chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Pt recvd 1st dose Engerix-B 15OCT91 & 16OCT91 pt exp rash around inject site, swelling, itching & pain; MD visit was required; pt was treated w/meds; 24 hrs p/inject exp fever @ site, itching, burning; poss allergic reaction;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Infection
Clinical narrative: Pt recvd Engerix-B & exp Hepatitis; Pt recovered;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & it was determined that pt had inadequate antibody titers about 6 mos p/last inject;
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 5SEP90, 5OCT90, 5MAR91 & f/u testing p/last dose revealed neg HBSAB; pt recvd 4th dose of vax;
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Chest pain, Cough, Pyrexia, Urticaria
Clinical narrative: Pt recvd 2 Engerix-B vax 30APR91 recvd 1st dose 1MAY91 & exp intestinal discomfort/intestinal agony, gall baldder disease;21 hrs p/GI pain hives occurred; t101, tightness in chest, bronchial bark; Pt exp same events w/2nd dose 1JUN91;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 10 pts recvd 3 doses of Engerix-B & 15AUG91 it was determined that six out of ten pts did not respond to the vax;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Eructation, Headache, Hyperhidrosis, Nausea
Clinical narrative: Pt recvd a dose of Engerix-B & exp h/a, dizziness, & nausea;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Tachycardia, Vasodilatation
Clinical narrative: Pt recvd a dose of Engerix-B & exp h/a, dizziness, & nausea;
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Myalgia, Pyrexia, Serum sickness
Clinical narrative: Pt recvd 2 doses of Engerix-B shortly p/1st dose pt exp serum sickness-like reaction, soreness in muscles, fever @ night 99 degrees & premature atrial beats;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & p/1st dose was given exp pain for 2-3 days; P/recvd 2nd dose exp discomfort @ inject point; Pt is still in pain;
Sex: F
Vaccine: HEP
Symptoms: Amblyopia, Optic neuritis
Clinical narrative: Pt recvd 3 doses of Engerix-B APR91, 1MAY91 & OCT91 & 10 days p/2nd dose exp optic neuritis & blurred vision; sx resolved p/1mo or a little longer w/o tx; pt tolerated 1st & 3rd doses w/o problems;
Sex: U
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Pt recvd Hep B & shortly p/ began to c/o systemic pruritus & upon PE no sx of local rxn @ site of inject noted; Pt tx meds which failed to relieve pruritus; steroids relieved pruritus but d/c pruritus back;
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Gaze palsy, Hyperhidrosis, Hypertonia, Pallor
Clinical narrative: Pt recvd Engerix-B on 5SEP9 given in ER & w/in 5 min became pale, diaphoretic, eyes rolled back of head, pulse 54, BP 112/68; also head drew back & arm & leg went out stiff; dx vasal vagal rxn;
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Pt recvd Engerix-B on 5SEP9 given in ER & w/in 5 min became pale, diaphoretic, eyes rolled back of head, pulse 54, BP 112/68; also head drew back & arm & leg went out stiff; dx vasal vagal rxn;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 27NOV90, & 29APR91 & 15SEP91 & it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 1NOV90, 29NOV90, & 29APR90 & 15SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B;
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 27NOV90 & 9MAY91 & 23SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 7DEC90, & 9MAY91 & 27SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 27NOV90, & 2MAY91 & 9SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 26NOV90, & 2MAY91 & 10SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 26NOV90, 6MAY91 & 17SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 30NOV90 & 2MAY91 & 11SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 5NOV90, 4DEC90, & 9MAY91 & 9SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 5DEC90, 8JAN91 & 3JUN91 & 12SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 4DEC90 & 6MAY91 & 4SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 10NOV90, 7DEC90 & 2JUL91 & 9SEP91 it was determined tha tpts titer was neg p/3 doses of Engerix-B;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses Engerix-B 10NOV90, 7DEC90 & 2MAY91& 15SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 5NOV90, 2DEC90 & 29APR91 & 4SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 30NOV90, & 2MAY91 & 12SEP91 it was determined that pts titer was neg p/3 doses of Engerix-b;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 30NOV91 & 12MAY91 & 4SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 4NOV90 & 27NOV90 & 29APR91 & 6SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 4NOV90, 27NOV90, 1MAY91 & 10SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 30NOV90 & 1MAY91 & 11SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 5NOV90, 4DEC90, & 30APR91 & 7SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 