chart and call back to clarify the information discussed". Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Scrotal oedema
Clinical narrative: Information has been received from a health professional concerning a 5 year old male pt who on 8/7/00 was vaccinated with the 2nd dose of MMR II, a 1st dose of DPT (Infanrix), a 1st dose polio virus vaccine (IPOL) and the 1st dose of varicella virus vaccine. On 8/10/00, the pt experienced left testicular swelling, mild erythema of the left scrotum with generalized tenderness and swelling. The pt also walks with legs slightly abducted. The pt's dx was orchitis. The pt's mother stated that "we can only conclude that it was a reaction to the vaccine". He was seen by a pediatric urologist who reported "that there had not been a documented case of this type of reaction in a juvenile in over 17 years". The reporter considered the pt's experiences to have resulted in a significant disability. Follow-up information from a nurse stated "she vaguely recalled this child's experience, and believed he had seen a pediatric urologist who was the primary physician treating the pt for this experience". The nurse also stated "she thought it was the urologist who felt the child's orchitis was related to MMR II vaccination, though she was not certain of this". She also stated "that she believed the child walked with his legs abducted due to the testicular swelling and orchitis and this was not a separate adverse experience, but again she could not definitively state this without checking th pt's chart". She also stated "she would obtain the pt's chart and call back to clarify the information discussed". Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 13 month old white female pt with Otitis Media, at the time of vaccination, who was vaccinated in the left anterior thigh with the 1st dose of MMR II on 10/12/00 and also in the right thigh with a 4th dose of Hib vaccine. On 10/28/00 at 10:00 AM, the pt's mother called and stated "the child's injection site was red and warm". The physician inspected the pt on 10/28/00 at 18:00 and the injection site was red and warm but not fluctuant. The physician thought it was a local reaction (2 weeks later) to MMR II. On 10/30/00, the pt's mother called and stated "the injection site area was increasingly red and the center was fluctuant". The physician's evaluation that evening, showed a hot, red area on the left thigh with central fluctuance. The abscess was incised, drained and packed with sterile gauze. The pt continued on Biaxin for the treatment of Otitis Media. Upon internal review the pt's experiences were considered an "Important Medical Event". Follow-up information from a physician reported that the pt subsequently, recovered. No further information is available.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Injection site abscess, Injection site erythema, Injection site warmth, Otitis media
Clinical narrative: Information has been received from a physician concerning a 13 month old white female pt with Otitis Media, at the time of vaccination, who was vaccinated in the left anterior thigh with the 1st dose of MMR II on 10/12/00 and also in the right thigh with a 4th dose of Hib vaccine. On 10/28/00 at 10:00 AM, the pt's mother called and stated "the child's injection site was red and warm". The physician inspected the pt on 10/28/00 at 18:00 and the injection site was red and warm but not fluctuant. The physician thought it was a local reaction (2 weeks later) to MMR II. On 10/30/00, the pt's mother called and stated "the injection site area was increasingly red and the center was fluctuant". The physician's evaluation that evening, showed a hot, red area on the left thigh with central fluctuance. The abscess was incised, drained and packed with sterile gauze. The pt continued on Biaxin for the treatment of Otitis Media. Upon internal review the pt's experiences were considered an "Important Medical Event". Follow-up information from a physician reported that the pt subsequently, recovered. No further information is available.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac arrest, Respiratory arrest
Clinical narrative: The pt arrived at the medical center in full arrest. Grandmother had found him struggling for breath in bed. Death certificate received states cause of death: respiratory arrest due to cardiac arrest due to respiratory distress. Other significant conditions noted was a brain tumor.
Age: 0.08
Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Aphasia, Autism, Infantile spasms
Clinical narrative: Child had infantile spasms, 1 day, post vax, 1st Tetramune vaccine. He was hospitalized for 4 days for observation. Treated with steroids. Autism began to develop at 12 months when child lost ability to speak. Dx'd as mild autism at 2 years. Currently in therapy.
