chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Fatigue, Headache, Injection site inflammation, Malaise
Clinical narrative: Mother reports:  patient started feeling sick the morning after the shot. She started out with a mild headache, neck, and back pain. She originally attributed it to being tired. By 9:00 pm on 4-11-07 she was running a high fever, hurting everywhere, had back pain, and a severe headache. She left work early because she was so ill. She did not sleep well that night. Her fever was high enough that you could feel the heat rising from her from a foot away. She was delirious, saying strange things throughout the night. I gave her tylenol and kept cold rags on her head. During her high fever time she had chills and severe headache. The shot sight was approximately four inches in diameter. Patient was unable to walk without assistance because she was dizzy and lightheaded. She was in bed with someone watching her for two days. She was still very week on the third day and slept most of the time. The shot was given on 4-10-07. She missed school Thursday (4-12) and Friday (4-13). She returned today 4-16-07. She still has a headache and neck pain. She is taking tylenol every four hours so that she can function. Patient has asthma and is allergic to septra and ceclor. She also had seizures from the pertussis in DPT shots and was never able to finish the series. She is still tired and has no color in her face but continues to do what she has to because she needs to be at school due to graduation being only 24 days away. If she had been the only one to get sick we would have said she must have had something else but we know of three other students to have reactions, that is why we were concerned.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Neck pain, Pain, Pallor, Pyrexia, Sleep disorder
Clinical narrative: Mother reports:  patient started feeling sick the morning after the shot. She started out with a mild headache, neck, and back pain. She originally attributed it to being tired. By 9:00 pm on 4-11-07 she was running a high fever, hurting everywhere, had back pain, and a severe headache. She left work early because she was so ill. She did not sleep well that night. Her fever was high enough that you could feel the heat rising from her from a foot away. She was delirious, saying strange things throughout the night. I gave her tylenol and kept cold rags on her head. During her high fever time she had chills and severe headache. The shot sight was approximately four inches in diameter. Patient was unable to walk without assistance because she was dizzy and lightheaded. She was in bed with someone watching her for two days. She was still very week on the third day and slept most of the time. The shot was given on 4-10-07. She missed school Thursday (4-12) and Friday (4-13). She returned today 4-16-07. She still has a headache and neck pain. She is taking tylenol every four hours so that she can function. Patient has asthma and is allergic to septra and ceclor. She also had seizures from the pertussis in DPT shots and was never able to finish the series. She is still tired and has no color in her face but continues to do what she has to because she needs to be at school due to graduation being only 24 days away. If she had been the only one to get sick we would have said she must have had something else but we know of three other students to have reactions, that is why we were concerned.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Speech disorder
Clinical narrative: Mother reports:  patient started feeling sick the morning after the shot. She started out with a mild headache, neck, and back pain. She originally attributed it to being tired. By 9:00 pm on 4-11-07 she was running a high fever, hurting everywhere, had back pain, and a severe headache. She left work early because she was so ill. She did not sleep well that night. Her fever was high enough that you could feel the heat rising from her from a foot away. She was delirious, saying strange things throughout the night. I gave her tylenol and kept cold rags on her head. During her high fever time she had chills and severe headache. The shot sight was approximately four inches in diameter. Patient was unable to walk without assistance because she was dizzy and lightheaded. She was in bed with someone watching her for two days. She was still very week on the third day and slept most of the time. The shot was given on 4-10-07. She missed school Thursday (4-12) and Friday (4-13). She returned today 4-16-07. She still has a headache and neck pain. She is taking tylenol every four hours so that she can function. Patient has asthma and is allergic to septra and ceclor. She also had seizures from the pertussis in DPT shots and was never able to finish the series. She is still tired and has no color in her face but continues to do what she has to because she needs to be at school due to graduation being only 24 days away. If she had been the only one to get sick we would have said she must have had something else but we know of three other students to have reactions, that is why we were concerned.
