chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Sudden infant death syndrome, Vomiting
Clinical narrative: She had gotten really high fevers around 104 and she was really fussy and was vomiting really bad. She also had dirrea almost everyday scince she had recivied the vaccine we took her to the emercancy once and the doctor just told us that it was the normal reaction the the vaccines she hsd recieved and just to give her alot of fluids. About a week later she died. The autopsy states SIDS.
Age: 0.4
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Diarrhoea, Insomnia, Pyrexia, Vomiting
Clinical narrative: She had gotten really high fevers around 104 and she was really fussy and was vomiting really bad. She also had dirrea almost everyday scince she had recivied the vaccine we took her to the emercancy once and the doctor just told us that it was the normal reaction the the vaccines she hsd recieved and just to give her alot of fluids. About a week later she died. The autopsy states SIDS.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea, vomiting, fever, red skin
Age: 1.3
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Cough, Drug ineffective, Haemolytic uraemic syndrome, Hyperhidrosis, Laboratory test abnormal
Clinical narrative: Developed invasive pneumococcal disease (pneumonia with empyema and hemolytic uremic syndrome) beginning 10/27/2003.  Still hospitalized in pediatric intensive care unit at the time this form completed. Per review of ER record and history and physical from admitting hospital, states respiratory distress, fever, cough, vomit, tachypnea, diaphoresis, and pleural effision. The 60 day follow up received on 1/6/04 states pt moved away from this area. No longer am able to see her for follow up.
Age: 1.3
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Pleural effusion, Pneumonia, Pyrexia, Respiratory distress, Tachypnoea
Clinical narrative: Developed invasive pneumococcal disease (pneumonia with empyema and hemolytic uremic syndrome) beginning 10/27/2003.  Still hospitalized in pediatric intensive care unit at the time this form completed. Per review of ER record and history and physical from admitting hospital, states respiratory distress, fever, cough, vomit, tachypnea, diaphoresis, and pleural effision. The 60 day follow up received on 1/6/04 states pt moved away from this area. No longer am able to see her for follow up.
Age: 1.3
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Vomiting
Clinical narrative: Developed invasive pneumococcal disease (pneumonia with empyema and hemolytic uremic syndrome) beginning 10/27/2003.  Still hospitalized in pediatric intensive care unit at the time this form completed. Per review of ER record and history and physical from admitting hospital, states respiratory distress, fever, cough, vomit, tachypnea, diaphoresis, and pleural effision. The 60 day follow up received on 1/6/04 states pt moved away from this area. No longer am able to see her for follow up.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Laboratory test abnormal
Clinical narrative: RECD PRIMARY SMALLPOX ON 10/02/2003 ON DAY 9 10/11/2003 EXPERIENCED SUBSTERNAL CHEST PAIN 5/10 IN INTENSITY. EXPERIENCED CHESTPAIN FOR THREE DAYS BEFORE SEEKING MEDICAL ATTENTION. CHEST XRAY, EKG,TROPONIN LEVEL OBTAINED. TREATED WITH MOTRIN 800MG TID.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Laboratory test abnormal, Pericarditis
Clinical narrative: 10 days S/P vaccination developed chest pain 8-9/10 and shortness of breath on exertion. A 60 day follow report received 1/14/04 adds: Unknown whether pt has recovered. Pt is at sea at this point; we do not have any further info. The 60 day follow up received on 1/14/04 states pt is at sea at this point we do not have any further info. Health record on 04/30/04 states: Myopericarditis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Feeling hot, Swelling
Clinical narrative: Upper deltoid to elbow swollen and hot to the touch the evening of 10/22/03.  Area of reddness and swelling 4"x2" today 10-24-03 client states she is much better today.  Able to move arm today, client has been taking asprin for dicomfort instead of ibuprophen.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Diarrhoea, Erythema, Pruritus, Skin exfoliation
Clinical narrative: hands started burning, itching, peeling.  Reddness spots around arm.  Sat. AM started having asthma signs and mom startied albuterol inhaler.  This continued through the day.  By Sunday peeling spread to knees and reached feet, by Monday toes.  Full asthma attack Tuesday night at hospital.  Wed diarehea, vomiting. Continued until Friday 10-24-03.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: hands started burning, itching, peeling.  Reddness spots around arm.  Sat. AM started having asthma signs and mom startied albuterol inhaler.  This continued through the day.  By Sunday peeling spread to knees and reached feet, by Monday toes.  Full asthma attack Tuesday night at hospital.  Wed diarehea, vomiting. Continued until Friday 10-24-03.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Dizziness, Vomiting
Clinical narrative: (Inactivated Influenza) Vaccine administered at 1:00pm, at 2:00am the following morning I suffered from stomach cramps and vomitting (although limited since my stomach was empty). The following day I was dizzy and weak with stomach ache.
Age: 0.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: swollen right wrist
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiomyopathy, Myocardial infarction
Clinical narrative: This subject is an 81 year old male who according to his wife was admitted to the hospital due to an acute myocardial infarct while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. Subject was admitted to the hospital 284 days post immunization and died 13 days later. Investigator has requested a discharge summary. The myocardial infarction was reported by the investigators as not related to the study vaccine. The death certificate received on 11/20/03 states cardiomyopathy. Follow up on 11/26/03: " Additional information received 11/18/03.  Death Certificate: Date of death: 08/10/03.  Cause of death: PEA arrest due to Global Dilated Cardiomyopathy.  The PEA arrest secondary to Global Dilated Cardiomyoptahy was reported by the Investigator as not related to the study vaccine."