Sex: F
Vaccine: DTP
Symptoms: Convulsion, Coordination abnormal, Encephalopathy, Hypotonia, Lethargy
Clinical narrative: The pt suffered severe and permanent injuries including a seizure disorder, convulsions, encephalopathy, mental retardation, hypotonicity, coordination problems, ataxia, lethargy, developmental delay, physical and mental pain, suffering and emotional distress.
Sex: F
Vaccine: DTP
Symptoms: Mental retardation severity unspecified, Pain
Clinical narrative: The pt suffered severe and permanent injuries including a seizure disorder, convulsions, encephalopathy, mental retardation, hypotonicity, coordination problems, ataxia, lethargy, developmental delay, physical and mental pain, suffering and emotional distress.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: A pt received Pnu-Imune 23 on 11/28/00 and subsequently, was hospitalized overnight. The adverse event was not stated. As of 11/29/00, no further information was available. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Pnu-Imune 23.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: The pt experienced generalized tonic clonic seizure, lasting 20 seconds in duration.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Cardiac failure congestive, Injection site erythema, Injection site swelling, Upper respiratory tract infection
Clinical narrative: The pt received an injection of Engerix-B on 10/19/00. That evening, the injection site became red and raised. The next day, the redness extended to the pt's left shoulder and he developed an upper respiratory infection. He was seen by a physician on 10/27/00. That day, he was hospitalized in an ICU, reportedly with the dx of  "CHF related to vaccine". He was treated with Glucophage and Lasix. The pt was discharged from the hospital on 10/28/00. The upper respiratory infection, injection site redness and injection site swelling resolved. The pt was seen by a physician on 12/6/00; his lungs were reportedly clear, at that time.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Coma, Hypotonia
Clinical narrative: Hypotonic "limp" episode; was unresponsive 3-4 hours, post vax. Paramedics transported to ER and pt was admitted to the hospital for 24 hour observation.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Hypothermia, Pain
Clinical narrative: Shortness of breath and hospitalization within 30 hours, post vax. Developed chills, aches, etc. Reports subnormal temperature. Treated with IV's, steroids and antibiotics by pt history. "Reaction to Flu shot".
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Difficulty in walking, Joint stiffness, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Within 2 days the pt reported she had joint pain and was aching. The pt feels it was a result of the shot. Follow up information states that the pt is still experiencing pain and stiffness in her joints and muscles although it is better than what it was several months ago. The pt states she has Parvo B19 which her children had 2 1/2 years ago but she never did. She states that "all my problems started after the shot". She states "I used to walk 2-3 miles a day, not it is hard to walk for exercise, if I can at all". It was noted that she was "unable to walk great distances; she had to drop out of school and her health is poor". Upon internal review the pt's experiences were considered an "important medical event". Additional information has been requested.F/U information has been rec'd from a female with allergic sinusitis who on 5/16/00 and 06/22/00 was vaccinated with hepatitis B vaccine. pt is still experiencing pain and stiffness in her joints and muscles, although it is better than what it was several months ago. She also states that the doctor's name provided was nto the one wh found the Parvo 819. She reports she has Parvo 819, which her children had 2 years ago but she never did. She states that all my problems started after the shots. The reporter indicated that the pt's experience resulted in a persstent or significant disability. As of 3/14/01 the pt indicated that she had changed physicians. She also indicated that before the 2 vaccinations she was completely healthy. No further information is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Within 2 days the pt reported she had joint pain and was aching. The pt feels it was a result of the shot. Follow up information states that the pt is still experiencing pain and stiffness in her joints and muscles although it is better than what it was several months ago. The pt states she has Parvo B19 which her children had 2 1/2 years ago but she never did. She states that "all my problems started after the shot". She states "I used to walk 2-3 miles a day, not it is hard to walk for exercise, if I can at all". It was noted that she was "unable to walk great distances; she had to drop out of school and her health is poor". Upon internal review the pt's experiences were considered an "important medical event". Additional information has been requested.F/U information has been rec'd from a female with allergic sinusitis who on 5/16/00 and 06/22/00 was vaccinated with hepatitis B vaccine. pt is still experiencing pain and stiffness in her joints and muscles, although it is better than what it was several months ago. She also states that the doctor's name provided was nto the one wh found the Parvo 819. She reports she has Parvo 819, which her children had 2 years ago but she never did. She states that all my problems started after the shots. The reporter indicated that the pt's experience resulted in a persstent or significant disability. As of 3/14/01 the pt indicated that she had changed physicians. She also indicated that before the 2 vaccinations she was completely healthy. No further information is available.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea, Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Following vaccination with Prevnar, the pt experienced a fever of 103 and a febrile convulsion. The pt also experienced diarrhea and vomiting.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Cough, Dyspnoea, Laryngitis, Pyrexia
Clinical narrative: Through the night the pt had an increasing cough (croup like) and a fever of 102. Treated with Tylenol/Motrin and Augmentin.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: The pt experienced joint pain in the left elbow and left knee. Beginning in 7/00 and still occurring. It varies in intensity, sometimes can not ever pick up a gallon of milk.
