chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Arthralgia, Back pain, CSF white blood cell count increased, Headache, Lumbar puncture
Clinical narrative: Initial report received on 21 August 2009 from a health care professional. A 13-year-old female patient, with unknown medical history, had received a dose of MENOMUNE (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. On day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provider for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009; however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Documents held by sender: None.  10/2/09 Hospital records received DOS 8/15/09 to 8/18/09. Assessment: Viral syndrome, gastroenteritis. Patient presents with a history of myalgias and fever. Back pain, headache. muscle aches involving back, legs, knees, ankles, feet and neck. Nothing po for 2 days. Nauseated. Cough, chills, eyes hurt and swollen. Erythema cheeks and shins. Abdominal pain.  10/2/09 Hospital records received DOS 8/21/98 to 8/25/09. Assessment: Viral meningitis. Prior admission for presumed viral illness. Patient c/o worsening headache and back pain. Vomited, fever, loose stools. Bothered by sounds, light and smell. Cough. Macular rash on chest, arms, and cheeks. 1/13/09 Medical records received. PMD notes for DOS 6/9-8/21. . Sports physical. Vaccines given. H/O sinusitis.  Approx 2 months later emesis, worst HA of life. Possible prolonged viral illness.ED visit.  CT head neg. To be admitted. LP planned.  Follow up information received on 18 September 2009 from a health care professional who reported that the patient was diagnosed with viral meningitis. Lot number was provided for MENOMUNE, UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Meningitis viral, Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report received on 21 August 2009 from a health care professional. A 13-year-old female patient, with unknown medical history, had received a dose of MENOMUNE (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. On day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provider for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009; however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Documents held by sender: None.  10/2/09 Hospital records received DOS 8/15/09 to 8/18/09. Assessment: Viral syndrome, gastroenteritis. Patient presents with a history of myalgias and fever. Back pain, headache. muscle aches involving back, legs, knees, ankles, feet and neck. Nothing po for 2 days. Nauseated. Cough, chills, eyes hurt and swollen. Erythema cheeks and shins. Abdominal pain.  10/2/09 Hospital records received DOS 8/21/98 to 8/25/09. Assessment: Viral meningitis. Prior admission for presumed viral illness. Patient c/o worsening headache and back pain. Vomited, fever, loose stools. Bothered by sounds, light and smell. Cough. Macular rash on chest, arms, and cheeks. 1/13/09 Medical records received. PMD notes for DOS 6/9-8/21. . Sports physical. Vaccines given. H/O sinusitis.  Approx 2 months later emesis, worst HA of life. Possible prolonged viral illness.ED visit.  CT head neg. To be admitted. LP planned.  Follow up information received on 18 September 2009 from a health care professional who reported that the patient was diagnosed with viral meningitis. Lot number was provided for MENOMUNE, UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chemotherapy, Hodgkin's disease
Clinical narrative: Developed Hodgkins lymphoma. We diagnosed patient's cancer in August, 2008, and she is continuing chemotherapy. She will have a stem cell transplant too.  9/28/09 Hospital records received, multiple admissions and outpatient visits, DOS 8/22/09 to 9/09/09. Assessment: Hodgkin's Lymphoma stage II-A, bulky disease. Patient c/o "losing my voice'. (L) vocal cord paralysis. Dysphagia. Mediastinal mass. Chemotherapy. Fever. Neutropenia. Radiation therapy. Relapsed with positive B symptoms, mediastinal mass, neck and lung involvement. Cervical lymphadenopathy. Chemotherapy. Nausea, decreased appetite. Throat pain. Lung sounds diminished (R). Dry nonproductive cough and rhinorrhea. Stem cell harvest.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Rash papular, Rash pruritic, Skin plaque
Clinical narrative: About 3-4 hours after vaccine administration, patient developed several large about 5 X 6 cm confluent, pruritic erythematous papular plagues on upper forearms and lower legs.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: L humeral area 5x5cm red in duration.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 9 cm across, redness, warm to the touch.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Report of muscle ache throughout entire body, extreme left arm pain; generalized joint pain & fatigue.  Note:  Had previous dose of Tdap 3/5/2009 (per mm registry).
