chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: within 24 hours of (unknown brand) influenza vaccination, my mom felt weak and dizzy - "very weird" most of day - she just made it to the next room to a chair and would have fallen to the floor but the chair broke her fall - she spun the easy chair completely around, did not pass out by would have fallen she was so dizzy. I do not know which specific flu shot she got.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Chest discomfort, Chills, Cough
Clinical narrative: Tightness of chest, wheezing, coughing, tightness and burning in throat 4 hours after shot.  Took 1 benadryl.  Throat relaxed, chest still tight, took another benadryl 1 hour later.  Severe aches, and chills set in.  Took 2 motrin and went to bed with 3 blankets on at 10:00pm.   Woke up next morning at 9:00 AM felt better.  Just had headache, and joint and back aches.  Chest still a little wheezy.  Took 1 benadryl.  Symptoms went away by 5:00 pm.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pharyngolaryngeal pain, Wheezing
Clinical narrative: Tightness of chest, wheezing, coughing, tightness and burning in throat 4 hours after shot.  Took 1 benadryl.  Throat relaxed, chest still tight, took another benadryl 1 hour later.  Severe aches, and chills set in.  Took 2 motrin and went to bed with 3 blankets on at 10:00pm.   Woke up next morning at 9:00 AM felt better.  Just had headache, and joint and back aches.  Chest still a little wheezy.  Took 1 benadryl.  Symptoms went away by 5:00 pm.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: L arm feels numb and tingly to finger tips  Some L sided chest wall discomfort noted.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Vaccine leaked from syringe upon injecting intramuscularly into deltoid muscle and landed in patient's eye.  Rinsed eye with lubricating eye drops and notified patient's personal physician and physician with whom Hy-Vee has collaborating protocol.  Also contacted Poison Control Center and Vaccine manufacturer for additional info.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site warmth, Joint range of motion decreased
Clinical narrative: PER PATIENT:  REC'D TETANUS SHOT ON 11/15/06.  MY ARM THAT EVENING WAS REDDENED AND WARM TO TOUCH FROM MY WRIST TO MY SHOULDER.  IT WAS ALSO HARD AND I WAS UNABLE TO MOVE IT.  WENT TO CLINIC ON FRIDAY AND REC'D CARE FROM PHYSICIAN. PER TX CLINIC:  LT SHOULDER CELLULITIS/ALLERGIC RX   STARTED ON ANTIBIOTIC, MEDROL DOSE PACK, AND ANALGESIC RTW 11/20/06 WITHOUT COMPLICATIONS.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Diarrhoea, Dyspepsia, Flatulence, Headache
Clinical narrative: 11/10/2006 and 11/11/2006(Dose 2): Mild headache, overall achy feeling, bloating, mild nausea; 11/12/2006, 11/13/2006(Dose 3) and 11/14/2006: Bad heartburn, flatulence, aches, mild headache; 11/15/2006(Dose 4): diarrhea, lethargy and sleepiness; 11/16/2006: sleepiness; 11/17/2006: feel normal.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Lethargy, Nausea, Pain, Somnolence
Clinical narrative: 11/10/2006 and 11/11/2006(Dose 2): Mild headache, overall achy feeling, bloating, mild nausea; 11/12/2006, 11/13/2006(Dose 3) and 11/14/2006: Bad heartburn, flatulence, aches, mild headache; 11/15/2006(Dose 4): diarrhea, lethargy and sleepiness; 11/16/2006: sleepiness; 11/17/2006: feel normal.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Dx. HERPES ZOSTER after varicella immunization.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Disorientation, Somnolence
Clinical narrative: About 15-20 minutes after receiving the flumist I felt very drowsy and could barely stay awake.  I also was very disoriented and literally walked into a wall after going through a doorway.  A few minutes after that I rose from sitting and nearly fell over.  I felt similar to if I was very inebriated for several hours and was afraid to drive until much later that evening.
