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Case Details (Sorted by Age)

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VAERS ID:519078 (history)  Vaccinated:2014-01-06
Age:60.0  Onset:2014-01-07, Days after vaccination: 1
Gender:Female  Submitted:2014-01-13, Days after onset: 6
Location:Tennessee  Entered:2014-01-13
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: Allergies; ALEVE; Heart disease
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0058500SCLA
Administered by: Other     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt says she has had hives for a week. Has been using BENADRYL. I told her to call her dr.

VAERS ID:519120 (history)  Vaccinated:2014-01-08
Age:60.0  Onset:2014-01-08, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Hawaii  Entered:2014-01-13
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH897AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J010332 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Chills, Neck pain, Swelling, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Chills, wheezing, swell like grapefruit, pain all the way to neck and under arm.

VAERS ID:519236 (history)  Vaccinated:2014-01-09
Age:60.0  Onset:2014-01-10, Days after vaccination: 1
Gender:Female  Submitted:2014-01-14, Days after onset: 4
Location:Minnesota  Entered:2014-01-14
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
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Pruritus, Tenderness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: In 24 hrs pt had a red welt approx 3 ins long x 21 ins wide that was itching, burning and tender to touch.

VAERS ID:519286 (history)  Vaccinated:2014-01-13
Age:60.0  Onset:2014-01-14, Days after vaccination: 1
Gender:Female  Submitted:2014-01-14, Days after onset: 0
Location:Massachusetts  Entered:2014-01-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc 5 mg daily, estring 2 mg
Current Illness: No
Preexisting Conditions: Hypertension, allergy reaction to tb toxin (wheal) lidocaine with epinephrine (tissue sloughing, palpitations, syncope) doxycycline (diplopoda, nausea) Kenalog knee injection (hypertensive response)
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCLA
Administered by: Unknown     Purchased by: Other
Symptoms: Erythema, Local swelling, Pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling, erythema rash itch and pain 6cm diameter.

VAERS ID:519306 (history)  Vaccinated:2014-01-08
Age:60.0  Onset:2014-01-11, Days after vaccination: 3
Gender:Female  Submitted:2014-01-13, Days after onset: 2
Location:West Virginia  Entered:2014-01-14, 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:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0112120SCLA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Erythema, Local swelling, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Administered on Jan. 8, 2014, came in on Jan. 11, 2014 and arm was swollen, red and sore to touch. Patient was advised to go to the ER and diagnosed with Cellulitis.

VAERS ID:519296 (history)  Vaccinated:2013-11-01
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2014-01-15
Location:Unknown  Entered:2014-01-15
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: Morphine allergy
Diagnostic Lab Data:
CDC 'Split Type': 2014040031
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDR53307A IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Nerve injury, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This medically confirmed report (initial receipt 06-Jan-2014) concerns a 60 year old female patient with a medical history of morphine allergy. On the 01-Nov-2013, the patient received AFLURIA (batch number R53307A) 0.5mL via the intramuscular route. On an unspecified date, the patient developed excruciating pain and numbness in the entire arm in which AFLURIA was injected. These symptoms lasted approximately three days. The patient went to see the pharmacist and reported her symptoms to the pharmacist about two weeks after AFLURIA was administered and at that time she had recovered. On an unspecified date (in December 2013 or January 2014), the patient returned to the pharmacy and stated that the nerve was damaged. Outcome was not reported. The events of pain and numbness in the entire arm were reported as recovered.

VAERS ID:519373 (history)  Vaccinated:2009-11-17
Age:60.0  Onset:2009-11-17, Days after vaccination: 0
Gender:Male  Submitted:2014-01-15, Days after onset: 1520
Location:West Virginia  Entered:2014-01-15
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: Dyslipidemia; Obesity; Asthma; Obstructive Sleep Apnea; GERD; Hepatitis C Virus; Post Traumatic Stress Disorder
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1175Y UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Anaphylaxis and angioedema.

VAERS ID:519445 (history)  Vaccinated:2013-11-22
Age:60.0  Onset:2013-11-22, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:West Virginia  Entered:2014-01-15
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: Allergic to sulfa drugs
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDR56108 IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: I went to pharmacy late afternoon on the 22nd of November 2013 to get my flu shot. When he put the shot in my arm, I remarked it did not feel right--I could feel something running all the way down to my finger tips. It didn''t hurt at the needle site as much as some other shots I have had in previous years, but he kept pushing in much longer than most do. It bothered me some that evening. I woke up in the night and put my arms up to yawn and I noticed the left arm (where I got the shot) did not come up, just the right. I thought I might be dreaming, so later I tried it again and lo and behold, it did not come up. I had to take my right arm and pull my left one up. It hurt to do that, also. I have been taking pain pills (xtra strength TYLENOL and 800 MG ibuprofen). I also put Absorbine Jr liniment to try to help the pain. I keep praying and waiting for this to go away, but it is still there. I called on Monday after I first got the shot and another pharmacist suggested he might have nicked a nerve. He advised me to keep moving it and it would soon go away. I don''t even know how to describe the pain I have with it now. It almost makes me cry to try to get my hair pulled up in the morning. From my shoulder to my elbow is the most painful. I can''t lift my arm with pain. I would like some suggestions on how to get this problem solved. I don''t want to even get anymore flu shots after this bad experience. If you have any ideas on how to help with this, please let me know.

VAERS ID:519506 (history)  Vaccinated:2013-12-18
Age:60.0  Onset:2013-12-29, Days after vaccination: 11
Gender:Male  Submitted:2014-01-16, Days after onset: 18
Location:Unknown  Entered:2014-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; vitamin D (unspecified); PRILOSEC; aspirin
Current Illness: Drug hypersensitivity; Miliaria
Preexisting Conditions: AUGMENTIN, Rash erythematous
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA004611
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Rash erythematous, Rash vesicular, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a 60 year old male pharmacist who is also the patient who has been prone to heat rash in the summer for the last three or four years and AUGMENTIN allergy. On 18-DEC-2013, the patient was (route not provided) vaccinated with ZOSTAVAX (lot number and expiry date not provided). Concomitant therapies included LIPITOR, vitamin D (unspecified) (manufacturer unknown), PRILOSEC and aspirin (manufacturer unknown). On 29-DEC-2013, 12 days after onset of therapy the patient experienced rash with blisters and peeling on his face and part of his neck. The pharmacist stated that the rash "looks like sunburn". The pharmacist was taking prednisone (manufacturer unknown) and FLOMAX (manufacturer unknown) to treat the rash which he has since stopped. The blisters went away; however, the redness, flaking and peeling is still occurring. The patient sought medical attention. The outcome of rash with blisters and peeling on his face and part of his neck was reported as recovering/resolving. Additional information has been requested.

VAERS ID:519572 (history)  Vaccinated:2013-10-29
Age:60.0  Onset:2013-10-30, Days after vaccination: 1
Gender:Male  Submitted:2014-01-16, Days after onset: 78
Location:Pennsylvania  Entered:2014-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril; Simvastatin; ACTOS; COQ10
Current Illness: None
Preexisting Conditions: Hypertension; Hyperlipidemia; Type II DM.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Persistent, daily, aching pain at left upper arm with tenderness at biceps muscle and biceps tendon. No bruising, mass, erythema or swelling. Normal neuro/vascular.

VAERS ID:519590 (history)  Vaccinated:2013-10-14
Age:60.0  Onset:2014-01-02, Days after vaccination: 80
Gender:Female  Submitted:2014-01-16, Days after onset: 14
Location:Ohio  Entered:2014-01-16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Many vision tests; CBC and Diff; CRP 1.6; ESR 8
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS13423P3IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Blindness unilateral, C-reactive protein increased, Differential white blood cell count, Full blood count, Optic neuritis, Papillitis, Red blood cell sedimentation rate normal, Sudden visual loss, Visual acuity tests
SMQs:, Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Retinal disorders (broad), Ocular infections (broad)
Write-up: Sudden vision loss (L) eye 1/2/14 (10 wks after flu vaccine) optic neuritis/papillitis (L) eye.

VAERS ID:519592 (history)  Vaccinated:2014-01-07
Age:60.0  Onset:2014-01-14, Days after vaccination: 7
Gender:Female  Submitted:2014-01-16, Days after onset: 2
Location:Iowa  Entered:2014-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Buproprion, citalopram, levothyroxine, omeprazole, simvastatin, valacylovir
Current Illness: No
Preexisting Conditions: Suspected allergy to sulfa drugs
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU4791CA4IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0033600IMLA
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Back pain, Breast pain, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Lipodystrophy (broad), Hypersensitivity (narrow)
Write-up: Pain and rash on right side of upper back, axilla, and lateral right breast.

VAERS ID:519604 (history)  Vaccinated:2013-10-21
Age:60.0  Onset:2013-10-22, Days after vaccination: 1
Gender:Female  Submitted:2014-01-16, Days after onset: 86
Location:Maine  Entered:2014-01-16
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: Fibromyalgia
Diagnostic Lab Data: MRI 1/10/2014 full thickness supraspinatus tear
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUNKNOWN6IMLA
Administered by: Public     Purchased by: Public
Symptoms: Bursal fluid accumulation, Motor dysfunction, Muscle atrophy, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Shoulder pain and motor deficit later definitively diagnosed as a rotator cuff tear--complete supraspinatus tear on 1/10/2014, with subacromial bursa fluid and muscle atrophy.

VAERS ID:519747 (history)  Vaccinated:2014-01-10
Age:60.0  Onset:2014-01-10, Days after vaccination: 0
Gender:Female  Submitted:2014-01-17, Days after onset: 7
Location:Washington  Entered:2014-01-17
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
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS13402P IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J010396 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash.

VAERS ID:519768 (history)  Vaccinated:2014-01-17
Age:60.0  Onset:2014-01-18, Days after vaccination: 1
Gender:Female  Submitted:2014-01-19, Days after onset: 1
Location:Oregon  Entered:2014-01-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VIT D3, METOPROLOL, PRAVASTIN, BABY ASPIRIN, LEXAPRO
Current Illness: NONE THE FLU VACCINE WAS GIVEN FREE AT HOSPITAL. I DONT KNOW THE NAME OF THE NURSE.
Preexisting Conditions: CORONARY ARTERY DISEASE; SULFA ALLERGY
Diagnostic Lab Data: NA
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Hypoaesthesia, Injection site pain, Joint stiffness, Middle insomnia, Neck pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: I WOKE UP IN THE NIGHT AND MY RIGHT ARM FELT SORE AND PAIN WENT UP INTO MY SHOULDER AND NECK. THE NEXT MORNING I AWOKE WITH MY HAND TIGHT AND FELT LIKE I HAD SLEPT ON AND IT WOULD NOT WAKE UP. THE DAY WENT BY AND IT GOT BETTER AND WAS GONE BY THE NEXT DAY.

VAERS ID:519885 (history)  Vaccinated:2013-11-20
Age:60.0  Onset:2013-11-21, Days after vaccination: 1
Gender:Female  Submitted:2014-01-20, Days after onset: 60
Location:Wisconsin  Entered:2014-01-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Colchicine, cyclobenzaprine, Hydrocodone/apap, Indomethacin, Lisinopril/Hctz, Multi-vitamin, Omeprazole, Ranitidine
Current Illness: None
Preexisting Conditions: Allergy to PCN - no other allergies noted
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH910AC3IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Flu vaccine was given on 11/20/13. Patient c/o''s she has experienced upper arm pain where she received the flu vaccine injection since the injection was given.

VAERS ID:520025 (history)  Vaccinated:2014-01-10
Age:60.0  Onset:2014-01-10, Days after vaccination: 0
Gender:Male  Submitted:2014-01-14, Days after onset: 4
Location:New Mexico  Entered:2014-01-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0088020SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site reaction - consisting of moderate to severe redness, swelling, firmness and heat beginning day after vaccine, maximizing 2 days later, and subsiding over 2-3 more days.

VAERS ID:520337 (history)  Vaccinated:2014-01-16
Age:60.0  Onset:2014-01-16, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-23, Days after onset: 7
Location:Colorado  Entered:2014-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA008962
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J007857 SCLA
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. The pharmacist reported that on 16-JAN-2014, the patient received a dose of ZOSTAVAX (lot # J007857, expiration date: 28-SEP-2014) (0.6 ml, once, subcutaneously left deltoid). The patient received a dose of ZOSTAVAX that had been reconstituted with Sanofi Pasteur saline diluent. She (the pharmacist) stated that she was "busy", and she grabbed a diluent for a yellow fever vaccine; she stated, "The labels of Merck diluent and the Sanofi diluent were so similar, I didn''t notice until I was documenting the vaccination after it was administered." The diluent that was used was NDC# 49281-912-01, lot # UH380AB, expiration date 15-MAR, and the volume was "between 0.5 and 0.6 mL" of 0.9% saline solution. The patient had not any adverse effect. Additional information has been requested.

VAERS ID:520556 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:2014-01-01
Gender:Female  Submitted:2014-01-24, Days after onset: 23
Location:Unknown  Entered:2014-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA010821
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient no known allergies. On 18-JAN-2014, the patient was vaccinated with ZOSTAVAX. Dose, route and frequency were unspecified. Approximately in January 2014, the patient developed a rash at the injection site. Patient described the rash to the pharmacist as a shingles like rash. VZVIP packet faxed. The outcome of shingles like rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.

VAERS ID:520648 (history)  Vaccinated:2007-06-15
Age:60.0  Onset:2009-01-16, Days after vaccination: 581
Gender:Male  Submitted:2014-01-24, Days after onset: 1834
Location:Florida  Entered:2014-01-24
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergic Rhinitis
Diagnostic Lab Data: MRI of Brain; Carotid doppler; CBC; CMP; ESR
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Full blood count, Metabolic function test, Nuclear magnetic resonance imaging brain, Optic ischaemic neuropathy, Red blood cell sedimentation rate, Ultrasound Doppler
SMQs:, Optic nerve disorders (narrow)
Write-up: Non-arteritic ischemic optic neuritis (NAION).

VAERS ID:520712 (history)  Vaccinated:2013-08-05
Age:60.0  Onset:2013-08-10, Days after vaccination: 5
Gender:Female  Submitted:2014-01-24, Days after onset: 167
Location:Texas  Entered:2014-01-25, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: cold~Vaccine not specified (no brand name)~1~60.00~Patient|fever~Vaccine not specified (no brand name)~1~60.00~Patient|sore thro
Other Medications: Metformin, quinapril, Shingles Vaccine, Zetia, flutacasone, timolol pf, baby aspirin, Byetta, Lantus, clinadamycin lotion, desonide, triaminacinalone cream, Clobetasol ointment, Restore eye drops, silver sulfadiazine.
Current Illness: Diabetes, HBP, high cholesterol, glaucoma, several genetic anomalies, psoriasis, spongiotis, atopic dermatitis, boils, bone spur, osteo arthritis, porosis, penia, sclerosis, kidney stones, gout, and many more.
Preexisting Conditions: Panlor ss, gabapentin, Timolol, Lumigan, Xalatan, penicillin, antibiotics, citrus, clindamycin (internal)
Diagnostic Lab Data:
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.000064963410UNLA
Administered by: Unknown     Purchased by: Public
Symptoms: Chills, Nasopharyngitis, Odynophagia, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Sinusitis, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: Cold, sore throat, sneezing, sinus infection, congestion, fever, chills.

VAERS ID:520727 (history)  Vaccinated:2014-01-24
Age:60.0  Onset:2014-01-25, Days after vaccination: 1
Gender:Female  Submitted:2014-01-26, Days after onset: 1
Location:Virginia  Entered:2014-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.7E9WHKA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Feeling hot, Local swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized redness, swelling and warmth. Area tender to touch.

VAERS ID:520808 (history)  Vaccinated:2014-01-13
Age:60.0  Onset:2014-01-15, Days after vaccination: 2
Gender:Female  Submitted:2014-01-27, Days after onset: 12
Location:Unknown  Entered:2014-01-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Penicillin (unspecified), Drug Reaction: Drug hypersensitivity
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA006780
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J011338 SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had drug reaction/allergy for penicillin. Pertinent medical history not reported. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J011338, exp. date: 19-DEC-2014, single dose, subcutaneous injection in the right arm) for vaccination. No concomitant therapies reported$g on 15-JAN-2014 the patient developed redness, warmth, swelling, and itching at the injection site on the right arm. The patient also developed right arm pain and tingling of the fingers. The patient sought medical attention via pharmacy visit. No treatment was given. The outcome of events was not recovered. The relatedness between ZOSTAVAX and events was not reported. Additional information is not expected.

VAERS ID:520986 (history)  Vaccinated:2013-10-23
Age:60.0  Onset:2013-10-25, Days after vaccination: 2
Gender:Female  Submitted:2014-01-23, Days after onset: 90
Location:Massachusetts  Entered:2014-01-28, 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: Lisinopril; Timolol; Latanoprost; B-12 OTC
Current Illness: None
Preexisting Conditions: Pre-diabetic; Neuropathy; High blood pressure
Diagnostic Lab Data: Bacteria in body or a virus; needed days of antibiotics
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J005750 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Bacterial infection, Chills, Decreased appetite, Fall, Gait disturbance, Headache, Muscular weakness, Pyrexia, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)
Write-up: Very bad headache 48 hrs. after vaccination; fever; chills; headache was all day, all night; no appetite; both legs were weak and walking was unsteady; fell once; could not walk at all need physical therapy and occupational therapy.

VAERS ID:520995 (history)  Vaccinated:2014-01-09
Age:60.0  Onset:2014-01-10, Days after vaccination: 1
Gender:Female  Submitted:2014-01-23, Days after onset: 13
Location:Tennessee  Entered:2014-01-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tamoxifen; Omeprazole; Atorvastatin; Venlafaxine
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS009031A IMLA
Administered by: Other     Purchased by: Public
Symptoms: Pain in extremity
SMQs:
Write-up: Pain when laying on left arm.

VAERS ID:521191 (history)  Vaccinated:2013-06-26
Age:60.0  Onset:2013-06-27, Days after vaccination: 1
Gender:Male  Submitted:2014-01-06, Days after onset: 193
Location:Unknown  Entered:2014-01-29, Days after submission: 23
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: Pulse: 79 (06/26/2013 09:00); Blood Pressure: 134/82 (06/26/2013 09:00); Respirations: 16 (06/26/2013 09:00); Patient Weight: 217.2 lb [98.7 kg] (06/26/2013 09:00); Patient Height: 72 in [182.9 cm] (08/24/2010 13:12); Patient BMI: 29.5; Pain: 0 (06/26/2013 09:00) (0-10 scale); O2 Saturation: Measurement DT POx (L/MIN)(%) 06/26/2013 09:00 97; CBC, CMP, HgbA1c ok.; vit B12, 175; LDL chol, 140; CMP, UA ok
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J004936 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to vaccine, Dermatitis allergic, Full blood count normal, Glycosylated haemoglobin normal, Haemorrhage, Low density lipoprotein normal, Metabolic function test normal, Papule, Rash generalised, Rash pruritic, Scab, Skin lesion, Urine analysis normal, Vitamin B12 normal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: 6/27/13 60 year old male. Pt walked into the ER. Pt states he received a zoster vaccine yesterday and today he developed an itchy rash all over his body, except face. No SHOB, lip, tongue or throat swelling, or other problems. 6/29/13 Pt presented day before yesterday with lower body rash. Was seen by ER physician (See ER Physician notes of 27th). Pt says that he is still itchy. He had couple of more lesions which appeared. No fever/chills or other symptoms. There is small round isolated widely spaced papular lesion, some with scab on them due to itching/bleeding. Distribution is mainly on legs. No cellulitis. Allergic rash to zoster vaccine-non injection site. D/C home. Increase BENADRYL to 50 mg po bid. C/E prednisone as prescribed before. PCP to follow. I have advised patient to seek further care immediately if the current condition and symptoms get worse or do not seem to get better or if any new symptom or problem develops. The patient voiced understanding and agreed.

VAERS ID:521206 (history)  Vaccinated:2014-01-18
Age:60.0  Onset:2014-01-19, Days after vaccination: 1
Gender:Male  Submitted:2014-01-29, Days after onset: 10
Location:Utah  Entered:2014-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE 20 MG QD
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: HAS SEEN ER DOCTOR WITH NO HELP WILL SEE REGULAR DOCTOR SOON
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1310301 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site reaction, Muscular weakness, Neuralgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: NERVE PAIN IN INJECTION LEFT SITE ARM AND MOVING THROUGH NECK AND BACK AREA WITH SEVERE HEADACHES AND PAIN UPON TOUCH WITH WEAKNESS IN EXTREMITIES UPPER BODY.

VAERS ID:521276 (history)  Vaccinated:2014-01-13
Age:60.0  Onset:2014-01-18, Days after vaccination: 5
Gender:Female  Submitted:2014-01-30, Days after onset: 12
Location:Texas  Entered:2014-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec D
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Other     Purchased by: Other
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)
Write-up: Extreme soreness, no range of motion in my arm. Can''t lift anything.

VAERS ID:521319 (history)  Vaccinated:2014-01-23
Age:60.0  Onset:2014-01-28, Days after vaccination: 5
Gender:Female  Submitted:2014-01-29, Days after onset: 1
Location:Texas  Entered:2014-01-30, 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: KLONOPIN; TOPROL; PLAQUENIL; NORVASC; ACIPHEX
Current Illness: None
Preexisting Conditions: Lupus; M.S.; anxiety; HTN; GERD
Diagnostic Lab Data: None
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0118820SCLA
Administered by: Private     Purchased by: Private
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Patient presented 5 days post vaccine c/o sudden onset of vertigo not sure if related.

VAERS ID:521442 (history)  Vaccinated:2013-12-17
Age:60.0  Onset:2013-12-19, Days after vaccination: 2
Gender:Female  Submitted:2013-12-30, Days after onset: 11
Location:Iowa  Entered:2014-01-31, Days after submission: 32
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil; multivitamin; calcium
Current Illness:
Preexisting Conditions: Hyperlipidemia; Fibrocystic disease breasts; Sulfa allergy
Diagnostic Lab Data: None
CDC 'Split Type':
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J009689 IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS9443E IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J007858 SCRA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient received a TDAP rt deltoid and ZOSTAVAX in right posterior upper arm 12/14/13. Then noticed mild erythema on 12/19 and 12/20 was seen by myself for cellulitis extending 10.5 X 5.5cm.

VAERS ID:521504 (history)  Vaccinated:2013-09-23
Age:60.0  Onset:2013-09-23, Days after vaccination: 0
Gender:Female  Submitted:2014-02-01, Days after onset: 131
Location:Illinois  Entered:2014-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Lodine, HCTZ, Bystolic, Klor-Con
Current Illness: NO
Preexisting Conditions: Penicillin, Duricef, Erythromycin, Macrobid, Lotrel, Zofran; Diabetes, Hypertension
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS    
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dysstasia, Headache, Hyperhidrosis, Nausea, Pain in extremity, Sensation of heaviness
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 30 min. after shot - Rt. arm heavy, feeling weak. 45 min. after shot - diaphoretic, nauseated & weaker. 1 hr. after shot - too weak to stand. Home to bed, headache & Rt. arm throbbing, Took Tylenol, slept. 5 hrs. after shot - symptoms gone. Has never happened before!

VAERS ID:521524 (history)  Vaccinated:2013-02-22
Age:60.0  Onset:2013-02-24, Days after vaccination: 2
Gender:Female  Submitted:2014-02-02, Days after onset: 343
Location:Florida  Entered:2014-02-02
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:
CDC 'Split Type':
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VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Viral infection
SMQs:
Write-up: Standard symptoms and antiviral treatment.

VAERS ID:521582 (history)  Vaccinated:2013-12-30
Age:60.0  Onset:2014-01-01, Days after vaccination: 2
Gender:Female  Submitted:2014-02-02, Days after onset: 32
Location:California  Entered:2014-02-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling, redness~Tdap (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: Osteoarthritis
Preexisting Conditions: Horse - serum
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH905AB0UNAR
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0078550SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Dysphonia, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pain in extremity
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 12/30/13 Rash, redness, soreness, at injection site 24 hrs after receiving shingles shot on left arm. Arm still sore after 1 month of shot. Hoarseness of voice also. 1/31/14 Rash, redness, warmth, soreness at injection site after pneumonia shot. Arm slightly sore from shingles.

VAERS ID:521616 (history)  Vaccinated:2014-01-01
Age:60.0  Onset:2014-01-01, Days after vaccination: 0
Gender:Female  Submitted:2014-02-03, Days after onset: 33
Location:Unknown  Entered:2014-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA014456
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow)
Write-up: This spontaneous report was received from a physician via company representative refers to a 60 year old female patient. On an unknown date in January 2014, the patient was vaccinated with ZOSTAVAX standard dose. On an unknown date in January 2014 (also reported as 2-3 weeks ago), the patient experienced ophthalmic shingles. The patient sought medical attention and visited the physician office for treatment. The patient was treated with VALTREX. The outcome of the event ophthalmic shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.

VAERS ID:521678 (history)  Vaccinated:2014-01-31
Age:60.0  Onset:2014-02-01, Days after vaccination: 1
Gender:Female  Submitted:2014-02-03, Days after onset: 2
Location:Connecticut  Entered:2014-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
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VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, Swelling, Tenderness of upper left arm.

VAERS ID:521730 (history)  Vaccinated:2014-01-26
Age:60.0  Onset:2014-01-27, Days after vaccination: 1
Gender:Female  Submitted:2014-01-31, Days after onset: 4
Location:Maryland  Entered:2014-02-04, 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALST25EG1UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Neck pain, Pain, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Rt deltoid area swollen since vaccine was given on 1/26/14, bright red rashes, very hard around and at vaccine site, painful to movements of Rt arm pain radiates to my right neck. Heat application only. On Sunday, January 26, 2014, I went to clinic to have a PPD and a TDAP vaccination, a requirement of my school for my upcoming advanced nursing clinical. I received the two vaccines, the PPD in my left forearm and the TDAP my right deltoid. The next morning I felt pain, soreness and swelling in my right arm, at and around the vaccination site. I am aware that these symptoms are usually indicated after most vaccines but my arm had a rash started at and around the vaccine area, it became hard and swollen, pain continues and radiates to my neck. I applied heat compress and applied some BENADRYL cream but it did not feel any better. I went back to the clinic on Wednesday to have my PPD read and spoke with the CRNP that was there; I showed her the vaccine site, she had no explanation for the reaction. Today, the date of this letter is six days, my arm is still as previously indicated, except the rashes are less visible but the redness remains. I have never had the TDAP vaccine before but it 2007, I had the DT booster which was also required by my school for clinical. Following that vaccine, I had soreness, mild pain with red rashes that looked more like red bumps (similar to pox). The CRNP who administered the vaccine let me speak with the physician from (infectious disease). His response was "This is a normal reaction, apply heat and some BENADRYL and in a few days it should be fine". In about four days, the pain, soreness, swelling and red rashes/bumps subsided and I was ok. Unfortunately, the experience with the TDAP is prolonged now to six days with all the above mentioned symptoms and the heat and BENADRYL is not effective in this case. I would like to know, what is the component in this vaccine that causes this reaction. I was given this form to report this problem and will appreciate your feedback as soon as possible.

