chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female with a penicillin allergy and latex allergy who on 03-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL. Concomitant therapy included Concerta. Later that evening, on 03-JAN-2007, the patient developed nausea and vomited once. At approximately 07:00 am on 04-JAN-2007, the patient developed a headache and temporal blindness that lasted approximately 40 seconds. The patient was taken to the emergency room. At 10:03 am, the patient had a second incidence of headache and temporal blindness that also lasted approximately 40 seconds. At the time of this reported, the patient was stable but was to be admitted to the hospital for observation. At the time of this report, the outcome was unknown. Additional information has been requested. 01/22/07-records received and reviewed from Medical Center for DOS 01/0407-transferred with DX of new onset seizures to another Hospital. Records requested. CT brain without contrast: negative exam, recommend MRI.  01/30/07-rcords received for DOS 01/04-01/05/07 DC DX: 1. Vasovagal response secondary to dehydration 2. Syncope secondary to #1. Hospital Course: Transferred from Med Ctr. Admitted with vomiting decreased oral intake since yesterday, complained of blindness and severe headaches this morning with fever of 101.4. Experienced 35-45 second of complaining of blindness, loss of consciousness and staring episode at Med Ctr.  PMH: Status post Kawasaki disease two weeks after developing chicken pox, attention deficit/hyperactivity disorder.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Viral infection
Clinical narrative: Information has been received from a physician and health professional concerning a 13 week old male, with no medical history and no allergies, who on 29-NOV-2006 was vaccinated with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). Concomitant vaccines administered on the same day included Ipol, Comvax, Prevnar and DTaP. The patient developed diarrhea on an unknown date and was seen in the emergency room. The patient was not hospitalized. At 3 months of age, on 03-JAN-2007, the patient tested positive for rotavirus. The reporter was not sure which rotavirus test was performed. The reporter did not have any additional information at the time of the report. The patient's rotavirus was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive
Clinical narrative: Information has been received from a physician and health professional concerning a 13 week old male, with no medical history and no allergies, who on 29-NOV-2006 was vaccinated with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). Concomitant vaccines administered on the same day included Ipol, Comvax, Prevnar and DTaP. The patient developed diarrhea on an unknown date and was seen in the emergency room. The patient was not hospitalized. At 3 months of age, on 03-JAN-2007, the patient tested positive for rotavirus. The reporter was not sure which rotavirus test was performed. The reporter did not have any additional information at the time of the report. The patient's rotavirus was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Deafness, Deafness unilateral, Labyrinthitis, Vestibular disorder, Viral labyrinthitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hearing loss in a male subject aged between 40 and 49 years old who was vaccinated with Fluarix for prophylaxis. The subject's medical history included thyroidectomy. Concurrent medications included Synthroid and Aspirin. The subject had on adverse events following receipt of prior immunizations of influenza virus vaccine. On 18 October 2006 the subject received unspecified dose of Fluarix in the left arm. On 25 November 2006, 38 days after vaccination with Fluarix, the subject experienced hearing loss in the right ear. On 30 November 2006, the subject was seen by a physician. An audiogram was performed on 30 November 2006 and revealed vestibular labyrinthitis. The reporter stated that the vestibular labyrinthitis was probably viral. The subject was treated with steroid and anti viral medication (Antiviral). At the time of a follow up appointment with a physician on 13 December 2006, the events had improved. The healthcare professional considered the events to possibly be related to vaccination with Fluarix. Comment: hearing loss was assessed as medically serious by manufacturer.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Varicella
Clinical narrative: Had chicken pox. Per follow up: Broke out with chicken pox type lesion 1 wk prior to shot.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Facial palsy, Facial paresis, Fatigue, Muscle tightness, Muscle twitching
