chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Initial report received on 12/04/06 from a health care professional. A male pt, with no concurrent illnesses, had received a dose of Adacel, on 1/10/06. The lot number, route and site of administration were unk. A some point after receipt of Adacel, the pt was hospitalized and diagnosed with Guillain Barre syndrome. The pt was paralyzed from the waist down. he received rehabilitation therapy, and at the time of this report, the pt had fully recovered. Treatments received, and diagnostic test performed were not reported.  12/21/06 Received medical records from PCP which reveal patient received DT on 1/10/06 & note indicates healthy at that time.  Next note is for 11/21/06 which reveals patient had resolving GBS.  2/26/07 Received medical records from hospital which reveal patient admitted 3/06//06-4/14/06 after experiencing a several week history of progressive neck & back pain & muscle weakness.  Condition continued to worsen after admission.  Treated w/IVIG , plasmapheresis & steroids  During hospitalization developed ascending paralysis from feet to ocular muscles.  No respiratory compromise.  Neuro consult, PT/OT provided & transferred to inpatient rehab facility then to home with 24 hour care & home health PT then to day rehab program.  When d/c from inpatient rehab patient was max assist with rolling & assist to sit.  Was w/c bound w/RUE weakness.   FINAL DX: acute demyelinating polyneuropathy, most likely GBS; nypercholesterolemia.  7/21/09 Medical record received DOS 1/10/06 to 2/5/06. Onset of paralysis on 2/5/06. Still trouble climbing stairs in Nov.'06.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Ventricular tachycardia
Clinical narrative: Initial report received on 04 December 2006 from a health care professional. A 53-year-old male patient, with unknown medical history, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2184AA on an unspecified date. Reportedly, several hours post-immunization, the patient experienced ventricular tachycardia and a seizure.  The patient was subsequently hospitalized (dates not reported). Treatments received and diagnostic tests performed were reported as unknown.
Age: 24.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Dyspnoea, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: A report was received from a healthcare professional concerning a 24 year old female. the vaccinee has a history of splenectomy and penicillin allergy and had no concomitant medications. On 10/27/06 the vaccinee was administered influenza virus vaccine (brand unspecified) at and unspecified site and Pneumovax 23 0.5 ml SC in her left arm. On the evening of 10/27/06 the vaccinee developed a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the vaccinee developed shortness of breath, was hospitalized, and diagnosed with cellulitis of the left arm. The vaccinee was treated with an unspecified antibiotic through a PICC line. her white cell count was 46.2 )no units provided) and blood cultures were neg. An MRI of the upper left arm was also performed (no results were provided). The vaccinee was hospitalized for 5 days, and by 11/14/06 she had fully recovered. The reporter considered the events to be serious, immediately life threatening and medically significant (OMIC). The vaccinee had been vaccinated with Pneumovax 23 five years ago with no reported reactions. Further information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Pyrexia, White blood cell count increased
Clinical narrative: A report was received from a healthcare professional concerning a 24 year old female. the vaccinee has a history of splenectomy and penicillin allergy and had no concomitant medications. On 10/27/06 the vaccinee was administered influenza virus vaccine (brand unspecified) at and unspecified site and Pneumovax 23 0.5 ml SC in her left arm. On the evening of 10/27/06 the vaccinee developed a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the vaccinee developed shortness of breath, was hospitalized, and diagnosed with cellulitis of the left arm. The vaccinee was treated with an unspecified antibiotic through a PICC line. her white cell count was 46.2 )no units provided) and blood cultures were neg. An MRI of the upper left arm was also performed (no results were provided). The vaccinee was hospitalized for 5 days, and by 11/14/06 she had fully recovered. The reporter considered the events to be serious, immediately life threatening and medically significant (OMIC). The vaccinee had been vaccinated with Pneumovax 23 five years ago with no reported reactions. Further information has been requested.
Age: 56.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: A report was received from a healthcare professional concerning a 56 year old male vaccinee. No details concerning the vaccinee's past medical history were provided. On 11/7/06 the vaccinee was administered influenza vaccine (brand unspecified) and Pneumovax 23 0.5ml SC in separate sites (not specified). It was reported that the vaccinee developed a cellulitis shortly after his recent Pneumovax 23 vaccination, which was treated with oral antibiotics. The event outcome was not provided. The reporter considered the events to be serious, medically significant (OMIC).
