chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Syncope
Clinical narrative: This case was reported by a physician and described the occurrence of vasovagal response in a 15-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included BOOSTRIX; GlaxoSmithKline given on 25 June 2009. On 25 June 2009 at 16:40 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 25 June 2009, immediately after vaccination with TWINRIX, the subject experienced vasovagal response, fainting and inadvertent exposure to vaccine. The 15-year-old subject inadvertently received TWINRIX. Additionally, the subject had a vasovagal response immediately after receiving TWINRIX and then fainted. The office subsequently checked the subject blood sugar and blood count, which were both normal. This case was assessed as medically serious by GSK. At the time of reporting the vasovagal response had resolved, the outcome of the fainting was unspecified.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Electrocardiogram normal, Pulse absent, Respiratory arrest
Clinical narrative: On 6/21/09 mother put infant to sleep on his back at 8:30 pm. She then checked him at 9:00 pm and found him face down and not breathing. Grandpa performed CPR because no breathing no pulse. Taken to ER and admitted, d/c after one night. No labs or x-ray done at ER.  7/13/09 MR received for DOS 6/21-22/2009 with D/C DX:  ALTE or near SIDS event.  Infant found face down, limp and cyanotic in crib.  Rescue breaths delivered by family member with fairly quick recovery.  Admitted for monitoring with no further apneic events.  ICD9-786.9
Age: 2.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Myositis, Pyrexia
Clinical narrative: Unable to bear full weight. Fever, R thigh erythematous swelling --> Dx: R thigh myositis at site of injection, ultimate rebound with supportive cares. 9/4/09 Hospital records received DOS 6/25/09. Assessment: Myositis secondary to Pneumovax. Patient presents with inability to bear weight on (R) leg and foot. Hip held in external rotation, flexion of knee, mild swelling of thigh. Fever. Runny nose, cough. Fussy. Cafe au lait spots. tachycardia.  10/8/09 ICD-9 Codes received: 729.1 Myalgia and myositis unspecified, 518.89 Restrictive lung disease, 237.71 Neurofibromatosis Type I, V13.7 Hx prenatal problems, 780.60 Fever.  11/20/09 Duplicate med recs received from date 9/4/09.
Age: 2.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Ultrasound scan abnormal, Weight bearing difficulty
Clinical narrative: Unable to bear full weight. Fever, R thigh erythematous swelling --> Dx: R thigh myositis at site of injection, ultimate rebound with supportive cares. 9/4/09 Hospital records received DOS 6/25/09. Assessment: Myositis secondary to Pneumovax. Patient presents with inability to bear weight on (R) leg and foot. Hip held in external rotation, flexion of knee, mild swelling of thigh. Fever. Runny nose, cough. Fussy. Cafe au lait spots. tachycardia.  10/8/09 ICD-9 Codes received: 729.1 Myalgia and myositis unspecified, 518.89 Restrictive lung disease, 237.71 Neurofibromatosis Type I, V13.7 Hx prenatal problems, 780.60 Fever.  11/20/09 Duplicate med recs received from date 9/4/09.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood lactic acid increased, Brain injury, Cardiac operation, Injection site erythema, Injection site induration
Clinical narrative: GARDASIL. Redness, swelling area hard around vaccine. Had open heart surgery 6/27/09. Suffered brain injury. Lactic acids raised to brain, abnormal white matter.  7/13/2009 MR received from PCP 6/20-/2009.  In for WCC on 6/20/09. For surgical repair of ASD in 1 week.  Impression:  Healthy. ASD. Returned 6/23/09 to have throat checked. Impression: Pharyngitis.  In for surgury ~6/27/09 with "catastrophic event" intraoperatively with subsequent encephalopathy. ? Mitochondrial defect. Pt currently with L hemiparesis, R dystonia, non-verbal with receptive language intact. S/P pancreatitis with G-tube feeds. Transferred to higher level of care.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling, Metabolic function test abnormal
Clinical narrative: GARDASIL. Redness, swelling area hard around vaccine. Had open heart surgery 6/27/09. Suffered brain injury. Lactic acids raised to brain, abnormal white matter.  7/13/2009 MR received from PCP 6/20-/2009.  In for WCC on 6/20/09. For surgical repair of ASD in 1 week.  Impression:  Healthy. ASD. Returned 6/23/09 to have throat checked. Impression: Pharyngitis.  In for surgury ~6/27/09 with "catastrophic event" intraoperatively with subsequent encephalopathy. ? Mitochondrial defect. Pt currently with L hemiparesis, R dystonia, non-verbal with receptive language intact. S/P pancreatitis with G-tube feeds. Transferred to higher level of care.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Blood pressure decreased, Death, Deep vein thrombosis
Clinical narrative: Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk.  She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date.  8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG;  s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall.  Neuro consult done.  Intensive care.  BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm,  Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion,  Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Endotracheal intubation, Gait disturbance, Gastrointestinal tube insertion, Guillain-Barre syndrome
