chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Apnoea, Asthenia, Atelectasis, Back pain
Clinical narrative: This patient was vaccinated with the flu shot by another nurse/friend.  It was a on a Monday or Tuesday (Oct. 20 or 21) that she was given the shot, and towards the end of the week, she began feeling unusual symptoms such as weakness, back and leg pain, feeling ill, and numbness in arms and legs.  The Sunday after she had the shot, she came home from work and was not feeling like "herself."  That afternoon, she collapsed and was paralyzed.  She was taken to the Hospital to have tests done the following day.  Early the next morning, she was unable to breathe and was then airlifted to the Hospital.  She was then put on a respirator, and was then diagnosed with Guillain Barre Syndrome.  She was taken into another Hospital on October 27, 2003, and is still currently in ICU.  She is still unable to breathe on her own, and also had a tracheostomy done on her.  She can move her head and shoulders somewhat, but is still unable to move anything else. The medical records received on 1/12/04 states respiratory failure. The medical record received on 3/23/04 states basilar atelectasis, decubitus ulcer, anemia, depression and urinary tract infection. She is still paralyzed and cannot fully move on her own. She can move her right arm, but without much control. She was just moved to a long term Rehab Center as of February 2, 2004.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Depression, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Loss of consciousness
Clinical narrative: This patient was vaccinated with the flu shot by another nurse/friend.  It was a on a Monday or Tuesday (Oct. 20 or 21) that she was given the shot, and towards the end of the week, she began feeling unusual symptoms such as weakness, back and leg pain, feeling ill, and numbness in arms and legs.  The Sunday after she had the shot, she came home from work and was not feeling like "herself."  That afternoon, she collapsed and was paralyzed.  She was taken to the Hospital to have tests done the following day.  Early the next morning, she was unable to breathe and was then airlifted to the Hospital.  She was then put on a respirator, and was then diagnosed with Guillain Barre Syndrome.  She was taken into another Hospital on October 27, 2003, and is still currently in ICU.  She is still unable to breathe on her own, and also had a tracheostomy done on her.  She can move her head and shoulders somewhat, but is still unable to move anything else. The medical records received on 1/12/04 states respiratory failure. The medical record received on 3/23/04 states basilar atelectasis, decubitus ulcer, anemia, depression and urinary tract infection. She is still paralyzed and cannot fully move on her own. She can move her right arm, but without much control. She was just moved to a long term Rehab Center as of February 2, 2004.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Paralysis, Skin ulcer, Urinary tract infection
Clinical narrative: This patient was vaccinated with the flu shot by another nurse/friend.  It was a on a Monday or Tuesday (Oct. 20 or 21) that she was given the shot, and towards the end of the week, she began feeling unusual symptoms such as weakness, back and leg pain, feeling ill, and numbness in arms and legs.  The Sunday after she had the shot, she came home from work and was not feeling like "herself."  That afternoon, she collapsed and was paralyzed.  She was taken to the Hospital to have tests done the following day.  Early the next morning, she was unable to breathe and was then airlifted to the Hospital.  She was then put on a respirator, and was then diagnosed with Guillain Barre Syndrome.  She was taken into another Hospital on October 27, 2003, and is still currently in ICU.  She is still unable to breathe on her own, and also had a tracheostomy done on her.  She can move her head and shoulders somewhat, but is still unable to move anything else. The medical records received on 1/12/04 states respiratory failure. The medical record received on 3/23/04 states basilar atelectasis, decubitus ulcer, anemia, depression and urinary tract infection. She is still paralyzed and cannot fully move on her own. She can move her right arm, but without much control. She was just moved to a long term Rehab Center as of February 2, 2004.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Urine abnormality
Clinical narrative: This patient was vaccinated with the flu shot by another nurse/friend.  It was a on a Monday or Tuesday (Oct. 20 or 21) that she was given the shot, and towards the end of the week, she began feeling unusual symptoms such as weakness, back and leg pain, feeling ill, and numbness in arms and legs.  The Sunday after she had the shot, she came home from work and was not feeling like "herself."  That afternoon, she collapsed and was paralyzed.  She was taken to the Hospital to have tests done the following day.  Early the next morning, she was unable to breathe and was then airlifted to the Hospital.  She was then put on a respirator, and was then diagnosed with Guillain Barre Syndrome.  She was taken into another Hospital on October 27, 2003, and is still currently in ICU.  She is still unable to breathe on her own, and also had a tracheostomy done on her.  She can move her head and shoulders somewhat, but is still unable to move anything else. The medical records received on 1/12/04 states respiratory failure. The medical record received on 3/23/04 states basilar atelectasis, decubitus ulcer, anemia, depression and urinary tract infection. She is still paralyzed and cannot fully move on her own. She can move her right arm, but without much control. She was just moved to a long term Rehab Center as of February 2, 2004.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema
Clinical narrative: Pt received a flu shot (Fluzone,lot # U1147AA, 0.5ml/IM/Rt. Deltoid) at approximately 07:45am.  Client had reported receiving previous flu shots and denied allergies at time of administration.  Approximately 2hrs later, at 09:50am, presented at the Health Dept., stating his co-worker noticed his lip was swollen.  Client's supervisor sent him the the HD for follow-up.  Client was in no discernable distress, and apart from a swollen lower lip, showed no other allergic signs or symptoms.  The above-named MD examined pt and ordered Benadryl 50mg, IM, which was given at approximately 09:55am.  Client was instructed to remain at HD for 30 min. for further observation, and left without further incident at 10:25am.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin exfoliation, Skin ulcer
Clinical narrative: A half-dollar sized ulceration, peeling and slight oozing, with the injection site directly in the middle, with acute redness lasting approx 2 weeks. Tender only upon touch, no signs of infection.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Pain
Clinical narrative: Vaccine administered early afternoon of 11/25/03. In late evening, I had an asthma attack. I feel general achiness today but have no fever and do NOT feel sick. Each (especially the asthma attack since I have had asthma for years and don't know for sure what set it off) could be coincidental. At this point, the asthma attack has long passed. I am still a bit achy, but it is not severe. Mild aches in arms, legs, back, buttocks, etc. It feels like how I think I would feel if I had never exercised and then worked out for an hour.  In regard to the asthma attack, at the time, I had no epinephrine on hand, which has stopped my worst attacks dead in their tracks. I used a little too much of my albuterol inhaler, but the attack did subside without my having to administer epinephrine or visit the ER.  I have completely recovered from the asthma attack, and it seems that my achiness has improved somewhat over the course of today, so I expect it will be gone soon. Therefore, I am marking "yes" on question #9.  Also, in regard to question #13, I am not sure about the route, but I suspect it was intramuscular. I list 9 as # of previous doses, as I have received flu vaccine every year for AT LEAST the last 10 years.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Ear pain, Pain in jaw, Shoulder pain, Sleep disorder
Clinical narrative: I RECENTLY GOT A FLU SHOT ON 11/04/2003. A COUPLE OF WEEKS LATER, I DEVELOPED A CRONIC ACHING PAIN IN MY RIGHT SHOULDER (SAME ONE WHERE I GOT THE SHOT) THAT CONTINUES TO THIS DAY.  THE PAIN IS SIGNIFICANT ENOUGH THAT IT KEEPS ME FROM BEING ABLE TO SLEEP AT NIGHT WHICH RESULTS IN LOST TIME AT WORK.  I HAVE BEEN GETTING FLU SHOTS NOW FOR THE PAST 3 YEARS.  I EXPERIENCED A SIMULAR PROBLEM IN THE PAST BUT NEVER MADE A CONNECTION TO THE FLU SHOT. I HAD AN ACHING PAIN IN MY RIGHT EAR AND JAW THAT LASTED FOR 60-90 DAYS. IT APPEARS THAT THIS PAIN IN MY SHOULDER WILL LAST JUST AS LONG.  EVERTHING THAT I HAVE READ SAYS THAT THE FLU SHOT CAN CAUSE ACHES AND PAINS FOR 2-3 DAYS. I WANT IT TO BE ON THE RECORD THAT THEY CAN LAST FOR SEVERAL MONTHS.  I AM NOT ALLERGIC TO EGGS.  I WILL NEVER GET ANOTHER FLU SHOT. I WOULD RATHER DIE FROM THE FLU THAN SUFFER THE PAIN.
Age: 8.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site reaction, Pruritus, Rash erythematous, Urticaria
Clinical narrative: PT BROUGHT IN 24 HOURS POST INJECTION WITH LOCAL REACTION OF 3 X 5 PATCH RED RAISED HIVES OVER RIGHT DELTOID AND PRURITIS AT SITE.  NO RESPIRATORY S/S.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Fatigue, Headache, Pharyngolaryngeal pain, Vertigo
Clinical narrative: FATIGUE, SORE THROAT, VERTIGO/DIZZINESS, HEADACHE.   RESTED, DRANK FLUIDS, TOOK TYLENOL FOR 24 HOURS AFTER ONSET OF SYMPTOMS.   SYMPTOMS STARTED WITH FATIGUE AND SORE THROAT AROUND 9PM ON 11/21 (DATE OF VACCINE) AND I WOKE UP ON 11/22 WITH VERTIGO/DIZZINESS/HEADACHE AND THOUGHT I WOULD FAINT IF I TRIED TO GET OUT OF BED. SYMPTOMS RESOLVED BY THE TIME I WOKE UP ON 11/23
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: LR-4 REACTION RESOLVED.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Respiratory disorder, Respiratory distress, Wheezing
Clinical narrative: Pt received her second flu shot on 11/26/03 at 2:45.  Her first shot was received one month earlier (this was her first year with the flu shot).  After her first shot she seemed to have a wheeze, but we all assumed it was a cold.  After the second flu shot, she woke up at 3:00 on 11/27/03 with a strange sounding cough.  She coughed all day and seemed tired.  Again we assumed she was coming down with a cold.  At 7:30 pm I noticed she was breathing funny.  At 10:00 pm we noticed her breathing was even worse and labored.  We immediately called the on call physician from Medical Office and then rushed her to Hospital. Doctors in the ER advised she was in respatory distress.  She was placed on a nebulizer for 3 treatments, given steroids orally, and received a chest x-ray to rule out pneumonia.  After being stabilized she was discharged from the hopsital at 2:30 am on 11/28/03.  It is suspected that Arianna may be allergic to something on the list that would indicate she should not get flu shots.  She will be tested for allergies shortly to help us determine what it is she may be allergic to.  We know it is not eggs.  Pt will be on oral seroids for the next 3-5 days and now has an inhaler.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling since vaccination limited to vaccination area less than 1 cm wide. I have applied neosporin.  Vaccination administered at work through Centro Med and paid by employer.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Influenza vaccine administered on 11/28/2003 at 3:30 pm.  Patient developed spreading erythema, induration, pain and warmth at intramuscular injection site (left anterior thigh)first noticed on 11/29/2003 at 9:30 am.  Oral Augumentin started on 11/29/2003 at 11:30 pm.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Headache, Neck pain, Pain, Pharyngolaryngeal pain
