chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Anorexia, Headache, Pain, Photophobia, Pyrexia
Clinical narrative: 1 day post smallpox vaccine patient developed severe headache, body aches, fever and loss of appetite.  Was hospitalized for 3 days and received lumbar punture, blood work, IV fluids, and brain MRI  60 day follow up states pt has not recovered. Continued chronic daily headache with photophobia.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Headache, Photophobia, Pyrexia, White blood cell count increased
Clinical narrative: 1 day post smallpox vaccine patient developed severe headache, body aches, fever and loss of appetite.  Was hospitalized for 3 days and received lumbar punture, blood work, IV fluids, and brain MRI  60 day follow up states pt has not recovered. Continued chronic daily headache with photophobia.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Bacterial infection, Erythema, Feeling hot
Clinical narrative: 2-25-03-Report came into Health Dept. of possible bacterial infection from site. Patient reports an area which is red, swollen, and hot approx. 2-3 cm. from actual site. Recommendation made to vary the position of the gauze and opsite. Also to culture the site before starting on any antibiotics. 2-27-03-Call back made to patient. She states that after varying the position of the gauze and opsite, the symptoms resolved overnight and she did not do the culture or take antibiotics.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pityriasis rosea, Pruritus, Rash papular
Clinical narrative: Erythematous papules - upper extremities, chest, back - following skin fold, positive pruritus - seen by a dermatologist. Clinically Pityriasis Rosea
Age: 45.0
Sex: F
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Lymphadenopathy, Rash pustular
Clinical narrative: "Husband" received Dryvax on 2/10/03. Area on husband's wife (subject of this report) appeared 2/17/03. A single, slight tender pustule about 3 mm, with a concave center, appeared at right wrist. Developed swollen LN's on 2/14/03 submandibular area 12-24 deg. No other rash noted.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Myalgia, Pyrexia, Rash, Rash papular
Clinical narrative: PT developed fever and myalgias 5 days subsequent to vax. 7 day post vax developed papular trunkal eruption. Rash waxed and waxes over next 10 days w/few vesicles. All symptoms stopped on 21st day when scab fell off.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Lymphangitis
Clinical narrative: Cellulitis with lymphangitis. Treated with 5 days of Hevoquin (500mg daily).
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Vaccination complication
Clinical narrative: Possible self-innoculation to right collarbone.  Very limited, single pustule, with bordering erythema.
Sex: U
Vaccine: SMALL
Symptoms: Chest pain, Laboratory test abnormal, Pain, Pain in jaw
Clinical narrative: Jaw pain radiating to head and chest
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Asthenia, Dizziness, Encephalitis, Headache, Hypoaesthesia
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Laboratory test abnormal, Neck pain, Pyrexia, Syncope, Urinary retention
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Difficulty in walking, Encephalitis, Headache, Hypoaesthesia, Infection parasitic
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Laboratory test abnormal, Micturition urgency, Pharyngolaryngeal pain, Pyrexia, Sensory disturbance
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Urinary retention
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Asthenia, Depressed level of consciousness, Difficulty in walking, Encephalitis, Headache
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH, FLUX, HEP, HEPA, IPV, MMR, TYP, YF, ANTH, HEP, HEPA, MMR, VARCEL, YF
Symptoms: Hypoaesthesia, Laboratory test abnormal, Pharyngolaryngeal pain, Pyrexia, Urinary retention
Clinical narrative: On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: PT RECIEVED HIS 5TH ANTHRAX VACCINE ON 9 JAN 03. PT DEVELOPED A FEVER WITH A TEMP OF APPROX 102, BY SUBJECTIVE FOR A COUPLE OF DAYS. fEVERS DISAPPEARED. PT BEGAN TO HAVE SLOUGHING OF EPIDERMIS ON BOTTOM OF RIGHT AND HAND, NO OTHER AREAS WERE AFFECTED. PT WAS TX'D ON 27 JAN 03 WHEN HE REPORTED TO THE BMC FOR EXAMINATION. TX'D WITH EUCERIN CREAM TID TO AFFECTED AREA WITH GOOD RESULTS. NO SPECIFIC CAUSE FOR CONDITION IS NOTED, QUESTIONABLE REACTION TO VACCINE.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site oedema, Injection site warmth
Clinical narrative: SWOLLEN AND HOT TO THE TOUCH LEFT TRICEP.  DIAGNOSED WITH CELLULITS BY AN E.R. PHYSICIAN. GIVEN IM SHOT OF ANCEF AND 20 DAYS AUGMENTIN.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Splashed smallpox vaccine in eyes while preparing vaccine for administration to soldiers. Sent to TMV and was given viroptic eye drops and has an ophtho appointment.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Cow pox, Headache, Lymphadenopathy, Rash
Clinical narrative: General vaccinia, sores in mouth, swollen lymph nodes, cellulitis of site, severe headache, rash to back and face.  Given in ER, Ancef 1 gram IV, Decadron 4 mg IM, Depromedrol 80mg IM. Keflex 500 mg to go (script), Darvocet (script), Benadryl, Medrol dose pack to go.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Pt. had a sore throat was seen by local Dr. in the office diagnosis viral pharyngitis. Dr. visit was on 2-11-2003.
