chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old patient who in approximately October 2002 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 642722/0165M).  Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm.  Within hours of vaccination, in approximately October 2002, the patient developed a "big time reaction" from the deltoid to the elbow.  The reaction persisted for 3 to 5 days.  The patient received palliative treatment.  The physician reported that the patient had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago.  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The patient sough unspecified medical attention.  Additional information has been requested.  This is one of a total of four patients.  Three other patients had similar reactions after vaccinations with pneumococcal vaccine 23 polyvalent (WAES # 0210USA02060, 0306USA02765, 0306USA02766).
Age: 60.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old pt who in approximately October 2002, was vaccinated in the arm with a dose of pneumoccocal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately October 2002, the pt developed a "big time reaction" from the deltoid to the elbow. These reaction persisted for 3 to 5 days. The pt received palliative treatment. The physician reported that the pt had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the CBER and was released. The pt sought unspecified medical attention. Additional information has been requested. This is one of a total of four patients. Three other patients had similar reactions after pneumococcal vaccine 23 polyvalent (WAES numbers 0210USA02060, 0306USA02764 and 0306USA02766).
Age: 60.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old pt who in approximately October 2002, were vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately October 2002, the pt developed a "big time reaction" from the deltoid to the elbow. The reaction persisted for 3 to 5 days. The pt received palliative treatment. The physician reported that the pt had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the CBER and was released. The pt sought unspecified medical attention. Additional information has been requested. This is one of a total of four patients. Three other patients had similar reactions after vaccination with pneumococcal vaccine 23 polyvalent (WAES 0210USA02060, 0306USA2764 and 0306USA02765).
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a physician's office employee concerning an adult male who on 10/30/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #6075M-invalid). On approx 10/30/2002 the pt developed swelling, redness, and soreness on the arm where he received the shot. The pt sought unspecified medical attention. It was also reported that another adult male pt had a similar experience (WAES #0306USA02770). Additional info has been requested.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox
Clinical narrative: vaccina on front of chest, abdomen, back and left arm around site.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Chest discomfort, Erythema, Headache, Injection site hypersensitivity
Clinical narrative: 02/13/03- received anthrax #1 02/15/03- painful swelling of the injection site x couple of weeks- became a thick quarter sized painful knot in the following two months- still palpable. 03/19/03- received anthrax #2 03/20/03- Painfully swollen and red upper right arm x1wk 03/27/03- right elbow/shoulder joint pain, painful soft lump under her right arm, constant lower neck pain, constant pressure-like headache, constant dull pressure over her left chest muscle, and muscle spasm around the left chest area. Will mail patient's clinical summary via Fed-Ex.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site mass, Injection site oedema, Muscle spasms, Neck pain, Pain
Clinical narrative: 02/13/03- received anthrax #1 02/15/03- painful swelling of the injection site x couple of weeks- became a thick quarter sized painful knot in the following two months- still palpable. 03/19/03- received anthrax #2 03/20/03- Painfully swollen and red upper right arm x1wk 03/27/03- right elbow/shoulder joint pain, painful soft lump under her right arm, constant lower neck pain, constant pressure-like headache, constant dull pressure over her left chest muscle, and muscle spasm around the left chest area. Will mail patient's clinical summary via Fed-Ex.
Age: 4.0
Sex: M
Vaccine: DT, IPV, MMR, UNK
Symptoms: Asthenia, Autism, Balance disorder, Coordination abnormal, Demyelination
Clinical narrative: roughly 2 weeks after his immunizations he became, fatigued, weak, and unsteady; he kept falling.  I finally took him to a neurologist, and an MRI was reformed; result found were: MS,Demyelinating Encephalopathy,Post Vaccination Reaction,  also diagnoised with Hypotonia, gait disturbance/Ataxia.In PT and OT at Easter Seals. Suffers also from: asthma, allergies, AD, fatigue and weakness. In continious treatment now. The medical record states congenital atonia, attention deficit disorder, and R frontal venous angioma.
Age: 4.0
Sex: M
Vaccine: DT, IPV, MMR, UNK
Symptoms: Encephalopathy, Fatigue, Gait disturbance, Hypotonia, Multiple sclerosis
Clinical narrative: roughly 2 weeks after his immunizations he became, fatigued, weak, and unsteady; he kept falling.  I finally took him to a neurologist, and an MRI was reformed; result found were: MS,Demyelinating Encephalopathy,Post Vaccination Reaction,  also diagnoised with Hypotonia, gait disturbance/Ataxia.In PT and OT at Easter Seals. Suffers also from: asthma, allergies, AD, fatigue and weakness. In continious treatment now. The medical record states congenital atonia, attention deficit disorder, and R frontal venous angioma.
