chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Red, swollen, tender lump at site of DTaP injection.  Also developed mild Varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles that subsequently crusted over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Red, swollen, tender lump at site of DTaP injection.  Also developed mild Varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles that subsequently crusted over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Irritability, Pyrexia
Clinical narrative: Red, swollen, tender lump at site of DTaP injection left thigh.  Also developed mild varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles which would eventually crust over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.   *****I SUBMITTED THIS REPORT THROUGH VAERS ONCE ALREADY TODAY.  AM RESUBMITTING WITH MORE COMPLETE INFO INCLUDING LOT NUMBERS AND MANUFACTURERS OF VACCINES.*****
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Red, swollen, tender lump at site of DTaP injection left thigh.  Also developed mild varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles which would eventually crust over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.   *****I SUBMITTED THIS REPORT THROUGH VAERS ONCE ALREADY TODAY.  AM RESUBMITTING WITH MORE COMPLETE INFO INCLUDING LOT NUMBERS AND MANUFACTURERS OF VACCINES.*****
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Red, swollen, tender lump at site of DTaP injection left thigh.  Also developed mild varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles which would eventually crust over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.   *****I SUBMITTED THIS REPORT THROUGH VAERS ONCE ALREADY TODAY.  AM RESUBMITTING WITH MORE COMPLETE INFO INCLUDING LOT NUMBERS AND MANUFACTURERS OF VACCINES.*****
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Red, swollen, tender lump at site of DTaP injection left thigh.  Also developed mild varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles which would eventually crust over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.   *****I SUBMITTED THIS REPORT THROUGH VAERS ONCE ALREADY TODAY.  AM RESUBMITTING WITH MORE COMPLETE INFO INCLUDING LOT NUMBERS AND MANUFACTURERS OF VACCINES.*****
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Red, tender lump at site of vaccine administration on left thigh.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling
Clinical narrative: Extreme swelling around eyes. Three days before returning to normal. I have eaten eggs on numerous occasions since with no adverse effects.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Inactivated Influenza Vaccine received October 17, 2003 between 12 and 1:00 PM.  Approximately 1 hour later patient was sitting in chair on our driveway talking to a friend when he experienced a moderately strong dizzy spell which lasted about 15 minutes and then subsided.  No other adverse symptoms noted.  Patient did not feel it necessary to contact either the clinic or the doctor.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pruritus
Clinical narrative: Fatigue,myalgias. Area of erythema and tenderness at injection site and pruritis. Treated with NSAIDs and antihistamines.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia, Tinnitus
Clinical narrative: Immediately after receiving the flu vaccine, became sick with the flu. Serious fatigue, fever, headache, elevated temperature. A follow up report received 10/22/2003 adds: Plus ringing in ears.
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Neck pain, Pain
Clinical narrative: TYPHOID INJECTION 0.5ML GIVEN INTRAMUSCULAR IN RT DELTOID @ APPROX 1000HRS. APPROX 1100-1115HRS PT. EXPERIENCED STRONG THROBBING TO THE RT 2ND,3RD AND 4TH FINGERNAILS WITH MILD RT NECK PAIN
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Chest pain, Cough, Dyspnoea, Eye pain
Clinical narrative: 2 days after recieving vaccine I began to experience a mild cough, a "twitchy" feeling that didn't go away.  After appr. 12 days, I started to experience shortness of breath, severe fatigue, feeling like I had a moderate case of the flu, along with mild headache, dry cough, chest pain, sore eyes, muscle weakness,  and loss of appetite. A prescription for Z-Pack was called in, and I am on this medication at the present time.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Influenza like illness, Muscle twitching, Muscular weakness
Clinical narrative: 2 days after recieving vaccine I began to experience a mild cough, a "twitchy" feeling that didn't go away.  After appr. 12 days, I started to experience shortness of breath, severe fatigue, feeling like I had a moderate case of the flu, along with mild headache, dry cough, chest pain, sore eyes, muscle weakness,  and loss of appetite. A prescription for Z-Pack was called in, and I am on this medication at the present time.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Pruritus, Respiratory rate increased
Clinical narrative: After eight hours from the time of the flu shot, I experienced a rapid heat beat and increased resperation.  Normal sitting pulse for me is 70 to 80 per minute, I was experiencing a pulse rate from 135 to 145 per minute.  Normal sittting resperation is 12 per minute, resperation increased to 21 per minute.  I have a persciption for Trazadone, I took a 20 mg tablet, at that point pulse was reduced to 90 beats per minute and resperation was reduced to 14 per minute, after 20 minutes after taking trazadone.  I fell a sleep after that.  12 hours later I woke up, feeling okay, skin was iching the night before as well.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Aphthous stomatitis, Stevens-Johnson syndrome, Urinary incontinence, Urinary tract disorder, Visual acuity reduced