VAERS ID:521780 (history)  Vaccinated:2014-01-29
Age:60.0  Onset:2014-01-29, Days after vaccination: 0
Gender:Female  Submitted:2014-02-04, Days after onset: 6
Location:Colorado  Entered:2014-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Triamcinolone Acetanide
Current Illness: None
Preexisting Conditions: Azithromycin, Penicilins (hives), Sulfonamides, Aspirin; Hyperlipidemia; Hypertension; Osteopenia; Eczema
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0040610IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Injected limb mobility decreased, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Approximately 3 hours after receiving vaccine patient''s (L) arm became extremely sore. She was unable to lift (L) arm w/out supporting it w/ her (R) arm. She felt feverish but didn''t take temperature. Pain and weakness lasted for 4 days but lessened each day.

VAERS ID:521791 (history)  Vaccinated:2014-01-28
Age:60.0  Onset:2014-01-29, Days after vaccination: 1
Gender:Male  Submitted:2014-02-04, Days after onset: 6
Location:Unknown  Entered:2014-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA000541
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
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: This spontaneous report was received from a 60 year old male consumer regarding himself. On 28-JAN-2014 the patient was vaccinated with ZOSTAVAX. On 29-JAN-2014, the patient developed redness, swelling, soreness and warmth at the injection site. The outcome of injection site redness, warmth at the injection site, injection site soreness and injection site swelling was reported as not recovered/not resolved. No treatment was given for the adverse events. No lab diagnostics studies were performed. The patient did not see any medical attention. Additional information has been requested.

VAERS ID:522065 (history)  Vaccinated:2013-12-16
Age:60.0  Onset:2013-12-16, Days after vaccination: 0
Gender:Unknown  Submitted:2014-02-07, Days after onset: 53
Location:Unknown  Entered:2014-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Varicella as a child
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA012366
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0165770SCUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from Healthcare worker refers to a 60 year old patient. The patient''s medical history included chicken pox as a child. On 16-DEC-2013 the patient was vaccinated with the first dose of VARIVAX (merck), 0.5 ml, lot# H016577, exp. 05-SEP-2014, subcutaneous. The patient inadvertently received single (first) dose of VARIVAX (merck) instead of ZOSTAVAX (Merck). The outcome of event was unknown. No adverse effects reported. Additional information has been requested.

VAERS ID:522239 (history)  Vaccinated:2014-02-01
Age:60.0  Onset:2014-02-01, Days after vaccination: 0
Gender:Female  Submitted:2014-02-09, Days after onset: 8
Location:Unknown  Entered:2014-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1402USA001635
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013021 SCLA
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. On 01-FEB-2014, the patient was vaccinated with expired ZOSTAVAX lot # H013021 (Expiry: 09-OCT-2013), 0.65 ml, subcutaneous in the left arm. No adverse effects reported. No further details provided. Additional information has been requested.

VAERS ID:522339 (history)  Vaccinated:2014-01-08
Age:60.0  Onset:2014-01-10, Days after vaccination: 2
Gender:Female  Submitted:2014-02-10, Days after onset: 31
Location:Colorado  Entered:2014-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QNASL 80mcg/act
Current Illness:
Preexisting Conditions: Allergy to tetracyclines
Diagnostic Lab Data: n/a
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0028680SCLA
Administered by: Other     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient reported developing 4-5 dime- sized welts on left arm and 2-3 dime-sized welts on upper right arm starting two days after vaccine administration. Welts were accompanied by itching. Patient reports that signs/symptoms started to subside on 2/8/14.

VAERS ID:522606 (history)  Vaccinated:2013-09-24
Age:60.0  Onset:2013-10-03, Days after vaccination: 9
Gender:Male  Submitted:2014-02-13, Days after onset: 133
Location:New Mexico  Entered:2014-02-13
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro; Atorvastatin
Current Illness: None
Preexisting Conditions: High cholesterol
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS13586011IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H014561 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Abasia, Aphasia, Blood pressure fluctuation, Blood test, Computerised tomogram, Dysphagia, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test, Lumbar puncture, Mechanical ventilation complication, Mobility decreased, Nuclear magnetic resonance imaging, Pain, Paralysis
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (broad), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.

VAERS ID:522760 (history)  Vaccinated:2014-02-13
Age:60.0  Onset:2014-02-15, Days after vaccination: 2
Gender:Female  Submitted:2014-02-15, Days after onset: 0
Location:California  Entered:2014-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Hay fever; Asthma; Work injury; High blood pressure
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYR 
Administered by: Unknown     Purchased by: Private
Symptoms: Dysphonia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Swelling, redness, soreness, itchy at injection site, hoarseness, wheezing, treated with Benadryl and Albuterol.

VAERS ID:522772 (history)  Vaccinated:2013-10-10
Age:60.0  Onset:2013-10-10, Days after vaccination: 0
Gender:Female  Submitted:2014-02-16, Days after onset: 129
Location:Oregon  Entered:2014-02-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4762BA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: None.

VAERS ID:522865 (history)  Vaccinated:2014-02-14
Age:60.0  Onset:2014-02-14, Days after vaccination: 0
Gender:Female  Submitted:2014-02-17, Days after onset: 3
Location:Texas  Entered:2014-02-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAZODONE HCL 50 MG TABS take 2 tablets daily AMITRIPTYLINE HCL 10 MG TABS Take one by mouth every day METOPROLOL TARTRATE 25 MG TABS Take one by mouth every day METFORMIN HCL 500 MG TABS Take one by mouth every day SIMVASTATIN 20 MG T
Current Illness: None
Preexisting Conditions: No Allergies, Fibromyalgia, Rosacea, Granuloma Annulare, HBP, High Cholesterol
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness & swelling at injection site. Has grown continually worse. Swelling & redness now about 4 inch diameter. Informed Doctor''s office, waiting for call back.

VAERS ID:522866 (history)  Vaccinated:2013-11-22
Age:60.0  Onset:2013-11-22, Days after vaccination: 0
Gender:Female  Submitted:2014-02-17, Days after onset: 87
Location:Washington  Entered:2014-02-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin 10 mg QD; levothyroxine 75 mcg QD; metoprolol succ er 25 mg QD
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4787AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: None.

VAERS ID:522880 (history)  Vaccinated:2014-02-01
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2014-02-17
Location:Unknown  Entered:2014-02-17
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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J007855 SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin hypertrophy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling 2 inches around shot area; thickening of skin; 1/4 inch radius redness; pain for 5 days; sensitive to touch for couple of days but not unbearable.

VAERS ID:523181 (history)  Vaccinated:2014-01-27
Age:60.0  Onset:2014-01-29, Days after vaccination: 2
Gender:Female  Submitted:2014-02-20, Days after onset: 22
Location:California  Entered:2014-02-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonazepam 0.5; Sulfamethoxazole/Thimethoprim oral
Current Illness: NO
Preexisting Conditions: Cut on finger taking antibiotics
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)SANOFI PASTEUR    
Administered by: Private     Purchased by: Private
Symptoms: Headache, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Deep muscle pain and pain on entire left side, headache.

VAERS ID:523340 (history)  Vaccinated:2014-02-19
Age:60.0  Onset:2014-02-19, Days after vaccination: 0
Gender:Male  Submitted:2014-02-21, Days after onset: 2
Location:Iowa  Entered:2014-02-21
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0050670IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4472AA1IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0113410SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Muscular weakness, Pain in extremity, Syncope, Tenderness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient presented to ER afternoon of 2/19/14 c/o bad (L) arm pain. Needed medication. C/o syncope and dizziness. Admitted for observation. Significant tenderness and weakness in arm. Patient has hx of leukemia.

VAERS ID:523366 (history)  Vaccinated:2013-11-18
Age:60.0  Onset:2013-12-01, Days after vaccination: 13
Gender:Female  Submitted:2014-02-23, Days after onset: 84
Location:California  Entered:2014-02-23
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenal; simvastatin; estrogen
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0078570SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Autoimmune disorder, Gingival bleeding, Oral mucosal blistering, Pemphigoid, Pemphigus
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Bleeding gums and onset of oral blisters pemphigoid/ pemphigus autoimmune disease onset.

VAERS ID:523380 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2014-02-23
Location:Unknown  Entered:2014-02-23
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Examination: an area was identified around the area of vaccination - that was diagnosed as Merkel Cell Cancer
CDC 'Split Type': WAES1402USA009582
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNAR
Administered by: Other     Purchased by: Other
Symptoms: Fall, Injection site reaction, Neuroendocrine carcinoma of the skin, Pain in extremity, Upper limb fracture
SMQs:, Accidents and injuries (narrow), Malignant tumours (narrow), Skin malignant tumours (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The pharmacist reporting that his niece''s husband, received ZOSTAVAX (dose, frequency, route, lot # unknown) a year ago in 2013 (specified date unknown) and following vaccination (a week) the patient had pain in his vaccinated arm and then fell and broke his arm, during examination an area was identified around the area of vaccination - that was diagnosed as Merkel Cell Cancer. The pharmacist stated that the patient now was in Stage 4 of Merkel Cell cancer. The patient had not started treatment yet for his cancer but he would be receiving chemotherapy, radiation and an unspecified treatment which would stimulate his immune system. One of the facilities he would be getting treatment from was a cancer center. The patient would be undergoing just radiation for treatment (no date specified). The pharmacist stated that the patient had "2 factors" (unknown what factors - but pharmacist believed had to do with immune system) missing and the radiation treatment would "generate" what was missing. The patient sought medical attention via unspecified contact. Stage 4 of Merkel Cell cancer, fell and broke a bone was reported as not recovered. Outcome of pain in his vaccinated arm was unknown. Upon internal review, merkel cell cancer was considered to be medically significant. Merkel cell cancer, fell and broke a bone were considered to be life threatening by reporter. Additional information has been requested.

VAERS ID:523455 (history)  Vaccinated:2014-02-01
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:2014-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH907AD IMAR
Administered by: Unknown     Purchased by: Private
Symptoms: Pain in extremity
SMQs:
Write-up: Pt states that shortly after administration her arm was sore and became progressively worse over following 3 weeks. Shot given 2/1/14.

VAERS ID:523506 (history)  Vaccinated:2014-02-19
Age:60.0  Onset:2014-02-20, Days after vaccination: 1
Gender:Male  Submitted:2014-02-24, Days after onset: 4
Location:South Carolina  Entered:2014-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: syncope~Typhoid Vi Polysaccharide (no brand name)~1~19.75~Patient
Other Medications: ASA 162mg Q AM, tenoretic 50/25 1/2 Q AM, Centrum Silver MV, fish oil, Vit D
Current Illness: No
Preexisting Conditions: Hypertension
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Feeling hot, Flushing, Hyperaesthesia
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Joint pain in elbow, flushing, warmth in area surrounding elbow. Severe sensitivity to touch on elbow necessitating high dose NSAID tx. Escalating to narcotic meds. Now resolving (5 days post injection) but not gone. It feels as though recovery will continue based on decreased symtoms the last day but complete recovery cannot be assured at this time.

VAERS ID:523557 (history)  Vaccinated:2013-10-22
Age:60.0  Onset:2013-10-22, Days after vaccination: 0
Gender:Male  Submitted:2013-10-30, Days after onset: 8
Location:Missouri  Entered:2014-02-24, Days after submission: 117
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2013SE79820
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2029 IN 
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: A report has been received from a Pharmacist concerning a 60 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 22-Oct-2013. It was reported that consumer was administered FLUMIST QUADRIVALENT to a person over 49 years who was 60 years old which started on 22-Oct-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a person over 49 years/60 YO is unknown. The report was considered to be non-serious.

VAERS ID:523601 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:2013-10-14
Gender:Male  Submitted:2013-10-23, Days after onset: 9
Location:Unknown  Entered:2014-02-24, Days after submission: 124
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2013SE78318
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2029 IN 
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: A report has been received from a Pharmacist concerning a 60 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced ADMINISTERED FLUMIST TO A HEALTHY 60 YEAR OLD PATIENT which started on 14-Oct-2013. The outcome of the event of ADMINISTERED FLUMIST TO A HEALTHY 60 YEAR OLD PATIENT is unknown. The report was considered to be non-serious by the reporter.

VAERS ID:524010 (history)  Vaccinated:2014-01-27
Age:60.0  Onset:2014-01-27, Days after vaccination: 0
Gender:Female  Submitted:2014-02-25, Days after onset: 29
Location:Florida  Entered:2014-02-26, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS13442P0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad)
Write-up: Pt says she cannot move her arm due to shoulder pain since receiving vaccine on 1/27/14.

VAERS ID:524424 (history)  Vaccinated:2014-02-27
Age:60.0  Onset:2014-03-01, Days after vaccination: 2
Gender:Female  Submitted:2014-03-03, Days after onset: 2
Location:Missouri  Entered:2014-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair 10 mg, Fosamax 70 mg, Pravastatin Sodium 40 mg, Flonase 50 mcg/act, Mucus ER, Zyrtec 10 mg, Vit C 500 mg, Cinnamon 1000 mg, Osteo Bi-flex, Aspirin 81 mg, & Calcium + D.
Current Illness: None known
Preexisting Conditions: Diabetic, High Cholesterol; chronic non-specific allergies/sinus issues. Birth defects: cleft lip and palate. Conditions at time of vac. None out of normal.
Diagnostic Lab Data: None, treated with Extra Strength Benadryl Spray
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.NCD00006496340SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Severe itching, redness around injection site (approx. size 4 x 6 inch area) with small knot in muscle.

VAERS ID:525538 (history)  Vaccinated:2014-03-08
Age:60.0  Onset:2014-03-08, Days after vaccination: 0
Gender:Female  Submitted:2014-03-11, Days after onset: 2
Location:Florida  Entered:2014-03-11
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J007884 SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site pustule, Local swelling, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and edema on arm that spread down toward elbow. Sore at injections site with visible pustule present. Patient states started 2 hours post vaccination and has been present for 3 days.

VAERS ID:525849 (history)  Vaccinated:2014-03-06
Age:60.0  Onset:2014-03-07, Days after vaccination: 1
Gender:Female  Submitted:2014-03-14, Days after onset: 6
Location:Louisiana  Entered:2014-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Centrum Silver Vitamin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYRAR
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Red rash 2" wide x 4" long extending down inner arm from injection area and very sore. Reddened skin 3" wide x 6" long extending down inner arm starting below rash almost to elbow, and very hot to the touch. Symptoms subsided after 7 to 8 days.

VAERS ID:75898 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:1995-06-26
Location:Foreign  Entered:1995-07-17, Days after submission: 21
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dexamethasone, Chemotherapy
Current Illness:
Preexisting Conditions: lymphoma/ 1990
Diagnostic Lab Data: HBsAg neg; Hep C antibody neg; HBsAg strongly reactive; Anti-HBc pos; HBe-Ag pos; Hbvdna pos; Anti-HBs neg; Anti-HBc-IgM neg; delta agent neg; hep C test neg;
CDC 'Split Type': WAES95065060
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Drug ineffective, Hepatic failure, Hepatitis, Hypotension, Infection, Pseudo lymphoma
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad)
Write-up: recv HepB series 86,had adequate [conc]antiHBS.1990-tx for lymphoma w/ chemo - AST & ALT rose as dose of med was tapered then pt to Asia; pt presented 5 wk later w/fulminant hepatitis consistent w/reactivation of chronic Hep B;

VAERS ID:83031 (history)  Vaccinated:1995-11-21
Age:60.0  Onset:1995-11-26, Days after vaccination: 5
Gender:Male  Submitted:1996-02-20, Days after onset: 86
Location:Foreign  Entered:1996-02-26, Days after submission: 6
Life Threatening? No
Died? Yes
   Date died: 1995-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atrovent, digoxin dak tabs;capoten, seroxat
Current Illness:
Preexisting Conditions: cardiac disease
Diagnostic Lab Data:
CDC 'Split Type': CO6464
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)CONNAUGHT LABORATORIES    
Administered by: Other     Purchased by: Other
Symptoms: Bronchitis, Cardiovascular disorder, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Cardiomyopathy (broad)
Write-up: resp insufficiency & bronchitis w/cardiac disease;died-unrelated to drug;

VAERS ID:84209 (history)  Vaccinated:1996-03-11
Age:60.0  Onset:1996-03-12, Days after vaccination: 1
Gender:Male  Submitted:1996-03-22, Days after onset: 10
Location:Foreign  Entered:1996-04-01, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tenormine
Current Illness:
Preexisting Conditions: hypertension
Diagnostic Lab Data:
CDC 'Split Type': 960034271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Cerebral ischaemia
SMQs:, Ischaemic cerebrovascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: pt recv vax & 24hrs later on 12MAR96 acute memory disorder appeared,for which the pt was hosp;no hypertension flare was noted;The reporter''s causality assessment is: poss related to Engerix-B;further details were requested & will follow

VAERS ID:99835 (history)  Vaccinated:1997-02-12
Age:60.0  Onset:1997-02-15, Days after vaccination: 3
Gender:Male  Submitted:1997-06-30, Days after onset: 134
Location:Foreign  Entered:1997-07-08, 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:
Current Illness:
Preexisting Conditions: chronic membrano-proliferative glomerulonephritis;nicotinism;diabetes mellitus;hyperparathyroidism;
Diagnostic Lab Data: 15FEB97 creatinine 65;18FEB97 creatinine 55;25FEB97 creatinine 51;7APR97 creatinine 42;2MAY97 creatinine 54;creatinine 30;urine creat clearance 24 hr 15.7;urine creat cl 24 18.5;abd echography cortico medullar dedifferentiation of 2 kidneys
CDC 'Split Type': 970153201
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 1IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Azotaemia, Blood creatinine increased, Condition aggravated, Creatinine renal clearance decreased, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad)
Write-up: 15FEB97 4 days p/vax pt exp severe renal failure aggravation w/inc creatinin & dec creatinin clearance levels causing hosp;25FEB97 abd echography showed cortico medullar dedifferentiation of the 2 kidneys 2MAY97;

VAERS ID:108074 (history)  Vaccinated:1998-01-20
Age:60.0  Onset:1998-01-24, Days after vaccination: 4
Gender:Female  Submitted:1998-03-06, Days after onset: 41
Location:Foreign  Entered:1998-03-09, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: dog bite on lt ankle on 17JAN98
Diagnostic Lab Data: a corneal smear & blood was sent for analysis & was negative for Rabies;
CDC 'Split Type': 2808
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)CHIRON CORPORATION 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Myasthenic syndrome, Paraesthesia, Speech disorder
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Malignancy related conditions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: pt recv vax 20JAN98 & pt was alleged to have devel post vax sx of tingling, numbness & weakness in both lower limbs accompanied by diff in speaking p/4 days;pt hosp 24JAN98;

VAERS ID:109051 (history)  Vaccinated:1998-03-04
Age:60.0  Onset:1998-03-06, Days after vaccination: 2
Gender:Male  Submitted:1998-04-01, Days after onset: 26
Location:Foreign  Entered:1998-04-02, Days after submission: 1
Life Threatening? Yes
Died? Yes
   Date died: 1998-03-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: immunosuppressive drugs
Current Illness:
Preexisting Conditions: stray dog bite on lt leg;stated to be abnormal;
Diagnostic Lab Data:
CDC 'Split Type': 2962
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)CHIRON CORPORATION 3IM 
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Hypokinesia
SMQs:, Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax 4MAR98 & 2 days p/vax pt devel a severe backache, loss of motor power in lt leg, inability to walk w/o support;pt died 4 days later, cause unk;

VAERS ID:112548 (history)  Vaccinated:1996-10-01
Age:60.8  Onset:1996-10-01, Days after vaccination: 0
Gender:Male  Submitted:1998-06-11, Days after onset: 618
Location:Foreign  Entered:1998-07-13, Days after submission: 32
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: allergic to most inflammatory tablets (antiinflammatory agents);
Diagnostic Lab Data: NONE
CDC 'Split Type': EML97833
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)MEDEVA PHARMA, LTD.    
Administered by: Other     Purchased by: Other
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: pt recv vax & approx 1 wk later exp tightness in the chest p/egg consumption;this response disappeared 5mo ago;pt had avoided eggs during this period;

VAERS ID:113912 (history)  Vaccinated:1998-07-01
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:1998-09-01
Location:Foreign  Entered:1998-09-08, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': U199800513
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Leukocytosis, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: pt recv vax & exp urticaria, fever & dry cough 15 days p/vax;tests reveale a biological inflammatory synd w/granulocytosis;no infect etiology was found;sx improved w/in approx 3wk under antihistaminic & antipyretic drugs;

VAERS ID:117231 (history)  Vaccinated:1998-10-01
Age:60.4  Onset:1998-10-02, Days after vaccination: 1
Gender:Female  Submitted:1998-11-30, Days after onset: 59
Location:Foreign  Entered:1998-12-09, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Rotator cuff syndrome-left shoulder,
Diagnostic Lab Data: UNK
CDC 'Split Type': 19980286471
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hypertonia, Injection site pain, Myopathy, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt recv vax in 10/98; 1 day post vax pt exp fever, flu like sx, vax site pain & stiffness, difficulty moving LA; dx=tear; tx=corticosteroid prep, Lidocaine

VAERS ID:120519 (history)  Vaccinated:1999-01-20
Age:60.9  Onset:1999-01-21, Days after vaccination: 1
Gender:Male  Submitted:1999-03-19, Days after onset: 57
Location:Foreign  Entered:1999-03-23, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 19990064991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: pt recv vax & 21JAN99 1 day p/vax pt devel neuropathy;the reporting MD considers this event to be probably r/t vax;

VAERS ID:122034 (history)  Vaccinated:1999-03-17
Age:60.0  Onset:1999-03-19, Days after vaccination: 2
Gender:Female  Submitted:1999-05-05, Days after onset: 46
Location:Foreign  Entered:1999-05-11, 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: Adalate;Atarax;Calcidia;Cozaar;Elisor;Glipizide;Lasix;Lopressor;Lovenox;Maalox;Iohexol;Rocaltrol;Allopurinol
Current Illness: renal insufficiency requiring dialysis
Preexisting Conditions: non insulin dependent diabetes, renal insufficiency (segmental & focal hyalinosis);
Diagnostic Lab Data: 25MAR99 - WBC=20600; C-Reactive protein nl;Cytomegalovirus neg;Epstein Barr virus negative;Serology: mycoplasma/syphylis negative
CDC 'Split Type': 19990096901
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Leukocytosis, Rash pustular
SMQs:, Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: 19MAR99 pt hosp for dialysis catheter placement & recv IV contrast & Lovenox for dialysis; 24MAR99 pt devel acute gen pustular exanthema;skin biopsy performed, confirmed pustulosis; completely recovered w/ corticosteroids & other med chang

VAERS ID:129281 (history)  Vaccinated:1999-09-29
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:1999-09-29
Location:Foreign  Entered:1999-10-13, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 1999026249
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Depression, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: p/vax pt devel 12hr p/vax & exp depression, fever 38C, joint c/o & red spots of the whole body;unspecified time p/vax;vax became incapacitated;event was considered as serious;

VAERS ID:129825 (history)  Vaccinated:1999-07-12
Age:60.9  Onset:1999-07-18, Days after vaccination: 6
Gender:Female  Submitted:1999-10-21, Days after onset: 95
Location:Foreign  Entered:1999-10-26, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: this patient has no relevant medical history & is on no concomitant medication;
Diagnostic Lab Data:
CDC 'Split Type': 1999027634
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Herpes zoster, Neuralgia
SMQs:, Peripheral neuropathy (narrow)
Write-up: p/vax pt devel herpes zoster;tx w/Pamvir;pt recovered but was still suffering from postherpetic neuralgia;reporting MD considered the event to be disabling/incapacitating & poss r/t vax;

VAERS ID:133146 (history)  Vaccinated:1999-09-17
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:1999-10-30
Location:Foreign  Entered:2000-01-07, Days after submission: 69
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin, hypericin
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Bone marrow biopsy, basophil count (0), eosihophil count (2), lymphocyte count (3.3 - 5.2), neutrophil count(3) , serum c-reactive protein (normal)
CDC 'Split Type': WAES99122092
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMA
Administered by: Other     Purchased by: Other
Symptoms: Bone marrow depression, Laboratory test abnormal, Thrombocytopenia
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Myelodysplastic syndrome (broad)
Write-up: Post vaccine, pt''s blood examination revealed thrombocytopenia of 39000/microl. No hematoma or hemorrhage. Previous thrombocyte counts have been within normal range. Pt was hospitalized for bone marrow biopsy.

VAERS ID:134242 (history)  Vaccinated:1999-12-15
Age:60.0  Onset:1999-12-25, Days after vaccination: 10
Gender:Male  Submitted:2000-02-15, Days after onset: 52
Location:Foreign  Entered:2000-02-29, Days after submission: 14
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': U2000000770
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)PASTEUR MERIEUX INST.P11812  RA
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER008031 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myalgia, Myasthenic syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Malignancy related conditions (narrow), Eosinophilic pneumonia (broad)
Write-up: On 12/15/99, pt recv''d IPV & TD vax. A few days later, he exp myalgia in both upper arms & then weakness in the left arm. Pt saw a neurologist but an exact dx could not be obtained.

VAERS ID:150784 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2000-04-05
Location:Foreign  Entered:2000-04-06, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 20000091462
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Hypokinesia
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Approximately 1 - 2 years ago the pt received an injection with Havrix. Post vaccination, the pt experienced rheumatic disease with swelling and pain of the big joints and movement restriction. The pt was treated for the event with cortisone and a stay in a hospital. The most recent information received on 3/31/00 reports the outcome of the pt as not yet recovered. The reporter did not specify the causality.

VAERS ID:152227 (history)  Vaccinated:1999-12-28
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2000-05-19
Location:Foreign  Entered:2000-05-23, 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: Pulmicort, Serevent, Zyrtec.
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: VR 1.0 eg, VL 0.5 eg pressure. PRL 19/25 pressure right eye. 5 days later: VR 0.8 eg, LR1 0.8. PRL 14/17.
CDC 'Split Type': WAES00051078
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Infection, Intraocular pressure increased, Laboratory test abnormal, Pyrexia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (narrow), Lens disorders (broad), Retinal disorders (broad)
Write-up: Information has been received from a health authority concerning a 60 year old male, who was vaccinated on 12/28/1999 with pneumococcal vaccine 23 polyvalent. In December, 1999 the pt experienced fever and increased intraocular pressure. The increased pressure in his eyes caused blurred vision. He was seen in a dept of ophthalmology where he previously had been investigated concerning glaucoma heredity with a somewhat higher pressure in his left eye. He was hospitalized. There were some signs of eye infection. The pt recovered without sequelae. The reporter felt the fever was probably related to vaccination, however, the relationship between intraocular pressure and the vaccine was unclassifiable. No further information is available.

VAERS ID:157662 (history)  Vaccinated:1999-10-19
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2000-05-05
Location:Foreign  Entered:2000-07-20, Days after submission: 76
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MPU2000000860
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)MEDEVA PHARMA, LTD. 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Herpes simplex
SMQs:, Arthritis (broad)
Write-up: Pt experienced pains in joints (knees, elbows, ankles) after receiving vax. Pain reported as often being quite severe. Pt also developed cold sores inside nose.

