chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Face oedema, Hypoaesthesia, Injection site inflammation, Pruritus
Clinical narrative: Flu vaccine given 10-27-2004.  Started feeling itchy morning of 10-28-2004 and as the day progressed she became worse.  As of 10-29-2004 she presents to the clinic with urticarial rash scattered over entire body, has been taking Benadryl since 7pm on 10-28-2004.  Woke up on 10-29-2004 at 0130 with numbness and inflammation on lower lip.  She has been taking soda baths to relieve the itching.  Her lower lip is quite edematous and red.    Benadryl 50mg every 6 hours - was ordered by provider.  Patient instructed to call ER if symptoms worsen or persist.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Flu vaccine given 10-27-2004.  Started feeling itchy morning of 10-28-2004 and as the day progressed she became worse.  As of 10-29-2004 she presents to the clinic with urticarial rash scattered over entire body, has been taking Benadryl since 7pm on 10-28-2004.  Woke up on 10-29-2004 at 0130 with numbness and inflammation on lower lip.  She has been taking soda baths to relieve the itching.  Her lower lip is quite edematous and red.    Benadryl 50mg every 6 hours - was ordered by provider.  Patient instructed to call ER if symptoms worsen or persist.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Pruritus, Urticaria
Clinical narrative: Woke up with a rash(hives) on her stomach.  Within hours in had spread to her entire body.  This caused severe itching and irratibility.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Received Pneumococcal Polysaccharide Vaccine on 10/20/04.  It was a shot in the back of my left arm.  Fever and chills began October 21.  Hot red area at the site kept growing larger and stayed hot through 10/23/04 with some fever.  I measured it on 10/23 and it was 9" long traveling down the arm and about 5 1/2" wide.  On 10/24/04 the site started to stop spreading and by 10/26 the color was fading.  It still had a hard lump at the site but is getting better.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Received Pneumococcal Polysaccharide Vaccine on 10/20/04.  It was a shot in the back of my left arm.  Fever and chills began October 21.  Hot red area at the site kept growing larger and stayed hot through 10/23/04 with some fever.  I measured it on 10/23 and it was 9" long traveling down the arm and about 5 1/2" wide.  On 10/24/04 the site started to stop spreading and by 10/26 the color was fading.  It still had a hard lump at the site but is getting better.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash in 10 cm area of right deltoid around site of administration.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient notified immunization clinic on 10/11/04 that immediately after receiving flu shot on 10/7/04 she felt pain radiating down her right arm to her elbow. She did not complain to immunization staff at that time. She has since seen a family practice physician on 10/08/04 and an orthopedic surgeon on 10/25/04, who administered a cortisone injection into her right arm to relieve the discomfort.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Eye swelling, Pyrexia
Clinical narrative: fever to 101 puffy eyes, eyes swollen shut
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Dysphonia, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: Wheezing, Hoarseness, Fast Heartbeat, Difficulty Breathing
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Erythema multiforme, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: 3 days after Flu-Mist developed urticaria.  The wheals spread and coalesced and had the appearance of erythema multiforme by the next day. Low grade fever, 99.1 with mild cough and rhinorrhea noted.  Otherwise, child acting and playing normally.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 3 days after Flu-Mist developed urticaria.  The wheals spread and coalesced and had the appearance of erythema multiforme by the next day. Low grade fever, 99.1 with mild cough and rhinorrhea noted.  Otherwise, child acting and playing normally.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Chills, Dizziness, Headache, Hypokinesia
Clinical narrative: Within 2 hours, I became very chilled and was running a fever. I could barely move my right arm. I also was very achy and had a headache. In the next half hour, I suddenly became tingly all over and very faint. I almost passed out. In 15 minutes, I felt some better, but my right arm continued to become tingly and the site of the injection hurt and burned. I am thankful that I was not driving when this happened. After a few hours, I regained the use of my right arm, but I was very weak the rest of the day and maintained a slight headache. I received a Typhoid Fever shot in my right arm shot and Hep. B and Tetanus/Diptheria in ny left arm.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Injection site pain, Pain, Paraesthesia, Pyrexia, Thermal burn
Clinical narrative: Within 2 hours, I became very chilled and was running a fever. I could barely move my right arm. I also was very achy and had a headache. In the next half hour, I suddenly became tingly all over and very faint. I almost passed out. In 15 minutes, I felt some better, but my right arm continued to become tingly and the site of the injection hurt and burned. I am thankful that I was not driving when this happened. After a few hours, I regained the use of my right arm, but I was very weak the rest of the day and maintained a slight headache. I received a Typhoid Fever shot in my right arm shot and Hep. B and Tetanus/Diptheria in ny left arm.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Muscle spasms, Pyrexia