Clinical narrative: Vaccine Administered 9:30 AM Nov 28 Developed sore throat, cough, and headache two hrs later. Condition worsened during day. Experienced intermittent pain in neck, arms, legs. Developed red rash on buttocks.  Applied anti itch ointment, and antibiotic cream. No benefit. Condition same Nov29. Took 50 mg Benadryl every 4 hrs. Took two Tyanol. Condition about same on Nov 30 Slight improvment in headache, no change in rash, cough, and sore throat. Neck pain continues
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Vaccine Administered 9:30 AM Nov 28 Developed sore throat, cough, and headache two hrs later. Condition worsened during day. Experienced intermittent pain in neck, arms, legs. Developed red rash on buttocks.  Applied anti itch ointment, and antibiotic cream. No benefit. Condition same Nov29. Took 50 mg Benadryl every 4 hrs. Took two Tyanol. Condition about same on Nov 30 Slight improvment in headache, no change in rash, cough, and sore throat. Neck pain continues
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: Within about 18 hours of receiving the shot:  Hives on scalp, ears, eyelids, throat/neck, chest, hips, back, legs, wrists.  Swollen eyelids.  Chills.  Treatment:  Patient took Benadryl and used Benadryl cream before seeing the doctor (recommended by the advice nurse.)  The doctor recommended that the patient take Claritin, and the patient took the generic equivalent (Loratadine).  The treatment temporarily eased some of the itching, and the hives appeared to flatten out and spread in diameter.   As of 11/30/03: Hives are still present, large, and are even darker pink than before.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Bacterial infection, Pyrexia, Urticaria
Clinical narrative: She broke out with extreme hives all over her body. We went on vacation and had to take her to a doctor out of state 2 days after the vaccine for steroid meds and allergy meds because benadryl was not working.  When the hives started it was just a few and I called clinic after hours #.  They told me to use cortisome cream and if it got worse Benadryl. 2 days later she was worse & we ended up at a drs. office.  At that time she had also started running a low grade temp.  The pricked her finger and ran a blood test and said she had some type of bacterial infection.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: Client denies any on-going cardiac sequelae. Results of echo, Stress ECG, Resting ECG and lab pending
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: Client denies any on-going cardiac sequelae. Results of echo, Stress ECG, Resting ECG and lab pending
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: Mr. XXXXXX has done very well. He denies any on-going cardiac sequelea.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: Mr. XXXXXX has done very well. He denies any on-going cardiac sequelea.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Stupor, Viral infection
Clinical narrative: It was reported that a 2 year old male pt received Fluzone administered IM in the right arm on 11/11/03 at 10:40 am. Three days later the pt experienced a generalized tonic/clonic seizure lasting one to two minutes while in bed with his parents. The pt did not have a fever. Short post-ictal phase. The pt has no prior history. The pt reportedly did recover from this event. From additional info received on 11/24/03 from reporter: The dose of Fluzone given wsa.25ml. This child was seen by a neurologist, who stated that the test results were coming back within normal limits. An EEG was scheduled, and the results will be forwarded. He felt the causality will be determined after the EEG report was obtained. The name and contact info of the neurologist was provided.  Follow up on 12/12/03: "From additional information received on 12/08/03 from the reporting physician, the results of the EEG report were provided.  On 12/02/03, the pt underwent a resting 19-channel EEG.  The impression was moderately abnormal EEG indicative of potential epileptogenic focus that was maximal over the left anterior temporal central regions.  Clinical correlation is advised.  No other information was provided at this time."
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: It was reported that a 2 year old male pt received Fluzone administered IM in the right arm on 11/11/03 at 10:40 am. Three days later the pt experienced a generalized tonic/clonic seizure lasting one to two minutes while in bed with his parents. The pt did not have a fever. Short post-ictal phase. The pt has no prior history. The pt reportedly did recover from this event. From additional info received on 11/24/03 from reporter: The dose of Fluzone given wsa.25ml. This child was seen by a neurologist, who stated that the test results were coming back within normal limits. An EEG was scheduled, and the results will be forwarded. He felt the causality will be determined after the EEG report was obtained. The name and contact info of the neurologist was provided.  Follow up on 12/12/03: "From additional information received on 12/08/03 from the reporting physician, the results of the EEG report were provided.  On 12/02/03, the pt underwent a resting 19-channel EEG.  The impression was moderately abnormal EEG indicative of potential epileptogenic focus that was maximal over the left anterior temporal central regions.  Clinical correlation is advised.  No other information was provided at this time."