Clinical narrative: Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk.  She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date.  8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG;  s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall.  Neuro consult done.  Intensive care.  BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm,  Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion,  Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Lumbar puncture, Muscular weakness, Somnolence, Transfusion
Clinical narrative: Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk.  She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date.  8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG;  s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall.  Neuro consult done.  Intensive care.  BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm,  Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion,  Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Death
Clinical narrative: It was reported from an article published on 29-JUN-2009 that a 20 year old patient was vaccinated with a dose of GARDASIL. On 15-NOV-2008 the patient deceased due to undetermined cause. This is one of several reports received from the same source. Attempts are being made to verify the existence of an identifiable patient and reporter.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Autopsy, Death, Migraine
Clinical narrative: It was reported from an article published on 29-JUN-2009 that a 20 year old patient was vaccinated with a dose of GARDASIL. On 15-NOV-2008 the patient deceased due to undetermined cause. This is one of several reports received from the same source. Attempts are being made to verify the existence of an identifiable patient and reporter.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Convulsion, Death
Clinical narrative: It was reported from an article published on 29-JUN-2009 that a 20 year old patient was vaccinated with a dose of GARDASIL. On 15-NOV-2008 the patient deceased due to undetermined cause. This is one of several reports received from the same source. Attempts are being made to verify the existence of an identifiable patient and reporter.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Asthenia, Blood pressure normal, Convulsion, Dizziness
Clinical narrative: Information has been received from a certified medical assistant concerning a 7 year old female patient who on 25-JAN-2003 was vaccinated with the first dose of VARIVAX (Merck) and had no adverse effects after her first dose. However, today on 29-JUN-2009 post vaccination with the second dose of VARIVAX (Merck) subcutaneous back of left thigh (there were no concomitant medications) (lot # 664020/0503Y) the patient was standing at the front desk at the doctor's office and fell to the floor, hit her head, and had "a mild seizure" which including trembling of her legs and arms. Caller says her legs, arms, and head could not be straightened. The patient was dizzy and felt sick to her stomach. Ice pack was placed on the patient's head, and she was monitored for at least 30 to 40 minutes. Blood pressure and blood oxygen level were "good", but the patient was still very weak when she left the office. Fall to the floor, hit head, mild seizure, dizzy, felt sick to stomach and still very weak were considered to be other important medical events by the certified medical assistant. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Fall, Head injury, No reaction on previous exposure to drug, PO2 normal, Tremor
Clinical narrative: Information has been received from a certified medical assistant concerning a 7 year old female patient who on 25-JAN-2003 was vaccinated with the first dose of VARIVAX (Merck) and had no adverse effects after her first dose. However, today on 29-JUN-2009 post vaccination with the second dose of VARIVAX (Merck) subcutaneous back of left thigh (there were no concomitant medications) (lot # 664020/0503Y) the patient was standing at the front desk at the doctor's office and fell to the floor, hit her head, and had "a mild seizure" which including trembling of her legs and arms. Caller says her legs, arms, and head could not be straightened. The patient was dizzy and felt sick to her stomach. Ice pack was placed on the patient's head, and she was monitored for at least 30 to 40 minutes. Blood pressure and blood oxygen level were "good", but the patient was still very weak when she left the office. Fall to the floor, hit head, mild seizure, dizzy, felt sick to stomach and still very weak were considered to be other important medical events by the certified medical assistant. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered at inappropriate site, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 9 year old female patient who on 16-Jun-2001 was vaccinated with the first dose of VARIVAX (Merck). Today on 29-JUN-2009 the patient was vaccinated with the second dose of VARIVAX (Merck) subcutaneous back of left thigh (lot # 664020/0503Y). There were no concomitant medications. While at the front desk the patient fainted, but she did "not have a seizure". The patient had sought medical attention in office and had recovered. Fainted was considered to be an other important medical event by the certified medical assistant. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy, Oral herpes
