chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Electromyogram abnormal, Feeling abnormal, Hypoaesthesia, Hypokinesia
Clinical narrative: 10/19 begin to feel bad, 10/21 high fever will not come down even with Tylenol or Advil,  10/24 ER chest X ray diagnosed with pneumonia, 10/25 Dr appt to check medication, 10/29 noticed weakness in legs beginning in morning balance problems and weakness worsen, 10/30, ambulance to ER, 11/02 spinal tap clear symptoms paralysis, foot drop, muscle spasms, inflamed nerve endings in legs and feet, 11/04 transferred to another hospital, 11/04 extremely high protein level in blood due to deterioration of muscles. Start on baclofen to stop spasms, 11/09 protein level back to normal, 11/11 transferred to rehab Unit cannot walk at all, 11/14-22 physical therapy 4 times a day for 45 minutes. Learn to walk again, balance problems, diagnosed with Post infectious myositis, released 11/22 on going therapy to improve function. 11/25 begin outpatient therapy 3 times a week on going due to peroneal nerve damage in feet. I have peroneal neuropathy- foot drop due to flu vacine. Swelling of feet and ankles, pain in feet, decreased movement, no feeling in toes ore feet. Still go to physicial therapy to regain strength and flexability. Constatn muscle spasms in feet. Nerve damage from ankles down. 3/31/2010 Follow up: No feeling in feet and legs due to damage to peroneal nerve. Loss of movement in ankles/swelling in feet neurological problems-short term memory loss, difficulty in concentration and difficulty finding words and thoughts.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Infective myositis, Joint swelling, Laboratory test abnormal, Lack of spontaneous speech, Lumbar puncture normal
Clinical narrative: 10/19 begin to feel bad, 10/21 high fever will not come down even with Tylenol or Advil,  10/24 ER chest X ray diagnosed with pneumonia, 10/25 Dr appt to check medication, 10/29 noticed weakness in legs beginning in morning balance problems and weakness worsen, 10/30, ambulance to ER, 11/02 spinal tap clear symptoms paralysis, foot drop, muscle spasms, inflamed nerve endings in legs and feet, 11/04 transferred to another hospital, 11/04 extremely high protein level in blood due to deterioration of muscles. Start on baclofen to stop spasms, 11/09 protein level back to normal, 11/11 transferred to rehab Unit cannot walk at all, 11/14-22 physical therapy 4 times a day for 45 minutes. Learn to walk again, balance problems, diagnosed with Post infectious myositis, released 11/22 on going therapy to improve function. 11/25 begin outpatient therapy 3 times a week on going due to peroneal nerve damage in feet. I have peroneal neuropathy- foot drop due to flu vacine. Swelling of feet and ankles, pain in feet, decreased movement, no feeling in toes ore feet. Still go to physicial therapy to regain strength and flexability. Constatn muscle spasms in feet. Nerve damage from ankles down. 3/31/2010 Follow up: No feeling in feet and legs due to damage to peroneal nerve. Loss of movement in ankles/swelling in feet neurological problems-short term memory loss, difficulty in concentration and difficulty finding words and thoughts.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle atrophy, Muscle spasms, Muscular weakness, Nerve injury, Neuropathy
Clinical narrative: 10/19 begin to feel bad, 10/21 high fever will not come down even with Tylenol or Advil,  10/24 ER chest X ray diagnosed with pneumonia, 10/25 Dr appt to check medication, 10/29 noticed weakness in legs beginning in morning balance problems and weakness worsen, 10/30, ambulance to ER, 11/02 spinal tap clear symptoms paralysis, foot drop, muscle spasms, inflamed nerve endings in legs and feet, 11/04 transferred to another hospital, 11/04 extremely high protein level in blood due to deterioration of muscles. Start on baclofen to stop spasms, 11/09 protein level back to normal, 11/11 transferred to rehab Unit cannot walk at all, 11/14-22 physical therapy 4 times a day for 45 minutes. Learn to walk again, balance problems, diagnosed with Post infectious myositis, released 11/22 on going therapy to improve function. 11/25 begin outpatient therapy 3 times a week on going due to peroneal nerve damage in feet. I have peroneal neuropathy- foot drop due to flu vacine. Swelling of feet and ankles, pain in feet, decreased movement, no feeling in toes ore feet. Still go to physicial therapy to regain strength and flexability. Constatn muscle spasms in feet. Nerve damage from ankles down. 3/31/2010 Follow up: No feeling in feet and legs due to damage to peroneal nerve. Loss of movement in ankles/swelling in feet neurological problems-short term memory loss, difficulty in concentration and difficulty finding words and thoughts.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Oedema peripheral, Pain in extremity, Paralysis, Peroneal nerve palsy
