chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Coordination abnormal, Diplopia, Eyelid ptosis, Fatigue, Headache
Clinical narrative: 12/30/03-extreme fatigue, 1/1/04 muscle weakness, 1/4-5/04-N/V, 1/3 HA, seeing double, 1/5-6/04 progressive weakness 1st hands then feet, hospitalized 1/6/04. Ptosis of R eye. Miller Fisher variant of Guillain Barre syndrome. The medical records received on 1/20/04 states URI, diplopia, ataxia, numbness, neck weak, absent refleses, and lethargy. 60-day follow up on 04/21/04: "Pt has not recovered from adverse event. Still recovering as of 04/08/04. Decreased stamina, persisting double vision, weakness in arms and legs." Per annual report- Per MD check-up, patient has recovered 45% of strength.  Patient has tingling sensation on hands.  No longer has double vision.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lethargy, Miller Fisher syndrome, Muscular weakness, Nausea
Clinical narrative: 12/30/03-extreme fatigue, 1/1/04 muscle weakness, 1/4-5/04-N/V, 1/3 HA, seeing double, 1/5-6/04 progressive weakness 1st hands then feet, hospitalized 1/6/04. Ptosis of R eye. Miller Fisher variant of Guillain Barre syndrome. The medical records received on 1/20/04 states URI, diplopia, ataxia, numbness, neck weak, absent refleses, and lethargy. 60-day follow up on 04/21/04: "Pt has not recovered from adverse event. Still recovering as of 04/08/04. Decreased stamina, persisting double vision, weakness in arms and legs." Per annual report- Per MD check-up, patient has recovered 45% of strength.  Patient has tingling sensation on hands.  No longer has double vision.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Upper respiratory tract infection, Vomiting
Clinical narrative: 12/30/03-extreme fatigue, 1/1/04 muscle weakness, 1/4-5/04-N/V, 1/3 HA, seeing double, 1/5-6/04 progressive weakness 1st hands then feet, hospitalized 1/6/04. Ptosis of R eye. Miller Fisher variant of Guillain Barre syndrome. The medical records received on 1/20/04 states URI, diplopia, ataxia, numbness, neck weak, absent refleses, and lethargy. 60-day follow up on 04/21/04: "Pt has not recovered from adverse event. Still recovering as of 04/08/04. Decreased stamina, persisting double vision, weakness in arms and legs." Per annual report- Per MD check-up, patient has recovered 45% of strength.  Patient has tingling sensation on hands.  No longer has double vision.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Ascites, Asthenia, Atelectasis, CSF test abnormal, Chills
Clinical narrative: 12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: "Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS." Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Constipation, Gait disturbance, Hypersensitivity, Immune system disorder, Liver function test abnormal
Clinical narrative: 12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: "Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS." Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myelitis transverse, Pain, Paralysis
Clinical narrative: 12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: "Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS." Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Prostatic disorder, Pulmonary congestion, Pyrexia, Sensory disturbance, Upper respiratory tract infection
Clinical narrative: 12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: "Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS." Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Urinary retention
Clinical narrative: 12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: "Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS." Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Swelling, Tenderness
Clinical narrative: Extreme swelling of both thighs; especially the right thigh. Very painful to touch. Occurred within 2-3 hours of receiving vaccinations.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hyponatraemia, Laboratory test abnormal, Pneumonia
Clinical narrative: After one week, was in hosp. for 2 wks with pneumonia. The discharge summary received on 1/28/04 states fever, chills, weakness and hyponatremia.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: After one week, was in hosp. for 2 wks with pneumonia. The discharge summary received on 1/28/04 states fever, chills, weakness and hyponatremia.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Polymyalgia rheumatica
Clinical narrative: Loss of strength, bad all over. Went to Dr 4 times. He said what I had was polymyalgia rheumatica. Tripped by the flu shot. I am still weak.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Erythema multiforme, Skin ulcer, Urticaria
Clinical narrative: Pt got shots 12/9/03 and on 12/11/03 pt developed right lower hip with urticarial lesions (erythema multiforme). Shot site had no rash and tenderness or swelling, there was no SOB.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Heart rate increased, Heart rate irregular
Clinical narrative: At approximately 24 hours from the time I received the flu shot this season, I developed a rapid and irregular heartrate/beat with overall feeling of "wooziness" and weakness, which resolved about 3 hours later.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: 11 AM received vaccine. 12 PM Pt noticed redness on neck and trunk. 2 PM redness less on neck and trunk.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt called after returning home and reported the development of hives after getting the flu shot.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Insomnia, Pain, Petechiae