Age: 2.6
Sex: M
Vaccine: HEPA, PNC
Symptoms: Urticaria
Clinical narrative: 24 hours post vax the pt developed generalized urticaria.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypotonia, Pallor, Staring
Clinical narrative: 7 hours post vax, the pt experienced a 5 minutes episode of pallor, limpness, staring, without jerking or shaking. Completely fine afterwards.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Cyanosis, Pallor, Vomiting
Clinical narrative: Within 1-2 hours of vax, the child was noted to be cyanotic, turned pale and vomited 2 times. No loss of consciousness and no difficulty breathing.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: The pt experienced a high pitched scream for 12 hours.
Age: 16.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Headache
Clinical narrative: Approximately 3 months post 3rd dose, the pt began experiencing severe headaches and fatigue. She has not sought medical attention. The headaches and fatigue persisted as of 12/06/00. A 15-day follow up report received 01/12/2001 adds: Report 2000035173-1 describes headaches in a 16-year-old female who received Lyme disease vaccine (Lymerix). This report was received from the pt's father and has been confirmed by a physician. Concurrent medical conditions include recurrent right knee offusion subsequent to an injury with hemarthrosis in April 1999. The pt is allergic to penicillin. She was taking no concurrent medications at the time of immunization. Theh pt's father stated that family history is significant for headaches in this pt's sister following receipt of Lymerix. This pt received her 1st injection of Lymerix (lot LY12009) on 04/14/1999 and her second injection of Lymerix (lot LY12079) on 05/29/1999. She had no adverse experiences following receipt of her first 2 doses of vaccine. She received her 3rd injection of Lymerix (lot LY23609) on 04/17/2000). The pt's father reported that the pt began experiencing severe headache and fatigue in July 2000 (precise date unknown) approx 3 months post-immunization. The vaccine provider stated that the pt underwent a routine, annual physical examination on 07/06/2000; she had no complaints at that time. Subsequently, the pt's mother reported to the vaccine provider that the pt began experiencing fatigue in May 2000. The mother reported that headaches began in August 2000, and became severe on 08/20/2000. The father indicated that the pt had not sought medical attention. However, the vaccine provider stated that the pt was seen by 2 pediatric neurologists. Each neurologist prescribed unspecified antidepressants, however the mother did not give the antidepressants to the pt. The vaccine provider reported a diagnosis of possible psychogenic headaches and stated, "I don't think headaches are due to Lyme disease vaccine." The pt has been treating her headaches with ibuprofen (Advil) 400 mg every six hours. The vaccine provider considers the headaches to be disabling/incapacitating. The most recent info, received on 01/02/2001 from the vaccine provider, indicated that the headaches persisted. On 01/02/2001, the vaccine provider also reported that the pt has been under the care of an orthopedic surgeon for the management patellamodal arthralgia of the right leg. The vaccine provider did not provide the onset date of the arthralgia, nor assess its relationship to Lymerix administration. ANA (Hep-2) titer and assay for RA factor performed by the orthopedic surgone on 07/31/2000 were negative. Erythrocyte sedimentation rate measured on 07/31/2000 was 5mm/hr. Lyme IgG and IgM by BIA was positive. Western blot for Lyme IgM, IgG and IgA was performed, the pattern of observed reactivity was interpreted as consistent with a response to OsoA Lyme vaccine. As a result of follow-up info received 01/01/2001, this report has been reclassified as serious, unexpected.