Clinical narrative: 10/19 begin to feel bad, 10/21 high fever will not come down even with Tylenol or Advil,  10/24 ER chest X ray diagnosed with pneumonia, 10/25 Dr appt to check medication, 10/29 noticed weakness in legs beginning in morning balance problems and weakness worsen, 10/30, ambulance to ER, 11/02 spinal tap clear symptoms paralysis, foot drop, muscle spasms, inflamed nerve endings in legs and feet, 11/04 transferred to another hospital, 11/04 extremely high protein level in blood due to deterioration of muscles. Start on baclofen to stop spasms, 11/09 protein level back to normal, 11/11 transferred to rehab Unit cannot walk at all, 11/14-22 physical therapy 4 times a day for 45 minutes. Learn to walk again, balance problems, diagnosed with Post infectious myositis, released 11/22 on going therapy to improve function. 11/25 begin outpatient therapy 3 times a week on going due to peroneal nerve damage in feet. I have peroneal neuropathy- foot drop due to flu vacine. Swelling of feet and ankles, pain in feet, decreased movement, no feeling in toes ore feet. Still go to physicial therapy to regain strength and flexability. Constatn muscle spasms in feet. Nerve damage from ankles down. 3/31/2010 Follow up: No feeling in feet and legs due to damage to peroneal nerve. Loss of movement in ankles/swelling in feet neurological problems-short term memory loss, difficulty in concentration and difficulty finding words and thoughts.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Protein total increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: 10/19 begin to feel bad, 10/21 high fever will not come down even with Tylenol or Advil,  10/24 ER chest X ray diagnosed with pneumonia, 10/25 Dr appt to check medication, 10/29 noticed weakness in legs beginning in morning balance problems and weakness worsen, 10/30, ambulance to ER, 11/02 spinal tap clear symptoms paralysis, foot drop, muscle spasms, inflamed nerve endings in legs and feet, 11/04 transferred to another hospital, 11/04 extremely high protein level in blood due to deterioration of muscles. Start on baclofen to stop spasms, 11/09 protein level back to normal, 11/11 transferred to rehab Unit cannot walk at all, 11/14-22 physical therapy 4 times a day for 45 minutes. Learn to walk again, balance problems, diagnosed with Post infectious myositis, released 11/22 on going therapy to improve function. 11/25 begin outpatient therapy 3 times a week on going due to peroneal nerve damage in feet. I have peroneal neuropathy- foot drop due to flu vacine. Swelling of feet and ankles, pain in feet, decreased movement, no feeling in toes ore feet. Still go to physicial therapy to regain strength and flexability. Constatn muscle spasms in feet. Nerve damage from ankles down. 3/31/2010 Follow up: No feeling in feet and legs due to damage to peroneal nerve. Loss of movement in ankles/swelling in feet neurological problems-short term memory loss, difficulty in concentration and difficulty finding words and thoughts.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Rash, Rash erythematous
Clinical narrative: Patient reportedly developed tiny, confluent fine raised rash on face-cheeks and forehead and at site of flu injection-upper L arm.  Non-erythematous, non-puritic, denies itching, difficulty breathing, swelling, hoarseness, wheezing, dizziness or fast heart rate.  Occurs 2 days after fluzone administration.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Laboratory test abnormal
Clinical narrative: Description: Developed chest pain several weeks after receipt of SPV.  Was seen in the ER.  He saw a civilian cardiologist a few days later and was cleared.  He is currently asymptomatic.  Symptom: Chest Pain Start: 03/11/2003; Symptom: Dyspnea (shortness of breath) Start: 03/11/2003; Symptom: Dizziness Start: 03/11/2003; Symptom: Chills Start: 03/11/2003.
