chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis, Nausea, Nuclear magnetic resonance imaging, Pain, Phonophobia
Clinical narrative: Gardasil shots - 1st shot (11/12/07) Painful at shot location and had a dull headache November through January.  2nd Shot (1/23/08)Pain at immunization site for a couple of weeks.  Developed cold and sinus issues by the next day.  Migraine type headache (very painful) began on 01/30/08. She began having major fatigue,dizziness, muscle pain, major sensitivity to light and sound, nausea and vomiting. We had several tests ran and trips to the emergency room.  She had CT scans, MRI of head and neck, and lumbar puncture.  She was out of school for 3 months unable to concentrate, short term memory loss, continuous pain (head and body).  Improved enough after doctors, medications, massage therapists to return to school for the last month and a half.  3rd shot (06/03/08)with 3 other shots.  She developed a cold sinus and her headache came back within a week to a worse level that before.  Her headache has never went away since January 30th.  She has muscle pain and spasms, short term memory loss, lethargic, dizziness, major sensitivity to light and sounds, nausea and vomiting.  She has no energy and basically has had no life for the last 11 months of her life.  12/19/2008 MR received from PCP. Seen 11/12/07 for 1st HPV and Flu vax.  Returned 11/27/07 with c/o chills, low grade fever, tight neck muscles. Dx:  Nausea, Vomiting. 2nd HPV 1/23/08. Returned  1/30/08 with c/o fatigue. Dx:  sinusitis/pharyngitis. Returned 2/5/08 with c/o h/a, neck soreness, productive cough and light sensitivity. Dx:  H/A. F/U visit 6/3/08 for hospital stay for h/a and 3rd HPV, to f/u with neurologist. OV 8/8/08 with c/o muscle spasms on back with shooting pain down left. DX:  Muscle spasm ? Polymyositis. Tx with Flexeril. OV 8/22/08 with c/o worsening H/A, nausea, and photo/phono phobia. DX: Tension H/a.  To see neurologist. 1/12/09 MR received for 2 ER visits and one outpt visit. Pt presented to ER on 2/26/08 with c/o 3 1/2 week hx of constant frontal h/A with intermittent emesis.  No releif with previously prescibed meds.  (+) photophobia.  PE WNL. To f/u with Neuro. Dx:  Migraine. Returned 3/10/08 with c/o H/A, worse at night disturbing sleep.  PE WNL. LP done to assess pressure-16. DX:  H/A. D/C to f/u with Neuro. Neuro visit 3/20/08 for persistant H/A (7 weeks) with photo and phonophobia. Pt reports depressed mood without energy and anxiety 2' to this condition and missing school as well. Dx: H/A.  Recommended psych eval.  1/29/09 MR received from neurologist dated 9/2/08 to 1/6/09 with DX: Chronic daily H/A, muscle spasms/fibromyalgia, functional L hemiparesis. Pt reports onset of H/A with photo/phonophobia after 1st HPV vax 11/12/2007.  Following Worsening of sx following subsequent vax, now with chronic daily H/A with minimal response from multiple medications, accupucture and chiropractic. PEs show no papilledema. PE 1/6/09 (+) for give-way weakness.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Sinusitis, Vomiting
Clinical narrative: Gardasil shots - 1st shot (11/12/07) Painful at shot location and had a dull headache November through January.  2nd Shot (1/23/08)Pain at immunization site for a couple of weeks.  Developed cold and sinus issues by the next day.  Migraine type headache (very painful) began on 01/30/08. She began having major fatigue,dizziness, muscle pain, major sensitivity to light and sound, nausea and vomiting. We had several tests ran and trips to the emergency room.  She had CT scans, MRI of head and neck, and lumbar puncture.  She was out of school for 3 months unable to concentrate, short term memory loss, continuous pain (head and body).  Improved enough after doctors, medications, massage therapists to return to school for the last month and a half.  3rd shot (06/03/08)with 3 other shots.  She developed a cold sinus and her headache came back within a week to a worse level that before.  Her headache has never went away since January 30th.  She has muscle pain and spasms, short term memory loss, lethargic, dizziness, major sensitivity to light and sounds, nausea and vomiting.  She has no energy and basically has had no life for the last 11 months of her life.  12/19/2008 MR received from PCP. Seen 11/12/07 for 1st HPV and Flu vax.  Returned 11/27/07 with c/o chills, low grade fever, tight neck muscles. Dx:  Nausea, Vomiting. 