chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Cardiac failure congestive, Chest pain, Chills, Dyspnoea
Clinical narrative: Flu like symptoms to excess (body aches, hot flashes, chills, chest pain) C/P into neck, face swollen, difficulty breathing. Cardiac symptom: atrial fib. Discharge Summary received on 1/12/2005 states congestive heart failure. Medical Records received on 1/12/2005 states fatigue. Follow up 02/02/05: Patient remains much weaker, more tired than before the vaccination. She gets somewhat shakey at times and has less energy. Her hoarseness is worse and her appetite is diminished. The chest pain, facial swelling, and extreme tiredness experienced within 2 hours of having the vaccine are gone now. Extreme shortness of breath is gone, but she still has more shortness of breath than before.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Fatigue, Hot flush, Influenza like illness, Laboratory test abnormal
Clinical narrative: Flu like symptoms to excess (body aches, hot flashes, chills, chest pain) C/P into neck, face swollen, difficulty breathing. Cardiac symptom: atrial fib. Discharge Summary received on 1/12/2005 states congestive heart failure. Medical Records received on 1/12/2005 states fatigue. Follow up 02/02/05: Patient remains much weaker, more tired than before the vaccination. She gets somewhat shakey at times and has less energy. Her hoarseness is worse and her appetite is diminished. The chest pain, facial swelling, and extreme tiredness experienced within 2 hours of having the vaccine are gone now. Extreme shortness of breath is gone, but she still has more shortness of breath than before.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Flu like symptoms to excess (body aches, hot flashes, chills, chest pain) C/P into neck, face swollen, difficulty breathing. Cardiac symptom: atrial fib. Discharge Summary received on 1/12/2005 states congestive heart failure. Medical Records received on 1/12/2005 states fatigue. Follow up 02/02/05: Patient remains much weaker, more tired than before the vaccination. She gets somewhat shakey at times and has less energy. Her hoarseness is worse and her appetite is diminished. The chest pain, facial swelling, and extreme tiredness experienced within 2 hours of having the vaccine are gone now. Extreme shortness of breath is gone, but she still has more shortness of breath than before.
Age: 1.04
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Conjunctivitis, Erythema, Irritability, Kawasaki's disease
Clinical narrative: Conjunctivitis, erythematous tongue/lips, rash (maculopapular) on back, SM/cervical nodes, fever about 6 days. Presumptive Kawasaki disease. Discharge Summary received on 1/3/2005 states pt experienced adenopathy.  Medical Record received on 1/3/2005 states pt experienced anorexia and was irritable.
Age: 1.04
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Lymphadenopathy, Pyrexia, Rash maculo-papular
Clinical narrative: Conjunctivitis, erythematous tongue/lips, rash (maculopapular) on back, SM/cervical nodes, fever about 6 days. Presumptive Kawasaki disease. Discharge Summary received on 1/3/2005 states pt experienced adenopathy.  Medical Record received on 1/3/2005 states pt experienced anorexia and was irritable.
Age: 1.56
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Severe urticarial reaction
Age: 1.61
Sex: M
Vaccine: FLU3, MMR
Symptoms: Convulsion, Cough, Hypocholesterolaemia, Hypokalaemia, Hyponatraemia
Clinical narrative: High fever , seizure lasting 40 min: 10 days after MMR no. 1. Medical records received on 1/20/2005 states cough and congestion.
Age: 1.61
Sex: M
Vaccine: FLU3, MMR
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: High fever , seizure lasting 40 min: 10 days after MMR no. 1. Medical records received on 1/20/2005 states cough and congestion.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oedema peripheral, Pain, Tenderness
Clinical narrative: On 10/29/2004 total body aches, swollen hands: sore, HA. So sore she couldn't get out of bed. By 11/1 she was better. Better, but not quite himself.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Received immunization (Fluzone) 2NOV04. Woke upon 3NOV04 with maculopapular rash on trunk that over course of next days progressed and spread to extremities. No pruritus , no other symptoms, no fever, no URI symptoms.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain at injection site (2 deltoid) beginning 90 min after injection with motor weakness of deltoid for next 48 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever 100F, Abdominal pain, Myalgias, Headaches, Chills: within 6 hours of vaccine.
