chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Tonsillitis, Tremor, Vision blurred, Vomiting
Clinical narrative: From initial correspondence received via fax on 10/18/02, it was reported that a 26 year old female patient was vaccinated with Fluzone on 10/14/02 IM in the left deltoid. The patient reported awakening from a sound sleep at 11:30PM on 10/14/02 and being unable to breathe. This was followed by an episode of coughing, shakiness, dizziness, disorientation, blurred vision, and later vomiting. She believes this might be related to Fluzone influenza vaccine received almost 12 hours earlier. The patient denies fever, rash, facial or upper airway swelling, abdominal pain/cramping, or diarrhea. There has been no recent illness among family members, or variation in food consumed by them as a group. At present, patient describes feeling worn out, but denies any respiratory distress. The responsible physician's assessment states, evolving sensitization versus delayed hypersensitivity response to unknown substance. Whereas serious adverse reaction to vaccines can produce similar respiratory symptoms, a delay of almost 12 hours seems unlikely. I am more likely to suspect the possibility of individual or synergistic response to one or both recently introduced Clarinex and Vitamin/Herbal Stimulant, the former of which is an unregulated product containing quite a number of plant products of undetermined concentration. It is noted that no ephedrine content is noted. The employee is advised to contact her PCP today to discuss any change in her current medical/supplement regimen, and guidance regarding the advisability of future vaccination.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Injection site erythema, Injection site oedema
Clinical narrative: From initial info received via telephone on 10/7/02, it was reported that a 46 year old female had been vaccinated with Fluzone (U0872AB) on 10/4/02 at 5 pm in the left deltoid. The following morning, the local site was approximately 2 inches in diameter, red and swollen. Within 24 hrs of receipt of the dose, the pt experienced nausea, diarrhea, excessive sweating, chills and rigors. On 10/7/02, it was reported that the injection site was red, swollen, tender to touch, now approximately 6 inches in diameter. This is the first time this person has ever had any local reaction to flu vaccine in 20 years.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nausea
Clinical narrative: From initial info received via telephone on 10/7/02, it was reported that a 46 year old female had been vaccinated with Fluzone (U0872AB) on 10/4/02 at 5 pm in the left deltoid. The following morning, the local site was approximately 2 inches in diameter, red and swollen. Within 24 hrs of receipt of the dose, the pt experienced nausea, diarrhea, excessive sweating, chills and rigors. On 10/7/02, it was reported that the injection site was red, swollen, tender to touch, now approximately 6 inches in diameter. This is the first time this person has ever had any local reaction to flu vaccine in 20 years.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness transient, Vaccine positive rechallenge
Clinical narrative: It was reported by a nurse that a 33 year old female was vaccinated with a dose of Fluzone *U0966BA) on 10/15/02 in the deltoid. She experienced temporary blindness in her right eye the evening of her vaccination. She was seen by her opthalmologist and Medrol pack was prescribed. According to the reporter, the physician feels its vaccine related. Last year she experienced the same event 2 weeks after she received a dose of Fluzone. The event lasted on and off for several months. She did not report the event because at that time it was not attributed to the vaccine. It was not reported whether the pt recovered.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: From information received via fax on 10/24/02, it was reported that a 39 year old male patient received Fluzone on 10/23/02 in the left deltoid at 10:00 AM. The patient called the vaccine administrator and reported that on 10/23/02, at 5:00 PM, he experienced a temperature of 102 degrees, chills, and body aches that began approximately six hours after the vaccine was given. He was referred to his primary care physician. It was not known if the patient recovered. From additional information received on 4/14/03 from a nurse, it was reported that the patient saw his personal care physician and recovered from the events. Reviewed, no additional information at this time. No further information is anticipated, this case is closed.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Pain
Clinical narrative: From fax correspondence received on 10/31/02, it was reported that a 43 year old adult female was vaccinated with Fluzone (lot # 40924DA) on 10/16/02. That day she developed soreness and weakness in left arm. Reportedly she recovered. Case is closed.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Retching, Tachycardia, Vomiting
