chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site warmth
Clinical narrative: Dizzy, stomach cramping, Rt arm pain down from deltoid to elbow. Immediate warmth around injection site. Temp 99.2, BP 90/60
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Palpitations
Clinical narrative: Shortly after receiving Gardasil on 4/24/07. Pt became "dizzy and lightheaded and heart was racing" - was reported to us today 6-25-07 also headache.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Baby was found in crib unresponsive by a babysitter. She moved the baby to a couch until EMS arrived. Was placed in the crib at 2pm and found 1 1/2 hrs later. No fever or prodromal symptoms per the ER doctor. Unknown if Tylenol had been given. Was seen by private MD at 10am.  2/26/08 Reviewed autopsy report which states COD as undetermined.  Pathologic findings: tox results neg; pulmonary vascular congestion, mild, combined weight of lungs 132 grams; petechiae of lung pleura, mild; no evidence of significant natural disease, injury, active infection, congenital anomaly, malformation metabolic disorders or malignancy.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Transaminases increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of transaminases increased in a 20-year-old male subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received unspecified dose of Engerix B (unknown). In 2007, at an unspecified time after vaccination with Engerix B, the subject experienced transaminases increased. At the time of reporting the event was unresolved. The healthcare professional considered the event was unrelated to vaccination with Engerix B.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a 2 y/o previously healthy male. He had a well-child examination performed on 6/18/07. where he received DTaP and Hib #4. One-two days after immunizations he developed (R) lower extremity (thigh) swelling and pain. 7/5/07-record received-seen on 6/20/07- C/O thrush on 6/18/07.Seen on 6/20/07 with C/O immunization reaction, swelling 2 days prior, leg red and swollen. PE: no over erythema or signs of infection, isolated rar raised lesions consistent with pityriasis. Right leg swelling
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Headache, Hypertension, Nasal congestion
Clinical narrative: Patient developed nasal congestion within 5 minutes of receiving the influenza vaccine. Prior immunizations of flu vaccine had been well tolerated. Patient was treated in the emergency room with Benadryl, Solumedrol, Albuterol and Ranitidine. After treatment in the emergency room patient improved and was discharged home. Manufacturer: Sanofi Pasteur Lot # U2249AA Expiration date: 6/30/07 Symptoms: 1. Headache, 2. Anaphylaxis, 3. Hypertension (4) swelling, shortness of breath.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient developed nasal congestion within 5 minutes of receiving the influenza vaccine. Prior immunizations of flu vaccine had been well tolerated. Patient was treated in the emergency room with Benadryl, Solumedrol, Albuterol and Ranitidine. After treatment in the emergency room patient improved and was discharged home. Manufacturer: Sanofi Pasteur Lot # U2249AA Expiration date: 6/30/07 Symptoms: 1. Headache, 2. Anaphylaxis, 3. Hypertension (4) swelling, shortness of breath.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Shortly after receiving Gardasil, pt blacked out and fell off exam table where she had been sitting. Her forehead struck the exam table stirrup, breaking it off, her left thigh scrapped against broken metal from stirrup and pt landed on the floor, where was found the the nurse
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: Narrative: fever, headache, severe weakness Symptoms: 1. Headache, 2. Fever (3) weakness. 6/28/07-records received for DOS 06/12-06/18/07. DC DX: Adverse systemic reaction to Diptheria, Pertussis, Tetanus injection. Abrupt onset o fever, weakness and right deltoid pain following DPT injection some 24 hours prior to admission. Temperature of 103. Extreme tenderness in right arm. Large indurated area of right shoulder.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Inflammation, Liver disorder
Clinical narrative: Liver inflammation /5/07-records received-DX Alcohol Abuse. Alcoholic liver damage. Alcohol withdrawal. Sleep disorder. Obesity. HX of sleep apnea. Nightmares cause anxiety. Low back pain, chronic condition. HX of gout. Attends alcohol rehab
Age: 0.6
Sex: M
Vaccine: HIBV, PNC, RV5, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Boostrix vaccine administered instead of Pediarix vaccine
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram, Jaw fracture, Laceration, Scan brain, Syncope
Clinical narrative: After immunizations Pt. fainted with laceration to chin Fx. Mandibles
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Hypotonia
Clinical narrative: Pt had several minutes episode of going limp no seizure activity noted. Lasted about 15 minutes total. Resolved without intervention.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: On 6/13/07 client was given Gardasil and VAR vaccines at public health office. Family reports client began to have reaction to VAR on 6/14, came to this office 6/15 reporting pain, swelling, itching around site of Varicella vaccine (L) arm-This area, reddened, hot with swelling noted by nurse. They returned that afternoon, reaction somewhat larger, client had headache, itching arm pain. Referred to MD, began antibiotics that eve. soon improved. Resolved by 6/19/07.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site warmth
Clinical narrative: On 6/13/07 client was given Gardasil and VAR vaccines at public health office. Family reports client began to have reaction to VAR on 6/14, came to this office 6/15 reporting pain, swelling, itching around site of Varicella vaccine (L) arm-This area, reddened, hot with swelling noted by nurse. They returned that afternoon, reaction somewhat larger, client had headache, itching arm pain. Referred to MD, began antibiotics that eve. soon improved. Resolved by 6/19/07.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Blister, Eye oedema, Eye swelling, Pruritus, Rash
Clinical narrative: 6-21-07 pt experienced itching in fingers. On 6-22 pt had swelling around eyes and rash on fingers. Symptoms worsened until 6-24 when pt took Benadryl. 6-25 pt showed multiple papules and vesicles on fingers and in between fingers. Skin around eyes edematous. Fingers pruritic.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: 6-21-07 pt experienced itching in fingers. On 6-22 pt had swelling around eyes and rash on fingers. Symptoms worsened until 6-24 when pt took Benadryl. 6-25 pt showed multiple papules and vesicles on fingers and in between fingers. Skin around eyes edematous. Fingers pruritic.