Clinical narrative: A report was received from a distributor on 10/06/2003 concerning a 70 year old male vaccinee who felt uncomfortable on the same day as receiving Fluvirin vaccine on 09/25/2003 and developed Stevens-Johnson syndrome with mouth ulceration requiring hospitalization an unspecified length of time after receiving Fluvirin vaccine.  On the evening of 09/25/2003 the vaccinee felt uncomfortable.  An unspecified length of time after vaccination the vaccinee experienced mouth ulcerationand Stevens-Johnson syndrome was diagnosed.  The vaccine was admitted to an intensive care unit on an unspecified date in order to prevent infection.  The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment.  Follow up pending. Update 1, 23 February 2004: A follow up report was received from a distributor which indicated that the vaccinee had ulceration of the urological system making it difficult for him to control his urine. The vaccinee had cataracts before he received Flurivin and his vision is now worse thatn before vaccination. The operation to rectify the cataracts cannot go ahead of the ulcerations.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pain
Clinical narrative: A report was received from a health care professional on 10/6/03 concerning a female vaccinee of unspecified age who experienced a red, sore arm with swelling and frozen shoulder with muscle wastage, was considered medically significant an unspecified length of time after receiving Fluvirin on an unspecifieed date in October 2002. On an unspecified date the vaccinee experienced a red, sore arm with swelling which lasted 4 to 6 weeks. The vaccinee had an orthopaedic referral which diagnosed a frozen shoulder with muscle wastage. The outcome of the event was not reported. There was insufficient info to determine the reporter's causality assessment. Follow up pending.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Small red area on right arm with increased warmth 2 days after injection. Pt given 5 day treatment of antibiotics in case it was infection.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Received flu vaccine on Wed. 10/15/03. On Thurs. 10/16/03 he noted "welts" on both arms from shoulders to wrist, area and a few on his neck. Today noted "red bumps" on his left side.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right thigh became dark red and hard 28 hours after vaccine administered. Began resolving within 12 hours.
Age: 0.15
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion
Clinical narrative: Nurse was informed on 9/26/03 via phone call that the child was vaccinated on 9/16/03 and on 9/19/03 had a convulsion which lasted 15 mins. After being hospitalized that day, had another convulsion, lasting 5 min. Child remains in a hospital. Follow up 01/24/05: Patient has recovered from adverse event.
Age: 4.75
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abasia, Cellulitis, Contusion, Erythema, Hypersensitivity
Clinical narrative: 9/29 immun. (DTaP and MMR) given R thigh because of diffuse bruising and hard tissue both arms. Mother states his leg got red and swollen and became so hard and large he couldn't walk. Taken and admitted and given antibiotics/steroids for possible cellulitis, possible "allergic reaction." Mother states blood work drawn also. The discharge summary received on 1/20/04 states immune rreaction.
Age: 4.75
Sex: M
Vaccine: DTAP, MMR
Symptoms: Oedema
Clinical narrative: 9/29 immun. (DTaP and MMR) given R thigh because of diffuse bruising and hard tissue both arms. Mother states his leg got red and swollen and became so hard and large he couldn't walk. Taken and admitted and given antibiotics/steroids for possible cellulitis, possible "allergic reaction." Mother states blood work drawn also. The discharge summary received on 1/20/04 states immune rreaction.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: Right deltoid - well demarcated area of erythema, not raised, blanchable, no increased warmth, nontender, no oozing, no bleeding. Pt afebrile. Pt nontoxic in office and alert/playful/cooperative. No tx given.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Paraesthesia
Clinical narrative: Redness of face, arms, bilateral hand swelling, tingling. Lips tingling.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Received flu vaccine on 10/14/03. Complained of chills/fever/lethargy approx 4-6 hours after receiving vaccine. Symptoms lasted 24-36 hours.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Joint stiffness, Pyrexia
Clinical narrative: Joints were locked, high fever (102), tightness in the chest, difficulty breathing, chest pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 17 x 10cm area of erythema on left thigh with 8 x 6cm central area of induration. Very hot. Began about 24-30 hours after injection.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Pallor, Tachycardia
Clinical narrative: Turned pale, then gray with extreme crying. Stopped enroute back to clinic at fire station. Tachycardic, otherwise stable, then to ER. No fever.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Pt received pneumonia vaccine at supermarket at about 12 PM. 4 hours later, swelling, pain at site of vaccine Left deltoid muscle. Treatment: ice, rest, antiinflammatory, etc.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: DTaP and polio vaccine given in left thigh on 10/15/03. Seen in clinic on 10/17/03 for redness, diffuse swelling and induration on left thigh, warm to touch, 12cm x 13cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Redness and local edema at vaccine site for 4-5 days. Left thigh: no pruritis. Mother said child did have fever. Left anterior: 5 x 5" plaque/erythema/warm/induration upper thigh.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site inflammation, Pain
Clinical narrative: C/o redness at site, soreness, inflammation. Pt instructed to put ice on site and take an antiinflammatory PRN.
