chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, C-reactive protein normal, Full blood count normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with an allergy to cashews and a history of ovarian cyst who on 05-JUN-2007 was vaccinated SC in the right arm with a second 0.5 mL dose of GARDASIL (lot #657736/0389U) and vaccinated with a dose of VARIVAX (Merck) (lot #657109/0444U). The patient was vaccinated IM in the left arm with the first 0.5 mL dose of GARDASIL on 27-SEP-2006. Concomitant therapy included ORTHO TRI-CYCLEN. On 23-JUN-2007, the patient experienced muscle pain, joint pain and nausea. The following tests were performed and noted to be normal: complete blood count with differential; C-reactive protein; antinuclear antibodies; rheumatoid factor; creatine phosphokinase; nerve conduction test. On 03-JUL-2007, the patient was improving. In August 2007, the patient was seen in the office with fever, sore throat and headache, and was diagnosed with viral infection. There was no mention of muscle pain, joint pain or nausea at that time. At the time of this report, the patient was recovered. It was reported that the patient did not have any reaction after the first dose of GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Myalgia, Nerve conduction studies normal, Rheumatoid factor negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with an allergy to cashews and a history of ovarian cyst who on 05-JUN-2007 was vaccinated SC in the right arm with a second 0.5 mL dose of GARDASIL (lot #657736/0389U) and vaccinated with a dose of VARIVAX (Merck) (lot #657109/0444U). The patient was vaccinated IM in the left arm with the first 0.5 mL dose of GARDASIL on 27-SEP-2006. Concomitant therapy included ORTHO TRI-CYCLEN. On 23-JUN-2007, the patient experienced muscle pain, joint pain and nausea. The following tests were performed and noted to be normal: complete blood count with differential; C-reactive protein; antinuclear antibodies; rheumatoid factor; creatine phosphokinase; nerve conduction test. On 03-JUL-2007, the patient was improving. In August 2007, the patient was seen in the office with fever, sore throat and headache, and was diagnosed with viral infection. There was no mention of muscle pain, joint pain or nausea at that time. At the time of this report, the patient was recovered. It was reported that the patient did not have any reaction after the first dose of GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Headache, Myalgia, Nausea, Nerve conduction studies normal, Oropharyngeal pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with an allergy to cashews and a history of ovarian cyst who on 05-JUN-2007 was vaccinated SC in the right arm with a second 0.5 mL dose of GARDASIL (lot #657736/0389U) and vaccinated with a dose of VARIVAX (Merck) (lot #657109/0444U). The patient was vaccinated IM in the left arm with the first 0.5 mL dose of GARDASIL on 27-SEP-2006. Concomitant therapy included ORTHO TRI-CYCLEN. On 23-JUN-2007, the patient experienced muscle pain, joint pain and nausea. The following tests were performed and noted to be normal: complete blood count with differential; C-reactive protein; antinuclear antibodies; rheumatoid factor; creatine phosphokinase; nerve conduction test. On 03-JUL-2007, the patient was improving. In August 2007, the patient was seen in the office with fever, sore throat and headache, and was diagnosed with viral infection. There was no mention of muscle pain, joint pain or nausea at that time. At the time of this report, the patient was recovered. It was reported that the patient did not have any reaction after the first dose of GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Pyrexia, Rheumatoid factor negative, Viral infection, White blood cell count normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with an allergy to cashews and a history of ovarian cyst who on 05-JUN-2007 was vaccinated SC in the right arm with a second 0.5 mL dose of GARDASIL (lot #657736/0389U) and vaccinated with a dose of VARIVAX (Merck) (lot #657109/0444U). The patient was vaccinated IM in the left arm with the first 0.5 mL dose of GARDASIL on 27-SEP-2006. Concomitant therapy included ORTHO TRI-CYCLEN. On 23-JUN-2007, the patient experienced muscle pain, joint pain and nausea. The following tests were performed and noted to be normal: complete blood count with differential; C-reactive protein; antinuclear antibodies; rheumatoid factor; creatine phosphokinase; nerve conduction test. On 03-JUL-2007, the patient was improving. In August 2007, the patient was seen in the office with fever, sore throat and headache, and was diagnosed with viral infection. There was no mention of muscle pain, joint pain or nausea at that time. At the time of this report, the patient was recovered. It was reported that the patient did not have any reaction after the first dose of GARDASIL. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female with an allergy to Carbamazepine-urticaria (1993) and exercise-induced bronchospasm who on 16-Oct-2007 was vaccinated intramuscularly with a 0.5ml dose of Gardasil (lot#658563/1063U), concomitant therapy included benzoyl peroxide, clindamycin and adapalene (DIFFERIN). The doctor stated that on 18-OCT-2007 the patient developed hives 36 hours after the vaccination. The patient received unspecified medical attention and it is unknown at this time if the patient has recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a 17 year old female with an allergy to Carbamazepine-urticaria(1993) and exercise-induced bronchospasms who on 16-Oct-2007 was vaccinated intramuscularly with the 1st 0.5ml dose of GARDASIL (lot#658561/1063U), concomitant therapy included benzoyl peroxide, clindamycin and DIFFERIN. The doctor stated that on 18-OCT-2007 the patient developed generalized uticaria and pruritus about 10 hours after the vacination. The patient received unspecified medical attention. The patient subsequently recovered. The VAERS ID number is 706923. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Urticaria, Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female with an allergy to Carbamazepine-urticaria (1993) and exercise-induced bronchospasm who on 16-Oct-2007 was vaccinated intramuscularly with a 0.5ml dose of Gardasil (lot#658563/1063U), concomitant therapy included benzoyl peroxide, clindamycin and adapalene (DIFFERIN). The doctor stated that on 18-OCT-2007 the patient developed hives 36 hours after the vaccination. The patient received unspecified medical attention and it is unknown at this time if the patient has recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a 17 year old female with an allergy to Carbamazepine-urticaria(1993) and exercise-induced bronchospasms who on 16-Oct-2007 was vaccinated intramuscularly with the 1st 0.5ml dose of GARDASIL (lot#658561/1063U), concomitant therapy included benzoyl peroxide, clindamycin and DIFFERIN. The doctor stated that on 18-OCT-2007 the patient developed generalized uticaria and pruritus about 10 hours after the vacination. The patient received unspecified medical attention. The patient subsequently recovered. The VAERS ID number is 706923. No additional information is expected.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: HIVES/RASH ON LEFT ARM AND SHOULDER LESS THAN 20 HRS AFTER VACCINE, PAIN AND DISCOMFORT OF AFFECTED AREA. STARTED VALTREX ON 11/3/07 PER DR VALTREX TAKEN 3/DAY FOR 7 DAYS
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Discomfort, Herpes zoster, Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: HIVES/RASH ON LEFT ARM AND SHOULDER LESS THAN 20 HRS AFTER VACCINE, PAIN AND DISCOMFORT OF AFFECTED AREA. STARTED VALTREX ON 11/3/07 PER DR VALTREX TAKEN 3/DAY FOR 7 DAYS
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Urticaria
Clinical narrative: HIVES/RASH ON LEFT ARM AND SHOULDER LESS THAN 20 HRS AFTER VACCINE, PAIN AND DISCOMFORT OF AFFECTED AREA. STARTED VALTREX ON 11/3/07 PER DR VALTREX TAKEN 3/DAY FOR 7 DAYS
Age: 1.1
Sex: M
Vaccine: DTPHIB, MMR, VARCEL
Symptoms: Aphasia, Autism, Blood test, Diarrhoea, Pyrexia
Clinical narrative: Developed fever 103 deg within 1 hour of shot's. Then began diarrhea. Fever and diarrhea Lasted for 8months solid. Now off and on; Pattern started Loosing Speech, eye contact. 7/17/07 diagnosed w/autism.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Cough, Eye swelling, Malaise, Ocular hyperaemia
Clinical narrative: Small cough started @ 2:00 p.m. By 3:30 I was feeling an illness coming on. Checked my temp.  101  and went to 102 by 6:00 p.m.  After taking Ibprofen fever went down to l01.  At l0:00 p.m. I took   Aleve.  Was very achey and had a sore throat all night...eyes very bloodshot and puffy in the morning.  Fever gone too.  Felt pretty normal as day wore on.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pharyngolaryngeal pain
Clinical narrative: Small cough started @ 2:00 p.m. By 3:30 I was feeling an illness coming on. Checked my temp.  101  and went to 102 by 6:00 p.m.  After taking Ibprofen fever went down to l01.  At l0:00 p.m. I took   Aleve.  Was very achey and had a sore throat all night...eyes very bloodshot and puffy in the morning.  Fever gone too.  Felt pretty normal as day wore on.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Chills, Dizziness, Erythema, Headache
Clinical narrative: Fever of 100.1 10:30 am 11/14/07  sent home from school.   Fever rose to 103.5 by 12:00 pm 11/14/07 extreme chills  redness of entire body then extremely pale aching body dizziness headache  stomachache. Contacted doctor was told to give motrin/ tylenol and put her in a tepid bath.Gave her soup and tea for stomachache. I did that and fever subsided for a few hours. it then returned  103.2 along with all the symptoms listed above, again i called the doctor at 6:00 pm 11/14/07 was told to give more tylenol and get her back in the bath. Gave her tea and a 1/2 bagel.The fever subsided again until 11:00 pm and again the symptoms returned 102.3,  again I put her back in the bath and gave more tylenol. Gave tea and toast for stomachache. Symptoms again subsided until 3:30 am 11/15/07 101.9 i then gave her more tylenol and a cup of tea to settle her stomach.  7:00 am 11/15/07 fever returned and the shot area is very swollen  chills are again back and fever is 100.4 i gave her more tylenol tea and a small amount of plain yogurt to try and settle her stomach  also an ice pack was applied to the swollen area. 8:27am 11/15/07 fever is returning it is 100.9 and she is jhaving chills and stomachache headache.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Pain, Pallor, Pyrexia