Clinical narrative: Information has been received from a physician concerning a 72 year old female patient who on 10-JUN-2009 was vaccinated with ZOSTAVAX (Merck). On 24-JUN-2009 the patient was seen in the office with a diagnosis of BELLs palsy and herpetic lesions of mouth. The physician did not prescribe treatment and stated that the condition was expected to be self-limited. The patient had not recovered. Upon internal review, BELLs palsy was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning two patients who within the last 30 days were vaccinated with ZOSTAVAX (Merck) (subcutaneously, 0.65ml, lot # not reported). On the same day as vaccination the patients had an infection at the injection site. The patients experienced initially redness and swelling at the injection site. The infection had been treated with 2 antimicrobial (unspecified). The pharmacist believed the infection could have been "staph" because of the 2 antimicrobial (unspecified) used and the potency of these antimicrobial (unspecified). The patients had sought medical attention via phone calls. The pharmacist considered the infections to be other important medical events. 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. Follow up information was received from the pharmacist. The pharmacist reported that the patient was administered ZOSTAVAX (Merck) (subcutaneously, 0.65ml) in May 2009. The injection site for ZOSTAVAX (Merck) was red, hot and the "red area grew up the patient's arm". The patient was treated with KEFLEX and BACTRIM. The patient was not hospitalized and the patient recovered. The pharmacist did not consider the patient's reaction to be disabling, life-threatening or serious (previously reported as other important medical event). The pharmacist felt that the patient's reaction to ZOSTAVAX (Merck) was related to the administration technique. This is one of several reports from the same source. Additional information is not expected. This report no longer meets criteria for expedited submission to the FDA, the adverse events are now considered non-serious.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received from a 24 year old female, for the Pregnancy Registry for GARDASIL, concerning the 24 year old female who in December 2007, was vaccinated intramuscularly with the first dose of GARDASIL and in June 2008, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient was two weeks pregnant while receiving the third dose of GARDASIL. The pregnancy test was positive. Unspecified medical attention was sought. Follow-up information on 01-JUL-2009 was received from an other healthy professional who reported that the patient with a history of 1 pregnancy and 1 live birth was vaccinated intramuscularly with the first dose of GARDASIL on 03-DEC-2007, on 04-FEB-2008, was vaccinated intramuscularly with the second dose of GARDASIL vaccine (lot # 655327/1287U) and on 04-JUN-2008, was vaccinated intramuscularly with the third dose of GARDASIL (lot # 655604/0052X). On 23-SEP-2008, ultrasound was performed with normal result. On 15-OCT-2008, maternal serum alpha-fetoprotein (MSAFP) was performed with negative result. On 13-FEB-2009 (Weeks from LMP: 39), the patient delivered a male infant with congenital anomaly cleft palate, weight: 8 lbs 3 oz and Apgar score 8/9. As of 01-JUL-2009, the outcome of cleft palate was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Activities of daily living impaired, Cough, Eye oedema, Eye swelling, Inappropriate schedule of drug administration
Clinical narrative: Initial information has been received from a physician concerning a 14 year old female patient who received the second dose of GARDASIL and experienced "swelling and edema of the eye" and saw treatment at ER where she was given BENADRYL. The physician stated that she had the same experience after the first dose. The patient was due for her third dose in about a week and she was planning on receiving it. The swelling resolved after about a week, the patient had recovered. Follow up information has been received from a registered nurse concerning the 15 year old (initial reported as 14 year old) female patient who on 04-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 0250X) and concomitantly received the second dose of HAVRIX (Lot # AHAVB264A). On 02-JAN-2009, the patient received the second dose of GARDASIL (lot# 0947X). On 24-Jun-2009, the patient was seen by the physician with complaints of a cough and wheezing. At the time of the physician's visit the patient's father stated that after the patient had received the first dose of GARDASIL, the patient was ill and nauseous and missed 1 week of school. The patient also had swelling and edema of both eyes. After the patient received the second dose of GARDASIL, the patient had swelling and edema of both eyes. The patient went to the Emergency Room and was treated with BENADRYL (route unknown to the reporter). The patient was not admitted to the hospital. The registered nurse stated that the patient was scheduled to receive the third dose of GARDASIL on 29-JUN-2009. The registered nurse requested to speak with a Merck physician prior to administering the third dose of GARDASIL to the patient. Follow up information has been received from a memo indicated that a Merck physician had spoken to the registered nurse. They have decided to not administer the third dose on 29-JUN-2009. Missing 1 week of school was considered to be disabling by the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Malaise, Nausea, Vaccine positive rechallenge, Wheezing
