chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Convulsion, Malaise, Pyrexia
Clinical narrative: High fever 104.9; malaise; admitted to hospital; szs while in hospital;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Screaming
Clinical narrative: Continuous crying for appr. 6 hrs; beginning 2 hrs p/injection; unrelieved by Tylenol PO & cold compress to site;
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Pyrexia
Clinical narrative: 8AUG91 AM mom reported to nurse that PT's T had gotten as high as 105 (104 ax.) the night before--7 days p/DPT, OPV, Hibtiter, & MMR were given; mom was advised to take PT to MD, but didn't go because MD advised to wait and monitor T;
Age: 0.5
Sex: F
Vaccine: DTP, HIBV
Symptoms: Urticaria
Clinical narrative: @ appr. 10 min p/Hibtiter & DPT vax, trunk of body developed large reddened blotchy areas; was transported to ER & given Epi & Benadryl;
Age: 2.0
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Hypokinesia
Clinical narrative: Leg "gave out" on him p/shot;
Age: 1.3
Sex: F
Vaccine: DT, HIBV, MMR, OPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: T104-105 on 22AUG91; sz; PT is on phenobarbitol for sz that occurred p/DPT when 4 mo old; PT has sz disorder--tuberous sclerosis;
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Pallor, Screaming, Somnolence
Clinical narrative: Slept p/shots; appr. 3.5-4 hrs later PT began crying & could not be comforted; seemed lethargic & pale; 27AUG91 remains pale, but is responsive & not crying; 6PM 26AUG to 5AM 27AUG crying intermittently, sometimes screaming;
Age: 3.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Anorexia, Malaise, Pyrexia, Tachycardia
Clinical narrative: Thurs PM T104.6 started; HR 145; Pt listless, not wanting to eat or play; mom called @ 150PM 6SEP91 & wanted MD to see PT; mom called @ 415 & said PT was still sick & mom would take to ER; 10SEP91 aunt said MDs at ER found nothing wrong;
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Agitation, Anorexia, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: mom states PT had T 103; would not dec w/Tylenol; T did dec temporarily w/Advil; mom states PT was irritable, crying most of night, no appetite; lt arm--that DPT was given in--was red, swollen & hot to touch; referred to PMD;
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Screaming, Vasodilatation
Clinical narrative: mom states PT had T 103; would not dec w/Tylenol; T did dec temporarily w/Advil; mom states PT was irritable, crying most of night, no appetite; lt arm--that DPT was given in--was red, swollen & hot to touch; referred to PMD;
Age: 1.2
Sex: F
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Cellulitis, Oedema, Pyrexia, Vasodilatation
Clinical narrative: T 101.5 w/swelling of lt arm from hand to elbow & warm to touch; 5SEP91 PMD dx cellulitis; rx Augmentin; dec rx p/1 day (gave PT diarrhea) & mom stated arm was OK next day p/seeing MD;
Age: 1.9
Sex: F
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Oedema, Pain, Pyrexia, Urticaria, Vomiting
Clinical narrative: Completed ATBs for ear infect 1 wk a/immuns; p/Tylenol PT T105ax thru night; sponged & T dec 103ax; this AM T103ax, emesis in early AM: dark green, thin liquid; lt leg "sore," blotchy, red, swollen; 12SEP91 later AM T101ax; no more vomit;
Age: 0.5
Sex: M
Vaccine: DTP, OPV
Symptoms: Pyrexia
Clinical narrative: PT started having a fever about 2 hrs p/receiving the immun; late in night mom discovered T of 106; stated gave Tylenol a/PT recvd injection; (event not reported 'til 3SEP91)
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site oedema, Rash, Vasodilatation
Clinical narrative: Rash on head & arm, inject site, rt deltoid, hot & swollen skin hot, dry red rash mostly on head;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Screaming
Clinical narrative: Mom states pt had prolonged crying for 6 hrs p/DTP, starting 1.5 hrs p/inject; Mom reported this to MD, same PM; Seen by MD next day; MD prescribed DT injects;
Age: 0.8
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Pyrexia, Vomiting
Clinical narrative: 3rd set of immun given in AM, phone call later stated pt had fever, pt was heard crying in background; Seen by MD in afternoon; pt fussy, t101.7, & vomited; MD advised no further Pertussis;
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Injection site hypersensitivity, Pyrexia, Vomiting
Clinical narrative: Fever 102 21SEP & 22SEP; fever broke 23SEP91; severe vomiting, redness @ vax site;
Age: 3.0
Sex: F
Vaccine: DTP, MMR, OPV
Symptoms: Pyrexia, Rash, Vasodilatation
Clinical narrative: 22SEP face red, felt hot (mom states 102), saw bumps on face, gave APAP; 23SEP felt warm did not take temp, rash only on face, taken to MD 23SEP91;
Sex: M
Vaccine: PPV, PPV
Symptoms: Agitation, Pain, Pleural disorder, Serum sickness
Clinical narrative: Complainant reports that last Monday 19AUG91 husband recvd Pneumonia prevention shot; a day later, pt exp a rxn of being very irritable & having a broken rib feeling, pleurisy; Hospitalized 4 days; MD felt was serum rxn;
Sex: M
Vaccine: PPV, PPV
Symptoms: Atelectasis, Chest pain, Myalgia, Pleural disorder, Pneumonia
Clinical narrative: Complainant reports that last Monday 19AUG91 husband recvd Pneumonia prevention shot; a day later, pt exp a rxn of being very irritable & having a broken rib feeling, pleurisy; Hospitalized 4 days; MD felt was serum rxn;
Sex: M
Vaccine: PPV, PPV
Symptoms: Vasodilatation
Clinical narrative: Complainant reports that last Monday 19AUG91 husband recvd Pneumonia prevention shot; a day later, pt exp a rxn of being very irritable & having a broken rib feeling, pleurisy; Hospitalized 4 days; MD felt was serum rxn;
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Guillain-Barre syndrome, Infection