Age: 81.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Malaise, Tachycardia
Clinical narrative: Within the first 24 hours his heart rate increased. When I took his pulse it was about 93 beats per minutes. He was not "ill", but said he did not feel very well. He has had each of the three shots given (listed below) with no adverse reactions when each was given separately in the past.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea, Eye swelling, Flushing
Clinical narrative: Patient complained of feeling flushed: did not appear flushed. Complained of difficulty breathing. Observed by RN at site. Patient given Lorazepam 0.25 mg orally. Patient exhibited increasing shortness of breath with puffy eyes. Doctor called. Pt given epinephrine 0.3cLx1 at 2PM. 2:15 patient transported to Emergency Department by ambulance. No interventions at hospital ED. Pt recovered by time of arrival. Diagnosis: possible reaction to flu shot vs. anxiety.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Rash, Rash erythematous
Clinical narrative: Developed face flushing within 3 hours of vaccine. Saturday, 11/6/04, developed raised, itchy rash from head to foot including palms of hands and soles of feet. "Looked like chicken pox without the blister". Took Benadryl / Zantac 11/6/04 and 11/7/04 and relief. Seen by MD 11/8/04. Allergist, Prednisone and Zantac 11/20/04 resolving.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Immunizations given 11/2/04. On 11/4/04, broke out in hives all across upper shoulders and buttocks. Afebrile.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Approximately 20 min after receiving an Influenza vaccination, patient feet itching and hives. No shortness of breath. She denied allergy to eggs to nurse administering vaccine. However, when seen in ER, told PA she is allergic to eggs. Medical Record received on 1/12/2005 states
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient's arm was sore about 1 hour after injection. Within 24 hours, she had a red oval swollen area from the shoulder to the elbows. Lasted about 1 week then was gone.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nasal congestion, Pain, Pulmonary congestion
Clinical narrative: Nasal and chest congestion. Right arm numbness to hand. Body aches.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nasal congestion, Pain, Pulmonary congestion
Clinical narrative: Nasal and chest congestion. Right arm numbness to hand, body aches
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Constipation, Mouth ulceration, Oral mucosal blistering
Clinical narrative: Received vaccine at 3:00. Around 5:30 noted blisters on tongue, mouth, states felt like the blisters were going down her throat. At bedtime noted improvement; took Benadryl. No respiratory distress by AM: blisters resolved. Also noted constipation.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Chills, Cough, Eye irritation, Hypotonia
Clinical narrative: A nurse reports accidental exposure to the flu following administration of Flumist to a pt in a physician's office. She presented with symptoms of burning eyes, scratchy throat, fever with chills, feeling achy and still with occasional cough four days after administering Flumist. The reporter stated that she had administered her first and only dose of Flumist to a child on 22Oct04. The child immediately sneezed after receiving FluMist. On 26Oct04, four days after exposure from the child's sneeze, the reporter became very achy and stiff. She developed a 101.8 degree fever with chills, scratchy throat, burning eyes, as well as a complaint that her joints hurt worse on 27Oct04. She began treatment with ibuprofen and the events improved. On 28Oct04 the chills continued along with the aches, burning eyes, and occasional cough. As of 29Oct04 she was mildly achy and her eyes continued to burn but she stated that she felt better. Of note, the reporter received a flu vaccine three weeks prior to her exposure to FluMist. No further information is available.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Infection transmission via personal contact, Medication error, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A nurse reports accidental exposure to the flu following administration of Flumist to a pt in a physician's office. She presented with symptoms of burning eyes, scratchy throat, fever with chills, feeling achy and still with occasional cough four days after administering Flumist. The reporter stated that she had administered her first and only dose of Flumist to a child on 22Oct04. The child immediately sneezed after receiving FluMist. On 26Oct04, four days after exposure from the child's sneeze, the reporter became very achy and stiff. She developed a 101.8 degree fever with chills, scratchy throat, burning eyes, as well as a complaint that her joints hurt worse on 27Oct04. She began treatment with ibuprofen and the events improved. On 28Oct04 the chills continued along with the aches, burning eyes, and occasional cough. As of 29Oct04 she was mildly achy and her eyes continued to burn but she stated that she felt better. Of note, the reporter received a flu vaccine three weeks prior to her exposure to FluMist. No further information is available.
