chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arrhythmia, Arthralgia, Asthenia, Back pain, Coordination abnormal
Clinical narrative: Onset of cardiac arrythmia with duration of up to one week, followed by severe neurological symptoms, including limb numbness and weakness, gait problems, ataxia. Four years later, still suffering from intermittent arrythmias, neurological symptoms, limb numbness, fatigue, joint pains. The symptoms described above were at times intermittent and at times acute in nature. Because of the nature of the symptoms, I went to four different physicians including two internists, an ENT and a neurologist. I was afraid of multiple sclerosis and had a MRI which was negative. I have had numerous x-rays and an MRI of my spine because of back and joint pain. The physicians in 2000 did not ask me about vaccinations and I did not suspect this either since we are certainly not warned of the possible side effects of these vaccines, especially hep B. Therefore, treatments were in the form of muscle relaxants, anti-depressants and pain killers. Muscle cramps were another symptoms. I now suffer some of these symptoms intermittently, however the joint pain, fatigue and limb numbness are almost a chronic problem. I have done alot of research into this and have been made aware of the possible side effects of the hep B vaccine. I find it a distortion of truth when people are vaccinated without sufficient warning of side effects (which are stated in the manufacturer's inset) and not properly interviewed as far as family history of auto-immune diseases. The onset of my original symptoms were shortly after my first vaccinations. I have never experienced any of these symptom prior to the vaccinations. It could not be coincidence. Someone has to be responsible for long term side effects of these vaccinations.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Fatigue, Gait disturbance, Hypoaesthesia, Muscle spasms, Neurological symptom
Clinical narrative: Onset of cardiac arrythmia with duration of up to one week, followed by severe neurological symptoms, including limb numbness and weakness, gait problems, ataxia. Four years later, still suffering from intermittent arrythmias, neurological symptoms, limb numbness, fatigue, joint pains. The symptoms described above were at times intermittent and at times acute in nature. Because of the nature of the symptoms, I went to four different physicians including two internists, an ENT and a neurologist. I was afraid of multiple sclerosis and had a MRI which was negative. I have had numerous x-rays and an MRI of my spine because of back and joint pain. The physicians in 2000 did not ask me about vaccinations and I did not suspect this either since we are certainly not warned of the possible side effects of these vaccines, especially hep B. Therefore, treatments were in the form of muscle relaxants, anti-depressants and pain killers. Muscle cramps were another symptoms. I now suffer some of these symptoms intermittently, however the joint pain, fatigue and limb numbness are almost a chronic problem. I have done alot of research into this and have been made aware of the possible side effects of the hep B vaccine. I find it a distortion of truth when people are vaccinated without sufficient warning of side effects (which are stated in the manufacturer's inset) and not properly interviewed as far as family history of auto-immune diseases. The onset of my original symptoms were shortly after my first vaccinations. I have never experienced any of these symptom prior to the vaccinations. It could not be coincidence. Someone has to be responsible for long term side effects of these vaccinations.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Reddened inderated area around injection site approx. 6-7cm in diameter.
Age: 89.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Reddened inderated area around injectiono site approx 6-7 cm in diameter.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Hypotonia, Lethargy, Movement disorder, Somnolence
Clinical narrative: Woke up at 6:30 am on 5/29/03-was very sleepy acting so I put her back to bed, thought she was extra tired due to having vaccines. Went in at 10:30 am and she could not move, had no muscle control, could not even open her eyes, when picked up she was very limp and floppy, very lethargic until late afternoon 5/29/03 wen to PP at 11:15 am.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Erythema
Clinical narrative: Red area 4" x 5 1/2".
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema
Clinical narrative: Swelling no fever 1/2 IN > no cellulitis.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: That evening after immunization experienced redness, swelling, tenderness, heat at site of injection on L arm. Had 1st dose of varicella on 10/23/03 with no local reactions and concerned about getting a local reaction after this 2nd dose. Advised anti-inflammatory meds, ice on heat for comfort.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Laboratory test abnormal
Clinical narrative: Pt had a case of varicella, titer shows no immunity.