VAERS ID:158193 (history)  Vaccinated:1999-11-08
Age:60.0  Onset:1999-11-11, Days after vaccination: 3
Gender:Female  Submitted:2002-01-10, Days after onset: 791
Location:Foreign  Entered:2000-08-01, Days after submission: 527
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 1st dose of Rabies HDC vax on 11/08/1999. On 11/11;Rabies (Imovax);1;60;In Patient
Other Medications: Imogam (immunoglubulin human antirabies)
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': U1999010970
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)AVENTIS PASTEUR  IM 
Administered by: Other     Purchased by: Other
Symptoms: Cough, Musculoskeletal stiffness, Rash, Serum sickness
SMQs:, Anaphylactic reaction (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: It was reported that a woman was bitten by a stray cat in early November. She was given Rabies immunoglobulin and 1st dose of Rabies HDC vax on 11/08/1999. On 11/11, she developed dry sore throat feeling. Later that day she received 2nd dose of Rabies HDC vax (same lot). Later that day she developed dry hacking cough. On 11/16, she developed a rash, initially forearms, then spread to legs and then to trunk. On 11/17, she saw a physician and was given Prednisone 25 mg. On 11/18. rash a bit better in the morning, took another Prednisone 25mg, and by evening the rash was back, accompanied by stiffness on extremities and trunk. On 11/19, Prednisone 20 mg, rash on face, cheeks, and chin; cough much more when lying down. At some point she was given an antibiotic (NOS) and cough syrup (time frame UNK and UNK if she is still taking antibiotic). Follow-up information requested. Reporters would not give telephone numbers. From additional information received on 12/28/99, it was reported, "serum sickness was the dx reported by the reporting physician. On 06/23/00, this case was reevaluated and reclassified as a 15-day alert report per health professional it falls in the classification of other serious criteria. From follow-up received on 12/10/2001 it was reported that the pt''s recovery status is unknown. From follow-up on 01/07/2002 it was confirmed that the Rabies vaccine that was administered to the pt was Imovax rabies IM.

VAERS ID:160752 (history)  Vaccinated:1995-12-15
Age:60.0  Onset:1996-07-01, Days after vaccination: 199
Gender:Female  Submitted:2002-06-25, Days after onset: 2185
Location:Foreign  Entered:2000-10-20, Days after submission: 613
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: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': 2000029935
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 1IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperreflexia, Hypokinesia, Muscle atrophy, Muscle spasticity, Muscular weakness, Nervous system disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Approximately seven months post vax, in July 1996, the pt developed motor activity deficiency and limbs sensitive disorder. She was hospitalized in neurologic unit, where amyotrophic lateral sclerosis was dx. The most recent information received on 10/12/00 reports the outcome of the pt as not yet recovered. The pt was treated with riluzole. It was noticed that lower limbs motor activity and sensitive disorder were still persistant, but were not incapacitating. Other diagnosis suspected: spinal amyotrophy and multifocal motor neuropathy. The most recent info received on 06/10/02 reports the outcome of the pt as not yet recovered. Received on 06/16/2003: "Medical history is unknown in this patient. On 11/14 and 12/15/1995, the patient was vaccinated with Engerix-B (hepatitis B vaccine) at a dose of 20mcg. Approximtately seven months later, in July 1996, the patient developed motor activity deficiency and limbs sensitive disorder. She was hospitalized in neurologic unit, where at first amyotrophic lateral sclerosis was suspected. In February 1997, it was noticed that lower limbs motor activity and sensitive disorder were still persistent, but were not incapacitating. Other diagnosis suspected: spinal amyotrophy and multifocal motor neuropathy. In April 2002, motor deficiency improved. The outcome of the patient as not yet recovered. Causality assessment was reported by the AFSSAPS as dubious for Engerix -B.

VAERS ID:165635 (history)  Vaccinated:2000-10-18
Age:60.0  Onset:2000-10-21, Days after vaccination: 3
Gender:Male  Submitted:2001-02-02, Days after onset: 104
Location:Foreign  Entered:2001-02-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: cardiomyopathy, congestive heart failure, coronary artery disease
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES01012650
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.HJ41640 IM 
Administered by: 0     Purchased by: 0
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: On 10/21/00 the pt developed paralysis. Upon internal review, the paralysis was considered an other important "medical event." Additional information has been requested.

VAERS ID:165868 (history)  Vaccinated:2000-09-26
Age:60.0  Onset:2000-09-28, Days after vaccination: 2
Gender:Female  Submitted:2002-06-24, Days after onset: 634
Location:Foreign  Entered:2001-02-14, Days after submission: 494
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES01012426
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anosmia, Dysgeusia, Sinusitis, Viral infection
SMQs:, Taste and smell disorders (narrow)
Write-up: Information has been received from a health professional concerning a 60 year old female who on 9/26/00 was vaccinated IM in the left upper arm, with a 1st dose of pneumococcal vaccine 23 polyvalent. On 9/28/00, the pt developed an "atypical" viral infection and sinusitis for 3 weeks. In October, 2000, the pt experienced anosmia and "taste diminishing", which lasted to the day of reporting on 1/24/01. The reporter considered the pt''s anosmia and "taste diminishing" to be both disabling and an "Important Medical Event". The reporter also considered the "atypical" viral infection and sinusitis to be disabling. No further information is available. Additional info received on 06/12/02 indicated that despite request, no further info was received. The outcome for the "atypical" viral infection and the sinusitis was recovered and the outcome for the anosmia and "taste diminishing" was unknown. No further info is available.

VAERS ID:168620 (history)  Vaccinated:1995-07-20
Age:60.0  Onset:1996-09-01, Days after vaccination: 409
Gender:Male  Submitted:2001-04-10, Days after onset: 1682
Location:Foreign  Entered:2001-04-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic lumbago; Enthesopathy; Arthrosis Rheumatism
Diagnostic Lab Data: Labs showed creatinine phosphokinase increase (255 iu/l; NR-170 iu/l; Creatinine phosphokinase was found between normal and 2 normal until 7/98. In 11/97, EMG was nml; Unspecified viral serologies were nml. Unspecified immune exam increased
CDC 'Split Type': 20010083061
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: 0     Purchased by: 0
Symptoms: Alanine aminotransferase increased, Back pain, Blood creatine phosphokinase increased, Fasciitis, Gamma-glutamyltransferase increased, Muscle disorder, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad)
Write-up: On 1/20/95, 2/20/95 and 7/20/95, the pt received 1 injection of unspecified Hep-B. In 9/96, 21 months later, the pt developed diffuse lower and upper limbs myalgia, paravertebra muscle myalgia (myalgia back). No inflammatory syndrome was found. In 6/99, the pt was hospitalized for check-up. Unspecified immune increased (340 iu/l (NR:0-170 iu/l) as well as SGPT and GGT (3N). SGOT was nml. No biological inflammatory syndrome was found. In 9/99, the pt was re-hospitalized. The pt was treated with unspecified corticoid drug. Myalgia persisted. The most recent information received on 4/2/01, reports the outcome of the pt as not yet recovered. The causality assessment was coded as dubious for unspecified Hep-B.

VAERS ID:172135 (history)  Vaccinated:2001-04-16
Age:60.0  Onset:2001-04-17, Days after vaccination: 1
Gender:Male  Submitted:2001-06-10, Days after onset: 54
Location:Foreign  Entered:2001-06-20, Days after submission: 10
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': 20010145721
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: 0     Purchased by: 0
Symptoms: Epistaxis, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: On 4/16/01, a dose of Engerix-B Adult (IM) was given. On 4/17/01, 24 hours, post vax, this male subject developed epistaxis and fever. Subsequently, he was hospitalized. After 48 hours, he had completely recovered and was discharged. The reporting physician did not assess a causal relationship. Additional information has been requested.

VAERS ID:177572 (history)  Vaccinated:2000-02-11
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2001-11-08
Location:Foreign  Entered:2001-11-12, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prednisolone
Current Illness:
Preexisting Conditions: Pulmonary fibrosis
Diagnostic Lab Data: Oxygen saturation was 60% on exercise
CDC 'Split Type': HQ8100406NOV2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IM 
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Cough, Dyspnoea, Hypoxia, Interstitial lung disease, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: It was reported that a 60 year old male received Flu-Shield (2000-2001) vaccine on 2/11/00. Additional suspect medication included Pneumovax II vaccine (Morson and Sons) (pneumococcal vaccine) and prednisolone. Following immunization, the pt developed an "activation of lung fibrosis" with increasing shortness of breath on exertion and a progressive cough. He was treated with an increased dose of prednisolone (increased from 10mg daily to 30mg daily). The pt developed progressive cryptogenic pulmonary fibrosis and died of respiratory failure with hypoxia after 8 months. Upon safety review info received 11/28/2001, the reporting product was changed to Begrivac. Pt received Begrivac vaccine on 02/11/2000.

VAERS ID:177894 (history)  Vaccinated:2001-08-28
Age:60.0  Onset:2001-09-15, Days after vaccination: 18
Gender:Male  Submitted:2002-01-15, Days after onset: 122
Location:Foreign  Entered:2001-11-19, Days after submission: 57
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Examinations of an otorhinolaryngologist, an opthamologist and a neurologist were normal. A computed tomography was normal.
CDC 'Split Type': 20010268081
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Hyperacusis, Visual disturbance
SMQs:, Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)
Write-up: On 08/28/01 the vaccinee received the first Twinrix adult hepatitis A and B vaccine. Approximately two weeks post vaccination, on an unknown date in the mid of September 2001, the pt experienced hyperacusis, visual disturbance and exhaustion. the patient was unfit to work. Examinations of an otorhinolaryngolist, an ophthalmologist and a neurologist were normal. Exhaustion resolved at first, followed by resolve of visual disturbance and hyperacusis. Information received on 11/13/ reports were resolved in the beginning of November. The reporter did not specify the causality. Additional information has been requested. According to follow up info from 1/14/02, nearly all events resolved. On 1/1/02, consultants, an opthalmologist and other physicians, told the reporting physician that they considered that the events were unrelated to vaccination with Twinrix adult. A psychogenic cause seemed probable and a psychotherapy was recommended. The pt observed himself extremely and did not give his consent to contact the consultants.

VAERS ID:179635 (history)  Vaccinated:2000-09-06
Age:60.0  Onset:2000-11-14, Days after vaccination: 69
Gender:Male  Submitted:2001-12-24, Days after onset: 405
Location:Foreign  Entered:2002-01-03, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Laboratory test results showed ESR to be 79, C-reactive protein 170 and rheumatoid factor negative.
CDC 'Split Type': 20010300391
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM640A6 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, Red blood cell sedimentation rate increased, Rheumatoid factor
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow)
Write-up: On 06-SEP-2000 the pt received a dose of Havrix. On 14-NOV-2000, the pt developed inflammatory arthritis. The reporter considered the event to be serious as it involved persistent of significant disability or incapacity. The most recent information received on 19-DEC-2001 reports that the pt had not recovered at the time of reporting. No other details were given. No further information is expected.

VAERS ID:179838 (history)  Vaccinated:1999-11-08
Age:60.0  Onset:1999-11-16, Days after vaccination: 8
Gender:Female  Submitted:2001-12-10, Days after onset: 755
Location:Foreign  Entered:2002-01-10, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rig Imo-gam UPS
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': U199901097
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)PASTEUR MERIEUX INST. 1  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Pharyngitis, Rash, Serum sickness
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Oropharyngeal infections (narrow), Hypersensitivity (narrow)
Write-up: A foreign report from the maufacturer regarding events in Canada. It was reported, "A 60-year-old woman was bitten by a stray cat in early November. She was given Rabies immunoglobulin and 1st dose of Rabies HDC vaccine on 8 November 1999. On 11 November 1999, she developed dry sore throat feeling; later that day she received second dose of Rabies HDC vaccine(same lot) On 16 November 1999, she received second ; later that same day she developed dry hacking cough. On 16 November 1999, she developed (a) rash-initially foreatms, the spread to legs and then to trunk. On 17 November 1999, she saw a physician, given Prednisone 25 mg. On 18 November 1999, rash a bit better in the morning, took another Prednisone 25mg; by evening rash back, stiff on extremities and trunk. On 19 November 1999, Prednisone 20 mg, rash face/cheeks/chin; cough much more when lying down. At some point given antibiotic (name unknown) and cough syrup (time frame unknown, and unknown if she is still taking antibiotic). Follow-up information requested. Reporters would not give telephone numbers. From addittional information received on 28-Dec-1999, it was reported, the diagnosis reported by the reporting physician. On 23-Jun-2000, this case was revaluated and reclassified as 15-day alert report; per health professional it fails in the classification of other seriousness criteria. From follow-up correspondence received on 10-DEC-2001 it was reported that the patient''s recovery status is unknown.

VAERS ID:182093 (history)  Vaccinated:1999-10-23
Age:60.0  Onset:2001-11-08, Days after vaccination: 747
Gender:Female  Submitted:2002-03-12, Days after onset: 124
Location:Foreign  Entered:2002-03-07, Days after submission: 5
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Labs were reported in SI units: glucose 11.05; Hb 7.2; HK 0.35; WBC 26.5; PTT 27; fibrinogen 6.7; AT III 122; potassium 3.68; osmolarity 299; gamma GT 0.59; CRP 164.5; TSH 0.15; FT3 1.94 and further routine parameters (not specified) were i
CDC 'Split Type': WAES0202USA02122
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1610H0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, CSF test abnormal, Drug ineffective, Meningitis, Somnolence, Ventricular arrhythmia
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a 60 year old female physician who on 10/23/99 was vaccinated in the left upper arm with a 1st dose of pneumococcal vaccine 23 polyvalent (lot HN74910). On 11/9/01, the pt became severely ill with somnolence, meningism and a remarkably impaired general condition. She was admitted to the hospital and dx''d with meningitis due to Streptococcus pneumonia (PCR (+), no subtyping of the pneumococcal bacteria). No foci were found in the ENT and dental region. After a 14 day antibiotic treatment with cefotaxmin and ampicillin + sulbactam, the pt''s condition improved. The date of discharge was not reported. After 9 weeks, the pt completely recovered. Meningitis and vaccine failure were considered to be life-threatening by the reporter. No further information is available. The file is closed. The US equivalent lot number was added to the report. Follow up info indicated that in the evening of 11/8/01 the pt suddenly felt a severe headache, at 1 am on 11/9/01 she vomited and the ER physician was called. The physician assessed "reduced vigilance and meningism" and sent her to another hospital. Cranial CT showed generalized cerebral edema and serum exams showed elevated infectious parameters (no details or values were reported). The pt was immediately transferred to the ICU of a hospital where she was hospitalized until 11/23/01. Subsequently, she was then treated in a rehabilitation hospital for some weeks. It was reported that since 10/30/01, she was having severe back pain with radiation to her thighs and suspicion of polymyalgia rheumatica was made. She was treated symptomatically and felt improvement. No further info is available. The file is closed.

VAERS ID:183762 (history)  Vaccinated:1995-07-20
Age:60.0  Onset:1996-09-01, Days after vaccination: 409
Gender:Male  Submitted:2002-04-17, Days after onset: 2054
Location:Foreign  Entered:2002-04-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Enthesopathy; lumbar pain; Rheumatism
Diagnostic Lab Data: Lab 1996 and 1999-no inflammatory syndrome; EMG-nml 11/97; lab immunologic test-nml 6/99; lab gamma GT-3 X N 6/99; muscular biopsy-left deltoid-macrophagic myofasciitis 7/99; lab-gamma GT-+96 9/99; serum creatine kinase-255 9/96; serum alan
CDC 'Split Type': WAES0204USA00884
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Blood creatine phosphokinase increased, Fasciitis, Gamma-glutamyltransferase increased, Muscle disorder, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a health authority concerning a 60 year old male who on 1/20/95, 2/20/95 and 7/20/95 was vaccinated with the 1st, 2nd and 3rd doses of Hep-B vaccine recombinant (yeast) IM. In 9/96, the pt developed diffuse myalgia in the 4 limbs and vertical muscles. Also in 9/96, the pt had an increased CPK of 255. It was reported that the CPK remained elevated until 7/98; however, conflicting lab data revealed in 6/99 (year appox.) CPK-340 and in 9/99 CPK-276. In 7/99, the pt was hospitalized for investigations and a left deltoid muscle biopsy showed macrophagic myofasciitis. It was reported that there was no inflammatory syndrome between 1996 and 6/99. Also in 9/99, the pt was started on a treatment with corticoids but the myalgia was persistent. The pt was considered as not recovered. Myalgia, CPK increased at 255 and macrophagic myofasciitis were considered to be disabling by the health authority. No further information is available.

VAERS ID:183907 (history)  Vaccinated:2000-07-18
Age:60.0  Onset:2000-07-20, Days after vaccination: 2
Gender:Female  Submitted:2002-04-23, Days after onset: 642
Location:Foreign  Entered:2002-04-25, 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: Haloperidol
Current Illness: UNK
Preexisting Conditions: Ankle fracture, Cholecystectomy
Diagnostic Lab Data: Mild disturbed EEG following excess of slow activity;
CDC 'Split Type': B0264871A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Apathy, Cognitive disorder, Dizziness, Faecal incontinence, Hypoacusis, Laboratory test abnormal, Nausea, Urinary incontinence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (broad)
Write-up: This report describes the occurrence of a rapid cognitive deterioration (differential diagnoses of Lewy body disease, Creutzfeld Jacob disease or rapidly progressive Alzheimer dementia) in a 60 year old female patient receiving Havrix (hepatitis A vaccine). On 18 June 2001, a booster dose of Havrix was given. On 02 June 2001, 2 days after vaccination, this patient developed a rapidly progressive cognitive deterioration with initial symptoms or sensation of dizziness and nausea for which she was treated rather unsuccessfully with Celestone. She became increasingly apathetic and absent. She was disoriented and bradyphrenic and may be somewhat less steady. On 30 June 2001, her husband came back from a travel and he found his wife ill and noticed that the house was less well kept than usual, however no changes in her behavior, nor in her independence. On 17 July 2001, she pretended having given a phone call which she actually did not do. From then on, her husband noticed that she became increasingly apathetic and absent. He also got the impression that she was having some hearing loss. On 08 August 2001, she was seen by an ENT specialist and she was found to have an abnormal audiogram. Subsequently, she was referred to a neurologist. On clinical examination she was found to be bradyphrenic, apathetic, disoriented with hearing loss on the left side. Subsequently, she was hospitalized. During hospitalization, she experienced an incontinence problem. Extensive investigations were performed but no diagnosis could be set. After 7 weeks she was discharged. After discharge, her husband tried to motivate and orientate her by using calendars to teach her the concept of day. However, hearing remained variable diminished as well as her speech. The husband noticed that she had increasing difficulties in finding words. She confabulated and sometimes showed comprehension difficulties. She had one more episode with incontinence. Her husband noticed that she started to improve and particularly that she regained interest. In spite of

VAERS ID:185310 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:2002-01-31
Gender:Male  Submitted:2002-05-16, Days after onset: 104
Location:Foreign  Entered:2002-05-24, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: omeprazole; promethazine
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: CXR-no abnormality; autoimmune profile-no abnormality; renal function study-no abnormality; WBC-13.2 10 over 9/L; basophil ct-0.1; hemoglobin-14.2 g/dl; eosinophil ct-0.5; lymphocyte ct-2.0; monocyte ct-0.5; neutrophil ct-10.2; ESR-20; seru
CDC 'Split Type': WAES0205USA00656
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood fibrinogen increased, Henoch-Schonlein purpura, Lymphopenia, White blood cell count increased
SMQs:, Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 60 year old male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included omeprazole and promethazine. On 01/31/2002 the pt developed henoch-schonlein purpura and was hospitalized from 01/31/2002 to 02/08/2002. Lab test for renal function, IgA, autoimmune profile, liver function and chest X-ray did not detect any abnormalities. Additional lab results included: Haemoglobin-14.2g/d; white blood cell count-13.2 10^9L; neutrophils-10.2; lymphocytes-2.0; monocytes-0.5; eosinophils-0.5; basophils-0.1; ESR-20; fibrinogen-594mg/dl (170-450). The pt was noted to be recovering. The reporter felt that henoch-schonlein purpura was possibly related to therapy with pneumococcal vaccine 23 polyvalent. Henoch-schonlein purpura was considered to be disabling and an other important medical event. No further info is available.

VAERS ID:186801 (history)  Vaccinated:2002-04-25
Age:60.0  Onset:2002-04-28, Days after vaccination: 3
Gender:Male  Submitted:2002-06-17, Days after onset: 50
Location:Foreign  Entered:2002-06-20, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC 'Split Type': WAES0206USA00928
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.060011 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a health care professional concerning a 60 year old male who on 04/25/2002 was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal vaccine 23 polyvalent. On 04/28/2002 in the night, the pt experienced chills and on 04/29/2002 the pt developed a fever up to 39.8, headache and pain in his limbs. It was reported that the pt was hospitalized due to his chills and fever. As of 06/03/2002, it was reported that the pt did not recover. No further info is available.

VAERS ID:187599 (history)  Vaccinated:2002-02-12
Age:60.0  Onset:2002-02-17, Days after vaccination: 5
Gender:Male  Submitted:2002-07-15, Days after onset: 147
Location:Foreign  Entered:2002-07-16, 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: Adipositas, Chronic Venous Insufficiency, Hyperuricemia, Runny nose
Preexisting Conditions: Adrenalectomy, Lymphadenectomy, Nephrectomy, Renal Cell Carcinoma Stage III
Diagnostic Lab Data: Sonography - left kidney is normal, no congestion, no kidney stones; urinary bladder is nearly empty. Lab examinations on 2/21/01 - urine/stool are normal, spcific weight was less than 1005; General exam on 2/21/01 - miction is normal
CDC 'Split Type': D0038917A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS233D6 IMRA
YF: YELLOW FEVER (YF-VAX)AVENTIS PASTEUR755211 SCLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Faeces pale, Hyperuricaemia, Malaise, Night sweats, Oedema peripheral, Renal failure, Rhinorrhoea, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow)
Write-up: Report number D0038917A describes the occurrence of renal failure in a 60 year old male receiving Twinrix adult for prophylaxis. This report was received from the regulatory authority which received this report through the manufacturer from an unreported health care professional. Medical history included wide-spreaded small cell renal cell carcinoma right removed in 09/2001 by tumor nephrectomy right, adrenalectomy and parabiliary lymphadenectomy. Computed tomography performed on 1/16/02 showed no tumor recurrence, no lymph nodes and normal liver. Current medical conditions included hyperuricemia, chronic venous insufficiency of the legs, adipositas and chronic purulent runny nose. Concurrent medications have not been reported. On 2/12/02 the vaccinee received the fourth dose of Twinrix adult (hepatitis A and B vaccine) and the first dose of Stamaril (yellow fever live vaccine). Approximately 5 days post vaccination on 2/17/2002 the vaccinee experienced renal failure with anuresis, peripheral edema in the legs, malaise, night sweat and thirst which improved after about two days. Additionally, the vaccinee experienced yellow stool and upper abdominal pressure pain. The vaccinee did not consult a physician until 2/21/02. On this day, an urologist found physical exam, urinary tract sonogram and lab analysis of urine and stool to be normal. This case has been assessed as serious according to manufacturer medical criteria. The most recent information received on 7/11/02 reported the outcome of the event as resolved. The reporter did not specify any causality of the events in relation to vaccination with Twinrix adult. The reporter considered that the events were possibly related to vaccination with Stamaril. The urologist considered the events to be related to vaccination without any further specification. No further information will be available. Per follow up: Stoll was still coloured.

VAERS ID:193589 (history)  Vaccinated:2002-09-24
Age:60.0  Onset:2002-09-28, Days after vaccination: 4
Gender:Female  Submitted:2002-11-15, Days after onset: 48
Location:Foreign  Entered:2002-11-20, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Back pain, shivering and nausea;Hep A (unknown mfr);;59;In Patient
Other Medications: Carbamazepine, Lansoprazole, Co-proxamol
Current Illness:
Preexisting Conditions: Esophageal reflux, neuralgia, pain
Diagnostic Lab Data: Alanine aminotransferase - 484; Alkaline phosphatase - 554iu/l; Bilirubin - 34mmol/l; GGT 450iu/l; Full blood count normal.
CDC 'Split Type': B0284668A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS738B6 IM 
Administered by: Other     Purchased by: Other
Symptoms: Chills, Chromaturia, Liver function test abnormal, Malaise, Nausea, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: A regulatory authority reported the occurrence of abnormal hepatic function in a 60 year old female who was vaccinated with hep A vaccine (Havrix). Medical history included an adverse reaction following a dose of hep a-typhoid vaccine (Hepatyrix) in December 2001, events included back pain, shivering and nausea. Concurrent medical conditions included neuralgia, oesophageal reflux and pain. Co-suspect medication included carbabazepine. Concurrent medications included lansoprazole and Co-proxamol. On 9/24/02 the subject received a dose of hep A vaccine 0.5ml IM. Four days post vaccination the subject developed abnormal liver function tests, aching all over, nausea, shivering, dark urine and severe general malaise. A full blood count was completely normal. The reporter considered the events to be disabling. The co-suspect drug was stopped on 10/2/02. The subject was noted to be recovering both biochemically and clinically. This case was considered serious (OMIC) according to the regulatory authority.

VAERS ID:196784 (history)  Vaccinated:2002-12-04
Age:60.0  Onset:2002-12-06, Days after vaccination: 2
Gender:Female  Submitted:2003-01-21, Days after onset: 46
Location:Foreign  Entered:2003-01-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0301USA00767
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Malaise, Pain
SMQs:
Write-up: Information has been received from a health authority concerning a 60 year old female who on 12/4/02 was vaccinated SC with a dose of pneumococcal vaccine 23 polyvalent (batch unknown). On 12/6/02 the patient presented with aches in the left arm and armpit and was reported to be feeling awful. The outcome was reported as unknown. The reporter considered the reaction to be serious as it involved or prolonged inpatient hospitalization. Additional information is not expected. The case is to be considered as closed.

VAERS ID:204845 (history)  Vaccinated:2003-04-17
Age:60.0  Onset:2003-04-18, Days after vaccination: 1
Gender:Male  Submitted:2003-06-10, Days after onset: 53
Location:Foreign  Entered:2003-06-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0306USA00433
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0516M   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Hypokinesia, Influenza like illness, Myalgia, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health professional concerning a 60 year old male pt with no reported relevant medical history who on 4/17/03 was vaccinated with a first dose of hep B virus vaccine rHBsAg (HS12300; 643219/0516M). On 4/18/03, the pt developed myalgia reported as "muscular aches and pains," flu-like symptoms, anorexia and weight loss. It was noted that symptoms had not resolved but "persisted to the state that he is now unable to comb his hair" and "a diagnosis of polymyalgia rheumatica" was being considered. The reporting physician has perfomred unspecified investigations, and results are awaiting. The pt was being treated with paracetamol and diclofenac. No further info was provided. "Muscular aches and pains," flu-like symptoms, anorexia and weight loss were considered to be disabling. Follow up on 02/13/04 states: Follow up information received on 01/29/04 indicated that this case was followed up 3 times in May, June, December 2003 to try to obtain details and outcome. No responses have been received to these letters. Unless data is subsequently received, the case is closed without outcome. "Muscular aches and pains", flu-like symptoms, anorexia and weight loss were considered to be disabling."

