chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Sarcoidosis, Urinary incontinence
Clinical narrative: Transverse myelitis with progressive paraplegia. Pt developed numbness in left 4th and 5th toes 1-2 weeks after receiving the influenza vaccine in Nov 02. The numbness radiated down the lateral side of the left foot and the pt thought it was due to his boots. Within a few days he had similar symptoms in the right foot. The numbness progressed to the ankles in Dec 02, and then to the calves and by Jan 03 he experienced numbness from the knees down to the toes bilaterally. He had no associated pain, no tingling. He was able to walk but no longer able to run. He was in the process of changing duty, which delayed his seeking medical care. In March 03 he went to ER after the numbness progressed to the waist and he was occasionally losing his balance. He was seen by a PA and treated for gout. He followed up with the PA without improvement and was given a "stronger medicine" for gout. By the end of March he was seen in neurology and underwent "outpatient testing" but he did not receive the results. In mid-Apr 03 he awakened one morning and "my knees gave out from under me" and he fell to the floor. He was taken to the ER and was admitted to hospital for 2 weeks. He was diagnosed with Guillain-Barr syndrome and received IVIG on 4/18/03. He reports that he initially re-gained movement of the knees but that the improvement didn't last.  However, when he was transferred to rehabilitation hospital on May 1 03 he reports making steady improvement during the first few weeks and began to walk using a walker. However, a week before his scheduled discharge in mid-June he relapsed. Noteworthy medical history includes new onset cough and dry rash on the neck, chest, back, abdomen, arms and thighs in Feb 00 while in over-seas. He states the rash looked like ringworm and was treated with a cream after which it resolved. The cough was non-productive and continuous and was treated with inhalers. The cough lasted for 2 years the member reports. In Mar 00 intermittent hoarseness began. By Apr 00 the hoarseness became constant and on bro. Follow up on 10/28/2003: "Vaccine recipient did not recover from adverse events.  I have sent in an update on this patient already and we have determined that his condition is not vaccine-related.  He had neurologic complications of sarcoidosis.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Dermatitis contact, Rash macular
Clinical narrative: On 03/18, 11 days after vaccination, pt developed mild macular rash on abdomen. Saw Dr in Employee Health/ER where she works. Diagnosis was contact dermatitis due to having used bleach when laundering clothing. Rash disappeared 2 days later and has not recurred. Pt stopped using the bleach.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain, Pruritus
Clinical narrative: Right arm swollen, hot and itchy. Left arm is also red. Swelling is located just below injection site. Pt states that arm is tender and sore to lay on.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis, Pruritus, Rash maculo-papular, Skin ulcer
Clinical narrative: Developed maculo-papular rash 36 hours after AVA #2. Symptoms continue to present. Itching. Lesions on posterior and anterior legs, both forearms and scattered patches on her back. She describes the lesions as individualized, dry, pruritic, having an erythematous base and resembling mosquito bites. Hot showers make them worse, little makes them better. Assessment: Chronic pruritic dermatitis temporally associated with anthrax vaccine #2. The follow up received on 12/31/03 states numular eczema has remained active in spite of prednisone course, UVB light treatments and many topical preparations. Member was patch tested to the components of the anthrax vaccine but tested negatively except for a possible allergic repsponse to formaldehyde. Pt reports that symptoms have worsened on the upper extremities.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Pt was seen in ER 7/20/03 - 12 x 11.5 cm red, raised area (RT) nontender. No fever. Swollen. 7/22/03 Followed up in PCP office - 4.5 x 4.5 red, raised, nontender, no fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The left thigh was swollen from the knee to the upper thigh and red. Mom noted symptoms since yesterday and today it is worse.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Walked in office about 2-3 PM. Child with temp 103. CBC OK. Blood cultures negative.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Temp 102.9 for 3 days, papular rash for 1 day. Rash diffuse torso and scalp.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Swollen area with redness axillary area and warm to touch.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 2 weeks, with blood in stool.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Pt went to ER on 7/11/03 with fever of 101 and 100.7 on 2 checks by mother and 99.9 in ER. Immunizations were given 7/9/03. No recent illness in pt or household member.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Local 6" x 6" erythema
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Morfilliform rash
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying
Clinical narrative: 24 hours after immunization, started crying unconsolable >4 hours, came back in to office.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Skin ulcer
Clinical narrative: Presented to ER with red, hot lesion on right thigh.  Given Motrin/Benadryl and cool compresses to site.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Skin ulcer
Clinical narrative: Afebrile: ~34 lesions trunk area (x5-6d) itchy.  Low grade temperature.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Left thigh with swelling and redness 11 x 8.5cm slightly warm to touch.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation, Crying, High-pitched crying, Irritability
Clinical narrative: Mother states he seemed fine the day of shots.  However the next day 112/14/2001, throughout morning and afternoon was fussy with intemittent crying.  Then at approximately 20:30, began crying continuously.  Nothing consoled him.  Cry was high-pitched.  Finally stopped crying around 23:00, and slept as usual throughout the night.  Denies fever/seizure act.  Limpness or paleness was given Tylenol every 4 hours as directed.  No irritation at injection site.  Did not call MD the next day was much better.