Clinical narrative: After receiving the flu shot at 2 pm on Oct. 26, I woke the next morning with lower back pain from muscle spasms, slight fever (1 degre), and very low energy.   I find this significant only because my brother had the same symptoms 2 weeks earlier, especially the back spasms.  He was in such pain that he went to a chiropractor for an adjustment.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Hyperglycaemia, Myocardial ischaemia, Pain, Paraesthesia
Clinical narrative: Soreness in upper left arm, tingling, shooting pain beginning same day and continuing until present time.  Bruising at upper shoulder which was the site of the shot. Medical Record received on 1/25/2005 states glucose elevation and ischemia.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Urticaria
Clinical narrative: Urticaria several weeks following administration of last of three doses of anthrax; urticaria continues and is kept under control by Zyrtec; miscarriage may have been caused by vaccine.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Ear pain, Flushing, Pharyngolaryngeal pain, Urticaria
Clinical narrative: hives through out trunk, face , neck , arms. Slight s.o.b. only. (R) ear ache , sore throat,flushed . OBset abouyt 20 min. per shot . Benadryl 50 mg. po through out day for recurring hives. Shortness of breath only at 1st. hour. no treatment for breathing needed. ( I anaphylact for bee stings, so can differenciate. have at this point had recurrence of hives through out  last 20 hours.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Pruritus, Urticaria
Clinical narrative: Was vacinnated at 13:15 hrs. and stayed at the flu clinic for 20 mins. drove home and about 15:45 hrs.- my arm at the injection site was itching me but I did not scratch it!  I noticed on my left hand; inject. was on my left arm- 2-3 large hives appeared and I wouldn't scratch them. Put Caladryl on my hand(lft.) took 2 Benadryl tabs and went to bed.  Later that evening- the itching stopped and the hives went away.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Dystonia, Electroencephalogram abnormal, Eye movement disorder, Gastrooesophageal reflux disease
Clinical narrative: CONVULSIONS/SEIZURES:  HEAD TILTED AND LOCKED TO BACK(LOOKING UP) WITH EYES LOCKED TO TOP WITH WHITE OF EYES SHOWING.  EYES TENDED TO LOOK FOR LIGHT (LIGHTBULBS AT HOME).  LENGHT:  1-3 MINUTES OCCURRING APPROX. 5-15 MIN. IN BETWEEN.  VACCINATIONS GIVEN ON 10-28-04 AT APPROX. 1000 HOURS.  THREE SHOTS: REQUIRED AT 4 MONTHS OLD.  DOSAGE NOT MENTIONED BY DOCTOR'S PERSONNEL OR DOCTOR.  BABY ALSO TAKING (GENERIC-METOCLOPRAMIDE)/REGLAN 5MG/5ML SYP ON SAME DAY OF VACCINATION.  DOSAGE:  .5 ML BY MOUTH 3 TIMES A DAY. BABY WAS HOSPITALIZED, AS ORDERED BY DR. PARENT NOTICED THAT DR. LOOKED AT PATIENTS CHART(RECORD) AND IMMEDIATELY ADVISED PARENT THAT REGLAN CAUSED SEIZURES IN PATIENTS BEFORE. PARENT ASKS DOCTOR IF THE COMBINATION OF REGLAN AND THE VACCINES (DPT) CAUSED THIS SEIZURE/CONVULSION REACTION AND DR. DID NOT ANSWER. CHILD STILL HOSPITALIZED. PARENTS ATTEMPT SEVERAL TIMES TO ASK DR.(S) IF THE VACCINES PLAY A ROLE AND DR.(S) DO NOT ANSWER PARENTS.  PLEASE HELP IN THIS MATTER.  WOULD DR.(S) REPORT THIS INCIDENT TO YOU BECAUSE IT RELATED TO VACCINES AND REGLAN AT THE SAME TIME? Follow up on 11/12/04 states: "Father of pt states baby took Reglan for 1 week at age 6 weeks for spitting up. When the spitting up recurred at 4 months when baby was placed on original type of formula, parents gave 2 doses of Reglan only. These were at 9AM and 3PM on 10/28/04.  The date of vaccination. Discharge Summary received on 1/25/2005 states Seizure confirmed. Other diagnoses were fever, resolved, dystonic reaction to Reglan, GERD, hyponatremia, resolved.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Gaze palsy, Hyponatraemia, Pyrexia
Clinical narrative: CONVULSIONS/SEIZURES:  HEAD TILTED AND LOCKED TO BACK(LOOKING UP) WITH EYES LOCKED TO TOP WITH WHITE OF EYES SHOWING.  EYES TENDED TO LOOK FOR LIGHT (LIGHTBULBS AT HOME).  LENGHT:  1-3 MINUTES OCCURRING APPROX. 5-15 MIN. IN BETWEEN.  VACCINATIONS GIVEN ON 10-28-04 AT APPROX. 1000 HOURS.  THREE SHOTS: REQUIRED AT 4 MONTHS OLD.  DOSAGE NOT MENTIONED BY DOCTOR'S PERSONNEL OR DOCTOR.  BABY ALSO TAKING (GENERIC-METOCLOPRAMIDE)/REGLAN 5MG/5ML SYP ON SAME DAY OF VACCINATION.  DOSAGE:  .5 ML BY MOUTH 3 TIMES A DAY. BABY WAS HOSPITALIZED, AS ORDERED BY DR. PARENT NOTICED THAT DR. LOOKED AT PATIENTS CHART(RECORD) AND IMMEDIATELY ADVISED PARENT THAT REGLAN CAUSED SEIZURES IN PATIENTS BEFORE. PARENT ASKS DOCTOR IF THE COMBINATION OF REGLAN AND THE VACCINES (DPT) CAUSED THIS SEIZURE/CONVULSION REACTION AND DR. DID NOT ANSWER. CHILD STILL HOSPITALIZED. PARENTS ATTEMPT SEVERAL TIMES TO ASK DR.(S) IF THE VACCINES PLAY A ROLE AND DR.(S) DO NOT ANSWER PARENTS.  PLEASE HELP IN THIS MATTER.  WOULD DR.(S) REPORT THIS INCIDENT TO YOU BECAUSE IT RELATED TO VACCINES AND REGLAN AT THE SAME TIME? Follow up on 11/12/04 states: "Father of pt states baby took Reglan for 1 week at age 6 weeks for spitting up. When the spitting up recurred at 4 months when baby was placed on original type of formula, parents gave 2 doses of Reglan only. These were at 9AM and 3PM on 10/28/04.  The date of vaccination. Discharge Summary received on 1/25/2005 states Seizure confirmed. Other diagnoses were fever, resolved, dystonic reaction to Reglan, GERD, hyponatremia, resolved.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Feeling hot, Oedema peripheral, Thermal burn
