chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Constipation, Deafness unilateral, Dizziness, Nuclear magnetic resonance imaging
Clinical narrative: I awoke on Nov. 10, 2009 to a noise in my left ear. It intensified and I got up and went about my usual routing preparing to go to work. I had severe constipation and finally became dizzy and had the dry heaves and complete hearing loss in my left ear. My husband took me to Dr. where they did a hearing test and he prescribed an antibiotic even though he didn't see any infection. When my hearing didn't return in a few days I made an appointment with an ENT. Dr. gave me a hearing test and prescribed prednisone which I was unable to take due to severe adverse reaction. I then went to another ENT, Dr. on 12/21 and he prescribed an antiviral and steroid. He recommended I see another doctor who specializes in this type of sudden hearing loss. I have an appointment with him on 1/7/2010. Also have appointment with an acupuncture doctor on 1/9/2010.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Sudden hearing loss
Clinical narrative: I awoke on Nov. 10, 2009 to a noise in my left ear. It intensified and I got up and went about my usual routing preparing to go to work. I had severe constipation and finally became dizzy and had the dry heaves and complete hearing loss in my left ear. My husband took me to Dr. where they did a hearing test and he prescribed an antibiotic even though he didn't see any infection. When my hearing didn't return in a few days I made an appointment with an ENT. Dr. gave me a hearing test and prescribed prednisone which I was unable to take due to severe adverse reaction. I then went to another ENT, Dr. on 12/21 and he prescribed an antiviral and steroid. He recommended I see another doctor who specializes in this type of sudden hearing loss. I have an appointment with him on 1/7/2010. Also have appointment with an acupuncture doctor on 1/9/2010.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Radiculitis brachial
Clinical narrative: Shoulder pain. severe, starting 6/09 and subsequent shoulder weakness, symptoms and MRI consistent with brachial neuritis.
Age: 53.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Fatigue
Clinical narrative: Developed dull chest pain, extreme fatigue one day post vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dyspnoea, Eyelid oedema, Oxygen saturation decreased, Urticaria, Wheezing
Clinical narrative: Swelling of eyelids, mild urticaria, increase work of breathing with wheezing within 10 minutes of vaccine. Immediately given EPI pen & Nebs with resolution of some symptoms soon after.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema Rt. deltoid, warm to touch. 9 x 9 cm.
Age: 1.06
Sex: M
Vaccine: FLU(H1N1), HEPA, MMR, VARCEL
Symptoms: Facial paresis, Pyrexia, Vomiting
Clinical narrative: 103F fever x 3 days by parent report. Laxity of left facial muscles of expression. Vomiting x 2.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Cough, Pain
Clinical narrative: Less than 24 hours after receiving FLU-MIST had 102 - 103 temp / body aches / cough, Sx's for about 2-3 days.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm significant swelling, heat, and redness after receiving shot Sunday 12-20-09. Pt taking TYLENOL. Swelling is decreasing wit ice, exercise. Pt continuing with ice, ibuprofen, BENADRYL.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Condition aggravated, Convulsion, Loss of consciousness, Syncope, Tremor
Clinical narrative: 12/22 4:20 pm - Pt playing with sister turned on floor trembling and LOC. RN called. Now feels ok, lucid. H/O seizure. Dx syncope, check seizure.