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash erythematous, Rash papular
Clinical narrative: 10 dys after smallpox, pt had diffuse erythematous papular rxn over chest, back and post neck. + pustular lesions x 4-5 with early crusting. No hx signif acne. Rxn most c/w erythematous papular E multiforme on CDC web site. Pt feels fine - will monitor for transition to progressive vaccinia. Tx Velosef to prevent 2 bacterial infxn.
Age: 1.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Cardiac failure congestive, Condition aggravated, Sepsis, White blood cell count increased
Clinical narrative: This subject is a one and half year old female who was admitted to the hospital due to complications from congenital anomalies she has had since birth; AV canal with severe coarctation, severe clotting disorder probable factor 13 mutation. She was enrolled P3T08, a Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the standard of care. The subject received three doses of Infanrix for primary series and last dose of DTaP on 6/26/03. Also given on same date was IPV, HboC, hep B and Prevnar. Per the pt's medical doctor, the subject had severe congenital anomalies since birth. The pt was born with AV canal with severe coarctation which was repaired in the first week of life. Volvulus was repaired in May 2002. Subject had Glenn operation in January 2003 which failed and was hospitalized in the pediatric ICU from January 2003 until expiration. The subject likely had a factor 13 mutation/ severe clotting disorder. During hospitalization the subject had repeated elevated white counts probably secondary to sepsis. The pt expired due to congestive heart failure. Autopsy was done and the records have been requested. These events were reported by the investigator as unrelated to the study vaccine. A 15-day follow up report was received 12/29/2003 and adds no new info except for the 4th vaccine reported to be Prevnar. Follow-up information 14 April 2004: After a medical reveiw of the case, a new version of the report has been generated to add the adverse event "condition aggravated" including lymphedema, since due to her progressively worsening status and her potential long-term outcome, the decision was made by the family to move the patient to the care suite and to withdraw the support from the patient. Also, the date of onset for Factor X111 disorder was corrected from 6 April 2003 to 6 APril 2002.
Age: 1.42
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Brain neoplasm malignant, Collapse of lung, Neuroblastoma, Pleural effusion, Pneumonia
Clinical narrative: This subject is a 17 month old male, who was noted to have vomiting and an abdominal mass while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received four doses of Infanrix. The last dose prior to the event was given on 6/30/03. Other vaccines given on the same date were IPV, PRP-T, MMR and VZV. The subject developed vomiting and an abdominal mass was found, 14 days post-immunization. The subject underwent a tumor biopsy on 7/25/03, along with bone marrow aspirations and biopsies. The pt was diagnosed as a stage 4 Neuroblastoma and was started on the COG A3973 protocol. According to the protocol, the pt was due to have a stem cell harvest after two cycles of chemotherapy. The subject was to have a future autologous stem cell transplant if enough stem cells were harvested and other requirements of the protocol has been completed. There was unanimous agreement among the transplant committee that this subject was a candidate for a stem cell transplant assuming the subject remained on the COG protocol, and the subject met transplant criteria. The subject died on 9/1/03. The event of neuroblastoma, secondary brain/ spine cancer, anoxic brain damage, pneumonia, and pulmonary collapse was reported by the investigator as not related to the study vaccine. Autopsy is pending. A 15-day follow up report received 12/19/2003 adds no new info.
Age: 1.42
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: This subject is a 17 month old male, who was noted to have vomiting and an abdominal mass while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received four doses of Infanrix. The last dose prior to the event was given on 6/30/03. Other vaccines given on the same date were IPV, PRP-T, MMR and VZV. The subject developed vomiting and an abdominal mass was found, 14 days post-immunization. The subject underwent a tumor biopsy on 7/25/03, along with bone marrow aspirations and biopsies. The pt was diagnosed as a stage 4 Neuroblastoma and was started on the COG A3973 protocol. According to the protocol, the pt was due to have a stem cell harvest after two cycles of chemotherapy. The subject was to have a future autologous stem cell transplant if enough stem cells were harvested and other requirements of the protocol has been completed. There was unanimous agreement among the transplant committee that this subject was a candidate for a stem cell transplant assuming the subject remained on the COG protocol, and the subject met transplant criteria. The subject died on 9/1/03. The event of neuroblastoma, secondary brain/ spine cancer, anoxic brain damage, pneumonia, and pulmonary collapse was reported by the investigator as not related to the study vaccine. Autopsy is pending. A 15-day follow up report received 12/19/2003 adds no new info.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: This report described the occurrence of sudden infant death syndrome in a two month old female pt who received DTaP and hep B vaccine for prophyalxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. The pt's medical history, concurrent conditions, and concurrent medications were not reported; however, the reporter stated that a younger sibling had "severe sleep apnea." The reporter stated that the pt received the first dose of hep B vaccine at the time of birth without incident. On 8/28/02, the pt received the first dose of DTaP and second dose of hep B vaccine. On the same date, the pt also received injections of IPOL, and HIB vaccines. Approximately 72 hrs post-immunization, on 8/31/02, the pt died at her residence. The reporter stated that the autopsy indicated that the pt had died due to SIDS. Additional info has been rerquested.