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash pustular
Clinical narrative: PUSTULAR RASH WITH FIRM RED BASE ON CHEST,ABDOMEN,UPPER ARMS, NECK AND SCALP
Age: 1.2
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Apnoea, Febrile convulsion, Intubation
Clinical narrative: Patient had a prolonged febrile seizure on 4/13/2007. MMRV was administered on4/05/2007. Patient developed apnea after diazepam was administered for seizing, and was intubated for several hours. 05/15/07-records received from receiving facility for DOS 4/14-4/16/07-DC DX: Probably febrile seizure. Apnea. unstable airway. 1-2 day history of congestion no rhinorrhea or cough. On 4/13/07 became unresponsive, staring. In ER rigid with arms extended upward and eyes deviated up and to the front. Period of apnea observed times 3 and subsequently intubated. Temp 103.4. Prior febrile earlier with upper respiratory like illness. No further seizures, weaned from ventilator.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia, Malaise, Nausea, Pain in extremity
Clinical narrative: Pain and numbeness in arm for 2 days after vaccine administered.  Malaise and intermittant nausea since day of vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Developed multiple watery stools, fever to 101, and fussiness overnight (vaccines given afternoon 4/16, got ill that evening).
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: Shingles r arm, vaccine related, no prior h/o chickenpox
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Diarrhoea, Dry skin, Fatigue
Clinical narrative: Had Tdap vaccine 10 am Friday moring. Dr recommended it because of a 1/2 cut fairly deep in ankle Following the shot headach, Nausea all day. Ibprophem would not stop headach. Work all day. By 8pm  vomiting and diarrhea, chilis, body aches, tiredness. Never took temputure. Saturday the above stayed till 5pm. Missed work saturday felt so bad. Nausea and headach stayed till Sunday mid moring. Sunday had no energy to do normal day activites body achs and tiredness stayed through out day. Area where shot was given was only mildly sore. But was warm to touch and had a bug bite type raise area. Monday eyes felt dry scap on head felt sore to run hand through. Energy level was very low. Shot area Monday was warm to touch no  Slightly sore but still raised. Tuesday shot area raised and now is starting to icth. Energy level is back to normal body acks is gone.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Had Tdap vaccine 10 am Friday moring. Dr recommended it because of a 1/2 cut fairly deep in ankle Following the shot headach, Nausea all day. Ibprophem would not stop headach. Work all day. By 8pm  vomiting and diarrhea, chilis, body aches, tiredness. Never took temputure. Saturday the above stayed till 5pm. Missed work saturday felt so bad. Nausea and headach stayed till Sunday mid moring. Sunday had no energy to do normal day activites body achs and tiredness stayed through out day. Area where shot was given was only mildly sore. But was warm to touch and had a bug bite type raise area. Monday eyes felt dry scap on head felt sore to run hand through. Energy level was very low. Shot area Monday was warm to touch no  Slightly sore but still raised. Tuesday shot area raised and now is starting to icth. Energy level is back to normal body acks is gone.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain of skin, Vomiting
Clinical narrative: Had Tdap vaccine 10 am Friday moring. Dr recommended it because of a 1/2 cut fairly deep in ankle Following the shot headach, Nausea all day. Ibprophem would not stop headach. Work all day. By 8pm  vomiting and diarrhea, chilis, body aches, tiredness. Never took temputure. Saturday the above stayed till 5pm. Missed work saturday felt so bad. Nausea and headach stayed till Sunday mid moring. Sunday had no energy to do normal day activites body achs and tiredness stayed through out day. Area where shot was given was only mildly sore. But was warm to touch and had a bug bite type raise area. Monday eyes felt dry scap on head felt sore to run hand through. Energy level was very low. Shot area Monday was warm to touch no  Slightly sore but still raised. Tuesday shot area raised and now is starting to icth. Energy level is back to normal body acks is gone.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia haemolytic autoimmune
Clinical narrative: Acute onset Autoimmune hemolytic anemia requiring IV steroids and hospitalization.Records received 4/24/07-from facility for DOS 02/13-02/15/07- DC DX: warm agglutinin autoimmune hemolytic anemia. Found at routine visit to be anemic by PCP.  RX with high dose steroids. Two week HX of fatigue pallor, nauseated. 4-6 weeks prior had URI .
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia, Anaemia haemolytic autoimmune, Blood bilirubin increased, Blood immunoglobulin G, Blood lactate dehydrogenase increased
Clinical narrative: Acute onset Autoimmune hemolytic anemia requiring IV steroids and hospitalization.Records received 4/24/07-from facility for DOS 02/13-02/15/07- DC DX: warm agglutinin autoimmune hemolytic anemia. Found at routine visit to be anemic by PCP.  RX with high dose steroids. Two week HX of fatigue pallor, nauseated. 4-6 weeks prior had URI .
