chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: Patient was given the varicella vaccine SQ in the Left arm.  The next day had a large red welt there and the site was very painful.  Pt had no fever.  2 days after injection the patient was examined at the clinic.  The area was erythematous and indurated to a size 7 cm wide and 5.5 cm high.  The patient was advised to take OTC Benadryl as needed and tylenol for pain.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure, Body temperature increased, Chest pain, Headache, Heart rate increased
Clinical narrative: Approximately one hour after receiving vaccine, complained of heart beating fast and left chest pain.  Seen at Hospital Emergency Department.  HR 101; Bp 102/61; RR 16; Temp 98.3; O2 sat:  98%.  complained of headache in ED;  MD dx - palpitations.  HR 96 at discharge from ED.  No complaints at 2 pm.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Oxygen saturation normal, Palpitations, Respiratory rate
Clinical narrative: Approximately one hour after receiving vaccine, complained of heart beating fast and left chest pain.  Seen at Hospital Emergency Department.  HR 101; Bp 102/61; RR 16; Temp 98.3; O2 sat:  98%.  complained of headache in ED;  MD dx - palpitations.  HR 96 at discharge from ED.  No complaints at 2 pm.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Eye rolling, Pallor
Clinical narrative: Pt. received two injections MMR & VZV. Skin was pale and eyes rolled in back of head.Time 8:45am pt was out about 3 seconds. She ask if she was a sleep.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Headache, Injection site pain, Neck pain, Pain, Pyrexia
Clinical narrative: 7/30/08 Client's mother reports fever, headache, body aches and neck pain continuing from day after these immunizations given (5 days).7/31/08  Symptoms have improved, no fever, continues to have headache but not as bad.  Did not seek MD.  8/4/08 Spoke with mother. Still with soreness at injection site of Tdap, but no more fever, headache, or bodyaches since 8/1/08.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Convulsion, Cyanosis, Mydriasis, Posturing, Tremor
Clinical narrative: Patient given dtap #4, mmr #1, and prevnar #4. Two minutes after administration of vaccines patient began seizing.  Seizure lasted for approximatley 2-3 minutes. He was  posturing and pupils were dialated, arms and legs shaking, lips and face were blue.  We did treat with 5L of oxygen.   Vitals were within normal limits and stable afterwards 128hr and 32 resp/minute, o2 sat 98%. Valium prepared but not needed.  911 called and pateint transported to Hospital.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling >3 cm over injection site, painful, hot to touch
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injectin site (L) deltoid swollen radiating to (L) shoulder with pain; warm-to-touch  Trreatment:                                     1) Keflex 500mg cap QID x 10days for cellulitis  2) Motrin 800mg TID PRN
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: patient received RotaTeq vaccine 7/22/08.  Diarrhea started 7/24/08.  4 or 5 diarrhea stools first 2 days then more than 20 stools per day.  patient admitted to hospital for fluids. 8/5/08-records received for DOS 7/28-7/31/08-DC DX-Diarrhea. Dehydration. Milk Protein Allergy. Diarhea began on 7/24/08-4-5 per day greenish in color, increasing over past 24 hours. Hungry, eating frequently. Cottage chees like stools. Half pound weight loss. No fever.  Admitted for hydration.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hypoaesthesia oral, Immediate post-injection reaction, Nausea, Paraesthesia
Clinical narrative: Immediately after IM injection the client c/o nausea and attempted to vomit, c/o dizziness, tingling and numbness of tongue. Was taken to the ER where blood work was done and later sent home.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Retching
Clinical narrative: Immediately after IM injection the client c/o nausea and attempted to vomit, c/o dizziness, tingling and numbness of tongue. Was taken to the ER where blood work was done and later sent home.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PPV, RV5
Symptoms: Blood culture negative, Crying, Ear infection, Full blood count, Grunting
Clinical narrative: 6/30/08: 8:30 a.m.-given shots. That evening: fussy,low grade temp.   7/1/08: 3:00a.m.- high pitched crying, 102 temp, grunting noises-alternately gave tylenol and motrin.    7/1/08: 3:00p.m.- Dr.'s office visit, sent to hospital- still has 101.5 temp, grunting noises and lethargic 9/8/08-records received for DOS 7/1-7/2/08-DC DX: Otitis Medial. Possible shot reaction. Medical observation for sepsis. Presented with fever and grunting respirations. Treated with IV antibiotics. Follow-up: I feel very strongly that this was indeed a vaccine reaction. My reasons behind this are as follows: I have two other children, one who had multiple ear infections before the age of two. I know what a ear infection entails. Pt's ears were checked at the doctor's office and that was it. They were never checked in the hospital or before she was released to see if her "ear infection" was doing better. Once admitted she was hooked up to an IV and her vitals checked every hour or two. She was hooked up to an apnea monitor to observe her breathing and heart rate. She was also hooked up to a continual pulse OX machine to observe that. He ordered blood tests and a urinalysis. All of this for an ear infection?! The day before her shots she was not running a temperature (I checked just in case), she was not pulling at her ears or favoring them, she was eating fine, and was not fussy at all. She also slept fine the night before. As I said previously, I feel very strongly that this was a vaccine reaction and would like this put on the record if possible.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PPV, RV5
