chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine abnormality
Clinical narrative: 3 day 6"x6" swollen at site.  Very itchy.  Scattered red spots on back looked like solid red mass.  5th day redness decreased injection swollen/no itch.  10th day nausea, dizziness, no hunger.  13th day better.  14th day 2/19/08 still dizzy, no nausea.  No fever, had dry cough.  Rapid heart beat (3rd day) 151/90.  Hydrated throughout time.  Urine smelled like tomato plant.  Darker.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Feeling cold, Headache, Pharyngolaryngeal pain
Clinical narrative: Patient developed a sore throat day after the vaccines.  Lasted few days & went away.  Then started low grade headaches & felt chilly.  No fever.  No swelling or redness of the injection site.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Nausea
Clinical narrative: (6:55 pm) feels nauseated.  Dizzy 15 minutes after.  Also took a WAL-ZYR (5 minutes after the flu shot).  BP went down from 150/80 at 6:45 pm to 130/80 (7:25 pm) after 30 minutes. Pt seemed normal after that.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased
Clinical narrative: Patient had a temperature of 101.7 ax on Wednesday night.  Had seen the doctor earlier in the day for his 4 month checkup.  Doctor advised to give Tylenol to patient and come in on 2/15/08.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blood culture negative, Chest X-ray normal, Febrile convulsion, Full blood count normal, Laboratory test normal
Clinical narrative: Fever and febrile seizure on 2/11/08 (day 6).
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever and febrile seizure on 2/11/08 (day 6).
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Diarrhoea
Clinical narrative: Inconsolable intermittent crying for 6-8 hrs 3 days after Rotateq with diarrhea.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, MMR, PPV, VARCEL
Symptoms: Blister, Erythema, Oedema peripheral, Rash generalised, Scab
Clinical narrative: Mom phoned to advise that rash of small red dots on child's wrists appeared 1/24/08 and continued to progress to full body rash over next 2 days, then redness, swelling of hands.  Seen by private MD 1/30 advised measles.  By 2/7 rash faded, hands and feet peeling with cracked skin.  On 2/8 second rash, blistery with fluid filled areas appeared, crusted & scabbed in 1-2 days.  No fever reported through all rashes.  Not seen by MD after 2nd rash developed.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, MMR, PPV, VARCEL
Symptoms: Skin exfoliation
Clinical narrative: Mom phoned to advise that rash of small red dots on child's wrists appeared 1/24/08 and continued to progress to full body rash over next 2 days, then redness, swelling of hands.  Seen by private MD 1/30 advised measles.  By 2/7 rash faded, hands and feet peeling with cracked skin.  On 2/8 second rash, blistery with fluid filled areas appeared, crusted & scabbed in 1-2 days.  No fever reported through all rashes.  Not seen by MD after 2nd rash developed.
Age: 37.0
Sex: M
Vaccine: PER, TD
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Hives spread progressively over several days across body from the site where the vaccine was administered. Arm where vaccine was administered swelled, was painful to touch and developed a fever.
Age: 1.01
Sex: M
Vaccine: HBHEPB, MMR, PPV
Symptoms: Pruritus, Rash
Clinical narrative: Child presented with rash on arms, legs, and face. Rash began on Tuesday 2-19-08, positive for itching.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Agitation, Erythema, Irritability, Pain in extremity, Pyrexia
Clinical narrative: Severe swelling, moderate pain from rt shoulder to elbow, redness, fever and very irritable/agitated. These symptoms lasted 6 days. Treated with Tylenol.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Severe swelling, moderate pain from rt shoulder to elbow, redness, fever and very irritable/agitated. These symptoms lasted 6 days. Treated with Tylenol.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Client received pneumonia polysaccharide vaccine 0.5 ml IM in right deltoid on 10/23/2007. (Had received Fluzone vaccine in same arm on 10/18/2007.)  Administering nurse reports no unusual appearance to arm, etc., and client expressed desire to receive the pneumonia shot in the same arm because of pre-existing lymphadema in the left arm.)  Client returned to Health Department on 10/25/2007 with c/o redness at site occurring on 10/24.  Nurse practitioner examined client's arm and noted no redness or localized swelling at injection site, but noted redness and swelling on inner aspect of left arm.  Encouraged to have area evaluated by her physician and let the Health Dept know his opinion.  The client was not back in contact with the Health Dept until 11/26/2007 when she requested and was given the record of her pneumonia shot administration and a copy of note regarding her 10/25 presentation, reportedly to be taken to her physician.  A note to him was included at the bottom of the record requesting he advise us of his final diagnosis.  This was never received, and the client was vague as to the actual physician's name.
