chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Type 1 diabetes mellitus, Urine ketone body present
Clinical narrative: 22 y/o was in his usual state of excellent health prior to Feb-Mar 2010. At the time, he was attending college. Looking back, around Feb 2010, former SM recalls developing fatigue and the feeling of being run down - "activity taking more out of me". He recalls experiencing polydipsia and polyuria during the month of March 2010. He was not aware of weight loss, but he recalls a few people asking him about how much weight he had lost. He did not experience visual changes, N/V, polyphagia or numbness and tingling in his extremities. By 21 Apr 2010, his symptoms had increased significantly to the point they were interfering with his daily activities and he sought evaluation with his PCM. At that time, a glucose level of 318, trace positive urine ketones, and HgbA1c of 10.5 led to his diagnosis of T1DM. Insulin was initiated as outpatient a time of diagnosis. Patient then received D5ME and his insulin was titrated as needed. Around May, he was evaluated by his Endocrinologist and in August 2010, he was placed on an insulin pump. He was medically discharged from the National Guard in Feb 2011. He currently is working and residing in MD and has found a local PCM, but continues Endocrinologist follow up. SM received Hepatitis B and Influenza vaccines in Nov 2009 and MMR vaccine in July 2009 - See left column for vaccine History. He denies any unusual or prolonged reactions within the first 1-2 weeks following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea in months prior to his diagnosis of T1DM. He denies a history of an elevated glucose levels, elevated blood pressure levels or history of hypertension prior to diagnosis of T1DM. He was not overweight and stayed very active. He has no family Hx of T1DM.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Activities of daily living impaired, Headache, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Violent vomiting, fever, headache, weight loss. Symptoms lasted for over two weeks. I was out of work for a week and a half.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Vertigo
Clinical narrative: PROBABLE ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY AIDP / GUILLAIN  BARRE SYNDROME DIAGNOSED 12/6/11 BY NEUROLOGIST. HOSPITALIZED ON 12/8/11. SYMPTOMS STARTED 11/19/11.  VERTIGO 11/28/11.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema multiforme, Pyrexia, Rash, Urticaria
Clinical narrative: Fever, urticarial, erythema multiforme rash.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Rash generalised, Rash morbilliform, Screaming
Clinical narrative: Took baby to the hospital because she was screaming on controllably. They diagnosed her with a slight ear infection. She was given ear drops and amoxocillin. Then on 12/09/2011 at 9:00 PM we noticed a rash all over her body. By morning on 12/10/2011, it was all over her scalp down to her toes. It looked like the measles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: The site injection given, left thigh has redness of 72mm x 55mm. Patient has pain, fever for 1 day.
Age: 1.24
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Nov. 6, 2011. Mother walk in to center escorted by an employee. Mother states child "broke out with rash over her body" after getting vaccines from the center. Mother states she didn't want to fill out report, "I'll take them to hospital" VAERS completed with info from immunisation record.
Age: 3.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Nov 6, 2011 Mother of patient walked into center escorted by employee. Mother stated child "broke out with rash over body after getting vaccines from center". Mother stated she didn't want to fill out a report, "I'll take them to Hospital". VAERS report completed with info from immunization records.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Nov 6, 2011 Mother of patient walked into center, escorted by employee. Mother stated child "broke out with rash over body after getting vaccines from center". Mother stated she didn't want to fill out a report, "I'll take them to Hospital". VAERS report completed with info from immunization records.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Mother of patient walked into center escorted by employee. Mother states child "broke out with rash over her body" after getting vaccines from center. Mother states she didn't want to fill out a report. I'll take them to hospital. VAERS report completed with info from immunization record.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site pruritus, Injection site reaction
Clinical narrative: After received PPV23 vaccine developed itching and a round circle at site of injection. Given BENADRYL and ice pack. Advanced to Erythema from shoulder to elbow. Went to M.D KEFLEX for 10 days cellulitis.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 12-15-11 Nauseated. Left upper deltoid muscle tender, pink & raised area 11 x 14 cm on 12-19-11. 12-17-11 pt. states had some diarrhea with nausea without any vomiting. 12-19-11 Rx for BACTRIM DS PO x10 days called to pharmacy. Pt. advised per MD to use warm soaks & MOTRIN PRN as directed.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: 12-15-11 Nauseated. Left upper deltoid muscle tender, pink & raised area 11 x 14 cm on 12-19-11. 12-17-11 pt. states had some diarrhea with nausea without any vomiting. 12-19-11 Rx for BACTRIM DS PO x10 days called to pharmacy. Pt. advised per MD to use warm soaks & MOTRIN PRN as directed.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Immunization for 2 months given today at 1130 am. Mom called at about 3pm, to report (R) leg was red and swollen, advised to bring baby in dr advised mom baby had localized reaction, mom instructed to apply ice to thigh 3 to 4 x a day and may give 0.4 mg of TYLENOL q 4-6 hrs until swelling goes down.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: There is a sharp shooting pain in her arm with a tingling sensation that started after flu shot given 12/5/11. Reported to pharmacist 12/20/11.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess sterile, Inflammation, Oedema peripheral
