chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reserved Varivax on 8-5-08. We saw patient in the office on 8-7-08. She had marked swelling (3 inches x 5 inches), erythema and pain in the right arm where vaccine was given. Pain began during the night 8/5/08-08/06/08.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site irritation, Injection site mass
Clinical narrative: Red irritated area on right arm where varicella was given. Bruised round knot on left arm were MENACTRA was given.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Acne, Erythema, Pruritus, Swelling
Clinical narrative: 8/8/08 12:00 - Client's mother called stating that client has 3 pimple like raised red areas, swelling and itching to L deltoid. Treatment recommended cool compress to site. Tylenol/advil for discomfort. Antihistamine if absolutely necessary.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: 08/11/08 14:05, received GARDASIL and MENACTRA. Walked to door to waiting area, LOC < 1 minute. No vomiting or seizure. Suspect vasovagal reaction.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Respiratory rate decreased, Syncope
Clinical narrative: Faint after MENOMUNE injection. EMS called BP 120/80 decreased respiration at time of fainting. EMS arrival, BP stable, patient alert and oriented X 3. Patient resting for 20-30 minutes, left on own with sister. Instructed to go to ER if worse. Left message for doctor.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Mass, Pain in extremity
Clinical narrative: Pt felt a knot to her right arm on 08/07/08 around 9:00 pm. Pt felt a "knot" to her left arm around 8:00 am on 08/08/08. Pt states both left and right arm hurts only to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Mom reports large area of redness, swelling, cantaloupe size knot with pain and blisters at injection site.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Right thigh with 2 cm linear erythematous mark punctuated by a 3mm bulla at injection site.
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Folliculitis, Injection site erythema, Injection site pruritus, Pruritus generalised, Pyrexia
Clinical narrative: Patient comes in with an adverse reaction to vaccination. She had several vaccinations done last Thursday, apparently reacting to varicella vaccine. She does have allergies to the MMR vaccine, although we do not know which component of the MMR. She apparently developed a fever within a day or two. Fevers were up to 104.0. They were running between 100.0-101.0 with medications. Is not running any fever of late. Has had some itching around the site where the injection was given, some redness there as well. Some kind of generalized itching. Also has been small rash that broke out under the breast. Also had a couple of spots on the abdomen. Dose not think she has rash anywhere else. The rash under the breast has resolved, but still has a couple of spots left on the abdomen. She is alert, orientated and pleasant. No acute distress. BP 110/76. P 64. R 10. T 98.6. WT 136. Allergic to MMR vaccine, varicella vaccine. Oropharynx is pink and moist, no lesions or exudate noted on the soft palate, pharynx or oral mucosa or buccal mucosa. Neck is supple, no masses. Skin with local erythematus lesion on the middle portion of the left arm. No tenderness over the area, slight warmth. Does blanch. No other rash is seen. No other skin changes are noted. Abdomen: Two small pink papular lesions on the abdomen, possibly resembling varicella. She has an infected hair follicle on her back, but really no other suspicious lesions on the back. Adverse reaction to varicella vaccine. Will report this. She is to try Xyzal for the itching. She is to keep the areas on the abdomen covered. Should clear up in the next couple of weeks. May scab over and once that happens, she should be fine. Did review the adverse reactions with her and she does seem to fit a lot of the symptoms that can occur. Fever seemed to happen a little earlier than what you would typically expect to see. Did recommend she not get the 2nd varicella shot. The first one should confer enough immunity to the virus. Also reviewed with her the lab report on her MMR titers. She is immune to the rubella and rubeola, but her mumps antibodies came back equivocal, which may simply mean she is not immune to mumps and if there is an outbreak, she needs to stay home until the outbreak is done. There is a chance she could get mumps. She is to watch for any acute changes. Patient will follow up if any other problems are noted.
