chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 26JUL90, 26AUG90, & 26JAN91 & was a non-responder;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 3AUG90, 15SEP90, & 5FEB91 & was a non-responder;
Age: 48.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd series of 3 Engerix-B vaxs (20mcg) on 13SEP90, 19OCT90, & 27MAR91 & was a non-responder;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: PT recd Heptavax series from SEP84 to 1985; titer p/series was positive; 31JUL90 titer neg; given booster of Engerix-B 30AUG90 (1cc, IM/rt deltoid); OCT90 titer still neg; 2nd booster 13FEB91 (1cc, IM/rt deltoid); 22MAY91 titer positive;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A total of 140 PTs were vaxd; 23 PTs did not respond p/a series of 3 Engerix-B vaxs & 1 pt was a borderline responder (see also EBU910660);
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Infection, Influenza, Leukocytosis
Clinical narrative: 23MAY91 PT recd vax (1cc, IM, deltoid); 8JUN91 PT exp fever (t104.2 ax), chills, flu-like pain in joints, polyarthralgia, but no erythema or edema; PT had t102-103 @ home, but normal temp 10JUN91; seen in ER 10JUN91; rx: Vibra-Tabs & Advil
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Urine analysis abnormal
Clinical narrative: 23MAY91 PT recd vax (1cc, IM, deltoid); 8JUN91 PT exp fever (t104.2 ax), chills, flu-like pain in joints, polyarthralgia, but no erythema or edema; PT had t102-103 @ home, but normal temp 10JUN91; seen in ER 10JUN91; rx: Vibra-Tabs & Advil
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: PT recd a series of 3 Engerix-B vaxs (20mcg lt del) 8MAY90, 5JUN90, & 22OCT90; 14JAN91 PT tested weakly positive for HBsAB; 6FEB91 PT tested weakly positive; titer drawn 7MAY91 tested strongly positive for HBsAB;
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic function abnormal, Liver tenderness, Malaise
Clinical narrative: PT recd vax (1cc/IM) @ 12 noon 31MAY91; following a prior vax PT exp pain in the liver area, malaise, elevated SGOT, SGPT & GGT; MD suggested that PT complete series;
Sex: F
Vaccine: HEP
Symptoms: Oedema peripheral, Pain
Clinical narrative: PT recd 3 vaxs (1cc, IM del) 4OCT90, 15NOV90, & 11JUN91; w/in 24hr p/inject PT devd edema in (?rt) del & pain in arm radiating toward hand; edema was 4" in diameter & .5" thick & had continued thru 20JUN91; rx: Advil (1QID) & cold packs;
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd 3 doses of Hepatitis B vax 27JUL90, 30AUG90, & 11OCT90; it was determined that PT did not seroconvert;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd 3 doses of vax 5JUL90, 6AUG90, & 7JAN91; PT did not seroconvert;
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT did not seroprotect p/3 vaxs (20mcg, del) given on unspecified date for 1st inject, APR90, & 27JUN90; PT still did not seroprotect p/14SEP90 inject; plan to give a 5th inject;
Sex: U
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: 2 nurses exp arthralgias following the Hepatitis B vax;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 2 Pts recd a series of Hepatitis B vax doses; PTs did not respond; 2 Engerix-B booster doses were given to each PT MAY91 & JUN91;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: PT exp myalgia & low-grade fever for 24hrs p/1st Engerix-B vax; rxd w/APAP; PT recd 2nd dose of Engerix-B (1cc/IM del) 28JUN91 which was uneventful;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Headache, Hepatic function abnormal, Hyperhidrosis, Pyrexia
Clinical narrative: PT recd Engerix-B on 30OCT90, 1JAN91, & 11JUN91; w/in 36hrs of 3rd dose became tired w/weakness; 50hrs later severity of symptoms inc & dev fever, chills, sweating, & severe h/a; to ER & rx w/Motrin (600mg PO); PT was alert; LFTs abnormal
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: PT recd 3 doses of Engerix-B (1cc/IM lt del) on 16AUG90, 17SEP90, & 5MAR91; HBsAB tests were neg on 20JUN91; recd 4th dose on 25JUN91;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recd series of Engerix-B vaxs (1cc/IM rt deltoid) 17SEP90, 19OCT90, & 28MAR91; Pt had needle stick 11MAR91 & had Hepatitis B Ag test done since series was incomplete; 13JUN91 f/u HBsAb test was neg; 20JUN91 recd 4th dose vax (1cc);
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recd series of 3 Engerix-B doses & it was determined that Pt did not respond;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Chills, Dizziness, Headache
Clinical narrative: Pt recd series of 3 vaxs (20mcg,IM, rt deltoid) 26NOV90, 2JAN91, & 24MAY91; 29MAY91 Pt expd chilling, hot flashes, weakness, burning in chest, bad headache, & lightheadedness; no rx given; Pt reported to be "OK" now;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Pt recd series of 3 vaxs (20mcg,IM, rt deltoid) 26NOV90, 2JAN91, & 24MAY91; 29MAY91 Pt expd chilling, hot flashes, weakness, burning in chest, bad headache, & lightheadedness; no rx given; Pt reported to be "OK" now;
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Pleural disorder
Clinical narrative: Pt recd 2 vaxs (1cc); 1st dose, either May or June, was uneventful; p/2nd dose, either June or July, "developed pain on breathing ('pleurisy')"; no rx given; Pt "got better w/in a few days (?)"; 3rd dose not given; p/2 doses neg Ab test;
Age: 79.0
Sex: M
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Influenza, Malaise