Clinical narrative: Doctor described her condition as a sterile abscess. Her entire arm from wrist to shoulder was swollen and inflamed. Her doctor prescribed antibiotics.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Disorientation, Dizziness, Dysstasia, Erythema, Influenza like illness
Clinical narrative: Weds. a.m. flu-like symptoms - sore arm at site. Took TYLENOL every 8 hrs. at 11:00 P.M. Weds. evening was disoriented, dizzy (could barely stand) had fever - 100 degrees. Breathing was alright - next morning - noticed redness spread down to elbow - went to express care. The DR. checked vital signs - drew outline around site to check for spreading. She prescribed KEFLEX 4 times per day - 10 days. Went back on 12-11-11 to have it checked. Had not spread; no fever or chills -- seemed better. Dr.'s office was notified 12-12-11. We were told Dr. would report lot number to CDC. Offered to see pt, but he was feeling better.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Weds. a.m. flu-like symptoms - sore arm at site. Took TYLENOL every 8 hrs. at 11:00 P.M. Weds. evening was disoriented, dizzy (could barely stand) had fever - 100 degrees. Breathing was alright - next morning - noticed redness spread down to elbow - went to express care. The DR. checked vital signs - drew outline around site to check for spreading. She prescribed KEFLEX 4 times per day - 10 days. Went back on 12-11-11 to have it checked. Had not spread; no fever or chills -- seemed better. Dr.'s office was notified 12-12-11. We were told Dr. would report lot number to CDC. Offered to see pt, but he was feeling better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site oedema, Injection site pruritus
Clinical narrative: On day after administered, developed a 5 cm diameter hard lump at injection site, also redness edema redness, edema, & itching spread over a 1 week period to include arm from elbow to armpit. Symptoms gradually disappeared over 10 day period.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema, Pruritus
Clinical narrative: On day after administered, developed a 5 cm diameter hard lump at injection site, also redness edema redness, edema, & itching spread over a 1 week period to include arm from elbow to armpit. Symptoms gradually disappeared over 10 day period.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Brain oedema, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Vision blurred, Visual impairment
Clinical narrative: This case was reported by a pharmacist and described the occurrence of brain swelling in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. The subject's medical history included Cesarean delivery, live birth and pregnancy. Concurrent medical conditions included endometriosis. Concurrent medications included Prenatal vitamin, TORADOL and PERCOCET. On 16 November 2011 at 11:30 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 16 November 2011 the subject received a dose of FLUZONE (unknown route). On 4 December 2011, 18 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced brain swelling, vision disturbance including "could not see side of face", and cloudy vision. The pharmacist reported that on 14 November 2011, prior to the administration of the vaccines, the subject gave birth to a baby by Cesarean delivery. The subject was hospitalized for 7 days due to the events and the pharmacist considered the events were disabling and clinically significant (or requiring intervention). The pharmacist explained that the subject was hospitalized at another facility for the adverse events. Relevant test results included nuclear magnetic resonance imaging that showed brain swelling and a lumbar puncture that was negative. The subject was treated with Corticosteroids. At the time of reporting the events were improved.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Blindness unilateral, Brain oedema, Nuclear magnetic resonance imaging brain abnormal, Vision blurred, Visual impairment
Clinical narrative: This case was reported by a pharmacist and described the occurrence of brain swelling in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. The subject's medical history included Cesarean delivery, live birth and pregnancy. Concurrent medical conditions included endometriosis. Concurrent medications included Prenatal vitamin, TORADOL and PERCOCET. On 16 November 2011 at 11:30 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 16 November 2011 the subject received a dose of FLUZONE (unknown route). On 4 December 2011, 18 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced brain swelling, vision disturbance including "could not see side of face", and cloudy vision. The pharmacist reported that on 14 November 2011, prior to the administration of the vaccines, the subject gave birth to a baby by Cesarean delivery. The subject was hospitalized for 7 days due to the events and the pharmacist considered the events were disabling and clinically significant (or requiring intervention). The pharmacist explained that the subject was hospitalized at another facility for the adverse events. Relevant test results included nuclear magnetic resonance imaging that showed brain swelling and a lumbar puncture that was negative. The subject was treated with Corticosteroids. At the time of reporting the events were improved.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood pressure increased, Blood test normal, Chest X-ray normal, Condition aggravated
