chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Pain
Clinical narrative: Phone call from client states he had 2nd post exposure (Rabies) vaccine on 01/13/2005. Pt c/o severe headache 3hr after vaccine. Next morning had temperature of 101 degrees Fahrenheit, flu-like symptoms, slight edema in extremeties progressing to midline chest pain and bi-lateral arm pain. No ER or DR. visit was made. Symptoms resolved in 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on right Deltoid area.
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: At 01/26/2005 Immunization appointment. Parents state they took child to ED the evening of 01/05/2005 immunizations. Child had fever over 104Fahrenheit. No other symptoms-0 seizures, 0 N&V. ED staff administered Motrin observed child x2 and sent child home on alternating Tylenol and Motrin protocol. Child afebrile within 24 hours No other problems. Mother was uable to recall if child had pre-antipyretic pre imm's
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at site diagnosed in urgent care.
Sex: M
Vaccine: DTAP, PNC
Symptoms: Staring, Tremor
Clinical narrative: 2 episodes of shaking. shots given on 01/17/2005 and on 01/18/2005 pt. stared and whole body shook x 20-30 seconds. 2nd episode length 20-30 seconds, staring to the right and generalized shaking.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Laboratory test abnormal, Shoulder pain
Clinical narrative: Pt reported after 4th day of vaccination he was extremely achy all over with joint pain much worse after the 2nd Hepatitis B. He stated "it would get bad in his shoulders then go to his knees" pt went to North Central Medical Center on 02/03/2005 (ER) The tx was Morphine and steroid injection, then to flu with steroid dose pack. Methyl Prednisone. Per pt.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Localized erythema tenderness
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Fluid retention, Rash, Rash papular
Clinical narrative: 2/1/05 started with rash which progressed today 2/2, plus papules of various sizes some with fluid.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Fluid retention, Rash papular
Clinical narrative: Rash appeared 2/3/05 and progressed, red papular rash of various sizes some with fluid on arms, trunk.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous
Clinical narrative: Mother noted fine, pin point, pink rash on face, back of head, trunk- chest and back. Symptom noted 2 days after vaccines administered. No treatment. Baby active, smiling, breast feeding well.
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Rash macular
Clinical narrative: Seen at clinic by PA 12d. Post vaccination with macular rash (5mm) over entire trunk. PE unremarkable except for rash.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Abnormal behaviour, Aggression, Anger, Blood cholesterol increased, Blood pressure increased
Clinical narrative: Pt is a 29-year-old male received a total of four anthrax immunizations between Nov 1999 and May 2000.   In February 2000 he was told he had high normal limits of his blood pressure, and increase in his cholesterol. He reports that both were normal before his trip to the desert. In May of 2002 he noticed periods of erratic behavior and forgetfulness. States he is normally a very passive person and was now experiencing aggression, rage and problem with his temper.  He states he felt better last October when he knew what was going on with him. Currently states he has more control and that he is not getting aggravated as often. In July 02 he developed a chronic cough with pneumonia like symptoms. Diagnosed with pneumonia, given medication and cough cleared. No cough now. In August 02 he noticed blood in his stools. Now episodes are sporadic and not associated with any factors. States he has an episode once every 3 months and it lasts only 2-3 days.  Noticed since the summer of 2002 periods of dizziness he states his MD's have no opinion. Pt states when he walks the floor drops. Distorted view when he walks. Complains of dizziness when he stands for prolonged periods of time. Has at least one episode a week and that it last 1-2 sec. He states it is not associated with any position change. He has no vision changes and no interference with activities. States his doctor is aware and for now he should not worry.  April 03 he went to his doctor for acid reflux and diagnosed later that month with glomerulonephritis. States reflux is now resolved. He states he gets headaches 3 times weekly since the year 2000 but now headaches are almost daily. Headaches last approximately 2 hours but when he takes Aspirin they only last 30 min. States he has occasional photosensitivity and no nausea. He is able to continue working through his headaches. He did mention headaches to his doctor who told him not to worry about them. Patient reports that his blood pressure is still high. Pt also reports periods of chest pain described as a constant sharp pressure in upper left chest with strenuous activity. Is associated with shortness of breath. States pain lasts a couple of minutes and when he takes a couple of deep breaths and rest, it eases.  Noticed in February 2000 and saw MD. EKG was normal. Pain still occurs with strenuous activity. He did mention it again to his doctor but not his nephrologists.   Update: 14 Feb 05 Patient reports that he is doing better. He states that his kidney function has stabilized and he does not require transplant or dialysis. He reports that his cholesterol is also under control and since his kidney function test has stabilized his headaches and chest pain has decreased. He states that he is working full time with no problems performing his duties.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Cough, Dizziness, Dyspepsia, Dyspnoea
