chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The injection site real red - swollen and very painful. I went to my Dr and he put me on Benadryl for about a week.
Age: 1.48
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Medication error
Clinical narrative: Pt accidentally given 0.5 ml PPD IM in lion of Prevnar vaccine. Taborsil started in wrong place. NA giving vaccines failed to note PPD not Provnar. No side effects at time of administration. Mother of child refuses to discus Pts condition.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, nausea, extreme chills, muscle soreness at injection site and all over body, fatigue. Treated with ibuprofen.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Syncope
Clinical narrative: Received Td in clinic - was ok, walked to lab station, fingerstick blood test done. Patient few minutes later felt dizzy and fainted. No loss of consuousiness. Blood presure normal. Patient rested and symptoms resolved after a few minutes. (Reaction felt probably secondary to blood draw not vaccine but form completed)
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: 30+ vesicular papules on face, numerous ones on back, trunk, arms. Onset 01/06/1997, low grade fever 100.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Acne, Erythema, Eye disorder, Headache, Pruritus
Clinical narrative: Redness of face, pimples, headache, itching, eyes itched.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Mouth plaque, Paraesthesia, Urticaria
Clinical narrative: 11/10/2005 about 10:15 pt telephone corpworx to report taking 2nd dose oral typhoid at about 06:00 - 6:30 today. Now she experiencing urticaria, tingling lips, mouth has a coding feeling, denies SOB or hives. Suggested PO Benadryl not to complete typhoid doses (2). See medical attention PRN.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Tenderness
Clinical narrative: Extreme muscles pain, follow followed by redness after 2nd day. Started in pm after shot. Continued then redness on 11/11/2005 it seems to have moved down arm. Tenderness and redness slowly to improve 11/12/2005. Seemed to travel from arm from injection site.
Age: 12.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: None Stated
Sex: F
Vaccine: UNK
Symptoms: Face oedema, Injection site oedema, Rash
Clinical narrative: Rash, swelling of face and at injection site LD, Benadryl every 6 hours.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Pain, Paraesthesia
Clinical narrative: Approx 4 hours following immunization the pt reported experiencing excruciating pain in the left shoulder area. That was followed by a tingling sensation in 4 of her fingers on left hand. The following day the left arm became red, swollen and warm to the touch.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Swelling
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of swelling in an 11-year-old male subject who was vaccinated with tetanus toxoid, redupced diptheria toxoid and acellular pertussis vaccine adsorbed (Boostrix) for prophylaxis.  On August 9 2005 the subject received a "booster" dose of Boostrix (lot AC52B003AA-incorrect lot number).  At an unspecified time following the adminstration of Boostrix, on either August 9 2005 or August 10 2005, the subject experienced swelling "at an unspecified location," diarrhea and upset stomach.  At the time of intial reporting, August 10, 2005, the outcome of the events was not reported.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Photophobia, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurence of photophobia in an 11-year-old male subject who was vaccinated with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular pertussis vaccine, adsorbed (Tdap) (Boostrix) for prophylaxis.  The physican is the mother of the subject.  There were no concurrent medications.  On 18 August 2005 the subject received a booster dose of Boostrix (lot number not specified) to the left arm.  At an unspecified time after vaccination with Boostrix, on 18 August 2005, the subject experienced photophobia, fever greater than 104 degrees Farenheit, nausea and pain in extremities (arm and foot).  At the time of reporting the events were unresolved.  The physician considered the events were probably related to vaccination with Boostrix.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of hives in a 14 year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Boostrix) for prophylaxis. On Aug 26 2005 the subject received a dose of Boostrix. On Aug 27 2005, 1 day after vaccination with Boostrix, the subject experienced hives and rash all around the body. The subject was seen at a physicians office and was treated with diphenhydramine hydrochloride (Benadryl). On Aug 30 2005, the events were resolved. the physician considered the events to probably be related to vaccination with Boostrix.