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Haematocrit decreased, Haemoglobin decreased, Nausea, Pallor
Clinical narrative: Acute onset Autoimmune hemolytic anemia requiring IV steroids and hospitalization.Records received 4/24/07-from facility for DOS 02/13-02/15/07- DC DX: warm agglutinin autoimmune hemolytic anemia. Found at routine visit to be anemic by PCP.  RX with high dose steroids. Two week HX of fatigue pallor, nauseated. 4-6 weeks prior had URI .
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Platelet count normal, Reticulocyte count increased, White blood cell count decreased
Clinical narrative: Acute onset Autoimmune hemolytic anemia requiring IV steroids and hospitalization.Records received 4/24/07-from facility for DOS 02/13-02/15/07- DC DX: warm agglutinin autoimmune hemolytic anemia. Found at routine visit to be anemic by PCP.  RX with high dose steroids. Two week HX of fatigue pallor, nauseated. 4-6 weeks prior had URI .
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Localized swelling, erythema and fatigue/malaise. Treated symptomatically with NSAIDs, Acetaminophen.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: C/O pain in her L arm where she got the Gardasil injection (02/10/07). Pain starts when she rotates arm inward or lift it shoulder level or above.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: C/O pain in her L arm where she got the Gardasil injection (02/10/07). Pain starts when she rotates arm inward or lift it shoulder level or above.
Age: 18.0
Sex: F
Vaccine: HPV4, MMR, TDAP
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: High fever, difficulty breathing, hives, diaphoresis, chills, weakness with difficult ambulation, tachycardia, arm swollen twice it's normal size per patient report, racing heard and severe dizziness (no syncope). Dizziness persists.
Age: 18.0
Sex: F
Vaccine: HPV4, MMR, TDAP
Symptoms: Neurological examination, Oedema peripheral, Palpitations, Pyrexia, Tachycardia
Clinical narrative: High fever, difficulty breathing, hives, diaphoresis, chills, weakness with difficult ambulation, tachycardia, arm swollen twice it's normal size per patient report, racing heard and severe dizziness (no syncope). Dizziness persists.
Age: 18.0
Sex: F
Vaccine: HPV4, MMR, TDAP
Symptoms: Urticaria
Clinical narrative: High fever, difficulty breathing, hives, diaphoresis, chills, weakness with difficult ambulation, tachycardia, arm swollen twice it's normal size per patient report, racing heard and severe dizziness (no syncope). Dizziness persists.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: 2" area of swelling, redness, tenderness, warmth. Gave Keflex 2 weeks later area better.
Age: 0.18
Sex: F
Vaccine: PNC
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Child has severe abdominal pain and diarrhea
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister
Clinical narrative: Scattered vesicles to trunk and R side of face, upper arms
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Facial palsy, Vaccination failure
Clinical narrative: Received shot on 1/30/07. Did not show signs until Wed/Thursday 1/31/07. By Saturday 2/3/07 had to go to ER due to facial paralysis. Restart series due to negative HbSAb titer.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Pt received vax 4/3 - red, swollen painful at injection site within 24 hours. 4/6 - erythema, warmth, "flushed feeling:, cheeks forehead and chin. Local reaction improved but still present left arm today 4/12/07.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthritis, Uveitis
Clinical narrative: B Uveitis (par planitis) treatment with steroids on-going 04/25/07-records received from PCP-eye exam by ophth on 4/5/07-3 week history of blurred vision in left eye. Ocular exam slowed acuities of 20/20 OD and 20/30 OS. Right eye had a few keratic precipitates, trace vitreous cells and a nevus along the superior arcade. Left eye had keratic precipitates, 10 AC cell/hpf, much more vitreous cell, pars plana exudation and mild macular edema. DX:acute bilateral uveitis most like pars planitis. PMH: anxiety.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Uveitis
Clinical narrative: B Uveitis (par planitis) treatment with steroids on-going 04/25/07-records received from PCP-eye exam by ophth on 4/5/07-3 week history of blurred vision in left eye. Ocular exam slowed acuities of 20/20 OD and 20/30 OS. Right eye had a few keratic precipitates, trace vitreous cells and a nevus along the superior arcade. Left eye had keratic precipitates, 10 AC cell/hpf, much more vitreous cell, pars plana exudation and mild macular edema. DX:acute bilateral uveitis most like pars planitis. PMH: anxiety.
