chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Contusion, Hepatic steatosis
Clinical narrative: Information has been received from a 40 year old female who on 11/17/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/19/03, the patient presented to the emegency room with excruciating pain in her arm and swelling at the injection site. The patient noted that within 3 days, the site had swelled to 5 inches in diameter. The patient also noted swelling at the site of the lymph node and swelling over her entire body. She also indicated that she cannot raise her arm at the present time. The patient was admitted to the hospital on 11/19/03, and received a shot of morphine for pain. It did not relieve her pain. She also received x-rays at the site of vaccination, and blood work was done. The results were not reported. The patient was discharged from the hospital on 11/20/03. On 11/23/03, she returned to the emergency room. At that time, she was given prednisone, which did not help. At the time of the report, the patient was still taking the prednisone. She was not admitted to the hospital on this occasion. On 11/25/03, the swelling at the site was reported as 3 inches in diameter, and the patient reported that she was still having excruciating pain at the site. The outcome was reported as not recovered. Follow up information received on 12/1/03 from the patient indicated that she went back into the hospital on 11/25/03. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Additional information has been requested. It has been determined that WAES #0311USA02852 is a duplicate of WAES #0312USA00048. Therefore, WAES #0311USA02852 is being deleted from our files and the reports consolidated into WAES #0312USA00048
Age: 40.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Hypokinesia, Infection, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a 40 year old female who on 11/17/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/19/03, the patient presented to the emegency room with excruciating pain in her arm and swelling at the injection site. The patient noted that within 3 days, the site had swelled to 5 inches in diameter. The patient also noted swelling at the site of the lymph node and swelling over her entire body. She also indicated that she cannot raise her arm at the present time. The patient was admitted to the hospital on 11/19/03, and received a shot of morphine for pain. It did not relieve her pain. She also received x-rays at the site of vaccination, and blood work was done. The results were not reported. The patient was discharged from the hospital on 11/20/03. On 11/23/03, she returned to the emergency room. At that time, she was given prednisone, which did not help. At the time of the report, the patient was still taking the prednisone. She was not admitted to the hospital on this occasion. On 11/25/03, the swelling at the site was reported as 3 inches in diameter, and the patient reported that she was still having excruciating pain at the site. The outcome was reported as not recovered. Follow up information received on 12/1/03 from the patient indicated that she went back into the hospital on 11/25/03. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Additional information has been requested. It has been determined that WAES #0311USA02852 is a duplicate of WAES #0312USA00048. Therefore, WAES #0311USA02852 is being deleted from our files and the reports consolidated into WAES #0312USA00048
Age: 40.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Laboratory test abnormal, Myopathy, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Information has been received from a 40 year old female who on 11/17/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/19/03, the patient presented to the emegency room with excruciating pain in her arm and swelling at the injection site. The patient noted that within 3 days, the site had swelled to 5 inches in diameter. The patient also noted swelling at the site of the lymph node and swelling over her entire body. She also indicated that she cannot raise her arm at the present time. The patient was admitted to the hospital on 11/19/03, and received a shot of morphine for pain. It did not relieve her pain. She also received x-rays at the site of vaccination, and blood work was done. The results were not reported. The patient was discharged from the hospital on 11/20/03. On 11/23/03, she returned to the emergency room. At that time, she was given prednisone, which did not help. At the time of the report, the patient was still taking the prednisone. She was not admitted to the hospital on this occasion. On 11/25/03, the swelling at the site was reported as 3 inches in diameter, and the patient reported that she was still having excruciating pain at the site. The outcome was reported as not recovered. Follow up information received on 12/1/03 from the patient indicated that she went back into the hospital on 11/25/03. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Additional information has been requested. It has been determined that WAES #0311USA02852 is a duplicate of WAES #0312USA00048. Therefore, WAES #0311USA02852 is being deleted from our files and the reports consolidated into WAES #0312USA00048
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures. Seizures stopped after 3 minutes and administration of Diastat, Ativan, and Versed. Child rec'd immunizations at approx 8am on 7/15/03. At midnight on 7/16/03, he experienced a febrile seizure and was hospitalized overnight.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Grand mal convulsion, Hypoxia, Injection site erythema, Injection site oedema