Clinical narrative: Erythema, edema, warmth of right upper extremity, trapezius through elbow.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Erythema, edema, warmth of right upper extremity, trapezius through elbow.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cow pox, Pruritus, Skin ulcer, Vaccination complication, Viral infection
Clinical narrative: Generalized eruption. Vesiculopustular coalescing to crusted plaques. Occurring 3 weeks after vaccination and after complete resolution of take site.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash vesicular
Clinical narrative: Generalized eruption. Vesiculopustular coalescing to crusted plaques. Occurring 3 weeks after vaccination and after complete resolution of take site.
Age: 0.19
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cardio-respiratory arrest, Sudden infant death syndrome
Clinical narrative: Patient expired 48 hours after immunization (Cardiopulmonary arrest). Autopsy Report received on 1/20/2005 states SIDS. - Review of medical records on 11/10/04 indicate the office visit of 9/30/04 was for nasal congestion and fussiness. TMs were clear and there was no fever or cough. Given NS drops and suggested use of vaporizer. Visit of 10/7/04 was for continued congestion, gassiness and fussiness. Temp was 100 rectally and 98.9 on repeat. Diagnosed with colic.
Age: 0.62
Sex: M
Vaccine: HIBV
Symptoms: Aggression, Drug toxicity, Fatigue, Irritability, Mood swings
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a consumer regarding a 3 year old male patient who received a dose on 7/10/00 and 9/15/00. The child also received a dose of Acel-Imune on 6/23/00 and 8/26/00 and other concomitant vaccines on 4/19/00, 5/8/00, and 7/17/00, and experienced mood swings, temper tantrums, irritability, extreme tiredness and heavy metal toxicity. Relevant medical history was not provided. Indication for Hib-Titer vaccine was immunization. Product was administered on 7/10/00 and 9/15/00. Dose regimen was one dose (IM). Additional suspect vaccines included Acel-Imune vaccine administered on 8/26/00 and 6/23/00, Act-HIB administered on 5/8/00, Infanrix administered on 8/19/00 and Poliomyelitis vaccine inactivated administered on 5/8/00 and 7/17/00. Concomitant medications were not reported. A consumer, the mother of a 3 year old male patient, reported that her son received a dose of Hib-Titer on 7/10/00 and 9/15/00. The child also received a dose of Acel-Imune on 6/23/00 and 8/26/00 and other concomitant vaccines on 4/19/00, 5/8/00, and 7/17/00. The reporter stated, her son was diagnosed with heavy metal toxicity in 2003. She also stated, that when her son was around 12 months old, he began having mood swings, temper tantrums, irritability, and was always extremely tired. She stopped vaccinating her child at 10 months. The reporter indicated that her child has not recovered and declined to grant permission for follow up investigation with her pediatrician. No additional information was available at the time of this report.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Initial and follow up nformation has been received from a registered nurse concerning an 81 year old female patient who on 10/15/04 was vaccinated into the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). On 10/16/04 the patient felt soreness around the injection site. Later in the day she noticed a swelling and redness around the injection site (about 4 inches in diameter). The soreness continued and it began to itch as well. The patient went to the emergency room and was treated with prednisone 10mg twice a day until the swelling and redness went down. She was also instructed to take diphenhydramine hydrochloride and to use an ice pack on the area. On 10/18/04 the patient told the nurse that the swelling, soreness and redness had subsided. It was noted that the patient was recovering. According to the nurse as of 10/27/04 the patient's symptoms had subsided and treatment with diphenhydramine hydrochloride and prednisone was discontinued. The reporter considered the patient's experiences to be other important medical events (OMIC). Additional information has been requested. Follow up 03/03/05: Patient has recovered from the adverse event.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Aplastic anaemia, Ecchymosis, Laboratory test abnormal, Liver function test abnormal, Petechiae
Clinical narrative: Published information has been received concerning a 25 year old male who was vaccinated with a booster dose of Hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown).  Seven days later, he presented to the ER with diffuse skin lesions and bruises of his extremities of 24 hour duration. The pt was subsequently hospitalized. His initial labs showed WBC count of 2200/uL, hemoglobin 14.6g/dL, hematocrit 40%, and platelet count 4000/uL. The only positive physical findings were petechiae of oral mucosa and petechiae of the upper and lower extremities with occasional ecchymoses.  Liver function tests showed SGPT 747, SGOT 222, bilirubin 0.8, and alkaline phosphatase 49. Follow up lab tests showed decreasing liver function tests over a 2 week period. Initially he received prednisone and IVIG for ITP, but there was no improvement in his counts so on the 4th hospital day, a bone marrow biopsy was performed, which showed hypocellular marrow with 15% cellularity.  