chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neutropenia, Urticaria
Clinical narrative: Urticaria onset 11/27/02; newtropenia onset 12/8/02 (ANC 300)
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: PT had a flu shot on 11/4/02. That evening, she developed hives on torso and both arms, next day both legs with intense itching. Hives and itching lasted 3 days then subsided. 12/13/02 PT used Aveno lotion - did not go to MD or take antihistamines. Now says hives occurred 48-50 hrs later on 11/6/02. Says this was flu 12 #2.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Oedema
Clinical narrative: Left arm swelling, shot #3 no swelling with the first 2 shots. Dizziness X 24 hrs.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Herpes zoster, Myalgia, Pain, Vasodilation procedure, Viral infection
Clinical narrative: Left arm acute muscular pain radiating down arm to fingers localized and inflammation of area similar to pain & sensitivity of shingles. Rx antiflammatory (Ibuprofen) Coproxinol (pain reliever). Treated 3 hrs from initial injection, take every 6 hrs. Monday morning pain & redness still there. 1-10 scale 10 on Friday 6 Monday morning
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site mass, Oedema, Vasodilation procedure
Clinical narrative: 2nd anthrax injection given on 1/25/03 in right arm. PT has redness and slight swelling from mid-arm to the elbow. Lymph nodes in armpit tender. Moderate hard know at site.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site oedema
Clinical narrative: Major swelling on the right side of the body, where the shot (vax) was given. Including right fec, Lot, tricyte, no node in ???
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Anorexia, Myalgia, Nausea, Pharyngitis
Clinical narrative: Myalgias, nausea, sore throat, loss of appetite
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Ecchymosis, Fatigue, Injection site pain, Vasodilation procedure
Clinical narrative: 1st day - pain at site, no Sx, 2nd day -  ~24 deg cold chills and redness with fatigue, and on 3rd day noticed the bruising.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site abscess, Injection site oedema, Vasodilation procedure
Clinical narrative: Chart reviewed: note dated 5/17/00. PT with local reaction, 10x20 cm of right upper arm included swelling, erythema, heat
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Influenza, Lethargy, Oedema
Clinical narrative: Shot was provided in left arm. Next day redness and swelling from shoulder to bicep, was provided Clariton. 2 days later still red and swelling almost down to elbow. Provided more Clariton and Motrin. PT felt lethargic like flu symptoms. Redness and swelling gone after 1 wk.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Convulsion
Clinical narrative: PT's mother said PT had a seizure in the evening, took daughter to hospital. Called office next day.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RAB
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Mother reports PT to develop "hives" 2 hrs post vax the ??? affecting feet and HE. Mother reports rash would resolve spontaneously only to return. Mother brought PT to ER after noticing lesion to affect entire body. PT with good appearance and acting. (+) no fever & several hours. The follow up states per TC 4/8/03 to MD's office hep B manuf and lot #.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema
Clinical narrative: Right thigh swelling 30 cm. MD prescribed = westcont - apply locally
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Back pain, Chest pain, Face oedema, Headache
Clinical narrative: BAck pain, chest pain, headache, muscle/joint aches, fever 1/31/03 late pm. Blue and purple spots in vision, lip swelling, upper, one side 2/1/03. Went to ER 2/1/03 no treatment given. 3/3/03 appears well.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Myalgia, Pyrexia, Visual disturbance
Clinical narrative: BAck pain, chest pain, headache, muscle/joint aches, fever 1/31/03 late pm. Blue and purple spots in vision, lip swelling, upper, one side 2/1/03. Went to ER 2/1/03 no treatment given. 3/3/03 appears well.
Age: 4.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Woke up 1/31/03 with R arm cellulitis. Entire upper arm red and swollen 18cm long.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Erythema, Eyelid oedema, Pyrexia
Clinical narrative: Redness to face, mild, puffiness to eyelids, uncontrollable crying, fever, documented 101 degrees (after Tylenol was given).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Mother reports that she noticed the swelling Thursday night that starts at the L shoulder and extends to the L elbow with redness and it. warm to touch. Child with 98 deg F temp orally and without any complaints of discomfort. Referred to MD, child's pediatrician.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Mother noted a "lump" on R deltoid area the day following vaccine adm with slight redness-no c/o pain, no fever. Very active and alert-moves arm well. Tel call to mother on 1/16/03 mother states redness and swelling resolved post she applied warm packs.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Approx. 14 hrs after immunizations were adm. mother states she noted hives on elbows which disappeared and post a while, reappeared on another site (L cheeck, L arm, and L wrist) per her put MD's orders, she gave infant 3/4 tsp. Benadryl q 6 hrs. Hives cont. to appear and disappear x 2 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: About 24 hrs following vaccination, mother noted redness to L deltoid area-child did not c/o pain-moves arm without difficulty. Applied warm compresses. Resolved within three days.