Age: 1.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Unevaluable event
Clinical narrative: No AE's.  Follow up received on 1/5/2010. Patient 1 yr old. Given H1N1 for 3 yrs & older, on 12/21/09. No adverse effects.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Dizziness, Full blood count
Clinical narrative: DIARRHEA, DIZZINESS
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Amnesia, Convulsion, Encephalitis, Fatigue
Clinical narrative: According to the patient's father, the patient was complaining of stomach pain, had a low grade fever of 99.6, was extremely tired, and was very pale on 12/09/2009.  On 12/10/2009 she developed seizures and was admitted to a local hospital.  The neurologist stated to her parents that she thinks that the patient developed encephalitis due to some type of virus.   The patient's father said that the patient still has problems with short term memory loss.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Lumbar puncture, Pallor, Pyrexia
Clinical narrative: According to the patient's father, the patient was complaining of stomach pain, had a low grade fever of 99.6, was extremely tired, and was very pale on 12/09/2009.  On 12/10/2009 she developed seizures and was admitted to a local hospital.  The neurologist stated to her parents that she thinks that the patient developed encephalitis due to some type of virus.   The patient's father said that the patient still has problems with short term memory loss.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Mechanical ventilation, Metabolic acidosis, Sepsis, Unresponsive to stimuli
Clinical narrative: Found unresponsive in a cell at prison. Brought to emergency room with temperature of 107F, metabolic acidosis, sepsis and required ventilation. No signs of illness on the evening of 11/26/2009.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Oedema peripheral, Ultrasound scan abnormal
Clinical narrative: Patient woke with enlarged leg, left thigh. Parents started factor right away. Called the office later to see what to do. Dr recommended ER. went to ER next day 12/19/09. Had ultra sound of leg, appeared injection went into muscle. Started on antibiotic to prevent cellulitis.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site nodule, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Left arm swollen, client complained of pain and stinging. States pain goes down all of arm.  Knot felt at injection site.  Denies any difficulty breathing or itching.  Referred to MD.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Activities of daily living impaired, Alopecia, Back pain, Depression
Clinical narrative: My entire life I have been very active, worked out every day of my life since 15, never ever in my life had any sort of acne...no health problems.  About a year ago everything changed, in the past year I have gained exactly 27 pounds and although I continue and try to workout I am unable to lose this weight...I am so fatigued to the point I cant get out of bed most days which has affected a few semesters of college and I have lost a few jobs due to this fatigue which I cannot control.  I am unable to bend over and pick anything up without getting dizzy and any activity as simple as running up the stairs my heart speeds up and I am out of breath and need to sit. I have consistently had a minimum of 2 migraines a week in which I am unable to leave the house this has been for the past year, and prior to these migraines I have extreme back and neck pain which painkillers cannot even help.  I have been to numerous dermatologists trying to resolve 2 issues, adult acne AND excessive facial hair growth on my jawline, chin and under chin to the point Ii just use a razor now to remove the hair as I am unable to afford full laser hair removal and insurance does not cover.  My entire life I have had beautiful thick hair, in fact so thick I would get stopped by people with compliments however the past year I pull chucks of hair out in the shower and it is very thin and brittle now.  I have done so much blood work and every test in the book.  In the past year I have been to a heart doctor, dermatologists, chiropractors, endocrinologist, natural homeopathic doctor, and 3 different physicians and NO ONE has a solution...my mom has been very down as she is upset for me and with me we feel so lost nobody has any idea what is going on.  The past year I have consistently described myself as "this is not me and this is not my body".  I now get depressed as I have no control of the weight gain or acne or facial hair or hair loss or any of this.  My numerous doctor visits and mental pain I have endured have left a hole in my family's wallet and in my spirit.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness exertional, Dyspnoea, Fatigue, Heart rate increased, Hypertrichosis
Clinical narrative: My entire life I have been very active, worked out every day of my life since 15, never ever in my life had any sort of acne...no health problems.  About a year ago everything changed, in the past year I have gained exactly 27 pounds and although I continue and try to workout I am unable to lose this weight...I am so fatigued to the point I cant get out of bed most days which has affected a few semesters of college and I have lost a few jobs due to this fatigue which I cannot control.  I am unable to bend over and pick anything up without getting dizzy and any activity as simple as running up the stairs my heart speeds up and I am out of breath and need to sit. I have consistently had a minimum of 2 migraines a week in which I am unable to leave the house this has been for the past year, and prior to these migraines I have extreme back and neck pain which painkillers cannot even help.  