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Dizziness, Hypoaesthesia, Injection site pain, Insomnia
Clinical narrative: Severe pain at injection site & arm (left) feels like hot pokers in muscle & joints. Last two fingers in left hand are numb. Fever, some dizziness. Cannot wear seat belt. Clothing hurts on skin. Pain radiates to neck & shoulders. Cannot sleep.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pain of skin, Pyrexia
Clinical narrative: Severe pain at injection site & arm (left) feels like hot pokers in muscle & joints. Last two fingers in left hand are numb. Fever, some dizziness. Cannot wear seat belt. Clothing hurts on skin. Pain radiates to neck & shoulders. Cannot sleep.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: No adverse event
Clinical narrative: Severe pain at injection site & arm (left) feels like hot pokers in muscle & joints. Last two fingers in left hand are numb. Fever, some dizziness. Cannot wear seat belt. Clothing hurts on skin. Pain radiates to neck & shoulders. Cannot sleep.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized erythema & swelling of dermis & sub dermal skin at site where VARICELLA & MMR Imm. were given. No fever or skin discomfort.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: 18-20 hrs after injection, pt developed redness, swelling, hot to touch on Rt arm. Seen in office on 8-19-09, recommend apply ice, use BENADRYL.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site abscess
Clinical narrative: L deltoid soft tissue abscess.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Ear discomfort, Osteitis
Clinical narrative: "I wake up at 4:30 AM with my Rt jaw swollen on the inside & my Rt. ear is killing me.  I have only a wisdom tooth on that side.  I don't think it's the tooth.  I think this is a reaction to that shot.  Can someone call me in an antibiotic."  Recommend visit to CMD.  Gave phone #'s of 2 local clinics which operate on 'sliding fee' basis & the # of the other HD.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lip swelling
Clinical narrative: (1) 4 + Local reaction (L) arm (2) C/o mild swelling of bottom lip, redness and swelling noted at site of injection and arm warm to touch - (3) Mom states TYLENOL given and cold towels used to arm as ordered - Advised to take child to PCP ASAP, use OTC BENADRYL, cold compresses to site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: Received 1st GARDASIL 8/13/09; mom reports 8/15/09 c/o headache lasting 2 days & vomiting. Had fluids & rest, no ER or follow-up visit. Family history of migraines.
Age: 20.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Syncope
Clinical narrative: Few minutes after shots, patient had a brief syncopal episode lasting 30-45 seconds; complete recovery.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain, Skin warm
Clinical narrative: Reports a lump as large as a baseball, red, hot, and painful. Advised pt to see her primary care physician.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 8/18/09, day following vaccinations, redness, warmth, tenderness both anterior thighs today, 8/19/09, just right thigh has redness, warmth, tenderness, some swelling.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 9x10 cm warm\pink\non-tender;  2x3cm induration centrally (R arm)
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Dyskinesia, Electroencephalogram, Loss of consciousness, Nausea
Clinical narrative: 30min after shot-BOOSTRIX mom returned to office with patient. She said he got nauseated in the car, became pale, flailed with his arms & passed out for short time. No loss of control. BP-113/73 pale, alert/cooperative. No V/tired. Rested on side in office for 30min. Appt for EEG made (negative). Appt with neurologist available.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: 30min after shot-BOOSTRIX mom returned to office with patient. She said he got nauseated in the car, became pale, flailed with his arms & passed out for short time. No loss of control. BP-113/73 pale, alert/cooperative. No V/tired. Rested on side in office for 30min. Appt for EEG made (negative). Appt with neurologist available.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient had Tdap and GARDASIL then stood up. Was helping sister get shots then felt lightheaded and fainted.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient started to experience warmth, pain and redness at injection site.  Also erythematous area measuring 7.5 cm X 6 cm.  Given CEPHALEXIN 500 mg TID X 7 days.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient developed tenderness, redness at injection site. Induration measuring 3cm by 3cm. Amoxicillin given 12ml BID 400mg/5ml.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site shows a swollen lump 1 1/2" in diameter tender, itchy. Arm is weak, child fatigued.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscular weakness
Clinical narrative: Injection site shows a swollen lump 1 1/2" in diameter tender, itchy. Arm is weak, child fatigued.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and tenderness at injection site.  Slight induration to area.  Given CEPHALEXIN 500 mg three times a day.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Varicella, Varicella post vaccine