Age: 1.07
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Erythema, Oedema, Rash papular
Clinical narrative: Right lateral thigh erythematous and mildly edematous.  Slim papule radule surrounding injection site.  Erythematous area measured 4cm x 4 1/2cm.  Full ROM to leg-appears in no discomfort-walks well.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Pain
Clinical narrative: Large area of induration over left deltoid muscle. Negative redness but painful.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema
Clinical narrative: L deltoid redness 2 days after vaccine (immunization 1/17/06) pt had IPV, Dtap.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Eye swelling, Movement disorder, Pain, Urticaria
Clinical narrative: After 1 day post imm. started hives at face, puffiness of eyes-redness of sclera, body ache, rocking problems. Mother gave BENADRYL and symptoms resolved.
Age: 52.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Lethargy, Skin reaction
Clinical narrative: Streaks on R arm one day post vaccine.  General lethargy and seen by Dr. on 2/2/06 at 7pm.  Received hydrocortisone shot and Augmentin
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Dysuria, Oral intake reduced, Pyrexia, Vomiting
Clinical narrative: Few hours after vaccine administered, patient inconsolable crying, vomited, fever (102), decreased PO intake, decreased urine output. Pt had to be given IV fluids. Then did well.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Rash, Rash macular, Rash papular
Clinical narrative: A maculopapular erythematous rash developed within 2 weeks of vaccine.  Administration of MMR.  No fever or pruritus noted.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: A maculopapular erythematous rash developed within 2 weeks of vaccine.  Administration of MMR.  No fever or pruritus noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: In for immunization.  Later in evening noted to have large red spot on L shoulder/upper arm.  Initially complained of itching at site.
Age: 4.0
Sex: F
Vaccine: DPP
Symptoms: Decreased appetite, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: DTaP administered by health dept 2/1/06.  Pt. seen 2/3/06 A.M. with erythema, warmth, induration, swelling, tenderness to entire upper left arm and extending just below elbow, including circumference of arm.  Mom also reports decreased appetite.  No fever, chills, SOB. No improvement with mom's application of cool compresses.  Recommended mom continue cool compresses and use Tylenol/Motrin for pain relief, monitor child closely for any new/additional symptoms.
Age: 4.0
Sex: F
Vaccine: DPP
Symptoms: Tenderness
Clinical narrative: DTaP administered by health dept 2/1/06.  Pt. seen 2/3/06 A.M. with erythema, warmth, induration, swelling, tenderness to entire upper left arm and extending just below elbow, including circumference of arm.  Mom also reports decreased appetite.  No fever, chills, SOB. No improvement with mom's application of cool compresses.  Recommended mom continue cool compresses and use Tylenol/Motrin for pain relief, monitor child closely for any new/additional symptoms.
Age: 1.51
Sex: F
Vaccine: FLU3
Symptoms: Drug ineffective, Viral infection
Clinical narrative: 1/2 dose flu shot on 11/10/05.  2nd 1/2 dose (same lot and exp) on 12/6/05.  Febrile 2/2/06 and Flu A test positive on 2-3-06 (rapid nasopharyngeal swab).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: A 34 yr old female pt who presents today with c/o local reaction to recent Tdap (Adacel) injection. Injection was given 2/1/06. Now with left arm injection site swelling, localized and generalized aches, generalized chills, low grade fever per patient. States the redness and swelling has increased from yesterday, taking tylenol/motrin ATC. No streaking noted down arm. No SOB, respiratory sx, GI c/o to report. No hx of adverse rxn in the past. Denies any URI sx at time of injection.  General Appearance: well appearing, in no acute distress, alert Skin: left deltoid area/arm with noted 5 X 5.5 cm diameter induration, errythematous, warm, and tender to touch. Marked with pen. Swollen to 5 mm. Lungs: Lungs clear to auscultation, No wheezing or rhonchi Heart: negative. RRR without murmur, gallop, or rubs.  No ectopy. Abdomen: Abdomen soft, non-tender. Bowel sounds normal. No masses, organomegaly  A/P E948.4 ADV EFF TETANUS VACCINE 782.1 NONSPECIF SKIN ERUPT NEC Note: Given presentation of symptoms, will treat, injection site reaction/mild cellulitis- warning signs to report. Area marked with pen, to report if area of induration increases or develops high fever. Patient verbalizes understanding. Plan: KEFLEX 250 MG CAP      Continue Motrin/Tylenol combo for symptomatic management