6DEC90 & 9MAY91 & 9SEP91 & it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 4NOV90, 28NOV90, & 29APR91 & 6SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 27NOV90, & 6MAY91 & 3SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B 6NOV90, 4DEC90, & 30APR91 & 7SEP91 it was determined that pts titer was negative p/3 doses of Engerix-B;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B on 4NOV90, 6DEC90, & 29APR91 & 13SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 8NOV90, 30NOV90 & 1MAY91 & 12SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B 1NOV90, 6DEC90 & 30APR91 & 9SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 30OCT90, 4DEC90 & 10MAY91 & 16SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 4NOV90, 1DEC90 & 29APR91 & 8SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 5NOV90, 30NOV90, & 9MAY91 & 8SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B according to a 0, 1 & 6 mo schedule & it was determined that pts titer was neg;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthropathy, Cough, Hypertonia, Lung disorder
Clinical narrative: Pt recvd 2 doses of Engerix-B 17SEP91, 15OCT91 2nd dose was uneventful; p/1st dose pt exp severe malaise, pain & stiffness in shoulders, legs, neck & hips; As of 24OCT91 pt still has joint pain;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Nuchal rigidity, Rhinitis
Clinical narrative: Pt recvd 2 doses of Engerix-B 17SEP91, 15OCT91 2nd dose was uneventful; p/1st dose pt exp severe malaise, pain & stiffness in shoulders, legs, neck & hips; As of 24OCT91 pt still has joint pain;
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Arthritis, Infection, Oedema, Pain, Vasculitis
Clinical narrative: Pt recvd 3 doses Engerix-B approx JAN91, FEB91 & AUG91; no rxn noted p/2 doses; p/3rd 4OCT91 pt exp acute arthritis/vasculitis as dx by MD; pt exp acute swelling w/not much pain of joints; MD visits required; pt tx med  poss lyme dis;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp pain @ inject site following 3 doses; pt was also a non-responder;
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt was a non-responder p/completing series of Engerix-B; last dose of vax was administered @ the end of 1988;
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Pt was given Engerix-B p/1st dose of vax given pt exp tingling in fingers (exact time of event is unk); no tx given;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: 21OCT91 pt recvd Engerix-B 48 hrs p/vax devel rash, hives & palms of hands itchy; 24OCT91 presented to ER where pt was treated w/DPH & Epi; sx discontinued w/tx & the pt was sent home p/3 hrs;
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 7JAN91, 7FEB91 & 11JUL91 & reporter indicated due to neg HBSAB titer result; 4th dose of Engerix-B required 20SEP91;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 7JAN91, 7FEB91 & 11JUL91 & reporter indicated due to neg HBSAB titer result, 4th dose of Engerix-B was required 21SEP91;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 15JAN91, 16FEB91 & 16JUL91; reporter indicated due to neg HBSAB titer result, 4th dose of Engerix-B required 29SEP91;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd series of 3 Engerix-B on 22JAN91, 22FEB91 & 19JUL91 & SEP91 exp onset of inc liver enzymes;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B 19JUL91, 21AUG91 & in AUG or SEP91 exp onset of inc liver enzymes;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 18JAN91, 18FEB91 & 17JUL91 & reporter indicated due to neg HBSAB titer result, 4th dose of vax required 29SEP91;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: Pt recvd 3 doses of Engerix-B 18FEB91, 18MAR91 & 18AUG91 & 10OCT91 reporter indicated pt gave blood & was found to be positive for anti-HBC
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Neck pain, Pain, Pyrexia
Clinical narrative: Pt recvd 2 Hep B vax & recvd 3rd vax Engerix-B 24OCT91; p/3rd dose exp fever, shoulder (at inject site) & neck pain, vague radiating pain; recovered w/o treatment;
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Post needle stick, pt recvd 3 doses of Engerix-B given 27FEB91, 3APR91 & 27AUG91 & on 27FEB91 recvd HBIG also 18OCT91 pt had no titer; 2 more doses of vax will be given;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd series of 3 Engerix-B on 21MAR91, 6MAY91 & 30SEP91 titer checked 24OCT91, 1 wk earlier than usual because pt had a needle stick;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 Engerix-B vax on 20NOV90, 22DEC90, 28MAY91; pt recvd HBIG on 15APR91 for needle stick; 22OCT91 pt had no titer; will give two more doses of vax;
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Face oedema, Sinusitis
Clinical narrative: Recvd a series of 3 Engerix-B dose on 16APR91 & 17MAY91 & 22OCT91; 1st 2 doses were uneventful; 23OCT91 day p/recvd 3rd vax pt exp periorbital edema, swelling of eyelids w/sinus trouble; Pt has always had sinus problems; rxd w/meds;
