chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPVX, VARCEL
Symptoms: Headache, Heart rate increased, Myalgia, PO2 normal, Tachycardia
Clinical narrative: Came to ER at 10:09 7/18/07 with complaints of chest pain of severity of 5 on a scale of 0-5 (5 being worst pain)  Stated it started at 9 a.m. 7/18/07.  VS 100.9 - 111-18  109/73 room air sat was 94%.  Other complaints were cough, headache, and trouble breathing.  EKG was normal - tachy.  Diagnosis by ER physician - mylagia, possible reaction to vaccine.  Given 1 gram tylenol.  Instructed to return if wheezing or rash.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Hyperhidrosis, Pallor, Syncope
Clinical narrative: five minutes after vaccine given, patient fainted.  Patient pale , diaphoretic, weak.  Placed in supine position, cold cloth to head, vital signs done, sugar containing drink given.  Patient recovered back to normal conditon in twenty minutes and was able to walk out of clinic.
Age: 0.54
Sex: M
Vaccine: SMALL
Symptoms: Decreased appetite, Irritability, Laboratory test, Pyrexia, Rash maculo-papular
Clinical narrative: Possible/rule-out case of contact transmission vaccinia.  This infant presented to hospital on 7/12/07 with fever of 102F and a history X 1 day of scattered discrete macular/papular rash, irritability, and decreased appetite.  Seen by Dr., infectious disease physician. Infant had been in contact with a patient on 7/7/07, who had received smallpox vaccination on 6/28/07, possibly having direct contact with the patient's uncovered vaccination site, giving rise to concern for potential contact transmission vaccinia.  The patient was due to deploy.  Fever responded to acetaminophen. The infant was placed under inpatient observation; the rash remained maculo-papular without forming vesicles and resolved within 3 days. An oropharyngeal swab was obtained and sent from Lab to CDC in lieu of any vesicular fluid specimen. Upon discharge, vaccinia was felt to be very unlikely. 8/1/07-records received for 2 ER visits on 7/12 and 7/13/07- DX: Acute rash with pyrexia vaccinia smallpox vaccination exposure. C/O rash and fever occuring 5 days after significant exposure to person recently vaccinated with vaccinia. Macular papular rash scattered. No oral lesions. Temp now 97.
Age: 0.54
Sex: M
Vaccine: SMALL
Symptoms: Rash vesicular, Viral test
Clinical narrative: Possible/rule-out case of contact transmission vaccinia.  This infant presented to hospital on 7/12/07 with fever of 102F and a history X 1 day of scattered discrete macular/papular rash, irritability, and decreased appetite.  Seen by Dr., infectious disease physician. Infant had been in contact with a patient on 7/7/07, who had received smallpox vaccination on 6/28/07, possibly having direct contact with the patient's uncovered vaccination site, giving rise to concern for potential contact transmission vaccinia.  The patient was due to deploy.  Fever responded to acetaminophen. The infant was placed under inpatient observation; the rash remained maculo-papular without forming vesicles and resolved within 3 days. An oropharyngeal swab was obtained and sent from Lab to CDC in lieu of any vesicular fluid specimen. Upon discharge, vaccinia was felt to be very unlikely. 8/1/07-records received for 2 ER visits on 7/12 and 7/13/07- DX: Acute rash with pyrexia vaccinia smallpox vaccination exposure. C/O rash and fever occuring 5 days after significant exposure to person recently vaccinated with vaccinia. Macular papular rash scattered. No oral lesions. Temp now 97.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Healthy client received Menactra 0.5 cc IM L Deltoid at 4PM on 07/12/07 without incident. Mother of client reported the following information at 4PM on 07/17/07.  Onset of symptoms during the night of 07/12/07- fever of 100-101 degrees F, nausea, stiff neck, blurred vision, sore L arm, generalized joint aching  severe headache,malaise, sl. mental "fogginess," without seizure paralysis, generalized rash or vomiting.  Parents gave client tylenol as needed to reduce aching and fever symptoms over the course of next 3 days, during which time client was not able to go to work due to symptoms, but was able to lay on the couch and eat some foods and liquids. At 4PM on 7/17/07 mother reports client is "Slowly getting better-she was able to go to work today, but she's still tired and the L arm is still tender.  The headache is going away, too.  Interestingly, my sister's son had the Menactra vaccine last summer, and she just told me that her son had three days of fever and aching when he had it, too."  I encouraged mother to call Dr. to report the adverse symptoms and any symptoms that may occur in the future related to the vaccination. Mother agreed to contact Dr. as follow up to incident.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Pyrexia, Vision blurred
Clinical narrative: Healthy client received Menactra 0.5 cc IM L Deltoid at 4PM on 07/12/07 without incident. Mother of client reported the following information at 4PM on 07/17/07.  Onset of symptoms during the night of 07/12/07- fever of 100-101 degrees F, nausea, stiff neck, blurred vision, sore L arm, generalized joint aching  severe headache,malaise, sl. mental "fogginess," without seizure paralysis, generalized rash or vomiting.  Parents gave client tylenol as needed to reduce aching and fever symptoms over the course of next 3 days, during which time client was not able to go to work due to symptoms, but was able to lay on the couch and eat some foods and liquids. At 4PM on 7/17/07 mother reports client is "Slowly getting better-she was able to go to work today, but she's still tired and the L arm is still tender.  The headache is going away, too.  Interestingly, my sister's son had the Menactra vaccine last summer, and she just told me that her son had three days of fever and aching when he had it, too."  I encouraged mother to call Dr. to report the adverse symptoms and any symptoms that may occur in the future related to the vaccination. Mother agreed to contact Dr. as follow up to incident.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Asthenia, Crying, Dyspnoea, Injection site pain