Clinical narrative: Developed fever and fatigue 24 hrs after vaccination. Developed facial weakness, tightness, and twitching. Bells Palsy. 01/23/07 records received and reviewed. 12/19/06-Day after vaccination developed fever and fatigue and malaise. Seen in Er received IV fluids. Couple days later developed right facial weakness, tightness and twitching. right eye facial paralysis right side. Pressure in right eye. Asymmetry of right upper and lower lips with smiling.  Neuro consult 12/20/06. Impression: Bell's Palsy. Sickle cell disease. Anemia. Could be related to the vaccination or incidental finding.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal, Pyrexia
Clinical narrative: Developed fever and fatigue 24 hrs after vaccination. Developed facial weakness, tightness, and twitching. Bells Palsy. 01/23/07 records received and reviewed. 12/19/06-Day after vaccination developed fever and fatigue and malaise. Seen in Er received IV fluids. Couple days later developed right facial weakness, tightness and twitching. right eye facial paralysis right side. Pressure in right eye. Asymmetry of right upper and lower lips with smiling.  Neuro consult 12/20/06. Impression: Bell's Palsy. Sickle cell disease. Anemia. Could be related to the vaccination or incidental finding.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Patient began with rash four to five days ago and continues to become more prominent and patient has all over entire body.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Right arm muscle, shot given. Mild at first. It settled in the muscle on the underside of the arm. Became very painful. Especially 1st thing in am. Went to doctor 12-13-06. Prescribed Ibuprofen 800 mg, didn't help. Prescribed Sanindoc 200 mg, did not help December 22 December 28 Methocarban 500 mg no help and then Hydrocol Apap 5 500 mg. On 1/2/07 went to orthopedic physician. X-rays showed nothing. Gave me a cortisone shot. It worked and pain went away. Will see him again 1/30/07. He could not tell me if the flu shot was to blame. I called the above service and asked what was in my shot. Have not heard back still would like to know. Do I get another shot next fall?
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Erythema, Inflammation, Injection site bruising, Injection site discolouration
Clinical narrative: No fever, Right thigh red inflammation. Darker in color where shot was given, bruise in area. (W) 7in x (L) 6in. Consulted with doctor. Benadryl 12.5 mg 15ml tsp by mouth every six hours.  Follow-up - vaccine manufacturer provided.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Injection site on Left leg red. Redness is 4 cm x 3cm with a 1cm induration.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Herpes zoster
Clinical narrative: Had a cold the day I received my Flu and Pneumonia shots but, generally I was in good condition. Next day 10/26/2006 I developed the shingles and had to go immediate Care and my primary physician out on Valtrex 21 pills and Triaminolone. No blisters at this time 1/2/2007. Can you get the shingles again?
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Patient developed 6x6.5 cm area of redness around injection site, left arm.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Four days following the Gardasil vaccine, the patient developed a rash all over her body that was itchy and skin colored. It seemed to be worse on the arm of injections site. The patient received an antihistamine and cortisone creme.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash papular
Clinical narrative: generalized macular papular rash body and face. Benadryl 11/2 tsp by mouth every 10 hours for 5 days.
Age: 1.02
Sex: F
Vaccine: FLU3, HBHEPB, HEPA, MMRV
Symptoms: Convulsion, Full blood count normal, Pyrexia
Clinical narrative: Child reportedly had low grade fevers day after vaccines and received ibuprofen. About 48 hours after vaccines fever spiked to 105 and child had seizure lasting about 2 minutes, post-ictal about 15 minutes. Transported by ambulance to emergency department. MR received from hospital visit of 01/07/2007 for c/o febrile seizure 2 days post vax. HPI: Child began running fever day of vax.  Parents using Motrin but underdosing for weight.  Day of seizure child went limp and then began jerking and this lasted about a minute.  In ER temp was 105.1'F.  Dropped to 102.5F with Tylenol and Motrin. She was D/Cd home from ER on Tylenol and Motrin for fever control. Discharge DX: Febrile Seizure.