Age: 4.0
Sex: M
Vaccine: DT, IPV, MMR, UNK
Symptoms: Paralysis flaccid, Vascular anomaly
Clinical narrative: roughly 2 weeks after his immunizations he became, fatigued, weak, and unsteady; he kept falling.  I finally took him to a neurologist, and an MRI was reformed; result found were: MS,Demyelinating Encephalopathy,Post Vaccination Reaction,  also diagnoised with Hypotonia, gait disturbance/Ataxia.In PT and OT at Easter Seals. Suffers also from: asthma, allergies, AD, fatigue and weakness. In continious treatment now. The medical record states congenital atonia, attention deficit disorder, and R frontal venous angioma.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: Left arm red, hot, swollen after 2 days.  Told to see private MD.  Mom stated some fever-did not measure
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: 4/14/03- received smallpox vaccine. 4/23/03- noticed shortness of breath at night, mild chest pain, lightheadedness alternating with chills and sweat. 4/25/03- all the above symptoms resolved without any intervention- patient went to ER concerned that his smallpox vaccine site looked "infected."- due to the elevated cardiac enzymes levels, he was admitted to ICU for observation- diagnosed with Myocarditis (lesion on his vaccinated site "normal.") 4/27/03- patient discharged in stable condition with decrease in cardiac enzymes levels Will mail patient's clinical summary via Fed-Ex.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site infection, Laboratory test abnormal, Myocarditis
Clinical narrative: 4/14/03- received smallpox vaccine. 4/23/03- noticed shortness of breath at night, mild chest pain, lightheadedness alternating with chills and sweat. 4/25/03- all the above symptoms resolved without any intervention- patient went to ER concerned that his smallpox vaccine site looked "infected."- due to the elevated cardiac enzymes levels, he was admitted to ICU for observation- diagnosed with Myocarditis (lesion on his vaccinated site "normal.") 4/27/03- patient discharged in stable condition with decrease in cardiac enzymes levels Will mail patient's clinical summary via Fed-Ex.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Chills, Dizziness, Erythema, Feeling hot, Nausea
Clinical narrative: Tetanus vaccine administered 8/1/03 ~9am.  Temperature 100deg F that evening with shaking chills and chattering teeth.  Arm also sore, swollen, and red.  Also, complain nausea and dizziness.  No relief with Tylenol.  Day 2 - temp 100 again, chills persisted, arm increased soreness.  Day 3 - temp 102.  Started Tylenol/ Motrin alternating every 3hrs and Benadryl 50mg q6hrs.  Some improvement with meds.  Day 4 - received Benadryl 50mg IM in office, told to continue Tyl/Motrin.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Tetanus vaccine administered 8/1/03 ~9am.  Temperature 100deg F that evening with shaking chills and chattering teeth.  Arm also sore, swollen, and red.  Also, complain nausea and dizziness.  No relief with Tylenol.  Day 2 - temp 100 again, chills persisted, arm increased soreness.  Day 3 - temp 102.  Started Tylenol/ Motrin alternating every 3hrs and Benadryl 50mg q6hrs.  Some improvement with meds.  Day 4 - received Benadryl 50mg IM in office, told to continue Tyl/Motrin.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Injection site reaction, Myalgia, Shoulder pain
Clinical narrative: Scab came off 4/17/03. On 4/28, intermittent "deep" ache in l.arm, shoulder, joint and muscle. Ache gradually intensified. Had 2 episodes 2 wks. apart: late June, early July. Pt.felt like she was getting her vx "all over again". No fever, no rash, no swelling or other noticeable symptoms.
Age: 53.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Hearing impaired, Laboratory test abnormal
Clinical narrative: started to develop subacute  sensorineural hearing loss 3 weeks after second dose of lymerix, unexplained by any other etiology, being treated with steroids and low dose methotrexate
Age: 53.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Dizziness, Hypoacusis, Immune system disorder, Influenza like illness, Joint stiffness
Clinical narrative: started to develop subacute  sensorineural hearing loss 3 weeks after second dose of lymerix, unexplained by any other etiology, being treated with steroids and low dose methotrexate
Age: 53.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Sleep disorder, Vertigo
Clinical narrative: started to develop subacute  sensorineural hearing loss 3 weeks after second dose of lymerix, unexplained by any other etiology, being treated with steroids and low dose methotrexate
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Acne, Skin ulcer
Clinical narrative: MEMBER EXPERIENCED BIG LESIONS AND SMALL PIMPLES FOLLOWING VACCINATION OF SMALLPOX VACCINE
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site swelling, Pruritus, Thermal burn
Clinical narrative: MEMBER EXPERIENCED SWOLLEN, RED, ITCHY, BURNING SENSATION LOCALIZED AT THE INJECTIONS SITE FOLLOWING VACCINATION.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling
Clinical narrative: member experienced localized swelling following injection
Age: 8.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cough, Feeling hot, Flushing, Pruritus, Wheezing
Clinical narrative: 8/5/03 11:15am  After immunization VZV & Hep B given to child, approximately 10 min. later, face started flushing, child started wheezing with cough, c/o feeling hot and then started itching.  Alert & oriented x3.  Per emergency protocol, Epinephrine given x2 0.1ml SQ every 5 minutes, 911 called, EMS responded as the 2nd dose of Epinephrine given.  Transported to Hospital ER.  Parent followed EMS.  Follow-up with ER, child treated and released to parent to go home.