Clinical narrative: Pt received both Fluzone and Pneumovax. Had red, swollen arm; was feverish according to pt. Pt found in grand mal seizure around 2000. Pt found to be hypoxemic, wheezing, tachycardic, tachypnic in ER. Inj site was red and swollen.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pyrexia, Tachycardia, Tachypnoea, Wheezing
Clinical narrative: Pt received both Fluzone and Pneumovax. Had red, swollen arm; was feverish according to pt. Pt found in grand mal seizure around 2000. Pt found to be hypoxemic, wheezing, tachycardic, tachypnic in ER. Inj site was red and swollen.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Arthralgia, Bacterial infection, Bone disorder, Bursitis
Clinical narrative: Fatigue and joint pain onset after 3nd hepatitis B series 5/02. Continued decline and severe worsening after unidentified vaccine given 7/02. onset of flu-like symptoms, headaches, cognitive challenges etc. culminating in hospitalization 10/02. Over last 1.5 year, various diagnosis given: chronic fatigue, fibromyalgia, bursitis, anxiety, sleep apnea, spinal stenosis, heavy metals, etc. Most recent positive Lyme test with improvement with ongoing treatment. Symptoms less severe and not persistent but episodial. Dementia/memory cognitive impairments, depression, fatigue, pain in joints & dist, head, neck, malaise.  Being treated with mega doses of anti-biotics with flex-leinor reactions for every anti-biotic adjustment- improving slowly.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Cognitive disorder, Dementia, Depression, Fatigue, Fibromyalgia
Clinical narrative: Fatigue and joint pain onset after 3nd hepatitis B series 5/02. Continued decline and severe worsening after unidentified vaccine given 7/02. onset of flu-like symptoms, headaches, cognitive challenges etc. culminating in hospitalization 10/02. Over last 1.5 year, various diagnosis given: chronic fatigue, fibromyalgia, bursitis, anxiety, sleep apnea, spinal stenosis, heavy metals, etc. Most recent positive Lyme test with improvement with ongoing treatment. Symptoms less severe and not persistent but episodial. Dementia/memory cognitive impairments, depression, fatigue, pain in joints & dist, head, neck, malaise.  Being treated with mega doses of anti-biotics with flex-leinor reactions for every anti-biotic adjustment- improving slowly.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza like illness, Laboratory test abnormal, Malaise, Neck pain
Clinical narrative: Fatigue and joint pain onset after 3nd hepatitis B series 5/02. Continued decline and severe worsening after unidentified vaccine given 7/02. onset of flu-like symptoms, headaches, cognitive challenges etc. culminating in hospitalization 10/02. Over last 1.5 year, various diagnosis given: chronic fatigue, fibromyalgia, bursitis, anxiety, sleep apnea, spinal stenosis, heavy metals, etc. Most recent positive Lyme test with improvement with ongoing treatment. Symptoms less severe and not persistent but episodial. Dementia/memory cognitive impairments, depression, fatigue, pain in joints & dist, head, neck, malaise.  Being treated with mega doses of anti-biotics with flex-leinor reactions for every anti-biotic adjustment- improving slowly.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Sleep apnoea syndrome
Clinical narrative: Fatigue and joint pain onset after 3nd hepatitis B series 5/02. Continued decline and severe worsening after unidentified vaccine given 7/02. onset of flu-like symptoms, headaches, cognitive challenges etc. culminating in hospitalization 10/02. Over last 1.5 year, various diagnosis given: chronic fatigue, fibromyalgia, bursitis, anxiety, sleep apnea, spinal stenosis, heavy metals, etc. Most recent positive Lyme test with improvement with ongoing treatment. Symptoms less severe and not persistent but episodial. Dementia/memory cognitive impairments, depression, fatigue, pain in joints & dist, head, neck, malaise.  Being treated with mega doses of anti-biotics with flex-leinor reactions for every anti-biotic adjustment- improving slowly.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient received influenza vaccine (AP) 11/19.  Patient reported dizziness that started 3 days later and lasted greater than 1 week.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Myalgia, Oedema peripheral
Clinical narrative: This 74 year old male had a flu vaccine 7 days ago in his physicians office.  He was doing well until 3 days ago when he developed fever to 102 degrees, chills, nonproductive cough, myalgias, arthralgias.  He has also developed some painful swollen palms and soles of his feet with redness.  No vesicles, no sore throat or conjuctival discharge.  No known exposure.  He has been taking aspirin since yesterday for this.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: This 74 year old male had a flu vaccine 7 days ago in his physicians office.  He was doing well until 3 days ago when he developed fever to 102 degrees, chills, nonproductive cough, myalgias, arthralgias.  He has also developed some painful swollen palms and soles of his feet with redness.  No vesicles, no sore throat or conjuctival discharge.  No known exposure.  He has been taking aspirin since yesterday for this.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: I received a flu vaccination in my left shoulder and it caused severe aching and throbbing pain throughout my entire arm that lasted for over 3 weeks.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Arthritis, Joint stiffness, Swelling
Clinical narrative: Knots, swelling, stiffness at ankles, knees and hands. Arthritis; prescribed Naproxen. Nurse follow up on 06/08/04 states: add, arthralgia.
