chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, swollen left thigh, hot to touch for one day. Placed on PO Keflex 6/4/03. Seen 6/6/03 - cellulitis improving on PO Keflex.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: 24-36 hours after MMR - pt had generalized urticaria. No symptoms of anaphylexis. Resolved with single dose of Benadryl.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Injections DTaP left thigh and Hib given 5/8/03. Later that night left leg hot, red, very hard and sore. Rash on chest 5/9 and 5/10. Third day 5/11 rash spread to abdomen. On 5/12 skin erythematous plaques coalesce over chest and abdomen 1-8 cm, non blanching and somewhat raised. Few small lesions about 1 cm on upper back and inner left anterior thigh, groin region 2-3 cm plaques of erythema as well. Also evidence at injection site left thigh, 3-4 cm area of edema slight induration and erythema almost ecchymotic in appearance. Right thigh where Prevnar given unremarkable.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Injections DTaP left thigh and Hib given 5/8/03. Later that night left leg hot, red, very hard and sore. Rash on chest 5/9 and 5/10. Third day 5/11 rash spread to abdomen. On 5/12 skin erythematous plaques coalesce over chest and abdomen 1-8 cm, non blanching and somewhat raised. Few small lesions about 1 cm on upper back and inner left anterior thigh, groin region 2-3 cm plaques of erythema as well. Also evidence at injection site left thigh, 3-4 cm area of edema slight induration and erythema almost ecchymotic in appearance. Right thigh where Prevnar given unremarkable.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Orange sized red area left arm - warm to touch - slightly raised
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Hypokinesia, Pyrexia
Clinical narrative: ~9 d. s/p vaccination developed fever & Chills ® 12 d. s/p vaccine developed progressive dyspnea and mid-chest pain ® evaluated overseas ® evac'd back to US for further evaluation
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Headache, Lymphadenopathy, Skin ulcer, Urticaria
Clinical narrative: Received smallpox vaccine between 5/26 and 5/29. Experienced fatigue, lymphadenopathy and headaches for 2 1/2 weeks. Denies chest pain, SOB or cough. Around PM of 6/10/03, generalized symptoms had resolve4d, but noted lesions on abdomen which spread to trunk, back and extremities. Seen in clinic 1 time and ER 1 time; referred to Allergy/Immunology Clinic, where Dx'd with acute urticaria, temporally associated with smallpox vaccine. Tx'd with Allegra.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Left upper forearm/lower legs, both erythermatous. Maculo-papular rash, 5 vesicles/blisters.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dysphagia, Irritability, Pharyngolaryngeal pain, Pyrexia, Rash erythematous
Clinical narrative: Developed high fever, crankiness, sore throat (had trouble swallowing/drooling a lot), just wanted to be held all the time.  This started 8 days after receiving MMR vaccination.  Took him to the doctor and was actually diagnosed as having the Coxsackie Virus - - too coincidental.  I truly believe that all this was a reaction to the MMR Vaccination.  Also, on the 11th day he came down with a rash of tiny red bumps that started around his face and neck and traveled down through out torso area, similar to a measles rash.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot
Clinical narrative: Greater than 12 cm, erythemic, and warm to touch, radiated up left upper extremity and down past left elbow.
Age: 46.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Lymphadenopathy, Vertigo
Clinical narrative: LYMES-LIKE SYMPTOMS, INCLUDING JOINT PAIN IN R-SHOULDER-FINGERS-NECK-LUMBAR;NUMBNESS IN BOTH HANDS-FEET-TONGUE;EXTREME MUSCLE FATIGUE; SWOLLEN LYMPH GLANDS; BONE SPUR GROWTH IN CERVICAL VERTIBRE; DEGENERATIVE CHANGES IN CERVICAL-LUMBAR VERTIBRE.  ALL THE ABOVE ARE OCCURING AT PRESENT TIME.  TREATMENT HAS BEEN NERVE-BLOCKING INJECTIONS AND MEDICATIONS.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Redness, warmth, edema upper arm below elbow involvement with peri-articular soft tissue swelling (LRG)
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Had a severe side effect to the Smallpox Vaccine... woke up on Day 9 following the vaccination with an extreme headache and nausea.  I have never had a headache to the magnitude/degree like this one.  It completely incapacitated me for the day.  I couldn't keep any food down.
Age: 71.0
Sex: M
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: Was vaccinated on 3/20/2003, scab fell off the last week in May, about 8-9 weeks after vaccination.
Age: 41.0
Sex: F
Vaccine: SMALL
Symptoms: Dyspnoea
Clinical narrative: Patient describes shortness of breath since time of vaccination. She has SOB with walking. Saw own doctor on 6/3 who did EKG and other tests on 6/4 and has not heard from doctor about results.