Age: 49.6
Sex: F
Vaccine: FLUN3
Symptoms: Erythema
Clinical narrative: A consumer reported the development of redness on the neck and face of her 49 year old sister hours after receiving her first FluMist inhalation. The pt has a history of early childhood brain damage associated with whooping cough and a detailed history involving drug reactions to other medications. Detailed drug allergy history was not provided. The pt received FluMist on the afternoon of 23Oct04. The reporter stated that by dinner a red streak formed done one side of the pt's face and it had gradually spread to her neck by evening. Pain nor itching were not reported. As of 28Oct04 the redness had resolved.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site induration, Injection site oedema, Tenderness
Clinical narrative: Large local reaction: erythema and induration (approximately 5 inches in diameter). Tender. Worst at day 3; resolved after day 8. Edema at injection site >120mm not beyond elbow, erythema, tenderness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt had hard bump at site and redness down to elbow
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Right limb swelling, redness, pain at site of Dtap. Swelling 15cm.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm red, swollen, continues to be red, swollen 11/8/04 went to Dr. received antibiotic.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Erythema, Oedema, Rash, Rash pruritic
Clinical narrative: TC from pt states rash started 11/02/04 and progressively spread and now covers her arms, legs, ears, face, and into her eyes. Rash fine red rash with a few blisters. Rash is itchy, no fever, bilateral swelling of neck, below ears.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Red firm area on Left lateral arm, warm to touch
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: 10 hrs after injections T 105 fever came down with Tylenol. Examined next day doing well. Fever 100-103 x 28 hours no other sx.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: 30-40 lesions, temp 104 x 2-3 days
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Lymphadenopathy
Clinical narrative: Pt complains of swollen lymph node on left side of neck, knot on left deltoid with swelling and redness at sight of knot
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mild edema and erythema right arm decreasing MOC history. Using Tylenol and cool soaks.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site reaction, Rash maculo-papular
Clinical narrative: Local reaction, red raised rash, left deltoid area, warm to touch. Tx Benadryl and cool compresses.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Lethargy, Pain, Urticaria
Clinical narrative: Nov 1 received TD Tues AM felt lethargic, arm hurting. Wed AM HA, arm hurting. By late afternoon broke out in hives. By early Thurs AM hives from collarbone down. Given Medrol dose pak. Fri was given shot at urgent care. Prednisone and Antihistamine
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Swelling, redness, hot, given Keflex 25 mg PO tid x 10d
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt seen in ER (on afternoon of shots) w/ tonic clonic seizure activity for 2 to 3 seconds on 2 to 3 occasions and low grade fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Pt received Dtap immunization in right arm deltoid. Pt developed swelling, pain and warmth from shoulder to elbow resulting in an ER visit.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chills, Feeling hot, Injection site mass, Oedema, Pyrexia
Clinical narrative: 24 hrs after vaccine admin came in with large wheal 10cm in size, warm and edematous. Hard to touch, chill and febrile.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: 24 hrs after vaccine admin came in with large wheal 10cm in size, warm and edematous. Hard to touch, chill and febrile.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Dysphagia, Oedema, Rash, Vomiting
Clinical narrative: Pt given TD for dog bite 11/15/04  stated on feeding bone, 30-45 min developed facial rash, throat swollen, diarrhea and vomiting and was able to breath and swallow, swallowing difficult.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Body temperature decreased, Rash, Rash pruritic
Clinical narrative: Mom reports child exposed to her father with shingles 10/26/04. Child developed blistered rash 11/05/04 with 15 lesions, with itching, T96.8 x24 hrs after breaking out.
Age: 31.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Convulsion
Clinical narrative: Seizure occurred 2 days after receiving MMR and either a seizure or loss of consciousness 17 days after (I was alone so I can't verify seizure). I have also run a mid to high grade fever, around 99.5-101.5 with Motrin and Tylenol for the last four weeks since the vaccine. Still with on and off migraine headache.
Age: 31.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Condition aggravated, Convulsion, Loss of consciousness, Migraine, Pyrexia
Clinical narrative: Seizure occurred 2 days after receiving MMR and either a seizure or loss of consciousness 17 days after (I was alone so I can't verify seizure). I have also run a mid to high grade fever, around 99.5-101.5 with Motrin and Tylenol for the last four weeks since the vaccine. Still with on and off migraine headache.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: Limited mobility left arm; pain from shoulder to elbow
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: 1-2 days after vaccination has had sharp pain in his arm.  He says it is excruiciating pain in both arms and has lasted for almost 2 weeks.  Has been taking Tylenol and applying heat to the arm per directions from his doctor.  Still is having pain
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Client came in to the HD on 11/17/04, four days after recieving the flu shot, reporting that her arm was swollen and red. The swelling started a few hours after the injection and had improved somewhat since then. Said she had a slight fever of 99/6 to 99/8 starting the 2nd day after the shot. Today her arm had an area of redness and some swelling with a litlte warmth 3" by 4". While the client was here we called her physician to set up an appointment for evaluation. He saw her a couple of hours later. When we called the client on 11/15/04 she said the Dr. said he was 90% sure she had a reaction to the shot; not to get any more flu shots again. He gave it a 10% chance of being cellulitis and Rxed an antibiotic. Client reports her arm is better.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Patient given IM injection 11/14 into left arm. On 11/15, Nurse noticed arm was swollen and warm. Patient said the arm bothered her when it was tocuhed or if she moved. MD aware.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Palpitations, Respiratory distress
Clinical narrative: Received Fluzone ~0930.  Developed palpitations ~1000. Developed resp. distress ~ 1015. Used personal inhaler at that time w/o relief.  Repeated x1 w/o relief.  Contacted PMD, who directed her to ED.  Arrived at ED ~1200. Received Benadryl 50mg po.  Only other sx. was dizziness; no hives, nausea.  To continue onZyrtec x1 week.  D/D diagnosis Asthma exacerbation d/t flu vaccine.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis
Clinical narrative: Did not see any change in temperature, however the evening following the vaccination he was quite diaphoretic, and weak that evening and the following day.