Age: 1.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site swelling
Clinical narrative: Swelling of injection site with numbness in fingers of right hand. (Right arm injection) Duration of 3 days until medical help was asked for. LR-6 from literature
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia
Clinical narrative: LR 7 Adverse event >120MM Distal to Elbow with Numbness
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: Numbness, tingling (L) side: arm and face; Tremors.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Erythema, Pain in extremity
Clinical narrative: 4cm x 5cm erythema under L arm painful, joint pain L shoulder. Temp 99 deg.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Rash all over the body
Age: 1.3
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: L th red swollen, fever (RN's on call - suggested taking pt to ER - they gave pt Keflex 125/5 one tsp PO BID - follow up with Dr in 2 days.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular, Rash pustular, Skin lesion
Clinical narrative: developed papules then pustules (pox) lesions 6/22 with low grade fever. Fever resolved in 1 day. Maximum 27 lesions all resolving. Lesions concealed on head and neck
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Anorexia, Disorientation, Headache, Migraine, Nausea
Clinical narrative: Headaches, Migranes, Neck pain, Nausea, lose of appatiate, disoreintation.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Neck pain
Clinical narrative: Headaches, Migranes, Neck pain, Nausea, lose of appatiate, disoreintation.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: itchy rash all over body started 24 hours after vaccine and lasted a week.  resolved with benadryl, zyrtec.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse effect
Clinical narrative: none
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Irritability, Pyrexia, Rash generalised
Clinical narrative: Red rash all over body, worse with heat,febrile On the 14th  a rash apppeared on abdomen 15th pt was irritable, 16th febrile 17th febrile and rash, 18th febrile and rash worse , By the 23rd patient rash completely cleared.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Cold compress therapy, Heat therapy, Induration, Injection site erythema, Injection site swelling
Clinical narrative: The very next day after the administration of the Tdap (Adecel)I woke up with a very sore, red, hot, swollen shoulder just at the injection site and approximately 6-8 inches around the site and a stiff neck on the right side. I used a cool compress at the site for the first 48 hrs and then went to the doctors to have it checked and they suggested i start using warm compresses now so that is what i am doing right now.Area is still very sore, red,hot and swellen and has a hard lump under the skin and I continue with a slight stiff neck on the right side
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: The very next day after the administration of the Tdap (Adecel)I woke up with a very sore, red, hot, swollen shoulder just at the injection site and approximately 6-8 inches around the site and a stiff neck on the right side. I used a cool compress at the site for the first 48 hrs and then went to the doctors to have it checked and they suggested i start using warm compresses now so that is what i am doing right now.Area is still very sore, red,hot and swellen and has a hard lump under the skin and I continue with a slight stiff neck on the right side
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia, Pyrexia
Clinical narrative: 8:00 pm patient became fevered with temp of 101.5, complaints of parathesia in L arm with tingling radiating to L breast. L arm with swelling and redness at the site.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Anticonvulsant drug level below therapeutic, Apnoeic attack, Blood glucose normal, CSF cell count normal, CSF culture
Clinical narrative: Pt had two seizures on the day of vaccination, and subsequent to receiving diastat became apneic and was intubated. 8/8/07-records received -DC DX: Seizures. Neutropenia.presented to ER with prolonged seizure. Febrile 101.7. Tachycardic 140. Admitted overnight.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: CSF glucose normal, CSF protein normal, Convulsion, Intubation, Neutrophil count decreased
Clinical narrative: Pt had two seizures on the day of vaccination, and subsequent to receiving diastat became apneic and was intubated. 8/8/07-records received -DC DX: Seizures. Neutropenia.presented to ER with prolonged seizure. Febrile 101.7. Tachycardic 140. Admitted overnight.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Urine analysis normal
Clinical narrative: Pt had two seizures on the day of vaccination, and subsequent to receiving diastat became apneic and was intubated. 8/8/07-records received -DC DX: Seizures. Neutropenia.presented to ER with prolonged seizure. Febrile 101.7. Tachycardic 140. Admitted overnight.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Fatigue, Full blood count normal