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Dementia
Clinical narrative: Rapidly progressive dementia, likely CJD. 01/02/07-records received and reviewed. DC DX for DOS 11/11-11/23/06 DX: rapidly progressive dementia, likely Creutzfeldt-Jakob disease. 30 minutes after receiving tetanus shot she reported roaring sensation in both ears, 2 weeks prior to admission she was evaluated and felt to have eustachian tube dysfunction. She had slowing mentation, blunted affect and confusion.  Allergist consults: rapid progressive dementia, although acute/chronic encephalopathy have been prescribed for a subset of vaccinations, not aware of this to be a result from Td vaccination. Per information received from the annual follow up she died Dec. 16th 2006. Follow-up: She died. Doctors did not admit that her affliction was triggered by a vaccine, but she developed symptoms 1/2 hr. after having the shot.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: At time of flu vaccine visit, child vomited right after admin in clinic room. Mom stated child had more vomiting. Temp up to 103F, complained of fatigue-went to Emergency Room. Two days later younger sister developed fever, no appetite and the next week the other sister developed fever. Took comment from mother she was not getting second doses of flu vaccine because of these illnesses-that flu vaccine "caused" them to be terribly ill with nausea, vomiting, fatigue, fever.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Headache, Injection site reaction, Swelling
Clinical narrative: 2 days after immunization with Menactra got hives all over. Had headache. Localized reaction at injection site with redness 4cm heat and swollen. Tender to touch. Hives short lived for about 30 minutes.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 2 days after immunization with Menactra got hives all over. Had headache. Localized reaction at injection site with redness 4cm heat and swollen. Tender to touch. Hives short lived for about 30 minutes.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: Redness started 12/6. Came back to clinic 1:30pm 12/7. Right lateral upper 1/2 of upper leg indurated-deep pink-13cm circle-warm to touch.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: Within 24 hours, golf ball size red induration evenly around injection site. Patient complained of itching at site of injection. Mother treating patient at home with Benadryl.
Age: 11.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Vomiting
Clinical narrative: Mother stated child threw up and had a slight fever and had a red mark on right arm.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Nausea, Pain, Rhinorrhoea
Clinical narrative: I received Influenza IM on Tuesday 11/28/2006. By Saturday I was experiencing a runny nose, congestion with creamy white chunks prn w/cough, body aches, NO fever, and a queasy stomach. I have never had any reaction to past IM influenza vaccines before.  I do have an egg yoke/white intolerance, but have had no respiratory/rash/or anaphylatic problems. I don't eat eggs-upsets stomach.  PMH: NKDA, hemangioma removed as infant, seasonal allergies. MEDS: musinex for congestion and sudafed for clear nasal discharge. No medical treatment with PCP has been arranged by SM at this time. Denies shortness fo breath, chest pain, palpitations, n/v/d, pruritis, headaches or rash/hives/edema. For deployment next month.
Age: 2.0
Sex: M
Vaccine: DPP, HIBV, IPV, MMR
Symptoms: Decreased appetite, Rash erythematous, Skin discolouration
Clinical narrative: My son, age 6 (BD 4/18/2000), had an adverse event to his 2 yr old immunizations in 2002.  Approximately 6 hours post 4 immunizations (MMR, polio, HibB, Dtap) he developed a fine raised rash all over his body for 2-3 day that itched. Mom does not remember any fever, breathing difficulties. He did have a decrease in appetitie for a few days but no problem with fluid intake. He has no medical problems and NKDA, no past vaccine reactions. Neg Family history for asthma or skin diseases. He has the middle child with one brother and one sister.  He continues to have a "darkened" skin area behind his neck, in elbow creases and behind knee's that periodically have a "non-blanching small red bumpy-beaded" rash there.  MD state it is not eczema. He treats the area with Hydrophor and Eucerin cream 2-3x/day with relief of itch and dryness. He is being f/u by Allergy/Imm for skin testing 12/12 and sinus scans.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Agitation, Anorexia, Dizziness, Headache
Clinical narrative: Tdap given 10/12/06.  Heart raced 10/13/06.  Occasional dizziness, agitation, headache for two days, nausea/stomach cramps, and no appetite 10/14/06 to 10/22/06.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Nausea
Clinical narrative: Tdap given 10/12/06.  Heart raced 10/13/06.  Occasional dizziness, agitation, headache for two days, nausea/stomach cramps, and no appetite 10/14/06 to 10/22/06.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: PT. RECEIVED A FLU SHOT 12-12-06 AT 3:45PM AT OUR PUBLIC HEALTH CLINIC (HER HUSBAND ALSO RECEIVED A FLU SHOT AT THE SAME TIME, WITH THE SAME SERUM, AND RECEIVED NO REACTION) WITH IN A FEW HOURS SHE EXPERIENCED A HEADACHE, OVERALL BODY ACHES, FEVER, (DID NOT TAKE HER TEMPERATURE) WAVES OF NAUSEA AND VIOLENT SHAKING FOR AN HOUR AND 45 MINUTES. IT WAS SEVERE ENOUGH THAT SHE HAD HER HUSBAND CALL HER DOCTOR. SHE REPORTED SPINAL STENOSIS ON HER CONCENT FORM FOR A CHRONIC MEDICAL CONDITION, AND HAS HAD MANY PRIOR FLU SHOTS WITHOUT INCIDENT. SHE CALLED THIS MORNING TO SEE IF ANY OTHER PERSON HAD SIMILIAR EXPERIENCES AND REPORTED THAT SHE STILL FELT WEAK AND WASHED OUT BUT BETTER.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: PT. RECEIVED A FLU SHOT 12-12-06 AT 3:45PM AT OUR PUBLIC HEALTH CLINIC (HER HUSBAND ALSO RECEIVED A FLU SHOT AT THE SAME TIME, WITH THE SAME SERUM, AND RECEIVED NO REACTION) WITH IN A FEW HOURS SHE EXPERIENCED A HEADACHE, OVERALL BODY ACHES, FEVER, (DID NOT TAKE HER TEMPERATURE) WAVES OF NAUSEA AND VIOLENT SHAKING FOR AN HOUR AND 45 MINUTES. IT WAS SEVERE ENOUGH THAT SHE HAD HER HUSBAND CALL HER DOCTOR. SHE REPORTED SPINAL STENOSIS ON HER CONCENT FORM FOR A CHRONIC MEDICAL CONDITION, AND HAS HAD MANY PRIOR FLU SHOTS WITHOUT INCIDENT. SHE CALLED THIS MORNING TO SEE IF ANY OTHER PERSON HAD SIMILIAR EXPERIENCES AND REPORTED THAT SHE STILL FELT WEAK AND WASHED OUT BUT BETTER.