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician assistant to a sales representative and described the occurrence of injection site pain in an adult male subject (specific age unspecified) who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. On an unspecified date on or before Oct 11 2005, the subject received 1st dose of Boostrix. The site of injection of Boostrix was not provided. At an unspecified time after vaccination with Boostrix, on an unspecified date on or before Oct 11 2005, the subject experienced injection site pain. At the time of initial reporting, Oct 11 2005, the outcome of the injection site pain was not reported. The physician assistant considered the injection site pain to probably be related to vaccination with Boostrix.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: 104 Fever, localized reaction down arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site induration, Myalgia, Oedema
Clinical narrative: Chills, fever, swollen, redness and pain with lump 5x8, muscle ache, continued until 11/15/2005. Verbalized she has severe itching, redness but kept under control with Advil and Cortisone cream on arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: Chills, fever, swollen, redness and pain with lump 5x8, muscle ache, continued until 11/15/2005. Verbalized she has severe itching, redness but kept under control with Advil and Cortisone cream on arm.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Hypersensitivity
Clinical narrative: Redness 24 hours after, size of nickel, redness increased 48 hours after, Treated for cellulitis, allergic reaction.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Cardiac arrest, Cardio-respiratory arrest, Coma
Clinical narrative: Found in crib non responsive by sitter later that afternoon. Asystole on admission to ER.  Added from Discharge summary rec'd 12/12/2005: Cardiopulmonary arrest and apnea./sr
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea
Clinical narrative: Initial report received on Nov 14 2005 from a consumer. A 41 year old female patient with a history of allergy to penicillin and whooping cough in Feb of 2005 was administered (route not reported) Fluzone SV 2005-2006 USP, lot number U17622A ( the lot number reported was not a valid lot number for the flu vaccine) in the left arm on Nov 11 2005 at 11:30am. At 13:30 that afternoon she experienced a severe coughing spell and was seen by a nurse. She took Benadryl liquid and the cough subsided but she had difficulty breathing. At 18:30 that evening she was seen in the ER and was treated with intravenous fluids and medications. The name, route and site of administration of medications used to treat these events were not reported. Blood work, urinalysis and a chest x ray were completed in the ER. The patient was release to go home that same evening. The patient had recovered from these events at the time of this report.
Age: 10.0
Sex: U
Vaccine: FLUN3
Symptoms: Erythema multiforme, Rash
Clinical narrative: MEDI 0003824 is a serious spontaneous case from a physician involving erythema multiforme. The reporter causality is probably not related to FluMist vaccine. A physician reported that a 10 year old child developed a rash 2 weeks after receipt of FluMist. The rash included the palms and was reported to be erythema multiforme. However, no mucosal involvement was reported. The reporter did not think this was related to FluMist. The patients clinical outcome is unknown. No other information is available at the time of this report. Important medical Event (OMIC).
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Face oedema, Oedema, Pruritus, Rash
Clinical narrative: 11/12 Sat evening rash on buttocks, 11/13 Sunday rash on legs and ankles, 11/14 Monday ankles very swollen and behind knees, 11/14 Wed face rash, swollen lips, plus itching x 5 days. Call to RHHD then TO Dr. family has no insurance, was given order to place client in bath tub with baking soda and use Benadryl as needed.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Abnormal behaviour, Asthenia, Dizziness, Emotional distress
Clinical narrative: 11/06-11/09/2005 fever, muscle aching, nausea, severe weakness, abdominal pain, dizziness, felt mentally strange, inappropriate behavior such as turning lamp on and lamp already on, flicking lights off and on.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 11/06-11/09/2005 fever, muscle aching, nausea, severe weakness, abdominal pain, dizziness, felt mentally strange, inappropriate behavior such as turning lamp on and lamp already on, flicking lights off and on.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, DTAP, FLUX, IPV, MMR
Symptoms: Rhinitis, Urticaria
Clinical narrative: 11/16/2005 9:00am received vaccines (DTaP, OPV, MMR, Flu) 7:10 am started with tight coriza, 9:20 am hives started appearing 9:30 transport to ER via EMT.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, DTAP, FLUX, IPV, MMR
Symptoms: Cough, Cyanosis, Dysphonia, Dyspnoea, Rash
Clinical narrative: 11/16/2005 9:00am received vaccines (DTaP, OPV, MMR, Flu) 7:10 am started with tight coriza, 9:20 am hives started appearing 9:30 transport to ER via EMT.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, DTAP, FLUX, IPV, MMR
Symptoms: Urticaria
Clinical narrative: 11/16/2005 9:00am received vaccines (DTaP, OPV, MMR, Flu) 7:10 am started with tight coriza, 9:20 am hives started appearing 9:30 transport to ER via EMT.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: 2 or 3 days after injection left arm started hurting felt tingling and numbness in left arm and 3 fingers and is slowly getting worse. TC to Employee health 11/11/2005 stated maybe hit nerve ant to see my doctor.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Hypersensitivity, Pruritus, Rash macular
Clinical narrative: 11/11/05 shot administered, 11/12/05 pm felt itchy took Benadryl for 24 hours, 11/13/05 lips, face, swollen, blotchy, ED steroids Benadryl, 11/14/05 worse blotches, 11/16/05 PMD Zantac, Zyrtec given, 11/17/05 felt worse saw allergist possible Naprosyn reaction.