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Patient comes in with an adverse reaction to vaccination. She had several vaccinations done last Thursday, apparently reacting to varicella vaccine. She does have allergies to the MMR vaccine, although we do not know which component of the MMR. She apparently developed a fever within a day or two. Fevers were up to 104.0. They were running between 100.0-101.0 with medications. Is not running any fever of late. Has had some itching around the site where the injection was given, some redness there as well. Some kind of generalized itching. Also has been small rash that broke out under the breast. Also had a couple of spots on the abdomen. Dose not think she has rash anywhere else. The rash under the breast has resolved, but still has a couple of spots left on the abdomen. She is alert, orientated and pleasant. No acute distress. BP 110/76. P 64. R 10. T 98.6. WT 136. Allergic to MMR vaccine, varicella vaccine. Oropharynx is pink and moist, no lesions or exudate noted on the soft palate, pharynx or oral mucosa or buccal mucosa. Neck is supple, no masses. Skin with local erythematus lesion on the middle portion of the left arm. No tenderness over the area, slight warmth. Does blanch. No other rash is seen. No other skin changes are noted. Abdomen: Two small pink papular lesions on the abdomen, possibly resembling varicella. She has an infected hair follicle on her back, but really no other suspicious lesions on the back. Adverse reaction to varicella vaccine. Will report this. She is to try Xyzal for the itching. She is to keep the areas on the abdomen covered. Should clear up in the next couple of weeks. May scab over and once that happens, she should be fine. Did review the adverse reactions with her and she does seem to fit a lot of the symptoms that can occur. Fever seemed to happen a little earlier than what you would typically expect to see. Did recommend she not get the 2nd varicella shot. The first one should confer enough immunity to the virus. Also reviewed with her the lab report on her MMR titers. She is immune to the rubella and rubeola, but her mumps antibodies came back equivocal, which may simply mean she is not immune to mumps and if there is an outbreak, she needs to stay home until the outbreak is done. There is a chance she could get mumps. She is to watch for any acute changes. Patient will follow up if any other problems are noted.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Father of the patient called office. Patient slept several hours post vaccine. Awoke with severe headache and vomiting. TYLENOL no help for headache. Instructed to give sips of water every 5 minutes for 30 minutes and then call back. Patient did improve and was recovered later that evening.
Age: 1.1
Sex: F
Vaccine: HEP, HEPA, HIBV, MMR, VARCEL
Symptoms: Crying, Diarrhoea, Flatulence, Herpes virus infection, Pallor
Clinical narrative: 07/29/08, child seen for 12 month physical and follow-up on cat bite. On AUGMENTIN, treatment doing well. Received MMR, varicella, Hib, hepatitis B, Hib vaccines. 8/4/08, fever 102 X 1 1/2 days. Diarrhea X 1 day, excessive gas. Dx: Viral GE. 08/08/08, fever 102 X 2-3 days. When fever stopped, child got a rash to all body surfaces. She had runny nose, no diarrhea at that time. The rash was macular, with blanching, it was to all body surfaces, behind ears, palms. Dx: Viral exanthem. 08/08/08 at 5 PM, child crying, pulling on ears and hair. I asked to see the child. Appearance of rash changed. She was covered with herpes lesions to all body surfaces. Today, then skin is almost clear with some spots here and there.
Age: 1.1
Sex: F
Vaccine: HEP, HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash macular, Rhinorrhoea, Viral skin infection
Clinical narrative: 07/29/08, child seen for 12 month physical and follow-up on cat bite. On AUGMENTIN, treatment doing well. Received MMR, varicella, Hib, hepatitis B, Hib vaccines. 8/4/08, fever 102 X 1 1/2 days. Diarrhea X 1 day, excessive gas. Dx: Viral GE. 08/08/08, fever 102 X 2-3 days. When fever stopped, child got a rash to all body surfaces. She had runny nose, no diarrhea at that time. The rash was macular, with blanching, it was to all body surfaces, behind ears, palms. Dx: Viral exanthem. 08/08/08 at 5 PM, child crying, pulling on ears and hair. I asked to see the child. Appearance of rash changed. She was covered with herpes lesions to all body surfaces. Today, then skin is almost clear with some spots here and there.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: 07/15/08 vaccine given at 14:20, with slight redness after 15 minutes. Mother called later that day to say daughter having reaction; red, warm and patient has slight fever. Instructed to follow "after shots paper recommendations" & read pamphlet to her. Apply cool cloth & APAP, if worse call back or go to ER. 07/16/08, mother here with patient. Left arm SQ site red, swollen, more. Seen by doctor given antibiotics by physician.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea
Clinical narrative: Pt c/o severe headache and nausea x 3 days prior to Tdap IM - prescribed Hydrocodone with APAP 800 mg and used excedrin.