Age: 55.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: As part of redeployment readiness preparation, pt received initial vaccinations on 28 January 2008 consisting of anthrax number one, and typhoid.  She reports developing the following symptoms persisting for two days following these vaccinations: Headache, malaise, nausea to the point of near emesis, and fatigue that impacted on her quality of life and duties at work.  For fear of affecting the immune response, she of weighted medical therapy until day two on which she took Tylenol.  Whereas those symptoms resolved by the end of two days, persistence of fatigue and malaise was experienced below her baseline that continued through to her next injection occurred on the 12th of February.  On the 12th, she received the second anthrax vaccination in the series on time and without other vaccinations.  She experienced reemergence of the same symptoms listed above and worsening of her fatigue and malaise following this vaccination.  She now presents for advice on whether to receive the third injection next week.  She also reports that this has been a tendency for her to have some form of malaise following any vaccination.  However the reaction to these most recent vaccinations has been much more pronounced.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pain, Fatigue, Headache, Hypoaesthesia, Hypokinesia
Clinical narrative: Two weeks after receiving the flu vaccine, I lost feeling in my right leg, had severe headaches above my right eye, tremors, fatige. After three (confirmed) years of tests, I was diagnosed with ADEM. I had NO prior problems before the vacination. I now have a lesion on my optic nerve, and my vision in my right eye is 20/100 (and was perfect before the shot).  My left eye/side of my body remain "normal". I underwent three years of MRI's, spinal taps, dozens of eye tests/ coordination tests/etc... I was unable to continue with my teaching career and have only worked (substituted) a few days since the vaccine was given to me.  I take pain medication as needed for eye/leg/pain.  I am unable to springboard dive (my sport of choice since I was nine).  I was the diving coach for the local high-school prior to getting ADEM. My treatment is:  Live with it. 3/5/08-records received-2/11/04-C/O fatigue, chills, fevers, sweats, loss of appetitie, sedation, weight gain/loss, insommis. Blurring, double vision, vision loss, eye pain, light sensitivity. 3/11/04-C/O tremor left hand, twitching of eye, mild numbness and tingling in legs. Assessment:optic neuritis.  10/29/04-loss of vision right eye. 5/9/05-neurologic exam unable to identify localizing symptoms. Testing negative.  6/14/05-Impression right trigeminal neuropathy.  02/05/2010 Dx: ADEM (Accute Dissemenating Encephalomyelitis). Eye pain, loss of vision in right eye, right leg/arm pain, extreme fatigue.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Optic nerve disorder, Pain in extremity, Paraesthesia
Clinical narrative: Two weeks after receiving the flu vaccine, I lost feeling in my right leg, had severe headaches above my right eye, tremors, fatige. After three (confirmed) years of tests, I was diagnosed with ADEM. I had NO prior problems before the vacination. I now have a lesion on my optic nerve, and my vision in my right eye is 20/100 (and was perfect before the shot).  My left eye/side of my body remain "normal". I underwent three years of MRI's, spinal taps, dozens of eye tests/ coordination tests/etc... I was unable to continue with my teaching career and have only worked (substituted) a few days since the vaccine was given to me.  I take pain medication as needed for eye/leg/pain.  I am unable to springboard dive (my sport of choice since I was nine).  I was the diving coach for the local high-school prior to getting ADEM. My treatment is:  Live with it. 3/5/08-records received-2/11/04-C/O fatigue, chills, fevers, sweats, loss of appetitie, sedation, weight gain/loss, insommis. Blurring, double vision, vision loss, eye pain, light sensitivity. 3/11/04-C/O tremor left hand, twitching of eye, mild numbness and tingling in legs. Assessment:optic neuritis.  10/29/04-loss of vision right eye. 5/9/05-neurologic exam unable to identify localizing symptoms. Testing negative.  6/14/05-Impression right trigeminal neuropathy.  02/05/2010 Dx: ADEM (Accute Dissemenating Encephalomyelitis). Eye pain, loss of vision in right eye, right leg/arm pain, extreme fatigue.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, Visual acuity reduced
Clinical narrative: Two weeks after receiving the flu vaccine, I lost feeling in my right leg, had severe headaches above my right eye, tremors, fatige. After three (confirmed) years of tests, I was diagnosed with ADEM. I had NO prior problems before the vacination. I now have a lesion on my optic nerve, and my vision in my right eye is 20/100 (and was perfect before the shot).  My left eye/side of my body remain "normal". I underwent three years of MRI's, spinal taps, dozens of eye tests/ coordination tests/etc... I was unable to continue with my teaching career and have only worked (substituted) a few days since the vaccine was given to me.  I take pain medication as needed for eye/leg/pain.  I am unable to springboard dive (my sport of choice since I was nine).  I was the diving coach for the local high-school prior to getting ADEM. My treatment is:  Live with it. 3/5/08-records received-2/11/04-C/O fatigue, chills, fevers, sweats, loss of appetitie, sedation, weight gain/loss, insommis. Blurring, double vision, vision loss, eye pain, light sensitivity. 3/11/04-C/O tremor left hand, twitching of eye, mild numbness and tingling in legs. Assessment:optic neuritis.  10/29/04-loss of vision right eye. 5/9/05-neurologic exam unable to identify localizing symptoms. Testing negative.  6/14/05-Impression right trigeminal neuropathy.  02/05/2010 Dx: ADEM (Accute Dissemenating Encephalomyelitis). Eye pain, loss of vision in right eye, right leg/arm pain, extreme fatigue.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Insomnia, Rash erythematous
Clinical narrative: Patient developed erythematous welt and several days of "inconsolable crying and not sleeping" after administration of DTaP (Daptacel) at both the 2-month and 4-month well-child visits.  Because the crying and insomnia lasted for several days, it was not entirely attributed to the vaccine after the first adminstration.  Given the same response after the second administration, this report was made.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: After the fourth dose of rabies vaccine administered to this client (Immune Globulin and Imovax Rabies vaccine doses on days 0, 3, and 7 having been given without incident), this patient developed soreness and redness at the area of injection in the left deltoid muscle within a few hours.  Family physician was unable to determine if this was a hypersensitivity reaction or possible cellulitis, so prescribed antibiotic.  Retrospectively she mentioned that the 3rd dose "had been sore and a little red" as well.  The 5th dose scheduled for day 28 was witheld per order of the Health Department Medical Dlirector and corroborated by the Deparatment of Health, the risk for vaccination reaction being considered greater than that for rabies, as contact with the animal (a bat that was not available for testing) was not verifiable.  (It had been in her home for an undetermined amount of time, possible during sleep hours.)