Age: 81.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Muscular weakness, Pain, Pharyngolaryngeal pain, Vaccine positive rechallenge
Clinical narrative: Flu vaccine administered 11/14.  Patient fell ill early on the 15th.  Had headache, sore throat, and achy muscles and weakness.  Was sickly 5 days.  Took Tylenol.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash papular
Clinical narrative: Patient received flu vaccine 10/20/2003 on left deltoid.  Patient complained of itching Monday night and noticed a papule on 10/21/2003.  Complained of severe itching at site.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Patient was given pneumovax in right deltoid and within a minute he complained of itching at the site.  After 15-20 minutes, site was red, hot to touch.  Swollen and had an indurated white area 1/4x1/4 inch in center.  Red area was 1.5x2 inches.  Resolved after 30-35 minutes with ice pack.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Malaise, Mucosal inflammation, Nasal congestion
Clinical narrative: Had flu vaccine just before noon 11/19/2003.  Became extremely ill by evening.  Have been recovering for past 10 days-was very weak-upset stomach-could not eat solid food the first 4-5 days.  Chest phlegm and heavy cough.  To date, I am still coughing a little congested.  Only drank tea, honey and lemon; took only Tylenol.  Stayed at home and did not go to a doctor.  Note: Was not sick previously.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Stomach discomfort
Clinical narrative: Had flu vaccine just before noon 11/19/2003.  Became extremely ill by evening.  Have been recovering for past 10 days-was very weak-upset stomach-could not eat solid food the first 4-5 days.  Chest phlegm and heavy cough.  To date, I am still coughing a little congested.  Only drank tea, honey and lemon; took only Tylenol.  Stayed at home and did not go to a doctor.  Note: Was not sick previously.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Flushing, Vomiting
Clinical narrative: Flushing-2 hours; Vomiting-3 hours; Weakness-3 hours;
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Approximately 1 hour after receiving pneumococcal vaccines (left deltoid) area became red and swollen and painful.  Tender to touch.  Swelling experienced from shoulder to elbow for 2 days.  Resolved on day 3.
Age: 0.1
Sex: M
Vaccine: DTP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever onset 7 hours after vaccination.  Fever and rash at 10 days ago per vaccination.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Morbiliform rash parallel and after MMR. T to 104.5.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Redness, warmth and swelling around site of Prevanar and Comvax. About 1" x 1/2", no streaking, is tender to touch. Mom has not treated at all yet.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Myalgia, arthralgia, night sweats and chills, elevated temperature, fatigue for 2 days.
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Myalgia, arthralgia, night sweats and chills, elevated temperature, fatigue for 2 days.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Urticaria
Clinical narrative: Urticaria 24 hours post immunization.  Prescribed Benadryl
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Febrile 48 hours after injection 100.4 left arm extremely sore-16-18 hours after injection.  11/19/2003-enlarged lymph node right side of neck, decreased hip pain.  Pain with wacking.  11/20/2003.  Body aches generalized with increased right hip pain.  Body aches unable to ambulate.  Patient sore.  Called next after month, used strain for nourishment.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Fatigue
Clinical narrative: Had seizure 2-3 days after vaccine. No temp. Was taking Tylenol every 6 hours and Trileptal 2ml tid. Tries to give meds 9-10:00 AM, 1:30-2:00 PM and 7-8:00 PM but sometimes is late. He acts exhausted all time. Local physician recommended he return to pediatric neurologist for medicine evaluation. 11/25/03: no more seizures per mother. Has not seen PMD or pediatric neurologist.