Age: 1.6
Sex: U
Vaccine: DTAP, HIBV, MMR
Symptoms: Anaphylactic reaction, Face oedema, Pruritus, Stridor, Urticaria
Clinical narrative: It was reported in a published article that a 19 month old patient (gender not reported) with no history of atopy, was vaccinated on an unknown date with a dose of MMR (lot # not reported) and a dose of Hib conjugate vaccine (lot # not reported). Secondary therapy included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). Five to ten minutes post vaccination, the patient developed anaphylaxis with urticaria, pruritis, swollen lips and slight stridor. The patient was treated with epinephrine and IM diphenhydramine. The patient's outcome was not reported. Upon internal review, anaphylaxis, urticaria, pruritis, swollen lips and slight stridor were determined to be other important medical events (OMIC). Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: DT, MMR
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Flushing, Hypoaesthesia
Clinical narrative: It was reported in a published article, that a 17 year old pt with no history of atopy, was vaccinated on an unknown date with a dose of MMR II. Secondary therapy included a dose of DT. Within one hour post-vaccination, the pt developed anaphylaxis with facial flushing, SOB, nausea, lightheadedness and numbness in legs. The pt was treated with epinephrine, IM diphenhdyramine, IV hydrocortisone and D5W. The pt's outcome was not reported. Upon internal review, anaphylaxis, facial flushing, SOB, nausea, lightheadedness, and numbness in legs were determined to be other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01792, WAES0310USA01902, WAES0310USA01904, WAES0310USA01905 and WAES0310USA01906).
Age: 17.0
Sex: U
Vaccine: DT, MMR
Symptoms: Nausea
Clinical narrative: It was reported in a published article, that a 17 year old pt with no history of atopy, was vaccinated on an unknown date with a dose of MMR II. Secondary therapy included a dose of DT. Within one hour post-vaccination, the pt developed anaphylaxis with facial flushing, SOB, nausea, lightheadedness and numbness in legs. The pt was treated with epinephrine, IM diphenhdyramine, IV hydrocortisone and D5W. The pt's outcome was not reported. Upon internal review, anaphylaxis, facial flushing, SOB, nausea, lightheadedness, and numbness in legs were determined to be other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01792, WAES0310USA01902, WAES0310USA01904, WAES0310USA01905 and WAES0310USA01906).
Age: 1.3
Sex: U
Vaccine: MMR
Symptoms: Anaphylactic reaction, Erythema, Rash, Tachycardia, Wheezing
Clinical narrative: It was reported in a published article, that a 16 month old pt with a history of asthma NOS and eczema was vaccinated on an unknown date with a dose of MMR II. Within one hour post-vaccination, the pt developed anaphylaxis with erythema, wheezing, tachydardia and rash. The pt was treated with albuterol and diphenhydramine elixir. The pt's outcome was not reported. Upon internal review, it was determined that anaphylaxis, erythema, wheezing, tachycardia and rash were other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01792, WAES0310USA01903, WAES0310USA01904, WAES0310USA01905 and WAES0310USA01906).
Age: 0.08
Sex: U
Vaccine: DTAPH, HEP
Symptoms: Anaphylactic reaction, Cyanosis, Dyspnoea, Petechiae, Tachycardia
Clinical narrative: It was reported in a published literature article, that a 7 week old pt with no history of atopy, was vaccinated on an unknown date with a dose of hep B virus vaccine. Secondary therapy included a dose of diphtheria toxoid+Hib conj vaccine+pertussis vaccine+tetanus toxoid and a dose of poliovirus vaccine inactivated. Two hours pot-vaccination, the pt developed anaphylaxis with petechial lesions, cyanosis, dyspnea, and tachycardia. A chest radiograph and electrocardiogram were performed, but no results were reported. The pt was treated with acetaminophen. The pt's outcome was not reported. Upon internal review, anaphylaxis, petechial lesions, cyanosis, dyspnea, and tachycardia were determined to be other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01902, WAES0310USA01903, WAES0310USA01904, WAES0310USA01905 and WAES0310USA01906).