Clinical narrative: Had the Guardasil shot in right arm, which itself caused a little more pain than expected but that went away, and 2o minutes later she has severe pain in opposite arm (left) and weakness. She was crying. I thought maybe it was anxiety, and called Dr.s office, and CDC vaccine line and they both didn't know what to say because it shouldn't hurt in opposite arm. She then was having some trouble breathing so I brought her to ER and they couldn't really figure it out. She took some benadryl. It lasted several hours and was completely gone by next day. Other daughter had shot without incident. My daughters are up to date with vaccines and get a yearly flu shot without any problems ever so this was weird. Not sure on exact time of shot, put in time within one half hour, but reaction started 20 minutes after shot. I looked at my watch at the time because I thought that was relavent.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Had the Guardasil shot in right arm, which itself caused a little more pain than expected but that went away, and 2o minutes later she has severe pain in opposite arm (left) and weakness. She was crying. I thought maybe it was anxiety, and called Dr.s office, and CDC vaccine line and they both didn't know what to say because it shouldn't hurt in opposite arm. She then was having some trouble breathing so I brought her to ER and they couldn't really figure it out. She took some benadryl. It lasted several hours and was completely gone by next day. Other daughter had shot without incident. My daughters are up to date with vaccines and get a yearly flu shot without any problems ever so this was weird. Not sure on exact time of shot, put in time within one half hour, but reaction started 20 minutes after shot. I looked at my watch at the time because I thought that was relavent.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: FEVER OVER 104 DEG
Age: 0.36
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Lethargy, Listless, Pyrexia, Screaming
Clinical narrative: Symptoms: Fever >100 up to 103.4 degrees over the course of 7 days, beginning 3 hours post immunization. Screaming and crying began ~ 3 hours post immunization and continued in 1-4 hour incriments over the course of 7 days.  Lethargic & Listless demeanor > 5 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pharyngolaryngeal pain, Urticaria, Wheezing
Clinical narrative: Urticaria, wheezing, sore throat. Came to my office one hour after he left. Currently receiving a nebulizer treatment. Does not appear in respiratory distress.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Carpal tunnel syndrome, Condition aggravated, Epicondylitis, Injection site pain, Myalgia
Clinical narrative: RHEUMATOID ARTHRITIS - COURSE AS FOLLOWS:  Immediate localized tenderness at injection site.  Muscle pain within two weeks, attributed to injection and dismissed as minor by phone consultation w nurse.  Bilaterial Carpel Tunnel Syndrome one month post injection - diagnosed during office visit.  Tennis Elbow in left arm one month post injection - diagnosed during office visit.  Rheumatoid arthritis flare 4 months post injection - diagnosed via blood test taken during emergency visit to doctor's office.  Ongoing RA symptoms to current date, including one additional RA flare requiring ER visit.  Current medication treatment:  mevachor, relafen, norco, flexeril, calcium supplement, multivitamin,  folic acid.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS - COURSE AS FOLLOWS:  Immediate localized tenderness at injection site.  Muscle pain within two weeks, attributed to injection and dismissed as minor by phone consultation w nurse.  Bilaterial Carpel Tunnel Syndrome one month post injection - diagnosed during office visit.  Tennis Elbow in left arm one month post injection - diagnosed during office visit.  Rheumatoid arthritis flare 4 months post injection - diagnosed via blood test taken during emergency visit to doctor's office.  Ongoing RA symptoms to current date, including one additional RA flare requiring ER visit.  Current medication treatment:  mevachor, relafen, norco, flexeril, calcium supplement, multivitamin,  folic acid.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Patient reportedly had a seizure within 12 hours of recieving Gardisil Vaccine.  This was her first dose.  It is undetermined how long the seizure lasted as the patient and her mother are poor historians.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Cold compress therapy, Erythema, Eye swelling, Injection site mass, Lip swelling
Clinical narrative: Eyes were swollen shut on 7/12, lips swollen, severe nasal congestion, errythema, mass at injection site, fever 103F on 7/13 early morning.  Patient took Benadryl PO at home, then went to the ED in Opelousas where they gave her Benadryl IM, Tylenol and an ice pack for her arm.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: Eyes were swollen shut on 7/12, lips swollen, severe nasal congestion, errythema, mass at injection site, fever 103F on 7/13 early morning.  Patient took Benadryl PO at home, then went to the ED in Opelousas where they gave her Benadryl IM, Tylenol and an ice pack for her arm.