Age: 45.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain in extremity, Radiculitis brachial, Skin burning sensation
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 April 2007 from the patient. A 45-year-old female patient had received a right arm, intramuscular injection of TD ADS adult, lot number U1185AA, on 11 June 2004. Illness at the time of vaccination included an "accent while at work." Immediately post-vaccination, the patient experienced pain and redness at the injection site. She continued to have burning pain in the right arm and was examined by a physician and a neurologist. (The onset of the event was also reported as a few weeks post-vaccination.) Per the reporter, she was diagnosed with brachial neuritis and is currently being followed by another neurologist. Relevant diagnostic testing included "lab work, skin biopsy, MRI, and CT scan.". Results of testing were not provided. At the time of this report, the subject had not recovered.
Age: 45.0
Sex: F
Vaccine: TD, TD
Symptoms: Biopsy skin, Burning sensation, Computerised tomogram, Injection site erythema, Injection site pain
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 April 2007 from the patient. A 45-year-old female patient had received a right arm, intramuscular injection of TD ADS adult, lot number U1185AA, on 11 June 2004. Illness at the time of vaccination included an "accent while at work." Immediately post-vaccination, the patient experienced pain and redness at the injection site. She continued to have burning pain in the right arm and was examined by a physician and a neurologist. (The onset of the event was also reported as a few weeks post-vaccination.) Per the reporter, she was diagnosed with brachial neuritis and is currently being followed by another neurologist. Relevant diagnostic testing included "lab work, skin biopsy, MRI, and CT scan.". Results of testing were not provided. At the time of this report, the subject had not recovered.
Age: 45.0
Sex: F
Vaccine: TD, TD
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Radiculitis brachial
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 April 2007 from the patient. A 45-year-old female patient had received a right arm, intramuscular injection of TD ADS adult, lot number U1185AA, on 11 June 2004. Illness at the time of vaccination included an "accent while at work." Immediately post-vaccination, the patient experienced pain and redness at the injection site. She continued to have burning pain in the right arm and was examined by a physician and a neurologist. (The onset of the event was also reported as a few weeks post-vaccination.) Per the reporter, she was diagnosed with brachial neuritis and is currently being followed by another neurologist. Relevant diagnostic testing included "lab work, skin biopsy, MRI, and CT scan.". Results of testing were not provided. At the time of this report, the subject had not recovered.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, PNC, RV5, UNK
Symptoms: Abdominal pain, Intussusception, Surgery
Clinical narrative: Information has been received concerning a 7 month old male with no medical history who on 09-JAN-2007 at 14:30 was vaccinated with a PO second dose of Rotateq (lot # 654504/0695F). Concomitant vaccination at the same time included a second IM dose of PedvaxHib (lot # 652704/1159R) in the left thigh, a second of Prevnar in the left thigh and a second dose of an unspecified vaccine. There was no illness at the time of vaccination. On approximately 12-MAR-2007 the patient was brought to the emergency room for abdominal pain and was diagnosed with intussusception. The patient was hospitalized for an unknown duration and "had it" surgically repaired. Subsequently, the patient recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea haemorrhagic, Intussusception, Ultrasound abdomen, Vomiting
Clinical narrative: Information has been received from the FDA through the CDC concerning a 3 month old male with no medical history who on 05-FEB-2007 in the morning was vaccinated with ROTATEQ (lot #655406/1114F). Concomitant vaccination administered at the same time included an IM second dose in the left leg of PEDIARIX, an IM second dose in the right leg of PEDVAX HIB and a second dose of PREVNAR (B086840). There was no other concomitant therapies. There was no illness at the time of vaccination. On 18-MAR-2007 the patient went to the emergency room for vomiting and bloody diarrhea. The patient was diagnosed with intussusception. Air contrast enema and abdominal ultrasound were performed. He was treated with reduction twice. He was hospitalized from 18-MAR-2007 to 20-MAR-2007. The patient recovered on an unspecified date. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and research and was released by the regulatory agency. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Bacteria stool identified, Carbon dioxide decreased, Culture stool positive, Gastrointestinal haemorrhage, Haematocrit decreased
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haemoglobin decreased, Heart rate increased, Intensive care, Intestinal resection, Intussusception
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Lethargy, Livedo reticularis, Red blood cell count decreased, Surgery, Swelling
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Gangrene, Life support, Peritonitis, Rectal haemorrhage, Small intestinal resection
