chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site warmth, Nausea
Clinical narrative: From information received on 11/19/02, it was reported by a nurse that a 46 year old female employee was vaccinated with a 0.5ml dosage of Fluzone, lot # U0929AA, given IM, on 11/19/2002. Recipient reported that on the same day she experienced dizziness, fatigue, nausea, and soreness at injection site with pain down to her forearm, injection site was also warm to touch. Patient was not evaluated by a physician.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: From telephone contact received on 11/20/02, it was reported by a nurse that a 48 year old female received Fluzone (lot number U0966AA) administered IM in the left deltoid on 11/14/02 at 1:45 pm. The patient reported that on 11/19/02, she started having numbness in her thighs. The patient has not seen a doctor. The symptom has not yet resolved.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: From telephone contact received on 20/Nov/2002, it was reported that a 45-year-old female had been vaccinated with FLUZONE SV'2002-'2003 USP (lot number U0953AA) on 19/Nov/2002. The patient developed a migraine headache within 2 hours of the vaccination. It is not reported whether the patient recovered.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Rash papular
Clinical narrative: It was reported by a physician that a 5 year old female developed a hand-sized area of erythema with white papules at vaccination site several days after vaccination. Pt was vaccinated with Fluzone (U0941AA), date not reported. This was reported by child's mother, pt was not seen by a physician, recovery status is unknown. From additional correspondence received on 1/23/03, it was reported that the date of vaccination was 11/25/02. The pt did not have any pre-existing diagnosis or illnesses at time of vaccination. No other vaccinations were given within 4 weeks of the original vaccination date. The pt reportedly recovered from the events. This case is closed.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Ecchymosis, Injection site inflammation, Skin exfoliation, Skin necrosis
Clinical narrative: It was reported that a 32 year old female pt was vaccinated with a 0.5ml of Fluzone (U0930FA) IM in the deltoid on 10/29/02. The pt developed a fluid filled blister that drained spontaneously 2 days later. The pt was seen at a walk in clinic and was given an antibiotic cream. A couple of days later, she went to see her private physician, who diagnosed the reaction as "cell death." She was prescribed an oral antibiotic and compresses. According to the physician at the health clinic on 11/4/02, the pt developed mild induration, inflammation, ecchymosis and epidermis sloughing. A scab and an area of indentation are still present. The pt was also seen by a dermatologist.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Tenderness
Clinical narrative: It was reported that a 59 year old male pt received Fluzone (U0922AA) on 11/13/02. Route/site of administration was not reported. The pt developed a sore arm the first 24 hrs and reportedly subsided. On 11/16/02, a bilateral axillary rash began to develop, itchy and red, extended from the center of the armpit 6 inches down to the center of the body 6 inches upwards towards the biceps. The pt denied of any new product use. Pt has no allergies to eggs and thimerosal, but has history of hypertension.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site induration, Injection site warmth, Nausea
Clinical narrative: It was reported that a 62 year old female received Fluzone (U0933AA) in the right deltoid on 12/7/02. The pt developed a hard and hot to the touch area at the site later that day. Within 24 hrs after vaccination, the pt experienced nausea and headache the lasted for a day.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: It was reported that a 37 year old female received Fluzone (U0872AB), IM in the right deltoid on 10/25/02. Approximately one week later, the pt developed a nodule at the injection site, no pain or redness present. The nodule subsided gradually over the next two weeks. No other symptoms reported. All the symptoms resolved. This case is closed.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: He was previously given antibiotics. It was reported that he did not recover from the event.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia, Pelvic pain
Clinical narrative: It was reported that a 70 year old male pt received a Fluzone vaccination on 11/25/02. About 10 days later, the pt developed pain in his hip, which was described as being like sciatic nerve pain. At the time of this report, the symptoms are unresolved. Further info is expected.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough
Clinical narrative: It was reported that a 70 year old female pt was vaccinated with first dose of Fluzone (U0672AA), IM in the left deltoid at 2 pm on 10/21/01. In January of 2002, the pt stated that it caused coughing, specific date and time not reported. Chest x-ray was performed and the result was normal. The pt was treated with antibiotics, Nexium and was sent to a Pulmonologist who treated her for reactive airway disease. The pt reported has not recovered from the event. Linked to case: U2002-01139.
Age: 20.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Nausea, Pain
Clinical narrative: It was reported that a 20 year old female pt received Fluzone and Menomune at approximately 3:30pm on 11/5/02. The pt reportedly felt well prior to receiving vaccinations. At 8:30pm on 11/5/02, the pt experienced onset of slight headaches and slight stiff neck with muscular aching but without joint pain. The pt felt nauseated without vomiting, no nuchal rigidity but complained of slight pain with head flexion. The pt also experienced slight tenderness at upper arm. The reporter spike with pt by phone on 11/11/02 and she was asymptomatic by 11/9/02. Th pt was not on any other medications at time of vaccination and had no previous history of any medical conditions or allergies.
Age: 20.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Tenderness
Clinical narrative: It was reported that a 20 year old female pt received Fluzone and Menomune at approximately 3:30pm on 11/5/02. The pt reportedly felt well prior to receiving vaccinations. At 8:30pm on 11/5/02, the pt experienced onset of slight headaches and slight stiff neck with muscular aching but without joint pain. The pt felt nauseated without vomiting, no nuchal rigidity but complained of slight pain with head flexion. The pt also experienced slight tenderness at upper arm. The reporter spike with pt by phone on 11/11/02 and she was asymptomatic by 11/9/02. Th pt was not on any other medications at time of vaccination and had no previous history of any medical conditions or allergies.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: It was reported that a 56 year old female pt received Fluzone (U0962BA) administered in her left arm IM at 9:50 am on 11/13/2002. Five minutes after administration the pt developed localized erythema, an area the size of a 50 cent piece on the left deltoid above bendaid, not at injection site specifically. Vitals were taken, upon request from pt, Benadryl 25mg per oral was given. Pt was monitored for 30 minutes-no swelling, no SOB, no pain or numbness was noted, pt returned to work. Pt was instructed to use cool compresses and Tylenol, pt instructed to call infection control nurse as occasion requires. Reportedly the pt recovered from this experience. This case is closed.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Tongue disorder
Clinical narrative: It was reported that a 61 year old female pt received 0.5cc of Fluzone (U0926BA) administered in her left arm IM at 9:10 am on 11/13/02. Fifteen minutes later the pt complained of numbness and tingling of lips and she stated her "tongue felt thick." Her vital signs were stable. Benadryl 25mg was given per oral and she was monitored for 30-40 minutes. Pt stated she was "feeling better" and denies any SOB or wheezing. The pt was given a Benadryl 25mg tablet to take with her in case of reocurrence and instructed to call back. The pt reportedly recovered from this experience and returned to work. This case is closed.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing
Clinical narrative: It was reported that an 18 year old female pt received a Fluzone (U0926BA) administered in her right deltoid, at 6:25 pm on 11/12/02. Immediately after vaccination the pt stated she felt flushed and dizzy. She was given orange juice and cookies, ammonia inhalent was offered. No rash at injection site was noted, no SOB, and lungs sound clear bilaterally. Reportedly the pt recovered. This case is closed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: It was reported that Fluzone vaccination was administered to 2 persons who had local reactions at injection site. No specifics were provided. No pt info was provided therefore this case is not meeting the reporting criteria at the present time. Additional info received on 9/26/02: It was reported that the pt was vaccinated with Fluzone in the left deltoid on 10/24/01. Within 1-2 days post vaccination, the pt's whole upper arm became reddened and inflammed, swollen, tender and firm to the touch. The events subsided after one week. This case is closed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: It was reported that Fluzone vaccination was administered to 2 persons who had local reactions at injection site. No specifics were provided. No pt info was provided therefore this case is not meeting the reporting criteria at the present time. Additional info received on 9/26/02: It was reported that the pt was vaccinated with Fluzone in the left deltoid on 10/24/01. Within 1-2 days post vaccination, the pt's whole upper arm became reddened and inflammed, swollen, tender and firm to the touch. The events subsided after one week. This case is closed.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Malaise, Nasal congestion
Clinical narrative: It was reported that a 59 year old female pt received first dose of Fluzone given IM in the left deltoid on 1/22/03. On 1/27/03, the pt experienced headache, malaise, congestion (nasal, chest), rhinorrhea, chills and fatigue that continued to the doctor's visit on 1/30/03 and was given a vitamin B12 shot, Tamoflu and Humabid treatment. The pt was not taking any medication and had no illnesses at the time of vaccination. The pt has no pre-existing medical conditions. No lab/diagnostic test were performed. It is not known whether the pt recovered from the events.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: It was reported that a 59 year old female pt received first dose of Fluzone given IM in the left deltoid on 1/22/03. On 1/27/03, the pt experienced headache, malaise, congestion (nasal, chest), rhinorrhea, chills and fatigue that continued to the doctor's visit on 1/30/03 and was given a vitamin B12 shot, Tamoflu and Humabid treatment. The pt was not taking any medication and had no illnesses at the time of vaccination. The pt has no pre-existing medical conditions. No lab/diagnostic test were performed. It is not known whether the pt recovered from the events.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: flu-like symptoms with fever,nausea,vomiting,loose stool over a weekend period. pt visited medical center e.r. pt was treated and released same day.
Age: 30.0
Sex: M
Vaccine: ANTH, DT, HEP, HEPA, IPV, MMR, SMALL
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: fevers, chills, and painful lymphadenopthy admitted to facility  treated with IV antibiotics
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngeal oedema, Pharyngolaryngeal pain, Rash, Rash macular, Urticaria
Clinical narrative: This case was considered to be medically important based on follow up info received. Follow up info received provided an additional event of throat swelling and pt status of recovered. Info regarding Flumist was received from a healthcare professional regarding a 10 year old male pt who experienced hives, blotchy rash and "weird sensation" in throat. At 10 years of age, the pt received a dose on 12/16/03. On 12/16/03, the pt experienced hives (urticaria), blotchy rash (rash macular) and "weird sensation" in his throat (pharyngolaryngeal pain) and throat swelling on 12/16/03 twenty minutes following receipt of Flumist. The pt's symptoms improved when he was administered two teaspoons of Benadryl. He did not experience difficulty in breathing. Throat swelling was considered a medically important event (OMIC).
Age: 0.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: 11/15 arm began getting red and warm-area of redness was golf ball size-continued until 11/17 when only slightly red and no induration
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3-4cm area became red and "stingy" continuing for 3 days.Stayed red for another day.
Age: 0.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain moving from injection site up through shoulder joint and left side of neck.  Approximately 1"-2" site of reddness working way down upper arm remained sore and red for 2 days.
Age: 0.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rash, Wheezing
Clinical narrative: Rash noted within 5 minutes of vaccination and wheezing about 4 hours after vaccination
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 CM X 3CM ERYTHEMA AND SWELLING AND PAIN/TENDERNESS AT SITE OF 2ND ANTHRAX
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Decreased appetite
Clinical narrative: DECREAESED APPETITE FOR 2 DAYS, CRIED OFF AND ON FOR 1 DAY  TREAT PATIENT WITH TYLENOL AT HOME, ENCOURAGE FLUIDS BY MOUTH, FOLLOW UP APPOINTMENT WITH DOCTOR IF NOT BETTER IN 2 DAYS
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Anorexia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Developed fever, chills, headache, nausea and left cervical and subclavicular lymphadenopathy; feeling weak and generally fatigued - developed elevated liver enzymes & TSH, pancytopenia, and anorexia over the course of 2 months. Onset of initial symptoms was 2 days s/p smallpox and 7 days s/p anthrax #3. Medical records reviewed. Please add COSTARTS of PANCYTOPENIA and ANOREXIA.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Laboratory test abnormal, Lymphadenopathy, Nausea, Pancytopenia, Pyrexia
Clinical narrative: Developed fever, chills, headache, nausea and left cervical and subclavicular lymphadenopathy; feeling weak and generally fatigued - developed elevated liver enzymes & TSH, pancytopenia, and anorexia over the course of 2 months. Onset of initial symptoms was 2 days s/p smallpox and 7 days s/p anthrax #3. Medical records reviewed. Please add COSTARTS of PANCYTOPENIA and ANOREXIA.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Mild grade fever, local swelling/redness
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Patient developed maculopapular rash three weeks after receiving varicella vaccine.