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Full blood count normal, HIV antibody negative, Metabolic function test normal
Clinical narrative: Patient given MMR vaccine on 1/25/08. Patient developed parotitis, excess salivation on 2/4/08. Patient taken off work for 9 days after onset of symptoms and referred to Infectious Disease physician for one time evaluation.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Mononucleosis heterophile test negative, Mumps antibody test, Parotitis, Salivary hypersecretion
Clinical narrative: Patient given MMR vaccine on 1/25/08. Patient developed parotitis, excess salivation on 2/4/08. Patient taken off work for 9 days after onset of symptoms and referred to Infectious Disease physician for one time evaluation.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: 2/14/08 Dx with cellulitis of left arm. Redness and swelling on outer arm to elbow and extends to inner arm 2.5 inches below the elbow. Dr. prescribed Keflex 500mg QID x 10 days, ice, rest and elevation. By the next day pt said arm was much better and today is completely better per phone conversation. (2/22/2008)
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative, Bacterial test negative, Chest X-ray, Culture negative, Delirium
Clinical narrative: Approx 48 hrs after receiving Zostavax pt developed fever 101.3.  Was initially treated for post-vaccine related fever with Tylenol with subsequent resolution of fever.  At approx 72 hrs pt had delirium, incontinence and repeat temp of 103.  Was sent to ED and subsequently required ICU admission for fever control, work-up of altered mental state and worsening rash.  Underwent extensive workup of fever including (and not limited to) CXR, LP, urinalysis, CBC, and MRI brain.  All bacterial and viral cultures were initially negative.  In addition, DFA varicella of skin lesions (rash) was negative.  At present, the cause of pt's febrile illness, delirium and rash continues to remain unclear.  03/24/2008 MR received for DOS 02/18-25/2008 with Transfer DX: Fever, rash, altered mentation 2' to presumed viral syndrome vs varicella vaccine reaction, currently improving, Dementia, Parkinson's Disease, De-conditioning, Hyperlipidemia. Pt presented with worsening mental status, rash and fever (up to 103'F) x 1 week with worsening tremors, confusion and weakness over the past 3 days.  PE (+) for tremor L arm and sometimes the whole body, increased muscle tone, no meaningful content to speech, dry mucus membranes, decreased breath sounds, rash covering entire back, chest and shoulders. Some vesicles with scabbed lesions.  Parkinsonian features. ID and Neuro consults. Pt had significant hypokalemia during hospitalization. Tx with Acyclovir and topical cream to rash. Improvement noted in mentation, tremors and rigidity and reduction in fever noted and D/C to skilled nursing facility.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Incontinence, Influenza serology negative, Intensive care, Lumbar puncture
Clinical narrative: Approx 48 hrs after receiving Zostavax pt developed fever 101.3.  Was initially treated for post-vaccine related fever with Tylenol with subsequent resolution of fever.  At approx 72 hrs pt had delirium, incontinence and repeat temp of 103.  Was sent to ED and subsequently required ICU admission for fever control, work-up of altered mental state and worsening rash.  Underwent extensive workup of fever including (and not limited to) CXR, LP, urinalysis, CBC, and MRI brain.  All bacterial and viral cultures were initially negative.  In addition, DFA varicella of skin lesions (rash) was negative.  At present, the cause of pt's febrile illness, delirium and rash continues to remain unclear.  03/24/2008 MR received for DOS 02/18-25/2008 with Transfer DX: Fever, rash, altered mentation 2' to presumed viral syndrome vs varicella vaccine reaction, currently improving, Dementia, Parkinson's Disease, De-conditioning, Hyperlipidemia. Pt presented with worsening mental status, rash and fever (up to 103'F) x 1 week with worsening tremors, confusion and weakness over the past 3 days.  PE (+) for tremor L arm and sometimes the whole body, increased muscle tone, no meaningful content to speech, dry mucus membranes, decreased breath sounds, rash covering entire back, chest and shoulders. Some vesicles with scabbed lesions.  Parkinsonian features. ID and Neuro consults. Pt had significant hypokalemia during hospitalization. Tx with Acyclovir and topical cream to rash. Improvement noted in mentation, tremors and rigidity and reduction in fever noted and D/C to skilled nursing facility.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Mental status changes, Pyrexia, Rash, Skin lesion, Urine analysis