Symptoms: High-pitched crying, Inappropriate schedule of drug administration, Irritability, Lethargy, Urine analysis normal
Clinical narrative: 6/30/08: 8:30 a.m.-given shots. That evening: fussy,low grade temp.   7/1/08: 3:00a.m.- high pitched crying, 102 temp, grunting noises-alternately gave tylenol and motrin.    7/1/08: 3:00p.m.- Dr.'s office visit, sent to hospital- still has 101.5 temp, grunting noises and lethargic 9/8/08-records received for DOS 7/1-7/2/08-DC DX: Otitis Medial. Possible shot reaction. Medical observation for sepsis. Presented with fever and grunting respirations. Treated with IV antibiotics. Follow-up: I feel very strongly that this was indeed a vaccine reaction. My reasons behind this are as follows: I have two other children, one who had multiple ear infections before the age of two. I know what a ear infection entails. Pt's ears were checked at the doctor's office and that was it. They were never checked in the hospital or before she was released to see if her "ear infection" was doing better. Once admitted she was hooked up to an IV and her vitals checked every hour or two. She was hooked up to an apnea monitor to observe her breathing and heart rate. She was also hooked up to a continual pulse OX machine to observe that. He ordered blood tests and a urinalysis. All of this for an ear infection?! The day before her shots she was not running a temperature (I checked just in case), she was not pulling at her ears or favoring them, she was eating fine, and was not fussy at all. She also slept fine the night before. As I said previously, I feel very strongly that this was a vaccine reaction and would like this put on the record if possible.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: 8/1/08 patient describes swelling of his arm from the elbow to shoulder and swelling across 1/2 of his chest, Nausea, pain, fever, lethargy
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Swelling face, Urticaria
Clinical narrative: 4 Year well child exam.  Healthy prior to visit. Normal physical exam.  Recived Havrix booster dose(#2) and Varivax booster dose(#2).  Within 10 minutes of leaving office, mom returned with patient actively wheezing and in anaphylaxis. Sats 91%.  Gave epinephrine times one, then 10 mg of loratidine. Pt status dramatically improved.  Clear lungs, improved sats, resolved urticaria. No history of egg allergy(eats eggs all the time).  8/18/2008 Office records received from PCP for WCC 8/4/08. 10 minutes after receiving vax pt developed wheezing and respiratory distress, coughing, hives and SOB. Tx with epi and antihistamine in office and d/c on Benadryl at home.  Sx resolved, no further hives. 04-AUG-2008: Within 20 minutes of vaccinations of chicken pox (2nd booster) and hepatitis my child began coughing, his face and eyes swelled and had severe breathing difficulties. We rushed back to doctor and received epinephrine.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: 4 Year well child exam.  Healthy prior to visit. Normal physical exam.  Recived Havrix booster dose(#2) and Varivax booster dose(#2).  Within 10 minutes of leaving office, mom returned with patient actively wheezing and in anaphylaxis. Sats 91%.  Gave epinephrine times one, then 10 mg of loratidine. Pt status dramatically improved.  Clear lungs, improved sats, resolved urticaria. No history of egg allergy(eats eggs all the time).  8/18/2008 Office records received from PCP for WCC 8/4/08. 10 minutes after receiving vax pt developed wheezing and respiratory distress, coughing, hives and SOB. Tx with epi and antihistamine in office and d/c on Benadryl at home.  Sx resolved, no further hives. 04-AUG-2008: Within 20 minutes of vaccinations of chicken pox (2nd booster) and hepatitis my child began coughing, his face and eyes swelled and had severe breathing difficulties. We rushed back to doctor and received epinephrine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: On 8/4/08 child's aunt called to report child had developed red raised rash after immunizations given.  Reports child had fever (up to 101.4) right after immunizations and a very faint rash soon after immunization.  Reports the past few days child developed red raised rash over "back, front, arms and legs".  Reports child has been traveling with father and has not been seen by Dr.  Reports child had slight fever (not taken) on Sat (8/2/08) but is acting more like himself now.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt received TDAP on 7/31/08. pt called the clinic 8/4/08 stating that her injection site left deltoid is warm to touch, red, swollen and the symptom is getting worst. pt feels feverish also. Since no available appt in the clinic until 8/6/08, instructed pt to go to ER to be evaluated.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Vesicular Rash in clusters in 10 cm area around site of injection.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: l DELTOID REDNESS/SWELLING 5 MM X 4 MM. WARM TO TOUCH