Age: 1.92
Sex: M
Vaccine: HIBV, PPV
Symptoms: Diet refusal, Irritability, Lethargy, Pyrexia
Clinical narrative: Patient ran a fever of 102 for 3 days.  Wouldn't eat. Extremely fussy.  Lethargic, non active.  Treatment was tylanol administered every 4 hours, but didn't drop the fever.
Age: 2.0
Sex: M
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: Patient began fevering (up to 101 degrees F) about twelve hours after vaccination.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: All symptoms started approximately 30 hours after vaccine was given.  The symptoms were: dull headache, extreme fatgiue, grogginess, mild nasea, fever of 102.5 with chills, warm, sore injection site that was light reddish pink. No form was given so spouse called the pharmacy and asked if symptoms were normal. The response was yes.  I (patient dozed on & off for 4 hours then took two Advil pm (for arm pain) and went to bed. The next morning 48 hours later, most all symptoms had disappeared except dull headache and extremely sore arm. It was noticed about 50 hours after vaccine by a friend that the injection site was still swollen and had a large pink perimeter around swollen injection site.  I (patient) called the nurse at the clinic and was told to come in and have a nurse look at the injection site.  So 51 hours after vaccine I went back to the clinic and two nurses, including administering nurse evaluted the injection site. A pen mark was drawn around the reddish pink part to measure its possible expansion in the next few days.  I was told to apply frequent heat to site and to come back by Friday if the reddish area grew larger. Both nurses acknowledged the symptoms I had were not normal for this shot.  Now, 54 hours later it is possible to apply heat and will monitor situation. The only symptoms right now are a dull headache and a very painful injection site. Just thought this should be reported and information for this site was obtained off the CDC vaccine page I was given today.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia, Somnolence
Clinical narrative: All symptoms started approximately 30 hours after vaccine was given.  The symptoms were: dull headache, extreme fatgiue, grogginess, mild nasea, fever of 102.5 with chills, warm, sore injection site that was light reddish pink. No form was given so spouse called the pharmacy and asked if symptoms were normal. The response was yes.  I (patient dozed on & off for 4 hours then took two Advil pm (for arm pain) and went to bed. The next morning 48 hours later, most all symptoms had disappeared except dull headache and extremely sore arm. It was noticed about 50 hours after vaccine by a friend that the injection site was still swollen and had a large pink perimeter around swollen injection site.  I (patient) called the nurse at the clinic and was told to come in and have a nurse look at the injection site.  So 51 hours after vaccine I went back to the clinic and two nurses, including administering nurse evaluted the injection site. A pen mark was drawn around the reddish pink part to measure its possible expansion in the next few days.  I was told to apply frequent heat to site and to come back by Friday if the reddish area grew larger. Both nurses acknowledged the symptoms I had were not normal for this shot.  Now, 54 hours later it is possible to apply heat and will monitor situation. The only symptoms right now are a dull headache and a very painful injection site. Just thought this should be reported and information for this site was obtained off the CDC vaccine page I was given today.