Age: 0.0
Sex: F
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Laboratory test abnormal, Skin ulcer, Unintended pregnancy
Clinical narrative: Described patient is the wife of a patient who was vaccinated. She is currently seven weeks pregnant. Wife was innoculated by contact with vaccination site. Localized lesion currently. Wife was not known to be pregnant at time of vaccination.  Listed date of vaccination is for the husband.  Wife's lesion is, per history, 3-5 days old.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness,pain at site of injections.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Blood pressure increased, Chest pain, Diarrhoea, Fatigue
Clinical narrative: 4 hours after vaccine, began having severe stabbing abdominal pain and diarrhea. Next day had overwhelming fatigue and blurred vision. Blood pressure found to be 188/118 (I am a healthy fit individual whose BP runs 120's over 60's) Continued to have these severe spikes in BP for 3 weeks along with palpitations and blurred vision. Overwhelming fatigue persisted as well for about 2 weeks  Nurse follow up on 07/27/04 states: "Chest pain, Headache."
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Palpitations, Vision blurred
Clinical narrative: 4 hours after vaccine, began having severe stabbing abdominal pain and diarrhea. Next day had overwhelming fatigue and blurred vision. Blood pressure found to be 188/118 (I am a healthy fit individual whose BP runs 120's over 60's) Continued to have these severe spikes in BP for 3 weeks along with palpitations and blurred vision. Overwhelming fatigue persisted as well for about 2 weeks  Nurse follow up on 07/27/04 states: "Chest pain, Headache."
Age: 0.32
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Supraventricular tachycardia
Clinical narrative: Information has been received from a health professional concerning the reporter's 4 month old daughter who in approximately December 2001, was vaccinated with a dose of hep B virus vaccine. Concomitant vaccination included a dose of Hib conj vaccine, a dose of poliovirus vaccine inactivated and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. Subsequently in approximately December 2001, the pt developed supraventricular tachycardia that lasted for four days. At the time of the report approximately two years later, the supraventricular tachycardia was controlled by medicine and it was reported that the pt had not recovered. Supraventricular tachycardia was considered to be disabling. It was reported that the pt did not recover from these events. From additional information received on 20Jan04 from manufacturer, it was reported that the event was reported by a health care professional and that the event of supraventricular tachycardia occurred in approximately December2001. The supraventricular tachycardia was considered to be disabling. The pt has not recovered. No other information was reported. From additional information received on 21Jun04 from the responsible physician, it was reported that the pt was not their health center pt. She was seen in another clinic by a different physician. The reporter that has been provided has no address or phone number available. No other information was provided. No further information is anticipated, this case is considered closed.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Medication error, Thermal burn
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 39 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of LYMErix on 4/20/99, 5/20/99, and 6/22/99 according to the client. This represents an inappropriate schedule of vaccine administration, in that the patient received LYMErix vaccinations on a 0, 1, and 2 month schedule rather than the recommended schedule of 0, 1, and 12 months. On 1/12/04, the patient's attorney alleged that the patient developed treatment resistant Lyme arthritis and/or treatment resistant Lyme disease, with symptoms including extreme knee pain and burning. The attorney further alleged that the patient suffered pain that was described as at times debilitating and which severely limited his employment options and opportunities. According to the attorney, the patient was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Back pain, Dyspepsia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injection of LYMErix on 5/12/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease." with symptoms including "headaches, numbness, fatigue, neck, shoulder, back, hip and knee pain, rashes, insomnia, joint stiffness, stomach distress, and dyspepsia." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, Infection, Insomnia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injection of LYMErix on 5/12/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease." with symptoms including "headaches, numbness, fatigue, neck, shoulder, back, hip and knee pain, rashes, insomnia, joint stiffness, stomach distress, and dyspepsia." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Joint stiffness, Neck pain, Pelvic pain, Rash, Shoulder pain