Clinical narrative: From fax correspondence received at manufacturer on 10/31/02, it was reported that a 31 year old adult female was vaccinated with Fluzone SV 2002-2003 USP (Lot # 40924DA) on 10/16/02.  The same day she developed nausea, vomiting, dry heaves, and tachycardia. Symptoms resolved the next morning at 5am.  Pt noted similar reaction from previous hepatitis B vaccination with questionable hypersensitivity to the preservative component. See case # U2002-00934 with the same reporter.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: A report received concerning a 58 year old female administered with Fluzone (U0920AA) IM in the left arm on 11/7/02 at 3:05 pm. It was reported, "Pt received her flu shot prior to her appointment for a screening mammography. She has received flu shots yearly without problems. During her mammogram procedure, she suddenly felt lightheaded and nauseous. Thought she was going to get sick. She sat for a few minutes, drank some juice and then felt better. Client did not appear to be anxious about mammogram. Vital signs were normal. Spoke to pt today 11/10, she is feeling fine. Denies any symptoms or adverse affects today. VAERS form submitted due to the sudden onset on feeling lightheaded and nausea. The case is closed.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hyperhidrosis, Nausea, Oedema, Rash
Clinical narrative: A VAERS report received from hospital concerning a 39 year old female administered with Fluzone (U0920AA) IM in the right arm on 11/7/02. It was reported, "Pt received her flu shot, then her daughter received her shot. They sat in the lobby for 15-20 minutes due to first time flu shot for her daughter. They had checked back in with the nurse and were released to go. They were outside when she suddenly had chest discomfort/ tightness, began to sweat and become very nauseated. 911 called, client evaluated 12-lead EKG negative, released to go home. Spoke to client today 11/10, she stated that yesterday she develop a rash on her left shoulder and back, the rash later disappeared and she developed some swelling to the left side of her neck and burning sensation in her left shoulder. She still has the burning sensation slightly today and mild swelling in her neck. Denies any chest discomfort. Client has received flu shots in 2001 & 2000 without problems. Denies feeling ill that day, no allergies to eggs." The pt has been taking Naicin 500mg daily, Lasix, vitamin B & E, Ginko, grapeseed extract & CoEnzyme 10 for 10 years.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: A VAERS report received from hospital concerning a 29 year old female administered with Fluzone (U0920AA) IM in the left arm on 11/7/02. It was reported, "1.5 hrs after receiving her flu shot she develped sudden tingling and numbness in her chin and lower jaw. No hives or rash. No symptoms of throat swelling. No hoarseness or wheezing. Symptoms isolated to her jaw. Spoke with client today 11/10. She is doing fine symptoms are gone. They lasted for several hours after her flu shot. She last had a flu shot 4 years ago. This case is closed.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness, Tongue disorder
Clinical narrative: A VAERS report received from hospital concerning a 73 year old female administered with Fluzone IM in the right right arm 11/7/02. It was reported, "Call center RN was conducting a call back on her husband who had received a flu shot and had complained of tingling/ pain in his arm, he has MS. (Adverse form not submitted). During the conversation, the pt had indicated that his wife had not felt well after her flu shot. Information related as follows to RN. 24 hrs after receiving her flu shot, the pt stated she had bumps on the base of her tongue and a strange feeling in her throat and the roof of her mouth. States she "very much felt like something was wrong. Call back took place on 11/7/02, the pt stated at that time her symptoms were gone. Attempted to reach client 11/10/02 unsuccessfully. Successfully reached the client today. In reviewing her symptoms she indicated that she had itching on her back on the evening of 11/6/02, they were gone by the morning of 11/7. Approximately around 8am on 11/7, as they were driving, her throat suddenly became scratchy and tight, denies difficulty breathing or swallowing. She drank water, took a mint to help but she felt like something was caught in her throat, she felt like she needed to clear her throat frequently. She was frightened and almost turned back. Eventually the symptoms disappeared but came back later that night. Today her throat is still a little scratchy but is able to drink and talk without difficulty. On 11/7, she was advised to take Benadryl, which she did and it helped. Advised client to call if symptoms became worse or to call 911 if her throat feels tight. This was her first flu shot. She denies an allergy to eggs, but the smell of eggs nauseates her. She received a pneumonia vaccine one year ago without problems." The pt "takes several medications" but unspecified. The case is closed.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pruritus, Rash, Swelling
