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From the 11/12/2021 release of VAERS data:

Found 4,089 cases where Vaccine targets Influenza (FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1) and Disabled

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Case Details

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VAERS ID: 205555 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: California  
Vaccinated:1998-12-18
Onset:1998-12-24
   Days after vaccination:6
Submitted: 2003-06-26
   Days after onset:1644
Entered: 2003-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Private
Symptoms: Facial palsy, Guillain-Barre syndrome, Headache, Nerve injury, Pain, Speech disorder, Urinary retention
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Demyelination (narrow), Hearing impairment (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Sinusitis, Bronchitis
Preexisting Conditions: Perennial Allergic Rhinitis; Anxiety; Depression; Hypertension; irritable bowel; degenerative joint disease; allergy;
Allergies:
Diagnostic Lab Data: Spinal tap test and blood tests were done. CSF abnormal;
CDC Split Type:

Write-up: 12/18/1998 Influencia Vaccination given at Kaiser 12/26/1998 Hospitalized at Kaiser Hospital with severe case of Guillain-Barre Syndrome (GBS). I was given plasmapheresis (blood exchange) treatment at Kaiser Hospital. Recovery took over 2 years. Physical recovery after 2 years was about 90% of before GBS disease. The 60 day follow up received on 9/3/03 states after 2 years, pt was 90% recovered. Residual symptoms that remained were partial paralysis of face, toes and finger not working right, nerve damage, speech problems. Nurse follow up on 08/31/04 states: "Headache, pain lower extremities, urinary retention,


VAERS ID: 206590 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Male  
Location: Nevada  
Vaccinated:2002-11-06
Onset:2002-11-13
   Days after vaccination:7
Submitted: 2003-07-21
   Days after onset:249
Entered: 2003-07-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0983AA / 5 - / -

Administered by: Military       Purchased by: Military
Symptoms: Balance disorder, Cough, Difficulty in walking, Dysphonia, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test abnormal, Paraplegia, Pyrexia, Rash, Sarcoidosis, Urinary incontinence
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 90 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Cough; Dry rash on neck, chest, back, abdomen, arms and thighs; Hoarseness; Atropy of the right supraspinatus muscle; Beta Thalassemia, sickle cell trait; Vocal cord dysfunction; Vocal cord surgery
Allergies:
Diagnostic Lab Data: MRI brain normal study; MRI lumbar spine "degenerative dsk disease at L5-S1 with a diffuse dsk bulge effacing the epidural fat. No spinal stenosis. No neural impingement, multi-level degenerative facet arthropathy." MRI C, T and L-spine "no
CDC Split Type:

Write-up: Transverse myelitis with progressive paraplegia. Pt developed numbness in left 4th and 5th toes 1-2 weeks after receiving the influenza vaccine in Nov 02. The numbness radiated down the lateral side of the left foot and the pt thought it was due to his boots. Within a few days he had similar symptoms in the right foot. The numbness progressed to the ankles in Dec 02, and then to the calves and by Jan 03 he experienced numbness from the knees down to the toes bilaterally. He had no associated pain, no tingling. He was able to walk but no longer able to run. He was in the process of changing duty, which delayed his seeking medical care. In March 03 he went to ER after the numbness progressed to the waist and he was occasionally losing his balance. He was seen by a PA and treated for gout. He followed up with the PA without improvement and was given a "stronger medicine" for gout. By the end of March he was seen in neurology and underwent "outpatient testing" but he did not receive the results. In mid-Apr 03 he awakened one morning and "my knees gave out from under me" and he fell to the floor. He was taken to the ER and was admitted to hospital for 2 weeks. He was diagnosed with Guillain-Barr? syndrome and received IVIG on 4/18/03. He reports that he initially re-gained movement of the knees but that the improvement didn''t last. However, when he was transferred to rehabilitation hospital on May 1 03 he reports making steady improvement during the first few weeks and began to walk using a walker. However, a week before his scheduled discharge in mid-June he relapsed. Noteworthy medical history includes new onset cough and dry rash on the neck, chest, back, abdomen, arms and thighs in Feb 00 while in over-seas. He states the rash looked like ringworm and was treated with a cream after which it resolved. The cough was non-productive and continuous and was treated with inhalers. The cough lasted for 2 years the member reports. In Mar 00 intermittent hoarseness began. By Apr 00 the hoarseness became constant and on bro. Follow up on 10/28/2003: "Vaccine recipient did not recover from adverse events. I have sent in an update on this patient already and we have determined that his condition is not vaccine-related. He had neurologic complications of sarcoidosis.


