chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lumbar puncture, Lumbar puncture normal, Metabolic function test normal, Nuclear magnetic resonance imaging normal, Skin warm
Clinical narrative: Seizure involving left side approximately 2 hours after receiving immunizations lasting about a minute. 3 days later another seizure involving all extremities, vomiting, and blank stare lasting about 90 seconds. His body was extremely hot when this was happening. Had another one involving one side of body and blank stare with rhythmic blinking of eyes 3 days later.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Staring, Vomiting
Clinical narrative: Seizure involving left side approximately 2 hours after receiving immunizations lasting about a minute. 3 days later another seizure involving all extremities, vomiting, and blank stare lasting about 90 seconds. His body was extremely hot when this was happening. Had another one involving one side of body and blank stare with rhythmic blinking of eyes 3 days later.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted after receiving injection.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Areflexia, Arthralgia, Back pain, Fall, Gait disturbance
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Injection site erythema, Injection site pain
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Injection site swelling, Lumbar puncture abnormal, Muscular weakness, Musculoskeletal pain, Neurological examination abnormal
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Anti-SS-A antibody positive, Antinuclear antibody positive, Blood product transfusion, Epstein-Barr virus antibody negative, Fall
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Immunoglobulin therapy, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Intensive care, Local reaction, Muscular weakness, Rheumatoid factor positive
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Oedema peripheral
Clinical narrative: Pt received vaccine on 5/18.  On 5/24, noticed arm redness at injection site - became painful, swollen, and tender to touch.  Returned to MD office and was given cortisone cream and possibly a Medrol Dosepak.  On 5/30, noticed numbness/tingling in toes/balls of feet; pain in knees, back, shoulders, and both arms; gradually worsening.  Also noticed LE weakness; had difficulty walking and fell x 2 before seeking treatment in ER.  Transferred to another facility and diagnosed with Guillain Barre syndrome.  Received IVIG therapy.  Currently remains a patient undergoing inpatient rehab.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Blood test normal, Chest X-ray normal, Lethargy, Pyrexia
Clinical narrative: Temperature increasing throughtout day, everyday since vacination. Starts at 98.4F at wakeup and rises throught the day to about 100.5F.  Causes significant lethargy and napping in afternoon as temperature rises.  She never needed naps previously.  Fever significantly influences her ability to function normally.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Tuberculin test negative
Clinical narrative: Temperature increasing throughtout day, everyday since vacination. Starts at 98.4F at wakeup and rises throught the day to about 100.5F.  Causes significant lethargy and napping in afternoon as temperature rises.  She never needed naps previously.  Fever significantly influences her ability to function normally.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None (pt given vaccine although over age limit) No reaction.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4, MEN, PPV, TDAP
Symptoms: Pyrexia, Urinary tract infection, Urine analysis
Clinical narrative: Patient described had a high fever for 4 days total. Treated at hospital on 6-4-10, noted administered TORADOL and Rx - Tx LEVAQUIN AB Tx 3 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately following vaccination of Tdap, MENACTRA, and GARDASIL. Episode only lasted few brief seconds and pt recovered spontaneously without any treatment. Pt was observed in clinic for 20 minutes after event and discharged home without further issues.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Fever temp 103 F 62 days. Rash 6 days post vaccine. No bleed raised, red area 3 days after vaccine administration.
Age: 27.0
Sex: F
Vaccine: HEP, MEN, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Client into clinic on 5-3-2010 for immunizations. Administered 1st Hep B (L) Deltoid, Tdap (R) Deltoid and MCV4 (R) Deltoid. Client reports played tennis after IZ and (R) arm began to hurt. By evening redness, swelling, fever of 102 degrees that lasted 2 days. Redness and swelling totally gone by 8-9 days after immunizations. Took MOTRIN for pain. Ice and heat to area. Did not seek medical attention or contact Health Department.