Age: 17.9
Sex: M
Vaccine: TD
Symptoms: Back pain, Body temperature increased, Dizziness, Headache, Injection site pain
Clinical narrative: Evening of injection arm tender.  In AM 03/28/2002 when awoke was lightheaded, and backache.  Took Tylenol and went to school.  By 14:30 that afternoon had throbbing headache and states "temples were swollen".  Temperature 100.7-101.  Lighheaded.  Again took Tylenol.  Slept off and on.  Called MD who also advised taking Benadryl which he did.  On 04/01/2002 in AM felt much better.  Was seen at health department.  No swelling at temples noted.  Injection site not red.  Only slightly tender to touch. No other symptoms noted or experienced.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Coordination abnormal, Crying, Hemiparesis, Hypotonia
Clinical narrative: Unconsolable crying, found crying in crib, stiff positive head & limbs, stiff x 30 seconds then limp, lack of coordination.  Right side weakness lasted 48 hours now resolved.  Infant with normal exam today.  (Possible seizure activity) Afebrile.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Musculoskeletal stiffness
Clinical narrative: Unconsolable crying, found crying in crib, stiff positive head & limbs, stiff x 30 seconds then limp, lack of coordination.  Right side weakness lasted 48 hours now resolved.  Infant with normal exam today.  (Possible seizure activity) Afebrile.
Age: 4.7
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red & swelling at injection site with involvement of left upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: 5 min after shots, developed hives: throat itching, itching all over.  Benadryl 25mg per mouth with good results.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR, OPV
Symptoms: Autism, Drug toxicity, Neurodevelopmental disorder
Clinical narrative: Pt had his last set at 12 mos and shut down at 14 mos regressed have him on video at 12 mos clapping and saying yes and after 14 mos on video diagnosed PDD at 22 mos had urine test for mercury done results as of 7/18/03 very highly elevated and has twice the maximum amount of mercury in him. My sister noticed him at 6 mos not developing but never mentioned it to me until he was diagnosed.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rapid eye movements sleep abnormal
Clinical narrative: Infant went to sleep day of vaccine at 23:00 and did not wake up until 12 noon next day.  Mom fed infant at 17:00 but child slept through feeding.  Then seemed fine.  No fever.
Age: 0.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature increased
Clinical narrative: Mother contacted sctp, reported elevated temp 103 last night and 101.  Now spoke with RN.  Instructed to call pediatrician.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Dyskinesia, Syncope
Clinical narrative: Brief syncopal episode (seconds) with some jerky movements, approximately 4 hours after Td immunization.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pain
Clinical narrative: Hospital reported on 07/21/2003 that child received injury and had leg pain.  child had been given Tylenol and Motrin and warm bath.
Age: 4.0
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Face oedema
Clinical narrative: 7/16 mother called and stated child received shots on yesterday and now has a swollen face on right side.  Denies fever this time.  Had fever last night  instructed to apply warm compresses to face.  If swelling gets worse go to ER and see MD.  Denies any other symptoms. 2:45 called and spoke with grandmaother, instructed her to bring child to health department so nurse can examine face.
Age: 23.0
Sex: F
Vaccine: RUB
Symptoms: Unevaluable event
Clinical narrative: had rubella vaccine 7-2-2003.  Complete form 07-23-2003 without correct vaccine information
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: 26 y/o male developed sub-sternal chest pain on day 13 following smallpox vaccination.  Symptoms were on and off x3 days lasting 20-30 min. and not associated with nausea, diaphoresis, dizziness or SOB.  Presented to cardiology office for evaluations and was referred to the emergency room. Elevated cardiac elevations, no significant EKG changes.  He was give IV nitroglycerin, Asprin and Lovenox.  He was diagnosed with myocarditis secondary to the smallpox vaccine and admitted x 2 days for further observation and treatment.
