chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: Pt. had redness at the site day of shot. Two days post immunization she has full body itching, scratching in her throat, redness. Site is bumpy, raised, and warm to touch.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Pt. had redness at the site day of shot. Two days post immunization she has full body itching, scratching in her throat, redness. Site is bumpy, raised, and warm to touch.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Woke up and felt weak and "numb all over" tingling sensation in his arms and hands, some on his face. c/o some non-specific chest heaviness, but it is difficult to ascertain from patient if this is new. Just had flu shot yesterday.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: left arm is red, warm, and tender to touch.  States LPN gave him injection at same spot.  running fever and chills.
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash and hives all over.  Started 30 min after receiving flu shot.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Musculoskeletal chest pain
Clinical narrative: Complaints of right lower chest/rib pain x3 days several days after flu shot.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: 4 hour after FLUZONE injection had 4 extremity pain with crying. Reported fever but not documented. Hard to walk due to symptoms but seen by MD next day with no visual skin/extremity changes. Will walk but still c/o pain. Reflexes normal.
Age: 73.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm radiating to neck shoulder and back.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt. has a history of seizure disorder. Pt. has a small seizure about 15 mins following flu shot. Recovered and went home.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Pain, Pruritus, Rash
Clinical narrative: Edema, severe, painful itching, rash.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Lethargy, Oropharyngeal pain, Stomach discomfort
Clinical narrative: 4 hours after vaccination pt had some chest heaviness, SOB, abd upset, sore throat, lethargy.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Malaise
Clinical narrative: 8 days after receiving FLUMIST, became very ill with flu symptoms.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient received varicella , hepatitis A, and pneumococcal (PREVNAR) vaccines 11 days prior to one year birthday (12 mos). No adverse event or reaction occurred.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 10/29/2008 doctor notified RN
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Injection site rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Localized maculopapular mildly erythematous - multiple discrete lesions 2-4 mm clustered in 1" x 2/5" area @ site of influenza vaccine. Rash was not pruritic not vesicles w/o underlying swelling. No tenderness. No systemic symptoms. Improved 24 hr w/ po BENADRYL/ improving after 24 hrs
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reaction. Patient is 16 years old. Was given FLULAVAL which is for 18 year olds and older.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reaction noted. Patient is a 3 yo given FLULAVAL flu vaccine which is indicated for greater than or equal to 18 yo.
Age: 13.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reaction. Patient is a 13 year old given FLULAVAL which is for 18 year olds and older.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reaction. Patient is an 11 year old boy, given FLULAVAL flu vaccine which is for 18 years and older.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: 9:45 AM c/o itching (L) arm at site. BP 120/80. Administered 50 mg BENADRYL IM (L) arm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Flank pain, Nasal congestion, Nausea
Clinical narrative: Nausea, dizzy, diarrhea, flank pain, nasal congestion, and wheezing.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: Nausea, dizzy, diarrhea, flank pain, nasal congestion, and wheezing.
Age: 8.7
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction at injection site 10cm x 10cm.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Crying, Pallor
Clinical narrative: Noted to be pale and was crying for 2 hours the day after the vaccine (Hep B #1) was given.
Age: 17.0
Sex: M
Vaccine: FLUX, MEA, MEN, OPV, SMALL, TD
Symptoms: Bacteria sputum identified, Body temperature increased, Breath sounds abnormal, Bronchitis, Chest X-ray abnormal
Clinical narrative: MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.
Age: 17.0
Sex: M
Vaccine: FLUX, MEA, MEN, OPV, SMALL, TD
Symptoms: Dizziness, Dyspepsia, Erythema, Fall, Flushing
Clinical narrative: MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.
Age: 17.0
Sex: M
Vaccine: FLUX, MEA, MEN, OPV, SMALL, TD
Symptoms: Gait disturbance, Gastroenteritis, Gastrooesophageal reflux disease, Gram stain positive, Haemoptysis
Clinical narrative: MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.
Age: 17.0
Sex: M
Vaccine: FLUX, MEA, MEN, OPV, SMALL, TD
Symptoms: Headache, Joint sprain, Lobar pneumonia, Lung infiltration, Lymphadenopathy
Clinical narrative: MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.
Age: 17.0
Sex: M
Vaccine: FLUX, MEA, MEN, OPV, SMALL, TD
Symptoms: Nausea, Pain, Pain in extremity, Sputum discoloured, Varicose vein
Clinical narrative: MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.