Age: 1.1
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Child broke out in a rash 2 days after receiving 1 year immunizations.  The rash was on the trunk and back of her head.  The rash appeared to be raised with a white pus like head. It resembled baby acne. The vesical lasted about 1 day and did not scab over.  New vesicals appeared for about 1 week.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: PER MOM:  REDNESS THE SIZE OF A SMALL ORANGE,TENDER, HOT AT INJECTION SITE
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Anorexia, Cyanosis, Dehydration, Diarrhoea, Gastroenteritis
Clinical narrative: A mother reported that her 1 month old daughter received her first injection of Prevnar on 11/1/02. Concomitant vaccines included DTaP, Haemophilus influenzae type B vaccine, hep B vaccine, and IPOL. There was no relevant medical history. Concomitant medications were unknown. On 11/2/02, one day post-immunization, the child developed "heavy" vomiting, lethargy, "inability to keep fluids down," diarrhea, and "heavy" urination and was subsequently hospitalized for seven days. She recovered. The reporter indicated that the child's physician considered the adverse event to be caused by the pertussis vaccine; the pertussis immunization series was discontinued. No additional info was available at the time of this report.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Insomnia, Lethargy, Somnolence, Vomiting
Clinical narrative: A mother reported that her 1 month old daughter received her first injection of Prevnar on 11/1/02. Concomitant vaccines included DTaP, Haemophilus influenzae type B vaccine, hep B vaccine, and IPOL. There was no relevant medical history. Concomitant medications were unknown. On 11/2/02, one day post-immunization, the child developed "heavy" vomiting, lethargy, "inability to keep fluids down," diarrhea, and "heavy" urination and was subsequently hospitalized for seven days. She recovered. The reporter indicated that the child's physician considered the adverse event to be caused by the pertussis vaccine; the pertussis immunization series was discontinued. No additional info was available at the time of this report.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Lethargy, Pollakiuria, Vomiting
Clinical narrative: A mother reported that her 1 month old daughter received her first injection of Prevnar on 11/1/02. Concomitant vaccines included DTaP, Haemophilus influenzae type B vaccine, hep B vaccine, and IPOL. There was no relevant medical history. Concomitant medications were unknown. On 11/2/02, one day post-immunization, the child developed "heavy" vomiting, lethargy, "inability to keep fluids down," diarrhea, and "heavy" urination and was subsequently hospitalized for seven days. She recovered. The reporter indicated that the child's physician considered the adverse event to be caused by the pertussis vaccine; the pertussis immunization series was discontinued. No additional info was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Hearing impaired, Infection, Speech disorder, Vomiting
Clinical narrative: At 3 months of age, constant ear infections, throwing up. (13) ear infections led to several hearing problem-tubes in ears, speech impediment. Now in special needs classes.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Back pain, Fatigue, Hypokinesia
Clinical narrative: Joint pains (feet, hips, shoulders). Medications (NSAIDS, pain medicines); Physical therapy, musculoskeletal stiffness. Fatigue, thoracic region back pain; MRI; NSAID. The follow up received on 10/1/03 states hospitalization was for infection and inflammation of finger on R hand s/o laceration. Range of motion limited in both shoulders (hypokinesia). Osteoarthritis both hips.  60 day follow up on 11/20/2003: "Vaccine recipient did not recover from the adverse event.  Joint aches/osteoarthritis hips rotator cuff injuries, including complete tear in right supraspimatous muscle with accompanying significant inflammation.  Tests for HLA 4 were positive."
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Infection, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Joint pains (feet, hips, shoulders). Medications (NSAIDS, pain medicines); Physical therapy, musculoskeletal stiffness. Fatigue, thoracic region back pain; MRI; NSAID. The follow up received on 10/1/03 states hospitalization was for infection and inflammation of finger on R hand s/o laceration. Range of motion limited in both shoulders (hypokinesia). Osteoarthritis both hips.  60 day follow up on 11/20/2003: "Vaccine recipient did not recover from the adverse event.  Joint aches/osteoarthritis hips rotator cuff injuries, including complete tear in right supraspimatous muscle with accompanying significant inflammation.  Tests for HLA 4 were positive."
