chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: LYME
Symptoms: Abdominal pain, Back pain, Injection site oedema, Injection site pain, Neoplasm
Clinical narrative: p/vax pt exp back pain to lt side as well as abdominal pain; back pain became more diffuse; CT scan revealed pelvic mass;under investigation;MD states mass no clear relation to vax; also local react; sore & swollen arm; low-grade fever;
Age: 61.0
Sex: F
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: p/vax pt exp back pain to lt side as well as abdominal pain; back pain became more diffuse; CT scan revealed pelvic mass;under investigation;MD states mass no clear relation to vax; also local react; sore & swollen arm; low-grade fever;
Age: 81.0
Sex: F
Vaccine: LYME
Symptoms: Eye disorder, Eye pain, Herpes zoster
Clinical narrative: p/vax pt devel pain in lt eye; seen by MD who noted an abrasion in eye; 2wks later had mammogram & shingles were found both breasts; MD representative stated pt had mild herpes zoster on rt chest; tx w/famvir
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Asthenia, Dyspepsia, Headache, Weight decreased
Clinical narrative: p/vax pt c/o weight loss; arthritis symptoms; h/a; tiredness & upset stomach; took ADVIL; it helped a little; Medical record of April 27, 1999 noted that the patient complained of pain in both breasts. The diagnosis was "rule out breast mass". April 3, 2000 medical record noted "lumpy left breast". The vaccinee was diagnosed with "rule out breast mass" and PREMPRO was prescribed. May 2, 2000 physical therapy note: The vaccinee complained of pain in both hands, lumbar spine, both hips, both feet, toes, callus muscles, adn forearm muscles. Patient also had a "constant" headache and weak grip. The vaccinee stated that these symptoms were caused by "medication". The vaccinee had positive myofascial restrictions, normal upper and lower extremity range of motion, and normal ankle strength. May 30, 2000 physical therapy report: the vaccinee received six sessions of physical therapy. Treatment protocol consisted of soft tissue techniques, range of motion, stretching, moist heat, "E-stim", paraffin to bilateral hands, home exercise program, and a comprehensive stretching and strengthening pool program. At discharge, the vaccinee reported good/bad days. Pain complaints fluctuated in intensity and region. Objectively, active range of motion was normal throughout all tested regions. Gross strength was within functional limits. Special testing revealed scoliosis. Myofascial restrictions were significant throughout T/&/L/S (thoracic and lumbar spine) At discharge, the vaccinee was encouraged to manage her condition with stretching and strengthening, including a pool program. It was recommended that patient perform light impact activities, i.e. walking, swimming, for cardiovascular fitness. Recommendation: discharge with home exercises program. June 29, 2000 medical record noted"vaginal lump". The vaccinee was diagnoses with left Bartholin abscess and underwent marsupialization of the left Bartholin abscess on July 1, 2000. The patient tolerated the procedure well. The Bartholin biopsy abscess showed "fragments of fibroconnective tissue with acute and chronic inflammation; no epithelial lining seen." Please note that the events of "lumpy breast mass" and "Bartholin abscess" were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's health records. Therefore they are not listed as adverse events. As of June 12, 2001, the outcome of the events is unknown. The adverse events of 'headache' and 'osteoarthritis' do not meet ICN serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Follow up received 7/2001.
Age: 43.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Asthenia, Injection site hypersensitivity, Injection site mass, Myalgia, Pruritus
Clinical narrative: p/vax pt exp rash on arm; sore muscles; fatigue; inj site induration & itching;
Age: 43.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Rash
Clinical narrative: p/vax pt exp rash on arm; sore muscles; fatigue; inj site induration & itching;
Age: 43.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Influenza, Injection site hypersensitivity, Injection site oedema
Clinical narrative: p/vax pt exp rash on arm; sore muscles; fatigue; inj site induration & itching;
Age: 43.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Asthenia, Injection site hypersensitivity, Injection site mass, Myalgia, Pruritus
Clinical narrative: p/vax pt exp swelling & persistent redness @ the inj site;also 5 days later pt exp flu-like sx & joint pain;
Age: 43.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Rash
Clinical narrative: p/vax pt exp swelling & persistent redness @ the inj site;also 5 days later pt exp flu-like sx & joint pain;
Age: 43.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Influenza, Injection site hypersensitivity, Injection site oedema
Clinical narrative: p/vax pt exp swelling & persistent redness @ the inj site;also 5 days later pt exp flu-like sx & joint pain;
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Pyrexia
Clinical narrative: p/vax pt exp chills; fever and fatigue; no treatment given
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Somnolence
Clinical narrative: p/vax pt exp feeling tired and sleepy
Age: 38.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Influenza
Clinical narrative: p/vax pt exp fatigue; arthralgias and flu-like symptoms; supportive measures were given as tx
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Eczema, Rash
Clinical narrative: p/vax pt devel a rash near inj site it was most intensely red, but also broke out on both upper & lower extremities including hands & tops of feet;tx cortaid 1% & claritin;described as eczematous dermatitis by dermatologist;
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: p/vax pt exp nausea, feeling cold, internal tremors & had an elevated temp of 101.6;
Age: 18.0
Sex: M
Vaccine: LYME
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: p/vax pt exp uncontrollable sweating, chills, & legs hurt;
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Injection site pain, Vaginal haemorrhage