Age: 7.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Arthralgia, Haematocrit normal, Haemoglobin normal, Juvenile arthritis
Clinical narrative: Gardasil adverse reaction resembling RA pauciarticular joint pain  elevated sed rate, elevated RF, anemia
Age: 7.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor increased
Clinical narrative: Gardasil adverse reaction resembling RA pauciarticular joint pain  elevated sed rate, elevated RF, anemia
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Lethargy, Vomiting
Clinical narrative: Headache 24 hrs after injection then vomiting multiple times, pt lethargic
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Chapped lips, Discomfort, Fatigue, Herpes zoster disseminated, Impetigo
Clinical narrative: Approximately 3 weeks after booster, patient developed sores in mouth.  Next day, sores spread to lips and throat, and target like spots appeared on arms, trunk and legs.  At that point Dr. prescribed 400 mg acyclovir 3x daily.  Symptoms continued to worsen, especially lips which were oozing blood, cracked, and blackish. Patient couldnt eat, barely open mouth enough to drink. Another pediatrician saw him and diagnosed him with chicken pox, disseminated herpes virus and impetago, and prescribed 800 mg acyclovir 5x and augmentin. A herpes lesion on his face very close to the eye seems also to have caused eye involvement and an opthamologist prescribed viroptic.  Patient lost approx. 18 lbs in 12 days until lesions on mouth and throat began to heal.  No fever or headaches.  A few teardrop chicken pox vessicles on chin and arms, rest of the spots on body were like bullseyes.  Itchiness reported just for 2-3 days and then subsided. Patient was unable to sleep for any length of time throughout the 10 day period due to great discomfort of the mouth, lips and throat.Patient has now basically recovered other than residual tiredness, not quite back to regular strength. About 10 days after innoculation, patient was exposed to sunlight, was on a beach for quite a number of hours and returned with a sunburn.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Lip haemorrhage, Pruritus, Stomatitis, Sunburn, Varicella
Clinical narrative: Approximately 3 weeks after booster, patient developed sores in mouth.  Next day, sores spread to lips and throat, and target like spots appeared on arms, trunk and legs.  At that point Dr. prescribed 400 mg acyclovir 3x daily.  Symptoms continued to worsen, especially lips which were oozing blood, cracked, and blackish. Patient couldnt eat, barely open mouth enough to drink. Another pediatrician saw him and diagnosed him with chicken pox, disseminated herpes virus and impetago, and prescribed 800 mg acyclovir 5x and augmentin. A herpes lesion on his face very close to the eye seems also to have caused eye involvement and an opthamologist prescribed viroptic.  Patient lost approx. 18 lbs in 12 days until lesions on mouth and throat began to heal.  No fever or headaches.  A few teardrop chicken pox vessicles on chin and arms, rest of the spots on body were like bullseyes.  Itchiness reported just for 2-3 days and then subsided. Patient was unable to sleep for any length of time throughout the 10 day period due to great discomfort of the mouth, lips and throat.Patient has now basically recovered other than residual tiredness, not quite back to regular strength. About 10 days after innoculation, patient was exposed to sunlight, was on a beach for quite a number of hours and returned with a sunburn.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Weight decreased
Clinical narrative: Approximately 3 weeks after booster, patient developed sores in mouth.  Next day, sores spread to lips and throat, and target like spots appeared on arms, trunk and legs.  At that point Dr. prescribed 400 mg acyclovir 3x daily.  Symptoms continued to worsen, especially lips which were oozing blood, cracked, and blackish. Patient couldnt eat, barely open mouth enough to drink. Another pediatrician saw him and diagnosed him with chicken pox, disseminated herpes virus and impetago, and prescribed 800 mg acyclovir 5x and augmentin. A herpes lesion on his face very close to the eye seems also to have caused eye involvement and an opthamologist prescribed viroptic.  Patient lost approx. 18 lbs in 12 days until lesions on mouth and throat began to heal.  No fever or headaches.  A few teardrop chicken pox vessicles on chin and arms, rest of the spots on body were like bullseyes.  Itchiness reported just for 2-3 days and then subsided. Patient was unable to sleep for any length of time throughout the 10 day period due to great discomfort of the mouth, lips and throat.Patient has now basically recovered other than residual tiredness, not quite back to regular strength. About 10 days after innoculation, patient was exposed to sunlight, was on a beach for quite a number of hours and returned with a sunburn.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling about 4-5 cm on left trapezius at site of Varivax - day after vaccine was given.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea since 7/17/07 after Rotateq
Sex: F
Vaccine: HIBV, MMR
Symptoms: Drug administration error
Clinical narrative: Wrong diluent was used to reconstitute HIB vaccine-Instead of diluent provided with vaccine sterile water was used No adverse effects from this event