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Eye oedema, Feeling abnormal
Clinical narrative: On 2.27.03 patient felt her eyes were puffy @ 1030.  She took benadryl 25mg po.  At 1130 wen out side x 30minutes.  Started to feel "funny" inside.  she returned to the building sat down and 911 was called.  BP 140/80.  In the Rmergency room reseived IV Tagamet, Benadryl and Solu medrol.  Good relief of symptoms.  Home to with benadryl.  will see MD in the am for follow-up.  The pollen count and the red tide are documented to be very high today.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Cough, Erythema, Eye disorder, Pruritus
Clinical narrative: Eye lids from  10mm from inner corner of eyes and 1/16 of an inch below lid looks like light red eye liner both upper and lower lids.  Left is more pronounced than the right. The reddened area is slightly raised.  Patient states it itches at times.  Patient states awoke this morning with this. Today is Thursday.  On sunday he pateint was walking the beach and had to leave based on coughing and itching eyes from the heavy red tide.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Anorexia, Hypotonia, Somnolence
Clinical narrative: It was reported that a 2 month old female pt received first dose of ACTHIB, UA772AA, given in the left leg, IPOL, W0332, given in the right leg, TRIPEDIA, U0845DA, given in the left leg and PCV-7, 489749, given in the right leg at 4:30pm on 1/6/03. On 1/10/03, pt experienced poor appetite, poor feeding, poor sucking, fussiness, developed excess secretions-possibly upper respiratory infection, hypotonia, a weak cry and was lethargic. Pt was hospitalized on 1/18/03. It was reported that the pt did not recover. Pt's lab/diagnostic tests for metabolic, infectious and neurologic work ups were all negative. Pt's botulism toxin was reported to be pending. It was reported that the pt had no illnesses, was not taking any medication, or had any pre-existing diagnoses at time of vaccination.  Follow up on 07/17/2003: "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.  From additional information received on 07/08/2003 from the reporting physician, it was reported that the patient was diagnosed with Botulism Type A on 02/13/2003.  The patient continues with poor oral intake and remains on tube feedins via gastrostomy tube.  Slow recovery of milestones are noted to date.  Also provided was the dates of hospitalization (from 01/18/2003 to 01/22/2003) and route of administration of each vaccine.  No additional information is expected.  Case is closed.  On 07/08/2003, the patient was reported as not recovered." A 15-day follow up report received 8/8/2003 adds: From additional info received via telephone from the reporting physician on 07/31/2003, it was reported that the botulism was diagnosed using a stool sample from the pt. A stool culture and isolation, toxin detection and toxin type were performed. Additionally, a mouse toxicity test, rapid ANA, fatty acid profile, GLC and gram stain were performed from the sample. The specific specimen used to demonstrate the botulism toxin was stool. The tests were positive for botulism. No additional info is expected. Case is closed.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Asthenia, Decreased appetite, Hypotonia, Irritability
Clinical narrative: It was reported that a 2 month old female pt received first dose of ACTHIB, UA772AA, given in the left leg, IPOL, W0332, given in the right leg, TRIPEDIA, U0845DA, given in the left leg and PCV-7, 489749, given in the right leg at 4:30pm on 1/6/03. On 1/10/03, pt experienced poor appetite, poor feeding, poor sucking, fussiness, developed excess secretions-possibly upper respiratory infection, hypotonia, a weak cry and was lethargic. Pt was hospitalized on 1/18/03. It was reported that the pt did not recover. Pt's lab/diagnostic tests for metabolic, infectious and neurologic work ups were all negative. Pt's botulism toxin was reported to be pending. It was reported that the pt had no illnesses, was not taking any medication, or had any pre-existing diagnoses at time of vaccination.  Follow up on 07/17/2003: "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.  From additional information received on 07/08/2003 from the reporting physician, it was reported that the patient was diagnosed with Botulism Type A on 02/13/2003.  The patient continues with poor oral intake and remains on tube feedins via gastrostomy tube.  Slow recovery of milestones are noted to date.  Also provided was the dates of hospitalization (from 01/18/2003 to 01/22/2003) and route of administration of each vaccine.  No additional information is expected.  