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Case Details (Sorted by Age)

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VAERS ID:333325 (history)  Vaccinated:2008-11-05
Age:49.0  Onset:2008-11-05, Days after vaccination: 0
Gender:Male  Submitted:2008-11-18, Days after onset: 13
Location:Minnesota  Entered:2008-11-26, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergic to penicillin; Sulfa; aspirin; REGLAN; hydrocodone PMH: sleep obstructive apnea, anxiety.
Diagnostic Lab Data: On sheets from clinic and Emergency Room visit.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0614X IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Dizziness, Fatigue, Non-cardiac chest pain, Pyrexia, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Had Polysaccharide vaccine on 11/5/08 during office physical before a surgery (left hand ring trigger finger) on 11/11/08. Got 102 temp on 11/5/08. To ER hospital on 11/6/08 and temperature was 103 degrees. I still had a 99.2 temperature on the day of my surgery 11/11/08 and surgery was done. 1/19/09 Reviewed ER medical records of 11/06/2008 FINAL DX: febrile reacton s/p pneumovax vaccination Records reveal patient experienced fever, dizziness, fatigue, dry cough, right lower chest pain w/cough. Temp in Er 103.3. Tx w/antipyretics & d/c to home.

VAERS ID:333424 (history)  Vaccinated:2008-10-04
Age:49.0  Onset:2008-10-13, Days after vaccination: 9
Gender:Male  Submitted:2008-11-28, Days after onset: 46
Location:Unknown  Entered:2008-11-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Anxiety/depression
Preexisting Conditions: Testicular cancer; Deep venous thrombosis.
Diagnostic Lab Data:
CDC Split Type: MA20082400
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89881 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Computerised tomogram normal, Confusional state, Depressed level of consciousness, Electroencephalogram abnormal, Encephalitis, HIV test negative, Headache, Herpes simplex serology negative, Influenza like illness, Lethargy, Lumbar puncture, Musculoskeletal stiffness, Pain, Pyrexia, Red blood cells CSF positive, Virus serology test negative
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: We received from a health care professional via the Medical Communication the following information on 16 OCT 2008: A 49-year-old man, born on 26 FEB 1959, was vaccinated with 0.5 ml FLUVIRIN, batch-no. 89881, i.m. on 04 OCT 2008. On 13 OCT 2008 the patient began to experience pain between his shoulders, with pain progressing throughout the body, he developed a low grade fever, and became lethargic and confused. The patient was transported to the emergency room, where he was started on vancomycin, rocephin, and acyclovir for possible meningeal encephalitis. Patient was admitted to the hospital on 14 OCT 2008. On 15 OCT 2008 a lumbar puncture revealed the following: first 4 ml tube showed cerebral spinal fluid clear and colorless, no white blood cells, no red blood cells, and the second tube showed cerebral spinal fluid protein 40 (high), red blood cells 40 (high), protein 86 (high), and glucose 84 (within normal limits). Review of manufacturing protocols demonstrated that there were no deviations affecting product. No change in assessment. We received from the reporting health care professional the following information on 30 OCT 2008: The patient was discharged on 20 OCT 2008. No change in assessment. We received additional information from a physician on 17 NOV 2008: The patient recovered from meningoencephalitis symptoms completely in 5-6 days. Due to HIPAA rules, the physician is unable to send the hospital report. No change in assessment. We received the hospital report on 24 NOV 2008: The patient was admitted after having a flu-like illness for approximately one to two days prior to admission. On presentation to the emergency department, the patient was obtunded with complaint of generalised body aches and neck stiffness. He had a waxing and waning mental sensorium and was therefore admitted for neurological evaluation and monitoring. CNS cultures remained no growth. Viral serologies remained negative. CT scan was performed, which did not show any abnormal enhancing masses, midline shift or intracranial hem

VAERS ID:333399 (history)  Vaccinated:2008-11-07
Age:49.0  Onset:2008-11-08, Days after vaccination: 1
Gender:Female  Submitted:2008-11-28, Days after onset: 20
Location:Missouri  Entered:2008-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89966 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0868X1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Rash macular, Skin warm
SMQs:, Hypersensitivity (narrow)
Write-up: Rash on upper arm. Blotchy, doesn''t itch, warm to touch, no drainage, not raised. On the inner aspect of arm

VAERS ID:333677 (history)  Vaccinated:2008-11-26
Age:49.0  Onset:2008-11-26, Days after vaccination: 0
Gender:Female  Submitted:2008-11-28, Days after onset: 2
Location:Ohio  Entered:2008-12-02, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibramyalgia, chronic bronchitis, ulcerativecholitis, decreased thyroid, HTN
Preexisting Conditions: PMH: Ulcerative colitis, HTN, hypothyroidism, asthma. Allergies, MS, PCN, sulfa, lorabid, zoloft, zosyn./
Diagnostic Lab Data: increased WBC. Labs and Diagnostics: CBC with WBC 19.7. K+ 5.2. EKG (+) for sinus tach. CXR WNL. Shoulder X-ray (+) for calcification and spurring. Cardiac markers WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2810AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1076X IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood potassium increased, Body temperature increased, Cardiac enzymes normal, Chest X-ray normal, Electrocardiogram abnormal, Hypertension, Injected limb mobility decreased, Joint range of motion decreased, Leukocytosis, Myositis, Pain in extremity, Pyrexia, Sinus tachycardia, Tenderness, White blood cell count increased, X-ray limb abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Hypertension (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad)
Write-up: 3 hours after vaccine, severe arm pain, unable to move left arm. Fever 102. Leukocytosis 12/2/08. Still with severe arm pain and unable to perform active range of motion. 12/19/2008 MR received for DOS 11/25-26/2008 with DX: L shoulder myositis s/p pneumonia vaccine. Pt presented severe, worsening L arm pain. PE (+) for elevated BP 214/88, T=101.9''F, decreased ROM of L shoulder with (+) tenderness. Tx with abx, anti-inflammatories and pain meds and d/c to f/u w/ PCP.

VAERS ID:333723 (history)  Vaccinated:2008-11-21
Age:49.0  Onset:2008-11-29, Days after vaccination: 8
Gender:Male  Submitted:2008-12-03, Days after onset: 4
Location:Virginia  Entered:2008-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER    
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Military     Purchased by: Unknown
Symptoms: Cellulitis, Eschar, Induration, Lymphadenopathy, Lymphangitis, Paronychia, Post vaccination autoinoculation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt received smallpox vaccine in L deltoid. He reports scratching the vaccination site with his R hand and developed induration with eschar formation on his R thumb. Eschar similar in appearance to L detoid innoculation site eschar. Pt reports biting his fingernails. He has a R thumb paronychia with cellulitis and lymphatic streaking proximally to R forearm and B/L axillary and inguinal LAD. Clinical diagnosis of R thumb autoinoculation with paronychia/cellulitis presumed to be GAS. Treated with IM ceftriaxone and PO clindamycin.

VAERS ID:334113 (history)  Vaccinated:2008-12-02
Age:49.0  Onset:2008-12-03, Days after vaccination: 1
Gender:Female  Submitted:2008-12-04, Days after onset: 1
Location:Illinois  Entered:2008-12-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Food allergy; crustaceans
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0742X IMRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Pain in extremity, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Soreness on arm, swelling, rash and red bands.

VAERS ID:334160 (history)  Vaccinated:2008-12-01
Age:49.0  Onset:2008-12-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-04, Days after onset: 3
Location:New York  Entered:2008-12-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFEXOR; IMITREX; LUNESTA; Iron
Current Illness:
Preexisting Conditions: Allergy; IVP dye; diagnosed Anemia; IBS (irritable bowel syndrome); TMJ; headaches; depression, anxiety; ovarian cyst
Diagnostic Lab Data: 12/2/08 seen for follow up by Dr placed on XYZAL, 5mg, qd
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2853AB IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cough, Dry mouth, Lip swelling, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: 12/1/08 5pm patient states cough, some swelling under tongue and chills. 12/2/08 Patient called office complaining of mouth dry, lips puffy, throat scratchy. No swallowing or breathing difficulty. Injection site without redness or swelling, afebrile.

VAERS ID:334428 (history)  Vaccinated:2008-11-21
Age:49.0  Onset:2008-11-21, Days after vaccination: 0
Gender:Male  Submitted:2008-11-24, Days after onset: 3
Location:Washington  Entered:2008-12-09, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2831AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Chills, Conjunctivitis, Cough, Pyrexia, Wheezing
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: Conjunctivitis, fever, rigors, cough, wheezing.

VAERS ID:334553 (history)  Vaccinated:2008-11-13
Age:49.0  Onset:2008-11-13, Days after vaccination: 0
Gender:Male  Submitted:2008-11-21, Days after onset: 8
Location:South Carolina  Entered:2008-12-09, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: No Known allergies or birth defects; Med Dx GERD (not on meds, diet manipulation)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED01349111A0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Hypoaesthesia, Injection site erythema, Muscle spasms, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: S/S reported on 11/20/08 to nurse practitioner - reported that evening of 11/13/08, his arm "felt numb tingling" down (L) arm. Afebrile. Some redness noted @ injection site and he put alcohol on it and went away. Later, he said (L) leg was crampy and numb off/on several days. No loss of strength or motor movement of (L) side. Took Goody''s off/on with some relief. Only slight "tingling feeling" of (L) arm on 11/21/08.

VAERS ID:334628 (history)  Vaccinated:2008-10-21
Age:49.0  Onset:2008-10-21, Days after vaccination: 0
Gender:Female  Submitted:2008-11-12, Days after onset: 22
Location:Alabama  Entered:2008-12-09, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Grass Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA349CD0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Rec''d call from Patient 11/12/09. She reported that at the time of the injection she felt the usual amount of pain but 3 hours later she could not lift her arm. Had an appointment with Dr. for a turned left ankle 11/6/2008. While there asked about shoulder. Ultra sound fx''s ordered. Shoulder continues to hurt.

VAERS ID:334750 (history)  Vaccinated:2008-08-20
Age:49.0  Onset:2008-08-23, Days after vaccination: 3
Gender:Male  Submitted:2008-09-04, Days after onset: 12
Location:Unknown  Entered:2008-12-09, Days after submission: 96
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2299AB1IMRA
Administered by: Military     Purchased by: Military
Symptoms: Eye pain, Headache, Hypoaesthesia, Influenza like illness, Muscular weakness, Myalgia, Nasopharyngitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Eosinophilic pneumonia (broad)
Write-up: 8/20/08-8/21/08: Developed fever, headache, muscle ache, aching eye (Flu-like symptoms). 8/22/08 - Muscle achiness, cold symptoms, no fever. Took Tylenol purchased local pharmacy (unknown dose). 8/23/08 - Had Bilateral pelvic to ankle numbness. 9/3/08 - Numbness to (R) lateral pelvic to ankle, loss of some strength to (R) arm and (R) leg.

