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Case Details (Sorted by Age)

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VAERS ID:539947 (history)  Vaccinated:2014-08-01
Age:52.0  Onset:2014-08-01, Days after vaccination: 0
Gender:Female  Submitted:2014-08-14, Days after onset: 13
Location:Washington  Entered:2014-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Cough, Dizziness, Fatigue, Headache, Hyperhidrosis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Chills, weakness, feeling faint, progressed to more chills, fever, sweats, headache, back pain, hip joint pain throughout the night. Fever & chills broke the neck morning but headache continued next day; overall fatigue/weakness for 5 days; onset of minor cough on 5th day for a week.

VAERS ID:540030 (history)  Vaccinated:2014-08-05
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2014-08-14
Location:Unknown  Entered:2014-08-15, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA006792
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Skin mass, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The pharmacist stated that there was no record on patient of past history and medications and the patient had "never been a drug reaction". On 05-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, lot# was not provided) subcutaneously. On 07-AUG-2014, the patient sought for medical attention by contacting the pharmacist and stated that she (patient) had a lump under her skin, swelling, redness but no pain. Pharmacist stated she advised patient to consider cold compresses to the area. No lab diagnostics studies were performed. The outcome of the events was not provided. Additional information has been requested.

VAERS ID:540071 (history)  Vaccinated:2014-08-07
Age:52.0  Onset:2014-08-10, Days after vaccination: 3
Gender:Female  Submitted:2014-08-16, Days after onset: 6
Location:Virginia  Entered:2014-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Venlafaxine 250mg QD, metoprolol BID, 81 mg aspirin QD, tramadol 50mg PRN, low dose naltrexone 3 mg QHS (for MS), Singulair BID, triamterene QD
Current Illness: None
Preexisting Conditions: Relapsing Polychondritis; Fibromyalgia; MS; HSV II
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Hyperhidrosis, Injection site inflammation, Injection site mass, Injection site reaction, Malaise, Nausea, Pyrexia, Skin lesion, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Recieved Td vaccine on 8/7/14. On Saturday 8/9 I noticed an inflamed lump at injection site with another similar lesion next to it (about the diameter of a dime). On 8/10 the following began: vertigo, fever (101.2), sweats, chills, malaise, nausea, anorexia, prostration, headache, all began approx 2PM on Sunday. By Monday I was prostrate. This continued all week. As of today (8/16) I am improved but still fatigued, with headache, chills and sweats. Fever resolved.

VAERS ID:540229 (history)  Vaccinated:2014-06-10
Age:52.0  Onset:2014-06-12, Days after vaccination: 2
Gender:Female  Submitted:2014-08-06, Days after onset: 55
Location:Ohio  Entered:2014-08-18, Days after submission: 12
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J0145680SCUN
Administered by: Other     Purchased by: Unknown
Symptoms: Pain, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient experienced painful rash/hives all over body 2 days after receiving vaccine. Rash remained for 2 months after vaccine.

VAERS ID:540393 (history)  Vaccinated:2014-08-15
Age:52.0  Onset:2014-08-15, Days after vaccination: 0
Gender:Female  Submitted:2014-08-19, Days after onset: 4
Location:Texas  Entered:2014-08-19
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: WAES1408USA010378
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J009827 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient''s medical history, past drug history, or concomitant medications were unknown. On 15-AUG-2014 the patient was vaccinated with a dose of expired PNEUMOVAX23 (lot # J009827, exp. date: 10-AUG-2014, 0.5 ml, injection, site and route of administration not reported). The patient did not have any relevant laboratory data or tests. As of 15-AUG-2014, it was unknown if the patient would continue to receive PNEUMOVAX23, and the outcome of receiving an expired vaccine was reported as unknown. Additional information has been requested.

VAERS ID:541393 (history)  Vaccinated:2014-01-09
Age:52.0  Onset:2014-01-09, Days after vaccination: 0
Gender:Male  Submitted:2014-02-21, Days after onset: 43
Location:Unknown  Entered:2014-08-25, Days after submission: 184
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: 2014SE13093
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BL2148 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 52 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated accidentally gave FLUMIST to a 52 year old patient which started on 09-Jan-2014. The reporter stated accidentally gave FLUMIST to a 52 year old patient is unknown. The report was considered to be non-serious by the reporter. Corrected report 22-Apr-2014: Coding of the event was corrected from wrong drug administered to drug administered to patient of inappropriate age. Narrative updated.

VAERS ID:541494 (history)  Vaccinated:2013-11-21
Age:52.0  Onset:2013-11-21, Days after vaccination: 0
Gender:Female  Submitted:2014-02-20, Days after onset: 91
Location:Unknown  Entered:2014-08-25, Days after submission: 185
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: 2014SE12646
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 52 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 21-Nov-2013. One patient over 49 years received FLUMIST. The patient experienced patient over 49 years old received FLUMIST which started on 21-Nov-2013. The outcome of the event of patient over 49 years old received FLUMIST is unknown. The report was considered to be non-serious by the reporter.

VAERS ID:542218 (history)  Vaccinated:2013-11-01
Age:52.0  Onset:2013-11-01, Days after vaccination: 0
Gender:Male  Submitted:2013-12-17, Days after onset: 46
Location:Unknown  Entered:2014-08-25, Days after submission: 250
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Lisinopril; Hydrochlorothiazide; Amlodipine; Pravastatin
Current Illness: Type 2 Diabetes Mellitus; Hypertension; Hypercholesterolemia
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE90721
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BK2063 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 Health Professional concerning a 52 year old, Male subject, who had been receiving FLUMIST, (intranasal). The patient''s concurrent disease(s) included Type 2 Diabetes, Hypertension and Hypercholesterolemia. Concomitant medications included metformin, lisinopril, hydrochlorothiazide, amlodipine and pravastatin. FLUMIST started on 01-Nov-2013. It was reported that the patient over 50 years of age patient received FLUMIST which started on 01-Nov-2013. The outcome of the event of over 50 years of age patient received FLUMIS is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health professional: Form completed date was updated. Action taken was updated. Dechallenge rechallenge was updated. Concomitant drugs were added. Concomitant diseases added. Reporter tab updated.

VAERS ID:542346 (history)  Vaccinated:2014-01-03
Age:52.0  Onset:2014-01-03, Days after vaccination: 0
Gender:Male  Submitted:2014-01-10, Days after onset: 7
Location:Indiana  Entered:2014-08-25, Days after submission: 226
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: 2014SE02226
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.  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 52 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on 03-Jan-2014. The reporter mentioned that FLUMIST was inadvertently administered to a 52 year old patient which started on 03-Jan-2014. The outcome of the event of administration to a 52 year old patient is unknown. The report was considered to be non-serious.

VAERS ID:541330 (history)  Vaccinated:2014-07-31
Age:52.0  Onset:2014-07-31, Days after vaccination: 0
Gender:Female  Submitted:2014-08-26, Days after onset: 26
Location:North Carolina  Entered:2014-08-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B6; Sumatriptan
Current Illness: No
Preexisting Conditions: Food allergies; allergies to birch, CIPRO IV; migraines
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Immediately site of shingles injection got red, itchy, 2-3 tiny little hives appeared showed nurse/doctor before leaving. They said it was ok to go home and take BENADRYL. Next morning was fine but by night area was itchy, hard, swollen, hot to the touch, area shaped like an oval (2 1/2" by 2"). Called nurse line who advise to take BENADRYL. Continued taking BENADRYL over the weekend. Area got worse over time, got bigger especially at night time. It was better by Monday. Since then, has developed isolated hives in different areas of body at different times. Hive on right breast, right torso above hip area, right forearm. The hive in forearm still is itchy but healing. Still has shadow of redness in injection area. Doctor mentioned that must have reacted to preservative. Area is periodically itchy/sensitive.

VAERS ID:542109 (history)  Vaccinated:2014-08-29
Age:52.0  Onset:2014-08-29, Days after vaccination: 0
Gender:Female  Submitted:2014-09-02, Days after onset: 4
Location:Michigan  Entered:2014-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K007821 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt was given Pneumovax in the left arm afterwards some swelling some arm pain.

VAERS ID:542959 (history)  Vaccinated:2014-09-08
Age:52.0  Onset:2014-09-08, Days after vaccination: 0
Gender:Female  Submitted:2014-09-08, Days after onset: 0
Location:Ohio  Entered:2014-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine, omeprazole, albuterol, paroxetine
Current Illness: None reported
Preexisting Conditions: ALL: PCN, ASA, Celebrex, Vicodin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1452210IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Dysgeusia
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient experienced a metallic taste in mouth and feelings of dizziness. Instructed patient to sit down in store.

VAERS ID:543138 (history)  Vaccinated:2014-09-09
Age:52.0  Onset:2014-09-10, Days after vaccination: 1
Gender:Female  Submitted:2014-09-10, Days after onset: 0
Location:Tennessee  Entered:2014-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc, Benazepril, heparin, Lopressor
Current Illness: Accidental multi drug overdose
Preexisting Conditions: No known allergies, Chronic pain syndrome, HTN, COPD, Hep C, Bipolar, Chronic benzo usage, Acute renal injury
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K004483 IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large amnt of swelling, redness and pain in right deltoid area where shot was administered.

VAERS ID:543275 (history)  Vaccinated:2014-09-08
Age:52.0  Onset:2014-09-08, Days after vaccination: 0
Gender:Male  Submitted:2014-09-10, Days after onset: 2
Location:New Mexico  Entered:2014-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Acute Intermittent Porphyria, Seasonal Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14111011IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pruritus, Injection site swelling, Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Itching at the injection site. Then itching all over the body, rash on body and head. Injection site got a large bump.

VAERS ID:543411 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-11
Location:Unknown  Entered:2014-09-11
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: WAES1408USA016817
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 irritation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report was received from a 52 year old female physician refers to herself. On an unknown date the physician was vaccinated with one injection of ZOSTAVAX, subcutaneous (dose, lot # unknown). On an unknown date the physician experienced a hyper reaction to ZOSTAVAX which included redness and irritation around the injection site. No treatment was given for the events. No medical attention was sought. The outcome of events was unknown. Additional information is not expected as we could not contact the physician.

VAERS ID:543437 (history)  Vaccinated:2014-09-03
Age:52.0  Onset:2014-09-10, Days after vaccination: 7
Gender:Female  Submitted:2014-09-11, Days after onset: 1
Location:Montana  Entered:2014-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Morphine 60 mg ER; Percocet 2.5-325 mg
Current Illness: No
Preexisting Conditions: Yes she has FSH Muscular Dystrophy diagnosed 11 years ago. It is a genetic disorder. She is also allergic to Valium.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4853AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: She presented with a painful, hot and red left outer upper arm that measured 5-6 cm of redness. There was no swelling, it was tender and warm to touch. She had normal function of her arm. No respiratory symptoms. VS BP 126/76, T 97.9, P 76, R 14, O2Sat 98%, Pain 6/10. Advised to take an antihistamine like Benadryl or Zyrtec, an anti-inflammatory and to ice the area. To return to the clinic if any further problems.

VAERS ID:543626 (history)  Vaccinated:2014-09-12
Age:52.0  Onset:2014-09-12, Days after vaccination: 0
Gender:Female  Submitted:2014-09-14, Days after onset: 2
Location:Wisconsin  Entered:2014-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metro Gel topical, calcium w/vit. D, magnesium.
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Asthenia, Cough, Eye discharge, Eye pruritus, Injection site pain, Ocular hyperaemia, Oropharyngeal pain, Sensation of foreign body, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad)
Write-up: 7:00 started coughing like my lungs were thick bronchial dry cough like I needed an inhaler, 7:30 my eyes got itchy, very red and major yellow discharge (like pink eye), my throat sore and felt like a nodule or something in my throat, very weak and shaky, injected site sore. I spoke to two different hospitals and neither had heard of an eye reaction and one said they would likely put me on an IV and give me Benadryl so I went to the store and got Benadryl and spoke to the pharmacist at about 9:30 p.m. that night and he saw my eyes and symptons and again said he had never heard of such a reaction to the flu shot. I got home and took the Benadryl, went to bed elevated - woke up at 4 am and took another dose. By about 3:00 on 9/13/2014 I was felling back to normal.

VAERS ID:543790 (history)  Vaccinated:2014-09-11
Age:52.0  Onset:2014-09-12, Days after vaccination: 1
Gender:Female  Submitted:2014-09-15, Days after onset: 3
Location:Michigan  Entered:2014-09-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions:
Diagnostic Lab Data: Diagnosed as cellulitis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI73AB13IMLA
Administered by: Public     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Warmth, redness and swelling at site of injection.

VAERS ID:543795 (history)  Vaccinated:2014-09-10
Age:52.0  Onset:2014-09-11, Days after vaccination: 1
Gender:Female  Submitted:2014-09-15, Days after onset: 4
Location:North Carolina  Entered:2014-09-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Diabetes
Diagnostic Lab Data: Dr diagnosed as cellulitis, gave antibiotic rx
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.K0075480SCLA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Erythema, Fatigue, Malaise, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling, warm to touch, fatigue, malaise, low grade fever. Dr diagnosed as cellulitis, gave antibiotic rx.

VAERS ID:543928 (history)  Vaccinated:2014-09-10
Age:52.0  Onset:2014-09-11, Days after vaccination: 1
Gender:Female  Submitted:2014-09-12, Days after onset: 1
Location:California  Entered:2014-09-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI192AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K004542 IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site cellulitis
SMQs:
Write-up: Cellulitis at injection site.

VAERS ID:544428 (history)  Vaccinated:2014-09-09
Age:52.0  Onset:2014-09-10, Days after vaccination: 1
Gender:Female  Submitted:2014-09-11, Days after onset: 1
Location:Alabama  Entered:2014-09-17, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1410801 SYRLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness (1/2 dollar size), itching.

VAERS ID:544621 (history)  Vaccinated:2014-07-01
Age:52.0  Onset:2014-07-06, Days after vaccination: 5
Gender:Female  Submitted:2014-09-01, Days after onset: 57
Location:Pennsylvania  Entered:2014-09-19, Days after submission: 18
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.K0035951SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Pruritus, Varicella
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient developed a mild case of chickenpox. Pt consulted a dermatologist and was treated with hydroxyzine syrup for itching.

VAERS ID:544656 (history)  Vaccinated:2014-09-17
Age:52.0  Onset:2014-09-17, Days after vaccination: 0
Gender:Female  Submitted:2014-09-19, Days after onset: 2
Location:Louisiana  Entered:2014-09-19
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS145603 UNRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.K000328 SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left arm where injection site pt arm swelled, went to urgent care and diagnosed with cellulitis.

VAERS ID:544552 (history)  Vaccinated:2014-09-15
Age:52.0  Onset:2014-09-17, Days after vaccination: 2
Gender:Female  Submitted:2014-09-20, Days after onset: 3
Location:Pennsylvania  Entered:2014-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi vitamin; calcium/vitamin D
Current Illness: None
Preexisting Conditions: Allergic to Percocet, morphine, codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 1SCLA
Administered by: Other     Purchased by: Private
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Initial rash and pain at vaccine site (left arm) about 30 hour later entire left arm in severe pain from vaccine site to fingertips - pain lasted for 10 hours before slowly subsiding.

VAERS ID:544712 (history)  Vaccinated:2014-09-15
Age:52.0  Onset:2014-09-18, Days after vaccination: 3
Gender:Male  Submitted:2014-09-20, Days after onset: 2
Location:Oregon  Entered:2014-09-20
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14111010IMRA
Administered by: Other     Purchased by: Private
Symptoms: Decreased appetite, Dizziness, Hyperhidrosis, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Felt nauseous, woozy, low grade fever, sweats, no appetite x36 hrs.

VAERS ID:544682 (history)  Vaccinated:2014-09-15
Age:52.0  Onset:2014-09-16, Days after vaccination: 1
Gender:Female  Submitted:2014-09-22, Days after onset: 6
Location:Minnesota  Entered:2014-09-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS 1IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Fatigue, Headache, Pain, Respiratory tract congestion
SMQs:
Write-up: Body aches, headache, fatigue with chest congestion for 3 days.

VAERS ID:544906 (history)  Vaccinated:2014-09-17
Age:52.0  Onset:2014-09-18, Days after vaccination: 1
Gender:Female  Submitted:2014-09-24, Days after onset: 6
Location:Kentucky  Entered:2014-09-24
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI171AC IMRA
Administered by: Other     Purchased by: Private
Symptoms: Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: A RED RASH DEVELOPED ON RIGHT ARM BUT NOT IN THE AREA WHERE THE INJECTION WAS GIVEN.

VAERS ID:545141 (history)  Vaccinated:2014-09-16
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-25
Location:Indiana  Entered:2014-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL; LORATADINE; ESTROGEN-METHYLTESTOSTERONE
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI171AB IMLA
Administered by: Other     Purchased by: Private
Symptoms: Mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad)
Write-up: SORE SHOULDER LIMITING USE OF MUSCLE LASTING GREATER THAN 1 WEEK.

VAERS ID:545219 (history)  Vaccinated:2014-09-23
Age:52.0  Onset:2014-09-25, Days after vaccination: 2
Gender:Female  Submitted:2014-09-25, Days after onset: 0
Location:Arizona  Entered:2014-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flexeril 10 mg; Imitrex 100 mg; Meloxicam 7.5 mg; omeprazole 20 mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4965AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Localized redness and pain to the left deltoid.

VAERS ID:545317 (history)  Vaccinated:2014-09-16
Age:52.0  Onset:2014-09-18, Days after vaccination: 2
Gender:Female  Submitted:2014-09-25, Days after onset: 7
Location:Texas  Entered:2014-09-25
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: Iodine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14133010IMLA
Administered by: Other     Purchased by: Other
Symptoms: Myalgia, Rash, Sluggishness, Tremor, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypersensitivity (narrow)
Write-up: Rash area, chest, abdomen, hot happened 2 days later - muscle pain, vertigo, shaking, slow - motion.

VAERS ID:545391 (history)  Vaccinated:2014-09-11
Age:52.0  Onset:2014-09-11, Days after vaccination: 0
Gender:Female  Submitted:2014-09-26, Days after onset: 15
Location:New York  Entered:2014-09-26
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI188AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Soreness and muscle pain in left arm.

VAERS ID:545648 (history)  Vaccinated:2014-09-18
Age:52.0  Onset:2014-09-22, Days after vaccination: 4
Gender:Male  Submitted:2014-09-29, Days after onset: 7
Location:North Carolina  Entered:2014-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI192AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: FEVER; PAIN.

VAERS ID:545882 (history)  Vaccinated:2014-09-27
Age:52.0  Onset:2014-09-28, Days after vaccination: 1
Gender:Male  Submitted:2014-09-29, Days after onset: 1
Location:New York  Entered:2014-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT580060IMLA
Administered by: Other     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: Received flu shot on Saturday 9/27 and noticed under left arm 2 different places that were swollen and red. Area is where the arm meets the shoulder. He noticed that area changed on 9/28 and says it is slightly worse today. Advised to keep an eye on it for worsening symptoms and to contact doctor.

VAERS ID:546098 (history)  Vaccinated:2014-09-24
Age:52.0  Onset:2014-09-24, Days after vaccination: 0
Gender:Female  Submitted:2014-09-29, Days after onset: 5
Location:Texas  Entered:2014-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Minor skin reactions~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: CYMBALTA; Gabapentin; Nortriptyline; LIPITOR
Current Illness: No acute illness reported
Preexisting Conditions: Fibromyalgia; IBS; Restless Leg syndrome; Migraines
Diagnostic Lab Data: Obtained by private doctor
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS2A2KX UNRA
Administered by: Public     Purchased by: Public
Symptoms: Chest X-ray, Headache, Laboratory test, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Approximately 10 hours after vaccine, developed severe body aches, headache with fever 102 degrees oral. Persisted through 9/25/14; fever broke at 4:00 pm then returned that evening to 100.2 degrees. Seen by private doctor who indicated apparent reaction to influenza vaccine. Obtained lab work and chest x-ray (results not available to us as employer).