Clinical narrative: Initial information has been received from a physician concerning a 14 year old female patient who received the second dose of GARDASIL and experienced "swelling and edema of the eye" and saw treatment at ER where she was given BENADRYL. The physician stated that she had the same experience after the first dose. The patient was due for her third dose in about a week and she was planning on receiving it. The swelling resolved after about a week, the patient had recovered. Follow up information has been received from a registered nurse concerning the 15 year old (initial reported as 14 year old) female patient who on 04-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 0250X) and concomitantly received the second dose of HAVRIX (Lot # AHAVB264A). On 02-JAN-2009, the patient received the second dose of GARDASIL (lot# 0947X). On 24-Jun-2009, the patient was seen by the physician with complaints of a cough and wheezing. At the time of the physician's visit the patient's father stated that after the patient had received the first dose of GARDASIL, the patient was ill and nauseous and missed 1 week of school. The patient also had swelling and edema of both eyes. After the patient received the second dose of GARDASIL, the patient had swelling and edema of both eyes. The patient went to the Emergency Room and was treated with BENADRYL (route unknown to the reporter). The patient was not admitted to the hospital. The registered nurse stated that the patient was scheduled to receive the third dose of GARDASIL on 29-JUN-2009. The registered nurse requested to speak with a Merck physician prior to administering the third dose of GARDASIL to the patient. Follow up information has been received from a memo indicated that a Merck physician had spoken to the registered nurse. They have decided to not administer the third dose on 29-JUN-2009. Missing 1 week of school was considered to be disabling by the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: Information has been received from a female patient who on an unknown date was vaccinated with GARDASIL. "15 months from the completion of the GARDASIL vaccination" the patient had full blown cervical cancer. The patient's oncologist would like to do a hysterectomy at this time, but the patient stated that she always wanted children. The patient had chosen to wait. The patient stated that she had two of the strains that the shot was supposed to prevent. At the time of reporting the patient had cervical cancer. The outcome of the patient's cervical cancer was not reported. Upon internal review the patient's cervical cancer was considered to be other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Hypertension
Clinical narrative: Information has been received from a licensed practical nurse, for GARDASIL, a pregnancy registry product, concerning a 24 years old female patient with no medical history and no allergies who on 09-APR-2007 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 657005/0314U). The patient received IM the second 0.5ml dose of GARDASIL on 04-JUN-2007 (lot # 657002/0337U, which belongs to VARIVAX ). There was no concomitant medication. On 29-JUN-2009, the patient received the third dose of GARDASIL (lot # 661841/0653x). The patient did not receive any concomitant vaccinations when the three doses of GARDASIL were administered. After the patient was administered her second dose of GARDASIL she was determined to be pregnant. The patient required an unscheduled c-section on 18-MAR-2008 due to hypertension. The infant was a normal, full term baby with no complications. At the time of this report, the patient had recovered. It was reported that the patient sought unspecified medical attention. Upon internal review, the unscheduled c-section due to hypertension was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Contusion, Convulsion, Gingival bleeding
Clinical narrative: It was reported in a newspaper article that an 18 year old female who was vaccinated with GARDASIL (dose, route and lot numbers unspecified). On an unspecified date after the patient received the vaccine, she began having seizures in the spring 2008 (approximately March 2008), often more than once a day. Her body, her brain, her stomach ache, her hair fell out, her gums bleed, her legs bruise, her hands shake with tremors. The patient "didn't die, but there are days when death seems to hover nearby". At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Tremor
Clinical narrative: It was reported in a newspaper article that an 18 year old female who was vaccinated with GARDASIL (dose, route and lot numbers unspecified). On an unspecified date after the patient received the vaccine, she began having seizures in the spring 2008 (approximately March 2008), often more than once a day. Her body, her brain, her stomach ache, her hair fell out, her gums bleed, her legs bruise, her hands shake with tremors. The patient "didn't die, but there are days when death seems to hover nearby". At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Burning sensation, Dementia, Grunting, Hallucination
Clinical narrative: Information has been received from a physician concerning a female patient with asthma who on an unknown date, was vaccinated with the first dose of GARDASIL. Concomitant therapy included MAXAIR. A couple of days later after receiving GARDASIL, the patient started presenting with anxiety, dementia, panic attacks, loss of sleep, weight loss, hallucinations and hyperventilation. The patient was put on antidepressants (unspecified) and her symptoms got worse and she was taken to the ER on 02-FEB-2009. After the antidepressants the patient experienced burning, sweating, tics, rapid heart beat and vocal grunt and was admitted to the psychiatric hospital. The patient will not receive further doses of GARDASIL. The patient was released since she was feeling a little better and started eating, however she is showing early signs of dementia. The patient's adverse experiences were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Hyperhidrosis, Hyperventilation, Insomnia, Panic attack