Case is closed.  On 07/08/2003, the patient was reported as not recovered." A 15-day follow up report received 8/8/2003 adds: From additional info received via telephone from the reporting physician on 07/31/2003, it was reported that the botulism was diagnosed using a stool sample from the pt. A stool culture and isolation, toxin detection and toxin type were performed. Additionally, a mouse toxicity test, rapid ANA, fatty acid profile, GLC and gram stain were performed from the sample. The specific specimen used to demonstrate the botulism toxin was stool. The tests were positive for botulism. No additional info is expected. Case is closed.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Lethargy, Respiratory disorder
Clinical narrative: It was reported that a 2 month old female pt received first dose of ACTHIB, UA772AA, given in the left leg, IPOL, W0332, given in the right leg, TRIPEDIA, U0845DA, given in the left leg and PCV-7, 489749, given in the right leg at 4:30pm on 1/6/03. On 1/10/03, pt experienced poor appetite, poor feeding, poor sucking, fussiness, developed excess secretions-possibly upper respiratory infection, hypotonia, a weak cry and was lethargic. Pt was hospitalized on 1/18/03. It was reported that the pt did not recover. Pt's lab/diagnostic tests for metabolic, infectious and neurologic work ups were all negative. Pt's botulism toxin was reported to be pending. It was reported that the pt had no illnesses, was not taking any medication, or had any pre-existing diagnoses at time of vaccination.  Follow up on 07/17/2003: "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.  From additional information received on 07/08/2003 from the reporting physician, it was reported that the patient was diagnosed with Botulism Type A on 02/13/2003.  The patient continues with poor oral intake and remains on tube feedins via gastrostomy tube.  Slow recovery of milestones are noted to date.  Also provided was the dates of hospitalization (from 01/18/2003 to 01/22/2003) and route of administration of each vaccine.  No additional information is expected.  Case is closed.  On 07/08/2003, the patient was reported as not recovered." A 15-day follow up report received 8/8/2003 adds: From additional info received via telephone from the reporting physician on 07/31/2003, it was reported that the botulism was diagnosed using a stool sample from the pt. A stool culture and isolation, toxin detection and toxin type were performed. Additionally, a mouse toxicity test, rapid ANA, fatty acid profile, GLC and gram stain were performed from the sample. The specific specimen used to demonstrate the botulism toxin was stool. The tests were positive for botulism. No additional info is expected. Case is closed.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cardiac arrest, Cardiomyopathy
Clinical narrative: Cardiac arrest in emergency room x-ray dept. Autopsy related unexplained cardiomyopathy.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebellar syndrome, Coordination abnormal
Clinical narrative: It was reported that a pt was vaccinated with an influenza vaccine in November 2002 by the army. Three weeks later he experienced cerebellitis and was hospitalized. As a cause wasn't found, the treating physician felt a possible relationship with the influenza vaccination. He is treated with methylprednisone IV and slowly improving. At the time of this report he is not recovered yet. We asked for the hospital report. Further info is expected.  A 15-day follow up report received 04/17/2003 adds: The pt was hospitalized from 12/09/2002 till 12/17/2002 for further investigations. First symptoms as feeling unsteadiness while walking and clumsiness of speech occurred on 12/05/2002. These symptoms progressed during the following days and necessitated a neurologic consultation. The cranial MRI showed no abnormalities. Physical examination showed a gaze-evoked nystagmus to the left, marked cerebellar dysarthria, dysdiadochokinesis on the right, on the left, moderate broad-based gait ataxia, slightly dysmetric finger-to-nose test and heel-to-shin test, slight action tremor, markedly hypermetric finger-finger-test. No tremor at rest, no myoclonus. No sensory abnormalities. No vegetative dysfunction. Exam of heart, vessels, lymphnodes, lung, abdomen, thyroid, skin unremarkable. The pt was treated with corticosteroid (500 mg methyprednisolone/day IV from 12/12 till 12/14/2002. After this treatment there seemed to be a slight improvement of dysarthria and gait ataxia. The diagnosis of cerebillitis due to a viral disease or immunization or a paraneoplastic mechanism was discussed to be the cause of the cerebellar syndrome, but none could be verified. At the time of this report the symptoms improved slowly but the pt was not yet recovered. No further info is expected. File closed.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite, Difficulty in walking, Fatigue, Lethargy
