chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Myalgia
Clinical narrative: Vaccinated w/MMR developed diffuse arthralgias & myalgias. Tx anti-inflamatory meds. Bed rest.
Age: 17.0
Sex: F
Vaccine: MMR, TD
Symptoms: Arthralgia, Grand mal convulsion
Clinical narrative: Pt had one grand-mal sz-afebrile- 5hrs after receiving vax. Pt has a known sz disorder & is on Tegretol. Also had arthralgias in arms. No specific treatment given. 1 mo f/u  still c/o arthralgia.
Age: 1.2
Sex: M
Vaccine: HIBV
Symptoms: Apnoea, Cyanosis, Pallor
Clinical narrative: Pt became cyanotic; MD called no respirations present on auscultation. Head was tilted back & respirations started color improved then worsened slightly & remained slightly cyanotic & very pale. Temp 98.4.
Age: 2.0
Sex: F
Vaccine: DTP, OPV
Symptoms: Convulsion, Hypotonia, Pyrexia, Vomiting
Clinical narrative: Pt had T p/reaching home in 1/2 hr. Sz /p receiving DTP & was taken to ER. Emesis x 1. Seizure by mothers description as shaking all over the body for a few min then she became limp. D/C from hosp after two days.
Age: 0.3
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Agitation, Bronchiolitis, Infection, Pyrexia, Rash
Clinical narrative: Became fussy & had runny nose 20DEC. T @ MD office 100-101(R). On Fri night 21DEC developed a rash w/hives. 22Dec adm to hosp. Rx'd for Bronchilitis & an infection in bowel caused by Branhamella Catarrhalis generalized bacterial infect.
Age: 0.3
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Rhinitis, Urticaria
Clinical narrative: Became fussy & had runny nose 20DEC. T @ MD office 100-101(R). On Fri night 21DEC developed a rash w/hives. 22Dec adm to hosp. Rx'd for Bronchilitis & an infection in bowel caused by Branhamella Catarrhalis generalized bacterial infect.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Syncope
Clinical narrative: 4JAN91 Hives. 5JAN91 Swollen ears. MD prescribed Benadryl; 7JAN91 swelling of eyes & lips. Given Atarax. 8JAN91 fainted when got out of bed. Taken to ER given Prednisone.
Age: 0.3
Sex: F
Vaccine: DTP, OPV
Symptoms: Crying, Screaming
Clinical narrative: Continuous crying for 3 hrs. High pitched cry.
Age: 0.5
Sex: F
Vaccine: DTP
Symptoms: Agitation, Injection site reaction
Clinical narrative: DTP given 17NOV91; contact from pts father 22JAN91 stating site has swelling & inflammation developed date of call. Child crying due to discomfort was seen by PMD.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis, Pain
Clinical narrative: Arthralgia/arthritis; inflamation of joints; pain in joints, esp knees early AM & evening, also ankles, shoulder & back. 26OCT90 pt better but still has problem w/knealing; 28DEC90 All sx subsided by latter NOV90.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Diarrhoea, Otitis media, Pyrexia, Vomiting
Clinical narrative: 10JAN91 at 1PM child began running a T 101.6-102.6(AX) given Tylenol at 2PM. 5PM made a groaning sound & began seizuring. Seizure lasted about 3mins & child then vomited once. Pt taken to ER & T was 103.6(R). DX ear infect. 11Jan91 loose stools.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd a series of 3 Engerix-B inject (deltoid) according to 0, 1, 6 months schedule. About 1 mo following the 3 dose, results of testing for Hepatitis B surface Antibody indicated he had a low titer.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome, Hyporeflexia, Paraesthesia
Clinical narrative: Rec'd vax 9OCT90 five to seven days post vax developed progressive numbness & tingling on feet, ascending to waist over next 3 days. Reflexes diminished. MD dx: GBS secondary to Hep B vax. Event resolved over one week.
Age: 0.2
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Abdominal distension, Apnoea, Brain oedema, Haemorrhage, Haemothorax
Clinical narrative: 2 1/2 mo infant recvd immun on afternoon of 21DEC90; 2-3 hrs later pt had been put down for a nap; about 12 hrs p/immun pt was found dead on 22DEC90; autopsy revealed cause of death: acute respiratory failure, SIDS;
Age: 0.2
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Lung disorder, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: 2 1/2 mo infant recvd immun on afternoon of 21DEC90; 2-3 hrs later pt had been put down for a nap; about 12 hrs p/immun pt was found dead on 22DEC90; autopsy revealed cause of death: acute respiratory failure, SIDS;
Age: 0.2
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: 2 1/2 mo infant recvd immun on afternoon of 21DEC90; 2-3 hrs later pt had been put down for a nap; about 12 hrs p/immun pt was found dead on 22DEC90; autopsy revealed cause of death: acute respiratory failure, SIDS;
Age: 0.2
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Abdominal distension, Apnoea, Brain oedema, Haemorrhage, Lung disorder
Clinical narrative: 2 1/2 mo infant recvd immun on afternoon of 21DEC90; 2-3 hrs later pt had been put down for a nap; about 12 hrs p/immun pt was found dead on 22DEC90; autopsy revealed cause of death: acute respiratory failure, SIDS;
Age: 0.2
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: 2 1/2 mo infant recvd immun on afternoon of 21DEC90; 2-3 hrs later pt had been put down for a nap; about 12 hrs p/immun pt was found dead on 22DEC90; autopsy revealed cause of death: acute respiratory failure, SIDS;
Age: 0.5
Sex: M
Vaccine: DTP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Convulsion, Leukocytosis, Pyrexia
Clinical narrative: Received HIBTITER/DTP/OPV on 7DEC90. Same evening had several sz; hospitalized overnight for observation. Temp reading not available. Child had hx of hydrocephalus & meningomyelocele. No prior hx of sz.