Clinical narrative: Employee received MMR vaccination on 5/23/07. She reports increasing fatigue and "listlessness"  from 5/25 to 6/5/07. On 6/5/07, she reports achy joints and flu-like symptoms and the onset of a non-urticaric rash on her left arm that spreads to her chest.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Listless, Metabolic function test normal, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Employee received MMR vaccination on 5/23/07. She reports increasing fatigue and "listlessness"  from 5/25 to 6/5/07. On 6/5/07, she reports achy joints and flu-like symptoms and the onset of a non-urticaric rash on her left arm that spreads to her chest.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Thyroxine free normal, Tri-iodothyronine normal
Clinical narrative: Employee received MMR vaccination on 5/23/07. She reports increasing fatigue and "listlessness"  from 5/25 to 6/5/07. On 6/5/07, she reports achy joints and flu-like symptoms and the onset of a non-urticaric rash on her left arm that spreads to her chest.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PPV
Symptoms: Convulsion
Clinical narrative: Patient had seizure approximately 12 hours after administration of vaccines
Age: 13.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: No adverse effect
Clinical narrative: none
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse effect
Clinical narrative: none
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Oxygen saturation decreased, Throat tightness, Vomiting
Clinical narrative: Anaphylaxis-throat closing within minutes followed by vomiting with O2 sat 90%.  All sx resolved within 2 minutes of receiving epi-pen-ambulance transport to hospital 7/5/07-records received from facility for DOS 6/26/07-DX: Anaphylaxis to varicella vaccine. Twenty minutes after he received his second booster of Varivax, complained of tightness of throat and began vomiting. Oxygen saturation 89%, administered an EpiPen. Throat felt better. Upon arrival at ER developed hives and facial redness. HX of asthma induced by common cold. Treated with Benadryl and Orapred. Observed and discharged
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: none
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: none
Age: 21.0
Sex: F
Vaccine: HEPA, IPV, TD, TYP
Symptoms: Condition aggravated, Convulsion, Syncope vasovagal
Clinical narrative: Patient had a vaso-vagal response but then went into a seizure.  Patient has a history of seizure disorder.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: none
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Fall, Head injury, Loss of consciousness, Somnolence
Clinical narrative: Approx 5 minutes after receiving vaccines which included Tdap, HPV#1 and Menactra, pt had syncopal episode, falling to the floor and hitting her head.  She was unconscious for approx 10-15 seconds, then groggy but oriented x 3.  She was unable to remember the day's events and kept asking the same questions repeatedly.  Was observed in outpatient clinic x 2 hours with no improvement.  Transported via ambulance to ER, CT of head was normal, was observed 2 more hours and discharged home.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Approx 5 minutes after receiving vaccines which included Tdap, HPV#1 and Menactra, pt had syncopal episode, falling to the floor and hitting her head.  She was unconscious for approx 10-15 seconds, then groggy but oriented x 3.  She was unable to remember the day's events and kept asking the same questions repeatedly.  Was observed in outpatient clinic x 2 hours with no improvement.  Transported via ambulance to ER, CT of head was normal, was observed 2 more hours and discharged home.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Arthralgia, Body temperature increased, Chills, Full blood count
Clinical narrative: Approximately 12 hours after injection of vaccine, patient reported body aches, joint aches, fever, chills, abdominal discomfort. Temp of 103.0
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Pain, Pyrexia
Clinical narrative: Approximately 12 hours after injection of vaccine, patient reported body aches, joint aches, fever, chills, abdominal discomfort. Temp of 103.0
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Oral herpes, Rash, Rash vesicular
Clinical narrative: 1 day after vaccination with Zostavax the patient developed an intense local reaction at the injection site. 10 days post-vaccination the patient developed cold sores (herpes labialis) which she has had before. 14 days post-vaccination the patient developed a typical zoster rash on the L chest starting at about T12 and radiating anteriorly to the mid-axillary line.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Convulsion, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Hives, swollen feet 24 hr after receiving HPV, Meningococcal and Varivax.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Pruritus, Syncope, Urticaria
Clinical narrative: Hives, swollen feet 24 hr after receiving HPV, Meningococcal and Varivax.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Hives, swollen feet 24 hr after receiving HPV, Meningococcal and Varivax.
