chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother advised to contacted local health department.  Patient received total of 5 shots on 5/20/08.  Mother received call from daycare center on morning of 5/21/08 indicating that patient's left arm was swollen and red.  Mother also stated that patient's arm is warm to touch and hard.  Mother did not notice any swelling while giving patient a bath on the morning of 5/21/08.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Rash on shoulder and upper back, extremely itchy
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Induration, Skin warm, Tenderness, Urticaria
Clinical narrative: Allergic reaction. Patient given T.Dap.  Subsequently, large wheal and flare the length of the upper arm developed; also was warm, tender, and firum to touch.  Treatment: benadryl 25 mg Q6H PRN and Ibuprofen 400 mg TID, PRN.
Age: 7.0
Sex: F
Vaccine: TYP
Symptoms: Medication error
Clinical narrative: Patient received Hep A in afternoon clinic and returned to night clinic and received Hep A again along with other immunizations brought in by the mother.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Vaccination failure, Varicella
Clinical narrative: PATIENT CAME INTO THE OFFICE TODAY WITH A RASH ALL OVER HIS BODY. THE DOCTOR DX'D HIM WITH HAVING THE CHICKENPOX.  PATIENT HAS RECIEVED BOTH DOSES OF THE VACCINE.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Laboratory test normal, Myalgia, Pain in extremity
Clinical narrative: After receiving TDAP pt has had multiple complaints of muscle aches and pain in both hips and legs bilaterally. She has had to change jobs because of the pain.  She has had multiple tests done by her doctor for lupus, arthritis, ms, etc with all tests being negative.
Age: 36.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Client was seen in our clinic for consult and vaccines.  She contacted us this morning and stated that she just found out she is pregnant. Regarding number of previous doses in block #13, client received Hepatitis A vaccine (not Twinrix) on 01/13/1999.  NOTE:  client is in process of moving.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinee complained of pain at the injection site, lethargy, headache and later fever up to 104 degree Fahrenheit. The day after vaccine administered site did appear swollen and warm, no redness noted. Vaccinee missed 2.5 days of work and was sick over a weekend. Saw a physician who diagnosed: "skin infection"
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Lethargy, Pyrexia, Skin infection
Clinical narrative: Vaccinee complained of pain at the injection site, lethargy, headache and later fever up to 104 degree Fahrenheit. The day after vaccine administered site did appear swollen and warm, no redness noted. Vaccinee missed 2.5 days of work and was sick over a weekend. Saw a physician who diagnosed: "skin infection"
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Nasopharyngitis, Oral herpes, Vaccine positive rechallenge
Clinical narrative: 1st shot 7/07- cold symptoms. 2nd shot 1/08 -she missed her period, then severe cold symptoms with what seemed to be a massive herpes-type infection, sores on her gums, face and throat. 3rd shot 4/08- the herpes-like reaction recurred, but milder - then she stopped menstruating for 3 months!
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Lymphadenopathy, Measles antibody negative, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Patient was given MMR dose as pre-employment protocol for an immune screen that showed no immunity to measles.  Patient did not have documentation of any vaccines from childhood.  Employee stated sore throat, localized redness to injection site, swollen lymphnodes, and slight rash to face, back, neck, and chest on 5/20/08.  Patient reports no fever.  Stated slight muscle ache 2 days prior to rash apprearing (5/18/08).
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient was given MMR dose as pre-employment protocol for an immune screen that showed no immunity to measles.  Patient did not have documentation of any vaccines from childhood.  Employee stated sore throat, localized redness to injection site, swollen lymphnodes, and slight rash to face, back, neck, and chest on 5/20/08.  Patient reports no fever.  Stated slight muscle ache 2 days prior to rash apprearing (5/18/08).
Age: 0.2
Sex: F
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Abnormal behaviour, Anorexia, Somnolence
Clinical narrative: Stopped babbling for approx 5 weeks, extreme sleepiness, temporary loss of appetite, would not make eye contact as she had before. Vax's given: Rota, Hib, PCV, and IPV/OPV.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased
Clinical narrative: Kept leg straight, did not like bending it to try and push up or crawl. Still does it sometimes.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, swelling, itch, tenderness of upper arm on side of injection.  Ache from shoulder to elbow, occurring within 24 hours of injection.  No fever.  TX: steroid tapering dose (Medrol dosepak), antihistamine (hydroxyzine 25 mgm q6h).