Age: 1.0
Sex: F
Vaccine: DPP, VARCEL
Symptoms: Respiratory distress
Clinical narrative: Severe acute respiratory dristress.  Patient initially treated at pediatrician's offce, then transported by ambulance to emergency room.  Emergency room physicians and staff administered treatment for approxmately 5 hours before patient discharged.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Anorexia, Diarrhoea, Headache
Clinical narrative: Loss of appetite, headache, diarrhea, abdomoinal pain
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: Crying, Screaming
Clinical narrative: Unconsolable crying after immunizations, approximately 4hours.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Injection site oedema, Injection site warmth, Malaise, Myalgia
Clinical narrative: Injection site left deltoid was firm, warm,tender,and edematous measuring 6cm x 6cm.Left supraclavicular area edematous, spongy,and tender 48 hrs following tetanus injection pt.sought treatment. Also complained of general malaise and fatigue. She was afebrile: temp. oral 97.8
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Nausea, Vision blurred
Clinical narrative: Nause, vomiting, diarrhea, lightheadedness, blurred vision and abdominal cramps, with onset 4-5 hours after last in series of rabies post-exposure prophylaxis.   Seen by physician about 24 hours after onset.  Awaiting chart retrieval to obtain mfr, lot no., etc.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Nause, vomiting, diarrhea, lightheadedness, blurred vision and abdominal cramps, with onset 4-5 hours after last in series of rabies post-exposure prophylaxis.   Seen by physician about 24 hours after onset.  Awaiting chart retrieval to obtain mfr, lot no., etc.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthralgia, Dizziness, Dyspnoea, Encephalitis, Hypoaesthesia
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Influenza like illness, Laboratory test abnormal, Memory impairment, Neuropathy, Pain
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia, Throat tightness, Tremor, Vertigo, Vomiting
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Weight increased
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Amnesia, Choking, Coordination abnormal, Difficulty in walking, Diplopia
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Dizziness, Encephalitis, Hyperacusis, Neuropathy, Oedema
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 32.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain, Tremor
Clinical narrative: Called pt on 6/10/03. Stated she had sore arm and swelling for 3 days, no other problems noted. 7/15/03 called by husband for vaccine info, relating wife had been hospitalized since 7/9/03 for dizziness, choking feeling and inability to walk very well. Was treating self since 5 days after vaccinations given for choking feeling up until going to the doctor on 7/9/03. Husband relates wife is being tested for latent MS and epilepsy but are waiting for test results to come back. The medical records indicates a final diagnosis of ADEM (acute demyelinating encephalomyelitis). Additional symptoms mentioned were: memory impairment, difficulty concentrating, weakness, tremor, hyperacusis, and ataxia.
Age: 17.0
Sex: M
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Leukocytosis, Lymphadenopathy, Malaise, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: From initial information received from a physician regarding an adverse event occurring in the USA, it was reported that an 17 year old male patient received Typhim VI vacicnation, lot number W1366-2, administered IM in the left deltoid and a Hepatitis A vaccination, lot number WHA764A2, administered IM in the left deltoid during the morning on 7/8/03. Two hours post vaccination, the patient developed swollen lymph nodes in the jaw area and a fever ranging from 101.4-102.9. Patient was seen by physician and sent home. On 7/11/03 the patient developed continuous vomiting and a fever. On 7/12/03 the patient developed ulcers in his mouth and was lethargic. Patient was seen in emergency room and admitted to the hospital. The patient's recovery status is currently unknown. From additional information received on 9/22/03 from a registered nurse, it was reported that the patient was released from the hospital with possible diagnosis of Chronic Fatigue Syndrome. No further information available at this time. No further information is anticipated, this case is considered closed.
Age: 17.0
Sex: M
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Stomatitis, Vomiting, White blood cell count increased
Clinical narrative: From initial information received from a physician regarding an adverse event occurring in the USA, it was reported that an 17 year old male patient received Typhim VI vacicnation, lot number W1366-2, administered IM in the left deltoid and a Hepatitis A vaccination, lot number WHA764A2, administered IM in the left deltoid during the morning on 7/8/03. Two hours post vaccination, the patient developed swollen lymph nodes in the jaw area and a fever ranging from 101.4-102.9. Patient was seen by physician and sent home. On 7/11/03 the patient developed continuous vomiting and a fever. On 7/12/03 the patient developed ulcers in his mouth and was lethargic. Patient was seen in emergency room and admitted to the hospital. The patient's recovery status is currently unknown. From additional information received on 9/22/03 from a registered nurse, it was reported that the patient was released from the hospital with possible diagnosis of Chronic Fatigue Syndrome. No further information available at this time. No further information is anticipated, this case is considered closed.