Age: 18.0
Sex: F
Vaccine: LYME
Symptoms: Headache
Clinical narrative: Approximately 11/1/00, 198 days post vax, the pt began experiencing mild headaches. She has not sought medical attention. The headaches persisted as of 12/6/00.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Dyspnoea
Clinical narrative: The infant woke up with difficulty breathing. Mom states this started around 6:00. They were concerned the pt may have something in her throat. Everything was normal in the ER. Was advised to not give anymore vaccine.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: Pt complained of deltoid pain since receiving Anthrax #3. Since had Anthrax #4 in left - problems. Had intermittent soreness since. Increasingly complaining of pain, July 2000. Has not consulted a physician about symptoms.  Follow up on 12/21/2000: "Patient partially recovered from adverse event.  Still experiences some sharp pain and stiffness in upper right arm.  Patient did not receive any further shots since reported event."
Age: 25.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Antinuclear antibody positive, Connective tissue disorder, Laboratory test abnormal
Clinical narrative: The pt experienced an onset of undifferentiated connective tissue approximately 2 weeks post vax.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Difficulty in walking
Clinical narrative: Inability to walk properly. Progressed to gait instability with pelvic girdle weakness.  Presently there is no diagnosis. The pt has consulted a neurologist and needs a can or wheelchair for mobility.
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Right and left thigh swelling with erythematous reaction on right side.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site hypersensitivity
Clinical narrative: Pt received flu vax, some redness, approximately 2m, and warmth noted. Pt instructed to return if any increase. Minute increase in size of redness next day. Pt referred to physician who also gave him instructions to return if any increase in reaction.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pain, Pallor, Pyrexia
Clinical narrative: High fever, weakness, paleness, dizziness, aches from Thursday to Tuesday. Sought medical treatment and received prescription Z-Pak.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, nausea/vomiting, fever, myalgia within 45 minutes of receiving vax. Temperature increased to 101.3. She sought medical attention and received prescription for Tigan. Compazine was administered in the office. Symptoms resolved within 48 hours.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Received vax on Monday, Nov 27. Wednesday evening, started itching. Thursday morning, got red, flat rash all over body except feet. Dizzy also. Sought medical treatment and physician did not relate to flu shot.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Injection site hypersensitivity, Injection site pain, Pain
Clinical narrative: Two to 5 minutes post vax, "whole left side arm, armpit, back to legs hurt, tingling, numb. Felt dizzy 1-2 hours later. Called physician and went to ER. Was given "calming pill" and sent home. Pt did put ice on arm at home. Has redness size of silver dollar and is still sore form shoulder to elbow.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Two to 5 minutes post vax, "whole left side arm, armpit, back to legs hurt, tingling, numb. Felt dizzy 1-2 hours later. Called physician and went to ER. Was given "calming pill" and sent home. Pt did put ice on arm at home. Has redness size of silver dollar and is still sore form shoulder to elbow.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia, Arthralgia, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Approximately 3 days post vax, this pt developed vomiting, chest congestion, fever to 101 degrees F, diarrhea, and myalgia. He consulted physician one week later on 11/13/00. He later developed a severe arthralgia and discoloration of both distal feet. Testing conducted yielded results consistent with polyarthralgia and vasculitis. Also mild anemia.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Skin discolouration, Upper respiratory tract infection, Vasculitis, Vomiting
Clinical narrative: Approximately 3 days post vax, this pt developed vomiting, chest congestion, fever to 101 degrees F, diarrhea, and myalgia. He consulted physician one week later on 11/13/00. He later developed a severe arthralgia and discoloration of both distal feet. Testing conducted yielded results consistent with polyarthralgia and vasculitis. Also mild anemia.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Ear pain, Heart rate increased, Nasal congestion
Clinical narrative: Received vax about 2 PM 12-7-00. AT about 8 PM, she had shortness of breath. At 9:30 chills, and then rapid heart beat. Ears were also hurting. Has head congestion today. Right eye is red.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Received vax about 2 PM 12-7-00. AT about 8 PM, she had shortness of breath. At 9:30 chills, and then rapid heart beat. Ears were also hurting. Has head congestion today. Right eye is red.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema
Clinical narrative: Left side of face slightly swollen.