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Pain distal to site lasting at least 3 weeks
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anorexia, Headache, Insomnia, Musculoskeletal stiffness, Photophobia
Clinical narrative: A case was received from a health professional on 15 June 2007. An 18-year-old female patient with a medical history of "cequor", vocal cord dysfunction, and ADD (attention deficit disorder) had received an intramuscular left deltoid injection of Adacel (lot number C2644AA) and an intramuscular right deltoid injection of Menactra (lot number U2234AA) on 08 June 2007. Beginning one day after vaccination, on 09 June 2007, she developed a stiff neck, photophobia, severe headache, loss of appetite, and difficulty sleeping. She presented to an emergent care facility where diagnostic testing, including CT scan and hematology, were within normal limits. She was treated with intravenous steroids and Valium. Concomitant medications included Singulair and Allegra. The events remained ongoing.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, No adverse effect, Ultrasound scan
Clinical narrative: Information has been received from a physician's assistant through the Merck Pregnancy registry concerning a 15 year old female patient with asthma who on 16-JAN-2007, was vaccinated IM with a second dose of Gardasil (Lot# 655617/1447F). Concomitant therapy included albuterol MDI. After the second dose, it was discovered that she was pregnant. No adverse events were noted. On 24-MAY-2007, the patient elected to terminate the pregnancy. The patient was 21 weeks from last menstrual period. On 20-MAY-2007 and 22-MAY-2007, an ultrasound was performed and the results were unknown. At the time of this report, the patient's outcome was unknown. It was also reported on 16-NOV-2006, the patient was vaccinated with a first dose of Gardasil (Lot# 653736/0868F). No product quality complaint was involved. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not to be expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site inflammation, Injection site warmth, Muscle spasms, Neck deformity, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no allergies and with a urinary tract infection who on 12-JUN-2007 was vaccinated intramuscularly with the third 0.5 mL dose of Gardasil, (Lot number known by the reporter). Concomitant therapy included "birth control" "antibiotic" (unspecified) and sulfamethoxazole/trimethoprim (BACTRIM). On 14-JUN-2007, approximately 36 hours after vaccination, the patient developed severe neck pain and spasms on the same side (unspecified) of her injection. The patient was seen and her neck was described as "crooked" and "off center". The back of the patient's neck was palpitated up to the skull and the patient expressed severe pain. Also, the site of injection was warm to the touch with signs of inflammation. The patient lost a day of work. The patient sought unspecified medical attention. It was reported that ice was used along with ibuprofen (MOTRIN) for the symptoms. On the morning of 15-JUN-2007, the patient felt a little better but her neck was still "crooked". The patient had an appointment with an orthopedist. No further information was available. At the time of the report, the patient had not recovered. The reporter considered the patient's neck pain, spasms, neck described as "crooked" and "off center" and injection was warm to the touch with signs of inflammation to be disabling. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Effusion, Fluid retention, Hypokinesia, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a physical therapist concerning a 19 year old female with an allergy to "vicryl sutures" who on approximately 20-APR-2007 was vaccinated with a dose of Gardasil. On approximately 25-APR-2007, five days after vaccination, the patient developed shoulder pain on the side where the vaccination was given. She saw her pediatrician, and was referred to an orthopedic physician. Magnetic resonance imaging was performed and showed an 8 mm in diameter fluid filled sack underneath the deltoid. The patient can not use the arm due to the pain in her shoulder. The patient's shoulder pain and fluid-filled sack underneath the deltoid have persisted. The physician considered the shoulder pain and fluid-filled sack underneath the deltoid to be disabling events. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physical therapist concerning a 19 year old female with an allergy to "vicryl sutures" who on approximately 20-APR-2007 was vaccinated with a dose of Gardasil. On approximately 25-APR-2007, five days after vaccination, the patient developed shoulder pain on the side where the vaccination was given. She saw her pediatrician, and was referred to an orthopedic physician. Magnetic resonance imaging was performed and showed an 8 mm in diameter fluid filled sack underneath the deltoid. The patient can not use the arm due to the pain in her shoulder. The patient's shoulder pain and fluid-filled sack underneath the deltoid have persisted. The physician considered the shoulder pain and fluid-filled sack underneath the deltoid to be disabling events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HEPA, HPV4
Symptoms: Grand mal convulsion, Oxygen supplementation, Syncope
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 15 year old female with a drug sensitivity to SEPTRA and a  history of seeing a neurologist and cardiologist for neurocardio syncope (Vasovagal) who on 26-MAR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. On approximately, 16-JUN-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil (lot # 657868/0523U). There was no concomitant medications. On 16-JUN-2007, while in the physicians office, the patient fainted and then had a grand mal seizure. The patient was given oxygen. The office called for an ambulance and the patient was taken to the emergency room and released. There were no laboratory or diagnostic test performed. On 16-JUN-2007, the patient recovered from fainting and the grand mal seizure. On 18-JUN-2007, the patient was seen in the physicians office and was referred to a neurologist. Upon internal review, grand mal seizure was considered to be an other important medical event. The registered nurse is requesting a lot check. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HEPA, HPV4