VAERS ID:335254 (history)  Vaccinated:2008-10-29
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:D.C.  Entered:2008-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOVENT/ALBUTEROL; SYNTHROID
Current Illness: L rotator cuff injury diagnosed (03/06)
Preexisting Conditions: Levaquin allergy/thyroid removed/asthma/mitral valve prolapse heart murmur
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLAA172AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Joint range of motion decreased, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: Pain began @ time of administration. At day 3 client realized pain was not diminishing and due to this, client''s ROM was and is limited. Today is 9 wks post immunization, states pain is transient but when present is sharp upon movement and achy at night. Pain is to high triceps brachii site, back of arm, described & points to site with fingers.

VAERS ID:335627 (history)  Vaccinated:2005-11-22
Age:49.0  Onset:2005-11-23, Days after vaccination: 1
Gender:Male  Submitted:2008-12-18, Days after onset: 1121
Location:Oklahoma  Entered:2008-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinus infection self reported.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS500390P0IN 
Administered by: Public     Purchased by: Public
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Ct. states that he had nosebleed for one month following administration of intranasal influenza vaccine.

VAERS ID:335751 (history)  Vaccinated:2008-11-14
Age:49.0  Onset:2008-11-14, Days after vaccination: 0
Gender:Male  Submitted:2008-12-01, Days after onset: 17
Location:Washington  Entered:2008-12-19, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: nerve damage~Influenza (no brand name)~0~48~In Sibling
Other Medications: Allergy med- CLARITEN
Current Illness: None
Preexisting Conditions: Seasonal allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS87684 UNLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site rash, Rash papular, Rash pruritic, Scar
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: The evening of the flu shot, noticed raised lesions that resemble hives, vesicle fluid filled, itched-broke out on arms, chest- injection site- no lesions noted- no fever noted - lesion scarred in two days.

VAERS ID:337887 (history)  Vaccinated:2008-10-24
Age:49.0  Onset:2008-10-28, Days after vaccination: 4
Gender:Female  Submitted:2008-11-12, Days after onset: 15
Location:California  Entered:2008-12-19, Days after submission: 37
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Viral Syndrome
Diagnostic Lab Data:
CDC Split Type: 200814267
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED02349111A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Report received from a Pharmacy Buyer on 31-Oct-2008. A patient (age/sex/initials not reported) received AFLURIA (CSL Influenza vaccine) on an unknown date. On an unknown date, patient experienced vertigo. Per the Pharmacy Buyer, she does not know any more details. Pharmacy Buyer to have the Pharmacist call CSL Biotherapies and provide additional information. Pharmacy Buyer would not provide name nor phone number of pharmacist. No serious criteria mentioned. Causality: unassessable/unclassifiable. Follow-up information received on 03-Nov-2008 from a pharmacist. A 49 year-old female received AFLURIA (CSL Influenza vaccine; lot 02349111A, exp date 30-Jun-2009) on 24-Oct-2008. On 28-Oct-2008, she was experiencing vertigo. Patient''s physician does not believe the vertigo was caused by the AFLURIA, physician believes the patient''s viral syndrome which she had two weeks prior to the flu shot was the cause. Patient had not yet recovered. Assessment: The company considered this event unlikely to be related to the suspect drug. Informaiton derived from this AE report does not change the current safety profile of AFLURIA (CSL Influenza vaccine).

VAERS ID:335853 (history)  Vaccinated:2008-10-21
Age:49.0  Onset:2008-10-22, Days after vaccination: 1
Gender:Female  Submitted:2008-11-05, Days after onset: 14
Location:Tennessee  Entered:2008-12-22, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: TN08035
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSUA367EA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1344U UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Local swelling, Pain
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient called stating left side if neck was swollen at pneumonia and flu shot on 10-21-08. Asked patient to go to family Dr and to call and seeing him. patient called 10-23-08. States family Dr gave a cortisone shot and pain meds. Told to apply cold compress 20 min then off 10 min, then back on neck 20 min. Patient states pain is less and swelling is going away. Told by Dr and health dept to never take another pneumonia shot.

VAERS ID:335857 (history)  Vaccinated:2008-10-10
Age:49.0  Onset:2008-10-10, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 4
Location:Texas  Entered:2008-12-22, Days after submission: 69
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMBIEN
Current Illness:
Preexisting Conditions: Asthma; Heart valve defect
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS88910 UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0555U UNLA
Administered by: Other     Purchased by: Other
Symptoms: Axillary pain, Dizziness, Erythema, Hypersensitivity, Injection site mass, Injection site pain, Injection site swelling, Injection site vesicles, Lymphadenitis, Musculoskeletal stiffness, Pruritus, Pyrexia, Skin burning sensation, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: 4:20 patient says, dizzy, "arm on fire", burning and stiff, left arm. had 102 degree fever. 11 th and 12th noted lump size of lemon at injection site, tight and painful. Whole arm burning and very hot. 13th and 14th swelling extend to below elbow with redness and burning around arm. Also lump under armpit red and sensitive. Later blisters at injection site, itching at elbow. Patient said she put ice on the same. Follow up 11/21/08, patient went to the Emergency room and was given pain medication, and the Doctor informed her that she had an allergic reaction. She was given SULFADERM x 20 days, and instructed to apply alternately heat and cold. She stated that after two weeks she was better.

VAERS ID:335980 (history)  Vaccinated:2008-12-11
Age:49.0  Onset:2008-12-22, Days after vaccination: 11
Gender:Male  Submitted:2008-12-23, Days after onset: 1
Location:Arkansas  Entered:2008-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-vitamin
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0453X SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Chills, Pain, Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 12/21/08-chills; 12/22/08-spots across chest and back of neck; 12/23/08-low grade fever, itching, aching; rash over face, head, chest

VAERS ID:336511 (history)  Vaccinated:2009-01-05
Age:49.0  Onset:2009-01-05, Days after vaccination: 0
Gender:Female  Submitted:2009-01-05, Days after onset: 0
Location:Maryland  Entered:2009-01-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: SULFA; PCN; Seafood
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAVBVB517AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Dizziness, Muscle tightness, Tinnitus
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: Ringing in ears, jaw tightness, lightheadedness, chest tightness 20 after Engerix-B #1

VAERS ID:336916 (history)  Vaccinated:2008-11-16
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-01-09
Location:Virginia  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED03149111A IN 
Administered by: Military     Purchased by: Military
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE

VAERS ID:336931 (history)  Vaccinated:2008-10-10
Age:49.0  Onset:2008-10-10, Days after vaccination: 0
Gender:Female  Submitted:2009-01-09, Days after onset: 91
Location:Utah  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. PMH: C4-C5 fusion. hiatal hernia repair. NKDA.
Diagnostic Lab Data: Arterial Blood Gas / Chest XRay (findings unknown). Labs and Diagnostics: CXR WNL. CK 46 WNL. CKMB 1.9. Lactate (H) 2.5.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89975 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Anaphylactic reaction, Anxiety, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Blood gases abnormal, Blood lactic acid increased, Chest X-ray, Chest X-ray normal, Deep vein thrombosis, Dyspnoea, Flushing, Headache, Hyperhidrosis, Hypertension, Immediate post-injection reaction, Immunisation reaction, Injection site pruritus, Injection site warmth, Metabolic acidosis, Oedema peripheral, Pain in extremity, Pruritus, Tachycardia, Throat tightness, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: 1) 5 min after injection, heat flush & abd cramping. 2) 10 min after, itching & heat @ injection site. 3) 15 min after, itching & hives over entire arm/shoulder area. 50mg Benadryl given. 4) 25-30 min after, heat flush, diaphoretic taken next door to urgent care. 5) 45 min after, diaphoretic, shortness of breath, spasms in throat. Epi dose of 0.3mg given. Ambulance called to urgent care. 6) ER - O2 100% NRB face mask, patient doesn''t remember other treatments except stated she was given ativan. She was in the hospital for 3 days. After discharge, saw primary care physician for severe arm pain & swelling. Ultrasound showed DVT in arm from infiltrated IV. Currently on Coumadin for 6 months. Primary physician will have to strip vein. Released for return to work on 10/31/08. 2/10/2009 MR received for DOS 10/10-12/2008 with D/C DX: Anaphylactic Reaction to Flu vaccine. Mild metabolic acidosis. Tachycardia. Pt presented to ER following receipt of Flu shot and immediate flushing, hives, diaphoresis, abdominal pain and H/A. Received Benadryl, Solumedrol and epi prior to arrival with poor response. Becam tachycardic, hypertensive and anxious en route to hospital. Upon arrival pt still c/o of throat closing and difficulty breathing. BP 212/69. PE WNL. Admitted for further med mgmt.

VAERS ID:337150 (history)  Vaccinated:2008-12-04
Age:49.0  Onset:2008-12-11, Days after vaccination: 7
Gender:Female  Submitted:2009-01-08, Days after onset: 28
Location:Massachusetts  Entered:2009-01-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: CT Contrast dye
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0062X0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Oedema, Rash generalised, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Generalized body rash with mild edema,"patches" and hives.

VAERS ID:338444 (history)  Vaccinated:2008-11-06
Age:49.0  Onset:2008-11-06, Days after vaccination: 0
Gender:Male  Submitted:2009-01-27, Days after onset: 82
Location:Pennsylvania  Entered:2009-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Rhinitis allergic; Asthma
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811USA02652
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1161X IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from a physician concerning a 49 year old male with asthma and allergic rhinitis who on 06-NOV-2008 was vaccinated with PNEUMOVAX 23 (lot number 661577/1161X) intramuscularly in the right arm. On 06-NOV-2008 the patient developed tenderness, swelling and pain at the injection site after receiving the dose of PNEUMOVAX 23. The pain became severe and stemmed from the shoulder up through the neck. The patient recovered after stopping therapy. Follow up information was received from the physician. The physician stated that on 06-NOV-2008 post vaccination the patient developed erythema, warmth and pain at the injection site. On 08-NOV-2008 the pain stemmed from shoulder through the neck. The patient was treated with MEDROL and VICODIN. On 14-NOV-2008 the patient''s symptoms and signs resolved. There were no additional diagnostic tests. The physician felt the patient''s injection site pain, erythema, warmth, and pain from shoulder through the neck were other important medical events. Additional information is not expected.

VAERS ID:338488 (history)  Vaccinated:2008-10-21
Age:49.0  Onset:2008-10-21, Days after vaccination: 0
Gender:Female  Submitted:2009-01-28, Days after onset: 99
Location:Alaska  Entered:2009-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: MRI, XRAYS, AND PATIENT FILES.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Military
Symptoms: Muscle injury, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome, X-ray
SMQs:, Accidents and injuries (narrow)
Write-up: THE FLU SHOT WAS GIVEN DIRECTLY IN TO MY LEFT SHOULDER, UP VERY HIGH, AND BEHIND. I NOW HAVE A TEAR ON MY SUPRASPINATUS AND INFRASPINATUS MUSCLES, AND A PERFORATION ON MY ROTATOR CUFF TENDON. I FELT EXTREME PAIN WITHIN AN HOUR OF RECEIVING THIS IMMUNIZATION. I AM NOW IN PHYSICAL THERAPY, AND I AM GOING TO HAVE SURGERY TO REPAIR IT. I AM SURPRISED AT THE NUMBER OF PEOPLE WITH SHOULDER INJURIES FROM IMMUNIZATIONS. BETTER TRAINING NEEDS TO BE AVAILABLE TO ALL HEALTH CARE PERSONNEL ADMINISTERING THESE IMMUNIZATIONS. THEY ARE CAUSING MORE HARM, THEN GOOD.