Clinical narrative: 8-10-09 Received varicella vaccine. 8-11-09 Site became red and swollen and stayed that way. Area involved in oval shape-approx 1 1/2 x 2 1/2 inches with raised area around perimeter. 8-22-09 A few pox appeared on abdomen. 8-24-09 More pox on face and body.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Convulsion, Dizziness, Feeling abnormal, Tremor
Clinical narrative: Approximately 20 hrs after administration of DT pt felt fuzzy & according to grandmother who witnessed the following pt c/o lightheadedness felt dizzy "Then went into a seizure" while sitting in a chair. States "shaking all over" arms legs & body - lasted "couple of minutes had t LOC.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Injection site induration, Laboratory test abnormal, Sarcoidosis
Clinical narrative: knots on arm at vaccine site that did not disappear.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Bruxism, Convulsion, Foaming at mouth, Immediate post-injection reaction, Muscle disorder
Clinical narrative: Pt. was a 22 yr old Female, inprocessing received a G6PD blood draw with no complications. Pt. received a TwinRix # 3 vaccination to the R-Bicep, immediately upon receiving vaccination pt. began seizing, to include lose of muscle control with immediate onset of décorticate posture bilateral, foaming at mouth, clenching of teeth that lasted approximately 3 minutes.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Haematochezia, Haematocrit normal, Haemoglobin normal, Occult blood positive
Clinical narrative: Rotavirus Vaccine administered on 21 August 2009, on 26 August 09, mother of baby reported blood in baby's stool, returned to clinic, occult blood positive, baby otherwise fine with no other complaints.  H&H 11&37,
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: White blood cell count normal
Clinical narrative: Rotavirus Vaccine administered on 21 August 2009, on 26 August 09, mother of baby reported blood in baby's stool, returned to clinic, occult blood positive, baby otherwise fine with no other complaints.  H&H 11&37,
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Anxiety, Aphasia, Cerebrovascular accident, Computerised tomogram abnormal, Headache
Clinical narrative: Pt was due to be discharged after undergoing cardiac catherization.  Per chart, pt became restless and nonverbal 5-10 minutes after receiving pneumonia and influenza vaccine. Pt "passed out." Pt also variously decribed to have HA, tongue numbness, and to be diaphoretic and anxious.  Pt then reported trouble seeing.  CT scan subsequently revealed a CVA. 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. DC DX: Hypertensive heart disease, heart failure. Secondary DX: Cerebral embolism w/ infarction, anaphylactic shock, unspecified hemiplegia, systolic heart failure/CHF, coronary atherosclerosis, adverse affect of viral vaccine, low potassium, BPH, urinary obstruction, cataracts, homonymous hemianpsia.  Presenting SX: In ER c/o abdominal pain, worsening constipation, chest pain, and SOB, difficulty with speech past 3 days. Assessment: jugular venous distention, systolic murmur, irregular heartbeat, bi-lateral lung crackles, abdominal distention, tenderness, +BS, neuro exam WNL. Pt had cardiac cath completed w/o incident. At some point during inpatient pt had CVA. CT on 1/4/09 results, development of a large intraparenchymal hemorrhage in the right temporal and parietal lobes with significant surrounding edema and resultant right to left subta-cine and transtentoria herniation. Craniotomy performed for a right intraparenchymal hematoma converted to hemorrhage, right frontotemporal craniotomy for evacuation of hematoma, placement of ventricular drain. Pt sent to rehab facility 1/14-2/7/09 had PT and OT, speech therapy. Pt DC home and f/u with PC.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hyperhidrosis, Hypoaesthesia oral, Loss of consciousness, Restlessness, Visual impairment
Clinical narrative: Pt was due to be discharged after undergoing cardiac catherization.  Per chart, pt became restless and nonverbal 5-10 minutes after receiving pneumonia and influenza vaccine. Pt "passed out." Pt also variously decribed to have HA, tongue numbness, and to be diaphoretic and anxious.  Pt then reported trouble seeing.  CT scan subsequently revealed a CVA. 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. DC DX: Hypertensive heart disease, heart failure. Secondary DX: Cerebral embolism w/ infarction, anaphylactic shock, unspecified hemiplegia, systolic heart failure/CHF, coronary atherosclerosis, adverse affect of viral vaccine, low potassium, BPH, urinary obstruction, cataracts, homonymous hemianpsia.  Presenting SX: In ER c/o abdominal pain, worsening constipation, chest pain, and SOB, difficulty with speech past 3 days. Assessment: jugular venous distention, systolic murmur, irregular heartbeat, bi-lateral lung crackles, abdominal distention, tenderness, +BS, neuro exam WNL. Pt had cardiac cath completed w/o incident. At some point during inpatient pt had CVA. CT on 1/4/09 results, development of a large intraparenchymal hemorrhage in the right temporal and parietal lobes with significant surrounding edema and resultant right to left subta-cine and transtentoria herniation. Craniotomy performed for a right intraparenchymal hematoma converted to hemorrhage, right frontotemporal craniotomy for evacuation of hematoma, placement of ventricular drain. Pt sent to rehab facility 1/14-2/7/09 had PT and OT, speech therapy. Pt DC home and f/u with PC.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: 80mm red circle