I have been to numerous dermatologists trying to resolve 2 issues, adult acne AND excessive facial hair growth on my jawline, chin and under chin to the point Ii just use a razor now to remove the hair as I am unable to afford full laser hair removal and insurance does not cover.  My entire life I have had beautiful thick hair, in fact so thick I would get stopped by people with compliments however the past year I pull chucks of hair out in the shower and it is very thin and brittle now.  I have done so much blood work and every test in the book.  In the past year I have been to a heart doctor, dermatologists, chiropractors, endocrinologist, natural homeopathic doctor, and 3 different physicians and NO ONE has a solution...my mom has been very down as she is upset for me and with me we feel so lost nobody has any idea what is going on.  The past year I have consistently described myself as "this is not me and this is not my body".  I now get depressed as I have no control of the weight gain or acne or facial hair or hair loss or any of this.  My numerous doctor visits and mental pain I have endured have left a hole in my family's wallet and in my spirit.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Neck pain, Weight increased, Weight loss poor
Clinical narrative: My entire life I have been very active, worked out every day of my life since 15, never ever in my life had any sort of acne...no health problems.  About a year ago everything changed, in the past year I have gained exactly 27 pounds and although I continue and try to workout I am unable to lose this weight...I am so fatigued to the point I cant get out of bed most days which has affected a few semesters of college and I have lost a few jobs due to this fatigue which I cannot control.  I am unable to bend over and pick anything up without getting dizzy and any activity as simple as running up the stairs my heart speeds up and I am out of breath and need to sit. I have consistently had a minimum of 2 migraines a week in which I am unable to leave the house this has been for the past year, and prior to these migraines I have extreme back and neck pain which painkillers cannot even help.  I have been to numerous dermatologists trying to resolve 2 issues, adult acne AND excessive facial hair growth on my jawline, chin and under chin to the point Ii just use a razor now to remove the hair as I am unable to afford full laser hair removal and insurance does not cover.  My entire life I have had beautiful thick hair, in fact so thick I would get stopped by people with compliments however the past year I pull chucks of hair out in the shower and it is very thin and brittle now.  I have done so much blood work and every test in the book.  In the past year I have been to a heart doctor, dermatologists, chiropractors, endocrinologist, natural homeopathic doctor, and 3 different physicians and NO ONE has a solution...my mom has been very down as she is upset for me and with me we feel so lost nobody has any idea what is going on.  The past year I have consistently described myself as "this is not me and this is not my body".  I now get depressed as I have no control of the weight gain or acne or facial hair or hair loss or any of this.  My numerous doctor visits and mental pain I have endured have left a hole in my family's wallet and in my spirit.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blindness, Excoriation, Loss of consciousness
Clinical narrative: Patient was standing for injections Gardisal #3 administered in L.A. then Hep A #2 administered in R.A. About 2 minutes after receiving injections, patient stated "Can't see" and passed out.  Mom and I helped her to the floor.  Patient aroused in a few seconds was helped to table.  BP was 114/68.  Patient did have breakfast this AM.  Received small 1/2 inch superficial abrasion on left elbow. Cleansed with sterile water and gauze, neosporin and bandaid applied.   Patient moved to sitting position BP 118/62.  Patient moved to standing position. Patient able to walk out of office, no dizziness, feeling fine.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Hypokinesia, Injection site atrophy, Injection site inflammation, Injection site pain, Monoplegia
Clinical narrative: Soreness, inflamation, partial paralysis and muscle atrophy at vaccination site (upper right arm). In ability to raise arm above shoulder height.  Fully normal use of right arm returned after 4-5 months.  Still have "depression" in muscle at vaccine site.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Heart rate increased
Clinical narrative: Headache, dizziness, increased heart rate that had subsided within short time.
Age: 14.0
Sex: F
Vaccine: HEPA, HPVX, MEN, VARCEL
Symptoms: Anogenital warts, Biopsy, Precancerous skin lesion
Clinical narrative: Started noticing Anal Warts, Patient didn't report them to her mother until 20th of October when they were advanced to an uncomfortable stage, Near 20th of October, saw Dr regarding the warts, referred to another Dr, seen on November 4th and November 16th.  Sent to surgeon on November 26th.  1st Surgery to remove outer anal warts was on December 18th.  Patient requires future surgery to remove internal anal warts.  Biopsy on November 16th showed pre-cancerous evolution of warts.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, and induration at injection site on left leg (Prevnar).  Red area around 4 inches across, also around injection site on left leg. Irritability and increased sleepiness.  Stumbling either from pain, dizziness or lack of coordination (exact cause unknown).
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Irritability, Somnolence
Clinical narrative: Swelling, pain, and induration at injection site on left leg (Prevnar).  Red area around 4 inches across, also around injection site on left leg. Irritability and increased sleepiness.  Stumbling either from pain, dizziness or lack of coordination (exact cause unknown).