Age: 0.8
Sex: U
Vaccine: DTPHIB, HIBV, OPV
Symptoms: Anaphylactic reaction, Face oedema, Rash, Wheezing
Clinical narrative: It was reported in a published article, that a 10 month old pt with a history of asthma NOS was vaccinated on an unknown date with a dose of hep B virus vaccine. Secondary therapy included a dose of diphtheria toxoid+Hib conj vaccine+pertussis vaccine+tetanus toxoid and a dose of poliovirus vaccine inactivated. Two days post-vaccination, the pt developed anaphylaxis with swollen lips, rash and wheezing. The pt was treated with epinephrine, IM dexamethasone, albuterol an dhydroxyzine syrup. The pt's outcome was not reported. Upon internal review, anaphylaxis, swollen lips, rash and wheezing were determined to be other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01792, WAES0310USA01902, WAES0310USA01903, WAES0310USA01905 and WAES0310USA01906). Follow up 3/15/05: Patient's outcome is unknown.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Rash
Clinical narrative: It was reported that a 56 year old female pt received a dose of Fluzone SV '2003-'2004, lot #U1135EA, administered IM in the left deltoid on 10/15/03. Two days later, the pt developed rash on her back, arms and torso for which she took Benadryl and steroids. On 10/19/03, the pt was admitted to the ER due to generalized rash, for which she was given Zyrtec, Prednisone, and Rantidine and then discharged. The following day, the pt reported bilateral leg swelling and was hospitalized the next day due to persistent symptoms and remains hospitalized. Reportedly, the pt is vaccinated with the flu shot every year. Due to previous cellulitis of the legs 10/2/03, cause dby insect bites, the pt was recently treated with 500mg of Duricef.  Follow up on 11/17/2003: "From additional information received through a telephone call on 11/10/2003 from the primary reporter, the patient's primary physician's information was reported.  The reporter indicated that all the information available has been provided.  A call was made to patient's primary physician, who was out of the office that day.  The secretary provided the patient's full name and correct physician information, as well as the fax number for the office.  No additional information was given at this time." From additional information received on 17/Jan/2004 from a physician, it was reported that the case was reviewed and there is no additional information at this time. Further information is not anticipated, this case is considered closed. Follow up 01/06/05: Medical assessment: There were no investigations reported. The amount of availabe data is not sufficient to readly assess the case. In the absence of another etiology, the hypothesis that skin eruption and leg swelling correspond to clinical manifestations of a serum sickness like reaction after administration of cefadroxil or due to insect venom could be evoked.
Age: 7.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizure (partial complex) occurred approximately 5 hours after immunization. Off and on seizure for 2 hours; active seizure witnessed by physician. Patient has known seizure disorder/developmental delay.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Apnoea, Congenital anomaly, Convulsion, Encephalopathy, Hypoxia
Clinical narrative: Child developed fever to 102 ax (103.7 pr later). At 5:30, given Tylenol. At 1 AM 2/13/01, the child was found in status epilepticus. EMS called. Patient given 4 different anticoagulants, intubated. Given dopamine; ICU care. Depressed neuro function persisted. The death certificate received on 11/21/03 states pneumonia, pulmonary failure, and CP.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Pneumonia, Pyrexia, Status epilepticus
Clinical narrative: Child developed fever to 102 ax (103.7 pr later). At 5:30, given Tylenol. At 1 AM 2/13/01, the child was found in status epilepticus. EMS called. Patient given 4 different anticoagulants, intubated. Given dopamine; ICU care. Depressed neuro function persisted. The death certificate received on 11/21/03 states pneumonia, pulmonary failure, and CP.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pruritus, Sedation, Urticaria
Clinical narrative: Patient received Amevive from MD, for psoriasis AM of 10/28/2003 (IV).  Also had external Oxsoralen ultra treatment that AM (10th or 11th Amevive tx).  Had flu shot about 2-3 hours later.  Approximately 14:00 on 10/28, experienced itching.  When patient got home from work about 17:00, noted hives on legs, trunk, arms and groin.  Felt nervous and took Benadryl x 1 at 18:00.  Minor relief and repeated Benadryl at 21:30.  Slept OK, and reported to our office at about 08:20 10/29/2003.  Currently only feels "drugged" and "head pressure".
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Periorbital oedema, Pruritus
Clinical narrative: Severe periorbital edema, pruritis, mild facial edema.  Onset approximately 15 hours after vaccination.  Patient instructed by provider to take Benadryl 25mg every 6 hours as needed.  Symptoms subsiding.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Erythema upper and lower arm (left).