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, swelling, itch, tenderness of upper arm on side of injection.  Ache from shoulder to elbow, occurring within 24 hours of injection.  No fever.  TX: steroid tapering dose (Medrol dosepak), antihistamine (hydroxyzine 25 mgm q6h).
Age: 20.0
Sex: M
Vaccine: IPV, MNQ, TYP, VARCEL
Symptoms: Blood pressure, Convulsion, Dissociation, Foaming at mouth, Gaze palsy
Clinical narrative: Almost immediately after 4th vaccine injection (sitting in a chair): eyes rolled back, passed out, copious frothy sputum pouring from mouth, arms and hands contracted up to chest in seizure like movements, pale & diaphoretic. Nurse snapped what appeared to be an ammonia cap under his nose, and patted face and arms, calling his name. She said he was having a severe vasovagal response and would "come back." I could not feel a radial pulse and was ready to dial 911 and access need for CPR. I pulled out my EpiPen, but did not useno wheezing or signs of anaphylaxis. He regained consciousness after approximately 1 minute, asking how long he was out and reported feeling "detached." Nursed called doctor on call and reported reaction. Blood Pressure 98/60 and pulse 56 at 11:01 a.m. approximately 4-5 minutes after he regained consciousness. He slept most of the day and said he felt fine the next morning. I do not know which vaccines were injected into right arm and which were injected into left arm.
Age: 20.0
Sex: M
Vaccine: IPV, MNQ, TYP, VARCEL
Symptoms: Heart rate decreased, Hyperhidrosis, Hypersomnia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Almost immediately after 4th vaccine injection (sitting in a chair): eyes rolled back, passed out, copious frothy sputum pouring from mouth, arms and hands contracted up to chest in seizure like movements, pale & diaphoretic. Nurse snapped what appeared to be an ammonia cap under his nose, and patted face and arms, calling his name. She said he was having a severe vasovagal response and would "come back." I could not feel a radial pulse and was ready to dial 911 and access need for CPR. I pulled out my EpiPen, but did not useno wheezing or signs of anaphylaxis. He regained consciousness after approximately 1 minute, asking how long he was out and reported feeling "detached." Nursed called doctor on call and reported reaction. Blood Pressure 98/60 and pulse 56 at 11:01 a.m. approximately 4-5 minutes after he regained consciousness. He slept most of the day and said he felt fine the next morning. I do not know which vaccines were injected into right arm and which were injected into left arm.
Age: 20.0
Sex: M
Vaccine: IPV, MNQ, TYP, VARCEL
Symptoms: Muscle contractions involuntary, Pallor
Clinical narrative: Almost immediately after 4th vaccine injection (sitting in a chair): eyes rolled back, passed out, copious frothy sputum pouring from mouth, arms and hands contracted up to chest in seizure like movements, pale & diaphoretic. Nurse snapped what appeared to be an ammonia cap under his nose, and patted face and arms, calling his name. She said he was having a severe vasovagal response and would "come back." I could not feel a radial pulse and was ready to dial 911 and access need for CPR. I pulled out my EpiPen, but did not useno wheezing or signs of anaphylaxis. He regained consciousness after approximately 1 minute, asking how long he was out and reported feeling "detached." Nursed called doctor on call and reported reaction. Blood Pressure 98/60 and pulse 56 at 11:01 a.m. approximately 4-5 minutes after he regained consciousness. He slept most of the day and said he felt fine the next morning. I do not know which vaccines were injected into right arm and which were injected into left arm.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL, DTAPHEPBIP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling around site of immunization on client right thigh.  The swelling was stated to be the size of an orange.  Area was also painful to the touch and red with white area around injection site.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL, DTAPHEPBIP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Redness and swelling around site of immunization on client right thigh.  The swelling was stated to be the size of an orange.  Area was also painful to the touch and red with white area around injection site.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Penile oedema, Scrotal oedema
Clinical narrative: On 5/9/08, pt developed swelling from his belly button to his scrotum including his penis.  Evaluated at ER that day.  Instructed to monitor swelling.  Swelling resolved on 5/13/08.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope, Syncope vasovagal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient had what appeared to be a vaso-vagal response 10-15 seconds after vaccines received.He became unconscious, lost bladder control and collapsed,was not responsive to verbal and physical stimulation.911 was activated. An assessment of his pulse and respirations was in progress when he regained consciousness. Pt responsive to verbal stimuli. Remained in resting state for 10min, drank water and was then able to stand. 911 call was cancelled. Pt ambulated from the clinic without assistance.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, TDAP