Clinical narrative: Went to local Pharmacy after work to get a Flu Shot (12-15-11). It was approximately 5:00/5:15pm. Filled out paperwork and Pharmacist administered Flu Shot. I went home and on with my evening. Woke from sleep at about 12:30 feeling not good. Went to the bathroom and looked at my face because my tongue felt stiff and my throat felt tight. Was kind of fuzzy because because I was sleep. Decided to go to hospital. Was taken to ER. They rushed me in and begin to administer, DECADRON, BENADRYL by IV and gave me PEPCID. Was kept a the ER until morning (12-16-11) for evaluation to make sure swelling had gone down. Was given RX to fill for, Ranitidine HCL, Prednisone and Diphenhydramine HCL. Filled Rx and started taking medications. On the third day (12-18-11), started feeling sick, unusual feeling, was taken back to ER. Test were run, Blood work, EKG, and Chest x-rays. They could find nothing wrong but they did tell me to stop taking the BENADRYL because I was dehydrated from the amount I was taking. Also my blood pressure was up quite a bit. Had doctors apt with my physician: 12-19-11 at 5:00pm. She instructed me to continue taking the Prednisone to completion and will have me make another apt for later unless I am having more problems. (12-20-11) I am on my last day of the Prednisone which is making me feel very bad and I am at work, I am also out of a lot of money due to the ER visits and lost time from work and not being able to participate and function during this time of year. Current Medications: I am currently on HBP medications and Sinus medications (spray) which I have been on for a couple years. Other than that I am okay. Go to the gym 2-3 x per week, work a full-time job. Note. I have had a flu shot before, about 3 years ago with no problems.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Electrocardiogram normal, Feeling abnormal, Laboratory test normal, Malaise
Clinical narrative: Went to local Pharmacy after work to get a Flu Shot (12-15-11). It was approximately 5:00/5:15pm. Filled out paperwork and Pharmacist administered Flu Shot. I went home and on with my evening. Woke from sleep at about 12:30 feeling not good. Went to the bathroom and looked at my face because my tongue felt stiff and my throat felt tight. Was kind of fuzzy because because I was sleep. Decided to go to hospital. Was taken to ER. They rushed me in and begin to administer, DECADRON, BENADRYL by IV and gave me PEPCID. Was kept a the ER until morning (12-16-11) for evaluation to make sure swelling had gone down. Was given RX to fill for, Ranitidine HCL, Prednisone and Diphenhydramine HCL. Filled Rx and started taking medications. On the third day (12-18-11), started feeling sick, unusual feeling, was taken back to ER. Test were run, Blood work, EKG, and Chest x-rays. They could find nothing wrong but they did tell me to stop taking the BENADRYL because I was dehydrated from the amount I was taking. Also my blood pressure was up quite a bit. Had doctors apt with my physician: 12-19-11 at 5:00pm. She instructed me to continue taking the Prednisone to completion and will have me make another apt for later unless I am having more problems. (12-20-11) I am on my last day of the Prednisone which is making me feel very bad and I am at work, I am also out of a lot of money due to the ER visits and lost time from work and not being able to participate and function during this time of year. Current Medications: I am currently on HBP medications and Sinus medications (spray) which I have been on for a couple years. Other than that I am okay. Go to the gym 2-3 x per week, work a full-time job. Note. I have had a flu shot before, about 3 years ago with no problems.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Swelling, Throat tightness
Clinical narrative: Went to local Pharmacy after work to get a Flu Shot (12-15-11). It was approximately 5:00/5:15pm. Filled out paperwork and Pharmacist administered Flu Shot. I went home and on with my evening. Woke from sleep at about 12:30 feeling not good. Went to the bathroom and looked at my face because my tongue felt stiff and my throat felt tight. Was kind of fuzzy because because I was sleep. Decided to go to hospital. Was taken to ER. They rushed me in and begin to administer, DECADRON, BENADRYL by IV and gave me PEPCID. Was kept a the ER until morning (12-16-11) for evaluation to make sure swelling had gone down. Was given RX to fill for, Ranitidine HCL, Prednisone and Diphenhydramine HCL. Filled Rx and started taking medications. On the third day (12-18-11), started feeling sick, unusual feeling, was taken back to ER. Test were run, Blood work, EKG, and Chest x-rays. They could find nothing wrong but they did tell me to stop taking the BENADRYL because I was dehydrated from the amount I was taking. Also my blood pressure was up quite a bit. Had doctors apt with my physician: 12-19-11 at 5:00pm. She instructed me to continue taking the Prednisone to completion and will have me make another apt for later unless I am having more problems. (12-20-11) I am on my last day of the Prednisone which is making me feel very bad and I am at work, I am also out of a lot of money due to the ER visits and lost time from work and not being able to participate and function during this time of year. Current Medications: I am currently on HBP medications and Sinus medications (spray) which I have been on for a couple years. Other than that I am okay. Go to the gym 2-3 x per week, work a full-time job. Note. I have had a flu shot before, about 3 years ago with no problems.