Age: 35.0
Sex: F
Vaccine: HIBV
Symptoms: Drug administration error, Eye irritation, Vision blurred
Clinical narrative: Information has been received from an emergency medical technician concerning a 35 year old female mother. On 1/6/03 her child was vaccinated with a dose of Haemophilus B conjugate vaccine (lot number not reported). A small drop of vaccine splashed in the mother's eye and she reported a slight sting and blurring of vision. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Abasia, Contusion, Erythema, Feeling hot, Injection site induration
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 month-old male patient with allergies to amoxicillin and has no other allergies, who on 15-Apr-2003 in the AM was vaccinated IM in the right upper thigh (also reported as right leg top) with a fourth dose of Haemophilus B conjugate vaccine (Lot #641690/1307L). There was no concomitant injections given to the patient in the right thigh on that day, 15-Apr-2003. It was noted that the patient's mother had reported to the physician's office that beginning on 16-Apr-2003 (also reported by medical assistant as 18-Apr-2003), the patient had a reaction to the top of right leg, which was described as the area was black and blue, hardened, hot to touch, red, swollen, which was described as "he had swelling at the site, that "traveled" to the hip area, and he "ran" a fever. It was reported the mother also stated, the leg was sore to the point the patient "couldn't walk" on the leg for a day due to swelling. The medical assistant stated, the physician had instructed the mother to treat the patient's area with cool compresses. On 17-Apr-2003 the patient's mother called the physician office and reported the patient's fever had resolved. the patient could now walk on his right leg, and the "site reaction" was improving. It was noted there were no laboratory tests performed and the patient had not had adverse events following prior vaccination. The certified medical assistant reported the patient has since recovered from all of the adverse events reported. Unspecified medical attention was sought. Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 month-old male patient with allergies to amoxicillin and has no other allergies, who on 15-Apr-2003 in the AM was vaccinated IM in the right upper thigh (also reported as right leg top) with a fourth dose of Haemophilus B conjugate vaccine (Lot #641690/1307L). There was no concomitant injections given to the patient in the right thigh on that day, 15-Apr-2003. It was noted that the patient's mother had reported to the physician's office that beginning on 16-Apr-2003 (also reported by medical assistant as 18-Apr-2003), the patient had a reaction to the top of right leg, which was described as the area was black and blue, hardened, hot to touch, red, swollen, which was described as "he had swelling at the site, that "traveled" to the hip area, and he "ran" a fever. It was reported the mother also stated, the leg was sore to the point the patient "couldn't walk" on the leg for a day due to swelling. The medical assistant stated, the physician had instructed the mother to treat the patient's area with cool compresses. On 17-Apr-2003 the patient's mother called the physician office and reported the patient's fever had resolved. the patient could now walk on his right leg, and the "site reaction" was improving. It was noted there were no laboratory tests performed and the patient had not had adverse events following prior vaccination. The certified medical assistant reported the patient has since recovered from all of the adverse events reported. Unspecified medical attention was sought. Additional information is not expected.
Age: 1.7
Sex: M
Vaccine: DTP, HIBV, PNC
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 20 month old white/hispanic male with no medical history and no allergies who on the morning of 5/27/03 was vaccinated IM in the left leg with an expired fourth dose of Haemophilus B conjugate vaccine (lot # 636991/1422L; expired on 5/26/03). On 5/27/03, the patient was also vaccinated with a dose of Streptococcus pneumoniae vaccine and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. There was no illness at the time of vaccination. There were no adverse vents following prior vaccinations. On the morning of 5/28/03 the patient developed diarrhea for 4-5 days. It was noted that no other family members had diarrhea during that time. No diagnostic studies were performed. Unspecified medical attention was sought. On 6/2/03 the patient recovered. No product quality complaint was involved.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 month old male with no past medical history and no known drug allergies who on 3/25/03 in the AM was vaccinated in the left thigh with a fourth dose of Haemophilus B conjugate vaccine (lot # 644865/1101M). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR (lot # 642700/0528M) administered in the right thigh and a fourth dose of Streptococcus pneumoniae vaccine (batch # 491565) administered in the right thigh. On 3/25/03 in the PM the patient developed a small knot in his left thigh and slight redness to the area, which was golf ball sized. No fever was noted. Unspecified medical attention was sought. The outcome was reported as recovered. There were no relevant diagnostic tests or lab data. No further information is expected.
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Agitation, Irritability, Pyrexia
Clinical narrative: Information has been received for diphtheria toxoid (+) hepatitis B vaccine recombinant (+) pertussis vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) vaccine. On an unspecified date, an infant was vaccinated with a dose of Haemophilus B conjugate vaccine. Concomitant therapy included a dose of diphtheria toxoid (+) hepatitis B vaccine recombinant (+) pertussis vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (lot # 21881C9). At an uknown time post-immunization, the patient developed a fever of 102 to 104 degrees F, irritability, and inconsolable crying. The patient was seen by the physician. The patient recovered after an unspecified period of time. This was originally reported by a physician. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia
Clinical narrative: This report was received for PEDIARIX. This report concerns a child patient who was vaccinated with a dose of HIB conjugate vaccine. Concomitant vaccination on the same day included diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid. Subsequently, the patient experienced a fever of 101.3 degrees F. Medical attention was not sought. The outcome of the event is unknown. This was originally reported by a physician. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a mother concerning her 3 year old son who had no pertinent medical history who on 9/5/03 was vaccinated IM with the fourth dose of HIB conjugate vaccine (lot # 646412/0429N). There was no concomitant therapy. The patient's mother reported that on 9/5/03, after being vaccinated, her son developed a knot at the injection site. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the knot at the injection site persisted. The patient's mother wanted to know if there was a problem with lot # 646412/0429N. The mother also reported that her other son developed a knot at the injection site after being vaccinated with HIB conjugate vaccine. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a mother concerning her son who had no pertinent medical history who on 10/2/03 was vaccinated IM with the second dose of HIB conjugate vaccine (lot # 646412/0429N). There was no concomitant therapy. The patient's mother reported that on 10/2/03, after being vaccinated, her son developed a knot at the injection site. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the knot at the injection site persisted. The patient's mother wanted to know if there was a problem with lot # 646412/0429N. The mother also reported that her other son developed a knot at the injection site after being vaccinated with HIB conjugate vaccine. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Pt received Anthrax #5 2 days ago,denies previos sensitivity-no other vaccines given that day.10 cm errythema warm to touch Right deltoid,"itchs". Adverse reaction to routine vaccination,"moderate,localized"Tx as follows:(1)Benadryl 25 mg #16,(3)Tylenol 325 mg #30.