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest X-ray normal, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: RECIEVED VARIVAX VACCINE ON 8/01/2008. REPORTED TO HAVE HIVES ALL OVER ON 8/02/2008. REPORTED THAT TONGUE AND LIPS SWOLLEN ON 8/03/2008.  MOTHER GIVING BENEDRYL PO Q6HRS PRN.  NO REPORT OF RESPIRATORY DIFFICULTY
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling
Clinical narrative: local swelling
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient stood up after vaccine administration and lost conciousness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Fever and diarrhea, dehydration. 8/5/08-records received-presented to ED on 7/31/08- with C/O vomiting and diarrhea which began day before. Low grade fever. Decreased oral intake. Impression:immunization reaction. 8/1/08-presented to ED with C/O fever times three days, vomitting diarrhea. Impression: Fever. 8/2/08-presented to ED with C/O fever, vomiting and diarrhea, decreased urine output and oral intake. Crying. Impression: Acute fever. Admitted.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Erythema, Injected limb mobility decreased
Clinical narrative: Chills, redness, swelling, 100.4 temp, could not lift arm, joint pain and swelling; 7-23-08 Began having pain in joints of (R) arm and (L) leg; red eye.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Ocular hyperaemia, Swelling
Clinical narrative: Chills, redness, swelling, 100.4 temp, could not lift arm, joint pain and swelling; 7-23-08 Began having pain in joints of (R) arm and (L) leg; red eye.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles 72 hours after administration of ZOSTAVAX.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Influenza like illness, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: Fever, now resolved, nasal congestion now resolving. Axillary lymph nodes on left sides with pain and swelling. Patient is using Tiger Balm and warm compresses. Swelling pain at injection site. Additional info see attached... A 29 yr old female who presents for Reaction to TDAP, immunization given in left delt on 07/31/08, PT states she has had flu like symptoms and swelling and pain in left delt. AL/SMMA.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nasal congestion, Pyrexia
Clinical narrative: Fever, now resolved, nasal congestion now resolving. Axillary lymph nodes on left sides with pain and swelling. Patient is using Tiger Balm and warm compresses. Swelling pain at injection site. Additional info see attached... A 29 yr old female who presents for Reaction to TDAP, immunization given in left delt on 07/31/08, PT states she has had flu like symptoms and swelling and pain in left delt. AL/SMMA.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Local reaction, Pain, Tenderness
Clinical narrative: Localized pain and tenderness (severe) Rt. arm.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Light headed, fainting x2. tx; O2 per mask (4L) rest/Lay down cool compress on forehead
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL, VARCEL
Symptoms: Hypersensitivity
Clinical narrative: After leaving clinic at 12:05 PM patient's mom called clinic at 12:45 PM stating that her daughter may be having an allergic reaction to the vaccine.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL, VARCEL
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity
Clinical narrative: After leaving clinic at 12:05 PM patient's mom called clinic at 12:45 PM stating that her daughter may be having an allergic reaction to the vaccine.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Cellulitis, Chest pain, Culture wound, Echocardiogram
Clinical narrative: Lrg amt. vesicles to Lt axilla & thorax - cellulitis Lt axilla-chest.  Chest pain-neg cardiac involvement after workup.  Lt arm vaccine site.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram, Full blood count, Injection site vesicles, Troponin
Clinical narrative: Lrg amt. vesicles to Lt axilla & thorax - cellulitis Lt axilla-chest.  Chest pain-neg cardiac involvement after workup.  Lt arm vaccine site.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cognitive disorder, Headache, Neurogenic bladder, Optic neuritis, Urine analysis
Clinical narrative: 8/07 - bladder symptom - later diagnosed as neurogenic bladder; 9/07 - Optic neuritis /Headaches; 10/07 - cognitive decline; Possible diagnosis - Multiple Sclerosis 8/26/08 Reviewed neurologist medical records of 11/1/07-7/14/2008 which included ophtho & PCP medical records. FINAL DX: optic neuritis & MS Records reveal patient experienced left eye dilated, HA w/sharp pains.  Had been seen by ophtho whose records are also included for decreasd color & peripheral vision.  Seen in ER for chest pain, dark vision, dizziness & had passed out x 2.  Had used imitrex & Topamax for HA & then developed chest pain.  Initial neuro consult had been done prior to ER for HA.  ER Dx: adverse effects of medication; vascular HA; chest pain secondary to AE of medication.  D/C to home.  Developed hand/foot tingling & dysuria w/overactive bladder.  By 3/2008 HA had almost completely resolved but continued w/bladder frequency & stress urinary incontinence.  Referred to urogynocologist & dx w/neurogenic bladder.  Referred to second opinion neuro & uro.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Urodynamics measurement, Visual evoked potentials