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash macular
Clinical narrative: Pt was one day history of macular rash over torso. It began in P.M.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis with pain 2d after varicella shot. occurred at sight of injection. Started on Keflex
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: 4x6 cm
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Amnesia, Arthralgia, Discomfort, Fatigue
Clinical narrative: Description:1. Tingling in back: pt reports that approx 3 months ago he began to develop a tingling sensation to left mid back area. He has 3-4 episodes a day with each one lasting 15 seconds. The area is about the size of a saucer 4-5 inches in diameter. He denies discomfort in skin area, and reports no skin changes. He is unable to correlate the sensation with any activity. His job requires extensive sitting but no twisting, turning or lifting. 2. Sinus: Problems with his sinus over the past 8-9 months since his return from Kuwait. He states that his sinus never really clears. Has tried Flonase and Allegra. Was given to him 6 wks ago but he is not taking it. He is trying to shake it off on his own. Reports no x-ray or CT of sinus area. Unsure if he had a trial of antibiotics. He reports nasal congestion only, no pain or fever. He reports that he has not been sleeping well and that he is never fully alert over the past couple of months. He said he went to Spain in March and passed his language test. He stated that when he returned he took the test again but failed. He stated that during the test he was unable to pay attention. He denies taking any medication. Has an appointment with his counselor. 4. GERD: he said it has been bothering him for years prior to anthrax. Has been taking acidphex for a couple of years with relief. He stated that he would have a post deployment endoscopy study. Has had a recent sonogram and is pending feedback. 5. Mild joint pain: he reports occasional pain right pinky of right hand. States it is very minor and has no known history of trauma. He states that the pain is very infrequent approx 4-5 times a week and lasts only a short time. He reports that the pain is not reproducible. 6. Red spots on abd: he said they could have been there all his life but that he did not notice them. He saw his MD who told him they were Cherry Angiomas that is a normal sign of aging. 7. Memory problems: he states that it is difficult to describe, but remembers one occasion that when he got into the shower he forgot which way to turn the hot water valve. Has only 1 other instance. He wants to know if this is normal or is he should be concerned. Symptom: Sensation, increase Start: 02/2004 Comment: tingling in left mid-back, 3-4 times/day, 4-5' diameter area, each lasting about 15 seconds Symptom: Fatigue, Malaise >60 Days Start: 02/2004 Comment: not sleeping well, not fully alert Symptom: Epigastric pain Comment: GERD Symptom: Joint Pain, isolated Comment: right pinky, occasional, minor in degree Symptoms: Memory Loss, long term
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Gastrooesophageal reflux disease, Haemangioma, Insomnia, Malaise, Memory impairment
Clinical narrative: Description:1. Tingling in back: pt reports that approx 3 months ago he began to develop a tingling sensation to left mid back area. He has 3-4 episodes a day with each one lasting 15 seconds. The area is about the size of a saucer 4-5 inches in diameter. He denies discomfort in skin area, and reports no skin changes. He is unable to correlate the sensation with any activity. His job requires extensive sitting but no twisting, turning or lifting. 2. Sinus: Problems with his sinus over the past 8-9 months since his return from Kuwait. He states that his sinus never really clears. Has tried Flonase and Allegra. Was given to him 6 wks ago but he is not taking it. He is trying to shake it off on his own. Reports no x-ray or CT of sinus area. Unsure if he had a trial of antibiotics. He reports nasal congestion only, no pain or fever. He reports that he has not been sleeping well and that he is never fully alert over the past couple of months. He said he went to Spain in March and passed his language test. He stated that when he returned he took the test again but failed. He stated that during the test he was unable to pay attention. He denies taking any medication. Has an appointment with his counselor. 4. GERD: he said it has been bothering him for years prior to anthrax. Has been taking acidphex for a couple of years with relief. He stated that he would have a post deployment endoscopy study. Has had a recent sonogram and is pending feedback. 5. Mild joint pain: he reports occasional pain right pinky of right hand. States it is very minor and has no known history of trauma. He states that the pain is very infrequent approx 4-5 times a week and lasts only a short time. He reports that the pain is not reproducible. 6. Red spots on abd: he said they could have been there all his life but that he did not notice them. He saw his MD who told him they were Cherry Angiomas that is a normal sign of aging. 7. Memory problems: he states that it is difficult to describe, but remembers one occasion that when he got into the shower he forgot which way to turn the hot water valve. Has only 1 other instance. He wants to know if this is normal or is he should be concerned. Symptom: Sensation, increase Start: 02/2004 Comment: tingling in left mid-back, 3-4 times/day, 4-5' diameter area, each lasting about 15 seconds Symptom: Fatigue, Malaise >60 Days Start: 02/2004 Comment: not sleeping well, not fully alert Symptom: Epigastric pain Comment: GERD Symptom: Joint Pain, isolated Comment: right pinky, occasional, minor in degree Symptoms: Memory Loss, long term