Sex: F
Vaccine: DTAP, HIBV, OPV
Symptoms: Drug toxicity
Clinical narrative: An attorney reported that a 5 year old female child received a series of Tripedia, ActHib, Engerix B, Varivax and MMR II, as well as, Orimune and Tetramune vaccines from 10/28/96 through 2/3/98. It is alleged that the vaccine contained "toxic" mercury in the form of thimerosal. The reporter indicated that the pt "has not manifested any signs or symptoms that her parents, or her doctors, attribute to mercury exposure." This event was considered medically important (OMIC). (Related case HQ0230428JAN2002 was cancelled).
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a mother concerning her son, with no pertinent medical history, who in August 1999 was vaccinated SC with a first dose of MMR II. In May 2002, when the patient was 4 years old, he received a second dose of MMR II. It was reported that "now the patient has autism." The mother reported that the patient was taking "antifungals, nutritional supplements and probiotics to treat the autism." It was reported that the patient was not taking any medication at the time of vaccination . According to the reporter autism was considered to be disabling. The outcome was reported as not recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site oedema, Pyrexia
Clinical narrative: R leg swelling from knee up, fever. Diagnosed cellulitis.
Age: 3.0
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Cellulitis, Erythema, Oedema, Tenderness
Clinical narrative: Significant erythema, swelling, and tenderness 5cm x 3cm at left interior thigh. The hospital discharge summary states, "cellulitis."
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Tinnitus
Clinical narrative: Follow up to initial VAERS on 9/1/99/follow up VAERS on 6/17/02.  Continues to have mild bilateral tinnitus, but does not interfere with activities of daily living or work duties. Has now received Anthrax #5 and #6 without worsening of tinnitus, and without return of other symptoms (fatigue, paresthesias, arthralgias, etc.) Anthrax follow up questionnaire received on 08/21/2003: "The vaccine recipient did recover from the adverse event.  The vaccine recipient's current employment status is full duty.  No workdays were missed as a result of this event.  The vaccine recipient did receive further Anthrax shots since the reported event, and there were no more adverse events." Follow up: Since her last VAERS report, patient continues to experience mild bilateral tinnitus, which does not interfere with her work duties or limit activities of daily living. She has not received any additioinal anthrax vaccines since her last follow up VAERS was filed. She has not had any recurrence of original sxs of fatigue, insomnia, hearing loss, paresthesias of the foremarm, arthralgias, or cognitive dysfunction.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Decreased appetite, Fatigue, Infection, Mouth ulceration, Oral intake reduced
Clinical narrative: Pemphigus Vulgaris diagnosed 3 months after Anthrax #3. Pre-vaccine serum negative for autoantibodies to pemphigus. Follow up: painful oral lesions, difficulty eating , infections, fatigue.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Pemphigoid
Clinical narrative: Pemphigus Vulgaris diagnosed 3 months after Anthrax #3. Pre-vaccine serum negative for autoantibodies to pemphigus. Follow up: painful oral lesions, difficulty eating , infections, fatigue.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Child cried constantly and was unable to be calmed from approximately 11:00 AM 6/12/03 to 5 PM 6/12/03. Child calmed 30 minutes after given Motrin 1/2 tsp and 1/4 tsp Benadryl.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Broke out in classic Varicella rash - presented 1 week later. Treated with Zyrtec and Omnicef for impetigo.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Shooting pain in shoulder with any mobility. Pinky and ring finger on left arm were numb day of vaccine.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Approx. 24 hours after immunizations 4-5 blisterlike lesions appeared on child are are still present.
Age: 48.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Myalgia, Pruritus
Clinical narrative: Emp. called on 6/16/03 at 1:30 PM stating that on Saturday PM, she developed itching on her upper trunk, nasal cavity, developed myalgias and joint pains. States she had large localized reaction of erythema and swelling (about 2 50cent piece size). Emp. spoke of her PMD and her Atarax dosage was doubled and all resolved on Sunday.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Dehydration, Diarrhoea, Hypotension, Pyrexia, Vomiting
Clinical narrative: Had oral typhoid vaccine first week August 2002, travelled to Ecuador, developed typhoid fever with fever, diarrhea, vomiting, hypotension and dehydration on 12/8/02. Blood test for typhoid (+), stool culture done 12/13/02 (+) salmonella typhi, treatment included 2l IV fluids at host home Amoxicillin 500 TID for 2 weeks and Cipro 500 BID for 5 days; repeat stool culture in January - no salmonella typhi.
Age: 1.08
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Temp of 105 degrees 12 hours after Prevnar and Comvax, continues to have elevated temp of 103-105 with muscle twitching. Was seen in office.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Pt had seizure-like activity with rhythmical movement of her head on the evening after her immunization.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching of arms and legs. Pt was prescribed hydrocortisone cream - should be able to receive 3rd dose (Dr visit 5/8/03).