Clinical narrative: 8/07 - bladder symptom - later diagnosed as neurogenic bladder; 9/07 - Optic neuritis /Headaches; 10/07 - cognitive decline; Possible diagnosis - Multiple Sclerosis 8/26/08 Reviewed neurologist medical records of 11/1/07-7/14/2008 which included ophtho & PCP medical records. FINAL DX: optic neuritis & MS Records reveal patient experienced left eye dilated, HA w/sharp pains.  Had been seen by ophtho whose records are also included for decreasd color & peripheral vision.  Seen in ER for chest pain, dark vision, dizziness & had passed out x 2.  Had used imitrex & Topamax for HA & then developed chest pain.  Initial neuro consult had been done prior to ER for HA.  ER Dx: adverse effects of medication; vascular HA; chest pain secondary to AE of medication.  D/C to home.  Developed hand/foot tingling & dysuria w/overactive bladder.  By 3/2008 HA had almost completely resolved but continued w/bladder frequency & stress urinary incontinence.  Referred to urogynocologist & dx w/neurogenic bladder.  Referred to second opinion neuro & uro.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Multiple sclerosis
Clinical narrative: 8/07 - bladder symptom - later diagnosed as neurogenic bladder; 9/07 - Optic neuritis /Headaches; 10/07 - cognitive decline; Possible diagnosis - Multiple Sclerosis 8/26/08 Reviewed neurologist medical records of 11/1/07-7/14/2008 which included ophtho & PCP medical records. FINAL DX: optic neuritis & MS Records reveal patient experienced left eye dilated, HA w/sharp pains.  Had been seen by ophtho whose records are also included for decreasd color & peripheral vision.  Seen in ER for chest pain, dark vision, dizziness & had passed out x 2.  Had used imitrex & Topamax for HA & then developed chest pain.  Initial neuro consult had been done prior to ER for HA.  ER Dx: adverse effects of medication; vascular HA; chest pain secondary to AE of medication.  D/C to home.  Developed hand/foot tingling & dysuria w/overactive bladder.  By 3/2008 HA had almost completely resolved but continued w/bladder frequency & stress urinary incontinence.  Referred to urogynocologist & dx w/neurogenic bladder.  Referred to second opinion neuro & uro.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: clear filled blisters on face, scalp neck-very itchy
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: clear filled blisters on face, scalp neck-very itchy
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Nausea, Tongue disorder
Clinical narrative: Pt had sensation of nausea/no emesis 20-30 mins post vaccine.  Felt lightheaded, felt SOB. Sent to ED-complained of tongue "thickness" no angioedema nor acute respiratory sx noted.  Advised possible vasovagal but to report to CDC.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Borrelia burgdorferi serology negative, Cardiolipin antibody negative, Complement factor C3 decreased
Clinical narrative: sudden onset bilat arthralgia; PE-neg labs-decreased platelet; refer hematologist decreased C3-C4-prednisone therapy increased DS DNA; refer rheumatologist  8/15/08 Reviewed PCP medical records which consisted of consultant records & labs. FINAL DX: ITP & probable drug induced lupus Heme/onc records reveal patient experienced joint aching & bruising.  Tx w/steroids.  Rheumatology records reveal patient evaluated for possible lupus erythematosus. Patient experienced extreme joint pain & fatigue that started several weeks after vaccinations.  Then developed petechia on hands & feet which resolved w/steroids.  ALso w/mild dyspnea. Follow-up Information 26-JUL-2008: This is a follow up on our mutual patient. She was referred to me by your nurse practitioner for thrombocytopenia. Her platelet was running in the range of 30,000. She also had ecchymosis and arthralgia. I have ordered workup. At the time when I did the CBC it showed her platelet acount was 31,000. I have reviewed her peripheral smear which showed she had giant platelet. Her thyroid function test was normal. Her C3 was low at 57, normal is 90-207. C4 level was less than 5.0, normal is 17-52. B12 level was low-normal 230. Folic acid was 16. ANA was negative, but initially her ANA was positive which was ordered by nurse practitioner. H. pylori was negative. Hepatitis profile was neagative. Immunoelectrophoresis was normal. Anticardiolipin antibody was 6, IgG and IgM, but anticardiolipin IgA level was less than 6. Double-stranded DNA was high at 294. Lyme titer was negative. Anti Smith antibody was 2. I have started her on prednisone 60 mg daily. Her platelet count today is 266,000. She is accompanied by her mother. I actually also referred her to another doctor for evaluation of lupus. SHe had seen the doctor this morning. Her mother was also with her. Patient is my office nurse. Doctor thinks that it is due to Gardasil. We have reviewed the literature. Seems to be Gardasil can cause drug-induced lupus. On today's examination, her blood pressure is 98/70 which according to her mother is normal for her. She has no oral thrush. She has no petachiae. Her arthralgia has significantly improved. She has no pedal edema. Drug-induced lupus, possibly from Gardasil. Will taper off prednisone 10 mg each week. Will follow up lab work in about five weeks. I have discussed with her mother that if she develops thrush, she should call us. Otherwise, I will see her back in about five weeks. She will be having a weekly CBC to monitor her blood sugar, as well as her platelet count.