chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Dehydration, Headache, Malaise, Neck pain
Clinical narrative: Patient had stayed up from working MN's and went to doctor to receive final HPV vaccine. Had been feeling 'fine' --other than the normal post MN feeling. Had the injection administered about 12:30 pm--went home had something to eat, then went to bed. awoke about 5:00 pm this same day, with a headache, low grade fever, achiness, neck pain , and abdominal discomfort. temperature at @ 6 pm = 99.2 orally.pt took advil x 1. went to work at 9 pm this same day. started to feel much worse, increased fever, headache, and neck pain and 'feeling just run down all over'. patient could not work her mn shift, and was going to be escorted home. pt works in an Ed department and upon arrival of parents to pick her up, pt had an syncopal episode, pallor skin --almost white, with mild tremors. pt required stat ed care, which included a ct, lab, ivf (pt very dehydrated) required 3 liters of fluid, hr =tachy with low bp. spinal tap was done to r/o meningitis. pt 's lab revealed wbc with slight elevation. other labs wnl. temperature spiked to 102.5 rocephin iv given, and cultures drawn. pt started to feel better, after antipyretics , ivf's, and comfort/ sleep. discharged to home after 7 hours in the ed. pt remains with mild --cluster type headache controlled with pain medication. final dx= ? viral meningitis. 11/19/08-records received-final HPV4 vaccine received on-11/5/08-C/O headache, fever, neck pain, abdominal discomfort. General malaise and pale. Passed out.  Dehydration. Diagnosed with viral meningitis and discharged from ED. Continues to C/O mild headache and tiredness and slowly progressing. No C/O with 2 previous HPV4 vaccines.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pallor, Pyrexia, Syncope, Tachycardia
Clinical narrative: Patient had stayed up from working MN's and went to doctor to receive final HPV vaccine. Had been feeling 'fine' --other than the normal post MN feeling. Had the injection administered about 12:30 pm--went home had something to eat, then went to bed. awoke about 5:00 pm this same day, with a headache, low grade fever, achiness, neck pain , and abdominal discomfort. temperature at @ 6 pm = 99.2 orally.pt took advil x 1. went to work at 9 pm this same day. started to feel much worse, increased fever, headache, and neck pain and 'feeling just run down all over'. patient could not work her mn shift, and was going to be escorted home. pt works in an Ed department and upon arrival of parents to pick her up, pt had an syncopal episode, pallor skin --almost white, with mild tremors. pt required stat ed care, which included a ct, lab, ivf (pt very dehydrated) required 3 liters of fluid, hr =tachy with low bp. spinal tap was done to r/o meningitis. pt 's lab revealed wbc with slight elevation. other labs wnl. temperature spiked to 102.5 rocephin iv given, and cultures drawn. pt started to feel better, after antipyretics , ivf's, and comfort/ sleep. discharged to home after 7 hours in the ed. pt remains with mild --cluster type headache controlled with pain medication. final dx= ? viral meningitis. 11/19/08-records received-final HPV4 vaccine received on-11/5/08-C/O headache, fever, neck pain, abdominal discomfort. General malaise and pale. Passed out.  Dehydration. Diagnosed with viral meningitis and discharged from ED. Continues to C/O mild headache and tiredness and slowly progressing. No C/O with 2 previous HPV4 vaccines.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Patient had stayed up from working MN's and went to doctor to receive final HPV vaccine. Had been feeling 'fine' --other than the normal post MN feeling. Had the injection administered about 12:30 pm--went home had something to eat, then went to bed. awoke about 5:00 pm this same day, with a headache, low grade fever, achiness, neck pain , and abdominal discomfort. temperature at @ 6 pm = 99.2 orally.pt took advil x 1. went to work at 9 pm this same day. started to feel much worse, increased fever, headache, and neck pain and 'feeling just run down all over'. patient could not work her mn shift, and was going to be escorted home. pt works in an Ed department and upon arrival of parents to pick her up, pt had an syncopal episode, pallor skin --almost white, with mild tremors. pt required stat ed care, which included a ct, lab, ivf (pt very dehydrated) required 3 liters of fluid, hr =tachy with low bp. spinal tap was done to r/o meningitis. pt 's lab revealed wbc with slight elevation. other labs wnl. temperature spiked to 102.5 rocephin iv given, and cultures drawn. pt started to feel better, after antipyretics , ivf's, and comfort/ sleep. discharged to home after 7 hours in the ed. pt remains with mild --cluster type headache controlled with pain medication. final dx= ? viral meningitis. 11/19/08-records received-final HPV4 vaccine received on-11/5/08-C/O headache, fever, neck pain, abdominal discomfort. General malaise and pale. Passed out.  Dehydration. Diagnosed with viral meningitis and discharged from ED. Continues to C/O mild headache and tiredness and slowly progressing. No C/O with 2 previous HPV4 vaccines.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Band neutrophil percentage increased, Blood culture negative, Chest X-ray abnormal, Culture stool negative, Culture urine negative
Clinical narrative: Received Hep A, Influenza, and PCV7 on 11/5/08.  Had febrile seizure in am of 11/07/08.  See at Hospital ED.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Febrile convulsion, Full blood count, Lymphocyte percentage increased, Neutrophil percentage decreased, Platelet count normal
Clinical narrative: Received Hep A, Influenza, and PCV7 on 11/5/08.  Had febrile seizure in am of 11/07/08.  See at Hospital ED.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: White blood cell count
Clinical narrative: Received Hep A, Influenza, and PCV7 on 11/5/08.  Had febrile seizure in am of 11/07/08.  See at Hospital ED.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: NONE