Age: 33.0
Sex: F
Vaccine: IPV, TD, TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received 3 vaccines on 11-11-04, Typhoid Vi, Tetanus/Diphtheria, and Polio (IPV) for an upcoming trip.  The following evening, on 11-12-04, patient developed generalized itching and then on Saturday, 11-13-04, she developed itchy hives on her neck, hands, knees, feet and stomach that have persisted through today (11-17-04).
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Skin ulcer
Clinical narrative: approximately 2 days after vaccine administration, site became tender, red, hot, and achy. Symptoms increase over the next several days and spread from site (left deltois area) to inner aspect of upper arm in several similar lesions. Patient presented to Emergency Department on day 5 and was given benadryl.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Headache, Herpes simplex, Herpes zoster
Clinical narrative: Bad Headache, Flu like symptoms, and very sore arm after first shot.  After second shot, I developed shingles on my forehead.  Now a few months later, I am having difficulties and severe pain in my left knee, as well as aching in other joints, but especially in the knees. - 1/10/06 Reviewed 2-page medical record. Diagnoses included: recurrent cutaneous herpes, most likely HSV 1 rather than zoster or shingles; and bilateral knee pain left > right.  Initial crepitus was noted over right knee. Famvir prescribed.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Similar reaction on previous exposure to drug
Clinical narrative: Bad Headache, Flu like symptoms, and very sore arm after first shot.  After second shot, I developed shingles on my forehead.  Now a few months later, I am having difficulties and severe pain in my left knee, as well as aching in other joints, but especially in the knees. - 1/10/06 Reviewed 2-page medical record. Diagnoses included: recurrent cutaneous herpes, most likely HSV 1 rather than zoster or shingles; and bilateral knee pain left > right.  Initial crepitus was noted over right knee. Famvir prescribed.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Confusional state, Erythema, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old male with a respiratory disorder, idiopathic pulmonary fibrosis, chronic hypoxemia and cor pulmonale who on 11/2/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). It was noted that the proper syringe for injection was used. Subsequently, the patient developed a red, swollen and painful arm. On 11/4/04, the patient became acutely ill. He developed a fever, chills, respiratory distress, and confusion. He was hospitalized in the intensive care unit. He was placed on bi-pap because he refused to be intubated. It was also noted that in October 1999 the patient also received a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other patient's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's. (WAES0411USA00638, 0411USA00945, and 0411USA00947).
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory distress, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old male with a respiratory disorder, idiopathic pulmonary fibrosis, chronic hypoxemia and cor pulmonale who on 11/2/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). It was noted that the proper syringe for injection was used. Subsequently, the patient developed a red, swollen and painful arm. On 11/4/04, the patient became acutely ill. He developed a fever, chills, respiratory distress, and confusion. He was hospitalized in the intensive care unit. He was placed on bi-pap because he refused to be intubated. It was also noted that in October 1999 the patient also received a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other patient's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's. (WAES0411USA00638, 0411USA00945, and 0411USA00947).
Sex: U
Vaccine: HEPA
Symptoms: Mania, Rash
Clinical narrative: Information has been received from another manufacturer. It was reported that a patient was vaccinated with a dose of hepatitis A virus vaccine inactivated. Subsequently, the patient experienced manic episodes and reticulated skin rash. The patient's outcome was unknown. Manic episodes were considered to be an other important medical event (OMIC). This report was originally reported by a physician. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Bacterial infection, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician in a hospital laboratory concerning a 15 month old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced breakthrough varicella followed by an infection. The reporter indicated that the patient had eczema. It was also noted that the patient was not a normal host. Patient history was not definitely known at the time of the report. The patient had breakthrough varicella and a secondary staphylococcus and streptococcal infection and may have been hospitalized. The reporter was checking to see if a potential VZV PCR specimen could be obtained. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Malaise
Clinical narrative: Information has been received from a registered nurse concerning a male who 20-30 years ago, as a child was vaccinated with a dose of MMR (lot # not reported). Subsequently, the patient had a reaction where he became very sick. The patient was seen by a doctor and hospitalized. The patient's outcome was not reported. It was noted that at the time of the report, the patient was an adult. It was also reported that the patient's father (WAES0411USA00681) had a similar experience following vaccination with MMR. Additional information has been requested. Follow up 03/03/05: Patient date of birth, Age at time of vaccination, Adverse event onset date and time, lot number of vaccine and vaccine administration date and time not provided per reporter.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Left whole upper arm was swollen hugely and erythematous, slightly tender, heavy and itchy. Double size of arm. Got better in four days with Benadryl