Age: 25.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Dizziness, Mouth haemorrhage, Oral pain, Pain
Clinical narrative: Patient received Hep A, Hep B in left arm, flu in right arm. She stated in phone call to me she had increase pain in right arm, mouth soreness, mouth bleeding when brushing teeth that night and AM. She states a slight dizzy spell upon rising Sunday morning that lasted a few minutes.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Chills, Pain, Pyrexia
Clinical narrative: One hour after shot ached all over, chills, fever 103. Saw medical doctor next day 12/15 blood work ordered and prednisone ordered for 5 days. No reaction at injection site. Experiencing chest pain and back pain. Tylenol as needed to decrease pain. Saturday 12/16 face broke out in rash. Medical doctor contacted 12/17 continue prednisone call if problems persist.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Employee complained of pain, numbness in left arm within days of getting flu vaccine. Has been treated with physical therapy, anti inflammatories. Has orthopedic referral pending.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site pain, Tenderness
Clinical narrative: 1/8/7 rcv'd vaccine; by 1/9 had pain @ site, by 1/10 site was fire red w/"50 cent"-size knot that was movable. Pt treated herself w/warm compresses.  The knot was decreasing by 1/13 and today 1/16 the knot is dime size but still tender to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pyrexia, Vomiting
Clinical narrative: Approx. 16 hrs. post injections, he experienced vomiting, fever and redness and swelling at the injection site.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Client had pain, redness, warmth, whelps, swelling, and itching at the injection site.  Client had a headache and weakness in both legs.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Client had pain, redness, warmth, whelps, swelling, and itching at the injection site.  Client had a headache and weakness in both legs.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Contusion, Injection site oedema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: Patient had swelling like a softball in her left arm injection area and a fever. We were told to put ice on it and give her motrin and/or tylenol for pain and swelling.  I thought it  was common so at the time I was not too worried.  A few days later it went away.  She then had reoccuring swelling with pain and fever and brusing that sent us to the doctor again.  We came home and were told that it was alright. Once again she got better.  One evening about a week later the softball swelling and pain reappeared with the fever, and the bruising also. I took her back to the doctor and they gave her an xray.  It came back alright and at that time they told me that she probably had two injections given too close together and it formed a blood pocket.  It went down and now 3 months later a fever has reappeared and she has pain and swelling as well as itching and the two injections sights are red and blistery looking. I am very concerned and need to report this so I can find out what is going on with my daughter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient had swelling like a softball in her left arm injection area and a fever. We were told to put ice on it and give her motrin and/or tylenol for pain and swelling.  I thought it  was common so at the time I was not too worried.  A few days later it went away.  She then had reoccuring swelling with pain and fever and brusing that sent us to the doctor again.  We came home and were told that it was alright. Once again she got better.  One evening about a week later the softball swelling and pain reappeared with the fever, and the bruising also. I took her back to the doctor and they gave her an xray.  It came back alright and at that time they told me that she probably had two injections given too close together and it formed a blood pocket.  It went down and now 3 months later a fever has reappeared and she has pain and swelling as well as itching and the two injections sights are red and blistery looking. I am very concerned and need to report this so I can find out what is going on with my daughter.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Lip oedema, Oedema peripheral
Clinical narrative: Developed swelling of hands, face and lips 2-3 hrs. after receiving second dose of hepatitis B vaccine.  Seen by personal physician who adminstered IM Benadryl with resolution of problem +/- 8 hrs after treatment
Age: 47.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Malaise, Pyrexia, Somnolence, Urticaria
Clinical narrative: Approximately 24 hours after vaccination patient states she had a low grade fever, hives, a film in her mouth, malaise, dizziness upon standing, and she felt bad for 2-3 days after administration of vaccine.  She also stated she slept most of the time.  No treatment was sought out by the patient.  She did however call her physician who referred her to us.