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthropathy, Asthenia, Atelectasis, Congenital anomaly, Dyspnoea
Clinical narrative: 8 days after receiving Pneumovax and 5 weeks after receiving flu vaccine, developed horrific pain in left upper arm. Pain was in there and continued. 1 week later developed same pain in my right arm. 1/5/03 developed wrist drop right wrist. Referred to neurosurgeon for bulging disk C-7 which he thought was causing wrist drop. 1/16/03 had cervical diskectomy with graft and plate. This surgery did not improve left wrist drop or right arm weakness. 2 months later i deveeloped severe weakness in my left arm. I was re-hospitalized and had a bone scan, MRI of brachial plexus, MRI; all of these tests were negative. The diagnosis I was given at discharge was Brachial Pleuropathy with unusual presentation. I was then referred to another clinic. I had EMG's, spinal tap, blood work. They could find no reason for the condition I was in except for a possible reaction to one of the vaccines I received. They gave me a diagnosis of Bilateral Parsonage-Turner Syndrome. In March, I was told I have a left paralyzed diaphragm. I am now facing surgery on my left shoulder for rotator cuff tear (8/18/03). Orthopedist felt was possible due to the neuritis. I had been healthy and working up until 5/03 when I developed the wrist drop and arm weakness. Medical record states degenerative jt dx, shotty nodes, atelectasis, neuropathy, numbness, spinal stenosis, and SOB.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Lymphadenopathy, Neuropathy, Neuropathy peripheral, Pain
Clinical narrative: 8 days after receiving Pneumovax and 5 weeks after receiving flu vaccine, developed horrific pain in left upper arm. Pain was in there and continued. 1 week later developed same pain in my right arm. 1/5/03 developed wrist drop right wrist. Referred to neurosurgeon for bulging disk C-7 which he thought was causing wrist drop. 1/16/03 had cervical diskectomy with graft and plate. This surgery did not improve left wrist drop or right arm weakness. 2 months later i deveeloped severe weakness in my left arm. I was re-hospitalized and had a bone scan, MRI of brachial plexus, MRI; all of these tests were negative. The diagnosis I was given at discharge was Brachial Pleuropathy with unusual presentation. I was then referred to another clinic. I had EMG's, spinal tap, blood work. They could find no reason for the condition I was in except for a possible reaction to one of the vaccines I received. They gave me a diagnosis of Bilateral Parsonage-Turner Syndrome. In March, I was told I have a left paralyzed diaphragm. I am now facing surgery on my left shoulder for rotator cuff tear (8/18/03). Orthopedist felt was possible due to the neuritis. I had been healthy and working up until 5/03 when I developed the wrist drop and arm weakness. Medical record states degenerative jt dx, shotty nodes, atelectasis, neuropathy, numbness, spinal stenosis, and SOB.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Angioneurotic oedema, Arthralgia, Erythema, Headache, Myalgia
Clinical narrative: Polyarthralgias-symptoms increased 4 days after Anthrax #3. Anthrax 3 given on 3/30/03 in left arm. A report was filed on this pt in August 2003 for polyarthralgias and chronic urticaria. Two separate reports were filed by the vaccine healthcare center. The pt continues to experience multiple symptoms and has had an extensive evaluation. He was exempt from receipt of further anthrax vaccines. Enclosed is the clinical summary update covering pt symptoms and evaluation through Sept 2004. Pt has been off steroids since early June and off all medications since late July. He reports a few isolated incidents of 1-10 red, non-raised, mildly pruritic lesions since then; most lesions have been on upper extremities. No recent episodes of angioedema involving eyes, lips or throat, but has had episodes involving hives on his hands with associated myalgias/arthralgias in fingers. Joint pain is primarily affecting fingers, but also affects feet after prolonged weight-bearing and knees after increased bending and weightbearing. Mood changes may be improving since off Prednisone, but still not back to his usual self. Headaches are less frequent since all medications discontinued; has taken Tylenol 1-2 times for headaches over last 2 months. Family has voiced concerns regarding changes in personality over the past 15 months-moody, withdrawn; some improvement noted since off Prednisone.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Personality disorder, Rash pruritic, Urticaria
Clinical narrative: Polyarthralgias-symptoms increased 4 days after Anthrax #3. Anthrax 3 given on 3/30/03 in left arm. A report was filed on this pt in August 2003 for polyarthralgias and chronic urticaria. Two separate reports were filed by the vaccine healthcare center. The pt continues to experience multiple symptoms and has had an extensive evaluation. He was exempt from receipt of further anthrax vaccines. Enclosed is the clinical summary update covering pt symptoms and evaluation through Sept 2004. Pt has been off steroids since early June and off all medications since late July. He reports a few isolated incidents of 1-10 red, non-raised, mildly pruritic lesions since then; most lesions have been on upper extremities. No recent episodes of angioedema involving eyes, lips or throat, but has had episodes involving hives on his hands with associated myalgias/arthralgias in fingers. Joint pain is primarily affecting fingers, but also affects feet after prolonged weight-bearing and knees after increased bending and weightbearing. Mood changes may be improving since off Prednisone, but still not back to his usual self. Headaches are less frequent since all medications discontinued; has taken Tylenol 1-2 times for headaches over last 2 months. Family has voiced concerns regarding changes in personality over the past 15 months-moody, withdrawn; some improvement noted since off Prednisone.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Urticaria
Clinical narrative: Rash developed at beginning of May. Physician diagnosed as persistent urticaria.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Dizziness, Hypertension, Hypokinesia, Panic reaction
Clinical narrative: Rapid breathing, high blood pressure, panic attack, chest pain, cannot move, dizziness. Tx: anti-depressant.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Respiratory rate increased
Clinical narrative: Rapid breathing, high blood pressure, panic attack, chest pain, cannot move, dizziness. Tx: anti-depressant.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax on 01/18/00. Reported dx of chickenpox 04/29/03.