Age: 1.01
Sex: F
Vaccine: FLU3, HEP, MMR, PNC
Symptoms: Rash
Clinical narrative: MMR vaccine administered 11/08/2005, mom noted rubeoliform rash on trunk, slightly noted on extremities and face.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Headache, Pyrexia, Somnolence
Clinical narrative: 10/17 light headed, slight headache began, 10/21 temp 99.4, sleeping more naps, 10/22 severe diarrhea onset 4am diarrhea has continued to this day. uniformed stools, hyperactive bowel stimulated every time I eat or drink. Unimproved diarrhea for one month. Treated with Pepto Bismol, Loperamide, BRAT diet, fluids with electrolytes. Diagnosed as post injection inflammation.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Face oedema, Tongue oedema
Clinical narrative: Patients daughter reported that her moms tongue, lip and face swelled up. Patient was a little short of breath. She took Claritin and the swelling went down a little. Next morning pt was better but still had slight swelling.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Beginning the day after she received vaccine, patient complained of her arm being very sore. As of Monday, Nov. 21 ( 1 week later ), she stated her arm was still very sore. She contacted MD but had not heard back yet.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Injection site erythema, Injection site oedema, Pain, Urticaria
Clinical narrative: Redness, swelling where the shot was given, soreness, aches. Hoarseness, wheezing, hives ( mild ) Shot was given on 11/15/05 I still have
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Redness, swelling where the shot was given, soreness, aches. Hoarseness, wheezing, hives ( mild ) Shot was given on 11/15/05 I still have
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Pt given varivax on 09/05/02 Pt developed break through varicella on 11/16/05
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Myalgia
Clinical narrative: 5 hours later got chills body ached all over was ok next am
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Pox mark - trunk/ derriere
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Skin irritation
Clinical narrative: Pox mark - trunk face
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin irritation
Clinical narrative: Pox mark - trunk / face
Age: 65.0
Sex: M
Vaccine: TTOX
Symptoms: Face oedema, Pruritus
Clinical narrative: Right eye itchy - swelling under right eye - went to eye doctor. Eye drops - warm compresses.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injury
Clinical narrative: 100 X 88 mm redness - temp 99.3 . Small scabin middle of redness. Mom states child might have scraped arm.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site erythema, Malaise, Pyrexia, Skin striae
Clinical narrative: Intense erythema with warmth at injection site with streaking accompanied by systemic symptoms, fever, malaise. Symptoms improved quickly after starting antibiotics implicating infection. Similar events in Zofran patients
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Intense erythema with warmth at injection site with streaking accompanied by systemic symptoms, fever, malaise. Symptoms improved quickly after starting antibiotics implicating infection. Similar events in Zofran patients
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: numbness and pain (4 on pain scale) of left arm started in lower arm 20 minutes after receiving injection.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives over entire body about 14 hours after shot administered. Called the Stillwater emergency room and was told to take (2) Benedryl and watch for indications of breathing trouble or swollen eyes. Rash stayed about 48 hours but hives and itching ceased by morning.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Loss of consciousness, Vomiting
Clinical narrative: Patient received her flu vaccine at a Flu Clinic by our organization. She went home and then at noon felt very tired. She laid down and fell asleep. She felt this was unusual. In the afternoon she got up to get ready for a benefit. She went to the benefit early evening. Symptoms happended within 30 minutes of arriving. She ate something then vomited and passed out. They transported her via ambulance to ER. She was evaluated and released. She called me on Thursday. I interviewed her on Friday and she felt fine. I told her I would submit the report to you and she may be called for more information. She has received flu vaccines in the past with no problems.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache, Heart rate irregular, Hypoaesthesia, Malaise
Clinical narrative: Patient came to a Flu Clinic. She received the shot approximately at 11:00am. In 15 minutes she felt funny, "not right", "out of it". She complained of a headache and numbness in upper part of face which spread to lower face. BP was 144/80 then changed to 184/84, 190/84, 194/86 as she sat there for one hour with monitoring. Pulse was irregular (70s-80s). Her physicians where called promptly. Her medical physician was not in but her cardiologist called us back. The physician decided to have the patient go to his office at 3pm. I called the patient in the evening and the next day and she said she felt fine at this point. She slept well during the night. Doctor thoroughly evaluated her. She did not receive any medication treatments.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus, Vaccine positive rechallenge
Clinical narrative: ITCHING & REDNESS AROUND SITE OF VACCINATION STARTING DAY OF ADMINISTRATION 10/14/2005. PT STATED SHE HAD THE SAME REACTION LAST YEAR.  STATES EGGS MAKE HER "SICK".