Age: 47.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness postural, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Approximately 24 hours after vaccination patient states she had a low grade fever, hives, a film in her mouth, malaise, dizziness upon standing, and she felt bad for 2-3 days after administration of vaccine.  She also stated she slept most of the time.  No treatment was sought out by the patient.  She did however call her physician who referred her to us.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Dizziness, Myalgia, Pulmonary congestion, Pyrexia
Clinical narrative: With 48 hours of vaccine administration had severe reaction to vaccine, fever of 104+, dizziness, headache, muscle aches, cough, and chest congestion. Unable to attend work on Friday 12/15/2006 which was the next day scheduled to work.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Reaction to preservatives
Clinical narrative: With 48 hours of vaccine administration had severe reaction to vaccine, fever of 104+, dizziness, headache, muscle aches, cough, and chest congestion. Unable to attend work on Friday 12/15/2006 which was the next day scheduled to work.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Purpura, Rash, Rash erythematous
Clinical narrative: 47 YO developed erythematous, pruritic rash on eyelids and face after receiving flu vaccine on 11/21/06.  He had received flu vaccination previously without complications or reaction.  The rash was treated with PO diphenhydramine.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Painful, aching left arm persisting for 2 months post immunization
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Painful, aching left arm persisting for 2 months post immunization
Age: 1.14
Sex: F
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient received vaccines on 12/27/2006. On 12/29/2006, patient reportedly experienced a simple febrile seizure at home with fever 105.2 rectal documented. Patient defervesced with acetaminophen and ibuprofen. No subsequent seizures were reported on follow-up visit on 1/8/2007 at which time patient was seen for cough/otitis media. 01/25/07-records received and reviewed for DOS 12/29/06- DC DX: Febrile illness, upper respiratory infection, Viral Syndrome HX: Seen at office with temperature of 105 and had seizure, lasted 30 seconds. Acted normal afterwards. Runny nose and slight cough. IN ER temperature 100.  PE: WNL, positive for rhinorrhea. Impression:uncomplicated febrile seizure, source for the fever is upper respiratory type symptoms.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Anorexia, Asthenia, Diarrhoea, Hepatic enzyme abnormal, Liver function test abnormal
Clinical narrative: Near syncope in shower, weakness, fever 101, malaise, anorexia, loose stool X 1
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Malaise, Pyrexia, Syncope
Clinical narrative: Near syncope in shower, weakness, fever 101, malaise, anorexia, loose stool X 1
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Computerised tomogram, Decreased appetite, Dehydration
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Faeces discoloured, Intestinal obstruction, Intussusception, Lethargy, Pain
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Vomiting
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abnormal faeces, Appendicectomy, Computerised tomogram
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Decreased appetite, Diverticular hernia, Full blood count, High-pitched crying, Intestinal obstruction
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Intussusception, Laparotomy, Lethargy, Pain, Small intestinal obstruction
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 0.42
Sex: F
Vaccine: RV5, RV5
Symptoms: Volvulus, Vomiting, White blood cell count increased, X-ray
Clinical narrative: Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Five minutes after receiving vaccine was at pharmacy when had chest pain, like pinching on chest and was a bit out of breath. Went back to doctor's office and was given a Nexium - although patient comments that it was not acid reflux and lay down for 20 minutes. Felt better after 1 hour over the weekend pinching will come back every once in a while. Recovered by Monday.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain
Clinical narrative: Five minutes after receiving vaccine was at pharmacy when had chest pain, like pinching on chest and was a bit out of breath. Went back to doctor's office and was given a Nexium - although patient comments that it was not acid reflux and lay down for 20 minutes. Felt better after 1 hour over the weekend pinching will come back every once in a while. Recovered by Monday.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site warmth, Tenderness
Clinical narrative: Woke approximately 36 hours following injection with warm, red area on Left deltoid. Afebrile. No systemic symptoms. No pruritis. Tender to palpation. Area 10x8 cm on exam.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Erythema, Tenderness
Clinical narrative: 24 hours after injection complained of mild tenderness, mother noticed small bruise. Woke next day (approx 36 hours post injection) with her red area 9x7cm distal to injection site by about 1cm. No systemic symptoms. Tender to palpation.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site warmth, Pain, Swelling
Clinical narrative: Severe swelling, warmth, pain and induration of left arm to below elbow-treated with prednisone/benadryl
Sex: M
Vaccine: HEP
Symptoms: Chest discomfort, Syncope, Wheezing
Clinical narrative: 1. Syncopal episode with chest tightness and wheeze. Epinephrine 0.3 mg, Albuterol Nebulizer 0.5 mg
Age: 69.0
Sex: M
Vaccine: TYP
Symptoms: Tremor
Clinical narrative: Wife called stated that they took the train into the city after leaving clinic, had lunch. Started "shaking" denies any SOB, difficulty breathing or swallowing at present. Assured wife instructed  on was of Benadryl and to activate 911 if any increase signs and symptoms or difficulty breathing.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthralgia, Asthenia, Dizziness, Muscle spasms
Clinical narrative: Leg cramps, and muscles, anxiety, dizziness, sleep disturbance, weakness, pain joints, decrease sexual ability, skin rash.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Sexual dysfunction, Sleep disorder
Clinical narrative: Leg cramps, and muscles, anxiety, dizziness, sleep disturbance, weakness, pain joints, decrease sexual ability, skin rash.