VAERS ID:546188 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:2014-09-01
Gender:Female  Submitted:2014-09-30, Days after onset: 29
Location:Unknown  Entered:2014-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYMBICORT; XOPENEX; Ibuprofen; SINGULAIR; NEXIUM
Current Illness: Drug Hypersensitivity
Preexisting Conditions: Tetracycline, Drug hypersensitivity; Influenza virus vaccine, Injection site swelling, Injection site pain; Morphine, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1409USA011108
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H014653 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, Local swelling, Pain in extremity
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a pharmacy student refers to a 52 year old female patient who was allergic to macrolides, tetracycline, morphine and salicylates. The patient had experienced pain and swelling at the injection site in the past after receiving unspecified flu vaccines. On 19-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (in the left arm, 0.5 ml, intramuscularly, lot # H014653, expiration date, 19-APR-2014). Concomitant therapies included budesonide, SYMBICORT, XOPENEX, ibuprofen, SINGULAIR and NEXIUM. In September 2014 (exact date unspecified, reported as after receiving expired PNEUMOVAX 23) the patient was experiencing swelling and pain of her left arm. The patient was told to apply ice packs to her arm and to take BENADRYL. The patient sought medical attention via calling the pharmacy. The outcome of events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information has been requested.

VAERS ID:546375 (history)  Vaccinated:2013-10-08
Age:52.0  Onset:2013-10-11, Days after vaccination: 3
Gender:Female  Submitted:2013-10-15, Days after onset: 4
Location:Virginia  Entered:2014-09-30, Days after submission: 350
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Asthma~Influenza (Seasonal) (no brand name)~1~49.00~Patient
Other Medications: Albuterol; Chlorpheniramine maleate; Diclofenac; Fluticasone prop; Hydrocodone/acetaminophen; Pseudoephedrine HCL
Current Illness: Asthma; frequent rhinitis/bronchitis; Irritable bowel; Degenerative arthritis in spine; tobacco - 1/2 ppd; hyperlipidemia
Preexisting Conditions: Hx Gestational DM; Hx cervical dysplasia, last pap 2010
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0070591SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Chills, Erythema, Hyperhidrosis, Influenza like illness, Oropharyngeal pain, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Patient presents to clinic to f/u on c/o LA redness, swelling, and pain s/p PNA injection on 10/08. She reports that since receiving this vaccine she has developed flu like symptoms including sweats/chills (reported highest temp 101) joint pain, sore throat. T: 98.4 (36.9 C) P: 113 R: 18 B/P: 95/60* (sitting) Pulse Oximetry: 96% via room air Pain: 6.

VAERS ID:546457 (history)  Vaccinated:2014-09-20
Age:52.0  Onset:2014-09-30, Days after vaccination: 10
Gender:Male  Submitted:2014-09-30, Days after onset: 0
Location:New York  Entered:2014-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Observed 30 minutes no systemic reaction, ice pack applied
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS145302 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Immediate quarter sized red area with induration.

VAERS ID:546516 (history)  Vaccinated:2014-09-29
Age:52.0  Onset:2014-09-29, Days after vaccination: 0
Gender:Male  Submitted:2014-09-30, Days after onset: 1
Location:Maine  Entered:2014-09-30
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
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS34MM3 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Dizziness, Headache, Pain
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Vestibular disorders (broad)
Write-up: Pt states he experienced body aches and headache and diarrhea and backache a few hours after influenza vaccine was administered. Advised by provider to drink plenty of fluids and take TYLENOL or MOTRIN for body aches. Pt stated he did not plan to do this he will update provider with how he is feeling.

VAERS ID:546449 (history)  Vaccinated:2014-09-28
Age:52.0  Onset:2014-09-28, Days after vaccination: 0
Gender:Female  Submitted:2014-09-28, Days after onset: 0
Location:North Carolina  Entered:2014-10-02, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Got the flu~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: Many
Current Illness: None
Preexisting Conditions: None given on Var, can make assumptions
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS5979Z0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Angioedema severe, BENADRYL/steroids/Epi at urgent care, no prior hx of reaction to vaccine.

VAERS ID:547141 (history)  Vaccinated:2014-10-01
Age:52.0  Onset:2014-10-02, Days after vaccination: 1
Gender:Female  Submitted:2014-10-02, Days after onset: 0
Location:Ohio  Entered:2014-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI187AB SYRUN
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient woke up the day after FLUZONE was administered with a red, swollen and itchy area around the injection site.

VAERS ID:547173 (history)  Vaccinated:2014-09-22
Age:52.0  Onset:2014-09-22, Days after vaccination: 0
Gender:Female  Submitted:2014-10-02, Days after onset: 10
Location:Maryland  Entered:2014-10-02
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: Hypothyroidism
Diagnostic Lab Data: Urine eosinophils; total eosinophil ct
CDC Split Type:
Vaccination
Manufacturer
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.K0035980UNLA
Administered by: Other     Purchased by: Unknown
Symptoms: Discomfort, Eosinophil count, Eosinophils urine, Headache, Insomnia, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: Left sided headache, insomnia, paresthesia, scattered, sporadic itching, generalized sense of discomfort.

VAERS ID:546288 (history)  Vaccinated:2014-09-26
Age:52.0  Onset:2014-09-26, Days after vaccination: 0
Gender:Female  Submitted:2014-10-03, Days after onset: 7
Location:Missouri  Entered:2014-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Scoliosis, von Willebrand''s Disease
Diagnostic Lab Data: Point of care blood glucose "LO" per EMS, 53 mg/dL in ED after receiving IV D50.
CDC Split Type:
Vaccination
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Lot
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose decreased, Hypoglycaemia, Loss of consciousness
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt lost consciousness, was found to be hypoglycemic.

VAERS ID:546338 (history)  Vaccinated:2014-10-01
Age:52.0  Onset:2014-10-02, Days after vaccination: 1
Gender:Female  Submitted:2014-10-03, Days after onset: 1
Location:Ohio  Entered:2014-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Strattera, Cymbalta, Spirlatone, Levothyroxide, Statin
Current Illness: None
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT568050IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness 50mm in diameter pain on touch. No treatment.

VAERS ID:546526 (history)  Vaccinated:2014-09-18
Age:52.0  Onset:2014-09-18, Days after vaccination: 0
Gender:Female  Submitted:2014-10-05, Days after onset: 17
Location:Maryland  Entered:2014-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: October, 2013~Influenza (Seasonal) (Fluarix)~1~51.75~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
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FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS759XC0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Arthralgia, Axillary pain, Injection site pain, Neck pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Injection site right arm pain radiating to and into anterior, medial and posterior shoulder joint, including arm pit, elbow and right neck.

VAERS ID:546556 (history)  Vaccinated:2014-09-03
Age:52.0  Onset:2014-09-03, Days after vaccination: 0
Gender:Male  Submitted:2014-10-05, Days after onset: 32
Location:Ohio  Entered:2014-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole, fenofibrate, Lovastatin, Alprazalam, neouronton
Current Illness: Hyperlipidemia, Peripheral neuropathy, DERD
Preexisting Conditions: No
Diagnostic Lab Data: No tests. Have been ignored, like I'', complaining of a regular flu vaccine. I get them every year. This was bad shoulder and upper arm still hurt---,,
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Public     Purchased by: Private
Symptoms: Delirium, Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: First very sore upper arm and shoulder only got worse through the night- High fever all night and following day- Nausea-delirium.

VAERS ID:546656 (history)  Vaccinated:2014-09-23
Age:52.0  Onset:2014-09-24, Days after vaccination: 1
Gender:Male  Submitted:2014-10-06, Days after onset: 12
Location:Nevada  Entered:2014-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Citalopram, levothyroxin, Prempro, probiotics
Current Illness: Cold
Preexisting Conditions: Hypothyroidism, no spleen
Diagnostic Lab Data: CBC, CMP, lung volume
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Other
Symptoms: Back pain, Full blood count, Metabolic function test, Muscular weakness, Myalgia, Neck pain, Paraesthesia, Pulmonary function test, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Weakness and muscle pain in arm for 2 weeks so far, pain level 7, interrupted sleep, neck and upper back pain, tingling sensation in hand.

VAERS ID:546782 (history)  Vaccinated:2014-09-26
Age:52.0  Onset:2014-09-26, Days after vaccination: 0
Gender:Female  Submitted:2014-10-06, Days after onset: 10
Location:Texas  Entered:2014-10-06
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
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI197AD IMLA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure increased, Breath sounds abnormal, Conjunctivitis, Cough, Dyspnoea, Headache
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: Within ~ 2 hours post Fluzone vaccine, patient developed marked coughing, SOB, headache, and eventual bilateral conjunctivitis. Came back to clinic 4:40 pm (2 1/2 hours after onset cough) where BP elevated at 127/85, P92, resp 22-24, pulse OX 100%, and harsh expiratory breath sounds without wheezing. Given Benadryl 25 mg po, and 2 nebulizer treatments: one with Albuterol, other with Ipratropium and sent home on Prednisone.

VAERS ID:546912 (history)  Vaccinated:2014-10-06
Age:52.0  Onset:2014-10-06, Days after vaccination: 0
Gender:Female  Submitted:2014-10-07, Days after onset: 1
Location:California  Entered:2014-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine Timolol eye gtts Xalatan eye gtts
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI187AB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: One hour after the flu shot injection, my left upper arm (deltoid area) started to swell, felt warm to touch and achy. Today, the injection site is red, hot, and swollen. I think it is a reaction to the flu shot

VAERS ID:548165 (history)  Vaccinated:2014-10-01
Age:52.0  Onset:2014-10-01, Days after vaccination: 0
Gender:Female  Submitted:2014-10-06, Days after onset: 5
Location:Alabama  Entered:2014-10-07, Days after submission: 1
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
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FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI158AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives, itching began shortly after receiving flu vaccine on 10/1/14. Went to MD - took BENADRYL, received IM SOLU-MEDROL - later took dose pack steroids.

VAERS ID:548181 (history)  Vaccinated:2014-09-09
Age:52.0  Onset:2014-09-11, Days after vaccination: 2
Gender:Female  Submitted:2014-10-06, Days after onset: 25
Location:Texas  Entered:2014-10-07, 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: ENABPREL; ZYRTEC
Current Illness: No
Preexisting Conditions: High blood pressure; Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K0012310SCLA
Administered by: Public     Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: MMR given 9/9/14, 2 days later started with itching to back of legs noted. Rash from then kept getting rash only in evening. On 9-27-14 went to MD, still had rash, was told was a reaction to MMR. was not told was the measles. Per the MD, was told not to received the 2nd dose.

VAERS ID:547093 (history)  Vaccinated:2014-10-06
Age:52.0  Onset:2014-10-06, Days after vaccination: 0
Gender:Female  Submitted:2014-10-08, Days after onset: 2
Location:California  Entered:2014-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Maxide, Simvastatin
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYR 
Administered by: Public     Purchased by: Other
Symptoms: Injection site cellulitis
SMQs:
Write-up: Cellulitis at site injection.

VAERS ID:547184 (history)  Vaccinated:2014-10-06
Age:52.0  Onset:2014-10-07, Days after vaccination: 1
Gender:Female  Submitted:2014-10-09, Days after onset: 2
Location:North Carolina  Entered:2014-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED 4IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0117140IMRA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: 101 degree fever, aches, pains, exhaustion, pain at injection site.

VAERS ID:550319 (history)  Vaccinated:2014-10-08
Age:52.0  Onset:2014-10-08, Days after vaccination: 0
Gender:Female  Submitted:2014-10-09, Days after onset: 1
Location:Nevada  Entered:2014-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin; baby aspirin; BENADEYL; BONIVA; CENTRUM SILCER ULTRA; CIPRO; cyanocobalamin; MEDROL dose pak; metoprolol tartrate; omeprazole; spironolactone; VENTOLIN HFA; vitamin B complex; vitamin D2
Current Illness: None
Preexisting Conditions: COPD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Dose
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0135550IMLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Injection site bruising, Injection site swelling, Injection site warmth, Papule
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen, bruised and warm to touch at injection site. Small red papules on arm, sides and back. Tx w/MEDRIL dose pak, 4 mg tablets.

VAERS ID:549505 (history)  Vaccinated:2014-10-04
Age:52.0  Onset:2014-10-04, Days after vaccination: 0
Gender:Female  Submitted:2014-10-10, Days after onset: 6
Location:Illinois  Entered:2014-10-10
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: Contrast iodine
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT577060IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Frostbite, Induration, Pain in extremity, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: (R) arm became severely painful, induration. erythematous; next day measuring 4 inches diameter; diameter was serpiginous in shape; ice-burned areas; 3 days later swelling subsided, pruritus developed.

VAERS ID:550480 (history)  Vaccinated:2014-10-06
Age:52.0  Onset:2014-10-07, Days after vaccination: 1
Gender:Female  Submitted:2014-10-10, Days after onset: 3
Location:Georgia  Entered:2014-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Dose
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MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0155050SCLA
Administered by: Public     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient phoned on 10-9-14 - complained of redness and swelling at site of injection. Complaints of headache starting on 10-7-14. Phoned PMD was told to take ADVIL and use hydrocortisone cream at site. Patient stated when called on 10-9-14 that she had a reaction to a flu shot in the past at site, but not as much redness or swelling.

VAERS ID:547483 (history)  Vaccinated:2014-10-09
Age:52.0  Onset:2014-10-09, Days after vaccination: 0
Gender:Female  Submitted:2014-10-11, Days after onset: 2
Location:Florida  Entered:2014-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Fibromyalgia, asthma
Diagnostic Lab Data: Benadryl every 4 hours, Keflex 500 mg twice a day; ice area; see PCP 10/13/2014; if condition worsens go to ER immediately
CDC Split Type:
Vaccination
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PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Hyperaesthesia, Induration, Pain, Rash, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Redness, golfball size swelling, hot to touch; on 10/10/2014 swelling, hot to touch, redness moved down arm; 10/11/2014 rash on neck and chest; redness down more of arm; swelling, hardness, hot to touch; pain, sensitive to touch.

VAERS ID:547492 (history)  Vaccinated:2014-10-09
Age:52.0  Onset:2014-10-09, Days after vaccination: 0
Gender:Male  Submitted:2014-10-11, Days after onset: 2
Location:Michigan  Entered:2014-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluticasone Propionate nasal spray 50 mcg per daily spray and Pulmicort Flexhaler 180 mcg (budesonide inhalation powder) one daily dose
Current Illness: None.
Preexisting Conditions: Mild asthma.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Diarrhoea, Dizziness, Eyelid oedema, Headache, Myalgia, Nausea, Pallor, Pyrexia, Skin discolouration, Thinking abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Beginning at 1:00 pm (approximately 2 hours after I received the flu shot), I began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, I felt overcome with paleness (changing for a brief period to green, facial coloration, I was told by others), added weakness, added dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. For treatment, I relaxed at home and drank fluids. By 11:00 am the following day (10/10/14), a headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. My adverse reaction may likely be due in part to never before having a flu shot.

VAERS ID:550786 (history)  Vaccinated:2014-09-30
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2014-10-12
Location:Unknown  Entered:2014-10-12
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: WAES1410USA005583
Vaccination
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K004542 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a 52 year old female patient. No information about medical history, drug reactions and allergies was specified. On 30-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K0045422, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005587). Additional information has been requested.

VAERS ID:547706 (history)  Vaccinated:2014-10-07
Age:52.0  Onset:2014-10-07, Days after vaccination: 0
Gender:Female  Submitted:2014-10-13, Days after onset: 6
Location:California  Entered:2014-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexium
Current Illness: None
Preexisting Conditions: Sulpha
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED10249221A0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Dysphagia, Dysphonia, Throat tightness, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Sudden onset of wheezing, throat constriction, hoarse voice, trouble swallowing, dizziness.

VAERS ID:547806 (history)  Vaccinated:2013-05-03
Age:52.0  Onset:2013-05-04, Days after vaccination: 1
Gender:Male  Submitted:2014-09-03, Days after onset: 487
Location:Washington  Entered:2014-10-13, Days after submission: 40
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine sodium
Current Illness: Allergy to gluten
Preexisting Conditions: There were no reported adverse reaction to previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A1039040A
Vaccination
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Lot
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Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B107AA UNRA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 52-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to gluten. Concurrent medications included Levothyroxine. On 3 May 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On the morning of 4 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced arm numbness and leg numbness. The numbness occurred in the left arm and left leg. These events resolved. On 24 May 2013, the subject sought medical attention from the doctor with "numbness in the left arm and numbness in the left leg and this resolved itself as well." The doctor referred the subject to a neurologist for evaluation. Per the reporter, the physician was "not sure if this [was] a reaction to the vaccination or not." At the time of reporting the events were resolved. Follow up was received from a physician on 10 September 2013. The physician documented that the events onset on 4 May 2013, 1 day after vaccination with BOOSTRIX. The physician documented that the outcome was unknown; however, the events were previously reported as resolved. The physician did not consider this case serious.

VAERS ID:550631 (history)  Vaccinated:2014-09-30
Age:52.0  Onset:2014-10-01, Days after vaccination: 1
Gender:Female  Submitted:2014-10-03, Days after onset: 2
Location:Virginia  Entered:2014-10-13, 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: None
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 DIAGNOSTICS1452021IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0066810SCLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Stiff and couldn''t move arm 1 day after redness size bigger than softball and area was raised. Told patient to take BENADRYL and TYLENOL or MOTRIN. Left arm.

VAERS ID:547883 (history)  Vaccinated:2014-09-19
Age:52.0  Onset:2014-09-20, Days after vaccination: 1
Gender:Female  Submitted:2014-10-14, Days after onset: 24
Location:Florida  Entered:2014-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None Known
Current Illness: NO
Preexisting Conditions: No
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0009809 SC 
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J013449 SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Severe swelling in injection arm from shoulder to elbow.

VAERS ID:547890 (history)  Vaccinated:2014-10-09
Age:52.0  Onset:2014-10-10, Days after vaccination: 1
Gender:Female  Submitted:2014-10-14, Days after onset: 4
Location:Minnesota  Entered:2014-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS5SR2L0IMLA
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT519080IMRA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Chills, Erythema, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Fever, chills, and expanding local pain, redness, and swelling. Cellulitis was diagnosed and treatment was given.

VAERS ID:547894 (history)  Vaccinated:2014-10-06
Age:52.0  Onset:2014-10-06, Days after vaccination: 0
Gender:Female  Submitted:2014-10-14, Days after onset: 8
Location:Florida  Entered:2014-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid; Inderol; Unknown diuretic; Villi-dot; ASA 325; Topomax 50mg
Current Illness: No
Preexisting Conditions: Large granulated lymphocyte leukemia
Diagnostic Lab Data: Sent to physician
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI173AA24IMLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Local swelling, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 5 hrs after vaccination, employee noted redness and swelling at site; next day redness and swelling continued and began extending down towards elbow. Mild itching and warmth noted. 10/8/14 mild swelling noted below elbow and warm to touch.

VAERS ID:547950 (history)  Vaccinated:2014-10-14
Age:52.0  Onset:2014-10-14, Days after vaccination: 0
Gender:Female  Submitted:2014-10-14, Days after onset: 0
Location:New York  Entered:2014-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ambien, Elavil, Klonopin, propranolol, Crestor, multi vitamin, D3, rameprozol
Current Illness: No
Preexisting Conditions: Fibromyalgia, high blood pressure, being treated for history of migraines, IBS, high cholesterol
Diagnostic Lab Data: I haven''t called the doctor yet hoping this will pass
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Chest discomfort, Fear, Heart rate increased, Hypotension, Injection site pain, Mental impairment, Muscular weakness, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Sensation of heaviness, Speech disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Pain, nausea, fast heartbeat, low blood pressure of 98 over 58, weak, heaviness in arms, weakness in legs, pressure in chest, cant think straight and words arent coming out right, very painful at the injection site, stiff and painful arm, I haven''t called the doctor yet hoping this will pass, very scared.