Age: 19.0
Sex: F
Vaccine: ANTH, YF
Symptoms: Accident, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Patient got car sick on the drive back home and shortly after passed out in the bathroom. No one was around to see her fall. She complained of vomiting before falling onto the floor.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Administered Anthrax #2 one month ago and still has raised hardened area from it. Not painful to touch. Anthrax #3 given on on 6 Feb 2003 VAERS date 10 Feb 2003 has raised area that is 2 inches in diameter and is still having itchy reaction.
Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Symptoms are fatigue, severe pain in knees, general aches and pains throughout body, and headaches.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Pain
Clinical narrative: Symptoms are fatigue, severe pain in hands, general aches and pains throughout body
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Shoulder pain
Clinical narrative: PAIN IN LEFT SHOULDER JOINT
Age: 55.0
Sex: M
Vaccine: SMALL
Symptoms: Abdominal pain, Asthenia, Coordination abnormal, Diabetes mellitus, Eye oedema
Clinical narrative: Vaccinated 5/13/03 Patient did not have C/O except for itching post vaccination. On November 26, 2003. Patient reported that 2-3 weeks after vaccination he started getting tired and weak. He states this weakness progressed to where he would have to take frequent rests, could not run up the stairs. Legs felt like jelly, eye-sight progressively decreasing in acuity, neuralgias of the trunk.  He has since had to quit work d/t the failing health and eyesight. And is now unable to ski, continue as a flight instructor or drive. 5/20/03: Appointment with doctor for decrease in energy and intermittent blurry vision. DX: with Type II DM, Uncontrolled mild early peripheral neuropathy, Hyperglobulinemia. TRT: Started on Glucovance. 7/28/03: Doctor office visit: C/O "pain around the right side of abdomen in the dermatomal area, which started about two months ago but wasn't really severe until about a week or so ago." DX: Peripheral neuropathy, related to diabetes mellitus versus herpes zoster neuralgia. TRT: Neurontin, Vicodin. 8/5/03: Office visit: TRT: trial of Amitriptyline. 9/9/03: Office visit: C/O continues and increasing dysequilibrium and trouble walking in a straight line. 10/20/03: Office visit: C/O progressing leg weakness. Continues with neuropathy. DX: Pregressive leg weakness, possible related to smallpox injection. 12/2/03: Office visit: C/O neuropathy continues. TRT: acupuncture, Trialled Ultram, herbs, vitamins. December 2003: Doctor visit, Retinologist. Laser eye treatments. 1/5/04: Doctor visit, Neurologist. DX: Diffuse weakness, progressive, diabetes mellitus, peripheral neuropathy, autonomic neuropathy, diabetc myopathy. 1/9/04: Doctor office visit: DX: Type II diabetes mellitus with complicatons of retinopathy and neuropathy with leg weakness and possibly complicated by the Smallpox injection last year. 1/2004 saw doctor who reffered patient to Smallpox Research.  Patient has since found that the medical center is not doing current research. 2/5/04: Doctor office visit: BS WNL DX: Atypical rapidly progressing bilateral ulnar neuropathy and truncal neuropathy, rule out spinal cord injury. 2/10/04 Doctor office visit, allergist: DX: feels the rapid progression of symptoms is an allergic reaction to the smallpox vaccine.  Per annual follow up report patient continues with following S/S tires easily with physical activity, strenght is not back to 100%, right eye is swollen, vision is 20/60 R and legally blind in the left, continues with neuropathies and is on RX, can only read or use the ocmputer for about 10-15 minutes when  he gets a severe headache lasting up to 8 hours, no longer is emploted, is on disability.