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Nasal congestion, Paraesthesia, Sinus disorder
Clinical narrative: Description:1. Tingling in back: pt reports that approx 3 months ago he began to develop a tingling sensation to left mid back area. He has 3-4 episodes a day with each one lasting 15 seconds. The area is about the size of a saucer 4-5 inches in diameter. He denies discomfort in skin area, and reports no skin changes. He is unable to correlate the sensation with any activity. His job requires extensive sitting but no twisting, turning or lifting. 2. Sinus: Problems with his sinus over the past 8-9 months since his return from Kuwait. He states that his sinus never really clears. Has tried Flonase and Allegra. Was given to him 6 wks ago but he is not taking it. He is trying to shake it off on his own. Reports no x-ray or CT of sinus area. Unsure if he had a trial of antibiotics. He reports nasal congestion only, no pain or fever. He reports that he has not been sleeping well and that he is never fully alert over the past couple of months. He said he went to Spain in March and passed his language test. He stated that when he returned he took the test again but failed. He stated that during the test he was unable to pay attention. He denies taking any medication. Has an appointment with his counselor. 4. GERD: he said it has been bothering him for years prior to anthrax. Has been taking acidphex for a couple of years with relief. He stated that he would have a post deployment endoscopy study. Has had a recent sonogram and is pending feedback. 5. Mild joint pain: he reports occasional pain right pinky of right hand. States it is very minor and has no known history of trauma. He states that the pain is very infrequent approx 4-5 times a week and lasts only a short time. He reports that the pain is not reproducible. 6. Red spots on abd: he said they could have been there all his life but that he did not notice them. He saw his MD who told him they were Cherry Angiomas that is a normal sign of aging. 7. Memory problems: he states that it is difficult to describe, but remembers one occasion that when he got into the shower he forgot which way to turn the hot water valve. Has only 1 other instance. He wants to know if this is normal or is he should be concerned. Symptom: Sensation, increase Start: 02/2004 Comment: tingling in left mid-back, 3-4 times/day, 4-5' diameter area, each lasting about 15 seconds Symptom: Fatigue, Malaise >60 Days Start: 02/2004 Comment: not sleeping well, not fully alert Symptom: Epigastric pain Comment: GERD Symptom: Joint Pain, isolated Comment: right pinky, occasional, minor in degree Symptoms: Memory Loss, long term
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Rash papular
Clinical narrative: multiple erythemic papules approx 1 cm in size on legs and arms x 5 days started day after immunization. lesions have increased in size and #'s
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny nose Pt given Motrin
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 16 week who on approximately 23-MAR-2007 was vaccinated with the first dose Rotateq. The patient experienced infant received the first dose of Rotateq at 16 weeks of age. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 6-month-old patient who was vaccinated with the second dose of Rotateq. It was unknown if medical attention was sought. No adverse experience was reported. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 9-month-old male who on 05-JUN-2007 was vaccinated PO with the third 2.0 mL dose of Rotateq (1st dose given at 3 months of age, 2nd dose given at 5 months of age). Unspecified medical attention was sought. Follow-up information was received from the CMA who indicated that the third dose of ROATEQ was not administered to the patient. Therefore, WAES # 070608A00874 will be deleted from our files for ROTATEQ. No further information is available.
Age: 0.33
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4-month-old patient who on 06-JUN-2007 was vaccinated PO with a dose of Rotateq. Concomitant therapy that day included a dose of DTaP (+) tetanus toxoid, a dose of Prevnar, a dose of Hib (manufacturer unknown), and a dose of poliovirus vaccine. On 06-JUN-2007, several minutes after vaccination, the patient vomited. No other symptoms were noted. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse at a physician's office concerning a 2 month old patient (gender not reported) who, on an unspecified date, was vaccinated with Rotateq. Subsequently the patient experienced diarrhea. Therapy with Rotateq was discontinued. The patient outcome was not reported. Follow up information received from a licensed practical nurse indicated that on 13-MAR-2007 at a pproximately 7:00 PM, the patietn experienced diarrhea and vomiting for one week. the mother refused the second dose of ROTATEQ, feeling it was the cause of the patient's symptoms. Subsquently, the patient recovered. There were no relevant diagnostic tests or laboratory data. No  additional information is expected.