Age: 8.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swollen and red right upper arm. Ice pack applied.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face, trunk. Legs developed within 10 minutes of immunizations. Was given 0.2 ml Benadryl IM 15 minutes after immunization. Mom felt Prevnar #2 may have caused slight rash-undiagnosed. Rash resolved within 20 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Infection, Injection site erythema, Injection site oedema
Clinical narrative: Mom took child to Dr. He said there was an infection. Left arm where DTaP was given was swollen and red. Child was playing when mom reported this to us on 10/3/03.
Age: 1.67
Sex: F
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Mother states child had convulsion at night after immunization. Paramedics arrived at home. Child had increased temp. Child taken to ER. Mother states doctor told her convulsion was due to immunizations. Was discharged, all tests were negative.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash morbilliform
Clinical narrative: Pt developed morbiliform rash 8 hours after administration of immunizations, no reaction previously. Negative respiratory/GI complaints. Benadryl administered po.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swollen red thigh centered on injection site. 48 hours after DPaT injection. Almost pain free. Getting better already. No fever or other rash.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Vomiting
Clinical narrative: Vomiting, irritability
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Tongue oedema, Tremor, Urticaria
Clinical narrative: 30 minutes after injection started shaking and had chills.  Had "hourglass hives" on face.  Next morning tongue was swollen and developed hives all over body.  Throat and mouth was "beet red" saw family MD on 10/09/2003, was given Prednisone 20 mg one time a day for 1 week and Benadryl 25mg, `1 tab every 4 hours.  Had chills again today 10/13/2003 "right knee is swollen since 2 days after injection".  History of right knee surgery, history of breast cancer.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Vaccine (influenza) administered at 13:00 on 10/08/2003-patient developed high fever (105 F) with rigors beginning around 16:00.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash, Tongue oedema
Clinical narrative: Tongue swelling, difficulty breathing, rash on inner thighs bilateral.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pain
Clinical narrative: The night of 10/09/2003. Left thigh painful, swollen and red, measurment 3.5 x 2 inch.  Advised Benadryl, Tylenol and ice pack.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site oedema
Clinical narrative: Localized swelling, noted visible injection sites.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm swollen with localized erythema from shoulder to elbow.
Age: 1.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling to right leg onset about 24 hours after 12 administration to right leg.  No fevers, no fluctuance.  Hot compresses for 2 days and over the counter prn.  No improvement.
Age: 34.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Injection site oedema
Clinical narrative: Swelling right arm for 5 days.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Face oedema, Rash
Clinical narrative: 7-8 hours after administration of 4 vaccines, mother noticed significant swelling and redness of son's head, including ears.  No respiratory difficulty.  Red rash also noted on face and neck (only).  Treatment: Childrens Benadryl per MD.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Red, warm area 3-4 inches in diameter.  Treatment Diphenhydramine 50 mg every 6 hours; Ibuprofen 400 mg every 4-6 hours; around pneumonia vaccination site.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia
Clinical narrative: Jerky generalized seizure-like episodes occuring 3-4 times 5-15 seconds duration, starting approximately 36 hours after vaccination, until approximately 48 hours after vaccination.  No associated fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Patient received 4 year boosters on 10/08/2003.  Patient come to office 10/10/2003 with large area of redness at site.  Site was also warm and tender.  Patient told to apply cool cloths and take Motrin.
Age: 1.3
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Tender erythematous, soft-tissue swelling on right anterior thigh measuring 3 inches and on left anterior thigh about 1 inch.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Urticaria
Clinical narrative: Per mom's report on 10/09/2003, patient had "hives" on left thigh near injection sites.  Red, hot, and swollen thigh.  I saw patient next day 10/10/2003.  No adverse reaction noted at all.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Given DTAP/IPV at 5 year well child visit on 09/18/2003.  09/19/2003 mom called, noted 4 inch red area hot to touch on upper right arm.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctivitis, Rash macular, Rash pruritic
Clinical narrative: Blotchy rash, itchy over all body, mostly on neck and face.  No respiratory problems.  Adviced to use Benadryl, however parents used some home remedies and the rash and swelling went away.  His eyes remained injected and his skin in the neck area was itchy the next day in the office. A follow up report received 10/22/2003 adds: Conjunctivitis treated with Benadryl/Tetanol eye drops.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: Rash developed 7 days after receiving vaccine erythemous-papule with honey-colored crust on back-also arms-extending to penchael area.  Treatment: oatmeal bath, Benadryl PO, Tylenol PO
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Left arm swelling and redness from shoulder to elbow, induration, hot to touch.