Clinical narrative: Pt recd 2 vaxs (1cc); 1st dose, "given JUN90 (?)," was uneventful; p/2nd dose, given "JUL90 (?)," Pt felt ill, had grippe/flu-like feeling for a few days; no rx; Pt "got well";  Pt had lack of response to vax; p/2 doses had neg Ab test;
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Vasodilatation
Clinical narrative: Pt recd vax (deltoid) as a booster dose on 27JUN91 & developed events; Pt put an ice pack on the area; arm looked red deltoid to wrist; tingling in left deltoid & below;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site hypersensitivity, Nausea, Pruritus, Pyrexia
Clinical narrative: Pt recd 3 doses of vax; 1st & 2nd doses uneventful; 24JUN91 recd 3rd dose; 25JUN91 Pt's entire upper arm red @ inject site; same day Pt expd itching & t99; 26JUN91 Pt had h/a, nausea, & t100; 27JUN91 redness improving & no other c/o;
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Myalgia, Myasthenic syndrome, Neuritis
Clinical narrative: Pt recd 2 doses vax (1cc) 18FEB91 & 18MAR91; p/2nd dose devd numbness & weakness of left arm; symptoms worsened on 19MAR91; rx'd w/physical therapy; exp'd complete recovery; MD dx "post vax brachial plexus neuritis"; recommend no more vaxs;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Malaise, Pyrexia
Clinical narrative: 24JUN91 Pt recd 1st dose; 24JUN91 tired & expd intermittent low grade fever in PM for 2 wks; for 1st 24 hrs felt fatigue then felt just tired for appr 2 wks; temp >101 for 2 days; temp down for next 2 days; temp >99 again 2-3 days; no rx;
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Injection site hypersensitivity, Malaise, Myalgia, Pain
Clinical narrative: 3JUN91, 6hrs p/vax, expd muscle aches & pains esp ankles, wrists, & hands; c/o feeling sick & achy; took APAP @bedtime & felt OK next AM 4JUN91; 5JUN91, 48hrs p/dose, Pt expd intense "deep" itching @ inject site, resolved in 48hrs 7JUN91;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Rash maculo-papular, Vasodilatation
Clinical narrative: 18JUN91 Pt recd 1st dose (? 20mcg); about 5 days p/vax Pt developed itching, red areas in groin, elbows, behind knees; as of 1JUL91 condition is persisting; no rx given; given;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Several pts who had a series of 3 Engerix-B vaxs were seronegative/non-responders; rx: "unknown";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recd series of vaxs (20mcg); date of 1st & 2nd doses unspecified; 3rd dose given FEB91; all 3 vaxs were uneventful; as of JUN91 Pt has seroconversion w/o seroprotection; no rx given;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt failed to convert & was "not protected" p/series of 3 "Recombivax" vaxs, given 13OCT89, 13NOV89, & 13APR90; Pt completed a 2nd series of 3 vaxs (Engerix-B), given 7AUG90, 16OCT90, & APR91; Pt has not seroconverted;
Sex: U
Vaccine: HEP
Symptoms: Abdominal distension, Hyperbilirubinaemia, Malaise, Nausea, Vomiting
Clinical narrative: Pt recvd 1st & 2nd dose of Engerix-B; 1st dose uneventful; Onset of events occured about 2 wks p/2nd vax; no treatment given; gallstones were ruled out;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilatation
Clinical narrative: Pt recvd 1st Engerix-B on 22JUN91; immediately (w/in 5 min) inject site became red, swollen, warm to touch; Seen in ER; tx Seldane;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Pt recvd 1st & 2nd vax of series on 8MAY91 & 13JUN91; 1st dose was uneventful; p/2nd dose pt had immediate  (w/in 2 min) onset of dizziness & BP drop; w/in 1 to 2 hrs of vax pt exp severe abdominal cramping, stabbing, felt weak; Seen in ER;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hypotension, Nausea
Clinical narrative: Pt recvd 1st & 2nd vax of series on 8MAY91 & 13JUN91; 1st dose was uneventful; p/2nd dose pt had immediate  (w/in 2 min) onset of dizziness & BP drop; w/in 1 to 2 hrs of vax pt exp severe abdominal cramping, stabbing, felt weak; Seen in ER;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd series of 3 EngerixB vax 22FEB91, 22MAR91, 22APR91; Antibody test done 2 months p/last dose indicated pt was a non-responder; later tests indicated pt seroconverted;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B vax on 9FEB91 & 10MAR91 was a non-responder;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: A total of 140 pts were vaxed, 1 pt was borderline responder following a series of 3 Engerix-B vax & 23 pts did not respond (see also EBU910616);
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Pt exp a head to toe rash w/generalized slight itching DEC90 following the 2nd Engerix-B vax;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 100 employees had been enrolled in Hep B immun program & as of 4MAR91 approx 1/2 had completed or shortly would complete their vax; 19 had completed titer screening & of those, 8 had titers below 10;
Sex: U
Vaccine: DTP, HEP, OPV
Symptoms: Convulsion
Clinical narrative: Investigator indicated event not related to Engerix-B vax; Randomized to recvd Engerix-B (as the control vax) while a participant in Merieux trial of HIB; exp seizures;
Sex: U
Vaccine: DTP, HEP, OPV
Symptoms: Apnoea, Convulsion, Cyanosis, Febrile convulsion, Otitis media
Clinical narrative: Recvd Engerix B, exp seizures;
Sex: U
Vaccine: DTP, HEP, OPV
Symptoms: Convulsion
Clinical narrative: Pt recvd Engerix-B & exp sz
Sex: U
Vaccine: DTP, HEP, OPV
Symptoms: Convulsion, Cyanosis, Infection, Pyrexia, Tremor
Clinical narrative: Pt recvd Engerix-B & exp sz;
Sex: U
Vaccine: DTP, HEP, OPV
Symptoms: Apnoea, Convulsion, Cyanosis, Dyspnoea, Gastrointestinal disorder