VAERS ID:547989 (history)  Vaccinated:2014-10-07
Age:52.0  Onset:2014-10-08, Days after vaccination: 1
Gender:Male  Submitted:2014-10-15, Days after onset: 7
Location:Texas  Entered:2014-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 20 mg PRN; ASA 81 mg daily
Current Illness: None
Preexisting Conditions: Allergies to Penicillin, hyperlipidemia, obesity, and GERD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI172AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0105220IMRA
Administered by: Public     Purchased by: Private
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Next day patient reports fever of 102 degrees F resulting in the patient staying home in bed. Spot in the right deltoid where PPSV 23 vaccine was administered was reported by patient to be red, warm, sore and inflamed. 72 hours after injection, erythema expanded. Six days after injection, patient was seen by physician, and physician noted erythema with mildly increased warmth. Affected area was from the right deltoid down to the mid humerus for a total of about 18 cm long and 10 cm wide. Physician''s recommendations included acetaminophen and cold compresses. Eight days after injection, patient reports symptoms to almost be resolved.

VAERS ID:547993 (history)  Vaccinated:2014-10-08
Age:52.0  Onset:2014-10-09, Days after vaccination: 1
Gender:Female  Submitted:2014-10-15, Days after onset: 6
Location:North Carolina  Entered:2014-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochbethazide, Lisinopril, Metoprolol, Zoloft
Current Illness: No
Preexisting Conditions: Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14115010IMRA
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea, Oropharyngeal pain, Pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Slight sore throat, extreme fatigue, headache, body aches, loss of appetite, mild dizziness and nausea lasting through the weekend into Wed-10/15.

VAERS ID:548361 (history)  Vaccinated:2014-09-30
Age:52.0  Onset:2014-09-30, Days after vaccination: 0
Gender:Female  Submitted:2014-10-16, Days after onset: 16
Location:Pennsylvania  Entered:2014-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Entocort EC 3mg capsule po QD.
Current Illness: No
Preexisting Conditions: History of IBS
Diagnostic Lab Data: Shoulder X-ray and Cervical Spine MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Neck pain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Periarthritis, Tendonitis, X-ray limb
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: I received the influenza vaccine at work. The injection seemed to be given high on my right arm. My arm was sore and achy immediately following and worsened over course of next 10 days. On 10/9/2014, I awoke with increased pain in my arm, into right shoulder and neck. On 10/10/14, the pain was much worse and I could barely move my right arm and shoulder. I was seen by an orthopedic surgeon who treated me with a steroid injection in biceps groove for biceps tendonitis and into the capsule of my right shoulder for adhesive capsulitis and placed on pain medication. I saw an orthopedic specialist on 10/13/14, he started me on high dose steroids and a muscle relaxant. I am still recovering from this, followed up with ortho specialist today, 10/16/14. My mobility is improving and was given stretching and ROM exercises to do daily to improve mobility and increase strength. I am on the steroid taper so time will tell as this is completed and stretching exercises followed to see if I regain complete mobility again.

VAERS ID:548404 (history)  Vaccinated:2014-10-12
Age:52.0  Onset:2014-10-12, Days after vaccination: 0
Gender:Female  Submitted:2014-10-16, Days after onset: 4
Location:Louisiana  Entered:2014-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Neurontin, Wellbutrin, Zoloft, Potassium, Cymbalta, Norco, tramadol, trazodone, lasix (fluid pill), blood pressure medication, Bicillin 2.4 million units, altubuterol, and 6 more medications
Current Illness: URI w/cough; Multiple Sclerosis
Preexisting Conditions: Multiple Sclerosis, osteoporosis, Upper Respiratory Failure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SCRA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness, itching, hot.

VAERS ID:550791 (history)  Vaccinated:2014-10-08
Age:52.0  Onset:2014-10-08, Days after vaccination: 0
Gender:Female  Submitted:2014-10-10, Days after onset: 2
Location:Illinois  Entered:2014-10-16, 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: None
Preexisting Conditions: Allergy CIPRO; Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI189AC SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: C/o red, slightly raised area at site of flu shot injection. Throbs. Slight warm. Tx. Ice, ibuprofen.

VAERS ID:548577 (history)  Vaccinated:2014-10-15
Age:52.0  Onset:2014-10-16, Days after vaccination: 1
Gender:Female  Submitted:2014-10-16, Days after onset: 0
Location:D.C.  Entered:2014-10-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT58206 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J01396 IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large local erythema at site.

VAERS ID:548612 (history)  Vaccinated:2014-10-16
Age:52.0  Onset:2014-10-16, Days after vaccination: 0
Gender:Female  Submitted:2014-10-17, Days after onset: 1
Location:Texas  Entered:2014-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: Denied.
Preexisting Conditions: Denied.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI188AB10IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Site redness measuring 70mm, tenderness, swelling, and site warmth.

VAERS ID:548716 (history)  Vaccinated:2014-10-18
Age:52.0  Onset:2014-10-18, Days after vaccination: 0
Gender:Male  Submitted:2014-10-18, Days after onset: 0
Location:Illinois  Entered:2014-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None on that day
Current Illness: None
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dysgeusia
SMQs:, Taste and smell disorders (narrow)
Write-up: Metallic taste in mouth lasting currently.

VAERS ID:548865 (history)  Vaccinated:2014-10-19
Age:52.0  Onset:2014-10-19, Days after vaccination: 0
Gender:Female  Submitted:2014-10-19, Days after onset: 0
Location:Colorado  Entered:2014-10-19
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1452040IMRA
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Dyspnoea, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Sweating, clammy. SOB. Laid pt on floor. Administered 1 EPIPEN injection. Called 911; 2nd EPIPEN approximately 10 minutes later. EMT arrived. Pt recovered full consciousness.

VAERS ID:548802 (history)  Vaccinated:2014-10-08
Age:52.0  Onset:2014-10-17, Days after vaccination: 9
Gender:Male  Submitted:2014-10-20, Days after onset: 3
Location:Connecticut  Entered:2014-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Shellfish
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14110010IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0098090IMLA
Administered by: Other     Purchased by: Public
Symptoms: Local swelling, Skin warm
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received vaccine along with FLUVIRIN on 10/8/13. Came into pharmacy on 10/17/14 with swollen, warm arm. Advised to go to hospital. Was right arm FLURIVIN was cause.

VAERS ID:548949 (history)  Vaccinated:2014-10-17
Age:52.0  Onset:2014-10-17, Days after vaccination: 0
Gender:Female  Submitted:2014-10-20, Days after onset: 3
Location:California  Entered:2014-10-20
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: No
Diagnostic Lab Data: Talked to primary physician
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 20 LA
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Cold sweat, Dizziness, Fatigue, Headache, Hyperhidrosis, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Severe aching; cold clammy skin; profuse sweating; headache; dizziness; nausea; almost passed out; severe fatigue.

VAERS ID:549654 (history)  Vaccinated:2014-10-06
Age:52.0  Onset:2014-10-16, Days after vaccination: 10
Gender:Female  Submitted:2014-10-19, Days after onset: 3
Location:Pennsylvania  Entered:2014-10-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI187AA IMAR
Administered by: Other     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash beginning on arm starting below injection site spreading to other arm.

VAERS ID:548968 (history)  Vaccinated:2014-10-16
Age:52.0  Onset:2014-10-17, Days after vaccination: 1
Gender:Male  Submitted:2014-10-21, Days after onset: 4
Location:Puerto Rico  Entered:2014-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Patient monitored and antihistamine given for itching on forearm area. Instructed to report any additional signs or symptoms.
CDC Split Type:
Vaccination
Manufacturer
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FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS16023411IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSM7JX92IDRA
Administered by: Military     Purchased by: Military
Symptoms: Incorrect route of drug administration, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Tdap erroneously administered ID instead of IM. Local reaction on forearm noted on 17 Oct 2014.

VAERS ID:549309 (history)  Vaccinated:2014-10-09
Age:52.0  Onset:2014-10-09, Days after vaccination: 0
Gender:Female  Submitted:2014-10-09, Days after onset: 0
Location:California  Entered:2014-10-21, Days after submission: 12
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: Penicillin Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Eye pruritus, Pruritus generalised, Pruritus genital
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt. said entire body was itchy including eyeballs and between toes and private area. Took 2 BENADRYL pt took 2 caps at bedtime and has been better ever since.

VAERS ID:549131 (history)  Vaccinated:2014-09-30
Age:52.0  Onset:2014-09-30, Days after vaccination: 0
Gender:Male  Submitted:2014-10-22, Days after onset: 22
Location:Michigan  Entered:2014-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Lupus flare up, Rheumatoid arthritis flare up
Preexisting Conditions: Lupus, Rheumatoid arthritis
Diagnostic Lab Data: Blood work. Elevated white blood count.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU4996AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K004281 SCLA
Administered by: Public     Purchased by: Private
Symptoms: Blood test, Chills, Injection site swelling, Pain, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Chills, achy fever of 103.8. Arm re swollen at injection sight.

VAERS ID:549247 (history)  Vaccinated:2014-10-21
Age:52.0  Onset:2014-10-21, Days after vaccination: 0
Gender:Female  Submitted:2014-10-22, Days after onset: 1
Location:Ohio  Entered:2014-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diltiazem, Dexilant
Current Illness: None
Preexisting Conditions: History of high blood pressure, heart arrhythmia, seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI198AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal discomfort, Chest discomfort, Chills, Headache, Heart rate increased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: Approximately 4 hours after receiving vaccine, patient felt an increased heart rate, tightness of chest, and stomach pressure. Then the following day (today, 10/22/14) she has had a headache and feels chills and muscle aches that come and go.

VAERS ID:549374 (history)  Vaccinated:2014-10-23
Age:52.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Female  Submitted:2014-10-23, Days after onset: 0
Location:Missouri  Entered:2014-10-23
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: Latex allergy (contact - itchiness)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS161207 IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Felt like tongue was swelling within first 30 minutes of influenza shot. Given 50 mg diphenhydramine oral solution and observed. Felt stable. Will go back to hotel room and sleep. Will report to protocol physician and PCP. Has PCP visit tomorrow anyways.

VAERS ID:549488 (history)  Vaccinated:2014-10-21
Age:52.0  Onset:2014-10-23, Days after vaccination: 2
Gender:Female  Submitted:2014-10-23, Days after onset: 0
Location:California  Entered:2014-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DocQLace 100 MG Capsule take 1 capsule by mouth three times a day; Meloxicam 15 MG Tablet take 1 tablet by mouth once daily; Dicyclomine HCl 20 MG Tablet take 1 tablet by mouth three times a day; DiphenhydrAMINE HCl 50 MG Capsule take 2 cap
Current Illness: No
Preexisting Conditions: Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14129010IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema, Induration, Oedema peripheral, Pyrexia, Swelling
SMQs:, Cardiac failure (broad), 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: 3 cm induration with erythema and pyrexia, and edema of the rest of the upper arm. The swelling has started to resolve (8 hrs. later) No signs of anaphalaxis.

VAERS ID:549807 (history)  Vaccinated:2014-10-13
Age:52.0  Onset:2014-10-15, Days after vaccination: 2
Gender:Female  Submitted:2014-10-17, Days after onset: 2
Location:New York  Entered:2014-10-23, 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:
Current Illness:
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI185AB4UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (L) arm back of elbow, red, hot and tender 10cm x 8.5 cm. Tx: Dicloxacillin 500mg PO TID x 7 days

VAERS ID:549580 (history)  Vaccinated:2014-10-20
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2014-10-24
Location:Florida  Entered:2014-10-24
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14126010IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0117990IMLA
Administered by: Other     Purchased by: Private
Symptoms: 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: Arm red, swollen, painful still after 2 days. Patient did not seek medical attention.

VAERS ID:549594 (history)  Vaccinated:2014-10-20
Age:52.0  Onset:2014-10-22, Days after vaccination: 2
Gender:Male  Submitted:2014-10-24, Days after onset: 2
Location:Texas  Entered:2014-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multivitamin, zinc, omega-3, baby aspirin, Claritin
Current Illness: No
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain, Abdominal pain upper, Fatigue, Headache
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Mild to moderate pain in upper left abdomen. Pain more generalized through abdomen by evening. Generalized abdominal pain the next day (10/23), plus fatigue and mild headache.

VAERS ID:550025 (history)  Vaccinated:2014-10-22
Age:52.0  Onset:2014-10-23, Days after vaccination: 1
Gender:Female  Submitted:2014-10-25, Days after onset: 2
Location:Maryland  Entered:2014-10-25
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: Carpel tunnel issues, migraines
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Unknown     Purchased by: Other
Symptoms: Asthenia, Dizziness, Fatigue, Feeling cold, Hypersomnia, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)
Write-up: Exhausted, mild dizziness, could not get warm, could not stay awake. Slept for almost 22 hours Thursday. Friday morning was alot better & by Friday around 4:30 pm I was able to actually stay awake for my energy was limited but I was feeling alot better. Saturday morning I woke up almost my normal self my energy not up to normal but figured it was from being in bed for 2 days straight.

VAERS ID:550080 (history)  Vaccinated:2014-09-23
Age:52.0  Onset:2014-09-23, Days after vaccination: 0
Gender:Female  Submitted:2014-10-26, Days after onset: 33
Location:Illinois  Entered:2014-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair; Flonase; Montelukast Sodium Tablets; Metoprolol; Generic Prevacid
Current Illness: No
Preexisting Conditions: Celiac Disease, COPD
Diagnostic Lab Data: Have not been checked out by doctor yet. I have an appointment. Seems like it should have cleared up by now.
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER09749221N0SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Left shoulder where the injection was made was extremely painful at time of injection. Pain went away the next day; however, it came back the next week and as of 10/26/2015 is still painful. Worse in the mornings. I have never had a reaction before. Seemed like the injection was done very high up on the shoulder and the injection itself took longer then usual.

VAERS ID:550141 (history)  Vaccinated:2014-10-14
Age:52.0  Onset:2014-10-19, Days after vaccination: 5
Gender:Female  Submitted:2014-10-27, Days after onset: 8
Location:Tennessee  Entered:2014-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None. I am the patient and do not have the Manufacturer Brand information.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Dermatology confirmed shingles and received prescription for medication.
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
Administered by: Public     Purchased by: Private
Symptoms: Herpes zoster, Inflammation, Myalgia, Pain, Rash, Rash erythematous, Rash pruritic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Itchy red bumps appeared on left side of upper back. Applied hydrocortisone lotion for relief. Some minor muscle pain experienced on previous days. Rash spread and inflamed with increased pain and itch. Continued treating with calamine & hydrocortisone. Dermatologist visit confirmed shingles on 10/24/2014.

VAERS ID:551473 (history)  Vaccinated:2014-10-15
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2014-10-15
Location:Colorado  Entered:2014-10-28, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI212AA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect dose administered
SMQs:
Write-up: Given decreased dose than recommended by Manufacturer

VAERS ID:554060 (history)  Vaccinated:2014-09-15
Age:52.0  Onset:2014-09-20, Days after vaccination: 5
Gender:Female  Submitted:2014-09-26, Days after onset: 6
Location:Ohio  Entered:2014-10-28, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.K0080790IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: 9/20/14 approx 1800 noticed numbness/tingling to bilat hands from wrists - circumferential. Temperature sensitive - burning sensation to hot/cold/wind. Lasted approx 2 wks. Also - numbness/tingling bilat toes. 10/14/14 noted thoracic right sided numbness/tingling on back. Size of approx 3" x 6" area.

VAERS ID:550966 (history)  Vaccinated:2014-10-23
Age:52.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Female  Submitted:2014-10-29, Days after onset: 6
Location:California  Entered:2014-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SALONPAS PATCHES; IBUPROFEN, ROBAXIN, NORCO
Current Illness: LEFT ARM MUSCULAR STRAIN
Preexisting Conditions: LATEX ALLERGY ONLY
Diagnostic Lab Data: NONE; PATIENT STATES SHE HAS NO SYMPTOMS CURRENTLY AND SYMPTOMS RESOLVED 1 DAY POST ED VISIT.
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1198AE IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Cough, Headache, Pain, Rash, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: RASH; THAT NIGHT EXPERIENCED HA, CHILLS, BODY ACHES, COUGH, TIGHTNESS TO THROAT. TOOK ADVIL, TYLENOL. WAS SEEN IN THE ED ON 10/26/14; RECEIVED EXAM, ADVICE; NO TEST ORDERED.

VAERS ID:550974 (history)  Vaccinated:2014-10-28
Age:52.0  Onset:2014-10-28, Days after vaccination: 0
Gender:Male  Submitted:2014-10-29, Days after onset: 1
Location:Washington  Entered:2014-10-29
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: No
Diagnostic Lab Data: None done
CDC Split Type:
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FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS1602340IMLA
Administered by: Military     Purchased by: Military
Symptoms: Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Left sided facial swelling, and feeling of fluid under his face. No breathing issues, or itching, or rash. Took Tylenol and Benadryl. Symptoms began to resolve the next day. Did not miss any work time.

VAERS ID:551131 (history)  Vaccinated:2011-10-03
Age:52.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2014-10-24, Days after onset: 1117
Location:Arkansas  Entered:2014-10-29, 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: CLARITIN
Current Illness: No other
Preexisting Conditions: Asthma; multiple allergies respiratory and skin and GI
Diagnostic Lab Data:
CDC Split Type:
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Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH463AC0UNAR
Administered by: Public     Purchased by: Other
Symptoms: Blood pressure decreased, Contusion, Dehydration, Diarrhoea, Dyspnoea, Fall, Nausea, Tinnitus, Vision blurred, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Noninfectious diarrhoea (narrow)
Write-up: Blood pressure dropped, vision blurred, ringing in ears, difficulty breathing, then nausea, vomiting, diarrhea, fell against sink and bruised leg/hip, severe dehydration followed.

VAERS ID:551156 (history)  Vaccinated:2014-10-24
Age:52.0  Onset:2014-10-25, Days after vaccination: 1
Gender:Male  Submitted:2014-10-30, Days after onset: 5
Location:Alabama  Entered:2014-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data: CT SCAN (NEGATIVE)
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1464030IMRA
Administered by: Public     Purchased by: Other
Symptoms: Computerised tomogram normal, Eye irritation, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Corneal disorders (broad)
Write-up: PT WOKE UP WITH LEFT-SIDED FACIAL NUMBNESS AND EYE IRRITATION.

VAERS ID:551175 (history)  Vaccinated:2014-09-19
Age:52.0  Onset:2014-09-20, Days after vaccination: 1
Gender:Female  Submitted:2014-10-30, Days after onset: 40
Location:Arizona  Entered:2014-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BASED ON PRESCRIPTION HISTORY ON FILE: XOPENEX HFA / IBUPROFEN 800MG / NEXIUM40MG / MONTELUKAST 10MG / TRAMADOL50MG / SUMATRIPTAN 100MG / PROCHLORPERAZINE 10MG / SYMBICORT 160.4.5 / LORAZEPAM 0.5MG
Current Illness: None
Preexisting Conditions: Based on prescription history only: asthma migraines
Diagnostic Lab Data:
CDC Split Type:
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H014653 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: ON SITE SWELLING AND PAIN.

VAERS ID:551197 (history)  Vaccinated:2014-10-14
Age:52.0  Onset:2014-10-14, Days after vaccination: 0
Gender:Male  Submitted:2014-10-31, Days after onset: 17
Location:Texas  Entered:2014-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses at time of vaccination
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR 25IDLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Erythema at the injection site. Swelling and pain at the injection site. A large nodule forming at the injection site. Red rash at the injection site.