Symptoms: Asthenia, Blood pressure, Cold sweat, Dizziness, Heart rate
Clinical narrative: Pt developed dizziness, nausea and weakness 10min following immunizations. Public Health staff assisted her in lying down HR=60 RR=20 no difficulty breathing, no skin rash. Color was pale and skin clammy. She reported that this may be her "period" coming. She was assisted to an exam room and observed for and additional 30 min BP 98/60 HR 64. She was alert and oriented Gave pt 4 oz of juice. She ambulated from clinic with her mother and brother.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, TDAP
Symptoms: Nausea, Pallor, Respiratory rate
Clinical narrative: Pt developed dizziness, nausea and weakness 10min following immunizations. Public Health staff assisted her in lying down HR=60 RR=20 no difficulty breathing, no skin rash. Color was pale and skin clammy. She reported that this may be her "period" coming. She was assisted to an exam room and observed for and additional 30 min BP 98/60 HR 64. She was alert and oriented Gave pt 4 oz of juice. She ambulated from clinic with her mother and brother.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Alanine aminotransferase normal, Arthropod bite, Aspartate aminotransferase normal, Blood albumin normal, Blood bilirubin normal
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Blood potassium normal, Blood thyroid stimulating hormone, Blood triglycerides normal, Blood urea normal, Blood uric acid normal
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Borrelia burgdorferi serology negative, Carbon dioxide normal, Carpal tunnel syndrome, Glomerular filtration rate normal, Granulocyte count
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Haematocrit normal, Haemoglobin normal, Low density lipoprotein, Lymphocyte percentage, Mean cell haemoglobin concentration
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Mean cell haemoglobin normal, Monocyte percentage, Nerve conduction studies abnormal, Paraesthesia, Platelet count normal
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 58.0
Sex: M
Vaccine: DTOX
Symptoms: Protein total normal, Pruritus, Red blood cell count normal, White blood cell count normal
Clinical narrative: On March 28, 2007, Dr. gave me a tetanus immunization after he removed tic mouthparts from my arm.  Beginning the very next day, I began experiencing itching/tingling of the skin on my hands and forearms.  The symptoms continued to worsen during the next several weeks.    I sought medical assistance from my primary care physician, but I was not able to get an appointment with him until July 31, 2007.  During the next couple of months, Dr. requested some blood tests (see box #12 below) and prescribed Hydroxyzine HCl.  The Hydroxyzine did not help my symptoms, and only made me very sleepy.  In September 2007, Dr. requested additional blood tests (see box #12 below).  By October 2007, the tingling/itching of my skin had spread to my upper arms, upper back, and neck.  By December 2007, the discomfort had spread to  my legs.  Dr  referred me to a dermatologist.    I met with Dr. in January and February 2008.   Dr. performed no tests, but prescribed a topical cream including Hydrocortisone acetate 2.5% and Pramoxine HCl 1% and Fexofenading HCl tablets.  These medications did not help, so Dr. referred me to a neurologist.  I met with Dr. and/or his medical staff on five occasions between March 2008 and today, May 21, 2008.  He conducted some tests (see box #12 below) and concluded that I had mild carpal tunnel syndrome in the right wrist.  He injected me with cortisone in the right wrist, but it had no effect.  He did not seem to be able to explain why carpal tunnel syndrome in the right wrist might cause symptoms in all of my other extermities.  At my meeting with Dr's nurse practitioner today, she has requested a punch biopsy for small fiber neuropathy to be done in June 2008.  To the best of my knowledge, none of the physicians that I consulted have submitted an adverse reaction report, so I am completing one myself.  Please note that these symptoms began the day after I received the tetanus immunization.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Blood test normal, Chest X-ray normal, Convulsion