Age: 17.0
Sex: M
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Fatigue, Lethargy, Lymphadenopathy, Mouth ulceration, Pyrexia
Clinical narrative: From initial information received from a physician regarding an adverse event occurring in the USA, it was reported that an 17 year old male patient received Typhim VI vacicnation, lot number W1366-2, administered IM in the left deltoid and a Hepatitis A vaccination, lot number WHA764A2, administered IM in the left deltoid during the morning on 7/8/03. Two hours post vaccination, the patient developed swollen lymph nodes in the jaw area and a fever ranging from 101.4-102.9. Patient was seen by physician and sent home. On 7/11/03 the patient developed continuous vomiting and a fever. On 7/12/03 the patient developed ulcers in his mouth and was lethargic. Patient was seen in emergency room and admitted to the hospital. The patient's recovery status is currently unknown. From additional information received on 9/22/03 from a registered nurse, it was reported that the patient was released from the hospital with possible diagnosis of Chronic Fatigue Syndrome. No further information available at this time. No further information is anticipated, this case is considered closed.
Age: 17.0
Sex: M
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: From initial information received from a physician regarding an adverse event occurring in the USA, it was reported that an 17 year old male patient received Typhim VI vacicnation, lot number W1366-2, administered IM in the left deltoid and a Hepatitis A vaccination, lot number WHA764A2, administered IM in the left deltoid during the morning on 7/8/03. Two hours post vaccination, the patient developed swollen lymph nodes in the jaw area and a fever ranging from 101.4-102.9. Patient was seen by physician and sent home. On 7/11/03 the patient developed continuous vomiting and a fever. On 7/12/03 the patient developed ulcers in his mouth and was lethargic. Patient was seen in emergency room and admitted to the hospital. The patient's recovery status is currently unknown. From additional information received on 9/22/03 from a registered nurse, it was reported that the patient was released from the hospital with possible diagnosis of Chronic Fatigue Syndrome. No further information available at this time. No further information is anticipated, this case is considered closed.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cerebellar ataxia, Difficulty in walking, Dizziness
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. The infant had become dizzy and could not walk or crawl. This was reported to a neurologist for cerebellar ataxia. Unspecified medical attention was sought. It was also noted that this case was reported to the reporting physician on 6/27/03. As of 7/11/03, the reporting physician has not heard differently. Upon internal medical review cerebellar ataxia was considered an other important medical event (OMIC). Additional information has been requested. A 15-day follow up report received 8/12/2003 adds: Follow-up info indicated that the pt experienced cerebellar ataxia on 06/27/2003. A CT scan performed and no results were reported. As of 07/31/2003, the pt's recovery status was unknown. Upon internal medical review cerebellar ataxia was considered an other important medical event. Additional info has been requested. The follow up received on 8/6/03 from the physician indicated that developed cerebellar ataxia and her symptoms included difficulty crawling and dizziness. The physician reported that the parents were very concerned and the pt was referred to a neurologist. The neurologist reported to the physician that he "is 99% sure that the vaccine caused the cerebellar ataxia and the cerebellar ataxia could take up to 2 months to resolve." The pt's CT results were negative. Upon internal medical review cerebellar ataxia was considered an other important medical event (OMIC). Additional info has been requested.  A 15-day follow up report received 8/25/2003 adds: Follow-up info received on 8/15/2003 indicated that the pt was seeing a neurologist for her cerebellar ataxia which was still ongoing. Upon internal medical review cerebellar ataxia was considered an other important medical event. Additional info has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Cellulitis, Cognitive disorder, Mental retardation severity unspecified, Psychomotor hyperactivity, Speech disorder