Clinical narrative: Fever of 100.1 10:30 am 11/14/07  sent home from school.   Fever rose to 103.5 by 12:00 pm 11/14/07 extreme chills  redness of entire body then extremely pale aching body dizziness headache  stomachache. Contacted doctor was told to give motrin/ tylenol and put her in a tepid bath.Gave her soup and tea for stomachache. I did that and fever subsided for a few hours. it then returned  103.2 along with all the symptoms listed above, again i called the doctor at 6:00 pm 11/14/07 was told to give more tylenol and get her back in the bath. Gave her tea and a 1/2 bagel.The fever subsided again until 11:00 pm and again the symptoms returned 102.3,  again I put her back in the bath and gave more tylenol. Gave tea and toast for stomachache. Symptoms again subsided until 3:30 am 11/15/07 101.9 i then gave her more tylenol and a cup of tea to settle her stomach.  7:00 am 11/15/07 fever returned and the shot area is very swollen  chills are again back and fever is 100.4 i gave her more tylenol tea and a small amount of plain yogurt to try and settle her stomach  also an ice pack was applied to the swollen area. 8:27am 11/15/07 fever is returning it is 100.9 and she is jhaving chills and stomachache headache.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Employer offered flu shots to employees.  On 10-26-07 all employees interested had the shot.  Multiple employees have experienced continued aches/pains in the arm of the shot.  Personnally, if I lift my arm over shoulder height, I get a shooting pain in the area of the shot.  It has been almost three weeks. We spoke with two local nurses who said normally you could experience aches/pain in your arm for a couple of days but shouldn't last as long as three weeks.  Since multiple people have experienced the same thing, I can't help but think that maybe there was something wrong with the shot and/or the effectiveness of the shot.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder, Throat tightness
Clinical narrative: Respiratory Reaction. Needed to use inhaler and flonase one hour after getting vaccine because of tightness in throat. Symptoms lasted approximately 3 hours. Patient has history of severe Asthma, along with mutiple allergies.
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: The shot hurt in an unusually painfull way from when I have ever received the shot in the past. My shoulder hurts so bad to lift my arm is almost impossible. This has been going on for a little over a week now.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Client received flu vaccine injection at 4:45pm on 11/14/2007.  He awoke at 4:30am on 11/15/2007 feeling nauseous and dizzy.  He had diarrhea.  The symptoms lasted for 90 minutes. He then felt better and returned to bed.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: CLIENT CALLED 11/15/07 TO REPORT THAT ONE DAY AFTER INFLUENZA ADMINISTRATION (10/19/07) SHE BEGAN TO ITCH ON BOTH ARMS.  SHE REPORTS THAT SHE HAD TO BUY A CREAM TO CONTROL THE ITCHING.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Infantile spitting up, Irritability
Clinical narrative: My son went in on May 7th 2007 for his 4 month shots and a check-up. Was found to be a healthy baby boy. He was fussy and spit up but nothing out of the normal. 6 days later on May 13, 2007 died at 12:59pm.  11/16/07 Received autopsy report which reveals COD is sudden infant death syndrome. 11/27/07 Received vax record which confirms report.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: Can still feel tightness in left shoulder muscle.  For 3 weeks - could not use left arm much due to pain upon use of the arm.  Attempted to work out with 3 lb weights but did not help.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: Child's mother reports child c/o pain right arm where injection given 8/14/07. Site reported to be red, hard, painful, smaller than dime in diameter.  School nurse reported same symptoms. First reported 10/27/07 by child to mother.  Instructed mother to take child to physician.  Unknown if child was seem by physician. Followup call found mother's phone disconnected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: My Left arm at the top where the shot was given has been very painful ever since i received the flu shot. When I raise my left arm a certain way there is sharp pains in my shoulder where the shot was given.When I raise my left arm to put on deodorant there is sharp pains in my shoulder where the shot was given.When I try turning over in bed I have alot of sharp pain in my shoulder. When I try cleaning out the bathtub i cannot use any pressure in my left arm because of the pain. There is a constant aching in my shoulder all the time & there is also a burning feeling.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Diarrhoea, Dizziness, Hypertension, Pyrexia
Clinical narrative: Dizzy, diahrrea, fainted, fever, cough later, increase continues in symptoms related to hypertension
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: Dizzy, diahrrea, fainted, fever, cough later, increase continues in symptoms related to hypertension
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left upper arm.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in upper left arm.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm.