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neuropathy, Sensory disturbance, Skin burning sensation, Tenderness
Clinical narrative: Symptoms began with sore shoulder 1-2 days after injection the sore elbow around 10 days after injection burning and numbness in left hand. 10/27 was seen in clinic to follow up with neurology. 10/28 had new burning in both legs to the thigh. Seen in ER , had LP and neurology consult. Given Neurontin follow up out-patient. Had AMA and NCS 11/9: normal. Per neurologist's: autoimmune inflammatory polyneuropathy vs early Guillian Barre. 10/28: CBC, Chemistry Panel normal. 11/4: C3 C4 CRP RF ANLA: normal.   Follow up 03/07/05: Summary of nerve conduction studies: The left sural, posterior tibial and right peroneal respones are normal. the upper extermities, the left median and right radial sensor responses are normal. Motor conduction in the left media and ulnar nerves are normal. The left median CMAP amplitude proximall is larger thatn that distally. While stimulating over the median nerve in the antecubital fossa and recording over the abductor dititi minimi, a small response was obtained, consisent with median to ulnar (Martin-Gruber) anastomosis. Conclustions: This electrophysiologic study is normal. Specifically, there is no evidence for a large fiber polyneuropathy. The normal F-waves argue against acute inflammatory demeylinating polyradiculoneuropathy with symptoms presnet for two weeks. Clinical correlation is recommended. Incidently noted is a left median to ulnar forearm (Martin-Gruber) anastomosis, a normal variant seen in 15-30% of the population.  1/7/05 Information form patient:  She was hospitalized for 2 days and then followed up by a neurologit at the hospital.  At first they thought she had GBS, but now it has been diagnosed as chronic demyelating polyneuropathy.   03/07/05 From Medical Center Clinic Records; 03/07/05 Neurology Consult done in ER gives detailed exam findings and provides list of possible Dx; Auto-immune Inflamatory polyneuropathy named first and remains the finding.  Notes mention improvement on Neuronton.    03/08/2005 Neuro Clinic records reveal patient was diagnosed with auto immune inflammatory polyneuropathy.  Main symptoms were numbness, tingling, and pain.  These symptoms occurred 2 days after vaccination.
Age: 72.0
Sex: U
Vaccine: FLUX
Symptoms: Chills, Feeling hot, Influenza, Pharyngolaryngeal pain
Clinical narrative: Heard this clinic giving shots: made appointment that very day (hands, feet, mass ice cold). Evening body very hot. Throat so sore: when to doctor, no strep throat. Took three weeks to get over the flu. My doctor said I got the flu from shot. He said take Tylenol twice a day.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: About 3 hours after flu shot, developed fatigue, achiness, light-headedness and sharp, stabbing headache. Also developed shivering and numbness in fingers and toes of about 12:00am. The shivering and numbness abated after 3 hours. 23 hours later, still feels tired, with headache.  No other symptoms. No fever.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: About 3 hours after flu shot, developed fatigue, achiness, light-headedness and sharp, stabbing headache. Also developed shivering and numbness in fingers and toes of about 12:00am. The shivering and numbness abated after 3 hours. 23 hours later, still feels tired, with headache.  No other symptoms. No fever.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia
Clinical narrative: 3 days after the flu shot, I awoke with Extreme Weakness which lasted 3.5 days. No other symptoms. Treatment: bed rest, vitamins.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: 12x6.25 red area, warm to touch, also tender x 1 day. Advised Tylenol and cool compress.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching started 11/7/04 in 5-6pm. No fever/chills/SOB, wheezing
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Site was itchy immediately, around 24 hours later red, hot , swollen at injection site.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: At 6 months, well child check up 11/12/04: Baby received DTP #3 HIB#3 Pre#3, Fluzone#1. Within two minutes, patient covered with hives from head to toe. No anaphylaxis. No respiratory distress. Alert and playful. Received 2.75 Benadryl po within 20 min, hives faded. Babe sent home to follow up with allergy.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Nausea, Pallor, Tremor
Clinical narrative: Employee came to me 30 min (approx0 after influenza vaccine given, she was pale, clammy and shaky. She stated she was dizzy and nauseated. Had her sit down, placed cool wash cloth over forehead , blew into paper baby . Lasted approximately 30-45 min. Full recovery.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: Upon administration felt pain and tingling radiating down to fingertips ,tingling lasted for 1 hour. Doctor did not provide any recommendation. Then pain began from vax site to bottom of arm, restricted movement. Pain ha been chronic for 2.5 weeks and worsened to the point that can't raise arm to any degree. On 11/15 doctor prescribed Bextra 10mg daily.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Hypokinesia, Paraesthesia