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Dyspepsia, Headache, Injection site oedema, Injection site warmth
Clinical narrative: Administered both vaccines 10/21/2003.  Burned at time of injection. 10/22/2003: Arm swelling/hot/lack of sleep; 10/23/2003: Area shouting red streaks.  Visit to MD, given Clarinex.  Since then, patient has felt very nauseous, severe headache, while body aches and heartburn with is worse today.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Nausea, Pain, Skin burning sensation
Clinical narrative: Administered both vaccines 10/21/2003.  Burned at time of injection. 10/22/2003: Arm swelling/hot/lack of sleep; 10/23/2003: Area shouting red streaks.  Visit to MD, given Clarinex.  Since then, patient has felt very nauseous, severe headache, while body aches and heartburn with is worse today.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pruritus, Vision blurred
Clinical narrative: Received IM flu vaccine at 10:00 approximately 1.5 hours later, began itching took Benadryl per mouth.  Approximately 15-20 minutes later, vision blurred, legs weak, layed down on floor.  Transported to ER, received solumedrol IV.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pyrexia, White blood cell count decreased
Clinical narrative: Patient had chills, fever, nausea, headache.  Patient to take Benadryl 25mg 3 times a day for 1 day then as needed.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Palpitations
Clinical narrative: Dizziness, Palpatations, severe fatigue for 3 days.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Convulsion, Eye movement disorder, Staring
Clinical narrative: Approximately 4-5 minutes after receiving Fluzone vaccine, client fell and hit head on floor.  Client appeared to exhibit seizure-like activity (eyes rolling back of head, p?) for approximately 20 seconds.  After 20 seconds, client tried to focus eyes but could not.  EMS called and arrived in 5 minutes.  Speak coherently for 1-2 minutes.  Pulse 100, Respiratory 20.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Rash
Clinical narrative: Mother reports reaction from vaccine causing swelling, redness and rash to left upper arm requiring treatment by ER.  Prescribed Cephalexin 250mg 1.5 tsp twice a day for 10 days and Zyrtec syrup 1 tsp everday.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: 10/21/2003: Noticed right upper arm red, warm and swollen.  given decadron 10mg IM.  Better on 10/22/2003.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: On 10/23, patient had DTAP, MMR & Flu vaccine.  Mom called 10/24/2003 stating that left thigh was hard, red, and warm to touch.  Appointment made and seen by NP.  Left thigh 15 inch circumference area with edema, erythematous, firmness and warm to touch.  Right thigh 11.5 inch circumference same reaction.  Started on Zyrtec 1/1 2.5 mL per mouth every day.  Cephalexin 250/5 4mL.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Patient received pneumococcal vaccine 10/14/2003.  Following day developed fever, chills, severe pain from elbow to shoulder on affected arm.  Area extremely tender to touch.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Patient received Pneumococcal vaccine 10/14/2003.  Following morning developed severe pain in affected arm from elbow to shoulder.  Area very tender to touch.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Decreased appetite, Gait disturbance, Rash, Vasculitis
Clinical narrative: Received influenza 0.5mg IM left arm 10/21/2003.  On 10/26/2003 observed a non-itchy purple "rash" on left great toe left 2nd, 3rd toe, both legs extending to groin area, chest underneath both arms extending from wrist to elbows.  Notified MD.  No treatment at this time.  If not resolved in one week (11/03/2003) to see MD.  Has had flu vaccine annually with no ill effects. The follow up received on 11/11/03 states approximately five weeks ago, pt had tick bite on his right upper arm with a bull's eye rash which resolved without treatment. After receiving the flu vaccine on 10/21/03, his spouse noticed increased agitation while awake, but would readily fall asleep when sitting, loss of appetite and decreased interest in reading. He was seen by his dermatologist on 11/3/03 who diagnosed vasculitis and prescribed Cortisone cream 0.25% to the affected areas. On 11/4/03, pt was seen for a routine cardiology appointment and he was beginning to show signs of tremors and unsteady gait. He c/o chills and on 11/5/03 his T was 102 F. An appointment was made with his primary care physiican for 11/6/03. After being seen by his doctor, pt was admitted to hospital. Extensive blood work, neurology consult, leg lesion biopsy and medical consults have been done. He continues with unsteady gait and agitation.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient given pneumococcal vaccine polyvalent pneumovax 23 0.5cc sub cutaneously in left arm 10/23/2003.  Patient called 10/24/2003 AM to wake with left arm should be swollen and painful.  Nurse had patient come in for evaluation.  Fount 98.4 temperature.  Left arm swollen, painful, red and warm to touch.  Swelling left deltoid to pain upper arm.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site oedema, Nausea
Clinical narrative: Left upper arm swelling, red, warm to touch, painful to move arm, nausea, fever 100 degrees after shot.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Left upper arm swelling, red, warm to touch, painful to move arm, nausea, fever 100 degrees after shot.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Received fluvirin at 09:00 on 10/17/2003.  Developed hives around 16:00 that day.  Hives started at ankles then spread up legs and trunk.  Hives resolved in 36 hours.  Patient took Benadryl for hives.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 cm erythema with mild induration at injection site.  Improvement over 24 hours.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Received influenza vaccine on 10/10/2003.  States when woke up next day on 10/11/2003, approximately about 7:30 AM, felt shortness of breath, wheezing, headache and rapid heartbeat lasting 2 days.  Resolved on it's own.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Skin ulcer
Clinical narrative: Lesions noted 2 days post vaccine.  Lesions noted on both right and left arm right and left flanks.  Superior to iliac crest and medial to the frontal plane.  Also noted slightly superior to ankles.
Age: 0.9
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Fussy, temperature 100-101, injection site red, swollen, hot to touch, painful within 48 hours.
Age: 0.9
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fussy, temperature 100-101, injection site red, swollen, hot to touch, painful within 48 hours.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Cough, Pyrexia, Rash morbilliform
Clinical narrative: Acute onset of morbilliform rash first on trunk then over 2-3 days extending to arms and legs.  Cough and low-grade fever.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site oedema, Malaise, Muscle twitching
Clinical narrative: Injection 10/06/2003: Td administered to left deltoid 16-16:30.  About 3 hours after client had intense headache, pain to left shoulder and arm.  10/07/2003: Redness, swelling to left deltoid and arm.  Fever, twitching, to face and eye.  10/08/2003: Redness and swelling left deltoid decreased to elbow.  Left facial twitching; malaise, treatment: ibuprofen, rest.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Injection 10/06/2003: Td administered to left deltoid 16-16:30.  About 3 hours after client had intense headache, pain to left shoulder and arm.  10/07/2003: Redness, swelling to left deltoid and arm.  Fever, twitching, to face and eye.  10/08/2003: Redness and swelling left deltoid decreased to elbow.  Left facial twitching; malaise, treatment: ibuprofen, rest.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: 10/13/2003: Received pneumococcal vaccine.  Had previous vaccination in 1997.  That evening patient noticed red area at vaccination site about 50 cent piece size with tenderness.  10/14/2003: Redness about 4 cm by 6 cm in size, more tender.  Started running low grade temperature.  10/15/2003: Site is very tender 8cm by 8 cm, warm to touch.  Still has low grade temperature.