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Rash
Clinical narrative: Client noticed rash and swelling on face (only) on 11/11/2000 at 2AM. The flu vax was administered on 11/08/2000 at 10AM. Client called physician's office and was told the 'rash was caused by the flu shot and client should not receive flu shot next year.'
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt received a flu and pneumonia vax on 11/15/2000. Pt came in on 11/17 with red, swollen, hot right arm.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Feeling cold, Hot flush, Injection site pain
Clinical narrative: Received vax at 09:30 AM. At 10:30AM, pt developed symptoms of shakiness, weakness, hot/cold sensation, slight shortness of breath, left upper arm discomfort. at 11:00 - 11:15. He was given Benadryl, 25mg IM. Full assessment conducted by physician.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Received vax at 09:30 AM. At 10:30AM, pt developed symptoms of shakiness, weakness, hot/cold sensation, slight shortness of breath, left upper arm discomfort. at 11:00 - 11:15. He was given Benadryl, 25mg IM. Full assessment conducted by physician.
Sex: U
Vaccine: FLUX
Symptoms: Purpura
Clinical narrative: Purpura bilateral legs. Pt was given Medrol dose pack as treatment.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Pallor
Clinical narrative: Pt was pale and weak for approximately 4 hours post vax. Blood pressure without orthostatic change. Resolved with treatment.
Age: 11.0
Sex: F
Vaccine: FLU3, HEP, PPV, VARCEL
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Pain, Pyrexia
Clinical narrative: Pt complained of soreness the next day. Vax given to left upper arm. Felt lump about the size of a half dollar. After 3 days, has reddened and soreness to area remains and fever.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site hypersensitivity, Swelling, Vasodilation procedure
Clinical narrative: Post vax, the pt developed red blotches around injection site. Area was hot to the touch. Generalized swelling, no defining edges. Only verbal complaint was that arm felt numb. Watched child for 40 minutes. Blotches faded. No respiratory distress.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Post vax, the pt awoke complaining of itching and small hives all over body.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Screaming
Clinical narrative: Post vax, the pt developed high pitched screaming for 27 hours.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Post vax, the pt developed a perianal rash consist with varicella zoster.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Post vax, the child developed whelps and ankle edema. He was taken to ER, where physician stated that it was a reaction to the erythromycin he had been on for a few days.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Malaise, Rash erythematous
Clinical narrative: Within 6 hours post vax, the pt developed red raised areas over face, neck, and chest. Mother stated that pt complained of dizziness and feeling sick.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Face oedema, Urticaria
Clinical narrative: Post vax, the pt developed swelling of the face and urticarial type rash.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling jittery, Pruritus, Rash
Clinical narrative: Post vax, the pt complained of feeling jittery, lightheaded, and had an itchy red rash on both wrists and slightly up both arms.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Post vax, the pt contracted chickenpox.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Post vax, the pt developed chickenpox.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Post vax, the pt developed nonfebrile seizure for 2-3 minutes. Evaluated at ER and released.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Injection site pain, Vasodilation procedure
Clinical narrative: Post vax, the pt complained of lump, tenderness at injection site; occasional shooting pains down arm. Site was warm. Pt received ice to injection site for 30 minutes.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Red blood cell sedimentation rate increased, Urticaria
Clinical narrative: The pt experienced hives and arthritis. The pt is also experiencing ongoing rhematologic problems.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Post vax, the pt developed shingles after receiving vax.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Vasodilation procedure
Clinical narrative: Post vax, the pt developed erythema, warmth, and tenderness to area surrounding the injection site on left deltoid.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site pain
Clinical narrative: 2 weeks post vax, the pt experienced extreme muscle pain in left deltoid area, after a few days the pain radiated in to the right deltoid area and began experiencing extreme fatigue.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Nausea, Paraesthesia, Pruritus
Clinical narrative: Post vax, the pt developed tingling around mouth and itching from elbow to wrist, nausea, and tightness in chest. As a precaution he was sent to ER.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Difficulty in walking, Erythema, Headache, Oedema, Pruritus
Clinical narrative: Post vax, the pt developed total body erythema, faint fine papular rash over entire body, fever of 101-103, headache, itchy hands, feet swollen, and it hurts to walk.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash papular
Clinical narrative: Post vax, the pt developed total body erythema, faint fine papular rash over entire body, fever of 101-103, headache, itchy hands, feet swollen, and it hurts to walk.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Infection, Injection site induration, Injection site pain, Injection site warmth, Pain
Clinical narrative: Patient developed sore arm muscle. Her arm became hard and hot to the touch from shot to shoulder. She awoke Saturday night with shooting pains in her arm and had a fever of 102 degrees. She saw a physician on 11/19/00 and was told she had an infection. She was treated with ibuprofen and cephalexin.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Patient developed sore arm muscle. Her arm became hard and hot to the touch from shot to shoulder. She awoke Saturday night with shooting pains in her arm and had a fever of 102 degrees. She saw a physician on 11/19/00 and was told she had an infection. She was treated with ibuprofen and cephalexin.