Age: 55.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Gait disturbance, Headache, Hyperglobulinaemia, Laboratory test abnormal
Clinical narrative: Vaccinated 5/13/03 Patient did not have C/O except for itching post vaccination. On November 26, 2003. Patient reported that 2-3 weeks after vaccination he started getting tired and weak. He states this weakness progressed to where he would have to take frequent rests, could not run up the stairs. Legs felt like jelly, eye-sight progressively decreasing in acuity, neuralgias of the trunk.  He has since had to quit work d/t the failing health and eyesight. And is now unable to ski, continue as a flight instructor or drive. 5/20/03: Appointment with doctor for decrease in energy and intermittent blurry vision. DX: with Type II DM, Uncontrolled mild early peripheral neuropathy, Hyperglobulinemia. TRT: Started on Glucovance. 7/28/03: Doctor office visit: C/O "pain around the right side of abdomen in the dermatomal area, which started about two months ago but wasn't really severe until about a week or so ago." DX: Peripheral neuropathy, related to diabetes mellitus versus herpes zoster neuralgia. TRT: Neurontin, Vicodin. 8/5/03: Office visit: TRT: trial of Amitriptyline. 9/9/03: Office visit: C/O continues and increasing dysequilibrium and trouble walking in a straight line. 10/20/03: Office visit: C/O progressing leg weakness. Continues with neuropathy. DX: Pregressive leg weakness, possible related to smallpox injection. 12/2/03: Office visit: C/O neuropathy continues. TRT: acupuncture, Trialled Ultram, herbs, vitamins. December 2003: Doctor visit, Retinologist. Laser eye treatments. 1/5/04: Doctor visit, Neurologist. DX: Diffuse weakness, progressive, diabetes mellitus, peripheral neuropathy, autonomic neuropathy, diabetc myopathy. 1/9/04: Doctor office visit: DX: Type II diabetes mellitus with complicatons of retinopathy and neuropathy with leg weakness and possibly complicated by the Smallpox injection last year. 1/2004 saw doctor who reffered patient to Smallpox Research.  Patient has since found that the medical center is not doing current research. 2/5/04: Doctor office visit: BS WNL DX: Atypical rapidly progressing bilateral ulnar neuropathy and truncal neuropathy, rule out spinal cord injury. 2/10/04 Doctor office visit, allergist: DX: feels the rapid progression of symptoms is an allergic reaction to the smallpox vaccine.  Per annual follow up report patient continues with following S/S tires easily with physical activity, strenght is not back to 100%, right eye is swollen, vision is 20/60 R and legally blind in the left, continues with neuropathies and is on RX, can only read or use the ocmputer for about 10-15 minutes when  he gets a severe headache lasting up to 8 hours, no longer is emploted, is on disability.
Age: 55.0
Sex: M
Vaccine: SMALL
Symptoms: Muscular weakness, Myopathy, Neuralgia, Neuropathy peripheral, Pain
Clinical narrative: Vaccinated 5/13/03 Patient did not have C/O except for itching post vaccination. On November 26, 2003. Patient reported that 2-3 weeks after vaccination he started getting tired and weak. He states this weakness progressed to where he would have to take frequent rests, could not run up the stairs. Legs felt like jelly, eye-sight progressively decreasing in acuity, neuralgias of the trunk.  He has since had to quit work d/t the failing health and eyesight. And is now unable to ski, continue as a flight instructor or drive. 5/20/03: Appointment with doctor for decrease in energy and intermittent blurry vision. DX: with Type II DM, Uncontrolled mild early peripheral neuropathy, Hyperglobulinemia. TRT: Started on Glucovance. 7/28/03: Doctor office visit: C/O "pain around the right side of abdomen in the dermatomal area, which started about two months ago but wasn't really severe until about a week or so ago." DX: Peripheral neuropathy, related to diabetes mellitus versus herpes zoster neuralgia. TRT: Neurontin, Vicodin. 8/5/03: Office visit: TRT: trial of Amitriptyline. 9/9/03: Office visit: C/O continues and increasing dysequilibrium and trouble walking in a straight line. 10/20/03: Office visit: C/O progressing leg weakness. Continues with neuropathy. DX: Pregressive leg weakness, possible related to smallpox injection. 12/2/03: Office visit: C/O neuropathy continues. TRT: acupuncture, Trialled Ultram, herbs, vitamins. December 2003: Doctor visit, Retinologist. Laser eye treatments. 1/5/04: Doctor visit, Neurologist. DX: Diffuse weakness, progressive, diabetes mellitus, peripheral neuropathy, autonomic neuropathy, diabetc myopathy. 1/9/04: Doctor office visit: DX: Type II diabetes mellitus with complicatons of retinopathy and neuropathy with leg weakness and possibly complicated by the Smallpox injection last year. 1/2004 saw doctor who reffered patient to Smallpox Research.  Patient has since found that the medical center is not doing current research. 2/5/04: Doctor office visit: BS WNL DX: Atypical rapidly progressing bilateral ulnar neuropathy and truncal neuropathy, rule out spinal cord injury. 2/10/04 Doctor office visit, allergist: DX: feels the rapid progression of symptoms is an allergic reaction to the smallpox vaccine.  Per annual follow up report patient continues with following S/S tires easily with physical activity, strenght is not back to 100%, right eye is swollen, vision is 20/60 R and legally blind in the left, continues with neuropathies and is on RX, can only read or use the ocmputer for about 10-15 minutes when  he gets a severe headache lasting up to 8 hours, no longer is emploted, is on disability.
