chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: 5JUN92 pt recvd Engerix-B & 10 days later devel severe flu-like sx which lasted 4 days;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Chills
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp chills which do not require treatment;
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: 4 pts recvd 2 doses of Engerix-B & when donating blood they were informed they were Hep C Surface Antibody Pos;
Sex: F
Vaccine: HEP
Symptoms: Chills, Lymphadenopathy, Malaise, Neck pain, Pyrexia
Clinical narrative: Pt recvd Engerix-B & the noc of inject devel neck pain; the next morning felt off-not up to par; that afternoon exp chills, swollen lymph nodes under the arm of inject & a low grade temp;
Sex: F
Vaccine: HEP
Symptoms: Headache, Neck pain, Pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2nd dose given 7JUL92; 14JUL92 devel severe h/a & pains in the neck, arm & shoulder; describes the pain in neck & shoulder as feeling like a hot knife;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Pt recvd Engerix-B & 30JUN92 exp rash on arms/thighs/knees & generalized urticaria; hospitalized 6JUL92;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B;  titers drawn & neg for HBSAG antibodies; determined to be a nonresponder or that titers dec rapidly;
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: Pt recvd 1 dose of Engerix-B & on 12JUL92 devel a herpetic rash from the waist down & on both legs;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Ecchymosis, Myalgia, Oedema peripheral, Pruritus, Rash maculo-papular
Clinical narrative: Pt recvd Engerix-B 2JUL92 & 10JUL92 lt arm appeared swollen, hard & ached w/multiple raised rash areas; rash was hot, itchy, hard, the size of a fifty cent piece & appeared bruised @ inject site; tx Depomedrol & DPH;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Skin nodule, Vasodilatation
Clinical narrative: Pt recvd Engerix-B 2JUL92 & 10JUL92 lt arm appeared swollen, hard & ached w/multiple raised rash areas; rash was hot, itchy, hard, the size of a fifty cent piece & appeared bruised @ inject site; tx Depomedrol & DPH;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dizziness, Influenza, Pharyngitis
Clinical narrative: Pt recvd 1 dose of ENgerix-B & devel dizziness, aching of joints & sore throat, flu like;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B 1 1/2 yrs ago; just had titers drawn; did not sero-convert; 1APR92 recvd 4 dose (booster); pt now immune;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 6JUN91, 26JUL91 & 3JAN92 & on 26MAR92 pt titer was non-reactive; 4th dose Engerix-B has been given; pt currently takes Buspar for anxiety;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 26SEP91, 30OCT91, & 30MAR92 & 2MAY pt titer was non-reactive; 4th dose given 11MAY92;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B 23OCT90, 26NOV90, & 10JAN92 & on 12FEB92 pt's titer indicated that pt was not immune to Hep B; a 4th dose of vax was given & titer was non-reactive;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B 15OCT91, 20NOV92 & 29APR92 & on 17JUN92 pt's titer was non-reactive; a 4th dose of vax has been given;
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & was determined to be not immune to Hep B;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Dysgeusia, Encephalitis, Muscle spasms, Myasthenic syndrome
Clinical narrative: pt recvd vax & exp metallic taste, dizziness, tingling & numbness, weakness in arms, paresthesia, tonic-clonic spasms, burning & yawning, neurologic response, passed out, flushing, white ring around mouth, vaso/vagal response, felt washed
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Neuropathy, Paraesthesia, Syncope
Clinical narrative: pt recvd vax & exp metallic taste, dizziness, tingling & numbness, weakness in arms, paresthesia, tonic-clonic spasms, burning & yawning, neurologic response, passed out, flushing, white ring around mouth, vaso/vagal response, felt washed
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Bradycardia, Osteoarthritis, Vasodilatation
Clinical narrative: pt recvd 1 dose of Engerix B & devel swollen red knee joints approx 8 hrs later; no hx of prior injury;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Erythema nodosum
Clinical narrative: Pt recvd 2 doses of Engerix-B & approx 1 wk following exp redness @ site sx resolved; approx 6 wk following dose 2 exp erythema nodosum; seen by MD;
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Paraesthesia
Clinical narrative: pt recvd Engerix-B 15JUL92 & had swelling & tingling rt side of face; seen by MD; blood samples taken; sx resolved;
Sex: F
Vaccine: HEP
Symptoms: Dermatitis bullous, Injection site pain, Oedema peripheral
Clinical narrative: Pt recvd Engerix-B & 15JUL92 exp blisters rt side of face, both feet swollen & severe rt arm pain @ inject site; seen by MD;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic function abnormal
Clinical narrative: Pt recvd Engerix-B & exp elevated liver function tests;
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis bullous, Herpes zoster, Injection site hypersensitivity, Rash maculo-papular
Clinical narrative: Pt recvd 2 doses of Engerix-B & following both doses had a skin reaction; skin reaction dx as herpes zoster the day p/receiving 2nd dose; referred to dermatologist;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Laboratory test abnormal, Nausea, Neck pain, Vomiting
Clinical narrative: pt recvd 1 dose of Engerix-B & 16JUL92 had nausea, vomiting, h/a, burning from base of skull to spine & can't keep any food down; 18JUL92 seen by MD;