Clinical narrative: Approx 48 hrs after receiving Zostavax pt developed fever 101.3.  Was initially treated for post-vaccine related fever with Tylenol with subsequent resolution of fever.  At approx 72 hrs pt had delirium, incontinence and repeat temp of 103.  Was sent to ED and subsequently required ICU admission for fever control, work-up of altered mental state and worsening rash.  Underwent extensive workup of fever including (and not limited to) CXR, LP, urinalysis, CBC, and MRI brain.  All bacterial and viral cultures were initially negative.  In addition, DFA varicella of skin lesions (rash) was negative.  At present, the cause of pt's febrile illness, delirium and rash continues to remain unclear.  03/24/2008 MR received for DOS 02/18-25/2008 with Transfer DX: Fever, rash, altered mentation 2' to presumed viral syndrome vs varicella vaccine reaction, currently improving, Dementia, Parkinson's Disease, De-conditioning, Hyperlipidemia. Pt presented with worsening mental status, rash and fever (up to 103'F) x 1 week with worsening tremors, confusion and weakness over the past 3 days.  PE (+) for tremor L arm and sometimes the whole body, increased muscle tone, no meaningful content to speech, dry mucus membranes, decreased breath sounds, rash covering entire back, chest and shoulders. Some vesicles with scabbed lesions.  Parkinsonian features. ID and Neuro consults. Pt had significant hypokalemia during hospitalization. Tx with Acyclovir and topical cream to rash. Improvement noted in mentation, tremors and rigidity and reduction in fever noted and D/C to skilled nursing facility.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral test negative
Clinical narrative: Approx 48 hrs after receiving Zostavax pt developed fever 101.3.  Was initially treated for post-vaccine related fever with Tylenol with subsequent resolution of fever.  At approx 72 hrs pt had delirium, incontinence and repeat temp of 103.  Was sent to ED and subsequently required ICU admission for fever control, work-up of altered mental state and worsening rash.  Underwent extensive workup of fever including (and not limited to) CXR, LP, urinalysis, CBC, and MRI brain.  All bacterial and viral cultures were initially negative.  In addition, DFA varicella of skin lesions (rash) was negative.  At present, the cause of pt's febrile illness, delirium and rash continues to remain unclear.  03/24/2008 MR received for DOS 02/18-25/2008 with Transfer DX: Fever, rash, altered mentation 2' to presumed viral syndrome vs varicella vaccine reaction, currently improving, Dementia, Parkinson's Disease, De-conditioning, Hyperlipidemia. Pt presented with worsening mental status, rash and fever (up to 103'F) x 1 week with worsening tremors, confusion and weakness over the past 3 days.  PE (+) for tremor L arm and sometimes the whole body, increased muscle tone, no meaningful content to speech, dry mucus membranes, decreased breath sounds, rash covering entire back, chest and shoulders. Some vesicles with scabbed lesions.  Parkinsonian features. ID and Neuro consults. Pt had significant hypokalemia during hospitalization. Tx with Acyclovir and topical cream to rash. Improvement noted in mentation, tremors and rigidity and reduction in fever noted and D/C to skilled nursing facility.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: Patient reported tongue swelling and difficulty swallowing on the day after the vaccine was given.  Symptoms were mild and were not brought to my attention for 10 days.  She is still having some tongue swelling after 10 days, however she appears perfectly fine.  She has no difficulty breathing or swallowing.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: 1 week after getting vaccine, pt had numbness of nerve that goes under left side of ribcage. No blisters. Some itching and some tingling. Itched for 1 week. All symptoms then disappeared without treatment.  02/12/2010 Information has been received from a 60 year old female with no medical history or allergies who in fall 2007 was vaccinated with 0.65 ml dose of ZOSTAVAX. Concomitant therapy included MOBIC, NEXIUM, MSD and diabetic medications (unspecified). In 2007, about 3 weeks after vaccination the patient experienced itching from middle of back to abdomen for about 10 days. The patient also stated that her husband had shingles in the past and took Rofecoxib which cured the shingles. No diagnostic laboratory tests were under taken. At the time of report the patient had recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information received from VAERS (Temp, VAERS E-Report Number E21047) indicating that the patient has a drug hypersensitivity to codeine, benign essential hypertension, gastroesophageal reflux disease, type 2 diabetes mellitus, postmenopause and colonic polyp, who on 27-Sep-2007 the patient received a dose of ZOSTAVAX (lot# 654604/1406P) subcutaneously in the left arm. Concomitant therapy included MOBIC, NEXIUM, losartan potassium-HCTZ, sitagliptin phosphate and alavastatin. On 03-Nov-2007, the patient had numbness of nerve that goes under left side of ribcage. No blisters, some itiching and tingling. Itched for one week. All symptoms then disappeared without treatment. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: 1 week after getting vaccine, pt had numbness of nerve that goes under left side of ribcage. No blisters. Some itching and some tingling. Itched for 1 week. All symptoms then disappeared without treatment.  02/12/2010 Information has been received from a 60 year old female with no medical history or allergies who in fall 2007 was vaccinated with 0.65 ml dose of ZOSTAVAX. Concomitant therapy included MOBIC, NEXIUM, MSD and diabetic medications (unspecified). In 2007, about 3 weeks after vaccination the patient experienced itching from middle of back to abdomen for about 10 days. The patient also stated that her husband had shingles in the past and took Rofecoxib which cured the shingles. No diagnostic laboratory tests were under taken. At the time of report the patient had recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information received from VAERS (Temp, VAERS E-Report Number E21047) indicating that the patient has a drug hypersensitivity to codeine, benign essential hypertension, gastroesophageal reflux disease, type 2 diabetes mellitus, postmenopause and colonic polyp, who on 27-Sep-2007 the patient received a dose of ZOSTAVAX (lot# 654604/1406P) subcutaneously in the left arm. Concomitant therapy included MOBIC, NEXIUM, losartan potassium-HCTZ, sitagliptin phosphate and alavastatin. On 03-Nov-2007, the patient had numbness of nerve that goes under left side of ribcage. No blisters, some itiching and tingling. Itched for one week. All symptoms then disappeared without treatment. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Anger, Asthenia, Nausea, Pain, Throat irritation