Age: 1.34
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: 01/05/2007 3:30 - complain of reaction to vaccine given on Wednesday 01/03/2007 x 3" noted 9 1/2 cm red circular area on left anterior thigh. Also noted inner circle of 3 cm, red rash. Mom states "Baby has increase temperature - 99 - 100". Cold compress was applied as advised. 01/05/2007 Advised to take baby to see MD.
Age: 69.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Erythema, Pain, Swelling
Clinical narrative: Tetanus shot 10-13-06, swelling, redness, severe pain for 2 weeks after. Applied hot and cold compresses and took Ibuprofen. Redness and swelling gave but pain still persists. There is also a loss of strength in my shoulder and arm. I saw MD on 12-15-06. He didn't offer any remedies.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient has shingles on the left lower extremity from the mild post buttocks down to the knee.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: Patient has shingles on the left lower extremity from the mild post buttocks down to the knee.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient has shingles on the left lower extremity from the mid post sacral area to the bottom of his feet.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia
Clinical narrative: Joint pain-poor recovery from shoulder surgery (accident after)
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypoaesthesia, Joint stiffness, Joint swelling
Clinical narrative: Migrating pain, stiffness and swelling of joints. Began in bilateral toes and Left knee; 24 hours later it was gone, but appeared in Right knee. Again that was gone 24 hours later, but then affected bilateral hands and fingers, Right more than Left, lasting at least 4 weeks. Ibuprofen as needed. Intermittent numbness hands and fingers too.
Age: 13.0
Sex: M
Vaccine: HEP, TD
Symptoms: Anaphylactic reaction, Headache, Influenza, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 13 year old male subject who was vaccinated with Engerix B for prophylaxis. The subject has no significant medical history or concurrent conditions. Concurrent vaccination given the same date as Engerix B, On August 2003, included Decavac. On 05 August 2003 the subject received 1st dose of Engerix B (lot number ENG2355A2 with expiration 21 February 2004) At 10 mcg, intramuscular, to the right arm. Approximately 8 to 9 hours after vaccination with Engerix B, the subject experienced vomiting, headache, fever and pain. The events resolved. No additional details were provided. Follow up received on 24 July 2006 from the healthcare professional indicated that the patient experienced an anaphylactic reaction. The events resolved within three days on 08 August 2003. The reporter also indicated that the events could have been associated with the possibility of the patient having the flu but this was unknown. She considered that the events were related to the use of Engerix B.