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: pt recvd 2 doses of Engerix-B & following 2nd dose had multiple follicular erythematous papula pustules of thigh & legs;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Hypertension, Pruritus, Rash
Clinical narrative: Pt recvd Engerix-B & w/in 3 days exp red rash & itching;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Hyperhidrosis, Pruritus, Thinking abnormal
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1-2 days following exp severe reaction, itching sensation @ inject site, joint pain, extreme fatigue, hot flushes, sweating & mental attitude alteration;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1-2 days following exp severe reaction, itching sensation @ inject site, joint pain, extreme fatigue, hot flushes, sweating & mental attitude alteration;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Cholecystitis, Gastrointestinal disorder, Influenza
Clinical narrative: Pt recvd Engerix-B & 2 days following vax exp gassy, hyperperistalsis & gallbladder sx (difficulty eating fried foods); 17JUL92 also exp flu-like sx, chills, fever 102, arthralgia;
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Pt recvd Engerix-B & 2 days following vax exp gassy, hyperperistalsis & gallbladder sx (difficulty eating fried foods); 17JUL92 also exp flu-like sx, chills, fever 102, arthralgia;
Sex: M
Vaccine: HEP
Symptoms: Antinuclear antibody, Aspartate aminotransferase increased, Hepatic function abnormal, Laboratory test abnormal
Clinical narrative: Pt recvd Engerix-B & 2 wks ago had elevated SGOT, pos ANA, abn liver function tests & alkaline phosphatase dec;
Sex: F
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: Pt recvd Engerix-B & 8JUL92 exp flu-like sx; pt is self-medicating w/an Ampicillin prescription;
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Oedema peripheral
Clinical narrative: Pt recvd 2 doses of Engerix-B & the next day following dose 1 pt had full body swelling; following dose 2 had less swelling (legs, some facial); given DPH;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Paraesthesia
Clinical narrative: Pt recvd 2 doses of Engerix-B 8JUL92 following dose 2 had numbness, h/a & tingling in arms & lower extremities;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia, Rash, Urticaria
Clinical narrative: Pt recvd 2 doses of Engerix-B & about 1 wk following dose 2 JUN92 exp rash, fever & malaise;
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Tongue oedema
Clinical narrative: Pt recvd Engerix-B & the next morning following vax pts tongue became swollen; seen by MD; tx antihistimine;
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Dyspnoea, Tachycardia
Clinical narrative: several pts recvd Engerix-B & had flu-like sx following dose; 3-4 days p/dose had dizziness, weakness, SOB, tachycardia; seen by MD;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & was a nonresponder;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Dizziness, Infection, Pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1 wk p/vax pt devel delayed upper resp viral illness described as mono-like; tx bedrest;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngitis
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1 wk p/vax pt devel delayed upper resp viral illness described as mono-like; tx bedrest;
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Chills, Diarrhoea, Pyrexia
Clinical narrative: Pt recvd Engerix-B & devel chills, t102, diarrhea & abdo noc cramps; tx water & APAP;
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Oedema peripheral, Pyrexia
Clinical narrative: 10JUL92 pt recvd vax & 2 hrs post inject devel a fever of about 102, swelling around the mouth & feet; no tx was given; sx resolved w/in 12 hrs;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dyspepsia, Face oedema, Injection site pain, Palpitations, Pruritus
Clinical narrative: 7AUG92 pt recvd Engerix-B & 8AUG92 devel generalized itching, swollen upper lip, feeling of palpitations, heartburn & pain @ site; 10AUG92 seen by MD; prescribed Hydroxyzine;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Oedema peripheral
Clinical narrative: 12FEB92 pt recvd 1st dose of Engerix-B & the next day devel several abdo pain & cramps; 12MAR92 recvd 2nd dose of vax the next day arm swelled up (huge) all the way to elbow;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Pt recvd 2 doses of Engerix-B & 11AUG92 devel lymphadenopathy on rt side & a fever; took a day off from work;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus, Rash, Rash pustular
Clinical narrative: 12JUN92 pt recvd 1st dose of Engerix-B & 29JUN92 devel pruritic rash on back of legs, lower calf to thigh w/small pustules noted, allergic type response; 29JUN92 tx w/Medrol & erythematous lesions, blanches; devel rash;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Pt recvd 2 doses of Engerix-B & 29JUL92 devel itching on top of head, tops of feet, & arms; no visible lesions;
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactoid reaction, Asthma, Nausea, Tremor
Clinical narrative: 15JUL92 pt recvd 1st dose of Engerix-B & that same day devel wheezing, tremors, nausea, mild anaphylactoid reaction; no tx given;