Age: 1.49
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Agitation, Dyspnoea, Erythema, Pallor, Urticaria
Clinical narrative: Agitation, wheezing, shortness of breath at 1700. Albuterol/ATROVENT treatment given -> initially pale, developed hives/erythema by completion at treatment (1715). Received Epinephrine 0.15 mg IM x 1 at 1745 (vomited ORAPRED).
Age: 1.49
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Vomiting, Wheezing
Clinical narrative: Agitation, wheezing, shortness of breath at 1700. Albuterol/ATROVENT treatment given -> initially pale, developed hives/erythema by completion at treatment (1715). Received Epinephrine 0.15 mg IM x 1 at 1745 (vomited ORAPRED).
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Pyrexia
Clinical narrative: (Per mom) started like a "small knot"-turned red and redness spread to other side of arm. Fever of 101-102. Mom states that it started in the morning.
Age: 4.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) leg red and swollen at injection site.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Tetanus shot administered Saturday rt deltoid through tattoo, Sunday noticed tenderness (fine, no sx until Sunday) and mild tenderness, warm to touch. Sx's continue today: 2 inch diameter swelling and redness, warm to touch. Tx: monitor.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site vesicles, Scab
Clinical narrative: Developed cluster of vesicles on left anterior thigh  on 6/13/10. Very itchy. No fever. Now crusted on exam 6/15/10.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: Pt reports noticing reaction the day after administration. Red, raised area approx 6cm in diameter noted at site of injection. BENADRYL 50mg PO given x1 6/13/10 and x1 6/14/10. Pt reports induration is warm and "itchy" but has not increased in size since appearance.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Pt reports noticing reaction the day after administration. Red, raised area approx 6cm in diameter noted at site of injection. BENADRYL 50mg PO given x1 6/13/10 and x1 6/14/10. Pt reports induration is warm and "itchy" but has not increased in size since appearance.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Cough, Dysphonia, Fatigue, Headache
Clinical narrative: Received 1st injection GARDASIL. C/o Flu-Like symptoms immediately. Fever/chills, achiness, watery eyes, cough, nasal congestion, headache, fatigue, sore throat, hoarseness.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Influenza like illness, Lacrimation increased, Nasal congestion, Oropharyngeal pain
Clinical narrative: Received 1st injection GARDASIL. C/o Flu-Like symptoms immediately. Fever/chills, achiness, watery eyes, cough, nasal congestion, headache, fatigue, sore throat, hoarseness.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: Received 1st injection GARDASIL. C/o Flu-Like symptoms immediately. Fever/chills, achiness, watery eyes, cough, nasal congestion, headache, fatigue, sore throat, hoarseness.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 07 June 2010. A 28 year-old female subject with a medical history of dizziness or fainting spells and numbness or paralysis received ACAM2000 (lot number not reported) on 12 January 2010. Fourteen days after vaccination, the subject was diagnosed with acute pericarditis,unspecified. On Day 14 (26 January 2010), the subject had an abnormal electrocardiogram, and a normal Troponin I and echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram normal, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 07 June 2010. A 42 year-old male subject with a history of elevated cholesterol received ACAM2000 (lot number not reported) on 29 January 2010. The subject previously received the following vaccines on 06 January 2010: hepatitis B vaccine (other manufacturer and lot number not reported); and pandemic (H1N1) influenza vaccine (manufacturer unknown and lot number not reported). Ten days after receipt of ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. On Day 10 (08 February 2010), the subject had a Troponin I of 0.52 (abnormal); an electrocardiogram which was normal; and an echocardiogram which was abnormal. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) lateral thigh - swollen & red x 1 day measuring 4-5 cm.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUX(H1N1), SMALL, TYP, ANTH, FLUX(H1N1), SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator on 07 June 2010. A 20 year-old male subject with no significant medical history received the following vaccines on 27 January 2010: ACAM2000 (lot number not reported); TYPHIM Vi (lot number not reported; H1N1 (manufacturer unknown and lot number not reported); and ANTHRAX (other manufacturer and lot number not reported). Twenty-five days after vaccination, the subject was diagnosed with acute idiopathic pericarditis. On day 25 (21 February 2010), the subject had a Troponin I of 6.44 (abnormal); an abnormal electrocardiogram; and a normal echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Injection site pain