Age: 7.0
Sex: F
Vaccine: HEPA, IPV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling & tenderness 4 cm X 4cm right upper arm lower half at IM PREVNAR injection site.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Developed rash over body approx 4 days after received MMR and varicella vaccines. Persists off and on x 2 months. Seen by dermatologist. ? etiology
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Blood creatine phosphokinase normal, Blood immunoglobulin M, Blood test normal, Borrelia burgdorferi serology negative, Chest discomfort
Clinical narrative: weakness in legs, myalgia, headache, chest discomfort, neck pain, hyporeflexic 8/4, improved reflexor 8/5
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Full blood count normal, Headache, Hyporeflexia, Laboratory test normal, Muscular weakness
Clinical narrative: weakness in legs, myalgia, headache, chest discomfort, neck pain, hyporeflexic 8/4, improved reflexor 8/5
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Neck pain, Parvovirus B19 serology negative, Red blood cell sedimentation rate normal
Clinical narrative: weakness in legs, myalgia, headache, chest discomfort, neck pain, hyporeflexic 8/4, improved reflexor 8/5
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site warmth
Clinical narrative: Within 2 hours of vaccine - numbness of pt hand, arm. On 8-15-08 by exam - glove numbness of rt hand, not of arm. Good color, movement of arm/hand. 3 cm warm redness of rt arm at vzv site.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Facial palsy
Clinical narrative: Facial paralysis, diagnosed with Bell's Palsy. Dx: Nov 27, 2007  8/22/08 Reviewed PCP medical records of 11/27-3/17/2008. FINAL DX: right-side Bell's palsy Records reveal patient experienced left facial swelling, HA & neck pain on 11/27/07.  Noted to have weak right facial muscles.  Tx w/steroids & off work x 1 week.  Improved but had residual right side muscle tenderness.  Developed flat red lesions, some scabbing, on back in 3/2008.  Dx w/shingles.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Crying, Lethargy
Clinical narrative: Mom said about 4 hours after she left the office the baby cried inconsolably for 2 hours. She took him to ER and they said he was fine & he stopped crying. She came to office next day because he was taking his bottle well & was just laying. In the office he was alert & playful and he took about 6 oz of formula.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Rash
Clinical narrative: Big red rash 2 1/2" X 1 1/2".
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Warm to touch, red, swelling. Cellulitis
Age: 42.0
Sex: F
Vaccine: MU
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: History of left knee pain onset four days after receing Mumps vaccine.Pain started in left knee, progressed to upper back, lower back, worsened in left knee and then pain in feet. Pain gradually subsided but pain in left knee persits when climbing stairs, upon rising from sitting position, sometime when walking.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash generalised
Clinical narrative: Vaccinated with DTaP and IPV on 08/04/08.  Mom called, stated patient started with fever a few hours after being vaccinated, continued into next day, temp 102, had rash head to toe, raised, red, not itching, did not seem to bother him, looked like heat rash per mom, not ill appearing.
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood pressure, Dizziness, Heart rate normal, Loss of consciousness, Nausea
Clinical narrative: Client left the clinic with her mother and c/o nausea and went to her knees.  She requested to go back into the clinic and when she stood up she became dizzy and passed out in her mother's arms for approximately 30 seconds.  When she aroused, she vomited.  She was taken by wheel chair back into the clinic where she was placed on an exam table to lye down.  She was able to stand after approximately 15 minutes without c/o dizziness of nausea and escorted to her vehicle and released to her mother.
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Client left the clinic with her mother and c/o nausea and went to her knees.  She requested to go back into the clinic and when she stood up she became dizzy and passed out in her mother's arms for approximately 30 seconds.  When she aroused, she vomited.  She was taken by wheel chair back into the clinic where she was placed on an exam table to lye down.  She was able to stand after approximately 15 minutes without c/o dizziness of nausea and escorted to her vehicle and released to her mother.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site urticaria, No reaction on previous exposure to drug, Urticaria
Clinical narrative: MOM came to our clinic on 8/12/08 for the second Gardasil shot. When asked if any problems after the first shot mom reported that after she got home and broke out in hives at the injection site and on her back mom gave Benadryl. Pt also recieved varicella at the same time but had no previous reaction to varicella in the past per mom.