Age: 1.7
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Convulsion, Epilepsy, Fatigue, Pyrexia
Clinical narrative: Three or four days after receiving last shots, had seizure, was teething, temperature 102 rectally.  Took patient to MD and neurology clinic. EEG was performed-was told had abnormal brain wave around shunt.  Was not taking medicine for fever.  Was started on Trideptal 2mL three times a day for epilepsy. 11/20/2003: Today called mother to obtain info to compete VAERS form and to inquire about how patient did with dTAP #4 given 11/11/2003.  Mother reports he had seizure 2-3 days after vaccine.  No temperature was taking Tylenol every 6 hours and Trileptal 2mL three times a day.  Tries to give medicine 9-10 am, 1:30-2:00pm and 8-9 pm but sometimes is late.  Patient acts exhausted all the time.  Local physician has recommended he go back to neurologist for medicine evaluation.  Encouraged mother to give medicine around same time each day if possible and to return for medicine evaluation.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: LOCAL ERYTHEMA/INDURATION AT VACCINE SITE MEASURING 50mm BY 70mm. LOCAL TENDERNESS,PAIN. ONSET EVENING AFTER INJECTION RECEIVED 12/9/03 PRESENT STILL AM 12/11/03.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain, Skin discolouration
Clinical narrative: Received phone call from clients daughter.  She stated mothers right arm is red and swollen to the elbow.  warm to touch and painful to use it.  It look yellow under the skin where she was stuck.  She was advised to go to MD for evaluation.
Age: 14.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Parent stated her daughter has measles from getting the MMR vaccine.  She has a generalized rash, low grade fever, itching.  She was seen by her family doctor and Dx'd with measles.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Contusion
Clinical narrative: Patient had sever bruising on arm from Shoulder to hand X 5 days post injection.  Resolving patient said better now.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Urticaria
Clinical narrative: About 2 hours after receiving the vaccination, I broke out in hives and had shortness of breath for several hours. I took a dose of Benadryl and used my Albuterol inhaler and the symptoms gradually subsided. I consulted the pharmacy where I received the vaccine and the pharmacist recommended taking the Benadryl and monitoring it carefully, which I did, using my peak flow meter. My peak flow remained at my average level. It did not seem serious enough to go to the ER. By about 10 PM, the symptoms were gone. I hope this was helpful!
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Psychomotor hyperactivity
Clinical narrative: Since receiving the flu shot on November 7th, 2003, I have had consistent pain in my right arm.  The pain has subsided a little bit but I would have assumed that it would have gone away completely after a months time.  The pain mainly occurs when I move my arm and is limited to the upper part of my arm.