Clinical narrative: Pt recvd Engerix-B & exp sz;
Sex: U
Vaccine: DTP, HEP, OPV
Symptoms: Infection, Rectal haemorrhage, Respiratory disorder
Clinical narrative: Pt recvd Engerix-B & exp sz;
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen
Clinical narrative: Pt recvd 2 Engerix-B vax, 1st given MAR91 & 2nd given APR91; Had lab screen done for surgery planned wk of 1JUL91 to reconnect fallopian tubes; Lab screen revealed pt to be HBSAG post & HBSAB; concerned about exposing pts to Hep B;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a dose of Hep B vax (brand unk) in the buttock & it was determined that pt failed to seroconvert; No tx given;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Headache, Nausea, Pyrexia
Clinical narrative: Pt recvd 1st dose of Engerix-B 01MAY91 & 23MAY91 pt exp h/a, nausea, stomach cramps, & fever 102; Pt indicated that onset of events occurred 3 wks p/vax; pt indicated that MD did not know the cause of sx;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: Pt recvd 3 doses of a vax series; 24JUN91 pt exp a raised area & itching @ site; 25JUN91 pt exp entire upper arm red, itching, t99 & arm was sore; 26JUN91 exp h/a, nausea & t100.4;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Engerix-B vax on 05OCT90, 14NOV90 & 01MAR91; when tested @ completion of series was a non-responder & not protected;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Six months "about JAN91" ago pt had a needlestick; @ that time titer was checked & the result was negative; 1 booster dose of Engerix-B was given six months ago; 3 months p/booster, titer still neg; MD suggested pt recvd vax again;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd Engerix-B on 05JUL91 & on 07JUL91 & exp hives; tx DPH; sx resolved;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Engerix-B vax on 21SEP90 01NOV90 & 20MAR91; when tested @ completion of series was a non-responder & not protected;
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt recvd 1st dose of Engerix-B "soon" p/receiving inject; pt exp fever, nausea, & vomiting for 24hrs; events resolved p/24 hrs;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Pt recvd 1st dose of Engerix-B on 11JUL91; 8 hrs p/inject pt exp burning ears & face; No tx given;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: A total of 40 out of 70 hemodialysis pts have not responded to a 3 dose regimen of either Engerix B or Heptavax; Heptavax used up until 1 yr ago & then started using Engerix-B; pts were only given 3 doses instead of recommended 4 doses;
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd 1st dose of Engerix-B "recently" & four days p/inject exp intense itchy rash & urticaria; MD visit was required; tx DPH;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Hep B vax series & it was determined that pt was not protected; Pt recvd 2nd Hep B vax series & is still not protected;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Dizziness, Nausea
Clinical narrative: Pt recvd 1st dose of Engerix-B on 08JUL91; Evening of 08JUL91 pt exp slight nausea which continues on & off, felt tired, had slight stomach cramps, slight diarrhea; 10JUL891 pt felt dizzy; No tx given;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd 1st dose of Engerix-B on 29APR91; w/in 12 hrs of 1st dose pt exp trunk covered w/hives & raised, itching skin lesions; outpatient tx required to treat events; Resolved in 24 hrs;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A large percentage of pt recvd Engerix-B  Intradermal & it was determined that pt did not develop titers;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd Engerix-B, pt had a "blood test" & was determined that had a neg titer; Pt was exposed to Hep; The final dose of Engerix-B was administered about 1 month ago;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Myalgia, Nausea, Tremor
Clinical narrative: Pt recvd 2 doses of Hep B vax; 1st dose was given JUN91 was Recombivax; 2nd dose was Engerix-B given 11JUL91; 12JUL91 p/vax pt ex h/a, nausea, shaky, & sick all over;
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B vax on 16AUG90, 27SEP90, & 19FEB91; post vax indicated that pt was a non-responder; On 09MAY91 pt recvd booster dose for post exposure prophylaxis;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B vax on 22NOV89, 15DEC89, 30MAY90; post vax indicated that pt was a non-responder; on 09MAY91 pt recvd a booster dose for post exposure prophylaxis;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache
Clinical narrative: Pt recvd 1st & 2nd Engerix-B vax given 12JUN91 & 12JUL91; Pt exp h/a, dizziness p/1st & 2nd dose;
Age: 59.0
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Reporter indicated that over the past year there was a 50% rate of non-response in a group of 40-50 pt who were givan a series of 3 Engerix-B vax;7 out of 26 did not seroconvert following vax;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Headache, Nausea, Rash, Urticaria
Clinical narrative: Pt recvd 1st Engerix-B vax on 05JUN91 & next day had onset of rash (generalized); Seen in ER; given meds & rash resolved;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Dyspnoea, Headache, Nausea
Clinical narrative: Pt recvd 1st dose of vax on 02JUL91 & w/in several hrs of receiving vax, pt got hot, & tightness in chest & difficulty breathing;  Later got a h/a, nausea & weakness & then vomited; p/vomited undigested food, pt was fine;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation, Vomiting