Age: 12.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Student recieved VZV and Menactra in right arm, TDAP in left at the school clinic on 8/12/08. Mother complained on 8/14/08 that student has swelling and a "hard lump" with itching on right upper arm where she recieved the two vaccines. Has been applying ice.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Upper Right arm slightly swollen, hot to touch, pain with shoulder abduction. At site of varicella injection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt broke out in Hives approximately 3 hours after vaccine administered and had to go to the E.R.  Pt was given Benadryl add Hydrocortisone injections.  Hives cleared up shortly after E.R. visit. Denies local reaction to vaccine site.  Pt is also taking medications that could have caused a similar reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV, VARCEL
Symptoms: Cellulitis
Clinical narrative: cellulitis left thigh.  Put on Bactrim susp 8ml BID x 10 days
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Blood test, Computerised tomogram, Haematochezia, X-ray
Clinical narrative: Patient started having blood in stool at 5:00 p.m. in the evening on 7/11/08 after receiving Rotavirus and Pediarix vaccine. Patient has had blood in stools at least 1 time everyday sometimes 2-3 times everyday since the first episode on 7/11/08. Patient's sees Dr. Mother states all tests doctor has performed have been normal. Mom states child has an appointment with a gastro specialist on 9/2/08. Mother states the blood in the stool looks like a red string. States child's doctor thinks the blood may be due to something other than the Rotavirus vaccine because of the duration of symptoms.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Right arm pain, swelling, tenderness, started day after administration 8/14/08
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Blindness, Convulsion, Disability, Encephalitis, Epilepsy
Clinical narrative: on the next day of his vaccines,he has a seizure go to the hospital they use resusitation and he stay for 1 month, when he open his eyes after 2 weeks in the hospital,he was blind,with epilepsy,encephalitis,and comes home permantly disabled.  2/26/09 MR received for DOS 10/22-11/19/1997 with no specific D/C DX given.  Seizure activity and Encephalitis type picture-likely viral noted.  Pt presented to ER following an episode of cyanosis, limpness and unresponsiveness on 10/22/97. Initially brought to PCP  where O2 was given and EMS called. Seizure activity noted in ER and during admission.. Pt had some bloody stool which resolved, as well as elevated LFTs and renal issues which also resolved. Pt noted to be blind by ophth consult. Later records 10/12-14/98 report dx of CNS reaction to Pertussis vaccine, now with blindness, microcephaly, significant developmental delay and seizure disorder. Seizures 1-2/day.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Laboratory test, Resuscitation
Clinical narrative: on the next day of his vaccines,he has a seizure go to the hospital they use resusitation and he stay for 1 month, when he open his eyes after 2 weeks in the hospital,he was blind,with epilepsy,encephalitis,and comes home permantly disabled.  2/26/09 MR received for DOS 10/22-11/19/1997 with no specific D/C DX given.  Seizure activity and Encephalitis type picture-likely viral noted.  Pt presented to ER following an episode of cyanosis, limpness and unresponsiveness on 10/22/97. Initially brought to PCP  where O2 was given and EMS called. Seizure activity noted in ER and during admission.. Pt had some bloody stool which resolved, as well as elevated LFTs and renal issues which also resolved. Pt noted to be blind by ophth consult. Later records 10/12-14/98 report dx of CNS reaction to Pertussis vaccine, now with blindness, microcephaly, significant developmental delay and seizure disorder. Seizures 1-2/day.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Immunes were given to the pt. Two days ago, immune site appears midly sollen, warm to touch, and per pt it itches, it was recomended to put warm compresses on the affected site and a Rx was given for Benadryl and Tylenol to treat the symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: REDNESS AND INDURATION TO RIGHT DELTOID AREA WHERE DTAP WAS ADMINISTER
Age: 1.75
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: pediatric Hep B given rather then Pediatric Hep A
Age: 58.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Mass, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: I received my shots on March 3, 2008. One of the shots was anthrax and I received the usual lump in my shoulder. The shot was given directly into the muscle of the left shoulder. I was told that the lump and annoying ache would go away soon. I have since received my two remaining shots in my right shoulder, more in the back of the triceps, those two shots both had the accompanying lump and some stiffness but both dissipated without incident but the stiffness/aching has returned. I am now five and a half months into my tour and the ache in my left shoulder has not gone away. I have been to the medical clinic twice (Aril 29 and May13) to have them make observations and both times I received inflammation related medicine (Motrin, meloxicon, and toradol). I indicated to the doctor that the ache goes away (probably 90%) during the day with routine usage but during the night, when the shoulder is inactive, the ache