Clinical narrative: Was seen in ER 21AUG91 or 22AUG91 for ?infection, then was seen @ med ctr ER 2 times; was flown out on 26AUG91 to another Hosp w/weakness below shoulders; sx of Gullain Barre; Entire family had been ill w/some type of n,v,d 1st 2wks of Aug;
Age: 0.2
Sex: F
Vaccine: DTP, OPV
Symptoms: Convulsion, Grand mal convulsion, Mental retardation severity unspecified
Clinical narrative: Pt was a healthy 2mo old; the 1st sz occurred approx 12 hrs p/1st DTP shot; w/time, sz disorder became progressively worse & pt became developmentally delayed; seizures occur daily w/frequent episodes of status epilepticus requiring ER tx;
Age: 5.0
Sex: M
Vaccine: DTP, MMR
Symptoms: Cellulitis, Oedema
Clinical narrative: 1 day p/inject devel redness & swelling of rt shoulder area; Seen in ER & treated as possible cellulitis 21SEP91; Seen by MD 23SEP dec swelling;
Age: 1.0
Sex: F
Vaccine: DTP, OPV
Symptoms: Dysphonia
Clinical narrative: 24 hrs post inject lost voice; lasted x 6 days; afebrile; no loss of appetite; no lethargy;
Age: 1.5
Sex: F
Vaccine: HIBV, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile convulsions 2 days p/the vax given;
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Screaming
Clinical narrative: approx 30min p/immun, pt became irritable; persisting inconsolable screaming for @ least 5-6hrs;
Age: 1.3
Sex: M
Vaccine: HIBV, MMR
Symptoms: Urticaria
Clinical narrative: MMR/HIB TITER were given on 13SEP91; pt devel hives on 15SEP91; tx DPH;
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Oedema, Pruritus, Vasodilatation
Clinical narrative: 4SEP91 pt given DT & became itchy & swelling 7SEP91; Returned 11SEP91 approx 30-40% of lateral aspect pt arm inc warmth no drainage; given meds;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood lactate dehydrogenase increased, Paraesthesia
Clinical narrative: Pt c/o "numbness/fullness under rt rib cage"; pt (employee) went to family MD; Onset of sx occured approx 2 days p/inject;
Age: 0.4
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Convulsion, Leukocytosis, Pyrexia
Clinical narrative: Generalized tonic clonic sz lasting 10-15 min occurring 10-12 hrs p/inject; pt had fever 103.6; no tx for sz; pt given ATB secondary to high WBC; complete recovery;
Age: 4.0
Sex: F
Vaccine: DTP, OPV
Symptoms: Asthenia, Malaise, Pallor, Pyrexia, Screaming
Clinical narrative: fever 103.8 lasted 1.5 days; cried for 4 hrs; pale & weak 1 day; listless 1 day all day of shot;
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Hypotonia
Clinical narrative: Hyporeflexia, hypotonicity lasting less than ten minutes;
Age: 31.0
Sex: U
Vaccine: DT
Symptoms: Injection site hypersensitivity, Injection site oedema, Pain
Clinical narrative: Redness & swelling @ inject site, soreness w/mobility of deltoid muscles x 3 days;
Age: 1.3
Sex: F
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Screaming
Clinical narrative: Pt recvd vax 31JUL91 & devel fever of 102 w/severe crying spell which lasted a couple of hrs in duration;
Sex: F
Vaccine: RUB
Symptoms: Deafness
Clinical narrative: It was reported that on approx 11DEC89 pt was administered rubella virus vax live; subsequently, pt became totally & permanently deaf;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt vaxd w/3 doses of Hep B, 1st dose 16FEB90 & 3rd dose 24AUG90; pt noted was pregnant 21JUL90 & underwent C-section (WAES91020545) because was noted during labor umbilical cord was around baby's neck; dec dilation & baby not descending;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Myelitis
Clinical narrative: Pt recvd 2nd dose of Hep B & two wks following vax, pt exp transverse myelitis;
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt appeared lethargic, t103, APAP given & tepid bath; temp down approx 4 hrs temp inc again; pt was taken to ER; t105 R;
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 22MAY90; 13JUL90 & 30NOV90; pt did not convert positive for HBSAB; No tx given; Reporter indicated that pt will recvd 1-2 extra doses of vax to try to get pt to convert;
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Chest pain, Dizziness, Dyspnoea, Hypokinesia, Injection site pain
Clinical narrative: Pt c/o soreness @ inject site immediately p/recvd 22MAY91 inject; 3 hrs later exp dizziness & nausea, t100, hard to breathe, it felt as though chest was being held down, could not move her neck & shoulders;
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Nausea, Pyrexia
Clinical narrative: Pt c/o soreness @ inject site immediately p/recvd 22MAY91 inject; 3 hrs later exp dizziness & nausea, t100, hard to breathe, it felt as though chest was being held down, could not move her neck & shoulders;
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: Pt c/o soreness @ inject site immediately p/recvd 22MAY91 inject; 3 hrs later exp dizziness & nausea, t100, hard to breathe, it felt as though chest was being held down, could not move her neck & shoulders;
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Agitation, Pain, Pleural disorder, Serum sickness
Clinical narrative: Devel myalgia, flushed, rt sided pleuritic chest pain, same day as vax given ( approx 6hrs); Admitted for Pleurisy/ateletasis/?pneumonitis;
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Atelectasis, Chest pain, Myalgia, Pleural disorder, Pneumonia
Clinical narrative: Devel myalgia, flushed, rt sided pleuritic chest pain, same day as vax given ( approx 6hrs); Admitted for Pleurisy/ateletasis/?pneumonitis;
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vasodilatation
Clinical narrative: Devel myalgia, flushed, rt sided pleuritic chest pain, same day as vax given ( approx 6hrs); Admitted for Pleurisy/ateletasis/?pneumonitis;
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Convulsion, Dizziness, Hypertonia, Pallor, Pruritus