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Skin plaque, Urticaria
Clinical narrative: SCATTERED ERYTHEMATOUS PLAQUES APPROX 2-3 CM DIAMETER WITH A CENTRAL WHEAL OF 5MM,  THESE ARE LOCATED ON LOWER EXTREMITIES AND ABDOMINAL AREA WITH A FEW SPREADING TO UPPER EXTEREMITIES.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Maternal exposure during pregnancy
Clinical narrative: UNKNOWN AT This time due to Pregnancy.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration
Clinical narrative: 6 cm indurated area at injection site.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Soreness at site. Then on 12-20-11 at approx. 5:30PM noticed hives, welts around injection site, area was warm to touch & slightly itchy. Took 25mg BENADRYL at approx 6PM. Used Fluocinonide cream 0.05% twice a day, ALEVE for soreness. Followed up with PCP.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Muscle fatigue, Paralysis
Clinical narrative: About a week after shot, pt started experiencing extreme muscle fatigue/weakness/paralysis & also overall fatigue. It has lasted 3 months. She had just started getting slightly better over last 3 weeks. Couldn't perform normal daily functions.
Age: 40.0
Sex: F
Vaccine: DTAP, FLUX, HEPAB
Symptoms: Activities of daily living impaired, Back pain, Injection site joint pain, Insomnia, Musculoskeletal pain
Clinical narrative: I had shots for the flu, Hep, Tetanus and MMR.  Three shots in right arm and one in left arm.  Extreme pain continued in right arm/shoulder.  Can not lift heavy items, very difficult to dry hair, get dressed, pick up groceries.  Arm "pops" or "cracks" when moved to certain positions.  Difficult to sleep at night - continuous throbbing pain, starting in arm going into shoulder, back, neck and sometime leg.
Age: 40.0
Sex: F
Vaccine: DTAP, FLUX, HEPAB
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: I had shots for the flu, Hep, Tetanus and MMR.  Three shots in right arm and one in left arm.  Extreme pain continued in right arm/shoulder.  Can not lift heavy items, very difficult to dry hair, get dressed, pick up groceries.  Arm "pops" or "cracks" when moved to certain positions.  Difficult to sleep at night - continuous throbbing pain, starting in arm going into shoulder, back, neck and sometime leg.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient received vaccine, waited 5-10 minutes, and returned to desk. Soon after patient reported being sick to stomach. Patient walked to bathroom and passed out. Patient awoke with BP 100/70.  0.5cc, 1:1000, epinephrine injection to right deltoid. Patient came around. Emergency response arrived and took patient to hospital.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient alert and oriented x 3, steady gait, no signs or symptoms of distress upon arrival to vaccination room. Directly after injection administered, patient complained of sudden feeling of losing consciousness.  Patient lost consciousness for 45 seconds to 1 minute and regained consciousness. Patient lowered from chair to floor gently during fainting episode.  Person helped lay down patient with head supported on blanket.  Cool cloth applied to head and 911 called. Vital signs taken by emergency response and found stable. Patient advised to seek emergency treatment for follow up, refused. Patient returned to work.