Age: 47.0
Sex: M
Vaccine: RAB
Symptoms: Constipation, Diarrhoea, Fatigue, Hyperaesthesia, Hypoaesthesia
Clinical narrative: Three days after receiving HRIG and Rabies Vaccine, surface numbness started in legs.  Within 2 weeks, progressed to feet, groin, trunk, arms, head.  Total skin surface sensory deficit w/areas of temperature insensitivity.  Pin prick significantly redcued.  Light touch most impacted. Also gastro symptoms (diarrhea, constipation), fasciculations, burning sensations, muscle fatigue.  Also experienced cold/flu symptoms one week after vaccine. Weakness, low grade fever, chest & sinus congestion.
Age: 47.0
Sex: M
Vaccine: RAB
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: Three days after receiving HRIG and Rabies Vaccine, surface numbness started in legs.  Within 2 weeks, progressed to feet, groin, trunk, arms, head.  Total skin surface sensory deficit w/areas of temperature insensitivity.  Pin prick significantly redcued.  Light touch most impacted. Also gastro symptoms (diarrhea, constipation), fasciculations, burning sensations, muscle fatigue.  Also experienced cold/flu symptoms one week after vaccine. Weakness, low grade fever, chest & sinus congestion.
Age: 1.18
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Discomfort, Pruritus, Rash vesicular, Skin ulcer
Clinical narrative: Patient presented to office with vesicular rash on face, trunk that was causing itching and discomfort. Patient did not have fever. There were less than 50 lesions present at the time of visit.
Age: 47.0
Sex: M
Vaccine: HEPAB, MMR, TDAP, TYP
Symptoms: Chills, Dizziness, Malaise, Pyrexia
Clinical narrative: Patient's Girlfriend called and reported patient to have a fever, chills, lightheadedness, and malaise starting early this morning after receiving vaccinations yesterday.  Patient self treating with Tylenol for symptoms.  Unknown if symptoms are vaccine related, but advised her to tell patient to call his physician about symptoms he is experiencing.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Pharyngolaryngeal pain, Throat tightness
Clinical narrative: Evening of vaccination, states that she noticed she was continually clearing her throat. Throat felt "sore, scratchy, and on fire." Stated sternum was sore, and hurt to breathe. Stated she called local ER and was advised to just take tylenol and benadryl, and go to bed. States when she woke up this morning, "eyes were glued shut", still has sensation of "lump in throat, and it feels full of phlegm." Does state that she feels better this morning than she did last night.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Eye swelling, Ocular hyperaemia, Rash, Wheezing
Clinical narrative: Asthma like symptoms - wheezing when laying down - throat itching, eyes red and face slightly puffy, slight rash on abdomen.
Age: 0.31
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pruritus, Vision blurred
Clinical narrative: Dizzy, vision blurred and cloudy some nausea, some itching.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Dermatitis contact, Pruritus
Clinical narrative: SINCE VACCINE WAS ADMINISTERED PATIENT HAS HAD PROBLEMS WITH ITCHY SKIN.  PATIENT HAS SEEN NUMEROUS DOCTORS AND ALL HAVE DETERMINED IT TO BE "CONTACT DERMATITIS" PATIENT DID NOT RESPOND TO TOPICAL CREAMS/ANTIHISTAMINES.  PATIENT TOLD EACH PRACTICIONER THAT THE PROBLEM STARTED AFTER ANTHRAX/SMALLPOX VACCINATIONS WERE ADMINISTERED.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling injection site to elbow.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Pt diagnosed with Varicella today. Given fever precautions and told to return for any problems. Temp 101.3 at office. MD describes papulo-vesicular lesions on abdomen and back.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Redness swelling itching injection site to elbow.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Injection 11/10/2006 received a tetanus and diphtheria booster.  2 weeks later complained of pain at site. no treatment.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Confusional state, Pyrexia, Rash
Clinical narrative: SIRS, Developed left arm cellulitis and fever of 103 with delirium and confusion. Rash on lower extremeties and trunk.  1/16/07 Received medical records from hospital which reveal patient admitted 12/13/06-12/15/06.  Patient with known MS presented to ER on 12/12/06 after receiving vax on 12/11/06 with fever & altered mental status.  Noted to be quite delirious, combative & appeared septic in ER.   Temp 103.2.  Pneumovax site was markedly inflamed & indurated.  Had maculopapular erythematous rash on thighs. Treated with antibiotics & steroids & improved significantly. FINAL DX: Systemic Inflammatory Response Syndrome (SIRS); Immune reaction to pneumovax; multiple sclerosis; & delirium, resolved.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Patient became sore and had muscle aches. Work in engine room on heavy equipment after the flu shot may have contributed. Experiencing a fever and headache.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Anaemia, Blood glucose increased, Cellulitis, Discomfort, Erythema