Age: 0.5
Sex: M
Vaccine: DTP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Convulsion
Clinical narrative: Received HIBTITER/DTP/OPV on 7DEC90. Same evening had several sz; hospitalized overnight for observation. Temp reading not available. Child had hx of hydrocephalus & meningomyelocele. No prior hx of sz.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Consumer's husband, an army inductee was administered influenza virus vaccine (MFR unknown) during winter 1972-1973. Within 1 mo, pt condition dx as GBS. Hospitalized for 6 months. Pt currently under care of neurologist.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: CSF test abnormal, Infection, Pyrexia, Sepsis
Clinical narrative: 2 mo infant received HIBtiter/DTP/OPV on 3JAN91 on 6JAN91 had temp to 105; hospitalized - positive blood & spinal fluid cultures for H. Influenzae. Child doing well.
Age: 1.5
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Drug ineffective
Clinical narrative: 19 mo child received vaccination on 6DEC89 developed H. Influenza Meningitis on 4DEC90.
Age: 1.5
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Drug ineffective, Meningitis
Clinical narrative: 19 mo child received vaccination on 6DEC89 developed H. Influenza Meningitis on 4DEC90.
Age: 1.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Convulsion, Pyrexia
Clinical narrative: 1 yo child was given HIBtiter & tine test. Twelve hrs later felt feverish & then had 1-2 episodes of generalized sz. Seen in ER temp 104, post-ictal & was hospitalized-no treatment. A few hrs later was awake & back to normal.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: 4-5 hrs after receiving Influenza vaccine, pt experienced respiratory distress & fever of 105. Hospitalized for 3 days.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Epididymitis, Orchitis
Clinical narrative: A MD reported 14yr old male revaccinated w/a booster dose of MMR developed epididymitis & orchitis. He was hospitalized & later recovered.
Age: 2.0
Sex: M
Vaccine: DTP
Symptoms: Arrhythmia, Convulsion, Hyporeflexia, Hypotonia, Mental retardation severity unspecified
Clinical narrative: Pt admitted to hosp 22DEC67 w/convuls of 6 hrs duration, one day after vac.  Reporter told child should not receive more "P".  Child has some degree of retardation.  Mom wonders of d/t DTP.  See WORM for more info.
Age: 2.0
Sex: M
Vaccine: DTP
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt admitted to hosp 22DEC67 w/convuls of 6 hrs duration, one day after vac.  Reporter told child should not receive more "P".  Child has some degree of retardation.  Mom wonders of d/t DTP.  See WORM for more info.
Age: 3.0
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Cellulitis, Ecchymosis, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: 4DEC90 PM - low grade fever to 101; Lt leg mildly red, warm, sore. 10DEC90 lt leg became very swollen "baseball size" purple-red w/ inc warmth & tenderness no inc systemic fever- dx cellulitis & hematoma.
Age: 3.0
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Rash, Vasodilatation
Clinical narrative: 4DEC90 PM - low grade fever to 101; Lt leg mildly red, warm, sore. 10DEC90 lt leg became very swollen "baseball size" purple-red w/ inc warmth & tenderness no inc systemic fever- dx cellulitis & hematoma.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Rash
Clinical narrative: 12 hrs prior to rxn, pt received DTP HBOC & OPV. Pt rxn: Rash
Age: 0.2
Sex: M
Vaccine: DTP
Symptoms: Agitation
Clinical narrative: Prolonged fussiness, screaming.
Age: 24.0
Sex: F
Vaccine: DT
Symptoms: Back pain, Breast pain, Injection site pain, Neck pain, Paraesthesia
Clinical narrative: Severe pain at site of injection, entire arm affected, fingers feel numb & tingling, breast painful, pain in neck & back.
Age: 27.0
Sex: M
Vaccine: DT
Symptoms: Back pain, Injection site pain, Neck pain
Clinical narrative: Severe pain at site of inject, pain in entire arm, pain in neck & into back.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen
Clinical narrative: Rec'd 3 doses according to 0, 1, 2 months schedule. antigenemia occured following the third dose & resolved, without treatment.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vax was given on 10SEP90 found to have antigenemia on 11SEP90. No treatment given.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt given Engerix-B booster on 24OCT90, following nonresponse to 3 doses of Recombivax-HB & still has no antibodies.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache, Pruritus, Rash
Clinical narrative: First of 3 doses of Engerix-B on 9-10JUL90 developed a raised rash (legs, arms, back, trunk & neck that caused itching. Also developed fatigue & headache (described as poss. rxn to Hep-B vax). Tx Benadryl.
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: 1 of 3 nurses who rec'd Engerix-B, experienced headache ("pressure on top of head like head was going to explode"). Event was experienced "immediately" p/1st of a series of three injects. Treated w/Tylenol & "headache went away."