Age: 1.1
Sex: F
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: SHE DEVELOPED MILD CASE OF VARICELA AFTER 9 DAYS FROM RECIVIEING THE VARICELA VACCINE.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Three hours after having the shot he had a fever of 101.5, sweats, headache
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling about 3 inches in diameter and itching
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: The Flu shot was given at approx. 12:30p.m. on 12/10/03. Within just a few minutes she got very pale, dizzy, sweaty and felt clammy & nausea. She said she heard a buzzing sound in hear head. She heaved a few times, but nothing came up. The nurses there said it was probably from waiting in line for so long and it was warm and she needed to raise her blood sugar level. She fell asleep in the car on the way home, but when she awoke, had to throw up, which she did several times through out the evening, had a low grade fever until around 10:00a.m. 12/11.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Retching
Clinical narrative: The Flu shot was given at approx. 12:30p.m. on 12/10/03. Within just a few minutes she got very pale, dizzy, sweaty and felt clammy & nausea. She said she heard a buzzing sound in hear head. She heaved a few times, but nothing came up. The nurses there said it was probably from waiting in line for so long and it was warm and she needed to raise her blood sugar level. She fell asleep in the car on the way home, but when she awoke, had to throw up, which she did several times through out the evening, had a low grade fever until around 10:00a.m. 12/11.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Cardiovascular disorder, Coronary artery atherosclerosis, Depressed level of consciousness, Pyrexia
Clinical narrative: Patient could not be aroused from his cot by others. In presence of dependent lividity, his core body temperature was 108oF. Temperatures in the area at the time were at or above 120oF. Wet-bulb globe temperatures were "pegged" (at max recordable temp), but were typically at least 92oF. Final autopsy report: Cause of death--heat-related death. Autopsy diagnoses: Micro pulmonary findings suggestive of heat injury. Mild right ventricular hypertrophy. Mild coronary atherosclerosis.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: I NOTICED A LITTLE SWELLING IMMEDIATELY AFTER THE INJECTION. WE GAVE BENADRYL AND THE PATIENT WAS INSTRUCTED AFTER THE IMMUNIZATION OF SIDE EFFECTS AND WHAT THINGS TO WATCH FOR, AND WHAT  SHOULD BE REPORTED TO US.  PATIENT CALLED BACK 12-03-03 IN THE AFTERNOON AFTER RECEIVING HER SHOT AND STATED THAT SHE SAW A LITTLE REDNESS AND SWELLING AROUND THE INJECTION SITE. WE ADVISED HER ON MONITORING, THE SITE AND WHAT TO DO IF THINGS WORSENED. ALSO PROMISED TO FOLLOW UP WITH HER THE NEXT DAY.  CALLED ON 12-04-03 AND SPOKE WITH PATIENT AND SHE STATED EVERY THING HAD CLEARED UP AND SHE WAS FINE.
Age: 17.0
Sex: M
Vaccine: DT
Symptoms: Erythema, Infection, Joint range of motion decreased, Oedema, Pyrexia
Clinical narrative: Fever, redness, rash, swollen arm, unable to move arm, redness, swelling extended into armpit. Diagnosed with severe infection.  12-07-03 gave im antibiotics, oral antibiotics
Age: 17.0
Sex: M
Vaccine: DT
Symptoms: Rash
Clinical narrative: Fever, redness, rash, swollen arm, unable to move arm, redness, swelling extended into armpit. Diagnosed with severe infection.  12-07-03 gave im antibiotics, oral antibiotics
Age: 1.3
Sex: F
Vaccine: FLUX, PNC
Symptoms: Loss of consciousness, Shock, Vomiting
Clinical narrative: Fluvax and Prevnar - first dose of each for patient (my daughter).  Visit was for 15 month well-check.  Immunizations have been delayed so she has only received 2 doses HiB and 2 doses DTaP.  Within 10 minutes of receiving the vaccines, my daughter passed out; within 30 minutes she vomited twice; within 45 minutes she had vomited an additional 2 times.  Physician Assistant recommended we come back to the office to check her out.  Pulse-ox monitored and she was assessed to be "okay".  Doctor stated that it was either a reaction to something in the vaccine, or a shock reaction.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Atrial fibrillation, Bacterial infection, Deep vein thrombosis, Infection
Clinical narrative: The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Leukopenia, Muscular weakness, Neutropenia, Pneumonia, Pulmonary haemorrhage
Clinical narrative: The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Renal failure, Respiratory failure, Thrombocytopenia, Vasculitis
Clinical narrative: The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.