Age: 0.7
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Anorexia, Insomnia, Screaming
Clinical narrative: Uncontrolable crying high pitched.  Using motrin every 6 hours.  Not eating, not sleeping, unconsolable.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Allergic reaction to vaccine on right thigh.  Large, round, red circle on right side of right thigh.  Size of an orange.  Mother gave Benadryl MD gave prescription for CRA pred taper and Benadryl.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash appeared 10 days after administration of vaccine-varivax.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain, Rash
Clinical narrative: Arm badly swollen at injection site; tender, red, knot formed; blotchy red rash upper arm area; patient attributes reaction to the pneumococcal vaccine.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Arm badly swollen at injection site; tender, red, knot formed; blotchy red rash upper arm area; patient attributes reaction to the pneumococcal vaccine.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Rash macular, Skin ulcer
Clinical narrative: Vaccines were administered on 10/13/2003.  Noted to have rash 10/14/2003.  Treatment with Benadryl.  Macular-non-pruritic circular lesion on torso.  Sparse on extremity 4 x 3 cm red indurated at injection site.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 10/15/2003 @ 16:40: Patient in clinic crying continuosly with increased swelling, tenderness and redness to left thigh.  MD ordered Motrin 2 cc per mouth and apply ice pack to left thigh- done.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Feeling abnormal, Hypoaesthesia, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Client states he started feeling bad around 9:30pm on 4/10/03. States R arm hurt from shoulder on down. States neck felt stiff and had numbness to R hand. States he went to bed but woke up at 2:30am and had temp of 103.1 deg F. States he took four Motrin. RTC 4/11/03 for f/u.
Age: 21.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Developed a high fever on 5/10/03 and rash appeared on the 5/11/03. Vesticles dried up by the 16th.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot, Hypersensitivity, Oedema peripheral, Tenderness
Clinical narrative: 6/11/03: allergic reaction to Pneumovax, swelling, tenderness, eryth, warmth to R deltoid. 6/12: decreased pain, swelling with minimal erythema. 6/13: no erythema, slight induration.
Age: 34.0
Sex: F
Vaccine: HEP, TD
Symptoms: Dysphonia, Headache, Lacrimation increased
Clinical narrative: States had headache last night and was experienced hoarseness this am. After talking pt changed her mind and states her symptoms started last evening. Lungs CTA, bp 120/90, eyes watery.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: On 7/15/03 client received Td-awoke 7/16/03 with severe and progressive total body muscle aches/soreness-feels flu-like. States was fine previous to Td.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Oedema, Pain
Clinical narrative: Swollen and painful.
Age: 3.6
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blister
Clinical narrative: Blisters on bilateral palms of hands, knuckles, elbows, knees and bottom of feet. Blisters range in size of 1-22mm. Does not appear in distress. Is alert and active. Parent denies child with fever, itching or malaise.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt received 5th DTaP on 10/21/03 with a pretty good size area of erythema, induration and warmth at injection site. Pt had regular physical check up.
Age: 42.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Chest discomfort, Injection site erythema, Pyrexia, Sensation of heaviness, Urticaria
Clinical narrative: Onset of redness at injection site, SQ L upper arm noted by pt on 10/23/03 at 7pm with feeling of heaviness in calf carm, chest tightness and wheezing and fever. Reported on 10/24/03 at 3pm with 30mm x 50mm redness to L arm with 30mm wheal. No wheezing /t-97.0 BP: 165/118 P 74. Ref to hospital for evaluation. By 10/26/03 at7pm treated. BP was monitored x 2 days. Return to normal reading by 10/26/03. Pt states was symptom free by 10/26/03 at 7pm. Treated at hospital with Ventolin inhaler, ice pack to injection site.