Age: 1.67
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion, Full blood count abnormal, Pancytopenia, Pyrexia
Clinical narrative: Patient received first dose of Hepatitis A vaccine 3/14/07.  He developed fever of 102 that evening.  He had a febrile seizure 3/15/07 and a CBC done at that time revealed pancytopenia. He was hospitalized to monitor labs until 3/18/07. At discharge he was well, with resolving pancytopenia.  CBC 11/7/07 was normal.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: After injected, patient made the comment that it felt like the shot went into her muscle.  I assured her that that is where it is supposed to go.  Patient states that later that evening her arm began to hurt at the injection site and she applied ice.  She did not notice any inflammation, redness, or warmth.  Patient does not experience pain at rest; pain is with movement only.  She describes the pain at its worst to be 6-7 out of 10 pain scale.  The pain level has remained the same over the past 4 weeks since immunization.  She has not taken any medications for it and has not seen an MD, although she plans to at the beginning of December.  Past history includes whiplash 5 years ago and prior arm muscular pain, but not related to any past vaccinations.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Rotavirus vaccine #1 given.  Child 14 weeks old.  A calendar had been consulted before vaccine was given but (apparently) figured incorrectly for the 12 weeks time frame.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe body aches , red lump but not extensive swelling
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash erythematous
Clinical narrative: 3" red spot around the shor area, warm & tender. Red rash throughout body,mostly in warm areas; arm pits, waist, buttocks, back.  Other than the rash, I feel good, no itching or respirator issues. Do I need to be aware of anything else?
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, CSF protein increased, Demyelinating polyneuropathy, Diplopia, Dysarthria
Clinical narrative: 63yo male who received his flu shot on October 4 at an oustide facility.  On October 15 (six days prior to hospital admission), he started noticing weakness in his toes bilaterally which gradually progressed up to his legs, hips and arms. Patient was unable to crawl or ambulate. Symptoms associated with numbness and tingling to both feet and hands, diplopia and some dysarthia are consistent with demyelinating polyneuropathy (Guillain Barre Syndrome).  Patient admitted to Hospital.  Labs showed elevated protein and patient underwent plasmapheresis for 5 days. Patient is still hospitalized and degree of permenant disability or recovery status is unknown.  1/15/08 Reviewed hospital & rehab medical records which reveal patient experienced numbness & weakness in bilateral toes 6 days prior to admit which gradually progressed up legs to the point where he could only crawl, could not lift legs or arms, had double vision.  Also had congestion, SOB, cough, asthma, wheezing.  Neuro exam was areflexic, muscle weakness shoulders down, decreased sensation in glove & stocking distribution.  Admitted to intensive care 10/21-11/6/2007.  Neuro, Pulm, ST/OT/PT consults done.  LP done.  Tx w/plasmapheresis x 5 days via right femoral Quinton cath w/only slight improvement.  Transferred to inpatient rehab from 11/6-12/20/2007.  Improved to be able to ambulate w/rolling walker for short distances w/assist.  D/C to home for outpatient PT/OT, neuro & pcp f/u. FINAL DX: Guillain Barre syndrome, quadriparesis, HTN, COPD, asthma, UTI. Per 60 day follow up: Currently undergoing physical therapy, left hospital with residual effects from GUILLAIN BARRE.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram abnormal, Fibrin D dimer, Fibrin D dimer decreased, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: 63yo male who received his flu shot on October 4 at an oustide facility.  On October 15 (six days prior to hospital admission), he started noticing weakness in his toes bilaterally which gradually progressed up to his legs, hips and arms. Patient was unable to crawl or ambulate. Symptoms associated with numbness and tingling to both feet and hands, diplopia and some dysarthia are consistent with demyelinating polyneuropathy (Guillain Barre Syndrome).  Patient admitted to Hospital.  Labs showed elevated protein and patient underwent plasmapheresis for 5 days. Patient is still hospitalized and degree of permenant disability or recovery status is unknown.  1/15/08 Reviewed hospital & rehab medical records which reveal patient experienced numbness & weakness in bilateral toes 6 days prior to admit which gradually progressed up legs to the point where he could only crawl, could not lift legs or arms, had double vision.  Also had congestion, SOB, cough, asthma, wheezing.  Neuro exam was areflexic, muscle weakness shoulders down, decreased sensation in glove & stocking distribution.  Admitted to intensive care 10/21-11/6/2007.  Neuro, Pulm, ST/OT/PT consults done.  LP done.  Tx w/plasmapheresis x 5 days via right femoral Quinton cath w/only slight improvement.  Transferred to inpatient rehab from 11/6-12/20/2007.  Improved to be able to ambulate w/rolling walker for short distances w/assist.  D/C to home for outpatient PT/OT, neuro & pcp f/u. FINAL DX: Guillain Barre syndrome, quadriparesis, HTN, COPD, asthma, UTI. Per 60 day follow up: Currently undergoing physical therapy, left hospital with residual effects from GUILLAIN BARRE.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Muscular weakness, Paraesthesia, Plasmapheresis, White blood cell count normal