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: 1 of 3 nurses who received Engerix-B experienced headache ("Pressure on top of head like head was going to explode"). Experienced "immediately" p/1st of a series of 3 injections. Treated w/Tylenol & headache went away.
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: 1 of 3 nurse who rec'd Engerix-B experienced headache ("pressure on top of head like head was going to explode"). Experienced "immediately" p/1st of a series of 3 injects. Tx Tylenol & headache went away.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter indicates "significant failures in HB vax of employees (ages 30-50) p/switching fr Recombivax to Engerix-B were running approx 93% conversion w/Recombivax. Rate w/Engerix-B is estimated to be about 50%.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Pruritus, Rash, Vasodilatation
Clinical narrative: Rec'd first & second dose Engerix-B on 15OCT90 & 19NOV90, thirty min p/second dose, began to feel hot, started to itch & then experienced rash (upper trunk). Lips swelled.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypokinesia, Nausea, Neck pain, Vertigo
Clinical narrative: 17OCT90 rec'd 1st Engerix-B inject @ 930AM; @2PM extreme vertigo & nausea. @ 430 PM immobilized due to dizziness. Movement of head & neck extremely painful. Duration approx 24 hrs; 3 additional episodes of vertigo @ 3 wks, lasting 1-1.5hrs.
Sex: F
Vaccine: HEP
Symptoms: Agitation, Dizziness, Headache, Hyperhidrosis, Migraine
Clinical narrative: 1 hr post vax first dose experienced restlessness, lightheadedness, dizziness, vomiting, severe headache & "felt like she was crawling out of her skin".
Sex: F
Vaccine: HEP
Symptoms: Nausea, Nervousness, Vomiting
Clinical narrative: 1 hr post vax first dose experienced restlessness, lightheadedness, dizziness, vomiting, severe headache & "felt like she was crawling out of her skin".
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Chest pain, Dyspnoea, Headache, Influenza
Clinical narrative: 1 to 2 hrs post vax first dose vacinee had onset of nervousness, flu-like sx, achiness, nausea (no vomiting), slight headache.
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Nausea, Nervousness
Clinical narrative: 1 to 2 hrs post vax first dose vacinee had onset of nervousness, flu-like sx, achiness, nausea (no vomiting), slight headache.
Sex: F
Vaccine: HEP
Symptoms: Oedema, Pruritus, Urticaria
Clinical narrative: Rec'd a 1st dose of Engerix-B on the day of inject experienced localized itching & edema. Several days later general hives. Tx oral antihistamine (unspecified). Condition cleared.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthropathy, Asthenia, Chest pain, Headache
Clinical narrative: Onset of events occurred on the same day vaccinee rec'd her final vax (third dose in series) No tx given.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Rec'd 1st dose of Engerix-B 29MAY90. This was third dose in a series of which the first two doses were w/Recombivax because of negative titers restarted on Engerix-B 7SEP90 & was given dose 7OCT90 titers have remained negative.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd three doses Engerix-B (Deltoid) & did not have titers when checked three months p/the third dose.
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Nauseated x 5 days following 2nd inject. No problems p/1st inject; Reporter indicates "in my opinion rxn was not due to vax - rather obtained virus at the same time."
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee had "no response" p/receiving three doses of Engerix-B vaccine on  11AUG89, 23SEP89, & 24MAR90.
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Chills, Dizziness, Nausea, Vomiting
Clinical narrative: 7 of 10 people who received their 1st dose experienced nausea & vomiting for 24 hrs. Sx then resolved.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pharyngitis, Pruritus, Sinusitis
Clinical narrative: 1st Engerix-B vax given JAN90. 3-4 days p/ vax, experienced URI & sinusitis; sx resolved. p/2nd vax MARCH90 exp'd delayed hypersensitivity rxn incl extreme pruritus involving all extremities & scalp. Also exp'd arthralgias - still persists
Sex: U
Vaccine: HEP
Symptoms: Injection site pain, Myalgia
Clinical narrative: Vaccinees rec'd a series of 3 Engerix-B vax in APR, MAY & NOV90, & experienced pain on inject. Reporting nurse indicated that "too many" vaccinees (employees & pt) c/o inject site & muscle pain when administered Engerix-B.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "...failure to achieve antibody titers p/3 doses of Engerix-B."
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "..failure to achieve antibody titers p/3 doses of Engerix-B."
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "...Failure to achieve antibody titers p/3 doses Engerix-B.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "...failure to achieve antibody titers p/3 doses of Engerix-B."
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "..failure to achieve antibody titers p/3 doses of Engerix-B."
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "..failure to achieve antibody titers p/3 doses of Engerix-B."
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee experienced "...failure to achieve antibody titers p/3 doses of Engerix-B."
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Influenza, Malaise, Myalgia, Paraesthesia
Clinical narrative: Rec'd Engerix-B on 8JAN90, experienced a flare-up of arthritis. Also had shoulder aches, numbness & tingling of hands & fingers, & "felt bad" for six weeks. Pt required no tx from MD to date shoulder aches & joint discomfort continue.