Age: 42.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Wheezing
Clinical narrative: Onset of redness at injection site, SQ L upper arm noted by pt on 10/23/03 at 7pm with feeling of heaviness in calf carm, chest tightness and wheezing and fever. Reported on 10/24/03 at 3pm with 30mm x 50mm redness to L arm with 30mm wheal. No wheezing /t-97.0 BP: 165/118 P 74. Ref to hospital for evaluation. By 10/26/03 at7pm treated. BP was monitored x 2 days. Return to normal reading by 10/26/03. Pt states was symptom free by 10/26/03 at 7pm. Treated at hospital with Ventolin inhaler, ice pack to injection site.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Pain, Paraesthesia
Clinical narrative: TC from TR states woke up this am (10/24/03) with acute pain base of skull to L hip area-including L arm and "muscle spasms." L side of body-neck to hip and L arm-also states L fingers "tingle" spoke with MD and instructed to take a muscle relaxant and pain pill already available to her from previous back surgery and to go through ER-if not improved. 10/27-follow up TC to pt. States feeling better-pain did progress from L side as previously indicated, throughout entire body. States relief from meds as recommended by MD and improvement of sx's seen after about 24 hours.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Mild eruption of varicella-like rash on face/scalp
Age: 1.42
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Hypersensitivity, Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: 10/5/03: febrile and fussy; 10/7/03: rash on face and trunk. Seen by PCP. Dx: insect bite allergy. Tx: hydrocortisone cream. 10/8/03: Presented to ER. Afebrile, significant posterior cervical region nodes in the occipital node area, confluent erythematous maculopapular rash at hairline and on cheeks, small maculopapular 4-5mm diameter lesions on extremities. Dx: rubella, vaccine related. Tx: D/c hydrocortisone, Tylenol
Age: 1.42
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Skin ulcer
Clinical narrative: 10/5/03: febrile and fussy; 10/7/03: rash on face and trunk. Seen by PCP. Dx: insect bite allergy. Tx: hydrocortisone cream. 10/8/03: Presented to ER. Afebrile, significant posterior cervical region nodes in the occipital node area, confluent erythematous maculopapular rash at hairline and on cheeks, small maculopapular 4-5mm diameter lesions on extremities. Dx: rubella, vaccine related. Tx: D/c hydrocortisone, Tylenol
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt developed redness and swelling to left thigh, an area of 7cm x 7cm developed over a 2 day period. Treatment was cool compress, Motrin and Keflex.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site oedema, Pyrexia
Clinical narrative: Fever yesterday 10/8/03, small amount redness. Developed large 9cm diameter red, swollen, firm lump on left thigh today. Walking fine. No fever today.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dry throat
Clinical narrative: Approx 15 minutes after receiving injection of Hep B, presented to school nurse c/o dizziness, throat "stuffy", was given Benadryl by school nurse. Rescue squad called, but was not transported, was OK by the time the mother arrived at school. Taken to PMD, was told that they were not sure if was reaction to Hep B.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth, Lacrimation increased, Pharyngolaryngeal pain
Clinical narrative: Redness, heat, watery eyes, throat hurts
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pain, Pruritus
Clinical narrative: Redness around tender and hot. Pt c/o of itching. Prescribed HC .25%.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Within minutes of vaccine administration child developed one, then 2 hives above area of injection.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Pt reported nausea, vomiting, generalized body aches, headache that began 10/21/03 (2 days after receiving vaccine).
Age: 3.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Left arm reddened warm deltoid upper arm. 10/30/03 at 9 AM noticed 4" x 2" area.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Injection site erythema, Oedema
Clinical narrative: 11:00 vac. Crying but consolably. Red swelling bilat to thighs. 15:40 Motrin given and cold packs applied.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MM
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: Inflammation with induration right thigh. Rx Benadryl tsp po BID.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Injection given 9/23/03. 9/24/03: increased temp, erythema, swelling upper arm. Antibiotic dicloxicillin.  9/27/03 resolved.
Age: 0.42
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: High fever. Fever reducer.
Age: 1.17
Sex: M
Vaccine: FLU3, PNC
Symptoms: Injection site induration, Injection site oedema, Pain
Clinical narrative: 14 days after vaccination, 2 cm induration/tenderness, diffuse swelling.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Pt received pneumovax 10/10/03, the following day she experienced facial paresthesia which did resolve.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Oedema, Pruritus, Rash, Urticaria
Clinical narrative: Hives, itching rash all over body, swelling, nauseated. Within 2 hours after receiving shot.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Pain, Pyrexia, Urticaria
Clinical narrative: Local reaction to Td (Aventis) vaccine with swelling, redness, urticaria. Initially complained of fever and local pain.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Eyelid oedema, Face oedema, Urticaria
Clinical narrative: Approx 1 1/2 hours after receiving Td vaccine, pt reports swollen lips, puffy eyelids, hives on thighs, feet and arms. She took 2 Benadryl and was symptom-free by 9 AM the next day. She did not consult a physician.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Faeces discoloured
Clinical narrative: Within 24 hours of DTaP administration developed black stools. Afebrile.
Age: 54.0
Sex: F
Vaccine: BCG
Symptoms: Chromaturia, Dysuria, Insomnia
Clinical narrative: A 54 year old woman, with a 15-year history of Interstitial Cystitis (IC), reports she has received 4 weekly instillations of Tice BCG (on 7, 14,21, 08/28/2002), for treatment of her IC.  She states she does not have bladder cancer and that her treatments are not part of any clinical trial or study.  The initial instillation was tolerated well, but within a few hours following the second instillation (08/14/2002), she began to experience "terrible burning with urination".  Following her third and fourth instillations (08/21/2002 & 08/28/2002), her bladder irritative symptoms have progressively exacerbated, with the sensation of pressure, and the need to void, despite only small amounts or urine in the bladder and with pain so severe that she is having difficulty sleeping at night and has had to take oxydodone hydrochloride with paracetamol, dextropropoxyphene hydrochloride and oxycodone for the pain, with only partial relief from any of them (in the past her IC spin has been effectively managed by oxycode hydrochloride with paracetamil 5 mg).  She reports her pain since receiving Tice BCG is much more severe than she ever experienced with the initial IC, since her fourth instillation, she has also had blood-tinged urine (pink, no clots) with tissue particles also present.  She has advised her treating urologist of her significant symptoms, but he does not plan to discontinue her additional pending Tice BCG therapy.