Age: 2.3
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Developed red rash (small red area) and low grade fever after vaccination on 1/30/03. Developed symptoms 2/4/03. Red rash over upper trunk front and back.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large area of redness and swelling on outer aspect of R arm. Advised Benadryl as directed and re-check area in 24 hrs (area 7cm x 5cm at recheck-swelling decreased slightly).
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain, Muscular weakness
Clinical narrative: 6cm area of erythema with modest induration approx 5cm distal to injection site 24 hrs post injection. C/O weakness, numbness and tingling in left hand 36 hrs post injection with severe pain at radial and ? pulses intact capillary refill wnl treated with Keflex (antibiotic) and Medrol dose pak (steroid). 2/26/03 weakness improved. Local reaction resolved. Still has numbness and tingling.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: 6cm area of erythema with modest induration approx 5cm distal to injection site 24 hrs post injection. C/O weakness, numbness and tingling in left hand 36 hrs post injection with severe pain at radial and ? pulses intact capillary refill wnl treated with Keflex (antibiotic) and Medrol dose pak (steroid). 2/26/03 weakness improved. Local reaction resolved. Still has numbness and tingling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt was in on 2/24/03 and given DTaP IM R thigh, IPV SQ L thigh upper and MMR SQ L thigh lower. ON 2/25/03 mother called on call nurse after office closed and was told to give Benadryl and to be seen on 2/26/03. Pt came in on 2/26/03 had erythema and heat in a 10.5 c 8cm R upper outer thigh with central puncture.
Age: 73.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling and soreness at site of injection.
Age: 56.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Dyspnoea, Palpitations, Rash, Rash macular
Clinical narrative: #1 injection administered on 1/13/03 10am, 6pm experienced light-headedness, note has a history of dizziness, went to sleep 10pm. Noticed some blotchy areas on both inner ?, went to sleep. 2am-SOB and heart felt racey, next am 9:52 seen in ER, symptoms subsided, rash and still dizzy. No chest or heart discomfort a tthat time. Blotches were fading. Antivert 25mg po administered at 11:10 1/14/03. D/C at 11:25. Note: I was not informed of any reaction until 2/14/03. I had follow up visit with PCP post speaking with me. All complete information just received today 2/26/03.
Age: 56.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Rash
Clinical narrative: #1 injection administered on 1/13/03 10am, 6pm experienced light-headedness, note has a history of dizziness, went to sleep 10pm. Noticed some blotchy areas on both inner ?, went to sleep. 2am-SOB and heart felt racey, next am 9:52 seen in ER, symptoms subsided, rash and still dizzy. No chest or heart discomfort a tthat time. Blotches were fading. Antivert 25mg po administered at 11:10 1/14/03. D/C at 11:25. Note: I was not informed of any reaction until 2/14/03. I had follow up visit with PCP post speaking with me. All complete information just received today 2/26/03.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Faeces pale, Fatigue, Headache, Pharyngeal oedema
Clinical narrative: 2/18/03 2pm lower rt quadrant abdominal pain, headache, low grade fever. 5pm pain in abdomen worsens, headache 99.5 F. 10pm pain severe. 2/19/03 fatigue, 99.5 F, pain abates. 4pm white, chalky stool. 2/20/03 fatigue only. 2/21/03 fatigue only. 2/22/03 99.5, fatigue. 2/23/03 99.5, pain, fatigue, throat feels swollen.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: 2/18/03 2pm lower rt quadrant abdominal pain, headache, low grade fever. 5pm pain in abdomen worsens, headache 99.5 F. 10pm pain severe. 2/19/03 fatigue, 99.5 F, pain abates. 4pm white, chalky stool. 2/20/03 fatigue only. 2/21/03 fatigue only. 2/22/03 99.5, fatigue. 2/23/03 99.5, pain, fatigue, throat feels swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Arm hurt her that afternoon, and most of the next day, red, swollen at the area of injection. As of 2/5/03 she has what feels like a knot, the size of a pimple underneath her skin. Overall she seems fine, although complained of headache. On 2/2 little congested. My question is what/why for the booster did she have a reaction and prior for the DTaP series never had one.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Rash all over body, Ophenydramine 25mg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 1/9/03 Mom called to report swelling and sl. redness R upper arm. Rec'd DTaP, IPV R arm on 1/8/03. To give Tylenol and cool compresses prn. Will come tomorrow to tricep. 1/10/03 4x3.5 cm swelling and sl. redness to R upper outer arm. Mom says more comfortable with Tylenol and cool compresses. 1/21/03 spoke mom on another matter. States swelling gone by next day 1/11/03.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Post Varivax pt had rash on posterior LE (thighs) itching. Also itching at hands and feet.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Loss of consciousness