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Nausea, Oedema peripheral, Pyrexia, Tenderness
Clinical narrative: Swelling R upper arm and shoulder with tender enlarged axillar with temp 102 within 24 hrs, nausea, myalgia.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Approx 2 weeks after receiving Hep B vaccine 1st dose into left deltoid, experienced pain in subscapular and scapular muscles. Subsequent pain in deltoid, triceps and shoulder girdle on left. Numbness, tingling, paresthesias in left forearm and fingers to present time.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus, Pyrexia
Clinical narrative: Child spiked 101 at 11PM same day of vaccination. Mom noticed redness of left arm the evening of 6/9 and noticed puffiness of left arm next day. Applied ice 6/10/03 in the evening - still puffy and swollen and itchy since last night. Observed localized redness about 2" in diameter with puffiness and swelling of the left upper deltoid, arid, warm to touch.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Pt had routine administration of Hepatitis A (1st dose) vaccine. Within 2 hours started having chills and fever. Denies being sick before vaccine administration. Seen back in clinic at 1300 the temp was 102.5. No other symptoms. Sent home with Ibuprofen. 24 hours later temp 101.1. Still no other symptoms. Instructed to continue Ibuprofen and return in 24 hours. 48 hours after injection temp at 98. Pt had previously had entire hepatitis B series and all other childhood and military vaccines without reaction.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Pt with clinical chicken pox who received vaccine.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt was given Td .5cc IM  left deltoid on 6/6/03. She reported swelling/local reaction on 6/9/03 to us. 5 x 5" warm erythematous swelling involving left deltoid area and upper arm. Reaction occurred soon after 6/6/03 injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left upper arm became red, swollen evening of day after vaccine. To use cold compresses tid.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Face oedema, Flushing, Rash, Rhinorrhoea
Clinical narrative: Pt given vaccines DTaP, IPV, MMR. Nasal drip right onset turned to cloudy in a few minutes. Rash, swelling of face, flushing, dyspnea rhinorrhea approx 15-20 minutes after vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right upper quadrant with area of 3cm x 2.5cm induration and erythema. Area is non-tender vs stable. Area noted PM 6/11/03.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Left upper arm red and hot to elbow. Ran low grade fever. Gave Tylenol.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, MMR, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Vaccinated with MMR 5/20/03 - on 5/30 ran temp. Next day temp 102, 5/31/03, 105 per mom - then baby had a seizure. Took to ER. 5/31/03 temp 104.1. ER MD diagnosed febrile seizure.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling at left arm site. No fever. Started 6/10/03 PM, immunization given 9:40 AM.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: 6/10/03 Pt in to clinic with what appears to mild case of varicella. Mother states she and child went to Mexico 2 weeks ago and child had contact with cousin who had an active case of varicella. Child started with fever and chicken pox areas yesterday.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother brought pt to clinic 6/18/03 reporting pt's right deltoid injection site for Prevnar injection now reddened with added heat and never experienced such a large area of redness. Posterolateral to injection site and within reddened area is a small raised bump and next to that a very small abrasion - both appear to be a bug bite and possible site of scratching. Pt busy, not favoring arm, alert, oriented, no draining, no red lines. 48 hours after injection reddened area present. Axillary temp taken - 98 degrees. Mother used cool rag 6/17/03 on arm. 1.5"-1.75" area of redness around injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: Started 6/17/03, worse 6/18/03. Redness; swelling; fever; left upper arm. Given Augmentin 250 mg BID; advised mother to apply warm washcloth to affected area; call office tomorrow if no change or worse.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: Right Upper arm large oval area of redness, warmth, edema, prunritis approx. 10cm X 4cm. oval no fever, no systemic signs
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Infection, Laboratory test abnormal, Sepsis
Clinical narrative: On 06/11/03 patient was hospitalized for a Strep Infection. Blood culture was found to be positive for Strep Pneumo. Patient Recovered.
