chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Tinnitus
Clinical narrative: Pt recvd 2 doses of Engerix-B & exp no events following 1st dose but 4 days p/2nd inject exp severe dizziness, nausea, h/a, & ringing ears; treated w/Antivert & sx resolved;
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Chills, Hyperhidrosis, Myalgia
Clinical narrative: Pt recvd 2 doses of Engerix-B & had no reaction p/1st dose; hrs p/2nd dose devel fever of 102, chills, sweating, myalgia, nausea, vomiting, rigors, joint pains, upper abdominal pains & arthralgia; pt was seen by MD;
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt recvd 2 doses of Engerix-B & had no reaction p/1st dose; hrs p/2nd dose devel fever of 102, chills, sweating, myalgia, nausea, vomiting, rigors, joint pains, upper abdominal pains & arthralgia; pt was seen by MD;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: 26MAY92 recvd 1 dose of Engerix-B & immed exp mild inject site soreness which resolved; 16JUL92 215PM recvd 2nd dose of Engerix-B 17JUL92 w/fever of 99, severe h/a, dizziness, nausea, vomiting & achy joints allover;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: 26MAY92 recvd 1 dose of Engerix-B & immed exp mild inject site soreness which resolved; 16JUL92 215PM recvd 2nd dose of Engerix-B 17JUL92 w/fever of 99, severe h/a, dizziness, nausea, vomiting & achy joints allover;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Dyspnoea, Influenza, Pyrexia
Clinical narrative: 22JUN92 pt recvd 1st dose of Engerix-B & 2 days post vax devel mild flu-like sx & recovered; 24JUL92 recvd 2nd dose of Engerix-B & c/o flu like sx, difficulty breathing, dizziness, chest pain & t101.8; taken to ER via ambulance;
Age: 1.3
Sex: M
Vaccine: HEP
Symptoms: Agitation, Diarrhoea, Vomiting
Clinical narrative: Pt recvd 2 doses of Engerix-B & following each dose devel diarrhea @ 48 hrs; vomiting & irritability; both time events resolved w/in 1 1/2 wks w/o treatment;
Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Hypertension, Rash, Respiratory disorder, Tachycardia
Clinical narrative: pt recvd a dose of Engerix-B & exp resp sx, SOB, elevated BP, elevated heart rate, & rash, urticaria;
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: pt recvd a dose of Engerix-B & exp resp sx, SOB, elevated BP, elevated heart rate, & rash, urticaria;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Herpes simplex
Clinical narrative: Pt recvd 1 dose of Engerix-B & had inject site pain shortly p/dose; 2 days later devel a measles like rash on trunk & arms along w/fatigue & felt warm; did not receive tx; doesn't feel well;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: 11MAY92 pt recvd 3rd dose of Engerix-B & exp a few days of local inject site pain; almost 3 months later, pain is recurrent; no erythema, redness, swelling or fever; pt went to ER; x-ray & CBC findings pendings;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Headache, Hyperhidrosis, Insomnia
Clinical narrative: breathing problems, fatigue, headaches, low grade fever lymphadenopathy, pain shoulder, sleeplessness, sore throat, sweating weakness;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy, Pharyngitis, Pyrexia
Clinical narrative: breathing problems, fatigue, headaches, low grade fever lymphadenopathy, pain shoulder, sleeplessness, sore throat, sweating weakness;
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp severe local burning & pain, bilateral numbness & tingling in fingers, a sore arm & fatigue; all sx resolved in 24 hrs;
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis, Infection
Clinical narrative: 1JUL92 recvd 1st dose of Engerix-B & 11JUL92 donated blood & was found to have a pos Hep C test;
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd 1 dose of Engerix-B 16JUL9 & 31JUL92 devel a rash; pt was seen by MD;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 3 pts in the reporting MD office did not respond p/receiving a series of 3 vax of Engerix-B;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Paraesthesia, Tongue oedema
Clinical narrative: 31JUL92 pt recvd 1st dose of Engerix-B & that same day devel numbness in extremities, tingling, felt as if drunk in head, & thick tongue;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Influenza, Injection site pain, Neck pain, Pain, Vomiting
Clinical narrative: approx 10% of the 95 pts who recvd 2nd dose of Engerix-B c/o sore arms; arm swelled up to neck; some rxn occurred immed & some had delayed rxns; c/o muscle soreness @ inject site;
Sex: M
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: 31JUL92 recvd 1st dose of Engerix-B & 4AUG92 devel nausea, vomiting, diarrhea, myalgia & chills; treated w/rest & APAP;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Ear pain
Clinical narrative: Pt recvd 2 doses of Engerix-B 4-5 wks p/2nd dose had earache, dizziness, weakness, diarrhea, fainting, chills, fever; had 4 MD visits; recvd ATB;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Syncope
Clinical narrative: Pt recvd 2 doses of Engerix-B 4-5 wks p/2nd dose had earache, dizziness, weakness, diarrhea, fainting, chills, fever; had 4 MD visits; recvd ATB;
Sex: U
Vaccine: HEP
Symptoms: Respiratory disorder
Clinical narrative: Pt recvd Engerix-B; had acute resp distress synd;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Bradycardia, Dizziness, Headache