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: A 34 yr old female pt who presents today with c/o local reaction to recent Tdap (Adacel) injection. Injection was given 2/1/06. Now with left arm injection site swelling, localized and generalized aches, generalized chills, low grade fever per patient. States the redness and swelling has increased from yesterday, taking tylenol/motrin ATC. No streaking noted down arm. No SOB, respiratory sx, GI c/o to report. No hx of adverse rxn in the past. Denies any URI sx at time of injection.  General Appearance: well appearing, in no acute distress, alert Skin: left deltoid area/arm with noted 5 X 5.5 cm diameter induration, errythematous, warm, and tender to touch. Marked with pen. Swollen to 5 mm. Lungs: Lungs clear to auscultation, No wheezing or rhonchi Heart: negative. RRR without murmur, gallop, or rubs.  No ectopy. Abdomen: Abdomen soft, non-tender. Bowel sounds normal. No masses, organomegaly  A/P E948.4 ADV EFF TETANUS VACCINE 782.1 NONSPECIF SKIN ERUPT NEC Note: Given presentation of symptoms, will treat, injection site reaction/mild cellulitis- warning signs to report. Area marked with pen, to report if area of induration increases or develops high fever. Patient verbalizes understanding. Plan: KEFLEX 250 MG CAP      Continue Motrin/Tylenol combo for symptomatic management
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Hypokinesia, Injection site pain, Malaise, Pain
Clinical narrative: Pain at injection site that spread to shoulder joint, under arm and down toward elbow, around to back, and up toward neck.  Difficulty sleeping.  Soreness was severe upon movement of arm in the night (worse between 1:30a.m. and 1:00p.m.).  General feeling of sickness and fatigue for approximately 30 hours after vaccination. Arm itching and sore to the touch and difficulty raising it 39 hours after vaccination.  Received first Pneumovax in 2000.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Hypoaesthesia, Injection site hypersensitivity, Injection site induration, Injection site inflammation
Clinical narrative: Initial report received from a nurse practitioner on 11/04/2005. A 35 year old female patient developed a local reaction of redness, pain, warmth and induration at the injection site, six days after receiving the injection (route of administration not reported) of Adacel, lot number C2124AA (expiry date 3/17/2007) in the left deltoid on 10/24/2005. The patient received in concomitant a Pneumococcal vaccination lot number 0790P in the right deltoid. the patient who has a history of Hashimoto Thyroiditis was recovering from month long bronchitis. The patient went to the emergency department twice and was treated with IV Rocephin 2gms and Keflex. An ultrasound was negative, incision and drainage showed no pus, only blood. The patient was discharged with ER diagnosis of cellulitis. Recovery status of the patient was not reported. Seriousness criteria other medically significant (OMIC). Follow up information received on 2/1/2006 from a physician. Per the reporter, the patient was referred to an infectious disease physician who then referred the patient to a hand specialist physician for numbness and tingling in her left upper extremity, particularly the ring and small fingers. This began six days post vaccination on 10/30/2005. Per the medical records received, the patient was evaluated in 11/14/2005 by the hand specialist and he reported the patient had received her vaccination on 10/24/2005 and six days later she awoke in the morning with a swollen, red, itching area around the injection site, and numbness and tingling in her left ring and small finger, none of which she had previously. She went to the ER and a local drainage procedure was done on the injection site but no pus was encountered and no culture were taken. She was given two doses of IV antibiotics over 24 hours and was started on Keflex. The patient had noted slow, gradual improvement in her redness, swelling and itching, as well as partial improvement in the numbness and tingling. She has had some intermittent low grade fevers in the 99 degree F range. Her diagnosis that day was local reaction to the vaccination at the vaccination site with a combined allergy inflammatory response, but no infection. She also had clinical evidence for a brachial plexitis reaction to the vaccination. This is a true inflammatory response in the nerve of her left upper extremity. She had full range of motion of all left upper extremity joints, and normal strength in her hand. She was instructed to use lots of heat and message at the injection site area and apply an elbow pillow extension splint every night at bedtime for two weeks. She was started on a one week tapering dose of Prednisone. She was to be re evaluated in  a month to see if electrical studies were warranted. The patient had not recovered from these events at the time of this report.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth, Neuritis