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: NONE
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: NONE
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Presently, multiple small itching spots on feet, legs, arms, back, and stomach.  Most severe on the back.  None on face, head, hands, crotch, or neck area.  Began with a few spots on the legs.  Gradually spread to other areas as described.  Presently using Caladryl to relieve itching.  Tried using Coraid 10.  My vaccine was for shingles.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Back pain, Chills, Feeling hot, Injection site pain
Clinical narrative: I woke up during the night with severe chills that lasted about 2.5 hours.  I could not get warm nor could I stop the shaking or teeth chattering during this time.  Also, especially my neck, back and shoulders joints were very achySite of injection was painful for 4 days. I took Tylenol and finally fell asleep. Upon awaking in the morning, I was very warm and the shaking had finally stopped. The aches were still present.  I am ok now and not sick.  I am a radiographer at this hospital.  I have received the flu shot many times in the past and have never had this type of reaction.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Tremor
Clinical narrative: I woke up during the night with severe chills that lasted about 2.5 hours.  I could not get warm nor could I stop the shaking or teeth chattering during this time.  Also, especially my neck, back and shoulders joints were very achySite of injection was painful for 4 days. I took Tylenol and finally fell asleep. Upon awaking in the morning, I was very warm and the shaking had finally stopped. The aches were still present.  I am ok now and not sick.  I am a radiographer at this hospital.  I have received the flu shot many times in the past and have never had this type of reaction.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood product transfusion, Lymphocyte percentage increased, Mean cell volume decreased, Mean platelet volume decreased, Neutrophil count decreased
Clinical narrative: Thrombocytopenia, petechia. Tx - IV Immune globulin.  2/9/09 Received hospital medical records of 11/8-11/9/2008 FINAL DX: thrombocytopenia Records reveal patient experienced mild abdominal pain x 1 week, bleeding gums & petechial rash x 1 day.  Saw PCP & labs revealed dx.  Tx w/IVIG.  Improved & d/c to home w/serial labs.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Platelet count decreased, Thrombocytopenia, White blood cell count increased
Clinical narrative: Thrombocytopenia, petechia. Tx - IV Immune globulin.  2/9/09 Received hospital medical records of 11/8-11/9/2008 FINAL DX: thrombocytopenia Records reveal patient experienced mild abdominal pain x 1 week, bleeding gums & petechial rash x 1 day.  Saw PCP & labs revealed dx.  Tx w/IVIG.  Improved & d/c to home w/serial labs.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: 5 hours after getting flu shot patient's airway began to close. Rushed to ER meds administered and kept patient overnight.  11/18/2008 MR received for DOS 10/28-29/2008 with D/C DX: Possible allergic reaction to Flu shot, now doing well. The pm of Flu shot pt developed a sore throat, recurrant coughing, SOB and respiratory distress.  Tx with epi and solumedrol with no recurrance of sx.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Anaemia, Bronchiolitis, Chest X-ray normal, Full blood count abnormal, Leukocytosis
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057). On 12 June 2008 and 07 August 2008, he received the 1st and 2nd dose of HIB-MENCYT-TT, IM L thigh) and PEDIARIX, IM R thigh. On 29 October 2008, 83 days after the 2nd dose of PEDIARIX, 83 days after the 2nd dose of HIB-MENCY-TT, this six-month-old subject developed anemia, bronchiolitis and acute otitis media. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with ceftriaxone sodium, salbutamol sulphate and amoxicillin trihydrate. The events improved on an unspecified date. The investigator considered that there was a reasonable possibility that anemia may have been caused by PEDIARIX and HIB-MENCY-TT whereas there was no reasonable possibility that the bronchiolitis and acute otitis media may have been caused by PEDIARIX and HIB-MENCY-TT. Investigator Comments: Patient was admitted in Medical Center on 29Oct2008 for Bronchiolitis and Ear Infection. The CBC on that was taken showed anemia and leukocytosis. The Chest X-Ray was negative and RSV testing was positive. The Patient was given ROCEPHIN IV and Albuterol Nebs every 4 hours. The patient was discharged home that day after with orders to follow-up with her pediatrician.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Otitis media acute, Respiratory syncytial virus test positive
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057). On 12 June 2008 and 07 August 2008, he received the 1st and 2nd dose of HIB-MENCYT-TT, IM L thigh) and PEDIARIX, IM R thigh. On 29 October 2008, 83 days after the 2nd dose of PEDIARIX, 83 days after the 2nd dose of HIB-MENCY-TT, this six-month-old subject developed anemia, bronchiolitis and acute otitis media. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with ceftriaxone sodium, salbutamol sulphate and amoxicillin trihydrate. The events improved on an unspecified date. The investigator considered that there was a reasonable possibility that anemia may have been caused by PEDIARIX and HIB-MENCY-TT whereas there was no reasonable possibility that the bronchiolitis and acute otitis media may have been caused by PEDIARIX and HIB-MENCY-TT. Investigator Comments: Patient was admitted in Medical Center on 29Oct2008 for Bronchiolitis and Ear Infection. The CBC on that was taken showed anemia and leukocytosis. The Chest X-Ray was negative and RSV testing was positive. The Patient was given ROCEPHIN IV and Albuterol Nebs every 4 hours. The patient was discharged home that day after with orders to follow-up with her pediatrician.