Clinical narrative: Initial information was received from a registered nurse and follow up information received from a physician concerning the registered nurse's currently 6 year old son with seasonal allergies and a history of sinusitis, pneumonia, recurrent otitis media and a perforated tympanic membrane, who was vaccinated at 15 months of age with a dose of MMR (second generation) (lot not reported). Concomitant therapy included budesonide. At 15 months of age the patient had cellulitis localized at the injection site after vaccination with MMR (second generation) and this was treated with acetaminophen. The mother, a registered nurse, reported that at age 2 the patient developed symptoms of pervasive development disorder and the patient had difficulty with speech and was hyperactive. She reported that at 3 years of age the patient was diagnosed with autism and ADHD. The patient has received speech and occupational therapy, behavior modification and has been on a special diet of gluten free and casein free food. Follow up information from the physician reported that due to the recurrent otitis media and perforated tympanic membrane noted in past medical history, the child subsequently had placement of tubes on 3/5/99. The physician reported that on 4/19/99 the patient was noted to have a speech delay. In April 2001, the child was seen by a psychologist and was diagnosed with Pervasive Developmental Disorder (PPD) and ADHD. The physician reported that the child was not diagnosed with autism. The mother reported that the patient was diagnosed with a severe diary allergy at 4 years of age. It was also reported that at 4 years of age on 7/3/01, after Streptococcus pneumoniae vaccine the patient had cellulitis of his deltoid which was inflamed, red, and hot. This was treated with amoxicillin (+) clavulanate potassium, diphenhydramine and hydrochloride, acetaminophen or ibuprofen. It was reported that the cellulitis had resolved. The physician saw the patient in June 2003 and reported that at that time the child was in first grade in a life skills program. The physician noted that the child was only mainstreamed for subjects like music. The physician felt that the child had PPD and sensory integration problems. The patient was not being treated with any medications. The mother reported that the patient was now cognitively up to his grade level, but with difficulty processing sensory stimuli. A recent titer was negative for mumps. Unspecified medical attention was sought. Upon internal review, autism, pervasive developmental disorder and ADHD were determined to be other important medical events (OMIC). The registered nurse also reported that she had been vaccinated with MMR (second generation) and had a negative titer for mumps. No further information is expected.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthenia, Cyanosis, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient presented to ER via ambulance with an anaphylactic reaction to a flu shot. Shortly after receiving a flu shot at work, patient experienced itching, numbness to extremities, weakness, shortness of breath, and eventually became cyanotic. Epipen was administered and life squad called. IV was started and aerosols were given en route. Upon arrival to ER patient was blue and hypotensive. Treatment included hydration, Solumedrol, Pepcid, Benadryl, and aerosol treatments. Patient was still short of breath and was admitted to ICU for observation. History and physical revealed that patient had a similar reaction to iodine IVP dye two years ago. Reaction resolved and patient was discharged the next day. A follow up report received 11/21/2003 adds: (in hospital) Pt improved and was discharged 2 days later.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Pruritus
Clinical narrative: Patient presented to ER via ambulance with an anaphylactic reaction to a flu shot. Shortly after receiving a flu shot at work, patient experienced itching, numbness to extremities, weakness, shortness of breath, and eventually became cyanotic. Epipen was administered and life squad called. IV was started and aerosols were given en route. Upon arrival to ER patient was blue and hypotensive. Treatment included hydration, Solumedrol, Pepcid, Benadryl, and aerosol treatments. Patient was still short of breath and was admitted to ICU for observation. History and physical revealed that patient had a similar reaction to iodine IVP dye two years ago. Reaction resolved and patient was discharged the next day. A follow up report received 11/21/2003 adds: (in hospital) Pt improved and was discharged 2 days later.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Serum sickness
Clinical narrative: Serum sickness type reaction. 08/19/2003: Reporter now indicates there was no disability in this patient.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Convulsion, Pyrexia, Rash, Viral infection
Clinical narrative: Ran a fever of 106 degrees, went into a seizure. Had to call EMS. Admitted to the hospital. Broke out in a strange looking rash. The hospital discharge summary states viral syndrome.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cold sweat, Coma, Hypotonia, Pallor
Clinical narrative: Pt felt clammy. When mother went to change him, he was very pale, limp and floppy and had a bluish hue. He was unresponsive but was breathing. This lasted about 5-10 minutes and pt recovered on his own.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia, Rash
Clinical narrative: Td vaccine 7/10/03. Next day 7/11/03 fever to 104 degrees, not relieved by Tylenol/Advil. Family took to ER. Had spinal tap performed. 7/15-7/16 less fever, but rash on legs. Overall, we think this was viral infection, but are sending report, since it occurred within 24 hours of vaccination.