Clinical narrative: Pt is a 29-year-old male received a total of four anthrax immunizations between Nov 1999 and May 2000.   In February 2000 he was told he had high normal limits of his blood pressure, and increase in his cholesterol. He reports that both were normal before his trip to the desert. In May of 2002 he noticed periods of erratic behavior and forgetfulness. States he is normally a very passive person and was now experiencing aggression, rage and problem with his temper.  He states he felt better last October when he knew what was going on with him. Currently states he has more control and that he is not getting aggravated as often. In July 02 he developed a chronic cough with pneumonia like symptoms. Diagnosed with pneumonia, given medication and cough cleared. No cough now. In August 02 he noticed blood in his stools. Now episodes are sporadic and not associated with any factors. States he has an episode once every 3 months and it lasts only 2-3 days.  Noticed since the summer of 2002 periods of dizziness he states his MD's have no opinion. Pt states when he walks the floor drops. Distorted view when he walks. Complains of dizziness when he stands for prolonged periods of time. Has at least one episode a week and that it last 1-2 sec. He states it is not associated with any position change. He has no vision changes and no interference with activities. States his doctor is aware and for now he should not worry.  April 03 he went to his doctor for acid reflux and diagnosed later that month with glomerulonephritis. States reflux is now resolved. He states he gets headaches 3 times weekly since the year 2000 but now headaches are almost daily. Headaches last approximately 2 hours but when he takes Aspirin they only last 30 min. States he has occasional photosensitivity and no nausea. He is able to continue working through his headaches. He did mention headaches to his doctor who told him not to worry about them. Patient reports that his blood pressure is still high. Pt also reports periods of chest pain described as a constant sharp pressure in upper left chest with strenuous activity. Is associated with shortness of breath. States pain lasts a couple of minutes and when he takes a couple of deep breaths and rest, it eases.  Noticed in February 2000 and saw MD. EKG was normal. Pain still occurs with strenuous activity. He did mention it again to his doctor but not his nephrologists.   Update: 14 Feb 05 Patient reports that he is doing better. He states that his kidney function has stabilized and he does not require transplant or dialysis. He reports that his cholesterol is also under control and since his kidney function test has stabilized his headaches and chest pain has decreased. He states that he is working full time with no problems performing his duties.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Glomerulonephritis, Haematochezia, Headache, Laboratory test abnormal, Memory impairment
Clinical narrative: Pt is a 29-year-old male received a total of four anthrax immunizations between Nov 1999 and May 2000.   In February 2000 he was told he had high normal limits of his blood pressure, and increase in his cholesterol. He reports that both were normal before his trip to the desert. In May of 2002 he noticed periods of erratic behavior and forgetfulness. States he is normally a very passive person and was now experiencing aggression, rage and problem with his temper.  He states he felt better last October when he knew what was going on with him. Currently states he has more control and that he is not getting aggravated as often. In July 02 he developed a chronic cough with pneumonia like symptoms. Diagnosed with pneumonia, given medication and cough cleared. No cough now. In August 02 he noticed blood in his stools. Now episodes are sporadic and not associated with any factors. States he has an episode once every 3 months and it lasts only 2-3 days.  Noticed since the summer of 2002 periods of dizziness he states his MD's have no opinion. Pt states when he walks the floor drops. Distorted view when he walks. Complains of dizziness when he stands for prolonged periods of time. Has at least one episode a week and that it last 1-2 sec. He states it is not associated with any position change. He has no vision changes and no interference with activities. States his doctor is aware and for now he should not worry.  April 03 he went to his doctor for acid reflux and diagnosed later that month with glomerulonephritis. States reflux is now resolved. He states he gets headaches 3 times weekly since the year 2000 but now headaches are almost daily. Headaches last approximately 2 hours but when he takes Aspirin they only last 30 min. States he has occasional photosensitivity and no nausea. He is able to continue working through his headaches. He did mention headaches to his doctor who told him not to worry about them. Patient reports that his blood pressure is still high. Pt also reports periods of chest pain described as a constant sharp pressure in upper left chest with strenuous activity. Is associated with shortness of breath. States pain lasts a couple of minutes and when he takes a couple of deep breaths and rest, it eases.  Noticed in February 2000 and saw MD. EKG was normal. Pain still occurs with strenuous activity. He did mention it again to his doctor but not his nephrologists.   Update: 14 Feb 05 Patient reports that he is doing better. He states that his kidney function has stabilized and he does not require transplant or dialysis. He reports that his cholesterol is also under control and since his kidney function test has stabilized his headaches and chest pain has decreased. He states that he is working full time with no problems performing his duties.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Photosensitivity reaction, Pneumonia, Visual disturbance