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 6SEP90, 1 day p/1st Hepatitis B inject experienced urticaria (hives w/itching) & diffused erythematous rash. P/1st dose, took advil & tylenol. 9OCT90, one day p/2nd Engerix-B inject, urticaria more intense & lasted longer. 23OCT sxs persist
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee is one of five employees who have been identfied as non responders following a series of three Engerix-B inject.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee is one of five employees identified as non responders following a series of three Engerix-B injects.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee is one of five employees who have been identified as non responders following a series of three Engerix-B injects.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee is one of five employees who have been identified as non responders following a series of three Engerix-B inject.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Bursitis, Fibrosis tendinous, Hypokinesia, Pain
Clinical narrative: Rec'd "adult dose" Engerix-B injection on 2FEB90 & 2MAR90 Experienced pain in rt shoulder & decreased "motility" p/1st inject & more so p/2nd inject. MD dx: Bursitis-shoulder, myfascial pain synd shoulder - impingement synd.
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Neck pain
Clinical narrative: Rec'd a booster of Engerix-B on 22SEP90; Experienced arthritic back, knee, shoulder, & neck pain. Knee involved w/arthritic pain was not the knee which had surgery.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 3 doses Engerix-B given 4DEC89, 4JAN90 & 4JUN90. 11JUL90, fourth dose was given. Vaccinee did not convert p/fourth dose.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt rec'd Engerix-B as 4th dose following 3 doses of Recombivax-HB (nonresponse) & still did not respond.
Sex: U
Vaccine: HEP
Symptoms: Headache, Lacrimal disorder
Clinical narrative: Some employees receiving the vax experienced headaches & watery eyes.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Rec'd Engerix-B inject 21FEB90, 21MAR90 & 20SEP90. On 22OCT90, Hepatitis B S Antibody was negative.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Rec'd Engerix-B on 17OCT90, on 18OCT90 experienced pruritus but no rash. given Benadryl QID 3-4 days. had itching for 3-4 days & then resolved.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Rec'd Engerix-B on 15NOV89, 19DEC89, & 27JUN90. Pt was a non-responder. No tx was given: outcome is pending.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee rec'd 3 doses Engerix-B 23MAY90, 22JUN90 & on an unspecified date for an indication of "sexual contact." P/3rd dose, vaccinee was a non responder.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Did not convert; vaccinee "did not convert" following a  series w/Engerix-B (dosing schedule - 0, 1, 6).
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series with Engerix-B (dosing schedule 0, 1, 6).
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series with Engerix-B (dosing schedule 0, 1, 6).
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6).
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6);
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Rec'd Engerix-B on 8JAN90 & 2MAR90. p/second vax experienced an acute flare-up of her arthritis which required w/medication (unspecified).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Ecchymosis, Injection site oedema, Injection site pain, Vasodilatation
Clinical narrative: Vaccinee rec'd first Engerix-B vax on 5NOV90 & experienced pain, swelling, heat & 3" diameter bruised area @ the inject site. Pain & brusing resolved after 2 days.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Rec'd Engerix-B on 8FEB90 lot no ENG 585A4, 8MAR90 ENG 586A4, & 9AUG90 lot no ENG 618A4. Pt had no antibody response (10SEP90). Given a booster on 17SEP90.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee did not convert p/receiving Engerix-B vaccine.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: 3 doses of Engerix-B given on 8JAN90, 8FEB90 & 8JUL90; Titer done 8AUG90, post 3 doses of vax. Vaccinee did not convert. Fourth dose given 30AUG90.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Vaccinee experienced cramping (gastrointestinal) & diarrhea p/all 3 doses of Engerix-B.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd a series of 3 engerix-B vax (Deltoid) on 28SEP89, 30OCT89, & 12APR90 & was a non responder.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pruritus
Clinical narrative: Vaccinee experienced pruritus 2 days post 2nd Engerix-B inject (1st inject was rec'd 1 month prior to 2nd dose & was uneventful). Tx: Antipsychotics & a referral to a psychiatrist. MD has described event as permanently disabling.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Blood amylase increased
Clinical narrative: Vaccinee experienced increased serum amylase levels.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee tested negative for Hepatitis B Surface Antibodies p/a series of 3 inject (IM deltoid).
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Infection, Rash pustular
Clinical narrative: MD reports pt had outbreak of rash that formed pustules 4 days p/1st & 2nd injections of Engerix-B. First outbreak (following inject SEP90) resolved in one wk, while the second case (injection 11OCT90) (+ for pseudomonas) remains ongoing.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Pruritus, Rash, Urticaria
Clinical narrative: Vaccinee exp hives (48 hrs post inject), swollen lip (4 + days post inject) & rash (onset time frame is unk). tx oral Benadryl 50 mg PRN itching (one dose). sx resolved w/in 18 hrs.  Recovered
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd two boosters ("which may have been Engerix-B" indicates has not yet responded.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Myasthenic syndrome, Nausea, Serum sickness
Clinical narrative: Vaccinee rec'd vax 11SEP90 & experienced weakness, nausea & vomiting x 1 & diarrhea on 12SEP90. Returned to hlth dept on 15OCT90 c/o weakness in both knees for the entire month p/1st vax dose-2nd dose was not given.