VAERS ID: 206717 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Maine  
Vaccinated:1991-11-02
Onset:1991-11-15
   Days after vaccination:13
Submitted: 2003-07-24
   Days after onset:4268
Entered: 2003-07-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Congenital anomaly, Hypertonia, Paralysis, Polyneuropathy, Urinary incontinence
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Congenital, familial and genetic disorders (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Kerlon; Baby aspirin
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Awoke 13th day after flu shot paralyzed from waist down. Never recovered. In wheelchair; perfectly healthy before this. In 11/91 13 days after a flu shot, I awoke paralyzed from the waist down. Went to our doctor then to hospital ER. Called it acute ideopathic polyneuropathy fter x-rays and cat scan. Finally went to the hospital and then to another clinic where they thought it was GBS. Later transverse myelitis. From there to nursing home where I''ve been in a wheelchair ever since. Completely paralyzed from waist down with incontinence. The hospital discharge summary received on 1/2/04 states congenital malformation, spasticity, and neurogenic bladder.


VAERS ID: 207009 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2000-10-16
Onset:2000-10-16
   Days after vaccination:0
Submitted: 2003-07-28
   Days after onset:1015
Entered: 2003-08-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 2 RA / -
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH 471865 / 2 RA / -

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Constipation, Groin pain, Guillain-Barre syndrome, Ileus, Infection, Red blood cell sedimentation rate increased, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Albuteral, Metrobedrol
Current Illness: Fever, weakness
Preexisting Conditions: Asthma, sleep apnea, polyps in nose
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He had fever and weakness about three hours after vaccinated on 10/16/00 and never received treatment until 3/24/01 and was not drained in the spine. Abdominal pain, along with constipation. At this time, he has an ileus, and his other complaint is left groin pain, which has be undiagnosed. He kept going into shock up until December. I think his sed rate was still high even though it was in the normal range because his heart was infected, and they didn''t send him home with no antibiotics. GBS caused from the vaccines.


VAERS ID: 210127 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Colorado  
Vaccinated:2002-10-27
Onset:2002-10-27
   Days after vaccination:0
Submitted: 2003-10-01
   Days after onset:339
Entered: 2003-10-08
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 40928B / UNK - / -

Administered by: Public       Purchased by: Other
Symptoms: Hearing impaired, Laboratory test abnormal
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Medical record states abnormal lab test. msv
CDC Split Type:

Write-up: Within less than five minutes aft4er receiving the influenza injection in the left arm I lost most the hearing in the left ear. I used a cell phone before leaving my car in the parking lot and could hear fine. I went into the building, got the shot, returned to my car and tried to use the cell phone again but couldn''t understand the other party as the voice seemed distorted or muffled. Prior to this event, I have always had excellent hearing. I have received flu shots for many years probably since they were first available with no reactions. After losing hearing in the left ear I immediately made an appointment with doctor. He conducted test and then referred me to another doctor. He conducted tests, gave me drugs to take and made injections through the ear drum. None of these things helped. The 60 day follow up received on 12/16/03 states loss of hearing in the left ear. This occurred immediately upon receiving the innoculation, 2nd there has been no improvement since then. More info concerning this incident is in the report sent 10/1/03.


VAERS ID: 210605 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2002-10-14
Onset:2003-02-11
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2003-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gliglazide, Zalbutamol, Gaviscom Liquid, Mizatidine, Adalai, Metformin, Guinine Sulfmate, Peppermint Oil, Frosemde
Current Illness:
Preexisting Conditions: Hypertension, Diabetes Mellitus, Diverticular Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200300756

Write-up: 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.


VAERS ID: 212438 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Kansas  
Vaccinated:2003-10-31
Onset:2003-10-31
   Days after vaccination:0
Submitted: 2003-11-13
   Days after onset:13
Entered: 2003-11-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Headache, Joint range of motion decreased, Nausea, Oedema peripheral, Pain, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Proventil, estradiol, Allegra
Current Illness: Right upper quadrant pain
Preexisting Conditions: Allergic reaction to bee sting; Drug hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0311USA00151

Write-up: Information has been received from a 39 year old female consumer with allergies to bees and amoxicillin (+) clavulanate potassium who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine in the right arm. Concomitant therapy included montelukast sodium and Ester dial patch. By the afternoon on 10/31/03, her right arm began to swell from her shoulder to a little below the elbow. She says that her arm was so swollen that she could not move her right arm or do her daily routine. The pain was so intense that she was unable to move. She felt that she was going to die. Her daughter in law''s father is a physician who told her to take an antihistamine, which did not work. In the morning of 11/1/03, her arm was very swollen three times its normal size and she had a fever, headache and nausea. As of 11/03/03, her arm was still swollen and she was still complaining of a headache. She also reported that she had a raised white spot on her arm. She reported that her physician is a friend of hers and he is already aware of her situation. Unspecified medical attention was sought. There was no product quality complaint involved. On 11/6/03 the nurse reported that they had no information to add. The patient''s events were considered to be immediately life threatening and disabling. Additional information has been requested. A 15-day follow up report received 12/10/2003 adds: Follow-up info received 11/25/2003 from the nurse indicated that on 10/31/2003 at 3 PM, the pt experienced redness, swelling and discomfort in the IM site which lasted for 5 days. The pt recovered and her events were not considered to be life-threatening or disabling by the reporting health care professional. The pt considered her events to be immediately life-threatening and disabling. No further info is expected.