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Left arm swelling and redness from shoulder to elbow, induration, hot to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Left arm hot to the touch, redness and sore.  Mother stated child had temperautre 10/08/2003, gave temperature resolved.  No temperature 10/09/2003.  10/09/2003.  Mother stated my child had reaction to shots had some fever on 10/08/2003.  I gave  Tylenol temperature has resolved.  No temperature today.  Only has redness to left upper arm and soreness.  He is Ok today.  He has been playing.  Left deltoid redness, hot to touch, size 3 inch by 5 inch, no temperature, no shortness of breath.  Instructed mother to place cool compress to site for x per day till redness gone and comfort.  Instructed mother to give children tylenol over the counter and to give as directed in bottle.  Instructed other to buy OTC Benadryl for child.  give as directed in bottle or container.  Instructed mother if redness and soreness worse and envolved, more OT left extremity, to seek medical care for child via own MD.  If no MD, call ER.  Nurse will assist with appontment.
Age: 1.8
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cough, Face oedema, Rash
Clinical narrative: Facial edema, rash and cough about 5-6 hours after immunizations.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Injection site red and swollen
Age: 52.0
Sex: F
Vaccine: MMR, YF
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Injection site red, swollen and sore 2 days after 2 weeks after injection, onset axillary lymph node swelling, pustule over injecton sites, puffy and sore.  Evaluation by primary MD.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Injection site pain, Pyrexia, Sneezing
Clinical narrative: I received the shot about 4:45 pm on Thursday, October 16.  I was not feeling well that afternoon and evening: sneezing and some coughing.  I woke about 1 am the morning of Friday, October 17 with a high fever and a great deal of coughing. I was listless.  The site of the injection was painful (right arm, medial, shoulder)  I did not take my temperature until about 3 am and at that time it was 100.6 and climbing.  The fever increased to 101.2 by about 4:14 am at which time I took 1 table of 800 mg of Ibuprofen and 4, 500 mg capsules of amoxicillin that I am prescribed to take as a pre-medication for dentist visits.    I fell asleep and woke about 4 hour later and the fever was down, but the other symptoms persisted.    I continued to take 1 tablet / 1 capsule of the ibuprofen and amoxicillin at 4 hour intervals over Friday, Saturday, Sunday and into today (Monday).  The fever is under control and I am slowly improving.  Additional information for part 13, line 1.  The vaccine manufacturer is Evans
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Pain
Clinical narrative: Severe pain in legs and hip joints, light headed feeling.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Balance disorder, Dizziness, Headache, Hyperhidrosis
Clinical narrative: started 1 hour after injection: nausea, vomiting, diaphoresis, headache, blurred vision, lightheaded and dizzy, agitation. Presented to Employee Health office approximately 18 hours after injection with symptoms above. Given prescription for Phenergan 25mg suppositories.  10-20-2003 States headache, nausea/vomiting and blurred vision are cleared.  Now has generalized muscle aches and stiffness, feels balance is off, and developed small red sore rash around mouth and genital area.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Rash, Vision blurred
Clinical narrative: started 1 hour after injection: nausea, vomiting, diaphoresis, headache, blurred vision, lightheaded and dizzy, agitation. Presented to Employee Health office approximately 18 hours after injection with symptoms above. Given prescription for Phenergan 25mg suppositories.  10-20-2003 States headache, nausea/vomiting and blurred vision are cleared.  Now has generalized muscle aches and stiffness, feels balance is off, and developed small red sore rash around mouth and genital area.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: started 1 hour after injection: nausea, vomiting, diaphoresis, headache, blurred vision, lightheaded and dizzy, agitation. Presented to Employee Health office approximately 18 hours after injection with symptoms above. Given prescription for Phenergan 25mg suppositories.  10-20-2003 States headache, nausea/vomiting and blurred vision are cleared.  Now has generalized muscle aches and stiffness, feels balance is off, and developed small red sore rash around mouth and genital area.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Irritability, Malaise, Pain
Clinical narrative: Patient dropped in this a.m. stating that he awoke the morning of 18 October 2003 with malaise, general achiness, and crankiness ( per a close friend). This has continued until this a.m. No fever. Has slight pain at injection site, but no swelling or heat over area.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT STATES THAT SHE HAD REDNESS,SWELLING,WARM TO TOUCH AND SORENESS BELOW SITE OF INJECTION ON 10/16/03. SHE STATES THAT SIGNS AND SYMPTOMS HAD INPROVED BY 10/17/03 AND THAT SHE HAD TAKEN IBUPROFEN FOR TREATMENT. LOCAL REACTION ONLY.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: PT BEGAN HAVING ABDOMINAL PAIN AND DIARRHEA, THIS HAS BEEN ONGOING AND HAS NOT RESOLVED. ALSO COMPLAINS OF HEADACHES AND PERSISTANT FATIGUE
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood pressure decreased, Chest pain, Chills, Dehydration, Dyspnoea