Clinical narrative: 63yo male who received his flu shot on October 4 at an oustide facility.  On October 15 (six days prior to hospital admission), he started noticing weakness in his toes bilaterally which gradually progressed up to his legs, hips and arms. Patient was unable to crawl or ambulate. Symptoms associated with numbness and tingling to both feet and hands, diplopia and some dysarthia are consistent with demyelinating polyneuropathy (Guillain Barre Syndrome).  Patient admitted to Hospital.  Labs showed elevated protein and patient underwent plasmapheresis for 5 days. Patient is still hospitalized and degree of permenant disability or recovery status is unknown.  1/15/08 Reviewed hospital & rehab medical records which reveal patient experienced numbness & weakness in bilateral toes 6 days prior to admit which gradually progressed up legs to the point where he could only crawl, could not lift legs or arms, had double vision.  Also had congestion, SOB, cough, asthma, wheezing.  Neuro exam was areflexic, muscle weakness shoulders down, decreased sensation in glove & stocking distribution.  Admitted to intensive care 10/21-11/6/2007.  Neuro, Pulm, ST/OT/PT consults done.  LP done.  Tx w/plasmapheresis x 5 days via right femoral Quinton cath w/only slight improvement.  Transferred to inpatient rehab from 11/6-12/20/2007.  Improved to be able to ambulate w/rolling walker for short distances w/assist.  D/C to home for outpatient PT/OT, neuro & pcp f/u. FINAL DX: Guillain Barre syndrome, quadriparesis, HTN, COPD, asthma, UTI. Per 60 day follow up: Currently undergoing physical therapy, left hospital with residual effects from GUILLAIN BARRE.
Age: 8.0
Sex: U
Vaccine: FLUN3
Symptoms: Abdominal tenderness, Chills, Pyrexia, Streptococcal identification test, Tonsillar disorder
Clinical narrative: Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given.  She was evaluated 6 hours after the onset of symptoms. She received one dose of tylenol Her exam revealed 3+ red tonsils and generalized abdominal tenderness.  Her  temp was 98.2 and patient stated she was hungry for Burger King.
Age: 8.0
Sex: U
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given.  She was evaluated 6 hours after the onset of symptoms. She received one dose of tylenol Her exam revealed 3+ red tonsils and generalized abdominal tenderness.  Her  temp was 98.2 and patient stated she was hungry for Burger King.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Dry throat, Headache, Nausea
Clinical narrative: Day 1: Headache, dry throat. Day 2: Headache, sneezing, body ache, nausea, fever, dizzyness. Day 3: Headache, cough, body ache, nausea, fever, dizzyness.  Day 4: Headache, dizzyness, nausea.  Treated with asperin.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Sneezing
Clinical narrative: Day 1: Headache, dry throat. Day 2: Headache, sneezing, body ache, nausea, fever, dizzyness. Day 3: Headache, cough, body ache, nausea, fever, dizzyness.  Day 4: Headache, dizzyness, nausea.  Treated with asperin.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Loss of consciousness, Petit mal epilepsy
Clinical narrative: flu vaccine administered in left deltoid at 0954 and at 0955 became light headed and sat down.  At 10:05a client was in and out of conciousness and had a petite mal seizure lasting approx. 30 seconds in duration (paramedics on site).  Was transported to Hospital
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: nosebleed on 11/7/07 after receiving FluMist.  Bled approximately 10 min from right nostril.  moderate amount of bleeding.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Breast tenderness, Hypoaesthesia, Menopause, Menstrual disorder, Vaginal discharge
Clinical narrative: According to patient she has been menopausal for 2-3 years and the day after she received the influenza vaccine she had clear vaginal discharge (patient referred to it as if she was ovulating).  Later in the month she experienced breast tenderness and on 11/13 she started her period again after 2-3 years.  She also expressed concern that she had left leg numbness (back of leg) that began on 11/11/07.  She thinks this is related to previous neck injuries and surgeries, however she has never had the back of her leg hurt.  According to the patient she has not started any new medication (including OTC, herbal or dietary supplements)
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Myalgia, Pyrexia
Clinical narrative: Stomach ache, fever 100.8 degrees, Many muscles aching. Duration about 48 hours.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to animal, Diarrhoea, Feeling hot, Nausea, Pruritus
Clinical narrative: 8.45 am Flu vaccine given.10.20 am client felt hot, upset stomach,nausea and diarrhea. 10.45 skin itchy.To Urgent Care Clinic. Apparent testing and notified she was allergic to chicken feathers. Given benadryl and Cortisone plus 3 day supply of same. Told by physician not to have flu shot again.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Stomach discomfort
Clinical narrative: 8.45 am Flu vaccine given.10.20 am client felt hot, upset stomach,nausea and diarrhea. 10.45 skin itchy.To Urgent Care Clinic. Apparent testing and notified she was allergic to chicken feathers. Given benadryl and Cortisone plus 3 day supply of same. Told by physician not to have flu shot again.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: 11-14-07 0845 Client called and stated that her arm was still sore from when she received the flu shot.  She received the flu shot on 11-01-07 0905 Novartis Lot #80073 in left deltoid IM.  She noted there was no pain when she received the flu shot.  There is no redness or swelling present.  She has noticed no lumps or bumps in the area where she received the shot.  It is just sore and achy from her shoulder to her elbow on the left side.  She stated 'its just lame especially when I try and pull jeans up or pull a sweater over my head.'  She feels it doesn't bother her as much during the day as it does at night.  She does have arthritis in her hands and a spur in her neck.  She takes Vicodin daily for that and feels that may be why her arm doesn't hurt as much during the day.  She is seeing a Dr. on 11-16-07 for another reason and will visit with her about her arm.  She will notify me if there are any changes.