Clinical narrative: Pt recvd Engerix-B & later the same day exp a drop in pulse, drop in BP & fever;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hypotension, Pyrexia
Clinical narrative: Pt recvd Engerix-B & later the same day exp a drop in pulse, drop in BP & fever;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & tested neg for antibodies; plan to booster;
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Paralysis, Vomiting
Clinical narrative: 1JUN92 recvd 1 dose of Engerix-B & 3JUL92 exp nausea, vomiting, muscle paralysis & headache;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: 30APR92 recvd 1 dose of Engerix-B & 2AUG92 devel tiredness, dizziness, lightheaded, sl fever & diarrhea which lasted about 24 hrs & went away;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & titer test results indicated that pt did not seroconvert; booster doses will be given;
Sex: U
Vaccine: HEP
Symptoms: Immunoglobulins increased
Clinical narrative: recvd 1st dose of Engerix-B in JUN92; about 1 month later routine blood test revealed elevated gammaglobulins; pt was referred to a hematologist who saw the pt 29JUL92; gammagoblulins were still elevated;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: 23JUL92 recvd 1st dose of Engerix & 1 hr p/vax devel a non-itching macular rash; pt advised to discontinue Engerix-B series;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 7 individuals did not respond to a series of Engerix-B vax;
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Diplopia
Clinical narrative: Pt recvd 4 doses of Engerix-B & had mild blurred vison p/2nd & 3rd doses but did not report this; 8MAR92 devel double vision for distance both horizontal & vertical & episodic diplopia;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Rash, Rash maculo-papular
Clinical narrative: approx 2JUL92 recvd 1st Engerix-B vax & 2-3 wks later devel rash & migratory polyarthralgia; pt is taking Naprosyn for joint pain;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Oedema peripheral, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: 1PM 31JUL92 recvd Engerix-B & 1-2 hrs later devel a t101, nausea, vomiting, numbness, tingling & swelling of hands; ER or MD visit was required;
Sex: U
Vaccine: HEP
Symptoms: Injection site pain, Pallor
Clinical narrative: 5AUG92 recvd 1st dose of Engerix-B & w/in 5 minutes devel pain @ inject & lost color;
Age: 60.0
Sex: U
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: 29JUL92 recvd 1st dose of Engerix-B & devel fever, dizziness, h/a, nausea & diarrhea as of 5AUG92;
Sex: U
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: 23JUL92 pt recvd 1st dose of Engerix-B & subsequently devel flu-like sx;
Sex: U
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & exp no reaction following the 1st dose; exp pain & a lesion @ the inject site following 2nd dose;
Sex: U
Vaccine: HEP
Symptoms: Nuchal rigidity
Clinical narrative: Pt recvd 2 doses of Engerix-B & exp no reaction following 1st dose & stiff neck following 2nd dose;
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & did not respond;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Myalgia, Paraesthesia
Clinical narrative: 1JUL92 recvd 1st Engerix-B vax & later that same day devel severe arm pain, mainly in the delotid area but occasionally radiating to the biceps & triceps; this persisted as of 6AUG92 w/occasional numbness or loss of sensation in the arm;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dyspepsia, Headache, Hypertonia, Hypokinesia, Lymphadenopathy
Clinical narrative: 30JUL92 in the AM recvd 1st dose of Engerix-B & in the PM same day devel h/a & upset stomach; 31JUL92 devel bilateral swollen lymph nodes (painful) in the jaw area; 2AUG92 devel severe nausea & was unable to open jaws completely;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Nuchal rigidity, Pain
Clinical narrative: 30JUL92 in the AM recvd 1st dose of Engerix-B & in the PM same day devel h/a & upset stomach; 31JUL92 devel bilateral swollen lymph nodes (painful) in the jaw area; 2AUG92 devel severe nausea & was unable to open jaws completely;
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Back pain, Pain
Clinical narrative: p/1st & 2nd dose of Engerix-B pt exp pain in shoulder; p/3rd dose of Engerix-B pt exp pain between back & migrating arthritis; pt still has occasional discomfort;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction, Pruritus
Clinical narrative: Pt recvd 2 doses of Engerix-B on 24JUN92 & 22JUL92 & 22JUL92 following vax devel pain @ inject site w/discoloration & itching;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Malaise, Myalgia, Pyrexia
Clinical narrative: 21JUL92 9AM recvd 1st Engerix-B vax & that same day became feverish, achy w/general malaise, complete fatigue & joints were achy;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Malaise, Nausea
Clinical narrative: 6JUL92 pt recvd Engerix-B & the next morning 7JUL92 devel malaise, h/a, & nausea; pt could not work;
Sex: F
Vaccine: HEP
Symptoms: Hyperlipidaemia
Clinical narrative: pt recvd 1 dose of Engerix-B & w/in 30 days of the dose devel elevated triglycerides;
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hyperlipidaemia
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2 wks p/2nd dose devel elevated triglycerides, SGO & SGPT; pt seen by MD;