Clinical narrative: Upon administration felt pain and tingling radiating down to fingertips ,tingling lasted for 1 hour. Doctor did not provide any recommendation. Then pain began from vax site to bottom of arm, restricted movement. Pain ha been chronic for 2.5 weeks and worsened to the point that can't raise arm to any degree. On 11/15 doctor prescribed Bextra 10mg daily.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Cyst, Urticaria
Clinical narrative: A physician reported ganglion cyst in a 34 year old female after receiving her first dose of Flumist. The patient received Flumist at 3 PM on the afternoon of 10/29/04. The patient noticed lumps on her right wrist that resembled a ganglion cyst the afternoon of 10/31/04. More of the cyst-like symptoms developed around her wrist 11/1/04. By 11/2/04, the cyst had spread to both wrist, feet, and ankles. On 11/3/04, the cyst were spreading to her arms. The reporter stated that it maybe urticaria but he is not quite sure how to identify the events. He is referring the patient to another physician. As of 11/5/04, the cyst have not progressed but have not resolved. The reporter stated he did not believe the event were due to use of Flumist. 07Feb05: Additional information obtained: pt's age and date of birth.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Nasal congestion, Pain
Clinical narrative: This is a non-serious spontaneous case from a pharmacist who reports he experienced chills after administering FLUMIST. The reporter did not provide causality between events and FLUMIST administration. This case is submitted according to the VAERS safety surveillance accelerated reporting agreement for FLUMIST. A 32 year old male experienced slight chills, body ache, and congestion after administering FLUMIST. On 10/26/04, the patient experienced slight chills, body ache, and congestion after administering his third of five FLUMIST doses. He treated himself with ibuprofen and recovered within 24 hours after onset of events. The patient did not have any problems with administering FLUMIST and he had administered FLUMIST one or two days prior to the onset of the events. On 10/01/04, the patient received influenza vaccination. Additional information (lot number 500337P) received on 08Feb05. There is no date of vaccination because pt did not receive FLUMIST. Follow up 03/14/05: Vaccine adminstration time/date is not applicable because the subject did not received FLUMIST. A VAERS follow up was submit on 03/4/05.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: The administration of Prevnar to an adult instead of the intended adult Vaccine Pneumovax. The work "pneumococcal", which appears in the labeling of both vials, caused the confusion (error). The field alert is being issued for a product confusion event.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Approximately 36 hours after injection developed 5mm warm, red area around injection site. Very hard and sensitive to touch.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Pyrexia, Rash morbilliform, Rhinitis
Clinical narrative: Rash: Measles like in appearance. Preceded by rhinitis and slight fever.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Erythema, Headache, Hypoaesthesia, Nausea
Clinical narrative: Swollen arm; numb hand; red , nausea, headache, diarrhea.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: Swollen arm; numb hand; red , nausea, headache, diarrhea.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Received vaccine on Wednesday 10/27/04. Arm became painful by Thursday AM ad presented to our office on Friday 10/29/04. Received Keflex 500 qidx7days.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever to 102.3, severe swelling, and redness on 9/23/04.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Left upper arm pain, swelling since 24 hours after shots. + Erythema - ROM of arm.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever with shots
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hallucination, Pyrexia
Clinical narrative: Fever 102 oral with hallucinations. Tylenol given and patient not hallucinating now; he feels better and is playing. Still has fever 101.3 orally.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Joint swelling, Pain
Clinical narrative: Received Pneumovax on 11/3/04. Complaints of pain starting that evening, left elbow edema with transient arm edema. Cellulitis left arm; Rocephin and Keflex given.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, painful reaction to the site. Temp 98.3 11/12/04.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Difficulty in walking, Injection site swelling, Pain
Clinical narrative: Large, swollen, raised area on left thigh. Painful to walk and to touch. Patient's mom scheduled clinic appointment for 11/9/04. Also seen 11/10/04 and given Benadryl PO, Advil PO, Rocephin IM, and Keflex PO.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: 24 hours after injection of either DTaP or IPV, right thigh site became swollen, red, and hot. Slightly tender. Area 3.5cm X 3.5cm in diameter. Treatment with Benadryl PO TID until swelling resolved.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient received Varivax 9/28/99. Exposed to chicken pox week before rash appeared. Chicken pox rash on back, chest, legs, and arms.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Fever to 103-105, vomiting, headache. Evaluated by doctor. Diagnosed with viral illness; doubt reaction to vaccines.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria for 2 to 3 days following shots. Treated with Benadryl 2cc every 6 hours PO.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient stated Thursday afternoon, hives developed under arm and towards chest all left side. Hives less by Friday and Saturday was gone. Patient took Benadryl for symptoms. Patient denied any other symptoms.