Age: 13.0
Sex: M
Vaccine: HEP, TD
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 13 year old male subject who was vaccinated with Engerix B for prophylaxis. The subject has no significant medical history or concurrent conditions. Concurrent vaccination given the same date as Engerix B, On August 2003, included Decavac. On 05 August 2003 the subject received 1st dose of Engerix B (lot number ENG2355A2 with expiration 21 February 2004) At 10 mcg, intramuscular, to the right arm. Approximately 8 to 9 hours after vaccination with Engerix B, the subject experienced vomiting, headache, fever and pain. The events resolved. No additional details were provided. Follow up received on 24 July 2006 from the healthcare professional indicated that the patient experienced an anaphylactic reaction. The events resolved within three days on 08 August 2003. The reporter also indicated that the events could have been associated with the possibility of the patient having the flu but this was unknown. She considered that the events were related to the use of Engerix B.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Arteriosclerosis, Cardiac arrest, Coronary artery disease, Dyspnoea, Hyperhidrosis
Clinical narrative: This case was reported by a regulatory authority and described the occurrence of fatal asystole in a 36-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B). The subject's medical history included hypertension, obesity and a body mass index of 61. On an unspecified date before 31 January 2006, the subject received a 2nd dose of Engerix-B (lot# AHBVB171AA). Approximately 15 minutes following the 2nd dose of Engerix-B, while riding in a care with his father, the subject experienced dyspnea, diaphoresis, and syncope. The subject's father took him immediately to a hospital. At the hospital, the subject was found to be systolic. Advanced cardiac life support was unsuccessful. The subject expired approximately 40 minutes following the 2nd dose of Engerix-B. The medical examiner concluded that the cause of death was coronary artery disease, atherosclerosis, arteriosclerosis, and hypertensive cardiovascular disease. Per follow up information received on 31 January 2006, the medical examiner's staff looked for evidence of an allergic reaction, but found none. "They are thoroughly convinced that the death was due to the underlying cardiac problems". The autopsy report had not been forwarded to the manufacturer as of 31 January 2006.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Hypertensive heart disease, Life support, Syncope
Clinical narrative: This case was reported by a regulatory authority and described the occurrence of fatal asystole in a 36-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B). The subject's medical history included hypertension, obesity and a body mass index of 61. On an unspecified date before 31 January 2006, the subject received a 2nd dose of Engerix-B (lot# AHBVB171AA). Approximately 15 minutes following the 2nd dose of Engerix-B, while riding in a care with his father, the subject experienced dyspnea, diaphoresis, and syncope. The subject's father took him immediately to a hospital. At the hospital, the subject was found to be systolic. Advanced cardiac life support was unsuccessful. The subject expired approximately 40 minutes following the 2nd dose of Engerix-B. The medical examiner concluded that the cause of death was coronary artery disease, atherosclerosis, arteriosclerosis, and hypertensive cardiovascular disease. Per follow up information received on 31 January 2006, the medical examiner's staff looked for evidence of an allergic reaction, but found none. "They are thoroughly convinced that the death was due to the underlying cardiac problems". The autopsy report had not been forwarded to the manufacturer as of 31 January 2006.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Bedridden, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of lightheadness in a 52 year old female subject who was vaccinated with Engerix B for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes, high cholesterol and low thyroid (hypothyroid). Concurrent medications included Avandamet, Lipitor and Levoxyl. The subject reported that she had no adverse events following previous vaccinations. On 18 April 2006 and 22 May 2006, the subject received the 1st and 2nd dose of Engerix B (unknown), respectively. On 18 April 2006, after an unspecified time after vaccination with Engerix B, she experienced lightheadedness and headache which resolved after one day. On 22 May 2006, within one hour of receiving the second dose of Engerix B, she experienced lightheadedness and headache. She treated the headache with Excedrin Migraine. She then began to feel agitated and went back to the office that had administered the vaccine. Her blood pressure was checked and was found to be normal. By one o'clock that afternoon, she left work and went home with a fever of 100.4 degrees F. She treated the fever with Motrin. The fever went down as long as she took the Motrin. She also experienced body aches that were so severe that she was bedridden. She took unspecified muscle relaxers, Benadryl, and Motrin to treat these events. After four days, the fever was gone. The body aches have improved. She has developed fatigue and sensitivity to light. The fatigue was ongoing and had not improved at the time of reporting. For an unspecified time, she had to work in her office in the dark due to the sensitivity to light. The sensitivity to light had improved. She consulted her primary physician regarding these events. At that time, on 16 June 2006, her thyroid stimulating hormone level was found to be high. No other test were performed regarding these events.