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pruritus, Rash, Tinea versicolour, Vomiting
Clinical narrative: MOTHER REFERS THE PATIENT PRESENTED WITH VOMITING, ITCHING AND RASH IN SKIN WHICH GOT WORSE. THE DERMATOLOGIST DIAGNOSED TINEA VERSICOLOR AND RECEIVED TREATMENT.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Bradycardia, Dizziness, Electrocardiogram abnormal, Heart rate normal, Nausea
Clinical narrative: APPROX. 20 SECONDS AFTER RECVING HPV VACCINE #2 & HEPA #1 CHILD REPORTED FEELING NAUSEA & DIZZINESS, BECAME PALE & BRADYCARDIC AT 45BPM. SYMPS APPROX 10 MIN .  SUPINE, & ORAL FLUIDS.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Oxygen saturation normal, Pallor, Respiratory rate
Clinical narrative: APPROX. 20 SECONDS AFTER RECVING HPV VACCINE #2 & HEPA #1 CHILD REPORTED FEELING NAUSEA & DIZZINESS, BECAME PALE & BRADYCARDIC AT 45BPM. SYMPS APPROX 10 MIN .  SUPINE, & ORAL FLUIDS.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives developed on face and neck within approximately 18 to 20 hours following administration of the injection.  Treating with Benedryl.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Loss of consciousness, Tonic clonic movements, Vomiting
Clinical narrative: Vomitting; Loss Consciousness with tonic/clonic episode; Temp 96.1
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, IPV, PNC, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Pentacel along with IPV was administered today
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Alopecia
Clinical narrative: HAIR FALLING OUT
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Epistaxis
Clinical narrative: Patient left clinic after vaccinations and had a mild nose bleed while walking to car. Parents brought child back into clinic immediately and nosebleed had already resolved.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: redness, hardness & swelling, mildly unconfortable left deltoid - mother describing as on side of arm not posterior aspect - mother will apply ice pack.  If S/S worsen - will contact HCP.  Reviewed S/S of cellulitis (red, hot, swollen/shiny/translucent appearance to skin).  Reinforced need to contact HCP if uncomfortable w/situation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: CLIENT COMPLAINING OF PAIN AT INJECTION SITE, LEFT UPPER ARM.  REDNESS AND SIGNIFICANT SWELLING TO LEFT UPPER ARM.  DX WITH CELLULITIS PER DR.  ROCEPHIN 500 MG IM GIVEN WITH ORDERS FOR NEXT DAY FOLLOWUP WITH LOCAL ER.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Rash erythematous
Clinical narrative: mild localized erythema 7 X 5.5 cm with central more erythematous area about 3 cm
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Skin warm, Tenderness
Clinical narrative: DAY 2 - SORE, TENDER, ITCHING, WARM TO TOUCH
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: REC'D FLU VACCINE @9AM. @ 10:30AM SAME DAY BEGAN TO BREAK OUT IN HIVES [5] ON THE SAME ARM AS VACCINE WAS ADMINISTERED. BENADRYL 50MG ADMINISTERED AND CLIENT HAD NO FURTHER COMPLAINTS.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenitis
Clinical narrative: Rt Deltoid swollen, red, hot,itchy and Axillary lymphadenitis.
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: developed fever 101 degrees  12 hrs following vaccine without other symptoms. Resolved 24 hrs.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Zostavax administered on 8/10/2009 without difficulty.  On 8/14 broke out with herpes zoster severe involvment on left side T5-T9 dermatomal pattern
Age: 6.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PT LEFT ARM (DELTOID AREA) BUT ENTIRE UPPER ARM HAD GENERALIZED SWELLING, RED AND WARM TO THE TOUCH. THE PATIENT ALSO EXPERIENCED PURITIS. PATIENT TREATED WITH BENADRYL
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Borrelia burgdorferi serology, Computerised tomogram normal, Full blood count normal, Headache
Clinical narrative: Patient has had moderate to severe headaches and nausea ,as well neck and  upper back pain since her second injection.Patients father is a physician.He has checked for lymnes disease and patient has also been seen by another physician. She was also seen in the ER. She has a appointment with a neurologist next week.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immunology test, Nausea, Neck pain, Red blood cell sedimentation rate normal
Clinical narrative: Patient has had moderate to severe headaches and nausea ,as well neck and  upper back pain since her second injection.Patients father is a physician.He has checked for lymnes disease and patient has also been seen by another physician. She was also seen in the ER. She has a appointment with a neurologist next week.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Angiogram, Blood test, Computerised tomogram, Dizziness, Headache
