chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Pyrexia, Throat tightness, Urticaria, Wheezing
Clinical narrative: Approximately 21:30, developed wheezing, touble breathing, hives all over body and felt like throat was closing. Fever at 22:30 was 102, axillary. Was given 3 doses of liquid Benadryl and was better at 23:00. Hives did not return. Had enchiladas and strawberry shortcake for dinner. Has had strawberries since then and had no problems. No known allergies.
Age: 54.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Amnesia, Arthralgia, Fatigue, Hypotonia, Immune system disorder
Clinical narrative: A persistent sore spot on left rib cage, after vaccine, building to a case of full blown Lyme Disease on 1/30/2000, with possible immune problems. Disabled with multiple symptoms. 60 Day FU states has not been able to work since 1/30/00, severe fatigue, knee, hip, and elbow and finger pain. Lost 25 pounds, lost all muscle tone, short term memory loss, muscle twitches in legs, buttocks, and arms. Hearing and light sensitivity
Age: 54.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Infection, Muscle twitching, Sensory disturbance, Weight decreased
Clinical narrative: A persistent sore spot on left rib cage, after vaccine, building to a case of full blown Lyme Disease on 1/30/2000, with possible immune problems. Disabled with multiple symptoms. 60 Day FU states has not been able to work since 1/30/00, severe fatigue, knee, hip, and elbow and finger pain. Lost 25 pounds, lost all muscle tone, short term memory loss, muscle twitches in legs, buttocks, and arms. Hearing and light sensitivity
Age: 54.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Chest pain, Dysphagia, Influenza like illness, Laboratory test abnormal
Clinical narrative: A persistent sore spot on left rib cage, after vaccine, building to a case of full blown Lyme Disease on 1/30/2000, with possible immune problems. Disabled with multiple symptoms. 60 Day FU states has not been able to work since 1/30/00, severe fatigue, knee, hip, and elbow and finger pain. Lost 25 pounds, lost all muscle tone, short term memory loss, muscle twitches in legs, buttocks, and arms. Hearing and light sensitivity
Age: 54.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Muscle contractions involuntary, Muscular weakness, Myalgia, Similar reaction on previous exposure to drug
Clinical narrative: A persistent sore spot on left rib cage, after vaccine, building to a case of full blown Lyme Disease on 1/30/2000, with possible immune problems. Disabled with multiple symptoms. 60 Day FU states has not been able to work since 1/30/00, severe fatigue, knee, hip, and elbow and finger pain. Lost 25 pounds, lost all muscle tone, short term memory loss, muscle twitches in legs, buttocks, and arms. Hearing and light sensitivity
Age: 25.0
Sex: M
Vaccine: FLUX, MEN, TD
Symptoms: Systemic lupus erythematosus
Clinical narrative: This vaccinee, post vax, developed systemic lupus erythematous after receiving influenza vaccine, typhoid vaccine, meningococcal vaccine, tetanus vaccine and Immune serum globulin. He had not received any drugs known to induce SLE prior to vaccination. Treatment regiment included corticosteroids, cyclophosphamide, hydromycholoroqune and azathioprine. He continued to experience residual symptoms for up to 7 years of follow-up. Per doc no 199371, annual follow up, no further information received as of september 2001.
Age: 31.0
Sex: M
Vaccine: FLUX, MEN, TTOX, TYP
Symptoms: Systemic lupus erythematosus
Clinical narrative: This vaccinee, with no symptoms of connective tissue disease prior to vaccination, developed systemic lupus erythematous after receiving influenza vaccine, typhoid, meningococcal and tetanus vaccine and immune serum globulin. He had not received any drugs known to induce SLE prior to vaccination. Treatment included corticosteroids, cyclophosphamide, hydroxychloroquine and azathiprine. He continued to experience residual symptoms for up to 7 years of follow-up. Date of influenza vaccination and onset date of adverse event, not specified therefore associated with 1999/2000 season.
Age: 33.0
Sex: F
Vaccine: FLUX, MEN, MMR, TD, TYP
Symptoms: Systemic lupus erythematosus
Clinical narrative: This vaccinee with no symptoms of connective tissue disease prior to vaccination, developed systemic lupus erythematous, after receiving influenza, MMR, typhoid, meningococcal, tetanus and diptheria and oral polio vaccine. She had not received any drugs known to induce SLE prior to vaccination. Treatment included corticosteroids, cyclophosphamide, hydroxychloroquine and azathiprine. She continued to experience residual symptoms for up to 7 years of follow-up.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Pruritus, Rash
Clinical narrative: Pruritic eruption of left upper arm. Treated with topical cortisone cream.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Chest pain, Influenza like illness, Joint swelling, Pruritus
Clinical narrative: Rash, hives, swollen, painful joints, chest pains, flu-like symptoms, and itching from 11/12 to present.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Urticaria
Clinical narrative: Rash, hives, swollen, painful joints, chest pains, flu-like symptoms, and itching from 11/12 to present.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea, Feeling hot, Hypersensitivity, Pruritus
Clinical narrative: Mom states right arm, post vax, had increased redness and warmth to touch. Some itching noted (+) diarrhea. Benadryl given at 09:00 AM on 05/10/2000. On 5/12/2000, seen by doctor, improvement noted with no redness or swelling.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Swelling, redness and warmth around injection site.