Clinical narrative: To ER on 1/2/03 after blacking out in car-mom was driving-ER ordered blood panel-wnl. Saw PMD on 1/3/03-"nothing obvious going on." 1/8/03 blacked out in room while talking on phone. Taken to health center. More blood work done-wnl. EEG on 1/13-not conclusive. Reordered EEG done on 1/24/03 wnl. Will see neurologist-appt pending. Has had many episodes of feeling faint/weak. MRI on 1/21/03 also normal. Mom reports pt's father left home within past year. Mom in process of moving our of family home of 10 yrs due to toxic mold.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Pt's mom came in c/o redness and hot to touch are left thigh increased in size. Received immunization 9 days prior. Dx was cellulitis Rx given Augmentin 400mg x 10d. Pt was seen here for the shot reaction. We did not give the immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: C/O swollen, red, hot R arm. To ambulatory clinic 2/20. Celafen 200mg po X 7 days prescribed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Pruritus, Rash erythematous
Clinical narrative: red, raised area 4X6cm R thigh. C/O itching.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Decreased appetite, Dermatitis bullous
Clinical narrative: On Sunday (2/23/03) mom noticed small pox like rash on infants face - looked and found more at site of varicella vaccination. No temp noted. Child's appetite is off, otherwise is playing and normal. now has rash on face, legs and arms.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site rash, Pruritus, Rash
Clinical narrative: Rash started around injection site arm and spread on back and torso, itchy, burning at site area. Duration 5-7 days. Took benadryl 1 tab.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Eye movement disorder, Pyrexia, Tremor
Clinical narrative: Mother reports at 4am 2/20/03, child woke up, but laid back don. At 4:20am he let out a screech, his father picked him up and he had a 30 second episode of shaking and eyes rolling back,911 was called. He was taken to the ER the temp was 103F. Temp decreased with motrin. Home from ER by 8am. Mother states happy and eating.
Age: 3.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Pt developed hives immediately after MMR, DTaP, IPV. shots administered in pt's thighs. No shortness of breath or wheezing noted. Pt doing ok otherwise. No other symptoms. Dr ordered 15mg Oraprid that was given.
Age: 1.52
Sex: M
Vaccine: DTAP, IPV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure.  Treated at ER.  Seizure started @ 6 AM 2/25/03 duration 5 - 10 minutes. Transported by ambulance.  T 103.7 F at time of arrival at hospital.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Injection site swelling, Pyrexia
Clinical narrative: Mother reports high fever after Tylenol (although she never took temperature). Swelling, no redness in bilateral legs and non-stop crying for 3 hours.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX
Symptoms: Injection site induration, Injection site pain, Swelling
Clinical narrative: Approx 30 min after injection pt experienced pain in rt upper arm.  Swollen from elbow to shoulder. Next day this area was very hard and painful. Swollen 2 weeks and pain. Even to today's visit pt still has lots of pain in injection site.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Approx 30 min after injection pt experienced pain in rt upper arm.  Swollen from elbow to shoulder. Next day this area was very hard and painful. Swollen 2 weeks and pain. Even to today's visit pt still has lots of pain in injection site.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cyanosis, Hypotonia
Clinical narrative: 1-2 minutes after vaccine was administered infant became cyanotic  and limp, O2 via bag started. Infant recovered no further treatment administered. Discharged home 1 1/2 hours after vaccine in good health.
Age: 1.4
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Irritability, Urticaria
Clinical narrative: On 1/22 5 PM noted "red and hives", fussy. Did not progress to respiratory signs and symptoms. "Redness & hives" progressed to entire body. Mom contacted Dr who recommended Cortisone cream, applied. Didn't have Benadryl. Seen by Dr on 1/22, Histinex and calamine lotion prescribed. Resolved by 9:20 AM 1/26.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Chills, Decreased appetite, Hypoaesthesia, Injection site pain
Clinical narrative: Seen 02/13/2003 with soreness at injection site X 3 days. Fever, chills, nausea and decreased appetite X 2 days. With generalized abdominal pain X 2 days and numbness whole both arms X 3-4 days.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Nausea, Pyrexia
Clinical narrative: Seen 02/13/2003 with soreness at injection site X 3 days. Fever, chills, nausea and decreased appetite X 2 days. With generalized abdominal pain X 2 days and numbness whole both arms X 3-4 days.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Decreased appetite, Irritability, Pyrexia, Tremor
Clinical narrative: Approximately 1 hr after vaccine administered, child became fussy and whiny, had no appetite. T of 100 degrees F noted 7 hrs after vaccine.  Nine hours after vaccine child began to shake "like spasms" or writhed 3 times. He was taken to the ER, evaluated and sent home.  He remained listless until the ??
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Lymphangitis
Clinical narrative: L arm cellulitis and lymphangitis X 2 days. treated with Keflex.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Injection site reaction, Lymphangitis
Clinical narrative: Left arm peri vaccination cellulitis X 6cm with streaks extending toward axilla (lymphangitis).