VAERS ID:209248 (history)  Vaccinated:2003-04-01
Age:60.0  Onset:2003-04-01, Days after vaccination: 0
Gender:Male  Submitted:2003-09-05, Days after onset: 156
Location:Foreign  Entered:2003-09-16, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: Diagnostic lab test showed his acute phase to be elevated; Ultrasound slightly raised, enlarged spleen 12.7cm; Erythrocyte sedimentation rate 14; Serum C-reactive protein 30; Urine RBC count less than 10 red blood cells; Urine WBC count les
CDC 'Split Type': WAES0309USA00177
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Fatigue, Influenza like illness, Laboratory test abnormal, Night sweats, Polymyalgia rheumatica
SMQs:, Vasculitis (narrow)
Write-up: Information has been received from a health professional concerning a male patient with no relevant medical history reported who in April 2003, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast)(thimerosal free). One week post vaccination, the patient''s "symptom" began. It was noted in the clinic comments from 7/22/03 that following vaccination with hepatitis B virus vaccine, the patient developed generalized muscle pains, anorexia, and flu-like symtpoms. He felt drained, and washed out and was initially thoguht to have transient viremia following the vaccine. The symptoms did not spontaneously resolve and worsened. He described classic polymalgic symptoms with profound shoulder and pelvic girdle weakness, he also lost weight. It was noted that blood tests (not specified) showed his acute phase to be elevated. It was reported that he was diagnosed with polymyalgia. It was noted that he received 15mgs steroids which improved the symptoms. However when the steroids were reduced to 10mgs, symptoms recurred and he had difficulties with physical activities. He was prescribed prednisolone 10 mgs daily with diclofenac 50mgs three times a day and lansoprazole. The patient was examined with x-rays and immunoglobulins were checked to exclude alternative etiologies. The prednisolone was increaesd to 15mcgs, with bisphosphonate as osteoporotic prophylaxis. Additional clinic comments repoprted on 10/7/03 indicated the patient was examined. Blood tests and ultrasound were normal, other than a slightly raised, enlarged spleen 12.7 centimeters, ESR was 27, and CRP was 30 which showed an improvement since May. A urine cell count showed less than 50 white blood cells, and less than 10 red blood cells, and his thyroid function was normal. The patient reported feeling much better, although he still experienced night sweats, but less than once a week. His weight was increasing and his appetite was good. He had some aches and pains, and his most annoying symptoms, was that of an awareness of his arms and legs, whic

VAERS ID:217549 (history)  Vaccinated:2002-11-28
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2004-03-09
Location:Foreign  Entered:2004-03-10, 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: UNK
Current Illness: UNK
Preexisting Conditions: Cat allergy; for other reports posted on the same website see cases D0042952A, D0042953A, D0042956A, D0042963A, D0042964A ,D0042966A.
Diagnostic Lab Data: UNK
CDC 'Split Type': D0042965A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER    
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Granuloma, Injection site swelling, Pruritus, Sweat gland disorder
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: This report described the occurrence of injection site swelling in a 60 year old male who was vaccinated with hepatitis A-B vaccine for prophylaxis due to overseas travel. This report was received from a consumer via a web site posting on the internet side of a non-medical practitioner. Follow up was received from a physician, who could not fully verify the report. Another follow up was received from the treating homeopathist. Concurrent medical conditions included cat allergy. Concurrent medications included tetanus vaccine and rabies vaccine. The subject had received two former vaccinations with hepatitis A-B vaccine on 8/30/01 and 9/27/01. On 11/28/02, the subject received the third dose of hepatitis A-B vaccine. The consumer reported than an unspecified time later the subject developed injection site swelling with pruritus. Pruritus resolved and the outcome of swelling was not reported. The treating physician confirmed the vaccination dates and stated that the subject had not told him about any complaints after this or the former vaccinations. The physician did not see the subject until 1/1/04, when he visited him at home. At that time the subject complained about swelling at the injection site and recurring pruritus. Due to the bad light a clear evaluation by the physician was not possible. The treating physician and homoeopathist stated that the reaction to vaccination began in the beginning of 2003, but the subject visited her in December 2003 for the first time. According to her written report, the subject had swollen sweat glands and pruritus and received homeopathic treatment, but the events were still ongoing. The homoeopathist stated that the events were serious, as the subject had permanent damage. In a telephone call two days later the homoeopathist reported that the subject had swelling and pruritus at the injection site. The swelling was a subcutaneous granuloma with the size of a pea. The homoeopathist now stated that the subject later had allergies after working in the garden, probably to some p

VAERS ID:218634 (history)  Vaccinated:2002-08-29
Age:60.0  Onset:2002-09-21, Days after vaccination: 23
Gender:Male  Submitted:2004-04-05, Days after onset: 562
Location:Foreign  Entered:2004-04-07, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: Blood urine present; Body temperature 39.3C; Neutrophils 0.74%; Urinary protein positive; White blood cells 4600/mm3.
CDC 'Split Type': B0328910A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Coordination abnormal, Face oedema, Fatigue, Guillain-Barre syndrome, Headache, Laboratory test abnormal, Pyelonephritis, Pyrexia, Rash, Rash papular, Urine analysis abnormal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer and described the occurrence of a Guillain Barre syndrome in a subject of unknown gender and age who had received Hepatitis A vaccine injection for prophylaxis. A physician or other health care professional has not verified this report. The case was medically confirmed with a follow up received on 5/24/04. This subject has no history of drug hypersensitivity. On 8/29/02, the patient received Hepatitis A vaccine. On 9/21/02, 23 days after receiving Hepatitis A vaccine, this subject developed a rash on feet which later spread over the whole body. He developed also turbid urine as well as increasing tiredness, decreased strength and coordination. On 9/27/02, he was hospitalized due to vague complaints. The hospital report mentioned that the subject developed fever and headache of undetermined origin 6 days before admission. He took possibly aspirin and did not work for an unspecified duration. On admission the following findings were made: rash in the extremities and the whole body with pruritus and fever. He had also dark red-brownish papules in the postauricular region, face, trunk and extremities. The papules were slightly elevated on the back. Some papules were confluent to form a sheet of rash lesion. He was also found to have a swollen face and a decreased amount of urine volume. Lab tests retrieved the following results: white blood cell count: 4600/mm3, neutrophils 0.74%. Urine analysis: blood +, protein +++. Possible diagnoses of viral rash and pyelonephritis were made. He was referred to the emergency department and later seen at the department of infectious disease where an infectious disease could be excluded. On 9/29/02, a diagnosis of Guillain Barre syndrome was made. On 10/01/02 and 11/13/02, he was hospitalized again respectively for an unknown duration. He was treated with immunoglobulins until August 2003. Following this treatment, he was able to live normally again, but was still having residual phenomena for which he was actively treated. As of 4/2/04, at the

VAERS ID:222115 (history)  Vaccinated:2004-03-23
Age:60.0  Onset:2004-03-23, Days after vaccination: 0
Gender:Female  Submitted:2004-05-27, Days after onset: 64
Location:Foreign  Entered:2004-05-28, 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: Sibutramine hydrochloride; Alendronate sodium
Current Illness: UNK
Preexisting Conditions: Obesity; Osteoporosis
Diagnostic Lab Data: UNK
CDC 'Split Type': B0328189A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Headache, Liver function test abnormal, Pneumonia, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a physician and described the occurrence of pneumonia in a 60 year old female subject who had received hepatitis A, hepatitis B injection for prophylaxis. Co-suspect medication included a dose of typhoid vaccine also given on 3/23/04. Concomitant medication included sibutramine chlorhydrate monohydrate for obesity and alendronate sodic for osteoporosis. This subject has no known history of allergy and is not a at risk patient. On 3/23/04 the patient received a 1st dose of Twinrix (IM). The same day, 5 hours after vaccination, this subject developed headache and fever. On 3/25/04, the events were still as intense as on the onset date. On 3/26/04, laboratory results showed liver function disorders as well as an inflammatory picture. On 3/30/04, she was hospitalized. A diagnosis of pneumonia of the left lower lobe was made. She was treated with antibiotics. On 5/10/04, she had fully recovered. The reporter considered the vaccination and the onset of the events to be coincidental and hence unrelated to the vaccination. The vaccination course had been discontinued as the subject refused further vaccinations.

VAERS ID:225678 (history)  Vaccinated:2004-05-24
Age:60.0  Onset:2004-05-28, Days after vaccination: 4
Gender:Male  Submitted:2004-08-20, Days after onset: 84
Location:Foreign  Entered:2004-08-23, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: A MRI of thorax, abdomen and bone marrow showed no peculiarities.
CDC 'Split Type': B0342549A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Immune system disorder, Lymphadenopathy
SMQs:
Write-up: This case was reported by the authorities and described the occurrence of a non-hodgkin b-cell lymphoma in a 60 year old male subject who received Hepatitis A vaccine (Havrix 1440) injection for prophylaxis. On 05/24/04 the subject received a dose of Havrix 1440. On 05/28/04, 4 days following vaccination, he developed a swelling of the axillary lymph nodes. The swelling increased during the next 4 weeks. An excision was performed and the histologic primary finding was diagnosed as ultramalignant non-hodgkin b-cell lymphoma. A MRI of the thorax, abdomen and bone marrow showed no peculiarities. The subject was hospitalized and received a dose of chemotherapy. The receptor pattern in the immunhistologic investigation did not confirm the first diagnosis and classified the finding as atypical immunoreaction. The subject had recovered from the event and the resulting consequences. This case was assessed as medically serious by manufacturer (OMIC). The regulatory authority reported that the event was probably related to vaccination with Hepatitis A vaccine. No additional information are requested and therefore this case has been closed.

VAERS ID:225687 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2004-08-20
Location:Foreign  Entered:2004-08-23, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0342902A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Parkinsonism, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: The case was reported by a consumer and described the occurrence of Parkinson''s syndrome in a 60 year old female subject who received hepatitis B vaccine for prophylaxis. Around 2000, the subject received the first dose of Engerix. Two years after the injection, around 2002, the subject presented with dysequilibrium when swimming. Within an unspecified delay, she developed tremor and a diagnosis of Parkinson''s syndrome was made. At the time of reporting, the events were unresolved. This case was assessed as medically serious (OMIC). The reporter''s causality relationship was unknown. Follow up 02/14/05: this is a consumer case about Parkinson disease outcome is unresolved.

VAERS ID:225740 (history)  Vaccinated:2004-08-12
Age:60.0  Onset:2004-08-16, Days after vaccination: 4
Gender:Male  Submitted:2004-08-23, Days after onset: 7
Location:Foreign  Entered:2004-08-23
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Treated for rectal cancer about 1.5 years ago. Diet controlled diabetes mellitus.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hepatic failure, Pyrexia, Renal failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad)
Write-up: Fever began on 8/16/04. Had vomiting a few days after that. Hospitalized on 8/19/04. Has multiple system organ failure. Currently is in ICU with failing lungs, liver and kidneys.

VAERS ID:226828 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2004-09-17
Location:Foreign  Entered:2004-09-21, Days after submission: 4
Life Threatening? Yes
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': E200403061
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Hypoxia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was initially reported by a foreign regulatory authority on 9/13/04. A 60 year old male patient was administered influenza vaccine in 2001 (specific date not provided, batch number not reported and manufacturer unknown). The patient developed GBS in 2001 (exact date of onset not reported). The patient also developed respiratory distress, which was attributed to GBS. The patient was treated with ventilation and plasmaphoresis. The patient was also given human IVIG as a treatment, which is thought to be human immunoglobulin. The reaction text states the following: A few weeks later, patient was admitted to the ICU and required ventilation 2-3 times due to respiratory distress which was attributed to GBS. The patient was then discharged with a portable ventilator. Patient had not recovered at the time of the report, the date of which is not specified. No further information is expected, case is closed.

VAERS ID:229742 (history)  Vaccinated:2004-10-28
Age:60.0  Onset:2004-10-28, Days after vaccination: 0
Gender:Male  Submitted:2004-11-23, Days after onset: 26
Location:Foreign  Entered:2004-11-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Leftose; Ambroxol hydrochloride; Oxitropium bromide
Current Illness:
Preexisting Conditions: Gastric ulcer; Emphysema; Oxygen supplementation
Diagnostic Lab Data: Body temp 38.2-40C; WBC 6000/microL; Hematocrit 31.5%; Hemoglobin 9.9 g/dL; Platelet count 26.1; Serum creatine kinase 1189 IU/l; RBC 334/microL; WBC 5400/microL; Hematocrit 31.7%; Hemoglobin 10.0 g/dL; Platelet count 29.8; Serum C-reactive protein 6.97 mg/dL; Serum creatine kinase 1613 IU/l; RBC 340/microL; WBC 4700/microL; Hematocrit 24.8%; Hemoglobin 7.8 g/dL; Platelet count 34.9/microL; Serum C-reactive protein 2.75 mg/dL; Serum creatine kinase 656 IU/l; Stool culture negative; RBC 267; WBC 6000; Hematocrit 26.6%; Hemoglobin 8.3 g/dL; Platelet count 46.4; RBC 277/microL; WBC 5400/microL; Hematocrit 29.2%; Hemoglobin 8.9 g/dL; Platelet count 43.0; Serum creatine kinase 78 IU/l; RBC 293/microL
CDC 'Split Type': WAES0411USA03292
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Blood creatinine increased, Cellulitis, Hypokinesia, Injection site erythema, Laboratory test abnormal, Oedema peripheral, Pain, Pyrexia, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: Information has been received from a physician concerning a 60 year old male with emphysema and on oxygen supplementation at home since 7/27/04 and a history of gastric ulcer (4/04) who on 10/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine 0.5mL. Other concomitant therapy included oxitropium bromide, ambroxol hydrochloride, lysozyme HCl. On 10/28/04, the patient developed pyrexia of 38.2 to 40C and redness at the vaccination site. On 10/29/04, the patient visited the physician complaining of pain on the right thigh, right arm, face on the right side, disturbed right arm movement, swelling on the right side of the face and swelling of right upper and lower extremities. He was treated with lomefloxacin hydrochloride and loxoprofen sodium. On 11/1/04, the patient was placed on therapy with imipenem/cilastatin sodium, injection, 1gm, once a day for the treatment of cellulitis. On 11/1/04, the patient recovered from pyrexia. On 11/1/04, the patient developed anemia. Laboratory findings also revealed increased creatine kinase and increased C-reactive protein. He was treated with betamethasone butyrate propionate. On 11/4/04, the patient''s anemia worsened. Stool occult blood, uring occult blood or hemolysis were not observed. On 11/4/04, therapy with imipenem/cilastatin sodium was discontinued as inflammation findings improved. On 11/5/04, the patient visited the physician when he was recovering from swelling of the face and disturbed right arm movement. On 11/9/04, he recovered from disturbed right arm movement, swelling on the right side of the face, and swelling of right upper and lower extremities. On 11/15/04, he was recovering from anemia. The reporting physician considered disturbed right arm movement, swelling of face on the right side, swelling of right upper and lower extremities as other important medical events (OMIC). Pyrexia and anemia were considered non-serious. He felt that disturbed right arm movement, swelling face on the right side, and swelling of right upper and lower extremities and pyrexia were definitely related to pneumococcus vaccine, not related to therapy with imipenem/cilastatin sodium. He commented that bone marrow suppression was suspected as a cause of anemia and that such adverse experiences were not observed when he was administered with imipenem/cilastatin sodium and lomefloxacin hydrochloride previously. Additional information is not expected. Per Follow up report received on 06/14/2005: Patient''s recovery status is still unknown.

VAERS ID:232119 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2005-01-10
Location:Foreign  Entered:2005-01-11, 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: UNK
Preexisting Conditions: Allergy to Josacine; Hypertension Arterial
Diagnostic Lab Data: Anti-HBc antibody negative; Anti-HBs antibody positive; Biopsy muscle MMF; C-reactive protein normal; CBC normal; Hepatitis B surface antigen negative; Platelet count normal; At unspecified dates: Hepatitis C serology negative; Blood ionogr
CDC 'Split Type': B0363102A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Connective tissue disorder, Difficulty in walking, Fasciitis, Laboratory test abnormal, Muscle disorder, Myalgia, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of a possible connective tissue disease in a 60 year old female subject who received unspecified hepatitis B vaccine for prophylaxis. The subject''s medical history included allergy to Josacine and arterial hypertension. At unspecified date, the subject received a dose of unspecified hepatitis B vaccine (IM). In 1997, the subject presented with chronic asthenia and myalgia (described as aches), which were aggravated by efforts. In 2002, the subject walked with difficulty during 300 meters, she get up hills with difficulty, and she did not carry. In May 2002, muscular left biopsy showed lesions of macrophagic myofascitis associated with lymphohistiocytic vasculitis and myocyte suffering which suggested muscular impairment of connective type (possible connective tissue disease). At unspecified dates, biological tests showed positive anti-HBs antibody and negative HBs antigen, anti-HBc antibody and hepatitis C serology, C-reactive protein was normal. On an unknown date, the subject was hospitalized. Treatment with hydrocortisone was started (unknown date). Then the outcome was good. Hydrocortisone was stopped in February 2004 and the subject was able to start again her activities. It was mentioned that the events lasted seven years. At the time of reporting, the subject had recovered. The agency considered the events of myalgia and asthenia as unlikely related to hepatitis B vaccine. 08/18/2005: No further inforamtion is available.

VAERS ID:234884 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2005-03-11
Location:Foreign  Entered:2005-03-14, 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: Patient suffered from a post-influenza acute disseminated encephalomyelitis.
Diagnostic Lab Data:
CDC 'Split Type': E200500990
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Encephalitis, Laboratory test abnormal, Paresis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: It was reported in a published article that a 60 year old woman developed acute paraparesis 10 days after receiving the influenza virus vaccine and 6 months after an episode of post-influenza acute disseminated encephalomyelitis. A spinal cord MRI showed she had thoracic T2-hyperintense lesions at T10-11 and T12. She received high dose methylprednisolone and recovered almost completely. The case is closed. (OMIC)

VAERS ID:235177 (history)  Vaccinated:2005-01-18
Age:60.0  Onset:2005-03-09, Days after vaccination: 50
Gender:Male  Submitted:2005-03-18, Days after onset: 9
Location:Foreign  Entered:2005-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Irbesartan; Coaprovel; Atovaquone/Proguanil HCl
Current Illness: Hypertension
Preexisting Conditions: Hepatic: No medical history.
Diagnostic Lab Data: Alanine aminotransferase 347IU/L; Alkaline phosphatase 378IU/L; Aspartate aminotransferase 121UI/L; Bilirubin 108 micromol/L; Bilirubin unconjugated 5.8 micromol/L; Eosinophils normal. Hepatitis B and C serologies negative.
CDC 'Split Type': B0374448B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Jaundice, Laboratory test abnormal, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician and described the occurrence of icterus in a 60 year old male subject, who was vaccinated with hepatitis A vaccine for hepatitis A prophylaxis. Concurrent medical conditions included hypertension; the subject had no history of hepatic disorder. Concurrent medications included irbesartan, irbesartan + hydrochlorothiazide, and atovaquone + proguanil hydrochloride tablet. On 1/18/05, the subject received an injection of Hepatitis A vaccine. Same day, his hypertension treatment with irbesartan was switched to Coaprovel. On 2/20/05, the subject started Malarone (oral) at 1 tablet daily. On 3/9/05, approximately 17 days after starting Malarone and 3 days after his return from a trip, the subject experienced an episode of vomiting and mild abdominal pain. On 3/11/05, the subject had a routine visit with his physician, he was found with icterus. On the same day, the subject''s blood investigations showed alanine aminotransferase increased at 347 IU/L, alkaline phosphatase level increased at 378 IU/L, increased bilirubin level at 108 micromol/L with unconjugated bilirubin level of 5.8 micromol/L. Serologies performed for hepatitis B and C were negative. The subject''s eosinophil count was normal. Treatment with Malarone was discontinued. At the time of the report (3/11/05), the outcome of the events was unresolved. This case was assessed as medically serious (OMIC). Hepatitis A vaccine was not considered as suspected by the reporter. The reporting physician considered the events were possibly related to treatment with Malarone.

VAERS ID:235350 (history)  Vaccinated:1995-06-14
Age:60.0  Onset:2002-06-01, Days after vaccination: 2544
Gender:Male  Submitted:2005-03-23, Days after onset: 1026
Location:Foreign  Entered:2005-03-23
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypercholesterolemia
Preexisting Conditions: Concurrent medical condition included hypercholesterolemia initially treated with Atorvastatin, secondarily discontinued in 2002.
Diagnostic Lab Data: At unknown date, biological test showed white cell count at 53000 (NOS); neutrophils at 60%, eosinophils at 4%, basophils at 1%, lymphocytes at 27% and monocytes at 8%; sedimentation rate at 6; C-reactive protein <5; sodium at 140; potassium at 4.4; plasma protein at 77 g/L; plasma urea at 5.6 mmol/L; plasma creatinine at 98 (NOS); alkaline phosphatase at 72 IU/L; bilirubin total at 13mcmol/L; gamma GT at 18 IU/L; Aspartate aminotransferase at 23 (NOS); Alanine aminotransferase at 36 (NOS). On 27 May 2003, a muscle biopsy at left deltoid was performed and found macrophagic myofascitis lesions at the fascia level.
CDC 'Split Type': B0375356A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Asthenia, Basophilia, Blood alkaline phosphatase increased, Blood bilirubin increased, Eosinophilia, Fasciitis, Laboratory test abnormal, Monocytosis, Myalgia, Pain, Skin ulcer, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of myalgia in a 60 year old male subject who was vaccinated with Hepatitis B vaccine (Engerix B) for hepatitis B prophylaxis. Concurrent medical conditions included hypercholesterolemia initially treated with Atorvastatin (Tabor), secondarily discontinued in 2002. Concurrent medication included 3 injections of GenHevac B (20 November 1983, 14 May 1994, 19 June 1994) and 6 injections of Diphtheria Tetanus Poliomyelitis vaccine (20 November 1983, 20 December 1983, 24 January 1984, 25 January 1985, 18 May 1990, 14 April 1995). On 14 Jun 1995, the pt received Engerix B (IM). Approximately 7 years after the Engerix B vaccination, on 1 June 2002, the subject experienced ascending myalgia starting from legs then spreading to thighs and finally to upper limbs. Myalgia was associated with major asthenia and a weight loss of 4 kg. At unknown date, clinical examination was normal excepted a pain found at the left shoulder. At unknown date, biological test showed white cell count at 53000 (NOS); neutrophils at 60%, eosinophils at 4%, basophils at 1%, lymphocytes at 27% and monocytes at 8%; sedimentation rate at 6; C-reactive protein <5; sodium at 140; potassium at 4.4; plasma protein at 77 g/L; plasma urea at 5.6 mmol/L; plasma creatinine at 98 (NOS); alkaline phosphatase at 72 IU/L; bilirubin total at 13mcmol/L; gamma GT at 18 IU/L; Aspartate aminotransferase at 23 (NOS); Alanine aminotransferase at 36 (NOS). On 27 May 2003, a muscle biopsy at left deltoid was performed and found macrophagic myofascitis lesions at the fascia level. At time of reporting, the events resolved with sequelae. The outcome of pain at left shoulder was unknown. The regulatory authority reported that the events were disabling.

VAERS ID:235459 (history)  Vaccinated:2003-07-22
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2005-03-22
Location:Foreign  Entered:2005-03-28, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Armidex; Tamoxifen
Current Illness: Breast Cancer
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0503USA02840
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0860M1IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Joint stiffness, Pharyngitis, Rhinitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Arthritis (broad)
Write-up: Information has been received from a health authority concerning a 60 year old female with breast cancer and who has stopped hormone replacement therapy in February 2003, who on 6/24/03, was vaccinated with a first dose 1.0ml, IM dose of hepatitis B virus vaccine (batch # HS67420/lot # 643570/0982M) and on 7/22/03 was vaccinated with a second dose of hepatitis B virus vaccine (batch # HS45930/lot # 644093/0860M). The patient was taking tamoxifen citrate, 20mg, oral administration, between 3/31/03 and 5/19/03 for breast cancer. The patient was also taking anastrozole, 1mg, oral administration from 6/4/03 for breast cancer. Following vaccination, in June 2003, the patient experienced joint stiffness. Increasing joint stiffness occurred over several weeks. This disappeared for 10 days when the patient had a bad cold in January 2005. At the time of this report the patient has not yet recovered. Joint stiffness was considered to be disabling by the reporter. The health authority also considered the event to be serious. Other business partner numbers include: E200501049 and 485895. No further information is expected. Case is closed.

VAERS ID:241064 (history)  Vaccinated:2005-03-23
Age:60.0  Onset:2005-04-08, Days after vaccination: 16
Gender:Male  Submitted:2005-07-07, Days after onset: 90
Location:Foreign  Entered:2005-07-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol Succinate
Current Illness: UNK
Preexisting Conditions: Hypertension
Diagnostic Lab Data: Antineutrophil cytoplasmic ant normal; antinuclear antibody normal; blood count normal; blood electrolytes normal; c-reactive protein normal; catecholamines normal; coagulation test normal; rheumatoid factor normal; transaminases normal; Tr
CDC 'Split Type': D0046997A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABA030AA IM 
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEUR  IM 
TD: TETANUS DIPHTHERIA (NO BRAND NAME)AVENTIS PASTEUR  IM 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Cardiac disorder, Cyanosis, Dyspnoea, Headache, Hypertension, Hypertrophy, Laboratory test abnormal, Nausea, Raynaud's phenomenon, Renal cyst
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of Raynaud''s Syndrome in a 60 year old male subject who was vaccinated with Twinrix adult for prophylaxis. Medical conditions included hypertension. Previous vaccination included yellow fever vaccine (IM) given on 16 February 2005. According to the hospital report the subject also received typhus vaccine, together with yellow fever approximately 3 weeks before admission to the hospital. Co-suspect vaccination included diphtheria tetanus and poliomyelitis vaccine (IM) given on 23 March 2005. Concurrent medication included Metoprolol Succinate at low doses over a longer time. The subject has not been to foreign countries within the last 3 years. On 23 March 2005 the subject received an unspecified dose of Twinrix adult together with diphtheria tetanus and poliomyelitis vaccine. An unspecified time post vaccination, approximately 2 weeks before admission to hospital, in March 2005 the subject developed asthenia and tiredness. Five days before admission to hospital, in the evening of 31 March 2005, the subject developed sudden dyspnea attacks during mild exercise with acrocyanosis of the fingers and lips. This was followed by nausea and headache. On 05 April 2005 the subject was hospitalized for 4 days. On admission the symptoms had resolved. A myocardial infarction was excluded by laboratory tests. Echocardiogram showed minor tricuspid insufficiency with mild increase of pulmonary pressure up to 38 mmHg. An ergometric examination on exertion was without pathologic findings. Lung function test was normal. The pt was treated with enalpril. On 8 April 2005, during the final examination for discharge from hospital, the subject experienced Raynaud''s syndrome under treatment with beta blocker. Further diagnostics were performed to exclude secondary Raynaud symptoms. Catecholamines, rheumatic factors, ANA, and ANCA were normal. Treatment with beta blocker was changed to amlodipine (Norvasc). At the time of reporting Raynaud''s syndrome was improv

VAERS ID:243158 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2005-08-15
Location:Foreign  Entered:2005-08-19, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Body temp: high fever.
CDC 'Split Type': WAES0508USA01892
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a health professional concerning an adult female patient (age not reported) with an unknown medical history, who was vaccinated IM in the upper arm on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). Subsequently, two days post vaccination, she developed severe diarrhea and a high fever, lasting for more than one week$g Due to this , she collapsed and was admitted to the hospital for diagnostics. Results are pending. At the time of the report she had not yet completely recovered. Additioonal information is expected. Other business partner numbers include E2005-03056.