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Photophobia, Pyrexia, Sensation of pressure, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of lightheadness in a 52 year old female subject who was vaccinated with Engerix B for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes, high cholesterol and low thyroid (hypothyroid). Concurrent medications included Avandamet, Lipitor and Levoxyl. The subject reported that she had no adverse events following previous vaccinations. On 18 April 2006 and 22 May 2006, the subject received the 1st and 2nd dose of Engerix B (unknown), respectively. On 18 April 2006, after an unspecified time after vaccination with Engerix B, she experienced lightheadedness and headache which resolved after one day. On 22 May 2006, within one hour of receiving the second dose of Engerix B, she experienced lightheadedness and headache. She treated the headache with Excedrin Migraine. She then began to feel agitated and went back to the office that had administered the vaccine. Her blood pressure was checked and was found to be normal. By one o'clock that afternoon, she left work and went home with a fever of 100.4 degrees F. She treated the fever with Motrin. The fever went down as long as she took the Motrin. She also experienced body aches that were so severe that she was bedridden. She took unspecified muscle relaxers, Benadryl, and Motrin to treat these events. After four days, the fever was gone. The body aches have improved. She has developed fatigue and sensitivity to light. The fatigue was ongoing and had not improved at the time of reporting. For an unspecified time, she had to work in her office in the dark due to the sensitivity to light. The sensitivity to light had improved. She consulted her primary physician regarding these events. At that time, on 16 June 2006, her thyroid stimulating hormone level was found to be high. No other test were performed regarding these events.
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Chills, Tremor
Clinical narrative: A 65 year old male patient had received an intramuscular, left arm, third dose injection of Typhim VI, lot number Z0042-2, on 08/Jun/2006. Eighteen hours post vaccination, the patient experienced severe, body shaking chills that lasted for eight to ten hours. This was followed by profound weakness lasting three days. The patient had a history of coronary artery disease, hypertension, allergy to erythromycin and major trauma resulting in cardiac arrest. Other medications included zyloprin, Cardizem and seldane. At the time of this report, the patient had recovered.
Age: 51.0
Sex: M
Vaccine: HEPA, IPV, TYP, HEPA, IPV, TYP, HEPA, OPV, TYP
Symptoms: Drug hypersensitivity, Erythema, Rash pruritic
Clinical narrative: Initial report received on 28 Aug 2006 and 12 Sep 2006 from a nurse. A 51 year old male patient with no current illnesses who was taking HCTZ and Lisinopril had received a first subcutaneous dose of Ipol, lot number Y0638-2, in the right arm, a second intramuscular dose of Typhim VI, lot number Z0276-2 in the right deltoid, and a second intramuscular dose of Havrix, lot AHABV093AA, in the left deltoid on 23 Feb 2006. Approximately one week later, on 02/Mar/2006, the patient developed an itchy red rash on both of his underarms, chest, back, wrists, behind the left knee, and slightly on the right calf. The patient was evaluated by his primary care physician, a dermatologist, and an allergist. He was treated as if he had scabies by scrapings of the rash, but the scrapings were negative for scabies. Allergy testing was performed, and the patient had a positive reaction to Neomycin and was unaware of his allergy to this prior to the vaccinations on 23 Feb 2006. The physician thought the allergic reaction to Neomycin could be related to either the IPOL or Havrix vaccine since both use neomycin in the processing of the vaccine. The rash was continuing at the time of this report. The recovery status of the patient was reported as not recovered.
Age: 51.0
Sex: M
Vaccine: HEPA, IPV, TYP, HEPA, IPV, TYP, HEPA, OPV, TYP
Symptoms: Rash
Clinical narrative: Initial report received on 28 Aug 2006 and 12 Sep 2006 from a nurse. A 51 year old male patient with no current illnesses who was taking HCTZ and Lisinopril had received a first subcutaneous dose of Ipol, lot number Y0638-2, in the right arm, a second intramuscular dose of Typhim VI, lot number Z0276-2 in the right deltoid, and a second intramuscular dose of Havrix, lot AHABV093AA, in the left deltoid on 23 Feb 2006. Approximately one week later, on 02/Mar/2006, the patient developed an itchy red rash on both of his underarms, chest, back, wrists, behind the left knee, and slightly on the right calf. The patient was evaluated by his primary care physician, a dermatologist, and an allergist. He was treated as if he had scabies by scrapings of the rash, but the scrapings were negative for scabies. Allergy testing was performed, and the patient had a positive reaction to Neomycin and was unaware of his allergy to this prior to the vaccinations on 23 Feb 2006. The physician thought the allergic reaction to Neomycin could be related to either the IPOL or Havrix vaccine since both use neomycin in the processing of the vaccine. The rash was continuing at the time of this report. The recovery status of the patient was reported as not recovered.