Clinical narrative: Initial report received from a nurse practitioner on 11/04/2005. A 35 year old female patient developed a local reaction of redness, pain, warmth and induration at the injection site, six days after receiving the injection (route of administration not reported) of Adacel, lot number C2124AA (expiry date 3/17/2007) in the left deltoid on 10/24/2005. The patient received in concomitant a Pneumococcal vaccination lot number 0790P in the right deltoid. the patient who has a history of Hashimoto Thyroiditis was recovering from month long bronchitis. The patient went to the emergency department twice and was treated with IV Rocephin 2gms and Keflex. An ultrasound was negative, incision and drainage showed no pus, only blood. The patient was discharged with ER diagnosis of cellulitis. Recovery status of the patient was not reported. Seriousness criteria other medically significant (OMIC). Follow up information received on 2/1/2006 from a physician. Per the reporter, the patient was referred to an infectious disease physician who then referred the patient to a hand specialist physician for numbness and tingling in her left upper extremity, particularly the ring and small fingers. This began six days post vaccination on 10/30/2005. Per the medical records received, the patient was evaluated in 11/14/2005 by the hand specialist and he reported the patient had received her vaccination on 10/24/2005 and six days later she awoke in the morning with a swollen, red, itching area around the injection site, and numbness and tingling in her left ring and small finger, none of which she had previously. She went to the ER and a local drainage procedure was done on the injection site but no pus was encountered and no culture were taken. She was given two doses of IV antibiotics over 24 hours and was started on Keflex. The patient had noted slow, gradual improvement in her redness, swelling and itching, as well as partial improvement in the numbness and tingling. She has had some intermittent low grade fevers in the 99 degree F range. Her diagnosis that day was local reaction to the vaccination at the vaccination site with a combined allergy inflammatory response, but no infection. She also had clinical evidence for a brachial plexitis reaction to the vaccination. This is a true inflammatory response in the nerve of her left upper extremity. She had full range of motion of all left upper extremity joints, and normal strength in her hand. She was instructed to use lots of heat and message at the injection site area and apply an elbow pillow extension splint every night at bedtime for two weeks. She was started on a one week tapering dose of Prednisone. She was to be re evaluated in  a month to see if electrical studies were warranted. The patient had not recovered from these events at the time of this report.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Paraesthesia, Pruritus, Pyrexia
Clinical narrative: Initial report received from a nurse practitioner on 11/04/2005. A 35 year old female patient developed a local reaction of redness, pain, warmth and induration at the injection site, six days after receiving the injection (route of administration not reported) of Adacel, lot number C2124AA (expiry date 3/17/2007) in the left deltoid on 10/24/2005. The patient received in concomitant a Pneumococcal vaccination lot number 0790P in the right deltoid. the patient who has a history of Hashimoto Thyroiditis was recovering from month long bronchitis. The patient went to the emergency department twice and was treated with IV Rocephin 2gms and Keflex. An ultrasound was negative, incision and drainage showed no pus, only blood. The patient was discharged with ER diagnosis of cellulitis. Recovery status of the patient was not reported. Seriousness criteria other medically significant (OMIC). Follow up information received on 2/1/2006 from a physician. Per the reporter, the patient was referred to an infectious disease physician who then referred the patient to a hand specialist physician for numbness and tingling in her left upper extremity, particularly the ring and small fingers. This began six days post vaccination on 10/30/2005. Per the medical records received, the patient was evaluated in 11/14/2005 by the hand specialist and he reported the patient had received her vaccination on 10/24/2005 and six days later she awoke in the morning with a swollen, red, itching area around the injection site, and numbness and tingling in her left ring and small finger, none of which she had previously. She went to the ER and a local drainage procedure was done on the injection site but no pus was encountered and no culture were taken. She was given two doses of IV antibiotics over 24 hours and was started on Keflex. The patient had noted slow, gradual improvement in her redness, swelling and itching, as well as partial improvement in the numbness and tingling. She has had some intermittent low grade fevers in the 99 degree F range. Her diagnosis that day was local reaction to the vaccination at the vaccination site with a combined allergy inflammatory response, but no infection. She also had clinical evidence for a brachial plexitis reaction to the vaccination. This is a true inflammatory response in the nerve of her left upper extremity. She had full range of motion of all left upper extremity joints, and normal strength in her hand. She was instructed to use lots of heat and message at the injection site area and apply an elbow pillow extension splint every night at bedtime for two weeks. She was started on a one week tapering dose of Prednisone. She was to be re evaluated in  a month to see if electrical studies were warranted. The patient had not recovered from these events at the time of this report.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MER
Symptoms: Erythema, Swelling
Clinical narrative: redness, swelling L upper arm lateral side no signs of infection.