Clinical narrative: 1100AM recd vax; 1101AM c/o dizziness; 1102AM collapsed; 1103AM collapsed again; skin white, flushed cheeks, tonic-clonic activity trunk & arms; returned to alert; suddenly unresponsive; BP 54/12; 1112AM Epi & Benadryl; c/o itching;
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Stupor, Syncope
Clinical narrative: 1100AM recd vax; 1101AM c/o dizziness; 1102AM collapsed; 1103AM collapsed again; skin white, flushed cheeks, tonic-clonic activity trunk & arms; returned to alert; suddenly unresponsive; BP 54/12; 1112AM Epi & Benadryl; c/o itching;
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Pallor, Paraesthesia, Skin discolouration, Syncope
Clinical narrative: 19SEP91 PT recd vax; 20SEP91 PT c/o fingers tingling & numbess of left hand; arm was mottled & nurse said PT's arm had turned blue; rx Benadryl; 21SEP91 PT still pale & faint; to go to ER if needed; 24SEP91 PT is much better;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Pyrexia
Clinical narrative: T105R w/in 12 hrs of immun; no response to Tylenol; PT had T103-104R x 1 wk p/immun; no rx x/Tylenol;
Age: 0.3
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Anorexia, Screaming, Somnolence
Clinical narrative: PT screamed for 3 hrs, then slept long periods & would not eat; seen by MD 23AUG & 26AUG; MD recommends Ped. DT next visit; no fever;
Age: 1.4
Sex: M
Vaccine: DTP, MMR, OPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Mom states PT had fever of 107 & had szs; had not had Tylenol in 8-9hrs a/szs; @ 5AM had szs & was hospitalized; rx: Phenobarbitol; wk of 13SEP91 had fever of 104 & more szs; 17SEP91 PT placed on phenobarbital 'til age 3;
Age: 6.0
Sex: M
Vaccine: OPV, TD
Symptoms: Lymphadenopathy, Pyrexia, Skin discolouration, Tongue oedema
Clinical narrative: White patches, slight lingual swelling; swollen lymph nodes - neck; low grade fever - 100;
Age: 1.2
Sex: M
Vaccine: DTP, HIBV
Symptoms: Agitation, Gaze palsy, Hypokinesia, Hypotonia, Pyrexia
Clinical narrative: 5SEP91 PT woke up about 930PM screaming for a short time; had low grade fever; was given a tepid bath; became limp; unable to maintain balance; eyes rolled back in head; 6SEP91 ate good lunch; no other episodes of limpness or inc T;
Age: 5.0
Sex: F
Vaccine: DTP
Symptoms: Cellulitis, Oedema, Pyrexia, Vasodilatation
Clinical narrative: W/in 24 hrs PT seen in ER; given Cephradine--improved in 2 days; discontinued p/4 days because of diarrhea; inc T, redness, swelling arm--w/in elbow shoulder area--not totally encircling arm; dx of cellulitis
Age: 6.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Infection, Oedema, Vasodilatation
Clinical narrative: W/in 24 hrs swelling, redness of arm; 2nd day swelling & redness, shoulder to elbow; @ ER ATBs given, worsened; day 3 PT returned to ER & given IM ATBs; redness into chest area to wrist lt arm; MDs could not determine infection or allergy
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Crying, Screaming, Tremor
Clinical narrative: Reports continuous crying from 830AM to 1230; describes hard deep cry; extremities shaking; crying spontaneously; stopped; infant went to sleep; no other problems;
Age: 17.0
Sex: F
Vaccine: DT, MMR
Symptoms: Dizziness
Clinical narrative: PT reported dizziness; BP 80/60; recovered by smelling alcohol pads; no further rx necessary; PT went walking home w/mom;
Age: 5.0
Sex: M
Vaccine: DTP, MMR, OPV
Symptoms: Arthritis, Cellulitis, Hypokinesia, Oedema, Pain
Clinical narrative: 12FEB91 @ ER PT had edema of rt arm, pain & limitation of movements; given ATBs & acetaminophen; 14FEB PT had pain, redness & hyperthermia of rt arm & elbow; dx cellulitis p/vax vs. septic arthritis; cont on oral ATBs to complete 10 day rx;
Age: 5.0
Sex: M
Vaccine: DTP, MMR, OPV
Symptoms: Vasodilatation
Clinical narrative: 12FEB91 @ ER PT had edema of rt arm, pain & limitation of movements; given ATBs & acetaminophen; 14FEB PT had pain, redness & hyperthermia of rt arm & elbow; dx cellulitis p/vax vs. septic arthritis; cont on oral ATBs to complete 10 day rx;
Age: 1.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilatation
Clinical narrative: Rt thigh look red; edematous & warm at area of vax inject on 23JUL91; pt rx'd w/Bicellin 600,000 & ampicillin PO; 29JUL91 area of rxn vs cellulitis appear normal: no area of redness, inc warm or edema;
Age: 0.5
Sex: M
Vaccine: DTP, HIBV
Symptoms: Rash
Clinical narrative: PT appeared in erythematous, non-elevated lesions, aisle, all through body, vanishing on pressure & circular irregular, harder af .5-1 cm diameter; rx: Benadryl 12.5mg/5cc;
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Face oedema, Hyperhidrosis, Pruritus, Pyrexia
Clinical narrative: 30JUL91 PT states has fever 39C; 31JUL91 PT notice swelling of face & reness of eyes & swelling, sweating w/strong odor; PT also notice rash on lt leg & itchiness; PT seen by MD in ER; rx: Benadryl
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Skin odour abnormal
Clinical narrative: 30JUL91 PT states has fever 39C; 31JUL91 PT notice swelling of face & reness of eyes & swelling, sweating w/strong odor; PT also notice rash on lt leg & itchiness; PT seen by MD in ER; rx: Benadryl
Age: 0.6
Sex: F
Vaccine: DTP, HIBV
Symptoms: Crying, Injection site mass, Pyrexia, Screaming, Tremor
Clinical narrative: Mom refer PT; started w/high fever 39.5 C p/vax; appr .5 hr p/vax started w/high-pitch crying that last about 5 hrs; shake develops; induration @ both thighs;
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Rash
Clinical narrative: Rash
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 9 mo old given only HIB vax; mom had stated PT had diarrhea 1 mo previously; 26AUG91 mom stated PT was not ill; immun given 11AM; mom reported fever & diarrhea 1.5 hrs later; T100.3 @ PMD; persistant vomiting;