Clinical narrative: Onset Thurs evening with temperrature (102-103) through Friday. Achiness, sweats, dizziness and decrease in sleep. Monday night developed an itchy petechia rash on legs (bilaterally), lower shin area.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia
Clinical narrative: Onset Thurs evening with temperrature (102-103) through Friday. Achiness, sweats, dizziness and decrease in sleep. Monday night developed an itchy petechia rash on legs (bilaterally), lower shin area.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Sharp pains lasting a few seconds occurring in both elbows, hands and right upper leg.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Influenza like illness, Joint range of motion decreased, Oedema, Pain
Clinical narrative: Anthrax #3, fever, flu-like symptoms, severe erythema, edema, pain of right UE, unable to use arm secondary to symptoms. Sun in ER x2, no treatment/medications prescribed.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Anthrax #3, fever, flu-like symptoms, severe erythema, edema, pain of right UE, unable to use arm secondary to symptoms. Sun in ER x2, no treatment/medications prescribed.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Rash, Urticaria
Clinical narrative: 1640: Hive-like rash on face and upper torso 5 minutes after receiving MMR #1 and other immunizations. Pt given 12.5mg Benadryl suspension. 1655: Hives resolved.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Mild case of varicella, diagnosed 1/5/04.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Right upper outer thigh 11cm x 12cm redness with 6 x 4 induration blanched area at center of redness.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: Prolonged crying episode after shots (>3 hours).
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Pt given DTaP, HIB, IPV, Prevnar 4/30/03. 5/1 T 102.1, inconsolable crying. Seen by Dr who Dx with febrile rx to vaccines. Lasted til 5/2.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Nontender, erythematous, indurated swelling left arm on lateral aspect around vaccine site.
Age: 1.25
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, redness in left thigh where shot given, sore to touch.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash 11 days after immunization.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt received immunization on 12/24/03 then on 1/7/04 noticed arm was swollen and red.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pain, erythema, tenderness 24 to 48 hours after injection. In 7-9 days, fever, erythema, pain, tenderness mid mid and 4 areas of 4-5cm diameter.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: Medication error
Clinical narrative: Pt inadvertently received a Pediarix instead of DTaP. The result is that he received an extra dose of polio and a double dose of Hep B. Pt experienced no adverse reactions. Pt's mother was notified. Follow up on 01/23/04: "No adverse reaction occurred in the pt.  Date of vaccine 12/29/03.  Report is valued mistaken dosage."
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: Medication error
Clinical narrative: Pt inadvertently received Pediarix instead of a DTaP. The result is that she received an extra dose of the polio vaccine and a double dose of Hep B. Pt experienced no adverse reaction and pt's mother was notified. The occurrence was 12-29-03, there was no adverse reaction to the patient. The time of the occurence was approximately 3:45 pm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: 1/7/04: 11:30 AM shot given. 3:30 vomited 1x, diarrhea 1x. (No fever, encouraged fluids). 5:30 vomited 1x, diarrhea 1x. 1/8/04: No vomiting or diarrhea noted. Child feeling better.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site oedema
Clinical narrative: Left leg swelled at site shot (DTaP) was given, 2 days after shot was given. It had gone down 2 days later (swelling was almost as big as entire thigh).
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyspnoea, Grunting, Hypotonia, Muscle twitching, Pallor
Clinical narrative: 22:00: Infant was on changing table.  Had nursed well and seemed fine-no fever-suddenly became pale, limp, grunting noises, dyspnea, slight twitching.  No eye rollong, no post-ictal state, 911 called, infant recovered by time of arrival still pale.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site warmth, Oedema, Pain
Clinical narrative: Swelling of left upper arm 3.5x5cm erythema, no induration, hot and painful.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Edema/erythema of right anterior thigh 14x9cm about 3 days after.
Age: 0.9
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Erythema, Urticaria
Clinical narrative: After infant stopped crying, mother noticed redness and patches on scalp and face.  She walked right back to nurses for immediate assessment.  Assessment revealed hives on scalp, face, chest, arms bilat and legs bilat.  Respirations unlabored, infant content and calm.  MD notified at 4:55, advised parent to drive to MD office for Benadryl treatment 1/2 tsp every 6 hours was ordered.