Clinical narrative: p/vax pt exp extreme fatigue;approx 25 days later pt exp heavy vaginal bleeding;LoOvral given as tx;vaginal bleeding lasted 4 days & fatigue resolved;
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia
Clinical narrative: p/vax pt exp extreme fatigue;no tx given;
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Hypokinesia, Skin nodule
Clinical narrative: p/vax pt exp a lump on arm the size of a peach & diff lifting arm;sx were treated w/hot compresses;
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain, Pain
Clinical narrative: p/vax pt exp localized lt arm pain @ the inj site & pain on lt side from buttock to knee;
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: p/vax pt c/o severe soreness in shoulder area;pt sx ongoing;
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Chills, Hypokinesia, Infection, Influenza, Injection site pain
Clinical narrative: p/vax pt exp stiff neck-resolved in 1wk, lethargy, chills;tx for Lyme Disease w/doxycycline but tested IgG negative for Lyme disease;sx worsened became bedridden x 1wk;inability to think clearly;pallor & chills;dx clostridium difficile;
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Nuchal rigidity, Pallor, Somnolence, Thinking abnormal
Clinical narrative: p/vax pt exp stiff neck-resolved in 1wk, lethargy, chills;tx for Lyme Disease w/doxycycline but tested IgG negative for Lyme disease;sx worsened became bedridden x 1wk;inability to think clearly;pallor & chills;dx clostridium difficile;
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: p/vax pt exp arthralgias, myalgias & h/a, heart palpitations;no cardiac testing was performed;
Sex: F
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Myalgia
Clinical narrative: p/vax pt exp entire lt arm & shoulder became sore;3 days later exp rash 5x2 inches & swelling @ the inj site;no tx given & lymerix was discontinued;
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Vasodilatation
Clinical narrative: p/vax pt exp a 6-7 inch painful, red, hot & swollen area @ inj site;no tx given;the most recent info recv on 6/3/99 reports their sx resolved;
Age: 15.0
Sex: F
Vaccine: LYME
Symptoms: Influenza, Osteoarthritis
Clinical narrative: p/vax pt exp flu-like sx & joint swelling of the knees & fingers;sx resolved;
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Influenza, Injection site pain, Lymphadenopathy, Myalgia, Pharyngitis
Clinical narrative: p/vax pt exp inj site pain & tenderness;the next day pt exp muscle pain, body aches, worst sore throat ever had, swollen neck glands, fever & general flu-like sx;sx resolved;
Sex: F
Vaccine: LYME
Symptoms: Oedema peripheral
Clinical narrative: p/vax pt exp swollen hands;
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Amblyopia, Hypokinesia, Injection site pain, Laryngospasm, Nausea
Clinical narrative: p/vax pt devel blurred vision, facial flushing, nausea, felt as if throat was closing;pt also devel tenderness @ lt deltoid region which progressed to a sore lt arm where had limited ROM;pt recovered;
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Vasodilatation
Clinical narrative: p/vax pt devel blurred vision, facial flushing, nausea, felt as if throat was closing;pt also devel tenderness @ lt deltoid region which progressed to a sore lt arm where had limited ROM;pt recovered;
Sex: M
Vaccine: LYME
Symptoms: Facial palsy, Pain, Speech disorder
Clinical narrative: p/vax pt exp diff speaking & mouth was distorted;ER visit was required & was treated w/DPH;next day devel a severe tooth ache;seen by dentist who found nothing wrong;sx resolved in approx 2 days;
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Myalgia, Neck pain, Pain
Clinical narrative: p/vax pt exp pain, achiness & stiffness (no swelling) in the inj arm, which radiated up to neck & down the lt side of back;pt said could not lift arm above shoulder height;pt took some ASA & pain resolved;
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: p/vax pt devel a fever which reached 102.2 5/27/99;6/26/99 exp severe chills & diarrhea;tx w/APAP;lymerix was discontinued;pt condition is ongoing;
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: p/vax pt exp bilat hip pain;no tx given;lymerix was discontinued;pt condition is ongoing;
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Headache, Hyperhidrosis, Hypertonia, Hypokinesia
Clinical narrative: p/vax pt exp severe h/a, nausea, muscular cramping, sweating,joint pain, tingling in arms (could not grip), loss of strength in arms, diff walking;rx DPH;pt recovered;
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Myasthenic syndrome, Nausea, Paraesthesia
Clinical narrative: p/vax pt exp severe h/a, nausea, muscular cramping, sweating,joint pain, tingling in arms (could not grip), loss of strength in arms, diff walking;rx DPH;pt recovered;
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: p/vax pt noted pain in lt foot in the joint between the great toe & the ball of the foot;pt did not seek medical attention & as of 6/9/99 the pain persists;
Age: 53.0
Sex: U
Vaccine: LYME
Symptoms: Hypokinesia, Pain, Vasodilatation
Clinical narrative: p/vax pt exp inflammation of soles of the feet w/burning & redness;pt had great distress walking & could not wear shoes;
Age: 14.0
Sex: F
Vaccine: LYME
Symptoms: Erythema, Oedema, Pain
Clinical narrative: p/vax exp 2 1/2oval (red outlined) area which was swollen & was painful w/pressure;MD visit was required;pt condition unk; Case, reference number 1999013570-1, is a spontaneous report from a physician concerning a fourtenn year old female. No allergies, medical history, and concomitant medications. No illness at the time of vaccination. The patient received the first dose of LYMERIX (pre-filled syringe) without incident on April 24, 1999 to prevent Lyme disease. The patient received the second dose of LYMERIX (pre-filled syringe) on 27-May-99. Five days later, on 01-Jun-99, the patient experienced a 4 inch oval (red outlined) area around the injection site which was swollen and was painful with pressure. A doctor visit was required. No treatment was given.