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 1AUG90, 13SEP90, 27FEB91 & 11SEP91 tested & it was discovered that the pt did not respond;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 3 pts were non-responders p/receiving Engerix-B;
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza, Pyrexia
Clinical narrative: Pt recvd 1st dose of Engerix-B 20SEP91 & reporter indicated during that wk of administration pt exp flu-like sx; sx fever & h/a;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 22NOV90, DEC90, MAY91 & it was determined that pt was a non-repsonder;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Pt recvd 1st dose of Engerix-B on 25OCT91 & on 25OCT91 PM pt exp fever & a hot sensation; tx none; pt was fine 48hrs later;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Pt recvd 1st dose of Engerix-B vax on 25OCT91 & 24 hrs post vax pt exp fever, hot sensation & had a faint rash on face including nose; tx none; pt was fine 48 hrs later;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Myalgia, Oedema, Oedema peripheral, Pain
Clinical narrative: Pt recvd vax 3JUL91 1 dose of Engerix-B vax & 3AUG91 devel edema of ankles, lower leg & feet; erythema-macula of feet; fever of 101 & legs peeled; pt recvd APAP for fever which resolved x 2 days;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Pt recvd vax 3JUL91 1 dose of Engerix-B vax & 3AUG91 devel edema of ankles, lower leg & feet; erythema-macula of feet; fever of 101 & legs peeled; pt recvd APAP for fever which resolved x 2 days;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Oedema, Urticaria, Vasodilatation
Clinical narrative: Pt recvd 2 doses of Engerix-B MAY91 & JUN91; following 2nd dose of vax devel hives, swelling, redness throughout body & SOB; tx antihistamines & events resolved w/in 24 hrs;
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Pt recvd Engerix-B 1OCT91  @ 1230PM as part of hosp's immun program infect/prevent policy; w/in 3 hrs 330PM p/recvd vax pt exp periodic itching of arms; upper legs, back & abdomen w/rash appearing; pts recvd itching off & on through 9OCT91;
Sex: U
Vaccine: HEP
Symptoms: Influenza, Pyrexia
Clinical narrative: Pt reporter indicated that the use of Engerix-B made employees sick, I.E., temp 103 & flu like sx;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Ageusia, Vertigo
Clinical narrative: Pt recvd a dose of vax 10SEP91 & 17SEP91 exp dysgeusia & vertigo; no tx given; vax series was discontinued p/1st inject; Asof 29OCT91 sx continue;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthropathy, Hypokinesia, Pain, Tenosynovitis
Clinical narrative: 22JUL91 pt recvd 1 dose of Engerix-B devel vague knee discomfort w/in 24 hrs 2 days the following sx became clearly delineated; rt knee became stiff, pain w/motion, crepitus, activities of daily living were curtailed;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Hyperhidrosis, Vasodilatation
Clinical narrative: Pt recvd Engerix-B 23SEP91, 23OCT91 1st four days p/2nd inject pt felt hot & sweaty in face x 5 min every hr round the clock followed by cold; pt given APAP; Events resolved p/4 days 27OCT91;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: "some" pts did not respond p/receiving Hep B vax unk;
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Nurse reported 3 non-responders following routine prophylaxis for Hep B;
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hyperbilirubinaemia
Clinical narrative: Pt recvd 2 doses of Heptavax 26JAN84 & 28FEB84 & 1 dose of Engerix-B 11OCT91 & 1 wk p/3rd dose pt devel elevated SGOT, elevated SGPT & elevated total bilirubin; no tx given; blood work up will be repeated in 1 mo;
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Hep B vax & 1st & 2nd dose 9MAY90 & 7JUN90 & 3rd dose Engerix-B 8NOV90 & it was determined that pt was a non-responder; 4th dose of Engerix-B was administered 13JUN91;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 19JUL90, 23AUG90, & 11JAN91 & it was determined that pt was a non-responder; no tx given;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 19JUL90, 16AUG90 & 16JAN91 & it was determined that pt was a non-responder; 4th dose of Engerix-B recvd 11JUL91;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Herpes simplex, Pyrexia
Clinical narrative: Pt recvd 2 doses of Engerix-B 1st dose 13SEP91 & 2nd vax on 14OCT91 & on 16OCT91 following 2nd dose devel mouth lesion on inner mucosa & t99.3; 3rd dose not been administered;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B on 9APR90, 9MAY90, & 11OCT90 & mid OCT91 suffered a needlestick, described as a low risk needlestick; found to be HBSAG & HBCAG neg, non responder; pt will be given booster & titer will be retested;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Drug ineffective, Headache, Myalgia, Nausea