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Complement factor C4 decreased, DNA antibody, DNA antibody positive, Ecchymosis, Helicobacter pylori identification test negative
Clinical narrative: sudden onset bilat arthralgia; PE-neg labs-decreased platelet; refer hematologist decreased C3-C4-prednisone therapy increased DS DNA; refer rheumatologist  8/15/08 Reviewed PCP medical records which consisted of consultant records & labs. FINAL DX: ITP & probable drug induced lupus Heme/onc records reveal patient experienced joint aching & bruising.  Tx w/steroids.  Rheumatology records reveal patient evaluated for possible lupus erythematosus. Patient experienced extreme joint pain & fatigue that started several weeks after vaccinations.  Then developed petechia on hands & feet which resolved w/steroids.  ALso w/mild dyspnea. Follow-up Information 26-JUL-2008: This is a follow up on our mutual patient. She was referred to me by your nurse practitioner for thrombocytopenia. Her platelet was running in the range of 30,000. She also had ecchymosis and arthralgia. I have ordered workup. At the time when I did the CBC it showed her platelet acount was 31,000. I have reviewed her peripheral smear which showed she had giant platelet. Her thyroid function test was normal. Her C3 was low at 57, normal is 90-207. C4 level was less than 5.0, normal is 17-52. B12 level was low-normal 230. Folic acid was 16. ANA was negative, but initially her ANA was positive which was ordered by nurse practitioner. H. pylori was negative. Hepatitis profile was neagative. Immunoelectrophoresis was normal. Anticardiolipin antibody was 6, IgG and IgM, but anticardiolipin IgA level was less than 6. Double-stranded DNA was high at 294. Lyme titer was negative. Anti Smith antibody was 2. I have started her on prednisone 60 mg daily. Her platelet count today is 266,000. She is accompanied by her mother. I actually also referred her to another doctor for evaluation of lupus. SHe had seen the doctor this morning. Her mother was also with her. Patient is my office nurse. Doctor thinks that it is due to Gardasil. We have reviewed the literature. Seems to be Gardasil can cause drug-induced lupus. On today's examination, her blood pressure is 98/70 which according to her mother is normal for her. She has no oral thrush. She has no petachiae. Her arthralgia has significantly improved. She has no pedal edema. Drug-induced lupus, possibly from Gardasil. Will taper off prednisone 10 mg each week. Will follow up lab work in about five weeks. I have discussed with her mother that if she develops thrush, she should call us. Otherwise, I will see her back in about five weeks. She will be having a weekly CBC to monitor her blood sugar, as well as her platelet count.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis viral test, Immunoelectrophoresis, Platelet count decreased, Thyroid function test normal
Clinical narrative: sudden onset bilat arthralgia; PE-neg labs-decreased platelet; refer hematologist decreased C3-C4-prednisone therapy increased DS DNA; refer rheumatologist  8/15/08 Reviewed PCP medical records which consisted of consultant records & labs. FINAL DX: ITP & probable drug induced lupus Heme/onc records reveal patient experienced joint aching & bruising.  Tx w/steroids.  Rheumatology records reveal patient evaluated for possible lupus erythematosus. Patient experienced extreme joint pain & fatigue that started several weeks after vaccinations.  Then developed petechia on hands & feet which resolved w/steroids.  ALso w/mild dyspnea. Follow-up Information 26-JUL-2008: This is a follow up on our mutual patient. She was referred to me by your nurse practitioner for thrombocytopenia. Her platelet was running in the range of 30,000. She also had ecchymosis and arthralgia. I have ordered workup. At the time when I did the CBC it showed her platelet acount was 31,000. I have reviewed her peripheral smear which showed she had giant platelet. Her thyroid function test was normal. Her C3 was low at 57, normal is 90-207. C4 level was less than 5.0, normal is 17-52. B12 level was low-normal 230. Folic acid was 16. ANA was negative, but initially her ANA was positive which was ordered by nurse practitioner. H. pylori was negative. Hepatitis profile was neagative. Immunoelectrophoresis was normal. Anticardiolipin antibody was 6, IgG and IgM, but anticardiolipin IgA level was less than 6. Double-stranded DNA was high at 294. Lyme titer was negative. Anti Smith antibody was 2. I have started