chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: SWELLING OF ARM, RED, HOT, PAINFUL, PATCH.  FEVER OF 100-101 DEGREES F FOR ONE NIGHT WITH SEVERE HEADACHE.  GENERAL MALAISE FOR 4 DAYS AFTER SEVERE REACTION.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema, Pruritus, Tenderness
Clinical narrative: Woke up this am and the site was itchy and red about the size of a quarter. He scratched it during the day. At 1545 he presents with 80mm diameter red/itchy area at site of injection. Artuse reaction. Edematous and tender to touch.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Pain, Rash macular, Urticaria
Clinical narrative: My arm starting hurting severly as soon as nurse injected medicine in my arm.  Pain was very bad.  Arm at injection site was hot to touch, and blotchy hives around the site.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: 6x5 cm redness around injection site. 1 cm diameter area indurated, firm around injection site, area tender to touch, fever x 1 night only.
Age: 0.0
Sex: U
Vaccine: VARZOS
Symptoms: Medication error
Clinical narrative: I am reporting this only since I think there is a slight labelling problem:  Last August, my medical assistant administered Merck's Varicella Vaccine to an adult who was intended to get the Zostavax.  There were no ill effects, but I sustept if the adult vaccine (14-fold more concentrated) had been given to a child...there might have been significant Side effects.  I reported this to Mercks online site >60 days ago but they never acknowledged the problem.  The problem I believe could be corrected by having the box and bottle clearly labelled "FOR ADULTS ONLY" or "FOR PEDIATRICS ONLY".
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lymphocytosis, Sudden infant death syndrome, White blood cell count decreased
Clinical narrative: SIDS; gestational diabetes - uncontrolled, late prenatal care, c-section, positive tobacco use, maternal anemia
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Haematuria, Hypokinesia, Proteinuria, Pyrexia
Clinical narrative: Poor feeding. Decreased activity. vomited x 1, Low grade temp less than 24 hours post vaccine. Resolved in less than 12 hour time. Had neg sepsis work up. Received antibiotics. MR received from pediatrician for several well child exams and a F/U for an ER visit for low grade fever 1 day post Hep B vax. Assessment: "Adverse Effect, Other Vaccines"./pc Hospital MR received which revealed admission to hospital to R/O sepsis in previously healthy 5 week old, due to parental report of fever up to 100'F, and decreased oral intake, decreased activity, and emesis x1.  IV fluids and antibiotics given and infant was afebrile, taking po, and acting normally.  D/Cd after 1 night. DISCHARGE DX: Viral Illness and fever of unknown origin.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Urine abnormality, Viral infection, Vomiting
Clinical narrative: Poor feeding. Decreased activity. vomited x 1, Low grade temp less than 24 hours post vaccine. Resolved in less than 12 hour time. Had neg sepsis work up. Received antibiotics. MR received from pediatrician for several well child exams and a F/U for an ER visit for low grade fever 1 day post Hep B vax. Assessment: "Adverse Effect, Other Vaccines"./pc Hospital MR received which revealed admission to hospital to R/O sepsis in previously healthy 5 week old, due to parental report of fever up to 100'F, and decreased oral intake, decreased activity, and emesis x1.  IV fluids and antibiotics given and infant was afebrile, taking po, and acting normally.  D/Cd after 1 night. DISCHARGE DX: Viral Illness and fever of unknown origin.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm edema, erythema and heat covering entire distal to shoulder and immediately proximal to elbow. Pt c/o discomfort.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Face oedema, Rash pruritic
Clinical narrative: Client Developed itchy facial skin and swelling and redness on the left side of the face. Facial skin is also bumpy per clients report.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 10/02/2006 received Fluzone and Pneumovax. 10/03/06 left arm turned red, swollen, 10/04 visit to MD, 10/04 or 5 went to ER, 10/05 went to ER again and was admitted, 10/06 discharged with RX for Clindamycin 300mg and Bactrim DS.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness at site right arm, pain at site right, swelling at site right arm, red streaks from site pm of 10/26/06 gone on 10/27/06.