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: Pt recvd 2 doses of Engerix-B & 30JUL92 reported developing a raised pustular rash on arms & chest;
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Asthenia, Hypersensitivity, Oedema peripheral, Osteoarthritis
Clinical narrative: w/in 24 hrs of 1st dose of Engerix-B devel an allergic type reaction; arthritis; joint swelling, feet, hands, knees, t100-101 & fatigue;
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: w/in 24 hrs of 1st dose of Engerix-B devel an allergic type reaction; arthritis; joint swelling, feet, hands, knees, t100-101 & fatigue;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 2 doses of Recombivax & 1 dose of Engerix-B & tested neg, no seroconversion on 14JUL92; recvd a booster dose of Engerix-B & will be retested in 8 wks;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Recombivax & exhibited no seroconversion 15NOV92; recvd a booster of Engerix-B 10FEB92 & titer was still neg on 18APR92; recvd 2nd booster of Engerix-B  18MAY92 & 15JUL92 titer remained neg; 31JUL92 recvd another vax;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Lymphadenopathy, Nausea, Vomiting
Clinical narrative: Pt recvd 2 doses of Engerix-B & had no reaction following 1st dose; w/in 24 hrs of 2nd dose devel adenitis, nausea, vomiting & diarrhea which lasted for 3-4 days a/resolving w/o treatment;
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pharyngitis
Clinical narrative: w/in 24 hrs of 1st dose of Engerix-B & devel cervical adenitis; p/2nd dose of Engerix-B devel sore throat, more severe adenitis, muscle aches & nausea; MD advised pt not to get 3rd dose of vax;
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 8AUG92 recvd Engerix-B & 9AUG92 devel urticarial rash on face, trunk & legs; tx w/DPH for itching;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Hyperhidrosis, Hypertonia, Palpitations
Clinical narrative: Pt recvd 2 doses of Engerix-B 7AUG92 w/in 30 minutes of 2nd dose had heart palpitations, extremely hot flashes, perspiring, lightheadedness; 8AUG92 had h/a, stiffness;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Pt recvd 2 doses of Engerix-B 7AUG92 w/in 30 minutes of 2nd dose had heart palpitations, extremely hot flashes, perspiring, lightheadedness; 8AUG92 had h/a, stiffness;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Pt recvd 2 doses of Engerix-B & 7AUG92 w/in 2 hrs p/2nd dose had lightheadedness, dizziness; pt recovered;
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & when titer was checked it indicated non response;
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: w/in 3 days of Engerix-B vax pt devel severe systemic reaction including general achiness, low grade fever, nausea & diarrhea;
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: pt recvd 2 doses of Engerix-B & 2 hrs p/2nd dose devel itching, & red patch on both elbows, back knees, palms of hands & lt inner wrist;
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Face oedema, Headache
Clinical narrative: 2JUN92 pt recvd Engerix-B & 12 hrs p/administartion devel face swelling, tirednedd & h/a; no treatment given;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Eye pain, Face oedema, Lacrimal disorder, Pruritus
Clinical narrative: 5AUG92 while administering Engerix-B some of vax went into pt lt eys; exp burning & tearing that went away the same day; that noc a rash appeared on chest & abdomen; 8AUG92 both eyes & face edematous, lt eye swollen shut; also measles-like
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular, Vasodilatation, Visual disturbance
Clinical narrative: 5AUG92 while administering Engerix-B some of vax went into pt lt eys; exp burning & tearing that went away the same day; that noc a rash appeared on chest & abdomen; 8AUG92 both eyes & face edematous, lt eye swollen shut; also measles-like
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: several individuals have recvd as many as 4 doses of Hep B vax & they still don't have protective titers;
Sex: M
Vaccine: HEP
Symptoms: Back pain
Clinical narrative: 6AUG92 recvd Engerix-B & deel back pain w/in 8 hrs of vax;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Influenza, Malaise, Myalgia, Pyrexia
Clinical narrative: 23JUL92 recvd 1st dose of Engerix-B & around 24 hrs later devel low grade fever, flu-like sx, body aches & malaise;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea, Injection site oedema, Myalgia, Nausea
Clinical narrative: 9JUL92 pt recvd 1st dose of Engerix-B & 10JUL92 devel abdo cramps, diarrhea, nausea, local swelling @ inject site, aches all over & vision problems;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Visual disturbance
Clinical narrative: 9JUL92 pt recvd 1st dose of Engerix-B & 10JUL92 devel abdo cramps, diarrhea, nausea, local swelling @ inject site, aches all over & vision problems;
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 5AUG92 HBSAB titer was neg; may receive addtl vax doses;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 5AUG92 HBSAB titer was neg;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: had 3rd dose of Engerix-B & had titers drawn & they were low (level unk);
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: pharmacist thinks pt was pregnant p/1st dose of Engerix-B;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Myasthenic syndrome