Age: 55.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Retinopathy, Visual acuity reduced
Clinical narrative: Vaccinated 5/13/03 Patient did not have C/O except for itching post vaccination. On November 26, 2003. Patient reported that 2-3 weeks after vaccination he started getting tired and weak. He states this weakness progressed to where he would have to take frequent rests, could not run up the stairs. Legs felt like jelly, eye-sight progressively decreasing in acuity, neuralgias of the trunk.  He has since had to quit work d/t the failing health and eyesight. And is now unable to ski, continue as a flight instructor or drive. 5/20/03: Appointment with doctor for decrease in energy and intermittent blurry vision. DX: with Type II DM, Uncontrolled mild early peripheral neuropathy, Hyperglobulinemia. TRT: Started on Glucovance. 7/28/03: Doctor office visit: C/O "pain around the right side of abdomen in the dermatomal area, which started about two months ago but wasn't really severe until about a week or so ago." DX: Peripheral neuropathy, related to diabetes mellitus versus herpes zoster neuralgia. TRT: Neurontin, Vicodin. 8/5/03: Office visit: TRT: trial of Amitriptyline. 9/9/03: Office visit: C/O continues and increasing dysequilibrium and trouble walking in a straight line. 10/20/03: Office visit: C/O progressing leg weakness. Continues with neuropathy. DX: Pregressive leg weakness, possible related to smallpox injection. 12/2/03: Office visit: C/O neuropathy continues. TRT: acupuncture, Trialled Ultram, herbs, vitamins. December 2003: Doctor visit, Retinologist. Laser eye treatments. 1/5/04: Doctor visit, Neurologist. DX: Diffuse weakness, progressive, diabetes mellitus, peripheral neuropathy, autonomic neuropathy, diabetc myopathy. 1/9/04: Doctor office visit: DX: Type II diabetes mellitus with complicatons of retinopathy and neuropathy with leg weakness and possibly complicated by the Smallpox injection last year. 1/2004 saw doctor who reffered patient to Smallpox Research.  Patient has since found that the medical center is not doing current research. 2/5/04: Doctor office visit: BS WNL DX: Atypical rapidly progressing bilateral ulnar neuropathy and truncal neuropathy, rule out spinal cord injury. 2/10/04 Doctor office visit, allergist: DX: feels the rapid progression of symptoms is an allergic reaction to the smallpox vaccine.  Per annual follow up report patient continues with following S/S tires easily with physical activity, strenght is not back to 100%, right eye is swollen, vision is 20/60 R and legally blind in the left, continues with neuropathies and is on RX, can only read or use the ocmputer for about 10-15 minutes when  he gets a severe headache lasting up to 8 hours, no longer is emploted, is on disability.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Discomfort, Dizziness, Dyspnoea, Myocarditis
Clinical narrative: This is a 21-year-old who had been in his usual health until 02/11/04. He received his primary smallpox vaccination on 02 February 2004. On 11 February 2004, awoke @ 0800 hours with "really really bad chest pain". Walked around and "shook it off" and the pain subsided. Went to beach after spending ~2-3 hours at beach. Went home went to bed. After lying down developed chest pain (8-9/10) and shortness of breath. Could only get comfortable when "sitting in fetal position in corner of his room". Did not seek medical attention. However chest pain did not resolve.  On 13 February 2004, client went on mandatory run, however after completing ~1/8 of a mile had to stopped because of severe (10+/10) chest pain and severe shortness of breath. He was instructed to go to the BAS, was sent to Emergency Department and later transferred to another hospital and admitted to the Coronary Care Unit.  As of 02/18/04 client continues to have chest pain and shortness of breath. Client states he cannot lie completely supine or has chest pain (6-7/10) and short of breath. When he walks around the room/ward he develops some mild dizziness and minor pain at cardiac catheter injection site. When he stops walking the chest pain (6/10) and experienced moderate shortness of breath upon returning to a sitting position. Nurse follow up on 06/02/04 states: ADD: Pericarditis/Myocarditis.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis
Clinical narrative: This is a 21-year-old who had been in his usual health until 02/11/04. He received his primary smallpox vaccination on 02 February 2004. On 11 February 2004, awoke @ 0800 hours with "really really bad chest pain". Walked around and "shook it off" and the pain subsided. Went to beach after spending ~2-3 hours at beach. Went home went to bed. After lying down developed chest pain (8-9/10) and shortness of breath. Could only get comfortable when "sitting in fetal position in corner of his room". Did not seek medical attention. However chest pain did not resolve.  On 13 February 2004, client went on mandatory run, however after completing ~1/8 of a mile had to stopped because of severe (10+/10) chest pain and severe shortness of breath. He was instructed to go to the BAS, was sent to Emergency Department and later transferred to another hospital and admitted to the Coronary Care Unit.  As of 02/18/04 client continues to have chest pain and shortness of breath. Client states he cannot lie completely supine or has chest pain (6-7/10) and short of breath. When he walks around the room/ward he develops some mild dizziness and minor pain at cardiac catheter injection site. When he stops walking the chest pain (6/10) and experienced moderate shortness of breath upon returning to a sitting position. Nurse follow up on 06/02/04 states: ADD: Pericarditis/Myocarditis.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Swelling