Age: 0.71
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives, immediately, following influenza vaccine, resolved immediately with Benadryl PO. MR received revealing healthy infant with several food allergies and eczema, who developed hives within a few minutes of receiving Fluzone. Hives resolved quickly after PO Benadryl. F/U 1 week later with allergist who provided Epipen Jr. PRN, as well as Albuterol, and antihistamines PRN Primary DX: Influenza Vaccine  Allergy.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, swelling, and warmth covering entire deltoid region of left arm. Vaccine administered at 2:35pm and pt reports symptoms appeared in the evening of the same day.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain, Somnolence, Urticaria
Clinical narrative: 1 day after felt tired and achy, slept all day, day 2 broke out in hives all over body, 1 dose of Prednisone not helpful, 2 dose of prednisone helpful still on prednisone.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis
Clinical narrative: Mild cellulitis pt started on Keflex.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ, PNC
Symptoms: Medication error
Clinical narrative: Meningococcal mixed with Hib conjugate et administered IM to pt instead of Diluent mixed with Hib.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt had red, swollen, warm. Left arm. Size is 12x13cm pt denies pain on site. Pt was told to give 1/2 tsp Benadryl Q 6 hours and 1/2 tsp of Motrin Q 8 hours for 2-3 days. Pt will be back Monday 10/30/06 for follow up.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash started on face and back. Exposed to varicella.
Age: 1.62
Sex: M
Vaccine: HEPA
Symptoms: Eye disorder
Clinical narrative: Patient developed severe episodes of eye deviation to the right, tonic and clusters, lasted for several weeks.
Age: 0.96
Sex: F
Vaccine: DTPPHIB, HEP
Symptoms: Herpes zoster
Clinical narrative: Patient received Varivax 10/11/00 per old record. (?where or by whom) seen 10/2706 by me (her own pediatrician) with HERPES ZOSTER in L2 distribution.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: At the site of injection, redness 6 cm X 4 cm, induration 6 cm X 6cm later of the day injection given.  Treated with AUGMENTIN 600es 1 1/2 teaspoon twice a day for 10 days.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt reports that after receiving Hep. B vaccine, she developednausea, vomiting, and dizziness. Was given ANTIVERT and ZYRTEC and ER. Pt reported improvment with medications but not resolved. Pt called Clinic again 10/24/06. Reports mild dizziness, but stated that she felt much better.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Arm noted with redness 2" around injection site with swelling and increased warmth at 48 hours post injection,. recommended Advil alternate with Tylenol as per instruction of DRs nurse and instruct mom to call DR in am if swelling, redness increased.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Both arm red, hard and swollen at injection site, left arm measured 75mm wide and 68mm long around injection site. right arm measured 42 mm wide and 35mm long around injection site. Pt ran small low grade fever, advise give pt ibuprofen and Benadryl, per Dr.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site mass, Uterine leiomyoma
Clinical narrative: Fibrous Mass left thigh.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Tenderness
Clinical narrative: Pneumo vaccine given in am on 10/23/06, in afternoon, pt noticed swelling, tenderness. Came to clinic on 10/24/06, re upper arm, red, swollen tender to touch. Seen by DR. Recommended ice pack, Tylenol, Ibuprofen. Call us in 48 hours.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Generalized morbilliform rash on trunk and upper arms.
Age: 0.85
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Medication error, Rash pruritic, Viral infection
Clinical narrative: Pt received varicella vaccine 7/21/1999 was seen on 10/23/2006 and diagnosed with varicella, pruritic rash starting on back-chest.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Drooling, Eye movement disorder, Flushing, Hyperhidrosis, Postictal state
Clinical narrative: Within a minute pt became flush and faint. Then his arms tensed, his eyes rolled and he drooled, this lasted approx 30 seconds and was followed by a 10-20 min after ictal state (sleep and diaphoresis). Sugar soda was given, Blood sugar later recorded at 93, BP at 82/58 by nurse, 86/60 by DR.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Somnolence, Syncope, Tension
Clinical narrative: Within a minute pt became flush and faint. Then his arms tensed, his eyes rolled and he drooled, this lasted approx 30 seconds and was followed by a 10-20 min after ictal state (sleep and diaphoresis). Sugar soda was given, Blood sugar later recorded at 93, BP at 82/58 by nurse, 86/60 by DR.