Symptoms: Condition aggravated, Grand mal convulsion, Oxygen supplementation, Syncope, Urinary incontinence
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 15 year old female with a drug sensitivity to SEPTRA and a  history of seeing a neurologist and cardiologist for neurocardio syncope (Vasovagal) who on 26-MAR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. On approximately, 16-JUN-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil (lot # 657868/0523U). There was no concomitant medications. On 16-JUN-2007, while in the physicians office, the patient fainted and then had a grand mal seizure. The patient was given oxygen. The office called for an ambulance and the patient was taken to the emergency room and released. There were no laboratory or diagnostic test performed. On 16-JUN-2007, the patient recovered from fainting and the grand mal seizure. On 18-JUN-2007, the patient was seen in the physicians office and was referred to a neurologist. Upon internal review, grand mal seizure was considered to be an other important medical event. The registered nurse is requesting a lot check. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HEPA, HPV4
Symptoms: Cyanosis, Grand mal convulsion, Seizure anoxic, Syncope vasovagal, Urinary incontinence
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 15 year old female with a drug sensitivity to SEPTRA and a  history of seeing a neurologist and cardiologist for neurocardio syncope (Vasovagal) who on 26-MAR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. On approximately, 16-JUN-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil (lot # 657868/0523U). There was no concomitant medications. On 16-JUN-2007, while in the physicians office, the patient fainted and then had a grand mal seizure. The patient was given oxygen. The office called for an ambulance and the patient was taken to the emergency room and released. There were no laboratory or diagnostic test performed. On 16-JUN-2007, the patient recovered from fainting and the grand mal seizure. On 18-JUN-2007, the patient was seen in the physicians office and was referred to a neurologist. Upon internal review, grand mal seizure was considered to be an other important medical event. The registered nurse is requesting a lot check. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Dizziness, Feeling abnormal, Hyperglycaemia, Lethargy
Clinical narrative: Information has been received from a physician concerning a 14 year old female, with no pertinent medical history, who on 14-JUN-2007 was vaccinated IM, with a first dose of Gardasil (lot # "02630"). There was no concomitant medication. Approximately, on 14-JUN-2007 it was reported the patient was "light-headed", "out of it", and lethargic. On 15-JUN-2007 the patient had to be carried into the physicians office. Her sugar level was at 176 (hyperglycemic). She was tested for diabetes but it came back "negative". It was reported that by 16-JUN-2007 the patient "was feeling much better." The physician considered "light-headed", "out of it", lethargic, and a sugar level at 176 to be disabling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Back pain, Epstein-Barr virus antibody positive, Headache
Clinical narrative: Initial and follow-up information has been received from a nurse and a physician concerning a 24 year old female assistant manager with a drug allergy to DILANTIN who was vaccinated intramuscularly into the left deltoid with the first dose of Gardasil (lot # 657617/0684U) on 29-MAY-2007. Concomitant therapy included LEXAPRO and YASMIN. On 02-JUN-2007, the patient "became sick" and went to the emergency room (ER). It was reported that she experienced headache, elevated liver enzymes, fever, severe back pain and a complete blood count that revealed infectious process. The nurse reported that the patient had a variety of tests performed on her in the ER, including a liver function test (LFT) which showed that the patient's liver enzymes were high. On 06-JUN-2007, the patient underwent the following laboratory test: Lyme disease enzyme-linked immunosorbent assay, negative; absolute blood band neutrophil count, 2.35 K/uL, blood lymphocyte count, 10%; mean corpuscular volume, 75 fL, serum Epstein-Barr viral capsid antigen immunoglobulin G antibody test, positive; serum alanine aminotransferase test (ALT (SGPT), 486 U/L; serum aspartate aminotransferase test (AST (SGOT), 311 U/L; mean corpuscular hemoglobin (MCH), 26 pg. On 06-JUN-2007, the patient also underwent an abdominal ultrasound. The physician's impression was that there was no evidence of gallstones or dilated intra-, extrahepatic biliary ducts and there was a stable splenic cyst present. On 11-JUN-2007, the patient underwent the following laboratory tests: MCH, 26 pg, WBC count, 10.8 x 10E3/uL; AST (SGOT), 49 IU/L; ALT (SGPT), 147 IU/L. The nurse reported that the patient was doing better, but her liver enzyme levels were still elevated. At the time of the report, the outcome of severe back pain, headache, infectious process and fever were unknown. The reporting physician considered elevated liver enzymes, severe back pain, headache, fever, and complete blood count revealing infectious process to be other important medical events. Additional information is not expected. All available medical records will be provided upon request.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatic enzyme increased, Infection, Lymphocyte count decreased, Malaise, Mean cell volume decreased