VAERS ID:338813 (history)  Vaccinated:2009-01-30
Age:49.0  Onset:2009-01-31, Days after vaccination: 1
Gender:Female  Submitted:2009-02-02, Days after onset: 2
Location:Michigan  Entered:2009-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU27411AA   
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.144X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Flu vaccine received on 1/30/08 here in the office at 430 pm - over the past 3 days pt c/o R arm swelling at site with redness 2-4 cm non-puritic bump. Not allergic to eggs, has received flu imm before. Tx Benadryl/50mg every 6-8 hours. Contact us if no improvement.

VAERS ID:339280 (history)  Vaccinated:2008-11-04
Age:49.0  Onset:2008-11-24, Days after vaccination: 20
Gender:Male  Submitted:2009-02-09, Days after onset: 77
Location:Montana  Entered:2009-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Lerch, Fred~Influenza (Fluarix)~0~48~In Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Pt was evaluated by Physician
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA375AA3IMRA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Musculoskeletal pain, Paralysis, Similar reaction on previous exposure to drug
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Pt experienced shoulder girdle pain for 3 days followd by arm weakness and serratus muscle paralysis which has not resolved as of today. Pt had a similar symptoms after influenza shot in 2007 but only involved pain in the shoulder not weakness like this year.

VAERS ID:339410 (history)  Vaccinated:2009-02-02
Age:49.0  Onset:2009-02-02, Days after vaccination: 0
Gender:Male  Submitted:2009-02-10, Days after onset: 8
Location:Florida  Entered:2009-02-11, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hay fever
Preexisting Conditions:
Diagnostic Lab Data: Temperature measurement, 102.5 F, for 3 days
CDC Split Type: WAES0902USA01032
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Chills, Cough, Hyperhidrosis, Injection site cellulitis, Injection site erythema, Injection site pain, Pyrexia, Respiratory disorder, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician with had hay fever who on 02-FEB-2009 vaccinated himself with a 0.5 ml first dose of PNEUMOVAX 23 intramuscularly into his left deltoid. There was no concomitant medication. On 03-FEB-2009 he experienced a fever of 102.5F for 3 days, rigors, sweats and cellulitis from the left shoulder to left elbow. It was reported that the cellulitis area first started as a little red spot with pain and the developed into the cellulitis from the left shoulder to the left elbow. It was reported that the physician had "general upper respiratory" symptoms such as cough, vomited several times on 03-FEB-2009 and could not stay awake. At the time of the report, the fever was gone however the area of redness (cellulitis area) is extended. It was reported that the physician was taking AUGMENTIN XR two tablets twice daily and prednisone. There were no diagnostics studies performed. It was reported that the physician considered jumping into a cold pool and was also taking around the clock ibuprofen alternating with TYLENOL to lower his fever as intervention to prevent a serious criteria. The physician talked with another unspecified physician. The reporting physician considered fever, rigors, sweats, "general upper respiratory symptoms" could not stay awake, vomited several times and cellulitis to be life threatening and other important medical events. Additional information has been requested.

VAERS ID:339812 (history)  Vaccinated:2009-01-23
Age:49.0  Onset:2009-01-24, Days after vaccination: 1
Gender:Female  Submitted:2009-02-10, Days after onset: 17
Location:Illinois  Entered:2009-02-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM, CELEBREX
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF455CA UNLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Mass, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm became very swollen and red, itched, area about 2 1/2 X 2 1/2 inches. Lasted for 6 days. Then just swollen and started to go away. Had bump for 12 days.

VAERS ID:339933 (history)  Vaccinated:2009-01-19
Age:49.0  Onset:2009-01-21, Days after vaccination: 2
Gender:Female  Submitted:2009-01-21, Days after onset: 0
Location:New York  Entered:2009-02-18, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TAPAZOLE; PRAVASTATIN
Current Illness: None
Preexisting Conditions: Hyperthyroidism; Hyperlipidemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC1030AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Increasing redness, itching + swelling at shot site L upper arm starting approximately 24 hours after shot has 8x5cm are erythema + swelling + tenderness P OTC antihistamine hydrocortisone cream

VAERS ID:339935 (history)  Vaccinated:2009-01-08
Age:49.0  Onset:2009-01-08, Days after vaccination: 0
Gender:Female  Submitted:2009-01-23, Days after onset: 15
Location:New York  Entered:2009-02-18, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HTN; COPD; Back and hip pain
Preexisting Conditions: NKDA; Hypothyroidism; COPD; HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2787AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1124X0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:
Write-up: Right arm became very painful, unable to lift.

VAERS ID:339937 (history)  Vaccinated:2008-09-04
Age:49.0  Onset:2008-09-12, Days after vaccination: 8
Gender:Female  Submitted:2009-01-22, Days after onset: 132
Location:Unknown  Entered:2009-02-18, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Tetanus Toxoid (no brand name)~UN~49~In Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3 days after receiving tetanus shot- Had severe pain & aching (deep) in right upper arm - It has been 4 months & although the pain is less, is still very much present

VAERS ID:340076 (history)  Vaccinated:2009-01-12
Age:49.0  Onset:2009-01-12, Days after vaccination: 0
Gender:Female  Submitted:2009-02-02, Days after onset: 21
Location:Wisconsin  Entered:2009-02-19, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Recovering from fx heel since 4/08
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2768AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Pain in extremity
SMQs:
Write-up: 2/2/09 TC from client states "upper right arm has been hurting since she received the hepatitis A-B vaccine on 1/12/09". She has applied cold and heat, no discoloration noted, no warmth or redness but c/o pain, no decrease in ROM, no numbness reported by client. Still has sore arm.

VAERS ID:340259 (history)  Vaccinated:2006-11-17
Age:49.0  Onset:2006-11-17, Days after vaccination: 0
Gender:Female  Submitted:2006-11-30, Days after onset: 13
Location:Washington  Entered:2009-02-20, Days after submission: 813
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: -0-
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500437P1IN 
Administered by: Public     Purchased by: Private
Symptoms: Headache, Lymphadenopathy, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: "massive" headache. Facial swelling w/rash. Lymphandopathy. Prednisone at tapering dose. Doxycycline.

VAERS ID:340429 (history)  Vaccinated:2009-02-18
Age:49.0  Onset:2009-02-19, Days after vaccination: 1
Gender:Male  Submitted:2009-02-23, Days after onset: 4
Location:Pennsylvania  Entered:2009-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2938AA0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad)
Write-up: Tdap given on 2/18. C/o sitting soreness, muscle ache on 2/19. On afternoon of 2/19 & 2/20 had fever 38-38.9 degrees C, generalized body ache, injection site soreness. Resolved by 2/23/09.

VAERS ID:340508 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:2008-12-29
Gender:Female  Submitted:2009-02-19, Days after onset: 52
Location:Maine  Entered:2009-02-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient had a history of IGA deficiency and allergies to amoxicillin, aspirin, PROZAC, morphine, naproxen, MOTRIN, sulfa and INTRON. From information received 23/Jan/2009, the patient had a similar, but worse reaction following treatment with INFERON which included urticaria.
Diagnostic Lab Data: Sed rate, CRP, Rheumatoid factor, ANA, liver function panel, all normal findings; Lyme, Monospot, ASO, all negative; CBC, mild leukopenia at 3000 (no anemia); C3, 89; C4, 4; Hepatitis profile, consistent with prior vaccination; Parvovirus s
CDC Split Type: 200900242
Vaccination
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Lot
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody negative, Arthralgia, Borrelia burgdorferi serology negative, C-reactive protein normal, CD4 lymphocytes decreased, Full blood count abnormal, Impaired work ability, Joint swelling, Leukopenia, Liver function test normal, Mononucleosis heterophile test negative, Parvovirus B19 serology positive, Polyarthritis, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus identification test, T-lymphocyte count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: Initial information received on 21 January 2009 from a health care professional. Upon receipt of follow-up information on 17 February 2009, it was determined this case meets seriousness criteria. A 49 year old female patient with a history of IGA deficiency and allergies to Amoxicillin, aspirin, Prozac, Morphine, Naproxen, Motrin, Sulfa and Intron received ADACEL (lot number not known) "two weeks prior". On 29 December 2008 the patient complained of pain and swelling in her joints including fingers, knees, elbows, wrists, and ankles. During a doctor''s visit (date not provided), the doctor stated that the patient had visible swelling in the proximal interphalangeal joint (PIP) joints, however no visible findings in other joints. The patient was not recovered at the time of the report. No further information was provided. Follow-up information received 23 January 2009 from a physician. According to the reporter, the patient had a similar, but worse reaction following treatment with Inferon which included urticaria. That episode required treatment with steroids and a progressive taper. The patient had a history of IgA deficiency with no demonstrated problems associated with that condition to date. Laboratory test results (date not reported) included Sed rate (15), C reactive protein, rheumatoid factor, ANA, and liver function panel which were normal. C3: 89 (ref 90-185) and C4: 4 (ref 19-55). Lyme antibody, monospot, ASO titers and culture were negative. Hepatitis profile was consistent with prior vaccination and parvovirus serology was consistent with past infection. CBC results indicated mild leukopenia at 3000, otherwise normal, no anemia. The poly arthritis interfered with the patient''s ability to work and at the time of the report, the physician indicated a diagnosis had not been determined. Corrective treatments were not reported. At the time of the report, the patient had not recovered from the event. Follow-up information received 17 February 2009 from a physician. The similar type reaction previously refere

VAERS ID:341072 (history)  Vaccinated:2009-01-30
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-04
Location:Illinois  Entered:2009-03-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: no adverse reaction. Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.

VAERS ID:341158 (history)  Vaccinated:2008-12-30
Age:49.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-02-27, Days after onset: 58
Location:North Carolina  Entered:2009-03-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0866X0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB252AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA0IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Blister, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Came in today stating that the day after getting her shots she developed Blisters in her scalp and itchy rash on her body. She did not seek medical attention and used Benadryl and Hydrocortisone. Rash left several days.

VAERS ID:341168 (history)  Vaccinated:2009-03-02
Age:49.0  Onset:2009-03-03, Days after vaccination: 1
Gender:Female  Submitted:2009-03-05, Days after onset: 2
Location:North Carolina  Entered:2009-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 1. Albuterol, two puffs every 4-6 hours as needed for wheezing. 2. Bupropion sustained release 150 mg, one tablet twice a day for depression. 3. Candesartan (Atacand) 4 mg, one tablet daily for hypertension. 4. Cetrizine 10 mg, on
Current Illness: cold, cough
Preexisting Conditions: HTN, asthma, HL, Seasonal rhinitis, depression, degenerative arthritis of knee, NKDA,
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1332X IM 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 49 yo WF was given IM Pneumovax in left detoid on 3/2/09 at clinic visit for cough and sore throat. RN reported using one inch 25 gauge needle and proper technique. Pt voiced no concerns at the time the injection was given but developed fever and redness, swelling, and pain in the left arm on 3/3/09. Pt treated self with Tylenol alternating with Motrin every 4 hours. Returned to clinic 3/5 f/u. On assessment, pt''s L upper arm from a couple of inches above the elbow up to the shoulder was red, swollen, warm to touch and painful. Temp 98.8. Augmentin 875/125 PO bid for 10 days prescribed. Pt will f/u in clinic in 6 days.