Clinical narrative: A report was received from a health care professional via another company concerning a 38 year old female vaccinee. On 10/16/06 the vaccinee was administered an Influenza vaccine in her right arm and Pneumovax 23, 0.5ml IM in her left arm. By th evening of 10/16/06, the vaccinee had developed discomfort in her left arm with progressive difficulty in moving it. The injection site was also red painful and tender. On 10/17/06 the left arm discomfort continued, the arm became red and the vaccinee was unable to raise the arm. The vaccinee had also developed a temp of 10.F, sweats and a headache. There were no problems with the right arm at the site of influenza vaccination. On 10/18/06 the vaccinee started vomiting, a CBC was performed, and the vaccinee was called in for examination when the results were returned at 18K. Physical examination on 10/18/06 revealed a temp of 103.3, pulse 130, pulse OX 98, blood pressure 122/70 and a respiratory rate of 14. The vaccinee was diaphoretic, and tachycardia was confirmed. The skin was remarkable for tenderness and a 6cm patch of erythema at the injection site and another 2cm patch of erythema nearby. Investigations revealed a WBC of 18.1 with 85.7% neutrophils and leukocytosis. It was reported that the vaccinee had a febrile reaction to Pneumovax 23 vaccination and that a secondary infection at the injection site could not be ruled out. the vaccinee was commenced on Keflex. the vomiting was considered secondary and was to be treated with Phenegran. On 10/19/06, the vaccinee had a fever of 101\4F, continued vomiting, leukocytosis and a swollen arm. the vaccinee was admitted to hospital on 10/19/06 for left shoulder redness and tenderness consistent with cellulitis. As the symptoms were progressing it was considered that the Cephalexin was not working, so the vaccinee was commenced on IV Clindamycin and Vancomycin. The affected area was now 9x12 and the secondary smaller area was 3cm. the vaccinee white cell count on admission was 22000, T max 101.7 at 1:+1, pulse 105, RR 16, blood pressure 118/73 and oxygen Saturation 99% on room air. Ultrasound of the upper extremity on 10/20/06 showed no evidence of fluid collection or foreign body. As of 10/20/06 the redness had spread a little further but induration and inflammation was reduced. There was no axillary lymphadenopathy, no streaking, and the vaccinee could move her arm more freely. The white cell count was down to 18000, hematocrit down from 35 to 30, glucose 125 and UA showed a specific gravity of 1.031, greater than 300 protein and she remained afebrile from 10/19/06. Incidental findings were a hematocrit of 30 with a MCV of 91 post hydration probably consistent with iron deficiency anemia. The reporter considered the events to serious  other medical event (OMIC). The vaccinee recovered.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Haematocrit decreased, Headache, Hyperhidrosis, Hypokinesia, Injection site erythema
Clinical narrative: A report was received from a health care professional via another company concerning a 38 year old female vaccinee. On 10/16/06 the vaccinee was administered an Influenza vaccine in her right arm and Pneumovax 23, 0.5ml IM in her left arm. By th evening of 10/16/06, the vaccinee had developed discomfort in her left arm with progressive difficulty in moving it. The injection site was also red painful and tender. On 10/17/06 the left arm discomfort continued, the arm became red and the vaccinee was unable to raise the arm. The vaccinee had also developed a temp of 10.F, sweats and a headache. There were no problems with the right arm at the site of influenza vaccination. On 10/18/06 the vaccinee started vomiting, a CBC was performed, and the vaccinee was called in for examination when the results were returned at 18K. Physical examination on 10/18/06 revealed a temp of 103.3, pulse 130, pulse OX 98, blood pressure 122/70 and a respiratory rate of 14. The vaccinee was diaphoretic, and tachycardia was confirmed. The skin was remarkable for tenderness and a 6cm patch of erythema at the injection site and another 2cm patch of erythema nearby. Investigations revealed a WBC of 18.1 with 85.7% neutrophils and leukocytosis. It was reported that the vaccinee had a febrile reaction to Pneumovax 23 vaccination and that a secondary infection at the injection site could not be ruled out. the vaccinee was commenced on Keflex. the vomiting was considered secondary and was to be treated with Phenegran. On 10/19/06, the vaccinee had a fever of 101\4F, continued vomiting, leukocytosis and a swollen arm. the vaccinee was admitted to hospital on 10/19/06 for left shoulder redness and tenderness consistent with cellulitis. As the symptoms were progressing it was considered that the Cephalexin was not working, so the vaccinee was commenced on IV Clindamycin and Vancomycin. The affected area was now 9x12 and the secondary smaller area was 3cm. the vaccinee white cell count on admission was 22000, T max 101.7 at 1:+1, pulse 105, RR 16, blood pressure 118/73 and oxygen Saturation 99% on room air. Ultrasound of the upper extremity on 10/20/06 showed no evidence of fluid collection or foreign body. As of 10/20/06 the redness had spread a little further but induration and inflammation was reduced. There was no axillary lymphadenopathy, no streaking, and the vaccinee could move her arm more freely. The white cell count was down to 18000, hematocrit down from 35 to 30, glucose 125 and UA showed a specific gravity of 1.031, greater than 300 protein and she remained afebrile from 10/19/06. Incidental findings were a hematocrit of 30 with a MCV of 91 post hydration probably consistent with iron deficiency anemia. The reporter considered the events to serious  other medical event (OMIC). The vaccinee recovered.