Clinical narrative: CHILD DEVELOPED LARGE AREA OF SWELLING ON THIGH (MOM DID NOT REPORT UNTIL 2/17/04) BUT UNSURE WHICH THIGH.  SWELLING BEGAN 8/22/03 AND WAS SIZE OF "BASEBALL" BY 8/23/03.  WAS SEEN IN ER AND GIVEN BENADRYL/ICE PACK.  CHILD FULLY RECOVERED WITH NO LONG LASTING ILL EFFECTS.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis vs. significant localized reaction left leg.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Sleep disorder
Clinical narrative: Severe muscle pain at injection site beginning two days after immunization and continuing to date. No edema, redness, or warmth at injection site. Pain continues to interfere with sleep. Some relief with hot packs and pain medication.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Paraesthesia
Clinical narrative: Hepatitis B injection given on 2-6-04. On 2-11-04 client felt pain starting in L deltoid going down arm into hand.  Also noticed some tingling in hand. Pain became more severe.  Client went to ER.  Was given Darvocet for pain and arm in a sling.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: It was reported that a 20 year old female received a dose of Yellow vaccine on 7/18/02. Pt developed a red, warm, swelling and raised area measuring 2.5 inches x 4 inches at injection site on 7/22/02. Pt recovered.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Headache, Joint stiffness, Pain, Pyrexia
Clinical narrative: It was reported that a 51 year old male was vaccinated with YF vax on 10/21/02 at 10:30 am. On 10/25/02, pt began experiencing generalized body aches, joint stiffness of back and legs, and a mild headache. He felt feverish, but did not take his temp. He was taking aspirin for his symptoms and reportedly was improving.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pneumonia
Clinical narrative: From initial information received on 2/12/04 from a consumer regarding an adverse event occurring in the USA, it was reported that an 88 year old female patient received FLUZONE, lot number U1132AA, administered on 10/26/03. The route and site of administration were not reported. 46 days later, on 12/11/03, the patient developed viral pneumonia and was hospitalized for one week. Treatment included IV antibiotics. The patient is still ill and has not recovered from this adverse event. 22Sep2004: Despite continued attempts to obtain follow up, no further information was provided. No further information is anticipated, this case is considered closed.
Age: 0.3
Sex: F
Vaccine: PNC
Symptoms: Coma, Feeling hot, Sudden infant death syndrome
Clinical narrative: Infant found lifeless at 08-830 2/15/04 by pm. Infant fed at around 230 am. Reported to be doing fine except feel warm that afternoon after shot. Autopsy report received on 6/14/2004 states COD was SIDS.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Anorexia, Anxiety, Arthritis, Dizziness, Fatigue
Clinical narrative: I was given Lymerix shot when I was a salesperson in 1998. I was unaware they pulled the vaccine and have had several arthritis, numbness and tingling in my extremities, dizziness, loss of appetite, shooting pains, migraines, severe exhaustion, muscle fatigue and resulting in psychological problems as well.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Hypoaesthesia, Migraine, Muscular weakness, Neurosis, Pain
Clinical narrative: I was given Lymerix shot when I was a salesperson in 1998. I was unaware they pulled the vaccine and have had several arthritis, numbness and tingling in my extremities, dizziness, loss of appetite, shooting pains, migraines, severe exhaustion, muscle fatigue and resulting in psychological problems as well.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Panic reaction, Paraesthesia
Clinical narrative: I was given Lymerix shot when I was a salesperson in 1998. I was unaware they pulled the vaccine and have had several arthritis, numbness and tingling in my extremities, dizziness, loss of appetite, shooting pains, migraines, severe exhaustion, muscle fatigue and resulting in psychological problems as well.
Sex: M
Vaccine: LYME
Symptoms: Atrioventricular block, Bradycardia, Heart rate irregular
Clinical narrative: Developed hi-degree A-V block, requiring permanent pacemaker placement. 10/23/03 Pt complained of SOB on exertion. Heart rate was slow at 47 beats/min. 10/30/03 EKG revealed "profound bradycardia." Pt referred to cardoiologist. Pacemaker placed in 11/03.  Nurse follow up on 05/27/04 states: "Review of medical record confirms diagnosis of AV block."