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash vesicular, Skin ulcer
Clinical narrative: 15 lesions, red base, vesicular surface continuing to erupt; afebrile.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dyspnoea, Headache, Injection site pain, Lacrimation increased
Clinical narrative: Sore arm at injection site, nausea, chest and head congestion, headache, personality change, shortness of breath, coughing, excessive mucous, watery eyes: 10 days
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Nasal congestion, Nausea, Personality disorder, Rhinorrhoea
Clinical narrative: Sore arm at injection site, nausea, chest and head congestion, headache, personality change, shortness of breath, coughing, excessive mucous, watery eyes: 10 days
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Temperature: 101, decreased appetitie.  VZ in classroom, hundreds of papulo-vesicles from scalp down.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site induration, Rash vesicular
Clinical narrative: On right upper leg (thigh) pt's leg at site of Varicella was a vesicular rash.  Tiny area of firm tissue at site of Hib.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Broke out with chickenpox.  10 on cheek, 30 on abdomen.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swollen site, erythema
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt given immunizations.  Per mother, child seized at home (half-way house).  No medical care available until 01/07/04.  Child sent to ER for evaluation. Temperature 103 on 01/07/04.
Age: 6.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: Spoke to mom on 09/25/2003 states pt had red, swollen area that was warm to touch with fever noted, from DTAP site on increased left deltoid.  Noted that on 09/23/03 on 09/24/03 swelling progressed to elbow and was red and swollen.  Mom called MD was will start on Augmentin today.  Mom did not see MD-only telephone call.  States started Augmentin for "cellulitis" of left arm.
Age: 6.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Spoke to mom on 09/25/2003 states pt had red, swollen area that was warm to touch with fever noted, from DTAP site on increased left deltoid.  Noted that on 09/23/03 on 09/24/03 swelling progressed to elbow and was red and swollen.  Mom called MD was will start on Augmentin today.  Mom did not see MD-only telephone call.  States started Augmentin for "cellulitis" of left arm.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Pain, Paraesthesia
Clinical narrative: Swollen joints and pain tingling in the fingers.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Severe induration/edema with erythema of left thigh covering about 7x5cm.
Age: 20.0
Sex: M
Vaccine: HEPAB, MMR, SMALL, TD, YF
Symptoms: Pruritus, Rash maculo-papular, Thermal burn
Clinical narrative: 2 days of widespread symmetrical pink maculopapular eruption w/ pruritus and burning; started on ankles and has spread to feet, lower legs, hands, wrists, forearms, and sparsely on back and abdomen; includes palms and soles
Age: 37.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Erythema, Injection site mass, Swelling
Clinical narrative: Dizziness,Redness,Swelling of Arm with hardened lump
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Injection site inflammation, Injection site mass, Pruritus
Clinical narrative: Itchy,Inflamed area with lump in center of approximately 5 inches in diameter. Redness is spreading into Tricep area of right arm.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema
Clinical narrative: PATIENT REC'D ANTHRAX # 2 ON DEC 16, 2003. WITHIN 48 HOURS, HE DEVELOPED PAIN IN JOINTS OF SHOULDER,ELBOW,AND THUMB. REDNESS AND ERYTHEMA RESOLVED WITHIN ONE DAY, HOWEVER, JOINT PAIN PERSIST GREATER THAN 4 WEEKS. PAIN INCREASES WITH MOVEMENT AND ATTEMPTING TO LIFT OBJECTS.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Difficulty in walking
Clinical narrative: 36 hours after shot patient awoke very stiff with severe joint pain.  The pain started with major joints and traveled to minor joints.  Pain prevented typing and made stairs very difficult.  Final joint pain subsided in fingers on 24 Dec 03, 11 days after shot.
Age: 0.4
Sex: M
Vaccine: UNK
Symptoms: Eczema, Erythema, Irritability, Restlessness, Skin irritation
Clinical narrative: when i woke up on the 9th of January on Friday i noticed while i was changing my sons diaper that his two upper thighs were swollen and hard. His skin was very irritated to were the skin was red and bumpy. He is barely accepting any of the formula that i am giving him.  He is throwing up large quantities of milk.  When me and my grandma seen this we rushed him straight to the emergency room. Were they informed us that it was because i was feeding him to much. And that he was teething which has been ongoing for a month or two.  He does have eczema but vaccination caused a flare up of his eczema profuciously.  And he cries all night,sractches hives,very irritable,and very restless. medications prescribed for eczema is not effective. Such as; Triamcinoline 0.01%/eucerin 1GM prescribe 01/06/2004, Aquaphor oint 396 GM date prescribed 12/17/03,Eucerin cream113 GM date prescribed 10/25/03,Hydrocortisone cream received from hospital the first week of December 2003.