Clinical narrative: 15JUL92 recvd Engerix-B & devel muscle aches in biceps that progressed to weakness in both arms & loss of strength in fingers;
Age: 1.3
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Pyrexia
Clinical narrative: pt recvd 1st dose of Engerix-B on 6JUL92 & 24 hrs later devel rash & fever up to 102 which were attributed to roseola;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & was determined to be a non-responder;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & was a nonresponder;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & was a nonresponder;
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Arthralgia, Pyrexia
Clinical narrative: Pt recvd 1 doses of Engerix-B & 27JUN92 exp low grade fever, painful knee joints, loss of appetite & several bowel movements; no inject site reaction;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Influenza, Nausea
Clinical narrative: pt recvd 3 doses of Engerix-B & w/in hrs p/1st dose had abdo pain; p/3rd dose 12 hrs later had abdo cramps, flu-like sx, queasy;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Cardiovascular disorder, Infection, Influenza, Myalgia
Clinical narrative: pt recvd booster dose of Engerix-B 15JAN92 or 17JAN92 w/in hrs had flu-like sx, sore throat, heart murmur; had several visits to MD;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pharyngitis, Somnolence
Clinical narrative: pt recvd booster dose of Engerix-B 15JAN92 or 17JAN92 w/in hrs had flu-like sx, sore throat, heart murmur; had several visits to MD;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthropathy, Chills, Influenza, Malaise
Clinical narrative: Pt recvd booster dose Engerix-B & 4 hrs later had flu-like sx, vomiting; lasted 2 days; resolved;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Vasodilatation, Vomiting
Clinical narrative: Pt recvd booster dose Engerix-B & 4 hrs later had flu-like sx, vomiting; lasted 2 days; resolved;
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Nuchal rigidity, Osteoarthritis, Pain
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2-4 day p/2nd dose had stiff neck, shoulder pain, joint swelling & pain;
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: pt recvd Engerix-B & had rash, itching, elevated bumps;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Pt recvd Engerix-B & had dizziness, lightheadedness; sx subsided in 3 hrs p/onset;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Influenza, Nuchal rigidity
Clinical narrative: pt recvd Engerix-B had immed stiff neck, flu sx; pt seen by MD;
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Vertigo
Clinical narrative: pt recvd Engerix-B & 30 mins later was lightheaded;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Pt recvd Engerix-B & had general itching, severe scratching; lasted several days;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Hypokinesia, Influenza, Oedema peripheral
Clinical narrative: Pt recvd Engerix-B & 7JUN92 devel a rash & hives all over body; approx 10JUN92 felt general malaise, chills, swelling & pain in joints; had ER visit & was told had the flu; 2nd ER visit told has arthritis; MD dx serum rxn;
Sex: F
Vaccine: HEP
Symptoms: Osteoarthritis, Serum sickness, Urticaria
Clinical narrative: Pt recvd Engerix-B & 7JUN92 devel a rash & hives all over body; approx 10JUN92 felt general malaise, chills, swelling & pain in joints; had ER visit & was told had the flu; 2nd ER visit told has arthritis; MD dx serum rxn;
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Pt recvd 1 dose of Engerix-B & devel hives; did not receive treatment; still has hives;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspepsia, Nausea
Clinical narrative: Pt recvd 1 dose of Engerix-B & 3 days following dose exp dizziness resulting in fall, nausea, stomach upset, diarrhea & was tired; has 2 MD visit;
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis
Clinical narrative: Pt recvd 1st dose of engerix-B on 5MAR92 & 5 days p/the initial injection of vax exp night sweats lasting approx 10 days;
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt recvd 1 dose of Engerix-B & following dose 1 2 pts devel rash;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Hyperaesthesia, Hypersensitivity, Multiple sclerosis
Clinical narrative: Pt recvd Engerix-B 16JUN92 & had malaise, weakness, flushing, diarrhea, abdominal cramp, somnolence; 17JUN92 woke up wanted to move but couldn't; weak on lt side; dx allerg react; some tingling;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Myasthenic syndrome, Neoplasm, Osteoarthritis, Paraesthesia, Paralysis
Clinical narrative: Pt recvd Engerix-B 16JUN92 & had malaise, weakness, flushing, diarrhea, abdominal cramp, somnolence; 17JUN92 woke up wanted to move but couldn't; weak on lt side; dx allerg react; some tingling;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: Pt recvd Engerix-B 16JUN92 & had malaise, weakness, flushing, diarrhea, abdominal cramp, somnolence; 17JUN92 woke up wanted to move but couldn't; weak on lt side; dx allerg react; some tingling;
Sex: M
Vaccine: HEP
Symptoms: Face oedema
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp difficulty chewing, edema on the inside of mouth, & the outside of face looked edematous;