Age: 52.0
Sex: F
Vaccine: SMALL
Symptoms: Diarrhoea, Laboratory test abnormal, Myocardial infarction, Pyrexia, Vomiting
Clinical narrative: 4-5-03 Client went to the ER at the hospital she worked at with fever 100 degrees for 1 week, vomiting and diarrhea for 3 days.  Doctor in the ER examined her and noticed her scar.  He said he needed to do an ECG since she had been vaccinated.  ECG was abnormal.  He told her she needed to follow up with her PCP.  She went back to work.  She went for preop labs and ECG and was told she had had a Ventricular MI at sometime.  Last normal ECG was May 2002.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: patient began having central chest pain shortly after taking a vivarin. Pain lasted several days. Patient went to the ER and had a chest xray, EKG, and bloodwork. Patient was sent home. Treatment consisted of Lortab, Bactrim, ASA, and Potassium supplements. Patient was referred to a cardiologist. Echo stress test was normal. Troponin was less than .03. Cardiac enzymes were within normal limits.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Rash papular
Clinical narrative: Fever of 102-104 degrees from 6/13-17/03  Also had small papules (scattered, few) on face, then to trunk.  Had a couple of papules at site of MMR given on left leg.  Believed to be mild non-communicable measles.  No one else ill in home.  No exposure to prairie dogs, etc.  Rash resolving.  No other illness as per mother on 6/20/03.  Had induration, erythema, swelling on right leg at DTaP site 48 hours after DtaP given.  Delayed response -- localized, resolved after 2 days without ill effect.  Both vaccines were given on 6/6/03.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: sore, aching arm which has continued to date. Referred for physical therapy due to shoulder impingement.  Began physical therapy in early June 2003 and continuing treatment.
Age: 52.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Erythema, Rash pustular
Clinical narrative: Smallpox vaccine administered on 28 January 2003.(3rd smallpox vaccination during lifetime) Developed new angina on 8 or 9 February. No prior history of angina.  On no meds. No risk factors except age. No family members with symptomatic coronary artery disease before age 72. Extremely high exercise tolerance with outstanding scores on the majority of military PFT's and performing 8-13 miles a day in January 2003 on the crosstrainer at the highest resistance level with a sustained heart rate of 170 without anginal symptoms prior to vaccine. Deployed as medical officer. Daily  effort dependent and post prandial anginal symptoms initially controlled with nitroglycerine and aspirin. In May symptoms become progressive with positive exercise EKG. Started on high dose isordil and betablockers. Returned to States in May with positive treadmill and positive CT venous angiogram at hospital showing a soft plague in the left anteror descendng artery with a 75-80 percent occlusion.  Started on plavix. Had Stent placed on 18 June 2003 at hospital. Now experiencing anxiety and depressive symptoms concerning delayed stent occlusion in animal models using sirolimus stent.
Age: 52.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angina pectoris, Anxiety, Blood cholesterol decreased, Depression, Laboratory test abnormal
Clinical narrative: Smallpox vaccine administered on 28 January 2003.(3rd smallpox vaccination during lifetime) Developed new angina on 8 or 9 February. No prior history of angina.  On no meds. No risk factors except age. No family members with symptomatic coronary artery disease before age 72. Extremely high exercise tolerance with outstanding scores on the majority of military PFT's and performing 8-13 miles a day in January 2003 on the crosstrainer at the highest resistance level with a sustained heart rate of 170 without anginal symptoms prior to vaccine. Deployed as medical officer. Daily  effort dependent and post prandial anginal symptoms initially controlled with nitroglycerine and aspirin. In May symptoms become progressive with positive exercise EKG. Started on high dose isordil and betablockers. Returned to States in May with positive treadmill and positive CT venous angiogram at hospital showing a soft plague in the left anteror descendng artery with a 75-80 percent occlusion.  Started on plavix. Had Stent placed on 18 June 2003 at hospital. Now experiencing anxiety and depressive symptoms concerning delayed stent occlusion in animal models using sirolimus stent.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: A 68 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/16/02 and 205 days later died on 5/9/03. Investigator was notified by patient's family that he died at home. Will speak to family in a couple of weeks. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: "A 68 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/16/2002 and 205 days later died on May 9, 2003.  Investigator was notified by patient's family that he died at home.  Will speak to family in a couple weeks.  The investigator assessed the event as unrelated to the study product.  Follow up information received 07/01/2003.  Investigator spoke with family members regarding death.  Death certificate lists CHF as cause of death.  Subject went from a lengthy hospitalization to a nursing home where he died approximately 1 week later.  Prior hospitalization in File # 2003-00364.  The Investigator assessed the event as unrelated to the study product. HISTORY OF PRESENT ILLNESS:  The patient is a 68 year old white male well known to me who is being admitted to hospital for acute syncope with resultant facial contusions and left knee contusion.  The patient was seen by myself last week in the ofice for his usual followup and also had an episode of either slipping vs. syncope with resultant left facial contusion and left conjuctival hemorrhage.  He was back to his baseline status and saw doctor at hospital today who is his cardiologist.  He suggested placing him on a Holter monitor because of the facial ontusion and questionable syncopal episode.  The patient left the hospital.  Apparently, the patient became lightheaded and passed out.  He landed on his face and chest and does not recall any events thereafter until he was at the hospital.  He was complaning of chest discomfort which he felt was due to contusing his chest but was treated as if it was cardiac in origin with aspirin, Nitroglycerin paste and morphine.  He also was placed in a left knee immobilizer.  He underwent a CAT scan of his head which was normal.  Chest x-ray revealed questionable mild congestive heart failure.  His labs are notable for his usual chronic renal insufficiency, hypoatremia, hypoalemia and an elevated white count of 14,000.  It was determined that the patient needed to be further evaluated due to his complicated history as well as syncope and possible cardiac issues.  He has since been transferred to a other hospital where he is presently complaining left knee discomfort and mild palpable chest discomfort.  He is not short of breath and is frustrated with the overall situation.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A 71 year old male received RSV Vaccine or Placebo and Influenza Vaccine on 10/14/02 and 243 days later died on 6/14/03. Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks. Signs/Symptoms/Diagnosis: No data at present time. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: "A 71 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/14/2002 and 243 days later died on 06/14/2003.  Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks.  Signs/Symptoms/Diagnosis: No data at present time.  The investigator assessed the event as unrelated to the study product.  Follow up information received 07/01/2003.  Investigator spoke with family members, regarding death.  They stated that subject died in bed.  Family physician thought cause of death was heart attack.  Autopsy was performed.  Results of the autopsy are not known yet.  Diagnosis: MI?.  The investigator site assessed the event as unrelated to the study product.  Further information is expected."  Follow up on 02/09/04: "Additional information received 02/02/04.  After multiple attempts, unable to obtain autopsy results."