Age: 1.4
Sex: M
Vaccine: DTP, MMR, OPV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Inc T104R; onset in evening; mom had already given Tylenol x 2 doses; TC to PMD; advised to double Tylenol dose; PT lethargic next day per mom; no other symptoms;
Age: 0.1
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Diarrhoea, Insomnia, Pyrexia, Somnolence
Clinical narrative: 5SEP91 mom reported that for 2 days p/shots recd 1JUL91 PT slept a lot; 3JUL91 PT started to cry a lot-would not sleep >30 min; low-grade T; no vomit; diarrhea on 5JUL91 & 6JUL91; recovered by 6JUL91; MD said was DTP rxn & to only give DT;
Age: 5.0
Sex: M
Vaccine: DT, OPV
Symptoms: Pyrexia
Clinical narrative: 4AM temp 105.2 27AUG91 APAP given; Fever & APAP only also 1 tsp of Phenabarb @ 4AM (hx fever sz); 101.5 p/initial tx until p/Wed PM;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt died-SIDS on death certificate; Pt died evening p/immun were given; MD requested vax adverse rxn report be filed; Mom states pt did not seem to have had any reactions to the immun;
Age: 39.0
Sex: F
Vaccine: DT
Symptoms: Oedema, Pruritus, Rash, Urticaria
Clinical narrative: localized itching x 12hrs followed by erythema & urticaria & edema x 36hrs; Reported @ 36 hrs; Given Hydrocortisone Cream & DPH;
Age: 1.1
Sex: F
Vaccine: DTP
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt slept most of the day, woke @ MN w/t104.7; Mom gave APAP & bathed pt; Pt woke 2 more times t102 & 101; Seem to be about 100 this AM;
Age: 12.0
Sex: M
Vaccine: MMR, TD
Symptoms: Headache, Hypokinesia, Malaise
Clinical narrative: H/a, not feeling well 5-10 min p/immun collapsed to floor; did not lose consciousness;
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Confusional state, Dizziness, Myalgia, Paraesthesia
Clinical narrative: Began feeling fatigued 5-6 hrs p/inject; @ 3AM 24SEP91 (16 hrs p/inject) awoke from sleep w/dizziness, muscle aches, tingling in arm recvd inject, disorientation, visual disturbances (saw lights in front of self "spinning"); afebrile t97;
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Visual disturbance
Clinical narrative: Began feeling fatigued 5-6 hrs p/inject; @ 3AM 24SEP91 (16 hrs p/inject) awoke from sleep w/dizziness, muscle aches, tingling in arm recvd inject, disorientation, visual disturbances (saw lights in front of self "spinning"); afebrile t97;
Age: 1.3
Sex: F
Vaccine: HIBV, MMR
Symptoms: Rash
Clinical narrative: As of 16SEP91 12PM mom noticed red rash on face & back; Several small red spots on chest & leg; no temp;
Age: 0.3
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Drug ineffective, Infection, Meningitis
Clinical narrative: H. Influenzae type b meningitis;
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Ecchymosis, Petechiae, Thrombocytopenia, Thrombocytopenic purpura
Clinical narrative: Multiple diffuse 2-3cm diameter bruise of the trunk & extremities w/sparse periorbital & perpheral petechiae; Devel 10 days p/MMR/HIB; platelet count 9,000 compatible w/ITP;
Age: 0.3
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Sudden infant death syndrome, Vomiting
Clinical narrative: spitting up day before death, no diarrhea, fever;
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Drug ineffective, Infection, Meningitis, Pyrexia
Clinical narrative: Fever, vomiting, diarrhea 3 days p/HIB vax pneumoccocal meningitis day 6 p/vax;
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, diarrhea 3 days p/HIB vax pneumoccocal meningitis day 6 p/vax;
Age: 0.4
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Crying
Clinical narrative: About 24 hrs p/receiving vax, pt awoke from nap & cried for about 105 min; cry was high pitched & pt was inconsolable during this time; no apparent source of discomfort;
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: 6cm area of erythema & induration; rx Atarax;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Pyrexia, Screaming, Somnolence
Clinical narrative: Cried & fretful from 7PM to MN, then slept off & on for 24hrs-then was normal self x/fever to 103 intermittently for 3 days; APAP drops was only tx;
Age: 0.5
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Hypotonia
Clinical narrative: @ well pt exam age 1 on 6SEP91 mom related that pt became limp just p/recving immun; limpness reportedly lasted 20min; @ the time the shot were given on 15FEB91 pt was seen 10 min p/recvd injects by nurse who found pt sleeping & good color;
Age: 5.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Hyperhidrosis, Hypotonia, Pallor, Stupor
Clinical narrative: Approx 3 min p/vax pt became unresponsive, limp, sweaty & pale but maintained a HR of 60-80 - nl resp & BP 90/70;
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Hyperhidrosis, Hypertonia, Syncope, Vertigo
Clinical narrative: w/in seconds p/vax, body went rigid & unconscious; remembers feeling dizzy prior to loosing consciousness; Ice applied to forehead, legs elevated, & regained consciousness; Diaphoretic, cool skin; lasted 1-1.5 hr; occasional vertigo;
Age: 5.0
Sex: F
Vaccine: DTP, OPV
Symptoms: Hypotonia, Injection site pain, Rash
Clinical narrative: Devel large area of erythema 11cm by 21cm; slightly tender to touch @ site, on lt thigh of DTP; limping; no heat; no signs of infect;
Age: 1.2
Sex: F
Vaccine: HIBV
Symptoms: Agitation, Pyrexia
Clinical narrative: "high" fever & screaming w/in 2 days of vax administration;
Age: 0.7
Sex: M
Vaccine: DTP, HIBV, TD
Symptoms: Agitation, Pyrexia
Clinical narrative: Morning following vax, pt had t106F & was fussy;
Age: 1.5
Sex: M
Vaccine: DTP, OPV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever to 105.3, lethargy;
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema, Lymphadenopathy, Pain, Pruritus