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site induration, Injection site infection, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: A report was received from a health care professional via another company concerning a 38 year old female vaccinee. On 10/16/06 the vaccinee was administered an Influenza vaccine in her right arm and Pneumovax 23, 0.5ml IM in her left arm. By th evening of 10/16/06, the vaccinee had developed discomfort in her left arm with progressive difficulty in moving it. The injection site was also red painful and tender. On 10/17/06 the left arm discomfort continued, the arm became red and the vaccinee was unable to raise the arm. The vaccinee had also developed a temp of 10.F, sweats and a headache. There were no problems with the right arm at the site of influenza vaccination. On 10/18/06 the vaccinee started vomiting, a CBC was performed, and the vaccinee was called in for examination when the results were returned at 18K. Physical examination on 10/18/06 revealed a temp of 103.3, pulse 130, pulse OX 98, blood pressure 122/70 and a respiratory rate of 14. The vaccinee was diaphoretic, and tachycardia was confirmed. The skin was remarkable for tenderness and a 6cm patch of erythema at the injection site and another 2cm patch of erythema nearby. Investigations revealed a WBC of 18.1 with 85.7% neutrophils and leukocytosis. It was reported that the vaccinee had a febrile reaction to Pneumovax 23 vaccination and that a secondary infection at the injection site could not be ruled out. the vaccinee was commenced on Keflex. the vomiting was considered secondary and was to be treated with Phenegran. On 10/19/06, the vaccinee had a fever of 101\4F, continued vomiting, leukocytosis and a swollen arm. the vaccinee was admitted to hospital on 10/19/06 for left shoulder redness and tenderness consistent with cellulitis. As the symptoms were progressing it was considered that the Cephalexin was not working, so the vaccinee was commenced on IV Clindamycin and Vancomycin. The affected area was now 9x12 and the secondary smaller area was 3cm. the vaccinee white cell count on admission was 22000, T max 101.7 at 1:+1, pulse 105, RR 16, blood pressure 118/73 and oxygen Saturation 99% on room air. Ultrasound of the upper extremity on 10/20/06 showed no evidence of fluid collection or foreign body. As of 10/20/06 the redness had spread a little further but induration and inflammation was reduced. There was no axillary lymphadenopathy, no streaking, and the vaccinee could move her arm more freely. The white cell count was down to 18000, hematocrit down from 35 to 30, glucose 125 and UA showed a specific gravity of 1.031, greater than 300 protein and she remained afebrile from 10/19/06. Incidental findings were a hematocrit of 30 with a MCV of 91 post hydration probably consistent with iron deficiency anemia. The reporter considered the events to serious  other medical event (OMIC). The vaccinee recovered.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Laboratory test abnormal, Leukocytosis, Pyrexia, Tachycardia
Clinical narrative: A report was received from a health care professional via another company concerning a 38 year old female vaccinee. On 10/16/06 the vaccinee was administered an Influenza vaccine in her right arm and Pneumovax 23, 0.5ml IM in her left arm. By th evening of 10/16/06, the vaccinee had developed discomfort in her left arm with progressive difficulty in moving it. The injection site was also red painful and tender. On 10/17/06 the left arm discomfort continued, the arm became red and the vaccinee was unable to raise the arm. The vaccinee had also developed a temp of 10.F, sweats and a headache. There were no problems with the right arm at the site of influenza vaccination. On 10/18/06 the vaccinee started vomiting, a CBC was performed, and the vaccinee was called in for examination when the results were returned at 18K. Physical examination on 10/18/06 revealed a temp of 103.3, pulse 130, pulse OX 98, blood pressure 122/70 and a respiratory rate of 14. The vaccinee was diaphoretic, and tachycardia was confirmed. The skin was remarkable for tenderness and a 6cm patch of erythema at the injection site and another 2cm patch of erythema nearby. Investigations revealed a WBC of 18.1 with 85.7% neutrophils and leukocytosis. It was reported that the vaccinee had a febrile reaction to Pneumovax 23 vaccination and that a secondary infection at the injection site could not be ruled out. the vaccinee was commenced on Keflex. the vomiting was considered secondary and was to be treated with Phenegran. On 10/19/06, the vaccinee had a fever of 101\4F, continued vomiting, leukocytosis and a swollen arm. the vaccinee was admitted to hospital on 10/19/06 for left shoulder redness and tenderness consistent with cellulitis. As the symptoms were progressing it was considered that the Cephalexin was not working, so the vaccinee was commenced on IV Clindamycin and Vancomycin. The affected area was now 9x12 and the secondary smaller area was 3cm. the vaccinee white cell count on admission was 22000, T max 101.7 at 1:+1, pulse 105, RR 16, blood pressure 118/73 and oxygen Saturation 99% on room air. Ultrasound of the upper extremity on 10/20/06 showed no evidence of fluid collection or foreign body. As of 10/20/06 the redness had spread a little further but induration and inflammation was reduced. There was no axillary lymphadenopathy, no streaking, and the vaccinee could move her arm more freely. The white cell count was down to 18000, hematocrit down from 35 to 30, glucose 125 and UA showed a specific gravity of 1.031, greater than 300 protein and she remained afebrile from 10/19/06. Incidental findings were a hematocrit of 30 with a MCV of 91 post hydration probably consistent with iron deficiency anemia. The reporter considered the events to serious  other medical event (OMIC). The vaccinee recovered.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Tenderness, Vomiting, White blood cell count increased