Age: 1.05
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Agitation, Asthenia, Cyanosis, Dyskinesia, Eye movement disorder
Clinical narrative: Infant went to receive 1st varicella and 3rd Prevnar immunizations. Immunization given simultaneously by 2 nurses. Prevnar given R thigh IM and varicella L thigh. Infant cried initially for 3-5 sec then mother started to pull up child and noticed infant's eyes rolled back with jerky movement and became slightly dusky. Child then stimulated by a nurse and respond. A 2nd episode occurred with eyes rolled back and muscle flaccid. Infant stimulated again and infant stared eyes and dying. Pulse rate was irregular as checked by Dr. Infant responded was hospitalized for observation. medical records state asthenia, syncope. msv
Age: 1.05
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Heart rate irregular, Hypotonia, Syncope
Clinical narrative: Infant went to receive 1st varicella and 3rd Prevnar immunizations. Immunization given simultaneously by 2 nurses. Prevnar given R thigh IM and varicella L thigh. Infant cried initially for 3-5 sec then mother started to pull up child and noticed infant's eyes rolled back with jerky movement and became slightly dusky. Child then stimulated by a nurse and respond. A 2nd episode occurred with eyes rolled back and muscle flaccid. Infant stimulated again and infant stared eyes and dying. Pulse rate was irregular as checked by Dr. Infant responded was hospitalized for observation. medical records state asthenia, syncope. msv
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bronchiolitis, Erythema, Febrile convulsion, Otitis media, Respiratory syncytial virus infection
Clinical narrative: At approx 12 hrs after vaccine given pt had 102 deg fever and had 10 min seizure. WBC 14,000 nl diff. Ears red but previously well at time given. Full recovery. The follow up received on 1/14/04 states febrile seizure, bilateral otitis media and tachypneic. The discharge summaries for 12/03 states RSV and bronchiolitis.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tachypnoea, Trisomy 21
Clinical narrative: At approx 12 hrs after vaccine given pt had 102 deg fever and had 10 min seizure. WBC 14,000 nl diff. Ears red but previously well at time given. Full recovery. The follow up received on 1/14/04 states febrile seizure, bilateral otitis media and tachypneic. The discharge summaries for 12/03 states RSV and bronchiolitis.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain
Clinical narrative: Pain, erythema, swelling from injection site down to forearm.
Age: 0.67
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Mom noticed rash on stomach, back, neck, face, arms 2 days after immunization. Mother called clinic on 11/26/03 to speak to MD who instructed her not to have pt vaccinated with 2nd dose.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Petechiae, Pruritus, Urticaria, Vasculitis
Clinical narrative: Pruritis and urticaria one day after Influenza vaccine. Petechiae developed over the next 24 hours to most of body except face and neck, worst on legs. He otherwise felt fine. Probable vasculitis Dx.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site oedema, Pain
Clinical narrative: Noticed swelling around site and around arm 2 days after getting vaccinated. Swelling began moving down to elbow area, also had some tenderness and redness. Started to get better 11/16/03, 11/17/03. Advised warm soaks and call if no better 48 hours. Tylenol/Advil prn.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site oedema
Clinical narrative: Hypersensitivity to flu vaccine. Large edematous area left upper arm 14 x 13cm.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Swelling, redness at site right deltoid.  Complained of body aches.  Patient was prescribed Cipro 500mg 2 times a day for 7 days.  Tylenol 500mg every 4 hours as needed.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Upper arm became red, hot, itchy, hard per patient.  Now resolved.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Anthrax vaccination #4.  Right arm-swelling, redness, hot, itchy, diameter 10cm vaccination was given 11/16/2003 during UTA.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Rash
Clinical narrative: Swelling approximately 1-2 inches from site at the bicep area-rash did develop.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Neurodevelopmental disorder, Speech disorder
Clinical narrative: Mom describes child as autistic.  Child was slow in speech prior to vaccination.  On day of vaccination, child changed his personality.  He never spoke again.  He would not make eye contact.  He stopped pointing at objects and refused to interact with no one.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Developed an area of erythema on right upper arm about 10x7cm.  Non tenderness or swelling.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Child experienced a seizure after administration of vaccines.  Occurred approximately 10 minutes after the administration of MMR, VZV.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Muscle spasms, Musculoskeletal stiffness, Tenderness
Clinical narrative: Patient with injection site tenderness, fatigue, arthralgias, neck stiffness, muscle cramping.  Supportive care.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation
Clinical narrative: Local inflammatory resfuse at injection site.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: 11/23 developed about 20 varicella lesions, fever 102 in office.  Lesions localized face, abdomen, back 1 in mouth.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Reddened lump on right thigh.  Right thigh swelling with cellulitis.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Decreased appetite, Hypoventilation, Irritability, Pallor