Clinical narrative: Pt is a 29-year-old male received a total of four anthrax immunizations between Nov 1999 and May 2000.   In February 2000 he was told he had high normal limits of his blood pressure, and increase in his cholesterol. He reports that both were normal before his trip to the desert. In May of 2002 he noticed periods of erratic behavior and forgetfulness. States he is normally a very passive person and was now experiencing aggression, rage and problem with his temper.  He states he felt better last October when he knew what was going on with him. Currently states he has more control and that he is not getting aggravated as often. In July 02 he developed a chronic cough with pneumonia like symptoms. Diagnosed with pneumonia, given medication and cough cleared. No cough now. In August 02 he noticed blood in his stools. Now episodes are sporadic and not associated with any factors. States he has an episode once every 3 months and it lasts only 2-3 days.  Noticed since the summer of 2002 periods of dizziness he states his MD's have no opinion. Pt states when he walks the floor drops. Distorted view when he walks. Complains of dizziness when he stands for prolonged periods of time. Has at least one episode a week and that it last 1-2 sec. He states it is not associated with any position change. He has no vision changes and no interference with activities. States his doctor is aware and for now he should not worry.  April 03 he went to his doctor for acid reflux and diagnosed later that month with glomerulonephritis. States reflux is now resolved. He states he gets headaches 3 times weekly since the year 2000 but now headaches are almost daily. Headaches last approximately 2 hours but when he takes Aspirin they only last 30 min. States he has occasional photosensitivity and no nausea. He is able to continue working through his headaches. He did mention headaches to his doctor who told him not to worry about them. Patient reports that his blood pressure is still high. Pt also reports periods of chest pain described as a constant sharp pressure in upper left chest with strenuous activity. Is associated with shortness of breath. States pain lasts a couple of minutes and when he takes a couple of deep breaths and rest, it eases.  Noticed in February 2000 and saw MD. EKG was normal. Pain still occurs with strenuous activity. He did mention it again to his doctor but not his nephrologists.   Update: 14 Feb 05 Patient reports that he is doing better. He states that his kidney function has stabilized and he does not require transplant or dialysis. He reports that his cholesterol is also under control and since his kidney function test has stabilized his headaches and chest pain has decreased. He states that he is working full time with no problems performing his duties.
Age: 88.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Difficulty in walking, Dizziness
Clinical narrative: Extreme dizziness. "Walking is dangerous" Started 2/13/2005, vaccinated on 2/11/2005. Instructed to seek medical attention. MD order for Yellow Fever Vaccination for travel overseas.
Age: 25.0
Sex: F
Vaccine: HEP, TD
Symptoms: Erythema, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Awoke day after vaccinations (day 1) with pain and redness in left arm.  Day 2 - severe headaches Day 3 - neck pain; headaches improved; left arm swollen (3x3")good ROM although painful. Fever of 100.5 F. Day 4 - In health department for PPD reading.  3x3" redness in left deltoid.  good ROM still with pain.  Recommended MD visit.
Age: 34.0
Sex: F
Vaccine: DT, HEP
Symptoms: Headache, Injection site erythema, Injection site pain, Vision blurred, Visual disturbance
Clinical narrative: Patient had localized reaction with erythema, tenderness at the injection site. Also developed blurry vision initially in the R eye four days later and then in the L eye as well five days after that. Only near vision was affected and it is described as being a white spot off to the left of the visual axis. She has been seen by an Ophthalmologist and supposedly had a normal exam including fluorescein angiography. Field of vision showed no gross abnormalities. She is also c/o headaches that are described as dull, biparietal, constant not associated with N/V, flashing lights, or other neuro symptoms. She is scheduled for MRI on 2/15/05.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash papular, Skin burning sensation, Skin ulcer
Clinical narrative: At day 9 after vaccination on 4 Feb 05 developed "red bumps" (papules) on shoulders that spread down arms, then legs, then trunk, then face today.  Faint red macules also on palms and soles.  The erythematous lesions vary in size and some are confluent.  No pruritus, but "burning" present.  Only one lesion found to have an associated pustule or vesicle on back.  No fever.
Age: 1.33
Sex: M
Vaccine: DTAPH, HIBV
Symptoms: Convulsion, Otitis media, Pyrexia, Viral infection
Clinical narrative: Patient was vaccinated on 2/8/04.  That evening the patient developed a high fever and was brought to the emergency room.  The patient had a seizure and was admitted to Pediatric ICU. Discharge Summary received on 4/26/2005 states otitis media and infection viral.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient developed mumps in spite of recieving both MMR's.
Age: 3.0
Sex: M
Vaccine: DTAP, OPV, VARCEL, VARCEL
Symptoms: Blister, Cough, Erythema, Pyrexia, Rash papular
Clinical narrative: redness and cough for 2 days with fever followed by papules transformed into blisters, trunk, face and eruption in that order of appearance.