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoxia, Rash, Wheezing
Clinical narrative: Patient had generilized rash with wheezing and decreased oxygen saturation.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Clumsiness, Condition aggravated, Feeling cold, Hypoaesthesia
Clinical narrative: Patient with newly diagnosed MS admitted to neurology service 11/16 pm because for about two weeks patient has had numbness of the left upper thigh and left lower abdomen as well as recent history of numbness and clumsiness of right arm post flu shot given on 11/4/05.   There is a distinct cold sensation.  Patient admitted 11/16/05 for steroid therapy for presumed MS flare possibly precipitated by flu shot.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS, ? Mom rolled over on baby but not confirmed according to MD. Autopsy report received 11/30/2006 confirms SIDS/sr
Age: 0.16
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Autism, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in an 18 month old male subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) for prophylaxis. The reporter is the subjects mother. A physician or other health care professional has not verified this report. The subjects medical history included hand and foot and mouth disease, following a previous vaccination (vaccine not specified). Previous and or concurrent vaccination included Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTPa, manufacturer unspecified), inactivated poliomyelitis virus vaccine (IPV), live attenuated measles, mumps (Strain not specified), rubella vaccine (MMR), pneumococcal vaccine (manufacturer unspecified), varicella virus vaccine (Varivax), and combination haemophilus influenzae type B conjugate, hepatitis B vaccine (Comvax). On April 20 2002 the subject received the first dose of Infanrix (lot number not specified) 0.5 ml to the left thigh. Approximately on year later on an unspecified date in 2003, the subject experienced a change in behavior subject was diagnosed with autism. This case was assessed as medically serious by manufacturer  (OMIC). At the time of reporting, on Nov 21 2005, the events were unresolved.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myocardial infarction, Pain, Pleurisy
Clinical narrative: 10 days after flu injection, client experienced pain in upper chest, neck and back. Thought he was experiencing a heart attack. Taken by ambulance to hospital - was seen by cardiologist. Viral pleurisy was diagnosed. Condition was resolved 48 hours later. Pt. released and given Rx of protonix 40 mg BID.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Dyskinesia, Screaming
Clinical narrative: Temp - 103 - agitated - jerky reflexes, high pitched scream - unconsolable
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Flushing
Clinical narrative: 5 - 10 minutes after injection pt is face flushed c/o dizziness, chest tightness and shortness of breath / difficulty breathing
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Patient daveloped cellulitis of left arm where DTaP was given. Patient was started on Augmentin and will be followed up.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Medication error
Clinical narrative: Clients mother stated shot record was up to date showing client needed 15 month shots. After given shots, more updated record found on computer. Client had recieved same vaccines 3-23-05. 6 months had not passed between #3 DTaP and one received on 3-23-05. #3 DTaP given 11-04-04. Client also received #4 Hib on 3-23-05.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: BRIGHT RED, HOT TO TOUCH, AT INJECTION SITE HEADACHE
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Client seen by family physician on 10/18/05. Dr. reports pt. presented with localized reaction to immunization received in left thigh the prior day.  States left thigh warm, red, and swollen twice normal size from thigh to knee.  Prescribed Keflex and instructed to apply ice to affected leg.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Malaise, Vertigo
Clinical narrative: Onset within 10 minutes of vaccination beginning with vertigo without nausea, and numbness of tongue.  At no time was there "any difficulty breathing or heart palpitations."  This progressed over a 2 hour period to include numbness of body with pain in shot arm.  "It felt like I was shot up with novicaine everywhere and pain down my (left)arm and my left hand felt like it was smashed."  Client spoke with her physician by phone but was not seen.  The numbness and discomfort lasted approximately 24 hours.  This was followed by malaise for another 48 hours.  When contacted November 2, 2005, client stated that she felt completely recovered.  At no time did she check her temperature.
Age: 1.13
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PPV
Symptoms: Crying, Pyrexia, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: Fever; crying; large, red welt at sight of injection.  Mom stated that the child cried all night and had a fever.  She stated that she had had a reaction to Tetanus when she was young.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness and tenderness noted around injection site 2 days after immunization.  Brought in for eval.  No streak, fever, or nausea.  Exam showed poorly demarcated area of erythema without warmth.  Small area of tenderness with slight induration about 1cm in size central to erythematous area.  No other tenderness.  No significant adenopathy.