Clinical narrative: 7 weeks after HPV #2 patient blacked out and c/o severe headache, stiff neck. Admitted to hospital (after ER visit) all tests were negative. She has since had several seizures and c/o muscle and joint pain so severe she has missed 3 weeks of school. 6/2/08-records received for DOS 1/30/08-C/O morning stiffness, fatigue neck and back hurt. Back pain began in January.  Knees, ankles hurt since January, tender to touch. Last week with fever 102 and diarrhea. PE WNL. Assessment: Pain 7/2/08-records received for DOS 1/6-1/9/08-DC DX: neck stiffness, headache, joint pain, cervical muscle spasm.  C/O blacking out and nausea next day followed by headache and paleness. Next day increased neck stiffness and shooting pains down shoulder.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Loss of consciousness, Lumbar puncture normal, Musculoskeletal stiffness, Myalgia
Clinical narrative: 7 weeks after HPV #2 patient blacked out and c/o severe headache, stiff neck. Admitted to hospital (after ER visit) all tests were negative. She has since had several seizures and c/o muscle and joint pain so severe she has missed 3 weeks of school. 6/2/08-records received for DOS 1/30/08-C/O morning stiffness, fatigue neck and back hurt. Back pain began in January.  Knees, ankles hurt since January, tender to touch. Last week with fever 102 and diarrhea. PE WNL. Assessment: Pain 7/2/08-records received for DOS 1/6-1/9/08-DC DX: neck stiffness, headache, joint pain, cervical muscle spasm.  C/O blacking out and nausea next day followed by headache and paleness. Next day increased neck stiffness and shooting pains down shoulder.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: 7 weeks after HPV #2 patient blacked out and c/o severe headache, stiff neck. Admitted to hospital (after ER visit) all tests were negative. She has since had several seizures and c/o muscle and joint pain so severe she has missed 3 weeks of school. 6/2/08-records received for DOS 1/30/08-C/O morning stiffness, fatigue neck and back hurt. Back pain began in January.  Knees, ankles hurt since January, tender to touch. Last week with fever 102 and diarrhea. PE WNL. Assessment: Pain 7/2/08-records received for DOS 1/6-1/9/08-DC DX: neck stiffness, headache, joint pain, cervical muscle spasm.  C/O blacking out and nausea next day followed by headache and paleness. Next day increased neck stiffness and shooting pains down shoulder.
Age: 78.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme increased, Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B antigen positive in a 78-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline). Concurrent medical conditions included congestive heart failure, diabetes, hemodialysis and renal failure. Concurrent medications included DIGOXIN, Metoprolol, CARDIZEM, COUMADIN and LASIX. On 08 May 2008 and 9 April 2008 the subject received 2nd dose and 1st dose of Engerix B at 2 ml (40 mcg). Sometime in April 2008, the subject developed elevated alanine aminotransferase and elevated aspartate aminotransferase. On 08 May 2008, the subject alanine aminotransferase level was 891 and his aspartate aminotransferase level was 33. On 12 May 2008, 4 days after the 2nd vaccination with Engerix B, and an unspecified time after vaccination with Engerix B, the subject was tested and found to be hepatitis B antigen positive. The subject suffered a systemic reaction. Repeated tests showed that the subjects alanine aminotransferase and elevated aspartate aminotransferase levels were dropping (improving) with aspartate aminotransferase at 11 and alanine aminotransferase at 81. At the time of reporting the outcome of the positive hepatitis B antigen was unspecified. The physician considered the events were probably related to vaccination with ENGERIX B.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Benign intracranial hypertension, Blindness, Headache, Lumboperitoneal shunt
Clinical narrative: One month after vaccine, diagnosed with Pseudo Tumor Cerebri.  Major symptoms: headache, loss of vision, vomiting, neck pain, balance off.  Lumbar shunt was put from spine to abdomen to drain spinal fluid.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Vomiting
Clinical narrative: One month after vaccine, diagnosed with Pseudo Tumor Cerebri.  Major symptoms: headache, loss of vision, vomiting, neck pain, balance off.  Lumbar shunt was put from spine to abdomen to drain spinal fluid.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Paraesthesia, Tenderness
Clinical narrative: R arm and neck tingling, weakness, tenderness, sensation, strength reflexes intact
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: After receiving Tdap, arm became swollen, red and hot.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Nausea, Pyrexia, Speech disorder, Vomiting
Clinical narrative: First 24hrs post injection fever, nausea, vomiting and extreme irritability; Symptoms persist for 72hrs and revisit idiopathically >4 months; Speech regression withdrawal with minimal tone verbal communication. Speaking prior to event!