Age: 0.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis atopic, Erythema, Pruritus, Rash, Rash papular
Clinical narrative: SYMPTOMS:    GENERAL Patient to clinic for evaluation of rash on chest and trunk as well as axilla b/l.  He states that the rash has been  increasing for 2 days and it is itchy.  No fever chills or night sweats noted.  No chest pain.  No other constitutional  sx noted.  Has had smallpox vax 15days prior.  He has taken benadryl for 2 days without relief.  No known new  soaps, detergents, etc.    PHYSICAL EXAM:    GENERAL generalized erythematous papular rash along trunk and chest as well as under both axilla. blanches with presure, not associated with follicles.  No signs of infection noted.  Smallpox  vax area clean and no  irritation around vax site noted.    DIAGNOSIS:    GENERAL/SYS. INFECTIONS     oOther Atopic Dermatitis - 691.8  DISPOSITION STATUS:    oReturn to Normal Duty   NURSING NOTE:    DISPOSITION NOTE: ditribution without association with vax site - possible atopic derm.  However, can have  vaccinia in other sites beside inoculation area (usually within days of vax).  reviewed litereature on smallpox vax  adverse rxns and will give supportive care (antihistamines, NSAIDs, etc and f/u). patient will f/u in 2 days Zantac 150mg po bid x 10d Zyrtec 10mg po qd X10d
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphagia, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: On Wednesday 10/25/06 received the Flu vacine (via shot) along with his 3 year old twin brother and 5 year old sister.  All children were perfectly healthy prior to the vacination.  By early evening he was showing a 103 degree tempature, which progressively worsened.  On Friday night simptoms included sore throat with swelling (unable to swollow), aches, pains, continued high fever requiring a trip to the emergency room, where they suggested it might be a virus and (incorrectly) prescribed antibiotics.  We did not fill the antibiotic prescription as we know they have no affect on a virus.  Giving him over the counter Tylenol and Motrin throughout this event provided very little if any releif.  On Saturday morning we returned to the doctor where the vaccine was received.  The doctor ran throat cultures and performed an complete checkup determining that he has the flu.  I understand that the vaccine (shot) is prepared with dead cultures, but find it very difficult to believe that (being the only one sick in the home at this time) this event was not due to the vaccine.  He has had fever reaction to the vaccine in the past, but nothing like this.  The child has just returned from the doctor and now has a 104.2 degree tempature.  My child is more sick then he has ever been in his life and I am extremely upset that the media representation of this vacine does everything to insure the public of it's safety and nothing to report that there is a chance (however slight) that an adverse reaction could include full blown Flu.  I am also extremely concerned for my childs saftey in the immediate since, as well as longer term issues.  We will now be returning to the emergency room for the second time to try and obtain some relief.
Age: 6.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Feeling hot, Injection site pain, Pruritus, Rash macular
Clinical narrative: Upper right arm had extreme pain in muscle at vaccine administration site of Pneumococcal Polysaccharide Vaccine. Unable to lay on arm when sleeping do to extreme pain for approx 8 hrs beginning 7 hrs after vaccination was given at 10 AM 10/26/2006. At approx 8 AM the next day 10/27/2006, the skin on the right arm beginning at the vaccination site proceding 3 inches wide and 7 inches down the arm was raised with red blotches that were warm to touch and itched. Application of Triamcinolone 0.1% Ointment reduced the skin swelling to onlya few red raised blotches after 12 hours as of 10 AM on 10/28/2006.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed active herpes zoster 5 days after receiving Zostax.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Joint stiffness, Pain, Shoulder pain
Clinical narrative: Intense pain shooting through entire arm, sometimes into shoulder, sometimes into back at upper shoulder blade area, arm and hand weakness. Unrelieved by medications, ice applied several times, heat alleviated only slightly. Joint stiffness and weakness in shoulder, arm and hand. I received flu shot 12 hours ago and it's no better. Began about 5 minutes after receiving shot - just after reaching my car in the parking lot. 3 Advil tablets every 4 hours have not helped. It's the weekend and I live alone. I have no money for emergency room care. I'm really scared of this. I called "ask a nurse" but they didn't know what to have me do other than ice, heat and pain meds. They don't help at all.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Vaccination in A.M. of 10/26/06.  Reaction to pneumococcal polysaccharide vaccine.  Specific vaccine information unknown to patient.  Red inflammation up to 3" diameter as of 10/29/06; temp. to 102F; swelling and soreness in arm where vaccination was administered; treatment recommended: (10/28/06-1st visit) ice pack, tylenol/motrin rotation, lortab; (10/29/06-2nd visit) hot pack, bactrim.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: High fever and chills beginning evening of injections and lasting three days; swollen red upper arm at site of pneumonia injection from day of injection to present time; Motrin, liquids and bed rest as treatment.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Headache, Injection site pain, Migraine
Clinical narrative: swelling at sites muscular pain at sites and throughout the body nausea chills for 3 days sweats-temperature at 102 for 2 days vertigo migraine and cluster headaches severe fatigue Sleep Advil Inhaler
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: swelling at sites muscular pain at sites and throughout the body nausea chills for 3 days sweats-temperature at 102 for 2 days vertigo migraine and cluster headaches severe fatigue Sleep Advil Inhaler
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Face oedema, Lacrimation increased, Ocular hyperaemia, Pharyngolaryngeal pain