Clinical narrative: Pt received influenza vaccine 10/19/02 and since that evening pt felt tired, weak, had difficulty walking due to weakness and fever of 100-101 degrees; decreased appetite, lethargy.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Pt received influenza vaccine 10/19/02 and since that evening pt felt tired, weak, had difficulty walking due to weakness and fever of 100-101 degrees; decreased appetite, lethargy.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthritis, Diarrhoea, Dysgeusia, Inflammation, Influenza
Clinical narrative: 2nd anthrax shot. Burning in right arm, rash like burning itch on right arm. Right arm felt heavy. Flu like symptoms for 3 days, including diarrhea. Extreme pain in right arm kept PT from sleeping well. Funny taste in mouth, upper teeth felt numb. Above symptoms only lasted 3 days. However, PT has an arthritis feeling in his left shoulder and elbow that continues to bother him.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Myasthenic syndrome, Pain, Rash pruritic
Clinical narrative: 2nd anthrax shot. Burning in right arm, rash like burning itch on right arm. Right arm felt heavy. Flu like symptoms for 3 days, including diarrhea. Extreme pain in right arm kept PT from sleeping well. Funny taste in mouth, upper teeth felt numb. Above symptoms only lasted 3 days. However, PT has an arthritis feeling in his left shoulder and elbow that continues to bother him.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Arthralgia, Arthritis, Dysgeusia, Injection site inflammation
Clinical narrative: Burning at inject site. Achy joints. Bad taste and film like paste in mouth. Sore gums, arthritis in left elbow and shoulders. Abdominal bloating and cramping.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Amblyopia, Back pain, Dizziness, Headache, Nausea
Clinical narrative: PT contacted the center after experience adverse events following her first anthrax immunization on 1/26/03. 2 hrs post vax, she experienced dizziness, nausea and blurred vision. She also had a sharp headache behind both eyes. All of these symptoms resolved in a few hrs. About 2200 hrs she began having stiffness and soreness in her back. About 0200 the next morning she was awakened from sleep with severe back pain, severe enough to go to the local ER for treatment. There she was given an injection for pain and was sent home with muscle relaxants and ibuprofen. On 1/28/03 she contacted the Vaccine Healthcare Center because her pain continued. We recommended that she continue the treatment that was prescribed and follow-up with the Vaccine Healthcare Center by phone the following week. On 2/3/03 PT informed us that her symptoms had resolved on 1/29/03, 3 days post anthrax #1.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Tenderness, Tendonitis
Clinical narrative: PT states: "I received a flu vax in my left arm. I noticed some tenderness in the area of my left deltoid 2 days [post vax] that was especially pronounced when I did push-ups, pull-ups or swimming. This tendonitis is still present after several months, although milder. Otherwise my health is excellent. Is it possible that local inflammation from the fax predisposes people to tendonitis? Or is the timing and location of the tendonitis coincidental?
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Increased temp, febrile seizure approx 5 mins, inpt? tj? temp 24-30 deg; Family history epilepsy in cousin *F/U report on 3/5/03: Elevated temp leading to seizure of about 5 mins.*
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Hypertension, Rash, Tachycardia, Tremor
Clinical narrative: Presented with rash on both hands at 14:55 post tetanus vaccine at 14:17. BP and HR elevated. PT was shaky. Benadryl 25 mg lm given at 15:09.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site reaction
Clinical narrative: Local reaction to right upper arm. Redness to area and patch about 4" x 2" erythema. No treatment necessary. Only observation and apply or take Benadryl.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue and myalgias approximately 12 hours post injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Syncope
Clinical narrative: Possible seizure or syncope 2 days after vaccination-episode lasted < 5 minutes.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Dx chicken pox 2/12/03. Broke out 2/11/03. Child received varicella vaccine 11/22/00.