comes back full strength resulting in me being woke-up several times a night when I roll around. In the morning the shoulder is very stiff but it usually starts to feel better within a couple hours. I now have the ache in both my shoulders in the morning. I mentioned to the doctor that I played basketball and volleyball and she said the activity would be good. I mentioned about an x-ray but I believe everyone agrees this is a soft tissue problem and not a problem with the rotator cuff. That being said the only way to "see" what may be wrong is an MRI which there isn't one. I have mentioned this to several other persons and they said they had or heard of others with some degree of residual ache. If I take 800-Motrin that will help with the stiffness especially overnight. I have mentioned this to former super and deputy PPMD on multiple occasions and my current supervisor has heard me mention this as well.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Effusion, Injection site erythema, Injection site swelling, Myalgia, Skin warm
Clinical narrative: Swelling and redness at site of varicella vaccine.  Mild myalgias.  No SOB or throat tightness.  Left upper arm warm to touch with moderate effusion over tricep area.  No streaking or axillary LAP.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Ear discomfort, Headache, Pain, Pyrexia
Clinical narrative: Pt developed severe body aches, fever 101, and headache and feeling of clogged ears approx 20 hours after vaccination. At this time, she has not seeked medical care.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Anxiety, Crying, Screaming
Clinical narrative: As the treating physician, I did not witness the shot given in the immunization clinic. From the parent report, pt was very apprehensive and crying and screaming during the Hepatitis A shot. The family walked to the car and mother carried him most of the way.  She placed him in his seat and noticed that he had tensed up and would not respond to her questions. If he had any convulsions, it may have lasted 10 seconds. By the time she brought pt back into the clinic, he was back to his normal state. We checked his vitals and assessed him within 2 minutes of the event. No neurological sequelae afterwards. In my medical opinion, it's very difficult to say with certainty that he did have a true seizure. This possibly could have been some mytonoic reaction due to fatigue after receiving his shots or a behavioral issues as well. There was no fecal or urinary incontience.  No clear h/o eye deviation. No tongue biting.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Convulsion, Nuclear magnetic resonance imaging brain normal, Tremor
Clinical narrative: Patient experienced tremors or convulsions less than 24 hours after series of 4 month old vaccines. Tremors involved head and arms and were stopped when I aroused child by yelling his name. They were the most frequent the first week after the shot (several times a day) and stopped 3 weeks later. Most of the time they were while he was drinking a bottle or falling asleep and yelling his name would stop them. Duration of shaking was 10-30 seconds.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Nausea
Clinical narrative: Mother reported to our office on 08/12/08 that patient had a headache and nausea since injections on 8/6/08. Her mother felt it was from the HPV vaccine, however patient received 3 other vaccines as well. No fever noted. She stated she would be seeing her doctor that evening for a physical and would call me the next day. 2 messages left for mother but she never returned my call to let me know the outcome of the visit.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient experienced mild reddness and itching at injection site only.  Cool compress applied to site.  patient waited 30 min after incident & symptoms improved prior to discharge.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: Lesion appeared on left thigh.  Red in color.  Lesion is 7 cm in size.  The type of lesion is eythematous.  Isolated arrangement and has a localized distribution.  The status is spreading.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Regressive behaviour, Speech disorder developmental
Clinical narrative: developmental regression.  Stopped using pronouns, which he had been using for months.  As of today, he still does not use them.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Headache, Musculoskeletal stiffness, Nausea, Paraesthesia
Clinical narrative: Patient worked night shift, receive vaccine in AM at end of shift, went home and slept well, returned to work same day with symptoms progressively worsening that had started at 6:00 p.m. Patient describes symptoms as 'severe headache, nausea, stiff neck, arm tingling, hands hot, feet freezing'. Sent to MD. BP was 130/100. Temp 98.7F Treated for headache.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral coldness
Clinical narrative: Patient worked night shift, receive vaccine in AM at end of shift, went home and slept well, returned to work same day with symptoms progressively worsening that had started at 6:00 p.m. Patient describes symptoms as 'severe headache, nausea, stiff neck, arm tingling, hands hot, feet freezing'. Sent to MD. BP was 130/100. Temp 98.7F Treated for headache.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Received DTaP on 08/12/08 in left leg, the next day had small lump at injection site, 2nd day had 7cm red, hard circle.  Reported to staff/Dr.