Age: 17.0
Sex: M
Vaccine: FLUX, MEA, MEN, OPV, SMALL, TD
Symptoms: Weight increased
Clinical narrative: MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.
Age: 42.0
Sex: U
Vaccine: FLUN3
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal faeces, Anaemia, Arthralgia
Clinical narrative: Received FLUMIST 2007 then had severe bronchitis which lead to GI distress w/bloody diarrhea, pain and hospitalization. Received (not documented) FLUMIST 10/10/06 with aches/pains all joint esp knee's/shoulders that evening. Woke next day with severe bilateral ft pain/hurt to walk and continued joint pain-took Motrin w/some relief. Was tired w/nasal congestion and URI s/s. This lasted 1 week w/o resolution then developed cough w/diffuse abd cramping. Went to immunz dept and told this was nl. 10/19 saw PCP for chest tightness, sob, diff lying down, unable to sleep w/o sitting up, worsening cough unrelieved with home Albuterol, had thick clear phlegm. Abd cramping worse, problems eating/drinking due to increased bowel activity/cramps every 15-20 min. Some cramps made her double over. MD put on antibiotics x 5 days, then one week of steroids when stool/diarrhea began smelling foul, temp 101. CT abd showed bowel inflammation/ischemia and stool Guiac + blood. Admitted to hospital x 5 days, c-diff neg and no other cultures done per pt but treated with Flagyl for possible salmonella, K supplements and rehydration for anemia and low K and dehydration. Currently is doing fine w/o problems. Her MD wrote note for FLUMIST exemption, but again was sent by immunz dept for clarification on exemption. I gave temp exempt until I get her medical records to clarify events. She has received IM in past w/o problems so agreed with IM route. Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces). Not going to get into some of this as it's not related to the FLUMIST events; but need her records to accurately correlate and causality. She is very happy just to receive IM. She is an oncology nurse. She grew up on a farm in very rural area. They used outhouses with no indoor facilities, grew own food, store items were for staples only (flour to make own bread, etc.), worked pig farm, tobacco, etc.
Age: 42.0
Sex: U
Vaccine: FLUN3
Symptoms: Body temperature increased, Bronchitis, Chest discomfort, Cough, Dehydration
Clinical narrative: Received FLUMIST 2007 then had severe bronchitis which lead to GI distress w/bloody diarrhea, pain and hospitalization. Received (not documented) FLUMIST 10/10/06 with aches/pains all joint esp knee's/shoulders that evening. Woke next day with severe bilateral ft pain/hurt to walk and continued joint pain-took Motrin w/some relief. Was tired w/nasal congestion and URI s/s. This lasted 1 week w/o resolution then developed cough w/diffuse abd cramping. Went to immunz dept and told this was nl. 10/19 saw PCP for chest tightness, sob, diff lying down, unable to sleep w/o sitting up, worsening cough unrelieved with home Albuterol, had thick clear phlegm. Abd cramping worse, problems eating/drinking due to increased bowel activity/cramps every 15-20 min. Some cramps made her double over. MD put on antibiotics x 5 days, then one week of steroids when stool/diarrhea began smelling foul, temp 101. CT abd showed bowel inflammation/ischemia and stool Guiac + blood. Admitted to hospital x 5 days, c-diff neg and no other cultures done per pt but treated with Flagyl for possible salmonella, K supplements and rehydration for anemia and low K and dehydration. Currently is doing fine w/o problems. Her MD wrote note for FLUMIST exemption, but again was sent by immunz dept for clarification on exemption. I gave temp exempt until I get her medical records to clarify events. She has received IM in past w/o problems so agreed with IM route. Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces). Not going to get into some of this as it's not related to the FLUMIST events; but need her records to accurately correlate and causality. She is very happy just to receive IM. She is an oncology nurse. She grew up on a farm in very rural area. They used outhouses with no indoor facilities, grew own food, store items were for staples only (flour to make own bread, etc.), worked pig farm, tobacco, etc.