Age: 16.5
Sex: F
Vaccine: HEP, TD
Symptoms: Back pain, Hypersensitivity, Oedema, Pruritus, Throat tightness
Clinical narrative: 4pm Td booster+HBV #1 given. 4:10 feet swelling, back pain and itching. 4:15 Benadryl 50mg given po. 4:30pm c/o throat tightness Epinephrine .3cc given. Mom refused to bring pt to hospital vs stable. O2 sat 100% sent home with emergency instructions at 5pm. Pt had an allergic reaction to one of the shots. 5:40pm called home and she states pt is sleeping and denies her having any respiratory problems. Instructed to watch pt for the next 24-48 hrs.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Convulsion, Crying, Discomfort, Hypothermia
Clinical narrative: The pt was brought in by mom for evaluation of what appears to have been some seizure activity yesterday. On 2/20/03, she received her first DTaP immunization. It consisted of the combination vaccine Pediarix. In addition to that she received the H. Influenza type B vaccine as well as the pneumococcal vaccine. She tolerated the vaccines well. They were administered approximately 10:30am on 2/20/03 and really for the rest of the day except for being maybe a little fussy, she did relatively well. At about 3:30 in the morning on 2/21/03 she developed some irritability with a high pitch cry and emesis, an episode of hypothermia where the mom measured the temperature down to 96.6 rectal. She became pale and somewhat listless with hypotonia but  no fever. It lasted about 5-10 mins. She did not have any apnea or cyanosis during that time. She was able to go back to sleep and then upon awakening the remainder of the day she seemed to be cranky with slight decrease in her breastfeeding patterns but otherwise seemed to be OK and then at about 2pm in the afternoon while they were at a store, again on 2/21/03, she became really fussy and irritable. Mom took her to the public restroom there to change her diaper and while she was there, laying on her back in a supine position, had what appeared to be some seizure activity. Mom described it as tonic-clonic acitvity with eye deviation and the pt was not responsive to verbal or tactile stimulus. The first episode lasted a few seconds and then she had recurring episodes, each one lasting only a few seconds but on a recurring pattern for about a 15 minute period of time. Between those short episodes she was crying and seemed to be in discomfort and stressed. After that 15 minute period she seemed to go into a post-ictal phase which lasted about one hour to 1- 1 1/2 hours. She did not have any apnea. No loss of consciousness. No cyanosis. When she contacted our office we did recommend that she take her to the ER for evaluation, which she did. Basic lab were unremarkable except for slightly decreased CO2 at 18. The rest of the examination was normal and the rest of the labs were normal. There is a strong family history of epilepsy. A maturnal aunt, the mother's sister, has absence seizures, and then two second cousins on the mother's side have seizures, one apparently grand mal seizures, the other one also absence seizures.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Irritability, Listless, Pallor, Strabismus
Clinical narrative: The pt was brought in by mom for evaluation of what appears to have been some seizure activity yesterday. On 2/20/03, she received her first DTaP immunization. It consisted of the combination vaccine Pediarix. In addition to that she received the H. Influenza type B vaccine as well as the pneumococcal vaccine. She tolerated the vaccines well. They were administered approximately 10:30am on 2/20/03 and really for the rest of the day except for being maybe a little fussy, she did relatively well. At about 3:30 in the morning on 2/21/03 she developed some irritability with a high pitch cry and emesis, an episode of hypothermia where the mom measured the temperature down to 96.6 rectal. She became pale and somewhat listless with hypotonia but  no fever. It lasted about 5-10 mins. She did not have any apnea or cyanosis during that time. She was able to go back to sleep and then upon awakening the remainder of the day she seemed to be cranky with slight decrease in her breastfeeding patterns but otherwise seemed to be OK and then at about 2pm in the afternoon while they were at a store, again on 2/21/03, she became really fussy and irritable. Mom took her to the public restroom there to change her diaper and while she was there, laying on her back in a supine position, had what appeared to be some seizure activity. Mom described it as tonic-clonic acitvity with eye deviation and the pt was not responsive to verbal or tactile stimulus. The first episode lasted a few seconds and then she had recurring episodes, each one lasting only a few seconds but on a recurring pattern for about a 15 minute period of time. Between those short episodes she was crying and seemed to be in discomfort and stressed. After that 15 minute period she seemed to go into a post-ictal phase which lasted about one hour to 1- 1 1/2 hours. She did not have any apnea. No loss of consciousness. No cyanosis. When she contacted our office we did recommend that she take her to the ER for evaluation, which she did. Basic lab were unremarkable except for slightly decreased CO2 at 18. The rest of the examination was normal and the rest of the labs were normal. There is a strong family history of epilepsy. A maturnal aunt, the mother's sister, has absence seizures, and then two second cousins on the mother's side have seizures, one apparently grand mal seizures, the other one also absence seizures.