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: p/vax pt noticed joint pain;as of 6/9/99 pain persists;
Sex: U
Vaccine: LYME
Symptoms: Influenza, Injection site hypersensitivity
Clinical narrative: p/vax pt exp serious flu sx & erythema @ the inj site;pt was seen in ER;sx resolved on day 6 or 7;
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: p/vax pt c/o arthralgias, myalgias & fever;pt condition is unk;
Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Drug hypersensitivity, Erythema migrans, Immediate post-injection reaction, Pruritus, Rash
Clinical narrative: p/vax pt exp arthus phenomenon on a total of four occasions p/both lymerix doses respectively;tics were on for a short period of time (1-4 hours) producing this phenomenon;pt exp erythema migrans;pt condition outcome unk; Case, reference number 1999013677-1, is a spontaneous report from a 66 year old male physician/consumer and a physician. Allergic to penicillin. No medical history, or concomitant medications. No illness at the time of vaccination. On unspecified dates, the patient received the first and second IM-left deltoid doses of LYMERIX for prevention of Lyme disease. The patient experienced possible Arthus phenomenon on a total of four occasions within a few hours after both LYMERIX doses, respectively. Tics were on for a short period of time (1-6 hours) producing this phenomenon. A long lasting reaction (local reaction weeks up to more than one month at injection site) was experienced. The patient developed a localized area of induration without fever, chills, or arthritis. He also experienced erythema migrans, and intense itching. Patient stated that he had imperfect protection with LYMERIX. The physcian/consumer attributed this reaction to LYMERIX but when it was pointed out that the chance of being bitten by four infected ticks at the same time was extremely small, he realized that this was not probable, and concluded that these were local reactions to a tick bite possibly due to a reaction to tick saliva but probably not true Arthus reactions and not related to LYMERIX. The patient's physician stated that symptoms had an incomplete resolution. There is still itching at the sites. The most recent information, received on 10-Nov-99, reports the outcome of the patient as ongoing.
Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Serum sickness, Tic, Type III immune complex mediated reaction
Clinical narrative: p/vax pt exp arthus phenomenon on a total of four occasions p/both lymerix doses respectively;tics were on for a short period of time (1-4 hours) producing this phenomenon;pt exp erythema migrans;pt condition outcome unk; Case, reference number 1999013677-1, is a spontaneous report from a 66 year old male physician/consumer and a physician. Allergic to penicillin. No medical history, or concomitant medications. No illness at the time of vaccination. On unspecified dates, the patient received the first and second IM-left deltoid doses of LYMERIX for prevention of Lyme disease. The patient experienced possible Arthus phenomenon on a total of four occasions within a few hours after both LYMERIX doses, respectively. Tics were on for a short period of time (1-6 hours) producing this phenomenon. A long lasting reaction (local reaction weeks up to more than one month at injection site) was experienced. The patient developed a localized area of induration without fever, chills, or arthritis. He also experienced erythema migrans, and intense itching. Patient stated that he had imperfect protection with LYMERIX. The physcian/consumer attributed this reaction to LYMERIX but when it was pointed out that the chance of being bitten by four infected ticks at the same time was extremely small, he realized that this was not probable, and concluded that these were local reactions to a tick bite possibly due to a reaction to tick saliva but probably not true Arthus reactions and not related to LYMERIX. The patient's physician stated that symptoms had an incomplete resolution. There is still itching at the sites. The most recent information, received on 10-Nov-99, reports the outcome of the patient as ongoing.