Age: 1.17
Sex: M
Vaccine: MMRV, PPV
Symptoms: Rash, Viral infection
Clinical narrative: Child received Proquad 11/09/06.  Child came in with varicella rash on 11/20/06.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pharyngolaryngeal pain, Rash, Throat tightness, Tongue oedema
Clinical narrative: Patient called our pharmacy 11/20/06 @215pm and reported that she got sick four days later from receiving a flu vaccine on 11/7. She experienced rash, sore throat, soreness and swelling on tounge. She also reported that her throat closed up. She said she went to the ER and had to take several days off work. She is now stable.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Shot in left arm on Nov. 13th 2006; reactioncame as surprise I expected only a sore arm. Came home---- about 2 hours after shot felt like I had the flu -----muscles in whole body hurting----temperature went up about 1.5 degrees.  Called Doctor at pharmacy ---said to take tylenol and that I would feel better in about 2 days.   Severe muscle pain and fatigue-weakness like flu; congestion; cough; headache; had to go to bed  couldn't stay up.     Had no choice but to go to bed--------pushed all of the liquids I could to stay hydrated and cleanse my sytem.  Muscle pain was better on Wed. morning but not the congestion and coughing and the fatigue.   Literature says it takes 2 weeks for full immunity so don't know whether this reaction will last longer and to what extent.  Note the time of the vaccine I entered is approximate.  Was late afternoon about 5:00 p.m.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Shot in left arm on Nov. 13th 2006; reactioncame as surprise I expected only a sore arm. Came home---- about 2 hours after shot felt like I had the flu -----muscles in whole body hurting----temperature went up about 1.5 degrees.  Called Doctor at pharmacy ---said to take tylenol and that I would feel better in about 2 days.   Severe muscle pain and fatigue-weakness like flu; congestion; cough; headache; had to go to bed  couldn't stay up.     Had no choice but to go to bed--------pushed all of the liquids I could to stay hydrated and cleanse my sytem.  Muscle pain was better on Wed. morning but not the congestion and coughing and the fatigue.   Literature says it takes 2 weeks for full immunity so don't know whether this reaction will last longer and to what extent.  Note the time of the vaccine I entered is approximate.  Was late afternoon about 5:00 p.m.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Nausea, Pyrexia, Vomiting
Clinical narrative: pt. c/o alternating chills and fever, SOB and wheezing noted when he has chills, some N/V-symptoms started a couple days after receiving flu vaccine on 11/3/06.  Rocephin injection given on 11/7/06 labs, blood cultures, urine and chest xray checked.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: pt. c/o alternating chills and fever, SOB and wheezing noted when he has chills, some N/V-symptoms started a couple days after receiving flu vaccine on 11/3/06.  Rocephin injection given on 11/7/06 labs, blood cultures, urine and chest xray checked.
Age: 0.0
Sex: U
Vaccine: RV5
Symptoms: Cough, Dysphonia, Malaise, Medication error, Pain
Clinical narrative: At 3:30 pm, I (a registered nurse) was administering the Rotateq vaccine to an infant. After delivering half of it slowly, I paused and the baby sneezed, thereby spraying much of it into both of my eyes, with slightly more into the right eye. I immediately rinsed my eyes in the sink, but started having a tingling sensation, which progressed within a minute or two into a ground glass like pain. Then I began to cough uncontrollably, which lasted for hours, until I lost my voice altogether. MY eyes became very red and my face also became very red. I felt generally unwell. Due to the significant pain in my eyes, I was advised by one of our pediatricians to go immediately to Urgent Care, where my eyes were irrigated with two liters of saline. I was given Patanol and sent to another MD the next day. The Merck company was of little help, including the Merck pediatrician. I spent 4 hours at Occupational medicine and was told my eyes would improve gradually and that the chemicals in the vaccine were irritants to my eyes. My eyes improved slightly, but 6 days later I am still having an uncomfortable itching sensation. I was told to wear goggles and a face shield from now on with that vaccine. I believe everyone should have to do that.   I do not know the name of the patient, since I had to leave work abruptly.  Vaccines that are safe enough for babies, should be safe enough for the nurses administering them.
Age: 0.0
Sex: U
Vaccine: RV5
Symptoms: Paraesthesia
Clinical narrative: At 3:30 pm, I (a registered nurse) was administering the Rotateq vaccine to an infant. After delivering half of it slowly, I paused and the baby sneezed, thereby spraying much of it into both of my eyes, with slightly more into the right eye. I immediately rinsed my eyes in the sink, but started having a tingling sensation, which progressed within a minute or two into a ground glass like pain. Then I began to cough uncontrollably, which lasted for hours, until I lost my voice altogether. MY eyes became very red and my face also became very red. I felt generally unwell. Due to the significant pain in my eyes, I was advised by one of our pediatricians to go immediately to Urgent Care, where my eyes were irrigated with two liters of saline. I was given Patanol and sent to another MD the next day. The Merck company was of little help, including the Merck pediatrician. I spent 4 hours at Occupational medicine and was told my eyes would improve gradually and that the chemicals in the vaccine were irritants to my eyes. My eyes improved slightly, but 6 days later I am still having an uncomfortable itching sensation. I was told to wear goggles and a face shield from now on with that vaccine. I believe everyone should have to do that.   I do not know the name of the patient, since I had to leave work abruptly.  Vaccines that are safe enough for babies, should be safe enough for the nurses administering them.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: 11:30 am 11/17/06 pt reported pain at left deltoid shooting down left arm, no redness, swelling, induration noted. No resp distress observed. 11:40 am left message Dr office stated will give message to Dr when he calls 12:30 pm 11/20/06 spoke to pt by phone arm feels much better and every day getting better. Has been applying ice to arm per Drs instruction, states he called her on Friday.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives break out on Fri, Monday 24 hours later.