Clinical narrative: Pt recvd 3 doses of Engerix-B 22JAN91, 21FEB91, 22JUL91 & on 22JUL91 exp severe sore arm, nausea, h/a & dizziness; no tx given other than APAP; 48 hrs later sx abated; additionally p/completion of 3 doses pt only achieved a titer of 1.8;
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Cardiovascular disorder, Headache, Myalgia, Serum sickness
Clinical narrative: Pt recvd 2 Engerix-B on 8AUG91 & 23SEP91 following 2nd inject on 23SEP91 beginning @ noon pt c/o severe h/a & joint pain & muscle aches; pt sought medical help due to sx; 28OCT91 pt is still c/o pain (head, muscle & some joint);
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 27FEB91, 5APR91, & 26SEP91 & 30OCT91 Antibodies were checked & pt had a borderline titer;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: A number of pts recvd Engerix-B & exp pain @ inject site due to this pharmacy no longer uses Engerix-B but has switched to Recombivax HB;
Sex: F
Vaccine: HEP
Symptoms: Eczema, Pruritus, Rash
Clinical narrative: Pt recvd 1 dose of Engerix-B 31OCT91 & 1NOV91 exp eczema which was not only a skin rash, but red, itchy, inflammed rxn, all over body; tx antihistamines; 1NOV91 events still persisting;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & it was determined that pt was a non-responder;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Pt recvd Engerix-B on 26SEP91 & 28OCT91 & pt exp no adverse events following the first vax but the day following 2nd vax 29OCT91 pt devel dizziness; pt treated in ER w/Antivert; dizziness resolved by 3NOV91;
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia, Oedema peripheral, Pain, Pruritus
Clinical narrative: Pt recvd 2 Engerix-B vax on 12APR91 & 17MAY91 & 12 hrs p/2nd inject devel swelling of hands & feet, myalgias & arthralgias, & burning, itchy soles of feet & palms; tx meds; As of 30OCT91 pt gets achy hips;
Age: 79.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2 doses of Heptavax 10JAN91, 19FEB91 & 1 dose of Engerix-B 23JUL91; pts blood is drawn monthly; As of 10OCT91 blood tested neg;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B on 14MAR91; 15APR91 & 12SEP91 & upon completion of series pt was discovered to have not responded;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B on 8MAR91; 18APR91 & 6SEP91 & upon completion of series pt discovered to have not responded;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B on 14MAR91, 26APR91, 16SEP91 & upon completion of series pt was discovered to have not responded;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B on 13MAR91; 18APR91 & 16SEP91 & upon completion of series pt was dicovered to have not responded;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B on 15MAR91; 15APR91 & 10SEP91 & upon completion of series pt as discovered to have not responded;
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of Engerix-B on 13MAR91; 15APR91 & 11SEP91 & upon completion of series pt was discovered to have not responded;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter attended American College of Gastroenterology convention 12-15OCT91 & mentioned that pts exp non-response w/Engerix-B;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain, Visual disturbance
Clinical narrative: Pt recvd 1 dose of Engerix-B (dates of administration unk) & 28OCT91 exp visual disturbance & pain on inject site; As of 4NOV91 visual disturbance persists;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Pt recvd a dose of Engerix-B 25OCT91 & 27OCT91 2 days later pt exp pain radiating to lt shoulder; Event persisting as 6NOV91;
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Hypotension, Vertigo
Clinical narrative: 4OCT91 pt recvd Engerix-B on the morning of 5OCT91 devel hypotension which continued for about 1wk or so; Event resulted in an ER or MD visit & pt is reported to have recovered;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt was non-converting/not seroprotected p/3 doses of Engerix-B; 4th dose will be given to try to get Hep B protection;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Did not devel immun on Recombivax;
Sex: F
Vaccine: HEP
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Muscle pain, pain, severe h/a;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Infection, Nervousness, Nuchal rigidity
Clinical narrative: Pt recvd 2 doses Engerix-B 2nd dose 5NOV91 & 3 min later felt hot, nauseous, dizzy, did not feel well & heart started to pound; @ 5min pt started to vomit, hives, felt nervous from vax, exhausted; 7NOV91 seen by MD felt virus or drug rxn;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Syncope, Urticaria
Clinical narrative: Pt recvd 2 doses Engerix-B 2nd dose 5NOV91 & 3 min later felt hot, nauseous, dizzy, did not feel well & heart started to pound; @ 5min pt started to vomit, hives, felt nervous from vax, exhausted; 7NOV91 seen by MD felt virus or drug rxn;