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Area on right lateral thigh is red about 7cm X 8cm and warm to touch.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Hypothermia, Lethargy, Pyrexia
Clinical narrative: Pt became lethargic with an axillary temperature of 94.6, bundled and warmed by parents while at home. Temperature slowly increased to 97 (ax) after 1 1/2 to 2 hours. History of temperature of 100.4 preceeding hypothermia.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Diarrhoea, Headache, Malaise, Pyrexia
Clinical narrative: One day post vax, pt awoke with chills and emesis (lasting 1 day), temperature of 101.8, diarrhea (lasting 15 days), malaise and headache.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: One day post vax, pt awoke with chills and emesis (lasting 1 day), temperature of 101.8, diarrhea (lasting 15 days), malaise and headache.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Post each vax, pt developed a splitting headache lasting 3-4 hours.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Tremor, Vomiting
Clinical narrative: Fourth vax resulted in tremors in left arm for 2 weeks non-stop. Unable to hold down food or water for one weak, sporadic vomiting for one month, fatigue for one month.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Vasodilation procedure
Clinical narrative: Two days post vax, which was received SQ in left arm, area red, warm to touch, induration of redness across back of arm, tender to touch.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Pt presented to clinic with red, tender and swollen arm approximately 2 inches across. Seen by technician and nurse. Advised to take Motrin, Benadryl. Watch for more swelling and temperature.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site oedema
Clinical narrative: Onset beginning 1 day post vax. Flu-like symptoms 2-3 days post vax. Swelling in arm 4-5 days and localized approximately 5 inches across.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Malaise, Pyrexia, Upper respiratory tract congestion, Vaccination complication
Clinical narrative: Pt experienced malaise, fever, URI symptoms for 24-48 hours post 1st vax. Could not rule out post vaccination syndrome.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Myalgia, Oedema peripheral
Clinical narrative: Two days post vax, pt's signs and symptoms included near circumferential swelling and erythema of entire upper arm and half of forearm Some local myalgias and arthralgias. Pt did not report any systemic symptoms. Pt placed on oral prednisone, histamine blocking agents and had resolution within 24 hours.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: Itching, soreness, erythema @ site of Anthrax shot, Onset yesterday, Dx: Localized reaction to Anthrax shot, RX; Atarax
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Paraesthesia, Pruritus, Rash maculo-papular
Clinical narrative: In early evening following vax, the pt noticed raised red area on arms, legs and trunk. When awoke at 5:00 am, also had tingling of lips and itching palms and soles. No other symptoms. The pt was seen at a clinic and still has itching palms and soles. Reportedly the pt has not yet fully recovered.
Age: 18.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Urticaria
Clinical narrative: Pt recv vax on unspecified day; hr post vax pt exp urticaria; tx=Benadryl
Age: 39.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Bone pain, Myalgia, Pyrexia
Clinical narrative: approx 2hr p/vax pt exp fever 101, chills, aching & bone pain;acute phase lasted approx 2hr;
Age: 21.0
Sex: M
Vaccine: JEV, RAB, JEV, RAB
Symptoms: Convulsion, Syncope
Clinical narrative: day following vax pt a seizure & lost consciousness for approx 30 seconds. no treatment
Age: 53.0
Sex: F
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus, Vasodilatation
Clinical narrative: p/vax pt devel large area on arm 12'' long x 4" wide, raised bumpy, red, hot, itchy; tx: prednisone; lasting 5 to 8 weeks;
Age: 25.0
Sex: F
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Headache, Injection site hypersensitivity, Pyrexia
Clinical narrative: 1hr p/vax pt devel an incapacitating h/a;h/a worse lying down;could feel a throbbing in head that matched hear beat;h/a lasted 1hr;fever (did not take temp) devel 6hr p/vax gone by next day;red rash area @ yellow fever site;
Age: 19.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Headache, Neck pain
Clinical narrative: p/vax pt had severe h/a & neck pain, no fever, required adm for pain management & further observation;improved by 3rd day w/narcotic IV pain control then devel a lumbar puncture h/a;
Age: 69.0
Sex: M
Vaccine: JEV, RAB, JEV, RAB
Symptoms: Nausea, Rash, Urine analysis abnormal, Urticaria
Clinical narrative: 5 days p/vax pt c/o rash, urticaria, nausea & dark (orange-brown) urine;
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness, Pericarditis, Viral infection
Clinical narrative: On approximately, 7/15/1999, the vaccinee began to experience flu-like symptoms. In early August, 1999, it was "obvious" to the reporter that her husband's illness was "more serious than (the reporter and her husband) had thought." The vaccinee called his physician and was advised to have an immediate chest x-ray. When the physician compared it to the previous one of 2 years earlier, it was "obvious that something was wrong", as there was "fluid around his heart and at the lower porion of his lungs." He was hospitalized on 8/11/99 and released on 8/14/99. Cardiologist dx'd the pt as having pericarditis due to a viral infection. The vaccinee has been reportedly advised to forego the third dose of Lymerix. The most recent information, received on 5/15/2000, reports the condition of the vaccinee as unknown.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Neck pain, Pyrexia
Clinical narrative: Approximately 8 hours, post vax 2nd Anthrax, I started feeling muscle achiness, upon going to bed I had chills and fever, off and on, all night. Went to work the next day and still had muscle stiffness, minor headache with neck muscle achiness. 48 hours, later, symptoms were gone.