VAERS ID:341734 (history)  Vaccinated:2009-02-06
Age:49.0  Onset:2009-02-13, Days after vaccination: 7
Gender:Female  Submitted:2009-03-13, Days after onset: 27
Location:Michigan  Entered:2009-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2768AA IMRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB703AA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB275AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: One week after immunization she noticed a raised, red area (slightly bigger than a silver dollar) on her right deltoid. Broke out in "little bumps" around this area. Also reports area hot to touch and itched really bad.

VAERS ID:343193 (history)  Vaccinated:2008-09-03
Age:49.0  Onset:2008-09-03, Days after vaccination: 0
Gender:Female  Submitted:2009-03-06, Days after onset: 184
Location:New Jersey  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN; ADVAIR DISKUS; LEVOTHYROXINE SODIUM
Current Illness: Thyroid papillary carcinoma; Asthma; Drug hypersensitivity
Preexisting Conditions: Renal cyst
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04880
Vaccination
Manufacturer
Lot
Dose
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Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0475X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 49 year old female with thyroid papillary carcinoma, asthma and drug hypersensitivity to procaine and a history of renal cyst who on 25-JUL-2008 was vaccinated with RECOMBIVAX HB. Concomitant therapy included levothyroxine Na, LEXAPRO, WELLBUTRIN, and ADVAIR DISKUS. On 03-SEP-2008 the patient was vaccinated with a second dose of RECOMBIVAX HB (lot # 659670/0475X) and developed redness, pain, swelling and itching on her left arm at the injection site a few days after receiving her second dose of RECOMBIVAX HB. Medical attention was sought. The patient was diagnosed with a sterile abscess at the injection site. No other information was available. Additional information has been requested.

VAERS ID:342797 (history)  Vaccinated:2009-03-24
Age:49.0  Onset:2009-03-24, Days after vaccination: 0
Gender:Female  Submitted:2009-03-25, Days after onset: 1
Location:Pennsylvania  Entered:2009-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Diabetes; Hypertension; Chronic airway obstruction PMH: ASCAD, DOE, chest pain; aortic stenosis; DM; HTN; hyperlipidemia; obstructive sleep apnea; herniated disks; GERD; COPD. Recent ex-smoker. Allergy: PCN, tetanus, tetracycline & now pneumovax.
Diagnostic Lab Data: LABS: CXR WNL. EKG w/incomplete right BBB. Cardiac enzymes neg. CMP WNL. WBC 10.5
CDC Split Type:
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1441X IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Bundle branch block right, Cardiac enzymes normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram abnormal, Hypersensitivity, Metabolic function test normal, Palpitations, Pruritus, Throat tightness, Urticaria, Vaccination complication, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Within 10min of getting the shot, pt had hives, chest pain, difficulty breathing, had called 911, pt admitted to hosp. 4/6/09 Received hospital medical records of 3/24-3/25/2009. FINAL DX: dyspnea, chest pain, likely allergic reaction to pneumovax. Records reveal patient experienced chest pain, hives, itching, throat tightness, heart racing. Tx w/IV antihistamine, SL NTG improved. Cardio consult done.

VAERS ID:343077 (history)  Vaccinated:2009-03-17
Age:49.0  Onset:2009-03-17, Days after vaccination: 0
Gender:Female  Submitted:2009-03-31, Days after onset: 14
Location:Texas  Entered:2009-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: COPD; Mitral valve prolapse
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1162X0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Cellulitis to left arm. Running temperature started evening after vaccine. Started on Ax on 3-20-09.

VAERS ID:343710 (history)  Vaccinated:2007-10-23
Age:49.0  Onset:2007-10-25, Days after vaccination: 2
Gender:Female  Submitted:2008-10-24, Days after onset: 365
Location:Nebraska  Entered:2009-04-08, Days after submission: 166
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit B-12 injection
Current Illness: Environmental allergies
Preexisting Conditions:
Diagnostic Lab Data: Etiology of allergic reaction unclear.
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Angioedema, Enlarged uvula, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Angloedema & swelling of uvula.

VAERS ID:343790 (history)  Vaccinated:2003-10-01
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Missouri  Entered:2009-04-09
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Influenza (no brand name)~UN~0~Patient
Other Medications: AVAPRO; Insulin; EXTRADIOL; ALLEGRA D
Current Illness: cracked rib happen after four or five days later
Preexisting Conditions: Brice Windsor PMH: IDDM, asthma, URI, ganglion cyst, diabetic neuropathy, DKA & hypoglycemia, on HRT, cystitis, seasonal allergies, allergic rhinitis, GERD, endometriosis, HTN, hyperlipidemia, stress IBS, cellulitis, candidiasis intertrigo, strep throat, lumbago, atherosclerosis, obesity, Vit D deficiency, . Homeless & family stressors. Family Hx: CAD, DM, cancer.
Diagnostic Lab Data: Test CT-CT abdomen Oct. 17-2006 w/wo LABS:breast biopsy c/w cancer
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Arthropathy, Biopsy breast abnormal, Breast cancer, Breast cancer in situ, Chemotherapy, Computerised tomogram, Pain, Radiotherapy, Rib fracture, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Malignant tumours (narrow), Breast malignant tumours (narrow), Breast tumours of unspecified malignancy (broad), Arthritis (broad)
Write-up: When the rib cracked went to doctor. She prescribed pain pills, week later it went popped again. Years went by without problems, breast cancer showed up 2007. Went for chemo-radiation treatment. The rib acted up and has ever since. 4/29/09 Received PCP medical records of 9/2003-3/2009. FINAL DX: Type II DM; HTN; hyperlipidemia; hypothyroidism; right breast ductal carcinoma in situ stage 1; arthropathy Records reveal patient stated in 9/07 breast cancer was very small, surgically removed & no chemo or rad tx needed then started chemo 10/07.

VAERS ID:344242 (history)  Vaccinated:2009-04-10
Age:49.0  Onset:2009-04-14, Days after vaccination: 4
Gender:Female  Submitted:2009-04-15, Days after onset: 1
Location:Illinois  Entered:2009-04-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
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IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA11090SCUN
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives around neck, hairline and bilateral ears.

VAERS ID:345241 (history)  Vaccinated:2009-03-02
Age:49.0  Onset:2009-03-02, Days after vaccination: 0
Gender:Female  Submitted:2009-04-14, Days after onset: 42
Location:Unknown  Entered:2009-04-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; PRILOSEC; vitamins (unspecified)
Current Illness: Hypothyroidism; Gastroesophageal reflux disease
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0903USA01457
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pain, Swelling, Wrong drug administered
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a nurse practitioner (N.P.) concerning a 49 year old female with hypothyroidism and gastroesophageal reflux disease who on 2-MAR-2009 was inadvertently vaccinated IM with a 0.5 ml first dose of GARDASIL (lot # not reported) due to human error. It was reported that the patient was supposed to received a tetanus toxoid vaccination. There was no product confusion involved. Concomitant therapy included omeprazole (MSD), SYNTHROID and vitamins (unspecified). On 3-MAR-2009 the patient experienced pain and swelling in armpit after the vaccination. The patient sought medical attention at the practice. No lab test performed. As of 9-MAR-2009 the patient was recovering. Additional information has been requested,

VAERS ID:344439 (history)  Vaccinated:2009-04-17
Age:49.0  Onset:2009-04-18, Days after vaccination: 1
Gender:Female  Submitted:2009-04-20, Days after onset: 2
Location:Louisiana  Entered:2009-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen 400 mg BID
Current Illness:
Preexisting Conditions: Allergies: Latex, Vibramycin, Bananas, Strawberries, Nectarines Diagnosed with Plantar Fasciitis in heel 4/16/09.
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Headache, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Was aware of soreness in arm 4/18/09 while performing routine housework. Noticed red, swollen, warm 3 in X 3 in area 3-4 inches below injection site late pm of 4/18. Also reports slight headache since pm of 4/17.

VAERS ID:345344 (history)  Vaccinated:2009-02-18
Age:49.0  Onset:2009-02-18, Days after vaccination: 0
Gender:Female  Submitted:2009-04-27, Days after onset: 67
Location:South Carolina  Entered:2009-04-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None done at this time
CDC Split Type:
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TDAP: TDAP (ADACEL)SANOFI PASTEURUF457CA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Injection site erythema, Local reaction, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: C/o chest pain, local reaction seen in office 2/25/09 T97.7 P75 R16 Erythema at injection site rest of exam normal, BP 124 / 76 Wt 215 lbs, 4/7/09 still having arm pain (per phone conversation).

VAERS ID:346067 (history)  Vaccinated:2009-01-13
Age:49.0  Onset:2009-01-15, Days after vaccination: 2
Gender:Female  Submitted:2009-02-09, Days after onset: 25
Location:Indiana  Entered:2009-05-04, Days after submission: 83
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOCOR; ibuprofen; BENADRYL
Current Illness: None
Preexisting Conditions: The patient has a medical condition of hyperlipidemia for which she takes ZOCOR.
Diagnostic Lab Data: None
CDC Split Type: 200900244
Vaccination
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Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2032CA  LA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: A 49-year-old female patient, who has medical condition of hyperlipidemia for which she takes ZOCOR, had received a left deltoid booster dose of DECAVAC (lot number U2032CA) on 13 January 2009. two days post vaccination; the patient experienced swelling of the entire left arm and has joint pain. The patient was evaluated by a physician and prescribed ibuprofen and over the counter BENADRYL. No relevant diagnostic testes or laboratory data were performed. The patient recovered three to five days after onset of the adverse events. Follow-up information received 09 February 2009 from a health care professional who confirmed the patient had no illness at the time of vaccination. No additional information was provided at the time of the report. Documents held by sender: None. The reporter for this case is the same as for case 2009-00245.

VAERS ID:346361 (history)  Vaccinated:2009-05-12
Age:49.0  Onset:2009-05-13, Days after vaccination: 1
Gender:Female  Submitted:2009-05-12, Days after onset: 1
Location:New York  Entered:2009-05-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1435X IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2997AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt has rash left arm, swelling, no fever or vomit. Pt was seen today Doctor 5-22-09.