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac failure congestive
Clinical narrative: A 78 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/12/02 and experienced congestive heart failure and was admitted to the hospital (unknown date). Patient was discharged on 3/7/03. Patient has a history of Chronic Ischemic Heart Disease and COPD. The Investigator assessed the event as unrelated to the study product. Follow up information received on 6/13/03: A request for patient's records has been requested from hospital. Other records requested from the primary physician. The information received from the patient's primary doctor did not include any information regarding his hospitalization. An attempt will be made to contact the patient for information. The investigator assessed the event as a possible relationship to the study product.  Follow up on 06/27/2003: "Progress notes: 03/06/2003.  2nd Echo with Doppler 1) Technically difficult study. 2) NL LV site with mild conc. LVA, with NL overall LV function, est EF is 55%. 3) LA and RA enlargment 4) Dilated RV 5) Echo dense ascending aorta may reflux atherosclerotic plaque or calcium deposits. 6) Thickened aorta leafuts with mild AI, no AS by Doppler.  NP B Cardiology: 77 year old male with PMB of HTN, CAD - S/P CABG -99, A.Fib, NHL -'91, asthma type 2 DM.  Admitted 03/05/2003 with several day history of SOB and LE edema, + ocassional wheeze.  Pulmonary consult per doctor in ER.  Patient admitted for further evaluation.  S: "I'm feeling better"; O: 97.2 - 73-20  780/75 Tele. A. Fib; W: S1, S2 irregular/irregular;Weight 232.3lbs; Resp. -bilateral crackles; Abdomen: soft/nontender; Ext: 4 edema + distal pulses; Neurological: alert and oriented x 3.  A: #1 CHF - diuresing start Diovan - on Lasix. #2 Asthma - as per pulm. #3 NL LV function with EF = 55% per Echo 03/06/2003. #4 HTN - BP stable. #5 CAD - s/p CABG '99. #6 NHL - '91. #7 Lumbar pain - as per ortho.  2nd MLI of lumbar spin to lg. spinal stenosis.  Type 2 DM - on Prandin,  Diovan 80mg po qd; Decrease Norvasc to 5 mg po qh; K-Dur 40mg po x 1 for K + 3.6; MRI of lumbar spine; Continue med. prescription.  03/07/2003: Paitent discharged to home via wheelchair with all belongings.
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Autism, Drug toxicity, Nervous system disorder
Clinical narrative: An attorney reported that a male child received a series of HibTITER, Acel-Imune vaccines as well as MMR II vaccine, IPOL vaccines, Recombivax HB vaccines, hepatitis B vaccine, and Varivax vaccine from 9/3/03 through 8/12/99. Concomitant medication included tuberculin PPD. It is alleged that as a result of exposure to toxic mercury in the form of thimerosal contained in the vaccine(s), the child developed neurological injuries, including disintegrative (or regressive, late onset, or degenerative) autism. Mercury poisoning and autism were considered medically important (OMIC).
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation
Clinical narrative: A-Fib confirmed by EKG sent to ER, "converted without one dose Adenason per report.
Sex: M
Vaccine: HEP
Symptoms: Supraventricular tachycardia, Thrombocytopenia
Clinical narrative: Thrombocytopenia occurring within one day of receipt of Hep B vaccine and HBIG. The discharge summary states, "supraventricular tachycardia."