Age: 0.4
Sex: M
Vaccine: UNK
Symptoms: Swelling, Urticaria, Vomiting
Clinical narrative: when i woke up on the 9th of January on Friday i noticed while i was changing my sons diaper that his two upper thighs were swollen and hard. His skin was very irritated to were the skin was red and bumpy. He is barely accepting any of the formula that i am giving him.  He is throwing up large quantities of milk.  When me and my grandma seen this we rushed him straight to the emergency room. Were they informed us that it was because i was feeding him to much. And that he was teething which has been ongoing for a month or two.  He does have eczema but vaccination caused a flare up of his eczema profuciously.  And he cries all night,sractches hives,very irritable,and very restless. medications prescribed for eczema is not effective. Such as; Triamcinoline 0.01%/eucerin 1GM prescribe 01/06/2004, Aquaphor oint 396 GM date prescribed 12/17/03,Eucerin cream113 GM date prescribed 10/25/03,Hydrocortisone cream received from hospital the first week of December 2003.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Oral intake reduced, Otitis media, Pyrexia
Clinical narrative: 1/7/04 10:00 A.M.--Child crying inconsolably and nothing will calm him.Advised to call physician 10:30 A.M.--Still crying, and will not eat well.Has appt. to see Dr at 3. 1:00 P.M.--Baby sleeping lightly after Mom turned on vaccuum, still not wanting to eat.  Mom has given Tylenol 4:30 P.M.--Has seen Dr.Temp was 98.1. Mom was instructed to begin alternating ibuprofen with the Tylenol, and told to return if temp goes up, child begins crying inconsolably again or if he will not eat at all.  Baby has taken "about an ounce" of formula. 1-8-04 9:00 A.M.--Child began crying again during the night and had Temp over 100 which did not come down with ibuprofen, so Mom took him to E.R. where they gave him a Tylenol suppository.Fever is still up but he has been sleeping.Baby is to see Dr.again at 2:40 p.m. 1:00 P.M.--Not crying at this time.Taking formula better. 1-9-04 4:00 P.M.--No further crying and is eating better.Was able to go to Daycare today.Mom reports that at appt. last evening, Dr. found bilat. ear infection which was missed in E.R. and started child on antibiotics.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: This child and his parents volunteered to participate in a CDC sponsored study: "Extensive Swelling Reactions After Booster Doses of Acellular Pertussis Combined with Diptheria and Tetanus: 5th Dose Revaccination." The child developed swelling measuring 90mm(ht)x70mm(w)on the evening of the vaccination. Complete resolution by Day #5 morning. A diary and digital pictures were obained.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Contusion, Laboratory test abnormal, Rash, Thrombocytopenia
Clinical narrative: 2 weeks after MMR vaccine, patient began bruising on back and buttocks.  Bruising became more pronounced over next several weeks and more widespread. For approximately 1 month, pt had a fine red rash on his feet.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Contusion, Erythema, Laboratory test abnormal, Rash, Thrombocytopenia
Clinical narrative: 2 weeks after MMR vaccine, patient began bruising on back and buttocks.  Bruising became more pronounced over next several weeks and more widespread. For approximately 1 month, pt had a fine red rash on his feet.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Dysphonia, Headache, Neck pain, Pyrexia
Clinical narrative: Temperature about 24 hours, joint ache, headache, right side of neck hurting, injection site left arm.  12/11/03: Developed hoarseness which lasted till 12/25/03 or there about.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: 01/02/04: Grandmother reports rash around immunization site.  01/05/04: Grandmother reports "better today." Rash about the size of 50 cent coin.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Reddened 4.5 cm size area on left anterior thigh (round).
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Injection site-left arm very swollen-twice as big as right arm.  Very high fever: 103.6 - 24 hours after pneumonia injection.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Urticaria, Vaccine positive rechallenge
Clinical narrative: Erythema, slight edema onset 2 days after flu vaccine, one area that looks like a hive, central area measures 70x125mm.  "Hive" area 10mm.  LTDT.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: 24 hours after vaccination, right arm site red, swollen, onset of fever and chills which lasted three days.  Injection site developed cellulitis 3inch in diameter.  Tylenol and ice packs used.