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Mother reported: child was chipper until shortly after getting shot.  He became lethargic, dragging his book bag on the ground.  That night he ran a 102 degree temperature that last one week.  He then started vomiting which lasted 4-5 days.  He was sick for 2 weeks and was in and out the ER during that time.
Age: 37.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Cholestasis, Chromaturia, Injection site pruritus, Liver function test abnormal, Local reaction
Clinical narrative: The following day, she developed a local reaction at both vaccine sites, intense pruritus, and orange urine.  She had LFTs performed on 12/21/09 which revealed both a transaminitis and cholestatic pattern.
Age: 37.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Transaminases increased, Ultrasound scan normal
Clinical narrative: The following day, she developed a local reaction at both vaccine sites, intense pruritus, and orange urine.  She had LFTs performed on 12/21/09 which revealed both a transaminitis and cholestatic pattern.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Babinski reflex test, Dyspnoea, Epstein-Barr virus antibody negative, Facial paresis, Lipids normal
Clinical narrative: Bilateral leg weakness, progressive arm weakness, weakness in jaw muscles, shortness of breath, deep tendon reflexes of +3 with negative Babinski sign, decreased peak flow.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Liver function test normal, Metabolic function test, Mononucleosis heterophile test negative, Muscular weakness, Peak expiratory flow rate decreased
Clinical narrative: Bilateral leg weakness, progressive arm weakness, weakness in jaw muscles, shortness of breath, deep tendon reflexes of +3 with negative Babinski sign, decreased peak flow.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dermatitis allergic, Eye swelling, Pruritus, Rash, Swelling face
Clinical narrative: Felt itching and notice a small bump on her face and went to sleep. When she woke up, in the morning, she notice her tongue, eyes, and face was swollen, and has a rash like pimples all over her face, and also had 4 episodes of vomiting.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Swollen tongue, Vomiting
Clinical narrative: Felt itching and notice a small bump on her face and went to sleep. When she woke up, in the morning, she notice her tongue, eyes, and face was swollen, and has a rash like pimples all over her face, and also had 4 episodes of vomiting.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Abdominal pain upper, Asthenia, Cellulitis, Erythema, Fluid replacement
Clinical narrative: During the evening after the influenza and pneumovax vaccine, began to not feel well with headache, nausea and stomach pain. Right arm became swollen and red. The next day was spent in bed, taking tylenol for pain still in right arm. Early the next day at 0300, was nauseous, still in pain, weak, stood up from bed and had syncope. Taken by EMS to local hospital. Admitted, given fluids and iv antibiotics for presumed cellulitis of right upper arm. sent home on po levaquin. recovered fully.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Malaise, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: During the evening after the influenza and pneumovax vaccine, began to not feel well with headache, nausea and stomach pain. Right arm became swollen and red. The next day was spent in bed, taking tylenol for pain still in right arm. Early the next day at 0300, was nauseous, still in pain, weak, stood up from bed and had syncope. Taken by EMS to local hospital. Admitted, given fluids and iv antibiotics for presumed cellulitis of right upper arm. sent home on po levaquin. recovered fully.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Syncope
Clinical narrative: During the evening after the influenza and pneumovax vaccine, began to not feel well with headache, nausea and stomach pain. Right arm became swollen and red. The next day was spent in bed, taking tylenol for pain still in right arm. Early the next day at 0300, was nauseous, still in pain, weak, stood up from bed and had syncope. Taken by EMS to local hospital. Admitted, given fluids and iv antibiotics for presumed cellulitis of right upper arm. sent home on po levaquin. recovered fully.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Basophil percentage, Blood creatine phosphokinase increased, C-reactive protein normal, Eosinophil percentage, Lymphocyte percentage increased
Clinical narrative: Previously well 20yo woman who takes birth control pills only received H1N1 vaccination at Hospital on the afternoon of 12/17/09. 1-2 hours following vaccine administration in the left deltoid, she developed diffuse myalgias and malaise. The following day developed exquisite left thigh tenderness that worsened over the next 24 hours. Had an emergency room evaluation that was unrevealing except for mildly elevated CPK (163) and mild lymphocytosis. An ultrasound of the left leg to evaluate for deep venous thrombosis was negative. By 12/22/09, pain in the thigh has resolved somewhat. CPK has normalized, CRP and ESR remain normal. Clinical appearance is that of a focal myositis or mononeuritis of the lateral femoral cutaneous nerve.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lymphocytosis, Malaise, Monocyte percentage, Myalgia, Neutrophil percentage decreased