Age: 0.8
Sex: F
Vaccine: FLU3
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Crying for 5 hours, fever 102 degrees for 12 hours vomited x one.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: pt received FLUZONE 11/10/08, came to office for Tx of reaction 11/11/08.  Area where injection given is swollen, red blotches down arm, warm to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Aprox.  10 min after immunizations, patient had Urticarial hyper rash on abdomen, Lt. arm and back.  2 new spots were noted after 20 minutes of close observation.   ORAPRED given along with a prescription for ATARAX.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Pt c/o intermittent paresthesias beginning 24 hrs after vaccine. 11/19/08-records received for DOS 11/4/08-Allergies to sulfa. Diarrhea. DX: dysmenorrhea. No additional visits in record.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Temp 97.7 BP 118/68 complained of rash 2nd day after TdaP on arms, legs.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Chills, Hyperhidrosis, Myalgia
Clinical narrative: Started with muscle aches, temperature @ 11pm was 103.8 degrees decreased 101.8 degrees with Tylenol, started having aches and chills, started sweating, continued with muscle aches and unable to get out of bed next day.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Started with muscle aches, temperature @ 11pm was 103.8 degrees decreased 101.8 degrees with Tylenol, started having aches and chills, started sweating, continued with muscle aches and unable to get out of bed next day.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 3.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever 102- 103.7 x 5 days after two.  vaccines given R anterior/lateral thigh red, swollen 6X7 cm area (PNEUMOVAX given at this site).  FLUZONE given L ant/lat thigh
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of redness and swelling at injection site on (R) posterior arm.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Malaise, Pallor
Clinical narrative: PT. received #3 vaccines, approx 4 min later while sitting on exam table stated to nurse in room, "I'm not feeling well".  Nurse put pt's legs on table laid her down, pt had jerking all 4 extremities 3-5 sec. had loc-then recovered quickly-alert, pale.  MD in attendance after syncopal episode & syncopal seizure witnessed by nurse.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: PT. received #3 vaccines, approx 4 min later while sitting on exam table stated to nurse in room, "I'm not feeling well".  Nurse put pt's legs on table laid her down, pt had jerking all 4 extremities 3-5 sec. had loc-then recovered quickly-alert, pale.  MD in attendance after syncopal episode & syncopal seizure witnessed by nurse.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Muscle spasms, Pain, Pyrexia
Clinical narrative: Patient received INFANRIX, IPOL on Lt upper arm 11/3/08.  Parents noticed fever and cramping abd pain in the first 48 hrs.  Noticed redness, swelling at left upper arm > 48 hrs- progressively got worse, developed generalized urticarial rash all over the body.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient received INFANRIX, IPOL on Lt upper arm 11/3/08.  Parents noticed fever and cramping abd pain in the first 48 hrs.  Noticed redness, swelling at left upper arm > 48 hrs- progressively got worse, developed generalized urticarial rash all over the body.
Age: 53.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity
Clinical narrative: Dull ache that increases in intensity when arm is used- as in stretching arm out or lifting up or down.  The pain is in left upper deltoid.