Clinical narrative: 5x5cm area light induration, no redness, tender, immediately inferior to injection site.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness, Tuberculin test
Clinical narrative: After administering vaccines pt feel off exam table onto floor. Pt stated he blacked out/felt dizzy. Following administration of vaccines, mother stated pt got dizzy following PPD prior.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging abnormal, Pericardial disease
Clinical narrative: This report was received from the investigator on 07 June 2010. A 31 year-old male subject with a history of elevated cholesterol received ACAM2000 (lot number not reported) on 18 February 2010. Fourteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. On day 15, the subject was diagnosed with non-specific myocarditis and on day 18, the subject was diagnosed with acute pericarditis. On day 12 (02 March 2010), the subject had an abnormal electrocardiogram. On day 14 (04 March 2010), the subject had a Troponin I of 0.95 (abnormal). On day 15 (05 March 2010), the subject had a normal echocardiogram and an abnormal MRI of the heart. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator on 07 June 2010. A 31 year-old male subject with a history of elevated cholesterol received ACAM2000 (lot number not reported) on 18 February 2010. Fourteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. On day 15, the subject was diagnosed with non-specific myocarditis and on day 18, the subject was diagnosed with acute pericarditis. On day 12 (02 March 2010), the subject had an abnormal electrocardiogram. On day 14 (04 March 2010), the subject had a Troponin I of 0.95 (abnormal). On day 15 (05 March 2010), the subject had a normal echocardiogram and an abnormal MRI of the heart. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator on 07 June 2010. A 31 year-old male subject with no significant medical history received ACAM2000 (lot number not reported) on 23 February 2010. The subject previously received H1N1 (manufacturer unknown and lot number not reported) on 04 February 2010. Thirteen days after receiving ACAM2000, the subject was diagnosed with acute pericarditis, unspecified. On day 11 (06 March 2010), the subject had an abnormal electrocardiogram. On day 12 (07 March 2010), the subject had a Troponin I of 12.05 (abnormal) and on day 13 (08 March 2010) the subject had an abnormal echocardiogram. The outcome was not reported.  Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator on 07 June 2010. A 31 year-old male subject with no significant medical history received ACAM2000 (lot number not reported) on 23 February 2010. The subject previously received H1N1 (manufacturer unknown and lot number not reported) on 04 February 2010. Thirteen days after receiving ACAM2000, the subject was diagnosed with acute pericarditis, unspecified. On day 11 (06 March 2010), the subject had an abnormal electrocardiogram. On day 12 (07 March 2010), the subject had a Troponin I of 12.05 (abnormal) and on day 13 (08 March 2010) the subject had an abnormal echocardiogram. The outcome was not reported.  Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 0.83
Sex: M
Vaccine: IPV
Symptoms: Diarrhoea, Injection site rash, Pallor, Pyrexia, Rash macular
Clinical narrative: Child received IPV on 6-14-10 and on 6-19-10 mom noticed a faint rash on (R) leg at injection site. He had a 3-day hx of low-grade fever and diarrhea. PE-generalized erythematous macular, blanching rash.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at site of injection R upper lateral arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Bordetella test positive
Clinical narrative: Initial case was received on 09 June 2010 from a healthcare professional. A 12 year old female patient received an intramuscular injection of ADACEL (lot number C2937AA) on 02 August 2008. The patient's medical history and concomitant medications were not reported. It was unknown by the reporter if any other vaccinations were given within 4 weeks of the ADACEL vaccination. On 03 June 2010 at 13 years of age, the patient had a positive test for Bordetella pertussis via direct fluorescent antibody (DFA). As of this report the outcome is unknown. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blindness transient, Blood test, Computerised tomogram, Convulsion