Age: 9.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 24 hours after vaccination, right arm site red, swollen, onset of fever and chills which lasted three days.  Injection site developed cellulitis 3inch in diameter.  Tylenol and ice packs used.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Eye oedema, Eyelid ptosis, Face oedema
Clinical narrative: 2 days after having received an influenza vaccine 0.25mL, the pt developed diffuse facial swelling including eye swelling/ptosis.  No respiratory problems were noted (-) rash, no vomiting/diarrhea.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Headache-which lasted approximately 3-4 weeks.  Had CT of head: which was normal.  Treated with Prednisone-Headache went away after taking Prednisone.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Pruritus, Pyrexia, Rash
Clinical narrative: MMR on 12/30/03: Fever 100-102 axillary Friday (01/02/2004-01/04/2004) through Sunday. Rash started on forehead on 01/05/2004.  On 01/06/2004 rash generalized on trunk upper legs, around injection site (right thigh) and neck and face. Very irritable and head itches.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Contusion, Injection site oedema, Injection site warmth, Pain
Clinical narrative: 2 days after adult Td, developed soreness, swelling, bruise, warmth.  Involving left shoulder and lateral upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Injection site oedema
Clinical narrative: Came to office - pt with symptoms of S/A, sitting around, and redness with edema to right thigh. Saw per PNP and Dx with cellulitis (local reaction to immunization).
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Dry mouth
Clinical narrative: Dry mouth, dizziness 30 minutes to 1 hour post MMR vaccine. Pt went to ER at pt preference, was given Benadryl and prednisone injection. Took BP and watched 1 hour. Pt doing well at present.
Age: 40.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Dysphagia, Dyspnoea, Fatigue, Rash maculo-papular
Clinical narrative: Pt received below vaccines at 1000 01/05/04. At 1500 pt states she started feeling tired, at 1800 pt was eating dinner. She states she was having trouble swallowing. At 2100 she states she was having trouble breathing. She looked in her throat from back of tongue there were large bumps. At this time she states she took Benadryl 4 teaspoons liquid. Pt states at 2130 she was able to breathe comfortably again. She states she still has the large bumps in her throat.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: S/P vaccine 1/8. Came in to see RN and left thigh to knee + edema. No erythema. Seen again 1/9. Edema decreased with Benadryl. 70% improved by 1/9/04. Told to RTC if not better by 1/10/04.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV
Symptoms: Contusion, Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Left thigh had knot on it, it was red and hot to the touch. Mom thought he had a fever. Small bruised area over injection site. Treatment: Tylenol and Benadryl PRN and cool compresses.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Irritability, Listless, Pyrexia
Clinical narrative: Mother states 1 hour after receiving immunization child ran temp of 104, site gave Tylenol fever down to 102 (at 104 child was listless, not raising head, 102 child was grouchy). Child had diarrhea x2 days, fever 101 x1 week. Mother called pediatrician's office next day. No treatment, not seen in office.
Age: 0.83
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Infection, Pharyngitis, Pruritus, Pyrexia
Clinical narrative: Mild chicken pox infection 4 years after the vaccine for varicella given. 9/24/03: His symptoms started with a fever a week ago followed with some cough and cold symptoms. All the symptoms started to improve on Sunday. On Monday he broke out with a rash and has been itchy since then. It started from the abdomen and then started to move towards the arms.
Age: 0.83
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rhinitis
Clinical narrative: Mild chicken pox infection 4 years after the vaccine for varicella given. 9/24/03: His symptoms started with a fever a week ago followed with some cough and cold symptoms. All the symptoms started to improve on Sunday. On Monday he broke out with a rash and has been itchy since then. It started from the abdomen and then started to move towards the arms.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 2cm swelling and redness at injection site persisting at least 1 week. Left thigh. Still present 9 days after injection.