Clinical narrative: This is a 29y/o ? Cauc, Merchant Marine who has a long, approximate 3-4 month history of recurrent ear infections, upper respiratory infections. He has experienced chest pain, progressive shortness of breath,  and fatigue. This had resolved prior to vaccination. He had a large infected area on his thumb. He has also experienced an approximate 10-pound weight loss over last 1 month or so. Client received his primary anthrax vaccination on 08/12/03 and primary smallpox vaccination on 08/12/03, while at sea off shore of Kuwait.  He did not want to have the vaccination done because he had been so ill. He was threatened by the MSC officer threatened the client with being thrown off the ship that day, would loose his right to work, and the MSC would press charges. It was 130 degrees F. on the ship that day. He felt so bad that he didn't feel like packing his stuff to leave the ship so he took the shots. He was not HIV tested prior to his vaccination.   After he received the vaccination, while on ship, he became very ill on day ~8. He states that he laid in his room without medical attention. He states he had a fever, which was high and felt dehydrated, "felt like eye   sockets were dry and had sand in them". He reports that on ~ day 8, his vaccination site "opened up like a huge crater" and was shaped like a figure eight. He began having shortness of breath, chest pain, fatigue, fevers, sweats, and chills approximately the 8th day after the vaccination. States chest pain was of the same type as he had experienced earlier, but much more severe (8-9/10).  He was allowed off ship approximately 4 weeks post vaccination (09/09/03). Flew home from Georgia to Texas and rested at home. He continued to experience daily fever (101?-103? F.), accompanied by chills, night/evening sweats, chest pain and shortness of breath. On the 15th of September, continued feel bad with same symptoms, so went to the his family doctor, who sent him to the cardiologist the next day. He had an echocardiogram and also had low blood pressure. He was admitted with impending tamponade.  He was subsequently diagnosed with pericarditis with pericardial effusion that required a subxiphoid pericardial window with drainage of ~200cc of fluid. The procedure also revealed significant adhesions that were broken up by finger dissection both inferiorly and anteriorly as far as the finger dissection could reach. There was also some "filmy" material that was sent for pathology. He had a pericardial window done on the 18th of September. The client reports that the cardio-thoracic surgeon stated that the fluid in the sac was like jelly and it had to be manually removed. He had a PPD placed which was reportedly negative. The pathology revealed fibrovascular tissue of the pericardium with fibrosis and marked chronic and mild acute inflammation. The pericardial fluid was negative for malignant cells, lymphocytes and rare neutrophils. The gram stains  for fungus was negative and AFB stain was negative for mycobacterium  for both specimens.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Hyperhidrosis, Infection, Pericardial effusion, Pericarditis
Clinical narrative: This is a 29y/o ? Cauc, Merchant Marine who has a long, approximate 3-4 month history of recurrent ear infections, upper respiratory infections. He has experienced chest pain, progressive shortness of breath,  and fatigue. This had resolved prior to vaccination. He had a large infected area on his thumb. He has also experienced an approximate 10-pound weight loss over last 1 month or so. Client received his primary anthrax vaccination on 08/12/03 and primary smallpox vaccination on 08/12/03, while at sea off shore of Kuwait.  He did not want to have the vaccination done because he had been so ill. He was threatened by the MSC officer threatened the client with being thrown off the ship that day, would loose his right to work, and the MSC would press charges. It was 130 degrees F. on the ship that day. He felt so bad that he didn't feel like packing his stuff to leave the ship so he took the shots. He was not HIV tested prior to his vaccination.   After he received the vaccination, while on ship, he became very ill on day ~8. He states that he laid in his room without medical attention. He states he had a fever, which was high and felt dehydrated, "felt like eye   sockets were dry and had sand in them". He reports that on ~ day 8, his vaccination site "opened up like a huge crater" and was shaped like a figure eight. He began having shortness of breath, chest pain, fatigue, fevers, sweats, and chills approximately the 8th day after the vaccination. States chest pain was of the same type as he had experienced earlier, but much more severe (8-9/10).  He was allowed off ship approximately 4 weeks post vaccination (09/09/03). Flew home from Georgia to Texas and rested at home. He continued to experience daily fever (101?-103? F.), accompanied by chills, night/evening sweats, chest pain and shortness of breath. On the 15th of September, continued feel bad with same symptoms, so went to the his family doctor, who sent him to the cardiologist the next day. He had an echocardiogram and also had low blood pressure. He was admitted with impending tamponade.  He was subsequently diagnosed with pericarditis with pericardial effusion that required a subxiphoid pericardial window with drainage of ~200cc of fluid. The procedure also revealed significant adhesions that were broken up by finger dissection both inferiorly and anteriorly as far as the finger dissection could reach. There was also some "filmy" material that was sent for pathology. He had a pericardial window done on the 18th of September. The client reports that the cardio-thoracic surgeon stated that the fluid in the sac was like jelly and it had to be manually removed. He had a PPD placed which was reportedly negative. The pathology revealed fibrovascular tissue of the pericardium with fibrosis and marked chronic and mild acute inflammation. The pericardial fluid was negative for malignant cells, lymphocytes and rare neutrophils. The gram stains  for fungus was negative and AFB stain was negative for mycobacterium  for both specimens.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pyrexia, Weight decreased
