chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Lip swelling, Nausea, Neck pain
Clinical narrative: chronic debilitating headaches, chronic diahrrea, severe back & abdominal pain, tingling in hands and feet,numbness in hands & feet, stabbing pain in lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time.  These started right after the vaccination and continue to this day & have made her life as she knew it unmanageable.  She can no longer attend school.  Numerous trips to her pediatrician, blood tests, urine test, stool tests, emergency room visits, referred to neurologists, nutritionist.  No one knows how to treat her.  There is no treatment apparently.  3/16/09 Received consult records of 2/24/2009. FINAL DX: probable chronic fatigue syndrome, possibly exacerbated by recent EBV infection; reactive depression; likely vasovagal episodes; possible anxiety disorder. Records reveal patient experienced fatigue, nausea, numbness/tingling of hands/feet, HA, neck pain, intermittent diarrhea, chest pain w/SOB & heart pounding, intermittent difficulty walking, difficulty concentrating, decreased appetite, insomnia, apathy, moody, irritable.   Approx 1 wk after initial HPV & Depoprovera injections, 11/12/08, developed waxing/waning fatigue which escalated to missing school in Dec & Jan.  Suggested antidepressant & counseling.  3/9/09 Received PCP medical records of 2/2007-3/2/2009 included ER records of 2/9/2009. FINAL DX:none provided Records reveal patient experienced good health on 11/12, received depo-provera 1st dose along w/HPV #1.  RTC 2/11 s/p ER visit 2/9 for chest pain, cough, runny nose, phlegm congestion.  Parent reported back pain, hand tremors, leg pain, leg swelling, back pain, dizziness, joint stiffness, decreased concentration, fatigue, intermittent diarrhea, nausea since 11/08.  Missed several days of school.   Developed leg heaviness, gait disturbance, & LE weakness & increased fatigue. Referred to ID & Neuro but no records available.      ER records 2/9/09 FINAL DX: atypical chest pain Records reveal patient experienced sharp nonradiating chest pain, rapid breathing & tingling of hands/feet all of which had resolved by the time she was seen in ER.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate, Staring, Stool analysis
Clinical narrative: chronic debilitating headaches, chronic diahrrea, severe back & abdominal pain, tingling in hands and feet,numbness in hands & feet, stabbing pain in lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time.  These started right after the vaccination and continue to this day & have made her life as she knew it unmanageable.  She can no longer attend school.  Numerous trips to her pediatrician, blood tests, urine test, stool tests, emergency room visits, referred to neurologists, nutritionist.  No one knows how to treat her.  There is no treatment apparently.  3/16/09 Received consult records of 2/24/2009. FINAL DX: probable chronic fatigue syndrome, possibly exacerbated by recent EBV infection; reactive depression; likely vasovagal episodes; possible anxiety disorder. Records reveal patient experienced fatigue, nausea, numbness/tingling of hands/feet, HA, neck pain, intermittent diarrhea, chest pain w/SOB & heart pounding, intermittent difficulty walking, difficulty concentrating, decreased appetite, insomnia, apathy, moody, irritable.   Approx 1 wk after initial HPV & Depoprovera injections, 11/12/08, developed waxing/waning fatigue which escalated to missing school in Dec & Jan.  Suggested antidepressant & counseling.  3/9/09 Received PCP medical records of 2/2007-3/2/2009 included ER records of 2/9/2009. FINAL DX:none provided Records reveal patient experienced good health on 11/12, received depo-provera 1st dose along w/HPV #1.  RTC 2/11 s/p ER visit 2/9 for chest pain, cough, runny nose, phlegm congestion.  Parent reported back pain, hand tremors, leg pain, leg swelling, back pain, dizziness, joint stiffness, decreased concentration, fatigue, intermittent diarrhea, nausea since 11/08.  Missed several days of school.   Developed leg heaviness, gait disturbance, & LE weakness & increased fatigue. Referred to ID & Neuro but no records available.      ER records 2/9/09 FINAL DX: atypical chest pain Records reveal patient experienced sharp nonradiating chest pain, rapid breathing & tingling of hands/feet all of which had resolved by the time she was seen in ER.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Streptococcal identification test, Urine analysis, Vomiting
Clinical narrative: chronic debilitating headaches, chronic diahrrea, severe back & abdominal pain, tingling in hands and feet,numbness in hands & feet, stabbing pain in lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time.  These started right after the vaccination and continue to this day & have made her life as she knew it unmanageable.  She can no longer attend school.  Numerous trips to her pediatrician, blood tests, urine test, stool tests, emergency room visits, referred to neurologists, nutritionist.  No one knows how to treat her.  There is no treatment apparently.  3/16/09 Received consult records of 2/24/2009. FINAL DX: probable chronic fatigue syndrome, possibly exacerbated by recent EBV infection; reactive depression; likely vasovagal episodes; possible anxiety disorder. Records reveal patient experienced fatigue, nausea, numbness/tingling of hands/feet, HA, neck pain, intermittent diarrhea, chest pain w/SOB & heart pounding, intermittent difficulty walking, difficulty concentrating, decreased appetite, insomnia, apathy, moody, irritable.   Approx 1 wk after initial HPV & Depoprovera injections, 11/12/08, developed waxing/waning fatigue which escalated to missing school in Dec & Jan.  Suggested antidepressant & counseling.  3/9/09 Received PCP medical records of 2/2007-3/2/2009 included ER records of 2/9/2009. FINAL DX:none provided Records reveal patient experienced good health on 11/12, received depo-provera 1st dose along w/HPV #1.  RTC 2/11 s/p ER visit 2/9 for chest pain, cough, runny nose, phlegm congestion.  Parent reported back pain, hand tremors, leg pain, leg swelling, back pain, dizziness, joint stiffness, decreased concentration, fatigue, intermittent diarrhea, nausea since 11/08.  Missed several days of school.   Developed leg heaviness, gait disturbance, & LE weakness & increased fatigue. Referred to ID & Neuro but no records available.      ER records 2/9/09 FINAL DX: atypical chest pain Records reveal patient experienced sharp nonradiating chest pain, rapid breathing & tingling of hands/feet all of which had resolved by the time she was seen in ER.