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: 3 staff member recvd Engerix-B & exp ill effects;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Hep B vax & had neg Hep B core Antibody 6 wks following completion of series; 24JUN92 recvd booster dose of Engerix-B;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 6 wks following the inject had no HBSAB when titer was checked;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 6 wks following completion of the series titer test results indicated neg Hep B Core Antibody;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 6 wk following the 3rd dose the titer test results indicated no Hep B Core Antibodies;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Face oedema, Oedema peripheral, Rash, Urticaria
Clinical narrative: Pt recvd 2nd dose of Hep B vax 7AUg92 & 8 hrs later devel rash, joint pain, throbbing welts, & swelling in hands, feet & face; ER or MD visit was required for tx;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Pruritus, Rash, Vasodilatation
Clinical narrative: Pt recvd 2 doses of Engerix-B & on 1JUL92 a rash appeared; had sl wheezing p/ a hot flash; 20JUL92 seen by dermatologist; itching was eased w/Medrol but came back on taper down of regimen;
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema
Clinical narrative: 10AUG92 in the PM recvd 1st dose of Engerix-B that same day (?) devel inject site swelling; treated w/warm compresses & APAP as of 12AUG92 swelling persists;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Eye disorder, Eye pain, Headache, Insomnia, Multiple sclerosis
Clinical narrative: 10FEB92 recvd 2nd dose of Engerix-B & devel tingling & numbness in arm; pt was concerned that vax caused aggravation of multiple sclerosis; p/discussing this w/MD pt was advised not to receive 3rd dose;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Pupillary disorder, Tremor
Clinical narrative: 10FEB92 recvd 2nd dose of Engerix-B & devel tingling & numbness in arm; pt was concerned that vax caused aggravation of multiple sclerosis; p/discussing this w/MD pt was advised not to receive 3rd dose;
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: pt devel antigen & reporter did not know how many doses of vax pt had recvd; mom's hx is sketchy & incomplete;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Hyperbilirubinaemia
Clinical narrative: Pt recvd vax & devel severe abdo pain; liver function tests were performed & all were nl x/Bilirubin which was 2 times nl values;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 6 months p/3rd dose titer test result was neg, had not responded; will be given booster;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Injection site pain, Myasthenic syndrome, Pain
Clinical narrative: 7AUg92 pt recvd Engerix-B & 13AUG92 reported that immed felt pain from site of inject to wrist, pain in armpit & upper back, arms feels heavy;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Hyperhidrosis, Malaise, Nausea, Tachycardia
Clinical narrative: 7AUG92 recvd Engerix-B & 8-9AUG92 exp nausea, feeling bad; 10AUG92 was SOB, sweating & had tachycardia; 13AUG92 was feeling better;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Malaise, Pain
Clinical narrative: Pt recvd 1 dose of Engerix & felt bad & arm hurt the day of inject; joint pain;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypertension, Influenza, Lymphadenopathy, Malaise
Clinical narrative: 24JUL92 pt recvd Engerix-B vax & 25JUL92 devel h/a, feeling bad, & flu-like sx; 9AUG92 devel red knots on legs & swelling lymph nodes; 10AUG92 went to ER inc BP, inc temp, red knots on legs & thigh & sweling lymph nodes;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Skin nodule
Clinical narrative: 24JUL92 pt recvd Engerix-B vax & 25JUL92 devel h/a, feeling bad, & flu-like sx; 9AUG92 devel red knots on legs & swelling lymph nodes; 10AUG92 went to ER inc BP, inc temp, red knots on legs & thigh & sweling lymph nodes;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Ear pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & 30 mins p/2nd inject devel twinges of sharp pressure to lt ear & intermittent tightness of lt chest;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Hyperhidrosis, Nausea, Somnolence
Clinical narrative: Pt recvd 2 doses of Engerix-B & w/in 30 minutes of 2nd inject devel flushing, tired, nausea, vomiting, & diffuse abdo pain;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation, Vomiting
Clinical narrative: Pt recvd 2 doses of Engerix-B & w/in 30 minutes of 2nd inject devel flushing, tired, nausea, vomiting, & diffuse abdo pain;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Oedema, Pruritus, Urticaria
Clinical narrative: Pt recvd 2 doses of Engerix-B & 4 days p/2nd vax devel itching @ site, swelling & hives on upper arm, neck & chest; no tx was given & sx resolved;
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Headache, Pain
Clinical narrative: 4MAY92 recvd 1st dose of Engerix-B in the PM exp feeling as though could not breathe; pt recovered w/o tx; following 2nd dose of vax pt was grasping for breath, had cramps, 4JUN92 h/a, exhausted;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Headache, Hypertonia, Insomnia, Myalgia
Clinical narrative: 13AUG92 devel arm stiffness, itching @ inject site, sleepy, irritability, mild h/a, sore arm & sleeping difficulty;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Somnolence
Clinical narrative: 13AUG92 devel arm stiffness, itching @ inject site, sleepy, irritability, mild h/a, sore arm & sleeping difficulty;
Sex: F
Vaccine: HEP
Symptoms: Affect lability, Agitation, Nervousness, Pruritus
Clinical narrative: 13AUG92 pt recvd 1st dose of vax & devel itching; 14AUG92 devel agitation, mood change, nervousness, could not work & irritability;
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Cerebral ischaemia, Myasthenic syndrome, Stupor, Syncope