VAERS ID:347412 (history)  Vaccinated:2008-09-11
Age:49.0  Onset:2008-09-11, Days after vaccination: 0
Gender:Female  Submitted:2009-05-15, Days after onset: 246
Location:Arizona  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension
Preexisting Conditions:
Diagnostic Lab Data: complete blood cell 11/07/08 - within normal limit; blood chemistry 11/07/08 - within normal limit; serum C-reactive protein 11/07/08 - within normal limit; serum ANA 11/07/08 - within normal limit; serum VARICELLA ZOSTER 11/07/08 1.42 - ;
CDC Split Type: WAES0812USA00536
Vaccination
Manufacturer
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VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1024U1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Antinuclear antibody negative, Blood pressure increased, C-reactive protein normal, Ear pain, Full blood count normal, Heart rate increased, Injection site induration, Injection site pain, Injection site warmth, Laboratory test normal, Lymphadenopathy, Palpitations, Tachypnoea, Varicella zoster virus serology positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from nurse practitioner concerning a 49 year old female patient with hypertension who on 11-SEP-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # 658412/1024U). On 12-SEP-2008 the patient experienced general lymphadenopathy. The nurse practitioner reported that the patient received the same vaccine several years ago in another state but a recent titer was negative. The patient was given a course of an unspecified antibiotic and recovered. The patient sought unspecified medical attention. Follow up information was received from the nurse practitioner reported that the patient was a Caucasian registered nurse who on 11-SEP-2008 at 12:30 PM was vaccinated in her left upper arm with a second dose of VARIVAX (Oka/Merck) (lot # 658412/1024U). After receiving the vaccine, at 12:45 PM, the patient began feeling "hot" in mid sternum, neck and ears, heart rate increased to 115-120, palpitations, blood pressure increased and tachypnea. The following day, the patient''s lymph nodes in neck were swollen on left side, her left ear was painful. The injection site was hot, tender with 4 cm area of induration. On 07-NOV-2008 complete blood cell count, blood chemistry test, serum C-reactive protein test and serum antinuclear antibodies test were performed and the results were within normal limit. VARICELLA titer results were received on 26-JAN-2009 as 0.97 = equivocal. It was reported that a previous titer was positive on 07-NOV-2008 (1.42). At the time of the report. all the events recovered except the blood pressure remained elevated. Additional information has been requested.

VAERS ID:347063 (history)  Vaccinated:2009-05-19
Age:49.0  Onset:2009-05-20, Days after vaccination: 1
Gender:Female  Submitted:2009-05-21, Days after onset: 1
Location:North Carolina  Entered:2009-05-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; HCTZ 10/12.5 ml qd; TYLENOL Sinus PRN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF456CA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pitting oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Left arm red, swollen at sight of injection reports swelling under left arm since 5-20-09. 6 X 8 cm area; redness, heat to LUE @ injection site; pocket of pitting edema left axilla

VAERS ID:347545 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-27
Location:California  Entered:2009-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: blood tests - endocrinologist and gynecologist, several visits to dermatologists - had cortisone shots in temples
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN2IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Alopecia, Blood test
SMQs:
Write-up: Severe Hair loss (alopecia) around temples (around ear area, mainly in front) and some hair loss around hair line and crown. Has happened the last 3 years in October-November after administration of the Influenza vaccine (first vaccine in 2006). Noticeable loss each year starting approximately 30 days after administration of vaccines.

VAERS ID:348348 (history)  Vaccinated:2008-12-09
Age:49.0  Onset:2008-12-10, Days after vaccination: 1
Gender:Female  Submitted:2009-02-05, Days after onset: 57
Location:California  Entered:2009-06-02, Days after submission: 116
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA178AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient woke up the next day with raised, itchy rash all over body except on face, chest and upper trunk. Took OTC medicines and rash lasted 3 weeks. Reported to PMD and called today 6/2/09 for Lot number and Manufacturer. Patient has history of allergic reactions to many things but she attributes the rash to Influenza Vaccine received on 12/9/08.

VAERS ID:348456 (history)  Vaccinated:2009-04-21
Age:49.0  Onset:2009-04-21, Days after vaccination: 0
Gender:Female  Submitted:2009-06-03, Days after onset: 43
Location:Georgia  Entered:2009-06-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA03633
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1435X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial information has been received from a nurse and follow up information from a medical assistant who reported that a 49 year old female was on 20-APR-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot #662667/1435X), 0.5 ml. On approximately 20-APR-2009 the patient experienced pain, redness, warmth on the injection site and the injection site was tender to the touch. She sought unspecified medical attention. The medical assistant reported that she did not know the patient''s status as she had not kept her appointment. Follow up information received on 01-JUN-2009 from a medical assistant stated that a manager had no illness at the time of vaccination, and on 21-APR-2009 (not 20-APR-2009 as previously reported) at 12:22 was vaccinated with the first dose of PNEUMOVAX 23 (lot 662667/1435X), intramuscularly into the left deltoid. On the same date the patient developed severe swelling, warmth and erythema (patient reported). No laboratories studies performed. In follow up, the medical assistant reported that the severe swelling, warmth and erythema resulted in persistent or significant disability/incapacity. The patient''s outcome was unknown. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.

VAERS ID:348497 (history)  Vaccinated:2009-06-04
Age:49.0  Onset:2009-06-04, Days after vaccination: 0
Gender:Male  Submitted:2009-06-04, Days after onset: 0
Location:Oregon  Entered:2009-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)SANOFI PASTEURU2883AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chest discomfort, Dizziness, Feeling cold, Hyperhidrosis, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Pt received immunization 9:05 AM, pt went out to smoke a cigarette, 15 mins later started feeling dizzy and sweating. Pt went inside to sit, started to feel his chest constrict/tighten, resolved in 5 mins. Pt started to feel chilly, started to shake, feeling cold. Pt did say his teeth were chattering and felt cold during plasma donation previous to immunization. Pt recovered 10:08 AM

VAERS ID:348579 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2009-06-02
Location:Indiana  Entered:2009-06-05, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated

VAERS ID:348792 (history)  Vaccinated:2009-06-08
Age:49.0  Onset:2009-06-08, Days after vaccination: 0
Gender:Female  Submitted:2009-06-08, Days after onset: 0
Location:Arizona  Entered:2009-06-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to Pork, BENEDRYL, VALIUM, SULFA.
Diagnostic Lab Data: See by PCP 6/9/09 continues with symptoms Referred to neurology.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB703AA4IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypoaesthesia facial, Hypoaesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Employee given 5th HEP B today within 10 min of injection being given in (R)D. Employee noted back teeth became numb on both sides upper & lower, as if given novocaine @ the dentist office. Numbness traveled to (R) cheek, sinus & eyelid. No visible drooping to (R) side.

VAERS ID:349266 (history)  Vaccinated:2009-06-02
Age:49.0  Onset:2009-06-03, Days after vaccination: 1
Gender:Male  Submitted:2009-06-03, Days after onset: 0
Location:Missouri  Entered:2009-06-16, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PCN
Diagnostic Lab Data:
CDC Split Type: MO-2009-13
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURSPC3098AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: 6/03/09 1:10 p.m. - phone call from cl reporting he woke up at 3 a.m. this morning with severe muscle and joint pain in shoulders, elbows and hips. Encouraged to call HCP - 6-14-09 8:30 a.m. - phone call from cl reporting less soreness this am adn feelling better

VAERS ID:349408 (history)  Vaccinated:2009-01-12
Age:49.0  Onset:2009-02-01, Days after vaccination: 20
Gender:Female  Submitted:2009-06-17, Days after onset: 135
Location:Utah  Entered:2009-06-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Herpes zoster, Skin burning sensation, Skin discolouration
SMQs:, Peripheral neuropathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: I received my Zostavax DS PWD #1 ON jANUARY 12, 2009. I feel fine 95% of the time. The other 5% my shingles are on fire. Kind of like a hot poker on my skin. I got the Shingles vaccine on Jan 12, 2009 on a trip. Within a week or so I had a little spot of discoloration on my foot. No pain no bump. I didn''t pay it much attention. The spot had not changed in a month. The spot remained on my foot, still no pain or bump. However over the last 4 or 5 weeks the spot became a bump and the bump became several bumps. I saw my doctor and he put me on the Rx Keflex which didn''t really help the spots and bumps. Then this past Sunday June 14,2009, I had different type of spots appear on the same foot. On June 16, 2009 I had an appointment with my doctor for an unrelated matter and with the new spot pattern he diagnosed me with Shingles. On June 16, 2009 started on an antiviral medication Valtrex tab 1GM.

VAERS ID:349770 (history)  Vaccinated:2007-11-19
Age:49.0  Onset:2007-12-29, Days after vaccination: 40
Gender:Female  Submitted:2009-05-28, Days after onset: 515
Location:Unknown  Entered:2009-06-17, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0902USA04490
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dysfunctional uterine bleeding, Gastrointestinal disorder, Menstruation irregular, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (narrow)
Write-up: Information has been received regarding a case in litigation concerning a 49 year old female who on 19-Nov-2007 was vaccinated with first dose of hepatitis A virus vaccine inactivated and experienced pain, irregular bleeding and menstrual irregularities. The patient went to see a gynecologist on 28-Jan-2008 and reported having these symptoms the past four weeks (approximately 29-Dec-2008). The patient was diagnosed with dysfunctional uterine bleeding. The patient also experienced unspecified gastrointestinal symptoms (onset date unknown). At the time of report the patient had not recovered from the events. Additional information has been requested.

VAERS ID:349660 (history)  Vaccinated:2005-10-27
Age:49.0  Onset:2005-10-29, Days after vaccination: 2
Gender:Male  Submitted:2009-06-18, Days after onset: 1328
Location:West Virginia  Entered:2009-06-22, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history included multiple seasonal allergies.
Diagnostic Lab Data:
CDC Split Type: 200902505
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1753A UNUN
Administered by: Military     Purchased by: Other
Symptoms: Cardiac monitoring, Feeling of body temperature change, Malignant hypertension, Tachycardia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Hearing impairment (narrow)
Write-up: This case was received from a health professional on 09 June 2009. A 49-year-old male patient, with a history of seasonal allergies, received an injection of FLUZONE SV ''2005-''2006 USP (lot number U1753AA) on 27 October 2005. Two days post-vaccination, on 29 October 2005, he experienced malignant hypertension, tachycardia, "hot and cold" sensations, and ringing in the ears. He was treated with three courses of prednisone, and underwent a full cardiac work-up (results not provided). The "hot and cold" sensation and ringing in the ears remained ongoing. Of note, the patient had also received a flu vaccine (manufacturer and lot number not reported) in January 2005. In addition, this reporter noted that the patient''s sister also experienced a similar event after receiving FLUZONE (lot number U1846AA) in 2005. That event is captured in case number 2009-02506.

VAERS ID:349723 (history)  Vaccinated:2008-10-21
Age:49.0  Onset:2008-10-21, Days after vaccination: 0
Gender:Male  Submitted:2009-06-13, Days after onset: 235
Location:Unknown  Entered:2009-06-22, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Mild allergy to Indocin - slight rash
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Dysphagia, Swelling, Tenderness, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Within 15-20" minutes of vaccines my throat was scratchy. This progressed to swelling & severe tenderness of lower, external neck X 1wk. Hard to swallow.