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Petechiae, Rash
Clinical narrative: Pt recvd 1 dose of Engerix-B & 2 1/2-3 wks p/4JUN92 dose had rash on both legs that does not itch & looks like petechia;
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Pt recvd 1 doses of Engerix-B & 6 hrs p/inject had hives;
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & 19MAY91 tested pos for immunity to Hep B vax; 15JUN92 again because of a needlestick a titer was taken & pt was found to have no detectable antibodies;
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Neuritis, Paraesthesia
Clinical narrative: Pt recvd 1 dose Engerix-B exp sensory axillary nerve neuritis w/numbness & loss of sensation in the injected arm;
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache
Clinical narrative: Pt recvd 2 doses of Engerix-B & 2 & 1/2 hrs following dose 2 exp fatigue & h/a; still persisting;
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp a raised 1-2 cm maculopapular rash on 1 arm from shoulder to wrist "same arm that was injected"; arm still bright red with eruptions;
Sex: U
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Dysphonia, Hyperhidrosis, Tachycardia
Clinical narrative: 3 of 20 pts recvd Engerix-B 2JUL92 - 3JUL92 & had bad reactions to the vax; all had diaphoresis, tachycardia, & were described as anxious by the reporter; also had dizziness, loss of voice & 1 pt felt like was about to have a sz;
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Injection site hypersensitivity, Paraesthesia
Clinical narrative: Pt recvd 3 doses of Engrix-B & 1 1/2 hr p/3rd dose had sl rash @ site; then had numb & tingling lt arm but can move arm, & cool moist skin; seen by MD 26MAY92;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Influenza, Rash
Clinical narrative: Pt recvd 2 doses of Engerix-B & OCT90 exp a rash on arms & chest 18-24 hrs p/1st dose; NOV90 exp a more extensive rash progressive in severity on chest & limbs & flu-like synd p/2nd dose;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Face oedema, Influenza, Myalgia, Oedema peripheral
Clinical narrative: Pt recvd 2 doses of Engerix-B & recvd 3 of Engerix-B 10JUN92; 3 to 4 days p/dose 3 pt exp flu-like sx, swollen joints, red spots, rash, numbness of fingers, pain in joints, fingers tingling, hands swollen, face puffy;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Osteoarthritis, Paraesthesia, Rash
Clinical narrative: Pt recvd 2 doses of Engerix-B & recvd 3 of Engerix-B 10JUN92; 3 to 4 days p/dose 3 pt exp flu-like sx, swollen joints, red spots, rash, numbness of fingers, pain in joints, fingers tingling, hands swollen, face puffy;
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Dyspepsia, Eructation, Urticaria
Clinical narrative: Pt recvd Engerix-B 2JUL92 & had hives 1st on feet, then on hands, severe back pain, dyspepsia, belching;
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hepatic function abnormal
Clinical narrative: Pt recvd 2 doses of Engerix-B & following the 2nd dose exp arthralgias & elevated liver function tests;
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Hypertension, Tachycardia, Vertigo
Clinical narrative: Pt recvd 3 doses of Engerix-B & following dose 3 esp inc BP w/tachycardia, vertigo & weakness; The inc BP & weakess cont 3 wks & pt was off work during that period; returned to work 1JUL92;
Sex: U
Vaccine: HEP
Symptoms: Hypertension, Tachycardia, Vertigo
Clinical narrative: Pt recvd 3 doses of Engerix-B & following dose 3 exp inc BP w/no hx of same,vertigo & tachycardia; resolved in 24 hrs;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: all employees recvd 3 doses of Engerix-B; 5 who were tested did not respond;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponder p/2complete series; 1 of the prev 2 series was w/Engerix-B; reporter not certain if the other was Engerix-B; currently completing 3rd series; 3rd series is w/Engerix-B;
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Nausea, Somnolence
Clinical narrative: pt recvd 1st dose of Engerix-B & has been very ill w/nausea & vomiting for the past 24 hrs; also lethargic;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt recvd 2 dose of Engerix-B following 2nd dose exp high fever, h/a, nausea, vomiting, & diarrhea;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 2 pts recvd Engerix-B & have not had protection from the immun;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Pt recvd 1 dose of Engerix-B & 6JUL92 exp difficulty breathing; 7JUL92 also exp exertion on standing, tightness of breath, substernal pain, h/a, dizziness, felt faint & was unable to work; seen in ER; lungs were checked, & EKG was neg;
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Dizziness, Hyperhidrosis, Pain
Clinical narrative: pt recvd 1 dose of Engerix-B 8JUL92 following vax exp substernal pain lt arm/back/sternum, tingling in lt arm, pain on spine in middle of back, heaviness in chest, felt hot, perspiration, cardiac-type pain, & was lightheaded; seen in ER;
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Vasodilatation
Clinical narrative: pt recvd 1 dose of Engerix-B 8JUL92 following vax exp substernal pain lt arm/back/sternum, tingling in lt arm, pain on spine in middle of back, heaviness in chest, felt hot, perspiration, cardiac-type pain, & was lightheaded; seen in ER;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Amblyopia, Blindness, Headache, Optic neuritis, Pain