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: The pt was brought in by mom for evaluation of what appears to have been some seizure activity yesterday. On 2/20/03, she received her first DTaP immunization. It consisted of the combination vaccine Pediarix. In addition to that she received the H. Influenza type B vaccine as well as the pneumococcal vaccine. She tolerated the vaccines well. They were administered approximately 10:30am on 2/20/03 and really for the rest of the day except for being maybe a little fussy, she did relatively well. At about 3:30 in the morning on 2/21/03 she developed some irritability with a high pitch cry and emesis, an episode of hypothermia where the mom measured the temperature down to 96.6 rectal. She became pale and somewhat listless with hypotonia but  no fever. It lasted about 5-10 mins. She did not have any apnea or cyanosis during that time. She was able to go back to sleep and then upon awakening the remainder of the day she seemed to be cranky with slight decrease in her breastfeeding patterns but otherwise seemed to be OK and then at about 2pm in the afternoon while they were at a store, again on 2/21/03, she became really fussy and irritable. Mom took her to the public restroom there to change her diaper and while she was there, laying on her back in a supine position, had what appeared to be some seizure activity. Mom described it as tonic-clonic acitvity with eye deviation and the pt was not responsive to verbal or tactile stimulus. The first episode lasted a few seconds and then she had recurring episodes, each one lasting only a few seconds but on a recurring pattern for about a 15 minute period of time. Between those short episodes she was crying and seemed to be in discomfort and stressed. After that 15 minute period she seemed to go into a post-ictal phase which lasted about one hour to 1- 1 1/2 hours. She did not have any apnea. No loss of consciousness. No cyanosis. When she contacted our office we did recommend that she take her to the ER for evaluation, which she did. Basic lab were unremarkable except for slightly decreased CO2 at 18. The rest of the examination was normal and the rest of the labs were normal. There is a strong family history of epilepsy. A maturnal aunt, the mother's sister, has absence seizures, and then two second cousins on the mother's side have seizures, one apparently grand mal seizures, the other one also absence seizures.
Age: 1.08
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: ? maculopapular rash with intermittent fever up to 102 degrees x 3 days following Prevnar #1.
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Started on evening of day vaccine given arm swollen, erythematous, indurated upper arm (same arm vaccine given in). Treated with Tylenol, compress and Benadryl.
Age: 1.6
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pruritus, Rash macular, Rash pustular, Rash vesicular
Clinical narrative: "Onset vesicular rash 2/23 with itching" over face, torso, arms, legs with >50 eryth discrete macular-vesicular-pustular-crusted lesions.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Injection site oedema, Ocular hyperaemia, Pyrexia
Clinical narrative: Friday approx. 4-6 hrs post imm fever 104.6 crying leg swollen red eyes blood shot called ER-Friday.. Tues saw MD Tylenol, Motrin, antihist. still running fever 102 degrees.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema, Pyrexia
Clinical narrative: Swelling of left arm and fever 101 deg. Seen in ER - put on local Rei?? and autibols?.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Difficulty in walking
Clinical narrative: Report 2002000378-1 describes arthritis in a 44 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). The medical history included asthma, pneumonia, and epilepsy. The vaccinee had no known drug allergies. The vaccinee's occupation reportedly put him at risk for tick bites. There was no illness at the time of immunization. Concurrent medications were not known by the reporter. The vaccinee received his first injection of LYMErix (lot LY104A2) on 4/12/99. He had no adverse experience following receipt of this injection. He received his second injection of LYMErix (lot LY136B9) on 5/3/00. An unknown time post-immunization, he experienced extreme joint pain (NOS). The vaccinee reported that he was seen by an arthritis specialist, who made a diagnosis of arthritis (NOS). The vaccinee stated that this specialist recommended that he not receive the third injection of LYMErix. As of 1/8/02, the vaccinee stated that he remains in a lot of pain and is having difficulty just trying to move about. The most recent information, received 2/4/02, did not specify the treatment or outcome of the event. The adverse event arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special request per the June 28, 2000 letter.