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Anaemia, Asthenia, Dehydration, Haematuria, Infection
Clinical narrative: p/vax pt exp fever, chills & severe pain in inj site arm;pt w/fever & intermittent chills;T100 tympanic;also cough, body aches, fatigue & feeling dry;blood & leucocytes in urine & urine cult showed E-coli >100,000;tx w/cipro & keflex;
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Laboratory test abnormal, Myalgia, Pyrexia, Urine analysis abnormal
Clinical narrative: p/vax pt exp fever, chills & severe pain in inj site arm;pt w/fever & intermittent chills;T100 tympanic;also cough, body aches, fatigue & feeling dry;blood & leucocytes in urine & urine cult showed E-coli >100,000;tx w/cipro & keflex;
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: p/vax pt exp swelling, pain & redness @ the site of inj (which was the size of an orange);pt was seen by MD 5/21/99 who said that pt inj site looked like cellulitis;pt outcome unk;
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Influenza
Clinical narrative: p/vax pt exp flu-like sx & fatigue;no tx was given;pt condition is not yet resolved;
Sex: U
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: p/vax pt exp stiff joints;lymerix was discontinued;pt recovered;
Age: 33.0
Sex: M
Vaccine: LYME
Symptoms: Injection site hypersensitivity
Clinical narrative: p/vax pt exp a localized skin rxn blotchy erythema, triangular shaped & 5 inches in length;no tx given & lymerix was discontinued;pt recovered;
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Injection site hypersensitivity, Injection site oedema
Clinical narrative: p/vax pt exp a swollen lt arm from shoulder to just above elbow, a hot 4 inch red circle @ the inj site, & a recurrence of fatigue;pt took own antihistamines;lymerix discontinued;outcome not provided;
Age: 16.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Eye pain, Myalgia, Osteoarthritis
Clinical narrative: p/vax pt exp muscle pain, swollen knee, fatigue & burning eyes;MD visit was required & was treated w/Ibuprofen & eyedrops;pt condition is ongoing;
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Headache, Neck pain, Vomiting
Clinical narrative: p/vax pt exp intense h/a from head to back of neck, vomited once & was dizzy;ER or MD visit was required;all vital signs were nl @ time of report & sx were resolving;
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Tremor
Clinical narrative: p/vax pt exp uncontrolled shaking (no fever) which lasted thirty minutes & no fever;pt recovered;
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Chills, Influenza, Injection site pain, Myalgia
Clinical narrative: p/vax pt exp a sore arm @ inj site, body aches, flu-like sx & chills;pt shook all over & was fatigued;tx w/ 3 ecotrin tabs;lymerix was discontinued;pt recovered;
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Rash maculo-papular
Clinical narrative: p/vax pt devel a systemic hypersensitivity rxn of macular annular dermatitis & was dx w/Gianotti-Crosti synd;seen by dermatologist;tx w/pred;MD felt rxn r/t vax;
Age: 19.0
Sex: F
Vaccine: LYME
Symptoms: Face oedema, Headache, Myalgia, Urticaria, Vomiting
Clinical narrative: p/vax pt devel hives & swelling of lips;sx temporarily relieved w/antihistamines;next day pt devel low grade aches & pain which got worse;pt had muscle aches, h/a & by 6/14/99 pt presented to MD office vomiting;
Sex: M
Vaccine: LYME
Symptoms: Erectile dysfunction
Clinical narrative: p/vax pt exp impotence;
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Headache, Neck pain, Renal pain
Clinical narrative: p/vax pt exp h/a, joint ache, back pain, neck pain, kidney pain;h/a was described as being @ the base of the neck & whole head;no tx given;pt seen by MD office & had blood work done (results not available @ time of report);tx doxycycline;
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: p/vax pt exp severe arm soreness;
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Asthma, Dyspnoea, Rash maculo-papular
Clinical narrative: p/vax pt devel a papular rash on inside of rt thigh;over the next 24-36hr pt devel progressive rash;pt devel SOB w/wheezing;tx w/medrol dosepak;pt had dramatic improvement w/in 48hr of initiating steroid therapy;lymerix d/c;
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus, Vasodilatation
Clinical narrative: p/vax pt exp  itching & a hot swollen area greater than 2 inches @ the inj site & tx w/DPH & ice;pt condition ongoing;
Age: 35.0
Sex: M
Vaccine: LYME
Symptoms: Convulsion, Dizziness, Influenza, Laryngospasm, Pyrexia
Clinical narrative: p/vax pt started having convuls (shaking real bad), throat started to swell up, felt like fainting & had fever & flu like sx;pt was brought back to clinic & sx resolved in 1hr;no tx given;
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Chills, Headache, Injection site hypersensitivity, Injection site mass
Clinical narrative: p/vax pt w/a red, raised, itchy, & burning bullseye rash below the inj site way down past elbow;had chills, fatigue & h/a lasting almost 2wk;arm still burns & itches from time to time;pt found that was falling asleep @ work & while driving;
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Pain, Pruritus, Somnolence, Vasodilatation
Clinical narrative: p/vax pt w/a red, raised, itchy, & burning bullseye rash below the inj site way down past elbow;had chills, fatigue & h/a lasting almost 2wk;arm still burns & itches from time to time;pt found that was falling asleep @ work & while driving;
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Headache, Influenza, Injection site hypersensitivity, Injection site mass
Clinical narrative: p/vax pt exp fatigue, h/a & aches all over body;pt exp flu-like sx;inj site was 1 1/2inches long x 1 inch wide, raised, sore & bright pink;whole are, shoulder, & neck on the inj site side were most painful;
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain, Myalgia, Vasodilatation
Clinical narrative: p/vax pt exp fatigue, h/a & aches all over body;pt exp flu-like sx;inj site was 1 1/2inches long x 1 inch wide, raised, sore & bright pink;whole are, shoulder, & neck on the inj site side were most painful;
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Jaundice