Age: 53.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Dull ache that increases in intensity when arm is used- as in stretching arm out or lifting up or down.  The pain is in left upper deltoid.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site rash, Pain, Pruritus, Rash
Clinical narrative: Rash started at injection site on left arm, then appeared on right arm.  Also, patient complained of bodyaches, mild temperature increase and pruritis.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Peak expiratory flow rate
Clinical narrative: 2 minutes after IM injection of FLUZONE, Lot U2828AA, patient developed swelling 3 x 3 cm site of injection, intense pruritis, extending shoulder to elbow and increased ASMAY, decreased PEFN.  Treated Benadryl, steroids, cool compress, proventil inhaler.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Confusional state, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with an allergy to Ibuprofen who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot#659055/1522U), (site unknown) and on 28-JAN-2008 was vaccinated with the second dose of GARDASIL IM (Lot#659653/1448U), (site unknown). Concomitant therapy included DEPO-PROVERA (indication not specified). In November 2007, after receiving the first dose, the patient experienced nausea, vomiting, neck pain, back pain and headache. In July 2008, the patient began to experience seizures and numbness in various parts of her body. The patient sought medical attention. Laboratory tests performed included: "pregnancy test", "electrolytes", urinalysis and "CBC". The patient was not pregnant and the other test results were unknown. At the time of report on 05-NOV-2008, the patient was not recovered. The physician considered all these events to be significant disability or incapacity. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypokinesia, Nausea, Neck pain, Rash
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with an allergy to Ibuprofen who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot#659055/1522U), (site unknown) and on 28-JAN-2008 was vaccinated with the second dose of GARDASIL IM (Lot#659653/1448U), (site unknown). Concomitant therapy included DEPO-PROVERA (indication not specified). In November 2007, after receiving the first dose, the patient experienced nausea, vomiting, neck pain, back pain and headache. In July 2008, the patient began to experience seizures and numbness in various parts of her body. The patient sought medical attention. Laboratory tests performed included: "pregnancy test", "electrolytes", urinalysis and "CBC". The patient was not pregnant and the other test results were unknown. At the time of report on 05-NOV-2008, the patient was not recovered. The physician considered all these events to be significant disability or incapacity. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting, Weight decreased
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with an allergy to Ibuprofen who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot#659055/1522U), (site unknown) and on 28-JAN-2008 was vaccinated with the second dose of GARDASIL IM (Lot#659653/1448U), (site unknown). Concomitant therapy included DEPO-PROVERA (indication not specified). In November 2007, after receiving the first dose, the patient experienced nausea, vomiting, neck pain, back pain and headache. In July 2008, the patient began to experience seizures and numbness in various parts of her body. The patient sought medical attention. Laboratory tests performed included: "pregnancy test", "electrolytes", urinalysis and "CBC". The patient was not pregnant and the other test results were unknown. At the time of report on 05-NOV-2008, the patient was not recovered. The physician considered all these events to be significant disability or incapacity. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Convulsion, Headache, Hypoaesthesia, Nausea
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with an allergy to Ibuprofen who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot#659055/1522U), (site unknown) and on 28-JAN-2008 was vaccinated with the second dose of GARDASIL IM (Lot#659653/1448U), (site unknown). Concomitant therapy included DEPO-PROVERA (indication not specified). In November 2007, after receiving the first dose, the patient experienced nausea, vomiting, neck pain, back pain and headache. In July 2008, the patient began to experience seizures and numbness in various parts of her body. The patient sought medical attention. Laboratory tests performed included: "pregnancy test", "electrolytes", urinalysis and "CBC". The patient was not pregnant and the other test results were unknown. At the time of report on 05-NOV-2008, the patient was not recovered. The physician considered all these events to be significant disability or incapacity. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neck pain, Pregnancy test negative, Vomiting
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with an allergy to Ibuprofen who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot#659055/1522U), (site unknown) and on 28-JAN-2008 was vaccinated with the second dose of GARDASIL IM (Lot#659653/1448U), (site unknown). Concomitant therapy included DEPO-PROVERA (indication not specified). In November 2007, after receiving the first dose, the patient experienced nausea, vomiting, neck pain, back pain and headache. In July 2008, the patient began to experience seizures and numbness in various parts of her body. The patient sought medical attention. Laboratory tests performed included: "pregnancy test", "electrolytes", urinalysis and "CBC". The patient was not pregnant and the other test results were unknown. At the time of report on 05-NOV-2008, the patient was not recovered. The physician considered all these events to be significant disability or incapacity. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test normal, Convulsion, Electromyogram abnormal, Headache, Hypoaesthesia
Clinical narrative: Since vaccination has had painful neuropathy in lower extremities and painful cranial facial pain. Started night of 1st dose. 1/28/2010 Persistent remalgia, peripheral neuropathy and cognitive deficits.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Impaired work ability, Muscle spasms, Nerve conduction studies normal, Neuralgia, Neuropathy peripheral