Age: 1.25
Sex: M
Vaccine: MMR, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Uncontrollable crying >4 hours.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Contusion, Laboratory test abnormal, Rash, Thrombocytopenia
Clinical narrative: 2 weeks after MMR vaccine, patient began bruising on back and buttocks.  Bruising became more pronounced over next serveral weeks and more widespread. For approximately 1 month, pt had a fine red rash on his feet.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL, DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Contusion, Erythema, Laboratory test abnormal, Rash, Thrombocytopenia
Clinical narrative: 2 weeks after MMR vaccine, patient began bruising on back and buttocks.  Bruising became more pronounced over next serveral weeks and more widespread. For approximately 1 month, pt had a fine red rash on his feet.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Headache, Injection site induration, Injection site oedema, Pain
Clinical narrative: Client reports that she received her influenza vaccine in left arm on 10-28-03 ar Dr. office.  She had previous flu shots other years.. states she got sick on 10-30-03 pm. with vomiting, aching, dizziness and swelling of left arm.  She says there is an indention about 4" below shoulder wherelooks like flesh is out as if from surgery.  She says the area is still hard and swollen.  She still complains of headache and dizziness.  She says she has been back to Dr. office twice for the arm and he x-rayed it on 12-09-03.  she saw Dr. on 12-23-03 and he reported it to the Health Dept.  She gave this information per telephone one 01-05-04 and came to Health Dept. on 01-06-04 to show the arm to nurses.  Says it is painful to raise the arm.  The Dept. of Health & Senior Services will be sending via mail a picture of this arm and possibly the x-ray and lab work that was done on her.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Client reports that she received her influenza vaccine in left arm on 10-28-03 ar Dr. office.  She had previous flu shots other years.. states she got sick on 10-30-03 pm. with vomiting, aching, dizziness and swelling of left arm.  She says there is an indention about 4" below shoulder wherelooks like flesh is out as if from surgery.  She says the area is still hard and swollen.  She still complains of headache and dizziness.  She says she has been back to Dr. office twice for the arm and he x-rayed it on 12-09-03.  she saw Dr. on 12-23-03 and he reported it to the Health Dept.  She gave this information per telephone one 01-05-04 and came to Health Dept. on 01-06-04 to show the arm to nurses.  Says it is painful to raise the arm.  The Dept. of Health & Senior Services will be sending via mail a picture of this arm and possibly the x-ray and lab work that was done on her.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Injection site induration, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Client reports that she received her influenza vaccine in left arm on 10-28-03 ar Dr. office.  She had previous flu shots other years.. states she got sick on 10-30-03 pm. with vomiting, aching, dizziness and swelling of left arm.  She says there is an indention about 4" below shoulder wherelooks like flesh is out as if from surgery.  She says the area is still hard and swollen.  She still complains of headache and dizziness.  She says she has been back to Dr. office twice for the arm and he x-rayed it on 12-09-03.  she saw Dr. on 12-23-03 and he reported it to the Health Dept.  She gave this information per telephone one 01-05-04 and came to Health Dept. on 01-06-04 to show the arm to nurses.  Says it is painful to raise the arm.  The Dept. of Health & Senior Services will be sending via mail a picture of this arm and possibly the x-ray and lab work that was done on her.
Age: 1.27
Sex: M
Vaccine: HIBV, MMR
Symptoms: Aphasia, Autism, Colitis, Convulsion, Paraesthesia
Clinical narrative: After receiving MMR shot on 5/22/02 patient stopped speaking and went into his own world.  Diagnosed with Autism 11/02. The hospital discharge summary received on 2/4/03 states seizure. The medical record received on 2/12/04 states sensory deficit and colitis. 60-day follow up on 04/14/04: "Pt has not recovered from adverse events.  My son developed autism and there is no cure for that!" Per annual report- My son has Autism caused by the themirosal in his infant vaccines.  Compounded by injecting him with 3 live viruses (MMR) at one time.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Muscular weakness
Clinical narrative: Sustained back injury approximately 6 wks before receiving 4th anthrax. Worsening pain, weakness after receiving anthrax.  No improvement with PT.  Some improvement with NSAIDs, chiropractor.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: CELLULITIS LT ARM TREATED WITH BACTRIM
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Report 2001028056-1 describes injection site welts in a 23-year-old female who received hepatitis B vaccine recombinant (Engerix-B). The reporter submitted this report independently to VAERS. The pt had no medical history, concurrent conditions, or concurrent medications. She had no illness at the time of vaccination. On 11/06/2001 14:05, the pt received her 1st injection of Engerix-B. She experienced "immediate" redness and swelling at the injection site, and developed local welts 30 seconds later. She had no other symptoms. She required a doctor visit and was treated with application of ice for 30 minutes. She recovered on 11/06/2001.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Muscle atrophy, Pain, Paraesthesia
Clinical narrative: A physician reported the occurrence of myobrachial plexopathy in a 36 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. There were no concurrent medical conditions, known drug allergies, or medications. She received her first injection of Engerix B on 1/23/01: the vaccine was injected into her left deltoid. On 2/3/01, 11 days post-immunization, she was seen in the ER with pain, numbness and tingling of the left deltoid. Muscle atrophy of the left deltoid was noted. She was treated with unspecified steroids. The subject was lost to follow-up. The physician provided additional info on 4/2/03. He started that the subject returned for care and stated that another physician has made a diagnosis of myobrachial plexopathy. As of 4/2/03, the subject continued to experience paresthesia in the deltoid. The physician observed "focal atrophy in the mid-deltoid," which he described as "scalloping" and "mainly cosmetic."