Age: 1.0
Sex: M
Vaccine: HBHEPB
Symptoms: Bacterial infection, Brain oedema, Diabetes insipidus, Drug ineffective, Hernia
Clinical narrative: Information has been received from a physician concerning a 12 month old pt with a history of multiple hospitalizations for pneumonia, urinary tract infection and fever. It was noted that the pt was not immunocompromised and had no allergies to food or medications. On 4/3/03 the pt was vaccinated with a second dose of Comvax (543655/0738M). It was noted that the pt had not received the third dose of Comvax. On 11/3/03 the pt began symptoms and was later diagnosed with invasive haemophilus influenzae. Concomitant therapy included "other childhood immunizations." On 11/10/03 the pt died. The cause of death was invasive haemophilus influenzae. It was noted that an autopsy was performed and the results were unknown at the time of the report. Additional info has been requested.  The hospital discharge summary received on 12/16/03 states cerebral edema, diabetes insipidus and cerebral salt-wasting. Follow up information from the same physician indicated that the patient had a history of recurrent infections including pneumonia x 4, poor weight gain and UTI, but there was no immune compromise. On 03-Nov-2003 the child experienced "invasive HIB disease meningitis". Reported labs inlcuded CSF WBC of 12800 and WBC's of 880. The child died on 09-Nov-2003, rather than 10-Nov-2003 as previously reported. the causes of death were reported in the follow up as Hib meningitis, cerebral edema and herniation. Additional information, including autopsy findings, has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB
Symptoms: Hyponatraemia, Meningitis
Clinical narrative: Information has been received from a physician concerning a 12 month old pt with a history of multiple hospitalizations for pneumonia, urinary tract infection and fever. It was noted that the pt was not immunocompromised and had no allergies to food or medications. On 4/3/03 the pt was vaccinated with a second dose of Comvax (543655/0738M). It was noted that the pt had not received the third dose of Comvax. On 11/3/03 the pt began symptoms and was later diagnosed with invasive haemophilus influenzae. Concomitant therapy included "other childhood immunizations." On 11/10/03 the pt died. The cause of death was invasive haemophilus influenzae. It was noted that an autopsy was performed and the results were unknown at the time of the report. Additional info has been requested.  The hospital discharge summary received on 12/16/03 states cerebral edema, diabetes insipidus and cerebral salt-wasting. Follow up information from the same physician indicated that the patient had a history of recurrent infections including pneumonia x 4, poor weight gain and UTI, but there was no immune compromise. On 03-Nov-2003 the child experienced "invasive HIB disease meningitis". Reported labs inlcuded CSF WBC of 12800 and WBC's of 880. The child died on 09-Nov-2003, rather than 10-Nov-2003 as previously reported. the causes of death were reported in the follow up as Hib meningitis, cerebral edema and herniation. Additional information, including autopsy findings, has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pharyngitis, Pneumonia, Productive cough
Clinical narrative: This subject is a 70 year old male who was admitted to the hospital due to right lung pneumonia while enrolled in the RSV11 study. The subject received his second injection of RSV vaccine or Placebo and Influenza vaccine on 10/29/03. Subject developed a temperature, shortness of breath, cough, wheeze, and cold symptoms 37 days post immunization and was admitted to the hospital on 12/5/03. Wife notified investigator that subject was taken to local MD on 5/12/03 with SOB, cold, cough, sputum and fever and was diagnosed with pneumonia by CXR. Treatment included Ibuprofen, Tylenol, Rocephin injection, Avalox and Tussionex. The temperature, SOB, coughing, wheezing, cold symptoms and diagnosis of right lung pneumonia was reported by the investigator as life threatening and possibly related to the study vaccine. Additional info received 12/15/03. The seriousness classification has been downgraded. The pneumonia as reported by the investigator did not meet the criteria for an SAE and should not have been reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rhinitis, Wheezing
Clinical narrative: This subject is a 70 year old male who was admitted to the hospital due to right lung pneumonia while enrolled in the RSV11 study. The subject received his second injection of RSV vaccine or Placebo and Influenza vaccine on 10/29/03. Subject developed a temperature, shortness of breath, cough, wheeze, and cold symptoms 37 days post immunization and was admitted to the hospital on 12/5/03. Wife notified investigator that subject was taken to local MD on 5/12/03 with SOB, cold, cough, sputum and fever and was diagnosed with pneumonia by CXR. Treatment included Ibuprofen, Tylenol, Rocephin injection, Avalox and Tussionex. The temperature, SOB, coughing, wheezing, cold symptoms and diagnosis of right lung pneumonia was reported by the investigator as life threatening and possibly related to the study vaccine. Additional info received 12/15/03. The seriousness classification has been downgraded. The pneumonia as reported by the investigator did not meet the criteria for an SAE and should not have been reported.