Clinical narrative: Since vaccination has had painful neuropathy in lower extremities and painful cranial facial pain. Started night of 1st dose. 1/28/2010 Persistent remalgia, peripheral neuropathy and cognitive deficits.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia, Scan brain
Clinical narrative: Since vaccination has had painful neuropathy in lower extremities and painful cranial facial pain. Started night of 1st dose. 1/28/2010 Persistent remalgia, peripheral neuropathy and cognitive deficits.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Cognitive disorder, Electromyogram abnormal, Facial pain, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Since vaccination has had painful neuropathy in lower extremities and painful cranial facial pain. Started night of 1st dose. 1/28/2010 Persistent remalgia, peripheral neuropathy and cognitive deficits.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pain in extremity
Clinical narrative: Since vaccination has had painful neuropathy in lower extremities and painful cranial facial pain. Started night of 1st dose. 1/28/2010 Persistent remalgia, peripheral neuropathy and cognitive deficits.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB, Chest X-ray abnormal, Chest pain, Electrocardiogram ST segment elevation, Laboratory test normal
Clinical narrative: Reported to VHC on 10/5/08: 24 y/o previously healthy male with 2 day hx of pleuritic and substernal chest pain (6-7 out of 10), had fever, no dyspnea.  On exam he was afebrile with stable vital signs and O2 sat on room air.  Temp 98.6, Pulse 86, B/P 99/63, Resp 16.  Physical Exam was essentially unremarkable.  His primary inoculation site is healing over as anticipated.  He had some costochondral tenderness.  No s/s of reduced LV function by physical exam.  He received Indocin 50 mg, which nearly alleviated his chest pain, and he has been doing well since. 12/5/08-records received for DOS 10/8/08-C/O chest pain new onset began on 1/3/08 associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, diffuse tenderness to palpation over most of sternum.  Impression:Myopericarditis, secondary to immune response to smallpox immunization.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pleuritic pain, Pyrexia, Troponin I increased, Ultrasound scan normal
Clinical narrative: Reported to VHC on 10/5/08: 24 y/o previously healthy male with 2 day hx of pleuritic and substernal chest pain (6-7 out of 10), had fever, no dyspnea.  On exam he was afebrile with stable vital signs and O2 sat on room air.  Temp 98.6, Pulse 86, B/P 99/63, Resp 16.  Physical Exam was essentially unremarkable.  His primary inoculation site is healing over as anticipated.  He had some costochondral tenderness.  No s/s of reduced LV function by physical exam.  He received Indocin 50 mg, which nearly alleviated his chest pain, and he has been doing well since. 12/5/08-records received for DOS 10/8/08-C/O chest pain new onset began on 1/3/08 associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, diffuse tenderness to palpation over most of sternum.  Impression:Myopericarditis, secondary to immune response to smallpox immunization.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood electrolytes normal, Blood urea normal, Body temperature, Chest X-ray normal
Clinical narrative: Reported to VHC on 10/5/08: 24 y/o previously healthy male with 2 day hx of pleuritic and substernal chest pain (6-7 out of 10), had fever, no dyspnea.  On exam he was afebrile with stable vital signs and O2 sat on room air.  Temp 98.6, Pulse 86, B/P 99/63, Resp 16.  Physical Exam was essentially unremarkable.  His primary inoculation site is healing over as anticipated.  He had some costochondral tenderness.  No s/s of reduced LV function by physical exam.  He received Indocin 50 mg, which nearly alleviated his chest pain, and he has been doing well since. 12/5/08-records received for DOS 10/8/08-C/O chest pain new onset began on 1/3/08 associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, diffuse tenderness to palpation over most of sternum.  Impression:Myopericarditis, secondary to immune response to smallpox immunization.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Electrocardiogram normal, Heart rate normal, Oxygen saturation normal, Pleuritic pain
Clinical narrative: Reported to VHC on 10/5/08: 24 y/o previously healthy male with 2 day hx of pleuritic and substernal chest pain (6-7 out of 10), had fever, no dyspnea.  On exam he was afebrile with stable vital signs and O2 sat on room air.  Temp 98.6, Pulse 86, B/P 99/63, Resp 16.  Physical Exam was essentially unremarkable.  His primary inoculation site is healing over as anticipated.  He had some costochondral tenderness.  No s/s of reduced LV function by physical exam.  He received Indocin 50 mg, which nearly alleviated his chest pain, and he has been doing well since. 12/5/08-records received for DOS 10/8/08-C/O chest pain new onset began on 1/3/08 associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, diffuse tenderness to palpation over most of sternum.  Impression:Myopericarditis, secondary to immune response to smallpox immunization.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Respiratory rate, Tenderness, Troponin I increased
Clinical narrative: Reported to VHC on 10/5/08: 24 y/o previously healthy male with 2 day hx of pleuritic and substernal chest pain (6-7 out of 10), had fever, no dyspnea.  On exam he was afebrile with stable vital signs and O2 sat on room air.  Temp 98.6, Pulse 86, B/P 99/63, Resp 16.  Physical Exam was essentially unremarkable.  His primary inoculation site is healing over as anticipated.  He had some costochondral tenderness.  No s/s of reduced LV function by physical exam.  He received Indocin 50 mg, which nearly alleviated his chest pain, and he has been doing well since. 12/5/08-records received for DOS 10/8/08-C/O chest pain new onset began on 1/3/08 associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, diffuse tenderness to palpation over most of sternum.  Impression:Myopericarditis, secondary to immune response to smallpox immunization.