Clinical narrative: Pt recvd 1st dose of vax on 02JUL91 & w/in several hrs of receiving vax, pt got hot, & tightness in chest & difficulty breathing;  Later got a h/a, nausea & weakness & then vomited; p/vomited undigested food, pt was fine;
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Pt recvd 1st dose of Engerix-B 12JUN91, 02JUL91 exp a rash; 04JUL91 rash spread to neck, arms & chest & became large blister-like welts w/no fluid;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B for routine prophylaxis & failed to develop protective titers;
Sex: F
Vaccine: HEP
Symptoms: Headache, Pyrexia
Clinical narrative: Pt recvd 1st Engerix-B vax on 17JUL91 & onset of h/a, fever occurred approx 18JUL91;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax, the 1st two doses were Heptavax given 02DEC89 & 02JAN90 & the 3rd w/Engerix-B 15JUN90 & it was determined that pt did not have titers; A booster dose of Engerix-B was administered 16JUL91;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: The pt recvd 1st Engerix-B dose on 18JUN91 for Hep B prophylaxis; 4 days later pt devel a rash on lower extremities, few on torso, very itchy; given DPH
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B for immun against Hep B 19OCT90; 20NOV90 & 16APR91 & it was determined that pt had no response; Reporter indicated outcome to be "not immune".
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache, Hypertonia, Malaise, Vasodilatation
Clinical narrative: Pt recvd first dose of vax 21MAY91 for Hep vax & immediately felt strange, pt reported weakness, muscle spasms that lasted 2-3 wks; exp h/a & hot flashes 3 days post vax; Also devel bronchitis 3 wks post vax;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not convert p/a series of 3 Engerix-B vax on 13MAR90, 13APR90, & 18OCT90, respectively; Each inject recvd was 1 adult dose; Pt was advised of need for further inject & testing;
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not convert p/a series of 3 Engerix-B vax on 02NOV90, 02DEC90 & 02MAY91, repectively; Each inject recvd was 1 adult dose; Pt was advised of need for further inject & testing;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not convert p/a series of 3 Engerix-B vax on 11OCT90, 11NOV90, & 11APR91, respectively; each inject recvd was 1 adult dose; pt was instructed that 2 more injects, 1 mo apart are needed;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax & blood work showed that pt was neg for Hep B antibodies; recvd 2 Engerix-B booster doses on 24APR91 & 31MAY91, respectively for protection against Hep B; 09JUL91 titer was neg;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax & blood work for HBSAG was neg; Pt recvd 2 Engerix-B booster doses on 18APR91 & 21MAY91 & 17JUN91 titer was neg;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B vax on 18SEP90, 25OCT90, & 26MAR91 & 29APR91 titer was neg; Pt recvd 2 Engerix-B doses on 06MAY91 & 11JUN91 & 09JUL91 titer was neg;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd series of 3 Engerix-B vax on 20AUG90, 21SEP90, & 21FEB91 & was a non-responder;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: "Several" pt exp non-response p/completion of a series of 3 Engerix-B vax; These pts are not HBV protected;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & was a non responder;
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 10APR90, 10MAY90 & 12NOV90 & it was determined that pt had an insufficient antibody response;
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza, Nausea
Clinical narrative: Pt recvd 1st Engerix-B vax for prevention of Hep B infect in JUN91; pt exp flu-like sx, h/a, & nausea 12 hrs post vax; tx Advil & anaprox w/o much relief;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza, Mouth ulceration, Myalgia, Nausea
Clinical narrative: Pt recvd 1st dose of Engerix-B for Hep B vax exp a rash, icthing over entire body, nausea, vomiting, flu-like sx (muscles aches & pains), but not fever; 26JUL91, next day, pt exp sl h/a, fever blister; pt given meds;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Pt recvd 1st dose of Engerix-B for Hep B vax exp a rash, icthing over entire body, nausea, vomiting, flu-like sx (muscles aches & pains), but not fever; 26JUL91, next day, pt exp sl h/a, fever blister; pt given meds;
Sex: F
Vaccine: HEP
Symptoms: Arrhythmia, Hepatic function abnormal, Tachycardia
Clinical narrative: Pt recvd 3 doses of Engerix-B vax 23AUG90, 23SEP90, & 23MAR91 & exp elevated liver enzymes; Reported indicated that outcome is pending;
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood lactate dehydrogenase increased, Drug ineffective, Hepatic function abnormal, Hypoglycaemia
Clinical narrative: Pt recvd a booster dose of Engerix-B & exp elevated liver enzymes; Reporter indicated that pt is presently (as of 29JUL91) seeing a MD; outcome is pending;
Sex: F
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: Pt recvd a booster dose of Engerix-B & exp elevated liver enzymes; Reporter indicated that pt is presently (as of 29JUL91) seeing a MD; outcome is pending;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Hyperhidrosis, Nausea, Rhinitis
Clinical narrative: Pt recvd 1st Engerix-B vax on 25JUL91 & later that evening became cold & clammy, exp weakness especially arms, sl nausea which passed & had a runny nose; no tx given for events; 26JUL91 pt is "now feeling normal again";