VAERS ID:551216 (history)  Vaccinated:2014-10-24
Age:52.0  Onset:2014-10-24, Days after vaccination: 0
Gender:Female  Submitted:2014-10-31, Days after onset: 7
Location:Pennsylvania  Entered:2014-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: No known illness
Preexisting Conditions: No known allergies
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4993BA0IDLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site induration, Injection site swelling, Muscular weakness, Myalgia, Neck pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Pt states 4 hours after injection developed redness, hardness and swelling to site, muscle aches, neck and back hurting. By morning-pain in elbows, fever and legs feeling like jelly. Medicated with ibuprofen.

VAERS ID:551272 (history)  Vaccinated:2014-10-16
Age:52.0  Onset:2014-10-16, Days after vaccination: 0
Gender:Female  Submitted:2014-10-31, Days after onset: 15
Location:Wisconsin  Entered:2014-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: No meds or f/u orders needed
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1463010IMLA
Administered by: Other     Purchased by: Private
Symptoms: Blood glucose normal, Dizziness, Dry mouth, Gait disturbance, Headache, Thirst
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Pt c/o headache, dizziness, dry mouth, and extreme thirst. Pt unable to walk in straight line. VS BP142/94, P88, R18.Feet elevated. @220pm, VS BP180/100, P88, R20, still c/o thirst. 911 called. Ambulance crew reported Pulse ox 99%, blood sugar 122. Transported to hospital @245pm for evaluation.

VAERS ID:551404 (history)  Vaccinated:2014-10-25
Age:52.0  Onset:2014-10-26, Days after vaccination: 1
Gender:Female  Submitted:2014-11-01, Days after onset: 6
Location:Texas  Entered:2014-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Diarrhoea, Hyperhidrosis, Injection site discolouration, Injection site erythema, Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Sweating and severe diarrhea. Arm where shot was administered developed a red welp size of half dollar and stayed for over a week and then turned brown.

VAERS ID:551459 (history)  Vaccinated:2014-11-01
Age:52.0  Onset:2014-11-01, Days after vaccination: 0
Gender:Male  Submitted:2014-11-02, Days after onset: 1
Location:Oregon  Entered:2014-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc 10mg
Current Illness: None
Preexisting Conditions: No known medication allergies/ food allergies to shell fish. Member has history of CABG x 1 vessel mitral valve replacement and aneursym repair.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS3E53212IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSEA3Z20IMRA
Administered by: Military     Purchased by: Military
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Member stated he felt alittle itchy and developed hives systemically. Patient states that he never developed any shortness or difficulty breathing.

VAERS ID:551646 (history)  Vaccinated:2014-10-29
Age:52.0  Onset:2014-10-31, Days after vaccination: 2
Gender:Female  Submitted:2014-11-03, Days after onset: 3
Location:Missouri  Entered:2014-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen, atorvastatin, Depakote ER, diazepam rectal gel, docusate, fluoxetine, guaifenesin-DM, Lamictal, levothyroxine, Lyrica, polyethylene glycol, vitamin-D
Current Illness: No
Preexisting Conditions: Severe intellectual disability, obstructive hydrocephalus, hypothyroidism, seizure disorder, hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI195AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Local swelling
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, numbness of injection limb, extending distally to hand. Patient was taken to ED. Treating physician prescribed antibiotics but advised notification of immunizer as possible adverse event.

VAERS ID:551832 (history)  Vaccinated:2014-10-24
Age:52.0  Onset:2014-10-24, Days after vaccination: 0
Gender:Female  Submitted:2014-11-04, Days after onset: 11
Location:Alabama  Entered:2014-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: Not known
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI205AD IMLA
Administered by: Public     Purchased by: Private
Symptoms: Blood glucose, Cold sweat, Dizziness, Flushing, Mydriasis, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: The patient had flu injection, returned to her work area and within 10 minutes reported that she felt "dizzy and clammy" Checked B/P results 150/98. Patient appeared flushed on her face and neck, pupils dilated. After about 10 minutes she stated she felt better B/P now 138/84. Walked with patient back to flu clinic area where she again became flushed and pupils dilated, felt "dizzy and faint". BP now 160/110, pulse - 100 with regular rhythm. Her symptoms continued and B/P now 180/110. Placed 911 call to paramedics. On their arrival the patient was feeling better but when paramedic performed a finger stick to check her blood glucose she again became symptomatic. They advised client that she needed to see her MD or go to the ER today. She refused to go by ambulance. They left the scene. Her B/P was 140/80. Her husband was called to get her and transport her to the ER. On 10/27/2014 the client returned to work. She stated she went to the ER, was given ''something for dizziness and nausea and observed. They discharged her home the same day. Stated she had not exhibited any further symptoms.

VAERS ID:552032 (history)  Vaccinated:2014-10-20
Age:52.0  Onset:2014-10-20, Days after vaccination: 0
Gender:Female  Submitted:2014-10-24, Days after onset: 4
Location:Florida  Entered:2014-11-04, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Woke up on ventilator in ICU~Influenza (Seasonal) (no brand name)~1~26.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: 1988 after Flu shot woke up on ventilator in ICU
Diagnostic Lab Data: Diagnostic: Anaphylactic reaction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS2L7520IMRL
Administered by: Public     Purchased by: Public
Symptoms: Anaphylactic reaction, Burning sensation, Chest discomfort, Eye swelling, Skin warm, Somnolence, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow)
Write-up: Within approximately 5 min of receiving Flu shot the recipient felt drowsy and warm on face. Recipient had makeup on so didn''t notice rash or skin color changes, nor swelling. At 5:30PM while driving to her home she noticed eyes and face swelling, burning in face and chest pressure.

VAERS ID:551933 (history)  Vaccinated:2014-11-03
Age:52.0  Onset:2014-11-03, Days after vaccination: 0
Gender:Female  Submitted:2014-11-05, Days after onset: 2
Location:Michigan  Entered:2014-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Copaxone 20 mg; Synthroid 50 mg
Current Illness: None
Preexisting Conditions: Multiple sclerosis, Hashimotos hypothyroid, no allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT50307 IM 
Administered by: Public     Purchased by: Private
Symptoms: Aphonia, Dysphagia, Dyspnoea, Headache, Ocular hyperaemia
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad)
Write-up: Difficulty breathing, loss of voice, severe headache, blood red eyes, difficulty swallowing.

VAERS ID:551963 (history)  Vaccinated:2014-10-18
Age:52.0  Onset:2014-10-19, Days after vaccination: 1
Gender:Female  Submitted:2014-11-05, Days after onset: 17
Location:Vermont  Entered:2014-11-05
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: Went to doctor and chiropractor
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Activities of daily living impaired, Axillary pain, Back pain, Impaired driving ability, Mobility decreased, Muscular weakness, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Arm and shoulder pain and weakness, radiating down arm, into armpit, into back. Very painful and movement & use impaired. Can''t lift arm. Trouble driving and daily routines such as dressing. Doctor said nerve may have been hit. Chiropractor said muscles involved too. Treatment is gentle exercises to maintain motion and NSAIDs. 18 days out, my left arm is still VERY PAINFUL, can''t be used properly, and symptoms continue to worsen.

VAERS ID:552258 (history)  Vaccinated:2014-10-31
Age:52.0  Onset:2014-11-01, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Wisconsin  Entered:2014-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cold
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI197AD IMLA
Administered by: Other     Purchased by: Private
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)
Write-up: Injection site red, swollen, sore and hot. Approx. 16 hrs after injection I had a bad headache and nausea, diarrhea and vomiting. Symptoms resolved within 24 hrs or so from onset on 11/2/14 approximately 10 AM.

VAERS ID:552371 (history)  Vaccinated:2011-10-19
Age:52.0  Onset:2014-10-17, Days after vaccination: 1094
Gender:Male  Submitted:2014-10-29, Days after onset: 12
Location:Florida  Entered:2014-11-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4993000IDLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: States 48 hours after receiving vaccine developed an itchy rash on lower extremities. Loratidine 10 mg given with inst to cont daily until resolved. Lasted 1 week.

VAERS ID:552658 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:2014-10-14
Gender:Male  Submitted:2014-11-01, Days after onset: 18
Location:Unknown  Entered:2014-11-07, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4992BA IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Intradermal Flu Vaccine Adverse Event: Erythema at the injection site. Swelling and pain at the injection site. A large nodule forming at the injection site. Red rash at the injection site. There were another 30 hospital employees that have reported the same adverse event.

VAERS ID:552854 (history)  Vaccinated:2014-11-05
Age:52.0  Onset:2014-11-05, Days after vaccination: 0
Gender:Female  Submitted:2014-11-05, Days after onset: 0
Location:New York  Entered:2014-11-10, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Faintness, pressure on chest
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1414001 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient felt faint after shot.

VAERS ID:552903 (history)  Vaccinated:2014-11-05
Age:52.0  Onset:2014-11-05, Days after vaccination: 0
Gender:Female  Submitted:2014-11-10, Days after onset: 5
Location:New Hampshire  Entered:2014-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT581060IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Fever, Chills, Headache and no appeite lasting till 11.08.2014. Patient stated that she had slight head ache before vaccination. Arm at site remains tender.

VAERS ID:552922 (history)  Vaccinated:2014-10-17
Age:52.0  Onset:2014-10-28, Days after vaccination: 11
Gender:Female  Submitted:2014-11-10, Days after onset: 13
Location:Colorado  Entered:2014-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: nonw
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: Xray, MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI192AA2IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Axillary pain, Burning sensation, Flank pain, Impaired work ability, Injection site pain, Muscle spasms, Muscular weakness, Myalgia, Neck pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia, Tenderness, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Left shoulder pain, sharp, acute, throbbing,radiating to neck causing burning sensation and then down forearm causing sharp, acute pain with tingling into fingers and cramping of muscles on forearm; same pain then traveled to triceps, to axila and to left flank as well as to left pectoralis muscle. Entire arm is weak, painful to touch. Pain is unrelenting 10 out of 10 (10 being very painful). I have seen 3 medical doctors. I have had 1 shoulder xray, an MRI, and physical therapy since 10/28/2014. I have been prescribed Tramadol, Flexeril, and Daypro with little results. I continue to ice my neck, shoulder and arm. I am on light duty at work down graded from what I usually do as an endoscopy nurse.

VAERS ID:553123 (history)  Vaccinated:2014-11-06
Age:52.0  Onset:2014-11-08, Days after vaccination: 2
Gender:Female  Submitted:2014-11-10, Days after onset: 2
Location:Michigan  Entered:2014-11-10
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: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1205AC IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Inflammation, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Upper arm - inflammation, redness and itching. Much better today 11-10-14.

VAERS ID:553012 (history)  Vaccinated:2014-10-23
Age:52.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Male  Submitted:2014-11-11, Days after onset: 19
Location:Illinois  Entered:2014-11-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1414101 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Joint range of motion decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad)
Write-up: Shoulder pain. Some limited range of motion.

VAERS ID:553180 (history)  Vaccinated:2014-09-30
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-11
Location:Pennsylvania  Entered:2014-11-11
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT580060UNLA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt. stopped in today to notify us of a continued sore arm in the spot of vaccine, no redness or other rxn just off and on soreness -$g recommended heating pad and massage and follow-up with PCP if necessary.

VAERS ID:553093 (history)  Vaccinated:2014-09-24
Age:52.0  Onset:2014-09-26, Days after vaccination: 2
Gender:Female  Submitted:2014-11-12, Days after onset: 47
Location:Georgia  Entered:2014-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: MRI - negative
CDC Split Type:
Vaccination
Manufacturer
Lot
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FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI158AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blindness unilateral, Eye pain, Nuclear magnetic resonance imaging normal, Optic neuritis
SMQs:, Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Retinal disorders (broad), Ocular infections (broad)
Write-up: 9/26 = Left eye became sore to touch; 9/28 = Left eye vision loss; 9/29 = Primary eye MD referred her to ophthalmologist; 9/30 = ophthalmologist ordered MRI due to optic neuritis; 9/31 = MRI completed; 10/2 = Ophthalmologist ordered her to be admitted to hospital for further work-up. She received high doses of steroids and was admitted for 3 days; 11/4 = followed-up with neurologist. Outcome = optic neuritis has improved and she has regained most of her vision in the left eye.

VAERS ID:553243 (history)  Vaccinated:2014-11-10
Age:52.0  Onset:2014-11-10, Days after vaccination: 0
Gender:Female  Submitted:2014-11-12, Days after onset: 2
Location:Ohio  Entered:2014-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 88mcg
Current Illness: None
Preexisting Conditions: Allergies: sulfa, fish, intolerant of prednisone
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Dysphonia, Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Sore throat, low grade fever, hoarseness, soreness/redness/swelling around injection site. Unable to work and stayed home sick 11/11/2014. Felt better around 3:00 PM on 11/11/2014.

VAERS ID:553458 (history)  Vaccinated:2014-11-05
Age:52.0  Onset:2014-11-06, Days after vaccination: 1
Gender:Female  Submitted:2014-11-13, Days after onset: 7
Location:Michigan  Entered:2014-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: None
Preexisting Conditions: Allergic to Thirmerisol
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUIA1AB1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Bone pain, Dyspnoea, Headache, Nausea, Pain, Pyrexia, Rash generalised, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypersensitivity (narrow)
Write-up: States had violent nausea and vomiting, high fever of 102-103, body and bone ache along with SOB. Then had headache from the 6th to the 9th. This was accompanied by hives and a rash over the entire body which was worse under arms and breasts.

VAERS ID:553475 (history)  Vaccinated:2014-10-27
Age:52.0  Onset:2014-10-27, Days after vaccination: 0
Gender:Female  Submitted:2014-11-13, Days after onset: 17
Location:California  Entered:2014-11-13
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: x-ray and MRI - to be done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI169AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left shoulder pain and limited movement from flu shot on 10/27/2014. States that the pain started an hour after the flu shot was given and slowly and progressively increased at the left deltoid and shoulder.

VAERS ID:553532 (history)  Vaccinated:2014-11-13
Age:52.0  Onset:2014-11-13, Days after vaccination: 0
Gender:Female  Submitted:2014-11-14, Days after onset: 1
Location:Oklahoma  Entered:2014-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Estrogel- apply one pump am and pm Progestreone 200 mg once daily
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS146303 IMLA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Dizziness, Feeling cold, Feeling hot, Flushing, Nausea, Nervousness, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Initially chilled, then flushed with heat, shaky, dizzy, weak, nausea. All hit very suddenly. Went to lie down. Had friend drive me home. Fullness in throat with continued symptoms but less severe. Home and to bed. NyQuil. Much better today, still a bit weak at 8:30 AM.

VAERS ID:554137 (history)  Vaccinated:2014-10-29
Age:52.0  Onset:2014-11-01, Days after vaccination: 3
Gender:Female  Submitted:2014-11-06, Days after onset: 5
Location:Vermont  Entered:2014-11-17, Days after submission: 11
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: Aspirin; IMITREX; Theophylline; Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Herpes zoster, Immune system disorder, Induration, Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: I reacted by my arm swelling up, getting really red and hard, Dr said it also attacked my immune system which triggered shingles. ER Dr said that.

VAERS ID:554354 (history)  Vaccinated:2014-11-03
Age:52.0  Onset:2014-11-03, Days after vaccination: 0
Gender:Female  Submitted:2014-11-18, Days after onset: 15
Location:Virginia  Entered:2014-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT52708 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Influenza like illness, Injected limb mobility decreased, Local swelling, Malaise, Nasopharyngitis, Pain in extremity, 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: Patient said that within a day she had gotten a cold with a bad headache. She also complained of a rash and swollen/sore arm after the vaccine for a couple of days. She had a hard time lifting her left (vaccinated) arm for 2 days after getting vaccine. She reported this to us 4 days after receiving the vaccine and the arm no longer had a rash or was swollen but she felt sick with a cold/flu.

VAERS ID:554436 (history)  Vaccinated:2014-10-28
Age:52.0  Onset:2014-10-30, Days after vaccination: 2
Gender:Female  Submitted:2014-11-05, Days after onset: 6
Location:New York  Entered:2014-11-18, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI187AA IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Rash, Skin irritation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Painful rash, swelling and irritation on face and lips 2 days after vaccine.

VAERS ID:554419 (history)  Vaccinated:2014-11-14
Age:52.0  Onset:2014-11-15, Days after vaccination: 1
Gender:Female  Submitted:2014-11-18, Days after onset: 3
Location:Pennsylvania  Entered:2014-11-19, 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: Levothyroxine; Atorvastatin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT537090IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0044830IMRA
Administered by: Other     Purchased by: Private
Symptoms: Fatigue, Local swelling, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received PNEUMOVAX and AFLURIA in the afternoon of 11/14/14. The next day she woke up with a swollen arm, a fever of 102 degrees F, feeling fatigued and nauseated. She contacted her PCP and has been taking regular BENADRYL. Today (11/18/14) her arm is still swollen but she is feeling better, jut tired from the BENADRYL.

VAERS ID:554716 (history)  Vaccinated:2014-10-23
Age:52.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Male  Submitted:2014-11-19, Days after onset: 27
Location:Ohio  Entered:2014-11-19
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: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT568050IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site joint pain
SMQs:, Arthritis (broad)
Write-up: Left shoulder joint pain with certain motions, such as putting on coat. As of 11/19/14 he is still having pain in joint area.

VAERS ID:554751 (history)  Vaccinated:2014-11-07
Age:52.0  Onset:2014-11-08, Days after vaccination: 1
Gender:Female  Submitted:2014-11-19, Days after onset: 11
Location:Arizona  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine and Singulair
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data: Have not heard back from patient. She is seeing the Doctor today.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS146401 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Muscle soreness to upper arm. Painful to raise arm above head. Pain continued until now. Arm is not getting bigger.

VAERS ID:554809 (history)  Vaccinated:2014-11-17
Age:52.0  Onset:2014-11-17, Days after vaccination: 0
Gender:Female  Submitted:2014-11-20, Days after onset: 3
Location:Florida  Entered:2014-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy: Iodine, PCN, Sulfa and egg sensitivity. After talking with her, she said that sometimes eggs give her hives although she marked no egg allergy on the vaccine consent. States she was told she had a sensitivity to eggs, not allergy.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1158AA0IMLA
Administered by: Military     Purchased by: Private
Symptoms: Eye swelling, Headache, Lip swelling, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Started with headache. 1845 had mild itchiness (pin prick). About 2000 noticed hives on thighs and arms. 2330 Fever 101.8F and mild swelling of eyes/lips. Self medicated with OTC Tylenol and Benadryl. Symptoms resolved by end of next day.

VAERS ID:554832 (history)  Vaccinated:2014-11-17
Age:52.0  Onset:2014-11-17, Days after vaccination: 0
Gender:Female  Submitted:2014-11-20, Days after onset: 3
Location:Nevada  Entered:2014-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Allergy to naproxen
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU5008BA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K010523 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4875AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, 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: Severe pain, swelling of arm around injection site and below, fever, possible cellulitis. Treated with percocet and clindamycin.

VAERS ID:555114 (history)  Vaccinated:2014-10-20
Age:52.0  Onset:2014-10-20, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 32
Location:California  Entered:2014-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI194AA IMAR
Administered by: Other     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: NONE

VAERS ID:555290 (history)  Vaccinated:2014-11-19
Age:52.0  Onset:2014-11-19, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 2
Location:Kentucky  Entered:2014-11-21
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: DM II; HTN; Restless leg; Anemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI172AB UNRA
Administered by: Public     Purchased by: Other
Symptoms: Local swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Right arm swelling et itching-started 11/19/14. Tx-BENADRYL et warm compress.