Age: 1.25
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Cerebellar ataxia, Gait disturbance, Vomiting
Clinical narrative: Developed acute cerebellar ataxia 36 days after varivax and MMR were administered, with vomiting and wide-based unstable gait.  CT scan of the brain was normal, patient was observed with no medication or further intervention
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Cough, Dyspnoea, Face oedema, Hypersensitivity
Clinical narrative: Within one minute after administration patient started coughing.  Within 2 minutes he was wheezing, wasn't able to speak, wasn't able to drink water, had a rapid heart rate, had facial swelling and became pale.  The physician listed to his lungs and determined the wheezing.  A breathing treatment was administed (xopenex).  The wheezing decreased but he was still unable to speak and continued to cough and have difficulty breathing.  He was sent to the emergency room.  By the time he was seen since he stopped wheezing we were told to administer Benadryl that evening and that morning.  Within 3 hours total he was acting like himself although had garbled speech until the next morning. Medical records state anxiety, allergic reaction. msv
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pallor, Speech disorder, Tachycardia, Wheezing
Clinical narrative: Within one minute after administration patient started coughing.  Within 2 minutes he was wheezing, wasn't able to speak, wasn't able to drink water, had a rapid heart rate, had facial swelling and became pale.  The physician listed to his lungs and determined the wheezing.  A breathing treatment was administed (xopenex).  The wheezing decreased but he was still unable to speak and continued to cough and have difficulty breathing.  He was sent to the emergency room.  By the time he was seen since he stopped wheezing we were told to administer Benadryl that evening and that morning.  Within 3 hours total he was acting like himself although had garbled speech until the next morning. Medical records state anxiety, allergic reaction. msv
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Injury, Syncope
Clinical narrative: Immediately after receiving the Fluviron, she fainted and hit her head on the floor.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Skin nodule
Clinical narrative: Pain started in evening, next morning swelling and redness about 3 1/2 inch to 4 inch circumference around injection site raised about 1/8th inch high. Injection site darker red possibly bruised, feels hot. Another raised bump about 1/4 inch raised near posterior elbow, 2 inch oval, not as red or sore.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient called Pharmacy after receiving an injection 11-22-05 to report an injection site reaction. Painful, raised, swollen injection site circumference of 5 inches. Patient instructed to call physician as soon as possible for further evaluation.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Electrocardiogram abnormal, High density lipoprotein decreased, Injection site erythema
Clinical narrative: On 20Nov2005 the patient had severe chest pain and evaluation showed 3mm ST elevation on ECG; pain relieved with one Aspirin and one sublingual nitro.  Total 90 mins pain before sought care and got nitro.  Sent to hospital where was pain free but got lytic therapy for continued ST elevation.  Cardiac enzymes positive with total CK 1394, total MB 96.  Cardiac risk factors of smoking and low HDL (HDL 24 on 23NOV05).  Smoker of 1 ppd for over 20 years.  Pain free now since 20November after first nitroglycerine administration.  Cardiac cath on 23NOV (sent to hospital on 22NOV05) showed normal coronary arteries with no thrombus, no muscle bridging, and no spasm.  Wall motion by LV-gram and by echocardiogram on 23NOV was normal, with EF 60%.  Normal echocardiogram other than mild left atrial enlargement.  My assessment as his cardiologist:  Acute ST elevation MI due to vasospasm and possibly some degree of acute plaque rupture or thrombus, but relieved with nitroglycerine.  90 minutes of pain with enzyme proven cardiac injury.  Likely related to a combination of factors: (1) Patient was febrile, had severe local reaction to vaccinia site with erythema and pain and local lymphadenopathy and was feeling generally ill from 18-20NOV 2005, (2) Patient had upper respiratory illness starting 5NOV2005 that he felt became worse and more symptomatic over same time period of 18-20NOV05, (3) Smoker chronically and at the time of event, and (4) Possible abnormal lipids lending to endothelial dysfunction.  It seems likely that the brisk local and systemic reaction to the vaccine played a role in the event.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pain, Injection site reaction, Laboratory test abnormal, Lymphadenopathy, Malaise
Clinical narrative: On 20Nov2005 the patient had severe chest pain and evaluation showed 3mm ST elevation on ECG; pain relieved with one Aspirin and one sublingual nitro.  Total 90 mins pain before sought care and got nitro.  Sent to hospital where was pain free but got lytic therapy for continued ST elevation.  Cardiac enzymes positive with total CK 1394, total MB 96.  Cardiac risk factors of smoking and low HDL (HDL 24 on 23NOV05).  Smoker of 1 ppd for over 20 years.  Pain free now since 20November after first nitroglycerine administration.  Cardiac cath on 23NOV (sent to hospital on 22NOV05) showed normal coronary arteries with no thrombus, no muscle bridging, and no spasm.  Wall motion by LV-gram and by echocardiogram on 23NOV was normal, with EF 60%.  Normal echocardiogram other than mild left atrial enlargement.  My assessment as his cardiologist:  Acute ST elevation MI due to vasospasm and possibly some degree of acute plaque rupture or thrombus, but relieved with nitroglycerine.  90 minutes of pain with enzyme proven cardiac injury.  Likely related to a combination of factors: (1) Patient was febrile, had severe local reaction to vaccinia site with erythema and pain and local lymphadenopathy and was feeling generally ill from 18-20NOV 2005, (2) Patient had upper respiratory illness starting 5NOV2005 that he felt became worse and more symptomatic over same time period of 18-20NOV05, (3) Smoker chronically and at the time of event, and (4) Possible abnormal lipids lending to endothelial dysfunction.  It seems likely that the brisk local and systemic reaction to the vaccine played a role in the event.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Muscle spasms, Pyrexia, Respiratory disorder, Thrombosis