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Vaccinee rec'd vax 11SEP90 & experienced weakness, nausea & vomiting x 1 & diarrhea on 12SEP90. Returned to hlth dept on 15OCT90 c/o weakness in both knees for the entire month p/1st vax dose-2nd dose was not given.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Vaginal candidiasis
Clinical narrative: Vaccinee dev a vaginal yeast infect "...about 2 days p/inject" lt deltoid 20JUL90 & 19AUG90 sx treated w/Terazol vaginal suppository & cleared p/2-3 days. Vaccinee plans to take 3rd vax in series.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd a series of 3 doses AUG89, SEP89, FEB90-Glutteus) & when tested 5 months later (?JUL90), p/needlestick, had no antibodies-"no seroconversion." Event also occurred p/4th inject JUL90 (IM deltoid).
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Diarrhoea, Hyperhidrosis, Influenza
Clinical narrative: Vaccinee experienced malaise, chills, sweats, body aches, diarrhea (resolved), fevers & flu like sx 1 wk beyond 1st inject 20SEP90; Sx persisting for 3 wks. No tx has been given.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Vaccinee experienced malaise, chills, sweats, body aches, diarrhea (resolved), fevers & flu like sx 1 wk beyond 1st inject 20SEP90; Sx persisting for 3 wks. No tx has been given.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Drug ineffective
Clinical narrative: Vaccinee experienced "non responder" following a 3rd Hepatitis B vaccination (? first dose of Engerix-B).
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dyspnoea, Nausea, Vomiting
Clinical narrative: Vaccinee experienced nausea & vomiting on the evening of the inject IM deltoid (27SEP90). 24 hrs post inject experienced chest pains (& pressure), intermittently w/sob; Tx vistaril for sedation.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: MD indicates Engerix-B use has been "causing painful injects." Pain @ inject site was experienced by "12 to 15" pts. Pts would not return for 2nd dose of Engerix-B.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd the 3rd in a series of Engerix-B (Deltoid) 23AUG90 & was a "non responder."
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dyspnoea, Headache, Hyperhidrosis, Hyperventilation
Clinical narrative: Vaccinee experienced sweating, chest tightness, sob, nausea, tingling of hands, (Hyperventilating upon arrival in ER) & headache on 15OCT90 1/2 hr p/ vax. Tx w/ Benadryl 50mg/IM) w/ no relief of sxs.  Pt felt better early pm p/ resting.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Paraesthesia, Tremor
Clinical narrative: Vaccinee experienced sweating, chest tightness, sob, nausea, tingling of hands, (Hyperventilating upon arrival in ER) & headache on 15OCT90 1/2 hr p/ vax. Tx w/ Benadryl 50mg/IM) w/ no relief of sxs.  Pt felt better early pm p/ resting.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Dermatitis bullous, Headache, Pruritus
Clinical narrative: 2 day post vax experienced local tenderness @ site of inject which extended down arm & lasted for 2 wks. Had a pruritic blister-like lesion @ the site of inject. Experienced fatigue, UTI, & fever which cleared p/antibiotics.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pyelonephritis, Pyrexia, Urinary tract infection
Clinical narrative: 2 day post vax experienced local tenderness @ site of inject which extended down arm & lasted for 2 wks. Had a pruritic blister-like lesion @ the site of inject. Experienced fatigue, UTI, & fever which cleared p/antibiotics.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dry skin, Herpes simplex, Pruritus, Rash, Urticaria
Clinical narrative: Vaccinee experienced itching on the arm within 1 day post 1st inject. Approx 3 days post 1st dose: rash, dry skin & urticaria (spread to abdomen & entire body; rash became more pustular in nature "resembling a herpes type rash";
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee a non responder p/a series of 3 doses of Engerix-B IM/Deltoid). tx: none. outcome: pending.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee a non responder following a series of 3 Engerix-B vaccinations (deltoid).
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Hepatic function abnormal, Malaise, Myalgia
Clinical narrative: Vaccinee rec'd first inject-HIP on 3SEP90 & experienced fatigue, mild fever & malaise. P/2nd inject-hip on 23OCT90, experienced "greater" fatigue, mild fever & chills. No treatment given.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Somnolence
Clinical narrative: Vaccinee rec'd first inject-HIP on 3SEP90 & experienced fatigue, mild fever & malaise. P/2nd inject-hip on 23OCT90, experienced "greater" fatigue, mild fever & chills. No treatment given.
Sex: U
Vaccine: HEP
Symptoms: Chills, Hyperhidrosis, Myalgia, Pneumonia, Pyrexia
Clinical narrative: Rec'd vax IM lt deltoid 20mcg-c/o soreness in lt arm on the day of administration. Had chills & sweats 13OCT90 in PM. 15OCT90 had temp of 101 degrees F, chills & sweats, & arm is still sore.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Multiple sclerosis, Neuropathy, Neuropathy peripheral, Osteoarthritis
Clinical narrative: Vaccinee rec'd 1st dose of Engerix-B on 30SEP90 & experienced pain @ inject site. 24 hrs p/she rec'd 2nd dose of vax 30OCT90 had total body joint pain & was difficult to move. Treated @ ER w/local anesthetic/Orudis. Lower body pain resolved
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Paralysis, Renal impairment
Clinical narrative: Vaccinee rec'd 1st dose of Engerix-B on 30SEP90 & experienced pain @ inject site. 24 hrs p/she rec'd 2nd dose of vax 30OCT90 had total body joint pain & was difficult to move. Treated @ ER w/local anesthetic/Orudis. Lower body pain resolved
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee rec'd "Booster shots" w/Engerix-B vax series on 16MAY90, 15JUN90 & 5SEP90 & produced inadequate titers that decreased w/progressing boosters.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Nurse indicates 2 vaccines showed inadequate response after 3 dose vaccination series.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt rec'd 3 doses of Engerix-B (IM/Deltoid) & did not respond.