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site oedema
Clinical narrative: Pt received Varivax and had swelling in the area of injection.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain, Type III immune complex mediated reaction
Clinical narrative: IM DTaP delivered by Bioject (needleless) device in left deltoid. Approximately 8.5 hours later pt complained of arm hurting. Seen the next day with redness, warmth, swelling about 8 x 12 cm (non-tender) on left deltoid (seen by MD and dx as "Arthus type" reaction.
Age: 6.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: 6/9/03 (6 PM) tenderness at site; 6/10/03 Tenderness, erythema, warm to touch, warm compresses applied by parent, and Tylenol. 6/11/03 (AM) redness area enlarged, tenderness increased - Tylenol only by parent. 1:30 PM to PH Center, evaluated (Tylenol and cold pack). Parent will see family MD 6/11/03.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 12 cm area of right upper thigh with redness, heat, swelling, hard. Developed overnight and next day. Child brought to clinic 6/6/03. Not seen by MD. Condition resolving. Area now pink, soft, no heat, decreased discomfort.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: 6/14 Increased redness, swelling and warmth left thigh-seen in clinic. 6/14 and 6/15 seen at children's ER. 6/16 seen in clinic.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5 cm x 5 cm red/indurated, non tender area right upper thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Fever (low-grade) and vomiting within 24 hours of vaccines, followed by redness, warmth of leg just distal to site of DTaP and IPV.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: Rash all over body within 4-5 hours of receiving MMR vaccination. Patches - "hives" itching. Hands swelling. Denies any difficulty breathing or swallowing. Rash continues 4 days after vaccination. Hasn't seen MD - referred to PMD.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Lethargy, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Walk in child's mother said pt received 4 vaccines Friday 5/16/03 and later in the evening she had an episode of 101 temp, complained of sore right deltoid and neck area, nausea, vomiting 2-3 times during the night, was lethargic Saturday.  She's been fine since.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Opisthotonus, Screaming, Vomiting
Clinical narrative: Uncontrollable screaming/crying, arching back that night of shot.  Repeat of screaming next night, vomiting 3rd day.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Ear pain, Feeling cold, Glossodynia, Hot flush
Clinical narrative: 1st 24 hours: Rash on her tongue.  Rash gone in four days. 2nd 24 hours: Tongue hurt.  Hot and cold flashes. 4th Day: When moved, tongue, ears uncomfortable (sensitive).  Back begins to be sore and itching spots along her spine.  Spots are like someone is poking her from the inside.  7th Day:  Calves of legs are hurting.  Lymph nodes anterior legs swollen.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: 1st 24 hours: Rash on her tongue.  Rash gone in four days. 2nd 24 hours: Tongue hurt.  Hot and cold flashes. 4th Day: When moved, tongue, ears uncomfortable (sensitive).  Back begins to be sore and itching spots along her spine.  Spots are like someone is poking her from the inside.  7th Day:  Calves of legs are hurting.  Lymph nodes anterior legs swollen.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Oedema
Clinical narrative: Swelling, redness began 06/12
Age: 4.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ear pain, Oedema, Pain
Clinical narrative: Left sided parotid swelling, 9 hrs after injection.  Pain in cheek and ear.  No fever, gave motrin.  Saw next day in office.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash for 3 days, starting on face and extending to groin and legs on day 2.  Rash was blanching slap-cheek-like exanthem.  Fever, according to mom.  Cervical lymphadenopathy.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Vaccine DTaP given in left upper deltoid muscle on Tuesday 05/27/2003.  On 05/28, redness and swelling at site.  On 05/29 woke up spread down arm to elbow.
Age: 5.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Fever: 104 F after injection.  Lasted 24 hours.  Swelling on arm 2 x 2 in. with redness lasted 24 hours.  right arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: None.  Possible adverse reaction to MMR to child status post renal transplant and on immunosuppresants.