2nd HPV 1/23/08. Returned  1/30/08 with c/o fatigue. Dx:  sinusitis/pharyngitis. Returned 2/5/08 with c/o h/a, neck soreness, productive cough and light sensitivity. Dx:  H/A. F/U visit 6/3/08 for hospital stay for h/a and 3rd HPV, to f/u with neurologist. OV 8/8/08 with c/o muscle spasms on back with shooting pain down left. DX:  Muscle spasm ? Polymyositis. Tx with Flexeril. OV 8/22/08 with c/o worsening H/A, nausea, and photo/phono phobia. DX: Tension H/a.  To see neurologist. 1/12/09 MR received for 2 ER visits and one outpt visit. Pt presented to ER on 2/26/08 with c/o 3 1/2 week hx of constant frontal h/A with intermittent emesis.  No releif with previously prescibed meds.  (+) photophobia.  PE WNL. To f/u with Neuro. Dx:  Migraine. Returned 3/10/08 with c/o H/A, worse at night disturbing sleep.  PE WNL. LP done to assess pressure-16. DX:  H/A. D/C to f/u with Neuro. Neuro visit 3/20/08 for persistant H/A (7 weeks) with photo and phonophobia. Pt reports depressed mood without energy and anxiety 2' to this condition and missing school as well. Dx: H/A.  Recommended psych eval.  1/29/09 MR received from neurologist dated 9/2/08 to 1/6/09 with DX: Chronic daily H/A, muscle spasms/fibromyalgia, functional L hemiparesis. Pt reports onset of H/A with photo/phonophobia after 1st HPV vax 11/12/2007.  Following Worsening of sx following subsequent vax, now with chronic daily H/A with minimal response from multiple medications, accupucture and chiropractic. PEs show no papilledema. PE 1/6/09 (+) for give-way weakness.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Anorexia, Dizziness, Electrocardiogram normal, Headache, Hot flush
Clinical narrative: Within 15" of shot became hot/flush. Head became dizzy. Laid down & was better.  Each time I got up my head was very bad - dizzy, I guess. I threw up in the afternoon (rec'd flu shot at 10 am 11-17-08).  Went to doctor, everything ok, including an EKG. Lasted all day.  Couldn't eat. To bed at 10:30 pm & slept ok. Next morning, pretty much ok. Some residual headache.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Within 15" of shot became hot/flush. Head became dizzy. Laid down & was better.  Each time I got up my head was very bad - dizzy, I guess. I threw up in the afternoon (rec'd flu shot at 10 am 11-17-08).  Went to doctor, everything ok, including an EKG. Lasted all day.  Couldn't eat. To bed at 10:30 pm & slept ok. Next morning, pretty much ok. Some residual headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: 11-11-2008 Developed rash on right buttocks and right legs with itchiness and pain.  Saw Dr. on 11-13-08 Diagnosis Shingles Rx Zovirax pills and Kenalog cream given.  Spoke with patient on 11-18-08 patient states rash looks like it is getting better.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Death, Hypersensitivity, Oedema peripheral, Rash, Vasculitis
Clinical narrative: she presneted 10/23 for a blood pressure check up and in the course of that we did an annual flu shot for her. See the flu shot note:        10/23/08 The following questions were answered by the patient: Are you currently ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No Have you ever had a severe allergic reaction after getting the flu vaccine? (difficulty breathing, aiway swelling, hives, etc.) No Patient was given the opportunity to ask questions prior to immunization and have them answered to their satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009 Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08 Dose: 0.5 ml Site: left deltoid  She then reproted on 10/31 with swelling in hands and feet and rash. It looked like allergic reaction. she was not ill so we treated her as an out patient. she called a few days later and was getting worse. I had her admitted to hospital. I have not received a formal report. One of the diagnosis that was on the top of the list was influenza vaccine vasculitis. she was not getting better. The Dr. that was caring for her reported that her dau, a hospice nurse talked to her about what was going on and patient decieded to not have any more needle pokes or evaluation. She was sent to nursing home and died the next day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis. acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated. Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate states COD as acute renal failure with vasculitis & immunologic reaction as contributing factors.