Age: 26.0
Sex: F
Vaccine: HPV4, MMR, TDAP, VARCEL
Symptoms: Heart rate decreased, Hypotension, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: On 8/14/8 at ~0940 Pt had an adverse reaction to vaccines and/ or blood draw. Patient received Tdap Lot # C2774AA- left deltoid , MMR Lot # 1672U -left deltoid,  Varicella lot # 0393X -Right deltoid,   HPV Lot # 0072X -Right Deltoid .Patient also received blood draw of Standard tests Hepatitis A,B,C , HIV and RPR .Was not able to get CBC  due to patient fainted while obtaining blood specimen ~8 minutes after vaccines had been given. Vital signs obtained immediately after patient fainted were Blood pressure 60/40, RR = 18 Pulse = 60 . Was unable to arouse patient using tactile stimulation . after ~2 minutes. 911 initiated at 0942. Patient vomited stomach contents at ~0946.  EMS workers arrived at ~0948. Patient care relinquished to EMS workers at that time.  Patient was taken to Hospital by ambulance- ambulating on own, A&O x 3 VS at departure were BP 116/72, P=78, RR=18 .Patient had a child age  2years and 10 months old with her at time of incident. Patient child was unharmed and was cared for during incident. Patient child was also transported to hospital with patient. VAERS report completed . Please see attached
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Nasal congestion, Pyrexia, Rash pruritic, Rash vesicular
Clinical narrative: One week after vaccines, patient started to develop an itchy, vessicular rash in his left axillary area which spread over the course of a week to include additional vessicles on his legs.  He also had a low grade fever and nasal congestion.  Rash was evaluated by this MD on dat #14 after vaccination and thought to look like varicella with new vessicles and scabs. Concern for possible superinfection/impetigo promted this physician to treat with course of Augmentin.
Age: 13.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Sick relative, Type 1 diabetes mellitus
Clinical narrative: Patient had a rash a few days later and low fever. Patient was diagnosed with Diabetes Type 1 on 2/11/2005. They said she had probably had it for a year. Her brother, who is 3 years younger, got the same vaccination at the same time and was diagnosed with Diabetes type 1 4 months after his sister.  10/15/2008 MR received for DOS 2/10-12/2008 with D/C DX: Diabetic Ketoacidosis.  Type 1 diabetes, newly diagnosed, uncontrolled. Leukocytosis.  Nausea and vomiting 2' to DK. Pt presented with 2 week hx of increasing nausea and vomiting with increased thirst, urination, and abdominal pain. Recently dx with diabetes and placed on oral diabetic meds, however BS was 584 on admission. Oninsulin and hydration ketoacidosis quicky resolved. D/C on Lantus and Humulin with diabetic diet and ASA.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Agitation, Anxiety, Arthralgia, Depression, Ear pain
Clinical narrative: Mysterious rash began 9 days after receiving the initial injection with water blister type manifestion and systemic reaction like symptoms with agitation and anxiety (would come and go with no apparent provocation). Sore throat and ear pain. Swelling of right foot intermittent. Joint pain. Rash continued for months. Increasing fatigue, depression, mood swings, and emotional distress. Has seen general practitioner with no findings, dermatologist can not identify skin irritations and has prescribed lotions which have no effect.  9/26/08 Reviewed dermatologist medical records of 6/17/2008. FINAL DX: perioral dermatitis vs seborrheic dermatitis; nevi, freckling; keratosis pilaris, asymptomatic. Records reveal patient experienced rash on face, back & arms 2 days s/p initial HPV vaccine.  Rash noted as recurrent water blisters & facial redness that would dry up w/minimal itching.  Exam revealed rough patches over nose, cheeks, perioral area & chin area.  No vesicles noted on exam.  There was rough eczema appearing rash of antecubital & proximal aspects of bilateral forearms.  Keratosis pilaris was noted on bilateral upper arms.  Numerous macular freckles were noted on face & shoulders.  Tx w/lotion/cream.  Was to return should re-excerbation ocur.  No further visits on record.  9/30/08 Reviewed urgent care medical records of 6/2004-6/17/2008. FINAL DX: none provided Records reveal patient exprienced pruitic rash of face & arms, sore throat, sinus HA, swollen feet on 5/8/08 dx w/allergic reaction/rash, pharyngitis.  Tx w/antibiotics.  RTC 5/21/08 w/intermittent pruitic rash & swollen hands/knees.  Light pink papular itchy rash noted on cheek, scalp & upper arm but no joint swelling on exam.  Tx w/antihistamine & steroids.  Seen by dermatologist 6/17/08, records previously reviewed.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional distress, Fatigue, Mood swings, Oedema peripheral, Pharyngolaryngeal pain