Clinical narrative: From correspondence received via fax on 11/11/02, it was reported that a 46 year old male patient received FLUZONE, lot number U0904CA, in the left deltoid on 11/1/02 at 9:30 am. Patient experienced generalized rash, itching, and swelling on 11/2/02 sometime in the morning. Was seen in the emergency department on 11/3/02 at 3:00 am, was treated with steroids and Benadryl. Patient was also treated with secondary steroids for esophagitis. Followed up with family doctor on 11/5/02 and 11/6/02. The patient was still experiencing itching and rash, and also complained of muscle and joint aches. The patient did not recover. From additional information received on 4/14/03 from the physician assistant, it was reported reviewed no additional information at this time. No further information is anticipated, this case is closed.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: From initial correspondence received via fax on 10/11/02, it was reported that a 59 year old female patient had been vaccinated with Fluzone and a pneumococcal vaccine on 10/4/02. Both vaccines given in the left deltoid. Patient developed a swollen, red area the size of a grapefruit in the left arm on 10/4/02. Additionally, she had a fever. The patient went to clinic on 10/5/02 and saw PNP. She was diagnosed with sterile cellulitis and was given antibiotics (unspecified). GNP felt the reaction was probably the result of the vaccine being given SC instead of IM. The patient called the administering office on 10/7/02 to notify them of her reaction. Per the FNP, attempted to call; message left. I used a 5/8" needle to give an IM injection. Patient frail, elderly with small size. Reportedly, the patient recovered.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Lung disorder
Clinical narrative: It was reported that a 56 year old female pt was vaccinated with first dose of Fluzone (U0958AA) given in the left deltoid on 11/13/02. Approximately 10 minutes after vaccination, the pt complained of wave-like feeling insider her body and a need to clear her throat. Several days later, she experienced cold chills, perspiration and feeling of water in her lungs with difficulty breathing off and on. The pt reportedly recovered from these reactions. The pt had no illnesses at time of vaccination. It was not known whether or not the pt had any pre-existing diagnoses at time of vaccination. No lab/diagnostic tests were taken at time of vaccination.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Decreased appetite, Feeling hot, Hyperhidrosis
Clinical narrative: It was reported that a 52 year old male pt received first dose of Fluzone (U0913AA) given in the left deltoid on 11/4/02. The pt experienced a sore arm, dull aches for four days after injection, along with chill off and on, body aches, flu-like symptoms, little energy and feeling hot intermittently. On 11/28/02 and 11/29/02, the pt experienced heavy sweating, stomach cramps. He was unable to eat from 11/29/02 to 12/1/02. He reportedly felt better by 12/3/02 and recovered from these reactions. The pt had a heart attack in January of 1998, and is taking Glucovance. He had no other illnesses at time of vaccination and no lab/diagnostic tests were taken.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Tenderness
Clinical narrative: It was reported that a 52 year old male pt received first dose of Fluzone (U0913AA) given in the left deltoid on 11/4/02. The pt experienced a sore arm, dull aches for four days after injection, along with chill off and on, body aches, flu-like symptoms, little energy and feeling hot intermittently. On 11/28/02 and 11/29/02, the pt experienced heavy sweating, stomach cramps. He was unable to eat from 11/29/02 to 12/1/02. He reportedly felt better by 12/3/02 and recovered from these reactions. The pt had a heart attack in January of 1998, and is taking Glucovance. He had no other illnesses at time of vaccination and no lab/diagnostic tests were taken.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: It was reported that a 91 year old female pt was vaccinated on 10/30/02 at 9am with Fluzone (U0918AA) IM in the left deltoid. Pt had a rash and hives on her buttocks on the morning of 11/2/02. No lab/diagnostic tests were taken and no other vaccines were given. No adverse events following prior vaccination were reported. The pt did not recover. From additional info received on 4/14/03 from the reporting physician, it was reported that the pt had "no illness at time of vaccination and current condition is stable. She had her rash for several weeks, but rash finally cleared up and has not returned. Still no other med changes." No further info is anticipated, the case is closed.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Face oedema, Rash erythematous