Clinical narrative: On 20Nov2005 the patient had severe chest pain and evaluation showed 3mm ST elevation on ECG; pain relieved with one Aspirin and one sublingual nitro.  Total 90 mins pain before sought care and got nitro.  Sent to hospital where was pain free but got lytic therapy for continued ST elevation.  Cardiac enzymes positive with total CK 1394, total MB 96.  Cardiac risk factors of smoking and low HDL (HDL 24 on 23NOV05).  Smoker of 1 ppd for over 20 years.  Pain free now since 20November after first nitroglycerine administration.  Cardiac cath on 23NOV (sent to hospital on 22NOV05) showed normal coronary arteries with no thrombus, no muscle bridging, and no spasm.  Wall motion by LV-gram and by echocardiogram on 23NOV was normal, with EF 60%.  Normal echocardiogram other than mild left atrial enlargement.  My assessment as his cardiologist:  Acute ST elevation MI due to vasospasm and possibly some degree of acute plaque rupture or thrombus, but relieved with nitroglycerine.  90 minutes of pain with enzyme proven cardiac injury.  Likely related to a combination of factors: (1) Patient was febrile, had severe local reaction to vaccinia site with erythema and pain and local lymphadenopathy and was feeling generally ill from 18-20NOV 2005, (2) Patient had upper respiratory illness starting 5NOV2005 that he felt became worse and more symptomatic over same time period of 18-20NOV05, (3) Smoker chronically and at the time of event, and (4) Possible abnormal lipids lending to endothelial dysfunction.  It seems likely that the brisk local and systemic reaction to the vaccine played a role in the event.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Laboratory test abnormal, Pain in extremity
Clinical narrative: Diagnosed with Guillan-Barre.  Improved after IVIG therapy. Discharge summary states pain in legs, abnormal gait. msv
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Developed swelling of left deltoid muscle, redness & pain at injection site the day of the injection. We applied an ice pack and administered Ibuprofen. She then developed a severe headache and spiked a temperature of 101.4 at 2:20 am (Nov 24, 2005). Deltoid was more inflamed and local pain was increased. Today her left deltoid is still swollen, with localized pain but the redness is gone.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Developed swelling of left deltoid muscle, redness & pain at injection site the day of the injection. We applied an ice pack and administered Ibuprofen. She then developed a severe headache and spiked a temperature of 101.4 at 2:20 am (Nov 24, 2005). Deltoid was more inflamed and local pain was increased. Today her left deltoid is still swollen, with localized pain but the redness is gone.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed itching and then hives over entire body within hours of administration of Hep B vaccine.
Age: 46.0
Sex: M
Vaccine: DT
Symptoms: Pain
Clinical narrative: I received a DT shot at the hospital after a cut in my arm was stitched up. Around or about 2 to 3 weeks after I began to have pain in the right elbow which then spread to the left elbow and then one shoulder then the other. I saw my primary physician on about 8/24/05 who prescribed naproxen for inflamation. this has had no effect on the arms and the pain has progressed further into the thumbs now. It is painful to move any of these joints now and I have been referred to a orthopedic for appointment on 11/30/05. From study of FDA sites and others this seems similar to only Brachial neuritis. If any help of advice can be given please advise this has become very painful and debilitating.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema
Clinical narrative: Crimson spot @ site and 2x3" erythemtous macular reaction.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large area of erythema - 9x8" and induration 8/10". Benadryl 50 mg po, patient had taken Ibuprofen 800 mg 1 hour prior to being seen. She describes getting similar rxn to dT in past.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Received Vacination around 2:30 PM Tuesday Nov 22,2005. About 8:30 PM I started having chills, fever and loss of energy, and bad headaches, followed by aches and pain. Symptoms continued until approxamately 8AM on Nov. 23 2005, except for the loss of energy which I still have, but not as severe.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Pain, Paraesthesia
Clinical narrative: Deep muscle pain under site of injection R arm.T his pain is an ache and very bad, a 7 on a one to 10 scale. Pain is worse over injection site but extends across back over scapula to spine. Back of hand tingles and tip of right thumb is numb. No impairment of muscle function. No swelling. Pain started 11-24-05 (+16days). Has continued 3 days now,not relieved by Excedrin Migraine,some relief from Acetominaphen + codeine #3. No fever.Arm feels "heavy".Quite unbearble w/o pain med. I have tried to contact clinic but unavail due to holiday. There is nothing to "show" so haven't gone to ER or DR.yet. May go if continues. Some relief from heating pad. Really hurts a lot. Information from Follow-up report states: Recv'd IM Hep B on 11/08/05 in right arm. On 11/23/05 (16 days after inj) inject site became extremely painful ( 7 on 1-10 scale). Also right thumb became numb. Pain continued at that level for approx. 2 weeks. Currenty is 4 on 1-10 scale and right thumb still numb, occasionally right arm and thumb tingles. Relief from 3 aspirin or extra streneth Tylenol, which I must take everyday, several times.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Sensation of heaviness
Clinical narrative: Deep muscle pain under site of injection R arm.T his pain is an ache and very bad, a 7 on a one to 10 scale. Pain is worse over injection site but extends across back over scapula to spine. Back of hand tingles and tip of right thumb is numb. No impairment of muscle function. No swelling. Pain started 11-24-05 (+16days). Has continued 3 days now,not relieved by Excedrin Migraine,some relief from Acetominaphen + codeine #3. No fever.Arm feels "heavy".Quite unbearble w/o pain med. I have tried to contact clinic but unavail due to holiday. There is nothing to "show" so haven't gone to ER or DR.yet. May go if continues. Some relief from heating pad. Really hurts a lot. Information from Follow-up report states: Recv'd IM Hep B on 11/08/05 in right arm. On 11/23/05 (16 days after inj) inject site became extremely painful ( 7 on 1-10 scale). Also right thumb became numb. Pain continued at that level for approx. 2 weeks. Currenty is 4 on 1-10 scale and right thumb still numb, occasionally right arm and thumb tingles. Relief from 3 aspirin or extra streneth Tylenol, which I must take everyday, several times.