Age: 44.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Dysarthria, Muscle twitching
Clinical narrative: Slurred speech, muscle twitching treated by numerous doctors on-going.  Doc # 203384 states that sympoms consistant with ALA after vaccine, motor neuron destruction.He is dying.
Age: 44.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Dysarthria, Laboratory test abnormal, Muscle twitching, Muscular weakness, Neuropathy
Clinical narrative: Slurred speech, muscle twitching treated by numerous doctors on-going.  Doc # 203384 states that sympoms consistant with ALA after vaccine, motor neuron destruction.He is dying.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Since previous report, next shot series taken in December 1999. Shoulder pain (right) as prior report but less severe, but becoming more chronic. Still recurring in cycles.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Tinnitus
Clinical narrative: The pt experienced a ringing in her ears "one day after the third dose, the ringing disappeared, but sometimes reappears. The ringing in the right ear has been constant for 4-5 years since vaccination." The pt noted she has seen several specialists. Additionally the pt reported "initially had antibodies determined through titer after the series but now have no detectable level." Additional information has been requested.
Sex: F
Vaccine: HEP
Clinical narrative: The pt reported that after the first dose she experienced swelling of he hand 3-4 days post vax. The pt presented to her MD and was dx with rheumatoid arthritis. The pt noted that her rheumatoid factor is presently 741 and that she was been unable to work since. This is in follow-up to report(s) previously submitted on 03/07/2001. Information has been received from a female consumer who was vaccinated with hepatitis b vaccine recombinant (yeast). Subsequently, the patient experienced rheumatoid arthritis which she indicated was "from the hepatitis b vaccine." Additional information has been requested. It has been determined that WAES # 00091017 is a duplicate of WAES #'s 99102341 and 01011360. Therefore, WAES #'s 00091017 and 99102341 are being deleted from our files and the reports consolidated into WAES # 01011360.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dysarthria, Emphysema, Facial palsy, Headache
Clinical narrative: On 9/23/99 and again on 9/26/99, the pt went to an ER "with severe headaches, slurring speech, and drooping mouth." The pt was dx with Bell's Palsy. On 9/27/99, the pt presented to an MD with left side facial drooping, muscle aches and weakness and headaches. On 10/4/99, the pt was seen by an MD and presented with fever, chills, and facial drooping. On 10/21/99, the pt presented to an MD with uncontrollable headaches and slightly improved Bell's Palsy.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pyrexia
Clinical narrative: On 9/23/99 and again on 9/26/99, the pt went to an ER "with severe headaches, slurring speech, and drooping mouth." The pt was dx with Bell's Palsy. On 9/27/99, the pt presented to an MD with left side facial drooping, muscle aches and weakness and headaches. On 10/4/99, the pt was seen by an MD and presented with fever, chills, and facial drooping. On 10/21/99, the pt presented to an MD with uncontrollable headaches and slightly improved Bell's Palsy.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Rash
Clinical narrative: Information has been received from an MD concerning an approximately 40 year old female who was vaccinated IM with the first, second and third dose of Hep B. Subsequently, the pt experienced a rash after the first dose, a "worse" rash after the second dose and was hospitalized overnight after the third dose. Additionally it was noted that the pt had blood work which indicated a negative titer for Hep B.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a pharmacist concerning his 12 year old son who was vaccinated at school with one dose of Hepatitis B IM. Approximately one hour following vaccination, the child's arm became swollen and red at the injection site. The school nurse placed ice on his arm and the swelling subsided. No further information is available.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Injection site reaction, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 2 month old female who in 10/99 was vaccinated with second dose of Hep B. Subsequently, the pt developed brownish discoloration at the injection site with swelling about the size of three silver dollars. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old male pt who was vaccinated with Hep B vaccine IM, in the left deltoid. Twelve hours post vax, the pt experienced wheezing and difficulty breathing. Unspecified medical attention was sought. The symptoms stopped within 3 hours of onset. It was reported that the symptoms were not severe enough to be treated. Follow-up information from a registered nurse reported that the pt recovered "without further complaints of difficulty breathing."