Age: 79.0
Sex: F
Vaccine: BCG
Symptoms: Insomnia, Rash pruritic
Clinical narrative: A subject received an initial instillation of Tice BCG on 09/04/2002 for treatment of bladder cancer.  Within a few hours after, he experienced significant itching, which eventually subsided within less than 1 week.  On 09/11/2002 the patient received a second instillation of Tice BCG, without advising his physician of the significant itching he had experienced after the first treatment.  Within a few hours after, he again experienced severe itching "all over abdomen, back and thighs" and reported a sensation "like his nerve ending were all standing up", with discomfort so severe that he had difficulty standing, lying down or sleeping; no visible rash nor skin abnormality.  Tice BCG was administered with a red rubber catheter and the Tice BCG administration kit, using no Xylocaine as a lubricant.  On 09/12/2002 subject was advised to take Benadryl 25 mg per mouth; it is unknown if this was effective in relieving symptoms.
Age: 59.0
Sex: M
Vaccine: BCG
Symptoms: Injection site inflammation
Clinical narrative: A subject was treated with Oncotice since October 2001.  He suffered from a "huge prostate" with apparent inflammation since August 2002.  Also, he had inconsistently been testing both positive and negative for bladder tumor.
Age: 75.0
Sex: M
Vaccine: BCG
Symptoms: Dysuria
Clinical narrative: A subject received Tice BCG and developed a burning feeling with voiding and had a lot of pus and WBC's in urine on 09/17/2002 on the third day after the last instillation, but was afebrile.  Subject received a treatment for 6 weeks about 6 months ago and now received a second series for 3 weeks (once a week).  No antibiotics were given and the patient's symptoms have resolved.
Age: 76.0
Sex: F
Vaccine: BCG
Symptoms: Headache, Laboratory test abnormal, Urinary tract infection
Clinical narrative: A subject , diagnosed with bladder cancer with resection on March 2002, received an initial series of Tice BCG approximately.  May-July 2002 with no problems reported.  A second series of 6 weekly instillations was started approximately 09/12/2002, with the 2nd instillation on 09/17/2002.  Following each of the 2 recent instillation, the subject experienced a significant headache.  Also reported was a mild burning discomfort with voiding.  The 3rd instillation was withheld due to urinary tract infection.  Treatment headache: Tylenol.  Treatment: urinary tract infection: Keflex (oral), started 09/26/2002.
Age: 66.0
Sex: F
Vaccine: BCG
Symptoms: Headache
Clinical narrative: A 66 year old subject had received 4 previous series of Tice BCG weekly bladder instillations, from approximately 03/1999 through 08/2001, with no problems reported.  Recently she began to receive a planned series of 6 weekly instillations of Tice BCG with interferon alfa-2b.  Following the first and second instillation (on 4 and 09/11/2002) she experienced a significant headache which lasted 2-3 days.  After the third and fourth instillation no headache was reported.  In addition to the headaches she experienced increased blood glucose levels after each BCG treatment.  The headaches were treated with tylenol which gave only partial relief.  The increased blood glucose levels were treated with additional insuline for 3 days after.
Sex: M
Vaccine: BCG
Symptoms: Bacterial infection, Laboratory test abnormal, Pyrexia
Clinical narrative: A male patient (approximatley 57-58 years) received and initial series of Tice BCG to treat bladder cancer.  In mid-September, approximately 4 weeks after treatment ended, he developed a fever of 38.9-39.44 degrees C for 3-4 days and his urine tested positive for Enterococci.  These symptoms were treated successfully, however, reappeared two weeks later when his urine again tested positive for Enterococci.  He was diagnosed with Bacterial Prostatitis.  Cipro for one week after initial symptoms appeared.  Second series of Cipro prescribed to be taken over six weeks.  Symptoms are currently resolving.
Age: 63.0
Sex: M
Vaccine: BCG
Symptoms: Haematuria, Prostatic disorder, Urethritis
Clinical narrative: A 63 year old man received Tice BCG as an initial series of 6 weekly instillations and a series of 3 weekly instillations given 3 months later.  Following the last of these initial 9 instillations, he experienced hematuria with clots which lasted for 4-6 hours.  Due to the hematuria, he was given 2 instillations of 1/4 strength Tice BCG.  Since receiving the last instillations, he has experienced a "low grade apididymitis", recurrence of prostatitis, and also urethral discomfort after voiding which he describes as "urethritis".  No prostate or epididymal cultures have been obtained.  Treatment with tamsulosin.
Age: 70.0
Sex: M
Vaccine: BCG
Symptoms: Urinary tract infection
Clinical narrative: A 70 year old man received an initial instillation of Tice BCG and presented with a urinary tract infection two weeks later on 11/06/2002.  Nitrofurantoin 2-7 days, patient did not take the first full 7 days of antibiotics.