Clinical narrative: This is a 29y/o ? Cauc, Merchant Marine who has a long, approximate 3-4 month history of recurrent ear infections, upper respiratory infections. He has experienced chest pain, progressive shortness of breath,  and fatigue. This had resolved prior to vaccination. He had a large infected area on his thumb. He has also experienced an approximate 10-pound weight loss over last 1 month or so. Client received his primary anthrax vaccination on 08/12/03 and primary smallpox vaccination on 08/12/03, while at sea off shore of Kuwait.  He did not want to have the vaccination done because he had been so ill. He was threatened by the MSC officer threatened the client with being thrown off the ship that day, would loose his right to work, and the MSC would press charges. It was 130 degrees F. on the ship that day. He felt so bad that he didn't feel like packing his stuff to leave the ship so he took the shots. He was not HIV tested prior to his vaccination.   After he received the vaccination, while on ship, he became very ill on day ~8. He states that he laid in his room without medical attention. He states he had a fever, which was high and felt dehydrated, "felt like eye   sockets were dry and had sand in them". He reports that on ~ day 8, his vaccination site "opened up like a huge crater" and was shaped like a figure eight. He began having shortness of breath, chest pain, fatigue, fevers, sweats, and chills approximately the 8th day after the vaccination. States chest pain was of the same type as he had experienced earlier, but much more severe (8-9/10).  He was allowed off ship approximately 4 weeks post vaccination (09/09/03). Flew home from Georgia to Texas and rested at home. He continued to experience daily fever (101?-103? F.), accompanied by chills, night/evening sweats, chest pain and shortness of breath. On the 15th of September, continued feel bad with same symptoms, so went to the his family doctor, who sent him to the cardiologist the next day. He had an echocardiogram and also had low blood pressure. He was admitted with impending tamponade.  He was subsequently diagnosed with pericarditis with pericardial effusion that required a subxiphoid pericardial window with drainage of ~200cc of fluid. The procedure also revealed significant adhesions that were broken up by finger dissection both inferiorly and anteriorly as far as the finger dissection could reach. There was also some "filmy" material that was sent for pathology. He had a pericardial window done on the 18th of September. The client reports that the cardio-thoracic surgeon stated that the fluid in the sac was like jelly and it had to be manually removed. He had a PPD placed which was reportedly negative. The pathology revealed fibrovascular tissue of the pericardium with fibrosis and marked chronic and mild acute inflammation. The pericardial fluid was negative for malignant cells, lymphocytes and rare neutrophils. The gram stains  for fungus was negative and AFB stain was negative for mycobacterium  for both specimens.
Age: 3.0
Sex: F
Vaccine: HBHEPB, IPV, VARCEL
Symptoms: Erythema, Feeling hot, Urticaria
Clinical narrative: Pt received Varivax, Comvax, and IPV.  Within 5 minutes of receiving Varivax, pt developed an urticaric wheal with an erythematous base that was warm to touch.  Pt had no respiratory distress and was given Benadryl 12.5 mg/5cc po immediately and cool compresses were applied to leg. Pt waited for 20 minutes, wheal disappeared but erythematous base of 1" x 1/2" remained.  Pt was active, alert, and in no distress.  Mom instructed on what to observe for and to give Benadryl in 4 hours.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Fatigue, Headache, Injection site hypersensitivity, Injection site pain
Clinical narrative: On 10/18/2003 had fever of 103.4 F, chills, pain and itching at vaccination site, headache, extreme fatigue, and body ache. Vaccination was during the pustular stage. Site was tender and swollen.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site swelling, Pain, Pruritus, Pyrexia
Clinical narrative: On 10/18/2003 had fever of 103.4 F, chills, pain and itching at vaccination site, headache, extreme fatigue, and body ache. Vaccination was during the pustular stage. Site was tender and swollen.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site hypersensitivity
Clinical narrative: 10/19/2003 Complained of fever > 100.4, chills, pain and itching at vaccine site, headache, and fatigue. Vaccination at pustular stage with swelling and redness around vaccine site.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pain, Injection site pustule, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: 10/19/2003 Complained of fever > 100.4, chills, pain and itching at vaccine site, headache, and fatigue. Vaccination at pustular stage with swelling and redness around vaccine site.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Lymphadenopathy, Pruritus
Clinical narrative: 10/19/2003 Lymph node swelling to left arm with swollen red streak from vaccine site to inner arm. Pain, swelling and itching to vaccine site.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Skin striae
Clinical narrative: 10/19/2003 Lymph node swelling to left arm with swollen red streak from vaccine site to inner arm. Pain, swelling and itching to vaccine site.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Pt never had MMR b/c thought to have egg allergy- but was tested 2x and allergist said not egg allergy- therefore able to get vaccine.  Pt recently diagnosed with Crohn's disease- 9/03. PMH: Asthma and Allergies. Pt seen on 9/22/03, pt started getting hives on MOnday 10/29/03.  Then, spead- very bad, circumferencial around her mouth- 10/01/03 febrile- 101-102 x 5 days. Pt brought to a dermatologist- Dr. Dermatology- dx with Erythema Multiforme.  Pt still has some rash left- bull's eye type rash dark center and paler around- pt still has rash primarily below waist line and a few around mouth.  No fever since 10/05/03.  Pt was given Zyrtec 10 mg qd x4 dyas till decreaased itch, now on Claritin 10 mg qd ( Zyrtec made pt drowsy)  and lotion Clobex 1% cortisone lotion qd.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Injection site pain, Joint range of motion decreased
Clinical narrative: The 3rd dose of Hepatitis B vaccine was administered in the student's right arm on 10/8/03.  She stated that her arm and shoulder area has had pain and soreness since that time.  Came to the clinic on 10/20/03; no erythema, swelling or tenderness to the touch in the deltoid area of her right arm.  She did complain of discomfort when she elevated the arm.  Recommended tylenol or ibuprofen for discomfort; and to call back to the clinic if the discomfort continues past 4 weeks.