Clinical narrative: Previously well 20yo woman who takes birth control pills only received H1N1 vaccination at Hospital on the afternoon of 12/17/09. 1-2 hours following vaccine administration in the left deltoid, she developed diffuse myalgias and malaise. The following day developed exquisite left thigh tenderness that worsened over the next 24 hours. Had an emergency room evaluation that was unrevealing except for mildly elevated CPK (163) and mild lymphocytosis. An ultrasound of the left leg to evaluate for deep venous thrombosis was negative. By 12/22/09, pain in the thigh has resolved somewhat. CPK has normalized, CRP and ESR remain normal. Clinical appearance is that of a focal myositis or mononeuritis of the lateral femoral cutaneous nerve.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Red blood cell sedimentation rate normal, Tenderness, Transaminases, Ultrasound scan normal, White blood cell count normal
Clinical narrative: Previously well 20yo woman who takes birth control pills only received H1N1 vaccination at Hospital on the afternoon of 12/17/09. 1-2 hours following vaccine administration in the left deltoid, she developed diffuse myalgias and malaise. The following day developed exquisite left thigh tenderness that worsened over the next 24 hours. Had an emergency room evaluation that was unrevealing except for mildly elevated CPK (163) and mild lymphocytosis. An ultrasound of the left leg to evaluate for deep venous thrombosis was negative. By 12/22/09, pain in the thigh has resolved somewhat. CPK has normalized, CRP and ESR remain normal. Clinical appearance is that of a focal myositis or mononeuritis of the lateral femoral cutaneous nerve.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium increased, Blood sodium normal
Clinical narrative: difficulty of swallowing feeling food stuck at throat and painful anterior chest Follow-up Information 26-JAN-2010: Thank you very much. I like to inform you that I am the patient who received the H1N1 vaccine at the hospital. I have no recall of any prior symptoms of odynophagia nor dysphagia prior to the the vaccination I am currently suffering from continuous sore throat for the last 2 1/2 months you can contact me at my office I just finished this am a test at the university for tonometry of the esophagus, I am scheduled to have a videofluoroscopy tomorrow, and next week I shall have a Bravo capsule to evaluate the possible reflux which I believe is due to the loss of tone of the lower esophageal sphincter after the flu shot I don't recall having any prior symptoms of reflux nor any problem with swallowing prior to the injection I shall forward the information you want after is completed.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Blood thyroid stimulating hormone normal, Blood urea normal, Chest pain, Computerised tomogram normal, Dysphagia
Clinical narrative: difficulty of swallowing feeling food stuck at throat and painful anterior chest Follow-up Information 26-JAN-2010: Thank you very much. I like to inform you that I am the patient who received the H1N1 vaccine at the hospital. I have no recall of any prior symptoms of odynophagia nor dysphagia prior to the the vaccination I am currently suffering from continuous sore throat for the last 2 1/2 months you can contact me at my office I just finished this am a test at the university for tonometry of the esophagus, I am scheduled to have a videofluoroscopy tomorrow, and next week I shall have a Bravo capsule to evaluate the possible reflux which I believe is due to the loss of tone of the lower esophageal sphincter after the flu shot I don't recall having any prior symptoms of reflux nor any problem with swallowing prior to the injection I shall forward the information you want after is completed.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Electrocardiogram normal, Endoscopy abnormal, Haematocrit normal, Haemoglobin normal, Red blood cell count increased
Clinical narrative: difficulty of swallowing feeling food stuck at throat and painful anterior chest Follow-up Information 26-JAN-2010: Thank you very much. I like to inform you that I am the patient who received the H1N1 vaccine at the hospital. I have no recall of any prior symptoms of odynophagia nor dysphagia prior to the the vaccination I am currently suffering from continuous sore throat for the last 2 1/2 months you can contact me at my office I just finished this am a test at the university for tonometry of the esophagus, I am scheduled to have a videofluoroscopy tomorrow, and next week I shall have a Bravo capsule to evaluate the possible reflux which I believe is due to the loss of tone of the lower esophageal sphincter after the flu shot I don't recall having any prior symptoms of reflux nor any problem with swallowing prior to the injection I shall forward the information you want after is completed.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Sensation of foreign body, White blood cell count decreased