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: This case was reported by a consumer and described the occurrence of seizure in a 7-day-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. A physician or other health care professional has not verified this report. On 16 September 2006 the subject received 1st dose of Engerix-B (unknown). On 20 September 2006, 4 days after vaccination with Engerix-B, the subject experienced seizure. The subject was hospitalized. At the time of reporting the outcome of the event was unspecified. Further information was not reported.
Age: 1.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Red, macular, papular rash over head, face, truck, upper arms. Noticed on 1-15 (24 days after receiving MMR vaccine). Per follow-up: Not life threatening illness per reporter. None - Pt recovered and having no symptoms.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Bedridden, Body temperature increased, Convulsion, Meningism, Pyrexia
Clinical narrative: Information has been received from a physician concerning her 12-to 15-month-old niece with a history of fever three days prior to vaccination, who in June or July 2006, was vaccinated with ProQuad (upgrade process). Two to three days after the vaccination, she developed an elevated fever of 104 degrees. She also developed seizures and meningitis-like symptoms and was hospitalized (duration and time frame not specified). At the time of the report, the patient status was not recovered. The events were considered to be disabling and the patient remains bed-ridden. It was noted that a twin brother was vaccinated with ProQuad (upgrade process) at the same time and had no problems. No additional information to report. There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pruritus
Clinical narrative: Information has been received from a physician concerning a female who was intramuscularly, vaccinated with the second dose of HPV vaccine. Subsequently the patient developed an anaphylactic reaction (swelling of the throat, itching of hands and feet). At the time of the report, it was not reported if the patient recovered. The physician determined that the patient's anaphylactic reaction (Swelling of the throat, itching of hands and feet) was considered to be immediately life threatening, disabling and an other important medical event. Additional information has been requested.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: 36-48 hours after vaccines patient with seizure. Believed secondary to pertussis.   MR received documenting an ER transfer from a local hospital for a 4 month old with possible seizure activity.  Child was feeding and suddenly had bilateral shaking of his upper/lower extremities, and his eyes became fixed for 1-2 minutes.  No cyanosis.  Episode self-resolved.  No further episodes. Child observed, treated with Zantac for probale GER. Discharge DX: Acute Shaking Episode, Possible Sandifer Syndrome.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature, Hypokinesia, Screaming, Unresponsive to stimuli
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unresponsive to stimuli in a 4 month old male subject who was vaccinated with Pediarix, plus separate injections of Prevnar and Hib vaccine (unspecified manufacturer) for prophylaxis. The subject's medical history included acid reflux. Concurrent medications included Panitidine hydrochloride (Zantac). The subject had no adverse events following receipt of prior immunizations. On 14 November 2006 the subject received 2nd dose of Pediarix, 2nd dose of Prevnar and 2nd dose of Hib vaccine. On 14 November 2006, immediately after vaccination with Hib vaccine, Pediarix and Prevnar, the subject "screamed" for about 20 minutes. After the 20 minutes, on 14 November 2006, the subject "became unresponsive to external stimuli" and experienced "lack of movements, for approximately 45 minutes. The healthcare professional reported that there was no fever and after the 45 minutes, the symptoms resolved on 14 November 2006. The healthcare professional considered the events were possibly related to vaccination with Pediarix, Prevnar and Hib vaccine. Comment: unresponsive to stimuli was assessed as medically serious by manufacturer.