Clinical narrative: A report was received from a health care professional via another company concerning a 38 year old female vaccinee. On 10/16/06 the vaccinee was administered an Influenza vaccine in her right arm and Pneumovax 23, 0.5ml IM in her left arm. By th evening of 10/16/06, the vaccinee had developed discomfort in her left arm with progressive difficulty in moving it. The injection site was also red painful and tender. On 10/17/06 the left arm discomfort continued, the arm became red and the vaccinee was unable to raise the arm. The vaccinee had also developed a temp of 10.F, sweats and a headache. There were no problems with the right arm at the site of influenza vaccination. On 10/18/06 the vaccinee started vomiting, a CBC was performed, and the vaccinee was called in for examination when the results were returned at 18K. Physical examination on 10/18/06 revealed a temp of 103.3, pulse 130, pulse OX 98, blood pressure 122/70 and a respiratory rate of 14. The vaccinee was diaphoretic, and tachycardia was confirmed. The skin was remarkable for tenderness and a 6cm patch of erythema at the injection site and another 2cm patch of erythema nearby. Investigations revealed a WBC of 18.1 with 85.7% neutrophils and leukocytosis. It was reported that the vaccinee had a febrile reaction to Pneumovax 23 vaccination and that a secondary infection at the injection site could not be ruled out. the vaccinee was commenced on Keflex. the vomiting was considered secondary and was to be treated with Phenegran. On 10/19/06, the vaccinee had a fever of 101\4F, continued vomiting, leukocytosis and a swollen arm. the vaccinee was admitted to hospital on 10/19/06 for left shoulder redness and tenderness consistent with cellulitis. As the symptoms were progressing it was considered that the Cephalexin was not working, so the vaccinee was commenced on IV Clindamycin and Vancomycin. The affected area was now 9x12 and the secondary smaller area was 3cm. the vaccinee white cell count on admission was 22000, T max 101.7 at 1:+1, pulse 105, RR 16, blood pressure 118/73 and oxygen Saturation 99% on room air. Ultrasound of the upper extremity on 10/20/06 showed no evidence of fluid collection or foreign body. As of 10/20/06 the redness had spread a little further but induration and inflammation was reduced. There was no axillary lymphadenopathy, no streaking, and the vaccinee could move her arm more freely. The white cell count was down to 18000, hematocrit down from 35 to 30, glucose 125 and UA showed a specific gravity of 1.031, greater than 300 protein and she remained afebrile from 10/19/06. Incidental findings were a hematocrit of 30 with a MCV of 91 post hydration probably consistent with iron deficiency anemia. The reporter considered the events to serious  other medical event (OMIC). The vaccinee recovered.
Sex: F
Vaccine: FLU3
Symptoms: Respiratory distress, Stridor, Vocal cord paralysis
Clinical narrative: This case was reported by a consumer and described the occurrence of stridor in a female subject of unspecified age who was vaccainted with influenza virus vaccine (Fluarix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Fluarix. On 10/31/06, at an unspecified time after vaccination with Fluarix, the subject experienced stridor, respiratory distress and vocal cord paralysis. Her physician performed a tracheostomy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were unk.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling noted to Left arm at injection site. No pain, reassurance provided.
Age: 1.97
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Child was in for flu vaccine 12-11/06 approximately 12 noon mother phoned clinic 12-13/-06 related child had a febrile seizure @ 0 PM 12-12-06. Child's last seizure was a year ago after last flu shot mother reported. Was told not to withhold flu vaccine as he underwent testing for his seizure and was found to be normal. This recent seizure was a grand mal lasting 10 minutes. 12/27/06-records received and reviewed. per parent experienced seizure. Temp not recorded. HX of seizure 1/17/2006 after MMR vaccine, temp in ED on 1/17/2006- 104 (R).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Administered 0.5cc influenza vaccine to client on Left deltoid on 12/11/06. On 12/13/06 reports tenderness, redness and warmth at injection site. Denies any itching and other symptoms. Noted light color of redness on Left deltoid about 2x3 inches. No swelling or drainage. Negative for any other reactions.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Flu shot was given on November 29, 2006 at 10:30am. She comes on December 11, 2006 complaining of arm being numb.
Age: 10.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Feeling hot, Swelling
Clinical narrative: Mom stated child's arm where varicella vaccine was given is swollen and warm to touch. States was worse yesterday (12/12/06) and better today (12/13/06).
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Asthma, Chest X-ray, Condition aggravated, Depressed level of consciousness, Laboratory test normal
Clinical narrative: 1 hour past vaccines patient became hyporesponsive and pale. Mom brought him to clinic. He was saturation 85% room air and was difficult to arouse. His vital were stable and he responded to oxygen. Was transported to the ED where he recovered and was sent home. Normal labs, CXR ? mild RLL infiltrate. The nxt Day he was wheezing and is being treated for an asthma exacerbation. He has asthma. There was no symptoms prior to episode. He was well without any distress.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Lung infiltration, Pallor, Wheezing
Clinical narrative: 1 hour past vaccines patient became hyporesponsive and pale. Mom brought him to clinic. He was saturation 85% room air and was difficult to arouse. His vital were stable and he responded to oxygen. Was transported to the ED where he recovered and was sent home. Normal labs, CXR ? mild RLL infiltrate. The nxt Day he was wheezing and is being treated for an asthma exacerbation. He has asthma. There was no symptoms prior to episode. He was well without any distress.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash brook out on right arm 1-2 days after injection, no treatment.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Chest pain, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Chest Wall upper back painful with movement, 6x4.5cm induration at site of vaccine administration. 6x10cm overlying erythema, pain right deltoid. No fluctuance.