The number of megakaryocytes was markedly decreased. Diagnosis was consistent with aplastic anemia. After a month, a repeat bone marrow biopsy was performed which again showed 5% cellularity.  He ultimately received an allogeneic bone marrow transplant.  Further work up showed negative HIV tests. Serology study for parvovirus, CMV, IgM and ANA was negative. Hepatitis A as and Hepatitis A Ab (ACVPCR), Hepatitis A core Ab, and Hepatitis B surface Ag tests were negative. Hepatitis B surface Ab titers was high (>150).  It was hypothesized that an underlying immune predisposition might have enabled the vaccine to trigger the vigorous cytotoxic T lymphocyte response that possibly led to aplastic anemia.  Additional information has been requested. Follow up 01/05/05: Follow up information from the physician indicated that the patient was seen as a consultation approximately 2 years ago. A bone marrow biopsy was performed as a second opion and confirmed the aplastic anemia diagnosis. He received a bone marrow transpalnd and was doing well. The physician stated that he does not know or have the ability to find out which Hepatitis B product the patient received. Additional information is not expected. Follow up 03/03/05: Patient's recovery status is unknown. Per follow up report received on 06/14/2005:  Patient's recovery status is still unknown.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Rhinorrhoea, Thrombocytopenic purpura, White blood cell count decreased
Clinical narrative: Published information has been received concerning a 25 year old male who was vaccinated with a booster dose of Hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown).  Seven days later, he presented to the ER with diffuse skin lesions and bruises of his extremities of 24 hour duration. The pt was subsequently hospitalized. His initial labs showed WBC count of 2200/uL, hemoglobin 14.6g/dL, hematocrit 40%, and platelet count 4000/uL. The only positive physical findings were petechiae of oral mucosa and petechiae of the upper and lower extremities with occasional ecchymoses.  Liver function tests showed SGPT 747, SGOT 222, bilirubin 0.8, and alkaline phosphatase 49. Follow up lab tests showed decreasing liver function tests over a 2 week period. Initially he received prednisone and IVIG for ITP, but there was no improvement in his counts so on the 4th hospital day, a bone marrow biopsy was performed, which showed hypocellular marrow with 15% cellularity.  The number of megakaryocytes was markedly decreased. Diagnosis was consistent with aplastic anemia. After a month, a repeat bone marrow biopsy was performed which again showed 5% cellularity.  He ultimately received an allogeneic bone marrow transplant.  Further work up showed negative HIV tests. Serology study for parvovirus, CMV, IgM and ANA was negative. Hepatitis A as and Hepatitis A Ab (ACVPCR), Hepatitis A core Ab, and Hepatitis B surface Ag tests were negative. Hepatitis B surface Ab titers was high (>150).  It was hypothesized that an underlying immune predisposition might have enabled the vaccine to trigger the vigorous cytotoxic T lymphocyte response that possibly led to aplastic anemia.  Additional information has been requested. Follow up 01/05/05: Follow up information from the physician indicated that the patient was seen as a consultation approximately 2 years ago. A bone marrow biopsy was performed as a second opion and confirmed the aplastic anemia diagnosis. He received a bone marrow transpalnd and was doing well. The physician stated that he does not know or have the ability to find out which Hepatitis B product the patient received. Additional information is not expected. Follow up 03/03/05: Patient's recovery status is unknown. Per follow up report received on 06/14/2005:  Patient's recovery status is still unknown.
Age: 0.47
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Convulsion, Dyskinesia, Electroencephalogram abnormal, Gaze palsy
Clinical narrative: Immunizations given in morning. On PM of same day, temperature 101.4 (midnight), upward gaze, unresponsive to mom followed by cluster of about 20 episodes of jerking in all extremities. Diagnosed as myoclonic seizures.
Age: 0.47
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Myoclonus, Pyrexia
Clinical narrative: Immunizations given in morning. On PM of same day, temperature 101.4 (midnight), upward gaze, unresponsive to mom followed by cluster of about 20 episodes of jerking in all extremities. Diagnosed as myoclonic seizures.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: Late 1980s: neck pain, stiff neck; symptoms increased to tightness in right inguinal area in August 1997 and continued to get worse. 1997: Spasms in back on spine and radiating around to each side of back. Startle response to unexpected noise and touch. 2001: diagnosed with stiff person syndrome. Follow up 02/15/05: Patient sent address update. And states she was about 23 years old at the time of vaccination. She has siff peron syndrome, weakness in legs, pain in low back, stiffness in neck, trouble with walking, which includes balance, and fatigue. Stress related problems. I had a misscarriage after having 2 health boys (at the time were 4 and 10). I have to have IVIG (Gamma Globulin).$8000 per month approximately in medical cost. I have to take a lot of prescription medications. Due to all this I can no longer work. I was a medical technologist. This has caused a lot of stress and social problems for me.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Child had developed hives within few minutes after administering the vaccine.