Age: 1.27
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Patient developed rash consistent with Varicella on 10/14/05.  Patient had a diffuse papular rash that was itchy.  There had been no known exposure, but the distribution made me suspicious of Varicella.  I only treated with Zyrtec for symptom relief and he did well as far as I know.
Age: 0.19
Sex: M
Vaccine: DTAP
Symptoms: Coma, Hypotonia, Pallor
Clinical narrative: pt became limp and unresponsive for five minutes at home brought to ED and had another unresponsive episode. He maintained normal heart rate and respirations. Was pale but not blue.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: pt was hospitalized with cellulitis and on iv No new terms added from Discharge Summary rec'd 12/28/2005/sr
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Diarrhoea, Headache, Heart rate increased, Meningism
Clinical narrative: Initial report received on 14/Nov/2005 from a consumer. A 13 year old female patient had received her first administration of Menactra, lot number U1575AP, in the left arm on Aug 11 2005. The route of administration was not reported. Two hours later, she developed a severe headache, sore neck, diarrhea, vomiting and and elevated temperature of 102 degree F. She also experienced heart racing, dizziness and appeared white in her face. At the time of this report her continuing symptoms were head spinning unable to walk without help, feeling like she is going to pass out, severe headaches and hypersensitive hearing. She also was experiencing muscle weakness and appeared pale, She cannot eat anything with out vomiting and diarrhea. Her urine is a dark green in color. Per the reporter, the patient fell on 01/Sep/2005 from weakness. She has been on bed rest since then. The patient lost her vision on 11/Sep/2005, this was described as she was blind except to color. On 10/Oct/2005 the patient could again see objects and could read somewhat by 11/Oct/2005. She also experienced elevated blood pressure that continues. The patient was hospitalized on two different occasions once on 14/Sep/2005 through 16/Sep/2005 and another time on  16/Nov/2005 through 23/Nov/2005. At the time of this report the patient had not recovered from these events.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Musculoskeletal stiffness, Pallor, Pyrexia, Vomiting
Clinical narrative: Initial report received on 14/Nov/2005 from a consumer. A 13 year old female patient had received her first administration of Menactra, lot number U1575AP, in the left arm on Aug 11 2005. The route of administration was not reported. Two hours later, she developed a severe headache, sore neck, diarrhea, vomiting and and elevated temperature of 102 degree F. She also experienced heart racing, dizziness and appeared white in her face. At the time of this report her continuing symptoms were head spinning unable to walk without help, feeling like she is going to pass out, severe headaches and hypersensitive hearing. She also was experiencing muscle weakness and appeared pale, She cannot eat anything with out vomiting and diarrhea. Her urine is a dark green in color. Per the reporter, the patient fell on 01/Sep/2005 from weakness. She has been on bed rest since then. The patient lost her vision on 11/Sep/2005, this was described as she was blind except to color. On 10/Oct/2005 the patient could again see objects and could read somewhat by 11/Oct/2005. She also experienced elevated blood pressure that continues. The patient was hospitalized on two different occasions once on 14/Sep/2005 through 16/Sep/2005 and another time on  16/Nov/2005 through 23/Nov/2005. At the time of this report the patient had not recovered from these events.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Blindness, Blood pressure increased, Chromaturia, Decreased appetite
Clinical narrative: Initial report received on 14/Nov/2005 from a consumer. A 13 year old female patient had received her first administration of Menactra, lot number U1575AP, in the left arm on Aug 11 2005. The route of administration was not reported. Two hours later, she developed a severe headache, sore neck, diarrhea, vomiting and and elevated temperature of 102 degree F. She also experienced heart racing, dizziness and appeared white in her face. At the time of this report her continuing symptoms were head spinning unable to walk without help, feeling like she is going to pass out, severe headaches and hypersensitive hearing. She also was experiencing muscle weakness and appeared pale, She cannot eat anything with out vomiting and diarrhea. Her urine is a dark green in color. Per the reporter, the patient fell on 01/Sep/2005 from weakness. She has been on bed rest since then. The patient lost her vision on 11/Sep/2005, this was described as she was blind except to color. On 10/Oct/2005 the patient could again see objects and could read somewhat by 11/Oct/2005. She also experienced elevated blood pressure that continues. The patient was hospitalized on two different occasions once on 14/Sep/2005 through 16/Sep/2005 and another time on  16/Nov/2005 through 23/Nov/2005. At the time of this report the patient had not recovered from these events.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Diarrhoea, Dizziness, Fall, Headache, Heart rate increased