VAERS ID:243343 (history)  Vaccinated:2004-12-08
Age:60.0  Onset:2005-01-20, Days after vaccination: 43
Gender:Female  Submitted:2005-08-24, Days after onset: 215
Location:Foreign  Entered:2005-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Desloratadine
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0391174A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of asthenia in a 60 year old female subject who was vaccinated with hepatitis B vaccine for prophylaxis. Concurrent drug included desloratadine. On 12/8/04, the subject received unspecified dose of Engerix B. On 1/20/05, 43 days after vaccination with Engerix B, the subject experienced asthenia, arthralgia and somnolence. The healthcare professional considered the events were clinically significant (OMIC). At the time of reporting, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Engerix B. On 8/3/05, the subject received another dose of Engerix B.

VAERS ID:243916 (history)  Vaccinated:2005-08-01
Age:60.0  Onset:2005-08-09, Days after vaccination: 8
Gender:Male  Submitted:2005-09-07, Days after onset: 29
Location:Foreign  Entered:2005-09-08, 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:
Preexisting Conditions: No history reported.
Diagnostic Lab Data:
CDC 'Split Type': E200503434
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Myalgia, Night sweats, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was initially reported by a foreign health authority on 9/1/05. This case concerns a 60 year old male patient. Details of the patient''s medical history and concomitant have not been provided. The patient received a yellow fever vaccine, batch number and manufacturer not reported on 8/1/05. On 8/9/05, eight days after receiving the vaccination, the patient experienced aching joints and muscle and an intermittent fever. The patient had also experienced night sweats for three days which at the time of the report was improving. The patient received treatment with paracetamol and was recovering. The reporter considered this to be a non-serious reaction, however, the agency considered this to be a serious reaction. No further information is available, this case is closed. (OMIC)

VAERS ID:244927 (history)  Vaccinated:2005-03-01
Age:60.0  Onset:2005-04-15, Days after vaccination: 45
Gender:Female  Submitted:2005-10-04, Days after onset: 172
Location:Foreign  Entered:2005-10-04
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Decreased strength in arm, edema of hand, meningioma, thrombosis
Diagnostic Lab Data: Electromyography showed chronic neurogenous impairment of of muscles innervated by left Fasiculus dorsalis with signs of denervation of Musculus extensor digitorium communis as well as mild denervation of Musculus brachioradials. Electromyo
CDC 'Split Type': D0046982A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA060BA IMRA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Other     Purchased by: Other
Symptoms: Carotid artery occlusion, Condition aggravated, Hypotonia, Laboratory test abnormal, Lymphoedema, Movement disorder, Muscle atrophy, Myasthenic syndrome, Neuropathy, Oedema peripheral, Paralysis, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Ischaemic cerebrovascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: A physician reported the occurrence of paresis in a 60 year old female subject who was vaccinated with Influsplit for prophylaxis This case was also received from a regulatory authority. Final examination for withdrawal from working life revealed that the subject experienced complaints and decreased strength in both arms, but especially at the left elbow joint, since quite a while. In addition, the subject occasionally developed edematous swellings in hands which were more pronounced left than right. The subject did a lot of sports (golf, tennis, swimming). According to the hospital report concurrent medical conditions included chronic lymphedema left due to thrombotic occlusion of V. jugularis and involvement of V. subclavia left and Truncus brachiocephalicus. There was also meningioma in the frontal temporal junction are right (originating from orbital tectum). Co-suspect was a simultaneous vaccination with IPV on 01 March 2005 in to the left upper arm. There was no further concurrent medication. On 01 March 2005 the subject received 1st dose of influenza vaccine (IM, right deltoid). According to follow-up information there were no local or systemic side effects directly after vaccination. In the mid of April 2005, approximately six weeks after vaccination with influenza vaccine, the subject developed flaccid paralysis of the left arm and muscle atrophy after doing sports. Examinations had not revealed a clear cause for the events. The subject was hospitalized on 14 July 2005 for clarification. According to the hospital report in the mid of April the subject suddenly experienced paresis of left hand and initially distinct swelling of the arm. Under physiotherapy the events improved. However, extension of fingers and joint of the hand was still weak. There was relapsing swelling especially in the region of the hand. Electromyography showed chronic neurogenous impairment of of muscles innervated by left Fasiculus dorsalis with signs of denervation of Musculus extensor digitorium communis as well as mild denervati

VAERS ID:246266 (history)  Vaccinated:2005-08-16
Age:60.0  Onset:2005-08-16, Days after vaccination: 0
Gender:Male  Submitted:2005-10-25, Days after onset: 70
Location:Foreign  Entered:2005-10-28, 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: History of allergic asthma, reflux, dyslipidemia.
Diagnostic Lab Data:
CDC 'Split Type': E200504264
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)AVENTIS PASTEURUNK IMUN
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURUNK IMUN
RAB: RABIES (IMOVAX)AVENTIS PASTEURUNK IMUN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURERUNK IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alcohol poisoning, Diplopia, Dysarthria, Eyelid ptosis, Gait disturbance, Laboratory test abnormal, Malaise
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Initial report on Oct 21 2005. It was reported that a 60 year old male patient was administered intramuscularly on July 20 2005 a dose of rabies vaccine (vaccine Rabique, batch number not reported), diphtheria tetanus polio and acellular pertussis vaccine (Repevax, batch no not reported) and tick encephalitis vaccine (Ticovac, other manufacture) for professional reasons. On Aug 16 2005 he experienced malaise associated with feeling of drunkenness, walking deviation towards left, dysarthria, ptosis and diplopia in left lateral eye. On an unspecified date the symptomatology improved except diplopia. the cerebral scanner was normal. The cardiovascular check up (echocardiography and carotid Doppler velocimetry) was normal. the cerebral MRI showed multiple periventricular ischemic sequelae and also sequelae in both oval centers. At the time of reporting the patient had not recovered. Follow up received on Oct 24 2005. The reporter considered that the role of vaccine is not probable in this symptomatology but only a coincidence. File to be completed.

VAERS ID:247868 (history)  Vaccinated:2005-10-25
Age:60.0  Onset:2005-11-02, Days after vaccination: 8
Gender:Female  Submitted:2005-11-17, Days after onset: 15
Location:Foreign  Entered:2005-11-21, 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: Amlodin;Bisolvon;Blopress;Pepcid
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Serum aspartate aminotransferase GOT 1282 IU/L and GPT serum alanine aminotransferase 1868 IU/L.
CDC 'Split Type': WAES0511USA01946
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver disorder
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow)
Write-up: Information has been received from pharmacist concerning a 60 year old female who on Oct 25 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included simethicone (Gasoal), bromhexine HCL (Bisolvon), phenobarbital (Phenobal), amlodipine besylate (Amlodin), Candesartan cilexetil, (Blopress), famotidine, furosemide and digoxin. There was no information regarding ADR history or allergy. On Nov 2 2005 the patient developed transient liver disorder (a regular check performed on that day revealed GOT 1282 and GPT 1868. at the time of the report, values had com back to normal, No jaundice was found and no subjective symptoms was described. The patient recovered from the transient liver disorder (date not specified). The reporting pharmacist did not assess the causal relationship between transient liver disorder and pneumococcal 23v polysaccharide vaccine. The reporting pharmacist did not assess the seriousness of the transient liver disorder. Upon internal review transient liver disorder was determined to be an other important medical event (OMIC). Additional information had been requested.

VAERS ID:250279 (history)  Vaccinated:2005-12-02
Age:60.0  Onset:2005-12-06, Days after vaccination: 4
Gender:Male  Submitted:2006-01-11, Days after onset: 36
Location:Foreign  Entered:2006-01-11
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ventricular failure
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0405650A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Other     Purchased by: Other
Symptoms: Drug interaction, Haemorrhage, Prothrombin level increased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This case was reported and described the occurrence of hemorrhage in a 60 year old male subject who was vaccinated with influenza virus vaccine manufacturer unspecified for prophylaxis. Concurrent medical conditions included ventricular failure. On Dec 2 2005 the subject received unspecified dose of influenza vaccine (unknown). On Dec 6 2005, 4 days after vaccination the subject experienced hemorrhage, international normalized ratio increased and drug interaction. The reporter considered that the events were life threatening. At the time of reporting the events were improved. Verbatum text received: Patient on warfarin had flu jab. 4 days later INR increased. Patient usually stable on 4.5 mg. The reporter considered the reaction to be serious for the following reason: life threatening. (OMIC).

VAERS ID:251449 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2006-02-13
Location:Foreign  Entered:2006-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin trihydrate
Current Illness: Infection
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': D0048689A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Hepatic enzyme abnormal, Pruritus, Rash
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of increased liver enzymes in an approximately 60 year old female subject who was vaccinated with hepatitis A and hepatitis B recombinant vaccine for prophylaxis. Concurrent medical conditions included infection. Concurrent medications included Amoxicillin. The tolerance of the first two vaccinations with Twinrix was not reported. On an unspecified date, only four weeks after the second dose, the subject received 3rd dose of Twinrix adult (unknown route and injection site). A short time after vaccination with Twinrix adult, the subject experienced increased liver enzymes, exanthema, and persisting itching. At that time, the subject was treated with amoxicillin due to an unspecified infection. This case was assessed as medically serious (OMIC). At the time of reporting the outcome of the events was unspecified. Follow up information has been requested.

VAERS ID:252333 (history)  Vaccinated:2004-10-30
Age:60.0  Onset:2004-10-30, Days after vaccination: 0
Gender:Female  Submitted:2006-03-03, Days after onset: 489
Location:Foreign  Entered:2006-03-06, 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': 200600468
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)AVENTIS PASTEUR  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypokinesia, Injection site pain, Radiculitis brachial, Shoulder pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Seriousness criteria other medically significant (OMIC). A 59 year old female patient who never received vaccination as a child developed a tender arm after receiving the intramuscular injection of TD (lot number not reported) on 10/30/2004. the reporter, who is the patient was not sure if the vaccine was received in the right or left arm, however because her right arm is sore, she felt it must have been in her right arm. Reporter was also not sure of the exact date of administration. The reporter stated she had TD in Oct 2004 and her arm was tender immediately. In Dec 2004 her arm was still sore. In Jan 2005 she saw a physician who did blood work and said it was weird. She had an x ray of her neck or arm (patient cant remember which one). She had five visits to a chiropractor then went back to the physician. She has seen a physiotherapist and a sports doctor and now has an appointment to see a physiatrist. The patient stated her arm is painful and she is losing the use of it. Stated that physio and sports medicine physicians are treating her for adhesive capsulitis (frozen shoulder). She stated that she has read the TD product insert and say brachial neuritis described her symptoms to a T. She has not been diagnosed with brachial neuritis by a physician. The patient stated that a couple of days ago she discovered her sister had the same problem following the administration of TD IPV and she wonders if it is something in the tetanus. Case linked with 200600446, patients sister.

VAERS ID:253635 (history)  Vaccinated:2006-03-14
Age:60.0  Onset:2006-03-14, Days after vaccination: 0
Gender:Female  Submitted:2006-03-31, Days after onset: 17
Location:Foreign  Entered:2006-04-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor
Current Illness:
Preexisting Conditions: Mitral valve repair, hyperlipidaemia.
Diagnostic Lab Data:
CDC 'Split Type': WAES0603AUS00195
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Erythema, Fatigue, Oedema, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician, via another company, concerning a 60 year old female with hyperlipidemia and a history of mitral valve prolapse repair in 2001, who on 3/14/2006 was vaccinated intramuscularly with Pneumococcal 23v polysaccharide vaccine, 0.5ml. Concomitant therapy included atorvastatin calcium (Lipitor). On 3/14/2006, following vaccination with Pneumococcal 23v polysaccharide, the patient developed a swollen, red arm and that evening she experienced rigors and a temperature. On 3/15/2006 the swelling in her arm had decreased, the redness had gone and there was no abscess. The patient still felt she had a temperature but when measured by her physician, it was normal at 36 degrees C. On 3/17/2006 the physician called the patient and she stated that she had no temperature or pain in her arm but she felt tired and weak, She requested a blood test (unspecified), results of which were normal. Subsequently, the patient was recovering from weakness and tiredness but at the time of this report on 3/24/2006 the doctor had yet to call her to confirm her recovery. The reporter felt that swollen arm, red arm, rigors, tiredness, weakness and feeling hot (had temperature) were related to therapy with Pneumococcal 23v polysaccharide vaccine. Swollen arm, rigors, tiredness, weakness and feeling hot (temperature) were considered to be disabling. Additional information is not expected.

VAERS ID:253744 (history)  Vaccinated:2005-11-17
Age:60.0  Onset:2005-12-05, Days after vaccination: 18
Gender:Female  Submitted:2006-04-05, Days after onset: 120
Location:Foreign  Entered:2006-04-05
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': B0418557A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Lymphadenitis
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by an unknown source and described the occurrence of axillary lymphadenitis in a 59 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 11/17/2005 the subject received unspecified dose of Fluarix (intramuscular, unknown). On 12/05/2005, 72 hours after vaccination with Fluarix, the subject experienced pain in the axillar area of the injected arm and later, axillary lymphadenitis. This case was assessed as medically serious by manufacturer (OMIC). The subject was treated with anti inflammatory (anti inflammatory drug). At the time of reporting the outcome of the event was unspecified.

VAERS ID:254911 (history)  Vaccinated:2006-03-07
Age:60.0  Onset:2006-04-10, Days after vaccination: 34
Gender:Female  Submitted:2006-05-01, Days after onset: 21
Location:Foreign  Entered:2006-05-01
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': A0603675A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0 UN
Administered by: Other     Purchased by: Other
Symptoms: Eye oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of optic nerve swelling in a 60 year old female subject who was vaccinated with Twinrix. The reporter is the son of the subject. On 07 March 2006 the subject received 1st dose of Twinrix. On 10 April 2006, 34 days after vaccination with Twinrix, the subject experienced optic nerve swelling symptoms. The subject was seen at a physician''s office. The outcome of the event was not reported. Comment: Optic nerve swelling was assessed as medically serious by the manufacturer (OMIC).

VAERS ID:257815 (history)  Vaccinated:2006-04-13
Age:60.0  Onset:2006-04-14, Days after vaccination: 1
Gender:Female  Submitted:2006-05-09, Days after onset: 25
Location:Foreign  Entered:2006-06-05, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Chloroquine Phosphate as malaria; Prozac; INH; Estradiol prophylaxis
Current Illness: NONE
Preexisting Conditions: Allergic Rhinitis
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUR225B2SCLA
RAB: RABIES (IMOVAX)SANOFI PASTEURY09292IMRA
Administered by: Private     Purchased by: Private
Symptoms: Rash macular, Vaccine positive rechallenge
SMQs:, Hypersensitivity (narrow)
Write-up: Developed pin point macular rashes on right arm after 1st dose. Developed similar rashes on 2nd dose on both arms.

VAERS ID:258992 (history)  Vaccinated:2006-05-21
Age:60.0  Onset:2006-05-22, Days after vaccination: 1
Gender:Female  Submitted:2006-06-29, Days after onset: 38
Location:Foreign  Entered:2006-06-29
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0428501A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Injection site pain, Sleep disorder
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of arm pain in a 60 year old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix adult) for prophylaxis. Subject''s previous vaccination (other vaccines) were will tolerated without problem. On 5/21/06, the subject received 1st dose of Twinrix, IM. On 5/22/06, 24 hours after vaccination, the subject experienced strong arm and shoulder pain. After 1 week with pain, the pt was checked in the hospital but nothing abnormal was found. An infection was excluded. The pt had no visible signs at injection arm (no redness or rash). The subject was treated with diclofenac (voltaron) and the pain disappeared for a short time and then came back again. The intensity of the pain did not decrease since the first appearance. The subject experienced sleep problems because of the pain. The physician considered the events were disabling. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with Twinrix adult.

VAERS ID:261462 (history)  Vaccinated:2005-10-31
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2006-08-14
Location:Foreign  Entered:2006-08-14
Life Threatening? No
Died? Yes
   Date died: 2005-12-08
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Equirab
Current Illness:
Preexisting Conditions: Rabid dog bite
Diagnostic Lab Data:
CDC 'Split Type': MA20060617
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)CHIRON CORPORATION  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Phobia
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: A 60 yr old male pt was bitten by a rapid dog on 29Sep05. He received his first dose of Rabipur at clinic with proper wound management on 01Oct05. On 02Oct05 he was administered immunoglobulin Equirab. Additional vaccinations IM with Rapibur (batch no 1130) on 4, 8, 15, and 31Oct05. It was reported that the pt developed hydrophobia for one day and backache for 4 days. The pt was admitted to hospital on 06Dec05 at 11:15am. The pt expired on 08Dec05 at 10:40am.

VAERS ID:263088 (history)  Vaccinated:2006-09-06
Age:60.0  Onset:2006-09-06, Days after vaccination: 0
Gender:Male  Submitted:2006-09-14, Days after onset: 8
Location:Foreign  Entered:2006-09-15, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Blood pressure medication
Current Illness: Diabetes, Hypertension
Preexisting Conditions: Weight loss, the subject reported that he recently lost 14 pounds.
Diagnostic Lab Data: Blood pressure 9/6/06 90/60 mm Hg, 9/6/06 100/60mm Hg. The subject stated that his normal blood pressure is 118/70 mm Hg.
CDC 'Split Type': A0619456A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB247AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB082AA1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Dizziness, Hypoxia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of dizziness in a 60 year old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) plus a separate injection of hepatitis A vaccine inactivated Havrix for prophylaxis. The subjects medical history included a recent weight loss of 14 pounds. Concurrent medical conditions included hypertension and diabetes. Concurrent medications included an unspecified blood pressure medication. On 9/6/05 at 9:00am, the subject received 3rd dose of Engerix B in the left deltoid (lot AHBVB247AA) and the 2nd dose of Havrix in the right deltoid (AHABV082AA). Immediately after vaccination with Engerix B and Havrix, at 9:00am and 9/6/06, the subject experienced dizziness, lightheadness, feeling like fainting, and his blood pressure decreased to 90/60 mmHg. The subject reported to the healthcare professional that his normal blood pressure is 118/70 mm Hg. He also stated that he hated shots. The subject was treated with Oxygen, cool compress, and was made to lie down. At 9:05am on 9/6/06, the subjects blood pressure was 100/60 mm Hg. The events resolved within one hour, by 10:00 am on 9/6/06. Follow up regarding this case was received on 9/14/06. The healthcare professional considered the decreased blood pressure was life threatening.

VAERS ID:267289 (history)  Vaccinated:2006-11-06
Age:60.0  Onset:2006-11-07, Days after vaccination: 1
Gender:Female  Submitted:2006-11-15, Days after onset: 8
Location:Foreign  Entered:2006-11-20, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: WBC count 21000, serum C reactive protein 200.
CDC 'Split Type': WAES0611USA03768
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERA07561 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0754R0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza like illness, Injection site inflammation, Laboratory test abnormal, Leukocytosis, Lymphadenopathy, Myalgia, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a physician concerning a 60 year old female who on 11/6/06 was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 653138/0754R, batch ND20210) IM into the right upper arm and concomitantly with influenza virus split virion 3v vaccine inactivated Mutagrip (lot A0756-1) IM into the left upper arm. On 11/7/06 24 hours post vaccination, the pt experienced flu like symptoms with myalgia, injection site inflammation and lymph nodes were enlarged. The pt was hospitalized on 11/9/06. Preliminary lab test showed leukocytosis (leukocyte count 2100) and increased C reactive protein (200). Manufacturer numbers included E200605833. Additional information is expected.

VAERS ID:268246 (history)  Vaccinated:2006-10-20
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2006-12-04
Location:Foreign  Entered:2006-12-04
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': A0630087A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 4 RA
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective, Liver disorder
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Lack of efficacy/effect (narrow)
Write-up: This case was reported by a physician and described the occurrence of cholestatic liver disease in a 60 year old male subject who was vaccinated with Engerix B for prophylaxis. IN Aug 2005, March 2005 and Feb 2005 the subject received 3rd, 2nd dose and 1st dose of Engerix B to complete the primary series. One month later testing indicated that the subject was not responding to therapy. The subject received a 4th dose of Engerix B in Oct 2005. Testing performed a month later again indicated that the subject had not responded to therapy. The subject still had not responded as of Aug of 2006 and he received a 5th dose of Engerix B on 10/20/06. Before and during completion of the primary series and the additional doses, the subject was under the care of a liver specialist who diagnosed the subject with liver disease on an unspecified date. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were unresolved.

VAERS ID:269639 (history)  Vaccinated:2006-12-07
Age:60.0  Onset:2006-12-07, Days after vaccination: 0
Gender:Male  Submitted:2006-12-20, Days after onset: 13
Location:Foreign  Entered:2006-12-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Therapy unspecified, Antimicrobial (unspecified).
Current Illness:
Preexisting Conditions: Lung disorder
Diagnostic Lab Data:
CDC 'Split Type': WAES0612USA02317
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Hypoaesthesia, Hypokinesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Information has been received from a health professional concerning a 60 year old male patient who in on 07 Dec 2006 was vaccinated a second dose of Pneumococcal 23v polysaccharide vaccine (lot 653280/0838R, batch ND26510). Concomitant therapy included steroids intermittently (therapy unspecified) and inhalers (unspecified) for which he was receiving intermittently for severe chronic chest disease and regular antibiotics (unspecified). On approximately 07 Dec 2006, 20 hours after vaccination, the patient was unable to move his left arm, had numbness across the chest up to the neck and also experienced redness. The patient was seen in surgery and received treatment with intravenous hydrocortisone 1000 mg and Piriton (dose not reported). The patient was sent home with Chlorphenamine. The patient recovered in 2 days. A first dose of Pneumococcal 23v polysaccharide vaccine was given in 2001. The reporter considered the events to be serious and other important medical events (OMIC). Other business partner numbers included E200606686. No further information is available.

VAERS ID:272089 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2007-02-09
Location:Foreign  Entered:2007-02-12, 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: Heart transplant, Ischaemic cardiomyopathy
Diagnostic Lab Data: diagnostic laboratory test $g27 mg/dl Comment: anti-PPS antibodies pre HT, diagnostic laboratory test 10.7 mg/dl Comment: anti-PPS antibodies 3 months, diagnostic laboratory test 2.58 mg/dL, Comment: anti-PPS antibodies 6 months, diagnostic
CDC 'Split Type': WAES0702USA00482
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antibody test abnormal, Antibody test negative, Blood culture positive, Blood immunoglobulin G decreased, CSF test abnormal, Cytomegalovirus infection, Hepatitis B antibody, Hepatitis B surface antigen positive, Hypogammaglobulinaemia, Meningitis, Meningitis streptococcal, Streptococcal infection, Vaccination failure
SMQs:, Liver infections (narrow), Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Vasculitis (broad), Hypersensitivity (broad)
Write-up: Information has been received from a published literature article, title as stated above, concerning a 60 year old male with ischemic cardiomyopathy who underwent a heart transplant. Three months before heart transplant he received non-conjugate 23- valent pneumococcal vaccine (manufacturer unknown) and recombinant anti- hepatitis B virus (manufacturer unknown). He disclosed a normal antibody response to both vaccines. Pre transplant routine serologic studies showed negative anti-cytomegalovirus (CMV) IgG antibodies. Donor IgG serology for CMV infection was positive. Immunosuppression consisted of induction therapy with methyl prednisolone and daclizumab and was maintained with tacrolimus, mycophenolate and corticosteroids. No episodes of rejection were observed during follow-up. Prophylaxis of infections included cephazolin, trimethoprim-sulphamethoxazole, nystatin, norfloxacin, intravenous gancylovir, oral valganciclovir and cytomegalovirus hyper immune immunoglobin (CMVIG). Pre-HT mantoux test was positive and isoniazide was administered. IgG monitoring revealed that IgG levels at day had dropped top 424 mg/dL and that were persistently low 3 months after HT (463mg/dL). Five months after HT, he was readmitted with CMV disease. He was treated with IV gancyclovir, IgG replacement therapy (Flebogamma, 20 g every 3-4 weeks, total 9 doses) was added because associated hypogammaglobulinemai, until IgG levels were within normal ranges. Twenty months after Ht, he developed severe septic meningitis. Streptococcus pneumoniae serotype 15 was isolated from CSF and blood. Two months before meningitis, the patient was found to have hypogammaglobinenmia (636 mg/dL), the lowest level of anti-PPS (1.55 mg/dL) and undetectable anti-HBV surface antigen antibodies. After 10 weeks the patient could be discharged home. The patient remains well one year after discharge. Thirty months after HT he received a new dose of 23-valent PPS vaccine and of tetanus toxoid. An impaired response to both vaccines was observed. No further inform

VAERS ID:272796 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2007-02-21
Location:Foreign  Entered:2007-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0639951A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2 RA
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of Guillain Barre syndrome in a 60 year old male subject who was vaccinated with Engerix B for prophylaxis. In 1988-89 at 0,2 and 6 months, the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown). In 1997, the subject experienced Guillain Barre Syndrome. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events was unspecified.

VAERS ID:282696 (history)  Vaccinated:2007-05-16
Age:60.0  Onset:2007-05-16, Days after vaccination: 0
Gender:Female  Submitted:2007-06-22, Days after onset: 37
Location:Foreign  Entered:2007-06-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': B0475802A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B015CB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, 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: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 60-year-old female subject who was vaccinated with Ditanrix adult, GlaxoSmithKline for prophylaxis. The subject was not known for prior adverse reaction to any drug. On 16 May 2007, the subject received 1st dose of Ditanrix adult (intramuscular, unknown arm). On 16 May 2007, less than one day after vaccination with Ditanrix adult, the subject experienced fever and big extension of inflammatory signs at the injection site (redness and oedema from the shoulder to the wrist). The described adverse reaction motivated a visit to the health care centre. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Further information were expected.

VAERS ID:286448 (history)  Vaccinated:2007-07-21
Age:60.0  Onset:2007-07-23, Days after vaccination: 2
Gender:Female  Submitted:2007-08-01, Days after onset: 9
Location:Foreign  Entered:2007-08-01
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: The subject had no relevant medical history
Diagnostic Lab Data: Alanine aminotransferase 24Jul2007 166, Alkaline phosphatase 24Jul2007 83, Aspartate aminotransferase 24Jul2007 106, C-reactive protein 24Jul2007 128, GGT 24Jul2007 71
CDC 'Split Type': B0480565A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, C-reactive protein increased, Gamma-glutamyltransferase, Hepatocellular damage, Liver disorder, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a physician and described the occurrence of hepatocellular injury in a 60-year-old female subject who was vaccinated with Engerix B adult, GlaxoSmithKline for prophylaxis. The subject had no relevant medical history. On 21 July 2007, the subject received 2nd dose of Engerix B adult (20 mcg, unknown batch reference). On 23 July 2007, 2 days after vaccination with Engerix B adult, the subject presented with fever, myalgia and nausea. On 24 July 2007, physical examination was normal but events remained unresolved. Biological tests evidenced an hepatocellular injury with abnormal hepatic biology (ASAT at 106, ALAT at 166, gGT at 71 and alkaline phosphatase at 83) and increased CRP at 128. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. The physician''s causality assessment was unknown.