Age: 36.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Erythema, Injection site urticaria, Pruritus, Rash
Clinical narrative: One day after receiving the injection, a bump appeared at the injection site,lasting about a day. It disappeared and then retrurned about 1 week later.  The arm was itchy and a raised rash appeared, lasting over a month.  Application of OTC hydrocortisone cream relieved the redness and itching.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Muscular weakness, Nausea
Clinical narrative: within 24 hours after injection Pain at injection side, redness extending 7 inches by 4 inches; fever of 101 degrees orally; chills; severe weakness in arms and legs to the point of being unable to climb flight of stairs; severe nausea. I spoke to my doctor's NP. No treatment was indicated; I felt better the next day temp was down to 99.2 but my arm continued to be very red.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: within 24 hours after injection Pain at injection side, redness extending 7 inches by 4 inches; fever of 101 degrees orally; chills; severe weakness in arms and legs to the point of being unable to climb flight of stairs; severe nausea. I spoke to my doctor's NP. No treatment was indicated; I felt better the next day temp was down to 99.2 but my arm continued to be very red.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Convulsion, Differential white blood cell count, Full blood count, Laboratory test, Loss of consciousness
Clinical narrative: Seizure like activity, Loss of consciousness on 2/25/2009 see notes  4/27/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: seizure-like event Records reveal patient experienced approx 6-8 episodes of motor tics of moving head in cycles, right ear to right shoulder, cycles lasting approx 30 min over past 6 mo.  Night before admit had same sort of episode w/staring & blank expression, unresponsive to verbal stimuli, right leg drawn to chest in jerky movements lasting appro 20-30 min, then vomited, bowel & bladder incontinence, tired & fell asleep quickly.  Neuro consult done & found anxiety, slightly decreased tone & strength, truncal instability, slight tremor right more than left, mild delayed milestones.  No events while hospitalized.   D/c to home w/Neuro f/u, rx for diastat & video taping of events requested.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Urine analysis
Clinical narrative: Seizure like activity, Loss of consciousness on 2/25/2009 see notes  4/27/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: seizure-like event Records reveal patient experienced approx 6-8 episodes of motor tics of moving head in cycles, right ear to right shoulder, cycles lasting approx 30 min over past 6 mo.  Night before admit had same sort of episode w/staring & blank expression, unresponsive to verbal stimuli, right leg drawn to chest in jerky movements lasting appro 20-30 min, then vomited, bowel & bladder incontinence, tired & fell asleep quickly.  Neuro consult done & found anxiety, slightly decreased tone & strength, truncal instability, slight tremor right more than left, mild delayed milestones.  No events while hospitalized.   D/c to home w/Neuro f/u, rx for diastat & video taping of events requested.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Heart rate increased, Immediate post-injection reaction, Lip oedema, Swollen tongue
Clinical narrative: 5-8 min after receiving CODEINE child's tongue started swelling, vomited, HR increase, lips edematous, SOB, unresponsive EPI PEN given IM, O2 started, paramedics called child, transported to hospital approx 20 mins later, child more responsive at this time, asking for mother.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: 5-8 min after receiving CODEINE child's tongue started swelling, vomited, HR increase, lips edematous, SOB, unresponsive EPI PEN given IM, O2 started, paramedics called child, transported to hospital approx 20 mins later, child more responsive at this time, asking for mother.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site rash, Joint range of motion decreased, Musculoskeletal pain, Pyrexia
Clinical narrative: Pt. reports LUE arm, shoulder pain with rash at injection site. Left deltoid has localized cellulitic area 8 cm L X 5.5 cm W. temp is 99.5. No other system involvement. Pt. with difficulty lifting left arm to 90 degree active ROM. reported to medical director. Pt started on KEFLEX 500 mg by mouth one tablet every 6 hrs for 10 days. Affected skin rash (immune. site) instructed Dr to go to ER if no improvement in 24 hour (Since she has no PCP for follow-up).