Age: 3.0
Sex: M
Vaccine: DTAP, OPV, VARCEL, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: redness and cough for 2 days with fever followed by papules transformed into blisters, trunk, face and eruption in that order of appearance.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Loss of consciousness, Rash pruritic
Clinical narrative: Pt is a 4 year old with a history of single ventricle status post repair. He is currently on treatment with Lasix, Lisinopril 5mg, and baby aspirin and is heart function has been well compensated. He never had allergic symptoms, such as eczema, asthma or urticaria until he went to his doctor for the 4 year check up on the 11/29/04. At that time he was vaccinated with DTP, hep B and MMR and about 10 minutes after the injection he manifested difficulties in breathing, vomiting, flushing, itchy rash from the waist to his face and lost of consciousness. The family hadn't left the building yet, so pt was taken back to the pediatrician's office immediately. He was administered, after talking with his cardiologist, epinephrine, steroids, oxygen and antihistamine. He regained consciousness quickly, and he was sent home after 1 hour without admission or observation in a hospital setting. Since then he has had no further anaphylactic episodes and he has been doing fine. He is not currently following any diet and regularly eats peanuts. He doesn't like shellfish, and mom is not sure that he has been exposed to treenuts. Prior to the office visit he didn't eat any unusual foods or candy neither did he take any unusual medicine or NSAIDs. Lives with parents and 3 older healthy siblings in a 40 year old house with some wall to wall carpeting. Nobody smokes and the family doesn't own a pet. No family history of allergies. Today he was in good general condition, his weight was 15.2kg and his height 100.7cm. The skin was clear. The HEENT exam was unremarkable. The lungs were clear to auscultation. The abdomen was nondistended, nontender. The cardiovascular exam was within normal the limits. The rest of the physical exam was normal. We reviewed the ingredient of the single vaccines: DTaP vial stopper contains natural latex rubber IPV contains calf serum protein, neomycin, streptomycin, and polymyxin B, MMRII contains neomycin 25mcg, gelatin, human albumin, and bovine serum; produced in chick embryo cell culture. In order to assess his possible allergy to gelatin, latex and treenuts (in the event of unk exposure to nuts), we performed a RAST that showed only a class II sensitivity to bovine gelatin (1.30 NV <0.35 ku/l) porcine gelatine (2.41 nv<0.35). Assessment: Pt had an anaphylactic reaction 10 minutes after the administration of IPV, DTaP and MMR vaccine. Given the time correlation and the absence of exposure to other possible cause of anaphylaxis (food or medicine), we think that one of the vaccines administered caused the reaction. The most likely cause of anaphylaxis is probably the gelatin contained in the MMR vaccine. However we can not completely exclude that allergy to latex was the trigger to his reaction. He never had reaction to latex before, but parents has always tried to keep away from latex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Vomiting
Clinical narrative: Pt is a 4 year old with a history of single ventricle status post repair. He is currently on treatment with Lasix, Lisinopril 5mg, and baby aspirin and is heart function has been well compensated. He never had allergic symptoms, such as eczema, asthma or urticaria until he went to his doctor for the 4 year check up on the 11/29/04. At that time he was vaccinated with DTP, hep B and MMR and about 10 minutes after the injection he manifested difficulties in breathing, vomiting, flushing, itchy rash from the waist to his face and lost of consciousness. The family hadn't left the building yet, so pt was taken back to the pediatrician's office immediately. He was administered, after talking with his cardiologist, epinephrine, steroids, oxygen and antihistamine. He regained consciousness quickly, and he was sent home after 1 hour without admission or observation in a hospital setting. Since then he has had no further anaphylactic episodes and he has been doing fine. He is not currently following any diet and regularly eats peanuts. He doesn't like shellfish, and mom is not sure that he has been exposed to treenuts. Prior to the office visit he didn't eat any unusual foods or candy neither did he take any unusual medicine or NSAIDs. Lives with parents and 3 older healthy siblings in a 40 year old house with some wall to wall carpeting. Nobody smokes and the family doesn't own a pet. No family history of allergies. Today he was in good general condition, his weight was 15.2kg and his height 100.7cm. The skin was clear. The HEENT exam was unremarkable. The lungs were clear to auscultation. The abdomen was nondistended, nontender. The cardiovascular exam was within normal the limits. The rest of the physical exam was normal. We reviewed the ingredient of the single vaccines: DTaP vial stopper contains natural latex rubber IPV contains calf serum protein, neomycin, streptomycin, and polymyxin B, MMRII contains neomycin 25mcg, gelatin, human albumin, and bovine serum; produced in chick embryo cell culture. In order to assess his possible allergy to gelatin, latex and treenuts (in the event of unk exposure to nuts), we performed a RAST that showed only a class II sensitivity to bovine gelatin (1.30 NV <0.35 ku/l) porcine gelatine (2.41 nv<0.35). Assessment: Pt had an anaphylactic reaction 10 minutes after the administration of IPV, DTaP and MMR vaccine. Given the time correlation and the absence of exposure to other possible cause of anaphylaxis (food or medicine), we think that one of the vaccines administered caused the reaction. The most likely cause of anaphylaxis is probably the gelatin contained in the MMR vaccine. However we can not completely exclude that allergy to latex was the trigger to his reaction. He never had reaction to latex before, but parents has always tried to keep away from latex.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Rash starting behind ears and spreading down to stomach and back. Began 10d after vaccines given lasted 3 days. No fever, +produce fussiness 1-2d
Age: 0.22
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: 8 seizure like episodes which began 1 day following vaccinations and lasted 1 day, no episodes since (currently 3 days post last episode) sent to hospital and pt referred to neurology.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt was vaccinated on 06/27/1997 and on 01/24/05 came down with a rash diagnosed as chicken pox, reason for reporting is because several other pt's has chicken pox that were vaccinated.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt was vaccinated on 06/27/1997 and on 12/24/04 came down with a rash diagnosed as chicken pox, reason for reporting is: several other pt's have chicken pox that have been vaccinated also but at different times.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt was vaccinated on 06/08/00 and on 01/07/05 came down with a rash diagnosed as chicken pox, reason for reporting is because several other pt's have chicken pox that were vaccinated.