VAERS ID:349854 (history)  Vaccinated:2006-09-08
Age:49.0  Onset:2006-09-08, Days after vaccination: 0
Gender:Female  Submitted:2009-06-23, Days after onset: 1019
Location:Texas  Entered:2009-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to sodium pentathol
Diagnostic Lab Data: MRI of Left/Right Shoulder (Note: MRI was not of the bicep muscle which was where the pain was); EMG of Left/Right arms; Brain MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERU1786BA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Antinuclear antibody increased, Electromyogram, Muscle spasms, Muscular weakness, Myalgia, Nausea, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain, Periarthritis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow)
Write-up: I attributed the initial left bicep muscle aches to a common reaction to injections; however deep throbbing and aching in left bicep continued; and eventually my left bicep was hard and rigid; the muscle would spasm uncontrollably and with the least amount of movement of the arm. The spasms felt as if an electrical impulse was being sent through my arm; during the spasms I became extremely nauseous; I often walked as if I had had too much alcohol to drink, only thing, I don''t drink alcohol. I was unable to lift my arm which caused doctors to believe I had a rotator cuff tear - tested NEGATIVE. I was told I had frozen shoulder because I couldn''t move my arm, but the excruciating pain was not in my shoulder, it was in the bicep muscle. I contacted the health department for the state and was told that the nurse who administered the injection probably used an incorrect size needle and that was most likely causing my problem. When I experienced the muscle spasm, I could not move my arm in any direction, it was as if my arm was locked in the position it was in when the spasm started. I couldn''t lie on the left side of my body due to the excruciating pain. In late December 2007, the pain and muscle spasms became bilateral and transferred to the right bicep muscle. I then experienced the same pain, throbbing, and muscle spasms in the right arm, eventually unable to move or lift the right arm. I had a high ANA count which caused doctors to believe I had an autoimmune disease - I have been tested for several - all negative. I experienced the pain from the onset, however I believed others that the nurse stuck a nerve that I waited until 5 months after the symptoms began before bringing it to the attention of the doctor''s office that administered the injection, only to be told that I didn''t have a a reaction to the injection, that I was most likely ill or getting ill at the time I got the vaccine. Recently within the last month (May 2009) I no longer have the muscle spasms and can now lift my arms, however I do have considerable muscle weakness in both arms, but the right arm is displaying a greater weakness over the left arm. It is difficult lifting many things, even pillows off the bed. In item #8, I checked "required emergency room/doctor visit. I did not go to the emergency room, but have visited 3 MDs (General/Family Practice); 2 neurologists; 2 orthopedic surgeons; 1 Rheumatologist.

VAERS ID:350133 (history)  Vaccinated:2009-06-02
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-25
Location:Oregon  Entered:2009-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0153Y SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Lump at injection site, feels tender and is somewhat reddened but not warm or infected feeling.

VAERS ID:350255 (history)  Vaccinated:2008-10-09
Age:49.0  Onset:2008-10-10, Days after vaccination: 1
Gender:Female  Submitted:2009-06-22, Days after onset: 255
Location:Rhode Island  Entered:2009-06-26, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CADUET and ZANTAC
Current Illness: None
Preexisting Conditions: Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA364AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Pain in extremity
SMQs:
Write-up: Persistent pain in left arm after receiving flu shot.

VAERS ID:350425 (history)  Vaccinated:2009-06-22
Age:49.0  Onset:2009-06-24, Days after vaccination: 2
Gender:Female  Submitted:2009-06-26, Days after onset: 2
Location:North Dakota  Entered:2009-06-29, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None - was given CEPHAXRIN on 6/26/09 06/29/09 - less redness & swelling
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3031AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Mass, Pain, Pruritus, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness & swelling size - began 50 cent size - painful, itching enlarged - redness area warm to touch about 2 days - decreased grade fever aching - hard lump size of 50 cent

VAERS ID:350557 (history)  Vaccinated:2009-05-12
Age:49.0  Onset:2009-05-22, Days after vaccination: 10
Gender:Female  Submitted:2009-06-30, Days after onset: 39
Location:North Carolina  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: NONE
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHAB140AA2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient states that Right arm became swollen and painful, then began to hurt deep inside the muscle from the injection site to the wrist, patient still has pain in her right arm when she lifts the arm above her shoulder. Patient also states that a bruise developed one month after receiving the shot. On physical exam today, injection site is WNL. Not painful to touch. Recommend patient follow up with primary care physician at next appointment. Patient has appointment 07/14/2009.

VAERS ID:350578 (history)  Vaccinated:2009-06-22
Age:49.0  Onset:2009-06-24, Days after vaccination: 2
Gender:Female  Submitted:2009-06-30, Days after onset: 6
Location:Kentucky  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1117X IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3158AA IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling and redness of right arm.

VAERS ID:350718 (history)  Vaccinated:2009-06-24
Age:49.0  Onset:2009-06-26, Days after vaccination: 2
Gender:Female  Submitted:2009-07-01, Days after onset: 5
Location:Pennsylvania  Entered:2009-07-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Hyperlipidemia; PAM; Sleep apnea
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3030AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Induration, Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema, edema, tenderness at injection site, sm area of induration.

VAERS ID:351080 (history)  Vaccinated:2009-07-01
Age:49.0  Onset:2009-07-04, Days after vaccination: 3
Gender:Female  Submitted:2009-07-09, Days after onset: 5
Location:New Jersey  Entered:2009-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: none
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF630AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Nausea, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Received yellow fever vaccine on 7/1/09 no complications. 7/4/09 c/o: nausea, vomiting, severe stomach ache, diarrhea, low grade fever and flat rash to torso, no itching. Lasted about 2 1/2 hours, redness at injection site.

VAERS ID:351885 (history)  Vaccinated:2009-01-01
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-21
Location:Massachusetts  Entered:2009-07-14, Days after submission: 115
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of hypothyroidism and an allergy to antibiotics. The patient had a history of pertussis (whooping cough) approximately one and a half years ago. The patient received ADACEL due to a cut on her let finger which required sutures at the time of vaccination. The patient has had multiple "tetanus only" boosters in the past, "none ever caused this type reaction". The patient had
Diagnostic Lab Data: not reported. From information received 19 March 2009, no testing performed for the event; only routine lab work for TSH.
CDC Split Type: 200900841
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNRA
Administered by: Private     Purchased by: Other
Symptoms: Blood thyroid stimulating hormone, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This non serious case was received on 03 March 2009 from a consumer. A 49 year old female patient received a first time dose of ADACEL (lot not reported) in the right deltoid on 04 January 2009. On 05 January 2009 the patient developed a red, hard lump at the injection site 4 inches in diameter which lasted for 2 weeks. Currently she has a dime size hard lump under the skin at the injection site. She went to the doctor''s office multiple times with no relief. No further information was provided. Follow-up information was provided. Follow-up information received 19 March 2009 from a consumer. The patient received ADACEL due to a cut on her left finger which required sutures at the time of vaccination. She had not received any other vaccines within four weeks of ADACEL. The patient continued to have right upper arm ache/pain everyday and had been taking over the counter pain relief. No laboratory and diagnostic testing had been performed. The patient reported the event to multiple providers including the hospital were ADACEL was administered, when seen for follow-up for a respiratory illness; when sutures were removed; when she had her blood drawn and during an orthopedic appointment for an unrelated knee injury. According to the patient, she received multiple "tetanus only" boosters in the past and "none ever caused this type of reaction". She also reported that she had a past history of Pertussis "whooping cough" approximately one and a half years prior. No further information was provided. The reporter for this is the same as for case numbers 2009-01149 and 2009-01150. List of documents held by sender: none.

VAERS ID:351558 (history)  Vaccinated:2009-06-22
Age:49.0  Onset:2009-06-23, Days after vaccination: 1
Gender:Female  Submitted:2009-06-30, Days after onset: 7
Location:Unknown  Entered:2009-07-16, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COZAAR
Current Illness: None
Preexisting Conditions: Hypertension
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37BO39AH IMRA
Administered by: Other     Purchased by: Public
Symptoms: Back pain, Diarrhoea, Headache, Injection site pain, Myalgia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Migratory skin rash, diarrhea, soreness @ inj. site, headache, back pain, myalgia.

VAERS ID:351934 (history)  Vaccinated:2009-07-02
Age:49.0  Onset:2009-07-02, Days after vaccination: 0
Gender:Male  Submitted:2009-07-15, Days after onset: 13
Location:California  Entered:2009-07-20, Days after submission: 5
Life Threatening? No
Died? Yes
   Date died: 2009-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
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Dose
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Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0424Y SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B040AB IMLA
Administered by: Public     Purchased by: Public
Symptoms: Autopsy, Coronary artery disease, Death
SMQs:, Other ischaemic heart disease (narrow)
Write-up: Per translator client died 2 to 3 hrs. after receiving vaccines on 7/2/09. Autopsy is pending to determine cause of death. Due to language barrier unable to get more information.7/21/09-Nancy with Med Exam office called with preliminary COD: Coronary Artery Disease with no other significant conditions contributing to death. 8/13/09 Cause of Death: Coronary artery disease. Manner of death: Natural. Autopsy report summary of findings: I. Atherosclerotic cardiovascular disease. A. Calcific coronary artery disease, marked, involving three major vessels and left main. B. Aortic atherosclerosis, mild to moderate. II. Nephrosclerosis. III. Right rib fractures consistent with resuscitation efforts.

VAERS ID:352626 (history)  Vaccinated:2009-07-20
Age:49.0  Onset:2009-07-20, Days after vaccination: 0
Gender:Female  Submitted:2009-07-28, Days after onset: 8
Location:New York  Entered:2009-07-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol 325 mg as needed every four hours
Current Illness: None
Preexisting Conditions: Hypertension, Hepatitis C
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1148U1IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB285AB0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0856U0IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Anorexia, Headache, Injection site pain, Injection site swelling, Lethargy, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain, swelling at site of injection on Rt. upper arm, lethargy, nausea , fever,body aches and pains, vomiting, loss of appetite,headache.