Clinical narrative: 2nd day p/inject noted swelling & itching @ inject site lt deltoid; Also enlarged supra clavicular node on lt; lt arm, neck & upper chest discomfort;
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Infection
Clinical narrative: Pt recvd 3 doses of Hep B vax 30AUG83, 04OCT83 & 14MAR84; In DEC85 lab eval revealed anti-HBs positive; Apr91 donated blood & tested Hep B neg; Later tested positive for antibody to HB core antigen, indicating recent infect w/Hep B virus;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Aortic valve stenosis, Chest pain, Myocardial infarction
Clinical narrative: Pt recvd 1st & 2nd dose of vax 02NOV90 & 05DEC90 & recvd 3rd dose 20JAN91 & on 11MAY91 exp violent chest pain while playing football; Hospitalized & a myocardial infarction was dx following ECG; MD felt poss due to vax;
Sex: F
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: p/3rd dose of Engerix-B, pt exp diarrhea, vomited digested food & devel shivers, rigor, temp 40.1C on 17MAY91; Hospitalized & treated w/Ancef; No rxn to 1st & 2nd vax;
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Hyporeflexia, Influenza
Clinical narrative: Approx 1wk post vax, pt devel flu-like illness, felt run down, h/a; Seen by MD felt sinus h/a; 11DEC88 admitted to Hosp; sx included muscle weakness, gait disturbances, facial weakness, rt shoulder pain, neck stiffness, sensory  loss, GBS;
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Myasthenic syndrome, Paraesthesia
Clinical narrative: Approx 1wk post vax, pt devel flu-like illness, felt run down, h/a; Seen by MD felt sinus h/a; 11DEC88 admitted to Hosp; sx included muscle weakness, gait disturbances, facial weakness, rt shoulder pain, neck stiffness, sensory  loss, GBS;
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt devel Guillain-Barre Synd subsequent to receiving Influenza Virus vax;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3rd dose of vax 08NOV90 & did not seroconvert p/antibodies were checked "several" times;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & it was determined that pt was a non-responser; Booster dose of Engerix-B given 13FEB91;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & it was determined that pt was a non-responser; A bosster dose of Engerix-B was given 22FEB91;
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Pt recvd 1st dose of Engerix-B on 06MAY91 & 4 hrs later exp generalized rash which lasted about 2 hrs; Resolved w/o tx;
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Dyspepsia, Malaise
Clinical narrative: Pt recvd Engerix-B 2 doses & following 1st dose 26MAR91 pt felt lousy; Following 2nd dose exp feeling "punk"; pt had routine physical on 16MAY91 which revealed elevated alkaline phosphatase & SGOT levels; Also sharp abdo pain; indigestion;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd initial Hepatavax series in 1983, testing in 1989 revealed pt was non reactive; Pt given 4th dose booster shot SEP91, testing again 1991 revealed pt was non reactive; Pt given 5th dose;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal faeces, Anorexia, Asthenia, Malaise
Clinical narrative: Pt recvd Engerix-B 3 dose series 3rd dose given MAR91 & APR91 it was determined that pt was non reactive;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Heptavax series in 1987; JAN90 was surface negative; 4th dose given w/Recombivax in MAR90; JAN91 pt was non reactive; 5th dose given w/Engerix-B 18APR91 & 19JUN91 titer reactive;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt failed to seroconvert following a series of 3 doses of "Recombivax" & a booster dose of Engerix-B; Further info is not available as the pt subsequently left facility;
Sex: F
Vaccine: HEP
Symptoms: Hepatic function abnormal, Osteoarthritis, Rash
Clinical narrative: Pt recvd Engerix-B 13NOV90, &  about 11DEC90; On 08MAR91 (70-90 days) p/2nd vax, pt exp severe joint swelling, complete body rash & elevated liver function tests;
Sex: F
Vaccine: HEP
Symptoms: Oedema peripheral, Osteoarthritis, Rash
Clinical narrative: Pt recvd Engerix-B about 13NOV90, & about 11DEC90; On 08MAR91 (70-90 days) p/2nd vax pt exp complete body rash, balloon swelling in lower extremities & joint swelling; As of 03JUN91 pt exp joint swelling;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 1 dose Recombivax & 4 doses of Engerix-B, last dose given 01MAY91; "profile" done on 6JUN91 was positive;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: Pt recvd Engerix-B vax on 25FEB91 & exp arthralgias 2 wks later; Was treated w/Pred & seeing a specialist; 03JUN91 pt being treated w/meds; joint pain in arms, knees, ankles, & shoulders;
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B vax, 3rd dose given 27AUg90 & pt did not seroconvert;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt was given 3 doses of Hep B vax, 3rd dose given 23JAN89 & p/completion of the vax series, it was determined that the pt was a non responder & was not protected;
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep-B vax, 3rd dose on 23JAN89 & p/the completion of the series, it was determined tha pt was a non responder & was not protected against HBV;
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Muscle haemorrhage
Clinical narrative: Pt recvd 3 doses of Engerix-B vax  & w/2nd dose given 27DEC90 pt c/o pain @ inject site; site soreness, knot under skin @ site & some swelling @ site; poss exp tiny bleed in the muscle when inject given; p/vax arm only sore when touched;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 4 doses of Engerix-B, 4th dose given on 11APR91 & pt converted p/the fourth dose;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 4 doses of Engerix-B vax & converted p/the fourth dose;