Age: 1.28
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Fever to 104.7 fever started D7 after vaccine. Lasting at least 3 days.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt claims nurse administered vaccine on triceps not deltoid initially there was some redness and swelling at injection site. Numbness, pain, weakness which extended from shoulder to fingers which continued until 2nd week in Nov. Had appointment with neurologist on 17 but further testing cancelled since pt had recovered. Had doctor visit today.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Medication error, Pain
Clinical narrative: Pt claims nurse administered vaccine on triceps not deltoid initially there was some redness and swelling at injection site. Numbness, pain, weakness which extended from shoulder to fingers which continued until 2nd week in Nov. Had appointment with neurologist on 17 but further testing cancelled since pt had recovered. Had doctor visit today.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Unintended pregnancy, Vision blurred
Clinical narrative: Pt c/o blurring vision shortly after vaccination (30 minutes). Pt is 8 months pregnant also. Symptoms resolved on its own with no further problems.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 2 days post Flu vaccination, redness at site, swelling, warmth and painful to touch.
Age: 1.56
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Viral infection
Clinical narrative: Breakthrough varicella diagnosed per office visit 11/20/06, Varivax given 10/05/2006.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Thermal burn
Clinical narrative: Pts arm was burning which started immediately with needle. Several hours later she started having HAs and dizziness (ran into a wall at home) seen in ER and told symptoms were mostly likely due to adverse reaction to flu vaccine, took Benadryl helped a little.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Rash, Viral infection
Clinical narrative: Patient had rash and headache.  Doctor diagnosis was Varicella.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Wrong drug administered
Clinical narrative: LPN giving 6 month immunization noted that pneumococcal entry of 9-25-06 was a  manufacturer mentioned vaccine rather than other manufacturer mentioned.  Patient received Pneumovax rather than Prevnar.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Condition aggravated, Diabetic coma, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: A report was received from a health care professional via another company (E200605554) on 11/8/06 concerning a 59 year old female vaccinee. The vaccinee has a medical history of diabetes. On 10/11/2006 the vaccinee received Fluvirin and Pneumovax vaccination in separate arms. The vaccinee then developed an injection site reaction in the arm where the pneumovax was administered, that ranged from redness, blotchiness and pain. Medical attention was sought. It was also reported that the vaccinee had a problem with her blood sugar, that was described as went into a diabetic coma, but came right out. The vaccinee did not visit the hospital. The vaccinee is reported to be still experiencing symptoms. The diabetic coma was considered by the reporter to be an important medical event (OMIC).
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Rash macular
Clinical narrative: A report was received from a health care professional via another company (E200605554) on 11/8/06 concerning a 59 year old female vaccinee. The vaccinee has a medical history of diabetes. On 10/11/2006 the vaccinee received Fluvirin and Pneumovax vaccination in separate arms. The vaccinee then developed an injection site reaction in the arm where the pneumovax was administered, that ranged from redness, blotchiness and pain. Medical attention was sought. It was also reported that the vaccinee had a problem with her blood sugar, that was described as went into a diabetic coma, but came right out. The vaccinee did not visit the hospital. The vaccinee is reported to be still experiencing symptoms. The diabetic coma was considered by the reporter to be an important medical event (OMIC).
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Blood glucose increased, Condition aggravated, Diabetic coma, Injection site erythema, Injection site pain
Clinical narrative: A report was received from a health care professional via another company (E200605554) on 11/8/06 concerning a 59 year old female vaccinee. The vaccinee has a medical history of diabetes. On 10/11/2006 the vaccinee received Fluvirin and Pneumovax vaccination in separate arms. The vaccinee then developed an injection site reaction in the arm where the pneumovax was administered, that ranged from redness, blotchiness and pain. Medical attention was sought. It was also reported that the vaccinee had a problem with her blood sugar, that was described as went into a diabetic coma, but came right out. The vaccinee did not visit the hospital. The vaccinee is reported to be still experiencing symptoms. The diabetic coma was considered by the reporter to be an important medical event (OMIC).