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Skin exfoliation
Clinical narrative: #2 flu vaccine adm. R thigh on 1/9/04. 24 hrs post vacc. site became red, raised, individual, small bumps in localized area approx. 1.5" wide x 3-4" long. No apparent pain, itching, no fevers. No OTC meds or heat/ cold packs applied. No limit to activity. (+) warm to touch rxn appeared to be concentrated to skin surface. Site still visible. Skin rough, skaley almost excema appearance. Now applying (and had) lotion. (+) rxn to vaccine #1. Has eaten egg containing products w/o problems-no eggs alone consumed to date that father is aware of.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: Carnitine deficiency, Injection site rash, Mitochondrial enzyme deficiency, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash-abdomen/ thorax (erythematous macular papular diffusely over thorax/ abdomen). No fevers.  follow-up 2/11/2010 - information has been received from a nurse practitioner concerning a caucasian female child. recently diagnosed with carnitine deficiency and probable mitochondrial defect. who was vaccinated subcutaneously in the right thigh, with 0.5 ml on 29 dec 2006 with her first dose of measles virus vaccine live, + mumps virus vaccine. live  + rubella virus vaccine live, varicella virus vaccine live (oka/merck upgrade process) (lot # 656308/3392f). on that same day, at 6pm, the child developed three poxes near the injection site noted to be a varicella-like injection site reaction. these poxes went away after a few days. two weeks later, on approximately 12 jan 2007, the patient developed four to five poxs on various locations on her body. the patient recovered on 19 jan 2007. no laboratory or diagnostic studies were performed. unspecified medical attention was sought. there was no product quality complaint involved.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Extreme fatigue, low grade fever, joint pain, pain lower back.  2 hours of numbness in left arm 07:00-09:00; Headache.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, low grade fever, joint pain, pain lower back.  2 hours of numbness in left arm 07:00-09:00; Headache.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Injection 02/08/04.  Severe swelling and erythema left deltoid.  This was his 5th Anthrax, not infected.
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth, Rash, Rash pruritic, Thrombocytopenic purpura
Clinical narrative: 2-3cm rash on left deltoid (+) erythema (+) thrombotic thrombocytopenic purpura, rash is warm (+) pruritis.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth, Rash, Thrombocytopenic purpura, Urticaria
Clinical narrative: Large rash 3-4 inch in diameter on left deltoid (+) erythema.  In center of rash is a 3-4 cm welt, warm to touch (+) thrombotic thrombocytopenic purpura.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Flu-like symptoms (SEZA), local induration/erythema.
Age: 1.4
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Left upper arm red and swollen.  Give Tylenol or Advil as needed for pain.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC
Symptoms: Convulsion
Clinical narrative: Parent reported noticing seizure activity on 02/10/04 at 12:30am-12:32am.  Rescue squad called.  Arrived at local ER at 01:00am.  Infant evaluated and released at 2:45am. Recommended treatment: alternating doses of Tylenol and Children's Motrin to lower fever.
Age: 1.3
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Dermatitis bullous, Injection site rash
Clinical narrative: Varicella like rash at injection site.
Age: 1.1
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Conjunctivitis, Rash morbilliform, Rhinitis
Clinical narrative: Classic measles rash with coryza, mild conjunctivitis.  Treatment: Observation, isolate from unvaccinated people.
Age: 1.1
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Rash, Rash pruritic
Clinical narrative: Rash, red, itchy on entire body.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Gait disturbance, Oedema peripheral, Pain, Rash maculo-papular
Clinical narrative: Left leg significantly swollen from hip to knee.  Pt complained of pain and refusing to bear weight on leg.  Mild splotchy erythema about 2cm.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema
Clinical narrative: Erythematous area, 12x12cm, appeared at left lateral to medial anterior thigh, one day after IM injection of DTAP.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: 11/13/03: Broke out with rash on both forearms following injection of Hepatitis B (2-3 days after vaccine administered).  Pt then received Hep B #2 on 01/20/04-same rash appeared 2-3 day after vaccine.  No other symptoms experienced.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Rash erythematous
Clinical narrative: Evening of 02/04/2004 around 16:00 noticed pinpoint starting on lower leap and now on arm and trunk-Erythematous rash.  Joints are very achy including wrists, ankles, fingers.
Age: 42.0
Sex: U
Vaccine: HEP
Symptoms: Dermatitis bullous, Rash pruritic
Clinical narrative: 02/06/04: Noticed bumps under skin arms, legs and back.  Fells them more than sees them.  Itchy at times.  Taking Benadryl occasionally.  02/09/04: Saw MD, bumps still present-given Claritin to take daily for 7 days.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Upper respiratory tract infection, Viral infection
Clinical narrative: Simple febrile seizure 9 days after MMR and Varivax.  Seen in ER-felt to have simple febrile seizure 2 hours to MMR or viral syndrome.  Treated and released.  Pt seen in office 3 days later.  Had mild viral upper respiratory infection, no fever.
Age: 14.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Vesicular eruption covering body and scalp=chicken pox (more than 100 lesions).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Local swelling and erythema to right thigh starting about 24 hours after vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Injection site erythema, Urticaria
Clinical narrative: About 5 minutes after injection SC in left arm, a large red "hivey" area appeared at the site of the injection.  No shortness  of breath or other breathing problems occurred.  Pt was immediately examined by MD and given 2 tsp Benadryl and kept in office for 20 minutes to watch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Redness, swelling, tenderness and slight itching of left thigh.  Trial of Benadryl.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Skin ulcer
Clinical narrative: Varicella lesions 02/10/04 onset.