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TDAP
Symptoms: Cyanosis, Gaze palsy, Muscle rigidity, Pulse abnormal, Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unknown date was vaccinated with a dose of 0.5 ml GARDASIL (lot number, route and injection site unknown).  Concomitant vaccination included a dose of BOOSTRIX and MENACTRA.  After receiving GARDASIL, the patient experienced a seizure.  She was seen at the emergency room.  Patient's outcome was not reported.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TDAP
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unknown date was vaccinated with a dose of 0.5 ml GARDASIL (lot number, route and injection site unknown).  Concomitant vaccination included a dose of BOOSTRIX and MENACTRA.  After receiving GARDASIL, the patient experienced a seizure.  She was seen at the emergency room.  Patient's outcome was not reported.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Auricular swelling, Local swelling
Clinical narrative: Had MMR vaccine on 10/21/08. Developed red maculopapular rash on face, upper chest, upper back and arms. Developed swollen pre-auricular, post-auricular, maxillary and cervical lymph glands (mild mumps/mild measles)-Seen in office 10/16/08.
Age: 42.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood glucose normal, Haematocrit normal, Lymphadenopathy, Measles, Mumps
Clinical narrative: Had MMR vaccine on 10/21/08. Developed red maculopapular rash on face, upper chest, upper back and arms. Developed swollen pre-auricular, post-auricular, maxillary and cervical lymph glands (mild mumps/mild measles)-Seen in office 10/16/08.
Age: 42.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash erythematous, Rash maculo-papular, White blood cell count decreased
Clinical narrative: Had MMR vaccine on 10/21/08. Developed red maculopapular rash on face, upper chest, upper back and arms. Developed swollen pre-auricular, post-auricular, maxillary and cervical lymph glands (mild mumps/mild measles)-Seen in office 10/16/08.
Age: 17.0
Sex: M
Vaccine: FLUN3, MNQ, FLUN3, MNQ
Symptoms: Cardiac arrest, Implantable defibrillator insertion, Respiratory arrest, Syncope
Clinical narrative: Cardiac arrest due to ventricular tachycardia without known cause.
Age: 17.0
Sex: M
Vaccine: FLUN3, MNQ, FLUN3, MNQ
Symptoms: Cardiac arrest, Cardiac electrophysiologic study normal, Catheterisation cardiac normal, Chest X-ray normal, Echocardiogram normal
Clinical narrative: Cardiac arrest due to ventricular tachycardia without known cause.
Age: 17.0
Sex: M
Vaccine: FLUN3, MNQ, FLUN3, MNQ
Symptoms: Electrocardiogram normal, Implantable defibrillator insertion, Ventricular tachycardia
Clinical narrative: Cardiac arrest due to ventricular tachycardia without known cause.
Age: 12.0
Sex: F
Vaccine: FLUN3, FLUN3, MNQ
Symptoms: Facial palsy
Clinical narrative: Noticed crooked smile 11/02/08, more pronounced on 11/04/08. Call doctors office - went to ER. Diagnosed Bells palsy.
Age: 12.0
Sex: F
Vaccine: FLUN3, FLUN3, MNQ
Symptoms: Dyskinesia, Facial palsy, Lyme disease
Clinical narrative: Noticed crooked smile 11/02/08, more pronounced on 11/04/08. Call doctors office - went to ER. Diagnosed Bells palsy.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: 26 y/o ADSM, presented to the ER for redness and swelling in the arm 48+ after his receipt of AVA #4. Symptoms: Edema @ injection site >120 mm not beyond elbow, Erythema, Pruritus.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 26 y/o ADSM, presented to the ER for redness and swelling in the arm 48+ after his receipt of AVA #4. Symptoms: Edema @ injection site >120 mm not beyond elbow, Erythema, Pruritus.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated
Clinical narrative: Caused severe asthmatic attack. O2 level of 92. Required emergency treatment sopportive therapy and steriods. One week recovery.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Heart rate increased
Clinical narrative: About four or so hours after injection severe tightness across chest, rapid heart beat, shortness of breath with exertion.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: About four or so hours after injection severe tightness across chest, rapid heart beat, shortness of breath with exertion.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Induration, Oedema peripheral, Paraesthesia, Skin warm
Clinical narrative: Right arm became swollen, tight, hot to touch - 11/4/08.  AM 11/5 arm was numb and tingling/area affected was entire right upper arm - lateral.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Rash
Clinical narrative: General rash from just below shoulder to just above elbow- slight "lump" at injection site.