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was considered medically important (OMIC). Information regarding influenza virus vaccine was received from a healthcare professional regarding a male patient who experienced GBS. The patient received a dose on an unspecified date in 1985. The patient has a past history of poliomyelitis. Indication for influenza virus vaccine was immunization. Product was administered in on an unspecified date in 1985. Dose regimen was 1 dose. Concomitant medications were not reported. The patient was diagnosed with GBS after receiving a flu vaccine in 1985. The reporter stated that the patient does not have any continued problems associated with the event. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested. No additional information was available at the date of this report.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Liver function test abnormal, Myalgia, Pruritus, Pyrexia
Clinical narrative: Had overwhelming fatigue and fever to 101 and myalgias. Fever went to 102 and lasted until 10/14/03. Also had severe pruritis. Labs showed LFT's elevated, fever to 103.7 on 10/18. Admitted to hospital. Labs have all returned to normal presently.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Acidosis, Alanine aminotransferase increased, Alcohol poisoning, Apnoea, Blood urea increased
Clinical narrative: Patient reportedly experienced seizures morning of 12/6/03 and admitted to ICU. Status unknown. The discharge summary received on 2/9/04 states respiratory failure, decreased level consciousness, alcohol intoxication, metabolic acidosis, hypokalemia, azotemia, and hypoglycemia.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Convulsion, Hypoglycaemia, Hypoxia, Leukocytosis, Somnolence
Clinical narrative: Patient reportedly experienced seizures morning of 12/6/03 and admitted to ICU. Status unknown. The discharge summary received on 2/9/04 states respiratory failure, decreased level consciousness, alcohol intoxication, metabolic acidosis, hypokalemia, azotemia, and hypoglycemia.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Pyrexia, Rash
Clinical narrative: 10/15/03 RN spoke with client on phone. Client states, "I had a severe reaction to the Tetanus you gave me, 9 days after the shot. I ran a temp of 109 deg and I had problems breathing and a rash in my throat, I had to be admitted to the hosp. I have hep C cancer of the breast." Admitted on 10/13/03.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Ten minutes after administration pt c/o nausea, feeling hot and faint. Assisted to bed to lie down. BP 100/60, P 60. Diaphoretic. Thirty minutes after administration of vaccine c/o abdominal cramping and had BM. BP 110/70, P 68. Fifty minutes after administration of FluMist feeling normal.
Age: 21.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Cellulitis
Clinical narrative: Cellulitis on right UE started 24 hours after vaccine administration. No fever. Treatment: abx
Age: 1.83
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Vaccine given left leg 1:15 PM. Call from mother 3:30 PM. Rash on face, trunk, back. Raised bumps. No fever, no itching. No Tx. Gone in 3 days.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Oedema peripheral, Pyrexia
Clinical narrative: Large swelling of arm and shoulder, redness > 2" and fever. Seen at ER. Given antibiotic and diagnosed with cellulitis. Currently on Keflex at office follow up 12/4/03. To finish Abx and call office if worsens or not improved.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Diarrhoea
Clinical narrative: 14 hours after shot was given, pt experienced diarrhea within the 1st hour at 3-5 minute intervals. Pt was healthy before the shot was given. Pt was home from school for 2 days. She did not have fever or "feel achy". Just weak with diarrhea. Stayed home, ate "Brat" diet and recovered by evening 12/10/03.