Clinical narrative: Pt recvd 2 doses of Engerix-B & 12AUG92 devel syncope, weakness on lt side from head to foot; pt was not sure where was @ times; stupor; pt seen in ER; MD indicated pt had stroke-like sx;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dyspnoea, Hepatic function abnormal, Jaundice, Nausea
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1AUG92 devel nausea, abdo pain, epigastirc pain, fatigue, felt very tired (mono-like), looked a little jaundice, seen by MD treated w/Floxin for URI; liver function tests were run & enzymes were sl elevated;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Red blood cell sedimentation rate increased, Urinary tract infection, Visual disturbance
Clinical narrative: Pt recvd 2 doses of Engerix-B & 1AUG92 devel nausea, abdo pain, epigastirc pain, fatigue, felt very tired (mono-like), looked a little jaundice, seen by MD treated w/Floxin for URI; liver function tests were run & enzymes were sl elevated;
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Dermatitis bullous, Pruritus, Rash, Rash maculo-papular
Clinical narrative: Pt recvd 2 doses of Engerix-B & exp no reaction following 1st inject but 6 hrs p/2nd dose pt devel itchy rash; seen by MD for tx;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: 1 pt c/o very sore arm following 1st dose of Engrix-B & many c/o about inject site soreness p/2nd dose of Engerix-B;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: several individuals failed to produce pos titers following vax w/3 doses of Engerix-B;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: 7JUL92 pt recvd a booster dose of Engerix-B; the day of the vax got sick, nauseated, achy all over, sore arm; went home p/receiving inject & went to bed; spent the next day in bed too; felt like was run over by a mack truck;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & 13AUG92 titer test result indicated nonresponse;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain
Clinical narrative: p/receiving 2nd Engerix-B pt devel chest tightness which abated p/2 days; Reporter would not provide any addtl info;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: 20JUL92 pt recvd vax & 2AUG92 devel herpes zoster, was seen by MD & treated w/Zovirax; Herpes Zoster resolved;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Gait disturbance, Influenza, Pyrexia
Clinical narrative: 31JUL92 pt recvd 1st dose of Engerix-B & that noc devel flu-like sx, high fever, dizzy & stumbling; took APAP & had recovered by the evening of 1AUG92;
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Dizziness, Hyperhidrosis, Migraine
Clinical narrative: cool skin yet sweating, dizzy, general weakness, loose stools, migraine h/a, pale skin, severe nausea, skin hurt;
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain, Pallor
Clinical narrative: cool skin yet sweating, dizzy, general weakness, loose stools, migraine h/a, pale skin, severe nausea, skin hurt;
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus, Rash
Clinical narrative: 29JUL92 recvd vax & 24 hr later noted to have redness & induration of inject site w/local irritation; next morning awoke to a generalized rash on upper/lower extremities w/itching;
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert;
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & did not convert;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert;
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert;
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Headache, Myasthenic syndrome
Clinical narrative: 16JUL92 pt recvd 1st dose of Engerix-B & devel h/a for 1 1/2 - 2 days which was unrelieved by APAP; devel muscle weakness 1 1/2 wks p/inject; 1-2 wks later had trouble w/rt leg/hip; 4 days prior devel arthritis in lt wrist;
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Erythema nodosum, Oedema peripheral, Osteoarthritis
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2 wks later devel erythema nodosum, swelling of lower legs & ankles;
Sex: M
Vaccine: HEP
Symptoms: Pain, Rash maculo-papular, Vasculitis
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2 wks later devel erythema nodosum, swelling of lower legs & ankles;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Eye disorder, Eye pain, Hypotonia, Lacrimal disorder
Clinical narrative: Pt recvd 1 dose of Engerix-B & 10AUG92 lt eye not blinking & lower corner of mouth drooping;
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd 2 doses of Engerix-B & 14AUG92 the day p/recvd 2nd dose of vax pt devel rash;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Condition aggravated, Injection site hypersensitivity
Clinical narrative: Pt recvd 2 doses of Engerix-B & 13AUG92 devel severe erythema @ inject site & inflammation of knees;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Headache, Malaise, Paraesthesia, Paraesthesia oral
Clinical narrative: 30MAR92 pt recvd 1st dose of Engerix-B & had immed tightness in chest, tingling in mouth & gums, numbness in face & a severe h/a;
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Gastrointestinal haemorrhage, Injection site inflammation, Injection site pain
Clinical narrative: 13JUL92 pt recvd Engerix-B & w/in an hr devel inflammation & tenderness @ site of inject; that evening began a fever; 14JUL92 devel nausea & lightheadedness; later in the day diarrhea & bloody stool; 15JUL92 devel tingling & tenderness;
Sex: F
Vaccine: HEP