Age: 47.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Dizziness, Erythema, Fatigue, Headache, Sensory disturbance
Clinical narrative: Pt states he took 2 doses. He experienced headache, fatigue, light-headedness and "prickly feeling" "all over". He noted redness on his back. No rash or shortness of breath.
Age: 1.35
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever 103. 10/19/2004. Lethargic
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Malaise, Pyrexia, Rash
Clinical narrative: Fever joint pain, malaise, rash
Age: 5.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Erythema, warmth and swelling of left proximal arm deltoid region extending toward elbow. Has flu appointment.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Pt had a blister appear where immunization given.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Hypokinesia, Pain
Clinical narrative: Patient came into pharmacy on October 25th and complained that her arm hurt after receiving flu shot October 4th. Complained of arm pain that radiated to both shoulders. No medical attention received. Patient commented "it was hard to turnover in bed." Patient says it still slightly hurts across her shoulders.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Flu shot 0.5cc given 10/19/2004. Pt noted mild redness, slight swelling , warm feeling around injection site by 10/21/2004.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: About 4-6 hours after vaccination, left deltoid began swelling. Spread to mid left clavicle skin and just past left elbow skin, over 2 days. Began receding on Augmentin, Zyrtec, Motrin. Recovered over a few days.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Chills, Dizziness, Hyperhidrosis, Hypokinesia
Clinical narrative: Couldn't move arm, sick to stomach, nausea, chills, felt faint, pain in left arm, left shoulder, left neck. Thinks fever 24 hours later, woke up soaking wet.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: Couldn't move arm, sick to stomach, nausea, chills, felt faint, pain in left arm, left shoulder, left neck. Thinks fever 24 hours later, woke up soaking wet.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Skin discolouration, Swelling
Clinical narrative: Received vaccine 10/7/04: on 10/14 : my right arm from deltoid to elbow was swollen and discolored. Wife received shot on 10/14 and told the nurse about my swollen arm and discoloration on my deltoid became enlarged and swollen. Nurse told to go to ER. Also elbow to wrist was swollen.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Serious upper respiratory infection, still sick 2 weeks later. Was placed on decongestion then antibiotics. Doctor said it was from the flu vaccine. 101 F temp for days, nasal discharge severe, now to cough and asthma symptoms.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Upper respiratory tract congestion
Clinical narrative: Serious upper respiratory infection, still sick 2 weeks later. Was placed on decongestion then antibiotics. Doctor said it was from the flu vaccine. 101 F temp for days, nasal discharge severe, now to cough and asthma symptoms.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Hyperhidrosis, Pruritus, Pyrexia, Restless legs syndrome
Clinical narrative: 10/21/04: Pt reports: began to feel ill, 10/22 by 10PM 101.5 degrees. By midnight 102 T, became diaphoretic, had to change sheets and night gown, 10/23 low grade fever, Tachycardia, right leg was restless, right arm itching but had sot in left arm 10/24 entire body shaking, hoarseness present, low grade temp. 10/25 better 10/26 temp normal. No further problems. She call her doctor on 10/22. He told her he was not fine. had these symptoms did not suggest she see him.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Tremor
Clinical narrative: 10/21/04: Pt reports: began to feel ill, 10/22 by 10PM 101.5 degrees. By midnight 102 T, became diaphoretic, had to change sheets and night gown, 10/23 low grade fever, Tachycardia, right leg was restless, right arm itching but had sot in left arm 10/24 entire body shaking, hoarseness present, low grade temp. 10/25 better 10/26 temp normal. No further problems. She call her doctor on 10/22. He told her he was not fine. had these symptoms did not suggest she see him.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Face oedema, Pruritus, Swelling
Clinical narrative: After receiving flu vaccine (Aventis) shortly after, nose, mouth, cheek, became red, itching: after work, arm was very red, swollen 2x2" : also had angio edema to right side of face. Had had flu vaccine in past  6 years.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Irritability, Liver disorder, Nasal congestion, Nervous system disorder, Pulmonary congestion
Clinical narrative: Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death.  - Review of well-baby progress note on 11/8/04 indicates baby was apparently healthy at time of immunizations. No additional symptoms.  - - 03/23/2005 autopsy report rec'd.  COD was SIDS.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Sudden infant death syndrome, Unevaluable event
Clinical narrative: Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death.  - Review of well-baby progress note on 11/8/04 indicates baby was apparently healthy at time of immunizations. No additional symptoms.  - - 03/23/2005 autopsy report rec'd.  COD was SIDS.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: Pt was given 2 ANTHRAX shots within 5 minutes of each other each 0.5cc. No signs of Adverse reactions. Consulted with infectious disease LT.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dizziness, Headache, Pain, Photophobia