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 4 doses of Engerix-B required due to neg result;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 4 doses of Engerix-B required due to neg result;
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Rash total body;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: Pt recvd 1st Engerix-B vax & exp sedation & sleeping on 19JUL91 & on 26JUL91 exp resolution of all signs & sx;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Bronchitis, Chills, Headache, Nausea
Clinical narrative: Pt recvd 1st dose of Engerix-B on 26JUL91 & exp 26JUL91 low grade fever, general achiness, nausea, fatigue, chills, & h/a; sx lasted 2-3 days; dx w/tracheobronchitis approx 1 wk following vax;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: Pt recvd 1st dose of Engerix-B on 26JUL91 & exp 26JUL91 low grade fever, general achiness, nausea, fatigue, chills, & h/a; sx lasted 2-3 days; dx w/tracheobronchitis approx 1 wk following vax;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Candidiasis, Drug ineffective, Goitre, Sarcoidosis, Thyroid disorder
Clinical narrative: Pt recd 3 doses of Engerix-B 24MAY90, 26JUN90, & 29NOV90 & it was determined that pt did not respond; 4th dose Engerix-B administered 14JAN91 p/this pt did not respond; 5th dose given & did not respond; poss enlarged thyroid, yeast infect;
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 02MAY90; 5JUN90 & 09NOV90 & it was determined that pt did not respond; A 4th dose of Engerix-B was administered 17DEC90; p/this still did not respond; pt treated w/Prephenzine & Impramine; dx is unk/unconfirmed
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 17JUL90; 17AUG90 & 24JAN91; pt did not convert positive for HBSAB; no tx given;
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Depression, Drug ineffective, Pain
Clinical narrative: Pt recvd 3 doses of Engerix-B for the prevention of Hep B vax on 07SEP90, 17OCT90, & 19MAR91; pt did not convert positive for HBSAB; No tx given; Reported indicated pt will recvd 1-2 extra doses of vax to try to get pt to convert;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter indicated that six pts who were administered Engerix-B & "did not convert".
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd a series of 3 Engerix-B vax on 13FEB91, 03MAY91 & 3JUL91 & on 10JUL91 pt exp "whelps" & itching on upper & lower extremities which lasted for 3 days; tx w/DPH;
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Infection, Malaise, Pharyngitis
Clinical narrative: Pt recvd 1st dose of vax 08MAY91 & was uneventful; pt recvd 2nd dose of vax 12JUN91 & 16JUN91 exp skin eruptions, malaise, itching, fever, strep throat, chills, joint pain, & serum sickness; treated w/meds; MD advised not to complete series
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Pyrexia, Serum sickness
Clinical narrative: Pt recvd 1st dose of vax 08MAY91 & was uneventful; pt recvd 2nd dose of vax 12JUN91 & 16JUN91 exp skin eruptions, malaise, itching, fever, strep throat, chills, joint pain, & serum sickness; treated w/meds; MD advised not to complete series
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not convert p/a series of five doses of Hep vax; The 1st 3 doses of Hep vax were unspecified brand, but not Engerix-B were administered in buttock; the fourth & fifth doses were Engerix-B vax;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B vax & did not respond p/3rd dose; No tx given;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B on 18OCT90, 19NOV90 & 25APR91 & was a non-responder;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B on 18OCT90, 19NOV90, 25APR91 & did not respond; no tx given; reporter indicated that outcome was pending;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic function abnormal
Clinical narrative: Pt recvd 3 doses of Engerix-B 6AUG90, 2SEp90, & FEB91; 4AUG91 pt exp elevated liver enzymes; Pt was hospitalized & is being monitored;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nuchal rigidity, Vasodilatation
Clinical narrative: Pt recvd 1st dose of Engerix-B 19JUN91 & the same day 19JUN91 pt exp h/a of short duration & was flushed; 19JUL91 pt recvd 2nd dose of Engerix-B & 1/2 hr p/exp h/a, stiff neck & was flushed;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not respond to 3 doses of Engerix-B given for the prevention of Hep B;
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt did not respond to 3 doses of Engerix-B;
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Influenza, Myalgia, Nausea, Vomiting
Clinical narrative: Pt recvd 3 doses of Engerix-B 12SEP90; 29OCT90 & 14MAR91 & recvd Attenuvax 14MAY91; Pt was supposed to recvd a 2nd dose of Attenuvax but was mistakenly given a 4th dose of Engerix-B 16JUL91; 17JUL91 pt exp nausea, vomited & muscle aches;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Nuchal rigidity, Oedema, Skin discolouration
Clinical narrative: Pt recvd 1st Engerix-B vax 28JUN91 & 2 hrs p/receiving the inject pt noticed stiffness lt side of neck; Pt exp slight swelling of arm @ inject site; swelling inc & worked its way to the hand; unable to remove rings, hand turned white;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not convert p/a series of five doses of Hep vax;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B on 29AUG90; & dose 2 on 2OCT90, dose 3 date unk; pt was a non seroconverter;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B vax 30MAY90, 29JUN90, & 30NOV90 & it was determined that pt did not seroconvert;