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: 13JUL92 pt recvd Engerix-B & w/in an hr devel inflammation & tenderness @ site of inject; that evening began a fever; 14JUL92 devel nausea & lightheadedness; later in the day diarrhea & bloody stool; 15JUL92 devel tingling & tenderness;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Myasthenic syndrome
Clinical narrative: 15JUL92 pt recvd vax & 2 wks later became SOB & devel general weakness of arms & legs; lasted for 3 wks; 14AUG92 seen by MD;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Facial palsy, Hypokinesia, Myasthenic syndrome, Paraesthesia
Clinical narrative: 26JUN92 pt recvd 1st dose of Engerix-B & 13JUL92 devel bell's palsy; inability to shut eye, rt sided weakness & numbness of tongue; sx started to subside by 26JUL & were better by 2AUG92;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Myasthenic syndrome, Neck pain, Pain
Clinical narrative: 16JUL92 pt recvd 1st dose of Engerix-B & immed devel weakness of the lt arm & aching; the next day devel shoulder & neck pain, improved 4 days later;
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: 15JUL92 recvd 1st dose of Engerix-B & 2 days later devel lightheadedness;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Visual field defect
Clinical narrative: 14AUG92 pt recvd 1st dose of Engerix-B & 3 mins p/inject devel tunnel vision & felt like was going to faint; pt sat down & put head between legs; pt better the same day;
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Tremor
Clinical narrative: 13JUL92 pt recvd 1st dose of Engerix-B & devel severe joint aching which resolved by itself w/no tx; 13AUG92 recvd 2nd dose of Engerix-B & became faint, shakey & had sweaty palms;
Sex: U
Vaccine: HEP
Symptoms: Headache
Clinical narrative: 13JUL92 pt recvd 1st dose of Engerix-B & 13AUG92 pt recvd 2nd dose of vax & devel severe unresponsive h/a for 4 days; pt recvd APAP & Kronofold A;
Sex: U
Vaccine: HEP
Symptoms: Headache
Clinical narrative: 13JUL92 pt recvd 1st dose of Engerix-B w/no problems; 13AUG92 recvd 2nd dose of Engerix-B & devel severe h/a for 4 hrs which was unresponsive to APAP;
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Nausea
Clinical narrative: 13AUG92 pt recvd 1st dose of Engerix-B & devel severe fatigue & nausea; sx lasted about 6 hrs & resolved w/o tx;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B & pt is pregnant; estimated due date 6AUG92;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: 29JUN92 pt recvd 1st dose of Engerix-B & approx 2 wks later had swollen nodes in neck; 18AUG92 still had sx; multiple swollen glands on rt side of neck; pain in rt shoulder, numbness & pain in rt buttocks extending down to rt leg;
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: 17AUG92 pt recvd 1st dose of ENgerix-B & w/in 24 hrs devel inject site redness, swelling & a local pruritic reaction;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Amblyopia, Arthralgia, Blood urea increased, Face oedema, Headache
Clinical narrative: Pt recvd 1st dose of Engerix-B & devel hives, facial swelling & lip & tongue swelling; reaction required ER visit;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Hypertension, Tongue oedema, Urticaria
Clinical narrative: Pt recvd 1st dose of Engerix-B & devel hives, facial swelling & lip & tongue swelling; reaction required ER visit;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Injection site pain, Myalgia, Paraesthesia, Vocal cord paralysis
Clinical narrative: 7JUL92 pt recvd 2nd dose of Engerix-B & exp inject discomfort & hand tingling; 9JUL92 devel exhaustion & achiness all over; 12JUN92 devel myalgia, vocal cord paralysis & aperature of airway dec 50%; 14JUL92 clinic visit for voice problems;
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Chills, Pyrexia
Clinical narrative: 18AUG92 pt recvd 1st dose of vax & w/in 24 hrs devel fever, chills & abdo cramping;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Bone pain, Pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & exp no rxn p/1st dose & w/in 8 hrs of 2nd inject devel arthralgia (arm became tender in the bone) & arthritic pain in the arm; MD visit was required to treat events; pt still c/o pain & arthralgia;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: 28 or 29JUL92 pt recvd Engerix-B & 12AUG92 devel a rash on abdo & back; itching down arms & prickly feeling as opposed to itchy; MD visit was required to treat the events; blood was drawn to see if reaction was viral in nature;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not convert; pt recvd 4th dose of booster & still had a neg titer;
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Myalgia
Clinical narrative: 3 pts exp a throbbing pain upon injection of Engerix-B; all pts recvd the inject from the same lot#;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Nausea, Pyrexia
Clinical narrative: 18AUG92 330PM pt recvd 1st inject of Engerix-B & 6-7 hrs later in the AM 19AUg92 devel nausea, t101 & swelling @ inject site;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd vax 19MAY90, 5JUL90 & 5DEC90 & it was determined that pt did not respond; 2 addtl boosters were administered 13DEC91 & 21FEB92; pt now has a post titer response;
Age: 80.0
Sex: M
Vaccine: HEP
Symptoms: Petechiae
Clinical narrative: 14AUG92 pt recvd vax & w/in an hr devel several petechiae w/no other sx;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise
Clinical narrative: 13JUL92 pt recvd 1st dose of vax & immed devel intermittent h/a & was not feeling well; took APAP but  sx persists;
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise
Clinical narrative: 13JUL92 pt recvd 1st dose of Engerix-B & 1 wk later devel h/a & was not feeling well; ER visit was required;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pyrexia