Age: 61.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Difficulty in walking
Clinical narrative: Report 2002000379-1 describes aggravation of pre-existing arthritis in a 61 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). The medical history included hypertension and an unspecified form of arthritis. The vaccinee had no known drug allergies. The vaccinee's occupation reportedly put him at risk for tick bites. There was no illness at the time of immunization. Concurrent medications were not known by the reporter. The vaccinee received his first inejction of LYMErix (lot LY120F9) on 9/13/99. He had no adverse experience following receipt of this injection. He received his second injection of LYMErix (lot LY123B9) on 10/14/99. An unknown time post-immunization, he experienced extreme joint pain. The vaccinee reported that he did not seek medical attention for the joint pain. As of 1/8/02, the vaccinee stated that he is in a lot of pain and is having difficulty just trying to move about. He refused the third injection of LYMErix. The most recent information received 2/4/02 did not provide the treatment or outcome of the event. The adverse event arthritis aggravated does not meet ICH serious criteria, but is being submitted as an expedited report by special request per the 6/28/00 letter.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Difficulty in walking, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Report 2002000558 describes possible rheumatoid arthritis in a 43 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reported that he received his first and second injections of LYMErix in October 1999 and September 2000 (exact dates not provided), respectively. In the year 2000, an unspecified time following receipt of the second injection of LYMErix, the vaccinee reported that he experienced achiness for a couple of months that (he) thought was the flu. The achiness resolved. In December 2001, 15 months following receipt of the second injection of LYMErix, the vaccinee reportedly began to experience joint pain. His body was stiff and sore, and he found it difficult to walk due to arthritic feeling. He was seen by a general practitioner, who reportedly told the vaccinee he may be developing rheumatoid arthritis and referred the vaccinee to a rheumatologist. The rheumatologist saw the vaccinee on 1/11/02. The rheumatologist reportedly was not ready to label (him) as developing arthritis. The rheumatologist prescribed rofecoxib, and advised the vaccinee to exercise and watch his diet. The vaccinee stated that his body stiffness, and body soreness persisted. The vaccinee stated that his facility's health unit considered the events to be possibly related to LYMErix administration. The LYMErix immunization series was discontinued. The adverse events possible rheumatoid arthritis and joint pain do not meet ICH serious criteria, but are being submitted as an expedited report by special request per the 6/28/00 letter.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid arthritis
Clinical narrative: Report 2002000558 describes possible rheumatoid arthritis in a 43 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reported that he received his first and second injections of LYMErix in October 1999 and September 2000 (exact dates not provided), respectively. In the year 2000, an unspecified time following receipt of the second injection of LYMErix, the vaccinee reported that he experienced achiness for a couple of months that (he) thought was the flu. The achiness resolved. In December 2001, 15 months following receipt of the second injection of LYMErix, the vaccinee reportedly began to experience joint pain. His body was stiff and sore, and he found it difficult to walk due to arthritic feeling. He was seen by a general practitioner, who reportedly told the vaccinee he may be developing rheumatoid arthritis and referred the vaccinee to a rheumatologist. The rheumatologist saw the vaccinee on 1/11/02. The rheumatologist reportedly was not ready to label (him) as developing arthritis. The rheumatologist prescribed rofecoxib, and advised the vaccinee to exercise and watch his diet. The vaccinee stated that his body stiffness, and body soreness persisted. The vaccinee stated that his facility's health unit considered the events to be possibly related to LYMErix administration. The LYMErix immunization series was discontinued. The adverse events possible rheumatoid arthritis and joint pain do not meet ICH serious criteria, but are being submitted as an expedited report by special request per the 6/28/00 letter.
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: There was no relevant medical history. Concurrent conditions and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of LYMErix in his arm. On 11/30/01, an unspecified time post-vax, he experienced "mild" numbness of the arm. The numbness spread to his chest and down the arm to the fingers. The numbness resolved after "several hrs", w/out treatment. The nurse stated that she "probably hit his nerve to cause this reaction." She also indicated that the event was possibly related to LYMErix. The adverse event "numbness" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. Comment: The nurse reported that she administered LYMErix lot LY1Y7F9; however, this is not a valid lot #.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Urticaria
Clinical narrative: On 1/22/02, the vaccinee received his first injection of LYMErix. Later that day, an unspecified time post-vax, he experienced hives. He sought medical attention; treatment of the event was not specified. The hives resolved on 1/23/02, 10 hrs after onset. Medical history, concurrent conditions, and concurrent medications were not provided.