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B 13JUL90, 16AUG90, 23JAN91 & reporter indicated that pt did not seroconvert;
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B vax 13JUL90, 16AUG90, 23JAN91 & it was determined that pt did not seroconvert;
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B vax 01JUN90, 11JUL90 & 20DEC90 & it was determined that pt did not seroconvert;
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B vax 30MAY90; 11JUL90 & 12JUL90 & it was determined that pt did not seroconvert;
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pruritus
Clinical narrative: Pt recvd 1st dose of Engerix-B 01AUG91; 4 hrs p/vax pt exp nausea & itching for 2 days;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Skin discolouration
Clinical narrative: Pt recvd 1st Engerix-B vax 15JUL91 & immediately p/inject exp swelling @ inject site arm was rubbed & swelling went down immediately p/vax; Pt first noted on 29JUL91 p/ tan faded, a dark spot on inject site;big brown mark like sun blotch;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myasthenic syndrome
Clinical narrative: Pt recvd vax 1st & 2nd dose of Hep B vax (brand unspecified) & recvd 3rd, Engerix-B on 10MAY91; w/in 24 hrs of dose pt exp severe muscle weakness, & joint pain which moves around constantly; Seen by MD;
Sex: F
Vaccine: HEP
Symptoms: Cough, Dizziness, Dyspnoea, Hypertension, Palpitations
Clinical narrative: Pt recvd 1st Engerix-B vax in JUN91 & was uneventful; Approx 5-10min p/2nd dose given 01AUG91 pt exp itching of palms & SOB; 4 hrs p/2nd dose of shot exp elevated BP 140/90 & pounding HB (pulse-140);
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Tremor, Vasodilatation
Clinical narrative: Pt recvd 1st Engerix-B vax in JUN91 & was uneventful; Approx 5-10min p/2nd dose given 01AUG91 pt exp itching of palms & SOB; 4 hrs p/2nd dose of shot exp elevated BP 140/90 & pounding HB (pulse-140);
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 09NOV90, 13DEC90, & 15MAY91 & it was determined that pt did not seroconvert;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 31OCT90, 30NOV90, & 03MAY91 & it was determined that pt did not seroconvert;
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 26JUN90, 30JUL90, & 15JAN91 & it was determined that pt did not form antibodies p/3rd dose;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 13NOV90, 17DEC90, & 09MAY91 & p/3rd Engerix-B vax given antibody titer was 2.3; A 4th dose was given 11JUN91 & titers were inc to 4.2;
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Hypersensitivity, Laryngospasm, Myalgia, Paraesthesia
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2nd dose given MAR91 then 2 days post vax pt exp allergic rxn of rash & felt tightening in throat;
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2nd dose given MAR91 then 2 days post vax pt exp allergic rxn of rash & felt tightening in throat;
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B, 1st dose was given -7DEC90 & 3rd given 07MAY91; 02AUG91 Antibody titer was checked & was negative;
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B 24MAY90, 25JUN90 & 19NOV90 & p/3 doses of vax, Antibodies were checked 22FEB91 & there was no antibody;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Headache, Injection site pain, Malaise
Clinical narrative: Pt recvd Engerix-B & exp malaise, vomiting, & a slight fever;
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt recvd Engerix-B & exp malaise, vomiting, & a slight fever;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Pain, Pruritus, Vasodilatation
Clinical narrative: Pt recvd 1st Engerix-B vax 29JUL91 & exp, that same day, induration less than or equal to 20 cm in 24 hrs, hot to touch, pain & itching for 2 wks; treated w/Pred & DPH;
Sex: F
Vaccine: HEP
Symptoms: Pain, Pruritus, Skin nodule
Clinical narrative: Pt recvd Engerix-B 29JUL91 & on that same day, exp induration; pain & itching for 2 wks; tx DPH;
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pain
Clinical narrative: Pt recvd 1st Engerix-B vax on 15JUL91 & later that day pt exp "arm hurt a lot & achy; treated w/APAP;
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Asthma, Hypersensitivity, Pruritus, Rash
Clinical narrative: Pt recvd 1st Engerix-B vax on 02AUg91 & on 05AUG91exp itchy sensation on arms then fine rash from hands into shoulder area & wheezing; treated w/meds; pt went to ER or had MD visit;
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Arthropathy, Asthenia, Hypokinesia, Myalgia, Pain
Clinical narrative: Pt recvd 1st Engerix-B 31JUL & on 03AUG91 exp weakness in knees, aching, wouldn't hold pt up; tx ASA; f/u 12AUG91 MD feels it could be the vax as has seen it w/Recombivax;
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Tendon disorder
Clinical narrative: Pt recvd 1st Engerix-B 31JUL & on 03AUG91 exp weakness in knees, aching, wouldn't hold pt up; tx ASA; f/u 12AUG91 MD feels it could be the vax as has seen it w/Recombivax;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Convulsion, Coordination abnormal, Electrocardiogram abnormal, Headache
Clinical narrative: Recd vax 8AUG91 & exp h/a; 12AUG91 had one sz in AM & passed out; Had 2nd sz in PM & went to ER; EKG showed nonspecific T-wave abnormality; anemia was rx'd w/Fe PO; p/ d/c pos Lyme titer of 1.3 & c/o severe lethergy & instability see WORM..