Age: 1.54
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Varicella vesicle discovered on visit 12-20-2011.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Tremor
Clinical narrative: Patient Received 0.5mL Flulaval in left deltoid at 12:45 PM. 1:15 PM one of patient's friends states that patient was feeling dizzy. Nurse spoke with patient and stated was feeling a little dizzy and shaky but no complaints of swelling in the mouth or throat or shortness of breath. BP 117/76, P 72, R 21. 1:30 PM patient said still feeling a little dizzy and shaky and at this point did not feel the need to seek medical attention. Patient added that his shift was over at 2:00 PM and he would be going home and would seek medical attention if still felt dizzy.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count normal, Metabolic function test, Nasopharyngitis, Nausea, Pityriasis rosea
Clinical narrative: Soon after the vaccine, I had nausea and sinus/cold symptoms for about 2 days, then had a rash and still do have a rash.  Went to a doctor after a month of the rash and he diagnosed me with a viral rash of pityriasis rosea.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Sinus disorder, Viral rash
Clinical narrative: Soon after the vaccine, I had nausea and sinus/cold symptoms for about 2 days, then had a rash and still do have a rash.  Went to a doctor after a month of the rash and he diagnosed me with a viral rash of pityriasis rosea.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Pt received vaccines 12/08/11 and 11 days later developed a lump at site of Hib & varicella injection areas. Mother states similar thing happened when pt received HIB vaccine at 12 month check-up but this is worse. Pt was evaluated by Dr. who believes this (hard, round, red area at injection site) was a reaction to Pedvax Hib vaccine. Notation made on pt file and flagged in WIR.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Loss of consciousness, Malaise, Nausea, Vomiting
Clinical narrative: [Patient was seen at hospital ER on 11-29-11] Patient got up in the AM and was tired. Felt ill and went to the trash can due to nausea and passed out. Was passed out for three/four minutes, woke & vomited. 911 rescue came and ambulance transported to hospital.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: Blood glucose, Dizziness, Hypotonia, Miosis, Nausea
Clinical narrative: Within 5 min, pt experienced nausea, dizziness. Completely collapsed limply within 10 min. With help, checked for breathing, checked pupils. Revived quickly. Pupils were pinpoint after event & pt still nauseated & dizzy. Transported EMS to hospital.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Within 5 min, pt experienced nausea, dizziness. Completely collapsed limply within 10 min. With help, checked for breathing, checked pupils. Revived quickly. Pupils were pinpoint after event & pt still nauseated & dizzy. Transported EMS to hospital.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5 inch x 8 inch eryth, tender, warm spot to (R) thigh.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Fatigue, Irritability, Pain, Pyrexia
Clinical narrative: Fever 103.8 24 hours after immunization persisting 24 hours. Pt very fussy, tired, acts like in pain.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: After vaccine was administered, patient waited for her children to be vaccinated.  As they were leaving, she asked the front line staff if the rash she was experiencing on her neck, face and ear were normal reaction to the influenza vaccine. As the patient came into the nurses area (from the front reception area) patient took a Benadryl tab (25mg) from her purse.  In nurse area, vital signs were taken and were: B/P was 190/118, HR 102 at approximately 5:20PM.  EMS was called.  Patient was concerned that she did not have health insurance, but was reassured by staff that it was a needed precaution.  While waiting for EMS, Vitals were taken at 5:25PM, and were as follows: B/P 195/122, HR: 99, O2 95%.  When EMS arrived, patient was still seated in a chair with nurse at side, alert able to answer questions.  Patient never had breathing difficulties or reported feeling SOB.  O2 was applied by nasal cannula, as a precaution.  Patient agreed to be transported via EMS transport to Health Care Center for evaluation.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspepsia, Poor quality sleep
Clinical narrative: Terrible heartburn lasting for over 2 hours - woke me out of a sound sleep and kept me up for 2 hours.  I have never had heartburn in my life before!  This heartburn has persisted through the next day - current time is noon on 12/21/2011 and I still have it.  THis is so bad, I may never again get the flu shot!