Clinical narrative: Initial and follow-up information has been received from a nurse and a physician concerning a 24 year old female assistant manager with a drug allergy to DILANTIN who was vaccinated intramuscularly into the left deltoid with the first dose of Gardasil (lot # 657617/0684U) on 29-MAY-2007. Concomitant therapy included LEXAPRO and YASMIN. On 02-JUN-2007, the patient "became sick" and went to the emergency room (ER). It was reported that she experienced headache, elevated liver enzymes, fever, severe back pain and a complete blood count that revealed infectious process. The nurse reported that the patient had a variety of tests performed on her in the ER, including a liver function test (LFT) which showed that the patient's liver enzymes were high. On 06-JUN-2007, the patient underwent the following laboratory test: Lyme disease enzyme-linked immunosorbent assay, negative; absolute blood band neutrophil count, 2.35 K/uL, blood lymphocyte count, 10%; mean corpuscular volume, 75 fL, serum Epstein-Barr viral capsid antigen immunoglobulin G antibody test, positive; serum alanine aminotransferase test (ALT (SGPT), 486 U/L; serum aspartate aminotransferase test (AST (SGOT), 311 U/L; mean corpuscular hemoglobin (MCH), 26 pg. On 06-JUN-2007, the patient also underwent an abdominal ultrasound. The physician's impression was that there was no evidence of gallstones or dilated intra-, extrahepatic biliary ducts and there was a stable splenic cyst present. On 11-JUN-2007, the patient underwent the following laboratory tests: MCH, 26 pg, WBC count, 10.8 x 10E3/uL; AST (SGOT), 49 IU/L; ALT (SGPT), 147 IU/L. The nurse reported that the patient was doing better, but her liver enzyme levels were still elevated. At the time of the report, the outcome of severe back pain, headache, infectious process and fever were unknown. The reporting physician considered elevated liver enzymes, severe back pain, headache, fever, and complete blood count revealing infectious process to be other important medical events. Additional information is not expected. All available medical records will be provided upon request.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Neutrophil count decreased, Pyrexia, Ultrasound abdomen normal, White blood cell count increased
Clinical narrative: Initial and follow-up information has been received from a nurse and a physician concerning a 24 year old female assistant manager with a drug allergy to DILANTIN who was vaccinated intramuscularly into the left deltoid with the first dose of Gardasil (lot # 657617/0684U) on 29-MAY-2007. Concomitant therapy included LEXAPRO and YASMIN. On 02-JUN-2007, the patient "became sick" and went to the emergency room (ER). It was reported that she experienced headache, elevated liver enzymes, fever, severe back pain and a complete blood count that revealed infectious process. The nurse reported that the patient had a variety of tests performed on her in the ER, including a liver function test (LFT) which showed that the patient's liver enzymes were high. On 06-JUN-2007, the patient underwent the following laboratory test: Lyme disease enzyme-linked immunosorbent assay, negative; absolute blood band neutrophil count, 2.35 K/uL, blood lymphocyte count, 10%; mean corpuscular volume, 75 fL, serum Epstein-Barr viral capsid antigen immunoglobulin G antibody test, positive; serum alanine aminotransferase test (ALT (SGPT), 486 U/L; serum aspartate aminotransferase test (AST (SGOT), 311 U/L; mean corpuscular hemoglobin (MCH), 26 pg. On 06-JUN-2007, the patient also underwent an abdominal ultrasound. The physician's impression was that there was no evidence of gallstones or dilated intra-, extrahepatic biliary ducts and there was a stable splenic cyst present. On 11-JUN-2007, the patient underwent the following laboratory tests: MCH, 26 pg, WBC count, 10.8 x 10E3/uL; AST (SGOT), 49 IU/L; ALT (SGPT), 147 IU/L. The nurse reported that the patient was doing better, but her liver enzyme levels were still elevated. At the time of the report, the outcome of severe back pain, headache, infectious process and fever were unknown. The reporting physician considered elevated liver enzymes, severe back pain, headache, fever, and complete blood count revealing infectious process to be other important medical events. Additional information is not expected. All available medical records will be provided upon request.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Acne, Ageusia
Clinical narrative: abdomen cramps, abdominal pain, joints ache, muscles ache, body aches, high cholesterol, blood pressure: spikes and drops, acne, agitation, allergic reaction, allergies, alpha intrusion, Amblyopia, Amnesia, anal fissure, bursitis, Cachexia, Anaphylac, Anorexia, Anxiety, Cardiovascular dis, chills, cellulitis, chills fever, appetite loss, arm; hot to touch, arrhythmia, cold and flu like symptoms, concentration difficulty, concentration loss, concentration trouble, neurological confusion, asthma, blackouts, passing out, dizzy upon standing, falling down, dizzy spells, vertigo and dizziness, coordination problems, cough, cramps leg, balance problems, bladder problems, bloating, blood pressure high, numbness and tingling arms legs, paresthesia, photophobia, pain lower back, pain legs, pain shoulder hips, pain chest, pain groin, pain back, pain knees, pruritus, rash, macular papular rash, pustular rash, gout like pain in right foot, body pain, rectal bleeding, shortness of breath, exertion, stomach pain, bone and joint pain, muscle and joint pain, respiratory problems, satellite lesion (usually refers to rash), arthritis pain, ear pain, chemical sensitivity, shaking (tremors), sinusitis, cysts developed, itching, eczema, neck pain, burning