VAERS ID: 212546 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2003-10-20
Onset:2003-10-20
   Days after vaccination:0
Submitted: 2003-11-07
   Days after onset:18
Entered: 2003-11-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765799 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site haemorrhage, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: End state renal disease; No known allergies; Had flu shots in the past without problems.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 58 year old female with previous history of flu vaccination, developed severe pain and ecchymosis from site of injection from right arm to upper portion of arm (above elbow starting 5 hours after injection). The pain was severe requiring treatment with Vicodin. After 20 days, pain subsided, but ecchymosis still present.


VAERS ID: 212547 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2001-11-07
Onset:2002-04-01
   Days after vaccination:145
Submitted: 2003-11-10
   Days after onset:588
Entered: 2003-11-19
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0696BA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Hypokinesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: EMG decreased in nerve conduction.
CDC Split Type:

Write-up: Guillain-Barre syndrome with motor and sensory deficit.


VAERS ID: 212685 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2003-09-30
Onset:2003-10-08
   Days after vaccination:8
Submitted: 2004-03-05
   Days after onset:149
Entered: 2003-11-20
   Days after submission:106
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 1 - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 5452460029N / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Abscess, Apnoea, Cardiac valve disease, Chills, Confusional state, Cough, Cyanosis, Diarrhoea, Endocarditis, Hyperhidrosis, Neck pain, Pharyngolaryngeal pain, Pneumonia, Pyrexia, Renal failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-10-09
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin Lipito aspirin acetaminophen
Current Illness:
Preexisting Conditions: Coronary bypass surgery; Aortic valve replacement; Lumbar vertebral fracture; Aortic aneurysm; Cardiac murmur; Haemorrhoids; Smoker; Iodine allergy; Hyperlipidaemia; social alcohol drinker; hearing loss
Allergies:
Diagnostic Lab Data: Blood pressure 10/8/03, little low, Blood pressure, 10/9/03, 91 7:37AM, Blood pressure, 10/9/03, 101 8:25AM, Diagnostic laboratory, 10/8/03 normal, Chest x-ray 10/8/03 normal, Blood pressure 10/09/03, 80 10:41AM. Body temp 10/8/03 fever, Complete blood cell 10/8/03 unknown. INR, 06/23/03, 2.3 Prothrombin time, 06/23/03, 24.4 seonds 12.2-14.8 High Serum alanine, 05/12/03, 42U/L, 21-72 SCPT Serum creatinine, 05/12/03, 1.0mg/dL, 0.5-1.5 Serum cholesterol/HDL-C, 05/12/2003, 2.9, 1.7-6.7 Low Serum cholesterol, 5/12/03, 150mg/dL, 120-200 Serum chloride, 05/12/03, 103mmol, 98-110 Serum calcium, 05/12/03, 9.4mg/dL, 8.4-10.2 Serum blood urea, 05/12/03, 15mg/dL, 9-20 Serum aspartate, 05/12/03, 37U/L, 15-46, GOT Serum alkaline, 05/12/03, 92U/L, 38-126 Serum albumin, 05/12/03, 3.7g/dL, 3.6-5.0 Total serum protein, 05/12/02, 7.2g/dL, 6.3-8.2 Total serum carbon, 05/12/03, 30mmol, 22-32 Total serum bilirubin, 05/12/03, 0.8mg/dL, 0.2-1.3 Temperature measurement, 10/9/03, 96, 7:37AM Serum VLDL-C, 05/12/03, 11mg/dL, 5-51 Serum triglyceride, 05/12/03, 55mg/dL, 40-160 Serum sodium, 05/12/03, 137mmol, 137-145 Serum prostate specific, 05/12/03, 1.66ng/mL, 0.0-4.0 Serum potassium, 05/12/03, 4.4mmol, 3.5-5.3 Serum LDL-C calculated, 05/12,03, 87mg/dL, 0-135 Serum HDL-C, 05/12/03, 52mg/dL, 30-90 Serum glucose, 05/12/03, 85mg/dL, 75-115 Serum glucose, 05/12/03, 85mg/dL, 75-110 PT control, 06/23/2003, 13.5 second Serum direct bilirubin, 05/12/03, 0.1mg/dL, 0.0-0.5 Body temp, 10/08/2003, afebrile; normal Body temp, 10/07/03, 103 Blood drug screen, 10/02/03, 3.3, Coumadin level Body temp, 10/08/03, fever Blood glucose, 10/08/03, 104
CDC Split Type: WAES0311USA00578