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Serum sickness
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female pt who was vaccinated with Hep B vaccine. Subsequently, during the summer of 1999, the pt developed serum sickness. The pt sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an MD of pharmacy concerning a female pt who was vaccinated wit the 3 dose series of hep B. It was reported that prior to vaccination the pt tested negative for the Hep B core antibody test. Post vax, the pt tested positive for the hep b antibody. Unspecified medical attention was sought. It was reported that the pt did not have nay exposure that she is aware of."  No further information is available.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: The pt's mother reported that the pt experienced discomfort. There has been pain since the day of vaccination. It is not excruciating, however, it is constant and it started that day. It is very uncomfortable. The pt described it as localized to her shoulder. It hurts upon rotation. Unspecified medical attention was sought. It was reported that the pt is going to see an orthopedist.  Follow up information from a physician reported that the pain and aching in the right shoulder began on 5/18/99 and that the pt had "traveled to Guatemala one week after vaccination."  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Hallucination, Headache
Clinical narrative: Within 24 hours of vaccine, the pt developed a fever of 99.8. On 10/28/99 the pt experienced ear pressure, persisting fever and malaise through 11/2/99. On 11/3/99, the pt experienced a runny nose, headache, abdominal pain and diarrhea. The following day, the pt developed a fever of 102, hallucinated and experienced perisistent diarrhea. On 11/8/99, the pt was taken to and urgent care center where she was treated with Biaxin, and Tylenol. On 11/15/99, the pt experienced congestion and other symptoms persistning. Additional information has been requested. Follow up states the patient experienced hip and shoulder pain as well as a swollen left hand.
Sex: F
Vaccine: HEP
Symptoms: Malaise, Nasal congestion, Pyrexia, Rhinorrhoea, Swelling
Clinical narrative: Within 24 hours of vaccine, the pt developed a fever of 99.8. On 10/28/99 the pt experienced ear pressure, persisting fever and malaise through 11/2/99. On 11/3/99, the pt experienced a runny nose, headache, abdominal pain and diarrhea. The following day, the pt developed a fever of 102, hallucinated and experienced perisistent diarrhea. On 11/8/99, the pt was taken to and urgent care center where she was treated with Biaxin, and Tylenol. On 11/15/99, the pt experienced congestion and other symptoms persistning. Additional information has been requested. Follow up states the patient experienced hip and shoulder pain as well as a swollen left hand.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Headache, Pruritus
Clinical narrative: Approximately 12 hours post vax, the pt developed a severe headache, became short of breath and felt like she was having a heart attack. Additionally, the pt experienced itchy arms although she had no rash.  Follow up information from a physician reported that the pt did not seek medical treatment and that approximately 1 1/2 hours later the symptoms resolved with the severe symptoms lasting about 45 minutes.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Retinal disorder, Vitreous floaters
Clinical narrative: ON 11/4/99, the pt experienced "floaters" in her eye. She saw a physician, and a dx of retinal infiltrates was made. Blood tests and chest x-ray were normal. Follow up was received from a physician. The symptoms resolved without medication.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hypoaesthesia, Pain
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who on 11/1/99 was vaccinated with a third dose of Hep B vaccine. The following day, the pt experienced aching in her left arm, back and shoulder and numbness in her fingertips. The pt sought unspecified medical attention. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred, Visual disturbance
Clinical narrative: On 9/3/99, the pt experienced visual disturbances that included blurred vision and "seeing lines." the pt was seen by a physician who performed an ophthalmological and physical exam which were both normal.  pt recovered without treatment.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea
Clinical narrative: Shortly after vaccination the pt experienced a headache and nausea. the pt sought unspecified medical treatment. Subsequently the pt recovered from nausea and reported that she will not be receiving the second vaccination.  No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning an approximately 50 year old male who was vaccinated with "at least nine" doses of Hep B vaccine. Subsequently the pt experienced elevated liver function tests.  No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Movement disorder
Clinical narrative: Information has been received from a registered nurse concerning a female who on 8/23/99 was vaccinated with the 3rd dose of Hep B vaccine in her left arm. On 8/25/99, the pt reported that she was unable to lift her left arm above the shoulder level. It was noted that the pt is employed as a cook and unsure if the pt is seeking disability or if the reaction could actually be an injury."  Follow up information provided indicated that the pt had medical complaints and sought treatment. Can not provide any further details. No further information is available.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia areata, Autoimmune disorder
Clinical narrative: Information has been received from a consumer concerning her 7 year old daughter who in approximately 1994 was vaccinated with Hep B vaccine. It was reported by the mother that in 1994 the child contracted an autoimmune disorder and developed alopecia areata. No further information is available.