Clinical narrative: My formerly healthy 15 yr. old daughter received her one and only dose of the GARDASIL vaccine on July 30, 2009. Since then, she has been plagued with headaches, fatigue, dizziness, numbness and tingling of the legs and feet, non-epileptic seizures, temporary paralysis/blindness, fainting, ovarian cysts, etc. She was hospitalised once and has been to the ER 5 times. She missed nearly the entire school year due to her adverse reaction to the vaccination. She has been evaluation by a psychologist and a psychiatrist both of whom state she is psychologically healthy and well-adjusted. She was recently diagnosed with POTS by a cardiologist. She is on numerous medications and cannot be left alone. I have since learned that there are thousands of other girls experiencing the same thing. If it's not the vaccine, what is it? Please take this vaccine off the market for further study before more innocent lives are compromised.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram, Electroencephalogram, Fatigue, Headache
Clinical narrative: My formerly healthy 15 yr. old daughter received her one and only dose of the GARDASIL vaccine on July 30, 2009. Since then, she has been plagued with headaches, fatigue, dizziness, numbness and tingling of the legs and feet, non-epileptic seizures, temporary paralysis/blindness, fainting, ovarian cysts, etc. She was hospitalised once and has been to the ER 5 times. She missed nearly the entire school year due to her adverse reaction to the vaccination. She has been evaluation by a psychologist and a psychiatrist both of whom state she is psychologically healthy and well-adjusted. She was recently diagnosed with POTS by a cardiologist. She is on numerous medications and cannot be left alone. I have since learned that there are thousands of other girls experiencing the same thing. If it's not the vaccine, what is it? Please take this vaccine off the market for further study before more innocent lives are compromised.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Ovarian cyst, Paraesthesia
Clinical narrative: My formerly healthy 15 yr. old daughter received her one and only dose of the GARDASIL vaccine on July 30, 2009. Since then, she has been plagued with headaches, fatigue, dizziness, numbness and tingling of the legs and feet, non-epileptic seizures, temporary paralysis/blindness, fainting, ovarian cysts, etc. She was hospitalised once and has been to the ER 5 times. She missed nearly the entire school year due to her adverse reaction to the vaccination. She has been evaluation by a psychologist and a psychiatrist both of whom state she is psychologically healthy and well-adjusted. She was recently diagnosed with POTS by a cardiologist. She is on numerous medications and cannot be left alone. I have since learned that there are thousands of other girls experiencing the same thing. If it's not the vaccine, what is it? Please take this vaccine off the market for further study before more innocent lives are compromised.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Postural orthostatic tachycardia syndrome, Syncope, Urine analysis
Clinical narrative: My formerly healthy 15 yr. old daughter received her one and only dose of the GARDASIL vaccine on July 30, 2009. Since then, she has been plagued with headaches, fatigue, dizziness, numbness and tingling of the legs and feet, non-epileptic seizures, temporary paralysis/blindness, fainting, ovarian cysts, etc. She was hospitalised once and has been to the ER 5 times. She missed nearly the entire school year due to her adverse reaction to the vaccination. She has been evaluation by a psychologist and a psychiatrist both of whom state she is psychologically healthy and well-adjusted. She was recently diagnosed with POTS by a cardiologist. She is on numerous medications and cannot be left alone. I have since learned that there are thousands of other girls experiencing the same thing. If it's not the vaccine, what is it? Please take this vaccine off the market for further study before more innocent lives are compromised.
Age: 91.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed at the injection site. Treatment Drugs Used: 1 - CEPHALEXIN Dose: 500 Units: MG Freq: BID Route: PO
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Influenza like illness
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with and Arrithromycin allergy who on 15-JAN-2007 was vaccinated with the first dose of GARDASIL and on 17-FEB-2007 was vaccinated with the second dose of GARDASIL. On 17-FEB-2007 the patient experienced flu like symptoms that only lasted a few days. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Induration at vaccine site (left thigh) with erythema; persistent 1cm mass with tenderness.