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site reaction, Rash macular
Clinical narrative: A report was received from a health care professional via another company (E200605554) on 11/8/06 concerning a 59 year old female vaccinee. The vaccinee has a medical history of diabetes. On 10/11/2006 the vaccinee received Fluvirin and Pneumovax vaccination in separate arms. The vaccinee then developed an injection site reaction in the arm where the pneumovax was administered, that ranged from redness, blotchiness and pain. Medical attention was sought. It was also reported that the vaccinee had a problem with her blood sugar, that was described as went into a diabetic coma, but came right out. The vaccinee did not visit the hospital. The vaccinee is reported to be still experiencing symptoms. The diabetic coma was considered by the reporter to be an important medical event (OMIC).
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Arthritis, Hyperhidrosis, Lymphadenopathy, Nausea
Clinical narrative: Patient reports within 10 minutes after receiving vaccine-felt glands in neck felt huge and later "joints ached and felt like hot burning needles in them" "Joints felt like on pins and needles".  Then night of 10/26/2006 had fever with nausea.  Reported had "huge sweat during night and woke up in am feeling better.  10/27/06 1445 at time of report patient reported feeling fine.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient reports within 10 minutes after receiving vaccine-felt glands in neck felt huge and later "joints ached and felt like hot burning needles in them" "Joints felt like on pins and needles".  Then night of 10/26/2006 had fever with nausea.  Reported had "huge sweat during night and woke up in am feeling better.  10/27/06 1445 at time of report patient reported feeling fine.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Patient reports within 10 minutes after receiving vaccine-felt glands in neck felt huge and later "joints ached and felt like hot burning needles in them" "Joints felt like on pins and needles".  Then night of 10/26/2006 had fever with nausea.  Reported had "huge sweat during night and woke up in am feeling better.  10/27/06 1445 at time of report patient reported feeling fine.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Apnoea, Cyanosis, Gastrooesophageal reflux disease, Vaccination complication
Clinical narrative: Apneic episode with cyanosis approx 78 sec. MR received from PCP. PMH: 2 well child exams from 2 and 4 months with only c/o gassiness/possible colic, otherwise healthy. OV on 11/17/2006 which led to above admission for observation after apneic spell. Assessment- Apnea/cyanotic spell. Hospital MR received which revealed infant transported to ER after mother witnessed an ~ 35 second episode of apnea with cyanosis 3 days after 4 month immunizations. No report of any seizure activity PMH: significant only for mild reflux.  Clinical exam WNL without any further episodes. Assessment:  Apneic spell x 1.  Differential:  possible gastroesophageal reflux disease vs. adverse event 2' to recent immunizations.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pyrexia, Throat tightness
Clinical narrative: Patient developed redness at injection site and down left side of abdomen laterally, kept getting hot after intervals, fever later in evening around 5:30 pm developed tightness in throat.  Left arm aching/swollen- went to ER was given ? BENADRYL pill and prescription for antibiotic pills for 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Right arm, deltoid area, swelling with a little redness.
Age: 4.0
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: Patient accidentally given adult Td in right arm IM.  Patient with no adverse reactions currently.  Patient had last DTAP on 5/31/2002.
Age: 51.0
Sex: M
Vaccine: RAB
Symptoms: Skin nodule
Clinical narrative: Donor reported lump under his left arm, reported that he found it the day after his second rabies injection.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Eyelid oedema
Clinical narrative: Donor reported swelling of eyelids the morning after first rabies injection on 11/15/06, reports that eyelids have been swollen since and were most swollen on Friday 11/17/06.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block complete, Bronchoscopy normal, Dyspnoea, Fatigue, Hypersensitivity
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Irritable bowel syndrome, Lactose intolerance, Pneumonia, Pyrexia
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block, Cardiac failure, Fatigue, Heart rate decreased, Myocarditis
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Pneumonia, Rash
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block, Cardiac failure, Cough, Dyspnoea, Fatigue
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Heart rate decreased, Hypoxia, Myocarditis, Pneumonia, Rash
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block complete, Bronchoscopy normal, Dyspnoea, Fatigue, Hypersensitivity
Clinical narrative: This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Irritable bowel syndrome, Lactose intolerance, Pneumonia, Pyrexia
Clinical narrative: This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block, Cardiac failure, Fatigue, Heart rate decreased, Myocarditis
Clinical narrative: This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Pneumonia, Rash
Clinical narrative: This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block, Cardiac failure, Cough, Dyspnoea, Fatigue
Clinical narrative: This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Heart rate decreased, Hypoxia, Myocarditis, Pneumonia, Rash
Clinical narrative: This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block complete, Bronchoscopy normal, Dyspnoea, Fatigue, Hypersensitivity
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.