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hypochromic anaemia, Syncope, Thinking abnormal
Clinical narrative: Recd vax 8AUG91 & exp h/a; 12AUG91 had one sz in AM & passed out; Had 2nd sz in PM & went to ER; EKG showed nonspecific T-wave abnormality; anemia was rx'd w/Fe PO; p/ d/c pos Lyme titer of 1.3 & c/o severe lethergy & instability see WORM..
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Hep B vax 10MAR87; 9APR87, 10SEP87; titer was checked APR88 & it was determined that anti-Hep B surface was reactive; then titer was checked JUN90 & it was determined that anti Hep B was non reactive;
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B vax on 10NOV89, 10DEC89, & 10JUN90 & reporter indicated that pt exp a lack of therapeutic effect;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 10NOV89, 10DEC89, & 10JUN90 & reporter indicated that pt exp a lack of therapeutic effect;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 10NOV89, 10DEC89, & 10JUN90 & reporter indicated that pt exp a lack of therapeutic effect;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 7SEP90, 7OCT90, & 7MAR91 & it was determined that pt was a non responder;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 25SEP90, 25OCT90 & APR91 & it was determined that pt was a non responder;
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Pain
Clinical narrative: Pt recvd 1st dose of Engerix-B vax on 02AUG90 & 2nd dose on 18SEP90 & exp sore arm & lightheadedness for a few minutes; sx disappeared; w/in 2 min of 2nd dose, pt exp chest tightness & lightheadedness for several hrs;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd series of 3 Recombivax vax in 1984; In 1989 had "accident" titer checked & was "below minimum level" (non-response); Recvd 1 Recombivax booster in 1989; In 1991 had "accident" titer checked & was below minimum level;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Cushing's syndrome, Hyperglycaemia, Rash, Skin disorder, Skin nodule
Clinical narrative: Pt recvd Engerix-B vax 17-20 days later exp cutaneous eruption; MD indicated eruption was difficult to classify; it may reflect sweets synd; eruption was not uticarial, not erythema nodosum; was not a morbilliform; Rash was not serum sick
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Pt recvd dose of Engerix-B on 27JUN91 @ 12 noon booster dose; 2 hrs later 2PM exp tingling @ inject site & down lt arm from deltoid; sx disappeared next morning 28JUN91;
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt exp non-response p/a series of 3 doses of Engerix-B given 27AUG90, 26SEP90 & 05APR91; 2 additional doses will be given;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt exp non-response p/a series of 3 doses of Engerix-B given 16APR90, 14MAY90, & 9NOV90; 2 additional doses of vax given on 26FEB91 & 1APR91 & pt seroconverted;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax SEP90; OCT90 & APR91; the 3rd dose was w/Engerix-B; Report indicated that pts "began their series on Recombivax-most had 2 Recombivax & poss 1 Engerix-B;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax NOV89; DEC89, & JUN90; First 2 doses w/Recombivax; Reporter indicated that pt "began their series on Recombivax-most had 2 of Recombivax & possibly 1 Engerix-B;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax NOV89, DEC89, & JUN90; First 2 doses were w/Recombivax; 3rd dose was poss Engerix-B; Pharmacy did not have good records as to when Recombivax ran out & Engerix-B started;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B SEP90, OCT90, & APR91; 3rd dose was w/Engerix-B; Reported indicated that pt "began their series on Recombivax-most had 2 doses Recombivax & poss 1 dose Engerix-B;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd a series of 3 Engerix-B vax in MAR, APR, OCT90 respectively for prevention of Hep B infect; titers drawn in AUG91 are negative; Booster doses will be given;
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Diarrhoea, Gastroenteritis, Hepatic function abnormal
Clinical narrative: Evening of vax did not feel well, diarrhea; 10AUG91 exp diarrhea, sick cramps, joint cramps, low grade temp & coffee ground stools; 17AUG & 18AUG91 diarrhea, weakness; 20AUG91 admitted to hosp, dx: acute gastroenteritis & anemia; see WORM..
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Hypochromic anaemia, Infection, Leukopenia
Clinical narrative: Evening of vax did not feel well, diarrhea; 10AUG91 exp diarrhea, sick cramps, joint cramps, low grade temp & coffee ground stools; 17AUG & 18AUG91 diarrhea, weakness; 20AUG91 admitted to hosp, dx: acute gastroenteritis & anemia; see WORM..