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception, Small intestinal resection
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Bacteria stool identified, Carbon dioxide decreased, Gastrointestinal haemorrhage, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Heart rate increased, Intussusception, Lethargy, Life support, Livedo reticularis
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rectal haemorrhage, Red blood cell count decreased, Small intestinal resection, Stool analysis abnormal, Swelling
Clinical narrative: Information has been received from a physician concerning a male who on 23-MAR-2007 was vaccinated with oral Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. The patient had to have the small bowel removed. The intussusception was considered to be immediately life-threatening and disabling. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, RV5, RV5
Symptoms: Surgery
Clinical narrative: Information has been received from a physician concerning an approximately 5 month old male who on 12-JAN-2007 was vaccinated with a 2 ml PO first dose of Rotateq. In April 2007, the patient developed intussusception and was hospitalized. The patient underwent surgery. The patient's intussusception was considered to be immediately life-threatening. The patient's present status was unknown. There was no product quality complaint involved. The patient's intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning an approximately 5 month old male who on 12-JAN-2007 was vaccinated with a 2 ml PO first dose of Rotateq. In April 2007, the patient developed intussusception and was hospitalized. The patient underwent surgery. The patient's intussusception was considered to be immediately life-threatening. The patient's present status was unknown. There was no product quality complaint involved. The patient's intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Diplopia, Headache, Injection site erythema
Clinical narrative: pt with left deltoid erythema 11x10 cm.  Also with HA, chills, myalgias, double vision.  Symptomatic treatment.
Age: 2.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Vaccination failure, Varicella
Clinical narrative: 10 site of chickenpox-chest and back
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging
Clinical narrative: Gardasil #1 12/12/06, Gardasil #2 2/12/07 New onset seizures on 3/8/07 and 3/9/07 (non-hypoglycemic0
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Premenstrual syndrome
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 02-JAN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 654741/0013U). Concomitant therapy included ZOLOFT and ADDERALL TABLETS. It was reported that since receiving her vaccination 02-JAN-2007 the patient has experienced premenstrual low abdominal cramping for a week prior to her menstrual period. The patient was examined by a physician on 12-MAR-2007 and there were no abnormal findings. No treatment was recommended. The reporter requested a lot check. Additional information has been requested.  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot couples with the standards of the center, and was released.  The registered nurse reported that 3 other patients experiences after GARDASIL administration (WAES 0703USA02859, WAES 0703USA02815, WAES0703USA02840).  Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Death, Surgery, Truncus arteriosus persistent
Clinical narrative: Truncus arteriosis S/P partial repair. On Lasix and Captopril, Being followed by GI, cardiology.  8/3/07 Received Autopsy Report which reveals COD as failure to thrive due to congenital heart disease, s/p correction of truncus arteriosus.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Oedema peripheral, Pyrexia, Rash morbilliform
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 6-month-old female subject who was vaccinated with Pediarix for prophylaxis. Concurrent medical conditions included viral exanthem. On 03 April 2007 the subject received 3rd dose of Pediarix. Within hours of vaccination with Pediarix, the subject experienced fever. The fever continued for three more days and ranged from 103 to 106 degrees. The subject also experienced morbilliform rash and edema of hands and feet. The reporter described the subject as having a "Kawasaki like presentation" (did not diagnosis Kawasaki syndrome). The subject was hospitalized. On 12 April 2007, the events were resolved. The physician did not make note of the causality of the events with Pediarix; however, she did not that the events could have been associated with a concurrent medical condition of viral exanthema. records received 6/7/07-Hospital records for DOS 4/5-4/607 and 4/7-4/10/07. DC DX: Left otitis media. Viral exanthem. 3 day history of fever and 2 day history of rash. Spike fevers of 102 and at medical mall temp recorded as 106. Erythematous rash on trunk and quickly spread to limbs and face. Emesis. Watery diarrhea for 2 days.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 27-year-old female subject who was vaccinated with Fluarix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included oral contraceptive (Birth control pill). On 11 October 2006 at 15:00 the subject received unspecified dose of Fluarix in the left arm. Three hours after vaccination with Fluarix, the subject experienced injection site redness (baseball size), injection site pain, heat at injection site and radiating pain in arm. At the time of reporting the events were resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Pt describes pruritus (generalized) lasting 5-6 days. Now localized to injection site and is lessening.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Heart rate increased, Nausea