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Throat irritation
Clinical narrative: Pt called clinic reporting SOB, throat feels funny.  Instructed to go to ER.  At ER, patient did well and left with BENADRYL.  There was some confusion of symptoms related to new use of Niacin but symptoms did not recur.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash papular
Clinical narrative: Raised spots - back abd, 12/26/09 started ZOVIRAX 200 mg 3 PO BID X 5 days.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: None Phenyl & Pt sister PKU + mom strong on mercury free.  Physician ordered wrong in Epic
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: High-pitched crying, Screaming
Clinical narrative: High pitched screaming started ~45' with shots, continued X 45' Pt slept X 48' then cycle repeated X 5 days
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate decreased, Syncope, Vomiting
Clinical narrative: Upon leaving the clinic per mother, pt fainted, Dr responded, SPO2 100-98%. Pulse low. Oxygen given to pt after 10 min. Pt able to stand ambulate and was responsive (vomited 1 time).
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus generalised, Swelling face
Clinical narrative: Phone call - Employee stated  received an MMR on 1-16-09 and on 1-20-09 started itching in entire body and having facial swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching, took BENADRYL 50mg followed by 25 mg Q6 hour.
Age: 37.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: L arm injection site with large reddened/warm site- Better today.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection hot to touch, red and swollen.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Cyanosis, Gaze palsy, Hypotonia, Respiratory arrest
Clinical narrative: Received MMR, VARIVAX, and PREVNAR on 2/24.  That night had episode where child stopped breathing for 15-20 sec., eye rolled back, went limp, and had perioral cyanosis.  Question between breath holding spell or seizure activity.  Possible related to vaccine administration. 4/6/09-records received-office visit 2/24/09-well visit. ED visit 2/25/09-crying after bath held breath while crying, limp. Assessment:possible breath holding spell vs seizure night prior. 3/9/09-rash times 4 weeks. Assessment:eczema.
Age: 1.2
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, No reaction on previous exposure to drug, Nodule, Pyrexia, Rash generalised
Clinical narrative: The child is a 14 month old female whose mother called on 2/25 and spoke with RN, Mother advised child had "chickenpox" after vaccinations on 2/12. Child has no doctor. I advised that I would see patient today. Today, mother brings child to clinic. The following history was obtained. Family just moved to another state in 11/08. On 2/12 child received the following vaccines at the health center, PREVNAR, MMR and Varicella. Child did well until: 2/21: new onset fever with T=101.6; 02/22: fever continued but did not take temp; 2/23: rash started around face and in mouth; 2/24: rash spread "head to toe"; 2/25: rash unchanged; 2/26: rash "not as red". Child appears to be improving. Still has runny nose. Child lives at home with parents and 3 siblings, aged 18, 11 and 6. All siblings fully vaccinated according to mother. Child does not attend day care and no other children visit the home. Child has no prior vaccination adverse effects. Child is healthy with no underlying diseases, allergies, medications or surgeries. There has been no prior adverse vaccination effects. Child active, no distress. Skin: multiple small distinct nodular lesions covering essentially the entire body. Present on the face, scalp, neck, chest, abdomen, back, and extremities. No hives, vesicles, edema, ulcerations, or pox lesion. No particular lesions at any of the 4 injection sites. Assess: Rash of unknown etiology.  The timing of the symptoms of fever followed by rash started 89 days after receiving 4 vaccines (Nib, PREVNAR, MMR and Varicella). Thus, it possibly could be vaccine associated. However, I do not think the child has chickenpox. There are no pox lesions present. The lesions are fine, nodular lesions. My best estimate is that the rash is due to either Roseola or Coxsackie virus. The mother believes the rash is chickenpox. I advised that even if so, the child should receive the second dose of Varicella vaccine at age 4 - 6 years of age (see attached email from health care provider). AVEENO for skin. Child should continue to receive all scheduled vaccines. there is no reason to defer any vaccine based upon the above incident. Correction: The second paragraph of the assessment should state: "My best estimate is that the rash is due to rubella or coxsackie virus." I do NOT think the child has roseola as erroneously stated in the assessment.