Age: 0.29
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt was vaccinated on 05/06/97 and on 01/24/05 came down with a rash diagnosed as chicken pox, reason for reporting is because several other pt's have chicken pox that were vaccinated.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Child had hives next morning, around neck, creases of arms and legs, around waist, under arm. Was seen by MD that day given Benadryl, was fine after 1 dose of Benadryl. No temp or diff breathing.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Blood calcium increased, Blood chloride increased, Blood creatinine increased, Blood glucose increased
Clinical narrative: This case was initially considered non-serious. From follow up information received on 2/9/05 this case was considered serious. From initial information received on 11/1/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a FLUZONE vaccination, lot number U1446AA, administered IM in the left deltoid on 10/28/04. Reportedly two days later on 10/30/04 at 10:00 AM, it was noted that the injection site was warm to the touch and red measuring about a quarter in diameter. On 10/31/04 the patient was sleepy, tired, had a poor appetite, a temperature of 100.8 degrees F and her blood pressure was 120/90. The injection site reaction was fading in color and size. On 11/1/04 the patient had a temperature of 99.8 degrees F and remains tired with a poor appetite. No treatment was administered. The patient's recovery status is listed as not recovered. From additional information received on 2/9/05 from a registered nurse, it was reported that the patient was vaccinated at a long term care facility. Per the reporter, on 11/3/04, the patient was more alert and ate 100% of her breakfast and lunch. On 11/5/04, the patient reportedly became very lethargic. She presented with torticollis to the left as well as a temperature of 99.5 degrees F, blood pressure 120/58, pulse 86, and respiratory rate of 16. The patient continued to decline rapidly between 11/5/04 and 11/8/04. She expired on 11/8/04 at 9:00 PM. The physician reported the cause of death as cerebrovascular accident/stroke. Other information provided included the patient's daily medications including Norvasc, Duragesic patch, Trilisate, potassium, Tums, Aldactone, Lasix, Librium, Risperdal, and Sorbitol. It was also reported that the patient previously received a dose of influenza vaccine on 11/11/03 without any reactions. Reportedly, no other flu injections were noted prior to that date. The reporter of this case is the same reporter of cases 200403591, 200403592, 200403593, 200403594, and 200403595.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Blood sodium increased, Blood urea increased, Cerebrovascular accident, Fatigue
Clinical narrative: This case was initially considered non-serious. From follow up information received on 2/9/05 this case was considered serious. From initial information received on 11/1/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a FLUZONE vaccination, lot number U1446AA, administered IM in the left deltoid on 10/28/04. Reportedly two days later on 10/30/04 at 10:00 AM, it was noted that the injection site was warm to the touch and red measuring about a quarter in diameter. On 10/31/04 the patient was sleepy, tired, had a poor appetite, a temperature of 100.8 degrees F and her blood pressure was 120/90. The injection site reaction was fading in color and size. On 11/1/04 the patient had a temperature of 99.8 degrees F and remains tired with a poor appetite. No treatment was administered. The patient's recovery status is listed as not recovered. From additional information received on 2/9/05 from a registered nurse, it was reported that the patient was vaccinated at a long term care facility. Per the reporter, on 11/3/04, the patient was more alert and ate 100% of her breakfast and lunch. On 11/5/04, the patient reportedly became very lethargic. She presented with torticollis to the left as well as a temperature of 99.5 degrees F, blood pressure 120/58, pulse 86, and respiratory rate of 16. The patient continued to decline rapidly between 11/5/04 and 11/8/04. She expired on 11/8/04 at 9:00 PM. The physician reported the cause of death as cerebrovascular accident/stroke. Other information provided included the patient's daily medications including Norvasc, Duragesic patch, Trilisate, potassium, Tums, Aldactone, Lasix, Librium, Risperdal, and Sorbitol. It was also reported that the patient previously received a dose of influenza vaccine on 11/11/03 without any reactions. Reportedly, no other flu injections were noted prior to that date. The reporter of this case is the same reporter of cases 200403591, 200403592, 200403593, 200403594, and 200403595.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Lethargy, Pyrexia, Somnolence