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Hep B vax in JUL1983; In SEP83 pt had protective levels of antibodies; pt recvd a booster dose w/Engerix-B JAN91 & antibodies were checked in NOV91 & pt did not have protective levels; plans to revax;
Sex: F
Vaccine: HEP
Symptoms: Amblyopia, Visual disturbance
Clinical narrative: Pt recvd 2 doses of Engerix-B (APR & MAY91) & SEP91 exp blurred vision & changes in vision; pt has seen a MD & had glasses prescribed; however, pt vision continues to change so that glasses are not effective; events have not resolved;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt recvd 1st dose of Engerix-B (date unk) & a 2nd dose either MAR or APR91 prior to hemophilia replacement factor; On 14JUL91 found to be AntiHBC pos; 7NOV91 pt is AntiHBC neg;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1st dose recvd 6 months ago @ which time pt became deathly ill; reporter unaware of any further description regarding event; 2nd dose recvd recently although pt did not want it; 2nd dose tolerated well;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B  on 30APR90 & 29MAY90 & 23OCT90 subsequently found neg antiHBS p/3 doses @ 1mo, 2mo & 6mo intervals;
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 30ARP90, 5JUN90, 29OCT90 subsequently was found neg Anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 4MAY90, 31MAY90, 24OCT90 subsequently was found neg Anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 1MAY90, 31MAY90, 26OCT90 subsequently was found neg Anti-HBS p/3 doses @ 1mo, 2mo, 6mo intervals;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 27APR90, 24MAY90, & 24OCT90 subsequently found neg Anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B on 7MAY90, 5JUN90, 29OCT90 subsequently was found neg Anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 49.0
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 26APR90, 29MAY90, 23OCT90 subsequently was found neg Anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B on 26APR90, 23MAY90, 23OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B on 27APR90, 31MAY90, & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 1MAY90, 30MAY90, & 30OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 26APR90, 30MAY90, & 23OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 4MAY90, 31MAY90 & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo & 6mo intervals;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 17APR90, 21MAY90, & 6NOV90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 30APR90, 29MAY90 & 25OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B on 26APR90, 30MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 27APR90, 29MAY90, & 24OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 1MAY90, 1JUN90, & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 26APR90, 23MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B on 30APR90, 29MAY90, & 5NOV90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B (vax dates unk) subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 30APR90, 29MAY90, & 25OCT90 & subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 26APR90, 23MAY90, & 23OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B on 27APR90, 31MAY90, & 24OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 0.4
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 26APR90, 1JUN90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 27APR90, 31MAY90, & 26OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 1MAY90, 30MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 26APR90, 30MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B on 27APR90, 29MAY90, & 25OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B in 1989 & titer was checked post exposure in NOV91 found to be non responsive; tx will revax or give booster dose;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: In 1988 pt recvd 3 doses of Engerix-B; titers were checked in JUL91 post exposure & pt was found to be non responsive; booster of Engerix-B in JUL91 & pt now is protected;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 2 doses of Hep B vax 1st dose was w/REcombivax?, 2nd dose booster given w/Engerix-B titers p/1mo indicated the pt to be a non-responder;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Hep B vax 1st dose unspecified was given on 14NOV90; 2nd & 3rd dose w/Engerix-B 17DEC90 & 17MAY91 & it was determined that pt did not seroconvert;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not respond (no antibodies) p/receiving 1st Engerix-B booster dose plan is to revax;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B (dates unk) & pt was a non-responder following the series of injections; pt recvd 2 booster injects & still did not respond;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a sereis of 3 Engerix-B inject last yr & pt did not respond; Pt will be given booster & titer will be taken again;