VAERS ID:294217 (history)  Vaccinated:2007-08-14
Age:60.0  Onset:2007-08-24, Days after vaccination: 10
Gender:Female  Submitted:0000-00-00
Location:Foreign  Entered:2007-10-24
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: No known allergies (NKA)
Diagnostic Lab Data:
CDC 'Split Type': 200703489
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC2693AA IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pancytopenia
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Myelodysplastic syndrome (broad)
Write-up: Initial report received on 16 October 2007 from a pharmacist. An adult female patient, about 60 years old, with no known allergies (NKA) received on 14 August 2007, intramuscular 0.5 ml booster dose of Td Adsorbed (lot# C2693AA), into the deltoid. 10 days post-vaccination with Td Adsorbed, the patient developed redness and swelling at the site of injection. No fever. She was put on Keflex in case of cellulitis. The next day, the area was larger, but the redness was decreasing. On 11 October 2007 a blood work done and pancytopenia was noticed. The injection site redness and swelling lasted a few days.

VAERS ID:294795 (history)  Vaccinated:2007-10-10
Age:60.0  Onset:2007-10-10, Days after vaccination: 0
Gender:Male  Submitted:2007-10-29, Days after onset: 19
Location:Foreign  Entered:2007-10-30, 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': WAES0710USA04846
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Joint swelling, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from a Health authority (reference number ADR20173663) concerning a 60 year old male whose medical history and concomitant medications were not reported who on 10-OCT-2007 was vaccinated IM with a dose of Pneumovax 23. On 10-OCT-2007 the patient experienced joint swelling and swollen arm from the lower bicep to below the elbow. The patient was recovering at the time of reporting. The reporter considered the events to be disabling. Other business partner numbers included: E2007-07205 Additional information is not expected.

VAERS ID:295699 (history)  Vaccinated:2005-07-20
Age:60.0  Onset:2005-08-18, Days after vaccination: 29
Gender:Male  Submitted:2007-11-06, Days after onset: 810
Location:Foreign  Entered:2007-11-06
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: ASTHMA; REFLUX OESOPHAGITIS; DYSLIPIDAEMIA
Diagnostic Lab Data:
CDC 'Split Type': MA20071192
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diplopia, Dysarthria, Echocardiogram, Eyelid ptosis, Feeling drunk, Gait disturbance, Malaise, Nuclear magnetic resonance imaging brain abnormal, Scan brain, Wrong drug administered
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Case Description: An ICSR sent to manufacturer by foreign authority and forwarded to manufacturer was received on 24 OCT 2007. A 60-year-old male patient was vaccinated with Rabipur, Ticovac and DTaP due to professional indication-he is a gamekeeper-on 20 JUL 2006. It was his first vaccination with Ticovac and a booster shot with DTaP and rabies vaccine. On 16 AUG 2005 he complained about the following symptoms: malaise with a feeling of being drunken, gait disorder with deviation to the left side, dysarthria, ptosis, diplopia when looking to the left side. All symptoms improved, but diplopia persisted. Cerebral CT, cardiac echography and duplex of carotids normal. Cerebral MRI showed multiple ischaemic periventricular lesions and two central oval lesions. Update on 03 SEP 2007: probably vascular accident of brain stem with favorable prognosis. Patient''s medical history: dyslipidemia, allergic asthma, reflux. Company assessment: Seriousness criterion: hospitalisation. Causality: not related due to lack of biological plausibility and presence of other disease that explains the observed symptoms. Expectedness assessment according to package insert. The reported symptoms are not expected after vaccination with Rabipur. No change in benefit-risk-ratio. No measures necessary. Control no. ST0500594.

VAERS ID:296195 (history)  Vaccinated:2007-08-25
Age:60.0  Onset:2007-09-24, Days after vaccination: 30
Gender:Female  Submitted:2007-11-09, Days after onset: 46
Location:Foreign  Entered:2007-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Climen (Oestradiol valerate + Cyproterone acetate); Glucosamine sulphate
Current Illness: HYPOTHYROIDISM
Preexisting Conditions:
Diagnostic Lab Data: Hemoglobin 14.5; Lymphocytes 500; Neutrophils 14.800; Platelet count 25Sep2007 6000/mm^3; Platelet count 26Sep2007 5000/mm^3; Platelet count 27Sep2007 1000/mm^3; Platelet count 30Sep2007 38000/mm^3; Platelet count 10Oct2007 288000/mm^3; Whi
CDC 'Split Type': B0493954A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Epistaxis, Haemoglobin normal, Lymphocyte count decreased, Mouth haemorrhage, Neutrophil count increased, Platelet count decreased, Thrombocytopenia, White blood cell count increased
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of thrombocytopenia in a 60-year-old female subject who was vaccinated with (Tedivax, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included hypothyroidism. Concurrent medications included Climen. On approximately 01 July 2007 the subject started taking Glucosamine sulphate (Glucadol). Approximately on 25 August 2007 and on 23 July 2007 the subject received 2nd dose and 1st dose of Tedivax (intramuscular). On 24 September 2007, approximately 30 days after vaccination with the 1st dose of Tedivax, 2 months after vaccination with the 2nd dose of Tedivax, the subject experienced thrombocytopenia, nose bleed, mouth bleeding and platelets decreased. The subject was hospitalised from 26 September 2007 till 01 October 2007. Relevant test results included platelets count: on 25 September 2007 it was 6000/mm^3, on 26 September 2006 it was 5000/mm^3, on 27 September 2007 it was 1000/mm^3, on 30 September 2007 it was 38000/mm^3 and on 10 October 2007 it was 288000/mm^3. Other test included hemoglobin 14.5, white blood cell count 15.500 of which 14800 were neutrophils and 500 lymphocytes. On 1 October 2007, the events were resolved.

VAERS ID:298654 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-04
Location:Foreign  Entered:2007-12-04
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:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0055351A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: This case was reported by a physician and described the occurrence of increase in liver values in a 60-year-old female subject who was vaccinated with Influsplit SSW (GlaxoSmithKline). On an unspecified date the subject received a dose of Influsplit SSW (unknown route and application site). At an unspecified time after vaccination with Influsplit SSW, the subject experienced increase in liver values. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the event was unspecified. Follow-up information has been requested.

VAERS ID:299154 (history)  Vaccinated:2007-04-28
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-06
Location:Foreign  Entered:2007-12-10, 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: Atenolol, ABLOK
Current Illness:
Preexisting Conditions: Blood pressure disorder and allergy to smoke, dust and construction materials. No history of adverse reaction to vaccine.
Diagnostic Lab Data: hemoglobin: 27/Apr/07: 11.9; 07/Jul/07: 10.0; 08/Sep/07: 8.9; 24/Nov/07: 4.0; 26/Nov/07: 4.7; 27/Nov/07: 5.0; 28/Nov/07: 8.9 The patient''s husband did not specify the performed tests, neither tests units, nor reference values.
CDC 'Split Type': 200704105
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia haemolytic autoimmune, Fatigue, Feeling abnormal, Haemoglobin decreased, Malaise, Pain in extremity
SMQs:, Haemolytic disorders (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Dementia (broad)
Write-up: A 60-year-old female patient, with medical history of blood pressure disorder and allergy to smoke, dust and construction materials, was diagnosed with an autoimmune hemolytic anemia after receiving the 1st dose of influenza vaccine (from unknown manufacturer) intra-muscularly in the deltoid on 28 April 2007. The physician did not have additional information. The patient''s husband provided with further information. On 27 April 2007, hemoglobin level was 11.9. After the vaccination, on 28 April 2007, the patient started presenting legs pain. On 07 July 2007, patient''s hemoglobin level was 10.0. Due to this fact, other physician recommended treatment with iron for 120 days. On 08 September 2007, a new test showed hemoglobin level of 8.9. The patient stated feeling bad, with tiredness and malaise. On 24 November 2007, she went to hospital and her hemoglobin level was 4.0. She was hospitalized on the same day. Since, she underwent daily tests. She was under treatment with iron and a corticoid medication, reported as "metaprozol". Hemoglobin levels were 4.7, 5.0, 8.9 on 26, 27 and 28 November 2007 respectively. At the time of reporting, the patient was still hospitalized. Outcome, ongoing. In this case, auto-immune hemolytic anemia with first signs occurring about 2/4 months after vaccination is reported. Although no laboratory reference values were provided, the hemoglobin levels before vaccination seem already slightly below normal values. No investigation results were reported to support the diagnosis of auto-immune hemolytic anemia and to rule out other potential causes such as auto-immune disease. Considering the available information and time to onset, no relationship between event and vaccination appears to exist.

VAERS ID:299855 (history)  Vaccinated:2007-07-13
Age:60.0  Onset:2007-08-08, Days after vaccination: 26
Gender:Female  Submitted:2007-12-14, Days after onset: 128
Location:Foreign  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carbamazepine; Folic acid; Ibuprofen; Clopidogrel bisulphate; Prednisolone Na phosphate; Alpha-1 proteinase inhib
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unk
CDC 'Split Type': B0499408A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB374AC IMLA
Administered by: Other     Purchased by: Other
Symptoms: Lichen nitidus
SMQs:
Write-up: This case was reported by a regulatory authority (foreign agency #038438) and described the occurrence of lichen nitidus in a 60-year-old female subject who was vaccinated with Engerix B adult (GlaxoSmithKline). Concurrent medications included Carbamazepine (Tegretol), Folic acid, Ibuprofen (G), Clopidogrel bisulphate (Plavix), Prednisolone sodium phosphate (Prednesol) and Alpha-1 proteinase inhibitor. On 13 July 2007 and 13 June 2007 the subject received the 2nd dose and the 1st dose of Engerix B adult (intramuscular, unknown). On 8 August 2007, 26 days after vaccination with the 2nd dose of Engerix B adult, 56 days after vaccination with the first dose of Engerix B adult, the subject experienced lichen nitidus. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with clobestasol propionate (Dermovate). At the time of reporting the event was unresolved.

VAERS ID:300910 (history)  Vaccinated:2007-12-05
Age:60.0  Onset:2007-12-05, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 16
Location:Foreign  Entered:2007-12-26, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACTONEL; VALTREX
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: head computed axial tomography, 05Dec07, no details provided
CDC 'Split Type': WAES0712CAN00069
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Computerised tomogram head, Hypoaesthesia facial, Hypoaesthesia oral, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Paraesthesia oral, Pruritus, Rash, Throat irritation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a 60 year old female who on 05-DEC-2007 was vaccinated with PNEUMOVAX (Lot # not available). Concomitant therapy included ACTONEL and VALTREX. On 05-DEC-2007 the patient experienced tingling and then numbness in her lips and teeth within 5 minutes after receiving vaccine. Subsequently the patient''s numbness spread over the rest of her face below the eyes. The patient also experienced a slight itchy feeling, and a slight feeling of weakness in her knees, burning sensation in her throat and esophagus which felt like acid reflux. The patient went to the emergency department of the local hospital but she did not stay there overnight. Within 2 hours, the numbness began to dissipate and she felt completely back to normal within 3 hours. However, later that night, the area around injection site became very hard, rash broke out, skin around injection site became red, hot, and painful. Subsequently after 3 days, the patient recovered from tingling and then numbness in her lips and teeth, slight itchy feeling, slight feeling of weakness in her knees, burning sensation in her throat and esophagus that felt like acid reflux, area around injection site became very hard, rash broke out, and skin around injection site became red, hot, and painful. At the time of the patient''s call she still felt sore around the injection site. The patient had a head computed axial tomography but no details were provided. No further information is available.

VAERS ID:302131 (history)  Vaccinated:2007-10-30
Age:60.0  Onset:2007-10-31, Days after vaccination: 1
Gender:Male  Submitted:2008-01-09, Days after onset: 70
Location:Foreign  Entered:2008-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol; Aspirin; Rosuvastatin calcium
Current Illness: Unknown
Preexisting Conditions: Not stated.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0501782A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER09102 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Atrial fibrillation, Chest pain, Neck pain
SMQs:, Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of neck pain in a 60-year-old male subject who was vaccinated with Influenza vaccine for prophylaxis. Concurrent medications included Atenolol, Aspirin and Rosuvastatin calcium (Rosuvastatin). On 30 October 2007 the subject received unspecified dose of Influenza vaccine (.5 ml, intramuscular). On 31 October 2007, at an unspecified time after vaccination with Influenza vaccine, the subject experienced neck pain, chest pain and paroxysmal atrial fibrillation. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 1 November 2007, the events were resolved. Verbatim Text: Pains in neck, chest pain, also paroxysmal atrial fibrillation.

VAERS ID:306038 (history)  Vaccinated:2007-10-23
Age:60.0  Onset:2007-10-30, Days after vaccination: 7
Gender:Male  Submitted:2008-02-26, Days after onset: 119
Location:Foreign  Entered:2008-02-28, 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: The patient did not take concomitant medications at vaccination time.
Current Illness: The patient did not have illness at vaccination time.
Preexisting Conditions: The patient did not take concomitant medications nor had illness at vaccination time. The patient had no relevant medical history.
Diagnostic Lab Data: blood tests; CAT scan; X-ray; stool samples - all were normal or negative.
CDC 'Split Type': 200800535
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood test normal, Computerised tomogram normal, Musculoskeletal pain, Pain in extremity, Pyrexia, Stool analysis normal, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad)
Write-up: Seriousness Criteria: Other - Medically Significant. Initial report received on 20 February 2008 from the patient. A 60 year old male patient received on 23 October 2007 a dose of Typhim Vi (lot# reported as 021309553, and is not a valid sanofi pasteur lot#. It is the DIN# of the product). The patient also received on the same day hepatitis A + B (HepA/B) vaccine (product name and manufacturer were not reported). 3-4 days post immunization patient developed a fever. Within 1 week of immunization he developed pain up the back of legs from ankles to buttocks. Pain was ongoing. The patient saw acupuncturist in December 2007. This did not help. The patient took ibuprofen, which did not help. Family doctor had done blood tests, CAT scan, X-ray, stool samples. All were normal or negative. At the time of reporting the patient had developed pain in shoulders. The patient saw travel physician on 19 February 2008 who prescribed magnesium, novo quinine and clonazepam. The patient did not take clonazepam. Magnesium, novo quinine were not working. Travel physician was setting up consult with a rheumatologist. The patient did not take concomitant medications nor had illness at vaccination time. The patient had no relevant medical history. The patient had not recovered. In this medically unconfirmed case, a final diagnosis was not reported. Reportedly the patient is still undergoing investigations. A final diagnosis is needed to fully assess the case.

VAERS ID:311470 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:2008-04-05
Gender:Female  Submitted:2008-05-01, Days after onset: 26
Location:Foreign  Entered:2008-05-02, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USC00077
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Uveitis
SMQs:, Ocular infections (broad)
Write-up: Information has been received from an investigator concerning a 60 year old female who entered a study. The patient was vaccinated with blinded therapy. On 05-APR-2008 the patient experienced bilateral uveitis. The patient''s bilateral uveitis persisted. The reporting investigator felt that bilateral uveitis was related to study therapy. Bilateral uveitis was considered to be an other important medical event. The record for this patient was unblinded on 28-APR-2008. The patient was treated with ZOSTAVAX. Additional information has been requested.

VAERS ID:313530 (history)  Vaccinated:2008-01-08
Age:60.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-05-27, Days after onset: 139
Location:Foreign  Entered:2008-05-27
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:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0522102A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority (clinical) # 520000341) and described the occurrence of inflammation in a 60-year-old female subject who was vaccinated with DITANRIX adult (GlaxoSmithKline). On 8 January 2008, the subject received unspecified dose of DITANRIX adult (intramuscular, unknown injection site). Lot number not provided. On 8 January 2008, less than one day after vaccination with DITRANRIX adult, the subject experienced inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 8 January 2008, the inflammation was resolved. The fever lasted until 15 January 2008. The regulatory authority reported that the events were possibly related to vaccination with DITANRIX adult. No further information is available, therefore the case has been closed.

VAERS ID:315013 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-04
Location:Foreign  Entered:2008-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0057485A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Diabetes mellitus, Headache, Temporal arteritis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Optic nerve disorders (broad), Vasculitis (narrow)
Write-up: This case was reported by a physician and described the occurrence of arteritis temporalis in an approximately 60-year-old female subject who was vaccinated with TWINRIX ADULT, GlaxoSmithKline. Follow-up information was received on 03 June 2008 from the reporting physician via telephone. Concurrent medical conditions included diabetes. On an unspecified date the subject received the second dose of TWINRIX ADULT. Approximately 1-2 weeks after vaccination with TWINRIX ADULT, the subject developed severe headache and arteritis temporalis. Diagnosis was based on clinical symptoms. A biopsy was not performed. The subject was treated with cortisol. Subsequently the patient''s underlying diabetes got out of control. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:317419 (history)  Vaccinated:2007-12-20
Age:60.0  Onset:2007-12-25, Days after vaccination: 5
Gender:Male  Submitted:2008-06-25, Days after onset: 182
Location:Foreign  Entered:2008-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0525381A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diplopia, Eyelid ptosis, Myasthenia gravis, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: This case was reported by a consumer and described the occurrence of myasthenia gravis in a 60-year-old male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 20 December 2007, the subject received 1st dose of HAVRIX 1440 (unknown route and injection site), lot number not provided. On 25 December 2007, 5 days after vaccination with HAVRIX 1440, the subject experienced eyelid ptosis. In 2008, he experienced decreased vision. On 16 January 2008, the subject experienced diplopia. He also experienced myasthenia gravis. The subject was treated with MESTINON. At the time of reporting the diplopia and decreased vision were resolved whereas the outcome of myasthenia gravis and eyelid ptosis was unspecified.

VAERS ID:317865 (history)  Vaccinated:2007-09-10
Age:60.0  Onset:2007-09-30, Days after vaccination: 20
Gender:Male  Submitted:2008-06-27, Days after onset: 271
Location:Foreign  Entered:2008-06-30, 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: Unknown
Current Illness:
Preexisting Conditions: Low back pain
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA08236
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0393F UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Dyspepsia
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a health authority concerning a 60 year old male with a history of low back pain who since 1993 was regularly vaccinated with influenza vaccine (manufacturer unknown). On 10-SEP-2007 he was vaccinated with a dose of PNEUMOVAX 23 (Lot#654979/0393F and batch#NE09130). In the end of September 2007, he developed chronic dyspepsia and diarrhea and suspicion of pancreatitis was diagnosed. The patient was treated on an outpatient basis. At the time of the report the reporter assessed the outcome as "persisting damage." The health authority considered pancreatitis, diarrhea and dyspepsia to other important medical events. Other business partner numbers included: PEI2008007155 and E200805689. Additional information is not expected. This case is closed.

VAERS ID:318187 (history)  Vaccinated:2008-03-20
Age:60.0  Onset:2008-04-07, Days after vaccination: 18
Gender:Male  Submitted:2008-07-02, Days after onset: 86
Location:Foreign  Entered:2008-07-03, 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: Previous vaccinations with RABIPUR, lot-no. 428011A, Man. Novartis Behring) on 20-Feb-08 and (Tollwut-Impfstoff HDC, lot-no. A0591-1) on 27-Feb-08 as well as a first dose of ENGERIX B, lot-no. AHBVB404BB, Man. GSK) on 20-Feb-08 were well tolerated.
Diagnostic Lab Data:
CDC 'Split Type': E200805794
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB464AA1UNUN
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERA08642UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Shigella infection
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Case initially received on 23-Jun-08. This case was reported by HA (HA reference no. PEI2008008829) through SPMSD. It was reported that a 60-year-old male patient was vaccinated with a third dose of rabies vaccine TOLLWUT-IMPFSTOFF HDC inaktiviert, lot-no. a0864-2) and concomitantly with a second dose of ENGERIX B, lot-no. AHBVB464AA, Man. GSK), injection routes and sites not reported on 20-Mar-08. On 21-Apr-08 the patient experienced a Gullain-barre syndrome. He was hospitalised for an unspecified time. It is worth noting that the patient had shigellosis from 07-Apr to 14-Apr-08. Unspecified treatment was carried out. The patient recovered on 27-May-08 with only minimal impairment. Previous vaccinations with RABIPUR, lot-no. 428011A, Man. Novartis Behring) on 20-Feb-08 and TOLLWUT-IMPFSTOFF HDC, lot-no. A0591-1 on 27-Feb-08 as well as a first dose of ENGERIX B, lot-no. AHBVB404BB, Man. GSK) on 20-Feb-08 were well tolerated. File closed.

VAERS ID:320505 (history)  Vaccinated:2007-08-22
Age:60.0  Onset:2007-08-24, Days after vaccination: 2
Gender:Female  Submitted:2008-07-25, Days after onset: 336
Location:Foreign  Entered:2008-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine hydrochloride
Current Illness: Unknown
Preexisting Conditions: Patient had first dose of ENGERIX B 20mcg injection on the 15th August 2007.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0529529A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB37BBB1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Psoriasis
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of psoriasis of legs in a female subject aged between 60 and 69 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous and/or concurrent vaccination included ENGERIX B (GlaxoSmithKline) given on 15 August 2007. Concurrent medications included RANITIDINE. On 22 August 2007 the subject received 2nd dose of ENGERIX B (20 injection, unknown). On 24 August 2007, 2 days after vaccination with ENGERIX B, the subject experienced psoriasis of legs. This case was assessed as medically serious by GSK. The 3rd dose of ENGERIX B was delayed due to the adverse event, and was administered on 15 July 2008. At the time of reporting the event was unresolved. It was noted that the patient''s doctor did not believe that the psoriasis was related to ENGERIX B. Verbatim text received: On the 16th July 2007 a nurse reported that a female patient had been following the 0, 7, 21 days and 12 month schedule of ENGERIX B Injections. The first dose of ENGERIX B (batch number AHBVB305AN and expiry date April 2009) had been administered on the 15th August 2007. The second dose of ENGERIX B had been administered on the 22nd August 2007. On the 24th August 2007 the patient developed psoriasis of the legs which remained unresolved at the time of reporting. The third dose of ENGERIX B was delayed due to the adverse event experienced. The third dose of ENGERIX B (AHBVB500AF and expiry date May 2010) was administered on the 15th July 2008 as the patient''s doctor did not believe that the psoriasis was related to the ENGERIX B.

VAERS ID:322085 (history)  Vaccinated:2005-09-23
Age:60.0  Onset:2005-10-01, Days after vaccination: 8
Gender:Female  Submitted:2008-08-13, Days after onset: 1047
Location:Foreign  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: cardiac pain, eczema of hand, macrophagic myofascitis, neuritis, vertigo
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0058304A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA110AB0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Angina pectoris, Basal cell carcinoma, Blood test, Dyspnoea exertional, Electrocardiogram, Gilbert's syndrome, Nuclear magnetic resonance imaging, Ophthalmological examination
SMQs:, Congenital, familial and genetic disorders (narrow), Pulmonary hypertension (broad), Other ischaemic heart disease (narrow), Malignant tumours (narrow), Skin malignant tumours (narrow)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2008011465) and described the occurrence of basal cell cancer on face in a 60-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Co-suspect vaccination included FSME IMMUNE (Baxter). The subject had received two dosed of FSME vaccine on 27 June and 15 July 1994. After that, in September 1994, the subject developed macrophagic myofascitis, recurrent ischiadic neuritis and vertigo, which was all unresolved at the time of reporting. On 31 May and 27 June 2005 the subject received third and 4th dose of FSEME IMMUN (unknown route and application site). In August 2005 the subject developed recurrent cardiac pain and eczema of the hands. On 23 September 2005 the subject received 1st dose of INFLUSPLIT SSW (unknown route and application site). In October 2005, 1 month after vaccination with INFLUSPLIT SSW, at 4 months after vaccination with FSME IMMUN, the subject experienced basal cell cancer on the temple, exertional dyspnea and Gilbert''s syndrome. This case was assessed as medically serious by GSK. The subject underwent multiple examinations, including MRT of the lumbar spine, electrocardiogram (ECG), blood analysis and ophthalmologic examination. Rheumatism and organic heart disorder were excluded. In June 2008 the events were unresolved or resolved with sequelae. No further information will be available.

VAERS ID:331751 (history)  Vaccinated:2002-07-05
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-07
Location:Foreign  Entered:2008-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pancreatin
Current Illness: PANCREATIC INSUFFICIENCY
Preexisting Conditions:
Diagnostic Lab Data: Hepatitis B surface antibody, 2008, over 1000IU
CDC 'Split Type': D0058912A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Asthenia, Hepatic enzyme increased, Hepatic pain, Hepatitis A, Hepatitis B surface antigen positive, Nausea
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a consumer and described the occurrence of hepatitis a infection in a 63-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). A physician or other health care professional has not verified this report. Initially it was reported that on 5 July 2002, 7 August 2002 and 4 March 2003 the subject received 3 doses of TWINRIX ADULT (unknown route and application site). On an unspecified date in 2005, more than 2 years after vaccination with TWINRIX ADULT, the subject experienced hepatitis a infection (vaccination failure). This case was assessed as medically serious by GSK. According to follow-up information received on 31 October 2008 from the consumer, the subject was often traveling abroad. Concurrent medical conditions included pancreatic insufficiency. Concurrent medications included PANKREON. On unspecified dates the subject received numerous doses of TWINRIX ADULT (unknown route and application site). The subject experienced increase in liver values, pain in liver area, loss of appetite, nausea and weakness, which was later suspected as hepatitis a infection. She never was "yellow". On an unspecified date in 2008 the subject received another dose of TWINRIX ADULT. Afterwards a test for hepatitis B surface antibodies was more than 1000 IU. At the time of reporting the events were resolved. Further information was expected.