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Rash 11/9/02 < 50 (papules, itchy & scabs). PCR - vax strain virus
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Convulsion
Clinical narrative: A nurse reported that a female patient received a dose of Hib-Titer on 1/23/91 at 9 months of age and subsequently developed seizures at 9.5 months of age. The patient was treated with Tegretol. According to the reporter, the patient, now 12 years old, continues to experience seizures. Seizures are considered medically important.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Influenza, Pneumonia
Clinical narrative: A mother reporter that her 15 month old daughter received her fourth dose of Hib-Titer on 3/2/01. Subsequently, at the age of 30 months and with a history of several bouts of pneumonia and flu, the child did not have a normal antibody response to Hib-Titer. The reporter noted that her daughter's level was specified as intermediate. No further information was available at the date of this report.  Follow up on 06/17/2003: "From initial information received on 02/12/2003, it was reported that a 2-month-old female patient received first doses of ACTHIB, (UA772AA), given in the left leg, IPOL (W0332), given in the right leg, TRIPEDIA (U0845DA), given i the left leg, and PCV-7 (489749), given in the right leg at 16:30 on 01/06/2003.  On 01/10/2003, patient experienced poor appetite, poor feeding, poor sucking, fussiness, developed excess secretions - possibly upper respiratory infection, hypotonia, a weak cry and was lethergic.  Patient was hospitalized on 01/18/2003.  It was reported that the patient did not recover.  Patient's lab/diagnostic tests for metabolic, infectious and neurologic work ups were all negative.  Patient's botulism toxin was reported to be pending.  Patient also received 2nd dose of HBV, (5366D2), given in the left leg on 11/07/2002.  It was reported that the patient had no illnesses was nottaking any medication, or had any pre-existing diagnoses at time of vaccination.  From additional information received on 06/04/2003 from the reporting physician, it was reported that the "patient proved to have botulism, is regaining some milestones, but still has po difficulty".  No further information was provided at this time.
Sex: U
Vaccine: HIBV
Symptoms: Malaise
Clinical narrative: A pharmacy technician reported that an adult patient who had undergone a bone marrow transplantation received an injection of Hib-TITER along with other unspecified vaccines and subsequently complained of feeling sick and crummy. No further information was available at the date of this report.
Age: 1.7
Sex: M
Vaccine: HIBV
Symptoms: Speech disorder
Clinical narrative: A mother reported that her 20 month old son received his third dose of Hib-Titer on 3/27/00. On an unspecified date the mother reported that the child developed delayed speech and feels that this could be due to a vaccine he received as an infant. No further information was available at the date of this report.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: A physician reported via a company representative that a 15 month old female received an injection of Hib-TITER vaccine and subsequently developed an injection site reaction on her right thigh characterized by a 6cm by 8cm area of redness, warmth, and a lump. No further information was available at the date of this report.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, HIBV, PNC
Symptoms: Injection site rash, Injection site reaction, Rash papular
Clinical narrative: A physician's assistant reported that a 7 month old male received a 1st dose of Hib-TITER and Infanrix vaccines on 7/12/02, in his left thigh. He also received a 1st dose of Prevnar vaccine in his right thigh on 7/12/02. Following the injection, the child developed a localized reaction of red bumps with papules, 4cm in size, on his left thigh. No further information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Additional info was received on 7/10/02 from a healthcare provider regarding concomitant vaccines, an adverse event and event outcome. A nurse reported that a 2 month old male inadvertently received a dose of Hib-TITER and ACT-HIB vaccines at the same visit (date not specified). Concomitant vaccines of DTaP and IPV vaccines were also administered. The infant developed a fever of 101.4 degrees C. He was examined by the physician the following day and "was fine." The original report was received from manufacturer.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Injection site oedema, Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 6 month old female. She received her second injection of Hib-titer vaccine on 7/17/02. On 7/19/02, she experienced a local rash and swelling at the site of administration. On 7/22/02, she developed a diffuse rash over entire body with hives. She also experienced a tactile fever. She was seen in the physician's office and treated with diphenhydramine. No lab tests were done.
Age: 32.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Headache, Infection parasitic, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Report A0372018A describes Lyme disease in a 32 year old female who received Lyme disease vaccine recombinant OspA. This report was received from the vaccinee and has not been verified by a physician or other health care professional. Medical history and concurrent conditions were not specified. Concurrent medications included Synthroid and "Cetemil." The vaccinee reported that she received the third injection of LYMErix was administered in March 2000. In March 2000, post-immunization, the vaccinee experienced fatigue and stiffening in joints and muscles. "Prior to January 2002 but after March 2000," the vaccinee experienced swollen glands. In January 2002, she began to experience headaches, sore throats, and nausea. The vaccinee was seen by a physician. She stated that an unspecified test for Lyme disease was positive on 6/4/02. The physician reportedly made a diagnosis of Lyme disease and prescribed doxycycline. As of 6/18/02, the stiff muscles and joints and fatigue were worse. The swollen glands, nausea, headaches, and sore throats persisted.