Clinical narrative: 22JUL92 pt recvd 1st dose of Engerix-B & immed to 2 hrs later devel h/a & fever of 101; ER visit was required;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema, Pain, Pharyngitis
Clinical narrative: 3JUL92 pt recvd 1st dose of Engerix-B & 4JUL92 devel lump, redness & swelling @ inject site; 10AGU92 recvd 2nd dose of vax & 13AUG92 devel arm burning, itching, redness & swelling @ inject site; lump @ inject site; 14AUG92 devel URI; rash;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: 3JUL92 pt recvd 1st dose of Engerix-B & 4JUL92 devel lump, redness & swelling @ inject site; 10AGU92 recvd 2nd dose of vax & 13AUG92 devel arm burning, itching, redness & swelling @ inject site; lump @ inject site; 14AUG92 devel URI; rash;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Amnesia, Condition aggravated, Dizziness, Headache, Paraesthesia
Clinical narrative: 18AUG92 pt recvd 1st dose of vax & 20AUG92 devel numbness on the rt side of face spreadin to arm & leg, h/a & difficulty w/thought & speech processes; no tx was given;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Speech disorder, Thinking abnormal
Clinical narrative: 18AUG92 pt recvd 1st dose of vax & 20AUG92 devel numbness on the rt side of face spreadin to arm & leg, h/a & difficulty w/thought & speech processes; no tx was given;
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 3 doses of Engerix-B & did not respond; 2 of these pts recvd 4th dose of booster & seroconverted;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: 31JUL92 pt recvd 2nd dose of vax & 2 wks later came down w/the flu;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood amylase increased, Blood lactate dehydrogenase increased
Clinical narrative: pt recvd 1st dose of Engerix-B on 19AUG92 & on 23AUG92 exp inc liver function tests & severe rt upper quad pain which conts; no nausea or vomiting; has seen MD;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Gamma-glutamyltransferase increased, Hepatic function abnormal, Hyperbilirubinaemia
Clinical narrative: pt recvd 1st dose of Engerix-B on 19AUG92 & on 23AUG92 exp inc liver function tests & severe rt upper quad pain which conts; no nausea or vomiting; has seen MD;
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Neuritis, Paraesthesia
Clinical narrative: pt recvd 2nd dose of Engerix-B on 20AUG92 & 1 day later returned to MD w/tingling in ulnar distribution of ipsilateral arm; no weakness or objective neurological findings;
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: pt recvd 1 dose of Engerix-B 18AUG92 & had fever, chills, dizziness seen by MD who though sx were probably a rxn to Hep B vax; prescribed Ceclor; cleared to return to work;
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Insomnia
Clinical narrative: Pt recvd a booster dose of Engerix-B 19AUG92 & 19AUG92 pt exp peristent insomnia w/multiple nightly awakenings; pt indicated was exhausted from lack of sleep; Restoril & valium are of no help;
Age: 40.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 34.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 42.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 56.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 38.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 25.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 52.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 37.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & failed to seroconvert;
Age: 35.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & failed to seroconvert;
Sex: U
Vaccine: HEP
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: 3 employees recvd 1 dose of Engerix-B; all exp fever, h/a, & myalgias;
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: approx 1AUG92 pt recvd 1 dose of Engerix-B & the day p/dose had generalized redness on the arms, chest, abdo;  there was no itching or hives present, pt did not exp any resp problems;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: multiple pts recvd 2 or 3 doses of Engerix-B & p/inject had pain in the arm; resolved in 1 wk;
Sex: U
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: pt recvd Engerix-B & 6AUG92 pts arm got red p/inject; resolved;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: several pts recvd 2 doses Engerix-B; 6AGU92 @ time of inject recvd pain on inject; resolved;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: several pts recvd 1 dose of Engerix-B & 6AUG92 had pain on injection; resolved;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased
Clinical narrative: pt recvd 2nd dose of vax on 4AUG92 & exp gen malaise, low grade fever, weakness, nausea, loss of appetite & elevated liver enzymes;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Gamma-glutamyltransferase increased, Hyperlipidaemia, Malaise
Clinical narrative: pt recvd 2nd dose of vax on 4AUG92 & exp gen malaise, low grade fever, weakness, nausea, loss of appetite & elevated liver enzymes;
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & did not seroconvert 8 wks p/last dose;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & did not seroconvert 8 wks p/last dose;
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & did not seroconvert 8 wks p/last dose;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & did not seroconvert 8 wks p/last dose;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: approx MAY92 recvd Engerix-B & approx 8 wks following dose pt started experiencing GBS & is still experiencing sx; seen by MD; hospitalized in ICU;