Clinical narrative: difficulty of swallowing feeling food stuck at throat and painful anterior chest Follow-up Information 26-JAN-2010: Thank you very much. I like to inform you that I am the patient who received the H1N1 vaccine at the hospital. I have no recall of any prior symptoms of odynophagia nor dysphagia prior to the the vaccination I am currently suffering from continuous sore throat for the last 2 1/2 months you can contact me at my office I just finished this am a test at the university for tonometry of the esophagus, I am scheduled to have a videofluoroscopy tomorrow, and next week I shall have a Bravo capsule to evaluate the possible reflux which I believe is due to the loss of tone of the lower esophageal sphincter after the flu shot I don't recall having any prior symptoms of reflux nor any problem with swallowing prior to the injection I shall forward the information you want after is completed.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Erythema, Petechiae, Rash
Clinical narrative: Within a few hours after her two-month vaccinations, the baby developed a rash, restricted to the lower torso, mainly her legs, which cleared after five days.  No reaction at the immunization site, no swelling.  The parents did not report this.  With her second vaccination, this repeated itself but more prominently, showing petechial and confluent, intense erythema, same distribution, and timing, but no symptoms of systemic illness.
Age: 1.47
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Rash generalised
Clinical narrative: Rash all over body. No itching, fever or difficulty breathing. Saw Doctor on 12/21/09. No treatment or testing done. Rash beginning to diminish on own. On 12/22/09 rash only present on stomach and hands.
Age: 32.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arrhythmia, Back pain, Blepharospasm, Dizziness, Guillain-Barre syndrome
Clinical narrative: Dizziness, fainting. Days later legs, butt, and lower back experienced soreness. Approximately two weeks later night sweats, facial and neck/chest cramping, and eye twitching all day long with mild cardiac arrhythmias. All stimulants such as coffee were removed from diet and supplemental vitamins B6, B12, D, Calcium, Magnesium, Zinc were added to an increased daily fluid consumption. Symptoms are currently present, but have significantly decreased in strength and frequency over the last few days, as of 12/22/2009. The timeline and the symptoms suggest a mild case of the Miller Fisher variant of Guillain-Barré syndrome. The absence of fever and slow progression of symptoms caused a delay in reporting this as an adverse event relating to the vaccination.
Age: 32.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Miller Fisher syndrome, Muscle spasms, Musculoskeletal pain, Night sweats, Pain in extremity
Clinical narrative: Dizziness, fainting. Days later legs, butt, and lower back experienced soreness. Approximately two weeks later night sweats, facial and neck/chest cramping, and eye twitching all day long with mild cardiac arrhythmias. All stimulants such as coffee were removed from diet and supplemental vitamins B6, B12, D, Calcium, Magnesium, Zinc were added to an increased daily fluid consumption. Symptoms are currently present, but have significantly decreased in strength and frequency over the last few days, as of 12/22/2009. The timeline and the symptoms suggest a mild case of the Miller Fisher variant of Guillain-Barré syndrome. The absence of fever and slow progression of symptoms caused a delay in reporting this as an adverse event relating to the vaccination.
Age: 32.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Syncope
Clinical narrative: Dizziness, fainting. Days later legs, butt, and lower back experienced soreness. Approximately two weeks later night sweats, facial and neck/chest cramping, and eye twitching all day long with mild cardiac arrhythmias. All stimulants such as coffee were removed from diet and supplemental vitamins B6, B12, D, Calcium, Magnesium, Zinc were added to an increased daily fluid consumption. Symptoms are currently present, but have significantly decreased in strength and frequency over the last few days, as of 12/22/2009. The timeline and the symptoms suggest a mild case of the Miller Fisher variant of Guillain-Barré syndrome. The absence of fever and slow progression of symptoms caused a delay in reporting this as an adverse event relating to the vaccination.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Nerve injury, Pain, Physiotherapy
Clinical narrative: unable to lift arm where injection was given. Great deal of pain
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Cough, Dyspnoea, Pain
Clinical narrative: Severe cough, shortness of breath, chest pains and body aches. Patient saw Doctor on 12/22 and was given Avelox and Cyproheptadine.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: Fever 102.7 F
Age: 0.26
Sex: M
Vaccine: DTAP, PNC
Symptoms: Crying, Culture negative, Culture urine negative, Feeding disorder neonatal, Full blood count
Clinical narrative: Fever 102-104 x 3 days, inconsolable high pitched crying x 2 days, poor feeding.  Family went to ER.