Sex: F
Vaccine: HEP, PPV
Symptoms: Asthma, Drug ineffective
Clinical narrative: Information has been received from a health care professional concerning a female consumer who in April, May and October 1991 was vaccinated with Hep B vaccines. On 6/15/92 blood work revealed a negative hep b antibody. In April, June, and November 1963, the pt was again vaccinated with the Hep B vaccine. On 11/16/99 the pt experienced a needle stick at work and was immediately titered which showed nothing. It was noted that during the first series the pt experienced a severe asthma attack requiring treatment with prednisone and that this was thought to interfere with her immune response to the first series. Upon medical review, the pt's asthma attack was considered an "other medical event." Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling jittery, Nasal congestion
Clinical narrative: Ten minutes post vax the pt reported to the school nurse complaining of dizziness, lightheadedness, and congestion. The pt stated that he was jittery and felt like he was having an allergy attack. He was treated with Benadryl, and given orange juice. The nurse stated that there was no rash or acute reaction, no wheezing, his lungs were clear to auscultation, and his skin was warm and dry. He subsequently recovered from his experience. The pt had no problems following the initial dose of hep B vaccine. No further information is available.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Two days following the vaccine, the pt developed a blotchy rash on his face, lips, and body. He sought unspecified medical attention and the rash faded without treatment. Two days after receiving the second dose of Hep B vaccine, the pt developed the same rash. No further information is available.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: The pt experienced a rash all over her body. It was reported that the first two doses of the vaccine were Hep B vaccine and that the pt had developed a reaction following each dose. Unspecified medical attention was sought. It was reported that the rash resolved within several days. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis bullous
Clinical narrative: On approximately 11/25/99, the pt experienced a blister like reaction "which looks like chicken pox." It was noted that the pt experienced a similar reaction after the first and second doses of Hep B vaccine. These reactions occurred within 1-2 days after immunization. The pt sought unspecified medical treatment. Medrol was prescribed for one week for this recent episode. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Approximately seven days following vaccination, the pt developed elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase). The pt sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Hepatic enzyme abnormal
Clinical narrative: Following vaccination the pt experienced elevated liver enzymes. Unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Blood glucose increased
Clinical narrative: The pt experienced increased blood sugar (360). Unspecified medical attention was sought. Follow up information from the pt reported that the vaccine came from another company. Additionally, the pt's blood sugar level went down after one week.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: Post vax, the pt was rejected when giving blood due to the presence of an unspecified antigen. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Injection site haemorrhage
Clinical narrative: A few days post vax, the pt developed bruising at the injection site. On 12/16/99, the pt recevied the second dose of Hep b vaccine and bruised again. She did not seek medical attention. No further information is available.
Sex: F
Vaccine: MEN
Symptoms: Lip ulceration, Mouth ulceration, Petechiae
Clinical narrative: On 8/12/99 it was reported that the pt developed ulceration's on her lip and oral mucosa. The pt also developed petechiae on her arms and back.
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema
Clinical narrative: On 9/9/99, the pt experienced a local reaction of redness the size of a half dollar.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: The pt experienced syncope immediately following the injection.
Age: 37.0
Sex: M
Vaccine: JEV
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Approximately 3 hours post vax, the pt developed bilateral arm weakness, numbness and facial weakness, which lasted 3 hours then, resolved. the pt reportedly was seen in the ER.
Sex: U
Vaccine: HEP, HEPA, JEV, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reportedly sometime after the vaccination,the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Sex: U
Vaccine: HEP, HEPA, JEV, TYP
Symptoms: Rash erythematous
Clinical narrative: Sometime after the vaccination, the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Sex: U
Vaccine: HEP, HEPA, JEV, TYP
Symptoms: Rash erythematous
Clinical narrative: Sometime after the vaccination the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Sex: U
Vaccine: HEP, HEPA, JEV, TYP
Symptoms: Rash erythematous
Clinical narrative: Sometime following the vaccination, the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Sex: U
Vaccine: HEP, HEPA, JEV, TYP
Symptoms: Rash erythematous
Clinical narrative: Reportedly sometime after the vaccination, the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Age: 33.0
Sex: M
Vaccine: JEV, PPV, TD
Symptoms: Headache
Clinical narrative: It was reported that a male pt received JE-VAX, TD and Pneumovax vaccines on July 26, 1999. Reportedly the pt complained of a constant headache after the 1st dose.