Clinical narrative: Information has been received from a physician concerning a female patient with asthma who on an unknown date, was vaccinated with the first dose of GARDASIL. Concomitant therapy included MAXAIR. A couple of days later after receiving GARDASIL, the patient started presenting with anxiety, dementia, panic attacks, loss of sleep, weight loss, hallucinations and hyperventilation. The patient was put on antidepressants (unspecified) and her symptoms got worse and she was taken to the ER on 02-FEB-2009. After the antidepressants the patient experienced burning, sweating, tics, rapid heart beat and vocal grunt and was admitted to the psychiatric hospital. The patient will not receive further doses of GARDASIL. The patient was released since she was feeling a little better and started eating, however she is showing early signs of dementia. The patient's adverse experiences were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tic, Weight decreased
Clinical narrative: Information has been received from a physician concerning a female patient with asthma who on an unknown date, was vaccinated with the first dose of GARDASIL. Concomitant therapy included MAXAIR. A couple of days later after receiving GARDASIL, the patient started presenting with anxiety, dementia, panic attacks, loss of sleep, weight loss, hallucinations and hyperventilation. The patient was put on antidepressants (unspecified) and her symptoms got worse and she was taken to the ER on 02-FEB-2009. After the antidepressants the patient experienced burning, sweating, tics, rapid heart beat and vocal grunt and was admitted to the psychiatric hospital. The patient will not receive further doses of GARDASIL. The patient was released since she was feeling a little better and started eating, however she is showing early signs of dementia. The patient's adverse experiences were considered to be disabling. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Initial report received on 24 June 2009 from a health care professional. An 11 year old patient received a first time dose of DECAVAC (lot number U2348CA) intramuscularly in the right deltoid on 24 June 2009. Post vaccination, on 24 June 2009 the patient became dizzy, nauseous, and pale which lasted 20 minutes. However, the patient's recovery status was reported as unknown. The patient was given epinephrine and was sent home. No further information was reported. List of Documents held by Sender: none.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Culture stool, Dehydration, Diarrhoea, Pyrexia, Rotavirus test positive
Clinical narrative: Mom states infant started having diarrhea, vomiting, fever up to 102 on 4-15-09. Was put in hospital on 6-19-09 for dehydration. Received IV fluids and was released home on 6-22-09. Mom states stool culture was positive for Rotavirus.  8/19/09 MR received for DOS 4/17-18/2009 with Impression:  dehydration. diarrhea. Pt presented with 1 day hx of fever, vomiting and foul smelling, watery diarrhea.  Admitted to tx dehydration due to decreased UO.  Rotavirus found in stool.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Vomiting
Clinical narrative: Mom states infant started having diarrhea, vomiting, fever up to 102 on 4-15-09. Was put in hospital on 6-19-09 for dehydration. Received IV fluids and was released home on 6-22-09. Mom states stool culture was positive for Rotavirus.  8/19/09 MR received for DOS 4/17-18/2009 with Impression:  dehydration. diarrhea. Pt presented with 1 day hx of fever, vomiting and foul smelling, watery diarrhea.  Admitted to tx dehydration due to decreased UO.  Rotavirus found in stool.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood test, Intussusception, Urinary system X-ray
Clinical narrative: Pt was admitted to hospital on 4/13/09 for intussusception after receiving vaccines on 3/23.  7/7/09 Received vaccine & PCP records which include ER medical records of  4/13-14/2009. FINAL DX: Intussusception, enema reduced. REcords reveal patient experienced abdominal pain, constipation x 5 days, irritable, lethargic.  Seen in outlying ER & transferred to higher level of care.  Enema administered & successfully reduced IS.  Observed w/o complication s/p reduction & d/c to home w/PCP f/u.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myelitis transverse
Clinical narrative: Pt had 3rd GARDASIL Injection and was diagnosed with transverse myelitis and is being treated with steroids. Pt has LE weakness.  7/17/09 Medical records received DOS 6/25/09. Assessment: Skin sensation disturb, toxic effect venom, cervicalgia. Patient presents with entire left side numb, neck pain and trunk area tingling X 3 days. Not able to sleep because of neck pain, paresthesias. Decreased ROM of cervical spine.   7/23/09 Hospital records received DOS 6/30/09. Diagnosis: tranverse myelitis, hypertension, anxiety, constipation, urinary retention. Patient presented with worsening neck pain and weakness below the waist. Numbness left side of neck, shoulder, arm. Babinski (+) No patellar reflex on right. Tremor in hands. Weakness, paresthesias, brisk tendon reflexes, clonus ankles, alterations in temperature and vibration sense. Neck stiffness.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diplegia, Hypoaesthesia