Age: 1.9
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax on 2/28/02. Reported dx of chickenpox on 5/12/03.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax on 12/01/99. Reported with dx of chickenpox on 02/21/03.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax on 09/04/01. Reported with dx of chickenpox on 06/25/03.
Age: 1.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax on 09/04/01. Reported dx chickenpox 06/25/03.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax on 04/08/2001. Dx with chickenpox on 06/27/2003.
Age: 1.08
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Vaccinated with Varivax 06/28/02. Dx with chickenpox on 03/07/2003.
Age: 1.3
Sex: F
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Infection, Pruritus
Clinical narrative: Comes in with spots right upper chest, right chest, right arm and spot on upper nose between eyes with itching. Dx: varicella.
Age: 1.6
Sex: F
Vaccine: DTAPH, IPV, MMR, VARCEL
Symptoms: Decreased appetite, Injection site warmth, Irritability, Pruritus, Pyrexia
Clinical narrative: 7/28/03: Mom phoned community health office today at 10:15. States "her child has had a fever since Weds 07/23 ranging from 99.8-103.0" Mom is using Tylenol and Motrin for fever reducer. Child received varicella and MMR vaccine on 7/14/03. On Sat PM 07/26 Mom noticed a rash. Child was fussy and hot to touch. The rash started on shoulders and progressed to head/scalp, ears, trunk area, genital area, buttocks, arms and toes. Currently it is not on her thighs to ankles. The rash only seems to itch child on her head area. Mom has been using benadryl and calamine lotion for itching. The areas have no scabs or pustules. To the touch Mom states "the rash doesn't feel bumpy but like normal skin." On 07/27 in PM, Mom took child to ER. Dr in ER told Mom "I'm in a hurry, I have one pt dying of a heart attack and another one coming in." Dr told Mom it was chickenpox and discharged her from ER. Mom concerned because child continues to have fever, rash and lowered appetite and continues to be fussy. Child has also had a cold after given shot for approx one week. Encouraged Mom to call clinic. Mom has appointment at 1330 today. 7/28/03 spoke with mother of child. States "Dr says it is a viral infection not related to vaccination on 7/14/03." They can't quite pinpoint what the cause is but labs were drawn and her platelets were decreased. She has a prescription for Zyrtec 1/2 tsp daily. No other questions or concerns. Mom is to continue to watch child.
Age: 1.6
Sex: F
Vaccine: DTAPH, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: 7/28/03: Mom phoned community health office today at 10:15. States "her child has had a fever since Weds 07/23 ranging from 99.8-103.0" Mom is using Tylenol and Motrin for fever reducer. Child received varicella and MMR vaccine on 7/14/03. On Sat PM 07/26 Mom noticed a rash. Child was fussy and hot to touch. The rash started on shoulders and progressed to head/scalp, ears, trunk area, genital area, buttocks, arms and toes. Currently it is not on her thighs to ankles. The rash only seems to itch child on her head area. Mom has been using benadryl and calamine lotion for itching. The areas have no scabs or pustules. To the touch Mom states "the rash doesn't feel bumpy but like normal skin." On 07/27 in PM, Mom took child to ER. Dr in ER told Mom "I'm in a hurry, I have one pt dying of a heart attack and another one coming in." Dr told Mom it was chickenpox and discharged her from ER. Mom concerned because child continues to have fever, rash and lowered appetite and continues to be fussy. Child has also had a cold after given shot for approx one week. Encouraged Mom to call clinic. Mom has appointment at 1330 today. 7/28/03 spoke with mother of child. States "Dr says it is a viral infection not related to vaccination on 7/14/03." They can't quite pinpoint what the cause is but labs were drawn and her platelets were decreased. She has a prescription for Zyrtec 1/2 tsp daily. No other questions or concerns. Mom is to continue to watch child.