Clinical narrative: Mysterious rash began 9 days after receiving the initial injection with water blister type manifestion and systemic reaction like symptoms with agitation and anxiety (would come and go with no apparent provocation). Sore throat and ear pain. Swelling of right foot intermittent. Joint pain. Rash continued for months. Increasing fatigue, depression, mood swings, and emotional distress. Has seen general practitioner with no findings, dermatologist can not identify skin irritations and has prescribed lotions which have no effect.  9/26/08 Reviewed dermatologist medical records of 6/17/2008. FINAL DX: perioral dermatitis vs seborrheic dermatitis; nevi, freckling; keratosis pilaris, asymptomatic. Records reveal patient experienced rash on face, back & arms 2 days s/p initial HPV vaccine.  Rash noted as recurrent water blisters & facial redness that would dry up w/minimal itching.  Exam revealed rough patches over nose, cheeks, perioral area & chin area.  No vesicles noted on exam.  There was rough eczema appearing rash of antecubital & proximal aspects of bilateral forearms.  Keratosis pilaris was noted on bilateral upper arms.  Numerous macular freckles were noted on face & shoulders.  Tx w/lotion/cream.  Was to return should re-excerbation ocur.  No further visits on record.  9/30/08 Reviewed urgent care medical records of 6/2004-6/17/2008. FINAL DX: none provided Records reveal patient exprienced pruitic rash of face & arms, sore throat, sinus HA, swollen feet on 5/8/08 dx w/allergic reaction/rash, pharyngitis.  Tx w/antibiotics.  RTC 5/21/08 w/intermittent pruitic rash & swollen hands/knees.  Light pink papular itchy rash noted on cheek, scalp & upper arm but no joint swelling on exam.  Tx w/antihistamine & steroids.  Seen by dermatologist 6/17/08, records previously reviewed.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Skin irritation
Clinical narrative: Mysterious rash began 9 days after receiving the initial injection with water blister type manifestion and systemic reaction like symptoms with agitation and anxiety (would come and go with no apparent provocation). Sore throat and ear pain. Swelling of right foot intermittent. Joint pain. Rash continued for months. Increasing fatigue, depression, mood swings, and emotional distress. Has seen general practitioner with no findings, dermatologist can not identify skin irritations and has prescribed lotions which have no effect.  9/26/08 Reviewed dermatologist medical records of 6/17/2008. FINAL DX: perioral dermatitis vs seborrheic dermatitis; nevi, freckling; keratosis pilaris, asymptomatic. Records reveal patient experienced rash on face, back & arms 2 days s/p initial HPV vaccine.  Rash noted as recurrent water blisters & facial redness that would dry up w/minimal itching.  Exam revealed rough patches over nose, cheeks, perioral area & chin area.  No vesicles noted on exam.  There was rough eczema appearing rash of antecubital & proximal aspects of bilateral forearms.  Keratosis pilaris was noted on bilateral upper arms.  Numerous macular freckles were noted on face & shoulders.  Tx w/lotion/cream.  Was to return should re-excerbation ocur.  No further visits on record.  9/30/08 Reviewed urgent care medical records of 6/2004-6/17/2008. FINAL DX: none provided Records reveal patient exprienced pruitic rash of face & arms, sore throat, sinus HA, swollen feet on 5/8/08 dx w/allergic reaction/rash, pharyngitis.  Tx w/antibiotics.  RTC 5/21/08 w/intermittent pruitic rash & swollen hands/knees.  Light pink papular itchy rash noted on cheek, scalp & upper arm but no joint swelling on exam.  Tx w/antihistamine & steroids.  Seen by dermatologist 6/17/08, records previously reviewed.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Familial risk factor, Pyrexia, Rash, Sick relative, Type 1 diabetes mellitus
Clinical narrative: Patient had a rash and fever a few days later. He was diagnosed with Diabetes Type 1 on 7/11/05, just 5 months after his sister was diagnosed with Diabetes Type 1. She had the same vaccination at the same time. 8/27/08 Labs received from hospital unable to locate rest of chart.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Approximately 5-10 min after giving vaccines, student was sitting down in waiting area when he lost consciousness and his body and extremities started jerking for approx 5-7 seconds. He was then laid down on floor where he regained consciousness and became alert and oriented x3. HR@ 80 reg, B/P120/70.  911 called and student was transferred to Hospital.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: large (20 cm) raised, reddened, painful area over left deltoid, hot to touch
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap normal, Aspartate aminotransferase increased, Band neutrophil count increased
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood creatinine decreased, Blood glucose normal, Blood potassium normal, Blood urea normal, C-reactive protein increased
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Carbon dioxide decreased, Diarrhoea, Eosinophil count normal, Globulin, Haematocrit normal
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Haemoglobin normal, Irritability, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Mean cell volume abnormal, Monocyte count normal, Neutrophil percentage, Petechiae, Platelet count normal
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Protein total normal, Pyrexia, Red blood cell abnormality, Red blood cell count normal, Red cell distribution width increased
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Upper respiratory tract congestion, Vomiting, White blood cell count