VAERS ID:555292 (history)  Vaccinated:2014-11-17
Age:52.0  Onset:2014-11-18, Days after vaccination: 1
Gender:Female  Submitted:2014-11-18, Days after onset: 0
Location:Missouri  Entered:2014-11-21, 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: Amlodipine; gabapentin; metoprolol tartrate; nortrityline; ranitidine; topiramate; XANAX
Current Illness: None
Preexisting Conditions: FLEXERIL-intracranial aneurysm; Hypertension; Gastric ulcer
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1197AE IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K009876 IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (R) deltoid noted with redness and swelling approx 4 1/2" T x 5" wide hot to the touch. (L) deltoid 2" T x 1 1/2" wide. Warm to the touch. Pt c/o soreness and tenderness to the touch.

VAERS ID:555240 (history)  Vaccinated:2014-11-21
Age:52.0  Onset:2014-11-22, Days after vaccination: 1
Gender:Male  Submitted:2014-11-23, Days after onset: 1
Location:Florida  Entered:2014-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 5mg lisinopril
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Lymphadenopathy
SMQs:
Write-up: Crazy swelling in glands under arm painful difficulty in lifting up left arm that received flu shot.

VAERS ID:555253 (history)  Vaccinated:2014-11-20
Age:52.0  Onset:2014-11-20, Days after vaccination: 0
Gender:Female  Submitted:2014-11-23, Days after onset: 3
Location:Virginia  Entered:2014-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cytomel, levothyronine, metformin
Current Illness: I have a chronic autoimmune illness.
Preexisting Conditions: Celiac disease, type II Diabetes, Hashimoto thyroiditis, OA
Diagnostic Lab Data: WBC count was high. Required monitoring with Holter Monitor and IV fluids.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI212AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chest pain, Electrocardiogram ambulatory, Emotional distress, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)
Write-up: Extreme, severe, acute chest pain. It started suddenly and I was in such distress that my husband had to rush me to the ER. Then I was transported to Hospital to the PCU.

VAERS ID:555310 (history)  Vaccinated:2014-10-29
Age:52.0  Onset:2014-10-29, Days after vaccination: 0
Gender:Female  Submitted:2014-11-24, Days after onset: 26
Location:South Dakota  Entered:2014-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Got sick~Influenza (Seasonal) (no brand name)~1~23.00~Patient
Other Medications: Nothing
Current Illness: No
Preexisting Conditions: Allergies to mold, dust, dust mites, dairy
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1196AB1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased
SMQs:, Parkinson-like events (broad)
Write-up: Cannot lift arm up, back and over shoulder without discomfort.

VAERS ID:555505 (history)  Vaccinated:2014-11-18
Age:52.0  Onset:2014-11-18, Days after vaccination: 0
Gender:Female  Submitted:2014-11-18, Days after onset: 0
Location:Virginia  Entered:2014-11-24, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins
Current Illness: No
Preexisting Conditions: None Known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS45HX70IMUN
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Feeling abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)
Write-up: Described feeling funny after flu shot today weird, feeling all of her body parts, lightheaded. No SOB, swelling of tongue, chest tightness, rash.

VAERS ID:555633 (history)  Vaccinated:2014-10-23
Age:52.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Female  Submitted:2014-11-24, Days after onset: 32
Location:Virginia  Entered:2014-11-25, 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: HCTZ; ARMOUR THYROID; NORDETTE
Current Illness: None reported
Preexisting Conditions: Hypertension; Hypothyroidism
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI173AB IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS437T0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pain, Limb discomfort, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Call from clt. on 11/24/14, stated received TDAP on 10/23/14 and left arm has been "tender with movement" since. States no fever noted, redness or drainage from injection site following immunization. States left arm at injection site feels sore when attempting to lie on left side. No medical attention has been sought, advised clt. to speak to her primary medical doctor about left arm discomfort.

VAERS ID:555798 (history)  Vaccinated:2014-11-14
Age:52.0  Onset:2014-11-15, Days after vaccination: 1
Gender:Female  Submitted:2014-11-26, Days after onset: 11
Location:Wisconsin  Entered:2014-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QVAR
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI1205A0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0096890IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Arthralgia, Asthma, Condition aggravated, Erythema, Local swelling, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Vomiting, joint pain, swelling and redness in arm, asthma attack.

VAERS ID:555983 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2014-11-26
Location:New York  Entered:2014-11-26
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS146503 SYRLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K009105 SYRRA
Administered by: Other     Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt received PNEUMOVAX inj into right arm. A few hours later arm went numb. Pt was sent to ER where he was prescribed NSAID.

VAERS ID:555997 (history)  Vaccinated:2014-09-10
Age:52.0  Onset:2014-09-10, Days after vaccination: 0
Gender:Female  Submitted:2014-11-23, Days after onset: 74
Location:Pennsylvania  Entered:2014-11-28, 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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
Administered by: Other     Purchased by: Private
Symptoms: Dyspepsia, Eyelid oedema, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Gastrointestinal nonspecific dysfunction (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Approx 6:15pm began feeling what I first thought was heartburn. Approx 8-8:15pm severe congestion and swelling in both eyes. Right eye swelled almost closed. BENADRYL relieved the congestion, but eye swelling wasn''t entirely gone until the second morning.

VAERS ID:556028 (history)  Vaccinated:2014-05-12
Age:52.0  Onset:2014-09-10, Days after vaccination: 121
Gender:Male  Submitted:2014-11-28, Days after onset: 79
Location:South Carolina  Entered:2014-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinop/HCTZ20-25mg; Oxycodone 10mg; Metformin 500mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: GBS
CDC Split Type: C4565BA
Vaccination
Manufacturer
Lot
Dose
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Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH858AA1SYRLA
Administered by: Unknown     Purchased by: Other
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Woke up wed morning and right foot was numb. It stayed like that until Thur. Called my doc. She told me to go to emergency room. She thought it might be blood clot. Went to emergency room. They said it was not. Another week went by no better. Went to emergency. They done blood test. No results. Another week no better. Went to another emergency. They diagnosed me with GBS.

VAERS ID:556029 (history)  Vaccinated:2014-08-22
Age:52.0  Onset:2014-09-10, Days after vaccination: 19
Gender:Male  Submitted:2014-11-28, Days after onset: 79
Location:South Carolina  Entered:2014-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxycodone 10mg; metformin 500mg; lisinop/hctz20-25mg
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: Diagnosed with GBS
CDC Split Type:
Vaccination
Manufacturer
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Dose
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TDAP: TDAP (ADACEL)SANOFI PASTEURC4565BA1 LA
Administered by: Unknown     Purchased by: Other
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Stool analysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Woke up Wed morn. Right foot was numb. Hardly any feeling. Called doc. Thursday she said go to emergency room. Sounded like I had a blood clot. Went to ER. They said no clots. Sat had same symptoms in left foot up left leg and in my hands a week later went to ER. They done blood work and stool sample test. Still no better. A week later went to ER. Said I had GBS. They did a spinal tap. Then started IVIG infusion took it for five days.

VAERS ID:556558 (history)  Vaccinated:2014-11-25
Age:52.0  Onset:2014-11-25, Days after vaccination: 0
Gender:Female  Submitted:2014-12-02, Days after onset: 7
Location:Arizona  Entered:2014-12-03, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1454011IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling at injection site immediately. Gave her a BENADRYL 25g - she said that she usually takes that for allergies. She left after swelling was getting better.

VAERS ID:556682 (history)  Vaccinated:2014-11-20
Age:52.0  Onset:2014-11-20, Days after vaccination: 0
Gender:Female  Submitted:2014-11-25, Days after onset: 5
Location:Ohio  Entered:2014-12-03, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: BP 105/77. Pulse 77
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1412301A0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS9544Y0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Chest discomfort, Dizziness, Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Patient felt hot, light headed-immediately chest felt tight. Legs numb and tingly. Took blood pressure it was 105/77. Pulse 77.

VAERS ID:557286 (history)  Vaccinated:2014-11-23
Age:52.0  Onset:2014-11-23, Days after vaccination: 0
Gender:Female  Submitted:2014-12-07, Days after onset: 14
Location:Indiana  Entered:2014-12-08, 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: NEXIUM: Combi patch; Lisinopril
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED09649221A0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site bruising
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Patient given AFLURIA vaccine on 11-23-14, presented back at the pharmacy on 12-2-14. Had approximately 2" in diameter bruise at injection site.

VAERS ID:557529 (history)  Vaccinated:2014-10-01
Age:52.0  Onset:2014-10-01, Days after vaccination: 0
Gender:Female  Submitted:2014-11-27, Days after onset: 57
Location:Mississippi  Entered:2014-12-09, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa/Morphine-Allergies (pt reports)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS017021A0UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0044850UNLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Local swelling
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Temp of 103 the night of administration arm swelling with fluid filled sac hanging from arm.

VAERS ID:557548 (history)  Vaccinated:2014-11-19
Age:52.0  Onset:2014-11-21, Days after vaccination: 2
Gender:Female  Submitted:2014-12-02, Days after onset: 11
Location:Ohio  Entered:2014-12-09, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1414101 UNLA
Administered by: Other     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:557568 (history)  Vaccinated:2014-11-07
Age:52.0  Onset:2014-11-08, Days after vaccination: 1
Gender:Female  Submitted:2014-11-24, Days after onset: 16
Location:New Hampshire  Entered:2014-12-09, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic to sulfer
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI212AA2IMAR
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder, Tenderness
SMQs:
Write-up: C/O pain (R) deltoif. No reddness or swelling noted. Tender to the touvh upon palpation. Unable to raise arm above shoulder height without assistance from (L) arm. Pain disturbs sleep. TYLENOL ineffective. Level of pain has plateaued.

VAERS ID:557784 (history)  Vaccinated:2014-10-27
Age:52.0  Onset:2014-11-05, Days after vaccination: 9
Gender:Male  Submitted:2014-12-11, Days after onset: 36
Location:New York  Entered:2014-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: same~Influenza (Seasonal) (AFLURIA)~1~51.08~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Reaction for 2nd year in a row to this influenza vaccine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Erythema, Lymph node pain, Lymphadenopathy
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Left axilla lymph node tenderness, redness and swelling, two or three marble sized nodes.

VAERS ID:558100 (history)  Vaccinated:2014-10-28
Age:52.0  Onset:2014-10-28, Days after vaccination: 0
Gender:Male  Submitted:2014-12-12, Days after onset: 45
Location:Michigan  Entered:2014-12-12
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: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1412501 IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.

VAERS ID:44563 (history)  Vaccinated:1992-04-01
Age:52.1  Onset:1992-04-27, Days after vaccination: 26
Gender:Female  Submitted:0000-00-00
Location:Foreign  Entered:1992-08-27
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: ENG5035
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diabetes insipidus, Polyuria, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad)
Write-up: 27APR92 p/recvd 2nd dose of vax devel severe diabetes insipidus w/polydipsia & polyuria; pt was hospitalized & was Rxd successfully w/meds;

VAERS ID:45307 (history)  Vaccinated:1992-07-01
Age:52.0  Onset:1992-08-01, Days after vaccination: 31
Gender:Female  Submitted:0000-00-00
Location:Foreign  Entered:1992-09-21
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: No relevant hx
Diagnostic Lab Data: AUG92 Skin biopsy-granulomatous vasclitis; Renal biopsy-mesangeal proliferative glomerulon; CXR-pulmonary parenchymal nodules; CT Scan-pulmonary parenchymal nodules;
CDC Split Type: WAES92087727
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Glomerulonephritis, Granuloma, Laboratory test abnormal, Malaise, Mucous membrane disorder, Pyrexia, Vasculitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Chronic kidney disease (broad), Arthritis (broad)
Write-up: Pt recvd 1st dose Hep B vax JUL92; 1mo later, presented w/systemic vasculitis & was hospitalized; clinical manifestations included fevers, cutaneous vasculitis, glomerulonephritis, oral muscosal vasculitis & probable pulmonary vasculitis;

VAERS ID:76635 (history)  Vaccinated:1995-03-01
Age:52.7  Onset:0000-00-00
Gender:Female  Submitted:1995-08-08
Location:Foreign  Entered:1995-08-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: pt exp similar rxn to above rxn w/1st & 2nd dose Engerix-B
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 950042011
Vaccination
Manufacturer
Lot
Dose
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Chest pain, Hypertension, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)
Write-up: pt recv vax MAR95 & 5 days post vax pt felt poorly, anxious, had a h/a & felt nauseous & tired;also devel chest pain & hypertension;pt admitted to hosp

VAERS ID:98117 (history)  Vaccinated:1989-10-01
Age:52.0  Onset:1989-10-01, Days after vaccination: 0
Gender:Male  Submitted:1997-05-19, Days after onset: 2787
Location:Foreign  Entered:1997-05-20, 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:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Command: latex text for R$gA$g factir oisutuve 1.40
CDC Split Type: EML96679
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)MEDEVA PHARMA, LTD. 1IM 
Administered by: Other     Purchased by: Other
Symptoms: Hypokinesia, Myasthenic syndrome, Myopathy, Osteoarthritis, Paraesthesia, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (broad), Malignancy related conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax & exp tingling of fingers;pt exp myopathy, vasculitis, arthrosis & grip & mobility are poor;

VAERS ID:98212 (history)  Vaccinated:1996-10-10
Age:52.9  Onset:1996-10-10, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:1997-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin, Daktar, Flagyl, Lariam;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 20OCT96 skin biopsy was performed & revealed drug induced vasculitis;
CDC Split Type: 970092881
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye pain, Pain, Vasculitis, Vasodilatation
SMQs:, Glaucoma (broad), Vasculitis (narrow)
Write-up: pt recv vax 10OCT96 & pt devel vasculitis on arms, armpits & thorax corresponding to areas which had never tanned;had sl burning sensation but no itching or pain;burning sensation also present on eyes;areas red when taking hot bath;

VAERS ID:98222 (history)  Vaccinated:1997-02-07
Age:52.5  Onset:1997-02-08, Days after vaccination: 1
Gender:Male  Submitted:1997-02-08, Days after onset: 0
Location:Foreign  Entered:1997-05-23, Days after submission: 103
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: 970110611
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioneurotic oedema, Face oedema, Hypersensitivity, Oedema peripheral, Serum sickness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: pt recv vax vax 7FEB97 & 8FEB97 2PM pt exp swelling on of the lips & face;that noc whole arm was swollen & was seen in ER;DPh & claritin were prescribed;1MAR97 was seen by allergist who felt that the pt had devel allerg rxn;

VAERS ID:104612 (history)  Vaccinated:1997-07-23
Age:52.2  Onset:1997-08-03, Days after vaccination: 11
Gender:Female  Submitted:1997-11-04, Days after onset: 93
Location:Foreign  Entered:1997-11-12, 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: Evorel;prozac;
Current Illness:
Preexisting Conditions: depression nos, hormone replacement therapy;
Diagnostic Lab Data:
CDC Split Type: 970254661
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hepatitis
SMQs:, Hepatitis, non-infectious (narrow)
Write-up: pt recv vax 23JUL97 & 3AUG97 pt devel hepatitis;pt was hosp & d/c summary is not available;gradual improvement

VAERS ID:107441 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:1998-02-09
Location:Foreign  Entered:1998-02-12, 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: unk
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data: unk
CDC Split Type: WAES98020366
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuropathy, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: pt recv vax & 4wk post vax pt exp paresthesia of the hands & feet;because of aggravation pt was hosp;dx w/polyradiculitis;

VAERS ID:107442 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:1998-02-09
Location:Foreign  Entered:1998-02-12, 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: unk
Current Illness: unk
Preexisting Conditions: unk
Diagnostic Lab Data: unk
CDC Split Type: WAES98012502
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuritis, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: pt recv vax & 4wk post vax pt exp paresthesia of hand & feet;pt was hosp & dx w/polyneuritis;

VAERS ID:113435 (history)  Vaccinated:1994-09-20
Age:52.0  Onset:1995-10-02, Days after vaccination: 377
Gender:Female  Submitted:1998-08-13, Days after onset: 1046
Location:Foreign  Entered:1998-08-17, 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: HLA typing A3, DR1, DR4;
CDC Split Type: 19980203571
Vaccination
Manufacturer
Lot
Dose
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 3SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rheumatoid arthritis
SMQs:, Arthritis (narrow)
Write-up: pt recv vax 20SEP94 & approx 13mo p/vax pt exp rheumatoid polyarthritis (knees, ankles & wrists);pt hosp & vax stopped;

VAERS ID:116630 (history)  Vaccinated:1998-07-15
Age:52.0  Onset:1998-09-01, Days after vaccination: 48
Gender:Male  Submitted:1998-11-17, Days after onset: 77
Location:Foreign  Entered:1998-11-23, 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: NONE
Diagnostic Lab Data: hepatitis A serology old infect;hep b serology old infect;medullary MRI numerous hypersignals evoking a vasculitis;MRI numerous hypersignals (no gadolinium intake);
CDC Split Type: 19980270971
Vaccination
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Site
DT: DT ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  SC 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cerebellar syndrome, Gait disturbance, Hyperreflexia, Laboratory test abnormal, Neuropathy, Personality disorder, Vasculitis
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vasculitis (narrow)
Write-up: 6wk p/vax pt devel steppage gait which progressively changed towards an alcoholic like gait;2OCT98 physical exam retrieved bilat cerebellar synd & hyperreflexia;Brain MRI revealed hypersignale & medullary MRl showed same;anosognosia;

VAERS ID:117811 (history)  Vaccinated:1998-10-05
Age:52.7  Onset:1998-10-06, Days after vaccination: 1
Gender:Female  Submitted:1998-12-28, Days after onset: 83
Location:Foreign  Entered:1998-12-30, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 19980282221
Vaccination
Manufacturer
Lot
Dose
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site mass, Injection site oedema, Injection site pain, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: pt recv vax 5OCT98 & 1 day p/vax pt devel a pronounced local rxn @ the level of the lt deltoid;no systemic signs of anaphylaxis;pt also exp significant inflammation of lt proximal upper arm swelling, induration, redness, warmth & pain;

VAERS ID:124898 (history)  Vaccinated:1998-10-15
Age:52.0  Onset:1998-10-15, Days after vaccination: 0
Gender:Male  Submitted:1999-05-27, Days after onset: 224
Location:Foreign  Entered:1999-06-07, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Parkinson Disease;
Diagnostic Lab Data: NONE
CDC Split Type: EML982004
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)MEDEVA PHARMA, LTD.81024BB1   
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: p/vax pt exp numbness @ site of inj (2.5" in diameter) & pain @ times @ inj site;sx are still cont 1mo p/vax;

VAERS ID:124915 (history)  Vaccinated:1998-11-13
Age:52.8  Onset:1998-11-14, Days after vaccination: 1
Gender:Female  Submitted:1999-05-27, Days after onset: 193
Location:Foreign  Entered:1999-06-07, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine/thyroxine
Current Illness:
Preexisting Conditions: allergies: allergic to kiwi fruit;unspecified hypothyroidism;
Diagnostic Lab Data: NONE
CDC Split Type: REG982058
Vaccination
Manufacturer
Lot
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Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)MEDEVA PHARMA, LTD.  SC 
Administered by: Other     Purchased by: Other
Symptoms: Chills, Cough, Headache, Malaise, Myalgia, Pharyngitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Eosinophilic pneumonia (broad)
Write-up: p/vax pt exp pyrexia, shivering, malaise, h/a, myalgia, cough & sore throat;

VAERS ID:128746 (history)  Vaccinated:1999-09-07
Age:52.9  Onset:0000-00-00
Gender:Female  Submitted:1999-09-27
Location:Foreign  Entered:1999-09-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 1999025015
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: pt devel left upper chest pain; hosp; felt chest pain was muscular;

VAERS ID:128796 (history)  Vaccinated:1996-01-18
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:1999-09-28
Location:Foreign  Entered:1999-10-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt- 12/95;age 52; HepB, 1st dose; diffuse arthralgia
Other Medications: july 22,1996; Hep B, smithkline
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 1999025049
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 1SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rheumatoid arthritis
SMQs:, Arthritis (narrow)
Write-up: p/vax pt was Dx of rheumatoid arthritis was confirmed; Methotrexate; prednisone & Plaquenil were then initiated

VAERS ID:132896 (history)  Vaccinated:1999-12-07
Age:52.0  Onset:1999-12-08, Days after vaccination: 1
Gender:Female  Submitted:1999-12-15, Days after onset: 7
Location:Foreign  Entered:1999-12-29, Days after submission: 14
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: Allergy to eggs
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
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Site
MEN: MENINGOCOCCAL (MENOMUNE)CONNAUGHT LABORATORIES09926800SCLA
TD: TD ADSORBED (NO BRAND NAME)LEDERLE LABORATORIES456053 SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site reaction
SMQs:
Write-up: Right arm cellulitis, treated with antibiotics, anti-inflammatory and anti-histamine meds. Full recovery, went to American Mission on 12/10/99

VAERS ID:134378 (history)  Vaccinated:2000-01-01
Age:52.4  Onset:2000-01-25, Days after vaccination: 24
Gender:Female  Submitted:2000-02-24, Days after onset: 30
Location:Foreign  Entered:2000-02-29, 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: Premarin
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 20000033361
Vaccination
Manufacturer
Lot
Dose
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 4  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apathy, Drug ineffective, Myasthenic syndrome, Paraesthesia
SMQs:, Lack of efficacy/effect (narrow), 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), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Rcv''d 4 doses of HB Vax II in 1999 w/out seroconversion. 01/2000 pt rcv''d 1st Engerix B. 1/25 devel pins, needles in arms, marked sensory feeling loss, reduction of power-fingers. As of 2/21 pt not recovered.