Clinical narrative: This case was initially considered non-serious. From follow up information received on 2/9/05 this case was considered serious. From initial information received on 11/1/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a FLUZONE vaccination, lot number U1446AA, administered IM in the left deltoid on 10/28/04. Reportedly two days later on 10/30/04 at 10:00 AM, it was noted that the injection site was warm to the touch and red measuring about a quarter in diameter. On 10/31/04 the patient was sleepy, tired, had a poor appetite, a temperature of 100.8 degrees F and her blood pressure was 120/90. The injection site reaction was fading in color and size. On 11/1/04 the patient had a temperature of 99.8 degrees F and remains tired with a poor appetite. No treatment was administered. The patient's recovery status is listed as not recovered. From additional information received on 2/9/05 from a registered nurse, it was reported that the patient was vaccinated at a long term care facility. Per the reporter, on 11/3/04, the patient was more alert and ate 100% of her breakfast and lunch. On 11/5/04, the patient reportedly became very lethargic. She presented with torticollis to the left as well as a temperature of 99.5 degrees F, blood pressure 120/58, pulse 86, and respiratory rate of 16. The patient continued to decline rapidly between 11/5/04 and 11/8/04. She expired on 11/8/04 at 9:00 PM. The physician reported the cause of death as cerebrovascular accident/stroke. Other information provided included the patient's daily medications including Norvasc, Duragesic patch, Trilisate, potassium, Tums, Aldactone, Lasix, Librium, Risperdal, and Sorbitol. It was also reported that the patient previously received a dose of influenza vaccine on 11/11/03 without any reactions. Reportedly, no other flu injections were noted prior to that date. The reporter of this case is the same reporter of cases 200403591, 200403592, 200403593, 200403594, and 200403595.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Torticollis
Clinical narrative: This case was initially considered non-serious. From follow up information received on 2/9/05 this case was considered serious. From initial information received on 11/1/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a FLUZONE vaccination, lot number U1446AA, administered IM in the left deltoid on 10/28/04. Reportedly two days later on 10/30/04 at 10:00 AM, it was noted that the injection site was warm to the touch and red measuring about a quarter in diameter. On 10/31/04 the patient was sleepy, tired, had a poor appetite, a temperature of 100.8 degrees F and her blood pressure was 120/90. The injection site reaction was fading in color and size. On 11/1/04 the patient had a temperature of 99.8 degrees F and remains tired with a poor appetite. No treatment was administered. The patient's recovery status is listed as not recovered. From additional information received on 2/9/05 from a registered nurse, it was reported that the patient was vaccinated at a long term care facility. Per the reporter, on 11/3/04, the patient was more alert and ate 100% of her breakfast and lunch. On 11/5/04, the patient reportedly became very lethargic. She presented with torticollis to the left as well as a temperature of 99.5 degrees F, blood pressure 120/58, pulse 86, and respiratory rate of 16. The patient continued to decline rapidly between 11/5/04 and 11/8/04. She expired on 11/8/04 at 9:00 PM. The physician reported the cause of death as cerebrovascular accident/stroke. Other information provided included the patient's daily medications including Norvasc, Duragesic patch, Trilisate, potassium, Tums, Aldactone, Lasix, Librium, Risperdal, and Sorbitol. It was also reported that the patient previously received a dose of influenza vaccine on 11/11/03 without any reactions. Reportedly, no other flu injections were noted prior to that date. The reporter of this case is the same reporter of cases 200403591, 200403592, 200403593, 200403594, and 200403595.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Immediately after receiving the shot pain in upper arm then numbness (like hitting the "funny bone") shooting pain down arm to fingertips.  Mentioned to the nurse on-site.  After one month, saw doctor prescribed Neurontin and Elavil for chronic pain.  Advised not to lift over 4 lbs. Follow-up with physician in 2 weeks.
Age: 16.0
Sex: F
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: Rash all over body occurring several hours after receiving vaccine;  had received Td previously with no adverse reactions.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Laboratory test abnormal
Clinical narrative: 24 Mar 04, received my 5th anthrax shot, deployed in June and in July started getting severe headaches and fatigue.  Was given 800mg of Motrin to take to help.  Went to emergency room for severe headache given shot and told to have further testing at home.  Received a cat scan which was abnormal, then an MRI which revealed a lesion on left front brain.  Told to repeat in 3 months.  In meantime, fatigue continued as well as developing back and joint pain.  Was given anti-inflammatories.  Repeated MRI with no change indicated.  Saw a neurologist is recommending treatment for headaches and thought no neurological significance was indicated from the lesion.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 24 Mar 04, received my 5th anthrax shot, deployed in June and in July started getting severe headaches and fatigue.  Was given 800mg of Motrin to take to help.  Went to emergency room for severe headache given shot and told to have further testing at home.  Received a cat scan which was abnormal, then an MRI which revealed a lesion on left front brain.  Told to repeat in 3 months.  In meantime, fatigue continued as well as developing back and joint pain.  Was given anti-inflammatories.  Repeated MRI with no change indicated.  Saw a neurologist is recommending treatment for headaches and thought no neurological significance was indicated from the lesion.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: RASH BEHIND RIGHT KNEE.  NO ITCHING, NO FEVER, NO H/A.  NO OTHER COMPLAINT.