Clinical narrative: Patient has had moderate to severe headaches and nausea ,as well neck and  upper back pain since her second injection.Patients father is a physician.He has checked for lymnes disease and patient has also been seen by another physician. She was also seen in the ER. She has a appointment with a neurologist next week.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Patient has had moderate to severe headaches and nausea ,as well neck and  upper back pain since her second injection.Patients father is a physician.He has checked for lymnes disease and patient has also been seen by another physician. She was also seen in the ER. She has a appointment with a neurologist next week.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Febrile convulsion, Full blood count, Influenza serology, Rash
Clinical narrative: Febrile seizure, temp 104.3(temporal). Skin rash on trunk. 11/17/09 ER records received for date 8/26/09 to 8/27/09.  DX: febrile seizure vaccine related varicella. Presented to ER via EMS: crying, irritable, tachycardia. Assessment: rash, fever, seizure, vesicles on tonsils. Upon dc sx. resolved.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Streptococcal identification test, Urine analysis
Clinical narrative: Febrile seizure, temp 104.3(temporal). Skin rash on trunk. 11/17/09 ER records received for date 8/26/09 to 8/27/09.  DX: febrile seizure vaccine related varicella. Presented to ER via EMS: crying, irritable, tachycardia. Assessment: rash, fever, seizure, vesicles on tonsils. Upon dc sx. resolved.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: High fever (102.2) and Fever Seizure 7 days post MMR and Chicken Pox vaccine. Spotted rash under eyes and accross bridge of nose 10 days post vaccine. Seen at Woodinville Pediatrics for fever and seizure 7 days post vaccine.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Skin warm
Clinical narrative: After about 10 minutes after receiving the injection my arm got hot and very itchy. Shortly after that I started to get itchy and flushed on my face and head which started to progress over my whole body. I returned to see Dr. who gave me 10mg Zyrtec. The symptoms did not improve so he gave me epinephrine IM. The itching improved after approx 15-20 minutes. I returned to work and about 2 hours later the itching and flushing on my head and face started to return. I came back to see Dr. who gave me Benadryl and prednisone (40mg). The symptoms slowly resolved. I did not have any shortness of breath, and I have never had a reaction to a flu vaccine in the past. I am not allergic to eggs.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: VET CALLED BACK REPORTING PAIN AND SWELLING IN ARM WHERE SHE GOT INJECTION. SHE  SAID PAIN WAS 10/10 YESTERDAY AND WAS ACCOMPANIED BY NAUSEA. SHE REPORTS PAIN IS  AN 8/10 TODAY BUT REDNESS IN AFFECTED ARM IS WORSE ABOUT THREE INCHES. SHE  REPORTS THE LYMPH NODES UNDER HER ARM APPEAR TO BE INVOLVED. SHE REPORTS SHE  USED ADVIL YESTERDAY AND PUT ICE ON ARM BUT GOT LITTLE RELIEF.                                PLAN: Cool compress, rest, Ibuprofen 600mg one TID #24 given note for work off next 2 days. F/U with PCP
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Pt. presented to clinic for second MMR on 08-18-2009.  Reported pregnancy with EDC 12-18-2009
Age: 24.0
Sex: M
Vaccine: YF, YF
Symptoms: Pruritus, Rash
Clinical narrative: RASH AND ITCHING COVERING WHOLE BODY LASTING UNTIL THE NEXT DAY.
Age: 24.0
Sex: M
Vaccine: YF, YF
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: RASH AND ITCHING COVERING WHOLE BODY LASTING UNTIL THE NEXT DAY.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash macular, Tenderness
Clinical narrative: 65 y/o female/employee who presented today due to two 1cm eythematous macule in  thr right shoulder/deltoid/axillary area.It appeared last night afte injection  of pneumovax in the area. The lesion is not around yhe injection area.It is  itchy with mild tenderenss. No other lesions in other par of the body.no  headcahe, dizzines, shortness of breath, chest pain or abdominal pain.                        A/P 1.erythema, S/P pneumovax injection, right deltoid, possible local reaction from  the injection site - apply warm compress - if itchy apply hydrocortisone cream. - re-assurance
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Pain, Skin warm, Swelling
Clinical narrative: Vet reporting tender, warm and slightly swollen R shoulder. Afebrile, no  erythema, signs of infection, severe allergy symptoms. He had Pneumovax  injection @ 1500 yesterday and started to have warmth and pain ~ 2000 last  night. It was difficult for him to sleep, because he was awakened each  time he rolled onto injection site. He feels better just now, as he's  taken Vicoden earlier. Home care treatment advised with the caveat that he  call back if SYMPTOMS WORSEN, CHANGE or PERSIST.  PATIENT EDUCATION Vicoden may be used for injection site pain. Aspirin or ibuprofen also OK.  Tylenol NOT advised if you're taking multiple Vicoden's daily. Ice  treatments to site--20" on, 20" off-- prn may greatly reduce pain.  Symptoms may take a few days to go away and are not expected to worsen.  Call back for signs of infection or allergic reaction (explained).