Age: 1.2
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: The child is a 14 month old female whose mother called on 2/25 and spoke with RN, Mother advised child had "chickenpox" after vaccinations on 2/12. Child has no doctor. I advised that I would see patient today. Today, mother brings child to clinic. The following history was obtained. Family just moved to another state in 11/08. On 2/12 child received the following vaccines at the health center, PREVNAR, MMR and Varicella. Child did well until: 2/21: new onset fever with T=101.6; 02/22: fever continued but did not take temp; 2/23: rash started around face and in mouth; 2/24: rash spread "head to toe"; 2/25: rash unchanged; 2/26: rash "not as red". Child appears to be improving. Still has runny nose. Child lives at home with parents and 3 siblings, aged 18, 11 and 6. All siblings fully vaccinated according to mother. Child does not attend day care and no other children visit the home. Child has no prior vaccination adverse effects. Child is healthy with no underlying diseases, allergies, medications or surgeries. There has been no prior adverse vaccination effects. Child active, no distress. Skin: multiple small distinct nodular lesions covering essentially the entire body. Present on the face, scalp, neck, chest, abdomen, back, and extremities. No hives, vesicles, edema, ulcerations, or pox lesion. No particular lesions at any of the 4 injection sites. Assess: Rash of unknown etiology.  The timing of the symptoms of fever followed by rash started 89 days after receiving 4 vaccines (Nib, PREVNAR, MMR and Varicella). Thus, it possibly could be vaccine associated. However, I do not think the child has chickenpox. There are no pox lesions present. The lesions are fine, nodular lesions. My best estimate is that the rash is due to either Roseola or Coxsackie virus. The mother believes the rash is chickenpox. I advised that even if so, the child should receive the second dose of Varicella vaccine at age 4 - 6 years of age (see attached email from health care provider). AVEENO for skin. Child should continue to receive all scheduled vaccines. there is no reason to defer any vaccine based upon the above incident. Correction: The second paragraph of the assessment should state: "My best estimate is that the rash is due to rubella or coxsackie virus." I do NOT think the child has roseola as erroneously stated in the assessment.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abnormal behaviour, Dizziness, Headache, Hyperreflexia
Clinical narrative: Pt c/o headaches, severe @times (6/10) lasting for 10 days post immunization. During 1st 24hrs post vaccine, also c/o lightheadedness / dizziness - resolved in 24hrs.  3/5/09  MR received from PCP.  WCC 2/18/09 with vax given. TC from parent next day with c/o lightheadedness, dizziness, blurry vision and H/A. Not seen at this time. OV 2/25/09 for continued H/As, other sx resolving. Mom notes "not her usual perky self". PE (+) for DTRs 1+. Otherwise WNL. TC from parent 3/3/09-H/A are fine.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Crying, Pyrexia, Screaming, Staring
Clinical narrative: Less than 24 hours after administration, she cried and screamed for more than 6 hours and continued to scream and cry off and on for the next several days.  She also ran a high fever, and we gave her tylenol.  She was a different baby during this time.  She had blank stares and did not smile for days.  We do not know if she was permanently damaged in any way.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Anogenital warts, Caesarean section, Cervical dysplasia, Drug exposure during pregnancy
Clinical narrative: Information has been received from a Certified Nurse Midwife, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female who in August 2008, was intramuscularly vaccinated with a dose of GARDASIL. It was reported that the patient was pregnant at the time of vaccination. The patient's LMP was 07-APR-2008 and the EDD was 12-JAN-2009. It was reported that this was the patient's first pregnancy. Pregnancy test was positive and ultrasound was performed on 10/14/2008. Follow up information was received from a certified nurse midwife who indicated the patient had positive atypical squamous cell of undetermined significance (ASCUS) HPV both in genital warts and in PAP test. The patient also had anemia during pregnancy. At 17 weeks gestation the patient performed ultrasound. On 29-JAN-2009, 41 weeks+ from her LMP, the patient delivered a health male baby weighing 9 pounds and 7 ounces. Apgar score was 7/9. The patient experienced low transverse cesarean section (LTCS) due to failure to progress (FTP). Upon internal review, low transverse cesarean section due to failure to progress was determined to be an other important medical event. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Failed trial of labour, Human papilloma virus test positive, Pregnancy test positive, Smear cervix abnormal, Ultrasound scan
Clinical narrative: Information has been received from a Certified Nurse Midwife, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female who in August 2008, was intramuscularly vaccinated with a dose of GARDASIL. It was reported that the patient was pregnant at the time of vaccination. The patient's LMP was 07-APR-2008 and the EDD was 12-JAN-2009. It was reported that this was the patient's first pregnancy. Pregnancy test was positive and ultrasound was performed on 10/14/2008. Follow up information was received from a certified nurse midwife who indicated the patient had positive atypical squamous cell of undetermined significance (ASCUS) HPV both in genital warts and in PAP test. The patient also had anemia during pregnancy. At 17 weeks gestation the patient performed ultrasound. On 29-JAN-2009, 41 weeks+ from her LMP, the patient delivered a health male baby weighing 9 pounds and 7 ounces. Apgar score was 7/9. The patient experienced low transverse cesarean section (LTCS) due to failure to progress (FTP). Upon internal review, low transverse cesarean section due to failure to progress was determined to be an other important medical event. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Injection site pain, Loss of consciousness, Tremor