Age: 42.0
Sex: U
Vaccine: FLUN3
Symptoms: Diarrhoea haemorrhagic, Dyspnoea, Eating disorder, Fatigue, Increased upper airway secretion
Clinical narrative: Received FLUMIST 2007 then had severe bronchitis which lead to GI distress w/bloody diarrhea, pain and hospitalization. Received (not documented) FLUMIST 10/10/06 with aches/pains all joint esp knee's/shoulders that evening. Woke next day with severe bilateral ft pain/hurt to walk and continued joint pain-took Motrin w/some relief. Was tired w/nasal congestion and URI s/s. This lasted 1 week w/o resolution then developed cough w/diffuse abd cramping. Went to immunz dept and told this was nl. 10/19 saw PCP for chest tightness, sob, diff lying down, unable to sleep w/o sitting up, worsening cough unrelieved with home Albuterol, had thick clear phlegm. Abd cramping worse, problems eating/drinking due to increased bowel activity/cramps every 15-20 min. Some cramps made her double over. MD put on antibiotics x 5 days, then one week of steroids when stool/diarrhea began smelling foul, temp 101. CT abd showed bowel inflammation/ischemia and stool Guiac + blood. Admitted to hospital x 5 days, c-diff neg and no other cultures done per pt but treated with Flagyl for possible salmonella, K supplements and rehydration for anemia and low K and dehydration. Currently is doing fine w/o problems. Her MD wrote note for FLUMIST exemption, but again was sent by immunz dept for clarification on exemption. I gave temp exempt until I get her medical records to clarify events. She has received IM in past w/o problems so agreed with IM route. Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces). Not going to get into some of this as it's not related to the FLUMIST events; but need her records to accurately correlate and causality. She is very happy just to receive IM. She is an oncology nurse. She grew up on a farm in very rural area. They used outhouses with no indoor facilities, grew own food, store items were for staples only (flour to make own bread, etc.), worked pig farm, tobacco, etc.
Age: 42.0
Sex: U
Vaccine: FLUN3
Symptoms: Insomnia, Intestinal ischaemia, Nasal congestion, Occult blood positive, Pain
Clinical narrative: Received FLUMIST 2007 then had severe bronchitis which lead to GI distress w/bloody diarrhea, pain and hospitalization. Received (not documented) FLUMIST 10/10/06 with aches/pains all joint esp knee's/shoulders that evening. Woke next day with severe bilateral ft pain/hurt to walk and continued joint pain-took Motrin w/some relief. Was tired w/nasal congestion and URI s/s. This lasted 1 week w/o resolution then developed cough w/diffuse abd cramping. Went to immunz dept and told this was nl. 10/19 saw PCP for chest tightness, sob, diff lying down, unable to sleep w/o sitting up, worsening cough unrelieved with home Albuterol, had thick clear phlegm. Abd cramping worse, problems eating/drinking due to increased bowel activity/cramps every 15-20 min. Some cramps made her double over. MD put on antibiotics x 5 days, then one week of steroids when stool/diarrhea began smelling foul, temp 101. CT abd showed bowel inflammation/ischemia and stool Guiac + blood. Admitted to hospital x 5 days, c-diff neg and no other cultures done per pt but treated with Flagyl for possible salmonella, K supplements and rehydration for anemia and low K and dehydration. Currently is doing fine w/o problems. Her MD wrote note for FLUMIST exemption, but again was sent by immunz dept for clarification on exemption. I gave temp exempt until I get her medical records to clarify events. She has received IM in past w/o problems so agreed with IM route. Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces). Not going to get into some of this as it's not related to the FLUMIST events; but need her records to accurately correlate and causality. She is very happy just to receive IM. She is an oncology nurse. She grew up on a farm in very rural area. They used outhouses with no indoor facilities, grew own food, store items were for staples only (flour to make own bread, etc.), worked pig farm, tobacco, etc.