Age: 53.0
Sex: F
Vaccine: MM
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed urticaria with itching that lasted 2 weeks at time of being seen at ER on Feb. 14.  Patient treated with Hydroxyzine for itching and 5 day course of Prednisone.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Crying, Drooling, Dyspnoea, Fatigue
Clinical narrative: CHILD WAS A WELL BAY. aT 4 MONTHS, SHE RECEIVED HER FIRST SHOT OF DTAP,HIb,Polio and Pneumococcal. She had some crying and fever that evening. The doctor suggested to give some baby tylenol for pain. After that, she had brief episode of limp. She was not able to hold her head  or arms in the normal positions just for 10-20 seconds. She suddenly recovered and started to cry and tired. We had no clue as to why it happened. Then she had an epsiode of flu-like symptoms for which we had to take her to pediatrician's office during the weekend. The Doctor did not find any problems. The eipsode happened a week later, but just briefly again. the doctor was notified. He suggested it to be probably reflux. A barium swallow was performed and a reflux was noticed but was described as within normal pediatric range. At six months, she received a second series of the DTAP. Shortly after that, she had to taking by ambulance to emergency room for a more serious case of limping and acts of "gasping for air" in an effort to breath. A EEG was performed but was read as negative for seizures activities. The frequency has now reached 3-4 a day. We were still told that it could be reflux. I made video recordings of 4-5 episodes to show to the pediatrician. He thought that it could be atonic seizures but did not rule out reflux. She was given the third series of DTAP that same day.  So we went to see a Neurologist. He was not fully convinced that ts was seizures. He deferred any medications until he could do another EEG. A episode occured in the neurologist's office but he was not convinced that it was a seizure. A day after that, the baby had an episode of what seems to a classic seizure with shaking and drooling. We took her to peds office and was put on depakote spr 125 mg. It is three days now and she is still getting the episodes at least once a day. Vaccinations at 4, 6, and 8 months. The frequency increases after each vaccination to a full seizure after the third vaccination in December.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypotonia, Influenza like illness, Laboratory test abnormal, Pyrexia
Clinical narrative: CHILD WAS A WELL BAY. aT 4 MONTHS, SHE RECEIVED HER FIRST SHOT OF DTAP,HIb,Polio and Pneumococcal. She had some crying and fever that evening. The doctor suggested to give some baby tylenol for pain. After that, she had brief episode of limp. She was not able to hold her head  or arms in the normal positions just for 10-20 seconds. She suddenly recovered and started to cry and tired. We had no clue as to why it happened. Then she had an epsiode of flu-like symptoms for which we had to take her to pediatrician's office during the weekend. The Doctor did not find any problems. The eipsode happened a week later, but just briefly again. the doctor was notified. He suggested it to be probably reflux. A barium swallow was performed and a reflux was noticed but was described as within normal pediatric range. At six months, she received a second series of the DTAP. Shortly after that, she had to taking by ambulance to emergency room for a more serious case of limping and acts of "gasping for air" in an effort to breath. A EEG was performed but was read as negative for seizures activities. The frequency has now reached 3-4 a day. We were still told that it could be reflux. I made video recordings of 4-5 episodes to show to the pediatrician. He thought that it could be atonic seizures but did not rule out reflux. She was given the third series of DTAP that same day.  So we went to see a Neurologist. He was not fully convinced that ts was seizures. He deferred any medications until he could do another EEG. A episode occured in the neurologist's office but he was not convinced that it was a seizure. A day after that, the baby had an episode of what seems to a classic seizure with shaking and drooling. We took her to peds office and was put on depakote spr 125 mg. It is three days now and she is still getting the episodes at least once a day. Vaccinations at 4, 6, and 8 months. The frequency increases after each vaccination to a full seizure after the third vaccination in December.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Oedema peripheral, Pain, Red blood cell sedimentation rate increased, Shoulder pain, Tendon rupture
Clinical narrative: From initial information received on 2/8/05 from a certified nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 63 year old female patient received her second dose of FLUZONE, lot number U1488AA, administered IM in the left deltoid, and her second dose of PNEUMOVAX, lot number 656UN, administered IM in the left deltoid on 10/14/04 at 6:00 PM. The next day at 9:30 AM, the patient called her physician's office stating that her arm and fingers on her left side were swollen. She also complained of pain in the elbow to shoulder. She was advised to place ice on the area and to keep the arm elevated. She was also advised to take 600 milligrams of Motrin three times a day with food and to start Prednisone 10 milligrams in taper dose. On 10/21/04, the patient complained of pain in her left shoulder and she was seen the next day on 10/22/04. She did not have any swelling or redness and was diagnosed with tendonitis secondary to the vaccines. She was treated with 40 milligrams of Kenalog and 1 milliliter of Marcain injected in the joint and given Darvocet N-100. On 10/26/04, the patient stated that her left shoulder improved 98% and she had pain with abduction. On 11/8/04, the patient started physical therapy for tendonitis. On 12/17/04, she was treated with 40 milligrams of Kenalog injected in the joint and she was scheduled for an MRI. On 12/26/04, the patient was diagnosed with an anterior tear of the supraspinatus tendon for which she will have surgery. It was reported that the patient has not recovered from these events. (OMIC)