Age: 31.0
Sex: F
Vaccine: TDAP, TYP, TD, TYP
Symptoms: Headache, Nausea, Pain, Skin nodule
Clinical narrative: Local reaction at vaccination site of Tdap and typhoid vaccine on left deltoid region. Area swollen and tender with some redness and minimal warmth. Also had significant lymphedema under left axilla; no lymphadenopathy.
Age: 31.0
Sex: F
Vaccine: TDAP, TYP, TD, TYP
Symptoms: Feeling hot, Injection site reaction, Lymphoedema, Swelling, Tenderness
Clinical narrative: Local reaction at vaccination site of Tdap and typhoid vaccine on left deltoid region. Area swollen and tender with some redness and minimal warmth. Also had significant lymphedema under left axilla; no lymphadenopathy.
Age: 0.28
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intestinal gangrene, Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: 2 days after Rotateq given, pt began vomiting, hospitalized on 10 hours after vomiting began. Ultrasound on 12/01 showed mass and signs of obstruction of large bowel. Surgery on 12/01 revealed intussusception, Ascending transverse colon.  1/8/07 Received records from hospital.  No D/C summary available.  ER records reveal patient see 11/29/06 with vomiting after being placed on Augmentin on 11/27 for a cold & also received vax on that day.  Started with fever 100.4 on 11/28 & then vomiting.  Patient did not tolerate oral challenge in ER & was hospitalized.  Developed bilious emesis & bloody stools.  Mass was detected in LUQ on 11/30.  Taken to OR on 12/1/06 for dx: intussusception (IS) with necrosis. Final DX: intussusception with necrosis, surgically reduced; resection of necrotic colon; & appendectomy.
Age: 0.28
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: 2 days after Rotateq given, pt began vomiting, hospitalized on 10 hours after vomiting began. Ultrasound on 12/01 showed mass and signs of obstruction of large bowel. Surgery on 12/01 revealed intussusception, Ascending transverse colon.  1/8/07 Received records from hospital.  No D/C summary available.  ER records reveal patient see 11/29/06 with vomiting after being placed on Augmentin on 11/27 for a cold & also received vax on that day.  Started with fever 100.4 on 11/28 & then vomiting.  Patient did not tolerate oral challenge in ER & was hospitalized.  Developed bilious emesis & bloody stools.  Mass was detected in LUQ on 11/30.  Taken to OR on 12/1/06 for dx: intussusception (IS) with necrosis. Final DX: intussusception with necrosis, surgically reduced; resection of necrotic colon; & appendectomy.
Age: 0.28
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: 2 days after Rotateq given, pt began vomiting, hospitalized on 10 hours after vomiting began. Ultrasound on 12/01 showed mass and signs of obstruction of large bowel. Surgery on 12/01 revealed intussusception, Ascending transverse colon.  1/8/07 Received records from hospital.  No D/C summary available.  ER records reveal patient see 11/29/06 with vomiting after being placed on Augmentin on 11/27 for a cold & also received vax on that day.  Started with fever 100.4 on 11/28 & then vomiting.  Patient did not tolerate oral challenge in ER & was hospitalized.  Developed bilious emesis & bloody stools.  Mass was detected in LUQ on 11/30.  Taken to OR on 12/1/06 for dx: intussusception (IS) with necrosis. Final DX: intussusception with necrosis, surgically reduced; resection of necrotic colon; & appendectomy.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Crying, Discomfort, Fatigue, Irritability, Malaise
Clinical narrative: Saturday 12/02/2006: Discovered bumps/rash on legs, trunk. Tuesday 12/05/2006: Rash was worse, spreading to face and arms + bad itching. Brought her to see Doctor. (Dr. said b/c rash was not accompanied by a fever, it was not from vaccine.)  Friday 12/08/2006: Sick, unhappy, tired - crying. Discovered fever of 102-104. Called Doctor who said it was most likely from MMR vaccine and to give her motrin to reduce fever.  Tuesday 12/12/2006: Fever gone, but very cranky, uncomfortable - crying, screaming.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Mood altered, Pruritus, Pyrexia, Rash
Clinical narrative: Saturday 12/02/2006: Discovered bumps/rash on legs, trunk. Tuesday 12/05/2006: Rash was worse, spreading to face and arms + bad itching. Brought her to see Doctor. (Dr. said b/c rash was not accompanied by a fever, it was not from vaccine.)  Friday 12/08/2006: Sick, unhappy, tired - crying. Discovered fever of 102-104. Called Doctor who said it was most likely from MMR vaccine and to give her motrin to reduce fever.  Tuesday 12/12/2006: Fever gone, but very cranky, uncomfortable - crying, screaming.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Leg reddened area to left deltoid approx 4" in diameter hot to the touch treated with Benadryl PRN.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 5x4cm to left deltoid reddened area prescribed Benadryl.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Eye oedema, Hypersensitivity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: On 2/24/03 service member received AVA 1 she denies a significant local reaction to vaccine site. She recalls feeling nauseated for a few hours right after vaccine receipt, but denies any unusual or prolonged systemic symptoms. This was the only vaccine received on 2/24/03. On 3/8/03 service member received AVA 2 this was the only vaccination received on this date. Service member dose no recall specific details regarding this vaccination because she was getting ready to deploy. (Deployment was later postponed to Dec 2003. She does not recall any local reactions, but knows that this was the time of onset of her first break out, which she thought might be an allergic reaction to food or something. She had never previously experienced