Age: 7.0
Sex: F
Vaccine: FLU3, PPV, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: LOCALIZED REACTION ON RIGHT THIGH 7X7 CM LARGER ON DAY 2 THAN DAY ONE POST INJECTION TREATED WITH ZYRTEC 10 MG PO DAILY FOR A WEEK
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lethargy, Pallor
Clinical narrative: Patient recieved his 2 months immunizations on 9-18-07, mom states that about 5 hours after injections baby got very pale and very lethargic. The lethargy lasted about 2 hours and the paleness lasted about 2 days, but not as bad as the intial paleness. Mom was very concerned with this, however has not been in since his 2 month check (baby now 4 months old).
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: PATIENT RECEIVED FOLLOWING VACINATIONS:1) ANTHRAX 2) SMALLPOX 3) TYPHOID. PATIENT DID NOT KNOW AT THE TIME SHE WAS PREGNANT. LMP:12SEP07
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 77 year old female patient who on 25-SEP-2007, was vaccinated with a dose of Pneumovax 23 (Lot# 657528/0733U). On approximately 27-SEP-2007 two days after the vaccination, the patient was found fainted on her floor. The patient was admitted to the hospital from the emergency room. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Biopsy, Cyst, Full blood count, Glomerular filtration rate, Hypoaesthesia
Clinical narrative: Information has been received from a registered nurse concerning her a 31 year old niece with "one kidney from kidney disease" and no allergies who in June end or early July 2007 was vaccinated into shoulder bone with a 0.5 ml dose of Recombivax HB. Immediately after vaccination, the patient experienced extreme pain that was described as "like hot lead". The patient had minimal movement from the arm that was vaccinated and was under worker's comp. It was reported that at times the arm went numb. The patient was taking "massive" doses of ibuprofen (MOTRIN), doing physical therapy, and using hot/cold therapy to relieve the pain. An MRI from the area showed a cyst, which when biopsied was "a pocket of the vaccine at the shoulder joint within the bone". Calcification was found at and around the area of injection. A complete blood test, blood chemistry test and effective infiltration rate and was undertaken. At the time of report the patient had not recovered. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injected limb mobility decreased, Injection site calcification, Injection site cyst
Clinical narrative: Information has been received from a registered nurse concerning her a 31 year old niece with "one kidney from kidney disease" and no allergies who in June end or early July 2007 was vaccinated into shoulder bone with a 0.5 ml dose of Recombivax HB. Immediately after vaccination, the patient experienced extreme pain that was described as "like hot lead". The patient had minimal movement from the arm that was vaccinated and was under worker's comp. It was reported that at times the arm went numb. The patient was taking "massive" doses of ibuprofen (MOTRIN), doing physical therapy, and using hot/cold therapy to relieve the pain. An MRI from the area showed a cyst, which when biopsied was "a pocket of the vaccine at the shoulder joint within the bone". Calcification was found at and around the area of injection. A complete blood test, blood chemistry test and effective infiltration rate and was undertaken. At the time of report the patient had not recovered. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Information has been received from a registered nurse concerning her a 31 year old niece with "one kidney from kidney disease" and no allergies who in June end or early July 2007 was vaccinated into shoulder bone with a 0.5 ml dose of Recombivax HB. Immediately after vaccination, the patient experienced extreme pain that was described as "like hot lead". The patient had minimal movement from the arm that was vaccinated and was under worker's comp. It was reported that at times the arm went numb. The patient was taking "massive" doses of ibuprofen (MOTRIN), doing physical therapy, and using hot/cold therapy to relieve the pain. An MRI from the area showed a cyst, which when biopsied was "a pocket of the vaccine at the shoulder joint within the bone". Calcification was found at and around the area of injection. A complete blood test, blood chemistry test and effective infiltration rate and was undertaken. At the time of report the patient had not recovered. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from a pharmacist concerning a female patient who was vaccinated with a dose of Gardasil. Subsequently, the patient experienced grand mal seizures sometime after receiving the vaccine. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Grand mal seizures were considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle twitching