Clinical narrative: Same day loss of energy, next day scratchy throat, body aches, head spinning, disoriented, slight nuasea, making mistakes at work, easily upset (angry). Asked to sent home early.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Vertigo
Clinical narrative: Same day loss of energy, next day scratchy throat, body aches, head spinning, disoriented, slight nuasea, making mistakes at work, easily upset (angry). Asked to sent home early.
Age: 1.03
Sex: F
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Cyanosis, Dyspnoea, Pyrexia, Rash
Clinical narrative: 2/11/08 patient received MMR, Hep A, Varicella and Flu shot. On 2/19 symptoms of rash began at the head with purple lips.  Rash began moving down the rest of the body with fever of 101+.  On 2/20 she had a fever of 105.2 and rash fully covered body. On 2/22 she is having difficulty breathing...went to the doctor and was told that this will run its course and to give her Motrin.  Benedryl has not helped at all.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Autism, Convulsion, Dyskinesia, Electroencephalogram normal
Clinical narrative: Within 24 hours, patient started having jerky movements that resembled siezure activity. This lasted for four months before slowly going away. It then came back whe he received his next DTaP shot at 15 months.
Age: 0.88
Sex: M
Vaccine: DTAPHEPBIP, FLUX, PPV
Symptoms: Abnormal behaviour, Aphasia, Head banging, Irritability, Pyrexia
Clinical narrative: He had a low grade fever for the first couple of days and was very fussy when he was normally a very laid back baby. He stopped babbling and stopped saying Muma and Dada, which he had been for a couple of months. He stopped looking us in the eye, and then started banging his hand on the high chair for an hour to two hours if we let him. He was no longer interested in his rattles and teethers and started rocking back and forth for hours. We thought it might be a long term problem but were assured by the clinic staff that those are not symptoms of a problem, but we NEVER had those symptoms before these last vaccines. He slowly came out of it, as we refused any more vaccinations, and kept talking to him. We will no longer vaccinate for fear of a more long term reaction.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Influenza, Influenza serology positive, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza type a in a 20-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included diabetes.  Concurrent medications included Insulin.  On 15 November 2007 at 10:45 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 11 February 2008, 88 days after vaccination with Flulaval, the subject experienced high fever, cough and achiness.  On 13 February 2008, the subject tested positive for influenza A antigen and she experienced a vaccination failure.  This case was assessed as medically serious by GSK.  The subject was treated with oseltamivir phosphate (Tamiflu).  At the time of reporting the events were unresolved.  The nurse stated that she felt the causality for Flulaval causing the adverse event is unknown.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza type a in a 20-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included diabetes.  Concurrent medications included Insulin.  On 15 November 2007 at 10:45 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 11 February 2008, 88 days after vaccination with Flulaval, the subject experienced high fever, cough and achiness.  On 13 February 2008, the subject tested positive for influenza A antigen and she experienced a vaccination failure.  This case was assessed as medically serious by GSK.  The subject was treated with oseltamivir phosphate (Tamiflu).  At the time of reporting the events were unresolved.  The nurse stated that she felt the causality for Flulaval causing the adverse event is unknown.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion, Loss of consciousness, Pallor, Tremor
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated via injection with the first dose of Gardasil, (lot number not reported).  Concomitant therapy included BOOSTRIX and MENACTRA.  Subsequently the patient passed out, was pale white, shaking and having convulsions after receiving the first dose of Gardasil.  The physician reported that the patient did not have a seizure.  The physician also reported that it was unknown whether or not the patient would receive the second and third doses of Gardasil.  Subsequently, the patient recovered from passing out, being pale white, shaking and having convulsions.  Unspecified medical attention was sought.  Upon medical review it was determined that convulsions was considered an other important medical event.  Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Vertigo