Age: 66.0
Sex: F
Vaccine: JEV
Symptoms: Arthralgia, Malaise, Oedema
Clinical narrative: On 10/6/99, the pt experienced joint pain and swelling which had progressed until notification of the MD on 10/11/99. The pt also experienced general malaise. Prednisone was prescribed. Follow up states as of 2-Nov-99, the patient was still ill but better. Reportedly the patient recovered from this experience.
Age: 75.0
Sex: M
Vaccine: JEV
Symptoms: Arthralgia, Gait disturbance, Malaise, Oedema, Pain
Clinical narrative: The pt experienced joint pain and swelling which had progress until notification of an MD on 10/11/99. The pt also experienced general malaise. Prednisone was prescribed. From follow-up info received on 1/28/00, it was reported that four days after receiving vaccination the pt's feet became swollen, red and painful. The pt developed trouble walking. Treatment with Prednisone (as a tapered dose) 20-15-10-5-5 was given. Regression strongly even by 11/2/99, feet were tender, slightly inflamed on toes. The pt reprotedly recovered as of 11/10/99 according to primary doctor. Follow up 9/23/02: during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added rash, pain, and abnormal gait). The AE's were also re-ranked according to their seriousness.
Age: 75.0
Sex: M
Vaccine: JEV
Symptoms: Rash
Clinical narrative: The pt experienced joint pain and swelling which had progress until notification of an MD on 10/11/99. The pt also experienced general malaise. Prednisone was prescribed. From follow-up info received on 1/28/00, it was reported that four days after receiving vaccination the pt's feet became swollen, red and painful. The pt developed trouble walking. Treatment with Prednisone (as a tapered dose) 20-15-10-5-5 was given. Regression strongly even by 11/2/99, feet were tender, slightly inflamed on toes. The pt reprotedly recovered as of 11/10/99 according to primary doctor. Follow up 9/23/02: during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added rash, pain, and abnormal gait). The AE's were also re-ranked according to their seriousness.
Age: 20.0
Sex: M
Vaccine: HEPA, JEVX, MEN
Symptoms: Fatigue, Malaise, Swelling face
Clinical narrative: The pt experienced a puffy face, felt tired and general malaise.
Age: 28.0
Sex: F
Vaccine: JEVX
Symptoms: Urticaria
Clinical narrative: The pt developed hives from her waist to and including her thighs.
Sex: F
Vaccine: TYP
Symptoms: Parotid gland enlargement, Pyrexia
Clinical narrative: It was reported that a female patient received a Typhim Vi vaccination on 11/15/99. Reportedly on 11/19/99, the patient developed swelling of the left parotid gland and a low grade fever.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Pt experienced a large swollen area of warm erythema on both outer thighs. Both approximately 6x6 cm. These appeared 1 day post vax. Pt prescribed Keflex. Resolved before 3/7/00.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, OPV
Symptoms: Infection, Pyrexia, Rhinorrhoea
Clinical narrative: Pt experienced a fever of 102, axillary on 3/21/00 in the evening. A fever of 104.4 the following day 3/22/00. Saw an MD on the next day 3/23/00. Diagnosed with ear infection. Pt experienced a runny nose on 3/24/00. Physician told parents symptom were from MMR.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Pain, Paraesthesia
Clinical narrative: 5 minutes post vax, the pt experienced nausea, dizziness. Stated the arms and legs were hurting, and later arms and legs were numb. Called 911.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Pt developed scattered lesions (approximately 20) representing all 3 stages (lesion, vesicle, crusted vesicle). No fever was experienced.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle disorder, Pain, Paraesthesia, Skin discolouration
Clinical narrative: Pt experienced left arm discoloration, loss of muscle tissue occurred, some stinging/tingling sensation occur regularly. Lidocaine was prescribed.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pt experienced a 10 cm area of pain, tenderness, induration and erythema around injection site.
Age: 34.0
Sex: F
Vaccine: MMR, TTOX
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site mass, Oedema, Pain
Clinical narrative: Pt complained of pain in arm the day of vaccination. Pt also complained of swollen arm. The swelling ceased and the arm quit hurting. On 3/31/00, the arm became swollen again and started hurting with touch. Pt experienced induration, bruising and redness.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site abscess
Clinical narrative: Pt experienced cellulitis right thigh, and abscess / infection at injection site.