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 4 doses of Engerix-B, 4th dose given 11APR91 & pt converted;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis bacterial, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Pt recvd 4 doses of Engerix-B, given 4th dose MAY & "HBIG" was given for post-exposure prophylaxis; Pt exp septic arthritis, fever, joint pain in one ankle & one hand & elevated sed rate;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 doses of Engerix-B vax, 3rd dose given 13FEB91; 03APR91 titer level determined that pt did not seroconvert; Booster dose was administered;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd a series of 3 doses of Engerix-B, 3rd dose recvd 13FEB91 & 03APR91 titer level determined that pt did not seroconvert; A booster dose was administered;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B, 3rd dose given 13FEB91; 3APR91 titer level determined that pt did not seroconvert; A booster dose was administered;
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd 3 doses of Engerix-B vax p/1st & 2nd dose pt devel rash; 3rd dose will not be given until titer is taken then a decision will be made; A pharmacist told pt was allergic to fungus & poss allergic to vax;
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Urticaria
Clinical narrative: Pt recvd Engerix-B vax & later same day exp rash on arm where injected & small raised areas on lt arm & leg; No tx given, event resolved;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Vasodilatation
Clinical narrative: Pt recvd Engerix-B on 28MAY91 & exp hot flashes, became flushed @ time of inject & lightheaded;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 3 pts recvd 3 doses of Engerix-B, 1 pt recvd the vax in the buttock & had no response;
Sex: U
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Pt recvd Engerix-B & exp hot flashes & became flushed @ the time of the inject; No tx given; Events resolved; Reporter indicated that this has happened several time a/to  pts;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: PT recd Engerix-B (1ml IM deltoid) 26MAR91 & 30APR91; 12 hrs p/2nd dose (700PM) exp'd severe hives; PT went to ER & was rx'd w/Benadryl IM & Epi .25cc SC & Benadryl 75mg PO; PT stated throat feels itchy; rash subsided; no further hep vax;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: PT recd Engerix-B (1ml IM deltoid) 2APR91 & 1MAY91; 4MAY91 exp'd local swelling, redness, & itching @ inject site; no rx given;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Face oedema, Tongue oedema
Clinical narrative: PT recd vax 15APR91 & 16MAY91; experienced abdominal cramping @ 430PM; 17MAY91 @ 530AM PT exp'd tongue & face swelling; PT went to ER & was rx'd w/Benadryl IM for swelling; swelling dec; exp'd abdominal cramping on 16MAY91 @ 430PM;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Cystitis, Face oedema, Glucose tolerance decreased, Lung disorder, Paraesthesia
Clinical narrative: PT recd 1st Engerix-B vax 4NOV90; DEC90 exp'd upper & lower RTI; rx: ceftriaxone; events resolved; 2nd vax 20MAR91 was uneventful; recd 3rd vax 24MAY91; 3-4 wks a/vax PT had brown recluse spider bite; 24MAY91 dev'd hives, etc.; unresolved;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory disorder, Visual disturbance, Vomiting
Clinical narrative: PT recd 1st Engerix-B vax 4NOV90; DEC90 exp'd upper & lower RTI; rx: ceftriaxone; events resolved; 2nd vax 20MAR91 was uneventful; recd 3rd vax 24MAY91; 3-4 wks a/vax PT had brown recluse spider bite; 24MAY91 dev'd hives, etc.; unresolved;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd a series of 3 Engerix-B vaxs, 1cc, IM, deltoid, on 22NOV89, 3JAN90, & 20MAY90; PT did not seroconvert;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd a series of 3 Engerix-B vaxs, 1cc, IM, deltoid, on 6FEB90, 5MAR90, & 14AUG90; PT did not develop antibodies p/3 injects;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Albuminuria, Drug ineffective
Clinical narrative: PT recd vax (1cc, IM deltoid) JAN91 & FEB91; 10 days p/JAN91 dose, exp proteinuria; event reoccurred p/FEB91 dose, but persisted longer; rx: prednisone & cytoxan (?); event resolved; reporter indicated PT exp proteinuria p/JUN91 vax;
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypokinesia
Clinical narrative: 10MAY91 PT recd vax; 2 hrs p/vax exp dizziness which lasted 2-3 hrs & PT "could not move"; no rx; PT recovered p/3 hrs;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B MAY90, JUN90, & OCT90; Titers performed JUN91, revealed pt was a non responder; tx will give booster dose;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B, MAY90, JUN90, & OCT90, respectively; Titers performed JUN91 revelaed the pt was a nonresponder; tx will give booster dose;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 4 pts were given a series of 3 doses of Engerix-B & it was determined that all pt now have no antibody; series completed in 1989;
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Lymphadenopathy, Malaise, Oedema, Skin nodule
Clinical narrative: P/the administration of Engerix-B, pt exp swollen lymph nodes;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abscess, Ecchymosis, Oedema, Pain, Pyrexia
Clinical narrative: Pt recvd a 3rd dose of Engerix-B on 16MAY91 & 4th hrs later exp pain in rt arm, swelling, discoloration, t102, abscess, bruising; Pt missed 7 working days, 60 hrs due to rxn; PCN, pain meds, ice & heat were used to treat the events;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Skin discolouration, Tachycardia
Clinical narrative: Pt recvd a 3rd dose of Engerix-B on 16MAY91 & 4th hrs later exp pain in rt arm, swelling, discoloration, t102, abscess, bruising; Pt missed 7 working days, 60 hrs due to rxn; PCN, pain meds, ice & heat were used to treat the events;