Age: 0.3
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 20x14cm area of redness, warmth and induration right thigh surrounding DTaP and Hep A site; no fever.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2PM Thursday, patient received Td and MMR on right arm. Right arm was red and raised. On Friday morning, site warm, sore, but no fever.
Age: 28.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient felt dizzy/sweating, slumped to floor five minutes after administration of 2 immunizations. Returned consciousness immediately. BP 110/60, Pulse 62. Transferred to hospital for observation. Vital signs on arrival BO 128/83; Pulse 68; SP O2 97%; T-36. Discharged 6 hours later.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling, redness 12cmx12cm left anterior/lateral thigh. Suggested ice compress.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Received immunizations on 7/23/03. Within 12  hours he developed redness and swelling from left deltoid down to elbow. Was seen in office by CFNP 7/25/03. Treated with ice application and Tylenol or Ibuprofen PRN. Mom states redness/swelling resolved within several hours. No redness or swelling the next day.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Received immunizations 6/12/03. Phone call from parent on 8/1/03 after receiving invitation for 8/14/03 shot clinic. Reports patient had high fever and seizure on the way to hospital; was given Tylenol, cool baths to bring fever down. Was told by doctor seizure due to high fever. Had high fever for 2 days after receiving immunizations.
Age: 33.0
Sex: M
Vaccine: MEN
Symptoms: Blood creatine phosphokinase increased, Blood glucose increased, Chest pain, Heart rate increased, Rash
Clinical narrative: Rash with increased heart rate and chest pains.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Erythema, increased warmth right upper arm--2 sites of injection plus erythema, increased warmth left upper arm with one site of injection positive vesicle and 1 papulovesicle right arm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Left arm swollen and red to elbow; no complaint of pain. Reported to office on 7/24/03; advised ice and Tylenol or Motrin for pain.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Per telephone call, injection site very red and swollen and hot to touch. Advised to use ice and Tylenol and Motrin as needed.
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right arm DTaP #4 reaction 1" rom (redness/swollen). Left arm Prevnar #4 1/2" reaction (only swollen).
Age: 26.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Rash
Clinical narrative: Minor rubella rash about 1 week after vaccine. Also joint pain, 1gm positive. Rash and joint pain subsided.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Dyskinesia, Hypokinesia, Irritability
Clinical narrative: Mom described onset of symptoms after midnight on the day of vaccine. Symptoms included much irritability, but consolable by parent, jerking movements on arousal from sleep, greatly decreased responsiveness to verbal stimuli and primarily responsive to deep touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction left arm; warm, red, tense entire upper arm. Hydroxazine, Orapred and Augmentin.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10cmx11cm area of induration and erythema at site of injection within 24 hours of injection. No fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 13cmx11cm red, swollen, painful area left upper arm where DTaP and IPV injection given. Give Motrin and/or Benadryl per doctor.
Age: 1.1
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Rash erythematous
Clinical narrative: Red, raised bump with blisters. 5mm patch on left thigh.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Seizure approximately 17 hours after vaccination.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Small lump and erythema right thigh. Improved in 24-48 hours and redness resolved on 7/21/03.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Mom reports 50 cent sized red, hot, lump left leg.
Age: 1.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, VARCEL
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: Very high fever after vaccines, child was lethargic, fussy 105 fever on 7/17/03. Vaccines were given 7/16/03. Mother called today 7/22/03, child getting better but not herself yet. It has taken her more than 1 week to get over reaction to vaccines.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 14 month presented 7/22/03 c/o rash on face and trunk x 2 wks per mother's account. Pt was seen 7/1/03 for well child visit-she received MMR and varicella vaccines-approx one week post vaccine she developed cough, runny nose, low grade temp then rash.
Age: 12.0
Sex: F
Vaccine: DT, MMR
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: DT shot 7/21/03 in a.m. no reaction noted on Monday, Tuesday complaint arm just sore, Weds. said arm very red, sore (hard as rock), warm to touch. 4.5cm long and 4cm wide redness.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Cellulitis
Clinical narrative: Cellulitis of bilateral deltoid areas, started on Keflex (po antibiotics) for 10 days. Follow up on 08/21/2003: "Resulted in doctors visit to pediatricin for localized cellulitis."
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Per mom pt has had no reactions DTaP #1, but increasing reactions with #2, #3. She noted usual reaction until 8/1/03 a.m. when upper right arm quite indurated and red. That's the case at today's exam. No other findings.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: R upper leg swollen and red and warm started 2 hrs after immunizations using ice and Motrin for leg. R leg swollen twice the size of normal.