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site reaction, Joint dislocation, Musculoskeletal stiffness
Clinical narrative: Shoulder where shot was administered had restricted movement; unable to push arm in certain directions without extreme pain. My wife observed that the left shoulder stuck out compared to the right when I lay down. In retrospect, I believe the shoulder was partially dislocated. After approximately 7 weeks, I felt a pop when getting out of bed and pain was reduced and mobility improved. Now (10 weeks after shot), shoulder is back to 90% function. While shoulder was suffering, I tried ice, a sling, and ibuprofen -- ice for about 2 weeks, sling for a day, ibuprofen off and on during the 7 weeks.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Pyrexia
Clinical narrative: Shoulder where shot was administered had restricted movement; unable to push arm in certain directions without extreme pain. My wife observed that the left shoulder stuck out compared to the right when I lay down. In retrospect, I believe the shoulder was partially dislocated. After approximately 7 weeks, I felt a pop when getting out of bed and pain was reduced and mobility improved. Now (10 weeks after shot), shoulder is back to 90% function. While shoulder was suffering, I tried ice, a sling, and ibuprofen -- ice for about 2 weeks, sling for a day, ibuprofen off and on during the 7 weeks.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and tenderness to palpation at R deltoid injection site spreading down and anterior over bicept and down to R elbow. No loss in extremity strength or motion. Tx: rest limb, ice, nsaids.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: 12/14/11 Pt called office. Received flu shot on 12/11/11. Pt woke up on 12/14/11 with full body rash. Pt denied SOB. Denies fever. BENADRYL prn. Pt declined to schedule appt.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Discomfort, Gait disturbance, Injection site swelling, Pain
Clinical narrative: Left Thigh - swelling at injection site, patient discomfort and refusal to walk for a day, complaining of pain while walking for 3-4 days. No treatment - resolving by visit today.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B virus test positive
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hepatitis b positive in a 70-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included diabetes and dialysis. Concurrent medications included Aspirin, PLAVIX, CALCITROL, XANAX, Risperidone, Carvedilol, ALBUTEROL, NOVOLOG, ACETAMINOPHEN, PERCOCET, SENSIPAR, Isosorbide and Calcium acetate. On 6 December 2011 the subject received 1st dose of ENGERIX B (20 mcg, unknown route, right arm). On 8 December 2011, 2 days after vaccination with ENGERIX B, the subject experienced hepatitis b positive. Relevant test results included a blood draw that showed that the subject was hepatitis B positive on 08 December 2011. The healthcare professional noted that the subject had been negative for titers of hepatitis B for "several months" prior to the ENGERIX B vaccination. The healthcare professional considered the event was life threatening. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Skin lesion, Skin warm
Clinical narrative: Red warm region mid upper right thigh vaccine given 12/19/2011. Mother noticed red lesion right mid thigh. To ER pm 12/20/2011. JCE and hydrocortisone cream applied, amoxicillin p.o. given. To clinic 12/21/2011.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Influenza like illness, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous consumer report (initial report 12-Dec-2011) concerns a female patient, who had a medical history of allergy to codeine, TALWIN, ALEVE and MOTRIN. She has no pertinent medical history. On 01-Nov-2005 the patient received one dose of PNEUMOVAX 23 injection. Flu vaccine was reported as concomitant medication. In the evening of 01-Nov-2005 the patient experienced a 'white welt' at the injection site with redness and swelling in her upper arm from the shoulder to the elbow. She also developed 'flu-like' symptoms, aches and sweating on the same day. The patient saw the physician and the physician thought that the swelling and redness was 'cellulitis'. The patient was treated with a 7-day course of KEFLEX. On 04-Nov-2005 these symptoms were resolving. The symptoms completely resolved on an unspecified date. On 16-Nov-2007 the patient received a second dose of PNEUMOVAX 23 injection. Flu vaccine was reported as concomitant medication. Within a few minutes of receiving PNEUMOVAX 23 the patient developed severe redness and swelling at the injection site. The redness and swelling were so severe that the physician at the office tried to give her 'something to immediately stop the reaction'. She was prescribed prednisolone and XYZAL to treat the swelling. The redness and swelling did eventually resolve on an unspecified date.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site urticaria, Pain