Clinical narrative: Dizziness followed by worsening headache starting approximately 30 minutes after Anthrax ,Typhoid and smallpox immunizations. Pt presented back to the clinic with the above complaints. Pt had normal vitals and photophobia was noted on initial exam. Pt had worsening headache 10/10  pain and dizziness to the point in which he needed help ambulating. No local site erythema or reaction. Patient was given Totadol 60 mg IM and his symptoms improved over the next 30 minutes. Dizziness and headache resolved over 45 minutes.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Slight fever, significant swelling, redness, heat of upper arm extending to elbow so by 24 hours entire upper arm involved. Beginning to resolve at 48 hours.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Advises fever of 104, hives on face and legs. Took Tylenol 2 tab every 6 hours. S/s started the day after receiving pneumococcal vaccine. On 11/22 advises no fever x2 days and hives resolving.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Pt became pale, diaphoretic, dizzy, nauseated, approx 5 min after injections. Resolved 10 minutes afterwards.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Eye oedema, Rash pruritic
Clinical narrative: Parent reports itchy rash and eye swelling (periorbital) starting early AM 09/17/04.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Erythema and swelling of right arm from shoulder to wrist.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Approx 2 hrs of inconsolable crying
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Date 10/18/04 vaccine 2:00PM at 7:30PM, starting w/ fever and every muscle in my body, felt like a truck ran me over
Age: 71.0
Sex: M
Vaccine: TD
Symptoms: Cyanosis, Faecal incontinence, Somnolence, Tremor
Clinical narrative: 8 hrs after receiving vaccine pt exp severe total body shaking, skin developed bluish tint. 911 called by spouse. Rx'd in ER for 12 hrs, loss of bowel function, in and out of lucidity. 20 hrs later pt was back to normal.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Redness, swelling, heat at site of DTaP injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Redness, swelling and pain at site of DTaP
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Pain
Clinical narrative: Pt called clinic with c/o unable to lift arm. Gradual onset since 10/15. Went to ER 10/23 put on steroids and pain meds, X-rays neg.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Headache, Hypertonia, Hypokinesia, Injection site pain
Clinical narrative: On Sept. 7, 2004, I cut my hand and was advised by the health unit at work that, since it had been so long since my last tetanus shot, I should get one. So I received a TD booster. Immediately after the shot, there was some soreness in the arm that was injected, but I knew this was normal. Except for feeling run down, I didn't really notice anything else until Sept 30th. On that day, I was kneeling on the floor taking a photo and found that I could not get up. It was like my legs had just stopped working. While my husband lifted me up on one side, I pulled hard on a fence with my other hand and finally got to my feet. My legs felt wobbly and weak, but I dismissed it and thought I was coming down with the flu. About a week after the first incident, I tried running across the street and I almost pitched forward on my face because my legs would not move with me. At that point, I knew that there was a problem. I called the health unit that had given me the shot, but the nurse that answered the phone said she didn't know what I was talking about and had never heard of any side effects from the tetanus booster. So I decided to wait a while longer to see if the symptoms would subside.  They have not. Since receiving the shot, I have tried to go about my normal routine, but the muscles in my legs have grown stiff and weak. My legs ache constantly, especially when I am walking or trying to get up out of a chair. And walking up stairs has become almost impossible. The pain and weakness has also affected my neck, arms and shoulders. My hands shake, sometimes very badly, while at other times just slightly. I feel exhausted most of the time and sometimes I have a low grade fever or a headache.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Lethargy, Pain, Pyrexia, Tremor
Clinical narrative: On Sept. 7, 2004, I cut my hand and was advised by the health unit at work that, since it had been so long since my last tetanus shot, I should get one. So I received a TD booster. Immediately after the shot, there was some soreness in the arm that was injected, but I knew this was normal. Except for feeling run down, I didn't really notice anything else until Sept 30th. On that day, I was kneeling on the floor taking a photo and found that I could not get up. It was like my legs had just stopped working. While my husband lifted me up on one side, I pulled hard on a fence with my other hand and finally got to my feet. My legs felt wobbly and weak, but I dismissed it and thought I was coming down with the flu. About a week after the first incident, I tried running across the street and I almost pitched forward on my face because my legs would not move with me. At that point, I knew that there was a problem. I called the health unit that had given me the shot, but the nurse that answered the phone said she didn't know what I was talking about and had never heard of any side effects from the tetanus booster. So I decided to wait a while longer to see if the symptoms would subside.  They have not. Since receiving the shot, I have tried to go about my normal routine, but the muscles in my legs have grown stiff and weak. My legs ache constantly, especially when I am walking or trying to get up out of a chair. And walking up stairs has become almost impossible. The pain and weakness has also affected my neck, arms and shoulders. My hands shake, sometimes very badly, while at other times just slightly. I feel exhausted most of the time and sometimes I have a low grade fever or a headache.
Age: 25.0
Sex: F
Vaccine: DT
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Oedema
Clinical narrative: Pt had DT on 10/22/04, later that day had a fever, felt tired, felt wiped out, body aches, chills, decreased appetite, Left arm, Left neck, Left torso edematous and sore.
Age: 25.0
Sex: F
Vaccine: DT
Symptoms: Pain, Pyrexia
Clinical narrative: Pt had DT on 10/22/04, later that day had a fever, felt tired, felt wiped out, body aches, chills, decreased appetite, Left arm, Left neck, Left torso edematous and sore.