Clinical narrative: Pt had 3rd GARDASIL Injection and was diagnosed with transverse myelitis and is being treated with steroids. Pt has LE weakness.  7/17/09 Medical records received DOS 6/25/09. Assessment: Skin sensation disturb, toxic effect venom, cervicalgia. Patient presents with entire left side numb, neck pain and trunk area tingling X 3 days. Not able to sleep because of neck pain, paresthesias. Decreased ROM of cervical spine.   7/23/09 Hospital records received DOS 6/30/09. Diagnosis: tranverse myelitis, hypertension, anxiety, constipation, urinary retention. Patient presented with worsening neck pain and weakness below the waist. Numbness left side of neck, shoulder, arm. Babinski (+) No patellar reflex on right. Tremor in hands. Weakness, paresthesias, brisk tendon reflexes, clonus ankles, alterations in temperature and vibration sense. Neck stiffness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: 2 cm raised red wheal
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Irritability, Pyrexia
Clinical narrative: Patient became very fussy and developed fever to 102 after the immunizations. Patient did not want to eat and fussiness lasted more than 3hours. Fussiness continued X 24-48 hrs, then slowly improved. Appetite also slowly improving.
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Full blood count normal, Injection site reaction, Local reaction
Clinical narrative: Local tissue reaction Left arm and Right arm. VARIVAX and MMR SQ x 2. 6/24/09 at 10:00AM. Treatment ice and TYLENOL. No temperature. (Recovered).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Day after injection had raised, red, hard blotch at injection site. Slightly itchy. No temp. per pt. 5 days later pt reports all sx almost resolved. Feels fine.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Day after injection had raised, red, hard blotch at injection site. Slightly itchy. No temp. per pt. 5 days later pt reports all sx almost resolved. Feels fine.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash maculo-papular
Clinical narrative: Onset of whole body maculopapular rash with some areas of confluence and papa measure 2-13 mm in size. One large patch 34 cm on post (L) arm
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal discomfort, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt. Was given 1st GARDASIL shot today. Pt. passed out after feeling faint and sick to stomach. Pt. was pale but opened eyes and was alert after Ammonia salts.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site induration, Skin discolouration
Clinical narrative: Large induration over entire left outer thigh with central clearing with slight fluish like.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: While administering vaccines MMR and Varicella, patient began immediately having redness start @ injection site and spread to about a 50% area around both injection sites. Pt immediately evaluated by physician and given BENADRYL and TYLENOL. Patient was monitored for 15 minutes.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt. stated that the next day. After the shot in the late afternoon she started itching on her right arm in the area of the shot. States noted a rash with a 4x4 cm knot. States area was hot to touch. Instructed to go to MD since was also going to go visit her brother who has cancer and getting radiation tx. Placed on antibiotic and anti itch cream.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: Erythematous blanchable rash on trunk, neck, face and head several hours after PENTACEL and PREVNAR injections.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Cellulitis, Skin warm
Clinical narrative: Pt 1st noticed pain in (L) hip on 6/23/09 - then started with egg sized red area with heat - progressed to 11 X 5 cm area - upper: illiac crest - Pt presented to doctor on 6/30/09 for eval - erythromycin 250 mg with POTID with food for 7 days was Rx'd for cellulitis
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Eosinophil count increased, Headache, Monocyte count normal
Clinical narrative: 4/21/09 Headache, itching, rash, chest discomfort, tongue swelling, difficulty breathing.  8/14/09 MR received from pcp for DOS 3/12/09. HPV#1 given 0229X.  8/24/09 ER records received DOS 4/21/09 - 4/22/09. Assessment: Cephalgia, hypertension. Presents with headache associated with photophobia, nausea. Anxiety. Hypertensive. Obese. Flushed.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash, Scan brain, Swollen tongue, White blood cell count increased
Clinical narrative: 4/21/09 Headache, itching, rash, chest discomfort, tongue swelling, difficulty breathing.  8/14/09 MR received from pcp for DOS 3/12/09. HPV#1 given 0229X.  8/24/09 ER records received DOS 4/21/09 - 4/22/09. Assessment: Cephalgia, hypertension. Presents with headache associated with photophobia, nausea. Anxiety. Hypertensive. Obese. Flushed.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Injection site erythema, Musculoskeletal pain, Neck pain
Clinical narrative: 3 days after administration of vaccine. Pt had tight sided upper back pain which then radiated to her shoulder, neck + head. Also developed erythema at site. Treated with antibiotic and Ibuprofen. On 6/29/09, back pain still present, other sx's better.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Evening of 6/23 pt whole body turned red, arms & legs had red spots. Pt had 101 fever - Mother gave child TYLENOL. Pt was taken to ER - temp there 99 - checked over; no labs taken; given DECADRON by mouth & to continue MOTRIN. Clinical impression rash/secondary to imm. FUP w/ PCP 7/1/09.