Clinical narrative: Flu shot received on 10/24/06 at 1:45PM. At approximately  6:00 PM began severe throat pain, swelling of the lips and mouth area, reddening and tearing of the eyes. Constricted breathing. Taken to emergency room and treated and released after 3 hours. Steroid treatments followed and symptoms went way after approximately 48 hours.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: Local allergic reaction to the immunization, increased redness and swelling.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Day after pneumonia shot, sore arm, 2 days later left arm swollen, red and hot to the touch starting about 1" from where pneumonia shot was given. Red streaks going down arm towards hand. Went to urgent care. Was told by doctor it was either a reaction to the needle or to the medicine. Diagnosed with cellulitis and put on Cephalexin and Allegra, when I spoke with pt on 10/24 swelling gone and almost back to normal.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Day after pneumonia shot, sore arm, 2 days later left arm swollen, red and hot to the touch starting about 1" from where pneumonia shot was given. Red streaks going down arm towards hand. Went to urgent care. Was told by doctor it was either a reaction to the needle or to the medicine. Diagnosed with cellulitis and put on Cephalexin and Allegra, when I spoke with pt on 10/24 swelling gone and almost back to normal.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling and pain in the left arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Hypersensitivity, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red, warm flat rash left upper arm. with flushing and slight raised are of rash to chest and neck. Seen and observed in ED, TX with Anti histamine.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red, warm flat rash left upper arm. with flushing and slight raised are of rash to chest and neck. Seen and observed in ED, TX with Anti histamine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Child received immunization yesterday 10/19/06 at 2. Mother noticed this PM child RUA was red, hot to touch, firm, and painful. Brought child in at 4pm today. Applied ice to area. Doubtful cellulitis in such a short time period. Most likely local rxn to immunization. No systemic rxn noted. Pt should recover with advise given Ice, Tylenol, Benadryl, observation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 1/2 cm x 2 1/2 cm red, firm, warm area at injection site (right leg).
Age: 29.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Oedema, Pain, Rash macular
Clinical narrative: Swollen arm, blotchy skin, severe pain.
Age: 0.62
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Autism, Diarrhoea, Mental retardation severity unspecified, Oral intake reduced
Clinical narrative: This case was considered medically important (OMIC). Information was regarding Hib Titer vaccine was received from a consumer regarding her son male who experienced diarrhea episodes, autism and developmental delay. At 7 months of age, the pt received the third dose of Hib titer vaccine on 7/20/00, along with the third dose of Infanrix. Relevant medical history was not provided. Indication for Hib Titer vaccine was immunisation. Product was administered on 7/20/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Infanrix and Engerix B. Pt was not taking concomitant therapy. The boys mother states that in approx April or May 2000, her son seemed quieter, had difficulty taking the bottle and had frequent bouts of diarrhea. At 9 months of age, her son was not developing as he should. At 4 years of age, he began to speak. On an unspecified date, he was diagnosed with autism by a neurologist. No additional information was available at the time of this report.
Age: 0.62
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information was regarding Hib Titer vaccine was received from a consumer regarding her son male who experienced diarrhea episodes, autism and developmental delay. At 7 months of age, the pt received the third dose of Hib titer vaccine on 7/20/00, along with the third dose of Infanrix. Relevant medical history was not provided. Indication for Hib Titer vaccine was immunisation. Product was administered on 7/20/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Infanrix and Engerix B. Pt was not taking concomitant therapy. The boys mother states that in approx April or May 2000, her son seemed quieter, had difficulty taking the bottle and had frequent bouts of diarrhea. At 9 months of age, her son was not developing as he should. At 4 years of age, he began to speak. On an unspecified date, he was diagnosed with autism by a neurologist. No additional information was available at the time of this report.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Eclampsia, Premature baby, Unintended pregnancy
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a nurse on 4/3/06. A 40 year old female pt received a 0.5ml injection of Adacel, lot number C2151AC on 3/31/06 in the left deltoid. She also received Tybersol, lot number C2141AB, intra dermally (administration date and site not reported. She is currently on folic acid, albuterol and prenatal vitamins. She has had 9 previous pregnancies with normal/viable outcomes and the date of her last menstrual period was 11/28/05. The pt did not experience any adverse events. Follow up information received on 10/16/06. It was reported that the pt developed pre eclampsia and was delivered at 35 weeks gestation. An ultrasound on 3/17/06 was normal. The pts delivered a single live female neonate via vaginal delivery on 7/26/06. The baby's APGAR Scores were eight and nine. There were no congenital anomalies. Based upon the new information in this follow up report, this case is being upgraded to serious.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Nasal congestion, Pruritus, Wheezing
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/17/06 from a family member of the pt who is also a health care professional. A 40 year old female pt, with a past medical history of asthma and dust and pollen allergies, had received a left deltoid injection of Fluzone SV 2006-2007 lot number unk, on either 10/9/06 or 10/10/06. Fifteen minutes post vaccination, the pt experienced wheezing, and itchy throat, cough, nasal congestion and chest tickle. The event required a physician examination. She was treated with a Zopinex inhaler, and the symptoms resolved after 45 minutes. The pt had experienced the same symptoms following an cortisone injection two weeks prior to these events. Relevant diagnostic testing included an IgE of 630 and neg testing for egg and chicken allergies. The pt recovered from the event.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/17/06 from a health care professional. A 34 year old female pt, with a history of latex allergy, had received an IM injection of Fluzone SV 2006-2007, lot number U2165CA, on 10/17/06. Ten minutes post vaccination, the pt experienced lightheadedness and shortness of breath. She was treated with IV Benadryl and transported to the ER. At the time of this report, the pt had not recovered.