Clinical narrative: Information has been received from a physician concerning a 23 year old female who was vaccinated with a first dose of GARDASIL 0.5ml IM. Subsequently the patient experienced "seizure like reaction", the patient was shaking and passed out shortly after receiving the dose of GARDASIL 0.5ml IM. After receiving her vaccination the patient became responsive again within 1-2 minutes and noted that the injection was very painful. The patient was in the office when the event occurred. It was noted that the patient had since returned to receive the second dose of GARDASIL 0.5ml IM with no problems. Upon internal review seizures like reaction was determined to be an other medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Headache
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no medical history and drug allergies who, on an unspecified date, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient had experienced hip pain, lower back pain and headache after receiving the first dose of GARDASIL. It was noted that she had experienced pain in both of her hips but the left side had more pain than the right. The pain in her hips had made it difficult for the patient to participate in her soccer games. The patient sought medical attention and was seen by physician. The lot numbers and dates of administration were unknown. At the time of reporting (20-FEB-2009) the patient was recovering. The reporter considered the adverse experiences to be disabling. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Influenza like illness, Malaise, Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning her 26 year old daughter who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL several months ago. Subsequently the patient developed flu-like symptoms after administration of the first and second dose  of GARDASIL. She also experienced vomiting and muscle aches both times. She missed work because of the severity of her symptoms. Her symptoms were worse after the second dose of GARDASIL as compared to the first dose. She would not be administered a third dose of GARDASIL. The patient recovered on unspecified dates. Flu-like symptoms, vomiting and muscle aches (both occurrences) were considered to be disabling because the patient "was very, very ill". The patient sought unspecified medical attention. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning her 26 year old daughter who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL several months ago. Subsequently the patient developed flu-like symptoms after administration of the first and second dose  of GARDASIL. She also experienced vomiting and muscle aches both times. She missed work because of the severity of her symptoms. Her symptoms were worse after the second dose of GARDASIL as compared to the first dose. She would not be administered a third dose of GARDASIL. The patient recovered on unspecified dates. Flu-like symptoms, vomiting and muscle aches (both occurrences) were considered to be disabling because the patient "was very, very ill". The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Grand mal convulsion, Loss of consciousness, Neurological examination normal, Petit mal epilepsy
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies or reactions who on 24-SEP-2007 was vaccinated with the first 0.5 ml IM dose of GARDASIL. There was no concomitant medication. In December 2007, the patient experienced blackout episodes and petit mal seizures. On 06-DEC-2007 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL, and on 07-AUG-2008 the patient received the third GARDASIL. Some time in 2008, the patient experienced grand mal seizures and had been hospitalized multiple times (details of hospitalizations not provided). The patient had been subsequently evaluated by an unspecified neurologist who had prescribed an unspecified anti-seizure medication. Neurological tests were performed with normal results. At the time of this report, the patient's blackout episodes, petit mal seizures and grand mal seizures persisted. Blackout episodes, petit mal seizures and grand mal seizures were also considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information has been requested.  3/9/09 Received hospital records for multiple ER & admits: 3/20/2008 FINAL DX: syncopal episode vs anxiety attack Records reveal patient experienced brief episode of syncope while getting ready to travel to hospital for eye surgery she was very nervous about.  Exam in ER revealed chewing movement of mouth/lips, shaking of LUE but was awake & alert.  Tx w/anti anxiety med, improved & d/c to home.  4/20/2008 FINAL DX: syncope r/o seizure Records reveal patient experienced sudden LOC & fell to ground striking head.  Out for approx 5 min w/jerking/seizure activity for short time.  Exam in ER was WNL.  Remained stable, d/c to home & referred to Neuro.  10/9/2008 Final DX: postictal state, probable seizure PTA; hypokalemia Records reveal patient experienced HA, facial redness & passed out.  Remained stable, d/c to home w/PCP f/u.  PMH: congenital heart disease w/open heart surgery, lazy eye w/eye surgery, petit mal seizures x approx 6 mo.  2/18-2/19/2009 FINAL DX: No d/c summary dictated. Neuro states recurrent petit mal seizure Records reveal patient admitted by Neuro s/p petit mal seizure activity while at school w/inattention & shaking of RUE.  ER exam was WNL.  Meds adjusted  2/24-2/25/2009 FINAL DX: no d/c summary dictated.  Neuro states recurrent seizure activity, suspect to be petit mal in type, localized & partial.  Exam revealed tonic clinic activity of LUE intermittently.  Meds changed, d/c to home w/neuro f/u.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse in a physician's office concerning a female who was vaccinated with a dose of GARDASIL (lot # not reported). Subsequently the patient experienced a seizure after the vaccination. The patient was air lifted to an unspecified hospital and was admitted as an inpatient for unspecified amount of time. At the time of the report (23-FEB-2009), the patient was recovering. It was reported that the patient was not given the vaccine at this physician's office. The nurse learned of this adverse event through the grandmother of the patient. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 05-SEP-2008 was vaccinated with a first dose of GARDASIL and on 14-NOV-2008 was vaccinated with a second dose of GARDASIL. Then the patient was diagnosed with transverse myelitis, which the physician stated it mimics multiple sclerosis. The patient saw a neurologist. At the time of reporting, the outcome was unknown. Upon internal review, transverse myelitis was determined to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism, Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient developed mild symptoms of autism. At the time of this report, the outcome was unknown. The patient also experienced diarrhea while on therapy with ROTATEQ (MSD) (WAES 0902USA03976). No further information is available.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dry skin, Gait disturbance, Nasopharyngitis
Clinical narrative: On 2/12/2009 Pt. talked with PHN + and she stated she had a "reaction" to her Flu shot-stated she had "a temperature + chills, stated she could hardly walk to bathroom.   Sore arm, "Ached so bad she had nightmares + wasn't able to sleep.  Stated her left side + Lt arm itched.  Stated when she started to feel better, she got a bad cold.  Later stated she thought may be the itching was from dry skin.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nightmare, Pain in extremity, Pruritus, Sleep disorder, Tenderness
Clinical narrative: On 2/12/2009 Pt. talked with PHN + and she stated she had a "reaction" to her Flu shot-stated she had "a temperature + chills, stated she could hardly walk to bathroom.   Sore arm, "Ached so bad she had nightmares + wasn't able to sleep.  Stated her left side + Lt arm itched.  Stated when she started to feel better, she got a bad cold.  Later stated she thought may be the itching was from dry skin.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Discomfort, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt with extreme discomfort following inj.  LOC after standing up- approx 10-15 min to fully recover- pt symptoms Hx of LOC with vaccine, but mother has similar Hx.
Age: 0.8
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered, Wrong technique in drug usage process
Clinical narrative: Patient was administered diluent for ACT HIB vaccine only without reconstitution of HIB vaccine, but telephone call to mother to advise of error.  Mother noted child with no adverse reaction per reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient noticed patch of red skin in area where vaccine was administered 7 days after vaccine was given.  No itchiness, pain, or heat noted at site.  No other symptoms noted.
Age: 9.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: patient inadvertently received Tdap and MENACTRA that was meant for older sibling. Therefore get MENACTRA and Tdap earlier than usual schedule
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pain, Pyrexia, Skin warm
Clinical narrative: Day after vaccinations, Pt developed severe swelling, pain, redness and the area became hard. She initially had a fever, but it went away. The area(back of right arm) remained very hot. E.R. and clinic doctors couldn't tell if it was an allergic reaction or an infection - Prescribed BENADRYL and Anti-biotic.  Started to go away approx 5 days later.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Day after vaccinations, Pt developed severe swelling, pain, redness and the area became hard. She initially had a fever, but it went away. The area(back of right arm) remained very hot. E.R. and clinic doctors couldn't tell if it was an allergic reaction or an infection - Prescribed BENADRYL and Anti-biotic.  Started to go away approx 5 days later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 10 minutes after the shots where administered to the patient, patient's mom notified one of the medical  assistants that the patient was developing a rash around the shot site on her right leg. I went to look at Pt's right leg and the area around the shot site looked red and swollen. I notified Dr and he instructed me to give her 1 teaspoon of Children's BENADRYL. Pt waited 20 minutes post BENADRYL, the swelling in her right leg went down but the area was still red. Mom will continue to give BENADRYL at home.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash
Clinical narrative: Mom noted few itch spots on abd 4 days ago. Spots increased over next few days.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Arthralgia, Chest discomfort, Diarrhoea, Dyspnoea, Influenza like illness
Clinical narrative: This service member contacted the 24 hour vaccine call center to report reproducible flu-like symptoms of nausea, vomiting, low grade fever and diarrhea that occurred 5-6 days after receipt of ANTHRAX vaccine #1 and #2.  Received ANTHRAX, influenza (injectable), and TYPHOID vaccines in preparation for deployment the end of Feb 09 on 16 Dec 08.  Had no immediate significant local reaction and no systemic symptoms.  Approximately 6 days later he developed severe vomiting, diarrhea and joint aches that lasted about 24 hours.  The rest of the family had similar symptoms.  Patient fully recovered.  Service member received ANTHRAX vaccine #2 on 27 or 28 Jan 09 while in the field (according to the new dosing schedule that eliminates the 2nd 2 week dose.)  He reports he was clinically well at the time.  No other vaccinations were given simultaneously.  Six days later he developed severe vomiting (6-7x in 24 hours) and diarrhea (12-13 x in 24 hours) and low grade temp of 100.7.  States he also had a shortness of breath, tightness in the chest and Tachycardia for a few hours.  Went to see his civilian PCP for evaluation.  No labs drawn or medications given.  No one else in the home ill.  Slept 16 hours.  Feeling better within 24 hours.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Nausea, Pyrexia, Tachycardia, Vomiting