Age: 0.26
Sex: M
Vaccine: DTAP, PNC
Symptoms: Haemoglobin, Pyrexia
Clinical narrative: Fever 102-104 x 3 days, inconsolable high pitched crying x 2 days, poor feeding.  Family went to ER.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Intra-uterine death
Clinical narrative: Pregnancy symptoms lost. Two weeks later ultrasound confirmed development of embryo stopped at 5 weeks.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: High temp of 104 F per ear, this was noted @ 8pm. Noticed spots appearing on face and back @ this time also. She ran a temp until 12/20/09 PM. Spots are on most of her body at this time. She was taken to family Dr. Monday AM and was instructed to this website. Currently she still has spots but they are more faint now, she is afebrile, and no s/s of itchiness.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abasia, Abnormal behaviour, Acute disseminated encephalomyelitis, Aphasia, Asthenia
Clinical narrative: A serious, spontaneous report of encephalopathy with non-serious events of delirium, could not sleep, sore throat, irritable and nightmares has been received from a father/consumer concerning a 45-month-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal vaccination. Neither concomitant medications nor medical history were reported for this patient. The patient has received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 06-Nov-2009, the patient received a second dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days. The patient could not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Delirium, Drooling, Dysphagia, Encephalopathy, Gastrointestinal tube insertion
Clinical narrative: A serious, spontaneous report of encephalopathy with non-serious events of delirium, could not sleep, sore throat, irritable and nightmares has been received from a father/consumer concerning a 45-month-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal vaccination. Neither concomitant medications nor medical history were reported for this patient. The patient has received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 06-Nov-2009, the patient received a second dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days. The patient could not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Influenza A virus test negative, Insomnia, Irritability
Clinical narrative: A serious, spontaneous report of encephalopathy with non-serious events of delirium, could not sleep, sore throat, irritable and nightmares has been received from a father/consumer concerning a 45-month-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal vaccination. Neither concomitant medications nor medical history were reported for this patient. The patient has received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 06-Nov-2009, the patient received a second dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days. The patient could not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Lumbar puncture, Nightmare, Nuclear magnetic resonance imaging, Oropharyngeal pain, Poor quality sleep
Clinical narrative: A serious, spontaneous report of encephalopathy with non-serious events of delirium, could not sleep, sore throat, irritable and nightmares has been received from a father/consumer concerning a 45-month-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal vaccination. Neither concomitant medications nor medical history were reported for this patient. The patient has received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 06-Nov-2009, the patient received a second dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days. The patient could not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Posture abnormal, Pyrexia, Vomiting
Clinical narrative: A serious, spontaneous report of encephalopathy with non-serious events of delirium, could not sleep, sore throat, irritable and nightmares has been received from a father/consumer concerning a 45-month-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal vaccination. Neither concomitant medications nor medical history were reported for this patient. The patient has received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 06-Nov-2009, the patient received a second dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days. The patient could not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received via pediatric medical records from a physician concerning a newborn patient with passive smoke risk who's mother was vaccinated IM on 04-Dec-2008 with a 0.5ml first dose of GARDASIL while pregnant (WAES#0812USA1628). It was reported that on 13-JUL-2009, at the age of 3 days, the baby underwent an ultrasound test in order to investigate a scrotal mass. The ultrasound revealed moderate right sided hydrocele. The baby's testicles appeared to be normal with the right testicle measuring 1cm and the left testicle 9mm. Arterial flow was noted in both testicles. The epididmyides appear normal. On 13-JUL-2009 the following test results were obtained: blood lymphocyte count 25.0%, blood segmented neutrophil count 65.0%; blood band neutrophil count 4%, slight anisocyte observation, slight poikilocyte observation, slight polychromatic erythrocyte observation, slight macrocyte observation. Also performed on this day were congenital hypothyroidism, hemoglobinopathy, galactosemai, biotinidase deficiency, congenital adrenal hyperplasia, cystic fibrosis, amino acid profile, fatty acid profile and organic acid profile. All reported as normal. The baby was seen for multiple well visits where the genitalia was reported as normal. At the time of this event, the patient recovered from Hydrocele. No further information is available. All available medical records will be provided upon request.