Age: 40.0
Sex: M
Vaccine: TTOX
Symptoms: Hypoaesthesia, Muscle spasms, Neuropathy peripheral, Pain in extremity
Clinical narrative: On 10/22/06 pt was bitten by his dog. He was seen at ER and was given a tetanus shot at midnight. The following morning 3:00am, developed left arm pain and numbness, right arm pain and numbness of both feet with calf muscle spasms. Seen at center on 10/27/06 with peripheral neuropathy symptoms and muscle spasms. 12/12/06-obtained lot #U1786AA Aventis.  02/20/07-DC DX: Parathesia secondary to Tetanus Toxoid. DOS 10/27-10/28/06 Complaint of numbness left palm pain in right upper arm and numbness of both feet after tetanus vaccine. Prior to vaccine patient was bitten by his dog. Day after tetanus shot developed numbness of left thenar eminence, pain in right triceps ara numbness of both feet and spasms of calf muscles when standing but not walking. History of stomach virus several days prior.  PE:WNL: except for palpable spasm of calf muscles bilaterally. Sensation diminished to light touch and pinprick over just the left thenar eminence.  Assessment: unexplained fleeting neurologic deficits related to side effects of tetanus toxoid.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram abnormal, Full blood count
Clinical narrative: Seizures. DC DX: new onset seizures resolved and improved. Continues to have daily seizure activity.  Is being followed. Per 60 day follow up: Pt continues to have seizures which started the day after the vaccine. ? co-relation. Pt being followed by neurologist at this time for the problem.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Cerebrovascular disorder, Computerised tomogram abnormal, Death, Facial palsy
Clinical narrative: Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant.  Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius.  At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Hemiplegia, Neurological examination abnormal, Somnolence, Transient ischaemic attack
Clinical narrative: Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant.  Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius.  At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Erythema, Heart rate decreased
Clinical narrative: Severe red rash, hives, drop in blood pressure, and pulse, dizziness, weakness, nausea, faintness.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Rash, Urticaria
Clinical narrative: Severe red rash, hives, drop in blood pressure, and pulse, dizziness, weakness, nausea, faintness.
Age: 55.0
Sex: M
Vaccine: ANTH, FLUX, OPV, TD, TYP, YF
Symptoms: Arthritis, Blood cholesterol increased, Blood glucose increased, Cough, Diabetes mellitus
Clinical narrative: High blood pressure, high cholesterol, Insomnia, vision problem, diabetes mellitus, arthritis, pain right and left shoulder, pain feet, like a electrical shock. Initial report includes documentation of sick visit on 16 Jan. 2003 for fever and cough.  Txd with phenergan. Next visit 10 June 2003 discussing diabetes, HTN, and high cholesterol dx in Feb/March 2003, which placed him on limited duty to monitor response to diabetes tx. MR received from VA documenting multiple office visits for c/o dizziness, abdominal pain, chest pain, injury from bike accident, hand numbness and tingling, toenail avulsion, ear pain, sore throat, dysphagia, h/a, and upper and lower back pain between 06/2004 and 11/2006. Had carpal tunnel surgery 07/2006. Assessments: As above in PMH (Diabetes Mellitus dxd in 2003, HTN, lumbar disc herniation, bilateral rotator cuff tears repaired in 2004,depression, anxiety, hypercholesterolemia, elevated LFTs). As soon they put me the shoot my blood sugar raise until 557 and my joint start to pain red hard.  After that course me surgery in both shoulder and carpal tunnel in right hand also I have 3 bulgens on back (disk) I lost memory and deppresion I check with VA for this sickness I have to wear glasses because I lost vision  Per 60 day follow up: I never feel symptoms of diabetes, only after the vaccination occur. I sent evidence that all year, that I will be activated during regualr army and national guard never feel diabetes symptoms. Also army reserve. Those events "both sugery on my shoulders and carpal tunnel surgery" cause me highly depression.