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 5 doses of Engerix-B & Antibodies were checked 4-6 months p/3rd dose & there was no antibody; 4th dose was given AUG90 & antibodies were still neg; 5th dose was given 05MAR91;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B & antibodies were checked 4-6 months p/3rd dose & there was no antibody; 4th does of Engerix-B was given in AUG90;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Influenza, Malaise, Pharyngitis
Clinical narrative: Pt recvd 1st dose of Engerix-B 30APR91 or 01MAY91, following 1st dose pt exp severe h/a; following 2nd dose 28 or 29MAY91 or 03JUN91 or 04JUN91 exp blinding h/a & felt awful; malaise, chills, rash on x 5 days & sore throat, flu-like sx;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd 1st dose of Engerix-B 30APR91 or 01MAY91, following 1st dose pt exp severe h/a; following 2nd dose 28 or 29MAY91 or 03JUN91 or 04JUN91 exp blinding h/a & felt awful; malaise, chills, rash on x 5 days & sore throat, flu-like sx;
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt exp an "apparent failure" p/Hep B inject series;
Sex: U
Vaccine: HEP
Symptoms: Headache, Neck pain, Pain, Tremor
Clinical narrative: PT recd vax 11MAY91 ? & 11JUN91 @730; 1 hr p/2nd dose (830) exp'd h/a, neckache, hand shake, trembling, & shoulders ached;
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Hypertonia, Influenza, Injection site pain, Pyrexia
Clinical narrative: Pt recd vax 21APR91 & 24MAY91; p/each dose exp'd flu-like symptoms, pain @ inject site, & stiff muscles; rx: NSAIDs & antipyretics; events resolved;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Cholecystitis, Diarrhoea, Myalgia, Nausea
Clinical narrative: PT recd 10JUN91; exp'd n/v/d, gen. myalgia & rt-sided tender abdomin; rx for n/v & PT will be given a gallbladder workup; 48 hrs later PT slightly improved; reporter indicated events not related to vax; no ADR to 2nd dose given on 10JUL91
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: PT recd 10JUN91; exp'd n/v/d, gen. myalgia & rt-sided tender abdomin; rx for n/v & PT will be given a gallbladder workup; 48 hrs later PT slightly improved; reporter indicated events not related to vax; no ADR to 2nd dose given on 10JUL91
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Somnolence
Clinical narrative: 8JUN91 PT recd 1st vax; 6hrs p/inject PT had chills & felt flushed; 9hrs p/inject PT exp'd very severe bitemporal h/a & fever up to 103.6; rx: Tylenol & Ibuprofen & Darvocet N-100 for h/a; PT did not "feel normal" until 17JUN;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: 8JUN91 PT recd 1st vax; 6hrs p/inject PT had chills & felt flushed; 9hrs p/inject PT exp'd very severe bitemporal h/a & fever up to 103.6; rx: Tylenol & Ibuprofen & Darvocet N-100 for h/a; PT did not "feel normal" until 17JUN;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dental caries
Clinical narrative: Pt recvd 1st dose of Engerix-B 24APR91 & exp an abscessed tooth 16MAY91; pt recvd 2nd dose of Engerix-B on 28MAY91 & again exp abscessed tooth (same tooth as w/1st shot); tooth was extracted;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Ear disorder, Vertigo
Clinical narrative: Pt recvd 1st dose of vax 24APR91 & 4MAY91 exp vertigo w/congested ears; Pt recvd 2nd dose of vax 28MAY91 & on 7JUN91 exp vertigo w/congested ears again;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Asthenia, Cardiovascular disorder, Pneumonia
Clinical narrative: Pt recvd 1 booster dose Hep B vax 25APR95 (?91) for needle stick injury @ work; 01MAY pt exp t99-100, syncope, fatigue, joint pain all extremities, swelling small joint of hand & ankles & tenderness over lt tibial tendon, serum sick;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Serum sickness, Syncope
Clinical narrative: Pt recvd 1 booster dose Hep B vax 25APR95 (?91) for needle stick injury @ work; 01MAY pt exp t99-100, syncope, fatigue, joint pain all extremities, swelling small joint of hand & ankles & tenderness over lt tibial tendon, serum sick;
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza, Malaise, Myalgia, Nausea
Clinical narrative: Pt recvd 1st dose Engerix-B 06JUN91 & on evening of 12JUN91 pt c/o general malaise, muscle aches, nausea, & moderate to severe h/a; exp flu-like sx on 13JUN91; no tx given; MD suggest sx not related to vax & Globulin - poss viral infect
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthma, Depression, Dyspnoea, Headache
Clinical narrative: Pt recvd 1st dose of Engerix-B 12JUL90 & 1 hr p/12JUL90 dose given pt exp SOB, severe h/a, wheezing persistent >6 months, arthralgias, persistent >6 months myalgias, fibromyalgias, & depression; Taken to ER;
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Pt recvd 1st dose of Engerix-B 12JUL90 & 1 hr p/12JUL90 dose given pt exp SOB, severe h/a, wheezing persistent >6 months, arthralgias, persistent >6 months myalgias, fibromyalgias, & depression; Taken to ER;
Sex: M
Vaccine: HEP
Symptoms: Headache, Malaise, Pain
Clinical narrative: Pt recvd 1st dose of vax 04JUN91; 10 days post vax exp malaise, h/a & aches; no tx given;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Hep B vax doses & it was determined that pt did not respond; 2 booster doses of Engerix-B were given MAY91 & JUN91 respectively;
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Abnormal faeces, Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd 1st dose of Engerix-B & "several hrs" p/inject pt exp rash, itching, abdo pain & clay colored stools; events resolved in 24 hrs;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B doses 07NOV90, 05DEC90, & 13MAY91 & it was determined 12JUN91 that pt was not protected; no tx given as of 17JUN91;
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis
Clinical narrative: Pt recvd a series of Engerix-B doses 2 yrs ago; Reporter indicated this past wk JUN91 pt tested HBSAG positive & is not protected; No tx given 17JUN91;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B doses & did not respond; extra booster doses were administered;
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Pt exp urticaria rxn 1 wk p/ 1st inject;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain
Clinical narrative: Pt recvd 3 dose series of Engerix-B for prevention of Hep B 03DEC90, 03JAN91 & 06JUN91, respectively; 07JUN91 pt reported exp aching & nausea on 06JUN91; pt felt had sx w/1st & 2nd doses but not as severe; no tx;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Did not seroconvert;
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not seroconvert; pt then seroconverted p/ receiving a booster dose;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Infection, Nuchal rigidity, Urticaria
Clinical narrative: Pt recvd 1st Engerix-B vax 29MAY91 for post exposure prophylaxis; 14JUN91 exp hives, stiff neck & joint pain; tx none;
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Influenza, Pyrexia, Rhinitis
Clinical narrative: Pt recvd 1st Engerix-B vax 22MAY91, & 23MAY91 exp "cold-like sx, runny nose & fever; All sx resolved w/in 3 days w/o tx;
Age: 50.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt was a non-responder p/receiving a series of 3 Engerix-B vax; pt did not develop antibody titer when tested one month p/3rd vax & then one month subsequently;
Age: 68.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt was a non-responder p/receiving a series of 3 Engerix-B vax; pt did not devel antibody titer when tested one month p/3rd vax & then one month subsequently;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt was a non-responder p/receiving a series of 3 Engerix-B vax; pt did not devel antibody titer when tested one month p/3rd vax & then one month subsequently;
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 19MAR90, 13APR90, 06SEP90 & it was determined that pt failed to seroconvert;
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 09MAR90, 02APR90, & 06SEP90 & it was determined that pt failed to seroconvert;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 09MAR90, 13APR90 & 17SEP90 & it was determined that pt failed to seroconvert;
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 02MAR90, 06APR90, & 06SEP90 & it was determined that pt failed to seroconvert;
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 02MAR90, 06APR90, & 06SEP90 & it was determined that pt failed to seroconvert;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 07MAR90, 13APR90, & 09SEP90 & it was determined that pt failed to seroconvert;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 18MAY90; 27JUN90, & 13DEC90 & it was determined that pt failed to seroconvert;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 3 pts recvd a seeries of 3 Engerix-B vax on various dates followed by 2 booster doses of Engerix-B on various dates & were non-responders;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not convert p/2 series of 3 Engerix-B vax; Recvd 1st series 19FEB90, 20MAR90, 21AUG90; 11OCT90 titer neg; recvd 2nd series of 3 Engerix-B vax 24OCT90, 13DEC90 & 25APR91 & 5JUN91 titer neg;
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hypertonia, Myalgia
Clinical narrative: Pt did not convert p/2 series of Engerix-B vax; recvd last vax 24APR91 & titer 05JUN91 neg;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Amblyopia, Dizziness, Dyspnoea, Hypotension, Nausea
Clinical narrative: Pt recvd 1st vax on Engerix-B on 17JUN91 & 1 hr p/inject, pt exp hypotension, blurred vision, dizziness, nausea & SOB; sx resolved p/8hrs w/o tx;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Engerix-B vax & failed to seroconvert to HBSAB positive; six month dose was given FEB91; 15MAY91 lab tested neg;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Engerix-B vax & failed to seroconvert to Hep B surface antibody positive; six month dose was given MAR91; 15MAY91 lab test neg for Hep B surface antibodies;
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 engerix-B vax & failed to convert to HBSAB positive; six month dose was given MAR91 & 15MAY lab test neg;
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Ecchymosis, Oedema, Vasodilatation
Clinical narrative: Pt recvd 1st Hep B vax 20MAY91 & was uneventful; Recvd 2nd Engerix-B vax 17JUN91 & arm swelled, was warm & bruise devel the size of a quarter; tx ice bags;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Cough, Dyspnoea
Clinical narrative: Pt recvd 1st Engerix-B vax DEC90 & exp diarrhea on unspecified date (can't remember);  2nd vax JAN91 & exp wheezing, coughing, bronchial spasms that same month; respiratory sx tx w/proventil inhaler; 3rd vax 19JUN91 exp same sx as w/2nd vax
Age: 40.0
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: PT recd series of 3 Engerix-B vax (20mcg) on 14MAR90, 14APR90, & 16SEP90; 7NOV90 test indicated PT was a low responder; recd 2 more doses on 20JAN91 & 10MAR91; 30MAY91 tested pos for Abs;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 17JAN90, 20FEB90, & 13JUL90; 30SEP90 test indicated PT was a low-responder;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: PT revd series of 3 Engerix-B vaxs (20mcg) on 7MAY90, 5JUN90, & 13NOV90; 30JAN91 test indicated PT was a low responder; recd 2 more doses on 8FEB91 & 11MAR91; 29MAY91 tested positive for Abs;
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 15AUG90, 16SEP90, & 15FEB91; 18APR91 test indicated PT was a low responder;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 1DEC89, 11JAN90, & 6JUN90; PT was a non-responder; PT is receiving "EBV - IG";
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 4MAY90, 1JUN90, & 6NOV90 & was a non-responder;