VAERS ID:134617 (history)  Vaccinated:1992-10-06
Age:52.0  Onset:1994-12-01, Days after vaccination: 786
Gender:Female  Submitted:2000-03-03, Days after onset: 1919
Location:Foreign  Entered:2000-03-08, 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: ALAT, ASAT, Hepatitis B surface, Antibody, Anti HBC antibody, Cytomegalovirus, Epstein Barr, Hep A, HIV, Mononucleosis, Toxoplasmosis
CDC Split Type: 20000054851
Vaccination
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Lot
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 3IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hepatitis
SMQs:, Hepatitis, non-infectious (narrow)
Write-up: 12/94, ASAT increased and ALAT increase were discovered. At a date not specified, liver cytolysis disappeared. 3/95 liver cytolysis reoccurred with ASAT and ALAT increase. Diagnosis of hepatitis was made but no liver biopsy avail.

VAERS ID:151022 (history)  Vaccinated:1998-05-06
Age:52.0  Onset:1998-08-06, Days after vaccination: 92
Gender:Female  Submitted:2000-04-03, Days after onset: 606
Location:Foreign  Entered:2000-04-20, Days after submission: 17
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: migraine
Diagnostic Lab Data: Blood cultures, Serologies, MRI of the brain and spine/neck show marked white matter changes centrally and within both cerebral hemispheres of unspecified appearance.
CDC Split Type: 20000107401
Vaccination
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Other     Purchased by: Other
Symptoms: Demyelination, Fumbling, Nervous system disorder
SMQs:, Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: On 5/6/98, a 3rd dose of Engerix-B was given. In July or August, 1998, approximately 2.5 months post vax, this female pt developed neurological weakening with fumblingness of the right arm. She was investigated at a neurological dept. These changes could be of immunological as well as of infectious genesis. MS could not be excluded. A dx of unspecified demyelination of unknown origin was made. As of 4/12/2000, the events were ongoing. The reporting physician considers the events to be unlikely related to the vaccine due to onset interval delay of several weeks.

VAERS ID:151105 (history)  Vaccinated:1999-11-01
Age:52.0  Onset:1999-11-01, Days after vaccination: 0
Gender:Female  Submitted:2000-03-29, Days after onset: 149
Location:Foreign  Entered:2000-04-26, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Arthralgia, back pain.
Diagnostic Lab Data: Epstain-Barr virus infection - positive, Erythrocyte sedimentation rate - 6, hemoglobin - 15 g/dL, C-reactive protein - <10 mg/L.
CDC Split Type: MPO2000001770
Vaccination
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Lot
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Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Other     Purchased by: Other
Symptoms: Muscular weakness, Neuropathy, Pain, Sensory disturbance, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Neuropathy. Pt experienced demyelinating polyneuropathy post vax. The report states that, at about the same time as the flu jab the vaccinee developed an ached down the legs. This became more of a problem and she would waken at about 2:00 AM and gradually got very little sleep. The pt found it very difficult to bend down due to a tearing pain in the front of her thighs. Her general practitioner wondered whether it was polymyalgia rheumatica but blood tests were nml. The pt''s legs began to get weak. The reporter stated that the pt''s health has been excellent and she has never had a serious illness of injury. Long-lived, healthy family, except for brother with renal problems Non-smoker, drinks approximately 14 units of alcohol per week. On examination: normal speech, cranial nerve function intact, neck flexors nml. Unable to stand unaided and had particularly weak proximal muscles. Minimal sensory loss of over C5 and 6 in arms, but quite are flexic. Branchi-radialis weak. Results of examinations consistent with immune neuropathy with demyelination and secondary severe axonal degeneration. Deltoids, biceps, and triceps weak. Hand muscles ok. NO sensory loss over trunk, legs very weak but flexion and extension are flexic and plantar responded flexor. All modalities of sensation intact.

VAERS ID:156530 (history)  Vaccinated:2000-06-28
Age:52.0  Onset:2000-07-05, Days after vaccination: 7
Gender:Male  Submitted:2000-07-11, Days after onset: 6
Location:Foreign  Entered:2000-07-13, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: bilirubin - 6.7, GPT - 2722, GOT - 1144, gGT - 143, SGOT - 1244, SGPT - 1222, bimanual exam of liver - ? hepatomegalia, adenovirus antibodies - neg, bimanual exam - liver palpable, cytomegaly antibodies - not detectable, hepatitis serology
CDC Split Type: 20000203191
Vaccination
Manufacturer
Lot
Dose
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2812A40IM 
Administered by: Other     Purchased by: Other
Symptoms: Abnormal faeces, Alanine aminotransferase increased, Anorexia, Aspartate aminotransferase increased, Asthenia, Hepatic function abnormal, Hepatomegaly, Hyperbilirubinaemia, Jaundice, Urine analysis abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (broad)
Write-up: On 6/28/00, the vaccinee received the 1st injection with Engerix-B adult (2612A4). Approximately, 2 days, post vax, he experienced tiredness, inappetence with subsequent scleral jaundice, dark urine discoloration and discolored stool. On 7/5/00, the pt was hospitalized. On admission, blood exam revealed the pt''s hepatic enzymes severely increased. Hepatomegalia was suspected. Medical treatment is unknown so far. Information received on 7/5/00, reports the outcome of the vaccinee as not yet recovered. The reporting physician did not specify the causality. Further details have been requested. Follow-up received 8/7/00 states that the pt has not yet recovered and has hepatic enzymes are regressive. Medical treatment was not reported.

VAERS ID:157824 (history)  Vaccinated:1996-11-19
Age:52.0  Onset:1999-09-01, Days after vaccination: 1016
Gender:Male  Submitted:2002-06-25, Days after onset: 1028
Location:Foreign  Entered:2000-07-24, Days after submission: 701
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: Chronic gastric ulcer and a family history of hematologic disorders
Diagnostic Lab Data: cerebral MRI - hypersignals (cortex), Somesthesic evoked potentials - disturbed, visual evoked potentials - disturbed
CDC Split Type: 20000214471
Vaccination
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Other     Purchased by: Other
Symptoms: Diplopia, Dysuria, Laboratory test abnormal, Paraesthesia, Pollakiuria, Vertigo
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Ocular motility disorders (broad)
Write-up: On 5/20/96, 7/96, and on 11/19/96, the pt was vaccinated with Engerix-B. In 10/97, 11 months after the third injection, the pt developed dysuria and pollakiuria. In 11/98, he experienced diplopia and vertigo that lasted one week. In 2/99, the pt developed paresthesia which resolved in 9/99. In 9/99, 3 years after the last injection of Hep B (Engerix-B), he developed lower limbs pyramidal syndrome (especially on left side). Cerebral MRI showed cortex hypersignals in T2. Somesthesic and visual evoked potentials were disturbed. No regression of pyramidal syndrome has been reported. The symptoms were considered as disabling. The most recent information received on 8/12/00 reports the outcome of diplopia, vertigo and paresthesia as resolved, dysuria and pollakiuria as unknown and pyramidal syndrome as not yet recovered. Causality assessment was reported by French Agency as dubious for Hep B vaccine (Engerix-B).

VAERS ID:160182 (history)  Vaccinated:1992-02-20
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2000-09-26
Location:Foreign  Entered:2000-09-28, 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: Kidney cyst
Diagnostic Lab Data: Feb/1992: HLA typing; A2, A23, B27, B44, DR1-DR7
CDC Split Type: 20000278471
Vaccination
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Lot
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Fibromyalgia, Rheumatoid arthritis
SMQs:, Arthritis (narrow)
Write-up: On 02/20, 04/07, and 05/05/1992, this pt received hepatitis B prophylaxis. Early in 1993, the pt was dxed with rheumatoid arthritis (unspecified inflammatory signs on her hand, elbows and knees). In February 1993, hydroxychloroquine (Plaquenil) was started. On 02/26/00, the pt received another vax. In July 1993, hydroxychloroquine was stopped and replaced by gold salts (5 cg every 2 weeks) and unspecified corticotherapy (3.5 mg/day per os). From 19 to 31 May 2000, the pt was hospitalized for fibromyalgia and nondestructive polyarthralgia. The most recent information received on 09/19/00 reports the outcome of the pt as not yet recovered. Causality assessment was coded as dubious for the vaxs.

VAERS ID:164480 (history)  Vaccinated:1998-11-30
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2002-07-03
Location:Foreign  Entered:2001-01-08, Days after submission: 540
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: Arthrosis
Diagnostic Lab Data: UNK
CDC Split Type: 20000366971
Vaccination
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Lot
Dose
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: Other     Purchased by: Other
Symptoms: Amyloidosis, Movement disorder, Muscle contractions involuntary, Myelopathy
SMQs:, Peripheral neuropathy (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)
Write-up: In 1995, the pt had primovaccination for Hep-B prophylaxis. On 11/30/98, he received the booster injection with Engerix-B. During the winter of 1998, the pt experienced right hand motricity disorder with fasciculations. During the winter of 1999, he experienced right forearm and hand amyotrophy. In May, 2000, he was hospitalized and treated with avocado/soya and calcium colecalciferol for unspecified cervico-arthrosic myelopathy. On 5/22/00, amyotrophic lateral sclerosis-like disease was dx''d; the pt was treated from 5/30/00 with riluzole (Rilutek) and alpha-Tocopherol. On 10/10/00, the pt status was stable. The events were considered as life threatening. The most recent information received on 12/26/00, reports the outcome of the pt as not yet recovered. Causality assessment was reported as dubious for Engerix-B. F/U no additional info to list. The most recent info received on 06/18/02 reports the outcom eof the pt as not yet recovered. Causality assessment was reported as dubious for Engerix B. A 15-day follow up report received 05/14/2003 adds: This report describes the occurrence of amyotrophic lateral sclerosis-like disease in a 52-year-old male pt vaccinated with Engerix-B for the prophylaxis of hepatitis B. Medical history included unspecified surgery. Concurrent clinical conditions included arthrosis. In 1995 the pt had primovaccination (unspecified vaccine) for hepatitis B prophylaxis. On 11/30/1998, he received the booster injection with Engerix-B (hepatitis B vaccine). During winter 1998, the pt experienced right hand motricity disorder with fasciculations. During winter 1999 he experienced right forearm and hand amyotrophy. In May 2000, he was hospitalized and treated with avocado/soya (Piascledine) and calcium/colecaliferol (Calperos) for unspecified cervico-arthrosic myelopathy. On 05/22/2000, amyotrophic lateral sclerosis-like disease was diagnosed; the pt was treated from 05/30/2000 with riluzole (Rilutek) and alpha-tocopherol (Toco). On 10/10/2000 the pt status was stable. The events w

VAERS ID:165526 (history)  Vaccinated:1996-01-18
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2002-07-03
Location:Foreign  Entered:2001-02-02, Days after submission: 515
Life Threatening? No
Died? Yes
   Date died: 1998-06-19
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CT scan showed small strokes and brain MRI was normal; brain MRI showed many T2 hypersignlas (04/98); CT scan-cerebrovascular attacks.
CDC Split Type: 20010020911
Vaccination
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Lot
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Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 3IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Bone disorder, Cerebrovascular accident, Cerebrovascular disorder, Dysphagia, Muscle atrophy, Muscle contractions involuntary, Muscle disorder, Myalgia, Respiratory disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad)
Write-up: At an unspecified date in 1995 or 1996, the pt developed severe asthenia, myalgia and fasiculations. It is currently unknown if this symptom started prior or after the first, second, third or booster injection of Engerix. Then swallowing difficulties occurred and a gastric catheter was set up. The pt also developed phonation and respiratory disorders. Three diagnosis were suspected, amyotrophic lateral sclerosis, Kennedy disease or bulbo-spinal atrophy. On 6 19/98 approximately 1 1/2 year after the Engerix-B vax, the pt died. The most recent information received on 1/26/01 reports the outcome of the pt as died due to unknown cause. Follow up states that the final diagnosis was probable Kennedy syndrome with suspected cerebral vasculitis. According to the hospital report, the first events occurred in 1997. CT scan showed small cerebrovascular attacks. In April 1998, brain MRI showed many T2 hypersignals. Encephalopathy of a vascular etiology was suspected. According to the reporter, the pt was suffering from bulbo-spinal atrophy. Hypothesis of amyotrophic lateral sclerosis and Kennedy''s syndrome were suggested. The most recent info received on 06/18/02. Reporter''s causality assessment: probably unrelated to drug intake.

VAERS ID:168916 (history)  Vaccinated:2000-10-24
Age:52.0  Onset:2000-10-31, Days after vaccination: 7
Gender:Male  Submitted:2001-04-12, Days after onset: 162
Location:Foreign  Entered:2001-04-20, 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: Pulmicort; Serevent; Ventolin
Current Illness:
Preexisting Conditions: Asthma, pulmonary fibrosis
Diagnostic Lab Data: Chest x-ray clear, Chest x-ray - narrative.
CDC Split Type: WAES01040572
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)MEDEVA PHARMA, LTD.RT6086 IM 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: 0     Purchased by: 0
Symptoms: Asthma, Chest X-ray abnormal, Cough, Dizziness, Dyspnoea, Hypoxia, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Interstitial lung disease (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Information has been received from the health authorities concerning a 52 year old male who on 10/24/00 was vaccinated IM with pneumococcal vaccine 23 polyvalent. Concomitant therapy, the same day, included influenza virus vaccine (Fluvirin). Other concomitant therapy included albuterol sulfate (Ventolin), budesonide (Pulmicort) and salmeterol xinafoate (Serevent). On 10/31/00, the pt experienced worsening of shortness of breath on effort and at rest. He had severe coughing, light-headedness and severe hypoxia. The symptoms became progressively worse and after 6 weeks, he was admitted to the hospital. Chest x-ray before immunization had been clear. Following immunization, the chest x-ray showed shadows. Oxygen partial pressure was 4kPa. The pt had been dx''d, 1 year previously with asthma, which was later considered to be insidious onset of fibrosis. Despite the ongoing shortness of breath, the pt continued to work full time. Therapy with albuterol sulfate, budesonide and salmeterol xinafoate were discontinued in 12/00. The outcome of the pt''s events were reported as unknown. It was reported that the case was closed. No further information is available.

VAERS ID:169282 (history)  Vaccinated:2000-10-24
Age:52.0  Onset:2000-10-31, Days after vaccination: 7
Gender:Male  Submitted:2001-04-02, Days after onset: 152
Location:Foreign  Entered:2001-05-01, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ventolin (Salbutamol), Pulmicort (Budesonide).
Current Illness:
Preexisting Conditions: asthma, pulmonary fibrosis
Diagnostic Lab Data: Oxygen partial pressure 4kPa. X-ray prior to vaccination - clear. After vaccination - shadows.
CDC Split Type: MPU2001001830
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)MEDEVA PHARMA, LTD.  IM 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: 0     Purchased by: 0
Symptoms: Chest X-ray abnormal, Cough, Dizziness, Dyspnoea, Hypoxia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: The pt experienced shortness of breath on effort and at rest, coughing and lightheadedness. Those symptoms got progressively worse over 6 weeks and the pt was admitted to the hospital, where he was noted to be coughing and was discovered to be severely hypoxic. The pt continued to experience exacerbated shortness of breath for one year. A Chest x-ray showed diffuse shadows prior to the vaccine, the x-ray had been clear.

VAERS ID:169704 (history)  Vaccinated:1994-06-30
Age:52.0  Onset:1994-12-04, Days after vaccination: 157
Gender:Female  Submitted:2001-05-08, Days after onset: 2346
Location:Foreign  Entered:2001-05-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history included allergy to Clamoxyl (Amoxicillin) and cramps of the writer in 1984. The patient has two children. Concurrent clinical conditions included mild beta-thalasssaemia and ophthalmic migraines
Diagnostic Lab Data: 12/94 Biological check-up - Nml. Cerebral CT Scan - Nml. Cerebral MRI - Nml. Lumbar Puncture - Nml.
CDC Split Type: 20010110841
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  SC 
Administered by: 0     Purchased by: 0
Symptoms: Anaemia, Eye disorder, Muscle spasms, Myelitis, Neck pain, Paraesthesia, Viral infection
SMQs:, Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad)
Write-up: Report number 2001011084-1 describes the occurrence of suspected viral myelitis in a 52 year old female patient vaccinated with Engerix-B for prophylaxis of hepatitis B. This case was received from AFSSAPS. The patient belongs to the REVAHB association. Medical history included allergy to Clamoxyl (Amoxicillin) and cramps of the writer in 1984. The patient has two children. Concurrent clinical conditions included mild beta-thalasssaemia and ophthalmic migraines. On 05/31 and 06/30/94, the patient was vaccinated with Engerix-B. Approximately five months later, on 12/04/94, the patient developed sensitive disorder (paresthesia). From 12/08 to 12/17/94, she was hospitalized. Sensitive disorder had spread out from his legs to C4 level, with the exception of right part of the thorax. Besides that, physical examination was normal. Cerebral CT Scan and MRI were normal. Lumbar puncture and biological check-up were normal. Viral myelitis was suspected. On 01/07/95, the patient developed cervical pain and pain on the front side of the legs. On 02/01/95, paresthesia persisted with episodes of pricking sensation in one hand or in the feet. Neurological examination was normal. Beta-Thallassaemia showed anemia at 10.5 gm/dl (stable). Coombs test and hemocultures were negative. The most recent info received on 12/15/2001 reports the outcome of the patient as recovered without sequelae. Causality assessment was not specified by th AFSSAPS.