Clinical narrative: Pt recvd 1 doses of Engerix-B & 3JUN92 began to lose vision in rt eye; 10JUN92 had light perception only in rt eye; Reporter indicated these sx are consistent w/optic neuritis; seen by MD; no improvement;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Refraction disorder, Visual disturbance
Clinical narrative: Pt recvd 1 doses of Engerix-B & 3JUN92 began to lose vision in rt eye; 10JUN92 had light perception only in rt eye; Reporter indicated these sx are consistent w/optic neuritis; seen by MD; no improvement;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B of 24 individuals who recvd series p/3rd dose 13 h ad neg titer levels & failed to achieve protective titers;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B; titer drawn p/exposure, seronegative; recvd 4th dose of Engerix-B-2nd titer drawn, still neg;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Pt recvd Engerix-B & 17JUN92 had mild tenderness, pain @ inject site; lasted for 1 wk;
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: Pt recvd Engerix-B & approx 2 wks p/1st dose had macula-papula lesion on face; not pruritic & no indication of superinfection;
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Headache, Hepatic function abnormal, Petechiae
Clinical narrative: Pt recvd dose Engerix-B & the next day had h/a; As of 3JUN92 had tiredness, joint pain, rash (petechiae), elevated liver function tests; seen by MD; recvd Darvocet for h/a & joint pain;
Sex: U
Vaccine: HEP
Symptoms: Headache, Hypoaesthesia, Injection site pain, Malaise, Somnolence
Clinical narrative: Reporter indicated multiple individuals in various stages of their vax schedule who recvd Engerix-B or Recombivax exp arm hurting during inject & transient numbness in area of inject;
Sex: U
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: Reporter indicated multiple individuals in various stages of their vax schedule who recvd Engerix-B or Recombivax exp arm hurting during inject & transient numbness in area of inject;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: w/in 24 hrs of 2nd dose had fever (104 degrees fahrenheit) for 3 days, no rash or redness; resolved; treated by MD;
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Myalgia, Nausea
Clinical narrative: Total of 6 pts recvd Engerix-B & 2 days p/dose 3 pts had muscle aches 1 pt had local injection site reaction, 3 pts had nausea, treatment Excedrin otc tx; all 6 pts improved;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pt recvd 2 doses of Engerix-B & 12-14 hrs p/2nd dose had fever, aches, chills, h/a, local tenderness; tx APAP; sx lasted 24 hrs;
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Colitis, Influenza, Nausea, Pyrexia
Clinical narrative: Pt recvd 1 dose of Engerix-B & pt also recvd immune serum globulin; between 24-48 hrs p/dose had fever, abdo cramps, flu-like sx, nausea, vomiting;
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Pt recvd 1 dose of Engerix-B & pt also recvd immune serum globulin; between 24-48 hrs p/dose had fever, abdo cramps, flu-like sx, nausea, vomiting;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & had nonresponse;
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B had nonresponse;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: pt recvd dose of Engerix-B 30JUN92 evening had urticaria; took oral DPH; spontaneous resolution;
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Influenza, Malaise, Pyrexia
Clinical narrative: Pt recvd Engerix-B had diarrhea, flu-like sx, malaise, fever;
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 2 pts recvd Engerix-B were nonresponders;
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Nuchal rigidity, Pyrexia
Clinical narrative: pt recvd 1 dose of Engerix-B & had low grade fever, severe aching in joints, stiff neck;
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: pt recvd Engerix-B & 5 days later had herpes zoster; seen by MD recvd med;
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Amblyopia, Diplopia, Neuropathy, Ophthalmoplegia
Clinical narrative: Pt recvd 1 dose of Engerix-B & 60 hrs later had sixth nerve palsy resulting in double vision; was not treated; had partial improvement;
Sex: U
Vaccine: HEP
Symptoms: Chest pain, Influenza, Nausea, Vomiting
Clinical narrative: 3 pts recvd Engerix-B & had flu-like sx; 5 pts recvd Engerix-B & 4 pts had nausea & vomiting & 1 pt had chest pain;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dysuria
Clinical narrative: Pt recvd Engerix-B vax 10JUL92 & exp burning sensation when able to urinate; also has trouble urinating @ all;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Vaginal infection
Clinical narrative: pt recvd Engerix-B & had vaginal discharge & itching;
Sex: U
Vaccine: HEP
Symptoms: Influenza, Laryngitis
Clinical narrative: 1st dose of Engerix-B was given approx 3 wks ago; out of this group 2 pts exp flu-like sx 2 days post vax; reporter unsure if other 2 pts exp laryngitis;
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Glossitis
Clinical narrative: Pt recvd vax & &JUl92 was fatigued & tongue was hot & burning; has not been seen by MD; sx on going as of 10JUL92;