Age: 36.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Chest pain, Pain, Paralysis
Clinical narrative: Approximately 1 month following vaccine administration pt. experienced pain R upper arm, chest, shoulder which progresses to "paralysis".
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome, Upper respiratory tract infection
Clinical narrative: Probable SIDS.  3/9/06 Received autopsy report which revealed patient experienced cold s/s with COD Sudden Infant Death Syndrome/ss
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal pain, Blood culture negative, Blood glucose increased, Cardiac enzymes increased, Chest pain
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chest pain, Computerised tomogram, Computerised tomogram abdomen normal, Computerised tomogram normal, Diabetic ketoacidosis
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Discomfort, Dyspnoea, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Eye swelling, Fibrin D dimer normal, Hyperglycaemia, Leukocytosis, Malaise
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Metabolic acidosis, Neutrophil count increased, Protein urine present, Pyrexia, Shoulder pain
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Troponin I increased, White blood cell count increased
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthma, Bacterial infection, Chest pain, Dyspnoea, Enzyme abnormality
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.
Age: 1.94
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Serious Criteria: Other - Medically Significant (OMIC). Initial report received from a health care professional on 24/Jan/2006. A twenty three month old female patient with no significant past medical history, had received an injection of ActHIB, lot number UE548AA (lot number Y0304), as well as an injection of Varicella vaccine, lot number 0116R, on 06/Jun/2005. That same date (assumed as per the reporter), the patient developed a fever and had a seizure. The temperature and type of seizure were unknown as per the reporter. The child was treated in an emergency room and was not evaluated by the responsible physician. It is unknown if any laboratory or diagnostic testing was performed. The child has recovered from the events.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Facial palsy, Guillain-Barre syndrome, Hypoaesthesia, Hypokalaemia
Clinical narrative: On 1/12/06 client reported she experienced numbness and tingling in her hands and feet. This progressed to difficulty with ambulation and inability to use her facial muscles. She was diagnosed with GBS and hospitalized on 01/22/2006. Client was 22 weeks pregnant on 01/12/2006. Client also reported she was ill with cold symptoms prior to onset. Discharge DX Guillain Barr syndrome resolving. Information from Discharge summary states incontinence of urine. msv
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Paraesthesia, Pharyngitis, Rhinitis, Urinary incontinence
Clinical narrative: On 1/12/06 client reported she experienced numbness and tingling in her hands and feet. This progressed to difficulty with ambulation and inability to use her facial muscles. She was diagnosed with GBS and hospitalized on 01/22/2006. Client was 22 weeks pregnant on 01/12/2006. Client also reported she was ill with cold symptoms prior to onset. Discharge DX Guillain Barr syndrome resolving. Information from Discharge summary states incontinence of urine. msv
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Raised redness 7 cm in diameter, itching, no fever. Received flu shot on 4Feb06 around 14:00, symptoms started around 18:00 on 4Feb06
Sex: F
Vaccine: FLUN3
Symptoms: Face oedema, Malaise
Clinical narrative: A female child was vaccinated with Flumist, intra-nasally on 20 Jan 2006 for influenza.  After receiving Flumist the child complained to the school nurse about not feeling well.  The school nurse examined the child and sent the child back to class.  No specific symptoms were noted at that time.  On the evening of 20 Jan 2006, approximately 8 hours after vaccine administration, the parents took the child to the ER due to facial edema.  It was not reported whether or not treatment was received for the symptoms.  The child returned to school on 23 Jan 2006.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain, Agitation, Anger, Anxiety, Arthralgia
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Asthma, Back pain, Bronchitis, Confusional state, Conjunctivitis
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Constipation, Cyst, Depression, Diarrhoea, Difficulty in walking
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Disorientation, Eye pain, Groin pain, Haemorrhoids, Hyperhidrosis
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems