chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: BCG
Symptoms: Back pain, Bacterial infection, Bone disorder, CSF test abnormal, Joint tuberculosis
Clinical narrative: A 64 year old male patient was treated with 2 full courses of OncoTICE (12 total treatments) in 1998 and subsequently received maintenance doses every  months for an unknown amount of time. Reportedly the patient received a total of 36 instillations. He was experiencing back problems and was seen by a physical therapist but his back problems remained. At his spine as well as deterioration of the spine was detected. A culture and sensitivity test of bone material of the spine showed colonization of Mycobacterium bovis. He was diagnosed with bone TB of spine in April 2003. At an unreported date the infected bone was removed from the spine and plates and rods were inserted in his SSPINE.
Age: 64.0
Sex: M
Vaccine: BCG
Symptoms: Laboratory test abnormal
Clinical narrative: A 64 year old male patient was treated with 2 full courses of OncoTICE (12 total treatments) in 1998 and subsequently received maintenance doses every  months for an unknown amount of time. Reportedly the patient received a total of 36 instillations. He was experiencing back problems and was seen by a physical therapist but his back problems remained. At his spine as well as deterioration of the spine was detected. A culture and sensitivity test of bone material of the spine showed colonization of Mycobacterium bovis. He was diagnosed with bone TB of spine in April 2003. At an unreported date the infected bone was removed from the spine and plates and rods were inserted in his SSPINE.
Age: 37.0
Sex: M
Vaccine: BCG
Symptoms: Back pain, Bacterial infection, Gastrointestinal disorder, Groin pain, Haematuria
Clinical narrative: A 37 year old male patient was diagnosed with recurrent transitional cell carcinoma on 2SEPT2003. Treatment with Tice BCG was started with 6 weekly instillations from October 2003 through 7 November 2003. On 15JAN2004, the patient presented with significant pain in his lower back and groin, and GI upset. He was referred to the local ER where he was diagnosed with an "inflammatory prostate infection", and given Cipro and Anaprox for treatment . On 23JAN2004, his urologist prescribed him Flomax for further treatment of the prostate infection. On 28JAN2004, the patient had hematuria. His urologist took a "post massage urine sample" and sent it for AFB stain, which was found positive. On 6FEB2004, the patient's prostate condition was assessed as "prostate infection continued, prostate size less congestion". On 26FEB2004, due to positive AFB results , patient was referred to his county health department, and also referred to a pulmonary specialist , related to his active TB case." Case assessed as serious because of medical significance. Follow up informaiton 8 MAR 2004: Pt started with an abx for TB but developed an allergic reaction on 28FEB2004. No other information is reported.
Age: 37.0
Sex: M
Vaccine: BCG
Symptoms: Infection, Prostatic disorder, Upper respiratory tract infection
Clinical narrative: A 37 year old male patient was diagnosed with recurrent transitional cell carcinoma on 2SEPT2003. Treatment with Tice BCG was started with 6 weekly instillations from October 2003 through 7 November 2003. On 15JAN2004, the patient presented with significant pain in his lower back and groin, and GI upset. He was referred to the local ER where he was diagnosed with an "inflammatory prostate infection", and given Cipro and Anaprox for treatment . On 23JAN2004, his urologist prescribed him Flomax for further treatment of the prostate infection. On 28JAN2004, the patient had hematuria. His urologist took a "post massage urine sample" and sent it for AFB stain, which was found positive. On 6FEB2004, the patient's prostate condition was assessed as "prostate infection continued, prostate size less congestion". On 26FEB2004, due to positive AFB results , patient was referred to his county health department, and also referred to a pulmonary specialist , related to his active TB case." Case assessed as serious because of medical significance. Follow up informaiton 8 MAR 2004: Pt started with an abx for TB but developed an allergic reaction on 28FEB2004. No other information is reported.
Age: 50.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Dysuria, Haematuria, Micturition urgency, Pollakiuria
Clinical narrative: A 49 year male patient received the first instillation of a second course of OncoTICE and Introl A 50 MIU. The next day he experienced fever, chills, urinary urgency, urinary frequency , hematuria and dysuria. After the second instillation the patient experienced the same events. The treatment is not discontinued.
Age: 50.0
Sex: M
Vaccine: BCG
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: A 49 year male patient received the first instillation of a second course of OncoTICE and Introl A 50 MIU. The next day he experienced fever, chills, urinary urgency, urinary frequency , hematuria and dysuria. After the second instillation the patient experienced the same events. The treatment is not discontinued.
Age: 74.0
Sex: M
Vaccine: BCG
Symptoms: Pyrexia, Tremor
Clinical narrative: a 74 year old male patient was being treated with OncoTICE. At catheterizaton for the fifth instillation some bleeding was noticed, possibly due to scar tissue from previous surgery. After this instillation the patient presented with uncontrollable shaking and fever. The shaking and fever both subsided within 24 hours. The shaking could have been possibly caused by hypoglycemia brought on by the fact that the patient did not have anything to eat since the previoius evening. The patient was treated with an antituberculin for 7 days as a precaution.
Age: 66.0
Sex: M
Vaccine: BCG
Symptoms: Groin pain, Skin burning sensation, Urinary tract infection
Clinical narrative: A 65 year old man was treated with OncoTICE. After the third instillation he complained of pain in his penis and a burning with urination, described by the reporter as basic UTI symptoms. Antibiotic( unspecified).
Age: 54.0
Sex: M
Vaccine: BCG
Symptoms: Condition aggravated, Erythema, Pollakiuria, Pruritus, Rash
Clinical narrative: An approximately 53 year old male patient received 6 OncoTICE installations in 1997 for bladder cancer. Reportedly he started getting a tan colored rash in the groin area soon after receiving the treatment. Over the years the rash had progressed also to the upper leg area and became variously red, itchy, crusty and or/ burning. He had been treated with various medications with only temporary relief. A dermatologist had done a biopsy and this had rule out skin cancer. The patient also stated that his pre-existing urinary frequency problem worsened for urinating 7-8 times  a day to approximately 23 times a day. Steroid based creams/ ointments.
Age: 54.0
Sex: M
Vaccine: BCG
Symptoms: Skin burning sensation, Skin discolouration
Clinical narrative: An approximately 53 year old male patient received 6 OncoTICE installations in 1997 for bladder cancer. Reportedly he started getting a tan colored rash in the groin area soon after receiving the treatment. Over the years the rash had progressed also to the upper leg area and became variously red, itchy, crusty and or/ burning. He had been treated with various medications with only temporary relief. A dermatologist had done a biopsy and this had rule out skin cancer. The patient also stated that his pre-existing urinary frequency problem worsened for urinating 7-8 times  a day to approximately 23 times a day. Steroid based creams/ ointments.
Age: 53.0
Sex: M
Vaccine: BCG
Symptoms: Condition aggravated, Cystitis interstitial, Pollakiuria, Skin burning sensation
Clinical narrative: A 53 year old man had been treated with OncoTICE for chronic interstitial cystitis. After the last treatment he experience a worsening of his increased urinary frequency and a burning sensation when urinating since that same night. Levaquin, Pyridium and Uroblue.
Age: 66.0
Sex: M
Vaccine: BCG
Symptoms: Arthralgia, Back pain, Chills, Condition aggravated, Myalgia
Clinical narrative: A 66 year old man was treated with OncoTICE. After the first or second instillation he experienced worsening of his rheumatoid arthritis (back pain, joint pain, leg pain) and chills. Due to the events OncoTICE was discontinued. Medication resolved the events only temporarily. His treating urologist told him that the events were not related to OncoTICE. Medrol dosepak, Advil.
Age: 66.0
Sex: M
Vaccine: BCG
Symptoms: Rheumatoid arthritis
Clinical narrative: A 66 year old man was treated with OncoTICE. After the first or second instillation he experienced worsening of his rheumatoid arthritis (back pain, joint pain, leg pain) and chills. Due to the events OncoTICE was discontinued. Medication resolved the events only temporarily. His treating urologist told him that the events were not related to OncoTICE. Medrol dosepak, Advil.
Age: 68.0
Sex: M
Vaccine: BCG
Symptoms: Pyrexia
Clinical narrative: A 68 year old male patient with transitional cell carcinoma of the bladder was given 3 instillations of Tice BCG (last treatment on 17MAY2004) and developed a febrile episode and a systemic reaction to TICE BCG. The patient's fever was measured at 102.5-103 degrees Fahrenheit. Tice BCG treatments were stopped and the patient treated with anti-TB drugs. Rifampin and INH.
Sex: F
Vaccine: BCG
Symptoms: Abdominal pain
Clinical narrative: A female (age not reported) received OncoTICE for an unknown indication on 1/28/04. She reports that she is experiencing higher abdominal pain after the treatment.
Age: 62.0
Sex: M
Vaccine: BCG
Symptoms: Erythema, Skin exfoliation
Clinical narrative: A 61 year old man received an induction course and maintenance therapy with OncoTICE since August 2002. The patient had tolerated the OncoTICE instillations well, with no reported problems. At a dental appointment in March 2004, there were no abnormalities noted. Reportedly in June 2004, his dentist noted that the patient's gums were red and sloughing.
Age: 53.0
Sex: M
Vaccine: BCG
Symptoms: Blood thyroid stimulating hormone decreased, Blood uric acid increased, Condition aggravated, Influenza like illness
Clinical narrative: A 53 year old man, with a history of thyroid cancer and renal carcinoma, was diagnosed with bladder cancer in February 2004. Subsequently he received weekly OncoTICE instillations. After approximately three weeks, some abnormal lab values were seen (uric acid increased, creatinine clearance 1.2, glucose low, TSH decreased). According to the patient's MD's, these were either due to the patient's diet or his kidney. For the decreased TDH the patient's Synthroid dose was decreased to 150mcg. Since before completing the OncoTICE treatment he experienced flu-like symptoms and worsening of his arthritis.
Age: 64.0
Sex: M
Vaccine: BCG
Symptoms: Dizziness, Dysgeusia, Dysuria, Flushing, Headache
Clinical narrative: A 63 year old man received his first OncoTICE instillation on 12MAR2004 at 13:30. At about 17:00 reportedly he presented with dizziness, nausea, facial flushing, blurry vision, headaches and a "taste of medication in his mouth". The symptoms abated after 24 hours. A day or two later he presented with increased urinary frequency and burning during urination. At the time of reporting the burning still lingered.
Age: 64.0
Sex: M
Vaccine: BCG
Symptoms: Nausea, Pollakiuria, Vision blurred
Clinical narrative: A 63 year old man received his first OncoTICE instillation on 12MAR2004 at 13:30. At about 17:00 reportedly he presented with dizziness, nausea, facial flushing, blurry vision, headaches and a "taste of medication in his mouth". The symptoms abated after 24 hours. A day or two later he presented with increased urinary frequency and burning during urination. At the time of reporting the burning still lingered.
Age: 69.0
Sex: F
Vaccine: BCG
Symptoms: Chills, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: A 69 year old woman was treated with OncoTICE. Four hours after her first instillation of Oncotice she presented with chills and nausea. After the second instillation she experienced chills and nausea again and also vomited. The symptoms subsided without treatment and OncoTICE will be continued.
Age: 86.0
Sex: M
Vaccine: BCG
Symptoms: Urine analysis abnormal
Clinical narrative: A 86  year old male pt received his first instillation with OncoTICE on 25Feb04. When voiding the first time after 3-4 hours, he detected some dry blood pieces in his urine, followed by clear yellow urine. No further problems were reported.
Sex: M
Vaccine: BCG
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: A male pt had received OncoTICE for an unknown indication (dosing and date not reported) When further treatment was scheduled he presented with rash on his arms, which reportedly appeared after his previous OncoTICE instillation. It was suspected that the rash was an allergic reaction and it was decided to withhold the current treatment. Further information has been requested.
Sex: U
Vaccine: BCG
Symptoms: Pyrexia
Clinical narrative: A Pt  of unknown age and gender had been treated with OncoTICE for an unknown period of time. The pt experienced a fever after an OncoTICE instillation. No further information is available.
Age: 52.0
Sex: F
Vaccine: BCG
Symptoms: Urine analysis abnormal
Clinical narrative: A 52 year old female was treated with OncoTICE. After the first instillation she presented with gross blood in her urine. OncoTICE treatment was discontinued and the event was resolved.
Age: 68.0
Sex: M
Vaccine: BCG
Symptoms: Balanitis, Dysuria, Oedema
Clinical narrative: A 68 year old male pt was treated with OncoTICE. After 4 instillations, on 25Jun04 he presented dysuria and an area of induration on the dorsal side of the penis with edema on the skin of his penis. Treatment with Ciprofloxacin was started but on 29June04 the events had not yet abated.
Age: 41.0
Sex: M
Vaccine: BCG
Symptoms: Oral neoplasm, Rash
Clinical narrative: A 41 year old male pt was treated with OncoTICE for bladder cancer. On 02August04 he presented with fine red rash all over his body and a pea sized lump in his lip.
Age: 54.0
Sex: M
Vaccine: BCG
Symptoms: Abdominal discomfort, Dyspepsia, Headache
Clinical narrative: A 54 year old male pt was treated with OncoTICE for bladder cancer recurrence. On 13Jul04 he received his first installation of OncoTICE. On the  morning of 14Jul04, the pt ate a small bowl of hot cereal and shortly after he experienced a headache and an upset stomach with heartburn.
Age: 70.0
Sex: M
Vaccine: BCG
Symptoms: Dysuria, Erythema, Pyrexia, Vaccine positive rechallenge
Clinical narrative: A 70 year old male pt was treated with OncoTICE for bladder cancer. Since treatment start he experienced problems with urinating and burning during urination after each instillation. After the second instillation  he also presented with fever, which resolved with treatment. After the last instillation he was barely able to hold it for the prescribed 2 hours. He had extreme burning during urination and was prescribed antibiotics and the burning subsided after 1 week. On 26Jul04 a red spot in the area of the surgery was seen during a cystoscopy. His treating doctor is not sure if this is related to Oncotice treatment. Aspirin for fever, antibiotics for dysuria
Age: 76.0
Sex: M
Vaccine: BCG
Symptoms: Blood urine, Chills, Cough, Hypertonic bladder, Productive cough
Clinical narrative: A 76 year old male pt was treated with OncoTICE for bladder cancer since 27Apr2004. Follow the third instillation (approx 11May04) the pt experienced an intermittent coughing including some sputum. Other than the coughing the pt tolerated the initial series of 6 instillations well. On 12Jul04 the pt was diagnosed with inflamed bladder tissue. After the first instillation of a new treatment cycle on 10Aug04 that evening the pt experienced chills and a raised temp of 39.3C. His urologist advised the pt to take Tylenol and if the fever continued the pt should go to the ER. At the ER the consumer was given Levaquin IV and was sent home with a prescription for Levaquin 500mg for 7 days. The pt's temp had slowly been decreasing to 37.1C on 16Aug04. On the evening of 17Aug04 the pt experienced chills and fever (38.5C). He also noted bright red blood in his urine. The pt felt it was necessary to go to the hospital though the physician did not recommend it. The pt was treated with IV Rocephin 1g and the same evening he was sent home. On 18Aug04 his temp upon waking was 38C, he did not have any chills and there were only some small clots of blood in his urine.
Age: 76.0
Sex: M
Vaccine: BCG
Symptoms: Pyrexia
Clinical narrative: A 76 year old male pt was treated with OncoTICE for bladder cancer since 27Apr2004. Follow the third instillation (approx 11May04) the pt experienced an intermittent coughing including some sputum. Other than the coughing the pt tolerated the initial series of 6 instillations well. On 12Jul04 the pt was diagnosed with inflamed bladder tissue. After the first instillation of a new treatment cycle on 10Aug04 that evening the pt experienced chills and a raised temp of 39.3C. His urologist advised the pt to take Tylenol and if the fever continued the pt should go to the ER. At the ER the consumer was given Levaquin IV and was sent home with a prescription for Levaquin 500mg for 7 days. The pt's temp had slowly been decreasing to 37.1C on 16Aug04. On the evening of 17Aug04 the pt experienced chills and fever (38.5C). He also noted bright red blood in his urine. The pt felt it was necessary to go to the hospital though the physician did not recommend it. The pt was treated with IV Rocephin 1g and the same evening he was sent home. On 18Aug04 his temp upon waking was 38C, he did not have any chills and there were only some small clots of blood in his urine.
Age: 75.0
Sex: F
Vaccine: BCG
Symptoms: Arthralgia, Dysuria, Influenza like illness, Myalgia, Nausea
Clinical narrative: A 74 year old female pt was treated with OncoTICE for bladder cancer. On 24Jun, after her fourth installation, she experienced nausea, joint pain, painful urination and frequent urination. Following her fifth installation on 01July04 the symptoms became even more severe, especially the joint pain in her hip. After the sixth installation she reportedly had extreme flu-like symptoms and a 38.3C fever and ached all over on 08Jul04 with severe ongoing joint pain for four days. On 19July she reports a swollen left hand for three days.
Age: 75.0
Sex: F
Vaccine: BCG
Symptoms: Oedema, Pollakiuria, Pyrexia, Vaccine positive rechallenge
Clinical narrative: A 74 year old female pt was treated with OncoTICE for bladder cancer. On 24Jun, after her fourth installation, she experienced nausea, joint pain, painful urination and frequent urination. Following her fifth installation on 01July04 the symptoms became even more severe, especially the joint pain in her hip. After the sixth installation she reportedly had extreme flu-like symptoms and a 38.3C fever and ached all over on 08Jul04 with severe ongoing joint pain for four days. On 19July she reports a swollen left hand for three days.
Age: 58.0
Sex: M
Vaccine: BCG
Symptoms: Dysuria, Haematuria, Vaccine positive rechallenge
Clinical narrative: A 58 year old male pt was treated with OncoTICE for bladder cancer. Reportedly he experienced dysuria during the initial treatment. Due to cancer recurrence a second treatment cycle was started. In this second round the dysuria worsened. On 3Aug04 he also experienced hematuria.
Age: 64.0
Sex: M
Vaccine: BCG
Symptoms: Arthralgia, Blood urine, Fatigue, Nausea
Clinical narrative: A 64 year old male pt was treated with OncoTICE for bladder cancer since 5Jul04. Following his 4th instillation on 26July04, he reports he had blood in his urine which persisted for approx one day. On 29Jun04 he reports the blood in his urine was again very noticeable with urine red and with very small clots, and the bloody urine has continued through 30Jul04. He has also been experiencing some nausea, tiredness, and joint aching, especially his shoulder.
Sex: F
Vaccine: BCG
Symptoms: Eye irritation, Medication error
Clinical narrative: A female nurse of unknown age while handling OncoTICE accidentally squirted it into her eye. She subsequently experienced a little irritation to the eye.
Age: 71.0
Sex: F
Vaccine: BCG
Symptoms: Flushing, Pyrexia
Clinical narrative: A 71 year old female pt was treated with OncoTICE for bladder cancer. On 07Jul04 after her 4th instillation, she had retained OncoTICE in her bladder four about 10 hours. The pt reported that she experienced facial flushing and a possible fever. She reported that she took Tylenol at the time, and the symptoms resolved after a couple hours.
Age: 60.0
Sex: M
Vaccine: BCG
Symptoms: Malignant hypertension
Clinical narrative: A 60 year old male received six weekly instillations of Tice BCG for bladder cancer. On 24Jun03 the pt informed the healthcare professional that his internist started him on Norvasc treatment for malignant hypertension that day. The pt's hypertension was found to be related to progression of his disease. Bladder cancer was impinging on the ureters and surgery (Cystectomy) was done.
Sex: U
Vaccine: BCG
Symptoms: Arthralgia, Nausea
Clinical narrative: A pt (age and sex unknown) received Tice BCG (indication and therapy dates unknown), and had subsequently experienced joint pain and nausea for approx 1 wk. The pt is afebrile. F/U information: Adverse events resolved.
Age: 76.0
Sex: M
Vaccine: BCG, UNK
Symptoms: Cough
Clinical narrative: A 76 year old male experienced cough approx 6 hrs after a maintenance dose of 1/3 vial OncoTICE and Intron A. Reportedly the pt had a cold in the week prior to this maintenance but without cough.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Hypersensitivity, Pruritus
Clinical narrative: Started itching all over my body shortly after the shot was given.  I kept itching worse and worse until I itched from my head to the soles of my feet badly. Also my chest hurt inside.  Slightly hard to breathe.  Took Allergra and then called my doctor (talked on the phones, it was Saturday morning) for a prescription for Prednisone.  In addition to ADvair which I take daily, I used a nebulizer to help the breathing situation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Pruritus, Urticaria
Clinical narrative: 10mm X 10mm raised, itchy welt on upper L arm. Office visit on 10/30/04.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt. had hives mostly on chest one hour after given flu vaccine.  Referred to ER and given Benadryl for hives.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Apnoea, Cellulitis, Depressed level of consciousness, Dyspnoea, Injection site erythema
Clinical narrative: temp spike to 104 24 hours after injection and lethargic.  unable to get temp down at home, labored resp at 60, altered loc and cheynne stokes respirations and apnea of 35 seconds. Bright redness, very hot to touch measuring 4cm x 5cm and somewhat endurated at injection site and unable to touch the entire arm due to pain. Admitted to hospital treated with motrin Q3 hours alternating with tylenol Q3hours, solumedrol 30 mg IVP Q24, Rocephin 1 gm IVPB Q 24 for cellulitis at the injection site. Sent home on Keflex 250mg TID for 5 days. Orapred 15mg BID for 2 days.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Lethargy, Pain
Clinical narrative: temp spike to 104 24 hours after injection and lethargic.  unable to get temp down at home, labored resp at 60, altered loc and cheynne stokes respirations and apnea of 35 seconds. Bright redness, very hot to touch measuring 4cm x 5cm and somewhat endurated at injection site and unable to touch the entire arm due to pain. Admitted to hospital treated with motrin Q3 hours alternating with tylenol Q3hours, solumedrol 30 mg IVP Q24, Rocephin 1 gm IVPB Q 24 for cellulitis at the injection site. Sent home on Keflex 250mg TID for 5 days. Orapred 15mg BID for 2 days.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: temp spike to 104 24 hours after injection and lethargic.  unable to get temp down at home, labored resp at 60, altered loc and cheynne stokes respirations and apnea of 35 seconds. Bright redness, very hot to touch measuring 4cm x 5cm and somewhat endurated at injection site and unable to touch the entire arm due to pain. Admitted to hospital treated with motrin Q3 hours alternating with tylenol Q3hours, solumedrol 30 mg IVP Q24, Rocephin 1 gm IVPB Q 24 for cellulitis at the injection site. Sent home on Keflex 250mg TID for 5 days. Orapred 15mg BID for 2 days.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Received immunizations 10/12/04.  Mother noticed redness, swelling and rash around the site of DTaP on upper right thigh on 10/15/04.  She called the doctor who said to watch it and see him if increases.  Temperature 100.5 for two days after immunizations.  10/18/04 child okay, rash and redness gone.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Client received injections 10/12/04.  Over the weekend her mom noticed redness, swelling, and a rash on deltoid area and toward under the arm, around 4" long, no fever noted.  10/18/04 child okay, rash and redness gone.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Agranulocytosis, Cellulitis, Hypokalaemia, Injection site erythema, Injection site pain
Clinical narrative: Left arm swelling, pain, redness following receipt of pneumococcal polysaccharide vaccine. Patient was hospitalized and treated for cellulitis. Patient was treated with antibiotics. According patient she received shot in the sae arm as a flu shot that she received a day earlier. Discharge Summary received on 12/22/2004 states pt experienced hypopotassemia, serum reaction, and agranulocytosis.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Serum sickness
Clinical narrative: Left arm swelling, pain, redness following receipt of pneumococcal polysaccharide vaccine. Patient was hospitalized and treated for cellulitis. Patient was treated with antibiotics. According patient she received shot in the sae arm as a flu shot that she received a day earlier. Discharge Summary received on 12/22/2004 states pt experienced hypopotassemia, serum reaction, and agranulocytosis.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Pain, Sleep disorder
Clinical narrative: Client reports  right arm was achy for 2 days post vaccination. Client reports deep pain in upper arm and shoulder worsening on 10-24-04. Also less strength in arm and difficulty sleeping due to pain. Applied heat to arm and took Tylenol with little relief. Sought chiropractic care 10-25-04. Still has no relief. Will call MD today to make appointment
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Red erythamatous itchy rash to arms, torso and legs began approx. 4 hours after vaccination. Patient presented to medical after 2 hours. Pt. showed no signs of acute distress, no difficulty breathing, non toxic. Patient was treated w/150 mg. Benadryl IM and 100 mg prednisone by mouth immediately and was monitored for 30 minutes, until symptoms resolved, then was prescribed Prednisone taper times 6 days, Zantac 150 mg by mouth 2X per day and Benadryl 25 mg. by mouth every 6 hours.  Patient was instructed to return if symptoms persisted, rebounded, or worsened and to f/u in 1 day.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Fatigue, Nausea
Clinical narrative: Patient called states she has had extreme fatigue since shot 5 days ago.  She also gets nauseated everytime she tries to do any activity.  Also gets "clammy" and chills and has to sit down often.
Age: 0.44
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Rash
Clinical narrative: RASH APPEARED APPROXIMATELY 1 1/2 HOURS AFTER RECEIVING VACCINES.  RASH FIRST APPEARED ON HEAD AND HAIRLINE AND SPREAD OVER BODY BY 10/24/04.  RASH FULLY SUBSIDED BY 10/25/04.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Medication error, Pruritus
Clinical narrative: PLACED ANTHRAX AND PPD ON 27 OCT 04.  She mistakenly placed Anthrax ID on the left forearm and gave the PPD Subcutaneously in the outer aspect of the Left upper arm.  Pt was in clinic on 29 Oct for PPD reading, measuring 33mmX51mm.  A second PPD was place on 29 Oct.  Pt is in clinic today for reading of second PPD.  Results are Zero mm.  Pt had only a local reaction without any further complications.  Reaction on Left Forearm today measures 22mmX23mm.  Pt has minimal itching at this time.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Nasal congestion
Clinical narrative: severe nasal congestion that lasted for a week and a half to two weeks; took Sudafed cough and cold capsules, tylenol extra strength, Robitussin CF. mild but noticeable headache
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Pt. returned to walk-in clinic about 20 minutes after receiving Fluzone. C/O Itching on chest and upper back.  Area was reddened.  No hives or raised lesions were noted.  Denied difficulty breathing.  Called MD Consultant.  She ordered Benadryl 25-50mg.  Pt. instructed to take benadryl as soon as possible when returning home and to call personal physician if symptoms worsen.  I called the pt the next morning to see how she was.  She stated that the symptoms were gone about 30 minutes after taking the Benadryl.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Pain, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: Within 8 hrs of receiving Influenza vaccine developed severe headache, by next morning malaise and body aches, within 24 hours fever 103.  Resolved within 72 hours
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After receiving a Td booster in her right upper arm the client initally developed approx. 3 mm area of pinkness and slight swelling. This resolved after a couple of days. However, the client  has been having continious localized pain around the injection site (approx. quarter size area) since the morning after receiving the IZ. On a scale of 1-10 she describes the pain at a 2 when not moving her arm and a 4-6 when she moves her arm.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: MACULARPAPULAR RASH ALL OVER BODY (ARMS, LEGS, BACK, NECK, AND CHEST) ITCHINESS AND REDNESS. WENT TO CLINIC 06OCT04 GIVEN CREAM ARISTOCORTA 2X A DAY. 12OCT04 GIVEN CREAM TRIAMCINOLONEACETONIDE 2X A DAY/ZYRTEC PILLS. 18OCT04 GIVEN CREAM ACTICIN ONE TIME A DAY LEAVE ON FOR 10-12HOURS, RUB ALL OVER BODY, THEN WASH OFF (PERMETHRIN) HYDROXINE PILLS FOR ICHING/TWICE A DAY, ONE/TWO PILLS (ATARAX). 20OCT04 GIVEN PRENEZONE PILLS 20MG TAPERED OFF 60MG FOR DAYS 1-2 60MG/DAYS 3-4 40MG/DAYS 5-6 20MG/DAYS 7-8 1/2 TAB/HYDROXINE (ATARAX) 25MG TWICE A DAY/TWO TO THREE PILLS. 28OCT04 GIVEN PRENEZONE PILLS 20MG TAKEN ONCE A DAY/HYDROXINE 25MG/TWO TO THREE PILLS TWICE A DAY 01NOV04. 20MG PRENEZONE TAPER OFF OVER 2 WEEKS IN NOVEMBER(2st-19th). 60MG DAYS 1-3. 40MG DAYS 4-12. 20MG DAYS 13-19 CREAM FLUOCINONIDE .05%  15 GRAMS TWICE A DAY HYDROXINE (ATARAX) 25MG  2x A DAY (TWO OR THREE PILLS)
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Asthenia, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Flatulence, Headache, Hypoaesthesia, Influenza like illness, Malaise
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Memory impairment, Muscle spasms, Nausea, Oedema peripheral, Photophobia
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pyrexia, Rash, Skin exfoliation, Vaccine positive rechallenge
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Asthenia, Back pain
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Diarrhoea, Discomfort, Fatigue, Headache, Myalgia
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 55.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Swelling
Clinical narrative: 08/10/2004: Stomach distress/ diarrhea, increasing joint/ muscle pain, headache, fatigue: let work early, missed work 8/11/04 with increasing severity of above symptoms. 8/12/04 went to work, but right hand swollen to pint that knuckles obscured. Lowe back and right arm discomfort Off work 8/13/04, very weak, headache, fatigued, distental. Spoke by phone with person at health center 8/16/04. Consulted with local MD, off work 8/17-8/18. Returned to work 8/9/04. Continued muscle, joint pain, headache. 8/20: spoke with doctor. Follow up in 2 weeks.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Pain, Pyrexia, White blood cell count increased
Clinical narrative: After vaccination, patient complained of shoulder, neck, and jaw pain.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Arthritis, Chest pain, Chills, Discomfort, Pain
Clinical narrative: After vaccination, patient complained of shoulder, neck, and jaw pain.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Pyrexia, Tenderness
Clinical narrative: After vaccination, patient complained of shoulder, neck, and jaw pain.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Arthritis, Neck pain, Pain in jaw, Shoulder pain
Clinical narrative: After vaccination, patient complained of shoulder, neck, and jaw pain.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: From initial information received on 10/26/04 from another manufacturer (WAES0410USA00063) regarding an adverse event occurring in the USA, which was originally reported by a health care worker it was reported that a 70 year old female patient received a PNEUMOVAX 23 vaccination, lot number 647359/0740N administered IM in an unspecified site and a FLUZONE, lot number, route and site not specified, administered on 9/28/04. Reportedly the next day the patient developed lymph node swelling and fever. The patient was seen in the emergency room. It was also noted that the patient was hospitalized. The patient's recovery status is listed as not recovered. The reporter of this event expressed a concern with the PNEUMOVAX 23 lot number 0740N. The reporter also mentioned four other female patient's (WAES0410USA00906; 0410USA00907; 0410USA00908, and 0410USA00909) who were also vaccinated with a dose of PNEUMOVAX 23 and developed similar reactions. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. The reporter of this case is the same reporter of cases 200403407,  2004034408, 200403409, and 200403410.From additional information received on 15NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. A new telephone number was provided.  From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Medication error, Pyrexia
Clinical narrative: From initial information received on 10/26/04 from another manufacturer (WAES0410USA00063) regarding an adverse event occurring in the USA, which was originally reported by a health care worker it was reported that a 70 year old female patient received a PNEUMOVAX 23 vaccination, lot number 647359/0740N administered IM in an unspecified site and a FLUZONE, lot number, route and site not specified, administered on 9/28/04. Reportedly the next day the patient developed lymph node swelling and fever. The patient was seen in the emergency room. It was also noted that the patient was hospitalized. The patient's recovery status is listed as not recovered. The reporter of this event expressed a concern with the PNEUMOVAX 23 lot number 0740N. The reporter also mentioned four other female patient's (WAES0410USA00906; 0410USA00907; 0410USA00908, and 0410USA00909) who were also vaccinated with a dose of PNEUMOVAX 23 and developed similar reactions. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. The reporter of this case is the same reporter of cases 200403407,  2004034408, 200403409, and 200403410.From additional information received on 15NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. A new telephone number was provided.  From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cardiac arrest, Cyanosis, Lymphadenopathy, Pneumonia, Unevaluable event
Clinical narrative: None stated.Nurse follow up on 11/02/04 states: "cyanosis; v-fib; cardiopulmonary arrest." Autopsy report received which revealed COD as interstitial pneumonia (compatible w/viral pneumonia), petecchial hemorrhage of the lungs & thymus and Cervical lymphadenopathy.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Ventricular fibrillation
Clinical narrative: None stated.Nurse follow up on 11/02/04 states: "cyanosis; v-fib; cardiopulmonary arrest." Autopsy report received which revealed COD as interstitial pneumonia (compatible w/viral pneumonia), petecchial hemorrhage of the lungs & thymus and Cervical lymphadenopathy.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Lacrimal disorder, Pyrexia, Rhinitis, Sudden infant death syndrome
Clinical narrative: SIDS.  Nurse follow up on 11/04/04 states: "fever 1/22/04; nasal congestion 2/2/04; blocked tear duct 2/2/04."
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Patient received vaccine 10/21/04 about 2:00 PM. On 10/22/04 at 04:00, patient was found dead in bed.  Autopsy report received on 11/22/2004 states pt had SIDS.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Anorexia, Disturbance in attention, Throat tightness, Tremor, Urinary incontinence
Clinical narrative: From initial information received on 10/20/04 from the patient's mother regarding an adverse event occurring in the USA, it was reported that a 21 year old male patient that had previously been diagnosed with psychosis and also has a past medical history of severe head injuries with encephalopathy, leg injuries, and Lyme disease received a TD ADS ADULT vaccination, lot number not reported, administered in July 2004 for a Lyme bite. That evening the patient developed shaking of the head and complained of feeling his throat was closing and feeling foggy. Since the vaccination the patient has developed incontinence and has had a loss of appetite. Reportedly these symptoms persist and the patient was reported as not recovered. (OMIC).
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: From initial information received on 10/21/04 from a health care professional regarding an adverse event occurring, it was reported that a two year old male patient received FLUZONE, lot number U1442AA, administered IM on 10/19/04. The site of administration was not reported. One day later, on 10/20/04, the patient experienced tonic-clonic seizures that began focally in his foot and progressed to his entire body. He was afebrile with a temperature of 97.1 degrees F. The patient was admitted to the hospital. His past medical history is significant for premature birth at 28 weeks gestation, cerebral palsy, hydrocephalus, developmental delays and infantile spasms. He has a ventriculo-peritoneal shunt and has a triplet sibling who had an intraventricular hemorrhage. He was started on Dilantin and was scheduled to follow up with a neurologist. The seizure activity ceased after the patient was placed on Dilantin, but he is still being treated. The patient has not recovered from these events.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: From initial information received from a physician on 10/26/04 regarding an adverse event occurring, it was reported that a 54 year old female patient received her first dose of FLUZONE, lot number U1138AA, administered in an unspecified site on 10/29/03. Reportedly seven days later the patient was admitted to the hospital with complaint of bilateral lower extremity numbness and weakness. She was diagnosed with Guillain Barre Syndrome. The patient's recovery status is listed as not recovered as she remains wheelchair bound.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizures: fever
Age: 1.51
Sex: F
Vaccine: DTAP, IPV
Symptoms: Abdominal distension, Abnormal behaviour, Anorexia, Aphasia, Diarrhoea
Clinical narrative: Vomiting, diarrhea, diaper rash: yeast wouldn't eat 2 weeks.  Curled up in fetal position, sotmach distended. Started losing weight: looks dehydrated, but isn't , had to put on baby food, tantrums: doesn't want anyone to touch her or around her. Stares into space, stopped talking, stopped running and playing with others, sleeplessness. Follow up 02/04/05: She has recovered from some but it triggered the onset of celiac disease. As per annual follow up report: still has leaky gut symptoms, she has improved with a gluten free/castin free diet, but still has frequent loose bowels.
Age: 1.51
Sex: F
Vaccine: DTAP, IPV
Symptoms: Fungal infection, Insomnia, Irritability, Rash, Staring
Clinical narrative: Vomiting, diarrhea, diaper rash: yeast wouldn't eat 2 weeks.  Curled up in fetal position, sotmach distended. Started losing weight: looks dehydrated, but isn't , had to put on baby food, tantrums: doesn't want anyone to touch her or around her. Stares into space, stopped talking, stopped running and playing with others, sleeplessness. Follow up 02/04/05: She has recovered from some but it triggered the onset of celiac disease. As per annual follow up report: still has leaky gut symptoms, she has improved with a gluten free/castin free diet, but still has frequent loose bowels.
Age: 1.51
Sex: F
Vaccine: DTAP, IPV
Symptoms: Vomiting, Weight decreased
Clinical narrative: Vomiting, diarrhea, diaper rash: yeast wouldn't eat 2 weeks.  Curled up in fetal position, sotmach distended. Started losing weight: looks dehydrated, but isn't , had to put on baby food, tantrums: doesn't want anyone to touch her or around her. Stares into space, stopped talking, stopped running and playing with others, sleeplessness. Follow up 02/04/05: She has recovered from some but it triggered the onset of celiac disease. As per annual follow up report: still has leaky gut symptoms, she has improved with a gluten free/castin free diet, but still has frequent loose bowels.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: 8/16/04: 2-3 hours after vaccination. Bumps, hives, and axil. temp 102.3. 8/17/04: symptoms continued. 8/18/04: symptoms intensified: admitted to ER with hives, fever (105.1 pa per mom) about 3PM> examined, blood drawn, IV started, discharged 10 PM on ? amoxicillin. 0.04 ml TID. 8/19/04: per mom: alert, responsive, good appetite, to pediatrician today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Skin striae, Swelling
Clinical narrative: Vaccine administered 10/18/04. Patient presents 10/19/04 with right knee swollen/red streaks from knee. Started on oral antibiotic therapy. Presents 10/20/04 with more swelling. Referred to hospital.
Age: 0.54
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Positive blood culture for streptococcus pneumoniae. Possible vaccine failure. Vaccinated with 3 doses of Prevnar.
Age: 1.81
Sex: F
Vaccine: DTAP, FLU3, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: 11/01/2004: mother called in to report that the next morning after she received her immunization. Her right leg where injection was given was swollen. Approximately 4" red and hot for three days. Mom also states she had a rash "bumps" over face, chest and back.