VAERS ID:173251 (history)  Vaccinated:1997-01-16
Age:52.0  Onset:1997-01-17, Days after vaccination: 1
Gender:Female  Submitted:2001-07-12, Days after onset: 1636
Location:Foreign  Entered:2001-07-13, 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: Radiation Therapy
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Analysis of tissue specimen staining resulted in lymphoma malignium marginis
CDC Split Type: 20010165621
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2109A40IMRA
Administered by: 0     Purchased by: 0
Symptoms: Injection site hypersensitivity, Injection site reaction, Lymphoma, Pruritus, Skin disorder, Skin irritation
SMQs:, Anaphylactic reaction (broad), Malignant tumours (narrow), Hypersensitivity (narrow), Malignant lymphomas (narrow)
Write-up: On 1/16/97, a 1st dose of Engerix-B (lot 2109A4, IM, right upper arm) was given. On 1/17/97, 1 day, post vax. this female pt developed skin irritation at the injection site which worsened with itching and redness. On 2/20/97, a 2nd dose of Engerix-B (lot 2109A4, IM, left upper arm) was given. On 9/29/97, a 3rd dose of Engerix-B (lot 2058B4, IM, left upper arm) was given. On 11/1/00, she presented a skin irritation with sclerosis on the right upper arm which was excised under local anesthesia. Afterwards, the wound opened, due to tension, leading to the resection of the old wound and it''s edge. A sample was sent to the pathologist and a dx of malignant lymphoma was made. Subsequently, in 1/01, a radiation treatment was started. As of 2/16/01, at the time of this report, to the authorities, the outcome was unknown. The reporting physician did not assess a causal relationship. Additional information has been requested.

VAERS ID:174482 (history)  Vaccinated:2000-11-02
Age:52.0  Onset:2000-12-01, Days after vaccination: 29
Gender:Female  Submitted:2001-08-16, Days after onset: 257
Location:Foreign  Entered:2001-08-21, 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: Premarin since 1987; had BCG vaccine on 11/29/00
Current Illness:
Preexisting Conditions: Hysterectomy
Diagnostic Lab Data: Tuberculin skin test done on 10/2/00-results not reported; diagnostic lab test-positive (no details provided)
CDC Split Type: WAES01072583
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.R116520IMLA
Administered by: 0     Purchased by: 0
Symptoms: Laboratory test abnormal, Malaise, Rheumatoid arthritis
SMQs:, Arthritis (narrow)
Write-up: Information has been received from an occupational health dept concerning a 95 year old female who in 11/00 was vaccinated with the 1st dose of Hep-B (Batch R1165-2). The pt was dx''d with rheumatoid arthritis following the vaccination. It was indicated that this was initially reported as a non-serious case. Follow-up information was received from a health professional which indicated that the pt is a 52 year old female with a history of hysterectomy who on 11/2/00 was vaccinated IM in the left arm with a 1st dose of Hep-B (Batch R1165-2). Concomitant vaccination included a dose of BCG vaccine on 11/29/00 (Heaf test 10/12/00 results not reported). It was reported that in 12/00, she was feeling unwell, presented with arthritis in hands and feet and was unable to attend work. She was seen by her MD and by a consultant and was subsequently, dx''d with rheumatoid arthritis. A blood test performed (no details provided) was revealed as positive. The pt is now on methotrexate 2.5 mg/weekly, sulphasalazine 500 mg qd, meloxicam 7.5 mg and pregaday (iron-folic acid). At the time of the report, symptoms were still ongoing. Rheumatoid arthritis was considered to be an "Other Important Medical Event". No further information is available. The case is considered closed.

VAERS ID:178432 (history)  Vaccinated:2001-04-14
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2001-11-21
Location:Foreign  Entered:2001-11-30, Days after submission: 9
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oestrone
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 20010273771
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
Administered by: Other     Purchased by: Other
Symptoms: Malignant melanoma
SMQs:, Malignant tumours (narrow), Skin malignant tumours (narrow)
Write-up: This report describes the occurrence of an invasive nodular malignant melanoma in a 52 year old female vaccinee receiving Havrix for prophylaxis. Concomitant medications included oestrone. On 04/14/2001 the pt received a dose of Havrix. Subsequently the pt developed a blood blister. At an unknown date the vaccinee developed an invasive nodular malignant melanoma on the same site. The reporter considered the melanoma to be life-threatening. The most recent information received on 11/20/2001 reports that the pt recovered after excision of the melanoma on 07/06/2001. No other details were given. No further information is expected.

VAERS ID:178900 (history)  Vaccinated:2001-10-18
Age:52.0  Onset:2001-10-19, Days after vaccination: 1
Gender:Male  Submitted:2001-12-04, Days after onset: 46
Location:Foreign  Entered:2001-12-12, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; atorvastatin; bisoprolol; nifedipine
Current Illness:
Preexisting Conditions: Angina pectoris; cerebral aneurysm; hypercholesterolemia
Diagnostic Lab Data: Computed Axial Tomography of head-cerebral aneurysm; Spinal Tap; CSF-0.82 (raised)
CDC Split Type: WAES01113058
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: 0     Purchased by: 0
Symptoms: Arthralgia, Confusional state, Encephalitis, Influenza like illness, Intracranial aneurysm, Laboratory test abnormal, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Arthritis (broad)
Write-up: Information has been received from an agency concerning a 52 year old male who on 10/18/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included influenza virus vaccine (Fluarix) on the same day. On approx. 10/19/01, the pt experienced flu-like symptoms (aches and pains in all joints). On 10/26/01, the pt presented with encephalitis and was admitted to the hospital with acute confusion. The pt developed seizures while hospitalized. Therapy with IV acyclovir was started to treat possible viral encephalitis and phenytoin was also started. The pt underwent a head CT Scan which revealed an incidental cerebral aneurysm and a LP revealed no organisms or cells but did show a raised protein. The pt''s CSF was being sent for HSV PCR at the time of this report. The reporting agency felt that flu-like symptoms and encephalitis were considered life threatening. No further information is available.

VAERS ID:180848 (history)  Vaccinated:1999-11-15
Age:52.0  Onset:1999-11-25, Days after vaccination: 10
Gender:Male  Submitted:2002-01-31, Days after onset: 798
Location:Foreign  Entered:2002-02-04, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 20020015531
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 1IM 
Administered by: Private     Purchased by: Other
Symptoms: Difficulty in walking, Influenza like illness, Neuropathy, Pain, Respiratory disorder, Weight increased
SMQs:, Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad)
Write-up: The vaccinee reported that he received his 2nd injection of Engerix-B at his place of employment, in 11/99. On 11/25/99, 1.5 weeks post vax, he reportedly experienced "severe" soreness and cramping in his hands, "which spread to other parts of the body". He stated that he experienced flu-like symptoms and "asthma-like symptoms". He was seen by a neurologist at a tertiary care center, who reportedly made a dx of "post-vaccination inflammatory neuropathy". The neuropathy was treated with prednisone. The vaccinee stated that he subsequently, gained 100 pounds. As of 1/21/02, the vaccinee continued to find it difficult to walk and experienced "constant" pain. He remained under the care of the neurologist. Additional information was received from teh vaccinee on 3/8/02. He stated, every time muscle cells regenerate, there is a certain percentage of cells that do not regenerate. The vaccinee also reported that he received the third injection of Engerix B 5 months following the second injection because no one knew what was wrong at that time. The vaccinee stated that nerve damage persisted as of 3/8/02. Post-vaccination inflammatory neuropathy is considered GSK "Medically Serious".

VAERS ID:182716 (history)  Vaccinated:2001-10-01
Age:52.0  Onset:2001-10-03, Days after vaccination: 2
Gender:Female  Submitted:2002-03-18, Days after onset: 166
Location:Foreign  Entered:2002-03-21, 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: Methotrexate, prednisolone, Deflazacort, Activelle
Current Illness:
Preexisting Conditions: Primary chronic polyarthritis
Diagnostic Lab Data: c-reactive protein, serum - negative, erythrocyte sedimentation rate 16/30mm, G Glutamyl transferase, serum - 34U/L, rheumatoid factor 19.1IU/ml
CDC Split Type: 20020009331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS663B61IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Fatigue, Oedema peripheral, Polyarthritis, Weight increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: It was reported the occurrence of aggravated primary chronic polyarthritis in a pt receiving Havrix adult. Current medical conditions included primary chronic polyarthritis since 1993. Concurrent medications included methotrexate, deflazacort, prednisolone, estradiol and unspecified eye drops. The 1st Havrix adult had been well tolerated. On10/1/01 the pt rec''d the 2nd Havrix . Two days post vaccination on 10/3/01 the pt experienced aggravated primary chronic polyarthritis with pain in the finger, wrist, shoulder and feet, swelling and a new node in the finger. The pt developed tiredness and weight decrease. The pt was treated with higher doses of prednisolone. the most recent info rec''d on 2/7/02 reported that the aggravated primary chronic polyarthritis improved, but is still worse than before vaccination. The outcome of tiredness and weight decrease was not reported .The reporter did not assess the relationship of the events to vaccination with Havrix adult. The treating rheumatologist suspects an activation of the primary chronic polyarthritis by the vaccination.

VAERS ID:182870 (history)  Vaccinated:1992-06-01
Age:52.0  Onset:1993-08-01, Days after vaccination: 426
Gender:Female  Submitted:2002-05-16, Days after onset: 3210
Location:Foreign  Entered:2002-03-27, Days after submission: 49
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:
Diagnostic Lab Data: On 12/16/93, a wriste echography showed a suspicion of peritendinitis of the tendon of the flexor muscle. 12/13/1993 electromyogram: conclusion: discrete median nerve compression. deep tendon reflexes: symmetrical (four limb); muscular te
CDC Split Type: B0263031A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 3IM 
Administered by: Other     Purchased by: Other
Symptoms: Carpal tunnel syndrome, Discomfort, Hypoaesthesia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Report describes the occurrence of carpal tunnel syndrome in a 52 year old female pt vaccinated with Engerix-B for hep B prophylaxis. Medical and drug histories are unknown in this pt. On 04/09, 05/10, 06/07/1991 and 06/01/1992 the pt was vaccinated with Engerix-B at an unspecified dose. In August 1993, the pt experienced right hand discomfort with feeling of finger swelling, contraction of hand and both anterior side wrist pain. At an unspecified date, a diagnosis of carpal tunnel syndrome was made and a peritendinitis evidenced after unspecified examination. On 08/25/1994, the pt underwent a surgery. At an unspecified date after the surgery, a moderate decrease of left median nerve sensory conduction (abnormal nerve conduction) persisted on the carpal tunne. In 1999, the pt underwent a second surgery. This case was considered as disabling for the pt. The most recent info received on 03/18/2002 reports the outcome of the pt was unresolved. The follow up states the pt had no medical history. On 12/13/93, clinical examination showed symmetrical deep tendon reflexes, normal muscular testing, discrete hypoesthesia of right hand fifth finger and hypoesthesia of the median nerve area on the left and right side, bilateral positive Tinol''s sign. A diagnosis of discrete median nerve compression was made on electromyogram. On 12/16/93, a wrist echography showed a suspicion of peritendinitis of the tendon of the flexor muscle. The signs were very discrete at this time. At an unspecified date a diagnosis of De Quervain''s disease was made. On 3/31/94, the pt underwent a neurolysis for the treatment of the left carpal tunnel syndrome and of the De Quervain''s disease. On 5/25/94, the pt underwent a neurolysis for right carpal syndrome. In 1999, the pt underwent a new surgery (unspecified). The most recent info received on 5/3/02 reports the outcome of the pt as unresolved. A 15-day follow up report received 02/05/2003 adds: At an unspecified date after the surgery (of 05/15/1994) a moderate decrease of left median nerve senso

VAERS ID:183678 (history)  Vaccinated:1998-11-30
Age:52.0  Onset:1998-12-01, Days after vaccination: 1
Gender:Male  Submitted:2002-04-18, Days after onset: 1233
Location:Foreign  Entered:2002-04-19, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Arthrosis NOS; operation NOS
Diagnostic Lab Data: UNK
CDC Split Type: WAES0204USA01940
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscle atrophy, Muscle contractions involuntary, Myelopathy, Osteoarthritis
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a health authority concerning a 52 year old male with a past medical history of arthrosis and surgery (unspecified) who in 1995 was vaccinated with a 3 dose series of Hep-B recombinant (mfr unk) and a booster dose of Hep-B recombinant (Engerix-B) on 11/30/98. In the winter of 1998, he experienced muscle fasciculations of the right hand. During the winter of 1999, he developed amyotrophy of the right forearm and hand. On 5/5/00, a 1st dx was made of cervical arthrosis myelopathy. He was hospitalized and treated with calcium and avocado oil + soybean oil (Piacledine). On 5/22/00, the dx of lateral amyotrophic sclerosis was confirmed and a treatment with riluzole was started. In 10/00, his condition was stable. The pt''s experience was considered to be life-threatening and disabling. No further information is available.

VAERS ID:187257 (history)  Vaccinated:2002-01-09
Age:52.0  Onset:2002-05-01, Days after vaccination: 112
Gender:Male  Submitted:2002-07-03, Days after onset: 63
Location:Foreign  Entered:2002-07-08, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0038763A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS202A61IMRA
Administered by: Other     Purchased by: Other
Symptoms: Iridocyclitis
SMQs:, Ocular infections (broad)
Write-up: Report number D0038763A describes the occurrence of iridocyclitis in an approximately 52 year old receiving Twinrix adult for prophylaxis. There neither current medical conditions nor concurrent medications reported. On 09 January 2002, the vaccinee received the third dose Twinrix adult. Approximately one month post vaccination in the right deltoid in February 2002, the vaccinee experienced iridocyclitis on the right side. The patient was incapable of work for some time due to the event. The event was systemically treated with unspecified steroids and also treated locally. The reporting physician also stated that the same event occurred about three months after the first vaccination with Twinrix. He did not mention when the pt received the first vaccination. Info received on 07/31/02 reports the event as resolved. At the time of reporting the vaccinee was still incapable of work due to the event. In the reporter''s opinion, the event was possibly related to vaccination with Twinrix

VAERS ID:189517 (history)  Vaccinated:2002-07-30
Age:52.0  Onset:2002-07-30, Days after vaccination: 0
Gender:Male  Submitted:2002-08-27, Days after onset: 28
Location:Foreign  Entered:2002-08-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0277764A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Muscular weakness, Oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: This report describes the occurrence of muscle weakness in a 52 year old male pt receiving hepatitis B vaccine (Engerix B) for porphylaxis. This report was received from the Medicines Board (ref #029125). On 7/30/02, a dose of Engerix B (1ml IM( was given. The same day, after vaccination, the pt developed an edema and muscle weakness. The events were considered to be serious due to medical important condition. As of 8/22/02, at the time of this report, he had completely recovered. The reporting physician did not assess a causal relationship. Additional information has been requested but will unlikely be available.

VAERS ID:193059 (history)  Vaccinated:2000-10-24
Age:52.0  Onset:2001-04-01, Days after vaccination: 159
Gender:Female  Submitted:2002-11-11, Days after onset: 589
Location:Foreign  Entered:2002-11-13, 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: Carvedilol; Doxazosin mesylate
Current Illness: Hypertension
Preexisting Conditions:
Diagnostic Lab Data: Alat - 18 u/l; Alkaline Phosphatase - 193u/l; C-Reactive Protein - 14 mg/ml; Cholesterol - 252mg/dl; Creatinine 1.11gm/dl; Erythrocyte Sedimentation Rate - 50MM, 20MM, 80MM, 36MM; Gamma Glutamyl Transferase 84 U/L; Hemoglobin 12.2 G/DL; Pla
CDC Split Type: D0037539A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS182A4A1IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Autoantibody positive, Biliary cirrhosis, Immune system disorder, Red blood cell sedimentation rate increased
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Biliary tract disorders (narrow), Arthritis (broad)
Write-up: Report number 2001024601 describes the occurrence of auto-antibody response in a 52 year old female receiving Twinrix adult for prophylaxis. The vaccinee''s medical history included essential hypertension. Concomitant medications included Dilatrend and Cardular PP. On 7/18/00 and 10/24/00 the vaccinee received the first two doses of Twinrix adult. In August 2001 the vaccinee was diagnosed with auto-immune disease with elevated levels of anti-mitochondrial antibodies (AMA) and anti-thyroid antibodies, after having experienced pain in the joints (wrists, knees, shoulders) since April 2001. Lab values were determined on 8/1/01, 8/13/01 and 9/11/01. On 8/1/01 HLA-B27, rheumatoid factor, ASL, Waaler-Rose-test and anti-nuclear factors were determined to be not elevated. Anti-mitochondrial antibodies were elevated to 1:640. On 8/13/01 values elevated for erythrocytes sedimentation rate (50/80mm after 1 and 2 hrs, respectively), gamma glutomyl transferase (84 u/l) and C-reactive protein (14mg/ml). Thyroglobulin antibodies were elevated to 541 u/ml. All other lab tests for TPO-Ab, TSH basal, ASMA, o-ANCA and p-ANCa were not elevated. Hepatitis C serology was negative. On 9/11/01 erythrocytes sedimentation rate was 20/36 mm after 1 and 2 hrs, respectively and C-reactive protein was normal. The most recent info received on 12/14/01 reported the outcome of the vaccinee as not resolved in September 2001. The reporter considered that auto-antibody response was possibly related to vaccination with Twinrix biliary cirrhosis since an unknown date. This event was considered serious (OMIC). The reporting physician did not specify the relation of primary biliary cirrhosis to vaccination with Twinrix adult.

VAERS ID:193065 (history)  Vaccinated:2002-05-11
Age:52.0  Onset:2002-05-21, Days after vaccination: 10
Gender:Male  Submitted:2002-11-11, Days after onset: 174
Location:Foreign  Entered:2002-11-13, 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: Myelitis in 1987
Diagnostic Lab Data: The monosynaptic reflexes of the legs were normal and he showed no spasticity.
CDC Split Type: U200200978
Vaccination
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Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)AVENTIS PASTEURR11240IM 
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Myelitis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: Case upgraded to serious on 11/4/02 following info received that the pt is still not yet recovered and is unable to work. It was reported that a 52 year old man was administered a first dose D1 of Rabies vaccine (Imovax Rabies) on 5/11/02. Ten days after vaccination, the pt developed a myelitis, not resolved at the time of reporting. To be noted that the pt already suffered from myelitis in 1987. Follow up on 11/4/02: The case was initially reported on 5/31/02 as non-serious. It was upgraded to serious on 11/4/02 because follow-up info was given that the pt is still not yet recovered and is unable to work. It was reported by the 52 year old pt himself (he is a physician specialized of tropical medicine), that he was vaccinated with rabies vaccine inactivated on 5/11/02. About 10 days later, he showed paresthesia (pricking skin sensation) in the legs resulting in gait disturbances. The monosynaptic reflexes of the legs were normal and he showed no spasticity. The symptoms are still ongoing, but are varying. It was worth noting that the pt had myelitis in 1987. Further info is expected.

VAERS ID:193779 (history)  Vaccinated:1995-06-26
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2002-11-18
Location:Foreign  Entered:2002-11-22, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: With diphtheria tetanus vaccine on 03/05/1951, on 03/19/1951, on 04/02/1951, on 04/07/1952, on 12/21/1959: against variola in 1955, with diphtheria tetanus polio vaccine in 1989 and 1990, with genhevac B on 06/08/1995 and 07/17/1995.
Diagnostic Lab Data: In December 2001 lesions of macrophagic myofasciitis were discovered on a muscle biopsy.
CDC Split Type: U200201012
Vaccination
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Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEUR 0  
Administered by: Other     Purchased by: Other
Symptoms: Arrhythmia, Arthralgia, Asthenia, Coordination abnormal, Disturbance in attention, Fasciitis, Malaise, Memory impairment, Micturition disorder, Myalgia, Skin ulcer, Visual acuity reduced
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: It was reported by a female patient through an association of patients that at the age of 52, she had developed since year 1996 several troubles: myalgia, arthralgia, chronic asthenia, vision impairment, memory (impairment), concentration and coordination disorders, malaises, arrhythmia, dysaesthesia, micturition disorders. Her condition aggravated since 2001 and involved a sick leave in September 2001. In December 2001, lesions of macrophagic myofascitis were discovered on a muscle biopsy. Prior to the beginning of symptoms she had received concomitantly on 1/20/96 the third injection of GENHEVAC B and an injection of HAVRIX, on 6/26/95, a typhoid vaccine and on 6/8/95. Reported on 02/04/2003: "It was reported by a female patient through an association of patients that at the age of 52, she had developed since year 1996 several troubles: myalgia, arthralgia, chronic asthenia, vision impairment, memory (impairment), concentration and coordination disorders, malaises, arrhythmia, dysaesthesia, micturition disorders. Her condition aggravated since 2001 and involved a sick leave in September 2001. In December 2001 lesions of macrophagic myofascilitis were discovered on a muscle biopsy. Prior to the beginning of symptoms she had received concomitantly on 01/20/1996 the third injection of GENHEVAC B and an injection of HAVRIX (GSX hepatitis A vaccine), on 06/26/1995 a typhoid vaccine and on 06/08/1995." Follow up #1 (latest received date 01/17/2003): From faxed information received at Aventis Pasteur Inc. from Aventis Pasteur SA, it was reported:"Follow-up on 01/17/2003, this case was evaluated by local health authorities. The muscle biopsy was performed in December 2001. The patient in considered as disabled. No further information was available. To be mentioned that no clinical symptoms is reported, that the diphtheria tetanus polio vaccine is not considered as suspect and that the case is considered as a myopathy. Case is closed."