Age: 1.3
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site mass, Pain, Urticaria
Clinical narrative: Seen in office 02/10/04: Parent states hives began 02/08/04.  02/08/04, seen in ER.  Immunizations given 02/05/04: left shoulder hard, left deltoid 1cm firm nodule where Prevnar given on 02/05/04.  Pt complained of "hands hurting" as relayed by mom on 02/09/04.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 12 hours post injection of Td, developed a fever (103) with chills et generalized body aches.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Dyskinesia, Fall, Musculoskeletal stiffness, Mydriasis
Clinical narrative: Pt fell to floor, thrashed around for brief period, one leg noted to be stiff, question of dilated pupils.  Duration 20-25 seconds, then cried for 5-10 minutes and seemingly was fine thereafter.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Crying, Injection site erythema, Injection site oedema, Injection site pain, Rash
Clinical narrative: School nurse call to report child was crying due to pain in left arm.  Redness and swelling from shoulder to elbow.  Treated in school with ice and Motrin.  Mom reports rash-like redness almost to elbow (+) movement.  02/13/04: decreased edema; mom gave Benadryl, child returned to school. NOTE: Mother reports child received these same 3 shots (DTAP, IPV, HEP B) at PMD's somewhere else, but for some reason they were not recorded.  She states child's father took the child for those shots in Sept/Aug 2003.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Skin nodule, Tenderness
Clinical narrative: Received Small Pox vaccine-developed lump and tenderness in L clavicular area.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt received DTAP and Comvax in left thigh on 07/09/03.  Pt received IPV on 07/09/03 in right thigh.  ON 07/11, pt examined by MD and found to have on left thigh, 2 injection sites.  The lower distal site has a large indurated area about the size of a quarter with surrounding erythema in the SC area approximately 6cm at it's largest diameter.  Warm to touch, non tender.  Treatment: Keflex 200mg three times a day for 7 days.
Age: 1.3
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Pt received DTAP, IPV and Prevnar right thigh on 01/08/04.  DTAP and IPV were given in left thigh.  On 01/10/2004, pt was examined by MD and found to have a 3-4 cm in diameter area erythematous, warm, non-tender, easily blanched.  Right thigh noted to have similar reaction with area 1-2 cm in diameter.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Pain, heat, erythema, edema; WBC: 16000, afebrile;
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Injection site erythema, Injection site oedema, Injection site warmth, Shoulder pain
Clinical narrative: Redness, heat and edema in right deltoid area day 2 after vaccine (shoulder to elbow), pain in shoulder area.  Day 5 (12/22/03) after vaccine no pain, slight edema, some areas of redness on upper arm and near elbow, cool to touch, to consult MD as needed.
Age: 0.9
Sex: M
Vaccine: IPV
Symptoms: Erythema, Pyrexia, Rash macular
Clinical narrative: IPV given 01/05/2004.  At 21:00, father came home and noticed child looked red.  Pt reports redness of checks, arms below elbows and upper chest.  Went to ER.  In ER temperature 100. ER note indicated blanched, erythematous macular rash on cheeks, chest and left forearm.  Thought to be related to IPV.  NO treatment in ER.  Motrin given and Benadryl later that night.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: Swelling reaction right deltoid.  2.5x2 inch localized swelling, no erythema, no induration, no limitation of movement right shoulder.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia
Clinical narrative: Developed a fever to 104.9 (rectal).  Recommended that child go to the ER for evaluation.  Per phone note, mother decided to observe child and not go to ER unless symptoms evolved.  Office visit 02/10/04, temperature 98 (rectal).
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Erythema, Face oedema, Wheezing
Clinical narrative: Pt developed facial erythema, edema and mild wheezing about 5-20 minutes after injection.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Information regarding FluShield was received from a consumer, a 50 year old female patient who experienced injection site reaction, the site was big, red, hot. At 50 years of age, the patient received a dose in 2000. The patient's concurrent illness includes hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 2000. Dose regimen was 1 dose per 1 time per day (IM). Concomitant therapy included Synthroid. In 2000, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Subcutaneous nodule
Clinical narrative: A 43 year old female reported that she received an IM injection of a flu vaccine in 2000 at the age of 41 years, and experienced a red knot under her arm that would itch for several days and then resolve. The patient reports she has a possible allergy to preservatives. In 2001 and 2002, after receiving a flu vaccine, the patient experienced a red knot under her arm that would itch for several days and then resolve. Indication for the flu vaccine was immunization. Product was administered in 2000. Dose regimen was 1 dose (IM). Patient was not taking concomitant therapy. After receiving an IM injection of a flu vaccine in 2000, the patient experienced a red knot under her arm that would itch for several days and resolve. No additional information was available at the time of this report.