Age: 1.8
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site rash, Irritability, Oedema peripheral, Rash
Clinical narrative: Patient developed rash on torso on  the injection site.  With swelling arms patient became cranky- 24 hrs after the administration of DAPTACEL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Leukaemia, Neuralgia, Pain in extremity
Clinical narrative: Information has been received from a 60 year old female with no relevant medical history reported, who on 25-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck), Lot number 659268/0158X, 0.65 mL, subcutaneously.  There was no concomitant medication.  The caller reported that at the "end of July" on approximately 30-JUL-2008 when her left big toe "bends up" while she was walking, she sometimes experienced "nerve pain" in that toe and the top of her left foot.  In August 2008, the patient discovered she had leukemia and reported that she "was immunocompromised at the time she was vaccinated".  The patient sought medical attention.  At the time of the report, the patient had not recovered from "nerve pain" in her toe and the top of her left foot.  The patient's outcome for leukemia was not reported.  Upon internal review, leukemia was considered to be an other important medical event.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received, for the Pregnancy Registry for GARDASIL, from a nurse concerning a 24 year old female who on 05-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL. Subsequently, the patient found out she was pregnant (LMP = 15-SEP-2007). According to the reporter, it is believed that the patient was about 5 to 8 days pregnant at the time of vaccination. The patient sought unspecified medical attention. No further information was provided. Follow-up information was received on 04-NOV-2008 via phone call from a person of a doctor's office indicating that the patient was given the vaccine elsewhere and she came in for one prenatal visit and returned stating she had terminated the pregnancy elsewhere. The reporter could not confirm the gestational age at the time of the pregnancy termination. The patient later moved to another state and they have no further information to provide. Upon internal review, pregnancy termination was determined to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Caesarean section, Drug exposure during pregnancy, Failed trial of labour, Premature labour
Clinical narrative: Initial and follow up information has been received from a physician and nurse for the Pregnancy Registry for GARDASIL regarding a 19 year old female who on 12-APR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot #655165/1425F). On 12-JUN-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot #655165/1425F). There was no concomitant medication. On an unspecified date, the patient took an over-the-counter pregnancy test and the results were positive (date unspecified). The patient sought medical attention via telephone. As of 04-JUN-2008, the patient is 38 weeks + 1 day pregnant, her estimated due date is reported as 17-JUN-2008 (LMP estimated as 09-SEP-2007). Follow-up information was received on 05-NOV-2008 via phone call from a nurse indicating that the patient had an estimated delivery date of 16-JUN-2008 and went into spontaneous labor on 22-JUN-2008. She progressed well through the first stage and reached full dilatation, pushed for one and a half hours and had a cesarean section for a diagnosis of failure to descend. The patient delivered a healthy and normal baby girl, weighing 8.2 pounds, at 40 and 5/7 weeks RGA. The patient had a normal post-operation recovery and was doing well. Upon internal review, "failure to descend" was determined to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a an office manager, concerning 2 to 3 female patients who on an unspecified date were vaccinated with a dose of GARDASIL, Lot number was not available. The office manager reported that there were 2 to 3 patients who had miscarriage around the time when they received GARDASIL. At the time of the report the patients' outcome was unknown. The patient sought medical attention, seen by the physician. Miscarriage was considered to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an about 5 months old patient who was vaccinated with the second dose of ROTATEQ. A couple of months ago, in 2008, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. Intussusception was considered to be an other important medical event by the physician, as the patient underwent an enema. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Meningitis
Clinical narrative: Information has been received via a company representative who saw on a television news channel a mother who reported an AE on behalf of her 15 year old daughter. The patient developed headache and meningitis symptoms after getting GARDASIL. Lot# was not provided. The patient's headache and meningitis symptoms persisted at the time of the report. No further information is available.  01/14/09 Reviewed Neurology medical records of 10/24-11/04/2008. FINAL DX: pseudotumor cerebri; headaches Records reveal patient experienced severe frontal HA, blurry vision, decreased concentration x 3 days.  Neuro exam revealed florid bilateral papilledema & upgoing toes.  Developed spells of neck & extremities stiffness.  Tx w/high dose steroids, antiseizure meds & diuretic.  RTC 11/4/08 much improved, HA resolved.  Revealed that pt had started minocycline for acne on same day as HPV vax given.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bedridden, Brain oedema, Convulsion, Familial risk factor, Meningism