Clinical narrative: Information has been received from a consumer concerning her 85 year old husband with a history of myocardial infarction and no allergies who in February 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  In February 2007, 3 weeks after vaccination the patient developed a headache then began to develop numbness and paralysis of the right side of his face.  The patient was diagnosed with Bell's Palsy and then diagnosed with RAMSAY-HUNT Syndrome.  The patient lost the hearing in his right ear.  Multiple unspecified diagnostic laboratory tests were undertaken.  It was reported that various MRI's and CT scans were also undertaken.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Upon internal review, lost the hearing in right ear was determined to be an other important medical event.  This was one of several reports received from the same source.  Follow-up information has been received from a physician concerning an 85 year old male with a history of myocardial infarction who on 12-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 656608/0032U).  In approximately March 2007 about 1 month after vaccination, the patient developed shingles in his ear.  The patient also had BELL's PALSY and was droopy on the right and developed RAMSAY HUNT syndrome.  The physician thought the patient was treated with prednisone and acyclovir.  It was also reported that the patient's wife developed BELLS's PALSY (WAES# 0802USA02705).  Subsequently, the patient recovered was noted to be "done fine."  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain.  Additional information has been requested.  5/9/08 Received CT & MRI reports only. 5/13/08 Reviewed PCP medical records of 2/12/2007-1/24/208. FINAL PCP DX: BELL's PALSY, right; RAMSAY HUNT syndrome; post viral symptoms. On 2/12/07 pt w/DJD of hands, cough & congestion.  Returned on 3/19/07 w/pain on the right side of his head, scalp & ear for a few days.  Exam revealed slight inflamed right TM & no tenderness/no rash of scalp.  Returned 3/21 w/right eye & facial droop, HA & right ear pain w/decreased hearing.  Tx w/steroids, antiviral meds & eye ointment/patch.  Referred to ENT & seen 4/4/2007.  Exam revealed patient has bilateral hearing loss w/right increased, dizziness, right ear pain.  Patient had herpetic ulcers w/crusting of right inner & outer ear.  Audiology test revealed sensorineural hearing loss, right worse than left. Referred to neuro & seen 5/1/2007.  Continued w/extreme fatigue, hearing loss & intermittent vertigo but BELL's PALSY had resolved.  Tx w/PT for post viral symptoms & vertigo. To this day, my equilibrium is "off" when I walk. I equate this problem at about 20% vetigo. Also, thru examination I have lost about 60% of my hearing in my right ear. Since my encouter with RAMSAY-HUNT I am extremely tired most of the time.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 03-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 657872/0515U) 0.5 ml IM. On 05-OCT-2007, the patient was vaccinated with a second dose of Gardasil (lot # 658219/0680U 0.5 ml IM. On approximately 07-OCT-2007, about two days after the second dose, the patient developed a raised rash over her entire body. She went to the local emergency room for treatment. She was placed on prednisone dose pack at the emergency room and was then released. Subsequently, she fully recovered about 1 week post vaccination. The nurse felt that the raised red rash was serious and needed intervention (Other Important Medical Event). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil.  Subsequently after receiving the first dose of Gardasil the nurse wanted to draw blood from the patient and the patient started having a seizure.  The patient was taken to the emergency room (ER).  The representative does not know if the patient was admitted.  At the time of reporting the patient had recovered.  No further information was provided.  Upon internal review, seizure was considered to be an important medical event.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Convulsion, Musculoskeletal stiffness, Tetany
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 12-FEB-2008 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 659441/1446U). Concomitant vaccinations given 15 minutes prior to Gardasil included VARIVAX and MENACTRA. On 12-FEB-2008, 5 minutes after vaccination with Gardasil, the patient "stiffened up and looked as though she was having convulsion that lasted about 30 seconds". The physician diagnosed it as "carpo-pedal syndrome." It was reported that the physician "did airway straightening and applied ammonia salt and the patient recovered." The physician considered the patient's "carpo-pedal syndrome" as an other important medical event. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician's assistant (PA), concerning a 14 year old female patient, who on 12-FEB-2008 was vaccinated IM with the second dose, 0.5 ml, of Gardasil (lot # not reported).  Concomitant therapy included diphenhydramine HC1 (BENADRYL).  On 02-FEB-2008, following the vaccination, the patient developed syncope and a seizure.  She was rushed to the emergency room, and was released the same day.  At the time of this report, the patient had recovered (duration and date not specified).  The PA commented she "felt that the vaccine was administered incorrectly by one of the staff."  The PA considered syncope and seizure to be serious as an other important medical event.