Clinical narrative: Crying and irritability hours after vaccine given.  Decreased mouth intake.  At night baby developed shallow poor sleeping/breathing while sleeping difficult.  24 hours to arose, pale.  911 called, baby was fine upon arrival.  Taken to ER, normal exam.  Seen in office on 11/28/2003-fine.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sleep disorder
Clinical narrative: Crying and irritability hours after vaccine given.  Decreased mouth intake.  At night baby developed shallow poor sleeping/breathing while sleeping difficult.  24 hours to arose, pale.  911 called, baby was fine upon arrival.  Taken to ER, normal exam.  Seen in office on 11/28/2003-fine.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Epistaxis, Haematuria, Pyrexia, Thrombocytopenic purpura
Clinical narrative: Day after Hep A, fever for 3-4 days, followed by abdominal pain, vomiting, epistaxis, hematemesis, then gross hematuria (1 1/2 weeks after vaccine). Dx'd with ITP, being treated with IVIG. Still in hospital.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Day after Hep A, fever for 3-4 days, followed by abdominal pain, vomiting, epistaxis, hematemesis, then gross hematuria (1 1/2 weeks after vaccine). Dx'd with ITP, being treated with IVIG. Still in hospital.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Blood urine, Epistaxis, Haematemesis, Haematocrit decreased, Haematuria
Clinical narrative: Day after Hep A, fever for 3-4 days, followed by abdominal pain, vomiting, epistaxis, hematemesis, then gross hematuria (1 1/2 weeks after vaccine). Dx'd with ITP, being treated with IVIG. Still in hospital.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Haemoglobin decreased, Laboratory test abnormal, Lymphopenia, Pyrexia, Skin ulcer
Clinical narrative: Day after Hep A, fever for 3-4 days, followed by abdominal pain, vomiting, epistaxis, hematemesis, then gross hematuria (1 1/2 weeks after vaccine). Dx'd with ITP, being treated with IVIG. Still in hospital.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Thrombocytopenic purpura, White blood cell count increased
Clinical narrative: Day after Hep A, fever for 3-4 days, followed by abdominal pain, vomiting, epistaxis, hematemesis, then gross hematuria (1 1/2 weeks after vaccine). Dx'd with ITP, being treated with IVIG. Still in hospital.
Age: 1.33
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Upon waking 11/21/2003 parents noticed left thigh to be significantly larger with localized swelling and redness. Diameter of left thigh 34 cm.
Age: 3.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Respiratory distress, Urticaria, Wheezing
Clinical narrative: Pt received 5 vax's approx 12 PM today. (Unreadable) Pt's father. Pt broke out in hives approx 30 minutes after vax. Pt has hives in torso area. - distress, - wheezing. Pt seen back at clinic approx 2 1/2 hours after vaccination. Rx of Benadryl given.
Age: 1.08
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Contusion, Hyperhidrosis, Injury, Pyrexia, Rash erythematous
Clinical narrative: 11/12/03: per phone call request from father: rash on back noticed 11/9/03 red, slightly raised, small round areas, increased after bath 11/10/03. Few spots on chest. Redness at left arm injection site, not raised that has subsided. No fever (11/20/03). PC: no response, message left. 11/24/03: per father: had intermittent rash on arms, episodes of sweating, now reports T 100.5 Ax on 11/25, 11/26. Symptoms subsided. Now has bruises on left leg. 11/24/03: possible injury/bump (unreadable).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Myelitis transverse, Paralysis
Clinical narrative: A report was received from a health care professional on 11/18/2003 concerning a 45-year-old female pt who developed transverse myelitis with numbness and weakness in the lower extremities, and paralysis from the waist down approximately 12 days after receiving Fluvirin on 10/14/2003. On 10/26/2003, approximately 12 days after vaccination the pt began to experience symptoms of numbness and weakness in the lower extremities. This progressed to the point of paralysis from the waist down. The pt was hospitalized on an unspecified date. A spinal tap and a magnetic resonance imaging scan failed to reveal an infection or any other process. The attending neurologist diagnosed the condition as transverse myelitis. The pt had not recovered at the time of the report, and remains hospitalized. There was insufficient info to determine the reporter's causality assessment. The reporter indicated that the attending neurologist informed her that she (the neurologist) would be reporting this event to CDC. Follow up pending.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: This subject is a 6 month old female, who was pronounced dead due to sudden infant death syndrome while enrolled in a Comparative post-marketing study of CPDT Vaccine Absorbed administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received one dose of Pediarix on 4/15/03. Other vaccines received on the same day were PRP T and Prevnar. THe subject was pronounced dead at 18:26 hours on 8/14/03. The condition directly leading to death was consistent with sudden infant death syndrome. Anatomical diagnoses reported included pulmonary congestion and edema as well as visceral congestion. There were no congenital anomalies. 0.28mg/L of Atropine was detected in a heart blood sample. No other common acidic, neutral or basic drugs were detected. No blood Ethyl Alcohol or other alcohols or acetone were detected. No analgesics or barbiturates were detected by specific Immunoassay. According to the autopsy report, there were no blunt injuries to the body. The outcome of this event is fatal. The event of sudden infant death syndrome was reported by the investigator as unlikely/not related to the study vaccine.