Age: 1.1
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient was immunized with Varivax at 13 months of age. At 5 years of age, she developed a case of chicken pox with > 200 pox noted. She is being treated with acyclovir topical cream and Bactroban cream.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Parent to clinic on 11/10/04 for episodic visit. Mother stated baby had run a fever for 3 days after getting vaccines on 9/28/04 (103 F). Did not seek treatment.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abdominal pain upper, Dyspnoea, Eyelid oedema, Flushing, Nasal congestion
Clinical narrative: Child received shots at 9:30 AM. On drive home, at 9:35, child began sneezing every 15 seconds for 10 minutes. Her face became red, build up of congestion and mucous; she was rubbing her nose. Complained of having a difficult time taking a deep breath. Shortly after, began complaining of her stomach hurting. Arrived home at 9:55 AM; she continued to sneeze. Mom examined child. Found welts on right shoulder blade area and mid back. Now eyebrows and eyelids appeared swollen and puffy. Mom gave child appropriate dose of Benadryl liquid. Child also complained of bottom of feet burning/itchy and tingling. Mom noted right groin had red, raised rash 2" in diameter. Called PMD at 10:55; arrived in office at 11:30. Child was improved by this time. Was sent home with antihistamine (non-drowsy). Advised by MD to not receive any further vaccines until Mom check with him.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Paraesthesia, Pruritus, Rash erythematous, Skin burning sensation, Sneezing
Clinical narrative: Child received shots at 9:30 AM. On drive home, at 9:35, child began sneezing every 15 seconds for 10 minutes. Her face became red, build up of congestion and mucous; she was rubbing her nose. Complained of having a difficult time taking a deep breath. Shortly after, began complaining of her stomach hurting. Arrived home at 9:55 AM; she continued to sneeze. Mom examined child. Found welts on right shoulder blade area and mid back. Now eyebrows and eyelids appeared swollen and puffy. Mom gave child appropriate dose of Benadryl liquid. Child also complained of bottom of feet burning/itchy and tingling. Mom noted right groin had red, raised rash 2" in diameter. Called PMD at 10:55; arrived in office at 11:30. Child was improved by this time. Was sent home with antihistamine (non-drowsy). Advised by MD to not receive any further vaccines until Mom check with him.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Child received shots at 9:30 AM. On drive home, at 9:35, child began sneezing every 15 seconds for 10 minutes. Her face became red, build up of congestion and mucous; she was rubbing her nose. Complained of having a difficult time taking a deep breath. Shortly after, began complaining of her stomach hurting. Arrived home at 9:55 AM; she continued to sneeze. Mom examined child. Found welts on right shoulder blade area and mid back. Now eyebrows and eyelids appeared swollen and puffy. Mom gave child appropriate dose of Benadryl liquid. Child also complained of bottom of feet burning/itchy and tingling. Mom noted right groin had red, raised rash 2" in diameter. Called PMD at 10:55; arrived in office at 11:30. Child was improved by this time. Was sent home with antihistamine (non-drowsy). Advised by MD to not receive any further vaccines until Mom check with him.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Left arm swollen, red, tender, and warm. Tylenol PRN and ice packs. Follow up in 2 days.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Erythema
Clinical narrative: HIB and Prevnar was given LAT 11/2/04. Positive erythema 3-4cm. Hydrocortisone cream 1% applied TID; Benadryl 1 1/4 teaspoon every 6 hours.
Age: 0.51
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Urticaria
Clinical narrative: Widespread cutaneous reaction, scattered wheals/erythematous, acute urticarial reaction, began approximately 7 hours after immunization; cleared by 48 hours. Rx given hydroxyene 1/2 teaspoon every 8 hours PRN.