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Cough, Injection site inflammation, Injection site oedema
Clinical narrative: Pt recvd 2 doses of Hep B vax & exp fever, achiness & malise p/1st &/or 2nd dose; seen by MD; 10JUL92 some were still not feeling well;
Sex: U
Vaccine: HEP
Symptoms: Myalgia, Pyrexia, Rhinitis
Clinical narrative: Pt recvd 2 doses of Hep B vax & exp fever, achiness & malise p/1st &/or 2nd dose; seen by MD; 10JUL92 some were still not feeling well;
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity, Oedema, Urticaria
Clinical narrative: Pt recvd Engerix-B & had allergic phenomena including welts extending on chest & arm swelling;
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & exp a neg titer result p/the 3rd dose;
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/the 3rd dose;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/the 3rd dose;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose; 3rd dose administered 10MAY91;
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd doses of Engerix-B & exp a neg titer result p/3rd dose;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter states that 191 people were vaxed & 17 were found to be non-responders;
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: nonresponse;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: nonresponse;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Malaise, Nausea
Clinical narrative: Pt recvd 1st dose of Engerix-B & that evening exp nausea & malaise; The next morning was OK but felt tired; has resolved; tx none;
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: pt recvd 3 doses of Engerix-B & had a lack of therapeutic response;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis exfoliative, Dyspnoea, Injection site mass, Myalgia, Pain
Clinical narrative: following 2nd dose of vax pt devel tingling in the arm, lump formed @ the inject site which was accompanied by intermittent pain for 1 wk; 20JUN92 scalp started to itch; red rash, skin discolored & peeling; also painful palms;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Pruritus, Skin discolouration
Clinical narrative: following 2nd dose of vax pt devel tingling in the arm, lump formed @ the inject site which was accompanied by intermittent pain for 1 wk; 20JUN92 scalp started to itch; red rash, skin discolored & peeling; also painful palms;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Hepatomegaly, Myalgia
Clinical narrative: pt recvd 1 dose of Engerix-B on 4JUL92 & devel diarrhea, fever, weakness & felt achy; resolved; 6JUL92 felt like having a gall bladder attack; abdo pain & an enlarged liver devel on 8JUL92;
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: pt recvd 1 dose of Engerix-B on 4JUL92 & devel diarrhea, fever, weakness & felt achy; resolved; 6JUL92 felt like having a gall bladder attack; abdo pain & an enlarged liver devel on 8JUL92;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia, Myasthenic syndrome
Clinical narrative: Pt recvd 2 doses of Engerix-B p/both doses exp wrist pain @ the join & weakness @ wrist; treated w/Motrin; 3rd dose will not be given;
Sex: F
Vaccine: HEP
Symptoms: Arthropathy
Clinical narrative: pt recvd 2 doses of Engerix-B; 1 wk p/2nd dose c/o stiffness in the joints of arms & legs; pt is unable to work but seems to be improving; adverse exp required an ER or MD visit;
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Ecchymosis, Face oedema, Oedema peripheral, Paraesthesia
Clinical narrative: Pt recvd 1 dose of Engerix-B & p/3 days exp swollen & numb lt side of face, neck, arm & hand; numbness in lt shoulder & bruising @ site of inject;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp nausea, vomiting, dizziness, fever, h/a & diarrhea 2-6 hrs p/vax;
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp nausea, vomiting, dizziness, fever, h/a & diarrhea 2-6 hrs p/vax;
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp nausea, vomiting, dizziness, fever, h/a & diarrhea 2-6 hrs p/recvd vax;
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp nausea, vomiting, dizziness, fever, h/a & diarrhea 2-6 hrs p/recvd vax;
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 4 doses of Engerix-B & had a nonresponse;
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Anorexia, Chest pain, Condition aggravated, Hepatomegaly
Clinical narrative: Pt recvd 1 dose of Engerix-B on 10JUN92 & exp abdo pain, no appetite, rt lung pain & liver swelling; treated w/extra-strength APAP for pain; appetite has returned;
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: Pt recvd 1 dose of Engerix-B 1 yr ago & exp numbness in arm of site of inject which radiated down arm; occurred 24 hrs p/inject & lasted about 24 hrs; has recovered;
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Neck pain, Nuchal rigidity, Pyrexia
Clinical narrative: Pt recvd 2 doses of Engerix-B on 8JUL92, p/2nd dose devel a fever of 24 hrs duration & a stiff sore neck for 3-4 days; resolved on 3rd day;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd Engerix-B because wife has Hep b & was determined to be a nonresponder p/5 doses;
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Injection site hypersensitivity
Clinical narrative: pt recvd 2 doses of Engerix-B & following 2nd dose had hives rt under arm;