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Myasthenic syndrome, Paraesthesia
Clinical narrative: pt recvd Engerix-B in JUL & AUG92 & exp heaviness in arm, upper deltoid sore, numbness & tingling of extremities;
Sex: F
Vaccine: HEP
Symptoms: Malaise, Myalgia, Rash, Urticaria
Clinical narrative: pt was given Engerix-B in JUL & AUG92 & exp rash, hives, malaise & aches;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Diplopia, Dizziness, Nausea, Vomiting
Clinical narrative: pt recvd 1st dose of Engerix-B & several hrs later pt exp nausea, vomiting, diarrhea, dizziness, double vision & a 10 lb weight loss;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Weight decreased
Clinical narrative: pt recvd 1st dose of Engerix-B & several hrs later pt exp nausea, vomiting, diarrhea, dizziness, double vision & a 10 lb weight loss;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Insomnia, Orthostatic hypotension, Paraesthesia, Somnolence
Clinical narrative: pt recvd 1st dose of Engerix-B 21AUG92 & 24 hrs later pt exp tongue numbness, postural hypotension, insomnia & diarrhea; no tx was given; events resolved;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Tongue oedema
Clinical narrative: pt recvd 1st dose of Engerix-B 21AUG92 & 24 hrs later pt exp tongue numbness, postural hypotension, insomnia & diarrhea; no tx was given; events resolved;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter indicated that 10 pts did not respond p/receiving 3 doses of Engerix-B; titers were checked approx 1 to 1 1/2 months p/3rd inject;
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Neuropathy, Pain, Paraesthesia
Clinical narrative: pt recvd 1st dose of Engerix-B 23JUN92 & 5 days p/inject pt exp intense back pain w/no other stimulus, pain radiating down legs; major c/o pain & paresthesias; acute L4-5 radiculoneuropathy;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dyspepsia, Headache, Myalgia, Nausea
Clinical narrative: Pt recvd 2 doses of Engerix-B & on JUL92 & 21AUG92; 22AUG92 pt exp severe dyspepsia, weakness, h/a, nausea, vomiting, myalgia & somnolence;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Somnolence, Vomiting
Clinical narrative: Pt recvd 2 doses of Engerix-B & on JUL92 & 21AUG92; 22AUG92 pt exp severe dyspepsia, weakness, h/a, nausea, vomiting, myalgia & somnolence;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal faeces, Diarrhoea, Malaise, Myalgia, Nausea
Clinical narrative: Pt recvd 3 doses of Engerix-B 19FEB92 & 19MAR92 & 19AUG92 & p/1 & 2nd doses pt exp nausea, body aches, dark urine, light stools, diarrhea & malaise; 20AUG92 p/3rd dose pt exp nausea, body aches, dark urine, light stools, diarrhea & malaise;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Urine analysis abnormal
Clinical narrative: Pt recvd 3 doses of Engerix-B 19FEB92 & 19MAR92 & 19AUG92 & p/1 & 2nd doses pt exp nausea, body aches, dark urine, light stools, diarrhea & malaise; 20AUG92 p/3rd dose pt exp nausea, body aches, dark urine, light stools, diarrhea & malaise;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Face oedema, Nausea
Clinical narrative: Pt recvd 1st dose of Engerix-B 21AUG92 & 22AUG92 pt exp extreme nausea, rt upper quad pain, facial edema around eyes & abdo discomfort;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Myalgia
Clinical narrative: pt recvd 2 doses of vax 2nd dose was administered 10AUG92; 20AUG92 pt exp dizziness & muscle soreness in arm;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Myalgia
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2nd dose was administered 10AUG92; 21AUG92 pt exp dizziness & muscle soreness in arm;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Hypotonia, Injection site atrophy, Pruritus, Skin discolouration
Clinical narrative: pt recvd 2 doses of Engerix-B; 2nd dose given 2JUL92 & 20AUG92 pt exp hypomelanosis @ inject site;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Subcutaneous nodule
Clinical narrative: Pt recvd 2nd dose of vax 14AUG92 & w/in 20 minutes pt exp hives localized upper arm upper quad & hard raised nodules under skin or wrists @ pulse site;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: pt recvd 2 doses of vax 2nd dose on 24JUL92 & 25JUL92 p/Engerix-B exp a mild h/a; p/24 hrs h/a resolved;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd 1st dose of Engerix-B 11AUG92 & next day 12AUG92 pt exp a rash;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Migraine
Clinical narrative: pt recvd 1st dose of Engerix-B 21AUg92 & exp migraine h/a that lasted for 12 hrs; pt was prev hx of migraine h/a;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Oedema peripheral, Osteoarthritis, Paraesthesia
Clinical narrative: pt recvd 1st dose of Engerix-B & 21AUG92 pt exp swelling, numbness, tingling in both hands & both elbows; numbness & tingling prevents sleep; 24AUG92 swelling in fingertips;
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Face oedema, Hypersensitivity, Malaise, Oedema peripheral
Clinical narrative: 24AUG92 pt recvd 2 doses of Engerix-B  25JUN92 & 30JUL92 & p/2nd dose w/in 24 hrs pt mouth, face & hands blew up (became swollen); also exp a red, itching rash over entire body; also devel coughing & hives;
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 24AUG92 pt recvd 2 doses of Engerix-B  25JUN92 & 30JUL92 & p/2nd dose w/in 24 hrs pt mouth, face & hands blew up (became swollen); also exp a red, itching rash over entire body; also devel coughing & hives;
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Oedema, Rash