Age: 13.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria several hours after receiving Td, MMR, and Hepatitis vaccines. Itchiness in mid upper back, urticaria on left shoulder. Present when seen about 20 hours later. No other symptoms. No local reactions. Rx: Benadryl 50mg PO every 6 hours for itch.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Face oedema
Clinical narrative: Facial swelling from Flu shot.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye swelling, Face oedema, Skin burning sensation, Skin irritation
Clinical narrative: Facial swelling from Flu shot.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: with:c/o receiving the pneumovax vaccine Yesterday and now his left upper arm is red and sore and swollen. He has never had a pneumovax vaccine before that he knows about. SKIN: SMALL RED, TENDER, SWOLLEN AREA LEFT UPPER ARM POSTERIORLY WITH SOME SWELLING OF THE ARM RADIATING DOWN TO ELBOW POSTERIORLY Plan: Moist Compresses as directed x 20 mins bid Motrin 800mg tid prn
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Atrial flutter, Chills, Headache, Nausea, Pain
Clinical narrative: Presents @1730 With temp 100.4 after taking 2 8hr tylenol @ 1640 C/o chills, fever body aches, headache.  No redness or edema at site of injection.  Spoke with Pt on 11/10/04 stated had temp of 103 night before with total body hives, nausea,and chest flutters. Pt instructed to take Benadryl 50mg and Tylenol 1000mg every 6 hours. Inst if difficulty breathing occured go to emergency room.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Urticaria
Clinical narrative: Presents @1730 With temp 100.4 after taking 2 8hr tylenol @ 1640 C/o chills, fever body aches, headache.  No redness or edema at site of injection.  Spoke with Pt on 11/10/04 stated had temp of 103 night before with total body hives, nausea,and chest flutters. Pt instructed to take Benadryl 50mg and Tylenol 1000mg every 6 hours. Inst if difficulty breathing occured go to emergency room.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: Rash
Clinical narrative: MOTHER REPORTS ON 11/18/2004 THAT CHILD EXPERIENCED RASH AFTER IMMUNIZATIONS GIVEN ON 05/19/2004.
Age: 28.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Rash
Clinical narrative: HIV Pos. refugee received varcella on 9/28/04.  Was seen in clinic on 11/17/04. She has a body rash at the present time unsure if it is related to varicella vaccine.  She also recently stated on antiviral meds.
Age: 21.0
Sex: F
Vaccine: HEPA, MEA, VARCEL
Symptoms: Injection site erythema, Tenderness
Clinical narrative: 1 and 1/2 inch of erythema at site.  No warmth, no induration, minimally tender.
Age: 65.0
Sex: M
Vaccine: TTOX
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Bilaterally... continued muscle/joint pain and stiffness much the same as those right after the pneummonia and tetanus shots, one in each arm (Hydraulics not needle) 2d vac name missing below (see clinic records)
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: ITCHING TO INJECTION SITE, VERY HOT TO TOUCH, PAIN 2HOURS AFTER ADMINISTRATION. REDNESS PROGRESSED TO 8" x5". KEPT AREA ELEVATED, ICE PACK APPLIED.
Age: 0.86
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Pyrexia, Rash papular
Clinical narrative: APPROXIMATELY 24 HOURS POST VACCINATION, MOM NOTED A "RASH" ON BABY'S CHEST.  OF NOTE, MOM STATES BABY TO BE "CRANKY" AND WITH TACTILE TEMPERATURE ON THE DAY OF VACCINATION.  MOM DOES NOT REPORT ANY OF THE FOLLOWING:  COUGHING, WHEEZING, EYELID EDEMA, NOR LIP SWELLING.  RASH IS PAPULAR, NONPURITIC, AND CONFINED TO TORSO ONLY.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Pain
Clinical narrative: PAIN IN AXILLA AND TORSO ON SIDE WHER VACCINATION RECIEVED.  NO ERYTHEMA OR LYMPHADENOPATHY.
Age: 18.0
Sex: F
Vaccine: FLUX, HEP, HEPA, SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Adrenal disorder, Cardiac arrest, Coronary artery disease, Coronary artery occlusion, Diabetes mellitus
Clinical narrative: This subject is a 70 year old female, who died while enrolled in a study. The subject received the study vaccine on 6/21/04. The study is blinded in the age group for this subject. The subject died at home 140 days post immunization. The cause of death is unknown at this time. There is no report of hospitalization. The death certificate will be provided up receipt from the subject's family. Additional information to be provided when available. The death was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: ISAEF, Telephone Contact; SAE Reports, SAE Fax Transmittal and Confirmation. Death Certificate states COD is acute coronary occlusion, coronary artery disease, diabetes mellitus and cardiopulmonary arrest.  Medical Records received on 11/23/2004 states the pt experienced diabetes mellitus, diabetic neuropathy, hyperlipidemia, elevated liver enzymes, adrenal mass, and hypertension.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Hyperlipidaemia, Hypertension, Liver function test abnormal, Neuropathy
Clinical narrative: This subject is a 70 year old female, who died while enrolled in a study. The subject received the study vaccine on 6/21/04. The study is blinded in the age group for this subject. The subject died at home 140 days post immunization. The cause of death is unknown at this time. There is no report of hospitalization. The death certificate will be provided up receipt from the subject's family. Additional information to be provided when available. The death was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: ISAEF, Telephone Contact; SAE Reports, SAE Fax Transmittal and Confirmation. Death Certificate states COD is acute coronary occlusion, coronary artery disease, diabetes mellitus and cardiopulmonary arrest.  Medical Records received on 11/23/2004 states the pt experienced diabetes mellitus, diabetic neuropathy, hyperlipidemia, elevated liver enzymes, adrenal mass, and hypertension.