similar symptoms. Her reaction started with her eyes becoming swollen and then hives appeared under her arms and later, on her hips and on her neck and back. The affected areas were pruritic, raised and red. Lesions began as individual welts, but on hips, the welts coalesced. She did not seek evaluation and the hives resolved within 24-48 hours after vaccine receipt. She had no other reactions until after she received her next anthrax vaccine. On 11/13/03 service member received AVA 3 she also received Hep A, Hep B Typhoid and Influenza vaccination on this date. Service member does no recall any unusual local reactions at her vaccination sites. She denies any unusual or prolonged systemic symptoms except for recurrence of urticaria. Her records show lab results CBC from 11/24/03 from an ER visit for evaluation of this reaction had she also had photos of this reaction dated 11/24/03. This was about 11 days following vaccine receipt. AT the ER she was treated with 1-2 week course of prednisone, with complete resolution of hives but residual hyperpigmentation. For the next year, she continued to experience similar episodes of urticaria about once every 2-3 weeks. She was seen by a civilian dermatologist prior to deployment, she recalls the dermatologist performing a number of tests including a biopsy. During her deployment, she was evaluated and treated at troop medical clinics multiple times and and she was evaluated by an allergist. During the time she was treated with Prednisone, Zyrtec, Allegra and Zantac, as well Claritin, Between episodes, the areas remained discolored, and then with recurrent episodes, the discoloration was replaced with hives. Service member denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of or itchy throat. Last episode of urticaria was in November 2004.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Skin discolouration, Skin hyperpigmentation, Skin ulcer, Urticaria
Clinical narrative: On 2/24/03 service member received AVA 1 she denies a significant local reaction to vaccine site. She recalls feeling nauseated for a few hours right after vaccine receipt, but denies any unusual or prolonged systemic symptoms. This was the only vaccine received on 2/24/03. On 3/8/03 service member received AVA 2 this was the only vaccination received on this date. Service member dose no recall specific details regarding this vaccination because she was getting ready to deploy. (Deployment was later postponed to Dec 2003. She does not recall any local reactions, but knows that this was the time of onset of her first break out, which she thought might be an allergic reaction to food or something. She had never previously experienced similar symptoms. Her reaction started with her eyes becoming swollen and then hives appeared under her arms and later, on her hips and on her neck and back. The affected areas were pruritic, raised and red. Lesions began as individual welts, but on hips, the welts coalesced. She did not seek evaluation and the hives resolved within 24-48 hours after vaccine receipt. She had no other reactions until after she received her next anthrax vaccine. On 11/13/03 service member received AVA 3 she also received Hep A, Hep B Typhoid and Influenza vaccination on this date. Service member does no recall any unusual local reactions at her vaccination sites. She denies any unusual or prolonged systemic symptoms except for recurrence of urticaria. Her records show lab results CBC from 11/24/03 from an ER visit for evaluation of this reaction had she also had photos of this reaction dated 11/24/03. This was about 11 days following vaccine receipt. AT the ER she was treated with 1-2 week course of prednisone, with complete resolution of hives but residual hyperpigmentation. For the next year, she continued to experience similar episodes of urticaria about once every 2-3 weeks. She was seen by a civilian dermatologist prior to deployment, she recalls the dermatologist performing a number of tests including a biopsy. During her deployment, she was evaluated and treated at troop medical clinics multiple times and and she was evaluated by an allergist. During the time she was treated with Prednisone, Zyrtec, Allegra and Zantac, as well Claritin, Between episodes, the areas remained discolored, and then with recurrent episodes, the discoloration was replaced with hives. Service member denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of or itchy throat. Last episode of urticaria was in November 2004.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 24 hours after receiving pneumovax. I felt sick chilled, my left arm swelled and was red and hot. Over nite my fever was 101.3. I called telephone nurse, she said to put warm compress, antibiotic cream and report to Dr in am. Urgent care diagnosed cellulitis and put me on Amoxicillin after a shot of antibiotic.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise, Pyrexia, White blood cell count increased
Clinical narrative: 24 hours after receiving pneumovax. I felt sick chilled, my left arm swelled and was red and hot. Over nite my fever was 101.3. I called telephone nurse, she said to put warm compress, antibiotic cream and report to Dr in am. Urgent care diagnosed cellulitis and put me on Amoxicillin after a shot of antibiotic.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Neck pain
Clinical narrative: Swelling of left arm with fever, erythema, neck and arm pain. Left arm with 7x10cm area of erythema and induration. Resolving by 12/04/06 treatment with Prednisone and Keflex.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Swelling of left arm with fever, erythema, neck and arm pain. Left arm with 7x10cm area of erythema and induration. Resolving by 12/04/06 treatment with Prednisone and Keflex.