Clinical narrative: Pt recvd 2 doses of Engerix-B & following 3rd dose exp a rash all over & ?edeam;
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd vax in AUg & SEP 1989 & again in FEB90; had neg titer in DEC90; then recvd 3 doses of Engerix-B; titer showed immunity in DEC91 following last dose of Engerix-B in AUG91; titer in JAN92 was neg again;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2 doses of Recombivax followed by 4 doses of Engerix-B & all titer results through 17AUG92 were neg;
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Pruritus, Rash
Clinical narrative: pt devel diarrhea w/in 1 hr of inject; then in couple more hrs devel a whole body rash & itchiness;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 9 employees completed a series of vax w/Engerix-B; all 9 pts recvd same lot for each dose; serological testing showed that 4 employees did not reach seroprotection but had converted;
Sex: F
Vaccine: HEP
Symptoms: Hypertension, Injection site pain, Vasodilatation
Clinical narrative: pt recvd Engerix-B & the next day had pain & warmness @ inject site, & elevated BP 120/98; seen by MD; no meds prescribed;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & had local inject site pain on 2nd dose;
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: several pts recvd 3 doses of Engerix-B & had severe nausea, vomiting, vertigo (dizziness), extreme fatigue;
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vasodilatation, Vomiting
Clinical narrative: pt recvd 1 dose of Engerix-B & same day exp fever & vomiting which lasted until the next day 24JUL92; no tx was given;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Dyspepsia, Headache, Hyperhidrosis
Clinical narrative: pt recvd Engerix-B 19AUG92 & AUG92 reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; sx resolved w/in 6 hrs;
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia
Clinical narrative: pt recvd Engerix-B 19AUG92 & AUG92 reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; sx resolved w/in 6 hrs;
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Drug ineffective, Dyspepsia, Headache
Clinical narrative: Pt recvd 4 doses of Engerix-B 19AUG92; on the same day as 3rd dose was given 19JUL92 pt exp feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; all sx abated next day;
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Pt recvd 4 doses of Engerix-B 19AUG92; on the same day as 3rd dose was given 19JUL92 pt exp feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; all sx abated next day;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Dyspepsia, Headache, Hyperhidrosis
Clinical narrative: pt recvd 1 dose of vax AUG92 reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; sx resolved w/in 6 hrs;
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia
Clinical narrative: pt recvd 1 dose of vax AUG92 reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; sx resolved w/in 6 hrs;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Dyspepsia, Headache, Hyperhidrosis
Clinical narrative: pt recvd vax AUG92 & reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained;
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia
Clinical narrative: pt recvd vax AUG92 & reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: pt recvd 3 doses of Engerix-B & had a neg titer following the 3rd dose; pt then recvd 3 addtl doses & devel protective titers following the 6th vax;
Sex: U
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Vasodilatation
Clinical narrative: pt recvd 2 doses of Engerix-B & p/1st dose had tender arm, p/2nd dose @ inject site had 1 cm hot erythema, induration & tender spot;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Vomiting
Clinical narrative: pt recvd 2 doses of Engerix-B & 13AUg92 had h/a & vomiting; lasted aprpox 12 hrs;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Bronchitis, Chest pain, Cough
Clinical narrative: pt recvd Engerix-B & 5JUL92 had sudden chest discomfort, coughing, & abdo discomfort; lasted approx 2 wks; pt contacted by MD; dx w/bronchitis;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Lymphadenopathy
Clinical narrative: pt recvd 2 doses of Engerix-B & 17AUG92 had swelling of glands, chest & back pain; seen by MD; recvd ATB treatment;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & 14JUL92 (1 mo p/3rd dose) pt was tested for Hep B antibody & tested neg;
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: pt recvd 1st dose of Engerix-B & devel soreness @ inject site; p/2nd dose soreness cont progressing to rt arm; still has pain;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Confusional state, Dizziness, Headache, Myasthenic syndrome
Clinical narrative: pt recvd 2nd dose of vax & 15 mins later devel severe frontal h/a; confusion; lightheadedness; chest pressure; numbness, weakness of lt arm & leg; seen in ER;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: pt recvd 2nd dose of vax & 15 mins later devel severe frontal h/a; confusion; lightheadedness; chest pressure; numbness, weakness of lt arm & leg; seen in ER;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Amblyopia, Dizziness, Headache, Hypotension, Nausea
Clinical narrative: pt recvd Engerix-B & 15 mins p/inject devel sl dizziness, nausea, h/a, blurred vision & BP was 100/70; seen in ER & released;
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Headache, Hypersensitivity, Paraesthesia
Clinical narrative: Pt recvd Engerix-B vax & 10 mins p/inject exp a h/a, paced around & numbness in face; nurse could not tell whether rxn was a drug allergy, anxiety-venting or caused by other things in life;