Age: 55.0
Sex: M
Vaccine: ANTH, FLUX, OPV, TD, TYP, YF
Symptoms: Hypertension, Insomnia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: High blood pressure, high cholesterol, Insomnia, vision problem, diabetes mellitus, arthritis, pain right and left shoulder, pain feet, like a electrical shock. Initial report includes documentation of sick visit on 16 Jan. 2003 for fever and cough.  Txd with phenergan. Next visit 10 June 2003 discussing diabetes, HTN, and high cholesterol dx in Feb/March 2003, which placed him on limited duty to monitor response to diabetes tx. MR received from VA documenting multiple office visits for c/o dizziness, abdominal pain, chest pain, injury from bike accident, hand numbness and tingling, toenail avulsion, ear pain, sore throat, dysphagia, h/a, and upper and lower back pain between 06/2004 and 11/2006. Had carpal tunnel surgery 07/2006. Assessments: As above in PMH (Diabetes Mellitus dxd in 2003, HTN, lumbar disc herniation, bilateral rotator cuff tears repaired in 2004,depression, anxiety, hypercholesterolemia, elevated LFTs). As soon they put me the shoot my blood sugar raise until 557 and my joint start to pain red hard.  After that course me surgery in both shoulder and carpal tunnel in right hand also I have 3 bulgens on back (disk) I lost memory and deppresion I check with VA for this sickness I have to wear glasses because I lost vision  Per 60 day follow up: I never feel symptoms of diabetes, only after the vaccination occur. I sent evidence that all year, that I will be activated during regualr army and national guard never feel diabetes symptoms. Also army reserve. Those events "both sugery on my shoulders and carpal tunnel surgery" cause me highly depression.
Age: 55.0
Sex: M
Vaccine: ANTH, FLUX, OPV, TD, TYP, YF
Symptoms: Shoulder pain, Visual disturbance
Clinical narrative: High blood pressure, high cholesterol, Insomnia, vision problem, diabetes mellitus, arthritis, pain right and left shoulder, pain feet, like a electrical shock. Initial report includes documentation of sick visit on 16 Jan. 2003 for fever and cough.  Txd with phenergan. Next visit 10 June 2003 discussing diabetes, HTN, and high cholesterol dx in Feb/March 2003, which placed him on limited duty to monitor response to diabetes tx. MR received from VA documenting multiple office visits for c/o dizziness, abdominal pain, chest pain, injury from bike accident, hand numbness and tingling, toenail avulsion, ear pain, sore throat, dysphagia, h/a, and upper and lower back pain between 06/2004 and 11/2006. Had carpal tunnel surgery 07/2006. Assessments: As above in PMH (Diabetes Mellitus dxd in 2003, HTN, lumbar disc herniation, bilateral rotator cuff tears repaired in 2004,depression, anxiety, hypercholesterolemia, elevated LFTs). As soon they put me the shoot my blood sugar raise until 557 and my joint start to pain red hard.  After that course me surgery in both shoulder and carpal tunnel in right hand also I have 3 bulgens on back (disk) I lost memory and deppresion I check with VA for this sickness I have to wear glasses because I lost vision  Per 60 day follow up: I never feel symptoms of diabetes, only after the vaccination occur. I sent evidence that all year, that I will be activated during regualr army and national guard never feel diabetes symptoms. Also army reserve. Those events "both sugery on my shoulders and carpal tunnel surgery" cause me highly depression.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Cyanosis, Febrile convulsion, Laboratory test abnormal
Clinical narrative: Patient is a 3 year old male who had a seizure of 3 minutes on 10-25-06 PM. This progressed to cyanosis and no respirations. Mother gave 2 rescue breaths and then did not find the carotid pulse. She initiated CPR times 2 minutes. EMS arrived and found pulse and now breathing but posticial. Transported to Hospital and admitted overnight. DC DX: for 10/25-10/26/06 Febrile Seizure HX of febrile seizures times three in the past. Normal EEG 7/05. Previously followed by neurologist. URI symptoms for up to one week prior to seizure.  EEG pending CXR: normal chest  EKG normal Labs WNL with AST 45.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis injection site.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness in left arm over deltoid, swollen and warm, both vaccinations in same arm. Rocephin, Prednisone, Benadryl, Keflex.