Age: 21.0
Sex: M
Vaccine: TTOX
Symptoms: Syncope
Clinical narrative: Donor fainted after immunization. Out for 5 seconds. Given ice pack, 4 oz water and support care.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: 8 x 5 in long.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: 14 hrs post administration developed fever of 101 degrees and localized pain, redness and swelling in right arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Rash
Clinical narrative: Swelling of R thigh-splotchy rash started on day post vaccine given (7/30). pt seen on 7/31. Remains on Benadryl and antibiotics (Augmentin) started.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling, redness, hard right upper arm also warm to touch. Treat with Motrin 3 times per day until clear. Started one day post immunization.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Rash macular, Rash papular
Clinical narrative: Onset of rash, concentrated in/on trunk region. Rash is macular/papular and is wide spread. Rash onset 7/30.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 4x6cm redness, slightly raised, warm to touch. Onset 24 hrs post immunization no fever no c/o pain. Worsened 24-48 hrs post immunization.
Age: 15.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Pruritus, Rash papular
Clinical narrative: Itchy papular rash minimally but mostly on chin occurred several hours after vaccination. Rash resolving. On day 2 after immunization, rash resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Local red cutaneous reaction without infection. Imyculin-maximum dimension approx. 8cm -9cm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness and swelling at site of injection, warm to touch. Tx with cold compress, Tylenol. Time approx. 1 day post vaccines.
Age: 2.4
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Rt leg 2-2 1/2" in diameter-red, swollen area at injection site x 2 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Type III immune complex mediated reaction
Clinical narrative: 2 injection given at site RML thigh. Arthus reaction 4x8cm. Dr states pertussis reaction. Rx Orapred and Hydroxazine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: On 7/29/03 pt mm noticed swelling and red hot area on left upper arm. This a.m. area much larger. T96.6. 5x6cm erythematous area on left upper arm.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Joint range of motion decreased
Clinical narrative: Pt received DTaP L thigh/ MMR R thigh on 7/14. Approx. 36 h later child developed L knee effusion, induration around L ant. thihg. To ER L knee with effusion, decreased ROM, WBC 8,000, ESR 12. Most likely felt extension of local reaction with reactive aronritic. Placed on Motrin 2 d later, much improved with minimal residual effusion.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Cyanosis, Dizziness, Dysarthria, Gait disturbance
Clinical narrative: Shaky, dizzy, diaphoretic, lips bluish around mouth. Eyes, nose white then suddenly turned gray. Cold and clammy. BP 73/53, blood sugar 178. Slurred speech and staggering walk.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Hyperhidrosis, Tremor
Clinical narrative: Shaky, dizzy, diaphoretic, lips bluish around mouth. Eyes, nose white then suddenly turned gray. Cold and clammy. BP 73/53, blood sugar 178. Slurred speech and staggering walk.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Disorientation, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Severe pain in arm, swelling/redness, fever, nausea, weakness. Disoriented for 1 week. Patient put on Tequin 400mg.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Severe pain in arm, swelling/redness, fever, nausea, weakness. Disoriented for 1 week. Patient put on Tequin 400mg.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Eye oedema, Flushing, Rash
Clinical narrative: Mother states that patient had been playing around the house. She noticed that her daughter started turning red with a rash all over her body with swelling in both eyes.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Next day after vax always break out/hives/humbs regardless of vaccine, especially on upper part of arm and last for about a week. Benadryl is used to control itchiness so that bumps are not squashed by child.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Myalgia, Pericarditis
Clinical narrative: PERICARDITIS  Onset of chest pain and shortness of breath accompanied by fever, chills and myalgias on 23 July 2003.  Initially seen in the ER on 25 July 2003.  Pain was imnproved by leaning forward and splinting. Was treated in the ER with Toradol and sent home with Indomethacin.  He slowly improved was asymptomatic at follow-up on 3 Aug 2003.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pyrexia
Clinical narrative: PERICARDITIS  Onset of chest pain and shortness of breath accompanied by fever, chills and myalgias on 23 July 2003.  Initially seen in the ER on 25 July 2003.  Pain was imnproved by leaning forward and splinting. Was treated in the ER with Toradol and sent home with Indomethacin.  He slowly improved was asymptomatic at follow-up on 3 Aug 2003.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Erythema multiforme, Pyrexia, Rash, Rash erythematous, Tremor
Clinical narrative: Patient received IPV, Comvax, MMR, Varivax, DTaP, and Prevnar on July 30, 2003.  By Sunday, Aug. 3, pt. had developed high fever to 104F and erythema multiforme rash.  On Aug 4, pt. was given Benadryl, without improvement.  On Aug 5, pt. was given Zyrtec without improvement.  On Aug 6, he came to ER (where we saw him) with progression of rash, covering entire body, with raised red areas and flat blue areas.  Fever continued to be 104.  Pt. had tremors of hands and assymetrical Babinski reflex, upgoing on right only.  Rash did not appear to be itchy.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness
Clinical narrative: Immunized 7/31/03   Woke up next morning with stiff neck.  No other symptoms.  Stiffness as of 8/5/03
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Ecchymosis, Erythema
Clinical narrative: ECCHYMOTIC AREA LEFT DELTOID REGION AND BELOW 5 BY 3 CM PATCH OF SKIN, REDNESS WITH ILL DEFINED BORDERS, ITCH X GEL TID AND PAIN. CONTINUE TYLENOL PRN
Age: 4.0
Sex: M
Vaccine: MEA
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.7 ran for 2 days followed by a mild flat rash from the area behind the ears extending down torso to knees.  The fever responded to Tylenol.  The rash is still present.