Clinical narrative: This spontaneous consumer report (initial report 12-Dec-2011) concerns a female patient, who had a medical history of allergy to codeine, TALWIN, ALEVE and MOTRIN. She has no pertinent medical history. On 01-Nov-2005 the patient received one dose of PNEUMOVAX 23 injection. Flu vaccine was reported as concomitant medication. In the evening of 01-Nov-2005 the patient experienced a 'white welt' at the injection site with redness and swelling in her upper arm from the shoulder to the elbow. She also developed 'flu-like' symptoms, aches and sweating on the same day. The patient saw the physician and the physician thought that the swelling and redness was 'cellulitis'. The patient was treated with a 7-day course of KEFLEX. On 04-Nov-2005 these symptoms were resolving. The symptoms completely resolved on an unspecified date. On 16-Nov-2007 the patient received a second dose of PNEUMOVAX 23 injection. Flu vaccine was reported as concomitant medication. Within a few minutes of receiving PNEUMOVAX 23 the patient developed severe redness and swelling at the injection site. The redness and swelling were so severe that the physician at the office tried to give her 'something to immediately stop the reaction'. She was prescribed prednisolone and XYZAL to treat the swelling. The redness and swelling did eventually resolve on an unspecified date.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 09 December 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 18-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3591AA received on 02 June 2010, lot number C3591AA received on 30 July 2010 and lot number C3668AA on 30 September 2010 (route and site of administration not reported). The subject developed cold-like symptoms on 18 October 2011, approximately 1 year after the last dose. On 07 November 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 15 November 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 15 November 2011. The subject was not hospitalized. At the time of final contact on 28 November 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 09 December 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 18-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3591AA received on 02 June 2010, lot number C3591AA received on 30 July 2010 and lot number C3668AA on 30 September 2010 (route and site of administration not reported). The subject developed cold-like symptoms on 18 October 2011, approximately 1 year after the last dose. On 07 November 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 15 November 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 15 November 2011. The subject was not hospitalized. At the time of final contact on 28 November 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 09 December 2011 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 4 doses of TRIPEDIA; lot number U2290BA received on 15 February 2008, lot U2355AA received on 23 April 2008, lot U2355CA received on 18 June 2008, and lot U2470BA received on 30 March 2009 (route and site of administration not reported). The subject developed cold-like symptoms on 23 September 2011, approximately 2.5 years after the last dose. On 07 October 2011, the subject developed a paroxysmal cough, but no whoop or posttusive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 10 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 12 October 2011. The subject was not hospitalized. At the time of final contact on 01 November 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 40 days. The outcome was reported as not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 09 December 2011 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 4 doses of TRIPEDIA; lot number U2290BA received on 15 February 2008, lot U2355AA received on 23 April 2008, lot U2355CA received on 18 June 2008, and lot U2470BA received on 30 March 2009 (route and site of administration not reported). The subject developed cold-like symptoms on 23 September 2011, approximately 2.5 years after the last dose. On 07 October 2011, the subject developed a paroxysmal cough, but no whoop or posttusive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 10 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 12 October 2011. The subject was not hospitalized. At the time of final contact on 01 November 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 40 days. The outcome was reported as not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis
Clinical narrative: Initial report received on from an investigator participating in the trial under the reference number H-406-004 and 06 December 2011. A male subject (date of birth not reported) with no relevant medical history had received ACAM2000 (lot number not reported) on 14 November 2011. Seven days post inoculation/vaccination on 21 November 2011, the subject experienced severe right lower quadrant abdominal pain without a fever. The subject was taken to the hospital and admitted on 21 November 2011. The next day on 22 November 2011, the subject had surgery. The surgeon reported the subject's appendix was gangrenous but not ruptured. The subject was placed on the following post-op medications: oral trimethoprim and SEPTRA DS 800/160 milligrams (mg) twice a day (BID) for 5 days, oral FLAGYL 500 mg three times a day for 5 days, acetaminophen and PERCOCET 5/325 mg as needed (max 1-2 x 6 hours per day), and ibuprofen 600 mg as needed (up to 3 times per day). The subject had an uncomplicated recovery and was discharged from the hospital on 24 November 2011. The subject had returned to duty. The outcome was reported as recovered on 24 November 2011. Note: Information was collected from the physician since the subject was not present for his V2 follow-up. The investigator indicated that a causal relationship to the vaccine was considered remote. Documents held by sender: None.