Clinical narrative: This service member contacted the 24 hour vaccine call center to report reproducible flu-like symptoms of nausea, vomiting, low grade fever and diarrhea that occurred 5-6 days after receipt of ANTHRAX vaccine #1 and #2.  Received ANTHRAX, influenza (injectable), and TYPHOID vaccines in preparation for deployment the end of Feb 09 on 16 Dec 08.  Had no immediate significant local reaction and no systemic symptoms.  Approximately 6 days later he developed severe vomiting, diarrhea and joint aches that lasted about 24 hours.  The rest of the family had similar symptoms.  Patient fully recovered.  Service member received ANTHRAX vaccine #2 on 27 or 28 Jan 09 while in the field (according to the new dosing schedule that eliminates the 2nd 2 week dose.)  He reports he was clinically well at the time.  No other vaccinations were given simultaneously.  Six days later he developed severe vomiting (6-7x in 24 hours) and diarrhea (12-13 x in 24 hours) and low grade temp of 100.7.  States he also had a shortness of breath, tightness in the chest and Tachycardia for a few hours.  Went to see his civilian PCP for evaluation.  No labs drawn or medications given.  No one else in the home ill.  Slept 16 hours.  Feeling better within 24 hours.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness, Migraine
Clinical narrative: Mother called to report pt c/o "loosing vision on both sides." Parent to take pt to primary care provider (Dominican Health Clinic) for eval. Mother called back after eval & reported pt was dx with migrain headaches and was given Rx.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Histamine-like reaction. Hives - several days 1 week apart for 1 day.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Shaking chills, fever X 24 hrs. (X hrs)
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Nausea, Tremor
Clinical narrative: The day after shot employee experienced slight nausea & weakness & hand tremors.  Symptoms lasted 2 days.  No medical Tx sought.  Symptoms resolved spontaneously.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Fatigue, Headache, Influenza like illness, Nasal congestion
Clinical narrative: Headache, Flu- like symptoms, low grade fever sore throat, nasal congestion, SOB fatigue, aches, etc.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Headache, Flu- like symptoms, low grade fever sore throat, nasal congestion, SOB fatigue, aches, etc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives, throughout, injection site arm & neck, w/o resp. distress OTC BENADRYL
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling
Clinical narrative: Local Right - swelling redness- covering entire upper arm. Area marked with pen. If redness spreads start antibiotic.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Dizziness, Injection site pain
Clinical narrative: C/o dizziness and weakness approx 45 mins after receiving vaccine. Lasted 4 1/2 hours. Seen at ER given Benadryl. No co/ rash, SOB. Injection site sore no redness.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Body temperature increased, Eye swelling, Urticaria
Clinical narrative: Mom reported child got puffy around eyes the day after vaccination 2/19/09. It resolved 2/24/09. The evening of 2/23/09 child presented with patch, red hives to cheeks 12 hrs. Then they dimmed and hives presented chest, belly & bottom on 2/24/09. On evening of 2/24/09 hives dimmed and moved to face and sparsley on legs to date. T 101.5 highest2/24/09, 100.0 this am. Emergency room phone call by parents. Was told to give child tylenol and benadryl. They did and symptoms improved.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: C/O arm soreness and hand and fingers became tingling approx 1-2 hours after vaccine. Then tired and vomiting X2 at about 2-3 hours with headache, dizziness. Seen at ER received Sofran, Benadryl and Motrin.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: C/O arm soreness and hand and fingers became tingling approx 1-2 hours after vaccine. Then tired and vomiting X2 at about 2-3 hours with headache, dizziness. Seen at ER received Sofran, Benadryl and Motrin.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Flank pain, Headache, Pain in extremity, Vomiting
Clinical narrative: C/O dizziness and vomiting (4-5X) approx 1-2 hours after vaccination. After going to have lunch. Had slt headache and arm and flank soreness. Seen at ER approx 6 hours after vaccine. Given Benadryl and Motrin.
Age: 30.0
Sex: F
Vaccine: JEV
Symptoms: Angioedema, Hypotension, Lip swelling, Skin warm, Swelling
Clinical narrative: On 08 NOV 2005 around noon, swollen lips and wheals under eyes.  Took Claritin and wheals resolved, but lips swollen, so instructed to take Benadryl.  Overnight urticaria involving thighs developed, and physician added oral steroid burst for about 5 days.  Urticaria on thighs would wane during the day, but recur at night for more than 7 days. On 06 FEB 2006 around noon, pt again noted lip swelling and took Claritin, then Benadryl.  That night, spouse said her forehead was warm to touch and gave Motrin.  Overnight, diffuse urticaria of thighs developed along with angioedema of face, throat, arms, legs, and feet.  Pt awoke feeling thirsty and had syncope on rising from bed. In ER on 07 FEB 2006, labs were drawn and IV treatment included Zantac, Zyrtec, steroids, and fluids for hypotension (BP 50s/palp with orthostatic changes).  Swollen areas were tender to touch/weight-bearing but resolved over about 4 days of missed duty, with 5-day course of oral steroids and several weeks of oral Zyrtec and Zantac.  Urticaria continued to recur overnight for more than a week after angioedema resolved.  Pt evaluated by Allergy Extender in 2006: labs repeated and pt advised to stop hormonal birth control. Evaluated by Allergist 12 JUN 2008: labs sent, EpiPen Rx renewed, and hormonal birth control discouraged.  Neither work-up identified an etiology for the illness (labs were normal) or a reproducible trigger for the 2 events (no new food or environmental exposures). For the past 3 years, pt has not had angioedema or urticaria.