Age: 1.3
Sex: F
Vaccine: HEP, HIBV, PNC
Symptoms: Lacrimation increased, Oedema
Clinical narrative: One year 4 month old who received DTaP, Hib, Hep B and Prevnar immunizations at about 1600 on 7/14/03. Exam at time was normal. At about 1830 she developed acute edema and tearing of her eye-unilateral. Enough swelling to prompt ER visit. No respiratory symptoms. Rx with Benadryl. No further sequellae. Uncertain whether immunizations contributed to reaction.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Diagnosed in ER - chicken pox.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Muscle soreness at vaccine site. Started 2 days post vaccines and continues today. Soreness may be getting worse. Also, seems to have had an allergic skin reaction to the adhesive in the bandaid used to cover site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: 4" x 3" reddened and hived area appeared <5 minutes after administration of vaccine. Reaction was localized to site of administration. Pt given Benadryl and cool pack and observed for 20 minutes. Reaction began to subside 15 minutes after administration of Benadryl. Child complained of itching prior to Benadryl, itching relieved by Benadryl.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Pain in jaw
Clinical narrative: 3 days after Td booster given, pt's right jaw (upper and lower) felt "tight" and painful. Still not normal, but better.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Large local reaction 6" diameter around deltoid area injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pain, Skin hyperpigmentation
Clinical narrative: Swelling and pain, mild erythema, slight hyperpigmented skin below deltoid area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Red local reaction 7 x 5cm right upper arm. No induration.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Muscle spasms, Sensation of heaviness
Clinical narrative: 1) Muscle spasm in extremities (not arm where injection given) 2) Also feeling of lower extremity "heaviness/weakness".
Age: 5.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: 5 x 10cm red, swollen area (hive).  Almd immunization site (large local reaction).  Treated with Benadryl, Keflex (5 days).
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Rash papular
Clinical narrative: Child has red, palpable lumps at injection sites.  Right thigh has red, discolored area 3x4cm, left thigh lump area is 2x3cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Right arm red with vesicular rash dostal to injection site 9cm long and 14 cm wide.  Seen 07/22, prescribed with Zyrtec 2tsp every day, and Keflex (250/5ml) 1tsp initial dose x 7 days.  Call from mom 07/23, no change.  Zyrtec discharge and Benadryl 2tsp every 6 hours for 2 days ordered.  As of 07/24 not resolved.
Age: 0.9
Sex: F
Vaccine: HEP, PNC
Symptoms: Neurological symptom
Clinical narrative: Parent called office 10/12 hours, to report that patient had not been herself since immunizations given.  And 06/11/03 had slept the entire day and night-wouldjust go back to sleep when aroused-did take 2 bottles but just fell asleep after.  Seemed perfectly normal 06/12/03, no fever.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Local redness, swelling, tenderness 24-72 hours post IM injection.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 24-72 hours after IM in jection of 5th DTaP, developed warm, tender, swollen erythema 8inches in diameter at site.
Age: 4.1
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Ocular hyperaemia, Rash pruritic
Clinical narrative: Complained of itching all over.  Rash appearing on face, extremities and body.  Redness around eyes within 10-15 minutes of vaccine administration-gave Benadryl 1 tsp per mouth.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Ocular hyperaemia, Rash pruritic
Clinical narrative: Itching, all over rash appearing on the face and body extremities, redness around eyes within 10-15 minutes of receiving vaccine
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site induration
Clinical narrative: Cellulitis with induration right outer arm at the site.  History of polysaccharide continued immune dificiency on ganglobulin.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash vesicular
Clinical narrative: 07/18/2003: 1.5 inch pink area at vaccination site left arm.  sore to touch and itches.  Low grade temperature 07/15 & 07/16.  07/22/03: Vesicle on stomach and small lesions on thighs.  Generalized itching.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain, Pruritus
Clinical narrative: Routine Pneumovax injection given in left deltoid area 05/14.  Patient developed pain, itching, and warmth at site of injection several areas after the injection.  Ice was applied to area and IBU was prescribed for pain.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Agitation, Erythema, Feeling hot, Irritability, Pyrexia