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: A nurse reported the occurrence of flu-like symptoms in 37-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt had no relevant medical history, concurrent medical conditions or concurrent medications reported. The reporter submitted a report directly to VAERS (VAERS reference # not provided). On 10/15/2002, the pt received her 1st injection of hepatitis B vaccine recombinant (Engerix-B) (lot #ENG5312A6) 20 mcg in the left arm. Three hours post vaccination, the pt developed flu-like symptoms, body aches, fever, nausea and vomiting. The events resolved approx 2 weeks later. The reporter considered the events to be related to Engerix-B. The Engerix-B immunization series was discontinued.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: A physician reported the occurrence of vomiting in a 10-month-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received via Wyeth Research. Please reference their manufacturer control # HQ5348715NOV2002. The pt's medical history, concurrent medical conditions and concurrent medications were not reported. On 10/22/2002, the pt was vaccinated with hepatitis B vaccine recombinant (Engerix-B). One day later, on 10/23/2002, the pt experienced vomiting and retching. The outcomes for these events were unknown.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: This report describes the occurrence of SOB in a 34-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's spouse and has not been verified by a physician or other healthcare professional. The pt reportedly had no relevant medical history, concurrent conditions or concurrent medications. On 02/20/2003, the pt received his 1st injection of Engerix-B. Later that day, he reportedly developed SOB, hives, lower back pain, and joint pain. The pt's spouse considered these events to represent an allergic reaction to Engerix-B. The Engerix-B immunization series was discontinued. The SOB, back and joint pain resolved after an unspecified period of time. As of 03/14/2003, the pt reportedly continued to have hive on his face.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, TTOX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case described the occurrence of vomiting in a 12 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt's mother and has not been verified by a physician or other healthcare professional.  On 05/16/03 the pt received the 1st dose of Engerix-B. She also received injections of hepatitis A vaccine (manufacturer unknown) and tetanus toxoid (manufacturer unknown).  Approximately 3 hours post-immunization, on 05/16/03, the pt began to experience nausea.  Approximately 4 hours post-immunization the subject reportedly began to vomit "about every 20 minutes until around 03:00."  Reportedly, at approximately 4 hours post-immunization, the pt also began to experience a fever of 101 to 102 F.  The events resolved.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Erythema, Oedema, Rash maculo-papular
Clinical narrative: This case was reported by a physician and described the occurrence of an allergic reaction in a 1 month old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's current medical conditions and medical history were not reported.  On 09/03/03, the pt received the 1st dose of Engerix-B in the hospital after birth.  On 10/03/03, the pt received her second dose of Engerix-B (Lot # ENG5393A2).  Later that same day, at an unspecified time post-immunization, the pt experienced redness and swelling of her hands and feet.  As the redness and swelling of the hands and feet resolved, the pt developed redness and swelling of the back of her neck, extremities, and groin with erythematous splotches.  The physician described the erythematous splotches as "some with dosky centers and some with slightly raise, pale centers."  The pt was seen by the physician, who made a diagnosis of possible allergic reaction to Engerix-B.  The pt was also seen by a Dermatologist performed "test for yeast" which was negative.  The events resolved by 10/06/03.  The Engerix-B immunization series was discontinued.  The physician considered the allergic reaction to be almost certainly related to vaccination with Engerix-B.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal labour, Bacterial infection, Infection, Proteinuria, Unintended pregnancy