Age: 4.7
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient returned to clinic with mom.  Red, swollen, upper left arm.  DTAP and IPV were given in left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Redness, warmth, swelling of left upper arm.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Varicella-like rash, developed 06/06/2003.  Vaccine given 05/20/2003.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site oedema, Pruritus
Clinical narrative: 6in redness and swelling and itching.  5 x 5 in arm redness.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Left upper arm red, swollen, hardened area, warm to touch.  3 in wide x 2 in long.  Diagnosis: cellulitis per doctor.  Prescribed Levoquin 50mg.  Treatment: meds and warm compresses x 14 days.  Update on 06/23/2003.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Lymphadenopathy, Meningitis, Pyrexia, Systemic lupus erythematosus
Clinical narrative: This case was reported by a nurse and described the occurrence of possible viral meningitis in a pregnant 25 year old female pt who was vaccinated with hep B vaccine (Engerix B) for prophylaxis. The pt's medical history and concurrent medications were not reported. The pt was pregnant at the time of the events, it was not specified if she was pregnant at the time of immunization, or became pregnant after immunization. On 3/25/03, the pt received her first dose of Engerix B. On 4/9/03. 15 days post-immunization, the pt presented to the physician with arthralgia and "high" fever. She also developed cervical lymphadenopathy. The reporter stated, "It was suspected at one point that the pt had viral meningitis, and she was treated accordingly." However, treatment was not specified. The pt was hospitalized twice in April 2003. The events persisted as of 6/9/03. The reporting nurse considered the events to be possibly related to Engerix B administration.  A 15-day follow up report received 7/15/2003 adds: On 07/03/2003 the nurse reported that it was discovered that the pt "is positive for lupus." The most recent info was received on 07/11/2003. The pregnancy and lupus were ongoing. The pt's estimated date of delivery is 11/11/2003. The reporter stated that the pregnancy is "very high risk" because of lupus.  Follow up on 07/11/2003: "On 07/03/2003, the nurse reported that it was discovered that the patient "is positive for lupus."
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Sore arm-swollen, red, hot
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Rash started 1 day after immunization.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Blister, Ecchymosis, Feeling hot, Injection site inflammation
Clinical narrative: Mother stated child was at home in bathtub at approximately 08:00pm 06/22/2003 and observed an appropriate 2 x 3in. inflamed area on right upper arm.  Area warm to the touch.  Approximately 3 vesicles present.  Ecchymotis approximately 1cm in diameter noted 2 finger widths below shoulder in deltoid muscle.  Patient treated with antibodies.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema
Clinical narrative: 21 year old male with reaction to smallpox vaccine. Erythema 1mm spots to arm, back, shoulder. No streaking, No pustules noted. Possible generalized vaccinia.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: Papular eruptions. Generalized vaccinia.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme-like plaques on extensor surfaces, elbows and knees beginning 12 days after vaccinia administration.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis
Clinical narrative: Admitted with symptoms consistent with pericarditis. EKG demonstrates elevated ST segment. Troponin 2.5. Cardiac Cath wnl. ECHO pending.
Age: 12.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic, Rash pustular, Viral infection
Clinical narrative: 12 y.o. boy first time vaccinee given smallpox vaccine as post-exposure prophylaxis for monkeypox.  He was exposed to a prairie dog, and also to father who is confirmed monkeypox case.  On post day 6 had pustular rash on back; by post day 7: 15-20 rash lesions mainly on trunk, in different stages of development papules, vesicles, pustules, each 1-2 mm.  Otherwise asymptomatic and not acutely ill.  Rash is pruritic.  Specimens have been sent.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Erythema, Fatigue, Feeling hot, Oedema
Clinical narrative: 24 hours after administration developed severe fatigue, polyarthralgias, and whole L upper arm became red, hot and swollen. Reaction lasted 72 hours. Symptoms were somewhat relieved by Iboprofen 400 mg q 4-6 hours.
Age: 0.7
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Diarrhoea, Lethargy, Pyrexia
Clinical narrative: Client received immunizations approx 3:00P.M. on 06/18/03. At 4:00P.M. sleepy. Has had elevated temp, lethargy, anorexia ever since with mother giving alternating doses of Tylenol and Motrin. She was taken to Emergency Room on Saturday evening, 6/21. Lab tests performed, Tylenol Supp inserted with temp going from 105.1 to 102.9.  Had had oral Tylenol 2 hrs. previous to suppository. Mother reported no other symptoms. E-Room record reports diarrhea on 6/20. Mother called H.D. on Monday 6/23 with reports of continuing elevated temp, anorexia and lethargy. Mother encouraged to call family physician today. Child sent home on Amoxil 200/5ml,BID. Diagnosis Pharyngitis Child has appointment 2:15, 6-23
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Cough, Throat tightness, Wheezing
Clinical narrative: 37 yo male vaccinated against smallpox in childhood with no significant past medical history who experienced the onset of cough and wheezing 2 days after being re-vaccinated against smallpox on 3/18/03.  He denies any associated fever or rhinorrhea.  He does describe a "tickle in his throat."  He denies any chest pain or other cardiac symptomatology.  He has never wheezed before and has no history of reactive airways disease.  He was seen by an MD at Hospital and was treated with inhaled albuterol and inhaled steroids.  He missed one day of work (3/20).  His symptoms persisted for about one week.  He has been well since with no further episodes of wheezing.