VAERS ID:333608 (history)  Vaccinated:2008-09-19
Age:60.0  Onset:2008-09-20, Days after vaccination: 1
Gender:Male  Submitted:2008-11-25, Days after onset: 66
Location:Foreign  Entered:2008-12-02, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Allergic reaction~ ()~~0~In Patient
Other Medications: Atorvastatin calcium; Propafenone hydrochloride
Current Illness: Unknown
Preexisting Conditions: Atrial Fibrillation; Atrial Flutter; Hyperlipidemia
Diagnostic Lab Data: UNK
CDC 'Split Type': B0546693A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Musculoskeletal pain, Takayasu's arteritis
SMQs:, Rhabdomyolysis/myopathy (broad), Vasculitis (narrow)
Write-up: This case was reported by the Regulatory Agency (GB-MHRA-ADR 20339502) and described the occurrence of shoulder pain in a 60 year-old male subject who was vaccinated with TWINRIX for prophylaxis. The subject''s medical history included atrial fibrillation, atrial flutter and hyperlipidemia. Co-suspect vaccine included REVAXIS. Concurrent medications included Atorvastatin and Propafenone. On 19 September 2008 the subject received unspecified dose of TWINRIX (intramuscular). On 20 September 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced shoulder pain and aortic arch syndrome. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. Severe pain shoulder, painful arch syndrome. Drug/Event relatedness data:

VAERS ID:334152 (history)  Vaccinated:2008-10-07
Age:60.0  Onset:2008-10-09, Days after vaccination: 2
Gender:Female  Submitted:2008-12-05, Days after onset: 57
Location:Foreign  Entered:2008-12-08, 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: AQUAPHOR TABLETS; ATACAND; METHIZOL; SAROTEN; STANGYL TABLETS; SYMPAL
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Diagnostic microbiology test, 14Oct08, streptococcus pneumoniae; WBC count, 14Oct08, 13.3; Serum C-reactive protein, 14Oct08, 381; Erythrocyte sedimentation rate, 14Oct08, 70/86
CDC 'Split Type': WAES0812USA00608
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1038F UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Device related infection, Microbiology test abnormal, Pneumococcal infection, Red blood cell sedimentation rate increased, Streptococcal infection, Urinary tract infection, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Information has been received from a health authority on 26-NOV-2008 (HA reference no. PEI2008018186) concerning a 60 year old female patient, who on 07-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 into the upper arm (Lot # 656226/1038F, Batch # NF11260). Concomitant therapy included ATACAND, AQUAPHOR TABLETS, METHIZOL, SAROTEN, SYMPAL and STANGYL TABLETS. On 09-OCT-2008 the patient developed prosthesis related infection of the left hip. The patient was hospitalized from 12-OCT-2008 until 14-OCT-2008, then again from 14-OCT-2008 until 06-NOV-2008. Urinary tract infection was diagnosed. Laboratory findings on 14-OCT-2008 showed Leukocytes: 13.3, CRP: 381, ESR: 70/86. Microbiological findings showed streptococcus pneumoniae. Secondary hip TEP explanation (left) and cement spacer implantation was performed on 21-OCT-2008. Antibiotic treatment with CIPROBAY, gentamycin and hydrocortisone was administered at a gradual dose reduction. Medication upon discharge: CYSTIUM SOLIDAGO, NOVAMINSULFON, prednisolone, CALCILAC, ATACAND, AQUAPHOR, METHIZOL SD, SAROTEN, SYMPAL, STANGYL, 1A PHARMA, FENTANYL 1A PHARMA, CLEXANE. The patient was discharged in a good general condition. The treatment with CIPROBAY should continue for 3 months. Final outcome not reported. Other business partner numbers include E2008-10992. The case is closed. No further information is available.

VAERS ID:334880 (history)  Vaccinated:2008-10-17
Age:60.0  Onset:2008-10-24, Days after vaccination: 7
Gender:Female  Submitted:2008-12-10, Days after onset: 47
Location:Foreign  Entered:2008-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMOXIFEN CITRATE
Current Illness: Breast Carcinoma
Preexisting Conditions: Hysterectomy; Mastectomy
Diagnostic Lab Data: Body temperature, 24Oct2008, 40deg.C; Body temperature, 24Oct2008, 38.5deg.C; C-reactive protein, 24Oct2008, 33.2mg/dL; CA 15-3, 24-Oct-2008, 12.1U/mL; Computerized tomogram thorax, 24Oct2008, See text; Computerized tomogram thorax, 29Oct20
CDC 'Split Type': B0547588A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abscess, Bacterial test positive, Body temperature increased, Breast swelling, C-reactive protein increased, Carbohydrate antigen 15-3, Computerised tomogram thorax abnormal, Erythema, Fistula, Haemoglobin decreased, Inflammation, Pyrexia, Skin warm, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician and described the occurrence of abscess in a 60-year-old female subject who was vaccinated with ALPHARIX (GlaxoSmithKline). Concurrent medical conditions included left breast carcinoma which was operated in March 2008: Left mammectomy. Concurrent medications included NOLVADEX. On 17 October 2008, the subject received unspecified dose of ALPHARIX (unknown, right arm, lot number not provided). On 24 October 2008, 7 days after vaccination with ALPHARIX, the subject experienced high fever (40 deg. C) with inflammation localized at the level of the scar (left breast). Abscess localized at the scar of left mammectomy with left fistula in axillary area. At the time of reporting, the outcome of the events was unspecified. Follow up information received on 04 December 2008: Personal medical history included: G1P1; total radical hysterectomy (in 1996) and on 26 March 2008: Left mastectomy - immediate reconstruction + left axillary curage for a grade II biofocal infiltrating canal carcinoma at level of left breast, positive for oestrogen and progesterone receptors. Following FLUARIX, the subject started to get fever till 40 deg. C with a serious inflammation on the left breast reconstruction site. On 24 October 2008, the subject came to consultation. Clinical examination showed following: left breast: post-mastectomy status and TRAM-flap reconstruction. Breast extremely swollen, red and hot; left armpit: Fistula with pus +++; Temperature: 38.5 deg. C. CT thorax: In left axillary site, lesion partially fluid and oval, measuring more or less 8cm major axis for 3 cam diameter. The supero-internal area of lesion is situated just beneath the surgery clips. Its infero-internal end was situated at the skin. The lesion contained air probably coming from the outside by a fistulous way. Hypothesis of a subcutaneous weak tissues abscess seemed most probable. Lab tests were performed and showed the following: Hemoglobin: 11.1 g/dL; White blood cells count: 12900/mm3; C- reactive protein: 33.2 mg/dL

VAERS ID:339478 (history)  Vaccinated:2009-01-21
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2009-02-11
Location:Foreign  Entered:2009-02-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREMIQUE; bendrofluazide
Current Illness: Hypertension
Preexisting Conditions: Patient overweight
Diagnostic Lab Data: UNK
CDC 'Split Type': B0557574A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB199AD UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Decreased appetite, Jaundice, Liver function test abnormal, Malaise, Nausea
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by the Nurse and described the occurrence of feeling weak in a 60-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), REVAXIS (non-gsk). Concurrent medical conditions included hypertension. Concurrent medications included PREMIQUE and bendrofluazide. On 21 January 2009 the subject received unspecified dose of HAVRIX (1440 elisa unit, unknown arm), unspecified dose of REVAXIS (unknown, unknown arm). In January 2009, within days of vaccination with HAVRIX and REVAXIS, the subject experienced feeling weak, general unwell, nausea, poor appetite, jaundice and abnormal liver function tests. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. Verbatim text received: On the 4th of February 2009 a nurse reported that a patient received a dose of HAVRIX and REVAXIS in the other arm on the 21st of January 2009. A few days after she felt weak, generally unwell, experienced nausea, poor appetite, jaundice and her liver function tests were grossly abnormal. The patients concomitant medications are bendrofluazide 2.5mg and the hormone replacement therapy PREMIQUE 0.625mg.

VAERS ID:343513 (history)  Vaccinated:2009-01-19
Age:60.0  Onset:2009-02-01, Days after vaccination: 13
Gender:Female  Submitted:2009-04-03, Days after onset: 60
Location:Foreign  Entered:2009-04-03
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:
Diagnostic Lab Data: Body temperature, Feb2009, 41degC; C-reactive protein, above 20; Erythrocyte sedimentation rate, 60mmHg/h
CDC 'Split Type': D0061028A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthritis, Body temperature increased, C-reactive protein increased, Chills, Erythema nodosum, Fatigue, Pyrexia, Red blood cell sedimentation rate increased, Sarcoidosis
SMQs:, Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: This case was reported by a physician and described the occurrence of LOEFGREN syndrome in a 60-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 December 2008. On 19 January 2009 the subject received 2nd dose of TWINRIX (unknown route and application site). In February 2009, 4 weeks after vaccination with TWINRIX, the subject experienced fever, tiredness and joint inflammation. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 30 March 2009 by the physician. Previous vaccination included TWINRIX GlaxoSmithKline) given on 10 December 2008. On 19 January 2009 the subject received 2nd dose of TWINRIX (unknown route and application site). Four weeks post vaccination the subject experienced LOEFGREN syndrome, fever with a body temperature of 41 degC, severe chills and erythema nodosum. This case was assessed as medically serious by GSK. C-reactive protein was increased above 20 and erythrocyte sedimentation rate was approximately 60 mmHg in 1st hour. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:348680 (history)  Vaccinated:2009-04-28
Age:60.0  Onset:2009-04-28, Days after vaccination: 0
Gender:Female  Submitted:2009-06-05, Days after onset: 38
Location:Foreign  Entered:2009-06-08, 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: AMLODIN; BUFFERIN; LIVACT; LOXONIN; MUCODYNE; MUCOSTA; PARIET; SUMIFERON
Current Illness: Hepatic cirrhosis; Varices oesophageal; Hypertension; Glucose tolerance impaired; Otitis media; Splenic vein thrombosis; Portal
Preexisting Conditions:
Diagnostic Lab Data: WBC count, 28Apr09, 4160 /uL; body temp, 28Apr09, 40 degrees C; platelet count, 28Apr09, 12.9 10000/uL; WBC count, 01May09, 11010 uL; platelet count, 01May09, 13.7 10000/uL; serum C-reactive protein, 01May09, 4.73 mg/dL; WBC count, 07May09,
CDC 'Split Type': WAES0905USA01913
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Body temperature increased, C-reactive protein increased, Injected limb mobility decreased, Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth, Platelet count decreased, Pyrexia, Skin erosion, White blood cell count decreased, White blood cell count increased
SMQs:, Severe cutaneous adverse reactions (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 60 year old female patient with hepatic cirrhosis, gastrooesophageal varices, hypertension, glucose tolerance abnormal, otitis media serous, splenic vein thrombosis, portal vein thrombosis and no medical history, who on 28-APR-2009 was intramuscularly vaccinated with PNEUMOVAX 23, 0.5 ml to the right upper arm. Concomitant therapy included SUMIFERON, AMLODIN, PARIET, LIVACT, MUCODYNE, BUFFERIN, LOXONIN and MUCOSTA. On 28-APR-2009, SUMIFERON 6 MIU was subcutaneously injected to the left upper arm and PNEUMOVAX 23 0.5 ml was intramuscularly injected to the right upper arm. In the early evening, the patient developed pyrexia (40 degrees C). She took one tablet of LOXONIN 60 mg and one tablet of MUCOSTA 100 mg. On 29-APR-2009, the patient developed warmth, swelling and pain in the entire right upper arm and had difficulty in raising the arm. She had no pyrexia. On 01-MAY-2009, the patient visited the reporting physician to receive interferon alfa therapy, but it was not administered on the day. The patient was found to have developed blister of 3 cm in size. WBC was 11010 and CRP was 4.73. She orally took CRAVIT 400 mg/day. ACRINOL 0.5% compress (product name unknown) was used to the lesion. On 04-MAY-2009, the right upper arm warmth, swelling and pain disappeared. Administration of interferon alfa was interrupted. The patient was found to have developed subcutaneous haemorrhage of 3 x 3 cm in size at the injection site and there was an erosion of 8 x 8 mm in size in the middle. Blister was present Duo-Active ET was applied for protection. ON 07-MAY-2009, WBC was 5110. There was an erosion of 2 x 2 cm in size. Subcutaneous haemorrhage subsided. Duo Active ET was changed to new one. The dose of levofloxacin hydrate was changed to 200 mg/day. Therapy with subcutaneous interferon alfa 6 MIU injection was restarted for hepatic cirrhosis. On 15-MAY-2009, WBC was 3780 and CRP was 0.06. Erosion, subcutaneous haemorrhage and blister disappeared. The reporting physic

VAERS ID:349971 (history)  Vaccinated:2009-06-10
Age:60.0  Onset:2009-06-10, Days after vaccination: 0
Gender:Female  Submitted:2009-06-23, Days after onset: 13
Location:Foreign  Entered:2009-06-24, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0906CAN00070
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain, Pain in extremity, Sensation of heaviness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a nurse concerning a 60 year old female who in 2003 was vaccinated with the first dose of PNEUMOVAX, lot # not available. On 10-JUN-2009 the patient was vaccinated in the left deltoid with a booster dose of PNEUMOVAX, lot # not available. On approximately 10-JUN-2009 (reported as 6 to 8 hours later) the patient reported that her arm felt numb, sore and heavy. On approximately 11-JUN-2009 (reported as some time after that) the patient''s arm felt so heavy she couldn''t lift it. On 11-JUN-2009 the patient reported that during the night, when she got up to go to the washroom, she fainted. On 11-JUN-2009 the patient reported that she continued after that to have general aches and pains all over but no fever. Subsequently, the patient recovered from arm felt numb, sore and heavy, arm felt so heavy she couldn''t lift it, during the night she fainted and continued after that to have general aches and pains all over but no fever. Arm felt numb was considered to be an other important medical event based on agency requirements. Additional information has been requested.

VAERS ID:350824 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:2009-03-23
Gender:Unknown  Submitted:2009-06-19, Days after onset: 88
Location:Foreign  Entered:2009-06-25, Days after submission: 6
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: Pregnant: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 200914820
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED090622601 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Decreased appetite, Headache, Malaise, Myalgia, Oropharyngeal pain, Pyrexia, Thirst decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad)
Write-up: Report received from a nurse on 24-Mar-2009. A 60 year old patient (Initials: MI, date of birth: 10-Aug-1948, gender unknown) received FLUVAX on unknown date. The patient has previously received influenza vaccine. At unknown time after vaccination, the patient developed headaches, fever, sore throat, myalgia, can''t eat, can''t drink and feels very unwell. The patient was off work for a week. It is unknown if the patient received any treatment. Patient outcome was not specified. The company assessed the causality as conditional in relation to the suspect drug, pending further follow-up information. Related case IDs: 200914816, 200914818 and 200914819. Follow-up information received from the immunization nurse on 14-Apr-2009. The batch lot number for the FLUVAX dose administered was 0906 22601 with an expiry date of ??-Nov-2009. The onset of the reaction was 23-Mar-2009 and ended on 26-Mar-2009, 4 days in duration. The patient was treated for the adverse events with a course of antibiotics (prescribed by the general practitioner), bed rest, analgesics and fluids. The patient recovered on 26-Mar-2009. Time to onset of the reaction was not specified. The reporter considered events as non-serious. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:350516 (history)  Vaccinated:2007-11-20
Age:60.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2009-06-30, Days after onset: 587
Location:Foreign  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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0792865A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA014AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Adverse event
SMQs:
Write-up: This case was reported by a nurse via a regulatory authority (V0900711) and described the occurrence of an adverse event in a 60-year-old male subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 20 November 2007 the subject received 1st dose of FLUVIRAL (unknown). In November 2007, nine hours after vaccination with FLUVIRAL, the subject experienced adverse event not other wise specified that lasted for five days. The subject was hospitalised for three days. At the time of reporting the event was resolved.

VAERS ID:353390 (history)  Vaccinated:2009-07-11
Age:60.0  Onset:2009-07-16, Days after vaccination: 5
Gender:Female  Submitted:2009-08-07, Days after onset: 22
Location:Foreign  Entered:2009-08-07
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:
Diagnostic Lab Data: Unk
CDC 'Split Type': B0587036A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Influenza like illness, Pyrexia, Skin disorder
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of erythema multiforme in a 60-year-old female subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On 11 July 2009, thew subject received unspecified dose of HAVRIX adult (unknown route, unknown injection site). Lot number not provided. On 16 July 2009, 5 days after vaccination with HAVRIX adult, the subject experienced fever and influenza symptoms which resolved spontaneously. On 20 July 2009, 9 days after vaccination with HAVRIX adult, the subject experienced erythema multiforme and skin changes. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:355110 (history)  Vaccinated:2002-10-23
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-25
Location:Foreign  Entered:2009-08-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL, Unknown
Current Illness: Asthma
Preexisting Conditions: Hepatitis post-vaccination; Influenza vaccination
Diagnostic Lab Data:
CDC 'Split Type': MA20092210
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Gamma-glutamyltransferase increased, Hepatitis, Vaccine positive rechallenge
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow)
Write-up: On 13-AUG-2009, we received the following information: A 60-year-old female patient (date of birth unknown) was vaccinated with Influenza virus vaccine (batch no. and manufacturer unknown) on 23-OCT-2002. A few weeks later laboratory test showed a hepatitis type reaction with raised gamma glutamyltransferase (473) and alanine aminotransferase (967). Patient recovered. After a previous vaccination with Influenza virus vaccine in 2001 the patient showed a similar reaction (see case MA 2009-2212). On 19 AUG 2009 we were informed by the agency that no further information is available. No change in assessment. (Request was sent on 17 AUG 2009, no follow-up information received.)

VAERS ID:355835 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2009-08-28
Location:Foreign  Entered:2009-08-28
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MA20092275
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, 60-year-old male, see also cases MA2009-2272-2274), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.

VAERS ID:361635 (history)  Vaccinated:2009-10-03
Age:60.0  Onset:2009-10-03, Days after vaccination: 0
Gender:Female  Submitted:2009-10-19, Days after onset: 16
Location:Foreign  Entered:2009-10-20, 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: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0910USA01697
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was initially reported to a foreign Health authority on 09-OCT-2009. ADR 20504898. This case concerns a 60 year old female patient. The patient received 0.5 ml of a dose of PNEUMOVAX 23 (lot number not reported) intramuscularly on 03-OCT-2009. On 03-OCT-2009, five hours post vaccination the patient experienced fever chills and a very sore arm. The duration of the fever chills was two days and at the time of reporting the patient was recovering. The outcome of the sore arm was unknown. The reporter considered the events to be serious due to disability/incapacity. Other business partner numbers include E2009-09503. Case is closed.

VAERS ID:369092 (history)  Vaccinated:2009-10-26
Age:60.0  Onset:2009-10-26, Days after vaccination: 0
Gender:Female  Submitted:2009-11-20, Days after onset: 25
Location:Foreign  Entered:2009-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Allergic reaction NOS~ ()~~0.00~Patient
Other Medications: Amlodipine; Pravastatin sodium
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0603654A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Hypersensitivity, Palpitations, Tachycardia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 20522271) and described the occurrence of chest pain in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Amlodipine and Pravastatin sodium. On 26 October 2009 the subject received a single dose of FLUARIX (.5 ml, intramuscular). On the same date, soon after vaccination with FLUARIX, the subject developed chest pain, palpitations and tachycardia. The regulatory authority reported that the subject was hospitalised. The subject was treated with antihistamines for allergic reaction and was kept in the hospital most of the day. At the time of reporting the events were improved. Verbatim Text: Patient developed chest pains, palpitations, and tachycardia soon after the vaccination was given. Patient taken to hospital and treated with antihistamines for allergic reaction. Medically significant: patient kept in hospital for most of the day.

VAERS ID:370172 (history)  Vaccinated:1994-04-01
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2009-11-25
Location:Foreign  Entered:2009-11-25
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Compression of thoracic vertebra; Osteoporosis
Preexisting Conditions: Patient medical history included autoimmune familial diathesis.
Diagnostic Lab Data: Antinuclear antibody, 02Apr2004, <100; Blood 25-hydroxy vitamin D2, 02Apr2004, 10ng/ml; Rheumatoid factor, 02Apr2004, on 02 April 2004: rheumatoid factor was positive according to Waaler-Rose test and at 119IU/L according to latex assay. An
CDC 'Split Type': B0604839A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody negative, Blood 25-hydroxycholecalciferol, Blood thyroid stimulating hormone normal, Dysarthria, Oedema peripheral, Rheumatoid arthritis, Rheumatoid factor positive
SMQs:, Cardiac failure (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (narrow)
Write-up: This case was reported by a consumer via GSK Legal and described the occurrence of rheumatoid polyarthritis in a 61-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Subject medical history included autoimmune familial diathesis (NOS). Concurrent medical condition included osteoporosis with compression of thoracic vertebra T9 (in October 1995) and T6 (in September 1996). In March 1993, the subject received a 1st dose of ENGERIX B intramuscular (batch and injection site unknown). In April 1994, the subject received 2nd dose of ENGERIX B (intramuscular, batch and injection site unknown). In 1994, about one month and a half after vaccination with ENGERIX B, the subject experienced articulation pains and edema in wrists, according to the physician, and ankle edema according to the subject. In 1995, a rheumatologist diagnosed beginning rheumatoid polyarthritis (laboratory work-up not available). The subject was treated with PLAQUENIL from April 1995 to April 1996, ALLOCHRYSINE from April 1996 to March 1997, Corticoid NOS dates unknown at about 7 mg daily and unspecified infiltration in right forepart. On 02 April 2004, the subject had rheumatoid factor positive according to Waaler-Rose assay and at 119IU/L according to latex assay, normal thyroid stimulating hormone, negative antinuclear antibody, anti extractable nuclear antigen antibody negative and 25-hydroxy vitamin D2 at 10 ng/mL (mild-moderate deficiency). The physician considered the events were disabling. At the time of reporting the events were worse, the subject needs help for all-days life. Causality assessment of ENGERIX B with the events was not reported by the physician.

VAERS ID:370179 (history)  Vaccinated:2009-10-07
Age:60.0  Onset:2009-10-09, Days after vaccination: 2
Gender:Female  Submitted:2009-11-25, Days after onset: 47
Location:Foreign  Entered:2009-11-25
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:
Diagnostic Lab Data: Unk
CDC 'Split Type': D0064283A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA452AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Brachial plexopathy, No reaction on previous exposure to drug
SMQs:
Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2009024518) and described the occurrence of possible paresis of brachial plexus in a 60-year-old female subject who was vaccinated DRESDEN (GlaxoSmithKline). Previous annual vaccination with seasonal trivalent influenza vaccine (non-GSK) (Influenza vaccine, other manufacturer), given on unknown dates, have been well tolerated. On 07 October 2009 the subject received a dose of DRESDEN (0.5 ml, unknown, left deltoid). Approximately two days post vaccination with DRESDEN, the subject experienced possible paresis of brachial plexus. On 19 October 2009 the subject was hospitalised for neurological examinations for an unknown period of time. At the time of reporting, on 29 October 2009, the event was unresolved. No further information will be available.

VAERS ID:370774 (history)  Vaccinated:2008-10-06
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2009-11-30
Location:Foreign  Entered:2009-12-01, 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: SALBUTAMOL, Dosage was 200 ug PRN, Oropharingeal
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Albumin; 41 gm/L, normal; Blood pressure 117/76; C-ANCA positive, MPO 297; Creatinine, 169/142 umol/L; CRP, 15, normal; CSF, normal; E GFR, 46 ml/min; ECHO, no vegetations, normal; ESR, 10/12 mm/hr; Nerve conduction''s studies, pending; Platelet count, 285; Renal biopsy, 19/11; U, 12.8; Urine dipstick, positive of protein; USG, normal size kidney right, 8.8 cm, normal; WBC, 14.4/15.9
CDC 'Split Type': 2009021484
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED11401 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergic granulomatous angiitis, Antineutrophil cytoplasmic antibody positive, Arthralgia, Balance disorder, Biopsy, Biopsy kidney abnormal, Blood albumin normal, Blood creatinine increased, C-reactive protein increased, CSF culture negative, Cough, Dysphonia, Echocardiogram normal, Eosinophilia, Feeling cold, Gait disturbance, Glomerular filtration rate decreased, Haemoglobin increased, Haemorrhage, Hypoaesthesia, Malaise, Mononeuropathy multiplex, Muscle spasms, Myalgia, Nerve conduction studies, Nerve injury, Pain, Pain in extremity, Paraesthesia, Platelet count normal, Rash, Red blood cell sedimentation rate normal, Renal disorder, Renal vasculitis, Retinal disorder, Shock, Tenderness, Ultrasound kidney normal, Urine analysis abnormal, Vasculitis, Vision blurred, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (narrow), Retinal disorders (narrow), Vestibular disorders (broad), Vasculitis (narrow), Renovascular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad)
Write-up: Report received from a consumer on 23-NOV-2009. A 61 year-old male patient received Enzira influenza vaccine (batch number 11401, expiry date: 30-JUN-2009, details informed by GP) on 06-OCT-2008. The medical history prior to vaccination was not given. Concomitant medication included salbutamol CFC free inhaler 100mcg (2 puffs when required). Soon after Enzira vaccine was administered, the patient began to feel ill with a spiral of health problems. The patient developed myalgia, blurred vision, numbness of feet, was unsteady on his feet, hoarse voice and persistent cough. On 09-NOV-2009, the patient phoned for an out-of-hour doctor who then called for an ambulance immediately after seeing the patient. The patient was admitted to the emergency department for assessment. Investigations revealed the following: Ultrasonography normal sized right kidney, left kidney 8.8cm with good corticomedullary differentiation, C-ANCA positive MPO 297, echocardiogram with no vegetations, CSF normal protein, nerve conduction studies are pending and 19/11 renal biopsy focal changes. The patient was admitted to the renal ward at the hospital on 09-NOV-2009. The patient was diagnosed with Churg Strauss Syndrome, systemic and renal vasculitis with eosinophilia and mononeuropathy multiplex. The patient treated with Azathioprine (initially 100mg and increased to 150mg daily), alphacalcidol 0.5mcg per day, Omeprazole 40mg per day, Alendronic acid 70mg once per week and Prednisolone (60mg daily). At the time of diagnosis, the patient developed a rash under each elbow, on the scalp and top of forehead. With treatment, the rashes have disappeared. The patient was discharged on 21-NOV-2009. Upon discharge, the attending doctor stated that the patient was doing quite well, eating and drinking well, weight has increased by 2kg in the absence of pedal oedema and that clinical examinations regarding shock like sensations around the patient''s knees did not reveal any abnormality of the knees. Investigations upon discharge revealed the following: CRP: less than 5, ESR: 10/12 mm/Hr, Hb: 12.8/13.2, Creatinine: 169/142 umol/L, Urea: 12.8, WBC: 14.4/15.9, blood pressure: 117/76 mmHg, urine dipstick: positive for protein, eGFR: 46 ml/min, albumin: 41 gm/L, platelet count: 285. The blood tests suggest no evidence of active vasculitis at time of discharge. The doctor has reduced his corticosteroids to 10mg and increased his Azathioprine to 150mg due reduce relapse. The patient is expected to undertake blood tests in 2 weeks time to ensure that there are no adverse effects on his bone marrow due to the increased dose of Azathioprine. The dose of corticosteroids may be reduced from 15mg per day to 15/10mg on alternate days. The patient was discharged with additional drug therapy that included salmeterol with fluticasone CFC inhaler (25/125mcg actuation, 2 puffs when required), amphotericin lozenges (10mg four times a day), alendronic acid (70mg once per week), co-trimoxazole tablets (80/400mg one tablet daily), cyclophosphamide (50mg tablets, 3 tablets daily), fluticasone nasal drops (400mcg/unit, half a nasule in each nostril twice per day), omeprazole capsule (20mg per day) and prednisolone tablets. After discharge, the patient was still suffering from aching legs and was unable to bend without feeling pain and discomfort in the knees and legs. There was also numbness, coldness and tenderness in and around the knees, upper legs and thighs, and numbness in the toes and under the feet. Occasionally, there are aches in both calves with muscle spasms, and feelings of mild electric shock in the legs, fingers, toes and sometimes arms. The patient has restricted use of the fingers in both hands and has permanent tingling in several finger tips. There was some damage to the kidneys and bleeding but the consultant has informed that patient that the kidneys have improved with treatment and was regular blood tests. After walking over 50-100m, the patient will often have to rest fo

VAERS ID:371298 (history)  Vaccinated:2009-11-03
Age:60.0  Onset:2009-11-05, Days after vaccination: 2
Gender:Male  Submitted:2009-12-02, Days after onset: 27
Location:Foreign  Entered:2009-12-03, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2009-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0911USA04803
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, No reaction on previous exposure to drug
SMQs:
Write-up: Information has been received from health authority (HA) under HA reference no. PEI2009025843 concerning a 60-year-old previously healthy male patient who was vaccinated with an unspecified dose of PNEUMOVAX (lot #, injection route and site not reported) on 03-NOV-2009. Two days post vaccination the patient died "out of full health". An autopsy was not carried out. Vaccination with FLUAD on 15-OCT-2009 was well tolerated. File is closed. Other business partner numbers include E2009-10860.