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Pharyngitis
Clinical narrative: Pt recvd a series of 3 Engerix-B vax; 1st & 2nd doses were in JUN91, JUL91, & uneventful; Recvd 3rd dose in AUG91 & exp tightness in throat, upper chest on 2AUG91; treated in ER w/EPi, DPH; events resolved p/3 hrs;
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Anaemia, Conjunctivitis, Face oedema, Hypersensitivity, Oedema peripheral
Clinical narrative: 25JUL91 pt recvd 1 dose Engerix B; 8AUG91 pt reports "allergic reaction" described as tingling in tongue, urticarial rash across buttocks, rash on arms & sides & generalized edema; 9AUG91 pt seen by MD; rt arm hurt unable to lift objects;
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: 25JUL91 pt recvd 1 dose Engerix B; 8AUG91 pt reports "allergic reaction" described as tingling in tongue, urticarial rash across buttocks, rash on arms & sides & generalized edema; 9AUG91 pt seen by MD; rt arm hurt unable to lift objects;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B series (3 doses deltoid region) for prevention of Hep B infect; Pt reported as being a "nonresponder"; plan to administer additional doses;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Anorexia, Drug ineffective, Hepatitis, Infection
Clinical narrative: Pt recvd 1 dose of Engerix-B on 12JUN91 & 12JUL91 for vax against Hep B; 2 wks p/2nd dose pt exp anorexia, dark urine, epigastric pain & jaundice; Pt referred to MD & is under a MD care;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Jaundice, Urine analysis abnormal
Clinical narrative: Pt recvd 1 dose of Engerix-B on 12JUN91 & 12JUL91 for vax against Hep B; 2 wks p/2nd dose pt exp anorexia, dark urine, epigastric pain & jaundice; Pt referred to MD & is under a MD care;
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd Engerix-B inject & 48 to 72 hrs p/dose, pt exp a rash on both arms, chest, back & abdo; rash described as red & raised;
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic function abnormal, Hypertension, Tachycardia
Clinical narrative: Pt recvd Engerix-B on 17MAY90 & 3AUG90; Both times were uneventful; 19NOV90 pt recvd Engerix-B & exp elevated liver-enzymes, BP & pulse;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache, Myalgia
Clinical narrative: Pt recvd 1st dose of Engerix-B vax on 1JUL91 & 2nd dose 8AUG91 for Hep B prevention; 2 hrs p/2nd dose, pt exp h/a, then aching & fatigue; no fever; given APAP;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injections of Recombivax 12DEC90 & 14JAN91; 10JUN91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 12DEC90 & 14JAN91; 13JUN91 recvd Engerix-B; pt "did not develop immunity";
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 5DEC90 & 17JAN91; 6JUN91 recvd Engerix-B; pt did not develop immunity;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injections of Recombivax 1DEC90 & 1JAN91; 13JUN91 recvd Engerix-B; pt "did not develp immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 21NOV90 & 1JAN91; 23MAY91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 3DEC90 & 17JAN91; 3JUN91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 29NOV90 & 29DEC90; 31MAY91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 28NOV90 & 1JAN91; 29MAY91 recvd Engerix-B; pt "did not develop immunity";
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Hypertension, Hypertonia, Hypoaesthesia, Hypokinesia
Clinical narrative: Conjunctivitis, eye twitching, muscle twitching face arms legs entire body, neck pain; numb feeling from head down, occipital pain, pain down legs, problems sleeping, severe back pain, shoulder pain, stomach pain, tingling legs & arms;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Muscle twitching, Neck pain, Red blood cell sedimentation rate increased
Clinical narrative: Conjunctivitis, eye twitching, muscle twitching face arms legs entire body, neck pain; numb feeling from head down, occipital pain, pain down legs, problems sleeping, severe back pain, shoulder pain, stomach pain, tingling legs & arms;
Sex: F
Vaccine: HEP
Symptoms: Glossitis, Pharyngitis, Rash, Weight decreased
Clinical narrative: A MD reported that a pt received the 1st dose of Hep B (Recombinant); exp a rash, sore throat, weight loss & a "raw area" on the back of tongue; pt recvd 2nd dose of Hep B (Recomb) & the sx recurred;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 28NOV90 & 29DEC90; 30MAY91 recvd Engerix-B pt "did not develop immunity";
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 1DEC90 & 1JAN91; 4JUN91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 29NOV90 & 29DEC90; 29MAY91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 5DEC90 & 7JAN91; 6JUN91 recvd Engerix-B; pt "did not develop immunity";
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 29NOV90 & 1JAN91; 29MAY91 recvd Engerix-B; pt "did not develop immunity";
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injects of Recombivax 3DEC90 & 2JAN91; 6JUN91 recvd Engerix-B; pt "did not develop immunity";
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2-1cc injections of Recombivax 12DEC90 & 14JAN91; 13JUN91 recvd Engerix-B; Pt "did not develop immunity";
Sex: U
Vaccine: HEP
Symptoms: Dermatitis exfoliative, Hypersensitivity, Injection site reaction, Pharyngitis, Pyrexia
Clinical narrative: Pt recvd 2 doses of Engerix-B & exp "strep throat" p/2nd dose of Engerix-B; pt also exp localized skin peeling of the arm; dx as being "allergic to preservatives" in the vax; seen in emergency care; t104 given ATB;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter states that approx 1/3 of the employees treated to date w/Engerix-B failed to respond or had borderline titer levels produced (over the past 15 months) p/3rd dose; sixty to seventy employees have been treated to date;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax 1NOV90, 17JAN91, 23MAY91 & 1st dose was w/Recombivax, 2nd & 3rd w/Engerix-B; Reporter indicated that pt was a non-responder;
Sex: F
Vaccine: HEP
Symptoms: Oedema, Pruritus, Rash
Clinical narrative: Pt exp "swelling & a reddish rash" believes to be on the arm where pt recvd Engerix-B; Reporter stated pt also recvd a TB test "around the same time as the vax;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pyrexia
Clinical narrative: 17JUL91 pt recvd Engerix-B; 3rd day p/vax pt exp h/a & fever; tx Advil; events abated approx 4 days p/inject;