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female who on 05-NOV-2007 was vaccinated with a third dose of Gardasil (lot# 659435/1265U). About ten minutes post-vaccination, the patient experienced loss of consciousness for about 15 seconds, felt dizzy, and when she came to consciousness she had a little twitch like a mini seizure. It was reported that the patient was not hospitailzed and no intervention was needed. Subsequently the patient recovered, three days later and was feeling fine. Upon internal review, mini seizure was determined to be an other important medical event. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Coma, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a physician to a vaccine distributor and described the occurrence of fever in a 70-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Information regarding previous immunization with influenza virus vaccine was not provided. On 8 November 2007 the subject received unspecified dose of Flulaval (unknown). On 9 November 2007, 1 day after vaccination with Flulaval, the subject called the physician and reported that she experienced a fever and flu-like symptoms. The subject had to be hospitalized. The physician doesn't know if the subject has viral encephalitis or if she has meningitis. The subject is undergoing magnetic resonance imaging for the lumbar spine. The physician reported on 14 November 2007 that the subject is now in a near comatose state. At the time of reporting the fever and flu-like symptoms were worse.
Sex: M
Vaccine: HEPA
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of elevated liver enzymes in an adult male subject who was vaccinated with (Havrix, GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received 1st dose of Havrix at 1440 elisa units. At an unspecified time after vaccination with Havrix, the subject experienced elevated liver enzymes. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a 52-year-old male subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The reporter is the wife of the subject. A physician or other health care professional has not verified this report. The subject's medical history included asthma and disc herniation. Concurrent medications included Fluticasone propionate+salmeterol xinafoate (Advair), Salbutamol sulphate (Albuterol) and Naproxen. The subject had received influenza virus vaccine in previous years and experienced minor soreness at injection site. The subject had no adverse events following receipt of any other type of immunizations. On 17 October 2007 at 1:12 p.m., the subject received unspecified dose of Fluarix. The consumer reported that the subject inadvertently received this dose of Fluarix in the "joint space of the shoulder instead of the deltoid." As a result of this inadvertent administration into the joint space of the shoulder, the subject experienced drug administered at inappropriate site. The consumer reported on 09 November 2007, that the initial reaction was severe pain followed by barely being able to move the arm. The reporter also noted that the subject "Was initially put on light duty at work." The date of onset of these adverse events was not reported. The subject was seen at a physician's office. The consumer considered the events to be disabling and to jeopardize the subject or require intervention. At the time of reporting the pain and difficulty moving the arm were unresolved.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Diplegia, Hypoaesthesia, Paraesthesia, Paralysis, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist and described the occurrence of paralysis in a 88-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. On 8 November 2007, in the afternoon, the subject received unspecified dose of Fluarix at 0.5 ml in the right arm. In the morning, on 9 November 2007 the subject experienced lower extremity paralysis and numbness and tingling in her arms. The subject was seen by her local clinic physician and received no treatment. She was admitted to the hospital on 10 November 2007. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: TDAP
Symptoms: Medication error, Unevaluable event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of incorrect storage of drug in a subject of unspecified age and gender who was vaccinated with (Boostrix, GlaxoSmithKline) for prophylaxis. The healthcare professional reported that multiple subjects (number unknown) were given Boostrix that was improperly stored, however, a specific number of subject was not reported. The subject received no other immunizations on the date of receipt of Boostrix. The subject had no adverse following receipt of previous immunizations. In October 2007 the subject received unspecified dose of Boostrix (unknown) that had been stored incorrectly. The healthcare professional reported that according to the temperature log, on three separate occasions from 21 October 2007 to 24 October 2007, the temperature in the vaccine refrigerator got down to 33 degrees Fahrenheit. The healthcare professional considered the event was clinically significant (or requiring intervention) and could be jeoparding to the subjects. No clinical events were reported.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Unevaluable event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of incorrect storage of drug in a subject of unspecified age and gender who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The healthcare professional reported that multiple subjects (number unknown) were given Flulaval that was improperly stored, however, a specific number of subjects was not reported. The subject received no other immunizations on the date of receipt of Flulaval. In October 2007 the subject received unspecified dose of Flulaval (unknown) that had been stored incorrectly. The healthcare professional reported that according to the temperature log, on three separate occasions from 21 October 2007 to 24 October 2007, the temperature in the vaccine refrigerator got down to 33 degrees Fahrenheit. The healthcare professional considered the event was clinically significant (or requiring intervention) and could be jeoparding to the subjects. No clinical events were reported.