Clinical narrative: Erythematous rash over face and prox extremities and swelling to face.  Pt given EPI 1:1000 6mg and Benadryl 25mg.  Pt checked to ER at 14:12.  Discharged at 17:00.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Balance disorder, Difficulty in walking, Fatigue
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 55 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 an injection of LYMErix on 7/15/99 "according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered tingling of her legs, joint pain, fatigue, insomnia, difficulty walking, imbalance and headaches beginning the day after her vaccination according to the client." Upon follow-up received 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 "tingling in her legs and feet, numbness of both legs, joint pain, fatigue, insomnia, difficulty walking, imbalance, and headaches." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited her 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. On 15Sept04, the pt's attorney alleged that the pt, now 56 years old, experienced joint pain, numbness, tingling, headaches, neuropathy, insomnia, and gait disturbance with abnormal brain MRI. Time to onset treatment, and outcome were not reported. 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: 55.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Infection, Insomnia, Paraesthesia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 55 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 an injection of LYMErix on 7/15/99 "according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered tingling of her legs, joint pain, fatigue, insomnia, difficulty walking, imbalance and headaches beginning the day after her vaccination according to the client." Upon follow-up received 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 "tingling in her legs and feet, numbness of both legs, joint pain, fatigue, insomnia, difficulty walking, imbalance, and headaches." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited her 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. On 15Sept04, the pt's attorney alleged that the pt, now 56 years old, experienced joint pain, numbness, tingling, headaches, neuropathy, insomnia, and gait disturbance with abnormal brain MRI. Time to onset treatment, and outcome were not reported. 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: 54.0
Sex: M
Vaccine: LYME
Symptoms: Anxiety, Arthritis, Cognitive disorder, Depression, Dizziness
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 54 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings. Medical records were also received. The pt received injections of LYMErix on 6/22/99 and 12/9/99 "according to the client." He subsequently reported that his first injection of LYMErix was in April 1999. On 9/3/03, the pt's attorney alleged that the pt "suffered fatigue, decreased concentration, short-term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression and fever. The onset of his symptoms is not clear at this time." Upon follow-up received 1/12/01, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "fatigue, short-term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression, and fever." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" 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, antibiotic, and other medications without relief of symptoms. Medical records received via the attorney indicated that the 54 year old male pt received his first injection of LYMErix on 6/22/99, his second injection of LYMErix on 10/5/99. On 7/16/99, the pt saw his physician with complaint of a fever of four days duration. He had a bulls eye rash on his left calf consistent with erythema chronicum migrane. Per medical notes, by 7/28/99, all symptoms of Lyme disease had cleared. However the pt said he has been feeling poorly every since (dizziness, lightheadedness, vertigo, short term memory problems, decreased cognitive senses). On 1/1/00, the pt presented to the ER with complaints of dizziness (mainly vertigo). He was told that his symptoms were due to anxiety. On 15Sept04, the attorney alleged that the pt, now 59 years old, experienced fatigue, short term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression, gait disturbance with positive MRI and SPECT scan. Time to onset, treatment and outcome were not reported. 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: 54.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Infection, Memory impairment, Pain, Pyrexia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 54 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings. Medical records were also received. The pt received injections of LYMErix on 6/22/99 and 12/9/99 "according to the client." He subsequently reported that his first injection of LYMErix was in April 1999. On 9/3/03, the pt's attorney alleged that the pt "suffered fatigue, decreased concentration, short-term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression and fever. The onset of his symptoms is not clear at this time." Upon follow-up received 1/12/01, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "fatigue, short-term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression, and fever." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" 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, antibiotic, and other medications without relief of symptoms. Medical records received via the attorney indicated that the 54 year old male pt received his first injection of LYMErix on 6/22/99, his second injection of LYMErix on 10/5/99. On 7/16/99, the pt saw his physician with complaint of a fever of four days duration. He had a bulls eye rash on his left calf consistent with erythema chronicum migrane. Per medical notes, by 7/28/99, all symptoms of Lyme disease had cleared. However the pt said he has been feeling poorly every since (dizziness, lightheadedness, vertigo, short term memory problems, decreased cognitive senses). On 1/1/00, the pt presented to the ER with complaints of dizziness (mainly vertigo). He was told that his symptoms were due to anxiety. On 15Sept04, the attorney alleged that the pt, now 59 years old, experienced fatigue, short term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression, gait disturbance with positive MRI and SPECT scan. Time to onset, treatment and outcome were not reported. 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: 54.0
Sex: M
Vaccine: LYME
Symptoms: Rash, Vertigo
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 54 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings. Medical records were also received. The pt received injections of LYMErix on 6/22/99 and 12/9/99 "according to the client." He subsequently reported that his first injection of LYMErix was in April 1999. On 9/3/03, the pt's attorney alleged that the pt "suffered fatigue, decreased concentration, short-term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression and fever. The onset of his symptoms is not clear at this time." Upon follow-up received 1/12/01, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "fatigue, short-term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression, and fever." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" 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, antibiotic, and other medications without relief of symptoms. Medical records received via the attorney indicated that the 54 year old male pt received his first injection of LYMErix on 6/22/99, his second injection of LYMErix on 10/5/99. On 7/16/99, the pt saw his physician with complaint of a fever of four days duration. He had a bulls eye rash on his left calf consistent with erythema chronicum migrane. Per medical notes, by 7/28/99, all symptoms of Lyme disease had cleared. However the pt said he has been feeling poorly every since (dizziness, lightheadedness, vertigo, short term memory problems, decreased cognitive senses). On 1/1/00, the pt presented to the ER with complaints of dizziness (mainly vertigo). He was told that his symptoms were due to anxiety. On 15Sept04, the attorney alleged that the pt, now 59 years old, experienced fatigue, short term memory loss, impaired cognitive skills, lightheadedness, dizziness, depression, gait disturbance with positive MRI and SPECT scan. Time to onset, treatment and outcome were not reported. 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: 0.07
Sex: M
Vaccine: HEP
Symptoms: Autism, Drug toxicity, Neurodevelopmental disorder
Clinical narrative: This case was reported by a nurse and described the occurrence of autism in a 19 month old male pt who received hep B vaccine recombinant (Engerix B) and Infanrix. On an unspecified date in July 2000, the pt received the first dose of hep B vaccine. Approximately one month later, in August 2000, the pt received the second dose of hep B vaccine. On an unspecified date, the pt received the third dose of hep B vaccine. On unspecified dates, the pt received a series of three doses of Infanrix. On 2/2/02, the pt was diagnosed with autism and "mercury in his body he cannot excrete." The events were unresolved. Comment: This case was considered medically serious (OMIC) by manufacturer. On 19 February 2003 the patient was diagnosed with autism and questionable mercury poisioning. The nurse initially reported that the patient had "mercury in his body he connot excrete". On follow-up the nurse indicated that it was uncertain whether mercury was being retained, and diagnostic results were pending. The patient's developmental delays were unresolved at the time of reporting. In the nurse's opinion the events which were considered to be disabling were unrelated to Engerix-B or Infanrix. Information fron Annual Follow-up report states developmental delays persist.