Age: 13.5
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Cellulitis, Erythema, Full blood count normal, Oedema peripheral, Pain
Clinical narrative: 6/24/09 redness, swelling, warmth, soreness below sight of varicella immu Dx "Mild Superficial Cellulitis". Rx KEFLEX 500 mg po BID x 10d. 6/25/09 increased redness c/o painful thigh no streaking. Rx ROCEPHIN 1 Gm L buttocks D/C KEFLEX CBC WNL. 6/26/09 leg looking much better she is feeling better.
Age: 13.5
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Pain in extremity, Skin warm
Clinical narrative: 6/24/09 redness, swelling, warmth, soreness below sight of varicella immu Dx "Mild Superficial Cellulitis". Rx KEFLEX 500 mg po BID x 10d. 6/25/09 increased redness c/o painful thigh no streaking. Rx ROCEPHIN 1 Gm L buttocks D/C KEFLEX CBC WNL. 6/26/09 leg looking much better she is feeling better.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Patient developed bruising at injection site after withdrawal of needle, after 15 minutes had a small hematoma that improved with direct pressure for 15 minutes, and continued to apply pressure several times over the next 12 hours.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever + rash typical of rubella.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Hypersomnia, Incoherent
Clinical narrative: At 12:15 pm pt. felt dizzy (6/30/09) and cont to do so. 4:30 AM 7/1/09 oral temp of 101 degrees F. TYLENOL administered. Incoherent and fatigued all day on 7/1/09, slept all day. Came in to PMP at 4pm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Induration, Pain
Clinical narrative: Patient had a area - 10 cm- area of induration with erythema and pain. Central area of erythema with surrounding area of lighter erythema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of erythema and induration at site of injection 8.5cm x 6cm left arm.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: 14 days after vaccination postular rash on hands/feet - No systemic signs/symptoms, vaccine site healed normally. Treated with antihistamine.
Age: 1.7
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Injection site discolouration
Clinical narrative: 8.5 cm X 3 cm area of tan/lt. brown pigmentation of thigh where shot administered
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash pustular, Varicella post vaccine
Clinical narrative: Pt had eruption of pustules on erythematous base diffusely (out scattered), worse around head. Lesions were in different stage of healing. Atypical for varicella, but pt had been using steroid cream.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Red swollen, painful, hard felling (solid) area around injection site. 1 and 1/2 inch in diameter. Recommended cold compress, instructed to call MD or pharmacist if it does not improve or gets worse.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Erythema and induration
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Patient received HPV #2 @ 4 pm 6/29/09. Developed generalized urticarial rash 6/30/09 @ 8 pm.