Age: 47.0
Sex: M
Vaccine: HEPA, OPV, TD, TYP
Symptoms: Asthenia, Oedema, Pain
Clinical narrative: Pt developed "achy" fingers and toes approximately 2 days after the injection, had difficulty holding a pencil, took ASA and received some relief. Pt continued ASA for the next 2 days with 75% improvement of symptoms. States fingers are less swollen today (4/10/00).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt experienced an area of firmness at injection site 7 x 8 cm area of splotchy redness around injection site. Saw an MD on 4/3/00.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Pt complained of diarrhea, achey joints, flu like symptoms and headache beginning approximately one hour post injection. During the day, the pt reported that the headache improved but she felt tired and sleepy. on 1/20/00 reported diarrhea improving, headache better and complained of intercostal soreness.
Sex: F
Vaccine: HEP
Symptoms: Pain, Somnolence
Clinical narrative: Pt complained of diarrhea, achey joints, flu like symptoms and headache beginning approximately one hour post injection. During the day, the pt reported that the headache improved but she felt tired and sleepy. on 1/20/00 reported diarrhea improving, headache better and complained of intercostal soreness.
Age: 53.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pt was presented with a large 3" x 4" erythema with 30 x 40 mm induration at center of erythema. Skin is reddened, cool and dry to touch. Pt complained of mild pain upon palpation.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site urticaria, Pruritus
Clinical narrative: 3 weeks post vax, pt is complaining itching and soreness. The pt kept scratching and rubbing it. He felt a whelp on it. Onset was 10 days prior. Pt had a large circle on left arm, red with some induration around edge of one side. No infection or drainage. Temperature of 98.6. Pt didn't experience any adverse events with 1st dose.
Age: 28.0
Sex: M
Vaccine: MMR, TD
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: The pt received the TD booster and MMR on 3/28/00 in the same arm. No reaction. 2 days later, a 3" x 3" raised red area, warm to touch, pt denies itching or pain today. The day prior complained of tightness.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt experienced redness, tenderness at area over right arm 24 hours post vax. Treatment is cool compresses and Tylenol.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt experienced redness, warmth, tenderness to left lateral thigh 48 hours post vax.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt experienced redness, tenderness, warmth to the left lateral thigh. Treated with cool compresses and Tylenol.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Pt reports that she developed cellulitis at the site of the injection. This required treatment by her private MD with antibiotics.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blister
Clinical narrative: Pt received the varicella vaccine on 3/8/00. The child returned to the clinic on 3/22/00 with a reaction to the vaccine. Pt experienced vesicles on face and truck.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Pt experienced erythema, tenderness to right arm. Treated with Benadryl.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt experienced erythematous, indurated area on left leg, no discharge. Treated with Keflex for 10 days.
Age: 1.2
Sex: U
Vaccine: DTAP, HIBV, MMR
Symptoms: Dyskinesia
Clinical narrative: 2 days post vax, the pt had 2 quick jerks involving head and trunk to side. She was talking in one episode and she stopped in mid sentence. She had several others.
Age: 1.25
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: 24 hours post vax, the pt developed a swollen, large, red area around the injection site on the left thigh, the size of a softball or larger. Site was red with fever and very firm. All symptoms were gone within 72 hours of the reaction.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: Left anterior thigh 6 cm x 6 cm erythematous area with mild edema and warmth.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Hyperhidrosis, Injection site oedema, Injection site pain, Joint stiffness, Shoulder pain
Clinical narrative: Same day post vax, the pt developed slight swelling, local soreness. That night it became more red and swollen and his shoulder ached. He developed night sweats and stiff shoulder.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Hypokinesia, Pain, Pyrexia, Swelling
Clinical narrative: Three hours post vax, the pt developed swelling, redness, soreness, and irritation. Eight hours post vax, the pt developed fever, chills, and he could hardly move. Twenty hours post vax, the chills were not as bad, but he could hardly move his arm and it was very hot at injection site. Forty-eight hours post vax, the arm was still swollen, red, hot, and sore.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Vasodilation procedure
Clinical narrative: Three hours post vax, the pt developed swelling, redness, soreness, and irritation. Eight hours post vax, the pt developed fever, chills, and he could hardly move. Twenty hours post vax, the chills were not as bad, but he could hardly move his arm and it was very hot at injection site. Forty-eight hours post vax, the arm was still swollen, red, hot, and sore.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Cellulitis, Chills, Headache, Neck pain, Pain
Clinical narrative: Pt had a red streak about 3 inches long running down from her injection site. She also had severe body pain and chills all night. Had to leave work early the day of shot. Still has pain in neck and severe headache. Tylenol did not and still does not help.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Cellulitis, Hyperhidrosis
Clinical narrative: During sleep, sweating off and on throughout the night. Next day had a red line approximately 5 inches going down my arm. Day after that the line extended to elbow.