sensation on skin, skin discoloration, Charlie horse, pallor, palpitations, paralysis that lasted for one day on one side of her body, pustule sores on scalp, urinary retention, Uveitis, straie, insomnia, sleeping problems, unable to comprehend words, vertigo, feel not refreshed upon waking up, shifting sleep patterns, unable to sleep flat with out medication, poor tolerance for bright lights, tunnel vision, vision problems, photophobia, blurred, speech disorder, stomach problems, voice alteration, walking difficulty, weakness, weight gain, stupor, strength loss, stomatitis aphthous, suicide attempt, weight gain, sweating, inappropriately hot, joints welling, glands swollen, lump in neck below ear behind jaw line, syncope, tachycardia, loss of taste, tendon disorder, testicular failure, shrunken testicles, thinking abnormality, thirst increased, throat swelling and closing, Tinnitus, tiredness, tremors, twitching or jerking. 7/5/07-records received:Seen in clinic for DX: epididymal tumor. asthma unspecified. hypertension. gout. mixed hyperlipidemia. hydrocele. diverticulosos of sigmoid. external and internal hemorrhoids. low back pain. impaired fasting glucose. intervertebral disc disorders. osteoarthritis. overweight.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Agitation, Amblyopia, Amnesia, Anal fissure, Anaphylactic reaction
Clinical narrative: abdomen cramps, abdominal pain, joints ache, muscles ache, body aches, high cholesterol, blood pressure: spikes and drops, acne, agitation, allergic reaction, allergies, alpha intrusion, Amblyopia, Amnesia, anal fissure, bursitis, Cachexia, Anaphylac, Anorexia, Anxiety, Cardiovascular dis, chills, cellulitis, chills fever, appetite loss, arm; hot to touch, arrhythmia, cold and flu like symptoms, concentration difficulty, concentration loss, concentration trouble, neurological confusion, asthma, blackouts, passing out, dizzy upon standing, falling down, dizzy spells, vertigo and dizziness, coordination problems, cough, cramps leg, balance problems, bladder problems, bloating, blood pressure high, numbness and tingling arms legs, paresthesia, photophobia, pain lower back, pain legs, pain shoulder hips, pain chest, pain groin, pain back, pain knees, pruritus, rash, macular papular rash, pustular rash, gout like pain in right foot, body pain, rectal bleeding, shortness of breath, exertion, stomach pain, bone and joint pain, muscle and joint pain, respiratory problems, satellite lesion (usually refers to rash), arthritis pain, ear pain, chemical sensitivity, shaking (tremors), sinusitis, cysts developed, itching, eczema, neck pain, burning sensation on skin, skin discoloration, Charlie horse, pallor, palpitations, paralysis that lasted for one day on one side of her body, pustule sores on scalp, urinary retention, Uveitis, straie, insomnia, sleeping problems, unable to comprehend words, vertigo, feel not refreshed upon waking up, shifting sleep patterns, unable to sleep flat with out medication, poor tolerance for bright lights, tunnel vision, vision problems, photophobia, blurred, speech disorder, stomach problems, voice alteration, walking difficulty, weakness, weight gain, stupor, strength loss, stomatitis aphthous, suicide attempt, weight gain, sweating, inappropriately hot, joints welling, glands swollen, lump in neck below ear behind jaw line, syncope, tachycardia, loss of taste, tendon disorder, testicular failure, shrunken testicles, thinking abnormality, thirst increased, throat swelling and closing, Tinnitus, tiredness, tremors, twitching or jerking. 7/5/07-records received:Seen in clinic for DX: epididymal tumor. asthma unspecified. hypertension. gout. mixed hyperlipidemia. hydrocele. diverticulosos of sigmoid. external and internal hemorrhoids. low back pain. impaired fasting glucose. intervertebral disc disorders. osteoarthritis. overweight.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Anorexia, Anxiety, Aphthous stomatitis, Arrhythmia, Arthralgia
Clinical narrative: abdomen cramps, abdominal pain, joints ache, muscles ache, body aches, high cholesterol, blood pressure: spikes and drops, acne, agitation, allergic reaction, allergies, alpha intrusion, Amblyopia, Amnesia, anal fissure, bursitis, Cachexia, Anaphylac, Anorexia, Anxiety, Cardiovascular dis, chills, cellulitis, chills fever, appetite loss, arm; hot to touch, arrhythmia, cold and flu like symptoms, concentration difficulty, concentration loss, concentration trouble, neurological confusion, asthma, blackouts, passing out, dizzy upon standing, falling down, dizzy spells, vertigo and dizziness, coordination problems, cough, cramps leg, balance problems, bladder problems, bloating, blood pressure high, numbness and tingling arms legs, paresthesia, photophobia, pain lower back, pain legs, pain shoulder hips, pain chest, pain groin, pain back, pain knees, pruritus, rash, macular papular rash, pustular rash, gout like pain in right foot, body pain, rectal bleeding, shortness of breath, exertion, stomach pain, bone and joint pain, muscle and joint pain, respiratory problems, satellite lesion (usually refers to rash), arthritis pain, ear pain, chemical sensitivity, shaking (tremors), sinusitis, cysts developed, itching, eczema, neck pain, burning sensation on skin, skin discoloration, Charlie horse, pallor, palpitations, paralysis that lasted for one day on one side of her body, pustule sores on scalp, urinary retention, Uveitis, straie, insomnia, sleeping problems, unable to comprehend words, vertigo, feel not refreshed upon waking up, shifting sleep patterns, unable to sleep flat with out medication, poor tolerance for bright lights, tunnel vision, vision problems, photophobia, blurred, speech disorder, stomach problems, voice alteration, walking difficulty, weakness, weight gain, stupor, strength loss, stomatitis aphthous, suicide attempt, weight gain, sweating, inappropriately hot, joints welling, glands swollen, lump in neck below ear behind jaw line, syncope, tachycardia, loss of taste, tendon disorder, testicular failure, shrunken testicles, thinking abnormality, thirst increased, throat swelling and closing, Tinnitus, tiredness, tremors, twitching or jerking. 7/5/07-records received:Seen in clinic for DX: epididymal tumor. asthma unspecified. hypertension. gout. mixed hyperlipidemia. hydrocele. diverticulosos of sigmoid. external and internal hemorrhoids. low back pain. impaired fasting glucose. intervertebral disc disorders. osteoarthritis. overweight.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Asthma, Back pain, Balance disorder, Bladder disorder