Age: 32.0
Sex: F
Vaccine: LYME
Symptoms: Nausea, Oedema, Pharyngolaryngeal pain
Clinical narrative: Report A0372018A describes Lyme disease in a 32 year old female who received Lyme disease vaccine recombinant OspA. This report was received from the vaccinee and has not been verified by a physician or other health care professional. Medical history and concurrent conditions were not specified. Concurrent medications included Synthroid and "Cetemil." The vaccinee reported that she received the third injection of LYMErix was administered in March 2000. In March 2000, post-immunization, the vaccinee experienced fatigue and stiffening in joints and muscles. "Prior to January 2002 but after March 2000," the vaccinee experienced swollen glands. In January 2002, she began to experience headaches, sore throats, and nausea. The vaccinee was seen by a physician. She stated that an unspecified test for Lyme disease was positive on 6/4/02. The physician reportedly made a diagnosis of Lyme disease and prescribed doxycycline. As of 6/18/02, the stiff muscles and joints and fatigue were worse. The swollen glands, nausea, headaches, and sore throats persisted.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Balance disorder, Disorientation, Infection parasitic, Visual disturbance
Clinical narrative: Report A0372355A describes Lyme disease in a 48 year old female who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were unknown. In July 2000, the subject reportedly received her third injection of LYMErix. The subject stated that during the last six months she has been having vision problems "losing vision, equilibrium is terrible, have tendency to fall." She stated that she was "disoriented" and "living in a fog." She stated that she had MRI performed which indicated "11 or more brain lesions." She stated that her physician has "ruled out multiple sclerosis." She stated that her physician stated that her tests NOS indicated that she had "Lyme disease." As of 6/20/02, the events were ongoing.
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Muscle spasms
Clinical narrative: Report A0376618A describes leg cramping in a 64 year old male who received Lyme disease vaccine recombinant OspA for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional. There was no reported medical history, concurrent conditions, or concurrent medications. In 2000, the subject reportedly received his first "intravenous" LYMErix injection. He stated that during mid-summer 2000, 12 hours post-immunization, and after flying to his vacation destination, he "was walking down the beach and noticed that his legs were cramping. The subject reported he needed to sit down due to the cramping which was described as "sudden and went away quickly." The subject did not continue the LYMErix immunization series. He indicated that his physician never informed him that the LYMErix immunization series consisted of three injections.
Sex: F
Vaccine: LYME
Symptoms: Infection parasitic, Rash
Clinical narrative: This report describes the occurrence of Lyme disease in an adult female of unspecified age who was vaccinated with Lyme disease vaccine recombiannt OspA. This report was received from the subject and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not specified. Reportedly, the subject received the LYMErix immunization series three years ago. According to the subject, during the summer of 2002, she "found a tick on me several weeks ago." She noted a "bull's eye" rash around the bite several days later. She stated, "I have developed Lyme disease." The subject stated that she "had to limit my time in the sum. For the past few weeks, I have not been able to garden or go to the beach." The subject reported she was treated with a three week course of an unspecified antibiotic. She further reported that an unspecified blood test obtained after antibiotic therapy "proved negative" for Lyme disease.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Infection parasitic, Laboratory test abnormal
Clinical narrative: This report describes the occurrence of Lyme disease in a 48 year old female who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. This report was received from the subject and has been verified by a physician assistant. The subject's medical history reportedly included Lyme disease, for which she "took the appropriate antibiotics." The subject smoked less than one-half pack of cigarettes per day. The subject experienced no adverse events following previous immunizations. On unspecified dates, the subject received two injections of LYMErix. The subject reported, "I recently contracted the Lyme disease again." The physician assistant reported that the subject contracted Lyme disease in August 2001, with "positive confirmatory labs." The Lyme disease resolved on an unspecified date.