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp severe diarrhea on 2JUL92 which lasted 6 days; treated w/anti diarrheal agents;
Sex: F
Vaccine: HEP
Symptoms: Back pain
Clinical narrative: several pts recvd Engerix-B & exp back ache 1 to 10 days later;
Sex: U
Vaccine: HEP
Symptoms: Hepatic function abnormal
Clinical narrative: pt recvd dose of Engerix-B & devel elevated liver enzymes;
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chest pain, Face oedema, Osteoarthritis, Paraesthesia
Clinical narrative: pt recvd 3 doses of Engerix-B & antibody titer was due to be checked on 22MAY92; 18MAY92 pt devel a vaginal yeast infection; awoke on 19MAY92 w/dry mouth & devel a huge ulcer on rt roof of mouth which lasted a wk; ear & rt side of head hurt
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Skin ulcer, Vascular anomaly
Clinical narrative: pt recvd 3 doses of Engerix-B & antibody titer was due to be checked on 22MAY92; 18MAY92 pt devel a vaginal yeast infection; awoke on 19MAY92 w/dry mouth & devel a huge ulcer on rt roof of mouth which lasted a wk; ear & rt side of head hurt
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Hypertonia, Injection site hypersensitivity, Injection site pain, Myalgia, Oedema peripheral
Clinical narrative: Pt recvd 1 dose of Engerix-B & 2 hrs p/inject devel stiffness of the lt arm & erythema @ inject site; 4-6 hrs post inject tingling & numbness, also edema, soreness & pain; tinnitus;
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Pt recvd 1 dose of Engerix-B & 2 hrs p/inject devel stiffness of the lt arm & erythema @ inject site; 4-6 hrs post inject tingling & numbness, also edema, soreness & pain; tinnitus;
Sex: U
Vaccine: HEP
Symptoms: Headache, Malaise, Somnolence, Vasodilatation
Clinical narrative: multiple pts recvd Engerix-B vax JUN92 & the day p/vax had transient frontal pressure, were lethargic, not feel good, feels hot but not febrile; sx have recurred about once/wk for the past month;
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Pt recvd Engerix-B 16JUL92 had fine, rd, raised areas on trunk & back, under arms & around abdo area w/itching; seen by MD;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain, Pruritus, Rash, Urticaria
Clinical narrative: Pt recvd 2 doses of Engerix-B 6JUN92 & 6JUL92 & 2 days p/2nd dose exp a rash, nausea & vomiting; reporter indicated that the event was immediately life threatening; prescribed DPH;
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Pt recvd 2 doses of Engerix-B 6JUN92 & 6JUL92 & 2 days p/2nd dose exp a rash, nausea & vomiting; reporter indicated that the event was immediately life threatening; prescribed DPH;
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic function abnormal
Clinical narrative: Pt recvd 1 dose of Engerix-B & exp elevated liver enzymes (elevated SGOT & SGPT); pt is currently hospitalized; MD is investigating cause of liver enzyme elevation;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Rash
Clinical narrative: Pt recvd 1 dose of Engerix-B & following dose exp severe rash head to toe;
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 2 doses of Engerix-B & had a failure to seroconvert p/3 doses; 12mo booster has not yet been given;
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Following dose 2 of Engerix-B pt exp pain @ inject site; pt thinks that MD may have injected vax in bone (arm);
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Pt recvd 2 doses of Engerix-B & following doses had diarrhea & cramping;
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Pt recvd Engerix-B & exp h/a, nausea & fever 101; tx APAP; sx relieved by tx w/APAP;
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema, Injection site pain, Vasodilatation
Clinical narrative: Pt recvd 2 doses of Engerix-B & immed following both doses had redness, swelling, heat @ inject site, pain & lump;
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Hypokinesia
Clinical narrative: Pt recvd 2 doses of Engerix-B & following both doses could not turn neck to side of inject; resolved in 24 hrs;
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Lung disorder, Palpitations, Vasodilatation
Clinical narrative: Pt recvd Engerix-B & 1/2 hr following vax had mild pulmonary congestion, hot, palpitations & raised BP; tx relaxation, cold water;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dyspepsia, Headache, Myalgia, Nausea
Clinical narrative: approx 10 of 100 pts who recvd Engerix-B exp fever, etc; 1 pt exp t102, diarrhea, chills & abdo cramping; body aches, abdo cramps, nausea, vomiting, urticaria, t99, h/a, nervous stomach;
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: approx 10 of 100 pts who recvd Engerix-B exp fever, etc; 1 pt exp t102, diarrhea, chills & abdo cramping; body aches, abdo cramps, nausea, vomiting, urticaria, t99, h/a, nervous stomach;
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd 2 doses of Engerix-B & titer drawn in JUL92, did not seroconvert;
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: multiple employees had pain @ inject site p/2nd dose of vax between 6JUL & 10JUL92;
Age: 55.0
Sex: U
Vaccine: HEP
Symptoms: Chills, Leukocytosis, Pyrexia
Clinical narrative: Pt recvd 2 doses of Engerix-B & devel a fever on 13JUL92 p/2nd dose; diminishes w/APAP but recurs in the afternoon of the following day;