Age: 1.25
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site haematoma, Injection site mass
Clinical narrative: Very red at site of injection. Have never had any adverse reaction from any shots for first yr,  had two flu shots last yr with no problem.  Bruising and large bump under skin at site of injection. Continues to have medium bump under skin where she was given the shot.  Two other shots given that day with no other problems reported or noted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Fall, Hypokinesia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: IMMEDIATELY AFTER SHOT THERE WAS SWELLING AND A BRUISE THAT LASTED FOR 2 WEEKS. WHEN THE SWELLING AND BRUISE BEGIN TO GO AWAY PAIN BEGIN IN THE JOINTS OF MY KNEES, SHOULDERS, ELBOWS, AND HANDS ALONG WITH SWELLING SO SEVERE I CANNOT BEND MY FINGERS OR RAISE MY ARMS ABOVE MY SHOULDERS IN THE MORNINGS. I SAW MY DOCTOR TWICE FOR THESE PROBLEMS BEFORE BLACKING OUT AND FALLING. I WAS HOSPITALIZATED OVERNIGHT. ALL TESTS AND SCANS HAVE COME BACK COMPLETELY NORMAL. THE DOCTOR THINKS THE VIRUS HAS SETTLED IN MY JOINTS. THIS PAIN HAS BEEN CONSTANT AND ONGOING FOR 3 WEEK.  12/5/08 Reviewed hospital medical records of 11/13-11/14/2008. FINAL DX: syncope, probable vasovagal; facial contusion; severe myalgia w/muscle weakness. Records reveal patient experienced syncope in shower, fall, unconsciousness, facial contusions w/nasal laceration & leg pain x 1 day.  Also complaining of joint aching, muscle aching since 10/28.  Had been tx by PCP as outpatient w/antibiotics & steroids which helped but when steroids tapered, symptoms recurred.  No further episodes while hospitalized.  D/C to home w/referral to neuro as outpatient.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Viral infection
Clinical narrative: IMMEDIATELY AFTER SHOT THERE WAS SWELLING AND A BRUISE THAT LASTED FOR 2 WEEKS. WHEN THE SWELLING AND BRUISE BEGIN TO GO AWAY PAIN BEGIN IN THE JOINTS OF MY KNEES, SHOULDERS, ELBOWS, AND HANDS ALONG WITH SWELLING SO SEVERE I CANNOT BEND MY FINGERS OR RAISE MY ARMS ABOVE MY SHOULDERS IN THE MORNINGS. I SAW MY DOCTOR TWICE FOR THESE PROBLEMS BEFORE BLACKING OUT AND FALLING. I WAS HOSPITALIZATED OVERNIGHT. ALL TESTS AND SCANS HAVE COME BACK COMPLETELY NORMAL. THE DOCTOR THINKS THE VIRUS HAS SETTLED IN MY JOINTS. THIS PAIN HAS BEEN CONSTANT AND ONGOING FOR 3 WEEK.  12/5/08 Reviewed hospital medical records of 11/13-11/14/2008. FINAL DX: syncope, probable vasovagal; facial contusion; severe myalgia w/muscle weakness. Records reveal patient experienced syncope in shower, fall, unconsciousness, facial contusions w/nasal laceration & leg pain x 1 day.  Also complaining of joint aching, muscle aching since 10/28.  Had been tx by PCP as outpatient w/antibiotics & steroids which helped but when steroids tapered, symptoms recurred.  No further episodes while hospitalized.  D/C to home w/referral to neuro as outpatient.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Fluid replacement, Ultrasound abdomen normal, Vomiting
Clinical narrative: Bloody diarrhea, vomiting, no fever. Required IV fluids in ER for 6 hours and improved  Neg US for intussception
Age: 31.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: Received vaccine on 11/13/08 and developed itchy rash that spread on arms, legs, face. Evaluated on 11/17/08 and dx with chicken pox.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Dizziness, fever, nausea and generalized aches all with 24hrs of receiving MENACTRA vaccine
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Dizziness, fever, nausea and generalized aches all with 24hrs of receiving MENACTRA vaccine
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: Hives within 48 hour of administering the flu mist. No fever noted. BENADRYL recommended. No reaction to injectable flu 1 year ago.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Musculoskeletal pain, Toothache
Clinical narrative: On 11/18/2008 patient called and stated she was having tooth, stomach, shoulder and elbow pain, she was concerned that this was related to her vaccination. We have tried to contact her again but have not gotten a response.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Instantly caused deep pain during injection
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Familial risk factor, Malaise
Clinical narrative: After receiving flu vaccine pt walked over to recovery after pt stated he didn't feel very well - placed head between knees. B/P - 127/70, P - 70. Pt then laid flat for a few minutes without drinking anything. Placed  in W/C and brought to clinic for MD check when he felt well and was dismissed. He noted everyone in his family gets sick with shots.