Age: 70.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Erythema, Feeling hot
Clinical narrative: 4 inch diameter red, warm area right biceps
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Dermatitis bullous, Pyrexia, Rash papular, Rash pustular
Clinical narrative: Mild varicella like eruption about 3 weeks after immunizations. Papules, pustules, and vesicles at different stages of heading on trunk and head. also had fever.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Somnolence
Clinical narrative: Excessive sleepiness up to 18 hrs
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Approx 1hr after vaccinations developed general redness with whelps and itching on face, ears, trunk. No resp symptoms. Responded well to tx with antihistamine and steroids discharged.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pneumonia, Pyrexia, Respiratory disorder, Upper respiratory tract infection
Clinical narrative: Mom called and stated "my child had 5 shots 2 days ago and he's been running a high temp since the evening of the day he got them, his temp right now is 105.5. I have him in a cool bath and have been giving him Tylenol and Motrin alternatively every 4 hrs".
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site oedema
Clinical narrative: Diffuse, erythema and SC edema peaking 24-48 hrs after injection. However circumferential in process of resolving.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Chills, Confusional state, Fatigue, Feeling cold
Clinical narrative: My arm started hurting immediately. Started having chills. At 8PM I took my temperature, it was up 2 degrees. The night of the 25th my arm was so swollen and inflamed and hot, painful, I could hardly get out of bed. At 2AM I finally got up and put ice bags on it and had a fever and was up for 3 hrs. Chilling with the fever. Went back to bed for awhile, then got up because my arm was so painful I couldn't lay there. I was still chilling and could tell my fever was going up. At 9:45 AM my temperature was 100.6. As 10:15 I felt worse and worse, so cold, nose icy cold, hands icy cold, I wrapped up in a blanket and put on my winter gloves to try to warm my hands. I checked my temperature at 10:15 and it was 101.7 (Oct 26). At 12:30 noon, I took a shower which brought my temp down to 99.4. At 1:30PM, it was 101.5. I called Dr office and told her nurse the way I felt and what had happened since receiving the shot. She said she would talk to the Dr and call me back. They called me back at 4:15 and told me the Dr said it was a reaction to the pneumonia vaccination and to take Tylenol to try to get the fever down . While waiting for the nurse to call at 3:25PM, my temp was 100.9. Then I checked it at 7PM and it was 100.7. Had chills all day. My arm was really swollen, red and hot. The redness extended to almost my elbow and 3/4 of the way around my arm. The shot was at the top of the shoulder. One of my daughters came in and got me some Tylenol. Took it and went to bed at 7:30PM temp at that time was 100.5. Went to sleep immediately and didn't awaken until 9:48PM and I was wet with sweat hair went also and confused. Then went back to bed and slept. Awakened at 4AM, Oct 27th, soggy with sweat and my temp was 96.8. My normal temp runs 97.3 to 97.6 the reason I know is because I check it every morning about the same time, also weighing myself. Was completely exhausted and felt lousy, couldn't eat.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Hypokinesia, Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: My arm started hurting immediately. Started having chills. At 8PM I took my temperature, it was up 2 degrees. The night of the 25th my arm was so swollen and inflamed and hot, painful, I could hardly get out of bed. At 2AM I finally got up and put ice bags on it and had a fever and was up for 3 hrs. Chilling with the fever. Went back to bed for awhile, then got up because my arm was so painful I couldn't lay there. I was still chilling and could tell my fever was going up. At 9:45 AM my temperature was 100.6. As 10:15 I felt worse and worse, so cold, nose icy cold, hands icy cold, I wrapped up in a blanket and put on my winter gloves to try to warm my hands. I checked my temperature at 10:15 and it was 101.7 (Oct 26). At 12:30 noon, I took a shower which brought my temp down to 99.4. At 1:30PM, it was 101.5. I called Dr office and told her nurse the way I felt and what had happened since receiving the shot. She said she would talk to the Dr and call me back. They called me back at 4:15 and told me the Dr said it was a reaction to the pneumonia vaccination and to take Tylenol to try to get the fever down . While waiting for the nurse to call at 3:25PM, my temp was 100.9. Then I checked it at 7PM and it was 100.7. Had chills all day. My arm was really swollen, red and hot. The redness extended to almost my elbow and 3/4 of the way around my arm. The shot was at the top of the shoulder. One of my daughters came in and got me some Tylenol. Took it and went to bed at 7:30PM temp at that time was 100.5. Went to sleep immediately and didn't awaken until 9:48PM and I was wet with sweat hair went also and confused. Then went back to bed and slept. Awakened at 4AM, Oct 27th, soggy with sweat and my temp was 96.8. My normal temp runs 97.3 to 97.6 the reason I know is because I check it every morning about the same time, also weighing myself. Was completely exhausted and felt lousy, couldn't eat.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Peripheral coldness, Pyrexia
Clinical narrative: My arm started hurting immediately. Started having chills. At 8PM I took my temperature, it was up 2 degrees. The night of the 25th my arm was so swollen and inflamed and hot, painful, I could hardly get out of bed. At 2AM I finally got up and put ice bags on it and had a fever and was up for 3 hrs. Chilling with the fever. Went back to bed for awhile, then got up because my arm was so painful I couldn't lay there. I was still chilling and could tell my fever was going up. At 9:45 AM my temperature was 100.6. As 10:15 I felt worse and worse, so cold, nose icy cold, hands icy cold, I wrapped up in a blanket and put on my winter gloves to try to warm my hands. I checked my temperature at 10:15 and it was 101.7 (Oct 26). At 12:30 noon, I took a shower which brought my temp down to 99.4. At 1:30PM, it was 101.5. I called Dr office and told her nurse the way I felt and what had happened since receiving the shot. She said she would talk to the Dr and call me back. They called me back at 4:15 and told me the Dr said it was a reaction to the pneumonia vaccination and to take Tylenol to try to get the fever down . While waiting for the nurse to call at 3:25PM, my temp was 100.9. Then I checked it at 7PM and it was 100.7. Had chills all day. My arm was really swollen, red and hot. The redness extended to almost my elbow and 3/4 of the way around my arm. The shot was at the top of the shoulder. One of my daughters came in and got me some Tylenol. Took it and went to bed at 7:30PM temp at that time was 100.5. Went to sleep immediately and didn't awaken until 9:48PM and I was wet with sweat hair went also and confused. Then went back to bed and slept. Awakened at 4AM, Oct 27th, soggy with sweat and my temp was 96.8. My normal temp runs 97.3 to 97.6 the reason I know is because I check it every morning about the same time, also weighing myself. Was completely exhausted and felt lousy, couldn't eat.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Healthy 5 year old, Dtap left arm 10/26/04. Phone call from mom 10/28 site raised, red, silver dollar size 10/29/04 pt awake with significant swelling, erythema, edema 14x9cm. No evidence of abscess. Treated with cool compress, Ibuprofen.