Age: 0.1
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 5-week-old male who on 06-JUN-2007 was vaccinated with a dose of Rotateq. There was no product quality complaint. No additional information is expected.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a female who in 2007 and on approximately 08-APR-2007 was vaccinated with the first and second doses, respectively, of Rotateq (lot number not provided). In 2007, after receiving the first and second doses of Rotateq, the patient developed severe vomiting and diarrhea. Unspecified medical attention was sought. The patient was noted to be 6-months-old when the second episode of diarrhea and vomiting occurred. The patient subsequently recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a baby who was vaccinated with a dose of Rotateq. "A couple of months ago," in 2007, the patient developed a slight seizure. The patient was rushed to the emergency room. No product quality complaint was involved. No other information was provided. The patient's seizure was considered to be immediately life-threatening by the reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Abdominal distension, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first and second dose of Rotateq. The physician reported that, after the first dose, the patient experienced a distended stomach and diarrhea. At 4 months of age the patient was vaccinated with a second dose of Rotateq. The patient subsequently experienced a distended stomach and diarrhea again. The patient's events subsided within 24 hours. Additional information has been requested. Follow-up information was received from a physician who indicated they were not aware of who the patient was. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Hiccups, Infantile spitting up
Clinical narrative: Information has been received from a physician concerning a 10-week-old male with no other pertinent medical history on 11-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot #655406/1114F) (patient was noted to have hiccups at the time of vaccination). On 11-JUN-2007, while being administered Rotateq, the patient spit it up and regurgitated some saliva. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. The patient recovered in 2-3 minutes. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 3 month old male who on 24-MAY-2007 was vaccinated with the second dose Rotavirus (Lot# 656104/1167F). There was no concomitant medication. There was no medical history. On 26-May-2007 the patient experienced diarrhea that lasted 8-10 days. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who on 11-JUN-2007 was vaccinated with a dose of Rotateq (Lot # 656390/0236U). The RN reported that, after receiving the dose of Rotateq, the patient vomited. The dose was re-administered (Lot # 656193/0023U). No additional symptoms were reported. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Pharyngolaryngeal pain, Secondary transmission, Sneezing
Clinical narrative: Information has been received from a registered nurse concerning a mother whose infant was vaccinated with a dose of Rotavirus. It was reported that the infant sneezed after receiving Rotateq and the infant's mother claimed the droplets of the vaccine became airborne and went into her mouth. Subsequently the mother was taken to the emergency room with a severe sore throat. No product quality complaint was involved. Follow-up information from a medical assistant indicated that they did not have an employee named as indicated and as a result they did not have any information on the adverse experience. It was reported that the event may have been a joke and not adverse event at all. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Erythema, Mouth ulceration
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Rotateq. The physician reported that the patient subsequently developed a circular, 4 mL ulcer on her soft palate which had a raised red border with a clear center. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, IPV, RV5
Symptoms: Emotional distress, Flatulence, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no past medical history who on 12-JUN-2007 was vaccinated with the first dose of 2 ml oral Rotateq (Lot # 656187/1237F). Concomitant therapy included unspecified vaccinations and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 12-JUN-2007, the 15 month old was inadvertently administered first dose of Rotateq. On 12-JUN-2007, the patient was a little fussy and gassy. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Constipation
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated PO with the first and second 2mL doses of Rotavirus. Subsequently, after each dose, the patient was constipated for about 3 days. At the time of the report, the patient was "about 4-6 months old and didn't receive his third dose yet". No medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a patient who on 01-MAR-2007 and 14-JUN-2007 was vaccinated with the first and second doses, respectively, of Rotateq. It was unknown if medical attention was sought. No adverse symptoms were noted. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Abnormal behaviour, Crying, Emotional distress