VAERS ID:371717 (history)  Vaccinated:2009-10-30
Age:60.0  Onset:2009-10-31, Days after vaccination: 1
Gender:Male  Submitted:2009-12-04, Days after onset: 34
Location:Foreign  Entered:2009-12-04
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0608143A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)GLAXOSMITHKLINE BIOLOGICALSA81CA070A IJLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-FLU 00030153) and described the occurrence of muscle weakness in a 60-year-old male subject who as vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline). On 30 October 2009 the subject received unspecified dose of PANDEMRIX H1N1 (left arm). On an unspecified date the subject received unspecified dose of influenza virus vaccine (unknown). On 31 October 2009, 1 day after vaccination with PANDEMRIX H1N1, at an unspecified time after vaccination with Influenza virus vaccine, the subject experienced muscle weakness. The regulatory authority reported that the event was disabling. On 7 November 2009, the event was resolved. Verbatim Text: Reaction Severity: Bad enough to affect every day activities. Reaction Description: left arm.

VAERS ID:371861 (history)  Vaccinated:2009-11-20
Age:60.0  Onset:2009-11-20, Days after vaccination: 0
Gender:Male  Submitted:2009-12-04, Days after onset: 14
Location:Foreign  Entered:2009-12-07, 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: ATELEC; HOKUNALIN; MUCODYNE; ZYLORIC
Current Illness: Pneumoconiosis; Hypertension; Bronchitis; Hyperuricaemia; Angina pectoris; Food allergy
Preexisting Conditions:
Diagnostic Lab Data: body temp, 20Nov09, 38.5 degrees C
CDC 'Split Type': WAES0911USA04861
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0608Y0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Generalised erythema, Injection site erythema, Injection site swelling, Pyrexia, 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: Information has been received from a physician concerning a 60 year old male patient with pneumoconiosis, secondary bronchitis, hypertension, hyperuricaemia, angina pectoris and food allergy who on 20-NOV-2009 subcutaneously received the first inoculation with PNEUMOVAX (lot number 9MK07R (665158/0608Y)) for the prophylaxis of pneumococcal infection (dose and inoculation site were not provided). Concomitant therapy included MUCODYNE, HOKUNALIN, ATELEC and ZYLORIC. On 20-NOV-2009, at 10:00 A.M., the patient was inoculated with PNEUMOVAX (as mentioned above). One hour after the vaccination, the patient developed swelling and pyrexia. In the evening, he visited the reporting physician. His body temperature was 38.5 degrees C. At the same time, the physician confirmed he developed injection site redness, swelling and generalized erythema. On 25-NOV-2009, the patient was recovering from local redness, local swelling and generalized erythema, and recovered from pyrexia. The reporting physician considered that local redness, local swelling, generalized erythema and pyrexia were serious as an other important medical event. The reporting physician felt that local redness, local swelling, generalized erythema and pyrexia were definitely related to PNEUMOVAX. Additional information has been requested.

VAERS ID:375752 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Foreign  Entered:2010-01-04
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 and concomitant medications were not reported.
Diagnostic Lab Data: RT-PCR and cultures in C6-36 cells were used for detecting the presence of YF virus; MAC-ELISA test was used for detecting IgM YF antibody in CSF
CDC 'Split Type': 200905658
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture positive, Immunology test, Nervous system disorder, Polymerase chain reaction, Yellow fever, Yellow fever vaccine-associated viscerotropic disease
SMQs:
Write-up: In August 2007, a non fatal case of Yellow Fever Associated Viscerotropic Disease occurred in a 60-year-old female patient immunized against yellow fever who received a vaccine from a batch using the 17D-204 strain (vaccine from unknown manufacturer, lot number not reported). The findings were reported considering that there has never been any report indicating presence of yellow fever virus (YF) and IgM antibodies against YF in urine and cerebrospinal fluid (CSF) in YF and in Yellow Fever Associated-Viscerotropic Disease cases. The presence of YF virus in serum, urine and tissues samples, as well as the presence of IgM anti-YF antibody in serum and urine were determined from cerebro spinal fluid (CSF) of this patient who developed a neurological condition but survived. RT-PCR and cultures in C6-36 cells were used for detecting the presence of YF virus, and an MAC-ELISA test was used for detecting IgM YF antibody in CSF. In conclusion, this is the very first time that the presence of the vaccine virus and IgM anti-YF antibody is reported in urine and CSF from patients with YEL-AVD or with neurological condition and this may be useful for making a diagnosis according to the time with the disease. List of documents held by sender: none.

VAERS ID:378772 (history)  Vaccinated:2009-12-24
Age:60.0  Onset:2010-01-16, Days after vaccination: 23
Gender:Female  Submitted:2010-01-28, Days after onset: 12
Location:Foreign  Entered:2010-01-29, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2010-01-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: medical history of diabetes mellitus
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201000446
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURE5925 UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Coma, Coronary artery disease, Death, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow)
Write-up: Case received from lay media and foreign Health Authority on 18 January 2010 through the company representative under the reference number HKG-2010-009. A 60-year-old female patient with a medical history of diabetes mellitus had received an injection of PANENZA (batch number not mentioned, should be E5925) on 24 December 2009, a shot of seasonal influenza vaccine (Mfr unknown) on 02 November 2009 and a shot of pneumococcal vaccine (Mfr unknown) on 02 November 2009. On 16 January 2010, i.e. 23 days after the injection of pandemic influenza vaccine and 75 days after seasonal influenza vaccine and pneumococcal vaccine, the patient had complained of chills and vomiting. She was sent to the hospital on 17 January 2010. She was found to be in a coma and was certified dead on 17 January 2010. The patient had received an unknown kind of injection several days before the death. According to the government official statement, there was no evidence showing the death is related to the vaccination. At the time of the report, further examination by forensic pathologists was pending. Additional information received on 25 January 2010: according to the local Centre for Health Protection, the patient died of coronary heart disease and the death was not related to the vaccination.

VAERS ID:379306 (history)  Vaccinated:2009-11-09
Age:60.0  Onset:2009-11-10, Days after vaccination: 1
Gender:Female  Submitted:2010-02-03, Days after onset: 85
Location:Foreign  Entered:2010-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; smoker; vitiligo
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0616479A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)GLAXOSMITHKLINE BIOLOGICALS  UNLA
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Depression, Disturbance in attention, Fatigue, Headache, Hypoaesthesia, Insomnia, Lip pain, Pain in extremity, Palpitations, Paraesthesia, Restlessness, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow)
Write-up: This case was reported by a regulatory authority agency (#NO-NOMAADVRE-FHI-2009-9336) via a physician and described the occurrence of numbness on side in a 60-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline). Concurrent medical conditions included asthma and vitiligo. On 9 November 2009 the subject received unspecified dose of PANDEMRIX H1N1 (parenteral, unknown). On 10 November 2009, on day after vaccination with PANDEMRIX H1N1, the subject experienced numbness on left side, depression, paresthesia lower extremity left side, sleeplessness, restlessness, and sore upper lip. On an unspecified date in 2009, at an unspecified time after vaccination PANDEMRIX H1N1, the subject experienced concentration difficulties and reduced sensibility left lower extremity. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the numbness on left side, depression, paresthesia lower extremity left side, sleeplessness, restlessness, and sore upper lip was unresolved and the concentration difficulties and reduced sensibility left lower extremity was unspecified. The regulatory authority reported that the events were possibly related to vaccination with PANDEMRIX H1N1. Known asthma and vitiligo. Neurological investigations performed due to concentration difficulties and reduced sensibility left lower extremity. FHI asks for further information. Follow up information was received on 26 January 2010 from the regulatory authority: On 9 November 2009 the subject received unspecified dose of PANDEMRIX H1N1 (parenteral) and seasonal influenza influenza vaccine (parenteral, unknown manufacturer). The seasonal influenza vaccine was injected in the right arm (opposite arm of PANDEMRIX H1N1, same day). On 10 November 2009, one day after vaccination with PANDEMRIX H1N1 and seasonal influenza vaccine, the subject experienced numbness on left side, depression, paresthesia lower extremity left side, sleeplessness, restlessness, and sore upper lip, leg pain, fatigue, anxiety, palpitation, and headache. On an unspecified date in 2009, at an unspecified time after vaccination with PANDEMRIX H1N1 and seasonal influenza vaccine, the subject experienced concentration difficulties and reduced sensibility left lower extremity. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the sore lip, sleeplessness, leg pain, fatigue, numbness, restlessness, anxiety, paresthesia lower limb, palpitations, depressions, and headache was unresolved. The regulatory authority reported that the sore lip, sleeplessness, leg pain, fatigue, numbness, restlessness, anxiety, paresthesia lower limb, palpitations, depression, and headache were possibly related to vaccination with PANDEMERIX H1N1 and seasonal influenza vaccine. Concurrent medical conditions includes the subject is a smoker. 14 January 2010: Additional information from reporter: Remaining symptoms, detailed additional information - in improvement. No further information is expected. The Regulatory Authority has provided GSK with all the information currently available. If new information is received by the Regulatory Authority, it will be sent to GSK.

VAERS ID:380716 (history)  Vaccinated:2009-11-14
Age:60.0  Onset:2009-11-24, Days after vaccination: 10
Gender:Male  Submitted:2010-02-18, Days after onset: 86
Location:Foreign  Entered:2010-02-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart transplant; Hospitalization
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0632185A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER 0IJLA
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Cough, Decreased appetite, Muscle spasms, Palpitations, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Cardiomyopathy (broad)
Write-up: This case was reported by the regulatory authority (# GB-MHRA-FLU 00038185) and described the occurrence of chest tightness in a 60-year-old male subject who was vaccinated with H1N1 (manufacturer unspecified), influenza virus vaccine. The subject had a heart transplant. In between admission to the hospital, the subject had made three visits to his GP surgery. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; given on an unspecified date. On 14 November 2009, the subject received the first dose of H1N1 (1 injection, unknown, left arm), and on 10 December 2009 the subject received the second dose of H1N1 (1 injection, unknown, left arm), on an unspecified date the subject received unspecified dose of Influenza virus vaccine (1 injection, unknown). On 24 November 2009, 10 days after vaccination with the first dose of H1n1 unspecified, the subject experienced decreased appetite. Approximately 14 days after vaccination with the second dose of H1N1, on 24 December 2009, the subject experienced chest tightness. On 26 December 2009, the subject experienced weight loss, palpitation and cough. On 27 December 2009, the subject experienced chest tightness. On 29 December 2009, the subject experienced muscle spasm. The subject was hospitalised. At the time of reporting the events decreased appetite and muscle spasm were improved and the events weight loss, palpitation and cough were resolved with sequelae on 29 January 2010. The outcome of chest tightness was unknown. Verbatim text: Reaction Description: Normal flu jab Right arm Flue vaccination 1st and 2nd left arm. Was admitted on 27th December, 29th December, 19th January. Please note that I have had a heart transplant on 6th June 2006 . In between admission to the hospital I had made three visits to my GP surgery.

VAERS ID:389720 (history)  Vaccinated:2010-03-23
Age:60.0  Onset:2010-03-24, Days after vaccination: 1
Gender:Male  Submitted:2010-05-27, Days after onset: 64
Location:Foreign  Entered:2010-06-01, 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:
Preexisting Conditions:
Diagnostic Lab Data: CRP, 86.5; ESR, 10; Neut, 23.5; Platelets, 458; WCC, 26.4
CDC 'Split Type': 2010023401
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED27201 IJUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA72CA580A IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERVN9125471 IJUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.N2736 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, C-reactive protein increased, Joint swelling, Lethargy, Neutrophil count decreased, Pallor, Platelet count increased, Red blood cell sedimentation rate normal, White blood cell count increased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Report received from regulator on 20-MAY-2010 (case number: 266791). A 60 year old male patient received a FLUVAX vaccination (1 dose, 1 time, batch number: 27201) on 23-Mar-2010. Additional suspect drugs received on the same day include: HIBERIX (1 dose, 1 time, batch number A72CA580A), NEISVAC-C (1 dose, 1 time, batch number VN9125471) and PNEUMOVAX 23 (1 dose, 1 time, batch number N2736). Medical history and concomitant medications are unknown. On 24-Mar-2010, one day after vaccination, the patient experienced joint soreness and swelling, starting in the neck and jaw and then all over. He also experienced lethargy and was pale. The patient visited his Doctor. His CRP (C reactive protein) was 86.5, WCC (white cell count) 26.4, Neut (Neutrophils) 23.5, platelets 458 and ESR (erythrocyte sedimentation rate) 10. Treatment included PANADEINE FORTE and Prednisolone 10mg daily. On 28-Mar-2010, the patient was considered recovered from the events, 5 days later. The reporter considered events possibly related to the suspect drug FLUVAX, HIBERIX, NEISVAC-C and PNEUMOVAX 23. The reporter did not provide a seriousness assessment of the events. The company considers the case serious due to medical significance. The company considers events possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:391082 (history)  Vaccinated:2010-02-17
Age:60.0  Onset:2010-02-17, Days after vaccination: 0
Gender:Female  Submitted:2010-06-18, Days after onset: 120
Location:Foreign  Entered:2010-06-21, Days after submission: 3
Life Threatening? Yes
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': 2010024378
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER090203202 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Loss of consciousness, Pruritus, Skin warm, Syncope, Tremor, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Report received from the regulator on 10-JUN-2010. A 60 year old female patient received PANVAX H1N1 (batch 090203202) on 17-FEB-2010. The patient''s medical history and concomitant medications were unknown. On 17-FEB-2010, the day of vaccination with the suspect drug, the patient had an immediate reaction. The patient was initially shaking, then had a brief loss of consciousness, fainting, and was wheezy. The patient''s skin remained warm. The patient also complained of itch. The reaction was described as clinically anaphylaxis. The patient was treated with adrenaline. The event outcome was not yet recovered. The reporter considered events possible in relation to the suspect drug. The case was reported as serious as it was life threatening. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:391949 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2010-07-01
Location:Foreign  Entered:2010-07-02, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2010024893
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myopathy
SMQs:, Rhabdomyolysis/myopathy (narrow)
Write-up: Report received from a pharmaceutical company on 22-JUN-2010 (case originally reported by a pharmacist). A 60 year old male patient received a FLUVAX injection two weeks ago. The patient had been on LIPITOR for 15 years. Medical history and concomitant medications were unknown. On an unknown date, two weeks after vaccination, the patient was admitted to hospital for a ''myopathy related'' event. The event happened overnight. The event outcome was unknown at the time of reporting. The case was considered serious due to hospitalisation. The company considers event possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:397586 (history)  Vaccinated:2010-04-12
Age:60.0  Onset:2010-08-17, Days after vaccination: 127
Gender:Male  Submitted:2010-09-03, Days after onset: 17
Location:Foreign  Entered:2010-09-07, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2010026197
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED26101 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Endotracheal intubation, Influenza, Influenza A virus test positive, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Report received from the regulator on 25-AUG-2010 (case: 272452). A 60 year old male patient received a single dose of FLUVAX (batch number 26101) via injection on 12-APR-2010. It is unknown if the patient had a relevant medical history or was taking concomitant medication. On 17-AUG-2010, approximately 18 weeks and 2 days (128 days) post vaccination with FLUVAX, the patient developed pneumonia and was intubated. The patient developed respiratory failure (grade II). H1N1 was detected on a throat swab. Treatment was not specified. The reporter considered events serious due to the events causing or prolonging inpatient hospitalisation and possibly related to the suspect drug, FLUVAX. This case was reported as serious due to patient hospitalisation and medical significance. The company considered events possible to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:397694 (history)  Vaccinated:2010-07-29
Age:60.0  Onset:2010-07-30, Days after vaccination: 1
Gender:Female  Submitted:2010-09-07, Days after onset: 39
Location:Foreign  Entered:2010-09-08, 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: FOSAMAX; CALTRATE
Current Illness:
Preexisting Conditions: Medical history included osteopenia and allergies to adhesive bandages and flower pollen. The patient had no illnesses at the time of vaccination and had received no other vaccines at the same time or within 4 weeks.
Diagnostic Lab Data:
CDC 'Split Type': 201004177
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE12860IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURC3569A0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site erythema, Local reaction, Vaccination site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Initial report received on 05 August 2010 from a nurse in a foreign country. A 60 year old female, whose medical history was not reported, received a first left arm 0.5 ml intramuscular injection of TYPHIM VI (lot number E1286-2) and a first right arm 0.6 ml subcutaneous injection of YF-VAX (lot number C3569AB) on 29 July 2010 (vaccination date added on 01-Sep-2010). Twenty-four hours after vaccination, the patient developed a local reaction, consisting of redness and pruritus, at the yellow fever vaccination site on the right arm. In one week, the redness increased from 0 cm to 3 cm in length by 1 cm in height. Another redness also appeared at the same time, just above the fold of the right elbow. In one week, that redness also increased from 0 cm to 2 cm in height and from 0 cm to 9 cm in width. Since the patient also had pruritus, the reporter suggested that the patient take Benadryl as needed. On 04 August 2010, the patient consulted a physician who prescribed Fucidin 2% topical cream twice daily and Cefadroxil 500 mg twice daily for ten days starting on 04 August 2010. At the time of the report, a medical diagnosis had not been confirmed. The physician advised the patient to go to the hospital for intravenous antibiotics if the area continued to increase after 48 hours of treatment. The patient''s outcome was not reported. Follow-up information received on 27 August 2010 from a nurse in a foreign country. Due to the confirmed diagnosis of cellulitis, this case has been upgraded to serious. The patient''s medical history included osteopenia and allergies to adhesive bandages and flower pollen. Concomitant medications included Fosamax and Caltrate for osteopenia. She had no illnesses at the time of vaccination and had received no other vaccines at the same time or within 4 weeks. The physician''s diagnosis was cellulitis and the patient received treatment with Clindamycin for 10 days (dosage unknown). It was not specified if the patient had to go to the ER for IV antibiotics. The redness at the injection site lasted 7 days. The redness that was near the right elbow had decreased "++" in intensity. On 17 August 2010 and 24 August 2010, the reporter had been unsuccessful in contacting the patient to obtain an update on her recovery status.

VAERS ID:400985 (history)  Vaccinated:2010-08-15
Age:60.0  Onset:2010-09-10, Days after vaccination: 26
Gender:Male  Submitted:2010-09-28, Days after onset: 18
Location:Foreign  Entered:2010-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: animal bite
Diagnostic Lab Data: 09/10/2010, platelet count low, 71 G/L; 09/10/2010, white blood cell count low, 2.13 G/L
CDC 'Split Type': PHHY2010DE63596
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Infection, Leukopenia, Platelet count decreased, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (narrow)
Write-up: Initial report received from a physician on 14 Sep 2010: This patient had a dog bite in Aug 2010 and was vaccinated with first dose of RABIPUR (manufacturer and batch number were unknown, vaccinated in one country) on 15 Aug 2010. The vaccination was continued with RABIPUR (batch number unknown, vaccinated in another country), which was likely to be the last dose of the rabies vaccine series (fifth or sixth one of the series). On 10 Sep 2010, blood test showed leucopenia of 2.13 G/L accompanied by a low platelet count of 71 G/L. No countermeasures had been taken and a concomitant infection NOS was suspected. The outcome of the events was reported as not yet recovered. The reporting physician assessed leucopenia as serious (medically significant) and decreased platelet count as non-serious. The outcome, seriousness and causality for infection NOS were not reported.

VAERS ID:401482 (history)  Vaccinated:2010-09-16
Age:60.0  Onset:2010-09-16, Days after vaccination: 0
Gender:Female  Submitted:2010-10-01, Days after onset: 15
Location:Foreign  Entered:2010-10-01
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:
Diagnostic Lab Data: Blood pressure, 16Sep2010, 207/95mm Hg; Physical examination, Sep2010, see narrative; Pulse rate, 16Sep2010, 85/ min
CDC 'Split Type': B0675504A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dry skin, Flushing, Hypertension, Malaise, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (# DK-DKMA-20102803) via a physician and described the occurrence of hypertension in a 60-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). No relevant medical history or concomitant medication was reported. On 16 September 2010, the subject received unspecified dose of HAVRIX (intramuscular, unknown injection site). On 16 September 2010, less than one day after vaccination with HAVRIX, the subject experienced hypertension (207/95), dizziness, flushing and malaise. The subject was hospitalised. Some investigations were done. Blood pressure: 207/95 mm Hg, pulse rate: 85/ min. Skin warm, dry and natural colors. Egal and natural pupillary reaction. Stethoscope pulmonary vesicular breathing bilaterally without the hassle of wheezing. Stethoscope heart: nothing abnormal. Neck and throat without stasis of veins. There was no angioedema or rash and no itching. At the time of reporting the events were improved. The vaccination course with HAVRIX was discontinued.

VAERS ID:404079 (history)  Vaccinated:2010-04-13
Age:60.0  Onset:2010-04-14, Days after vaccination: 1
Gender:Male  Submitted:2010-10-18, Days after onset: 187
Location:Foreign  Entered:2010-10-19, 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:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201005268
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Local reaction, Rash pruritic
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-541). A 60-year-old male patient, whose medical history and concomitant therapies were not reported, had received a dose of H1N1 vaccine (batch number, route and anatomical site of administration not reported) on 13 April 2010, and the patient presented 24 hours later with itchy rash and local "flogistic" signs. The patient had good evolution of the symptoms. Anaphylaxis was reported. The patient was not hospitalized. According to the report, this case has been confirmed. The case was classified as "Moderate". Outcome was not reported. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to the Anaphylaxis. Documents held by sender: None.

VAERS ID:410332 (history)  Vaccinated:2010-10-18
Age:60.0  Onset:2010-10-18, Days after vaccination: 0
Gender:Male  Submitted:2010-11-24, Days after onset: 37
Location:Foreign  Entered:2010-11-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1011USA02818
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1631X0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Case received from the Health Authorities on 09-NOV-2010 (reference number PEI2010032002). Case medically confirmed. A 60 year old male patient had received the first dose of PNEUMOVAX 23 (Lot # 663852/1631X, batch # NK47920) IM in the left upper arm on 18-OCT-2010. In the following night, he developed an acute painful shoulder stiffness (it was not reported if the left or the right shoulder was affected). On 26-OCT-2010 the patient was admitted to an orthopedic hospital. Duration and outcome were not reported. HA coded: Shoulder pain, stiffness shoulder. Other business partner numbers include E2010-07190. No further information is available.

VAERS ID:411207 (history)  Vaccinated:2010-11-05
Age:60.0  Onset:2010-11-06, Days after vaccination: 1
Gender:Female  Submitted:2010-12-01, Days after onset: 25
Location:Foreign  Entered:2010-12-02, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: pulse oximetry, 16Nov10, 96; body temp, 17Nov10, 37.1 degrees C
CDC 'Split Type': WAES1011USA03342
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Injection site swelling, Interstitial lung disease, Loss of consciousness, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Initial information has been received from a physician concerning a female patient in her 60''s who on 05-NOV-2010 was intramuscularly vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown) 0.5 ml of pneumonia (injection site unknown). No information on concomitant medication was provided. On 06-NOV-2010, the patient developed injection site swelling (about 20 cm). Approximately one week later, injection site swelling (about 20 cm) disappeared. The patient recovered from the event. Approximately on 16-NOV-2010, the patient developed loss of consciousness of unknown cause. She was urgently taken to hospital by ambulance and detailed examinations were performed but the cause could not be identified. Pulse oximetry oxygen saturation measurement (SPO2) at the time of transfer was 96 and the low concentration was pointed out. The patient developed interstitial pneumonia (suspect). On 17-NOV-2010, the patient was discharged from the hospital with no abnormality. She recovered from loss of consciousness. Dry cough did not stop. The cough was not accompanied by sputum, etc. and there was no pyrexia. Her body temperature was 37.1 degrees C. At the time of the report, low oxygen concentration continued. Interstitial pneumonia was suspected. Evidence of swelling was still remaining. The patient had not recovered from interstitial pneumonia (suspect). The reporting physician felt that interstitial pneumonia (suspect) and swelling (about 20 cm) were non serious and loss of consciousness was serious due to hospitalization. The reporting physician felt that interstitial pneumonia (suspect) and swelling (about 20 cm) were definitely related to PNEUMOVAX 23 and loss of consciousness was definitely not related to PNEUMOVAX 23. As for loss of consciousness, PNEUMOVAX 23 was probably not related. However, regarding the dry cough, there might be some kind of causal relationship. Additional information has been requested.

VAERS ID:413717 (history)  Vaccinated:2010-10-29
Age:60.0  Onset:2010-11-01, Days after vaccination: 3
Gender:Female  Submitted:2010-12-29, Days after onset: 58
Location:Foreign  Entered:2010-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tiotropium; Losartan potassium; CALCI CHEW; Risedronic acid
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0690027A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB442AF UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURERE5061947601 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# NL-LRB-112505) via a specialist physician and described the occurrence of idiopathic thrombocytopenia in a 70-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline) and (non-GSK) STAMARIL. No relevant medical history was reported. Concurrent medications included Tiotropium, Losartan potassium, Calci chew and Risedronic acid. On 29 October 2010, the subject received unspecified dose of HAVRIX (1 ml, unknown injection site), unspecified dose of STAMARIL (.5 ml, unknown injection site). In November 2010, 29 days after vaccination with HAVRIX and STAMARIL, the subject experienced idiopathic thrombocytopenia. The subject was hospitalised. The subject was treated with prednisone and normal immunoglobulin. At the time of reporting, the event was improved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. The case has been closed.

VAERS ID:413910 (history)  Vaccinated:0000-00-00
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2010-12-30
Location:Foreign  Entered:2011-01-03, 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:
Current Illness:
Preexisting Conditions: The patient had a medical history of arterial hypertension, renal colic, acute myocardial infarction in 2005 and a cardiac stent placement in 2007.
Diagnostic Lab Data: Tests were performed (date not reported): CAT, cranial NMR, chest radiography, lumbar NMR and ECG and all these tests were normal. In a general blood test highlighted: GGT 105 U/l, 14400 leukocytes, ESR and CRP were normal. Serology negative for mycoplasma, HIV, lues, Epstein Barr, CMV, Borrelia and Brucella. A lumbar puncture performed showed, in the cyto-biochemist test, a increased in protein (137 mg/dl), with four cells; the bacteriological culture and PCR (herpes simplex, herpes zoster, enterovirus and CMV) in CSF were negative. A neuro-physiological test was performed with limited alterations (response in the blink-reflex, with stimulation in both supraorbital nerves, without synchronization and low range, normal direct response in bo
CDC 'Split Type': E201007990
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Bacterial test negative, Borrelia test negative, Brucella test negative, C-reactive protein normal, CSF cell count normal, CSF culture negative, CSF protein increased, CSF test normal, Chest X-ray normal, Computerised tomogram normal, Corneal reflex decreased, Cytomegalovirus test, Cytomegalovirus test negative, Eating disorder, Electrocardiogram normal, Enterovirus test negative,