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Barium double contrast, Blood test, Chest X-ray, Diet refusal, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no pertinent medical history or drug allergies who on 04-JAN-2008 was vaccinated PO with his first 2.0 ml dose of Rotateq (lot# 657984/1169U).  Concomitant vaccinations administered on that same day included a dose of DAPTACEL, a dose of PEDVAXHIB (manufacturer unknown), a dose of PREVNAR and a dose of IPOL (Vero).  On 30-JAN-2008 the patient was admitted to the hospital for 5 days and was initially being worked up for sepsis.  It was noted that the patient did not have "typical intussusception symptoms."  The patient was lethargic, not eating well, and only vomited a small amount.  The patient appeared to be getting better.  On 01-FEB-2008 the patient experienced a bloody stool and was diagnosed with intussusception and underwent surgery for treatment.  Lab diagnostic studies included: abdominal ultrasound, air contrast enema, unspecified blood work, unspecified work up for sepsis, spinal tap and a chest X-ray.  When asked if the patient's experience was life-threatening she replied, "I guess so if not diagnosed).  A section of his bowel had to be removed."  Subsequently, the patient recovered.  There was no product quality complaint.  The physician considered intussusception to be disabling, life-threatening and an other important medical event (surgery).  Additional information has been requested.  4/18/08 Reviewed initial hospital medical records for 1/30-01/01/2008. TRANSFER DX: Intussusception, failed air enema reduction. Records reveal patient experienced lethargy, irritability, vomiting x1, diet refusal.  Exam revealed decreased tone & head lag.  Developed rectal bleeding 2/1 & was transferred emergently to higher level of care for peds surgical consult.   5/1/08 Reviewed hospital medical records for 2/1-2/5/2008. FINAL DX: intussusception w/small bowel obstruction; Meckel's diverticulum. Records reveal patient experienced hyperglycemia & lethargy.   Seen at outlying hospital & transferred w/US revealed IS unable to be reduced by air enema.  Repeat US confirmed IS & repeat air enema failed to reduce.  Taken to OR where findings included necrotic bowel, ileocolic IS & Meckel's diverticulum.  Admitted to PICU for post op hypotension managed w/fluids.  Progressed well, tolerated oral feeds & d/c to home w/additional f/u regarding hyper/hypoglycemic episodes.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intestinal resection, Lethargy, Lumbar puncture, Oral intake reduced, Surgery
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no pertinent medical history or drug allergies who on 04-JAN-2008 was vaccinated PO with his first 2.0 ml dose of Rotateq (lot# 657984/1169U).  Concomitant vaccinations administered on that same day included a dose of DAPTACEL, a dose of PEDVAXHIB (manufacturer unknown), a dose of PREVNAR and a dose of IPOL (Vero).  On 30-JAN-2008 the patient was admitted to the hospital for 5 days and was initially being worked up for sepsis.  It was noted that the patient did not have "typical intussusception symptoms."  The patient was lethargic, not eating well, and only vomited a small amount.  The patient appeared to be getting better.  On 01-FEB-2008 the patient experienced a bloody stool and was diagnosed with intussusception and underwent surgery for treatment.  Lab diagnostic studies included: abdominal ultrasound, air contrast enema, unspecified blood work, unspecified work up for sepsis, spinal tap and a chest X-ray.  When asked if the patient's experience was life-threatening she replied, "I guess so if not diagnosed).  A section of his bowel had to be removed."  Subsequently, the patient recovered.  There was no product quality complaint.  The physician considered intussusception to be disabling, life-threatening and an other important medical event (surgery).  Additional information has been requested.  4/18/08 Reviewed initial hospital medical records for 1/30-01/01/2008. TRANSFER DX: Intussusception, failed air enema reduction. Records reveal patient experienced lethargy, irritability, vomiting x1, diet refusal.  Exam revealed decreased tone & head lag.  Developed rectal bleeding 2/1 & was transferred emergently to higher level of care for peds surgical consult.   5/1/08 Reviewed hospital medical records for 2/1-2/5/2008. FINAL DX: intussusception w/small bowel obstruction; Meckel's diverticulum. Records reveal patient experienced hyperglycemia & lethargy.   Seen at outlying hospital & transferred w/US revealed IS unable to be reduced by air enema.  Repeat US confirmed IS & repeat air enema failed to reduce.  Taken to OR where findings included necrotic bowel, ileocolic IS & Meckel's diverticulum.  Admitted to PICU for post op hypotension managed w/fluids.  Progressed well, tolerated oral feeds & d/c to home w/additional f/u regarding hyper/hypoglycemic episodes.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no pertinent medical history or drug allergies who on 04-JAN-2008 was vaccinated PO with his first 2.0 ml dose of Rotateq (lot# 657984/1169U).  Concomitant vaccinations administered on that same day included a dose of DAPTACEL, a dose of PEDVAXHIB (manufacturer unknown), a dose of PREVNAR and a dose of IPOL (Vero).  On 30-JAN-2008 the patient was admitted to the hospital for 5 days and was initially being worked up for sepsis.  It was noted that the patient did not have "typical intussusception symptoms."  The patient was lethargic, not eating well, and only vomited a small amount.  