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Vet reporting tender, warm and slightly swollen R shoulder. Afebrile, no  erythema, signs of infection, severe allergy symptoms. He had Pneumovax  injection @ 1500 yesterday and started to have warmth and pain ~ 2000 last  night. It was difficult for him to sleep, because he was awakened each  time he rolled onto injection site. He feels better just now, as he's  taken Vicoden earlier. Home care treatment advised with the caveat that he  call back if SYMPTOMS WORSEN, CHANGE or PERSIST.  PATIENT EDUCATION Vicoden may be used for injection site pain. Aspirin or ibuprofen also OK.  Tylenol NOT advised if you're taking multiple Vicoden's daily. Ice  treatments to site--20" on, 20" off-- prn may greatly reduce pain.  Symptoms may take a few days to go away and are not expected to worsen.  Call back for signs of infection or allergic reaction (explained).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT THIGH RED, SWOLLEN ANT-LAT. 12CM X 16CM.  INDURATED NOT TENDER, WARM
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: 4 episodes of atrial fibrillation (new onset) the week after vaccine administration, one episode required ER visit.  9/14/09 ER records received 8/21/09. Assessment: Atrial fibrillation. Presents with palpitations, fall, while playing paddle tennis. Felt dizzy. Atrial fibrillation. Converted to NSR. General weakness. Mild chest pain. Anxious.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Atrial fibrillation, Condition aggravated, Injection site erythema, Injection site pain
Clinical narrative: 4 episodes of atrial fibrillation (new onset) the week after vaccine administration, one episode required ER visit.  9/14/09 ER records received 8/21/09. Assessment: Atrial fibrillation. Presents with palpitations, fall, while playing paddle tennis. Felt dizzy. Atrial fibrillation. Converted to NSR. General weakness. Mild chest pain. Anxious.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local reaction, Muscular weakness, Tachycardia
Clinical narrative: 4 episodes of atrial fibrillation (new onset) the week after vaccine administration, one episode required ER visit.  9/14/09 ER records received 8/21/09. Assessment: Atrial fibrillation. Presents with palpitations, fall, while playing paddle tennis. Felt dizzy. Atrial fibrillation. Converted to NSR. General weakness. Mild chest pain. Anxious.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy muscle abnormal, Biopsy skin, Blood test, Dermatomyositis, Immune system disorder
Clinical narrative: 1st vaccine: 11/28/08; Rash on hands appeared soon after, seen by Dr. on 12/7/09 for rash; 2nd vaccine: 2/7/09; 3rd vaccine: 5/1/09 followed by extreme tederness at site and muscle fatigue and pain all over body; numerous doctor visits, tests, and muscle bioposies led to diagnosis on 8/6/09 of dermatomyositis by Dr. During this period (11/28/08 - 5/1/09) rashes also appeared on elbows, knees, hips, and face. In looking back over the time period, there appears to be a connection between the vaccinations their impact on her immune system. Medical literature suggests a possible link between Gardasil and juvenile dermatomyositis, a disease that only affects 5 in 1 million people.  9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. Assessment: Nonspecific liver enzyme elevation. Nonspecific myalgias, joint complaints, possible rheumatological disorder. On 5/1/09 patient presented with complaints of a red, puritic rash. On the dorsum of and fingers of both hands, concentracted around MCP joints. Later complains of achiness and fatigue on arms and legs, sleeping more. Rash on elbows and knee.   1/7/2010 ED records received. Service date 6/29/09. Assessment: Lympahdenopathy, difficulty swallowing. Patient c/o that it is hard to swallow. Cervical lymphadenopathy. Body aches. Myalgia, sore throat, rash.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscle fatigue, Pain, Rash generalised
Clinical narrative: 1st vaccine: 11/28/08; Rash on hands appeared soon after, seen by Dr. on 12/7/09 for rash; 2nd vaccine: 2/7/09; 3rd vaccine: 5/1/09 followed by extreme tederness at site and muscle fatigue and pain all over body; numerous doctor visits, tests, and muscle bioposies led to diagnosis on 8/6/09 of dermatomyositis by Dr. During this period (11/28/08 - 5/1/09) rashes also appeared on elbows, knees, hips, and face. In looking back over the time period, there appears to be a connection between the vaccinations their impact on her immune system. Medical literature suggests a possible link between Gardasil and juvenile dermatomyositis, a disease that only affects 5 in 1 million people.  9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. Assessment: Nonspecific liver enzyme elevation. Nonspecific myalgias, joint complaints, possible rheumatological disorder. On 5/1/09 patient presented with complaints of a red, puritic rash. On the dorsum of and fingers of both hands, concentracted around MCP joints. Later complains of achiness and fatigue on arms and legs, sleeping more. Rash on elbows and knee.   1/7/2010 ED records received. Service date 6/29/09. Assessment: Lympahdenopathy, difficulty swallowing. Patient c/o that it is hard to swallow. Cervical lymphadenopathy. Body aches. Myalgia, sore throat, rash.
Age: 0.92
Sex: M
Vaccine: PNC
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: SWELLING AND REDNESS WITH INDURATION AT INJECTION SITE
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, C-reactive protein increased, Musculoskeletal pain, Myalgia
Clinical narrative: Shoulders, hips, neck weakness, muscle pain.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Red blood cell sedimentation rate increased
Clinical narrative: Shoulders, hips, neck weakness, muscle pain.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: (L) lateral upper thigh 13x13 cm, light eryth/purple circle rash with central sl darker purple area with pinpoint noted centrally. Mild warmth to touch. (-) hot (-) swelling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient has a rash at rt side T5 & T11 area. T5 area started on 8/22/2009, T11 area started on 8/24/09. Shingles in Rt T5 & T11 distribution. VALTREX Rx given.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Pt received ADACEL vaccine on 8/25/09: Lot #C3248AA Sanofi Pasteur. The pt called on today 8/27/09 to report headaches since receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Upper arm redness, swelling & discomf. Ibuprofen & BENADRYL topical admin.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Upper L) arm red swollen, itchy area size of baseball. Told mom to administer BENADRYL PO and ice-pack to area.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema
Clinical narrative: 10 x 7 cm red erythema. Decreased at this moment.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Induration of 1 cm diameter at site of injection (induration still present 3 wks later).