Clinical narrative: Dizzy, Nausea, Rapid Heartbeat
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria on lower arm after HPV immunization
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Red, raised area approx. 1 3/4", warm to touch
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Culture throat positive, Guttate psoriasis, Rash macular, Rash maculo-papular, Streptococcal identification test positive
Clinical narrative: Patient returned to clinic within 24 hours of vaccination for macular rash on trunk. Macules approx 1-2 cm, annular. Pt did test (+) for strep and was diagnosed with gutate psoriasis vs vaccine rxn. This is in follow-up to report(s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning a 15 year old female with acne, who on 09-APR-2007 at 1:00 pm was vaccinated with a first dose of GARDASIL (lot #654895/1424F) into the right arm IM.  Concomitant therapy included VAQTA (lot # 656497/1213F) into the left arm IM, VARIVAX (lot # "0150F) into the left arm SC, and MENACTRA (lot # 42158CA) into the right arm IM.  Within 24 hours, the patient  experienced a diffuse maculopapular rash.  On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat.  The patient subsequently recovered from the strep throat and the maculopapular rash.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Patient returned to clinic within 24 hours of vaccination for macular rash on trunk. Macules approx 1-2 cm, annular. Pt did test (+) for strep and was diagnosed with gutate psoriasis vs vaccine rxn. This is in follow-up to report(s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning a 15 year old female with acne, who on 09-APR-2007 at 1:00 pm was vaccinated with a first dose of GARDASIL (lot #654895/1424F) into the right arm IM.  Concomitant therapy included VAQTA (lot # 656497/1213F) into the left arm IM, VARIVAX (lot # "0150F) into the left arm SC, and MENACTRA (lot # 42158CA) into the right arm IM.  Within 24 hours, the patient  experienced a diffuse maculopapular rash.  On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat.  The patient subsequently recovered from the strep throat and the maculopapular rash.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Culture throat positive, Pharyngitis streptococcal, Rash
Clinical narrative: Patient returned to clinic within 24 hours of vaccination for macular rash on trunk. Macules approx 1-2 cm, annular. Pt did test (+) for strep and was diagnosed with gutate psoriasis vs vaccine rxn. This is in follow-up to report(s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning a 15 year old female with acne, who on 09-APR-2007 at 1:00 pm was vaccinated with a first dose of GARDASIL (lot #654895/1424F) into the right arm IM.  Concomitant therapy included VAQTA (lot # 656497/1213F) into the left arm IM, VARIVAX (lot # "0150F) into the left arm SC, and MENACTRA (lot # 42158CA) into the right arm IM.  Within 24 hours, the patient  experienced a diffuse maculopapular rash.  On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat.  The patient subsequently recovered from the strep throat and the maculopapular rash.  Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Rash, Somnolence
Clinical narrative: Student c/o of rash above wrist left inner arm approximately 1 hour after immunizations (TDAP) upon returning to room 324. Benadryl 5mg IM at 300 PM. 300 PM - father came for student at 330PM student sleepy. Later stated chest pains while playing basketball. BP 90/60 mmgh, P 96 min 300 PM.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Patient c/o nausea, fever, HA, fatigue 3 days, cont. sxs.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: None noted
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Induration, Injection site mass
Clinical narrative: C/O lump at injection site. 1 cm induration, no erythema, no rash, no fever, no arthralgia. Recommend massage, heat alternate with ice.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Patient's mother states he had reaction to Td given Thursday 4/12/07, started Friday - fever, dizziness, localized swelling and redness in left deltoid, fatigue. Seen in ER 4/14 - ultrasound (-) fn abscess. S/S include chills, fever.  WBC WNL. 4/16 Mild residual occipital HA, left deltoid mildly sore "like a bruise", and erythema. Rec'd Tylenol, Amoxicillin at ER.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, White blood cell disorder
Clinical narrative: Patient's mother states he had reaction to Td given Thursday 4/12/07, started Friday - fever, dizziness, localized swelling and redness in left deltoid, fatigue. Seen in ER 4/14 - ultrasound (-) fn abscess. S/S include chills, fever.  WBC WNL. 4/16 Mild residual occipital HA, left deltoid mildly sore "like a bruise", and erythema. Rec'd Tylenol, Amoxicillin at ER.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient complained of inching on arm. 2" Swollen area on left arm, redness around swollen area.