Clinical narrative: Patient fell asleep on ride home after receiving DTaP and IPV.  Awoke screaming a short time after arriving at home.  His skin was hot, red lacy rash on legs, low grade fever.  He screamed inconsolably for approximately 3 hours.  I contacted the office to report, dr suggested tylenol.  Crying subsided, but rash lasted for approximately 3 months.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash
Clinical narrative: Patient fell asleep on ride home after receiving DTaP and IPV.  Awoke screaming a short time after arriving at home.  His skin was hot, red lacy rash on legs, low grade fever.  He screamed inconsolably for approximately 3 hours.  I contacted the office to report, dr suggested tylenol.  Crying subsided, but rash lasted for approximately 3 months.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, HEP
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: This was a series of 6 shots. 1st shot was 17March98. Swelling/soreness @ injection site. Nasal/sinus congestion with muscle burning in back and neck. Weakness over whole body. All symptoms lasted approximately 6 days. The 4th injection was on 10/13/98. I recieved flu-vaccine and Hepatitis B vaccine shots with the 4th injection of Anthrax. Five hours later I began to have fever, muscle aches over entire body, headache, chills, head congestion, nausea, diarrhea, stomach pain, and fatigue. These symptoms lasted a week. I felt like I was dying. On 29Oct99 I received 5th Anthrax shot with 3rd Hep. B shot. Lot #'s FA044, 7953A4. Four weeks later I had a Flu shot. I had flu-like symptoms for 2 weeks starting 29Oct99, and for another week after the flu shot the following month.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, HEP
Symptoms: Head discomfort, Headache, Injection site oedema, Injection site pain, Musculoskeletal discomfort
Clinical narrative: This was a series of 6 shots. 1st shot was 17March98. Swelling/soreness @ injection site. Nasal/sinus congestion with muscle burning in back and neck. Weakness over whole body. All symptoms lasted approximately 6 days. The 4th injection was on 10/13/98. I recieved flu-vaccine and Hepatitis B vaccine shots with the 4th injection of Anthrax. Five hours later I began to have fever, muscle aches over entire body, headache, chills, head congestion, nausea, diarrhea, stomach pain, and fatigue. These symptoms lasted a week. I felt like I was dying. On 29Oct99 I received 5th Anthrax shot with 3rd Hep. B shot. Lot #'s FA044, 7953A4. Four weeks later I had a Flu shot. I had flu-like symptoms for 2 weeks starting 29Oct99, and for another week after the flu shot the following month.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, HEP
Symptoms: Myalgia, Nasal congestion, Nausea, Pyrexia, Sinus congestion
Clinical narrative: This was a series of 6 shots. 1st shot was 17March98. Swelling/soreness @ injection site. Nasal/sinus congestion with muscle burning in back and neck. Weakness over whole body. All symptoms lasted approximately 6 days. The 4th injection was on 10/13/98. I recieved flu-vaccine and Hepatitis B vaccine shots with the 4th injection of Anthrax. Five hours later I began to have fever, muscle aches over entire body, headache, chills, head congestion, nausea, diarrhea, stomach pain, and fatigue. These symptoms lasted a week. I felt like I was dying. On 29Oct99 I received 5th Anthrax shot with 3rd Hep. B shot. Lot #'s FA044, 7953A4. Four weeks later I had a Flu shot. I had flu-like symptoms for 2 weeks starting 29Oct99, and for another week after the flu shot the following month.
Age: 0.3
Sex: M
Vaccine: DPP, HBPV, DTAP, HIBV, IPV, PNC
Symptoms: Insomnia, Irritability, Joint range of motion decreased
Clinical narrative: The vaccines were administered at approximately 11:00 a.m. on Thursday, July 24, 2003. Patient was given a .8 dosage of Tylenol prior to the shots. Immediately after the shots he ate and then fell asleep during a car ride. At about 3:00 p.m. I put him in his crib for a nap and noticed that he wasn't rolling (which he typically does--he's very active). He seemed frustrated and wanted to turn over to his stomach but was unable to do so. He then fell asleep. At approximately 4:30 p.m., after he woke up, I noticed that he was not moving his legs. I put him on the floor to kick and he only moved his arms. I continued to observe closely and try different positions--sitting, lying down, in an exercise saucer--and noticed that he did not move his legs or feet at all. He seemed slightly fussy and cried when I moved his legs too much. I contacted his doctor at approximately 7 p.m. When I picked his legs up, they would fall back down limp--he still did not attempt to move either his legs or his feet at all, although when I tickled his feet his toes would curl slightly. I proceeded to the emergency room, but no diagnosis was made because he did begin to move his legs at approximately 9:15 p.m. After that point, he did begin moving more--pulling up his knees, wiggling his feet and toes, and rolling over. Aside from being tired on the morning on 7/25, he has appeared to return to normal.  Please note that the doctoris submitting this form with the specific vaccination data below.