Age: 22.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Significant swelling and pain at injection site with fever over 101.5 degrees F developed within 18 hours of injection and lasted for more than 3 days.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6x8 cm area of swelling and erythema surrounding vaccine site in (L) deltoid.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC
Symptoms: Urticaria
Clinical narrative: Within a few minutes after the vaccines were administered developed hives on face, torso & all 4 extremities.  BENADRYL given IM & epinephrine.  Transferred to ER via ambulance for observation.  Did well.  No further care required.  Discharged from ER after 4 hours observation.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site reaction, Swelling
Clinical narrative: Local injection site reaction. Had temperature of 102 deg the evening that dose was given. Had redness and swelling lasting 3 days. Totally resolved within 3 days. No new symptoms.
Age: 18.0
Sex: M
Vaccine: TTOX
Symptoms: Gait disturbance, Pain, Paraesthesia
Clinical narrative: Donor states post tetanus toxoid injection received at 10:52 on 5-15-08 when he got home his shoulders began to ache moving down to hips and his body throbbed, legs felt light and tingled.  Donor states he has some trouble walking but denies any CP, SOB, rash, cramping, or other symptoms.  Donor reported it lasting about 30 minutes.
Age: 0.36
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Incorrect route of drug administration, Swelling
Clinical narrative: Right buttock is red and swollen
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PEDIARIX and IPV given on same day
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Condition aggravated, Eyelid oedema, Lip swelling, Rash erythematous, Rash generalised
Clinical narrative: Pt. received first dose of rabies vaccine (pre-exposure) on 8/5/08. 3 days after administration, she developed rash on arms, hand and back of legs. Pt stated that she had similar rash in past and felt it was unrelated to vaccine. 2nd dose of rabies vaccine given 8/12/08. 4 days after administration she developed a red itchy rash all over her body, but most on arms and legs. Also had swelling of upper lip and eyelid. Symptoms resolved with ZYRTEC & BENADRYL.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Rash pruritic
Clinical narrative: Pt. received first dose of rabies vaccine (pre-exposure) on 8/5/08. 3 days after administration, she developed rash on arms, hand and back of legs. Pt stated that she had similar rash in past and felt it was unrelated to vaccine. 2nd dose of rabies vaccine given 8/12/08. 4 days after administration she developed a red itchy rash all over her body, but most on arms and legs. Also had swelling of upper lip and eyelid. Symptoms resolved with ZYRTEC & BENADRYL.
Age: 16.0
Sex: F
Vaccine: JEV
Symptoms: Dizziness, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Pt stated that 2 days after receiving 1st Japanese Encephalitis vaccine, she developed dizziness, fever, throat discomfort, "swollen glands". Symptoms have since resolved. Further doses of JE deferred.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Mouth ulceration, Rash
Clinical narrative: On 5/19/08 - came in c/o rash to upper (L) arm and (R) arm, forehead. Also had mouth sores. Was prescribed abx (BACTRIM).