Sex: M
Vaccine: LYME
Symptoms: Fibrosis tendinous, Medication error, Muscle atrophy, Osteoarthritis, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of muscle wasting in a male pt in his twenties who received Lyme disease vaccine recombinant OspA (LYMErix). The reporter is the pt's mother. A physician or other health care professional has not verified this report. The pt's medical history was notable for diagnosis of Lyme disease (stage 3) in 1989, right leg pain and right knee swelling in 1994, and a family history of muscle disease. At the time of vaccinations, the pt was not receiving concurrent medications. On 2/16/00, the pt received the first dose of LYMErix. On 4/22/00, the pt received the second dose of LYMErix. On 4/2/01, the pt received the third dose of LYMErix. This represented a schedule of 0, 2, and 14 months rather than the recommended schedule of 0, 1, and 12 months. At an unspecified time following administration of LYMErix, the pt developed muscle wasting in his right leg and pain in his right leg. On 6/14/01, the pt was diagnosed with benign fibroma of the right knee. The events were unresolved. The consumer stated that as of 1/13/04, her son "can only lift 10 pounds with his right leg (but can lift) 100 pounds with his left leg." comment: This case was assessed as medically serious (OMIC) by manufacturer. Information from Annual Follow-up report states lost to follow-up.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Facial palsy, Hearing impaired, Hypoaesthesia, Infection
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 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 on 4/9/99, 5/14/99, "and 12 months later" "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 "numbness in her toes, finger, and lump on her right elbow, severe shoulder pain, elbow pain, hand pain, hearing loss, rashes, droopy face, right hip pain and stiffness." 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 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 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: F
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Pain, Rash, Shoulder pain, Skin nodule
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 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 on 4/9/99, 5/14/99, "and 12 months later" "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 "numbness in her toes, finger, and lump on her right elbow, severe shoulder pain, elbow pain, hand pain, hearing loss, rashes, droopy face, right hip pain and stiffness." 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 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 litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Confusional state, Depression, Dizziness
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 42 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 7/16/99, 8/9/99, and 6/18/00 "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 "short term memory loss, panic attacks, rashes, fatigue, flu-like symptoms, arthralgias, myalgias, chronic depression, insomnia, headache, numbness, dizziness, and confusion." 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 and other medications without relief of symptoms. On 15Sept04 the attorney alleged that the pt, now 43 years old, experienced arthralgia, myalgias, insomnia, numbness, dizziness, short term memory loss, and confusion. Time to onset, treatment, amd outcome were not reported. 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: 42.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, Infection, Influenza like illness
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 42 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 7/16/99, 8/9/99, and 6/18/00 "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 "short term memory loss, panic attacks, rashes, fatigue, flu-like symptoms, arthralgias, myalgias, chronic depression, insomnia, headache, numbness, dizziness, and confusion." 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 and other medications without relief of symptoms. On 15Sept04 the attorney alleged that the pt, now 43 years old, experienced arthralgia, myalgias, insomnia, numbness, dizziness, short term memory loss, and confusion. Time to onset, treatment, amd outcome were not reported. 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: 42.0
Sex: M
Vaccine: LYME
Symptoms: Insomnia, Memory impairment, Myalgia, Pain, Panic reaction
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 42 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 7/16/99, 8/9/99, and 6/18/00 "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 "short term memory loss, panic attacks, rashes, fatigue, flu-like symptoms, arthralgias, myalgias, chronic depression, insomnia, headache, numbness, dizziness, and confusion." 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 and other medications without relief of symptoms. On 15Sept04 the attorney alleged that the pt, now 43 years old, experienced arthralgia, myalgias, insomnia, numbness, dizziness, short term memory loss, and confusion. Time to onset, treatment, amd outcome were not reported. 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: 42.0
Sex: M
Vaccine: LYME
Symptoms: Rash
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 42 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 7/16/99, 8/9/99, and 6/18/00 "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 "short term memory loss, panic attacks, rashes, fatigue, flu-like symptoms, arthralgias, myalgias, chronic depression, insomnia, headache, numbness, dizziness, and confusion." 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 and other medications without relief of symptoms. On 15Sept04 the attorney alleged that the pt, now 43 years old, experienced arthralgia, myalgias, insomnia, numbness, dizziness, short term memory loss, and confusion. Time to onset, treatment, amd outcome were not reported. 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: 45.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Back pain, Infection, Medication error