Age: 41.0
Sex: F
Vaccine: SMALL
Symptoms: Neuralgia, Pain
Clinical narrative: Client began having pain in legs and back approximately 8 days after vaccination with Smallpox Dryvax vaccine
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Rash, Tenderness
Clinical narrative: HOT, TENDER, SWOLLEN, RASH. TREATED WITH KEFLEX.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP, YF, ANTH, TYP, YF
Symptoms: Chest discomfort, Chills, Heart rate increased, Nausea, Pain
Clinical narrative: It was reported that a 24 year old male pt received typhoid, yellow fever and a third dose of anthrax vaccine administered on 1/25/03. The next day, the pt experienced a fever of 103.1F, chills, aching, nausea, headache, ear pain and lightheadedness. He was hospitalized on 1/26/03. His chest x-ray showed no significant abnormalities. His throat culture showed normal respiratory flora and no beta hemolytic strep group A was isolated. His WBC was low at 4.2 on 1/27/03 an there were some unspecified abnormalities in the differential blood counts. The pt was discharged from the hospital on 1/28/03 with a diagnosis of viral syndrome. The pt fully recovered from this event. The pt stated that he had a similar reaction to a vaccine in 2001. He had been vaccinated on 1/2/01 with hep A and subsequently was hospitalized on 1/22/01 with a sore throat, nausea, vomiting and fever. He was diagnosed with pharyngitis and was treated with antibiotics. He was discharged on 1/24/01. From additional information recevied on 12/8/03 from the Yellow Fever Case Classification Workgroup Meeting, it was reported that this is a 24 year old member of the military who received typhoid, first dose of yellow fever, and third dose of anthrax vaccine on 1/25/03. On 1/26/03, he had fever of 103.1, chills, tremors, nausea, wheezing and tightness in chest and ear pain. Was hospitalized. CXR was normal. Blood culture had no growth. Had a diagnosis of viral syndrome. He was treated with IV hydration and discharged on 1/28/03. No specimens were sent to CDC for testing. Also had a history of hospitalization on 10/22/01 for red throat, tonsillitis, fever of 102, nausea and vomiting. Treated with antibiotics at that time and recovered. No other information was provided. From additional information received on 12/21/03 for the Centers for Disease Control and Prevention's Yellow Fever Working Group Meeting, it was reported that the final decision was that the events were not related to the yellow fever vaccine. No other information was provided. From additional information received on 4/27/04 through internal e-mail, it was reported by a professional from the CDC that the adverse event occurred in the USA. Batch number UB345AA was provided. A search on the batch number revealed that UB345AA corresponds to the diluent of YF-VAX. No other information was provided at that time. Additional information is not anticipated, this case is considered closed.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP, YF, ANTH, TYP, YF
Symptoms: Pyrexia, Tremor, Wheezing
Clinical narrative: It was reported that a 24 year old male pt received typhoid, yellow fever and a third dose of anthrax vaccine administered on 1/25/03. The next day, the pt experienced a fever of 103.1F, chills, aching, nausea, headache, ear pain and lightheadedness. He was hospitalized on 1/26/03. His chest x-ray showed no significant abnormalities. His throat culture showed normal respiratory flora and no beta hemolytic strep group A was isolated. His WBC was low at 4.2 on 1/27/03 an there were some unspecified abnormalities in the differential blood counts. The pt was discharged from the hospital on 1/28/03 with a diagnosis of viral syndrome. The pt fully recovered from this event. The pt stated that he had a similar reaction to a vaccine in 2001. He had been vaccinated on 1/2/01 with hep A and subsequently was hospitalized on 1/22/01 with a sore throat, nausea, vomiting and fever. He was diagnosed with pharyngitis and was treated with antibiotics. He was discharged on 1/24/01. From additional information recevied on 12/8/03 from the Yellow Fever Case Classification Workgroup Meeting, it was reported that this is a 24 year old member of the military who received typhoid, first dose of yellow fever, and third dose of anthrax vaccine on 1/25/03. On 1/26/03, he had fever of 103.1, chills, tremors, nausea, wheezing and tightness in chest and ear pain. Was hospitalized. CXR was normal. Blood culture had no growth. Had a diagnosis of viral syndrome. He was treated with IV hydration and discharged on 1/28/03. No specimens were sent to CDC for testing. Also had a history of hospitalization on 10/22/01 for red throat, tonsillitis, fever of 102, nausea and vomiting. Treated with antibiotics at that time and recovered. No other information was provided. From additional information received on 12/21/03 for the Centers for Disease Control and Prevention's Yellow Fever Working Group Meeting, it was reported that the final decision was that the events were not related to the yellow fever vaccine. No other information was provided. From additional information received on 4/27/04 through internal e-mail, it was reported by a professional from the CDC that the adverse event occurred in the USA. Batch number UB345AA was provided. A search on the batch number revealed that UB345AA corresponds to the diluent of YF-VAX. No other information was provided at that time. Additional information is not anticipated, this case is considered closed.