Age: 42.0
Sex: U
Vaccine: FLUN3
Symptoms: Pain in extremity, Upper respiratory tract infection
Clinical narrative: Received FLUMIST 2007 then had severe bronchitis which lead to GI distress w/bloody diarrhea, pain and hospitalization. Received (not documented) FLUMIST 10/10/06 with aches/pains all joint esp knee's/shoulders that evening. Woke next day with severe bilateral ft pain/hurt to walk and continued joint pain-took Motrin w/some relief. Was tired w/nasal congestion and URI s/s. This lasted 1 week w/o resolution then developed cough w/diffuse abd cramping. Went to immunz dept and told this was nl. 10/19 saw PCP for chest tightness, sob, diff lying down, unable to sleep w/o sitting up, worsening cough unrelieved with home Albuterol, had thick clear phlegm. Abd cramping worse, problems eating/drinking due to increased bowel activity/cramps every 15-20 min. Some cramps made her double over. MD put on antibiotics x 5 days, then one week of steroids when stool/diarrhea began smelling foul, temp 101. CT abd showed bowel inflammation/ischemia and stool Guiac + blood. Admitted to hospital x 5 days, c-diff neg and no other cultures done per pt but treated with Flagyl for possible salmonella, K supplements and rehydration for anemia and low K and dehydration. Currently is doing fine w/o problems. Her MD wrote note for FLUMIST exemption, but again was sent by immunz dept for clarification on exemption. I gave temp exempt until I get her medical records to clarify events. She has received IM in past w/o problems so agreed with IM route. Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces). Not going to get into some of this as it's not related to the FLUMIST events; but need her records to accurately correlate and causality. She is very happy just to receive IM. She is an oncology nurse. She grew up on a farm in very rural area. They used outhouses with no indoor facilities, grew own food, store items were for staples only (flour to make own bread, etc.), worked pig farm, tobacco, etc.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Death, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Coma, Death
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal discomfort, Antinuclear antibody negative, Autopsy, Cardiac enzymes increased, Catheterisation cardiac
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest discomfort, Chest pain, Coxsackie virus serology test negative, Death, Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dyspnoea, Echovirus serology test negative, Ejection fraction decreased, Hypoaesthesia, Hypoperfusion
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Influenza serology negative, Influenza serology positive, Myocarditis, Nausea, Polymerase chain reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pulmonary congestion, Resuscitation, Streptococcal identification test positive, Ventricular tachycardia, Viral test negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Virus serology test
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner stated that the patient "was admitted to the hospital while in a coma and died shortly afterward.  The physician at the hospital felt that this was caused by GARDASIL".  The cause of death was not reported.  The vaccine was not given to the patient at the nurse practitioner's office, so she was unsure of further details.  The reporter considered the event to be immediately life threatening and disabling.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3, TDAP
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Arm hurts with movement, (R) arm throbbing for 2 weeks due to flu shot given. Pt. given prescription for FLEXERIL 1 at bedtime or twice daily as needed. Discussed stretching and strengthening exercises.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3, TDAP
Symptoms: Induration, Pain, Pain in extremity
Clinical narrative: Arm hurts with movement, (R) arm throbbing for 2 weeks due to flu shot given. Pt. given prescription for FLEXERIL 1 at bedtime or twice daily as needed. Discussed stretching and strengthening exercises.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiovascular evaluation, Dizziness, Headache
Clinical narrative: Information has been received from a physician concerning a 17 year old female with benign cyst in the breast, fungal infection behind the ears and no allergies who on 16-SEP-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot number 655604/0052X) (injection site not reported).  There was no concomitant medication.  On 17-OCT-2008 the patient experienced severe dizziness and headache and went to the emergency room.  The ER found no factors relating to the symptoms.  The patient continued to have severe dizziness and could not stand.  Standing caused falling and so the patient was seen on 20-OCT-2008 by her primary physician.  The patient was admitted to the hospital that day for 2 days.  MRI, CT scan and blood work came back negative.  The patient was seen by both a neurologist and cardiologist.  The patient was then admitted to a hospital since 22-OCT-2008.  The patient was given intravenous fluid because the physician did not find the cause for her symptoms.  At time of this report, the patient's symptoms persisted.  The patient's severe dizziness, headache, could not standing and standing which caused falling were considered to be disabling.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dizziness, Dysstasia, Fall, Headache