Age: 38.0
Sex: M
Vaccine: YF
Symptoms: Eyelid oedema, Pharyngolaryngeal pain, Pruritus, Pyrexia
Clinical narrative: Swollen itchy eyelids. Some throat irritation. Temp 97.1, P 88, B/P 112/74, Resp. 18. Decadron 40mg IM stat. Allegra 60mg daily x 10. Prednisone 10mg bid.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia, Swelling
Clinical narrative: Patient states 1 1/2 hours after vaccine given had "throbbing" pain at site of injection and arm pit.  Called PCP office told to use ice packs and tylenol.  Never had appt in office.  C/O fever x 6 nights, chills 8-10 nights.  No temperature taken.  Swelling from armpit gone since week of Nov. 17th.  Can use arm more now.  Still has "stabbing" pain between shoulder and elbow.  Instructed patient to see PCP.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Dyspnoea, Oedema peripheral, Wheezing
Clinical narrative: Bilateral leg swelling, ED visit for shortness of breath and wheezing, received nebulizer treatment
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 HOURS AFTER RECEIVING THE FLU VACCINE ON 11/19/03, CLIENT EXPERIENCED ITCHING AND SORENESS AT THE SITE.  ON 11/20 CLIENT NOTICED REDNESS AND SWELLING AND PAIN IN RIGHT ARM.  CLIENT SEEN IN CLINIC 11/20.  INJECTION SITE SWOLLEN, RED AND WARM TO TOUCH.  AREA APPROXIMATELY 2 INCHES WIDE.  MD WROTE PRESCRIPTION FOR KEFLEX 500MG PO TID X 10 DAYS AND BENADRYL 50 MG TID X 5 DAYS.  CLIENT WAS CALLED ON 12/1 AND REPORTS SWELLING AND REDNESS WERE COMPLETELY GONE BY 11/29.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: 2 HOURS AFTER RECEIVING THE FLU VACCINE ON 11/19/03, CLIENT EXPERIENCED ITCHING AND SORENESS AT THE SITE.  ON 11/20 CLIENT NOTICED REDNESS AND SWELLING AND PAIN IN RIGHT ARM.  CLIENT SEEN IN CLINIC 11/20.  INJECTION SITE SWOLLEN, RED AND WARM TO TOUCH.  AREA APPROXIMATELY 2 INCHES WIDE.  MD WROTE PRESCRIPTION FOR KEFLEX 500MG PO TID X 10 DAYS AND BENADRYL 50 MG TID X 5 DAYS.  CLIENT WAS CALLED ON 12/1 AND REPORTS SWELLING AND REDNESS WERE COMPLETELY GONE BY 11/29.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Prothrombin level increased
Clinical narrative: PT IS ON COUMDIN AND INR LEVEL WENT UP OVER 100
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: developed chickenpox
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Coma, Convulsion, Dizziness
Clinical narrative: After receiving Hepatitis A vaccination on left arm, within several seconds patient stated she felt light-headed, slumped over and became unresponsive for several moments.  Patient may have had a seizure.  Patient was stabilized and released to father to see a private physician.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Injection site mass, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: anthrax #4 vaccination on November 8, 2002.  Immediately, he reports that he noticed a large knot at the vaccination site. Within 8 to 12 hours he developed a fever although he does not know how high his temperature was. At this time he noticed that his arm was warm to touch and had a moderate amount of swelling around the knot at the injection site. He also developed hives over his back and arm. He had never experienced hives prior to this. He reported to the immunization clinic and was directed to the emergency room. There he was instructed to take Benadryl for the symptoms he was experiencing. He did not find the Benadryl to be effective. He was also told that he would receive a call from an allergy and an appointment would be made for him to be seen. He did not receive that call. He reports that the warmth and swelling lasted 3-to-4 days. The knot at the injection site lasted for a much longer time. He was deployed on November 20, 2002. He received anthrax #5 while deployed on January 2003. Again, he reports he experienced a knot at the site immediately. Within 8-to-12-hours he again developed hives. At this time, he reports that he does not remember the specific duration of the symptoms due to the assignment and work he was involved in while deployed. He returned to the states in April 2003.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Discomfort, Gait disturbance, Injection site oedema
Clinical narrative: From initial information received on 03/17/2003 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a four-year-old male patient received an IPOL, Lot # W0334 and an Infanrix (SKB, Lot # DTPA583A2) vaccination administered intra-muscular in his left thigh at 15:00 on 02/24/2003.  He also received a subcutaneous injection of MMR (Merck, Lot # 1013M) in this right thigh on the same date.  In the morning of 02/25/2003, the patient's entire left thigh to his knee was swollen.  The patient complained of discomfort and was limping.  The patient was seen in his doctor's office on 02/26/2003 at which time he was afebrile, his entire left anterior thigh was swollen, including his knee, and inner aspect thigh was red.  The patient was treated with Keflex at 250mg three times a day for seven days.  The swelling improved as of 02/27/2003 and the event had resolved by 03/03/2003.  The patient was seen by his doctor a total of three times during this event, which he did recover from.  It was reported by the same reporter that a similar incident in another four year old child occurred two days later, that child having received a thigh injection of IPOL from the same lot (see case 2003-00438 for details).  The reporter of this case is the same reporter of case 2003-00438.