VAERS ID:353046 (history)  Vaccinated:2009-03-27
Age:49.0  Onset:2009-03-27, Days after vaccination: 0
Gender:Male  Submitted:2009-08-03, Days after onset: 129
Location:North Carolina  Entered:2009-08-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; Around age 6, pt was hospitalized x2 for pneumonia; 1987, S/P splenectomy after traumatic injury; Latent TB - positive PPD converter in March 2009 (not recorded as positive). Positive Quantiferon gold in April 2009; Hx of travel abroad during summer of 2008 with hx of last prior negative PPD in 2007 post-deployment. After VACCINE: Taking 4-month course of RIFAMPIN, with follow up at clinic. Extensive evaluation for TB while hospitalized in Apr 2009, with all specimens AFB negative; Bilateral, intermittent tinnitus started around 2004. 8/24/09 Hospital records received DOS 4/21/09 to 4/24/09. Alcohol use.
Diagnostic Lab Data: 18 Apr 2009, Glucose, 133; BUN/Cr, 23/1.1; Na+, 147; K+, 4.3; Cl-, 106; CO2, 22; Anion Gap, 22.3; Ca++, 10.3; CBC, WBC, 14.6; RBC, 4.7; Hgb, 15.4; Hct, 44.6; MCV, 95; MCHC, 32.7; Plt, 473; Neut, 66.9%; Lymph, 21.5%; Mono, 10.4; Eos, 0.6%; Baso, 0.6%; Neut, 9.8; Lymph, 3.1; Mono, 1.5; Eos, 0.1; 18 Apr 2009, Glu, 120; BU/Cr, 24/1.15; eGFR, $g59mL/min; Na+, 146; K+, 4.3; Cl-, 103; CO2, 26; Ca, 8.6; Protein, total serum, 3.9; Albumin, serum, 3.9; Bil, total, 0.5; Alk phosph, 58; AST, 25; ALT, 16; AFB Culture and smear, broth; Fluorescent smear: no ABB observed on smear. Culture results to follow. Fungus (mycology) culture: Culture initiated. Lower Respiratory Culture: Rout resp flora. Scant growth (Final report); MTHFR, DNA Analysis: Two copies
CDC Split Type:
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Dose
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ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTH 2IMLA
Administered by: Military     Purchased by: Military
Symptoms: Acid fast stain negative, Activities of daily living impaired, Alanine aminotransferase normal, Anion gap decreased, Anion gap increased, Arthralgia, Aspartate aminotransferase normal, Asthenia, Bacterial culture negative, Bacterial culture positive, Basophil count normal, Basophil percentage, Bed rest, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium increased, Blood urea increased, Carbon dioxide decreased, Carbon dioxide increased, Computerised tomogram abnormal, Condition aggravated, Cough, Crepitations, Culture positive, DNA antibody, Dehydration, Diarrhoea, Discomfort, Dysphonia, Dyspnoea, Eosinophil count normal, Eosinophil percentage decreased, Eye pain, Feeling hot, Full blood count, Fungus culture, Haematocrit normal, Haemoglobin normal, Headache, Herpes simplex serology positive, Hypophagia, Inguinal hernia, Latent tuberculosis, Leukoplakia oral, Lymphadenopathy, Lymphocyte count increased, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell volume normal, Monocyte count increased, Monocyte percentage increased, Myalgia, Neutrophil count increased, Night sweats, Oral candidiasis, Oral pustule, Oropharyngeal pain, Pain, Pharyngeal erythema, Pharyngeal leukoplakia, Pharyngitis, Platelet count increased, Protein total decreased, Protein urine present, Pulmonary congestion, Pyrexia, Red blood cell count decreased, Rhinorrhoea, Sinusitis, Sleep disorder, Specific gravity urine increased, Sputum abnormal, Throat irritation, Tonsillar disorder, Tuberculin test positive, Urine output decreased, Vomiting, Weight decreased, White blood cell count increased, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Parkinson-like events (broad), Oropharyngeal neoplasms (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow)
Write-up: Pt received his 3rd AVA booster on 27 March 2009. Within 8 hours of vaccine receipt, pt noted rhinorrhea. He denies any itching eyes, hives or rashes, difficulty breathing or angioedema. On 28 March, pt''s rhinorrhea continued and he also started feeling achy, feverish and was experiencing a nonproductive cough, fever-associated chills, and night sweats. On 29 March, pt''s cough worsened to the point it disrupted his sleep. He was also then experiencing constant arthralgias - "every joint ached"; he denies any redness, swelling or increased warmth over joints he reports joint pains resolved after 3-4 days. As a result of frequent coughing, his throat became irritated. On 28 March, pt contacted his PCM by phone and based on his symptom description, a course of CIPRO 500 mg BID was prescribed. Pt initiated the antibiotics on 2 April. On 3 April, pt''s temperature was running 101-102 (temperature taken in PCM''s office). His cough and sore throat continued to worsen. That evening, he was evaluated by his PCM and was told he had fluid in his lungs. He was treated with IV doxycycline and observed over a 48 hour period. He continued to take his oral CIPRO (He completed the 10 day course). Pt''s symptoms of fever, chills, night sweats, cough and sore throat continued to worsen through mid-April. Related to his coughing, around 12 April, pt also experienced hoarseness and vomiting. These symptoms continued through the end of April or early May. Due to his significant discomfort, he was getting very limited sleep. He had minimal oral intake due to his cough, sore throat and discomfort. He was on leave and was not able to perform his usually ADLs. He was essentially on bed rest. Around April 13th and 14th, pt experienced diarrhea x 2 days (3-4 brown, watery stools per day). He also experienced headaches which he attributed to dehydration secondary to minimal intake. The headaches were located behind the eyes an over both temples and described as pressure-type pain ("like a band around my head"). The headaches resolved within 1 week, after his oral intake increased. Pt also developed a left inguinal hernia and exacerbated an existing R) inguinal hernia due to intense coughing. On 14 April, pt phoned PCM describing his symptoms, and his PCM prescribed MUCINEX and LEVAQUIN for a presumed secondary throat infection. Pt initiated these medications on 15 April. On a follow up call to his PCM on 15 April, pt reported a lack of urine output. On 17 April, pt was evaluated by his PCM. At that time, he was weak, his temperature was 102, and he had experienced a 22 lb. weight loss over the past 2 weeks. He was told that his left lower lobe sounded "junky". Thrush was noted on his tongue, as well as white pustules were noted on his throat. Pt was treated with IV ROCEPHIN. On 18 April, pt was seen at ER where he had a CXR and was reported to have crackling in his lungs. He was given a referral to Infectious Disease but because he was military, was instead seen at clinic. On 20 April, pt was initially evaluated by Infectious Disease. By this time, pt''s cough was improving, but he continued to have a sore throat, night sweats, hoarseness, and fevers. A chest and neck CT showed nonspecific diffuse lymphadenopathy (no pulmonary involvement), prominent lingular tonsils, and acute left maxillary sinusitis. On 21 April, pt was admitted to clinic for evaluation of possible laryngeal tuberculosis. While hospitalized, pt had a biopsy of his posterior tongue and oral pharynx as well as cultures of his maxillary sinus per ENT. He remained off antibiotics during his hospitalization. After his biopsy, prophylactically placed on course of steroids for potential airway swelling. His subsequent labs showed a WBC elevation to 20, and pt continued running low-grade fevers (<101). On 5/6/09, pt followed up with Dr. who noted pt''s symptoms improving, but still had night sweats without significant fevers (<100). 8/24/09 Hospital records received DOS 4/21/09 to 4/24/09.

VAERS ID:353209 (history)  Vaccinated:2009-07-27
Age:49.0  Onset:2009-07-28, Days after vaccination: 1
Gender:Female  Submitted:2009-08-05, Days after onset: 8
Location:Illinois  Entered:2009-08-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benicar, levothyroxine, Lexapro
Current Illness:
Preexisting Conditions: erythromycin allergy, anxiety, hypertension, hypothyroidism, dyslipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3248AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: vomiting, diarrhea, fever of 102 x 2 days

VAERS ID:353357 (history)  Vaccinated:2008-11-03
Age:49.0  Onset:2008-11-03, Days after vaccination: 0
Gender:Female  Submitted:2009-07-30, Days after onset: 268
Location:Oregon  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: darbepoetin alfa
Current Illness: Anemia; Cancer; Asthma; Thrombocytopenia; Macrocytosis; Colitis ulcerative
Preexisting Conditions:
Diagnostic Lab Data: physical examination, mechanical purpura, upper extremity: erythema around the right biceps; tenderness; blood pressure, 144/9; hemoglobin, 11.1; hematocrit, 33.3
CDC Split Type: WAES0811USA01642
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IJRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0868X IMRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Haematocrit decreased, Haemoglobin decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Purpura
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a registered nurse concerning a 49 year old female patient with cancer and no drug reactions or allergies who on 03-NOV-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot # 661529/0868X). On 03-NOV-2008 the patient experienced cellulitis in the arm of administration. No lab diagnostics studies were performed. The patient was recovering from the cellulitis in the arm of administration. The patient sought medical attention via seen at the practice. Follow up information has been received concerning a 49 year old female patient with cancer, asthma, thrombocytopenia and macrocytosis who on 03-NOV-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot # 661529/0868X). Concomitant medication included influenza virus vaccine (unspecified) and darbepoetin. The illness at time of vaccination was multifactorial anemia thought to be related to her ulcerative colitis. On 03-NOV-2008 the patient developed the right upper biceps tenderness, erythema and swelling. She reported on right hand numbness nor tingling, but the tenderness was on the medial and axillary portion of her right upper arm. The patient denied shortness of breath, chest pain. She had no fevers, chills, night sweats, cough, cold, congestion or shortness of breath. Physical examination was performed, and the result showed that there was multilevel sites of mechanical purpura, the upper extremity had evidence of erythema running circumferential around the right biceps, and there was tenderness appreciated in the medical aspect deep portion of the right axilla in addition to the lateral aspect of the shoulder. The physician assessed that recent PNEUMOVAX and flu injection resulted in right upper extremity tenderness and swelling, and he could not rule out deep vein thrombosis (DVT) based on the patient''s physical exam. A Doppler will be ordered in addition will start AUGMENTIN. The physician also recommended the patient took BENADRYL, but the patient stated that caused profound anxiety. He would have the patient start anti

VAERS ID:353696 (history)  Vaccinated:2008-10-08
Age:49.0  Onset:2008-10-10, Days after vaccination: 2
Gender:Female  Submitted:2009-07-30, Days after onset: 293
Location:Texas  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness: PENICILLIN allergy; SULFONAMIDE allergy
Preexisting Conditions: Splenectomy
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA02028
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IJLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis
SMQs:
Write-up: Information has been received from a certified medical assistant concerning a 49 year old female with PENICILLIN and SULFONAMIDE allergies and a history of splenectomy who on an unspecified date was vaccinated with a first dose of PNEUMOVAX. (Lot # not reported). On 08-OCT-2008, the patient was vaccinated IM into the right arm with a second dose of 0.5 mL of PNEUMOVAX. (lot #659778/0024X given is for MMR). Concomitant therapy included influenza virus vaccine (unspecified) into the left arm, and hormonal contraceptives (unspecified). The medical assistant reported that on 10-OCT-2008 the patient was seen in the office and was diagnosed with cellulitis of her right arm at the injection site. At the time of the report, the cellulitis of her right arm at the injection site had not resolved. Additional information has been requested.

VAERS ID:353725 (history)  Vaccinated:2008-09-30
Age:49.0  Onset:2008-10-01, Days after vaccination: 1
Gender:Female  Submitted:2009-07-30, Days after onset: 302
Location:California  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBUTEROL; ADDERALL TABLETS; NECON; FLONASE; ADVAIR; SINGULAIR
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA00547
Vaccination
Manufacturer
Lot
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0619X SCUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: Information has been received from a physician concerning a 49 year old female with a history of asthma who on 30-SEP-2008 was given a 0.5ml dose of PNEUMOVAX (Lot # 660685/0619X) subcutaneously for vaccination. Concomitant therapy included ADVAIR, FLONASE, ADDERALL TABLETS, montelukast sodium (Merck) and NECON. On 01-OCT-2008 the patient developed severe cellulitis. The patient was seen in the physician''s office for a well check up and the cellulitis is described as being 6 inches in diameter. The patient not recovered from severe cellulitis at the time of report. Additional information has been requested.

VAERS ID:354105 (history)  Vaccinated:2008-11-11
Age:49.0  Onset:2008-11-11, Days after vaccination: 0
Gender:Female  Submitted:2009-07-30, Days after onset: 260
Location:Idaho  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunosupression
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811USA03556
Vaccination
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Lot
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Ecchymosis, Nausea, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse concerning a 49 year old female patient with immunosupression who on 11-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot # not provided) and was vaccinated on the same day and on the same arm with a dose of (FLUVIRIN). On 11-NOV-2008, six hour post vaccination, the patient experienced nausea, fever, vomiting, soreness of arm and a developed a 4 by 3 cm ecchymosis with no erythema in upper right arm. It was reported that the patient sought medical attention at a different clinic due to the reaction she was experiencing with the vaccination, and was told in the urgent care clinic that the PNEUMOVAX vaccine and the FLUVIRIN should have been given in different arms. Nurse reported that the patient might seek legal action against the physician''s office who gave the vaccinations. Additional information has been requested.