her on prednisone 60 mg daily. Her platelet count today is 266,000. She is accompanied by her mother. I actually also referred her to another doctor for evaluation of lupus. SHe had seen the doctor this morning. Her mother was also with her. Patient is my office nurse. Doctor thinks that it is due to Gardasil. We have reviewed the literature. Seems to be Gardasil can cause drug-induced lupus. On today's examination, her blood pressure is 98/70 which according to her mother is normal for her. She has no oral thrush. She has no petachiae. Her arthralgia has significantly improved. She has no pedal edema. Drug-induced lupus, possibly from Gardasil. Will taper off prednisone 10 mg each week. Will follow up lab work in about five weeks. I have discussed with her mother that if she develops thrush, she should call us. Otherwise, I will see her back in about five weeks. She will be having a weekly CBC to monitor her blood sugar, as well as her platelet count.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain
Clinical narrative: Reports developed sharp pain at collarbone region.  States was constant yesterday but today is only when laughs or takes a deep breath.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: High fever, 101-102 with malaise and fatigue for 36 hours beginning the night after vaccine given that morning.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Liver function test abnormal, Ultrasound scan abnormal
Clinical narrative: Received Hep A and HPV vaccine on 08/14/07. On 8/15 she began c/o pain (R) side. Saw doctor. Pts LFT's were elevated. Pain continued. Saw doctor again in Dec 2007 and LFT's were still elevated. Ultrasound showed sluggish gall bladder. Gall bladder removed on March 14, 2008. Still has pain. Surgeon told pt it could be the shots.  8/26/08 Reviewed PCP medical records of 8/13/07-7/29/2008. FINAL DX: none provided Records reveal patient experienced sore throat, rhinorrhea, irregular menses & on 8/13 BCP changed. RTC on 10/16/07 w/dizziness, HA, sore throat, left chest pain, wheezing, nonproductive cough, fever x 1 wk. Dx w/asthma, bronchitis & left lateral chest pain. Tx w/antibiotics.RTC next day w/increased left chest wall pain which increased w/inspiration.  Dx w/bronchitis & pleurisy.  Tx w/meds.  Developed gastroenteritis.  RTC 7/29/08 w/diffuse abdominal pain x 1 mo.  Had gallbladder removed 3/2008 & been seen in ER for abdominal pain.  Tx w/meds.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dyskinesia, Tension
Clinical narrative: Vaccinations given with patient laughing, bright affect.  After vaccinations completed patient got up and moved to another seat so a sister could be vaccinated.  After setting vaccinations on table, I and nurse heard gurgling noises and turn to see patient body tense up and jerk.  Pts eyes closed.  This lasted approx. 10 seconds.  Pt then relaxed body, opened eyes and said "I got dizzy".  Had pt assessed by RN and referred to medical clinic.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cough, Headache, Pruritus generalised
Clinical narrative: EMS called-unable to communicate with pt. language barrier. EMS ? H.A. Pt. with cough and itching all over-started tonight. Pt. on meds for TX x almost 3 months. cool mask applied
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: L arm erythema ~15x10cm, seen by ER on 8/1 BACTRIM started, f/u at PCA on 8/4 with decrease of erythema.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Erythematous, circular patch 5cm in diameter.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen 4 inches around at injection site, then progressed with swelling from left elbow up to left shoulder. Injection site was hard ant. hot to the touch no fever
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Inflammation, Injection site pain, Skin warm, Swelling
Clinical narrative: Red, inflamed, swollen area measuring 50mm in length and 40mm in width.  The site is warm to touch, and c/o minor soreness in the L deltoid area.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Patient was given Expired vaccine...No adverse effects noted Patient notified and scheduled to received a repeated dose of MMR. Expired vaccine was MMR- Lot# 0306F-Exp date- 7-4-08
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: (R) thigh HIB IM site 6 cm x 10 cm area of Redness, swelling with increased local temp.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Tingling in L arm & HA immediately after the injection.  The next day 5/13 still had severe HA, dizziness, fatigue, numbness in L arm & R wrist.  Also c/o pain & soreness in hips.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Tingling in L arm & HA immediately after the injection.  The next day 5/13 still had severe HA, dizziness, fatigue, numbness in L arm & R wrist.  Also c/o pain & soreness in hips.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Small amt redness & swelling noted per mom to Lt upper arm of patient starting 5-16-08 at 2100.  Mom states by Saturday night 5-17-08 at 2200-Lt arm was bright red, swollen, hard to touch, with blisters, from Lt shoulder to Lt elbow.  Mom took patient to ER.  Today 5-19-08, Lt upper arm still red, firm to touch around deltoid.