Age: 8.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, pain to site of injection. Advice to tx with warm compress and BENADRYL.
Age: 16.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Asthenia, Nausea, Syncope
Clinical narrative: 1118AM 3 minutes after shots were given, patient felt nauseous, became weak and fainted on the exam table. She responded immediately to ammonia inhalant; her BP 120/76. Ice pack was applied to her head. She was alert in a few minutes sitting up and ready to leave.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: Pt fainted, subsequent headache dizziness for 1 week (+).
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Eye movement disorder, Unresponsive to stimuli
Clinical narrative: Patient received MENACTRA and VARIVAX on 8/12/09, at 12 year check-up. Had no problems after getting shots in office. Seen at ER 8/26/09 for seizure, lasted 30 seconds. Patient was at school, had rapid eye movement? unresponsive episode.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, slight swelling, hot to touch around injection site (right arm).
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Dizziness, Pyrexia, Tremor
Clinical narrative: 8/28/09 Was shaking and off balance "dizzy" after shots.  Noted all the way to bedtime - didn't stop - Then 8/26/09 had febrile symptoms - Went to ER.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 1 d after immunization; pt developed erythema & edema to right upper arm at injection site.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus
Clinical narrative: Reported local redness and pruritis. Encouraged to use ice at site and BENADRYL po.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, slight swelling, hot to touch around injection site (right arm).
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administered DTAP instead of intended TD.  Patient notified and states no adverse effects.
Age: 10.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Convulsion, Depressed level of consciousness, Flushing, Foaming at mouth, Heart rate increased
Clinical narrative: 4:55 p: Decreased O2 saturation, 70's. Copious frothy trach secres, oral secres. Rx - suction, increased FiO2 (4:55 - 6:20 pm - back to room air). No wheeze. 5:15pm: Flushed - total body; c/o itch. Gave GT Diphenhydramine 5:30. About 5:50 pm: HR still high greater than or equal to 160 pm, L.O.C. altered - ?seizure (has sz d/o). 5:55 pm: 5 mg DIASTAT and extra dose TEGRETOL 150mg GT. 6:15p: Asleep, Hr 140-150, in room air, asleep.   8/31/09 PCP medical records 7/2/07 to 8/27/09. Assessment: Seizure. Decreased O2 saturation, altered level of consciousness, increased heart rate.
Age: 10.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Metabolic function test, Oxygen saturation decreased, Pruritus
Clinical narrative: 4:55 p: Decreased O2 saturation, 70's. Copious frothy trach secres, oral secres. Rx - suction, increased FiO2 (4:55 - 6:20 pm - back to room air). No wheeze. 5:15pm: Flushed - total body; c/o itch. Gave GT Diphenhydramine 5:30. About 5:50 pm: HR still high greater than or equal to 160 pm, L.O.C. altered - ?seizure (has sz d/o). 5:55 pm: 5 mg DIASTAT and extra dose TEGRETOL 150mg GT. 6:15p: Asleep, Hr 140-150, in room air, asleep.   8/31/09 PCP medical records 7/2/07 to 8/27/09. Assessment: Seizure. Decreased O2 saturation, altered level of consciousness, increased heart rate.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever. Hive type rash widespread.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Rash, Skin warm
Clinical narrative: Rash slight warm area to left leg.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient received MENACTRA & TDAP.  Became faint after.  Diaphoretic & pale.  Had client sit with head down till color returned.  About 15 min.  Left with mother.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient received Tdap and MENACTRA. Shortly after he became diaphoretic, pale and had a syncopal episode. Helped client to seated position, head between his legs. Felt better after 15 min. Left with mother.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Back pain, Dizziness, Migraine
Clinical narrative: Information has been reported in non medical media article that a 15 year old consumer and her mother reported that on an unknown date the patient was vaccinated with a first and second dose of GARDASIL. It was reported in the news media that after two doses, the vaccine knocked the patient "on her back for two months". It was also reported that the patient stated that though better now "I still have a lot of terrible migraine headaches and back pain, dizziness". The patient's mother also stated that: "That hits close to home in the sense of when your daughter's laying in a hospital's bed". It was not specified if the patient was hospitalized. Upon internal review "on her back for two months" was considered as disabling. No further information is available.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever that was 103.5, Vomiting, Rash