Age: 30.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Pruritus, Throat tightness, Urticaria
Clinical narrative: Shot given 2:15 PM, left office about 3:45 PM. Pt and wife were at travel agency when ears started itching, became red, hives, felt like throat was closing up-went to ER-given oxygen and antihistamines per wife. Discharged at 5:15 PM with Prednisone and Benadryl. 7/17/03-TC-talked with wife-states pt doing fine-has appointment with PMD 1:20 PM.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Shoulder pain
Clinical narrative: Left lateral bicep - 15cm X 6 cm red area.  Warm to the touch.  Bilateral shoulder and elbow joint pain.  No treatment needed.  Joint pain began to decrease on 8/6/2003.
Age: 74.0
Sex: F
Vaccine: PPV, TD
Symptoms: Hearing impaired, Laboratory test abnormal, Tinnitus
Clinical narrative: 2 days after recieving Td booster and Pneumovax vaccines, the patient had sudden onset of left side hearing loss, immediately preceded by a loud sound in the left ear.  This hearing loss has persisted to the present time.  Patient was evaluated at the clinic on 7/3/03 and referred for Audiogram and ENT appts. Audiogram showed total hearing loss in left ear on 7/16/03.  On 7/24/03 she was seen in ENT clinic, hearing loss described as idiopathic, and patient given a prednisone taper.  She has completed the prednisone taper without any change in her symptoms.  An MRI has been scheduled for 10/2/03, and the patient is going to follow up with ENT 8/15/03.  Although the definitive etiology of the hearing loss is unclear, the patient attributes it to the vaccines that she received 2 days prior to the onset of the hearing loss. Left hearing loss has not improved. Pt has follow up appts with Audiology and ENT at hospital 3/1/04. 10/27/03 MRI at hospital showed no explanantion for hearing loss.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Decreased appetite, Dehydration, Laboratory test abnormal, Oliguria, Pyrexia
Clinical narrative: High temp on evening of 7/9/03. Decreased po intake. ER visit 7/10/03 resulting in hospitalization x 2 days secondary to dehydration.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Decreased appetite, Dehydration, Pyrexia
Clinical narrative: High temp on evening of 7/9/03. Decreased po intake. ER visit 7/10/03 resulting in hospitalization x 2 days secondary to dehydration.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cerebrovascular accident, Chills, Disseminated intravascular coagulation, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 55 year old female pt with a history of hairy cell leukemia, and splenectomy who on 7/2/02 (also reported as "third quarter of 2002") was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (641115/1159L). Concomitant medications at the time of the vaccination were Celebrex, pyridoxine, homeopathic medications (Echinacea). On an unspecified date at the end of January 2003, the pt complained of fever, chills, and nausea. The physician reported the next morning the pt went to the ER and she was admitted to the hospital. Her condition continued to deteriorate progressing to positive blood cultures for pneumococcus, which was rpeorted as Pneumococcal sepsis. The physician also reported the pt experienced a stroke, and disseminated intravascular coagulation (DIC), and she was on the ventilator for a "few" days. Additionally the pt lost all of her fingers to amputation except for her thumbs on both hands. It was noted the pt remained in the acute care hospital for about one month and was then transferred to a rehabilitation hospital. According to the reporter, it was "fairly catastrophic," but now the pt is "much better," and she is undergoing physical therapy. The physician reported that he had seen the pt in his office about one month ago and she is making great progress, she drove herself to the appointment, and despite the stroke, she walks without any mechanical assistance. It was reported that the adverse event abated, and the pt is recovering with sequelae. The physician also mentioned a colleague had described a similar case (WAES0307USA03543), but details were not available. There was no product quality complaint involved. Pneumococcal sepsis, disseminated intravascular coagulation (DIC), stroke, and lost all fingers to amputation were considered to be immediately life-threatening. Pneumococcal sepsis, disseminated intravascular coagulation (DIC), stroke, and lost all fingers to amputation were considered to be disabling. Additional info has been requested. A 15-day follow up report received 10/27/2003 adds no new info.