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injection of LYMErix on 5/12/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease." with symptoms including "headaches, numbness, fatigue, neck, shoulder, back, hip and knee pain, rashes, insomnia, joint stiffness, stomach distress, and dyspepsia." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Arthralgia, Arthritis, Autoimmune disorder
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. This case is VAERS ID 215497. The pt received injections of LYMErix on 4/29/99, in May 1999, received this third injection on an unspecified date and received a fourth injection on 4/21/00 "according to the client." This represents an inappropriate schedule of drug administration, in that only three doses of LYMErix are recommended. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "right toe pain, joint pain and swelling, and tingling of his hands." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained. A treatment of Injuries was received on 21 April 2006. The statement of injuries indicated that the subject suffers and has suffered from the following additional conditions in addition to those already reported Flu like symptoms, tingling of extremities, headaches, possible memory loss and decreased activities of daily life. He additionally suffers from rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX. At the time of reporting, the outcome of the event was not specified. Future expedited VAERS reports for this LYMERIX case shall be referred to KH-IND 5420, which is a change from past reports referencing the voluntarily-revoked license (STN 103757).
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Headache, Incorrect dose administered, Influenza like illness, Joint swelling, Lyme disease
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. This case is VAERS ID 215497. The pt received injections of LYMErix on 4/29/99, in May 1999, received this third injection on an unspecified date and received a fourth injection on 4/21/00 "according to the client." This represents an inappropriate schedule of drug administration, in that only three doses of LYMErix are recommended. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "right toe pain, joint pain and swelling, and tingling of his hands." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained. A treatment of Injuries was received on 21 April 2006. The statement of injuries indicated that the subject suffers and has suffered from the following additional conditions in addition to those already reported Flu like symptoms, tingling of extremities, headaches, possible memory loss and decreased activities of daily life. He additionally suffers from rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX. At the time of reporting, the outcome of the event was not specified. Future expedited VAERS reports for this LYMERIX case shall be referred to KH-IND 5420, which is a change from past reports referencing the voluntarily-revoked license (STN 103757).
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. This case is VAERS ID 215497. The pt received injections of LYMErix on 4/29/99, in May 1999, received this third injection on an unspecified date and received a fourth injection on 4/21/00 "according to the client." This represents an inappropriate schedule of drug administration, in that only three doses of LYMErix are recommended. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "right toe pain, joint pain and swelling, and tingling of his hands." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained. A treatment of Injuries was received on 21 April 2006. The statement of injuries indicated that the subject suffers and has suffered from the following additional conditions in addition to those already reported Flu like symptoms, tingling of extremities, headaches, possible memory loss and decreased activities of daily life. He additionally suffers from rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX. At the time of reporting, the outcome of the event was not specified. Future expedited VAERS reports for this LYMERIX case shall be referred to KH-IND 5420, which is a change from past reports referencing the voluntarily-revoked license (STN 103757).