Age: 67.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Patient developed a red raised area around injection site. It itches, is about 1" x 3". It developed between an hour or two after injection. Patient waited a day before seeing the Dr. She prescribed Ibuprofen 800mg once-twice daily. At site of ZOSTAVAX admin.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Erythema multiforme, Immediate post-injection reaction, Rash, Urticaria
Clinical narrative: Dad stated that immediately after the PENTACEL shot, child had 3 raised scratch areas. Then received PREVNAR. Developed erythema multiforme 3/24/2009 and seen 6/25/09 in office. 6/28/09 rash gone after BENADRYL.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site inflammation, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt had fever 102-103, body aches, swelling at injection site , headache starting ~ 6 hours after injection of vaccine. Took NSAIDS + Benadryl. Fever persisted, site swelled, fever worse, gave Prednisone 60 mm taper on day 3. symptoms improved slowly. Site is still inflamed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 9 x 7.5 cm erythematous induration area on upper arm. Received DTaP A/ DTap reaction.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythematous, swelling at site of injection no fever no systemic symptoms. No other sign.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Patient received the varicella vaccine on 06/26/09 (2nd dose). On 06/28/09 the parent notified the office that patient developed a three inch welt at the injection site. Mother has been applying an ice pack to the area, and the swelling has lessened.
Age: 24.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted, went white, no treatment patient recovered fine with no ADR reported
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Hyperventilation, Myalgia, Paraesthesia
Clinical narrative: Pt had severe HA, myalgias followed by hyperventilation & paresthesias, no fever or focal neurologic changes on exam * improved with MOTRIN.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Half dollar sized area of redness over (L) lateral thigh with mild warmth to touch, now tender, no fluctuance noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swollen & hot to touch 7/3/09 at injection site. Tender, painful. Pt would not put pressure x2d. Resolving today 7/6/09 swelling decreased (+) walking.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea, Pyrexia
Clinical narrative: ER x2 6/22/09, Redness, fever, nausea, vomiting, swelling, pain. AUGMENTIN; BACTRIM DS, VICODIN, IBUPROFEN. 16 x14 cm erythematous warm macular lesion surrounding site left deltoid, then 20x16 cm site of erythema moved distal to original site. Still has pain at site. Requiring VICODIN . Out of work since 6/21/09.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Vomiting
Clinical narrative: ER x2 6/22/09, Redness, fever, nausea, vomiting, swelling, pain. AUGMENTIN; BACTRIM DS, VICODIN, IBUPROFEN. 16 x14 cm erythematous warm macular lesion surrounding site left deltoid, then 20x16 cm site of erythema moved distal to original site. Still has pain at site. Requiring VICODIN . Out of work since 6/21/09.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Within a few hours of vaccination the pt experienced pruritus at the injection site (VZV).  Within one day she had developed an itchy, red, swollen left arm.  2 days after IZ administration she presented to urgent care with 13 X 7 cm erythematons patch overlying a 6 X 6 cm area of induration.  Site was warm to touch, not painful and no longer itchy.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Within a few hours of vaccination the pt experienced pruritus at the injection site (VZV).  Within one day she had developed an itchy, red, swollen left arm.  2 days after IZ administration she presented to urgent care with 13 X 7 cm erythematons patch overlying a 6 X 6 cm area of induration.  Site was warm to touch, not painful and no longer itchy.
Age: 1.3
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Auricular swelling, Erythema, Rash
Clinical narrative: Admin IM Hep B dose # 2 of 3 at approx 11:30 AM 6/30/09 w/o incident mom called at about 16:40 reporting that his ears turned bright red and swollen and a flat red rash was spreading cephalocaudally.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Rash started at site of injection within 24 hrs & spread to bilat upper ext's. Macula/papular/ erythematous. Most intense at inj. site w/bumpy, almost confluent, almost vesicular lust.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Injection site reaction
Clinical narrative: Pt received ACAM2000 on 6/25/09. Experienced robust take - 15mm. noted on 7/2/09. On 7/4/09, pt called with c/o of chest pain, SOB, pain in arm and palpitations. Pt. sent to hospital. States she had EKG, echo - placed on KEFLEX and VICODIN. F/u with PCP and consult to Cardiologist.  7/17/09 ER records received DOS 7/4/09. Assessment: See the following. Patient short of breath last night. Heart racing. Chest pain left and under left rib. Fever, headaches, fatigue, neck stiff.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Pain in extremity, Palpitations
Clinical narrative: Pt received ACAM2000 on 6/25/09. Experienced robust take - 15mm. noted on 7/2/09. On 7/4/09, pt called with c/o of chest pain, SOB, pain in arm and palpitations. Pt. sent to hospital. States she had EKG, echo - placed on KEFLEX and VICODIN. F/u with PCP and consult to Cardiologist.  7/17/09 ER records received DOS 7/4/09. Assessment: See the following. Patient short of breath last night. Heart racing. Chest pain left and under left rib. Fever, headaches, fatigue, neck stiff.