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hepatic function abnormal, Leukocytosis, Malaise, Myalgia
Clinical narrative: Pt recvd 1 dose of Engerix-B 6SEP91 & exp an elevated white count & liver enzymes & was sick x 3 wks; the vax series was discontinued & the sx abated;
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pyrexia
Clinical narrative: Pt recvd 1 dose of Engerix-B 6SEP91 & exp an elevated white count & liver enzymes & was sick x 3 wks; the vax series was discontinued & the sx abated;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Pt recvd 1 dose of Engerix-B 13NOV91 & 1 to 2 hrs p/vax exp vertigo & h/a; pt went to ER where events were treated w/1 dose of antivert; sx resolved;
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
Clinical narrative: Pt recvd Engerix-B in MAY91, JUN91 & NOV91 p/3rd dose pt exp pain, erythema & induration @ inject site; these events occurred in 2 pts (also EUB911257); no tx was given;
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
Clinical narrative: Pt recvd Engerix-B in MAY91, JUN91, & NOV91 & p/3rd dose pt exp pain, erythema & induration @ inject site; these events occurred in 2 pts (see also EBU911256); no tx was given;
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B vax MAY90, JAN91, & MAY91 & was found to be a non-responder;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 Engerix-B doses in DEC90, JAN91, & MAY91 & pt did not seroconvert following the 3rd Engerix-B dose titer was drawn NOV91;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 8 people were vaxed w/Engerix-B on 20FEB91, 20MAR91, & 21AUG91 & 2 mos p/3rd dose 21OCT91 titers were tested & 5 of these 8 ptes had neg titer results (non-responders); These pts will receive 2 booster doses;
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Pain, Paraesthesia
Clinical narrative: 17OCT91 pt recvd dose of Engerix-B & nothing happened; 14NOV91 recvd Engerix-B & less htan 24 hrs p/vax pt felt burning, numbness which radiated to arms, toes & head; then devel h/a; c/o did not feel well; rxn still persists;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Approx 2 yrs ago pt began series of 3 Engerix-B vax on a regular dosing schedule (exact dates unk); pt waited for 2 yrs for a titer to be performed & when it was performed results were neg; pt will get booster;
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Dry mouth, Face oedema, Pruritus, Urticaria
Clinical narrative: Pt recvd Engerix-B 9NOV91 & 11NOV91 pt came to ER w/hives, lip swelling, dry mouth & intense itching; tx w/DPH & Pred; pt spent some time in ER but was not hospitalized; 18NOV91 pt returned to ER again w/hives- told poss vax rxn;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: non-response;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Osteoarthritis
Clinical narrative: Pt recvd 1st Engerix-B vax on 16OCT91 & w/in a few days to 1 wk exp joint pain which is persisting; vax series indicated as not discontinued;
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Engerix-B vax on 6MAR91, 10APR91 & 11SEP91; following the series NOV91 did not respond plan is to revax;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Lichenoid keratosis, Rash
Clinical narrative: Pt recvd 2 doses of Engerix-B vax on 3OCT91 & 1NOV91 p/2nd dose (unk onset/date/time), exp rash which was much worse than p/1st inject, on arms & legs which spread to trunk, hands & feet; tx meds; 18NOV91 pt improved;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Paraesthesia
Clinical narrative: Pt recvd a series of 3 inject of Engerix-B 14NOV91 30 min following 3rd dose c/o arm feeling dead or not there; This feeling lasted 8-12 hrs; As of 15NOV91 pt had normal feeling again; no tx required; pt found to be neg when needle stuck;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Neuropathy, Paraesthesia
Clinical narrative: Pt recvd 2 doses Engerix-B 12SEP91 & 13NOV91; 1st dose uneventful; 7 hrs p/2nd vax pt devel pain in elbows & joints; progressed to numbness in hand & upper extremities, weakness- dx reticular neuropathy; dx polyneuropathy secondary to vax;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Vertigo
Clinical narrative: Pt recvd series of Hep-B & 13NOV91 recvd 5th inject; 17NOV91 pt devel vertigo; no tx was given as of 19NOV91 vertigo was persisting;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 55 paramedics were vaxed w/ series of 3 doses of Engerix-B & 18 were non-responders when tested 30 days to 4 mos p/last inject; reporter indicated plans to revax the non-responders;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Influenza, Injection site hypersensitivity, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Pt recvd Engerix-B MAY & JUN91 w/no rxn; 3rd dose 13NOV91 & 14NOV91 pt devel red area @ inject site & c/o burning post vax; 15NOV91 red area spread to a 4x4 area, hard, hot & tender to touch; seen in ER 14NOV91 poss infect @ inject site;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Vasodilatation