Clinical narrative: Vomiting and irritability on the night of vaccination 7/14/08.  Irritability and diarrhea on day 6-8 following vaccination.  Fever 101-105 started 7/18 continued through 7/25.  Petechial rash on 7/26-7/27.  Severe upper chest congestion on 7/24-7/26.  8/26/2008 Reviewed hospital medical records of 7/23- FINAL DX: No d/c summary available. Admitted for gastroenteritis & dehydration Records reveal patient experienced diarrhea x 1 week, dehydration, vomiting x 1 day,  irritability, fever, mottled skin, nasal congestion, rhinorrhea, tachycardia, pulse ox 93-94%.  Tx w/oxygen supplementatio & IVF.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Anorexia, Headache, Musculoskeletal pain, Myalgia
Clinical narrative: Muscle pain in arm, neck, shoulder; stomachache, headache and loss of appetite.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Muscle pain in arm, neck, shoulder; stomachache, headache and loss of appetite.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Client developed redness, tenderness, swelling approximately 2-3 hours after administration of the Pneumovax and Fluviron vaccines. Is currently taking clindamycin to treat cellulitis.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abscess, Cellulitis
Clinical narrative: Cellulitis abscess right arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on abd, legs, arms - began on 8/3/08. Saw NP - Rx with Prednisone with prompt improvement.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, swelling to right arm.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis 3 days later, right arm. Placed on oral antibiotics.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Pink warm itchy symmetric oval swelling (6X8 cm) day after received vaccine in right upper thigh. No fever, no pain or fluctuance, improved with ice and MOTRIN. Suspect vaccine DTaP.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dysphonia, Dyspnoea, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Mom reports swollen, red, painful left arm. Temps at night of 1 greater than or equal to 104 degrees Fahrenheit . Patient stated difficult to breath. 8/15/08, mom states child still has elevated temp of 102-103 degrees, sore arm and "hoarseness." Child has no visible sign of difficult breathing per mom. Mom has not taken child to see ER or PMD.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mom reports swollen, red, painful left arm. Temps at night of 1 greater than or equal to 104 degrees Fahrenheit . Patient stated difficult to breath. 8/15/08, mom states child still has elevated temp of 102-103 degrees, sore arm and "hoarseness." Child has no visible sign of difficult breathing per mom. Mom has not taken child to see ER or PMD.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 2"area of induration & erythema 2 days after receiving varicella vaccine. August 11, 2008 date given.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at vaccine sites bilaterally.
Sex: U
Vaccine: TDAP
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of the use of expired vaccine in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, GlaxoSmithKline.  On 24 July 2008 the subject received unspecified dose of BOOSTRIX (unknown).  After vaccination with BOOSTRIX, it was noted that the vaccine given to the subject had expired.  The pharmacist considered the event was clinically significant (or requiring intervention) only for the reason that the subject would have to receive another dose of vaccine.  No adverse events were reported.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Anxiety, Caesarean section, Drug exposure during pregnancy, Fatigue, Headache
Clinical narrative: MEDI-0004973 is a Not Serious Spontaneous case from a Consumer involving VACCINE EXPOSURE DURING PREGNANCY: (Unlabelled). The reporter causality is Possible to FluMist. A 39-year-old female who is 14-weeks pregnant (obtained via ultrasound) received FluMist on 28-Sep-2006 from her child's pediatrician. A few hours after receiving the vaccine, the patient developed mild sore throat, mild headache and mild fatigue. There were no changes in symptom intensity and the symptoms dissipated on their own without any medical interventions. Sore throat was fully resolved on 30 Sep-2006. Headache and fatigue completed dissipated on 02-Oct-2006. After receiving the vaccine, the patient was told by her obstetrician that a "pregnant woman should not be receiving FluMist* vaccine. After hearing this statement and "reading up on FluMist," patient became "quite concerned and became very anxious." Patient attributed developing anxiety to "worrying about the possible effect FluMist may have on my (unborn) baby." This patient was G4P2 with a history of one elective abortion in April, 2006 for Down Syndrome. Her last menstrual period was 21-Jun-2006 and her estimated date of delivery was 30-Mar-2007. The patient denied having any history of medical problems. She denied taking any medications (prescribed and over the counter) during her pregnancy. The patient stated her anxiety persisted throughout her pregnancy. Her anxiety resolved after she delivered a healthy baby boy via scheduled caesarian-section on 21-Mar-2007. She stated that there were no complications during her pregnancy or during the birth of her baby. The baby "is doing well." The reporter causality is possible to FluMist. 27-Jun-2007: Follow up information obtained and incorporated in above narrative: information regarding clinical outcome.