Age: 30.0
Sex: F
Vaccine: JEV
Symptoms: Syncope, Tenderness, Thirst, Urticaria, Weight bearing difficulty
Clinical narrative: On 08 NOV 2005 around noon, swollen lips and wheals under eyes.  Took Claritin and wheals resolved, but lips swollen, so instructed to take Benadryl.  Overnight urticaria involving thighs developed, and physician added oral steroid burst for about 5 days.  Urticaria on thighs would wane during the day, but recur at night for more than 7 days. On 06 FEB 2006 around noon, pt again noted lip swelling and took Claritin, then Benadryl.  That night, spouse said her forehead was warm to touch and gave Motrin.  Overnight, diffuse urticaria of thighs developed along with angioedema of face, throat, arms, legs, and feet.  Pt awoke feeling thirsty and had syncope on rising from bed. In ER on 07 FEB 2006, labs were drawn and IV treatment included Zantac, Zyrtec, steroids, and fluids for hypotension (BP 50s/palp with orthostatic changes).  Swollen areas were tender to touch/weight-bearing but resolved over about 4 days of missed duty, with 5-day course of oral steroids and several weeks of oral Zyrtec and Zantac.  Urticaria continued to recur overnight for more than a week after angioedema resolved.  Pt evaluated by Allergy Extender in 2006: labs repeated and pt advised to stop hormonal birth control. Evaluated by Allergist 12 JUN 2008: labs sent, EpiPen Rx renewed, and hormonal birth control discouraged.  Neither work-up identified an etiology for the illness (labs were normal) or a reproducible trigger for the 2 events (no new food or environmental exposures). For the past 3 years, pt has not had angioedema or urticaria.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: 2-3 minutues following administration of the vaccine the patients left arm, where the vaccine was given began to turn red and develop whelps. Dr. looked at the site and 1 tsp of Benadryl was given. When the patient was leaving the facility the redness was beginning to fade.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Clinical narrative: Each time my identical twin sons were given a vaccine (they had the ones for RSV also), they got worse and worse until at 18 months of age, they were unmanageable and I didn't understand why.  3/16/09 MR received for both patients with DX:  Autism-relatively high functioning. Pt A has some decreased muscle tone on exam.  Pt B making significant progress. Developmental exam deferred. Follow-up: They still have autism. Quit requiring the shots!
Age: 58.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood pressure fluctuation, Blood thyroid stimulating hormone, Pain in extremity, Tremor
Clinical narrative: Pt called and spoke with RN on 2/19/09 with c/o tremors and high BP since vaccination on 11/4/08.  She reported that she did not know side effects of vaccination but would check with other RN.  Other RN called pt on 2/23/09.  He reported fluctating blood pressure: 200/100's to below 100/50's.  C/o intermittent tremors.  Pt stated that he didn't have these symptoms prior to vaccination and have persisted since.  Pt saw PA-C on 11/13/08 and "several times since."  Pt has also seen MD.  BP meds have been added and adjusted.  Also c/o left arm "deltoid" pain without redness, swelling or palpable lump.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Seen 2/24/09 at 2pm due to rash over entire body which started 2/23/09.  Received vaccines 2/6/09.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Cardiac ablation, Chest pain, Echocardiogram, Loss of consciousness
Clinical narrative: Was given the Gardasil shot in December 2007. In January 2008, diagnosed with Supraventricular Tachycardia (SVT): Blacked out/lost consciousness in the shower, woke up with a heart rate of 250bpm. Stayed for 45 minutes until given a shot of Adenosine. Required an Ablation (April 2008). Happened twice more after the first ablation (1 time requiring a double dose of the Adenosine shot). Will be having a second Ablation March 12, 2009. Also losing hair in clumps, chest pains similar to being stabbed 2-3 times a day (around the heart, but all over the chest area.) 3/13/09-records received-office visit 3/3/07 and first vaccine provided lot#0388U , vac #2 given on 8/14/07 lot#1060U and 3rd received 12/14/07 lot#1266U. Office visit 5/8/08-seen for gyn check up regular menses. ablation 4/08 for SVT. Taking oral contraceptives. 4/8/09-records received for DOS 4/17-4/18/08-DC DX: orthodoronic AV re-entry SVT. Recurrent drug resistant narrow complex tachycardia referred for electrophysiologic evaluation and successful ablation. First epidsode on 1/19/08 with sudden onset of lightheadedness with rapid palpitations and chest discomfort.Remote history of syncope that sounds vasovagal in nature.  Follow-up: I have had 2 cardiac ablations, and still suffer from chest pains.