Age: 87.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Herpes zoster, Malaise, Rash
Clinical narrative: Patient given Flu vaccine + Pneumovax vaccine on 10/15/07 and developed general weakness/malaise and a rash/ shingles 10/17/07. 12/28/07 Reviewed hospital medical records which reveal patient experienced vomiting & weakness.  Seen by pcp 3 days s/p vax & dx w/mild immunization reaction.  5 days later, had lightheadedness, syncopal episode, fall & head injury.  Returned to pcp for weakness & difficulty voiding.  Admitted 10/25-12/11/2007.  Neuro, urology, GI, Ortho,Ophthal consults done.  TX w/antibiotics & antifungal for asp pneumonia & UTI.  Received TPN x 2 wks & PEG tube placed.  Nectoric areas of left great toe & left heel debrided.  Improved minimally & was transferred to rehab unit at d/c.  It was felt his mental status changes were possibly a result of post concussive syndrome & mild encephalitis from herpes zoster. FINAL DX: syncopal episode w/prolonged altered mental status, etiology unclear.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient c/o severe pain to right arm after receiving Pneumovax vaccine went to ER - was kept overnight -.  11/30/07 Reviewed hospital medical records which reveal patient experienced severe right shoulder pain, dizzy & near syncope beginning 11/1/07.  Admitted 11/2/2007 overnight only.  Exam revealed marked swelling of deltoid. FINAL DX: severe drug reaction to pneumonia vaccine, reactive inflammatory response of deltoid.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Induration, Injection site erythema
Clinical narrative: Patient received Pneumovax in left arm on 10/8/07. Started 10/9, left arm felt stiff. Then, the left arm became very hard, stiff, red, and warm. Patient had temperature up to 102. Was diagnosed with cellulitis and admitted to a hospital.  11/30/07 Reviewed hosptial medical records which reveal patient experienced fever, chills, dry cough, malaise & redness at site of pneumo injection.  Had been seen at urgent care facility & referred to ER for elevated WBC.  Admitted 10/11-10/12/2007.  Temp on admit was 102.3.  Tx/w IV antibiotics & antihistamine FINAL DX: no d/c summary available, admit & d/c dates obtained verbally.  Left arm cellulitis.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Skin warm, White blood cell count increased
Clinical narrative: Patient received Pneumovax in left arm on 10/8/07. Started 10/9, left arm felt stiff. Then, the left arm became very hard, stiff, red, and warm. Patient had temperature up to 102. Was diagnosed with cellulitis and admitted to a hospital.  11/30/07 Reviewed hosptial medical records which reveal patient experienced fever, chills, dry cough, malaise & redness at site of pneumo injection.  Had been seen at urgent care facility & referred to ER for elevated WBC.  Admitted 10/11-10/12/2007.  Temp on admit was 102.3.  Tx/w IV antibiotics & antihistamine FINAL DX: no d/c summary available, admit & d/c dates obtained verbally.  Left arm cellulitis.
Age: 4.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Chills, Full blood count, Headache, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: 10/24 Presented to MD with fever, chills, headache and lower extremities pain, sore throat. Treated as viral gave Motrin. 10/25 symptoms worse patient admitted to hospital.  11/30/07 Reviewed hospital medical records which reveal patient experienced fever & HA x 2 days.  Exam revealed erythemic posterior pharynx.  Admitted 10/25-10/27/2007.  Tx w/IV antibiotics & decongestants.  Symptoms resolved, labs returned to normal & d/c to home on continued oral antibiotics & decongestant. FINAL DX: Fever of unknown origin.
Age: 4.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia
Clinical narrative: 10/24 Presented to MD with fever, chills, headache and lower extremities pain, sore throat. Treated as viral gave Motrin. 10/25 symptoms worse patient admitted to hospital.  11/30/07 Reviewed hospital medical records which reveal patient experienced fever & HA x 2 days.  Exam revealed erythemic posterior pharynx.  Admitted 10/25-10/27/2007.  Tx w/IV antibiotics & decongestants.  Symptoms resolved, labs returned to normal & d/c to home on continued oral antibiotics & decongestant. FINAL DX: Fever of unknown origin.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood potassium normal
Clinical narrative: Redness and swelling around Injection site, high Fever 103, Chills and sweats. Rapid heart beat and increased blood pressure. Er visited on 9/23/07 administered Clindamycin iv. Returned to Primary Care Physician on 9/24/07 and was admitted to Hospital for treatment from 09/24/07 to 09/27/0711/28/07-records received for DOS 9/24-9/26/07 DC DX: Left upper arm cellulitis, resolving.  Presented to ED with C/O left arm proximal area swelling. Redness around injection site and redness strated spreading around area. Fever 102 associated with heartbeating too fast. Pain and ache at site of injection.