Clinical narrative: Initial report received on 14/Nov/2005 from a consumer. A 13 year old female patient had received her first administration of Menactra, lot number U1575AP, in the left arm on Aug 11 2005. The route of administration was not reported. Two hours later, she developed a severe headache, sore neck, diarrhea, vomiting and and elevated temperature of 102 degree F. She also experienced heart racing, dizziness and appeared white in her face. At the time of this report her continuing symptoms were head spinning unable to walk without help, feeling like she is going to pass out, severe headaches and hypersensitive hearing. She also was experiencing muscle weakness and appeared pale, She cannot eat anything with out vomiting and diarrhea. Her urine is a dark green in color. Per the reporter, the patient fell on 01/Sep/2005 from weakness. She has been on bed rest since then. The patient lost her vision on 11/Sep/2005, this was described as she was blind except to color. On 10/Oct/2005 the patient could again see objects and could read somewhat by 11/Oct/2005. She also experienced elevated blood pressure that continues. The patient was hospitalized on two different occasions once on 14/Sep/2005 through 16/Sep/2005 and another time on  16/Nov/2005 through 23/Nov/2005. At the time of this report the patient had not recovered from these events.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hyperacusis, Muscular weakness, Neck pain, Pallor, Pyrexia
Clinical narrative: Initial report received on 14/Nov/2005 from a consumer. A 13 year old female patient had received her first administration of Menactra, lot number U1575AP, in the left arm on Aug 11 2005. The route of administration was not reported. Two hours later, she developed a severe headache, sore neck, diarrhea, vomiting and and elevated temperature of 102 degree F. She also experienced heart racing, dizziness and appeared white in her face. At the time of this report her continuing symptoms were head spinning unable to walk without help, feeling like she is going to pass out, severe headaches and hypersensitive hearing. She also was experiencing muscle weakness and appeared pale, She cannot eat anything with out vomiting and diarrhea. Her urine is a dark green in color. Per the reporter, the patient fell on 01/Sep/2005 from weakness. She has been on bed rest since then. The patient lost her vision on 11/Sep/2005, this was described as she was blind except to color. On 10/Oct/2005 the patient could again see objects and could read somewhat by 11/Oct/2005. She also experienced elevated blood pressure that continues. The patient was hospitalized on two different occasions once on 14/Sep/2005 through 16/Sep/2005 and another time on  16/Nov/2005 through 23/Nov/2005. At the time of this report the patient had not recovered from these events.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Vertigo, Vomiting
Clinical narrative: Initial report received on 14/Nov/2005 from a consumer. A 13 year old female patient had received her first administration of Menactra, lot number U1575AP, in the left arm on Aug 11 2005. The route of administration was not reported. Two hours later, she developed a severe headache, sore neck, diarrhea, vomiting and and elevated temperature of 102 degree F. She also experienced heart racing, dizziness and appeared white in her face. At the time of this report her continuing symptoms were head spinning unable to walk without help, feeling like she is going to pass out, severe headaches and hypersensitive hearing. She also was experiencing muscle weakness and appeared pale, She cannot eat anything with out vomiting and diarrhea. Her urine is a dark green in color. Per the reporter, the patient fell on 01/Sep/2005 from weakness. She has been on bed rest since then. The patient lost her vision on 11/Sep/2005, this was described as she was blind except to color. On 10/Oct/2005 the patient could again see objects and could read somewhat by 11/Oct/2005. She also experienced elevated blood pressure that continues. The patient was hospitalized on two different occasions once on 14/Sep/2005 through 16/Sep/2005 and another time on  16/Nov/2005 through 23/Nov/2005. At the time of this report the patient had not recovered from these events.