VAERS ID:354884 (history)  Vaccinated:2009-04-01
Age:49.0  Onset:2009-04-02, Days after vaccination: 1
Gender:Female  Submitted:2009-07-30, Days after onset: 119
Location:Connecticut  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma, Colitis
Diagnostic Lab Data:
CDC Split Type: WAES0906USA00104
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1679U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Limb discomfort, Musculoskeletal pain, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 49 years old female with asthma and colitis who on 01-Apr-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 via intramuscular administered at the left deltoid. Concomitant therapy included ADVAIR. There as no history drug reactions and allergies. On 02-Apr-2009, one day after receiving PNEUMOVAX 23 vaccine, the patient developed pain at the injection site of left upper arm. The patient was examined in the office on 22-Apr-2009 and was found to have pain on movement of the left arm but no edema, no swelling and no redness at the injection site. The patient was recommended to take Ibuprofen. The patient returned to the office on 29-May-2009 stating that the pain had persisted and radiated up to the left shoulder. The examination on revealed that the patient had full range of motion of the left arm but movement caused discomfort. An X-ray of the left arm was performed on 29-May-2009, and the result was negative. At time of reporting, the patient did not recover. Additional information has been requested.

VAERS ID:355596 (history)  Vaccinated:2008-11-20
Age:49.0  Onset:2008-11-20, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 139
Location:Missouri  Entered:2009-08-13, Days after submission: 126
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions: No medical history obtained.
Diagnostic Lab Data:
CDC Split Type: MEDI0007621
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500540P IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of expired FLUMIST given was received from a registered nurse concerning a 49 year-old female, It was discovered 21 days after dosing that the patient was given expired FLUMIST. The reporter indicated the FLUMIST expired at the beginning of the flu season. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.

VAERS ID:355958 (history)  Vaccinated:2009-02-24
Age:49.0  Onset:2009-02-24, Days after vaccination: 0
Gender:Male  Submitted:2009-05-12, Days after onset: 76
Location:New Jersey  Entered:2009-08-13, Days after submission: 93
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0008167
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500568P IN 
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:
Write-up: Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 49-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.

VAERS ID:355979 (history)  Vaccinated:2009-03-02
Age:49.0  Onset:2009-03-02, Days after vaccination: 0
Gender:Male  Submitted:2009-05-12, Days after onset: 70
Location:New Jersey  Entered:2009-08-13, Days after submission: 93
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0008190
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500568P IN 
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 49-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flue season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.

VAERS ID:354404 (history)  Vaccinated:2009-08-13
Age:49.0  Onset:2009-08-13, Days after vaccination: 0
Gender:Female  Submitted:2009-08-17, Days after onset: 4
Location:Florida  Entered:2009-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None given at clinic.
Current Illness: Patient denies
Preexisting Conditions: No drug allergies. Patient has medical conditions of hypothyroidism and fibromyalgia
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU2348BA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Fatigue, Head discomfort, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient states that she suffered from posterior headaches describes as heaviness, nausea, diarrhea, and fatigue. Thinks she may have had a low grade fever. The nausea and diarrhea resolved within a couple days. Headache ongoing, but improving.

VAERS ID:355212 (history)  Vaccinated:2009-08-14
Age:49.0  Onset:2009-08-15, Days after vaccination: 1
Gender:Female  Submitted:2009-08-25, Days after onset: 10
Location:Florida  Entered:2009-08-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes
Diagnostic Lab Data: Ultra sound venous doppler report, radiology, blood work incl: CBC, CMP, CPK.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0331Y1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Blood creatine phosphokinase, Bursitis, Full blood count, Metabolic function test, Oedema peripheral, Ultrasound Doppler, X-ray
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt''s left arm began to swell x 3 days after vaccination, reported to our worker''s comp advisor. At that time, she went to ER and dx as bursitis and sling was given and referred to ortho.

VAERS ID:355289 (history)  Vaccinated:2009-08-20
Age:49.0  Onset:2009-08-20, Days after vaccination: 0
Gender:Female  Submitted:2009-08-21, Days after onset: 1
Location:California  Entered:2009-08-25, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: diabetic
Preexisting Conditions: Diabetes (DMII); HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0611Y UNRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC3032AA UNLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure increased, Face oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow)
Write-up: Facial edema ("puffy eyelids"). Increased blood pressure.

VAERS ID:355674 (history)  Vaccinated:2009-08-18
Age:49.0  Onset:2009-08-19, Days after vaccination: 1
Gender:Female  Submitted:2009-08-20, Days after onset: 1
Location:Michigan  Entered:2009-08-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF551AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Report of muscle ache throughout entire body, extreme left arm pain; generalized joint pain & fatigue. Note: Had previous dose of Tdap 3/5/2009 (per mm registry).

VAERS ID:356181 (history)  Vaccinated:2009-08-14
Age:49.0  Onset:2009-08-14, Days after vaccination: 0
Gender:Male  Submitted:2009-08-24, Days after onset: 10
Location:Ohio  Entered:2009-09-01, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS438011C3IMLA
Administered by: Other     Purchased by: Private
Symptoms: Blister, Headache, Nausea
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: Approx 9-10:00pm on day of immunization patient stated had headache and nausea. Drank SPRITE, laid down and symptoms resolved about 2 hours later. On 08/17/09 patient stated he developed blisters on legs (1 on left, 2 on right) and blisters have not resolved. No other complaints.

VAERS ID:356513 (history)  Vaccinated:2009-08-24
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Virginia  Entered:2009-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME)UNKNOWN MANUFACTURER4089684 IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling erythema warmth around site of injection extending 4cm. 3 days later with T 100 and erythema extending distally about 6cm.

VAERS ID:356597 (history)  Vaccinated:2009-08-29
Age:49.0  Onset:2009-08-30, Days after vaccination: 1
Gender:Female  Submitted:2009-09-07, Days after onset: 8
Location:Virginia  Entered:2009-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, antibiotics
Current Illness: Absess on Left leg
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERN/A ON FORM0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Heart rate increased, Hyperhidrosis, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling, Pallor
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Redness, pain, extreme swelling & bruising at injection site. Headache, fatigue, chills & sweats on 8/30/09. By that evening and into 8/31/09, fast heart rate, difficulty breathing & paleness. Symptoms kept worsening so attempted to call on 8/31/09 around 10 am, ER where vaccine was administered and Charge Nurse was not helpful and very dismissive of symptoms.In fact he contradicted the literature that was given to me at the time of the injection. Either the staff is not versed on these vaccines or just don''t care. Called my primary care doctor for treatment. Symptoms finally subsided on their own. Arm continues to be bruised, red and painful on 9/7/09. Hoping this goes away eventually. Seems there is no one who knows of the reactions to these vaccines so they are very unhelpful to patients. I am lucky the worst of these symptoms went away and did not require another ER visit. I will NEVER take another vaccine again!

VAERS ID:356935 (history)  Vaccinated:2009-09-09
Age:49.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Female  Submitted:2009-09-10, Days after onset: 1
Location:Michigan  Entered:2009-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3207AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: Pt given double dose of flu vaccine-no adverse reaction.

VAERS ID:357042 (history)  Vaccinated:2009-09-10
Age:49.0  Onset:2009-09-11, Days after vaccination: 1
Gender:Female  Submitted:2009-09-12, Days after onset: 1
Location:Washington  Entered:2009-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: NKDA; NKFA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97838PZ IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: redness, warmth, soreness at swelling site about 2-3 inches across.

VAERS ID:357145 (history)  Vaccinated:2009-08-31
Age:49.0  Onset:2009-09-01, Days after vaccination: 1
Gender:Female  Submitted:2009-09-02, Days after onset: 1
Location:Arizona  Entered:2009-09-14, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0~Patient|None~ ()~~0~Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: Multiple Rx allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED02149211A0UNRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pruritus, Injection site warmth
SMQs:
Write-up: Localized warmth and pruritus at injection site (right deltoid).

VAERS ID:357254 (history)  Vaccinated:2009-09-02
Age:49.0  Onset:2009-09-03, Days after vaccination: 1
Gender:Female  Submitted:2009-09-10, Days after onset: 7
Location:Iowa  Entered:2009-09-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies - environmental
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED018449211A0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: On 9/3/09 in the evening face and ears began to itch, overnight the itching got worse. Nothing seen. Pt takes CLARITIN for seasonal allergies, so took some for the itching. Which improved. It was better by Sept. 5, 2009.

VAERS ID:357268 (history)  Vaccinated:2009-09-02
Age:49.0  Onset:2009-09-02, Days after vaccination: 0
Gender:Female  Submitted:2009-09-09, Days after onset: 7
Location:Hawaii  Entered:2009-09-14, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HCT2; LOPRESSOR.
Current Illness: None
Preexisting Conditions: Allergy to PCN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3173BA1UNLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Oropharyngeal pain, Pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (broad)
Write-up: Slight sore throat. Aches & pains in joints whole body. Started with symptoms with in 1 1/2 to 2 hours after vaccine. Took TYLENOL (symptoms lasted 3 days.

VAERS ID:357408 (history)  Vaccinated:2009-08-14
Age:49.0  Onset:2009-08-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-13, Days after onset: 30
Location:Florida  Entered:2009-09-15, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3097AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Asthenia, Body temperature increased, Diarrhoea, Erythema, Headache, Injection site reaction, Injection site scar, Oedema peripheral, Skin exfoliation, Skin warm
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Left arm very swollen, red, hot to touch. Weak, feverish, severe headache, diarrhea. Missed afternoon of 8/14, 8/17-8/21, tried to return to work 8/24 & only lasted 1/2 day, missed 8/25, 8/26. 8/27. Skin peeling around injection site, scar on arm. Stated on 9/3 that she was gradually seeing better. Couldn''t get out of bed those 2 wk. Never went to the OR/Hosp/ or doctor. Didn''t take temperature.

VAERS ID:357486 (history)  Vaccinated:2009-09-14
Age:49.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-16, Days after onset: 2
Location:Michigan  Entered:2009-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: 9/16/09 at 5:53pm - doing well strongly believes was reaction to vaccine.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3209AA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Nausea, Pain, Throat irritation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Received injection 10:30am within one hour nausea, aching, burning cough. 7:00 returned to clinic with symptoms. Conferred with Dr, Motrin 400mg 6-8 hours as needed and Compazine 10mg every 6 hours as needed. Freq small amount of fluids.

VAERS ID:357577 (history)  Vaccinated:2009-09-15
Age:49.0  Onset:2009-09-17, Days after vaccination: 2
Gender:Female  Submitted:2009-09-17, Days after onset: 0
Location:New Mexico  Entered:2009-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: being treated for anemia
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97845P20IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: arm described by employee as "swollen 3-4 inches below injection site, red and warm to touch"

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