Age: 57.0
Sex: F
Vaccine: BCG
Symptoms: Dysuria, Fatigue, Pain, Perineal pain, Pollakiuria
Clinical narrative: A 57 year old female received treatment with OncoTICE for recurrent bladder cancer. In August 2003 she reported fatigue, dysuria, urinary frequency, painful sexual relations and irritation in the area of the perineum. The patient had washed her external genitalia vigourously after each treatment. All adverse events, except the irritation resolved. The patient states she has now some lesions in this same area. FU information: At last visiton 22OCT2003 the labial/ perianal lesions were resolving.
Age: 57.0
Sex: F
Vaccine: BCG
Symptoms: Sexual dysfunction, Skin ulcer
Clinical narrative: A 57 year old female received treatment with OncoTICE for recurrent bladder cancer. In August 2003 she reported fatigue, dysuria, urinary frequency, painful sexual relations and irritation in the area of the perineum. The patient had washed her external genitalia vigourously after each treatment. All adverse events, except the irritation resolved. The patient states she has now some lesions in this same area. FU information: At last visiton 22OCT2003 the labial/ perianal lesions were resolving.
Sex: M
Vaccine: BCG
Symptoms: Urinary incontinence
Clinical narrative: A male patient reported that his "bladder began to shrink" after being treated with OncoTICE approximately 3 years ago.
Age: 54.0
Sex: F
Vaccine: BCG
Symptoms: Bladder pain, Hypertonic bladder, Pollakiuria
Clinical narrative: A 57 year old female was treated since January 2001 with OncoTICE. Reportedly she experienced bladder pain, bladder inflammation and frequent urination after each treatment. The adverse events worsened gradually after each treatment and became unbearable after the second instillation in April 2003 and ONCOTICE was discontinued. Rifambin, isoniazid, B6, ethambutol and Cipro at various time points without relief.
Age: 79.0
Sex: M
Vaccine: BCG
Symptoms: Abdominal pain upper, Asthenia, Chills, Cyst, Malaise
Clinical narrative: A 79 year old male patient was prescribed 6 treatments of OncoTICE by his urologist, beginning in June 2003. On the day following his first OncoTICE treatment, the patient experienced fever (101 degrees), weakness, aches, chills, and "did not feel well". After his second treatment he experienced a 99.7 degree fever, chills and an upset stomach. He received 2 more treatments through July 2003, and then was advised to stop the treatment. In September 2003 he had an ultrasound which showed a solid mass on his epididymis. A biopsy is pending but has not been schedule yet. The patient has no pain. An infectious disease specialist has prescribed Isoniazid and Rifampin, but the patient is hesitant to take these medications due to possible liver damage.
Age: 79.0
Sex: M
Vaccine: BCG
Symptoms: Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: A 79 year old male patient was prescribed 6 treatments of OncoTICE by his urologist, beginning in June 2003. On the day following his first OncoTICE treatment, the patient experienced fever (101 degrees), weakness, aches, chills, and "did not feel well". After his second treatment he experienced a 99.7 degree fever, chills and an upset stomach. He received 2 more treatments through July 2003, and then was advised to stop the treatment. In September 2003 he had an ultrasound which showed a solid mass on his epididymis. A biopsy is pending but has not been schedule yet. The patient has no pain. An infectious disease specialist has prescribed Isoniazid and Rifampin, but the patient is hesitant to take these medications due to possible liver damage.
Age: 66.0
Sex: M
Vaccine: BCG
Symptoms: Erythema, Joint swelling, Tenderness
Clinical narrative: A 66 year old male patient received once weekly treatments of Tice BCG starting in October 2002 for 6 weeks and was currently on a maintenance regimen of once weekly treatments for 3 weeks followed by a 2-3 month period of no treatments (in total 21 instillations). The last treatment was 27AUG2003 and in September 2003 the patient experienced significant red and tender joint swelling. The patient's family physician has ruled out gout as a cause of the swelling.