Age: 1.07
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Induration at vaccine site (left thigh) with erythema; persistent 1cm mass with tenderness.
Age: 49.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abscess sterile, Impaired work ability, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Left upper arm very painful to move. I cannot raise my arm above my head, reach behind my back or shoulder, painful to reach over under my right arm to apply deoderant, it wakes me up when I am asleep. I tried ice, heat, massage, using my arm, resting my arm, taking 400mg of Ibupro. After giving it several months to get better, to no avail. In May I went to see my doctor, she said she thought it was a "sterile abscess".  I gave it more time (June) and it is still not any better so I "GOOGLED" "sore arm months after getting H1N1 shot" and found a blog of people that have the same issue.  I am quite concerned now as it is very painful to do my job at work.  I am a CNA and lift, move, and shower patients.  I am very concerned that I take ibupro. on a regular basis.  I try not to, but sometimes it is the only way I can make it through my workday.
Age: 49.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Sleep disorder
Clinical narrative: Left upper arm very painful to move. I cannot raise my arm above my head, reach behind my back or shoulder, painful to reach over under my right arm to apply deoderant, it wakes me up when I am asleep. I tried ice, heat, massage, using my arm, resting my arm, taking 400mg of Ibupro. After giving it several months to get better, to no avail. In May I went to see my doctor, she said she thought it was a "sterile abscess".  I gave it more time (June) and it is still not any better so I "GOOGLED" "sore arm months after getting H1N1 shot" and found a blog of people that have the same issue.  I am quite concerned now as it is very painful to do my job at work.  I am a CNA and lift, move, and shower patients.  I am very concerned that I take ibupro. on a regular basis.  I try not to, but sometimes it is the only way I can make it through my workday.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture, Chest X-ray, Full blood count, Headache, Metabolic function test
Clinical narrative: Severe headache, high fever (104.6) sore throat, myalgias.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Severe headache, high fever (104.6) sore throat, myalgias.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Body temperature increased, Chills, Pain
Clinical narrative: Temp 101.3, back pain, body aches, stomach pain, chills.  Pt given Toradol injection in office and told to take Aleve at home.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Gaze palsy, Loss of consciousness, Muscle rigidity
Clinical narrative: Pt loss conciousness, eyes rolled to back of head, some muscle rigidity.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: REDNESS, ITCHING, AND SWOLLEN AT THE INJECTION SITE, AND LOCAL AREA (ARM).  THIS HAS IMPROVED OVER TIME WITHOUT ANY TREATMENT NECESSARY.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Fever, Chills, Lethargy
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) leg 10 x 10 cm red/swollen area (R) leg 2 x 2 cm red swollen area - noted 6/11/10 AM of red/swelling to both legs - above measurements were done at 4pm 6/11/10.