Clinical narrative: p/vax pt exp jaundice;ER or MD visit was required;no tx was given;lab studies were negative for hep A, B, & C;outcome of pt is unk;
Sex: U
Vaccine: LYME
Symptoms: Hypertonia, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: p/vax pt exp shoulder tightness; p/36hr pt devel nausea, fever & enlarged lymph nodes;pt outcome is unk;
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Herpes zoster, Osteoarthritis, Rash
Clinical narrative: p/vax pt exp bullseye rash, joint swelling, arthritic pain, herpes zoster outbreak;tx w/percocet for post herpetic neuralgia;lymerix was discontinued;pt recovered;
Age: 36.0
Sex: F
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: p/vax pt exp soreness @ the inj site;the next day pt exp severe pain @ the inj site & was unable to move arm;no tx given;
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Influenza
Clinical narrative: p/vax pt exp flu-like sx which resolved in a a few days;
Sex: M
Vaccine: LYME
Symptoms: Chills, Dyspepsia, Influenza, Myalgia
Clinical narrative: p/vax pt exp bilat flank pain & flu-like sx: chills & upset stomach;the flank pain increased then decreased in severity lasting 2-3minutes;
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Influenza, Myalgia, Pyrexia
Clinical narrative: p/vax pt exp flu-like sx: fever, muscle aches throughout body for 1 day which was followed by arthralgias throughout body;tx w/anti-inflammatory meds;lymerix discontinued;
Sex: U
Vaccine: LYME
Symptoms: Rash
Clinical narrative: p/vax pt devel a skin rash, not @ the inj site;pt condition is unk;
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: p/vax pt exp pain in rt hip joint;no tx given;addtl info recv states pt condition is worsening;
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Convulsion
Clinical narrative: 7days p/vax pt exp seizures. pt moved. reporter doesn't have any clinical info, has heard this dtap is bad lot. supposedly is taking pt to for further exam
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Convulsion, Hypertonia, Tremor
Clinical narrative: 7days p/vax pt exp seizures. pt moved. reporter doesn't have any clinical info, has heard this dtap is bad lot. supposedly is taking pt to for further exam
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Cough, Myalgia, Pyrexia
Clinical narrative: p/vax pt exp T103; cough; joint pain; muscle pain; sore shoulder; tx: antibiotic;
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Headache, Injection site hypersensitivity, Injection site pain, Myalgia
Clinical narrative: p/vax pt exp raised deep pink rash from elbow to shoulder on inj arm; inj arm achiness; shooting pain in neck & back; severe h/a; & achy joints;tx--ibuprofen;
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Neck pain, Rash
Clinical narrative: p/vax pt exp raised deep pink rash from elbow to shoulder on inj arm; inj arm achiness; shooting pain in neck & back; severe h/a; & achy joints;tx--ibuprofen;
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Pyrexia
Clinical narrative: p/vax pt exp a fever & a severe ache in joints;
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema, Injection site pain, Oedema peripheral
Clinical narrative: p/vax pt exp peripheral edema & pain;pt to MD w/sx;pt recovered;
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV, DTAP, HBHEPB, IPV, RV
Symptoms: Oedema peripheral, Pain
Clinical narrative: p/vax pt exp peripheral edema & pain;pt to MD w/sx;pt recovered;
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV, RV
Symptoms: Constipation
Clinical narrative: approx 3 wks p/vax pt exp unspecified side effects; 5/5 pt hosp, laparotomy & appendectomy performed, dx of intussusception was made.  Received on 09/12/2000: "A sales representative reported a 2-month-old male received his first dose of Rota Shild on 03/04/1999.  On 05/05/1999, he was hospitalized.  A laparotomy and appendectomy were performed, and a diagnosis of intussuception was made.  This is 1 of 2 patients from this facility who experienced this event following receipt of Rota Shield.  This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA.  Additional information was received from the physician on 07/23/1999.  The infant developed loose stools without fever, 2 or 3 days post-immunization.  The loose stools persisted until the time the infant was hospitalized.  The infant underwent surgical reduction of the intussusception and appendectomy.  No other resection of intestinal tissue was performed.  Follow-up information received from the physician on 09/05/2000 provided the Rota Shield lot number.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV, RV
Symptoms: Abnormal faeces
Clinical narrative: approx 3 wks p/vax pt exp unspecified side effects; 5/5 pt hosp, laparotomy & appendectomy performed, dx of intussusception was made.  Received on 09/12/2000: "A sales representative reported a 2-month-old male received his first dose of Rota Shild on 03/04/1999.  On 05/05/1999, he was hospitalized.  A laparotomy and appendectomy were performed, and a diagnosis of intussuception was made.  This is 1 of 2 patients from this facility who experienced this event following receipt of Rota Shield.  This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA.  Additional information was received from the physician on 07/23/1999.  The infant developed loose stools without fever, 2 or 3 days post-immunization.  The loose stools persisted until the time the infant was hospitalized.  The infant underwent surgical reduction of the intussusception and appendectomy.  No other resection of intestinal tissue was performed.  Follow-up information received from the physician on 09/05/2000 provided the Rota Shield lot number.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Epistaxis, Somnolence
Clinical narrative: p/vax pt exp a nose bleed in the car ride home from the ped office;pt returned to the office & only dried blood was noted in nostrils;
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Epistaxis
Clinical narrative: p/vax pt exp a nose bleed in the car ride home from the ped office;pt returned to the office & only dried blood was noted in nostrils;
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Diarrhoea, Gastrointestinal haemorrhage