Clinical narrative: This report describes the occurrence of Lyme arthritis and/or Lyme disease in a 45 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 4/2/99, 5/6/99 and 3/7/99 "according to the client." This represented an inappropriate schedule of drug administration, with LYMErix vaccinations given on a 0, 1, and 11 month schedule rather than 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 "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 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: 50.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Fatigue, Headache, Infection
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 50 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 winter 2000 and summer 2000 "according to the client." This represents an inappropriate schedule of drug administration, as the administration of LYMErix does not adhere to 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, fatigue, tingling, and headaches." 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: 50.0
Sex: M
Vaccine: LYME
Symptoms: Medication error, Pain, Paraesthesia
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 50 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 winter 2000 and summer 2000 "according to the client." This represents an inappropriate schedule of drug administration, as the administration of LYMErix does not adhere to 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, fatigue, tingling, and headaches." 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: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Laboratory test abnormal, Lymphopenia, Pruritus, Pyrexia
Clinical narrative: Information has been received from a medical technologist concerning a 5 year old male with no allergies and no history of chickenpox or recent exposure to chickenpox or herpes zoster who on 12/10/98 was vaccinated in the right lateral thigh with a 0.5ml first dose of varicella virus vaccine (627870/1260H). It was noted that no rash occurred at the injection site or elsewhere within 42 days of the vaccination. In May, 2003, the pt was diagnosed with thoracic Ewing's Sarcoma. Therapies included Septra, nystatin and granulocyte colony stimulating factor. On 12/22/03 the pt completed chemotherapy for Ewing's sarcoma. Three days later, on the morning of 12/25/03, the pt developed a temp of 38.2 C, an itching rash, and multiple vesicles that were widespread over most of his body. It was reported that the pt was also lymphopenic with a WBC of 0.7 and a lymphocyte coutn of 8%. There were no other systemic reactions and the pt experienced no pain. On the same day the pt was seen and admitted to the hospital. Specimens from an abdominal and an arm vesicle were sent for Direct flurorescent antibody and a culture. The results were positive for VZV. No specimen was collected for PCR analysis and it was requested that a specimen for typing be obtained. No photos were taken. On 12/30/03 the pt was discharged from the hospital and was reported to be recovering. Subsequently, the pt recovered. No product quality complaint was involved. Info received on 1/6/04 contained the following adverse experience: Ewing's Sarcoma (May 2003). Additional info has been requested. On 1/29/04 it ws reported that the results of the VZV PCR noted that the patient had the wild type strain of the virus. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Sarcoma, Viral infection
Clinical narrative: Information has been received from a medical technologist concerning a 5 year old male with no allergies and no history of chickenpox or recent exposure to chickenpox or herpes zoster who on 12/10/98 was vaccinated in the right lateral thigh with a 0.5ml first dose of varicella virus vaccine (627870/1260H). It was noted that no rash occurred at the injection site or elsewhere within 42 days of the vaccination. In May, 2003, the pt was diagnosed with thoracic Ewing's Sarcoma. Therapies included Septra, nystatin and granulocyte colony stimulating factor. On 12/22/03 the pt completed chemotherapy for Ewing's sarcoma. Three days later, on the morning of 12/25/03, the pt developed a temp of 38.2 C, an itching rash, and multiple vesicles that were widespread over most of his body. It was reported that the pt was also lymphopenic with a WBC of 0.7 and a lymphocyte coutn of 8%. There were no other systemic reactions and the pt experienced no pain. On the same day the pt was seen and admitted to the hospital. Specimens from an abdominal and an arm vesicle were sent for Direct flurorescent antibody and a culture. The results were positive for VZV. No specimen was collected for PCR analysis and it was requested that a specimen for typing be obtained. No photos were taken. On 12/30/03 the pt was discharged from the hospital and was reported to be recovering. Subsequently, the pt recovered. No product quality complaint was involved. Info received on 1/6/04 contained the following adverse experience: Ewing's Sarcoma (May 2003). Additional info has been requested. On 1/29/04 it ws reported that the results of the VZV PCR noted that the patient had the wild type strain of the virus. No further information is available.
Age: 74.0
Sex: M
Vaccine: TTOX
Symptoms: Cerebral ischaemia, Dysarthria, Haemorrhage, Hypertonia, Nervous system disorder
Clinical narrative: Ended up in hospital 4 days after shot with no platelets, mouthful of blood blisters. Sent home 12 days later. Back in hospital 30 minutes after got home with ITP. Stay in hospital for a total of 23 days. The hospital discharge summary received on 2/19/04 states fever, dysarthria, and tightness in arms/ hands.
Age: 74.0
Sex: M
Vaccine: TTOX
Symptoms: Pyrexia, Thrombocytopenic purpura
Clinical narrative: Ended up in hospital 4 days after shot with no platelets, mouthful of blood blisters. Sent home 12 days later. Back in hospital 30 minutes after got home with ITP. Stay in hospital for a total of 23 days. The hospital discharge summary received on 2/19/04 states fever, dysarthria, and tightness in arms/ hands.