Age: 55.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Injection site vesicles, Pyrexia
Clinical narrative: HUSBAND AND I BOTH RECEIVED FLU AND PNEUMONIA SHOTS, AND THAT EVENING WE BOTH STARTED TO GET ILL.  CHILLS, FEVER, DRY HEAVES, RASH, REDNESS, I ALSO HAD BILLIONS OF PUSS FILLED BLISTERS AT THE INJECTION SITE.  THIS STARTED AFTER THE SHOTS ON 10-9.  WE WERE BOTH SEEM AT THE CLINIC ON SATURDAY, THE 11TH.  THEN I HAD TO BE SEEN AT THE EMERGENCY ROOM ON NEXT TUESDAY NIGHT, 10-14.  WE WERE TOLD WE HAD CELLULITIS, AND NEEDED TO BOTH GO ON ANTI-BIOTICS.  WE ARE STILL TAKING THEM.  WE WERE GIVING OUR SHOTS BOTH IN THE SAME ARM.  WE UNDERSTAND WE WERE NOT SUPPOST TO GET THEM IN THE SAME ARM.  MY ARM STILL HAS BLACK SCABS AT THE INJECTION SITE. MY HUSBAND ALSO NEEDED A BREATHING TREATMENT WHILE WE WERE IN THE CLINIC.
Age: 55.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Rash, Retching
Clinical narrative: HUSBAND AND I BOTH RECEIVED FLU AND PNEUMONIA SHOTS, AND THAT EVENING WE BOTH STARTED TO GET ILL.  CHILLS, FEVER, DRY HEAVES, RASH, REDNESS, I ALSO HAD BILLIONS OF PUSS FILLED BLISTERS AT THE INJECTION SITE.  THIS STARTED AFTER THE SHOTS ON 10-9.  WE WERE BOTH SEEM AT THE CLINIC ON SATURDAY, THE 11TH.  THEN I HAD TO BE SEEN AT THE EMERGENCY ROOM ON NEXT TUESDAY NIGHT, 10-14.  WE WERE TOLD WE HAD CELLULITIS, AND NEEDED TO BOTH GO ON ANTI-BIOTICS.  WE ARE STILL TAKING THEM.  WE WERE GIVING OUR SHOTS BOTH IN THE SAME ARM.  WE UNDERSTAND WE WERE NOT SUPPOST TO GET THEM IN THE SAME ARM.  MY ARM STILL HAS BLACK SCABS AT THE INJECTION SITE. MY HUSBAND ALSO NEEDED A BREATHING TREATMENT WHILE WE WERE IN THE CLINIC.
Age: 56.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blister, Injection site pustule, Pruritus
Clinical narrative: Approximately 1mm hard "bumb" right arm at site of smallpox vaccination given 3/17/03.  has fine red rash on back.  patients received influenza vaccine on 10/6/03. Intial VAERS report number:  E-3466 and SC0331.  THIS REPORT IS A FOLLOW-UP TO THE INITIAL REPORT FILED ON 7/17/03.  I AM NOT ABLE TO INDICATE THIS IN BOX 27. BELOW
Age: 56.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blister, Pruritus, Rash maculo-papular
Clinical narrative: Approximately 1mm hard "bumb" right arm at site of smallpox vaccination given 3/17/03.  has fine red rash on back.  patients received influenza vaccine on 10/6/03. Intial VAERS report number:  E-3466 and SC0331.  THIS REPORT IS A FOLLOW-UP TO THE INITIAL REPORT FILED ON 7/17/03.  I AM NOT ABLE TO INDICATE THIS IN BOX 27. BELOW
Age: 56.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site mass, Rash
Clinical narrative: Approximately 1mm hard "bumb" right arm at site of smallpox vaccination given 3/17/03.  has fine red rash on back.  patients received influenza vaccine on 10/6/03. Intial VAERS report number:  E-3466 and SC0331.  THIS REPORT IS A FOLLOW-UP TO THE INITIAL REPORT FILED ON 7/17/03.  I AM NOT ABLE TO INDICATE THIS IN BOX 27. BELOW
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Asthenia, Atrial fibrillation, Blood pressure decreased, Cardiac failure congestive
Clinical narrative: An 81 year old female received RSV vaccine or placebo and Influenza vaccine on 10/30/02 and 107 days later came into the office with weakness, shortness of breath, malaise. She presented with BP 92/50 and weight loss of 20 lbs over the last month. She had not been eating very well. She was sent by ambulance to the hospital and admitted on 2/14/03. Signs/Symptoms/Diagnosis included esophageal dysfunction 9scheduled to have barium swallow in hospital), CHF, depression. The patient was treated with IV fluids and Prevacid. There was one episode of CHF due to over vigorous hydration which resolved. She refused to eat. Evaluated by psychiatry, transferred to psychiatry 2/20/03. The patient was prescribed Remeron from 2/20/03 until death. Patient was not responding in treatment program for depression. Found unresponsive in bed 3/1/03. CPR initiated there was no response and she was pronounced dead. Diagnosis was : Depression, Anxiety, Atrial Fib, Mitral Regurgitation. Cause of death was given as probable myocardial infarction. No autopsy will be performed. The investigator assessed the events as unrelated to the study products. Further information is expected. Additional information received on 10/7/03: Copy of death certificate: signed 3/1/03; date of death:3/1/03. Cause of death: lethal arrythmia - approximate interval between onset and death - 30 minutes. Secondary cause: atrial fib - approximate interval between onset and death - 5 years. Other significant conditions contributing to death but not resulting in the underlying cause given in Part 1 - Mitral valve regurgitation. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: 10/17/2003: No new info is anticipated. Case is closed. Death Certificate received on 10/27/2003 states COD was arrthymia and atrial fibrillation.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Coma, Depression, Dyspnoea, Malaise, Myocardial infarction
Clinical narrative: An 81 year old female received RSV vaccine or placebo and Influenza vaccine on 10/30/02 and 107 days later came into the office with weakness, shortness of breath, malaise. She presented with BP 92/50 and weight loss of 20 lbs over the last month. She had not been eating very well. She was sent by ambulance to the hospital and admitted on 2/14/03. Signs/Symptoms/Diagnosis included esophageal dysfunction 9scheduled to have barium swallow in hospital), CHF, depression. The patient was treated with IV fluids and Prevacid. There was one episode of CHF due to over vigorous hydration which resolved. She refused to eat. Evaluated by psychiatry, transferred to psychiatry 2/20/03. The patient was prescribed Remeron from 2/20/03 until death. Patient was not responding in treatment program for depression. Found unresponsive in bed 3/1/03. CPR initiated there was no response and she was pronounced dead. Diagnosis was : Depression, Anxiety, Atrial Fib, Mitral Regurgitation. Cause of death was given as probable myocardial infarction. No autopsy will be performed. The investigator assessed the events as unrelated to the study products. Further information is expected. Additional information received on 10/7/03: Copy of death certificate: signed 3/1/03; date of death:3/1/03. Cause of death: lethal arrythmia - approximate interval between onset and death - 30 minutes. Secondary cause: atrial fib - approximate interval between onset and death - 5 years. Other significant conditions contributing to death but not resulting in the underlying cause given in Part 1 - Mitral valve regurgitation. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: 10/17/2003: No new info is anticipated. Case is closed. Death Certificate received on 10/27/2003 states COD was arrthymia and atrial fibrillation.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: An 81 year old female received RSV vaccine or placebo and Influenza vaccine on 10/30/02 and 107 days later came into the office with weakness, shortness of breath, malaise. She presented with BP 92/50 and weight loss of 20 lbs over the last month. She had not been eating very well. She was sent by ambulance to the hospital and admitted on 2/14/03. Signs/Symptoms/Diagnosis included esophageal dysfunction 9scheduled to have barium swallow in hospital), CHF, depression. The patient was treated with IV fluids and Prevacid. There was one episode of CHF due to over vigorous hydration which resolved. She refused to eat. Evaluated by psychiatry, transferred to psychiatry 2/20/03. The patient was prescribed Remeron from 2/20/03 until death. Patient was not responding in treatment program for depression. Found unresponsive in bed 3/1/03. CPR initiated there was no response and she was pronounced dead. Diagnosis was : Depression, Anxiety, Atrial Fib, Mitral Regurgitation. Cause of death was given as probable myocardial infarction. No autopsy will be performed. The investigator assessed the events as unrelated to the study products. Further information is expected. Additional information received on 10/7/03: Copy of death certificate: signed 3/1/03; date of death:3/1/03. Cause of death: lethal arrythmia - approximate interval between onset and death - 30 minutes. Secondary cause: atrial fib - approximate interval between onset and death - 5 years. Other significant conditions contributing to death but not resulting in the underlying cause given in Part 1 - Mitral valve regurgitation. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: 10/17/2003: No new info is anticipated. Case is closed. Death Certificate received on 10/27/2003 states COD was arrthymia and atrial fibrillation.