Sex: U
Vaccine: BCG
Symptoms: Back pain, Pyrexia, Tongue oedema
Clinical narrative: A patient (sex and age unknown) received Tice BCG therapy with interferon and presented with enlarged tongue, sore back and low-grade fever.
Age: 78.0
Sex: M
Vaccine: BCG
Symptoms: Tuberculosis
Clinical narrative: A male patient received Oncotice therapy in 1999.  In October 2002 he was found to have a positive PPD test.  He is otherwise asymptomatic.  There is not baseline (pre-BCG) PPD for comparison.  He has not been evaluated by an Infectious Disease Specialist.
Age: 82.0
Sex: M
Vaccine: BCG
Symptoms: Dysuria, Pollakiuria
Clinical narrative: An 82 year old male patient has received 3 series of Tice BCG for treatment of Bladder Cancer.  The patient is a participant in a clinical trial with Schering-Plough since 02/26/2002, using Interferon with Tice BCG.  He initially received 6 weekly instillations of full-strength BDG with Interferon alpha @B, from 02/26/2002 through 04/12/2002, which he tolerated well.  Per study protocol, he received a "maintenance" series of 3 weekly instillations of 1/3 Strength Tics BCG with Interferon, from 06/25/2002 through 07/17/2002, and from 09/26/2002 through 10/10/2002.  Immediately following the instillation on 10/10/2002, the patient experienced urinary burning and extreme frequency of urination.  He reported this to his MD on 10/14/2002, at which time Cipro was prescribed for 7 days.  On 10/16/2002 the symptoms were still persisting, and a urine culture was obtained and Macrobid was added to the continuing Cipro therapy.  However, there was a problem with the Lab test, and the results of the urine culture were not available.  On 10/18/2002, the patient reported the need to void every 20 minutes; Flomax was prescribed and Cipro was extended for an additional 7 days and Macrobid for an additional 4 days.  On 10/21/2002, the patient reported voiding every 10 minutes, "60 times/day; at this time, Ditropan XL was prescribed and Flomax continued.  On 11/05/2002 the patient reported that immediately after starting Ditropan, he had 2-3 days during which he was able to hold his urine for 2-3 hours at a time, but the frequency has again worsened, despite continuing Ditropan and Flomax.  10/14/2002: Started with Cipro; 10/16/2002: Started with Macrobid and continued with Cipro; 10/18/2002: Started with Flomax and continued with Cipro and Macrobid; 10/21/2002: Started with Ditropan XL and continued with Flomax;
Sex: M
Vaccine: BCG
Symptoms: Rash
Clinical narrative: A male patient (age unknown) receiving Tice BCG developed a rash in the groin.  The reporter is not sure if the adverse event is related to the BCG therapy.
Age: 70.0
Sex: M
Vaccine: BCG
Symptoms: Unevaluable event
Clinical narrative: A 70 year old man had received Tice BCG, 3 installations (as of 11/26/2002) of a planned series of 6, for treatment of Bladder cancer, from early November 2002 to mid-November 2002 and Coumadine since August 2002, for treatment of a TIA and 2 aortic blood clots.  In October 2002 he had a significant drop in his monthly INR level, following the first 2 instillations of Tice BCG (from 2.5 in October 2002 to 1.5 on 11/21/2002).  Following the decreased INR level, his Coumadine therapy dose had been increased from 10 mg three times a day to 5 mg/day x 3 days, then 7.5 mg/day (taken x 2 days, as of 11/25/2002).  His INR level subsequently improved to 2.2 on 11/26/2002.
Age: 80.0
Sex: M
Vaccine: BCG
Symptoms: Fatigue, Myalgia, Pollakiuria, Pyrexia
Clinical narrative: An 80 year old male patient, diagnosed with bladder cancer in situ, received an initial Tice BCG instillation on 12/30/2002.  On 12/31/2002 the patient developed a high fever (102 degrees F), muscle soreness and significant fatigue.  He had also been experiencing urinary urgency and frequency.  He reported his symptoms to his treating urologist on 01/02/2003.  Following corrective treatment he was afebrile and his muscle soreness had resolved by 01/04/2003.  The fatigue and urinary urgency/ frequency have persisted, but have lessened.  It is unknown if further Tice BCG therapy will be received.  01/02/2003- Levaquin 500mg/day for 8 days (for presumed urinary tract infection), Rifampin 600mg QD and Isoniaside 300mg QD
Age: 86.0
Sex: M
Vaccine: BCG
Symptoms: Rash, Urinary tract infection
Clinical narrative: An 86 year old patient received OncoTICE instillations to treat bladder cancer on 12/10/2002, 12/23/2002, 12/30/2002, 01/09/2003.  It is reported that on 12/17/2002 the patient displayed symptoms of a urinary tract infection and a red groin rash, which had spread over the body "from the neck down" by 01/03/2003.  On 01/09 the rash had resolved and the patient received a further OncoTICE instillation.  On 01/17/2003 the rash continued to resolved.  The patient reported that he took 2 doses of ampicillin before the onset of the rash.  Benadryl 1-2 tablets qhs to treat the rash.  01/03/2003- Zyrtec 1 qd (am) to treat the rash.  Prednisone lotion 2.5% to treat the rash.