Age: 1.69
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 09 December 2011 from the Investigator under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject's vaccine history included 4 doses of TRIPEDIA; lot number U1813BA received on 27 March 2007, lot U1813BA received on number 01 June 2007, lot U1813BA received on number 07 August 2007 and lot U2397AA received on 06 October 2008 (route and site of administration not reported). The subject developed cold-like symptoms on 15 August 2011, approximately 3 years after the last dose. On 17 August 2011, the subject developed a paroxysmal cough, but no whoop or posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 22 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 23 August 2011. The subject was not hospitalized. At the time of final contact on 20 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 37 days. The outcome was reported as not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cough, Nasopharyngitis, Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 09 December 2011 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject was identified by the investigator based on review of data from the database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3404AA received on 07 September 2010, lot number C3494AA received on 04 November 2010, and lot number C3451AA received 04 January 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 27 July 2011, approximately 6 months after the last dose. On 16 August 2011, the subject developed a paroxysmal cough without a whoop and posttusive vomiting. Laboratory testing included positive PCR on 16 August 2011. Corrective treatments consisted of azithromycin for 5 days starting on 17 August 2011. The subject was not hospitalized. At the time of final contact on 02 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 34 days. The outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypoaesthesia, Tension, VIIth nerve paralysis
Clinical narrative: Patient received flu vaccine at 12:38PM. Patient came back to clinic at about 1:25PM complaining of right side facial numbness/tension and states, "it feels like there is water in head." Initial assessment slight droop to right side of mouth. Department manager contacted/911 called. Patient had clear speech. 1:45PM Fire Dept. here to assess patient. Pt ambulatory, A&Ox3, no respiratory distress. Patient taken to hospital per EMS.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Client described symptoms such as feeling nauseated, lightheaded with sore left arm approximately 1.5 hours after receiving influenza vaccine. No indication or symptoms of difficulty breathing. No fever present. BP 140/90. Provided wet cloth to apply to forehead and neck as well as water and food. Nurse instructed client to to remain seated with us for approximately 10 minutes to rule out any other type of reaction. Nurse encourage patient to eat and drink fluids. Patient has had food to eat and says is feeling better.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal
Clinical narrative: Client had never had a flu shot before and reported allergy to bee stings/pcn. After administering shot, nurse instructed patient to remain on premises. In approx 15 minutes, client returned and reported shortness of breath and chest heaviness. Nurse administered 0.5cc of 1:1000 epinephrine and called 911. EMT's arrived, monitored patient for 15 mintues. Patient declined transport to hospital, as she was breathing normally with normal EKG.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MMR, TDAP
Symptoms: Crying, Hypoaesthesia, Injection site anaesthesia, Injection site induration, Injection site pain
Clinical narrative: Severe pain in right arm where vaccines administered (HPV, Tdap, Hep. A, MMR), itching, severe swelling (very hard), redness, warm to touch, numbness traveling down right arm to hand. Unable to move right hand.  14 y.o boy crying from pain, according to mother.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MMR, TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Severe pain in right arm where vaccines administered (HPV, Tdap, Hep. A, MMR), itching, severe swelling (very hard), redness, warm to touch, numbness traveling down right arm to hand. Unable to move right hand.  14 y.o boy crying from pain, according to mother.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Edema, pain, fever within 12 hours. Improved over 72 hours.
Age: 1.11
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired drug administered
Clinical narrative: On 12-31-11 rec'd expired vaccine HIB lot UH160AA exp 11-27-11 consider non-dose spike event. Mother will bring child on 1-7-11 for repeat dose.
Age: 1.61
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Expired drug administered
Clinical narrative: On 12-3-11 rec'd expired vaccine HIB lot #UH160AA exp 11-27-11 consider non-dose spoke w/ father will bring checked on 1-7-12 repeat dose.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The vaccine was recorded as given 9/16/11 as above, however the emergency room note states that patient received the vaccine on 9/13/11.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: RN witnessed the allergic reaction but was unable to get employee to EHS as the employee wanted to go home instead.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Injection site joint pain, Neck pain, Pain in extremity
Clinical narrative: Patient received flu vaccine during the flu clinic. Patient said that his right arm started hurting around 2-2:30 AM on Nov. 9, 2011. His wife was the witness. The pain spray to his shoulder (right side) and his right arm and his neck, back. He had numbness of right arm as well. Patient went to the ER in Hospital.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient given Flumist at 18 weeks gestation.  Was not known that she was pregnant until after Flumist was given. Patient was 18 weeks gestation.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient with complaints of dizziness after shot was administered. Stated she was feeling well prior to shot (BP 128/97 prior to shot). BP 112/82 and 108/80 when nurse checked manual BP. Patient stated she felt better after being moved to another room, feet raised, BP taken, orange juice and bagel given. Patient remains A&Ox3, 122/80 at 10:25 AM. No complaints of dizziness. 10:50 AM patient stated she felt better with no complaints of dizziness or light-headedness.
Age: 1.23
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Vomiting
Clinical narrative: APPROX 30 MINUTES AFTER VACCINATION, CHILD VOMITED X 3; TAKEN TO ER BY MOTHER AND GRANDMOTHER. NO OTHER PROBLEMS; CHILD RECOVERED WITHOUT DIFFICULTY.