Clinical narrative: Information has been received from a physician concerning a 2 month old female who in February 2007, was vaccinated with Rotateq (Lot# 656187/1237F) and received her second vaccination at 4 months of age in April 2007. The mother refused the third dose because after the first two doses of Rotateq, the baby was taken home and put down for a nap. When she woke up about two or three hours after coming home from the doctor, she had a very strange crying behavior, irritability and could not be consoled. She was given MOTRIN and TYLENOL at different times. The physician reported that they were not complete doses of either drug. The irritability and crying was not helped. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who at 2 months old received the first dose of Rotateq. When the baby received the first dose, the baby experienced severe vomiting and diarrhea to the point of dehydration. The physician treated the patient and the patient recovered. The mother refused to give the baby a second dose of the vaccine. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Gastroenteritis rotavirus, Inappropriate schedule of drug administration, Rotavirus test positive, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a 2 year old male whose brother was vaccinated with a first oral dose of Rotateq. Five days later the 2 year old got a severe chest of Rotateq. The 2 year old was taken to the hospital where he was tested for Rotateq, which came back positive, it was not indicated if the patient was admitted to the hospital. The patient was treated for dehydration. It was reported that the patient's brother was vaccinated with a second oral dose of Rotateq, and 5 days after the brother developed what the physician believed to be rotavirus antigen. At that time the patient was not tested for rotavirus. It was noted that the patient's mother was concerned if she should have the younger child get the third dose of Rotateq. It was also noted that the children had little contact with other children. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Tongue black hairy
Clinical narrative: Information has been received from a nurse practitioner concerning a 6-month-old male who on 16-JAN-2007, 13-MAR-2007, and 15-MAY-2007 was vaccinated PO with the first, second, and third doses of Rotateq (Lot #'s 655407/1115F, 655407/1115F, and 656385/0030U, respectively). On 15-May-2007 the patient experienced a black tongue. It was noted that the mother was breastfeeding. The tongue was cultured on 11-JUN-2007 and stated that there was a "growth". The doctor referred the patient to the ENT specialist. The patient's black tongue persisted. No additional physician information was provided. There was no product quality complaint. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning her 9 and 1/2 week old daughter who on 18-JUN-2007 was vaccinated with a dose of Rotateq and immediately threw up. There was no concomitant medication. The patient recovered on 18-JUN-2007. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning patients who were vaccinated with Rotateq po. The nurse reported that about 5 patients have returned late for their second dose of Rotateq and have had no adverse drug effect. Additional information is expected.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 4 month old male who was vaccinated with Rotateq. Subsequently the patient experienced diarrhea and vomiting. The diarrhea lasted two weeks. As of 18-JUN-2007 the patient recovered from diarrhea and vomiting. The mother refused the third dose of Rotateq. Additional information is not expected.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a four month old patient who was vaccinated with Rotateq. The patient received the first dose at two months of age and received an additional dose at four months. Subsequently the patient experienced vomiting one week after receiving Rotateq. Therapy with Rotateq was discontinued. Subsequently, the patient recovered from the vomiting. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated PO with the first dose of Rotateq at 2 months of age. The second dose was missed at the 4-month visit, and was given PO on the 6-month visit. The child was told to return for the third dose in 4 weeks, but did not return. No additional information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on approximately 19-FEB-2007 was vaccinated with Rotateq. The patient received the 1st dose of Rotateq and had diarrhea for about 4 days. There was no intervention and it cleared on it's own. The parents did not report it until they came back for the second dose. As of 19-JUN-2007, the patient was recovered. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Culture stool negative, Dermatitis diaper, Diarrhoea, Frequent bowel movements, Gastroenteritis
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who was vaccinated with the third dose of oral Rotateq. Subsequently the patient experienced significant diarrhea. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a physician concerning a 6-month-old white female who on 06-MAR-2007 (1521) and 07-MAY-2007 (1151) was vaccinated PO with the second and third 2.0 mL doses, respectively, of ROTATEQ (Lot #656191/1365F).  Concomitant vaccinations administered on 07-MAY-2007 included the third 0.5 mL, IM dose in the left thigh of PREVNAR (Lot #B08670K), the thrid 0.5 mL IM dose in the right lateral thigh of ACTHIB (Lot #UE923AA) and the third 0.5 mL IM dose in the left lateral thigh of PEDIARIX (Lot #AC218092AA).  There was no illness at the time of vaccination.  Prior vaccinations administered on 06-MAR-2007 included the second 0.5 mL dose in the right thigh of PREVNAR (Lot #B0B670K) and the second 0.5 mL IM dose in the left lateral thigh of PEDIARIX (Lot #AC21B092AA).  On 07-MAY-2007, a few hours after being vaccinated, the patient developed significant diarrhea.  On 15-MAY-2007, the patient was seen by the physician.  At that time, the patient had no abdominal pain, hematocheria or nausea, fever or vomiting.  She was noted to have a stool frequency (diarrhea) of every 1-2 hours.  The patient was also noted to have a good appetite and had gained weight.  Clear liquids had been tried without improvement.  She had no known contact with contaminated food.  Bowel sounds were normal.  There was no tenderness, organomegaly, masses or hernia.  A large erythematous rash on her buttocks was noted characterized by several pinpoint erythematous papules on her entire genitourinary region.  A diagnosis of gastroenteritis and diaper dermatitis (suspect yeast component) was made.  A stool test for ova and parasitos and culture was negative.  It was recommended that A&D ointment with monistat cream be applied to the diaper region.  Diet as tolerated.  On 16-MAY-2007, the patient recovered.  Additional information is not expected.