The patient appeared to be getting better.  On 01-FEB-2008 the patient experienced a bloody stool and was diagnosed with intussusception and underwent surgery for treatment.  Lab diagnostic studies included: abdominal ultrasound, air contrast enema, unspecified blood work, unspecified work up for sepsis, spinal tap and a chest X-ray.  When asked if the patient's experience was life-threatening she replied, "I guess so if not diagnosed).  A section of his bowel had to be removed."  Subsequently, the patient recovered.  There was no product quality complaint.  The physician considered intussusception to be disabling, life-threatening and an other important medical event (surgery).  Additional information has been requested.  4/18/08 Reviewed initial hospital medical records for 1/30-01/01/2008. TRANSFER DX: Intussusception, failed air enema reduction. Records reveal patient experienced lethargy, irritability, vomiting x1, diet refusal.  Exam revealed decreased tone & head lag.  Developed rectal bleeding 2/1 & was transferred emergently to higher level of care for peds surgical consult.   5/1/08 Reviewed hospital medical records for 2/1-2/5/2008. FINAL DX: intussusception w/small bowel obstruction; Meckel's diverticulum. Records reveal patient experienced hyperglycemia & lethargy.   Seen at outlying hospital & transferred w/US revealed IS unable to be reduced by air enema.  Repeat US confirmed IS & repeat air enema failed to reduce.  Taken to OR where findings included necrotic bowel, ileocolic IS & Meckel's diverticulum.  Admitted to PICU for post op hypotension managed w/fluids.  Progressed well, tolerated oral feeds & d/c to home w/additional f/u regarding hyper/hypoglycemic episodes.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Enema administration, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 23-JAN-2008 was vaccinated with ROTATEQ (Lot #657673/0904U) PO first dose.  On 24-JAN-2008 the patient developed abdominal pain and bloody stool and was colicky at night.  The physician performed an air enema which was negative.  Therapy with ROTATEQ was discontinued.  Subsequently, the patient recovered from colic, abdominal pain and bloody stool.  There was no product quality complaint.  Colicky, abdominal pain and bloody stool were considered to be disabling.  Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood culture positive, CSF culture positive, Meningitis bacterial, Pneumococcal bacteraemia, Pyrexia
Clinical narrative: Pt given vaccines early afternoon on 2/14 -> pt starting having fevers of 103 degrees F that night.  Pt started vomiting on 2/17.  Pt transferred to hospital after found to have positive S. pneumo bacteremia and bacterial meningitis. 3/20/08-records received for DOS 2/18-3/3/08-DC DX:Meningitis, sepsis. Evening of vaccinations, developed fever up to 103. Patchy purple areas on body and limbs. Fevers continued for next 2 days, decreased oral intake and decreased wet diapers. Difficult to arouse. Vomited. Positive pain with neck movement. Sensitive to light. Urinalysis positive for urinary tract infection.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Streptococcal bacteraemia, Vomiting
Clinical narrative: Pt given vaccines early afternoon on 2/14 -> pt starting having fevers of 103 degrees F that night.  Pt started vomiting on 2/17.  Pt transferred to hospital after found to have positive S. pneumo bacteremia and bacterial meningitis. 3/20/08-records received for DOS 2/18-3/3/08-DC DX:Meningitis, sepsis. Evening of vaccinations, developed fever up to 103. Patchy purple areas on body and limbs. Fevers continued for next 2 days, decreased oral intake and decreased wet diapers. Difficult to arouse. Vomited. Positive pain with neck movement. Sensitive to light. Urinalysis positive for urinary tract infection.
Age: 23.0
Sex: M
Vaccine: ANTH, FLUN3, HEP, HEPA, SMALL
Symptoms: Abdominal pain, Biopsy colon abnormal, Biopsy intestine abnormal, Clostridial infection, Clostridium difficile toxin test positive
Clinical narrative: Healthy 24 year old preparing for deployment. Symptom onset on 31 Oct 2007 (within 24 hours post-vaccinations: Pan at AVA vaccination site, nausea, diarrhea (every time he ate it 'went through' him). Presenting complaint to Clinic on day 16 post-vaccination: 2 week history of abdominal cramping and diarrhea. Diagnosed as gastroenteritis and treated with IVFs, Bentyl, Lomotil, Acidophilus. Temporarily felt better after taking meds, but symptoms returned after 2-3 hours. Admitted to hospital with Diagnosis: Infectious Colitis secondary to C. diff, LUE. Admission date: 26 Nov 2007, Discharge Date: 18 Dec 2007. Upon discharge, symptoms had improved but not completely resolved. Worsened in early Jan and patient re-admitted on 5 Jan with discharge on 5 Feb. Working dx is inflammatory bowel disease and pt was discharged on oral steroids.  3/7/08 Received hospital medical records for 11/26-12/18/2007 admission which reveal: FINAL DX: infectious collitis secondary to c. difficile secondary to debilitated immunity; RUE thrombophlebitis. HPI: Patient experienced bloody diarrhea x 1 mo w/pain & abdominal cramping.  Patient passed out & came to ER.  Tx w/IVF, IV & oralantibiotics.  GI & ID consults done.  PICC line inserted for IV/TPN nutrition but removed due to basilic vein thrombophlebitis.  Gradually improved & d/c to home w/GI clinic f/u. 1/20/2010 SCE ECDE rolo with Biopsy ripoas -FBS 09 02/05/2010 Diagnosed with Ulcerative Colitis.