Clinical narrative: Information has been received from a public health registered nurse concerning a 19 year old female pt with an obstetrical history that included one previous pregnancy and no live births due to a miscarriage that occurred 11 1/2 weeks from the last menstrual period and with no birth defects noted in the previous pregnancy. On 3/20/03 the pt as vaccinated with a second dose of MMR II (640237/1479L). The pt had received the first dose of MMRII on 11/15/95. The pt was instructed about pregnancy before being vaccinated and reported that she was on birth control pills. The nurse reported that the pt's husband called the health dept on 4/16/03 and reported that they found out that the pt was pregnant. Her last menstrual period was 2/20/03. It was reported that the pt received the vaccine 4 weeks after her last menstrual period. Unspecified medical attention was sought. The pt's pregnancy was confirmed by a positive pregnancy test, which was done on an unspecified date. The estimated date of delivery was reported to be 11/27/03. It was reported that the pt was taking prenatal vitamins-iron. Follow up info received reported that nineteen weeks from her last menstrual period the pt underwent lab evaluation which revealed that on 6/6/03 "Triple Mark-normal." Lab evaluation also revealed "PN lab-normal," "Diabetes-normal" and protein in urine toward end of pregnancy. An ultrasound done on 8/18/03 revealed oligohydramnios. It was reported that thirty four weeks after the last menstrual period the pt experienced "Group Beta Strep" which was treated with antibiotics before delivery. On 11/20/03 the pt had a "C-section due to failure to progress." She gave birth 38 weeks from her last menstrual period to a male infant whose birth weight was 7 lbs 3 oz. The infant was normal and it was reported that the infant had no congenital anomalies and he did not have any complications. Upon internal review C-section due to failure to progress was considered an other important medical event (OMIC). No further info is available.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Uterine disorder
Clinical narrative: Information has been received from a public health registered nurse concerning a 19 year old female pt with an obstetrical history that included one previous pregnancy and no live births due to a miscarriage that occurred 11 1/2 weeks from the last menstrual period and with no birth defects noted in the previous pregnancy. On 3/20/03 the pt as vaccinated with a second dose of MMR II (640237/1479L). The pt had received the first dose of MMRII on 11/15/95. The pt was instructed about pregnancy before being vaccinated and reported that she was on birth control pills. The nurse reported that the pt's husband called the health dept on 4/16/03 and reported that they found out that the pt was pregnant. Her last menstrual period was 2/20/03. It was reported that the pt received the vaccine 4 weeks after her last menstrual period. Unspecified medical attention was sought. The pt's pregnancy was confirmed by a positive pregnancy test, which was done on an unspecified date. The estimated date of delivery was reported to be 11/27/03. It was reported that the pt was taking prenatal vitamins-iron. Follow up info received reported that nineteen weeks from her last menstrual period the pt underwent lab evaluation which revealed that on 6/6/03 "Triple Mark-normal." Lab evaluation also revealed "PN lab-normal," "Diabetes-normal" and protein in urine toward end of pregnancy. An ultrasound done on 8/18/03 revealed oligohydramnios. It was reported that thirty four weeks after the last menstrual period the pt experienced "Group Beta Strep" which was treated with antibiotics before delivery. On 11/20/03 the pt had a "C-section due to failure to progress." She gave birth 38 weeks from her last menstrual period to a male infant whose birth weight was 7 lbs 3 oz. The infant was normal and it was reported that the infant had no congenital anomalies and he did not have any complications. Upon internal review C-section due to failure to progress was considered an other important medical event (OMIC). No further info is available.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A male (unknown age) received RSV vaccine or Placebo and Influenza vaccine on 11/6/02 and later died (unknown date). The subject was lost to follow up. The phone was disconnected and certified letter returned with deceased 11/3/03 written on the envelope unopened. Will try and get information from PCP and follow up. Patient has a history of Hypertension, CHF, and back pain. Information from 5/15/03 telephone conversation with the Investigation. A 67 year old male, no family, has tried calling patient's family physician who is not available. The subject was called for follow up, found phone disconnected, then a certified letter was sent which was returned with deceased marked on it. Further information is expected. Follow up information received on 6/5/03. Investigator spoke to subjects doctor on 5/20/03, stated that he did not know his patient had passed away. Doctor does not know what happened or which hospital patient went to. No other information available. Additional information received on 1/12/04. Death certificate. DOB 4/22/35. Subject died on 3/9/03, 123 days post immunization. The state does not release cause of death information. Follow up on 01/21/04 : "The death was reported by the investigator as not related to the study vaccine.  Subject died 03/09/03.  Cause of death is unknown. Symptoms and treatment related to the serious adverse events are unknown. Subject had a history of hypertension and congestive heart failure. No further information is available."