Clinical narrative: Pt recvd Engerix-B MAY & JUN91 w/no rxn; 3rd dose 13NOV91 & 14NOV91 pt devel red area @ inject site & c/o burning post vax; 15NOV91 red area spread to a 4x4 area, hard, hot & tender to touch; seen in ER 14NOV91 poss infect @ inject site;
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B on 18SEP90, 18OCT90 & 20MAR91 for immun; NOV91 pt was tested was found to be non-immune; Reporter indicated that pt was scheduled to receive a booster dose on 20NOV91;
Sex: U
Vaccine: HEP
Symptoms: Paraesthesia, Pyrexia, Tachycardia
Clinical narrative: Pt recvd 1 dose of Engerix-B 15OCT91 & that same day exp sinus tachycardia, fever of 99.6 & sensation of numbness in arms & fingers; tx used were hot packs @ site of inject; events resolved;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A group of pts recvd Engerix-B & reporter indicated that there were a lot of non-responders;
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Hypersensitivity, Paraesthesia
Clinical narrative: Pt recvd Engerix-B w/in a few hrs p/the vax pt exp chest tightness, numbness, tingling in hands, & a poss allergic rxn; pt went to ER where events were tx w/DPH; pt discharged from ER & is improving;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Pt recvd 2nd dose of Engerix-B JUN91 & 1 wk later became fatigued x 3 wks & was dizzy w/h/a; these sx also subsided; no tx was required but the pt slept a lot; Pt is reported to be fine now; 3rd dose of Engerix-B has not yet been given;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 injects of Engerix-B & 3rd & final inject was given DEC90; testing indicated that pt had seroconverted 5NOV91 suffered a needlestick; pt was HBSAG neg; f/u testing of the pt indicated that pt anti HBS neg;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Headache, Nausea
Clinical narrative: Pt recvd 2 doses of Engerix-B on 8MAY91 & 5JUN91 & pt called reporter on 8JUL91 c/o of prolonged fatigue, dizziness, nausea, & h/a which occurred off & on for several wks p/2nd dose; no tx required; all c/o resolved;
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 1st dose was administered in early 1990; 3rd dose was administered in the summer 1990; 11NOV91 pt exp non-response; no tx was given;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B on 5APR91; 17MAY91 & 21OCT91 & 21NOV91 serology indicated non-responder no tx was given;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 doses of Engerix-B on 10MAR91, 20APR91, & 29SEP91 & 8NOV91 serology indicated "non-responder" no tx was given;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix on 26JUL91, 22AUG91 & 26SEP91 & 29OCT91 serology indicated non-responder; no tx was given;
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Malaise, Myalgia, Pyrexia, Syncope
Clinical narrative: 21JUN91 pt recvd 2nd dose of Engerix-B vax about 10 days p/2nd dose pt exp general weakness, fever, fainted (syncope) & achiness; pt treated in ER & lab work was done; pt remained sick x 10 days;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 7 pts were treated w/Engerix-B & it was determined that 4 out of 7 were non-responders;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 50-60 employees @ a nursing home were vaxed w/Engerix-B beginning DEC90; Repoter thinks it was ID; all employees have recvd 3 doses; titer checks now are coming back neg;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a Hep B vax series (3 injects) & it is not known if pt seroconverted p/receiving the initial series; however, in NOV91 pt was tested for HBSAB & it was determined that pt had no antibodies; pt will be revaxed;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Pt recvd 2 doses of Engerix-B on 18JUL91 & 16AUG91 & 24-36 hrs p/2nd vax (18AUG) pt devel rash generalized on trunk; The rash lasted 3-4 days & resolved w/o treatment;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: 24NOV91 pt recvd dose of Engerix-B & 24 hrs p/the inject pt devel a rash generlized on trunk; no tx was reported;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & it was determined that pt had no titer p/3rd dose;
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Reporter indicated that pt has become aware of 4 new pts who did not seroconvert;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt indicated was vaxed w/Engerix-B & had a borderline titer result;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter indicated that 10% of people are not converting;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd a dose of Engerix-B on 7NOV91 & 9NOV91 devel rash, bumps & pimples on neck (no pain); pt visited a dermatologist; tx w/prescription meds (not specified); tx reported not to have any effect;