Write-up: Information has been received from a health professional and a physician concerning a 61 year old male with a history of coronary bypass surgery who on 9/30/03 was vaccinated with a dose of penumococcal 23v polysaccharide vaccine (645246/0029N). Concomitant therapy included influenza virus vaccine and Coumadin. For several days after the vaccine the pt had a fever and chills. On 10/8/03 the pt was brought to the ER with chills, sweats and a fever. The report indicated that they "did tests." It was also reported that he had a chest x-ray and CBC and was given an injection of Rocephin and Phenergan. He was diagnosed with mild renal failure. He was discharged with a prescription for Keflex and went home. The next day, on 10/9/03, the pt died of pneumonia. The reporter expressed a concern with the lot. There was no product quality complaint involved. Pneumonia was considered to be immediately life-threatening and disabling. Additional info has been requested. The autopsy report states septic endocarditis. Follow up on 12/04/03: "The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information from a physician and medical records indicated that the pt had open heart surgery on 23Dec2002 which consisted of one by-pass and a valve replacement. It was reported that the operation went well and the pt had a remarkable recovery. He first had a heart murmur which felt to be benign. He followed up with his primary who ordered an echodardiogram and the problem with his heart valve was discovered. He was sent for a cardiac cathaterization and they recommended immediate replacement of his aortic valve together with a repair of the aneurysm. On 30Sep2003 the pt was seen by a physician and reported to be in good health, and would probably live to be 100. His physical exam was negative at that time. That day he received te pneumococcal 23v polysaccharide vaccine and the influenza virus vaccine. On 02Oct2003 the pt had his monthly labwork done for a a warfarin sodium level. The result was 3.3 and he was instructed to stay on the same dose. On 04Oct2003 the pt was feeling a bit under a the weather, was coughing and did not act up to par. On 05Oct2003 the pt felt the same way, but he had a slight cough and was hoarse. By 07Oct2003 the pt began to run a temperature of 103 and was having uncontrollable chills, sweating, vomiting and diarrhea. The symptoms were only temporary and he took acetaminophen which broke the fever. He had a good appetite and was eating three meals a day. On 08Oct2003 the pt felt good, but had a bout with uncontrollable chills and reported that he was so cold he couldn''t get warm. He took two acetaminophen and felt better, but later had the sweating, vomiting and diarrhea. At 8:30PM he was again having uncontrollable chills and the lobes of his ears looked blue. He was not running a temperature. He was seen in the ER and was told he had symptoms of pneumonia. His temperature was normal and his blood pressure was a little low. He was told by a physician that this was because he was sick. A chest x-ray and bloodwork were done and were reported to be normal, however his blood sugar was 184. He was told that this may make him a little confused. His wife reported that he was confused after taking it. It was reported that the doctor also ordered an injection of something for nausea and an injection of an antibiotic. The pt''s wife was assured by the nurse that these medications would not interact with anything the pt was currently taking. He was given IV to replace body fluids since his blood presure was low. While he was on the IV he had to go to the bathroom with diarrhea and vomiting. It was reported that he was very weak and almost fell off the commode. The pt was released from the ER with a diagnosis of a viral infection and was given prescriptions for dicyclomin hydrochloride 10mg capsule, cephalexia 500mg capsule and diphen/atrop 2.5mg tablet. It was reported that he rested well that night, but did a lot of night sweating. He felt better than the day before, but was still experiencing diarrhea and vomiting. ON 09Oct03 at 7:37AM the pt''s blood pressure was 91-56-117 and his temperature was 96. He tried to eat and drink and his blood pressure at 8:25 was up to 101-54-112. The pt indicated that he would be ok so his wife left the house. She found him at 10:30AM sitting on the floor. He had gotten up to go to the bathroom, but felt sick so he sat there to vomit in the trash can. His wife put him in bed, he took his medications and drank some water and reported that his throat burned. At 10:41AM his blood pressure was 80-44-68 and his nails were blue so the pt''s wife called 911. The pt reported that his neck hurt, so his wife removed pillows and the pt turned his head and stopped breathing. The wife started CPR. With no reponse after a few minutes, she ran out and screamed to a neighbor. The neighbors gave CPR until the ambulence arrived. The pt was taken to the ER where the family was told the pt passed away. An autopsy was performed and the cause of death was listed as septic paravalvular leak due to dehiscence of prosthetic aortic valve due to prosthetic valve endocarditis with ring abscess. The death was reported as natural. Pneumonia, sepsis, endocarditis, abscess and leakage were considered to be immediately life-threatening and disabling. Additional information is not expected."


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