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 6 months old male who on 04-AUG-2009 was vaccinated with the third dose of ROTATEQ (route and lot# not reported).  On 10-AUG-2009 the patient developed intussusceptions.  The patient required surgery.  At the time of the report, the patient's outcome was unknown.  Upon internal review, intussusception was determined to be an other important medical event.  Additional information has been requested.  9/22/09 Hospital records received DOS 8/13/09 to 8/22/09. Assessment: Ileo-Colic Intussusception.  Patient presented with history of bilious vomiting and abdominal pain. Lethargic, dry mucous membranes and skin. Dehydration. No bowel sounds. Abdominal mass. Respiratory distress. Barium Enema administration - unsuccessful reduction of intussusception. Surgical resection of intussusception, ileocolectomy with ilial transverse colostomy.  10/5/09 ICD-9 Codes: 751.5 Intestinal anomaly, 038.9 Septicemia NOS, 995.92 Severe Sepsis, 518.81 Acute Respiratory Fail, 785.52 Septic Shock, 285.9 Anemia NOS.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a medical assistant concerning an 8 weeks old male patient who on 25-JUN-2009 was vaccinated with a first dose of ROTATEQ (2ml, orally and lot number: 663461/085Y). Concomitant therapy included DTaP, ACTHIB, PREVNAR (dates, doses and lot numbers not reported). On 05-AUG-2009 the child was hospitalized with intussusception and surgery performed. The child was released at the hospital at the next day (on 06-AUG-2009). At the time of the report the patient was recovered and an other important medical event. Intussusception was considered to be immediately life-threatening. Additional information has been requested.  9/8/09 Hospital records received DOS 8/3/09 to 8/5/09. Assessment: Intussusception.  Patient presented with a one day history of vomiting and hematochezia. Bloody stool. Decreased activity, poor feeding. Projectile vomiting. Barium Enema - successful reduction.  10/13/09 ICD-9 Code: 560.0 Intussusception.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Convulsion, Dizziness, Inappropriate schedule of drug administration, Loss of consciousness, Overdose
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning an 18 year old female who on 11-OCT-2006, 21-FEB-2007, 21-JUN-2007 and 18-AUG-2009 was vaccinated with her first, second, third and fourth dose of GARDASIL respectively (lot # are 653735/0688F, 655165/1425F, 657868/0523U and 661952/1129X respectively).  Suspect vaccination included a second dose of VAQTA (inactive) (dose 2).  Concomitant therapy included MENACTRA (lot#U2866AA) and ADACEL (lot # 3068AA).  The nurse stated that she did not see the third dose of GARDASIL documented in the patient's vaccination chart.  The nurse stated the patient was given the fourth dose of GARDASIL in error.  On 18-AUG-2009, after the patient had received the vaccination she felt dizzy and had syncope.  The patient had loss of consciousness for about 10 seconds.  The patient regained consciousness.  The patient was pale, blood pressure 110/70, Oxygen Saturation on room air 98%.  Oxygen was administered, Oxygen Saturation increased to 100%.  The patient was observed for 30 minutes with blood pressure 102/62.  When the patient stood she felt dizzy.  The ambulance was notified and the patient was taken to hospital.  The patient was not admitted to the hospital.  Per the physician the patient had a seizure after the fourth dose vaccination and was taken to the ER, subsequently the patient was fine.  Upon internal review, the seizure was determined to be other important medical event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Oxygen saturation normal, Pallor, Syncope
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning an 18 year old female who on 11-OCT-2006, 21-FEB-2007, 21-JUN-2007 and 18-AUG-2009 was vaccinated with her first, second, third and fourth dose of GARDASIL respectively (lot # are 653735/0688F, 655165/1425F, 657868/0523U and 661952/1129X respectively).  Suspect vaccination included a second dose of VAQTA (inactive) (dose 2).  Concomitant therapy included MENACTRA (lot#U2866AA) and ADACEL (lot # 3068AA).  The nurse stated that she did not see the third dose of GARDASIL documented in the patient's vaccination chart.  The nurse stated the patient was given the fourth dose of GARDASIL in error.  On 18-AUG-2009, after the patient had received the vaccination she felt dizzy and had syncope.  The patient had loss of consciousness for about 10 seconds.  The patient regained consciousness.  The patient was pale, blood pressure 110/70, Oxygen Saturation on room air 98%.  Oxygen was administered, Oxygen Saturation increased to 100%.  The patient was observed for 30 minutes with blood pressure 102/62.  When the patient stood she felt dizzy.  The ambulance was notified and the patient was taken to hospital.  The patient was not admitted to the hospital.  Per the physician the patient had a seizure after the fourth dose vaccination and was taken to the ER, subsequently the patient was fine.  Upon internal review, the seizure was determined to be other important medical event.  Additional information has been requested.