Age: 73.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Hyperhidrosis, Influenza like illness, Memory impairment, Vision blurred
Clinical narrative: This report describes the occurrence of memory impairments in an adult male of unspecified age who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's medical history included allergy to Lescol; allergic rhinitis; 40+ pack-years of tobacco use; occupational asbestos and coal exposure; rectal polyp; diverticulosis; constipation; pneumonia (February 1999); pericarditis; atypical chest pain; chronic obstructiv epulmonary disease; hypercholesterolemia; bilateral medial carpal tunnel neuropathies 91992); bilateral ulnar neuropathies at the elbows and wrists (1992); bilateral neuropathic involvement of both the upper and lower plexus components (1992); bilateral Dupuytren's contractures (1992); degenerative joint disease in both hands and wrists (1993); "mild" degenerative joint disease of the cervical spine (1992); "minimal" disc space narrowing  at C4-5, C5-6 and C6-7 (1994); and foraminal narrowing of the lower cervical spine (1994). Surgical history included tonsillectomy with adenoidectomy as a child, excision of Dupuytren's contracture of the right hand (1992), decompression of the right median nerve (1992), decompression of the ulnar nerve (1992), "extensive" mesoepineurolysis of the median nerve, extensor flexor tenosynovectomy of the right carpal canal (1992), decompression of the ulnar artery and palmar arch (1992), neurolysis of the neurovascular bundles of the right fourth finger (1992), mesoepineurolysis of the distal branches of the ulner nerve (1994), excision of Dupuytren's contacture of the left palm (1994), and lysis of the palmar arch (1994). Concurrent medications were not specified. The subject reportedly received LYMErix, the number of injections administered and the dates of administration were not reported. On 24 september 2002, in a Statement of Injuries, the subject's attorney alleged that the subject "suffers from joint pain, muscle weakness and cramps. He also suffers from flu-like symptoms, fatigue, sweats, blurred vision, memory impairments and driving difficulties." Time to onset following immunization, treatment, and outcomes of these events were not reported. This subject's spouse allegedly experienced arthralgias, fatigue, pain, sweating, foot swelling, leg cramping and numbness following receipt of LYMErix (A0369261A).
Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Anxiety, Arthralgia, Back pain, Balance disorder
Clinical narrative: The pt received Lymerix on 6/12/99 (LY120E9) and 7/17/99 (LY120E9). In a Statement of Injuries, the pt's attorney alleged that the pt "suffers from a multitude of neuro-cognitive changes, including but no limited to, memory loss, lack of concentration, headaches, lightheadedness, confusion, difficulty with spacial orientation, balance problems, blurry vision and dry eyes". He also suffers from joint pain in his knees and fatigue. His symptoms began in 2/00 and gradually have worsened. He noted he had Lyme disease and was IgM positive and IgG negative for Western blot testing. He was treated with doxycycline 100mg twice daily for 1 month and was recently changed to amoxicillin and probenecid. Intermittently, he feels a burning sensation across his shoulders and a slight stiffness in his neck. He may have slight dizziness described as slight problems similar to a boat moving. The pt was seen by an infectious disease expert who, according to the pt, believed that he had Lyme disease. He had a normal neurological exam. During the course of doxycycline, he removed a tick from under his right arm in early August. He was also seen by a neurologist. From 9/25/00 to at least 4/22/02, the pt was under the care of a physician. He reported that he experienced visual problems, perceptual change, lightheadedness, trouble focusing, tiredness, fatigue, dry eye, lack of focus, strange nagging pain in his back, "spacey", emotionally worse, vertigo, fuzzy, cognitive problems, "balance", "disconnect", general dulling of senses, joint pain, exhausted nor refreshed, pt dropped 15 pounds and his "line broke, line leaking-3rd line". The physician also noted he was "off meds due to liver" and that he was "anxious/psychologic/OCD. Taken off (sic)". Additionally, The physician prescribed intramuscular bacillin, intramuscular tinidazole, elvil, sertraline hydrochloride (Zoloft), cholestyramine and IV Zithromax. He was found to have Lyme disease in the blood. Apparently he had this repeated and it was still positive and he had a neurological exam and a lumbar puncture was unrevealing. He has had multiple treatment for his Lyme disease and he is currently on IV Rocephin. The physician prescribed neutral density filters for his computer to help with flickering. Following the reported onset of blurred vision, the subject experienced thrush. This event was not reported as adverse event due to vaccine administration but was found during the course of review of the pt's medical records. The most recent information received on 9/26/02, did not provide the outcomes of the reported events.  Follow up on 02/27/04: "The most recent information, received on 06/30/03, did not provide the outcomes of the reported events."
Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Disturbance in attention, Dizziness, Dry eye, Fatigue, Headache
Clinical narrative: The pt received Lymerix on 6/12/99 (LY120E9) and 7/17/99 (LY120E9). In a Statement of Injuries, the pt's attorney alleged that the pt "suffers from a multitude of neuro-cognitive changes, including but no limited to, memory loss, lack of concentration, headaches, lightheadedness, confusion, difficulty with spacial orientation, balance problems, blurry vision and dry eyes". He also suffers from joint pain in his knees and fatigue. His symptoms began in 2/00 and gradually have worsened. He noted he had Lyme disease and was IgM positive and IgG negative for Western blot testing. He was treated with doxycycline 100mg twice daily for 1 month and was recently changed to amoxicillin and probenecid. Intermittently, he feels a burning sensation across his shoulders and a slight stiffness in his neck. He may have slight dizziness described as slight problems similar to a boat moving. The pt was seen by an infectious disease expert who, according to the pt, believed that he had Lyme disease. He had a normal neurological exam. During the course of doxycycline, he removed a tick from under his right arm in early August. He was also seen by a neurologist. From 9/25/00 to at least 4/22/02, the pt was under the care of a physician. He reported that he experienced visual problems, perceptual change, lightheadedness, trouble focusing, tiredness, fatigue, dry eye, lack of focus, strange nagging pain in his back, "spacey", emotionally worse, vertigo, fuzzy, cognitive problems, "balance", "disconnect", general dulling of senses, joint pain, exhausted nor refreshed, pt dropped 15 pounds and his "line broke, line leaking-3rd line". The physician also noted he was "off meds due to liver" and that he was "anxious/psychologic/OCD. Taken off (sic)". Additionally, The physician prescribed intramuscular bacillin, intramuscular tinidazole, elvil, sertraline hydrochloride (Zoloft), cholestyramine and IV Zithromax. He was found to have Lyme disease in the blood. Apparently he had this repeated and it was still positive and he had a neurological exam and a lumbar puncture was unrevealing. He has had multiple treatment for his Lyme disease and he is currently on IV Rocephin. The physician prescribed neutral density filters for his computer to help with flickering. Following the reported onset of blurred vision, the subject experienced thrush. This event was not reported as adverse event due to vaccine administration but was found during the course of review of the pt's medical records. The most recent information received on 9/26/02, did not provide the outcomes of the reported events.  Follow up on 02/27/04: "The most recent information, received on 06/30/03, did not provide the outcomes of the reported events."
Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Infection, Malaise, Musculoskeletal stiffness, Vision blurred, Weight decreased
Clinical narrative: The pt received Lymerix on 6/12/99 (LY120E9) and 7/17/99 (LY120E9). In a Statement of Injuries, the pt's attorney alleged that the pt "suffers from a multitude of neuro-cognitive changes, including but no limited to, memory loss, lack of concentration, headaches, lightheadedness, confusion, difficulty with spacial orientation, balance problems, blurry vision and dry eyes". He also suffers from joint pain in his knees and fatigue. His symptoms began in 2/00 and gradually have worsened. He noted he had Lyme disease and was IgM positive and IgG negative for Western blot testing. He was treated with doxycycline 100mg twice daily for 1 month and was recently changed to amoxicillin and probenecid. Intermittently, he feels a burning sensation across his shoulders and a slight stiffness in his neck. He may have slight dizziness described as slight problems similar to a boat moving. The pt was seen by an infectious disease expert who, according to the pt, believed that he had Lyme disease. He had a normal neurological exam. During the course of doxycycline, he removed a tick from under his right arm in early August. He was also seen by a neurologist. From 9/25/00 to at least 4/22/02, the pt was under the care of a physician. He reported that he experienced visual problems, perceptual change, lightheadedness, trouble focusing, tiredness, fatigue, dry eye, lack of focus, strange nagging pain in his back, "spacey", emotionally worse, vertigo, fuzzy, cognitive problems, "balance", "disconnect", general dulling of senses, joint pain, exhausted nor refreshed, pt dropped 15 pounds and his "line broke, line leaking-3rd line". The physician also noted he was "off meds due to liver" and that he was "anxious/psychologic/OCD. Taken off (sic)". Additionally, The physician prescribed intramuscular bacillin, intramuscular tinidazole, elvil, sertraline hydrochloride (Zoloft), cholestyramine and IV Zithromax. He was found to have Lyme disease in the blood. Apparently he had this repeated and it was still positive and he had a neurological exam and a lumbar puncture was unrevealing. He has had multiple treatment for his Lyme disease and he is currently on IV Rocephin. The physician prescribed neutral density filters for his computer to help with flickering. Following the reported onset of blurred vision, the subject experienced thrush. This event was not reported as adverse event due to vaccine administration but was found during the course of review of the pt's medical records. The most recent information received on 9/26/02, did not provide the outcomes of the reported events.  Follow up on 02/27/04: "The most recent information, received on 06/30/03, did not provide the outcomes of the reported events."
Sex: M
Vaccine: LYME
Symptoms: Infection parasitic
Clinical narrative: This report describes the occurrence of Lyme disease in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant for prophylaxis. This report was received from the subject and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditoins and concurrent medications were not reported. On an unspecified date, the subject received his first injection of LYMErix. At an unspecified time post-immunization, an unspecified Lyme disease test reflected a "positive" result.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This report describes joint pain in a 31 year old female who was vaccinated with Lyme disease vaccine recombinant for prophylaxis. This report was received from the subject and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions and concurrent medications were not provided. On 6/9/99, she reportedly received her second injection of LYMErix. The subject stated that, later that day, she began to experience "extreme" joint pain. She reported that she was seen by a physician. The subject stated that the joint pain persisted as of 11/11/02, but had "improved." The LYMErix immunization series was discontinued.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Abasia, Infection parasitic, Laboratory test abnormal
Clinical narrative: This report describes the occurrence of Lyme disease in a 40 year old female who was vaccinated with Lyme disease vaccine recombinant for prophylaxis. This report was received from the subject and has not been verified by a physician or other health care professional. The subject "suspected" that she had Lyme disease in 1990 and "it took a very long time" for her to recover. Concurrent medications were not reported. On an unspecified date, the subject reportedly received her third LYMErix injection. Reportedly, the third LYMErix injection "caused her to contract Lyme disease again." The subject stated that she "could hardly walk due to the Lyme disease." She was seen by her physician, who ordered Lyme serology. According to the subject, Lyme western blot was positive for 30 and 31 kD bands. The subject declined to provide additional info and declined to grant authorization to manufacturer to contact her physician for additional info.