Clinical narrative: p/vax pt devel loose stools containing blood tinged mucous;pt was seen by MD & recovered w/o tx;
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site hypersensitivity, Vasodilatation
Clinical narrative: 3days p/vax pt exp allergic react, palms red, rash on lt leg. warm compress & tylenol
Age: 10.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain, Rash
Clinical narrative: localized rash on left arm + pain down left arm immed p/inject
Age: 10.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: localized rash on left arm + pain down left arm immed p/inject
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, RV
Symptoms: Gastrointestinal necrosis
Clinical narrative: approx 3wk p/vax pt devel abd distress & vomiting; dx= intussusception; surgery 3/25;
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, RV
Symptoms: Dyspepsia, Gastrointestinal haemorrhage, Gastrointestinal necrosis, Vomiting
Clinical narrative: approx 3wk p/vax pt devel abd distress & vomiting; dx= intussusception; surgery 3/25;
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Chills, Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: pt felt dizzy then fainted
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Dizziness, Syncope
Clinical narrative: pt felt dizzy then fainted
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV, RV, DTAP, HIBV, IPV, RV
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Gastrointestinal haemorrhage, Vomiting
Clinical narrative: pt presented to ER on 7/31 w/vomiting & diarrhea. dx on 8/1 w/intussusception. pt had bloody stools and diarrhea
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV, RV, DTAP, HIBV, IPV, RV
Symptoms: Gastrointestinal haemorrhage, Haematemesis, Vomiting
Clinical narrative: pt presented to ER on 7/31 w/vomiting & diarrhea. dx on 8/1 w/intussusception. pt had bloody stools and diarrhea
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Blindness, Myasthenic syndrome, Pyrexia
Clinical narrative: white flashes, stringing black things in visual field, rt eye; intermittently:  arthralgias, nausea, vomiting, weight loss, fever, fatigue & muscle weakness; rt eye deteriorated; dx rt retinal necrosis & 1999 dx w/Raynaud's disease
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Red blood cell sedimentation rate increased, Retinal disorder, Visual disturbance, Visual field defect, Vitreous disorder
Clinical narrative: white flashes, stringing black things in visual field, rt eye; intermittently:  arthralgias, nausea, vomiting, weight loss, fever, fatigue & muscle weakness; rt eye deteriorated; dx rt retinal necrosis & 1999 dx w/Raynaud's disease
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting, Weight decreased
Clinical narrative: white flashes, stringing black things in visual field, rt eye; intermittently:  arthralgias, nausea, vomiting, weight loss, fever, fatigue & muscle weakness; rt eye deteriorated; dx rt retinal necrosis & 1999 dx w/Raynaud's disease
Sex: M
Vaccine: HEP
Symptoms: Sudden infant death syndrome, Unevaluable event
Clinical narrative: SIDS - 11/25/1998. MD reported pt had a displaced skull fracture
Age: 20.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abdominal pain, Alopecia, Arthralgia, Hypotension, Myalgia
Clinical narrative: pt has hx of thrombocytopenia, tx w/Vincristin; 7/98 pt recurrent episodes of thrombocytopenia, tx w/Vincristin; pt had painful rash lower extremities, severe myalgias& leg pain, dx=urticarial vasculitis; abd pain; low immunoglobulins Per follow-up dated 9/18/00, the pt continues to have severe recurrent vasculitis, thrombocytopenia, headaches, arthralgias, chronic pain, and immune suppression.  Doc #201751 states that patient continues to have severe recurrent, vasculitis, thrombocytopenia, headaches, arthralgias, chronic pain and immune suppression
Age: 20.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pain, Rash, Thrombocytopenia, Urticaria, Vasculitis
Clinical narrative: pt has hx of thrombocytopenia, tx w/Vincristin; 7/98 pt recurrent episodes of thrombocytopenia, tx w/Vincristin; pt had painful rash lower extremities, severe myalgias& leg pain, dx=urticarial vasculitis; abd pain; low immunoglobulins Per follow-up dated 9/18/00, the pt continues to have severe recurrent vasculitis, thrombocytopenia, headaches, arthralgias, chronic pain, and immune suppression.  Doc #201751 states that patient continues to have severe recurrent, vasculitis, thrombocytopenia, headaches, arthralgias, chronic pain and immune suppression
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: approx 8 days p/vax pt  document to have Alopecia Areata; Annual follow-up provided no additional data.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Diabetes mellitus
Clinical narrative: pt vax in 12/98 & in 4/99 pt was dx of type 1 diabetes
Age: 0.5
Sex: M
Vaccine: DTAP, RV, DTAP, RV
Symptoms: Dehydration, Vomiting
Clinical narrative: p/vax pt exp yellow/green vomiting w/every breast feeding; 10% dehydration treated w/IVF x2day; intussusception  dx'd w/ barium enema & reduced in radiology;
Age: 0.5
Sex: M
Vaccine: DTAP, RV, DTAP, RV
Symptoms: Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: p/vax pt exp yellow/green vomiting w/every breast feeding; 10% dehydration treated w/IVF x2day; intussusception  dx'd w/ barium enema & reduced in radiology;
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Anaemia, Constipation, Leukopenia, Pyrexia
Clinical narrative: 2days p/vax pt exp constipation, high fever-103F lasting 3days; white count down (2600); hosp; tx w/ampicillin/claforan I.V. for 48hr
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, RV, DTAP, HEP, HIBV, RV
Symptoms: Constipation, Gastrointestinal haemorrhage, Vomiting
Clinical narrative: 5days p/vax pt exp vomiting, no stool; 7/28 inc vomiting (currant jelly stool),w/ large blood; adm to hosp; ,barium enema reduction (unsuccessful); laparoscopic surgery to correct classic intussusception; still recovering
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, RV, DTAP, HEP, HIBV, RV
Symptoms: Gastrointestinal haemorrhage, Vomiting
Clinical narrative: 5days p/vax pt exp vomiting, no stool; 7/28 inc vomiting (currant jelly stool),w/ large blood; adm to hosp; ,barium enema reduction (unsuccessful); laparoscopic surgery to correct classic intussusception; still recovering