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Tendonitis
Clinical narrative: From initial information received on 2/8/05 from a certified nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 63 year old female patient received her second dose of FLUZONE, lot number U1488AA, administered IM in the left deltoid, and her second dose of PNEUMOVAX, lot number 656UN, administered IM in the left deltoid on 10/14/04 at 6:00 PM. The next day at 9:30 AM, the patient called her physician's office stating that her arm and fingers on her left side were swollen. She also complained of pain in the elbow to shoulder. She was advised to place ice on the area and to keep the arm elevated. She was also advised to take 600 milligrams of Motrin three times a day with food and to start Prednisone 10 milligrams in taper dose. On 10/21/04, the patient complained of pain in her left shoulder and she was seen the next day on 10/22/04. She did not have any swelling or redness and was diagnosed with tendonitis secondary to the vaccines. She was treated with 40 milligrams of Kenalog and 1 milliliter of Marcain injected in the joint and given Darvocet N-100. On 10/26/04, the patient stated that her left shoulder improved 98% and she had pain with abduction. On 11/8/04, the patient started physical therapy for tendonitis. On 12/17/04, she was treated with 40 milligrams of Kenalog injected in the joint and she was scheduled for an MRI. On 12/26/04, the patient was diagnosed with an anterior tear of the supraspinatus tendon for which she will have surgery. It was reported that the patient has not recovered from these events. (OMIC)
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Arthritis, Injection site swelling, Laboratory test abnormal, Oedema peripheral, Pain
Clinical narrative: From initial information received on 2/8/05 from a certified nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 63 year old female patient received her second dose of FLUZONE, lot number U1488AA, administered IM in the left deltoid, and her second dose of PNEUMOVAX, lot number 656UN, administered IM in the left deltoid on 10/14/04 at 6:00 PM. The next day at 9:30 AM, the patient called her physician's office stating that her arm and fingers on her left side were swollen. She also complained of pain in the elbow to shoulder. She was advised to place ice on the area and to keep the arm elevated. She was also advised to take 600 milligrams of Motrin three times a day with food and to start Prednisone 10 milligrams in taper dose. On 10/21/04, the patient complained of pain in her left shoulder and she was seen the next day on 10/22/04. She did not have any swelling or redness and was diagnosed with tendonitis secondary to the vaccines. She was treated with 40 milligrams of Kenalog and 1 milliliter of Marcain injected in the joint and given Darvocet N-100. On 10/26/04, the patient stated that her left shoulder improved 98% and she had pain with abduction. On 11/8/04, the patient started physical therapy for tendonitis. On 12/17/04, she was treated with 40 milligrams of Kenalog injected in the joint and she was scheduled for an MRI. On 12/26/04, the patient was diagnosed with an anterior tear of the supraspinatus tendon for which she will have surgery. It was reported that the patient has not recovered from these events. (OMIC)
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Tendon rupture, Tendonitis
Clinical narrative: From initial information received on 2/8/05 from a certified nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 63 year old female patient received her second dose of FLUZONE, lot number U1488AA, administered IM in the left deltoid, and her second dose of PNEUMOVAX, lot number 656UN, administered IM in the left deltoid on 10/14/04 at 6:00 PM. The next day at 9:30 AM, the patient called her physician's office stating that her arm and fingers on her left side were swollen. She also complained of pain in the elbow to shoulder. She was advised to place ice on the area and to keep the arm elevated. She was also advised to take 600 milligrams of Motrin three times a day with food and to start Prednisone 10 milligrams in taper dose. On 10/21/04, the patient complained of pain in her left shoulder and she was seen the next day on 10/22/04. She did not have any swelling or redness and was diagnosed with tendonitis secondary to the vaccines. She was treated with 40 milligrams of Kenalog and 1 milliliter of Marcain injected in the joint and given Darvocet N-100. On 10/26/04, the patient stated that her left shoulder improved 98% and she had pain with abduction. On 11/8/04, the patient started physical therapy for tendonitis. On 12/17/04, she was treated with 40 milligrams of Kenalog injected in the joint and she was scheduled for an MRI. On 12/26/04, the patient was diagnosed with an anterior tear of the supraspinatus tendon for which she will have surgery. It was reported that the patient has not recovered from these events. (OMIC)