Age: 1.25
Sex: F
Vaccine: DTAPH
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right thigh
Sex: M
Vaccine: DTP, OPV, VARCEL
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: School nurse diagnosed "bumps" 10-12 lesions itchy, no fever.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Swollen large area, red at site - after swelling went down - left dark brown area at site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site induration, Injection site irritation
Clinical narrative: Localized redness, irritation/ induration to left deltoid - quarter size some bruising.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, Injection site rash
Clinical narrative: Multi-dose (5 dose) vial dispensed to mom (nurse) who administered whole viale 2 ml instead of one 0.5 ml dose approximately 4/9/07. Patient developed large rash at administration site mostly resolved 1 week later.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm, Wheezing
Clinical narrative: Per patient - 1/2 upper arm red, painful and hot to touch. Wheezes that evening and the following day - Sx improved with use of Benadryl PO.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: 1.5 x 1.5 cm erythematous, indurated nodule 8 days after Varicella vaccine at vaccine site left lateral thigh.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting and Diarrhea
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Redness decrease injection in muscle tissue - hot to touch. Advised to watch closely and call if not improvement. Reaction occurred 5 days later.
Age: 1.27
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Developed urticarial itchy rash all over body 2 days after immunizations. Treatment with Hydrocortisone 2.5% cream.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Right upper arm swollen from shoulder to elbow.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Rash
Clinical narrative: Swelling from injection site right deltoid to wrist red raised rash below injection site. Treatment with Benadryl and Prelone.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Hypoglycaemia, Tremor, Vomiting
Clinical narrative: Pt reports that that following the Zostavax vaccine he had a hypoglycemic episode.  Was very shaky, vomited x1 and BGL was 60.  No sx now
Age: 16.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: PATIENT PRESENTED WITH HIVES ON TRUNK AND EXTREMITIES. STATED THAT YESTERDAY FACE AND NECK WERE COVERED WITH HIVES.  PATIENT TOOK TYLENOL PM LATER THAT EVENING.
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: PATIENTS MOTHER CALLED ON 04/15/2007 AND STATED THAT PATIENT HAD RECIEVED INJECTIONS ON 04/09/2007. SHE STATED ON 04/11/2007 THAT SHE NOTICED REDNESS AND A LUMP ON HIS RIGHT LEG AROUND THE INJECTION SITE.  sHE STATED THAT THE REDNESS HAD GOTTEN BETTER BUT THE LUMP IS STILL PRESENT.  AFTER EXPLAINING TO MOTHER, TO OBSERVE THE SITE AND USE WARM COMPRESSES TO AREA, SHE STATED THAT MAYBE THE REDDNESS IS STILL THERE.  DID ADVISE THE MOTHER TO BRING CLILD INTO URGENT CARE TO BE SEEN.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site induration, Injection site papule
Clinical narrative: about 2 weeks after vaccine was administered father noticed a 4cm in diameter erythematous region around site of injection of HepA & Varicella vaccines (right thigh).  Went to ED on this sunday and was started on Clindamycin which seemed to help redness per dad.  I saw patient in Peds Clinic on April 17th.  3-4cm erythematous region in diameter.  Two 3mm papules (appeared clear fluid filled) in the central region as well as a 8mm region also in the center that was bluish-purple color.  Whole 3-4cm area felt indurated.  No fluctulance.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope, Vomiting
Clinical narrative: Client states she sat in the chair a minute, then left and about 3-4 hours after receiving the injection, the client says she fainted.  Her boyfriend reported she vomited.  Advised by clinic RN to call Dr. or go to the ER.  Dr's nurse advised her to go to the ER but she didn't.  Called her pharmacist friend who advised her to go to the ER if anything else developed as she was OK now.  Also advised to talk to her doctor about possible allergy and if she should complete the series.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Cough, Lethargy, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: red blotchy rash, fever, runny nose, cough, lethary. Parents have administered tylenol, motrin and hydrocortisone for comfort.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash pustular, Varicella