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female patient who was vaccinated with a dose of GARDASIL (no lot number provided).  At "some point in the past" after receiving GARDASIL, the patient became pregnant and subsequently experienced miscarriage.  At the time of reporting, the outcome was unknown.  The patient sought unspecified medical attention.  Upon internal review, miscarriage was considered to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a respiratory therapist, pediatrician, nurse and office assistant via pediatric medical records concerning a newborn male patient with no known drug allergies who was born on 04-MAY-2009 by C-section (WAES# 0908USA03124). It was reported that on August 2008, the mother was vaccinated with a dose of GARDASIL (lot not reported) while pregnant. According to the reporter, the patient was born with "3 holes in his heart". It was unknown if the patient and her baby sought medical attention. The respiratory therapist stated that her baby was "doing OK right now". Nurse did confirm patient had a caesarian delivery on 04-MAY-2009 and he was a healthy male child. On 07-May-2009, a direct bilirubin test was performed with results of 0.23. Also on this day a blood urea nitrogen was performed with results of 7 and a total bilirubin was performed with results of 8.39. On 08-MAY-2009, a total bilirubin (7.73), direct bilirubin (0.19) and indirect bilirubin (7.54) were performed. There was no concomitant medication reported. It was reported that on 11-May-2009 that the baby experienced jaundice. According to the office assistant who pulled the baby's chart it was reported that at the office they had a report verbal only, noted in the chart from the pediatric cardiologist. It was reported that the baby was seen on 17-May-2009 and had a septal defect. The reporter stated that the cardiologist was going to "give it time to see if it was self-correcting, and scheduled a follow-up evaluation for the baby in six months". At that day the physician's office did not have any follow-up evaluation from the cardiologist. The office assistant provided cardiologist information. On 29-May-2009, the patient had a well child visit with no complaints. On 02-June-2009, the baby was seen for loose stools and fussiness. On 10-JUL-2009, the patient had his 2 month well child visit. On 31-JUL-2009 the baby was seen for upper respiratory infection and cough, which resolved on approximately 14-AUG-2009. On 21-AUG-2009 the baby was seen for a questionable earache. At the time of the report the outcome of the baby's cardiac septal defect, diarrhea, earache, Hyperbilirubinemia, irritability and jaundice were unknown. Upon internal review, "3 holes in heart" was considered to be a congenital anomaly. Additional information has been requested.  All available medical records will be provided upon request.
Age: 83.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Culture wound negative, Dyspnoea, Incisional drainage, Injection site discharge
Clinical narrative: Information has been received from a health professional concerning an 83 year old male patient who on 22-OCT-2009 was hospitalized due to cardiac failure congestive and hypoxia who on 25-OCT-2009 while he was hospitalized was vaccinated in the left deltoid with a dose of PNEUMOVAX and also was vaccinated in the right deltoid with a dose of influenza virus vaccine (unspecified) (manufacturer unknown) the same day. The patient was vaccinated with a dose of PNEUMOVAX 10 years prior, in 1999. The patient was discharged from the hospital on 25-OCT-2009. On 16-NOV-2009 the patient was seen in the physician office because he developed cellulitis in the left arm. The injection site area was red and swollen and there was a 5x5 area of induration. The patient had pustules and purulent drainage from the area. A culture was performed but no microorganisms were seen. The patient was change from CIPRO to LEVAQUIN. On 23-NOV-2009 the patient returned to the office for a follow-up visit, the physician observed some improvement but the purulent drainage continued. The wound was incised and drained. On 28-NOV-2009 the patient was readmitted to the hospital for shortness of breath and difficulty breathing. The cellulitis on the left arm was still mildly tender and draining. On an unspecified date the patient was discharged from the hospital. On 07-DEC-2009 the patient had a follow up visit with the physician. At the time of the report the patient's outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.