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Accident, Anaemia, Back pain, Blood lactate dehydrogenase increased, Blood pressure decreased
Clinical narrative: This case was derived from a newspaper and describes the occurrence of lupus and the subsequent death in a female subject of unknown age receiving hepatitis B vaccine for prophylaxis. Co-suspect drugs included measles vaccine, smallpox vaccine, mumps vaccine, anthrax, measles vaccine and typhoid fever vaccine. Early this year (about 3/03), the subject received shots against rubella, smallpox, mumps, anthrax, measles, typhoid fever and hepatitis B vaccine. In 4/03, she died from a complicated illness diagnosed as like lupus. According to the surgeon general's officer, receiving several shots at once is considered safe and not uncommon and the subject had no skin conditions or immune system issues that would have excluded her from having the smallpox vaccine and that the vaccination policies for the military will not be changed. According to the Army, 2 civilial medical panels reviewed the subject's case and there were agreed that her death was probably or possibly related to the vaccines.
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Chest pain, Collagen disorder, Convulsion, Cough, Dyspnoea
Clinical narrative: This case was derived from a newspaper and describes the occurrence of lupus and the subsequent death in a female subject of unknown age receiving hepatitis B vaccine for prophylaxis. Co-suspect drugs included measles vaccine, smallpox vaccine, mumps vaccine, anthrax, measles vaccine and typhoid fever vaccine. Early this year (about 3/03), the subject received shots against rubella, smallpox, mumps, anthrax, measles, typhoid fever and hepatitis B vaccine. In 4/03, she died from a complicated illness diagnosed as like lupus. According to the surgeon general's officer, receiving several shots at once is considered safe and not uncommon and the subject had no skin conditions or immune system issues that would have excluded her from having the smallpox vaccine and that the vaccination policies for the military will not be changed. According to the Army, 2 civilial medical panels reviewed the subject's case and there were agreed that her death was probably or possibly related to the vaccines.
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Laboratory test abnormal, Mental impairment, Nausea, Pleural effusion
Clinical narrative: This case was derived from a newspaper and describes the occurrence of lupus and the subsequent death in a female subject of unknown age receiving hepatitis B vaccine for prophylaxis. Co-suspect drugs included measles vaccine, smallpox vaccine, mumps vaccine, anthrax, measles vaccine and typhoid fever vaccine. Early this year (about 3/03), the subject received shots against rubella, smallpox, mumps, anthrax, measles, typhoid fever and hepatitis B vaccine. In 4/03, she died from a complicated illness diagnosed as like lupus. According to the surgeon general's officer, receiving several shots at once is considered safe and not uncommon and the subject had no skin conditions or immune system issues that would have excluded her from having the smallpox vaccine and that the vaccination policies for the military will not be changed. According to the Army, 2 civilial medical panels reviewed the subject's case and there were agreed that her death was probably or possibly related to the vaccines.
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Pneumonitis, Pyrexia, Sepsis, Supraventricular tachycardia, Vomiting
Clinical narrative: This case was derived from a newspaper and describes the occurrence of lupus and the subsequent death in a female subject of unknown age receiving hepatitis B vaccine for prophylaxis. Co-suspect drugs included measles vaccine, smallpox vaccine, mumps vaccine, anthrax, measles vaccine and typhoid fever vaccine. Early this year (about 3/03), the subject received shots against rubella, smallpox, mumps, anthrax, measles, typhoid fever and hepatitis B vaccine. In 4/03, she died from a complicated illness diagnosed as like lupus. According to the surgeon general's officer, receiving several shots at once is considered safe and not uncommon and the subject had no skin conditions or immune system issues that would have excluded her from having the smallpox vaccine and that the vaccination policies for the military will not be changed. According to the Army, 2 civilial medical panels reviewed the subject's case and there were agreed that her death was probably or possibly related to the vaccines.
Sex: F
Vaccine: ANTH, SMALL, ANTH, HEP, MEA, MU, RUB, SMALL, ANTH, HEP, MMR, SMALL, TYP
Symptoms: Systemic lupus erythematosus
Clinical narrative: This case was derived from a newspaper and describes the occurrence of lupus and the subsequent death in a female subject of unknown age receiving hepatitis B vaccine for prophylaxis. Co-suspect drugs included measles vaccine, smallpox vaccine, mumps vaccine, anthrax, measles vaccine and typhoid fever vaccine. Early this year (about 3/03), the subject received shots against rubella, smallpox, mumps, anthrax, measles, typhoid fever and hepatitis B vaccine. In 4/03, she died from a complicated illness diagnosed as like lupus. According to the surgeon general's officer, receiving several shots at once is considered safe and not uncommon and the subject had no skin conditions or immune system issues that would have excluded her from having the smallpox vaccine and that the vaccination policies for the military will not be changed. According to the Army, 2 civilial medical panels reviewed the subject's case and there were agreed that her death was probably or possibly related to the vaccines.