Age: 22.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Rash
Clinical narrative: Right after vaccination, pt experiences soreness in left arm (whole left arm), tingly feeling in left arm. patchy light rash on arm went away after about 10 min. and appears on left palm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Full blood count, Haemoglobin normal, Headache, Influenza serology negative
Clinical narrative: Pt had flu shot 10/29/08 at 8:30AM, by 12:30pm she developed symptoms of headache, muscle aches, fever (101 6/0), fatigue.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: Pt had flu shot 10/29/08 at 8:30AM, by 12:30pm she developed symptoms of headache, muscle aches, fever (101 6/0), fatigue.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Persistent deltoid pain esp. w/abduction. Onset w/vaccination
Age: 22.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Dyspnoea, Heart rate, Neck pain, Oxygen saturation
Clinical narrative: 9:00am Both vaccines administered, 9:04am c/e (R) side pain in neck, feeling dizzy, 9:08am Assessed by NP - oral liquid BENADRYL 50 mg given, 9:15 No relief from BENADRYL, breathing worse, Epi - Pin injected; 10:00am Symptoms of SOB continue, 25mg injectable BENADRYL given; 10:20am 911 called, patient transported to ER for further eval.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Antibody test negative, Ascites, Biopsy kidney abnormal, Bronchoscopy, Chromaturia
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Cytomegalovirus antibody negative, Diffuse alveolar damage, Dyspnoea, Generalised oedema, Glomerulonephropathy
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Histology, Nephrotic syndrome, Oedema, Pleural effusion, Purpura
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Respiratory distress, Rheumatoid factor positive, Streptococcal identification test negative, Syphilis test negative, Virus culture
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Arthralgia, Biopsy bronchus abnormal, Biopsy kidney abnormal, Bronchoalveolar lavage abnormal, Bronchoscopy
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Chest X-ray normal, Computerised tomogram thorax abnormal, Cough, Diffuse alveolar damage, Glomerulonephritis rapidly progressive
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Haemoptysis, Henoch-Schonlein purpura, Inflammation, Macrophages increased, Oedema peripheral
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Pain, Pitting oedema, Pleural effusion, Proteinuria, Pulmonary alveolar haemorrhage
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Rash erythematous, Renal failure acute, Respiratory distress
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Acute respiratory distress syndrome, Arthralgia, Biopsy kidney abnormal, Biopsy lung, Bronchial haemorrhage
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Bronchoalveolar lavage abnormal, Bronchoscopy, Chest X-ray normal, Computerised tomogram abnormal, Cough
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Diffuse alveolar damage, Glomerulonephritis rapidly progressive, Haemoptysis, Henoch-Schonlein purpura, Inflammation
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Laboratory test abnormal, Lung infiltration, Macrophages increased, Oedema peripheral, Pain
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Pitting oedema, Pleural effusion, Proteinuria, Pulmonary haemosiderosis, Rash erythematous
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Rash papular, Renal failure acute
Clinical narrative: Information has been received from a published abstract concerning a 26 year old male, who, on an unspecified date, was vaccinated with a dose of RECOMBIVAX HB. Subsequently, the patient developed arthralgias, bilateral lower extremity edema, and a painful erythematous rash, one week after receiving the vaccination. A physical exam of the patient revealed normal vital signs and a comfortable appearing patient. The patient had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. An admission chest x-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, a computed axial tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloddy aliquots and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture, and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage. A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of HSP. After treatment with corticosteroids and cyclophosphamide, the diffuse alveolar hemorrhage resolved and the glomerulonephritis stabilized. Upon internal review Henoch-Schonlein Purpura was considered to be an other important medical event. Additional information has been requested. Attached is a copy of the published abstract as further documentation of the patient's experience.