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Post 1st dose, vaccinee experienced pain & severe rash @ deltoid (site of inject) which lasted 5 days.
Sex: U
Vaccine: HEP
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Vaccinee experienced nausea, vomiting, headache & generalized aching x 2 days post Hepatitis B vax (? w/Engerix-B). PPD was given the same day.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: 4OCT90 vaccinee experienced generalized itching all over body (no fever, no rash) approx 8 hrs p/1st inject of series. Itching resolved w/in a few hrs
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: "quite a few vaccinees" experienced "non-response or low antibody titers" following the third dose in the vax series (IM Deltoid).
Sex: M
Vaccine: HEP
Symptoms: Eosinophilia
Clinical narrative: 1 day post Engerix-B labs showed: "abnormal lab values." Resolved in about a week.
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: MD indicates 2 pts have experienced 2 instances of urticaria post Engerix-B;
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Biliary colic, Hyperbilirubinaemia, Nausea
Clinical narrative: Vaccinee was administered 2nd dose of Engerix-B & experienced nausea & severe gallbladder pain. There was no adverse event post 1st dose Engerix-B.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster, Rash
Clinical narrative: Vaccinee experienced severe skin rash (like shingles) from neck to her waist (little on arms) 2 days post inject.
Age: 58.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Rec'd Engerix-B (20mcg/inj) in lt deltoid, on 26JUN90, 26JUL90, 28AUG90. Pt did not convert p/3rd dose.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Reporter indicates pts have c/o stinging which becomes progressively worse with each inject.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Amblyopia, Back pain, Diplopia, Headache, Multiple sclerosis
Clinical narrative: Vaccinee rec'd Engerix-B "early OCT90" & experienced "numbness of tongue; lightheadness/dizziness & tiredness" two or three wks later. Tx vaccinee is seeing a neurologist.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Myasthenic syndrome, Nuchal rigidity, Paraesthesia
Clinical narrative: Vaccinee rec'd Engerix-B "early OCT90" & experienced "numbness of tongue; lightheadness/dizziness & tiredness" two or three wks later. Tx vaccinee is seeing a neurologist.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Hepatomegaly, Hypochromic anaemia, Infection
Clinical narrative: Rec'd first dose of Engerix-B SEP90; 3 or 4 days later developed low-grade fever, malaise & jaundice. Hepatomegalia developed over the next month. Engerix-B was discontinued.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Jaundice, Malaise, Pyrexia
Clinical narrative: Rec'd first dose of Engerix-B SEP90; 3 or 4 days later developed low-grade fever, malaise & jaundice. Hepatomegalia developed over the next month. Engerix-B was discontinued.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Vaccinee experienced possible Herpes Zoster (lt trunk); Seen in ER by employee hlth MD & treated w/ "Predizone" ?(PREDNISONE). Sx abated "x3 days w/inject." ER MD stated he felt this could be Engerix-B related.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt did not respond after 3 doses.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee reports that he has not seroconverted after a series of five injections.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: 22SEP90; vaccinee experienced non-pruritic rash on head, neck & arms p/first vax (deltoid). Rash resolved w/out treatment.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee is a non-responder p/receiving a series of 3 Engerix-B vax (20 MCG/CC, Deltoid on 2JAN90 lot no. 586A4, 2FEB90 lot no. 586A4 & 16JUL90.
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Reporter indicates a total of ten nurses rec'd Engerix-B & all but one employee experienced events described in labeling e.g., low grade fever, joint pain, generalized aching.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee was given a series of 3 Engerix-B vaccinations on 4DEC89, 9JAN90 & 5JUN90. Serology testing on 29AUG90 showed that vaccinee failed to seroconvert. Vaccinee was one of six pt who failed to convert out of a group of 52 vaccinees.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Vaccinee was given a series of 3 Engerix-B vaccinations on 5DEC89 lot not 585A4, 2JAN90 lot no. 586A4, & 31MAY90 lot no 587A4; Serology testing on 29AUG90 showed that vaccinee failed to seroconvert.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee was given a series of 3 Engerix-B vax on 4DEC89 lot no. 585A4, 2JAN90 lot no 586A4, & 1JUN90 lot no 587A4; Serology testing on 29AUG90 showed that vaccinee failed to seroconvert.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee was given a series of 3 Engerix-B vax on 5DEC89 lot no 585A4, 2JAN90 lot no 586A4, & 4JUN90 lot no 587A4; Serology testing on 22AUG90 showed that vaccinee failed to seroconvert.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee was given a series of 3 Engerix-B vaccinations on 4DEC89 lot no. 585A4, 2JAN90 lot no 586A4, & 31MAY90 lot no 587A4; Serology testing on 22AUG90 showed that vaccinee failed to seroconvert.