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Fatigue, Infection, Medication error, Pain
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 64 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/23/00 and 7/24/00 "according to the client." This represents an inappropriate schedule of drug administration in that the second dose was administered approximately one month later that recommended. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "pain in his hands, pain in his right arm, left shoulder and right and left upper arm, and fatigue." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an orthopedist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Arthritis, Balance disorder, Fatigue
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 67 year old male pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/5/99 and 6/2/99 with the understanding that the third and final vaccination would be required at twelve months "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, fatigue, rashes, tingling, vision problems, nightmares, night sweats, neck and shoulder pain, balance problems, memory loss, and ear ringing." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an infectious disease specialist and received anti-inflammatory, antibiotic, and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcomed information, is being pursued through the litigation process and will be reported if obtained.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Infection, Neck pain, Night sweats, Paraesthesia, Rash
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 67 year old male pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/5/99 and 6/2/99 with the understanding that the third and final vaccination would be required at twelve months "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, fatigue, rashes, tingling, vision problems, nightmares, night sweats, neck and shoulder pain, balance problems, memory loss, and ear ringing." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an infectious disease specialist and received anti-inflammatory, antibiotic, and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcomed information, is being pursued through the litigation process and will be reported if obtained.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Shoulder pain, Tinnitus, Visual disturbance
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 67 year old male pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/5/99 and 6/2/99 with the understanding that the third and final vaccination would be required at twelve months "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, fatigue, rashes, tingling, vision problems, nightmares, night sweats, neck and shoulder pain, balance problems, memory loss, and ear ringing." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an infectious disease specialist and received anti-inflammatory, antibiotic, and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcomed information, is being pursued through the litigation process and will be reported if obtained.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Infection, Pain, Paraesthesia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 43 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 4/8/99 and 5/13/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "wrist and forearm pain and tingling in his feet." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Back pain, Infection
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 37 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix in early April 1999 and on 5/21/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "back pain and generalized joint pains." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a neurologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Fatigue, Headache, Infection
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 47 year old female pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix "in 1998, early 1999," and on 6/19/99 "according to the client." This represents an inappropriate schedule of drug administration in that the LYMErix administrations deviate from the recommended 0, 1 and 12 month schedule. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, flu-like symptoms, fatigue, rashes, tingling in her hands, arms, feet and toes, headaches, neck pain, and finger pain." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited her employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Medication error, Neck pain, Paraesthesia, Rash
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 47 year old female pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix "in 1998, early 1999," and on 6/19/99 "according to the client." This represents an inappropriate schedule of drug administration in that the LYMErix administrations deviate from the recommended 0, 1 and 12 month schedule. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, flu-like symptoms, fatigue, rashes, tingling in her hands, arms, feet and toes, headaches, neck pain, and finger pain." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited her employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Cognitive disorder, Disturbance in attention, Fatigue
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 52 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. According to the attorney, the pt received injections of LYMErix on unspecified dates. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "severe and constant pain in his hands, neck, elbows, knees and wrist, joint pain, fatigue, tingling, headaches, vision problems, poor attention span, short term memory loss, cognitive problems, and loss of concentration." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Headache, Infection, Memory impairment, Paraesthesia, Visual disturbance
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 52 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. According to the attorney, the pt received injections of LYMErix on unspecified dates. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "severe and constant pain in his hands, neck, elbows, knees and wrist, joint pain, fatigue, tingling, headaches, vision problems, poor attention span, short term memory loss, cognitive problems, and loss of concentration." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Age: 39.0
Sex: F
Vaccine: RUB
Symptoms: Glomerulonephritis, Henoch-Schonlein purpura, Oedema peripheral, Proteinuria
Clinical narrative: Information has been received from a 39 year old female pt who in approximately 1970 at the age of 5 or 6 years old was vaccinated with a dose of rubella virus vaccine live. The pt reported that after she was vaccinated she developed Henoch-Schonlein purpura and acute glomerulonephritis. She reported that her legs and ankles became swollen, the protein level in her urine was high and she had internal bleeding. She reported that she almost went into cardiac arrest. The pt was hospitalized for 6-8 weeks. She was treated with "medications," including an unspecified steroid and subsequently recovered. No further info was provided. Henoch-Schonlein purpura and acute glomerulonephritis were considered to be immediately life-threatening and disabling according to the reporter. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Anorexia, Convulsion, Cough, Glossitis, Influenza
Clinical narrative: On December 28, patient had a fever resulting in seizure. Taken to emergency room. Lab test for flu. Mom states A-B showed of flu. Transferred to hospital and kept overnight for observation. Siblings and parents also had flu at the time. The discharge summary received on 2/9/04 states decreased appetite, sore throat, otitis, and cough. The ER record received on 2/9/04 states incontinent, starting into space and biting.