Age: 12.9
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Facial pain, Facial palsy, Hypoaesthesia facial, Neurological examination, Similar reaction on previous exposure to drug
Clinical narrative: 11/7/08: Pt. c/o tingling of her tongue over the past week. Move up this arm, cannot smile, taste, or completely close (L) eye. Pt.'s mother concerned b/c GARDASIL + HAVRIX given 11/6/08. Dr. documented pt. with cold sores (L) corner of her mouth. Pt. was Dx with Bell's Palsy and placed on Prednisone 40 mg x 7 days, Acyclovir 20 mg x 7 days and pt. was to return to clinic in 1 week for a follow-up.
Age: 12.9
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Ageusia, Facial palsy, Oral herpes, Paraesthesia oral
Clinical narrative: 11/7/08: Pt. c/o tingling of her tongue over the past week. Move up this arm, cannot smile, taste, or completely close (L) eye. Pt.'s mother concerned b/c GARDASIL + HAVRIX given 11/6/08. Dr. documented pt. with cold sores (L) corner of her mouth. Pt. was Dx with Bell's Palsy and placed on Prednisone 40 mg x 7 days, Acyclovir 20 mg x 7 days and pt. was to return to clinic in 1 week for a follow-up.
Age: 12.9
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Ageusia, Facial palsy, Facial paresis, Oral herpes, Paraesthesia
Clinical narrative: 11/7/08: Pt. c/o tingling of her tongue over the past week. Move up this arm, cannot smile, taste, or completely close (L) eye. Pt.'s mother concerned b/c GARDASIL + HAVRIX given 11/6/08. Dr. documented pt. with cold sores (L) corner of her mouth. Pt. was Dx with Bell's Palsy and placed on Prednisone 40 mg x 7 days, Acyclovir 20 mg x 7 days and pt. was to return to clinic in 1 week for a follow-up.
Age: 12.9
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Paraesthesia oral
Clinical narrative: 11/7/08: Pt. c/o tingling of her tongue over the past week. Move up this arm, cannot smile, taste, or completely close (L) eye. Pt.'s mother concerned b/c GARDASIL + HAVRIX given 11/6/08. Dr. documented pt. with cold sores (L) corner of her mouth. Pt. was Dx with Bell's Palsy and placed on Prednisone 40 mg x 7 days, Acyclovir 20 mg x 7 days and pt. was to return to clinic in 1 week for a follow-up.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal dreams, Dizziness, Mobility decreased
Clinical narrative: light headed shortly after shot, had nap with odd dreams woke up went to sleep three hours later. about 4 am i was awake but could not move at all.all i could do is make small sounds untill someone could shake me and the rest of me was fine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash pustular
Clinical narrative: Two days after my flu shot I broke out in a severe rash on my legs. It is raised red bumps that itch severely. I also broke out with pustules (pencil eraser to dime-sized) on my back and stomach. Other than the flu shot there were no changes to my diet or medication during this time, so I drew the conclusion that it must be an adverse reaction to the vaccination.