Age: 56.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Chills, Fatigue, Hypersomnia, Pain, Pyrexia
Clinical narrative: Woke up Sat am (IZ give Thurs. 4pm) with fever (did not take temp), chills, achiness all over, extreme fatigue-slept most of Sat.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local reaction-raised, redness, and warm-to-touch around site of injection. Patient advised cold compress and BENADRYL by pharmacist and physician. Reaction cleared in approximately 5 days per patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Rt arm Eotematous and red also warm to touch. Patient denies pain and has full range of motion.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling & erythema adjacent to injection site with swelling/redness.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Gait disturbance, Oedema peripheral
Clinical narrative: Swollen leg, refusal to walk, limping for a few days
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Dysstasia, Gait disturbance, Incorrect dose administered, Movement disorder, Muscle spasms
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a physician regarding a 3-year-old female patient who experienced unwilling to use one of her legs, severe cramping of leg, couldn't get her to walk, wouldn't bend her leg, had excruciating pain in leg and overdose vaccine - extra dose administered. At 3 years of age, the patient received the first dose on 25-May-2010. The patient experienced being administered an overdose of vaccine - extra dose administered severe cramping of leg and unwilling to use one of her legs on 25-May-2010, within an hour of the PREVNAR 13 injection. These events resolved within 15 minutes. On 26-May-2010, while the child was at daycare, they could not get her to walk and she wouldn't bend her leg for an hour or so. On 04-Jun-2010, the patient continued to not bend her leg and was in excruciating pain in leg. Excruciating pain and not bending her leg were not resolved. Severe cramping, unwilling to use one leg, and unwillingness to walk were resolved. Outcome of extra dose administered, overdose is unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a physician regarding a 3-year-old female patient who experienced unwilling to use one of her legs, severe cramping of leg, couldn't get her to walk, wouldn't bend her leg, had excruciating pain in leg and overdose vaccine - extra dose administered. At 3 years of age, the patient received the first dose on 25-May-2010. The patient experienced being administered an overdose of vaccine - extra dose administered severe cramping of leg and unwilling to use one of her legs on 25-May-2010, within an hour of the PREVNAR 13 injection. These events resolved within 15 minutes. On 26-May-2010, while the child was at daycare, they could not get her to walk and she wouldn't bend her leg for an hour or so. On 04-Jun-2010, the patient continued to not bend her leg and was in excruciating pain in leg. Excruciating pain and not bending her leg were not resolved. Severe cramping, unwilling to use one leg, and unwillingness to walk were resolved. Outcome of extra dose administered, overdose is unknown. No additional information was available at the time of this report.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, Hyporeflexia, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Patient presents on 10/31/2009 with bilateral and symmetrical limb weakness as well as decreased deep tendon reflexes. LP performed on patient.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen. 4.5 inch red ring around the area, some nodules palpated. Left upper arm warm to touch almost to elbow. Treated with ice and warm compresses.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: No adverse event.  Expired # 2 HPV immunization given.  Re-given 7 days later.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: CSF protein increased, Hyporeflexia, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Patient presented on 04/24/2010 with symmetrical and bilateral limb weakness. Patient also presented with decreased deep tendon reflexes. LP was performed on patient on 4/25/2010.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: No adverse event.  Expired # 1 HPV immunization given.  Re-given 7 days later.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: No adverse event.  Expired # 2 HPV immunization given.  Re-given in 7 days.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth at site. Bilateral wrist pain/dizzy.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Oedema, Swelling, Tenderness
Clinical narrative: Patient c/o right axilla area burns, tender, swollen started this am 6/16/2010. Seen by nurse practitioner with no visible erythema at site of injection, no warmth, and no edema. Noted right axilla with visible edema.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Herpangina, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 6/11/2010 pt to office for left thigh, red swollen, warm at injection site. Pt also had a viral illness at this time, her pangina with high fever. Local Reaction, Tx-Ice and Motrin.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Viral infection
Clinical narrative: 6/11/2010 pt to office for left thigh, red swollen, warm at injection site. Pt also had a viral illness at this time, her pangina with high fever. Local Reaction, Tx-Ice and Motrin.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Body temperature decreased, Chills, Pain, Pyrexia
Clinical narrative: The day following vaccination, onset of fever of 103 degrees, the pt has chills. Temperature decreased without medication to 99.8. Pt did not seek medical advice. Temperature 99.8 degrees on 6/16/10. Also had c/o's body aches.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Back pain, Electromyogram abnormal, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Abdominal and back pain started in late April or early May 2010. Developed bilateral leg paresthesia, weakness on 5 May 10 and was hospitalised 7-8 May 2010. Neurology eval of 10 and 12 May 2010 indicated GUILLAIN BARRE is likely. Hospitalised for lower extremity weakness and for back and abdominal pain 7-8 May 10; vaccine given during this hospitalisation, outpatient evaluation on May.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Abdominal and back pain started in late April or early May 2010. Developed bilateral leg paresthesia, weakness on 5 May 10 and was hospitalised 7-8 May 2010. Neurology eval of 10 and 12 May 2010 indicated GUILLAIN BARRE is likely. Hospitalised for lower extremity weakness and for back and abdominal pain 7-8 May 10; vaccine given during this hospitalisation, outpatient evaluation on May.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Initial and follow-up information has been received from a physician and a medical assistant, concerning a female who on an unspecified date last  year, in 2007 was vaccinated with the third dose of GARDASIL. It was reported that the patient experienced seizure. The patient was walking out of the office and went down. In follow-up information received from the nurse, she reported that the patient did not have a seizure. She passed out and recovered while in the office. This is one of two patients concerning the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Pt. became pale and unresponsive, she slumped against her mother, preventing her from hitting her head, she became alert within 5-8 seconds. She laid down for 30 minutes with cold cloth on her head, had some water and juice. She reported she had not had breakfast or any fluids this am. After 30 minutes, she sat up with no adverse symptoms, mother took her home with instructions to call MD or go to ER for any further problems.