Age: 0.1
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Infection, Oedema peripheral, Vasodilatation
Clinical narrative: day p/vax pt exp swollen red hands & feet; pt currently being monitored in hosp
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Condition aggravated, Osteoarthritis
Clinical narrative: p/recv second dose of lymerix 2-3 days later pt exp general join pain, fatigue, joint stiffness, pain since chronic recurrent, w/severe joint pain hands & rt foot
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: p/vax inject site swollen, red, itching & tender; treated w/benadryl, atarax, ibuprofen, prednisone
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Ecchymosis, Malaise, Mental impairment, Nasopharyngitis
Clinical narrative: p/vax pt exp 2 ecchymotic areas over lt thigh, 12x8cms & lt arm 2x2cms; general malaise; joint aches; . continue evaluation. seen by allergist Per follow-up: Ring in ears continues (Tinitis). Energy level still low. Frequent chest congestion and colds, URI. Prolonged period of fatigue. Sore muscles and painful joints, mental fog and impaired concentration as well as items listed to the right, I feel this anthrax shot has damaged my overall health and immune system.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Respiratory tract congestion, Tinnitus, Upper respiratory tract infection
Clinical narrative: p/vax pt exp 2 ecchymotic areas over lt thigh, 12x8cms & lt arm 2x2cms; general malaise; joint aches; . continue evaluation. seen by allergist Per follow-up: Ring in ears continues (Tinitis). Energy level still low. Frequent chest congestion and colds, URI. Prolonged period of fatigue. Sore muscles and painful joints, mental fog and impaired concentration as well as items listed to the right, I feel this anthrax shot has damaged my overall health and immune system.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis contact, Injection site mass, Injection site pain
Clinical narrative: 48hr of tenderness + induration at vax site; max induration 6-7cm; devel dermatitis 3day p/vax, however, pt has hx of gardening w/ development of poison ivy dermatitis just like this; pt gardened day of vax
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site mass, Rash
Clinical narrative: 4days p/vax pt devel nodule, red and itchy rash, spreading from the nodule.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site hypersensitivity
Clinical narrative: p/vax pt exp rt upper arm 3'' circular pattern acneiform rash w/clear center; actual site is hyperpigmented
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Paraesthesia
Clinical narrative: 2days p/vax pt exp local pain/redness spreading to 12cm; positive edema noted to elbow & c/o coldness to lt hand
Age: 1.3
Sex: M
Vaccine: DTP, HEP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 8days p/vax pt exp seizure lasting 5min (full body), temp 104-R w/tylenol, 102 temp
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation, Anorexia, Crying, Hypertonia
Clinical narrative: p/recv vax pt exp a unusual cry for 2hr, was not eating, & could not be comforted, was seen in ER stated squeezing legs & crying as a result
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Chest pain, Hypertension, Injection site hypersensitivity, Lymphadenopathy, Pruritus
Clinical narrative: p/recv vax pt exp generalized itching sensation, 15min later itching @ waist, under breast, under arms, 15min later tight chest, hives at waist, @ mmr infect site & arm, hives bilaterally in axillae & behind knees, spots before eyes
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Urticaria, Visual disturbance
Clinical narrative: p/recv vax pt exp generalized itching sensation, 15min later itching @ waist, under breast, under arms, 15min later tight chest, hives at waist, @ mmr infect site & arm, hives bilaterally in axillae & behind knees, spots before eyes
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
Clinical narrative: 2days p/vax pt presented w/painful lt arm, raised red area approx 4'' across, slightly warm to touch.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: day p/vax pt devel itchy bumps, looked like blisters under & around back of rt arm & on chest, itching growing bigger than popping & scabbing over & clearing up
Age: 1.1
Sex: F
Vaccine: HIBV, MMR
Symptoms: Face oedema, Hypersensitivity, Photosensitivity reaction, Rash
Clinical narrative: p/recv vax pt exp allergic blotching on forehead, swollen eyes, photo sensitive vision
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia, Screaming
Clinical narrative: day of vax pt exp uncontrollable crying 48hr, fever 100.2-R
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, OPV
Symptoms: Herpes zoster, Infection
Clinical narrative: 3mo p/vax pt subsequently exposed to chickenpox w/i 28d w/o problem. now on 7/27 pt presented w/zoster x3day
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: weekend following vax pt devel hives & continued until pt went tubing, then got severe. seen in ER & treated w/IVs
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Convulsion, Cyanosis, Dysphagia, Muscle twitching, Vomiting
Clinical narrative: p/recv vax pt exp jerking arms/legs, not responding to me, blue lips & legs, gagging or chocking, like a mild seizure
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Malaise, Oedema peripheral, Pyrexia, Urticaria, Vasodilatation
Clinical narrative: p/recv vax pt exp swollen area, big red hot welt, about size of big coffee cup, felt feverish & ill. treated at med ctr, antibiotic/benadryl
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Gastroenteritis, Hypersensitivity, Nausea
Clinical narrative: p/recv vax pt exp weakness, nausea, fatigue. ER dx, gastroenteritis, r/o allergic react
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus, Vasodilatation
Clinical narrative: day p/vax pt exp area of induration, erythema & warmth on lt arm area assoc w/pruritus
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Pallor
Clinical narrative: Day of vax pt cried inconsolable, color very pale & around lips & nails. Nails dull color. When falls asleep awakes screaming.