Age: 0.75
Sex: F
Vaccine: FLU3, HEP
Symptoms: Pyrexia
Clinical narrative: Temp 103.6 24 hours after vaccine. No irritabililty or lethargy. Pt appeared her usual self.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Erythema, Feeling hot, Rash erythematous
Clinical narrative: R arm deltoid - warm to tuch, red, raised.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Palpitations
Clinical narrative: Dizziness, palpittoin, pruritis, chest tightness.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Pt received flu and pneumonia vac 11/4/03 PM. On 11/5/03 AM pt noted redness. Reported to health dept. Pt seen by PA 11/5/03 PM for F/U evaluation. Antihistamine Rx given. Red area marked. Pt to return if redness increased. Redness did increase. Pt returned. They Rx Keflex and to continue antihistamine and return if no improvements. Pt stopped into health dept. Will call HD if further concerns.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Joint range of motion decreased, Pain
Clinical narrative: States arm felt sore, but has still continued to be sore 6 weeks later, is sore to pressure, can feel small hard area, has some pain with movement of that arm.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Malaise
Clinical narrative: Pt received flu vaccine at 0950 on 12/09/03 and was discharged from clinic. Prior to vaccine, mom stated that pt had no allergies. Pt returned to clinic at 1015 stating that he felt funny and was having trouble breathing. Pt brought to room. BP and pulse Ox monitored. IV fluids given. Pt discharged at 1200.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: 3cm oral red swollen area left bicipital area. Entire left arm in bicipital and deltoid area swollen and tender. No itching. Began 1 day after receiving vaccine. Instructed re: Motrin, Allegra and ice packs. F/U with MD in AM.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on torso and extremities. Treated with Benadryl and the hives resolved. No recurrence of hives the following day.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Oedema, Pain, Pruritus
Clinical narrative: Immunization 2 days ago now warm, slight pruritis, swelling, pain moderate left arm.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Dizziness, Headache, Nasal congestion, Pain
Clinical narrative: Sore throat, fever 103, chills, headache, body aches, dizzy, congestion. From 11/20 afternoon to 11/25/2003 complete bed rest, liquids, Advil.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Sore throat, fever 103, chills, headache, body aches, dizzy, congestion. From 11/20 afternoon to 11/25/2003 complete bed rest, liquids, Advil.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Throat tightness
Clinical narrative: c/o nausea without vomit and tightness in throat 2 hours post flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site warmth, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Swelling in right upper arm, extending down to elbow. Extreme tenderness, some heat and swelling the size of "an orange" below injection site. Febrile, 100 degrees on 10/16/03. Pt to PCP. Rx: Clairin and Cephalexin 500mg every 6 hours for 10 days. Redness spreading, blotchy, redness on entry upper arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular
Clinical narrative: Swelling in right upper arm, extending down to elbow. Extreme tenderness, some heat and swelling the size of "an orange" below injection site. Febrile, 100 degrees on 10/16/03. Pt to PCP. Rx: Clairin and Cephalexin 500mg every 6 hours for 10 days. Redness spreading, blotchy, redness on entry upper arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Swelling, erythema, pain at site of injection left arm, lasting 2 days.
Age: 23.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Slight redness/puffiness at site. Cellulitis.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Pain
Clinical narrative: Pt was sitting and doing paper work, and she had no pain. About 4:15 PM she experienced severe pain in the right hip towards the lower back area. The pain was severe enough that walking was difficult. The pain lasted 2 hours, and there were no other symptoms.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Chills, Lethargy, Pyrexia
Clinical narrative: Less than 12 hours after receiving vaccine. Sx: fever, chills, abdominal bloating, lethargy. Sx lasted 24 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Onset of urticaria immediately after DTaP and IPOL.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pain
Clinical narrative: Nausea, headache, achiness all over, redness and pain at site of Pneumonia vaccine.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Pain
Clinical narrative: Headache, achiness, redness and pain to affected arm at vaccine site, general malaise.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Malaise, Nausea
Clinical narrative: Redness, swelling of arm (pneumonia site), nausea, headache, achiness all over general malaise.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Redness, swelling of arm (pneumonia site), nausea, headache, achiness all over general malaise.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Malaise, Nausea, Pain
Clinical narrative: Arm red, swollen, nausea, achiness, general malaise.
Age: 49.0
Sex: F
Vaccine: FLU3, TD, VARCEL
Symptoms: Anxiety, Hypertension, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Local systemic.  Swelling and pain at site of injection.  Fever, hypertension, tachycardia, anxiety.  Prescribed Dizadron, Benadryl
Age: 49.0
Sex: F
Vaccine: FLU3, TD, VARCEL
Symptoms: Tachycardia
Clinical narrative: Local systemic.  Swelling and pain at site of injection.  Fever, hypertension, tachycardia, anxiety.  Prescribed Dizadron, Benadryl
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Bone disorder, Joint swelling
Clinical narrative: 2 total hip replacements, swelling of joints, arthritis etc.