Clinical narrative: Information has been received via a company representative who saw on a television news channel a mother who reported an AE on behalf of her 15 year old daughter. The patient developed headache and meningitis symptoms after getting GARDASIL. Lot# was not provided. The patient's headache and meningitis symptoms persisted at the time of the report. No further information is available.  01/14/09 Reviewed Neurology medical records of 10/24-11/04/2008. FINAL DX: pseudotumor cerebri; headaches Records reveal patient experienced severe frontal HA, blurry vision, decreased concentration x 3 days.  Neuro exam revealed florid bilateral papilledema & upgoing toes.  Developed spells of neck & extremities stiffness.  Tx w/high dose steroids, antiseizure meds & diuretic.  RTC 11/4/08 much improved, HA resolved.  Revealed that pt had started minocycline for acne on same day as HPV vax given.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine
Clinical narrative: Information has been received via a company representative who saw on a television news channel a mother who reported an AE on behalf of her 15 year old daughter. The patient developed headache and meningitis symptoms after getting GARDASIL. Lot# was not provided. The patient's headache and meningitis symptoms persisted at the time of the report. No further information is available.  01/14/09 Reviewed Neurology medical records of 10/24-11/04/2008. FINAL DX: pseudotumor cerebri; headaches Records reveal patient experienced severe frontal HA, blurry vision, decreased concentration x 3 days.  Neuro exam revealed florid bilateral papilledema & upgoing toes.  Developed spells of neck & extremities stiffness.  Tx w/high dose steroids, antiseizure meds & diuretic.  RTC 11/4/08 much improved, HA resolved.  Revealed that pt had started minocycline for acne on same day as HPV vax given.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a physician and a licensed visiting nurse through the Pregnancy Registry for GARDASIL concerning an 18 year old female, with no previous pregnancies and no reported medical history who on 02-MAY-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # and site not provided). On 27-JUN-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot # and site not provided). Subsequently, it was reported that the patient was pregnant (LMP = 10-JUL-2007). On 31-AUG-2007, the patient had an ultrasound to confirm gestational age and the results were normal. Concomitant medications during pregnancy were prenatal vitamins (unspecified) and TYLENOL. On 10-APR-2008, the patient gave birth to a normal baby girl (8 lbs 10oz; 21.5 inches in length, and head circumference 13 inches). The infant's apgar scores were 9 and 9. There were no complications during pregnancy, or labor and delivery, and the infant had no congenital anomalies. Follow-up information indicated that the infant was seen on 14-APR-2008 and there was a concern that her feet were "turned in." The infant was assessed with bilateral feet inversion most likely from inutero positioning. The plan was to observe the infant over the next couple months and it was reported that it may take 6 to 12 months to fully correct. A orthopedic referral, evaluation, and possible splinting for this problem were all considered. The physician reported that there were no congenital anomalies. However, upon internal review bilateral feet inversion was considered to be a minor congenital anomaly. Additional information is not expected. Medical records are available upon request.
Age: 0.5
Sex: M
Vaccine: HEP, HIBV, IPV, PNC
Symptoms: Asthenia, Blood test, Convulsion, Epilepsy, Vaccine positive rechallenge
Clinical narrative: Seizures returned within 24 hours of 4 month vaccines. Seizures previously started after 2 month vaccines but were controlled by early Dec. 2006 after ACTH. 12/22/08-records received-consultation report DOS 6/2/08-history of medical refractory infantile spasms since age 3 months. Clusters of infantile spasms on daily basis, 3-9 clusters per dasy lasting approximately one minute. Mostly the spasms involve truncal jerk but occasionally evolve to clonic seizures involving left leg. Making progress in milestones. Mild left arm weakness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood test, Convulsion, Infantile spasms, Positron emission tomogram, Vaccine positive rechallenge
Clinical narrative: Seizures began 7-10 days after 2 Mon. Vaccines given on Aug. 21, 2006. Infantile spasms diagnosed on Oct. 18, 2006. After seizure free in Dec. 06, seizures returned 24 hrs after 4 mon. vaccines given on Dec. 19, 06. 12/22/08-records received-consultation report DOS 6/2/08-history of medical refractory infantile spasms since age 3 months. Clusters of infantile spasms on daily basis, 3-9 clusters per dasy lasting approximately one minute. Mostly the spasms involve truncal jerk but occasionally evolve to clonic seizures involving left leg. Making progress in milestones. Mild left arm weakness. 01/29/2010 Follow-up: Patient still suffers daily seizures that have caused global developmental delays. All testing has shown no other reason for his seizures.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: The mother called the office 41 minutes after vaccine administration stating the child was "covered in hives" and that his throat was "itchy, scratchy." Advised to activate EMS/911 immediately.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chest pain
Clinical narrative: I had severe chest pain and pressure for hrs.  that evening - I got the shot in the afternoon Oct 23/08
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: High fever more than or equal to 3d.  decrease appetite
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain, Skin ulcer, Skin warm
Clinical narrative: Small ulceration, swollen red upper arm warm to touch for about 1 week.  General aches for 2 or 3 days.  No increase in temp.