Age: 11.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Right arm sore, red, hard to move, low grade fever, Benadryl, Then Claritin, Ibuprofen.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain, Sensation of heaviness
Clinical narrative: Arm feels heavy and hurts, chest, back, underarm, cant lift up arm.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Throat tightness
Clinical narrative: Throat swollen, blood pressure increase, pt contacted doctor, was advised to take Benadryl.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphonia, Throat tightness, Urticaria
Clinical narrative: Pt stated within 30 mins. of receiving flu vaccine she was on her way home when she experienced tightness in her chest. She also experienced throat tightness and was hoarse. She had wheals on her arms and neck, No treatment got better on its own by this morning, advised to see MD.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left lat arm 8x11 cm erythema with 6x4 cm induration. non tender, increase local temp. on 10/25/06 exam reaction noticed 10/24/06 evening. Flu vaccine given IM left deltoid 10/23/06.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Wide spread urticaria and pruritis.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Arthritis bacterial, Injection site haemorrhage, Shoulder pain, Tendonitis
Clinical narrative: 10/06/2006 severe pain in right shoulder. 10/06/06 hospital ER. Given pain killer and told to see a physician. 10/09/2006 saw orthopedic Surgeon. Had W rays and MRI. 10/10/06 diagnosis deltoid hematoma from injection, acute rotator cuff tendonitis, septic arthritic from the injection. Given pain killer, antibiotics and rehab.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Shoulder pain
Clinical narrative: Approx 8-10 hours after receiving influenza vaccine, experienced pain in the shoulder, neck and severe headache.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Oedema, Pain, Pyrexia
Clinical narrative: Received pneumovax on 10/20/06, 10/23/06 reported on 10/21 developed fever and chills, hurts to abduct shoulder and arm, cellulitis DX'd Keflex 500 mg 4x daily started, 10/24/06 no improvement pt insisted on referral to dermatologist seen same day, recommended watchful waiting, to call if edema increased, 10/25/06 CBC drawn appt with DR suspect immunization reaction, cellulitis, no evidence of systemic reaction.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Eye oedema, Face oedema
Clinical narrative: Lip/eye swelling following Fluzone.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Eye oedema, Injection site oedema, Injection site reaction, Skin ulcer
Clinical narrative: Pt seen for Immunization administration. Returned to office 15 minutes later with swelling around eyes, 6cm diameter red, swelling, slight edema, around Varivax injection site, and few scattered urticarial lesions. Given Dexamethasone, Benadryl, Epi on hand. PT watches about 4 hours office released home.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt seen for Immunization administration. Returned to office 15 minutes later with swelling around eyes, 6cm diameter red, swelling, slight edema, around Varivax injection site, and few scattered urticarial lesions. Given Dexamethasone, Benadryl, Epi on hand. PT watches about 4 hours office released home.
Age: 1.19
Sex: F
Vaccine: FLU3, HIBV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site vesicles, Skin ulcer
Clinical narrative: On 10/06/06 or 10/07/06 mom noted several vesicular lesions on left thigh surrounded by erythema at injection site, increased swelling x 3-4 D, then decreased, slight tender, No fever no rash elsewhere. MD saw 10/11/06 left lower thigh with about 2cm area erythema, slight induration with overlying crusting vesicle. Non tender, Excoriated, no rash elsewhere, no evid. cellulitis/abscess. Sx TX.
Age: 1.19
Sex: F
Vaccine: FLU3, HIBV, MMRV
Symptoms: Tenderness
Clinical narrative: On 10/06/06 or 10/07/06 mom noted several vesicular lesions on left thigh surrounded by erythema at injection site, increased swelling x 3-4 D, then decreased, slight tender, No fever no rash elsewhere. MD saw 10/11/06 left lower thigh with about 2cm area erythema, slight induration with overlying crusting vesicle. Non tender, Excoriated, no rash elsewhere, no evid. cellulitis/abscess. Sx TX.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt returns to office c/o itching all over. Pt state approx 30 min after receiving flu vaccine began to itch from head to feet, soles of feet even itching. No SOB, no swelling, no vesicle rash. Pt states previous hx flu vaccine with no adverse reaction (approx 10 years ago). Pt has no egg allergy, no history any drug allergy. Claritin XL given with relief of itching.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red area with slight warmth around injection site, Painful to touch.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Feeling cold, Heart rate irregular
Clinical narrative: Immediately dizzy, diaphoretic, cold, clammy, blurred vision, pale, BP 60/86, pulse thready, Epi 0.5 given per RN, pulse better 86. Receipts and all information regarding Flu shot given to pt before transport to ER, Police arrive, then EMS arrived took to ER alert, orientated and feeling better. Cold pack followed and appropriate at time of administration of vaccine.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Immediately dizzy, diaphoretic, cold, clammy, blurred vision, pale, BP 60/86, pulse thready, Epi 0.5 given per RN, pulse better 86. Receipts and all information regarding Flu shot given to pt before transport to ER, Police arrive, then EMS arrived took to ER alert, orientated and feeling better. Cold pack followed and appropriate at time of administration of vaccine.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Urticaria
Clinical narrative: Immediate severe pain associated with pneumococcal vaccine redness, swelling, hive on the medial aspect of the injection site.