Sex: F
Vaccine: HEP
Symptoms: Dermatomyositis, Rash
Clinical narrative: Vaccinee rec'd 1st Engerix-B vax (unspecified date) & experienced a rash that lasted several days. P/2nd Engerix-B vax on 18OCT90 again experienced rash which lasted 7-10 days.
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Urticaria
Clinical narrative: P/1st Engerix-B vax, vaccinee developed hives & swollen lips; events resolved.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Drug ineffective
Clinical narrative: Vaccinee completed course of Engerix-B vaccinations (dates unspecified). Antibody test, done one month p/last dose or sooner, showed she was a non responder.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Visual disturbance
Clinical narrative: Pt had series of Engerix-B vaccinations; Did not respond to first 3 shots. P/given the 4th & 5th shots experienced visual disturbances described as "cob webs or floaters."  Eye MD said not serious. 05NOV90-floaters have dec; flashers unchng
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Eleven pts did not seroconvert /p 4 th dose are waiting for possible 5th dose.  Three women did not seroconvert /p 5th dose.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd an Engerix B series of 3 doses according to 0,1,6 months schedule. Serum Hepatitis BSAB test was Negative @ F/U. Repeat dosage of Engerix-B was planned @ month #9.
Age: 29.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 doses of Engerix B on 25FEb90, 26Mar90 & 27Apr90; 0,1, 2 dose prescribed for needlestick while working in hospital, has 2nd needlestick on 20Jul90
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Asthenia, Headache, Hypersensitivity
Clinical narrative: 5Oct90 /p the 2nd dose of Engerix B, pt experienced sweating;malaise;chills;weakness;headache;severe nausea & vomiting;abd cramps & muscular neuralgia, pt went to ER, was not admitted.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Neuralgia, Tinnitus
Clinical narrative: 5Oct90 /p the 2nd dose of Engerix B, pt experienced sweating;malaise;chills;weakness;headache;severe nausea & vomiting;abd cramps & muscular neuralgia, pt went to ER, was not admitted.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site pain, Lymphadenopathy, Malaise, Pain, Pseudo lymphoma
Clinical narrative: Pt had swelling of lymph gland(under armpit) 1 wk /p 1st vax, SX abated days later, event occurred again 2 days /p 2nd vax, pt recvd 1st dose 28Aug90 & a few days later developed sinusitis,9Sep90 noted lt axilla egg size lymph node,see WORM
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Pt had swelling of lymph gland(under armpit) 1 wk /p 1st vax, SX abated days later, event occurred again 2 days /p 2nd vax, pt recvd 1st dose 28Aug90 & a few days later developed sinusitis,9Sep90 noted lt axilla egg size lymph node,see WORM
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site pain, Lymphadenopathy, Malaise, Pseudo lymphoma, Pyrexia
Clinical narrative: Pt had swelling of lymph gland(under armpit) 1 wk /p 1st vax, SX abated days later, event occurred again 2 days /p 2nd vax, pt recvd 1st dose 28Aug90 & a few days later developed sinusitis,9Sep90 noted lt axilla egg size lymph node,see WORM
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Sinusitis
Clinical narrative: Pt had swelling of lymph gland(under armpit) 1 wk /p 1st vax, SX abated days later, event occurred again 2 days /p 2nd vax, pt recvd 1st dose 28Aug90 & a few days later developed sinusitis,9Sep90 noted lt axilla egg size lymph node,see WORM
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: 4Oct90 pt treated /w Engerix B & experienced shingles (1 or 2 days post vax) Event was teated /w Lortab (acetaminophen/hydrocodone) for pain. Event persists
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt non responder /p ea of 4 doses of Engerix B
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Reporter indicates pt experienced a "failure to achieve antibody titers /p 3 doses of 20 mcg ea of Engerix B".
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt recvd 3 Engerix B injections & experienced negative Hepatitis B antibody "/p injection 10Sep90".
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Migraine
Clinical narrative: Pt experienced severe migrainous headache ("worst headache of life") & dizziness on the night of 11Oct90 (this was post 1st dose-11Oct90)  treated /w Fiorinal & "still has headache."
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Myalgia, Pain, Somnolence
Clinical narrative: 28Sep90 pt (/p 2nd dose in series) developed heaviness in ankles in both feet (1st rt then lt) 10 min /p vax, couple days later developed pain in legs, then felt warm, Next day pain all over body lethargic, pt now "feels better".
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Vasodilatation
Clinical narrative: 28Sep90 pt (/p 2nd dose in series) developed heaviness in ankles in both feet (1st rt then lt) 10 min /p vax, couple days later developed pain in legs, then felt warm, Next day pain all over body lethargic, pt now "feels better".