Clinical narrative: Information has been received from a physician concerning a 17 year old female with benign cyst in the breast, fungal infection behind the ears and no allergies who on 16-SEP-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot number 655604/0052X) (injection site not reported).  There was no concomitant medication.  On 17-OCT-2008 the patient experienced severe dizziness and headache and went to the emergency room.  The ER found no factors relating to the symptoms.  The patient continued to have severe dizziness and could not stand.  Standing caused falling and so the patient was seen on 20-OCT-2008 by her primary physician.  The patient was admitted to the hospital that day for 2 days.  MRI, CT scan and blood work came back negative.  The patient was seen by both a neurologist and cardiologist.  The patient was then admitted to a hospital since 22-OCT-2008.  The patient was given intravenous fluid because the physician did not find the cause for her symptoms.  At time of this report, the patient's symptoms persisted.  The patient's severe dizziness, headache, could not standing and standing which caused falling were considered to be disabling.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female with benign cyst in the breast, fungal infection behind the ears and no allergies who on 16-SEP-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot number 655604/0052X) (injection site not reported).  There was no concomitant medication.  On 17-OCT-2008 the patient experienced severe dizziness and headache and went to the emergency room.  The ER found no factors relating to the symptoms.  The patient continued to have severe dizziness and could not stand.  Standing caused falling and so the patient was seen on 20-OCT-2008 by her primary physician.  The patient was admitted to the hospital that day for 2 days.  MRI, CT scan and blood work came back negative.  The patient was seen by both a neurologist and cardiologist.  The patient was then admitted to a hospital since 22-OCT-2008.  The patient was given intravenous fluid because the physician did not find the cause for her symptoms.  At time of this report, the patient's symptoms persisted.  The patient's severe dizziness, headache, could not standing and standing which caused falling were considered to be disabling.  Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: My son was vaccinated on 10/20/08 with the MMR vacine, on 10/26/08 he developed a fever and then had a seizure.  He was diagnosed with atypical complex febrile seizure.  We were in the hopital for 2 nights. 1/21/09-records received for DOS 10/27/08-DX: New onset atypical complex febrile seizure. Status epilepticus, upper respiratory infection likely viral. Presented with new onset seizure.  Day of admission abnormal looking eyes foaming at mouth, tremoring of arms. Subsequent seizures in ED.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female with a history of hernia and no drug allergies reported who on 08-Sep-2008 was vaccinated with the first dose of GARDASIL (lot # 0573X), 0.5 mL, IM. There was no concomitant medication. On 08-Sep-2008, after vaccination, the patient experienced pain at injection site. On around 12-Sep-2008, the patient developed shoulder pain. At the time of the report, on 26-Sep-2008, the patient was having constant pain on right arm. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/14/2008;  1/7/2009.  Follow-up information has been received from a registered nurse concerning a 25 year old female with mild dysplasia and a  history of hernia and no known allergies who on 08-SEP-2008 at 5:18 p.m. was vaccinated intramuscularly in the right deltoid with a 0.5 ml first dose of GARDASIL .  There was no concomitant medication.  The nurse reported that the adverse events resolved on their own.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome
Clinical narrative: Information has been received from a registered nurse, who was told by one of her patients that a female patient who an unknown date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed chronic fatigue syndrome. At the time of reporting, the patient's chronic fatigue syndrome persisted. There was no product quality complaint. This is one of several reports provided by the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome
Clinical narrative: Information has been received from a registered nursed, who was told by one of her patients that a female patient who an unknown date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed chronic fatigue syndrome. At the time reporting, the patient's chronic fatigue syndrome persisted. There was no product quality complaint. This one of several reports provided by the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female patient, who on 24-Sep-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, IM. On 26-Sep-2008, the patient was vaccinated with the second dose of GARDASIL, Lot# 660557/0072X, 0.5 mL, IM, earlier than recommended and she fainted on the second dose. Approximately 10 minutes after the second dose, that patient briefly fainted. On 26-Sep-2008, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information was received from a consumer concerning her daughter who on 08-JUL-2008, was vaccinated with the first dose of GARDASIL. On 23-SEP-2008, the patient was vaccinated with the second dose of GARDASIL. The mother reported that her daughter received her second dose of GARDASIL due to being on antibiotics. The mother did not wish to document the experience. No farther information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Ultrasound scan
Clinical narrative: Information has been received from an LPN for the Pregnancy Registry for HPV vaccine concerning a 24 year old female with attention deficit/hyperactivity disorder, who on 07-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 0250X). On 11-SEP-2008, the patient found out she was pregnant and on 26-SEP-2008, she confirmed that she was 10 weeks pregnant with a ultrasound performed that showed intrauterine pregnancy. The patient's LMP was approximately on 18-JUL-2008 and EDD 24-APR-2009. She subsequently took prenatal vitamins for pregnancy health and vitamin B for nausea. This was her first pregnancy. No further information is available.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Haemoglobin decreased, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with anaemia who in 2003 was vaccinated with PNEUMOVAX 23.  Concomitant therapy included EXJADE and PROCRIT.  On 13-OCT-2008 the patient experienced soreness and redness at the site and extend toward the back of the arm.  On 16-OCT-2008, the patient recovered from soreness and redness at the site and extend toward the back of the arm.  On 17-OCT-2008, the patient had a decrease in her hemoglobin to 9.3 and required transfusion of 2 units of packed red blood cells.  The patient's hemoglobin is normally in the mid 10's.  Upon internal review, decrease hemoglobin of 9.3 requiring blood transfusion was determined to be an other important medical event.  No further information is available.