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Body temperature, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Child developed rash (red, flat, no pimples) all over body on 6/30/08.  Temp 100 degrees F. Rash was shown mostly of face, abdomen, less on arms, legs.  Reported rash 7/1/08.  Called parent back 7/2: rash pink, receding, no fever; eating & drinking OK.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Hard, very swollen right leg from groin to below knee.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Laparoscopy, Laparoscopy abnormal, Surgery, Ultrasound scan abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old female who on 20-AUG-2007 was vaccinated with ROTATEQ, oral (Lot # 654795/0873F). Concomitant therapy included PEDIARIX (GSK) (Lot # A21CA294A); second dose of PREVNAR, IM (Wyeth) (Lot # 25680). On 22-AUG-2007, two days after vaccination, the patient experienced invagination for four to seven hours which was considered life threatening. The patient was hospitalised and the diagnosis of invagination (also referred to as "intussusception") was corroborated by physical examination, sonogram, and laparoscopy. The patient underwent surgery and recovered completely. On 22-AUG-2007, test results were: ultrasound scan (results: diagnosis of invagination); laparoscopy (results: diagnosis of invagination); and physical examination (results: diagnosis of invagination). This case is being treated according to the IFSG (Protection again Infection Act). The reporting source was not provided. The VAERD ID # is 290456. Lot check has been requested. Lot check results as follows: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information available.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Enema administration, Intussusception, Irritability, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 4 month old male who on 13-NOV-2007 was vaccinated orally with a second dose of ROTATEQ (Lot# reported as 657667/1392U).  Suspect therapy given IM in the right leg included a second dose of RECOMBIVAX HB (Lot # reported as /6376U).  Concomitant therapy included TYLENOL, IPOL (Sanofi Pasteur Lot # A0126), INFANRIX (GSK Lot #AC14B062) and PREVNAR (Wyeth Lot # B54015D).  On 02-JAN-2008 the patient experienced abdominal pain, diarrhoea hemorrhagic, enema administration, intussusception, irritability, oral intake reduced, urine output decreased and vomiting and was hospitalized.  The patient developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  23-JAN-2008 Vax record received and ROTATEQ Lot # updated.  It appears that the reported lot # was for the 18-SEP-2007 dose not the 13-NOV-2007 dose.  /pc 30-MAY-2008 MR received for DOS 2/3-JAN-2008 with DX: Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea.  Pt had been feeding poorly and had fewer wet diapers.  Reduced by Barium enema and admitted for o/n obs.  The patient had an abdominal ultrasound showed transverse colon intussusception.  Barium enema positive for IS at level of hepatic flexure.  Abdominal pain, diarrhoea hemorrhagic, enema administration, intussusception, irritability, oral intake reduced, urine output decreased and vomiting were considered to be life-threatening.  The original reporting source was not provided.  The VAERS ID # is 302536.  Lot check requested.  Lot check results: A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium enema abnormal, Diarrhoea haemorrhagic, Enema administration, Intussusception
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 4 month old male who on 13-NOV-2007 was vaccinated orally with a second dose of ROTATEQ (Lot# reported as 657667/1392U).  Suspect therapy given IM in the right leg included a second dose of RECOMBIVAX HB (Lot # reported as /6376U).  Concomitant therapy included TYLENOL, IPOL (Sanofi Pasteur Lot # A0126), INFANRIX (GSK Lot #AC14B062) and PREVNAR (Wyeth Lot # B54015D).  On 02-JAN-2008 the patient experienced abdominal pain, diarrhoea hemorrhagic, enema administration, intussusception, irritability, oral intake reduced, urine output decreased and vomiting and was hospitalized.  The patient developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  23-JAN-2008 Vax record received and ROTATEQ Lot # updated.  It appears that the reported lot # was for the 18-SEP-2007 dose not the 13-NOV-2007 dose.  /pc 30-MAY-2008 MR received for DOS 2/3-JAN-2008 with DX: Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea.  Pt had been feeding poorly and had fewer wet diapers.  Reduced by Barium enema and admitted for o/n obs.  The patient had an abdominal ultrasound showed transverse colon intussusception.  Barium enema positive for IS at level of hepatic flexure.  Abdominal pain, diarrhoea hemorrhagic, enema administration, intussusception, irritability, oral intake reduced, urine output decreased and vomiting were considered to be life-threatening.  The original reporting source was not provided.  The VAERS ID # is 302536.  Lot check requested.  Lot check results: A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Irritability, Oral intake reduced, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 4 month old male who on 13-NOV-2007 was vaccinated orally with a second dose of ROTATEQ (Lot# reported as 657667/1392U).  