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Hep-B vax in 1986 (brand unk); does not know if titers were checked in 1986; in 1988 MD recommended that pt receive booster dose p/having blood drawn; titer may have been checked; booster dose recvd in 1988 (brand unk);
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter indicated that Engerix-B was administered & it was determined that 3 pts were non-responders in the last six months;
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Several yrs go pt recvd Hep-b series; several months ago tested for antibodies to Hep B; pts antibody test was neg; pt indicated gave myself a booster dose waited several wks & repeated the antibody study & asked for an absolute titer;
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: In 1990 pt recvd a series of Engerix-B (exact dates & doses unspecified) & did not convert to a pos antibody until 6th dose;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 27NOV90, 27DEC90, & 10JUN91 & 25SEP91 it was determined that pt was a non-responder; 2 addtl doses of vax were administered;
Age: 1.0
Sex: M
Vaccine: DTP, HIBV
Symptoms: Convulsion, Hypersensitivity
Clinical narrative: Pt had sz & admitted to hosp on 13NOV91 appr 24hrs p/DTP; pt is fully recovered; mom reports admitting MD said pt had allergic rxn to pertussis;
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Hypotonia, Shock, Somnolence, Stupor
Clinical narrative: On the morning of 03NOV91, pt started w/lethargy, then had loss of muscle control & became unresponsive; MD termed it "hyporesponsive collapse"; pt was placed on a heart monitor;
Age: 0.4
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Otitis media, Pyrexia
Clinical narrative: Afternoon of vax t102 (even while on APAP); that night t103; next morning pt was irritable; was taken to ER, t104.2; @ that time pt was found to have an ear infection;
Age: 0.1
Sex: M
Vaccine: DTP, OPV
Symptoms: Blood creatine phosphokinase increased, Hyporeflexia, Myasthenic syndrome, Neuropathy
Clinical narrative: Devel of profound asymmetric muscle weakness R>L, LE>UE, w/loss of deep tendon reflexes all w/in 4 weeks p/recving 1st DTP/OPV; has had improvement in weakness, but still w/residual permanent muscle weakness R>L, LE>>UE;
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Dermatitis bullous, Glossitis, Mouth ulceration, Pain, Tongue oedema
Clinical narrative: "Cluster blisters" on back of hand & inside mouth; also, mouth ulcers, taste buds on tongue swollen & painful;
Age: 6.0
Sex: F
Vaccine: DTP, OPV
Symptoms: Dry skin, Myalgia, Oedema, Pain, Vasodilatation
Clinical narrative: Pt's rt arm red & sore w/slight swelling on 01NOV91 p/recving DTP; by 02NOV91 rt arm reddened from deltoid to elbow w/sl swelling & much soreness; by 04NOV91 redness almost gone along w/swelling & pain; area did have some scaly skin;
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Hypersensitivity, Injection site pain, Pyrexia, Urticaria
Clinical narrative: T99.2; pain @ inject site lt deltoid; hives; wheezing; Benadryl administered; dx: allergic rxn; recovery w/in 24 hrs;
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site oedema, Injection site pain, Lymphadenopathy, Paraesthesia
Clinical narrative: Local pain/adenopathy @ inject site; paresthesia to fingers; recovery w/in 48hrs;
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Swelling/redness @ inject site; recovery w/in 24 hrs;
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site mass, Pyrexia, Vasodilatation
Clinical narrative: T99.4; 3mm induration w/increased warmth @ site; recovery w/in 24hrs;
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Pt recd vax & about 2 wks later presented to a dermatologist w/ c/o pain & erythema; dx: shingles; rx: Prednisone;
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Insomnia, Nervousness, Rash
Clinical narrative: Pt recd vax; about a month later pt came in w/ complaints of rash, low back pain & restlessness @ night;
Age: 0.3
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Drug ineffective, Infection, Malaise, Meningitis
Clinical narrative: 4.5 mo pt became ill 13 days p/2nd immun; 3 days later pt was dx as having H. Influenza meningitis; @ time of report pt is doing fine;
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Expired 04DEC91; medical examiner called Health Dept - death not due to vax;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Apnoea, Cyanosis, Drug ineffective, Infection
Clinical narrative: Appr 3 hrs p/vax, pt devel apnea & cyanosis; required intubation & ICU stay; pertussis prep positive - so thought is this was likely due to pertussis & not vax;
Age: 0.2
Sex: M
Vaccine: DTP, HIBV
Symptoms: Apnoea, Respiratory disorder, Vomiting
Clinical narrative: Less than 24 hrs p/recving vax, pt vomitted, aspirated & had appr 15-20 seconds apnea; in hosp, pt was found to have much reflux; no apnea since pt started med tx;