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Skin warm, Urticaria
Clinical narrative: (R) thigh below imm site about 1 cm well demarcated borders, no warmth, + wheal, +flare reaction evident w/ changing hot circumferential.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Heart rate increased, Hypersensitivity, Immediate post-injection reaction, Pallor, Pharyngeal oedema
Clinical narrative: Shortly after shot approximately 5-10 minutes, patient complained of throat feeling tight, flushed, hivey face - chest sounded like a few faint wheeze by stethoscope.  I gave epi s/c and symptoms resolved.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria, Wheezing
Clinical narrative: Shortly after shot approximately 5-10 minutes, patient complained of throat feeling tight, flushed, hivey face - chest sounded like a few faint wheeze by stethoscope.  I gave epi s/c and symptoms resolved.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Flushing, Throat tightness, Urticaria, Wheezing
Clinical narrative: Shortly after shot approximately 5-10 minutes, patient complained of throat feeling tight, flushed, hivey face - chest sounded like a few faint wheeze by stethoscope.  I gave epi s/c and symptoms resolved.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood alkaline phosphatase increased, Blood culture negative, Blood electrolytes normal, Blood glucose normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with a history of removal of condylomas/genital warts, and a family history of breast cancer, who on 02-APR-2008 was vaccinated IM in the left upper quadrant of the thigh with a dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included PROVERA. On 04-APR-2008 the patient felt ill, feverish and achy. On 05-APR-2008 the patient developed a rash and swollen joints which were painful. The patient went to the emergency room and it was suspected that the patient had chicken pox, which was later ruled out. At this time the patient was not admitted to the hospital. On 09-APR-2008 the patient was admitted to the hospital for possible inflammatory arthritis, possible lupus, or possible rheumatoid arthritis. The patient experienced nausea, vomiting, and a rash with myalgia and arthralgias. Other symptoms included swelling and aches in her joints, elevated liver enzymes, fever, malaise, body aches, a rash over her trunk, arms, and legs, and an immediate weight gain of 20 pounds. It was unknown when the weight gain actually started. Rheumatoid studies were conducted. The patient's phosphatase level was 283 and her Creatinine reactive protein test was high. The patient's electrolytes, glucose, and abdominal ultrasound were normal and the blood culture was negative for infection. The patient was treated with intravenous fluid, intravenous pain medications, SOLU-MEDROL and MOTRIN. The patient was admitted to the hospital for three days and discharged with a diagnosis of a possible reaction to the vaccination. It was reported that there was a 75% resolution of acute symptoms with the use of SOLU-MEDROL and MOTRIN. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein increased, Hepatic enzyme increased, Joint swelling, Myalgia, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with a history of removal of condylomas/genital warts, and a family history of breast cancer, who on 02-APR-2008 was vaccinated IM in the left upper quadrant of the thigh with a dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included PROVERA. On 04-APR-2008 the patient felt ill, feverish and achy. On 05-APR-2008 the patient developed a rash and swollen joints which were painful. The patient went to the emergency room and it was suspected that the patient had chicken pox, which was later ruled out. At this time the patient was not admitted to the hospital. On 09-APR-2008 the patient was admitted to the hospital for possible inflammatory arthritis, possible lupus, or possible rheumatoid arthritis. The patient experienced nausea, vomiting, and a rash with myalgia and arthralgias. Other symptoms included swelling and aches in her joints, elevated liver enzymes, fever, malaise, body aches, a rash over her trunk, arms, and legs, and an immediate weight gain of 20 pounds. It was unknown when the weight gain actually started. Rheumatoid studies were conducted. The patient's phosphatase level was 283 and her Creatinine reactive protein test was high. The patient's electrolytes, glucose, and abdominal ultrasound were normal and the blood culture was negative for infection. The patient was treated with intravenous fluid, intravenous pain medications, SOLU-MEDROL and MOTRIN. The patient was admitted to the hospital for three days and discharged with a diagnosis of a possible reaction to the vaccination. It was reported that there was a 75% resolution of acute symptoms with the use of SOLU-MEDROL and MOTRIN. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Rash, Ultrasound abdomen normal, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with a history of removal of condylomas/genital warts, and a family history of breast cancer, who on 02-APR-2008 was vaccinated IM in the left upper quadrant of the thigh with a dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included PROVERA. On 04-APR-2008 the patient felt ill, feverish and achy. On 05-APR-2008 the patient developed a rash and swollen joints which were painful. The patient went to the emergency room and it was suspected that the patient had chicken pox, which was later ruled out. At this time the patient was not admitted to the hospital. On 09-APR-2008 the patient was admitted to the hospital for possible inflammatory arthritis, possible lupus, or possible rheumatoid arthritis. The patient experienced nausea, vomiting, and a rash with myalgia and arthralgias. Other symptoms included swelling and aches in her joints, elevated liver enzymes, fever, malaise, body aches, a rash over her trunk, arms, and legs, and an immediate weight gain of 20 pounds. It was unknown when the weight gain actually started. Rheumatoid studies were conducted. The patient's phosphatase level was 283 and her Creatinine reactive protein test was high. The patient's electrolytes, glucose, and abdominal ultrasound were normal and the blood culture was negative for infection. The patient was treated with intravenous fluid, intravenous pain medications, SOLU-MEDROL and MOTRIN. The patient was admitted to the hospital for three days and discharged with a diagnosis of a possible reaction to the vaccination. It was reported that there was a 75% resolution of acute symptoms with the use of SOLU-MEDROL and MOTRIN. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with a history of removal of condylomas/genital warts, and a family history of breast cancer, who on 02-APR-2008 was vaccinated IM in the left upper quadrant of the thigh with a dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included PROVERA. On 04-APR-2008 the patient felt ill, feverish and achy. On 05-APR-2008 the patient developed a rash and swollen joints which were painful. The patient went to the emergency room and it was suspected that the patient had chicken pox, which was later ruled out. At this time the patient was not admitted to the hospital. On 09-APR-2008 the patient was admitted to the hospital for possible inflammatory arthritis, possible lupus, or possible rheumatoid arthritis. The patient experienced nausea, vomiting, and a rash with myalgia and arthralgias. Other symptoms included swelling and aches in her joints, elevated liver enzymes, fever, malaise, body aches, a rash over her trunk, arms, and legs, and an immediate weight gain of 20 pounds. It was unknown when the weight gain actually started. Rheumatoid studies were conducted. The patient's phosphatase level was 283 and her Creatinine reactive protein test was high. The patient's electrolytes, glucose, and abdominal ultrasound were normal and the blood culture was negative for infection. The patient was treated with intravenous fluid, intravenous pain medications, SOLU-MEDROL and MOTRIN. The patient was admitted to the hospital for three days and discharged with a diagnosis of a possible reaction to the vaccination. It was reported that there was a 75% resolution of acute symptoms with the use of SOLU-MEDROL and MOTRIN. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Neurological symptom
Clinical narrative: Information has been received from a health care professional concerning a female (age unknown), who was vaccinated with a dose of GARDASIL.  Subsequently, the patient experienced neurological changes and had difficulty walking.  It was reported that she would not receive her third dose.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  The reporter considered the neurological changes and difficulty walking to be disabling.  Additional information is not available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female with concomitant medications, drug allergies and pertinent medical history not specified, who on 10-MAY-2008 was vaccinated with a dose of PNEUMOVAX 23, IM, (Lot# not specified), while hospitalised for an unspecified condition.  Subsequently in MAY-2008 the patient developed a severe localised reaction and the injection site was red and hot.  The patient also developed edema.  At the time of reporting, the outcome of the events was that the patient was "home and stable."  It was noted by the reporter that the patient's experiences caused a prolonged hospitalization.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Clinical narrative: Diagnosed intussusception treated at hospital.  6/24/08 Reviewed hospital medical records of 5/15-5/20/2008. FINAL DX: Ileocolic intussusception, surgically reduced.  No d/c summary available. Records reveal patient experienced crampy abdominal pain, vomiting X 2 days. Seen in outlying ER, dx w/IS & transferred to higher level of care.  Air contrast enema demonstrated IS but unable to reduce.  Taken to OR for manual reduction & appendectomy.  Had been seen in ER on 5/12-13 for crying & non-bilious vomiting.  Tolerated PO fluids at that time & d/c to home.
Age: 0.2
Sex: F
Vaccine: HEP, HIBV
Symptoms: Convulsion, Crying, Depressed level of consciousness, Electroencephalogram normal, Gaze palsy
Clinical narrative: Crying, decreased sleep followed by seizure like episode upward gaze, unable to arouse hyporesponsive.  6/24/08 Reviewed hospital medical records of 5/14-5/16/2008. FINAL DX: possible seizure Records reveal patient experienced fever, flushing, fine diffuse rash & left arm welt like rash, irritability, screaming x 2 days.  Left eyelid red, swollen w/drainage. On day of admission eyes rolled back, deep sleep, pale, difficult to arouse then very lethargic after awakened.  Neuro consult done.
Age: 0.2
Sex: F
Vaccine: HEP, HIBV
Symptoms: Insomnia
Clinical narrative: Crying, decreased sleep followed by seizure like episode upward gaze, unable to arouse hyporesponsive.  6/24/08 Reviewed hospital medical records of 5/14-5/16/2008. FINAL DX: possible seizure Records reveal patient experienced fever, flushing, fine diffuse rash & left arm welt like rash, irritability, screaming x 2 days.  Left eyelid red, swollen w/drainage. On day of admission eyes rolled back, deep sleep, pale, difficult to arouse then very lethargic after awakened.  Neuro consult done.