Age: 0.8
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Febrile convulsion
Clinical narrative: day p/vax pt exp febrile seizure
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Ear pain, Eye pain
Clinical narrative: while giving pt hepB vax, med squirted mom in the rt eye when needle retracted into syringe. no c/o burning or pain before leaving. that eve pt (mom) was having pain in eye & ear. flushed eye & instructed to use ice pack & see eye MD.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Somnolence
Clinical narrative: p/recv vax pt became quite somnolent, taking very little formula. pt seen in ER, no distress was noted according to ER rpt. p/ 10-12 pt acting normally
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, MMR, OPV, VARCEL
Symptoms: Headache, Oedema peripheral, Pyrexia, Vasodilatation
Clinical narrative: p/recv vax pt devel stomach ache, severe h/a, fever (104f), sent to ER, pt  arm slightly swollen & red.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Vomiting, Weight decreased
Clinical narrative: pt devel severe h/a, nausea, vomiting & general illness 11/2 weeks p/shot. lost 6lbs overall. refusing to complete HEP B series shot
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Malaise, Myalgia, Pyrexia
Clinical narrative: p/recv vax pt exp fever, malaise & generalized myalgia, localized erythema & edema devel. symptoms worsened 1/16 & 1/17/97, starting feeling better 1/21/97
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia, Rash
Clinical narrative: day following vax pt began to run fever & breakout in rash over chest lasting 4days.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Hypertonia, Injection site hypersensitivity, Malaise, Myasthenic syndrome, Pain
Clinical narrative: p/vax pt had pain w/soreness & stiffness involving entire arm. temp 100f x2days. next day had ring of tiny white pustules surrounding inject site. to date still c/o 10% weakness of arm, not norm feeling
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: p/vax pt had pain w/soreness & stiffness involving entire arm. temp 100f x2days. next day had ring of tiny white pustules surrounding inject site. to date still c/o 10% weakness of arm, not norm feeling
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Pallor, Pruritus, Urticaria
Clinical narrative: p/vax approx 3hrs pt had difficulty breathing & was pale & weak. in AM broke out w/hives on trunk of body. 24hrs later only c/o severe itch, but felt better
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, OPV
Symptoms: Urticaria
Clinical narrative: 15 min p/vax pt had hives on face, 40-60 min later hives all over body. given benadryl
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, OPV
Symptoms: Oedema peripheral, Pyrexia, Vasodilatation
Clinical narrative: 2days p/vax pt devel ? fever, hot to touch, swollen arm x1week. tx: ice, tylenol, warm compress
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Injection site inflammation, Injection site mass
Clinical narrative: 2days p/vax pt exp a 121/2 cm round inflamed area @ inject site. area raised approx 1/8'' warm to touch.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: day p/vax pt devel fever 101-102, severe back & arm pain
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Agitation, Pyrexia, Rash maculo-papular
Clinical narrative: fever, diffuse macular papular rash & irritability, not hives 7-10 days p/vax
Age: 12.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: pt fell to floor a few min p/recv vax, became pale, clammy. improved w/juice & rest. MD in to evaluate pt
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Somnolence, Stupor
Clinical narrative: 6days p/vax pt ran fever, was lethargic & unresponsive. 8 days later pt devel a rash over her body.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site hypersensitivity, Injection site mass, Vasodilatation
Clinical narrative: within 24hr of shot a 7x7cm red indurated area devel; hot to touch; hard;
Age: 26.0
Sex: M
Vaccine: TD
Symptoms: Rash maculo-papular
Clinical narrative: very fine erythematous papular rash over his torso
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR, OPV
Symptoms: Erythema multiforme, Rash
Clinical narrative: rash began 10days p/vax on neck + upper chest; over next 2-3days began spreading to torso, arms, lower extremities; rash target erythema multiforme
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Agitation, Dermatitis bullous, Pyrexia
Clinical narrative: mom rpt she noticed 2 blister bumps on pt on evening of vax; 8 more cam on 7/29, fever 101, was irritable;
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Vomiting
Clinical narrative: mom rpt pt started to vomit continuously; vomiting resolved by itself
Age: 9.0
Sex: M
Vaccine: HEP, MMR, OPV, TD
Symptoms: Alopecia
Clinical narrative: alopecia 2-3 days p/recv vax
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, OPV, VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema, Oedema peripheral, Vasodilatation
Clinical narrative: pt called 7/30/99, right leg red & swollen, 3'' above inject down to the knee; advised oral benadryl & motrin, apply ice
Age: 63.0
Sex: M
Vaccine: MMR, TD
Symptoms: Hypotonia, Injection site hypersensitivity, Injection site pain, Nervousness
Clinical narrative: 5weeks post vax devel mild pain & yellow spots near area of inject; also c/o loose feeling of limbs (legs & arms); is nervous
Age: 5.0
Sex: M
Vaccine: HEP, HIBV, MMR, OPV, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: onset of rash 4/24/99 for about 3days; no fever; no meds; no complications
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: onset of rash 4/10/99 for 3 days; about 51 pox
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Injection site reaction
Clinical narrative: rash devel for 7 days; no fever; less than 50 bumps/pox
Age: 1.9
Sex: F
Vaccine: DTAP, OPV
Symptoms: Urticaria
Clinical narrative: hives to left leg & all over body
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: rash lasted 3 days; approx 50 pos on whole body; no fever detected
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: rash lasted 3days; had less than 50 pox; no fever
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: onset lasting 5days; mom says very few pox, approx 50 on whole body.