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd a series of 3 Engerix-B, serology done (about 1 month /p 3rd dose) indicated that pt failed to develop titers, revax series (3 doses) started 12Sep90 /w Engerix B Lot # 618A4, and 15Oct90, no treatment has been required
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt recvd a series of 3 Engerix B vaxs. Serology done 31Aug90 (about 1 mon /p 3rd vax) indicated that pt failed to develop titers, revax was offered, pt restarted 3 shot vax series,1st inject 29Oct90, no treatment required
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Outcome "fine" /p 1st 2 doses Engerix B, titer found nonresponse /p 3rd dose, will give additional doses, 2 additional doses of vax @ a 1 month interval given, outcome not yet known.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Received 3 doses Hepatitis B vaccine (brand known) & was nonresponder.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Of 200 plus people who rec'd full series of Engerix-B, 7 people did not respond; Vaccinee is one of five employees who have been identified as non responders following a series of 3 engerix-B injections;
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Oedema, Vasodilatation
Clinical narrative: 2-3 days p/ 1st dose, reporter informed that pt had a red, 50 cent size mark on lt arm, paled in about a wk. 3 days p/2nd dose reporter informed lt arm swollen, red & warm to hot fr shoulder to elbow. Subsided in few days.
Sex: F
Vaccine: HEP
Symptoms: Depression
Clinical narrative: Vaccinee experienced depression the day after she rec'd a third dose. Condition resolved.
Age: 20.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Tongue discolouration
Clinical narrative: Pt rec'd first dose on 24SEP90; Had onset of yellow tongue ("Top & bottom") on 26SEP90. no treatment was given. Outcome is unknown;
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Dizziness, Nausea, Vomiting
Clinical narrative: Pt rec'd 1st dose Engerix-B experienced lightheadedness (immediately), anorexia; This was followed by nausea; vomiting started 8 hrs post vax & persisted for approx 8 to 10 hrs. sx resolved p/24 hrs, w/o treatment.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Outcome "fine" p/1st 2 doses Engerix-B (Deltoid). Titer found inadequate response p/3rd dose. Will give 2 additional doses.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Outcome "fine" p/ first 2 doses Engerix-B (Deltoid); Titer found inadequate response p/3rd dose. Will give 2 additional doses;
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: As of SEP, more than 2 months p/receiving Engerix-B as the 3rd dose in a series of Recombivax-HB (1st two doses) and Engerix-B, pt had inadequate levels of anitbodies.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: After 3rd dose 3AUG90, 20 MCG, Im Deltoid 4 pts experienced a non-response. Reporter indicated plan is to revaccinate w/2 more doses.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Skin discolouration
Clinical narrative: On 13AUG90 exp nightime swelling on face, around eyes, periorbital (nose), top lip, alar ridge(side crease on nose). Has daytime hyperpigmentation underneath eyes; swelling goes away during day, hyperpigmentation cont's.  No tx, no 3rd dose
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen
Clinical narrative: Pt rec'd 1st dose of Engerix-B on 31JUL90; Rec'd 2nd dose on 31AUG90; on 30SEP90 tested positive for Hepatitis B Surface Antigen; Hepatic profile was negative; Test repeated 2X at original lab w/ controversial results.  Another lab, was neg
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Anaemia, Diarrhoea, Hypokalaemia, Injection site reaction
Clinical narrative: First dose on 16JAN90 & 2nd dose on 16FEB90; P/2nd dose experienced local redness & swelling. Third dose given 26SEP90 & experienced severe N&V, diarrhea, abd cramps; Seen in ER; Given IV fluids for dec K & HCT; sxs resolved x/ abd cramps.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Oedema, Vomiting
Clinical narrative: First dose on 16JAN90 & 2nd dose on 16FEB90; P/2nd dose experienced local redness & swelling. Third dose given 26SEP90 & experienced severe N&V, diarrhea, abd cramps; Seen in ER; Given IV fluids for dec K & HCT; sxs resolved x/ abd cramps.
Sex: F
Vaccine: HEP
Symptoms: Influenza, Pyrexia
Clinical narrative: 21SEP90; w/in 8-10 hrs of receiving vax, pt developed influenza-type sx & fever; Events resolved w/in 5 days; No known tx provided;
Sex: M
Vaccine: HEP
Symptoms: Influenza, Pyrexia
Clinical narrative: 21SEP90: w/in 8-10 hrs of receiving vax, pt developed influenza-type sx & fever. Events resolved w/in 5 days; No known tx provided;
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Hair disorder, Hypercholesterolaemia, Malaise, Pruritus, Rash
Clinical narrative: Rec'd Engerix-B 25JUL90; 2 wks p/therapy 8AUG90 experienced itching, bilateral rash on arms & shins, & "felting" of hair; Engerix-B discontinued & was treated w/Histamil (? Hismanal) & topical ointments for rash. Sx subsided.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Injection site pain, Pain
Clinical narrative: Rec'd 1 shot of Engerix-B 26JUN90; Had pain on inject & experienced listlessness & fatigued for 3-4 wks; c/o varying deg pain & soreness in inject arm.  Vax d/c'd.
Sex: F
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: 24SEP90: w/in 8-10 hrs of being vaccinated, pt developed influenza-type sx; sx resolved w/in 5 days; No known tx required;
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Pt given 2nd dose of Engerix-B one month p/first; Six months later (recently) given third dose; M.D. did not seroconvert p/the third dose.
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Nausea, Neck pain, Pain
Clinical narrative: Some pts had pain @ inject site p/1st dose, some p/2nd & some p/the third dose; No tx was given.
Sex: U
Vaccine: HEP
Symptoms: Paraesthesia, Vasodilatation
Clinical narrative: Some pts had pain @ inject site p/1st dose, some p/2nd & some p/the third dose; No tx was given.