Age: 44.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dizziness, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pain
Clinical narrative: Fever, body aches, dizziness, swelling, and redness around injection site, chills, light headedness. Left arm sore to touch around injection site. Started feeling better on 4/3/00. Injection site still swollen and sore to touch.
Age: 44.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pyrexia
Clinical narrative: Fever, body aches, dizziness, swelling, and redness around injection site, chills, light headedness. Left arm sore to touch around injection site. Started feeling better on 4/3/00. Injection site still swollen and sore to touch.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Contusion, Erythema, Hypokinesia, Pain
Clinical narrative: Redness and bruising of entire back of left arm. Sore enough to not be able to lift it.
Age: 57.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Aching from shoulder to wrist, at times into shoulder area. Temperature exceeded 100, with redness and swelling in area of shot.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Pt developed swelling of entire left thigh from diaper area to knee without redness or pain lasting 36 hours.
Age: 13.0
Sex: M
Vaccine: DT, VARCEL
Symptoms: Dizziness, Erythema, Headache, Lymphadenopathy, Pain
Clinical narrative: Redness, swelling, and pain. Also, lymphadenopathy, headache, body ache, and dizziness.
Age: 13.0
Sex: M
Vaccine: DT, VARCEL
Symptoms: Swelling
Clinical narrative: Redness, swelling, and pain. Also, lymphadenopathy, headache, body ache, and dizziness.
Age: 12.0
Sex: F
Vaccine: DT, HEP
Symptoms: Hypoaesthesia, Nausea, Pain, Vertigo, Vomiting
Clinical narrative: Nausea, vomiting, and vertigo at approximately 1:30 pm. Rode bus home. Vomited after bus ride. Mother called physician. Gave Advil and felt better by bedtime. No fever, complained of numbness and pain in left arm extending to fingers.
Age: 8.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Decreased appetite, Face oedema, Nausea, Rash
Clinical narrative: Pt received vaccine on 3/10/00 at 9:30 am. at 2:30 PM on same day, the child's developed a rash on her face. The face started swelling around 6:30 PM. Notified MD at the clinic and gave child Benadryl. ON 3/13/00, pt experienced nausea, vomiting, abdominal cramps and poor appetite. On 3/15/00 pt is much better.
Age: 8.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Pt received vaccine on 3/10/00 at 9:30 am. at 2:30 PM on same day, the child's developed a rash on her face. The face started swelling around 6:30 PM. Notified MD at the clinic and gave child Benadryl. ON 3/13/00, pt experienced nausea, vomiting, abdominal cramps and poor appetite. On 3/15/00 pt is much better.
Age: 8.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Anorexia, Face oedema, Nausea, Rash
Clinical narrative: Pt received vaccine on 3/10/00 at 9:30 am. at 2:30 PM on same day, the child's developed a rash on her face. The face started swelling around 6:30 PM. Notified MD at the clinic and gave child Benadryl. ON 3/13/00, pt experienced nausea, vomiting, abdominal cramps and poor appetite. On 3/15/00 pt is much better.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Jaundice, Pyrexia, Wheezing
Clinical narrative: The child received his first injection with Havrix for prophylaxis on 5/10/2000. By that evening, he reportedly became febrile to 100 degrees and had some wheezing. Treated by his mother included Albuterol which relieved his wheezing. He remained mildly febrile for 3 days, but was active. On May 14, 2000, his mother noticed her son appeared to be jaundiced. By May 16, 2000 she thought his jaundice was improving, but on the advice of the health clinic, she brought him to an ER for evaluation. The mother reported her son did not have a tender or palpably enlarged liver during this exam. No blood work was drawn for laboratory analysis at that time. the information received on May 19, 2000 reported the child was not admitted to the hospital and was sent home from the ER.  This report is considered SB medically serious because of the jaundice. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Fatigue, Hepatomegaly, Jaundice, Nausea
Clinical narrative: Approximately seven months post second vax, this 28-year-old pt experienced hepatitis A symptoms including jaundice, swelling of the liver, fever, chills, nausea, fatigue, and tenderness. This report is considered medically serious. The information received on 05/18/2000 reported the symptoms were ongoing.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Tenderness
Clinical narrative: Approximately seven months post second vax, this 28-year-old pt experienced hepatitis A symptoms including jaundice, swelling of the liver, fever, chills, nausea, fatigue, and tenderness. This report is considered medically serious. The information received on 05/18/2000 reported the symptoms were ongoing.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: SIDS. Autopsy shows pulmonary congestion and edema
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Apnoea, Febrile convulsion, Rhinorrhoea
Clinical narrative: Fever on 5/17/2000 PM with possible febrile seizure. 2nd febrile seizure on 5/18/2000. Pt transferred to Medical Center. Also diagnosed with apnea and rhinorrhea.