Age: 0.3
Sex: M
Vaccine: DPP, HBPV, DTAP, HIBV, IPV, PNC
Symptoms: Hypokinesia
Clinical narrative: The vaccines were administered at approximately 11:00 a.m. on Thursday, July 24, 2003. Patient was given a .8 dosage of Tylenol prior to the shots. Immediately after the shots he ate and then fell asleep during a car ride. At about 3:00 p.m. I put him in his crib for a nap and noticed that he wasn't rolling (which he typically does--he's very active). He seemed frustrated and wanted to turn over to his stomach but was unable to do so. He then fell asleep. At approximately 4:30 p.m., after he woke up, I noticed that he was not moving his legs. I put him on the floor to kick and he only moved his arms. I continued to observe closely and try different positions--sitting, lying down, in an exercise saucer--and noticed that he did not move his legs or feet at all. He seemed slightly fussy and cried when I moved his legs too much. I contacted his doctor at approximately 7 p.m. When I picked his legs up, they would fall back down limp--he still did not attempt to move either his legs or his feet at all, although when I tickled his feet his toes would curl slightly. I proceeded to the emergency room, but no diagnosis was made because he did begin to move his legs at approximately 9:15 p.m. After that point, he did begin moving more--pulling up his knees, wiggling his feet and toes, and rolling over. Aside from being tired on the morning on 7/25, he has appeared to return to normal.  Please note that the doctoris submitting this form with the specific vaccination data below.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Purpura, Rash papular
Clinical narrative: 4 days after vaccination with DTaP, IPV, and MMR child developed rash consistent with Henloch-Schonlein purpura.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Chest discomfort, Dyspnoea, Erythema, Insomnia
Clinical narrative: 31 y/o hospital ER nurse first time vaccine (DOV 3/12/2003) had developed nonspecific rash (probably folliculitis) 3/23/2003 resolving over next few weeks.  A biopsy done and sent was reported to me by the pt as revealing dermatitis with focal vesicles c/w vaccinia, but PCR was negative for vaccinia.  Well until 5/30/2003 when she developed syndrome characterized by acute onset of shortness of breath (woke her up from sleep), chest tightness and sternal tenderness, myalgias, lymphadenopathy, and a "red spot under her L breast.".  She was seen by MD and work up was negative (including normal EKG, CXR, and negative troponins).  Over the last two months, although her acute syndrome resolved, she has developed recurrent skin lesions and an asymptomatic swollen left ankle without history of injury.  She sought care where she has been seen twice.  Plane film of the ankle was normal.  The skin lesions are painful and rarely if ever pruritic, begin as papules, and then become vesicles.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenopathy, Myalgia, Oedema peripheral, Pain, Pruritus
Clinical narrative: 31 y/o hospital ER nurse first time vaccine (DOV 3/12/2003) had developed nonspecific rash (probably folliculitis) 3/23/2003 resolving over next few weeks.  A biopsy done and sent was reported to me by the pt as revealing dermatitis with focal vesicles c/w vaccinia, but PCR was negative for vaccinia.  Well until 5/30/2003 when she developed syndrome characterized by acute onset of shortness of breath (woke her up from sleep), chest tightness and sternal tenderness, myalgias, lymphadenopathy, and a "red spot under her L breast.".  She was seen by MD and work up was negative (including normal EKG, CXR, and negative troponins).  Over the last two months, although her acute syndrome resolved, she has developed recurrent skin lesions and an asymptomatic swollen left ankle without history of injury.  She sought care where she has been seen twice.  Plane film of the ankle was normal.  The skin lesions are painful and rarely if ever pruritic, begin as papules, and then become vesicles.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Rash, Rash papular, Skin ulcer, Tenderness
Clinical narrative: 31 y/o hospital ER nurse first time vaccine (DOV 3/12/2003) had developed nonspecific rash (probably folliculitis) 3/23/2003 resolving over next few weeks.  A biopsy done and sent was reported to me by the pt as revealing dermatitis with focal vesicles c/w vaccinia, but PCR was negative for vaccinia.  Well until 5/30/2003 when she developed syndrome characterized by acute onset of shortness of breath (woke her up from sleep), chest tightness and sternal tenderness, myalgias, lymphadenopathy, and a "red spot under her L breast.".  She was seen by MD and work up was negative (including normal EKG, CXR, and negative troponins).  Over the last two months, although her acute syndrome resolved, she has developed recurrent skin lesions and an asymptomatic swollen left ankle without history of injury.  She sought care where she has been seen twice.  Plane film of the ankle was normal.  The skin lesions are painful and rarely if ever pruritic, begin as papules, and then become vesicles.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: 10 days after receiving smallpox vaccination he woke up with substernal chest pain. Pain got worse 5/10 and he was transported to the hospital. Remained in the hospital for 3 days. Had ST elevations on his EKG and troponin level was elevated to 1.25
Age: 54.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Tendonitis
Clinical narrative: On Week 5, had 5-day course of prednisone for tendinitis.  No recrudescent lesions, very faint scar after soughing small eschar at 4 weeks.  Patient had 3 or 4 smallpox vaccinations, the last one in the military in 1985.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Patient's Rt. arm, deltoid area, became red and swollen, warm to the touch.  Redness extended down to the Rt. elbow.  No fever, weight- 151lbs.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Purpura fulminans, Sepsis
Clinical narrative: Pneumococcal Sepsis with Purpura Fulminans