Age: 34.0
Sex: F
Vaccine: JEV
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Round reddish, raise, itchy warm Left arm Left anterior arm  Benadryl prefilled liquid 4x for 2 days.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a physician and a father concerning a 11 year old male student who on 04-NOV-2008 at 10:15 am, was vaccinated with the first dose of GARDASIL (Lot No 661764/0650X) in the left arm. Concomitant vaccination on 04-NOV-2008, included FLUZONE (Lot No U2799AA). The physician reported that inadvertently the GARDASIL was give to the patient instead of the patient's sister. At the time of the report no symptoms were reported. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 18 year old female patient who on 27-JUN-2007 and 25-JUL-2007 was vaccinated with a dose of GARDASIL (lot number, route and site not reported) which had been pre-drawn and stored in the refrigerator for up to one week.  No adverse effect was reported except for "it always stings." It was unknown if the patient sought medical attention.  The outcome was not reported.  This is one of several reports received from the same source.  No further information is available.
Age: 0.1
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 5 weeks old male who on 03-SEP-2008 was inadvertently vaccinated with GARDASIL IM in the right thigh 0.5 ml (lot # 659182/1757U instead of HEP B (manufacturer unknown). This was a human error. There were no fever and no local reactions. No adverse experiences reported. The patient sought medical attention at the office. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female who on 20-NOV-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 660612/0229X).  Concomitant therapy included ADACEL, ALEVE and Multi-Vitamin.  The patient developed hives on the left side of her face and neck after receiving her first dose of GARDASIL.  The dose of GARDASIL was administered in the patient's left arm.  At the time of reporting the patient was recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a medical assistant concerning a (approx.) 13 year old female who was not taking concomitant medications and was vaccinated (date, route and site not reported) with the 1st dose of GARDASIL (lot# not reported). On an unspecified date, the patient experienced abnormal periods. The patient's mother stated that after the 1st dose was received the patient periods became irregular. The patient did not receive medical attention via hospitalization nor an office visit. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female who on 29-JUN-2007 was vaccinated (route and site not reported) with the 1st dose of the GARDASIL (lot# not reported).  On 24-Aug-2007, the patient was vaccinated (route and site not reported) with the 2nd dose of the GARDASIL (lot # not reported).  The mother of the patient stated that her daughter had had abnormal periods since the 2nd dose.  The patient's periods were irregular from August to November.  The patient's mother also said that her daughter was new to getting her period and was not sure if it was the vaccine or her body adjusting.  The patient last period was November 2007.  The patient did not receive medical attention via hospitalization nor an office visit.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare professional, concerning a patient (age and gender not specified) who was vaccinated in the deltoid or thigh, on an unknown date with a dose of GARDASIL, and experienced pain, swelling and redness at the injection site.  No further identifying patient details were available.  Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Back of left upper arm became red, swollen and warm to touch.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Full blood count, Headache, Metabolic function test, Nausea