Suspect therapy given IM in the right leg included a second dose of RECOMBIVAX HB (Lot # reported as /6376U).  Concomitant therapy included TYLENOL, IPOL (Sanofi Pasteur Lot # A0126), INFANRIX (GSK Lot #AC14B062) and PREVNAR (Wyeth Lot # B54015D).  On 02-JAN-2008 the patient experienced abdominal pain, diarrhoea hemorrhagic, enema administration, intussusception, irritability, oral intake reduced, urine output decreased and vomiting and was hospitalized.  The patient developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  23-JAN-2008 Vax record received and ROTATEQ Lot # updated.  It appears that the reported lot # was for the 18-SEP-2007 dose not the 13-NOV-2007 dose.  /pc 30-MAY-2008 MR received for DOS 2/3-JAN-2008 with DX: Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea.  Pt had been feeding poorly and had fewer wet diapers.  Reduced by Barium enema and admitted for o/n obs.  The patient had an abdominal ultrasound showed transverse colon intussusception.  Barium enema positive for IS at level of hepatic flexure.  Abdominal pain, diarrhoea hemorrhagic, enema administration, intussusception, irritability, oral intake reduced, urine output decreased and vomiting were considered to be life-threatening.  The original reporting source was not provided.  The VAERS ID # is 302536.  Lot check requested.  Lot check results: A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Gastrointestinal surgery, Intussusception
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old female who on 14-MAR-2008 was po vaccinated with the third dose of ROTATEQ lot # reported as 659775/1664U.  Concomitant therapy included the third IM dose of PREVNAR (lot # reported as C45894) in the right leg and the third IM dose of PEDIARIX (lot # reported as AC21B141AA) in the left leg.  On 23-MAR-2008 records revealed a patient experienced abdominal pain, vomiting, lethargy and blood mucoid stools times one day.  Seen in outlying ER where abdominal x-ray suspicious for intussusception and transferred to a higher level of care.  An air contrast barium enema was unsuccessful at reducing the intussusception.  On 24-MAR-2008 (10 days after receiving ROTATEQ) patient was taken to the OR for exploratory laparotomy which was difficult to reduce.  Patient had to have ileal cecectomy (removed 3 inches of colon) with primary anastomosis.  Recovered well post operatively and discharged to home.  Intussusception, abdominal pain, haematochezia, intestinal ischaemia, lethargy, mucous stools and vomiting were considered to be life threatening.  The original reporting source was not provided.  The VAERS ID # is 311011.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Blood potassium decreased, Caecectomy
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old female who on 14-MAR-2008 was po vaccinated with the third dose of ROTATEQ lot # reported as 659775/1664U.  Concomitant therapy included the third IM dose of PREVNAR (lot # reported as C45894) in the right leg and the third IM dose of PEDIARIX (lot # reported as AC21B141AA) in the left leg.  On 23-MAR-2008 records revealed a patient experienced abdominal pain, vomiting, lethargy and blood mucoid stools times one day.  Seen in outlying ER where abdominal x-ray suspicious for intussusception and transferred to a higher level of care.  An air contrast barium enema was unsuccessful at reducing the intussusception.  On 24-MAR-2008 (10 days after receiving ROTATEQ) patient was taken to the OR for exploratory laparotomy which was difficult to reduce.  Patient had to have ileal cecectomy (removed 3 inches of colon) with primary anastomosis.  Recovered well post operatively and discharged to home.  Intussusception, abdominal pain, haematochezia, intestinal ischaemia, lethargy, mucous stools and vomiting were considered to be life threatening.  The original reporting source was not provided.  The VAERS ID # is 311011.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Enema administration, Explorative laparotomy, Haematochezia, Intestinal anastomosis, Intestinal ischaemia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old female who on 14-MAR-2008 was po vaccinated with the third dose of ROTATEQ lot # reported as 659775/1664U.  Concomitant therapy included the third IM dose of PREVNAR (lot # reported as C45894) in the right leg and the third IM dose of PEDIARIX (lot # reported as AC21B141AA) in the left leg.  On 23-MAR-2008 records revealed a patient experienced abdominal pain, vomiting, lethargy and blood mucoid stools times one day.  Seen in outlying ER where abdominal x-ray suspicious for intussusception and transferred to a higher level of care.  An air contrast barium enema was unsuccessful at reducing the intussusception.  On 24-MAR-2008 (10 days after receiving ROTATEQ) patient was taken to the OR for exploratory laparotomy which was difficult to reduce.  Patient had to have ileal cecectomy (removed 3 inches of colon) with primary anastomosis.  Recovered well post operatively and discharged to home.  Intussusception, abdominal pain, haematochezia, intestinal ischaemia, lethargy, mucous stools and vomiting were considered to be life threatening.  The original reporting source was not provided.  The VAERS ID # is 311011.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.