Clinical narrative: abdomen cramps, abdominal pain, joints ache, muscles ache, body aches, high cholesterol, blood pressure: spikes and drops, acne, agitation, allergic reaction, allergies, alpha intrusion, Amblyopia, Amnesia, anal fissure, bursitis, Cachexia, Anaphylac, Anorexia, Anxiety, Cardiovascular dis, chills, cellulitis, chills fever, appetite loss, arm; hot to touch, arrhythmia, cold and flu like symptoms, concentration difficulty, concentration loss, concentration trouble, neurological confusion, asthma, blackouts, passing out, dizzy upon standing, falling down, dizzy spells, vertigo and dizziness, coordination problems, cough, cramps leg, balance problems, bladder problems, bloating, blood pressure high, numbness and tingling arms legs, paresthesia, photophobia, pain lower back, pain legs, pain shoulder hips, pain chest, pain groin, pain back, pain knees, pruritus, rash, macular papular rash, pustular rash, gout like pain in right foot, body pain, rectal bleeding, shortness of breath, exertion, stomach pain, bone and joint pain, muscle and joint pain, respiratory problems, satellite lesion (usually refers to rash), arthritis pain, ear pain, chemical sensitivity, shaking (tremors), sinusitis, cysts developed, itching, eczema, neck pain, burning sensation on skin, skin discoloration, Charlie horse, pallor, palpitations, paralysis that lasted for one day on one side of her body, pustule sores on scalp, urinary retention, Uveitis, straie, insomnia, sleeping problems, unable to comprehend words, vertigo, feel not refreshed upon waking up, shifting sleep patterns, unable to sleep flat with out medication, poor tolerance for bright lights, tunnel vision, vision problems, photophobia, blurred, speech disorder, stomach problems, voice alteration, walking difficulty, weakness, weight gain, stupor, strength loss, stomatitis aphthous, suicide attempt, weight gain, sweating, inappropriately hot, joints welling, glands swollen, lump in neck below ear behind jaw line, syncope, tachycardia, loss of taste, tendon disorder, testicular failure, shrunken testicles, thinking abnormality, thirst increased, throat swelling and closing, Tinnitus, tiredness, tremors, twitching or jerking. 7/5/07-records received:Seen in clinic for DX: epididymal tumor. asthma unspecified. hypertension. gout. mixed hyperlipidemia. hydrocele. diverticulosos of sigmoid. external and internal hemorrhoids. low back pain. impaired fasting glucose. intervertebral disc disorders. osteoarthritis. overweight.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Blood cholesterol increased, Blood pressure fluctuation, Bone pain, Burning sensation, Bursitis
Clinical narrative: abdomen cramps, abdominal pain, joints ache, muscles ache, body aches, high cholesterol, blood pressure: spikes and drops, acne, agitation, allergic reaction, allergies, alpha intrusion, Amblyopia, Amnesia, anal fissure, bursitis, Cachexia, Anaphylac, Anorexia, Anxiety, Cardiovascular dis, chills, cellulitis, chills fever, appetite loss, arm; hot to touch, arrhythmia, cold and flu like symptoms, concentration difficulty, concentration loss, concentration trouble, neurological confusion, asthma, blackouts, passing out, dizzy upon standing, falling down, dizzy spells, vertigo and dizziness, coordination problems, cough, cramps leg, balance problems, bladder problems, bloating, blood pressure high, numbness and tingling arms legs, paresthesia, photophobia, pain lower back, pain legs, pain shoulder hips, pain chest, pain groin, pain back, pain knees, pruritus, rash, macular papular rash, pustular rash, gout like pain in right foot, body pain, rectal bleeding, shortness of breath, exertion, stomach pain, bone and joint pain, muscle and joint pain, respiratory problems, satellite lesion (usually refers to rash), arthritis pain, ear pain, chemical sensitivity, shaking (tremors), sinusitis, cysts developed, itching, eczema, neck pain, burning sensation on skin, skin discoloration, Charlie horse, pallor, palpitations, paralysis that lasted for one day on one side of her body, pustule sores on scalp, urinary retention, Uveitis, straie, insomnia, sleeping problems, unable to comprehend words, vertigo, feel not refreshed upon waking up, shifting sleep patterns, unable to sleep flat with out medication, poor tolerance for bright lights, tunnel vision, vision problems, photophobia, blurred, speech disorder, stomach problems, voice alteration, walking difficulty, weakness, weight gain, stupor, strength loss, stomatitis aphthous, suicide attempt, weight gain, sweating, inappropriately hot, joints welling, glands swollen, lump in neck below ear behind jaw line, syncope, tachycardia, loss of taste, tendon disorder, testicular failure, shrunken testicles, thinking abnormality, thirst increased, throat swelling and closing, Tinnitus, tiredness, tremors, twitching or jerking. 7/5/07-records received:Seen in clinic for DX: epididymal tumor. asthma unspecified. hypertension. gout. mixed hyperlipidemia. hydrocele. diverticulosos of sigmoid. external and internal hemorrhoids. low back pain. impaired fasting glucose. intervertebral disc disorders. osteoarthritis. overweight.