Clinical narrative: Pt. presented to clinic with c/o dizziness, nausea, vomiting and headache.  Sent to ER for further evaluation.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Urine analysis, Vomiting
Clinical narrative: Pt. presented to clinic with c/o dizziness, nausea, vomiting and headache.  Sent to ER for further evaluation.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Lethargy, Mental status changes, Nausea, Speech disorder
Clinical narrative: Patient appeared to have a change in mental status, appeared lethargic, speech slowed down, and stated she felt dizzy and nauseous, at that time her daughter was contacted reported to the pharmacy.  While waiting for patient's daughter we contacted the doctor's office to report incident and have her seen.  Meanwhile the patient's daughter arrived and preferred us to call an ambulance rather than take her herself as doctor had suggested.  Within 30 to 40 minutes of patients first report of reaction paramedics arrived and took patient to the hospital.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Nausea, Pyrexia
Clinical narrative: About hour after injection had low grade temp 99.0, nausea, fatigue, red and hot localized where injection given. Pt used ice and it's improving.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Heat rash, Irritability, Poor quality sleep, Rash erythematous, Rash generalised
Clinical narrative: 10 days post immunizations, pt had a pin point rash on his body resembling a heat rash (and he had been outside).  Now 12 days after, pt has large, red spots all over his whole body.  He is afebrile, but not sleeping as well, more fussy and clingy, drinking fluids, but not eating as many solid foods.  He is not actively itching his skin anywhere.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Patient developed hives without respiratory distress, lip swelling or joint swelling.
Age: 17.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: GAVE A PATIENT A HBV#1 IN LEFT DELTOID, THEN GAVE HPV#1 IN RIGHT VASTUS LATERALIS, PT GOT WHITE, AND PASSED OUT.  PT DID NOT FALL, NOR HIT HIS HEAD.  PT WAS OUT FOR ABOUT 10 SECONDS.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Pyrexia
Clinical narrative: High Fever of 102.7, persisting until next day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: THE DAY AFTER PT RECEIVED ZOSTER VACCINATION (SAT JUN 12) PT EXPERIENCED REDNESS AND SORENESS AT THE INJECTION SITE (POSTERIOR LEFT ARM).  BY EVENING THE AREA WAS SWOLLEN.  SUN JUN 13 AM THE SWOLLEN AREA HAD EXTENDED AND PT WAS TAKEN TO THE ER.  PT RECEIVED 2 IM ANTIBIOTIC INJECTIONS WITH DIAGNOSIS OF "INFECTION".  PT WAS SENT HOME AND TOLD TO RETURN IMMEDIATELY IF THE SWELLING GOT BIGGER.  MON JUN 14 AM THE AREA OF SWELLING WAS SPREADING DISTAL TO LEFT ELBOW.  PT WAS TAKEN TO THE ER AND WAS ADMITTED TO THE HOSPITAL.  PT RECEIVED IV ANTIBIOTICS EVERY 6 HOURS AND WAS DISCHARGED TUES JUN 15 IN THE AFTERNOON.  PT IS TAKING ORAL ANTIBIOTICS EVERY 6 HOURS AND INJECTION SITE IS REPORTED TO NOW BE ABOUT 2 INCHES IN DIAMETER AND PT IS FEELING MUCH BETTER.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Diet refusal, Heart rate increased, Incorrect dose administered, Vomiting
Clinical narrative: Patient vomited and would not take her bottle.  Her heart rate felt faster than normal.  The doctor informed me that they made a mistake and gave her one extra dose of DTaP and one extra dose of polio.
Age: 0.37
Sex: F
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: INCONSOLABLE CRYING/SCREAMING FOR 5 HRS AFTER DTAP.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after receiving vaccines. Administer ammonia inhalant. Felt better. Had patient wait 15 min. Felt fine and left.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Paraesthesia, Urticaria
Clinical narrative: 5 inch welt on L side along ribs, tingling in left arm and leg x 24 hours - symptoms resolved in 24 hours.