Sex: F
Vaccine: LYME
Symptoms: Hearing impaired, Pain, Sensory disturbance
Clinical narrative: Report A0360975A describes hearing loss in a female of unspecified age who received Lyme disease vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. On unspecified dates, the vaccinee completed "a series of injections" of LYMErix. One year later, the vaccinee experienced hearing loss, "vibrations," and pain. The vaccinee was treated with unspecified steroids, which provided "temporary relief." As of 2/28/02, the outcomes of the events were unknown. The adverse event "vibrations "does not meet serious criteria but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Report A0363116A describes memory loss in a 53 pt who rec'd Lyme disease vaccine recombinant OspA (LYMErix). This report was rec'd as part of litigation proceedings, with forwarding of medical records. Medical history included Lyme disease (1985), mild hypalgesia in the left ulnar nerve territory of L hand (1987), nephrolithiasis, plantar fasciitis, rectal polypectomy (1996), herpes simple II virus with occasional recurrence, rheumatic fever with subsequent trace mitral/aortic/tricuspid regurgitation (11996), possible mitral valve prolapse, possible history of measles, mononucleosis, cervical strain with left radiculopathy and headaches due to MVA (1985). Other medical history has nothing to do with adverse events from the vaccine. In 4/99, the pt rec'd his 1st injection of LYMErix. Subsequently, he experienced chills and myalgia. These adverse events resolved. In 5/99, and 3/00, the pt rec'd his 2nd and 3rd injection of LYMErix, respectively. In a statement of injuries,the pt's attorney alleged that the pt suffers from pain in his joints as swell as flu-like symptoms and fatigue. He also experiences headaches and memory loss. On 5/19/99, the pt was seen by his physician. The pt related during the case history that he had experienced head and neck pain, headaches, neck stiffness, pain between the shoulders, numbness, and arm pain since his MVA on 6/18/98. He denied these symptoms prior to his MVA. His current complaints were neck pain, neck stiffness and L arm pain. Initially these were rated a ten on a zero to ten scale with ten being excruciating pain and zero no pain at all. Currently, he rated his pain a four. In 3/00 the physician stated that "I cannot make a specific diagnosis. His history of morning stiffness lasting several hrs is disconcerting, but given his excellent examination and relatively normal blood work a specific diagnosis cannot be made... Whether or not his symptoms are related to his Lyme vaccine is difficult to say.. He does not show any signs of an inflammatory arthropathy on examination today.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness, Myalgia, White blood cell disorder
Clinical narrative: Report A0363116A describes memory loss in a 53 pt who rec'd Lyme disease vaccine recombinant OspA (LYMErix). This report was rec'd as part of litigation proceedings, with forwarding of medical records. Medical history included Lyme disease (1985), mild hypalgesia in the left ulnar nerve territory of L hand (1987), nephrolithiasis, plantar fasciitis, rectal polypectomy (1996), herpes simple II virus with occasional recurrence, rheumatic fever with subsequent trace mitral/aortic/tricuspid regurgitation (11996), possible mitral valve prolapse, possible history of measles, mononucleosis, cervical strain with left radiculopathy and headaches due to MVA (1985). Other medical history has nothing to do with adverse events from the vaccine. In 4/99, the pt rec'd his 1st injection of LYMErix. Subsequently, he experienced chills and myalgia. These adverse events resolved. In 5/99, and 3/00, the pt rec'd his 2nd and 3rd injection of LYMErix, respectively. In a statement of injuries,the pt's attorney alleged that the pt suffers from pain in his joints as swell as flu-like symptoms and fatigue. He also experiences headaches and memory loss. On 5/19/99, the pt was seen by his physician. The pt related during the case history that he had experienced head and neck pain, headaches, neck stiffness, pain between the shoulders, numbness, and arm pain since his MVA on 6/18/98. He denied these symptoms prior to his MVA. His current complaints were neck pain, neck stiffness and L arm pain. Initially these were rated a ten on a zero to ten scale with ten being excruciating pain and zero no pain at all. Currently, he rated his pain a four. In 3/00 the physician stated that "I cannot make a specific diagnosis. His history of morning stiffness lasting several hrs is disconcerting, but given his excellent examination and relatively normal blood work a specific diagnosis cannot be made... Whether or not his symptoms are related to his Lyme vaccine is difficult to say.. He does not show any signs of an inflammatory arthropathy on examination today.
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: Report A0363801A describes muscle pain in a 51 year old male who received Lyme disease vacicne recombiannt. This report was received from the vaccinee's wife and has not been verified by a physician or other healthcare professional. Medical history and concurrent conditions reportedly included tendonitis (treated with Celebrex) and elevated cholesterol (treated with Lipitor for 8 to 10 years). Additional concurrent medications reportedly included multivitamin, fish oil, and vitamin E. in September 2001, the vaccinee reportedly received his first injectin of LYMERix without adverse event. "Seven weeks later," the vaccinee received his second injection of LYMErix. It was reported that beginning in January or February 2002, he began to experience arm and leg muscle pain. He reportedly received no treatment for these events. As of 3/12/02, the vaccinee's muscle pain was reportedly ongoing.
Age: 15.0
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Report A0363826A describes flu-like symptoms in a male of unspecified age who received Lyme disease vaccine recombinant. This report was received from the vaccinee's wife and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions and concurrent medications were "unknown." On unspecified dates, the vaccinee received his first and second injections of LYMErix. It was reported that subsequent to an unspecified injection of LYMErix, the vaccinee experienced flu-like symptoms, injection site redness, and injection site pain. As of 3/20/02, the outcomes of the events were reportedly unknown.