Age: 37.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Headache, Nausea, Pain, Skin nodule
Clinical narrative: Patient developed swelling of her right arm, a knot under her skin, redness, body aches, headache and nausea.
Age: 37.0
Sex: F
Vaccine: TTOX
Symptoms: Swelling
Clinical narrative: Patient developed swelling of her right arm, a knot under her skin, redness, body aches, headache and nausea.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: The pt experienced a rash that started the morning of the visit. The pt had approximately 30 chicken pox lesions. No fever was noted.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Irritability
Clinical narrative: Patient developed irritability and had a seizure 12 hours after treatment.
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient noted to have injection site that was hot to touch and hard. Right thigh, which patient received vaccine in, was swollen to about 3 times the size of her left thigh. Patient constantly picked at site and reported pain. Mother treated patient with Tylenol and cool compresses.
Age: 62.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Oedema genital, Paraesthesia, Rash, Swelling, Swelling face
Clinical narrative: 11/21/00 at 4AM patient felt facial tingling, especially around mouth, and face and neck were puffy. At 9AM, he noted testicular swelling while showering. At 12 noon, he noted a slight rash bilaterally on upper arms with less swelling around eyes. He had no injection site pain or swelling.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Patient developed a pounding headache within one hour of receiving vaccine. The headache subsided that evening but returned the next day. Patient also complained of muscle aches and queasiness on the evening of the injection. Patient was all right by 1PM the day after the injection.
Age: 22.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient noted to have redness and swelling of right deltoid on 11/30/00.
Age: 11.0
Sex: F
Vaccine: HEP, TD
Symptoms: Rash erythematous
Clinical narrative: Patient developed a red rash over all of her body that lasted 4 full months. She was treated with steroid cream.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Irritability, Rash
Clinical narrative: Patient noted to have immediate irritability that lasted for 24 hours. She developed a rash after 5 days.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Nausea, Swelling, Urticaria
Clinical narrative: Beginning on 11/26/00, patient noted to have urticaria, swelling, nausea and joint pain. She was treated with prednisone and Claritin.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient noted to have fever, nausea, vomiting and left arm and left leg stiffness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient noted to have redness and swelling around inoculation site 1 day after vaccine.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Aggression, Agitation, Confusional state, Injection site erythema, Injection site pain
Clinical narrative: Patient became agitated, confused and verbally combative 1.5 hours after receiving vaccine. This lasted 6-7 hours. By the next afternoon, he developed spreading erythema at the vaccine site. By that evening, he had extensive erythema from his shoulder to his elbow and it was extremely sore.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Infection, Injection site erythema, Injection site mass, Injection site oedema, Skin nodule
Clinical narrative: Patient developed redness and puffiness in both thighs on 10/26/00. Patient was taken to hospital and told both legs were infected. She had white bumps on her leg. She was given antibiotic. On 10/27/00, patient broke out in hives. Physician instructed mother to give Benadryl along with antibiotic. On 10/30/00, mother reported bumps around upper injection on left thigh and on right thigh. On 11/13/00, mother reported there was still a lump in left thigh where DTaP was given but that other symptoms had resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: Patient developed redness and puffiness in both thighs on 10/26/00. Patient was taken to hospital and told both legs were infected. She had white bumps on her leg. She was given antibiotic. On 10/27/00, patient broke out in hives. Physician instructed mother to give Benadryl along with antibiotic. On 10/30/00, mother reported bumps around upper injection on left thigh and on right thigh. On 11/13/00, mother reported there was still a lump in left thigh where DTaP was given but that other symptoms had resolved.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV
Symptoms: Agitation, Condition aggravated, Pyrexia, Sepsis, Skin discolouration
Clinical narrative: Same day of vax, the pt developed a fever of 103 and vomiting. The infant was seen by a physician on 6/10/99. At that time, the pt had a fever of 101. The pt had six or nine episodes of vomiting on 6/11/99. The pt was hospitalized and evaluated for sepsis. On admission, the pt was irritable, had mottling of her extremities, and a fever of 103 which elevated to 104.8. The pt was treated with acetaminophen. After each dose, the pt vomited. On 6/11/99, the pt was treated with ampicillin and gentamicin. Within 24 hours, the fever decreased to 101, her appetite increased, and the vomiting subsided. The pt was discharged on 6/13/99. Subsequently the pt recovered. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV
Symptoms: Vomiting
Clinical narrative: Same day of vax, the pt developed a fever of 103 and vomiting. The infant was seen by a physician on 6/10/99. At that time, the pt had a fever of 101. The pt had six or nine episodes of vomiting on 6/11/99. The pt was hospitalized and evaluated for sepsis. On admission, the pt was irritable, had mottling of her extremities, and a fever of 103 which elevated to 104.8. The pt was treated with acetaminophen. After each dose, the pt vomited. On 6/11/99, the pt was treated with ampicillin and gentamicin. Within 24 hours, the fever decreased to 101, her appetite increased, and the vomiting subsided. The pt was discharged on 6/13/99. Subsequently the pt recovered. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV
Symptoms: Agitation, Gastrointestinal disorder, Pyrexia, Sepsis, Skin discolouration
Clinical narrative: Same day of vax, the pt developed a fever of 103 and vomiting. The infant was seen by a physician on 6/10/99. At that time, the pt had a fever of 101. The pt had six or nine episodes of vomiting on 6/11/99. The pt was hospitalized and evaluated for sepsis. On admission, the pt was irritable, had mottling of her extremities, and a fever of 103 which elevated to 104.8. The pt was treated with acetaminophen. After each dose, the pt vomited. On 6/11/99, the pt was treated with ampicillin and gentamicin. Within 24 hours, the fever decreased to 101, her appetite increased, and the vomiting subsided. The pt was discharged on 6/13/99. Subsequently the pt recovered. No further information is available.
Age: 0.08
Sex: U
Vaccine: HEP, HIBV, IPV, PNC, HEP, IPV, PNC
Symptoms: Decreased appetite, Hyperexplexia, Irritability, Staring, Vomiting
Clinical narrative: On 10/9/00, grandmother brought baby to ER because he was irritable, decreased appetite, spitting up, strange episodes of not focusing and unusual startling; keeps looking to his right side; episodes occurred starting that day; he was transferred to another hospital for further evaluation at ER. Admitted to Pediatric neurology.
Age: 0.08
Sex: U
Vaccine: HEP, HIBV, IPV, PNC, HEP, IPV, PNC
Symptoms: Decreased appetite, Irritability, Staring, Vomiting
Clinical narrative: On 10/9/00, grandmother brought baby to ER because he was irritable, decreased appetite, spitting up, strange episodes of not focusing and unusual startling; keeps looking to his right side; episodes occurred starting that day; he was transferred to another hospital for further evaluation at ER. Admitted to Pediatric neurology.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Circulatory collapse, Feeling abnormal, Vomiting
Clinical narrative: Pt volunteer fireman, called out on evening of 12/1/00, was photographer. Wasn't feeling well. Vomited at the scene. Refused treatment by EMT's. Returned home, collapsed and EMT's were unable to resuscitate.