Sex: M
Vaccine: LYME
Symptoms: Headache, Infection parasitic
Clinical narrative: This report describes the occurrence of Lyme disease in an adult male of unspecified age who was vaccinated with Lyme disease vaccine recombinant. This report was received from the subject and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Reportedly, the subject received his third injection of LYMErix in May 2000. He stated, "Shortly thereafter, I contracted full-blown Lyme and I have been dealing with symptoms of chronic Lyme ever since." He has reportedly been treated with tetracycline 1500mg daily. The subject stated that "regular cluster headaches persist." The subject reported that he was unable to work "as the result of these problems." Therefore, the events are considered persistently incapacitating.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This report describes the occurrence of migratory arthralgias in an adult male of unspecified age who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings involving the subject's spouse. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject reportedly received an injection of LYMErix. The subject's spouse also received LYMErix, and experienced adverse events (A0382469A). In the spouse's medical records from a neurologist dated 2/4/02, the neurologist noted, "her husband received the Lyme vaccine three years ago, following which he developed migratory arthralgias." Time to onset following immunization, treatment, and outcome were not specified.
Age: 50.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Oedema, Skin ulcer
Clinical narrative: Developed satellite lesion on left arm below original vaccination site and two red areas right side of face on 03-02-03 after smallpox vaccination.
Age: 50.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Vaccination complication
Clinical narrative: Developed satellite lesion on left arm below original vaccination site and two red areas right side of face on 03-02-03 after smallpox vaccination.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Autoinnoculation next to primary smallpox vaccination, secondary to tape reaction.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis bullous, Erythema multiforme, Rash erythematous
Clinical narrative: I saw the eruption after it was beginning to resolve. From the initial description, it was bullae on erythematous plaques, consistent with a bullous erythema multiforme, or bullous drug eruption. This eruption began 2 to 2.5 weeks after smallpox vaccination. Eruption decreased after 4 days of prednisone.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Eczema, Headache, Malaise, Rash
Clinical narrative: Pt received 3rd anthrax dose on 20 Feb 03 in right upper arm.  Now c/o of eczema-like dermatitis of back of her neck , headache and malaise for 6 days.  Pt afebrile, no finding at the injection site.  Vital signs are stable.  Symptomatic treatment provided with topical steroids for the skin rash and NSAIDS for headache.  Close f/u recommended in the 24-48-72 hours.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pustule, Pyrexia
Clinical narrative: Second pustule formed 2 inches from original site. Fever
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Generalized flat rash - treated with Atarax
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site oedema, Lymphadenopathy
Clinical narrative: Slight swelling of inoculation site with ?? long lymphadenopathy in that arm only.
Age: 50.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Feeling hot, Muscular weakness, Pain, Tendon disorder
Clinical narrative: Three day post shot L arm-tenderness in arm. Whole length of arm-warm sensation, pins and needles, feels very weak.
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right arm erythema/edema on post inoculation day 1
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Autoinnoculation site, about 2cm away from primary smallpox vaccination site - likely secondary to tape reaction.
Age: 29.0
Sex: M
Vaccine: MMR, SMALL
Symptoms: Vaccination complication
Clinical narrative: Tape reaction from bandage with resultant secondary innoculation site about one inch distal from primary smallpox immunization site.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: Small red, itchy bumps that came and went in crops. Non-pustular, no scarring. Symptoms improved with Claritin and have resolved.
Age: 50.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pruritus
Clinical narrative: Chills, nausea, fatigue, body aches, "itchy" sensation. Symptoms resolved after 4 days w/out intersection except symptomatic treatment (Motrin, anti-emetic)
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Acne, Cow pox
Clinical narrative: Vaccinia spread to pimple on arm
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Immunization provided 2/28/03, presented back to clinic 3/3/03 with c/o red, swollen left leg.  Father stated after immunization leg became red with swollen area, reddness increased to cover anterior and medial aspect of leg.  Pt. was taken to the ED over the weekend, prescribed steroid and antibiotic.  Upon presentation to clinic on 3/3/03, child does not c/o pain, left thigh red, warm to touch, reddness extends from groin to knee and medial.  Measures 7 1/2 in in length, 7 in in width.