Clinical narrative: Itchy  around upper arms (2) lower stomach and back--within 5-6 days. Followed by more locally areas followed by small pimple like pustules, very itchy over the following week. (Now in the 14th day) Have covered the areas (Small) with calydril lotion and getting good relief-called the Clinic and talked to a Nurse who said to stay away from children and this will pass. Said I have a small case of the "Chicken pox"
Age: 20.0
Sex: F
Vaccine: JEV
Symptoms: Abdominal pain, Anaphylactic reaction, Dizziness, Dyspnoea, Food allergy
Clinical narrative: Approximately 45 minutes after receiving vaccine patient developed urticaria.  This progress over one hour to swelling of the throat, difficulty breathing, dizziness.  Patient self treated with epinephrine (Epi-Pen) which she keeps for known peanut allergy.  Had excellent response to epinephrine.  She called EMS and was transported to Emergency Room. Observed overnight with minimal symptoms (itchy rash) on night of 4-16-07.  Only treatment in ER/hospital was Benedryl 50 mg IV.  Discharged on 4-17-07 and had no further symptoms until morning of 4-18-07 when awoke with swollen lips, itching of face and ears, dizziness, nausea, mild abdominal pain. Came to Student Heatlh Service for evaluation.  Developed throat swelling while at Student Health.  Treated with .3 mg epinephrine sq. with good response.  Infectious Disease consultant recommended close inpatient observation until steroids or other treatment could be initiated to stop reaction.  05/09/2007 Mr received for 2 ER o/n admits (4/16-1707 and 4/18-19/07) for c/o allergic reaction to JE vaccine.  Pt reports 2 hours after vaccine she developed a "choking" sensation, difficulty breathing, and trouble swallowing with rash.  Self-injected with epi-pen with relief and evaluated in ER.  Discharge DX;  Allergic reaction/anaphylaxis status post JE vaccination.  Pulmonary stenosis. Returned to ER 1 day after D/C with c/o facial swelling (lips and tongue).  Used Epi-pen and Benadryl en route to hospital with some resolution.  Admitted for observation. Discharge DX:  Resolved angioedema, allergic reaction/anaphylaxis related japanese Encephalitis vaccination immunization. Doing well.  No symptons at this reaction since May 2007.  Last seen by my office on 4-14-08 for an unrelated problem.
Age: 20.0
Sex: F
Vaccine: JEV
Symptoms: Laboratory test normal, Lip swelling, Nausea, Pharyngeal oedema, Pruritus
Clinical narrative: Approximately 45 minutes after receiving vaccine patient developed urticaria.  This progress over one hour to swelling of the throat, difficulty breathing, dizziness.  Patient self treated with epinephrine (Epi-Pen) which she keeps for known peanut allergy.  Had excellent response to epinephrine.  She called EMS and was transported to Emergency Room. Observed overnight with minimal symptoms (itchy rash) on night of 4-16-07.  Only treatment in ER/hospital was Benedryl 50 mg IV.  Discharged on 4-17-07 and had no further symptoms until morning of 4-18-07 when awoke with swollen lips, itching of face and ears, dizziness, nausea, mild abdominal pain. Came to Student Heatlh Service for evaluation.  Developed throat swelling while at Student Health.  Treated with .3 mg epinephrine sq. with good response.  Infectious Disease consultant recommended close inpatient observation until steroids or other treatment could be initiated to stop reaction.  05/09/2007 Mr received for 2 ER o/n admits (4/16-1707 and 4/18-19/07) for c/o allergic reaction to JE vaccine.  Pt reports 2 hours after vaccine she developed a "choking" sensation, difficulty breathing, and trouble swallowing with rash.  Self-injected with epi-pen with relief and evaluated in ER.  Discharge DX;  Allergic reaction/anaphylaxis status post JE vaccination.  Pulmonary stenosis. Returned to ER 1 day after D/C with c/o facial swelling (lips and tongue).  Used Epi-pen and Benadryl en route to hospital with some resolution.  Admitted for observation. Discharge DX:  Resolved angioedema, allergic reaction/anaphylaxis related japanese Encephalitis vaccination immunization. Doing well.  No symptons at this reaction since May 2007.  Last seen by my office on 4-14-08 for an unrelated problem.