Age: 37.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema, Skin disorder
Clinical narrative: Swollen lump just under left collar bone, also a raised line/streak (not red or painful) from site of immunization to swollen lump. 4-5 inch patch of red, sore, leathery skin all around site of immunization, very sore to touch.
Age: 37.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Skin nodule
Clinical narrative: Swollen lump just under left collar bone, also a raised line/streak (not red or painful) from site of immunization to swollen lump. 4-5 inch patch of red, sore, leathery skin all around site of immunization, very sore to touch.
Age: 1.04
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Dermatitis bullous
Clinical narrative: Classic pox rash on trunk.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Retching, Vomiting
Clinical narrative: Caused headache with Dry heaves, vomited twice about 15 minutes after leaving clinic.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Pallor, Pyrexia, Vomiting
Clinical narrative: 10/24/06 (day following vaccines) mother reports, pt pale, nausea, vomit x 1, headache, fever of 102+
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction, Pain, Pruritus
Clinical narrative: Pt is 21 y/o male, Received AVA (3 right) and primary smallpox vaccine (left) on 10/10/06. Denies significant local reaction at anthrax vaccine site. Smallpox vaccine site with some redness and pruritis, but no streaking or lymphangitis. No tender nodes in left axilla. Has been covering SPV site with dressing and following guidelines regarding site care and hand washing etc. SPV site assessed as take and undergoing normal progression. NO unusual or prolonged systemic symptoms following vaccine receipt, but did experience 2 day history of generalized body aches around post vaccine days 8 and 9. New onset of pruritic lesions around post vaccine day 10 (Oct 20th). Described appearance of about 10 red, slightly raised, pruritic lesions on both arms. By the following day, had generalized rash on arms, trunk, back and legs. Seen in ER on 10/21 and treated with Benadryl. Denies change in character of lesions other than lesions becoming confluent. Came in for follow up evaluation in Dermatology on 10/23 and had punch biopsy done. Continues to experience significant pruritis despite treatment with Benadryl. Denies previous history of any vaccine adverse events. Denies any recent symptoms of viral type illness or infections. No exposure to skin irritants, not using new soap, not new detergents, not new lotions and not recently changed cleansing agents. Allergies: no allergy to foods and no known drug allergies. past medical history denies history of chronic illnesses. Specifically denies history of allergies (aeroallergens), asthma, and eczema. No history of hospitalizations. No surgeries. Previously well, not feeling tired or poorly, no fever, and no chills, no headaches. No mouth sores, no lip sores and no sores on the tongue, Pruritus localized to a skin rash or sores. No blisters. Generalized lesions excluding the palms and soles. No tingling and no burning sensation. Lesions macule, papule, pruritus
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic, Skin ulcer
Clinical narrative: Pt is 21 y/o male, Received AVA (3 right) and primary smallpox vaccine (left) on 10/10/06. Denies significant local reaction at anthrax vaccine site. Smallpox vaccine site with some redness and pruritis, but no streaking or lymphangitis. No tender nodes in left axilla. Has been covering SPV site with dressing and following guidelines regarding site care and hand washing etc. SPV site assessed as take and undergoing normal progression. NO unusual or prolonged systemic symptoms following vaccine receipt, but did experience 2 day history of generalized body aches around post vaccine days 8 and 9. New onset of pruritic lesions around post vaccine day 10 (Oct 20th). Described appearance of about 10 red, slightly raised, pruritic lesions on both arms. By the following day, had generalized rash on arms, trunk, back and legs. Seen in ER on 10/21 and treated with Benadryl. Denies change in character of lesions other than lesions becoming confluent. Came in for follow up evaluation in Dermatology on 10/23 and had punch biopsy done. Continues to experience significant pruritis despite treatment with Benadryl. Denies previous history of any vaccine adverse events. Denies any recent symptoms of viral type illness or infections. No exposure to skin irritants, not using new soap, not new detergents, not new lotions and not recently changed cleansing agents. Allergies: no allergy to foods and no known drug allergies. past medical history denies history of chronic illnesses. Specifically denies history of allergies (aeroallergens), asthma, and eczema. No history of hospitalizations. No surgeries. Previously well, not feeling tired or poorly, no fever, and no chills, no headaches. No mouth sores, no lip sores and no sores on the tongue, Pruritus localized to a skin rash or sores. No blisters. Generalized lesions excluding the palms and soles. No tingling and no burning sensation. Lesions macule, papule, pruritus