VAERS ID:195363 (history)  Vaccinated:2001-08-23
Age:52.0  Onset:2001-08-23, Days after vaccination: 0
Gender:Female  Submitted:2002-12-23, Days after onset: 487
Location:Foreign  Entered:2002-12-26, 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: Estrogen + progestogen
Current Illness: UNK
Preexisting Conditions: Aspirin allergy; Sulpha allergy
Diagnostic Lab Data: Electroencephalogram normal; Lab test normal; Neurological examination normal
CDC Split Type: B0259209A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
TD: TD ADSORBED (DITANRIX)SMITHKLINE BEECHAM  IM 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Gastritis, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This report describes the occurrence of convulsion in a 52 year old female pt receiving Ditanrix and hep B vaccine (Engerix B) for prophylaxis. The report was received from the local health authority. Past medical history included benign fiborcystic neoplasm of left buttock, allergy to sulpha, anaesthetic, and aspirin. No records of convulsions. On 8/23/01, a dose of Ditanrix IM and a dose of Engerix B IM were given. On the same day, 5-10 minutes after vaccination, developed to loss of consciousness and convulsion and was hospitalized. The loss of consciousness lasted for few seconds and was followed by asthenia, nausea, gastric burning and vomiting. On admission, the neurological exam was normal. During hospitalization, lab tests and EEg were performed and showed to normal. On an unknown date, she had completely recovered. On 8/25/01, she was discharged. The reporting physician considered the event to be porbably related to Ditanrix and/or Engerix B and considerred convulsion and loss of consciousness more likely due to the syncope. No further details are expected and this case has therefore been closed.

VAERS ID:197032 (history)  Vaccinated:2002-02-25
Age:52.0  Onset:2002-02-25, Days after vaccination: 0
Gender:Male  Submitted:2003-01-29, Days after onset: 338
Location:Foreign  Entered:2003-01-31, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Sever pain over the kidneys.;Hep B (Engerix-B);1;0;In Patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Feb 2002: X-rays: no signs of kidney stone
CDC Split Type: B0290481A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1  
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Dyspnoea, Renal pain
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Reported on 03/14/2003: "This report was received from a nurse and describes the occurrence of renal pain in an approximately 52 year old male subject (born in 1950) receiving hepatitis B vaccine (Engerix B) for prophylexis. On 01/17/2002, a 1st dose of Engerix B was given. The same day, 1 hour after vaccination, this subject developed severe pain over the kidneys. This pain lasted for 3-4 days and then fully resolved. On 02/25/2002, a 2nd dose of Engerix B was given. The same day, 2 hours after vaccination, this subject developed again pain over the kidneys as well as severe back pain and dyspnea. He visited the health centre and acute kidney stone attack was suspected. He received analgesics and he fully recovered. Since then, he did not experience any similar attack. The same week, he underwent an x-ray examination and no signs of kidney stones were found. No cause of the events could be identified and no further exams were planned. It was decided that he would not receive the 3rd dose. The reporter considered this case to be serious (no criterion specified) and did not assess a casual relationship. Additional information has been requested. A 15-day follow up report received 04/22/2003 adds: On 01/17/2002 a first dose of Engerix B was given. The same day, 1 hour after vaccination, this pt developed severe pain over the kidneys. This pain lasted for 3-4 days and then fully resolved. Despite several attempts, no additional info could be obtained. This case has therefore been closed. A 15-day follow up report received 04/23/2003 adds no new information.

VAERS ID:197398 (history)  Vaccinated:2002-02-18
Age:52.0  Onset:2002-02-18, Days after vaccination: 0
Gender:Female  Submitted:2003-02-03, Days after onset: 350
Location:Foreign  Entered:2003-02-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ;DT Adsorbed, Ped. (no brand name);;0;In Patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Non-response in antibodies; test by rheumatologist have all been negative
CDC Split Type: WAES0301USA02229
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.T124013IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Joint swelling, Laboratory test abnormal
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from a health care professional concerning a female pt who was vaccinated IM with the third and fourth 0.1mL doses of hep B vaccine recombinant (thiomersal-free) (dates not specified). Following the third dose, the pt experienced some arthralgia in her small hand joints which did not settle. It was reported that she then received the fourth dose of the vaccine due to non-response in terms of antibodies. Immediately, she had worsening of her arthralgia which has been followed by widespread joint pains and joint swelling. This has put her off work. Tests by Rheumatologists have been negative. The reporter considered arthralgia to be an other medical event (OMIC). The reporter indicated that the arthralgia was considered to be disabling. Further details will be requested. Reported on 02/27/2003: "Follow up information indicated that on 02/18/2002, arthralgia of the small finger joints commenced, and was described as being mild. On 05/27/2002, widespread arthralgia and joint swelling commenced, and was described as being continuing and sever. The reporter considered these symptoms to be serious, and to have a possible relationship to the product. The patient was treated with non-steriodal and anti-inflammatory medication (unspecified) which was not found to be helpful. Full rheumatology investigations were performed, and nothing abnormal was detected. The case will continue to be followed up in one month. The reporter considered arthralgia and joint swelling to be other important medical events. The reporter indicated that the arthralgia and joint swelling were considered to be disabling. Other business partner numbers include: UK03 19 03. Further details will be requested. A 15-day follow up report received 03/20/2003 adds: Follow up info indicated that on 02/18/2002, arthralgia of the small finger joints commenced, and was described as being mild. On 05/27/2002, widespread arthralgia and joint swelling commenced, and was described as being continuing and severe. The reporter

VAERS ID:201911 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:2000-07-14
Gender:Female  Submitted:2003-04-18, Days after onset: 1008
Location:Foreign  Entered:2003-04-21, 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: Depressive Syndrome
Diagnostic Lab Data: June 2001-biological check-up: no dysthyroides and no digestive disorder. EBV serology negative. Parovirus serology negative. July 2001 coloscopy no abnormaltiy. November 2001-vitamin B12 and folate plasmatic level were normal. CPK level no
CDC Split Type: B0280895A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Diarrhoea, Fibrosis tendinous, Insomnia, Joint stiffness, Memory impairment, Muscle spasms, Myalgia, Visual acuity reduced
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case B0280895A was received from regulatory authority and described the occurrence of macrophagic myofascitis in a 52 year old female subject who received Engerix B and Twinrix for prophylaxis. Concurrent vaccination included three injectiosn of DTP for diphtheria, tetanus, and poliomyelitis prophylaxis on 3/1/99, 4/7/99 and 3/29/00. The subject''s medical history included a depressive syndrome ten years ago. In 1999, the subject received three injections of Engerix B. On 7/14/00, she reported the first adverse event (no precision). On 3/27, 4/27/01, the subject received an injection of Twinrix. On 6/12/01, the subject was hospitalized for asthenia for one month with lower limb stiffness. Clinical exam was normal. In July 2001, coloscopy was normal. On 9/27/01, the subject received a third injection of Twinrix. From 14 to 16 November 2001, the subject was hospitalized for persistent asthenia with lower limb myalgia. The pt reproted lower limb pain like burns, cramps and stiffness and persisitent asthenia since mid October. It was also reported chronic diarrhea treated with Flagyl. Clinical exam showed systolic murmur in aortic focus radiating throught hte neck vessels. Toxoplaemosis, hep B, C, and CMV serologies were negative. At an unspecified date, she reported memory loss, sleep loss and low vision in left eye. On 5/16/02, a muscular biopsy was realized and the diagnosis of macrophagic myofascitis was made (not provided). At the time of reporting the subject had not yet recovered. The reporter''s causality assessment for Engerix B and Twinrix was unlikely. Manufacturer case B0280898A is a duplicate of B0293558A. All future correspondence will be submitted to B0280898A.

VAERS ID:206135 (history)  Vaccinated:2002-11-12
Age:52.0  Onset:2002-12-11, Days after vaccination: 29
Gender:Male  Submitted:2003-07-10, Days after onset: 210
Location:Foreign  Entered:2003-07-14, 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: Biaxin
Current Illness:
Preexisting Conditions: Insomnia; Dupuytren''s contracture--left hand and right foot surgery; Smoker; Drinker;
Diagnostic Lab Data: Chest x-ray clear; HIV serology negative; Syphilis serology negative; CBC demonstrated a low platelet count of 67; Elevated alk phos of 305; AST of 97; Polyclonal hypergammaglobulinemia; Hepatitis C antibody positive; Significant chronic he
CDC Split Type: 200301226
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)AVENTIS PASTEURC1365AA SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Chills, Constipation, Cough, Demyelination, Dizziness, Feeling cold, Feeling hot, Headache, Hepatitis C virus, Hyperhidrosis, Laboratory test abnormal, Liver function test abnormal, Nausea, Pyrexia, Tremor, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)
Write-up: It was reported by a physician that a 52 year old male received Yellow Fever Vaccine on 11/12/02 and on 12/11/02 he experienced the feeling of hot and cold and got chills. His hands started to shake on and off; he was sort of dizzy and sometimes had a headache; balance was not the best. From letter, dated 1/13/03 from neurologist who was requested to see patient for dizziness and balance problem: History of present illness: Patient claims on 12/11, he went on a cruise. He claims that when the ship passed Devil''s Island he did not feel well, he felt hot and cold and got chills. His hands also started to shake on and off. He was also sort of dizzy and sometimes he had a headache. He also found his balance was not the best. He recalled it was rainy and wondered if he had contracted some type of infection. Upon returning home, he claims his symptoms remained the same, and he also got quite constipated. He had a lot of blood tests done. All the test results are not back to normal yet. Systemic and neurological review: Severe constipation with the illness--seen by doctor. Physical examination: Vital signs are stable. There is no anemia, no jaundice, no cyanosis, and no dyspnea. Cardiovascular, respiratory and GI-GU system are normal. Cervical movements are normal. There is no bruit over head and neck areas. TM joints are normal. Tympanic membranes are clear on both sides. Neurological examination: Patient is alert and oriented. Mental and intellectual functions are normal. Speech is normal. Cranial nerve examination: Fundi normal. Visual field is normal. There is no restriction of eye movements. There is no nystagmus. Pupils are symmetrical and react to light. Facial sensation and masticatory function are normal. There is no weakness of facial expression muscles. Gag reflex is normal. Tongue movements are normal. Motor system examination: There is no evidence of localized weakness, changes in tone or muscle atrophy. There is mild action tremor over both upper extremities. Gait is minor unsteady. Romberg test is negativ

VAERS ID:206721 (history)  Vaccinated:2003-06-17
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2003-07-25
Location:Foreign  Entered:2003-07-29, 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: Prednisone, Cyclosporine, penicillin NOS, Omeprazole
Current Illness: Non-Hodgkin''s Lymphoma
Preexisting Conditions:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE066318JUL03
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES 0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad)
Write-up: Information regarding Prevnar was received from an investigator regarding a 52 year old female patient who received her first dose of Prevnar on 6/17/03 as part of an independent study. The patient was randomized in the early group. The patient experienced progressive development of thrombocytopenia. The patient experienced progressive development of thrombocytopenia from the end of May 2003 to 6/1/03. The patient received a platelet transfusion which was ineffective. No biological symptom of microangiopathy was noted, and no antiplatelet antibodies or viral diseases were detected. The patient was hospitalized briefly on an unspecified date for IVIG for suspected immune thrombocytopenia. The patient''s platelet count did not improve until 7/15/03. The patient was removed from the study. The investigator considered the patient''s experience to be life-threatening. Follow up on 08/05/2003: "Information received on 07/29/2003 provided an investigator assessment. As a result of follow up information, this report has been reclassified as not related. Information regarding Prevnar was received from an investigator regarding a 52 year old female patient who received her first dose of Prevnar on 06/17/2003 as part of an independent study entitled, "Comparison Between Early and Late Immunization with Three Doses of Heptavalent Pneumococcal Conjugate Vaccine in Allogenic Stem Cell Transplant Recipients." The patient was randomized in the early group. The patient experienced progressive development of thrombocytopenia. The patient experienced progressive development of thrombocytopenia from the end of May 2003 to 07/01/2003. The patient received a platelet transfusion which was ineffective. No biological symptom of microangiopathy was noted, and no antiplatelet antibodies or viral diseases were detected. The patient was hospitalized "briefly" on an unspecified date for IVIG for suspected immune thrombocytopenia. The patient''s platelet count did not improve until 07/15/2003. The patient was removed from the study.

VAERS ID:207837 (history)  Vaccinated:2003-07-17
Age:52.0  Onset:2003-07-28, Days after vaccination: 11
Gender:Female  Submitted:2003-08-11, Days after onset: 14
Location:Foreign  Entered:2003-08-14, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: GPT: more than 2000; Glutamic-pyruvate transaminase: more 2000; Hepatitis A IgM: positive; Thromboplastin: 60%;
CDC Split Type: B0305724A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Abscess, Drug administration error, Dyspepsia, Hepatitis, Laboratory test abnormal
SMQs:, Hepatitis, non-infectious (narrow), Gastrointestinal nonspecific dysfunction (narrow)
Write-up: This report was received from a physician and described the occurrence of a fulminant hepatitis in a 52 year old female subject receiving hepatitis A and B vaccine for prophylaxis. On 7/10/03, a 1st dose of Twinrix was given. On 7/18/03, a 2nd dose of Twinrix was given. On 7/21/03, the subject had an indigestion after eating mussels and shrimps. She was also reported to have an hepatic abscess. The reporter indicated that salmonella could be the cause (without further specification). On 7/28/03, she developed a fulminant hepatitis. As of 7/30/03, at the time of this report, the outcome was unknown. Please note that regulatory reports have been scheduled for the above serious case. We first would like to draw your attention to the inconsistencies described below before you decide to submit the reports. The reporter wondered whether Twinrix could be the cause of the fulminant hepatitis. This case was assessed as serious because fulminant hepatitis and liver abscess are included in the list of serious terms (OMIC). However upon medical review, the following medical inconsistencies were noted: absence of clear events/signs to support the diagnosis of fulminant hepatitis and hepatic abscess, unusual vaccination schedule: 2 doses given 1 week apart. Despite several attempts, we were unable to get clarification from the reporter as he is on holiday. We have therefore decided to keep the case as serious despite the inconsistencies until further investigation is obtained. Follow up on 12/03/03: "Medical history included that the pt had high blood pressure. The subject use occasionally alcohol. On 07/10/03, a 1st dose of Twinrix was given. On 07/18/03, a 2nd dose of Twinrix was given. On 07/21/03, the subject had an indigestion after eating mussels and shrimps. She was also reported to have an ''hepatic abscess''. The reporter indicated taht salmonella could be the cause (without further specification). On 07/28/03, she developed a fulminant hepatitis. On 07/29/03, the serology for hepatitis A was made and the IGM we

VAERS ID:209333 (history)  Vaccinated:2003-07-24
Age:52.0  Onset:2003-08-03, Days after vaccination: 10
Gender:Male  Submitted:2003-09-12, Days after onset: 40
Location:Foreign  Entered:2003-09-17, 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: Coronary heart disease
Diagnostic Lab Data: UNK
CDC Split Type: D0041865A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5324D6   
Administered by: Other     Purchased by: Other
Symptoms: Angina pectoris
SMQs:, Other ischaemic heart disease (narrow)
Write-up: A physician reported the occurrence of angina pectoris in a 51 year old male who was vaccinated with hepatitis B vaccine for prophylaxis. Concurrent medical conditions included well stabilized coronary heart disease. Concurrent medications were not reported. Two previous influenza vaccinations were followed by similar events. On 7/24/03 the subject received the first dose of hepatitis B vaccine, lot number 5324D6. Approximately 10 days post vaccination, the subject developed angina pectoris. The subject was hospitalized in foreign country where he stayed in holidays at this time. Electrocardiogram and lab examinations were without pathological findings. The hospital reprot was not available. The outcome was unknown. Follow up on 10/01/2003: "On 07/15/2003 the subject received the first dose of hepatitis B vaccine, lot # 5324D6, IM in the left deltoid. Seventeen days post vaccination, on 08/01/2003, the subject developed angina pectoris with thoracic pain, feeling of narrowness in the thorax, dyspnea, severe loss of energy and muscle cramps in the legs. The subject was hospitalized in Italy, where he stayed in holidays at this time. Electrocardiogram and laboratory examinations were without pathological findings. The hospital report was not available. The events resolved after 6 days, on 08/07/2003. The reporter considered that the events were unlikely related to hepatitis B vaccine." Information received on 09/16/2004 and reported as follow up report Yes (resolved).

VAERS ID:209463 (history)  Vaccinated:2003-08-08
Age:52.0  Onset:2003-08-09, Days after vaccination: 1
Gender:Female  Submitted:2003-09-16, Days after onset: 38
Location:Foreign  Entered:2003-09-22, 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: Current concominant medications are Vitamin E, Evening Primrose and Q10 coenzyme.
Current Illness:
Preexisting Conditions: Chronic back pain since caesarian section 1979. Myalgic encephalomyelitis 1987.
Diagnostic Lab Data: On her examination, her weight was 66.2 kgs. Urinalysis normal. Pulse 93/minute, regular. BP 159/93. Normal heart sounds. Chest, abdomen normal. Crainial nerves intact. No cerebellar signs. Gait normal. Power, tone, normal. Hb 15.5 g/dl. No
CDC Split Type: E200301960
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
RAB: RABIES (IMOVAX)AVENTIS PASTEUR  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Cough, Fatigue, Gait disturbance, Malaise, Nausea, Pain, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: It was reported that a 51 year old female received booster doses of diptheria and tetanus vaccine and inactivated polio vaccine on 6-AUG-2003.The patient also received the first dose in a vaccination schedule of rabies vaccine into the right arm, and meningoccocal A and C vaccine into the left arm, on 8-AUG-2003. It was reported that on 9-AUG-03 the patient experienced a local reaction at the rabies injection site which was described as red and hard, from which the patient recovered by 12-AUG-03. It was also reported that the patient experienced tingling and aching in both upper arms, starting on the 14-AUG-03. Thirty minutes later the patient experienced tingling, weakness and numbness in her right arm. Her left arm was ok. It was reported that the patient feels unwell. At the time of the report the patient had not recovered. Further information requested. Case to remain open. Follow-up on 03-SEP-2003: Rabies 0.5 ml, batch number W1010, IM was confirmed as dose 1. Mengivac A+C 0.5 ml batch W0483 IM was confirmed as dose 1. The patient also received Hepatitis A monodose vaccine 0.5 ml batch VHA7706 booster, IM - other manufacturer. This case has been upgraded from non-serious to serious as the reporter has indicated that the symptoms resulted in persistent or significant disability/incapacity. The patient was reviewed by a consultant physician who reported that a week after receiving immunizations against diptheria, tetanus, meningitis A+C, rabies and a booster dose of hepatitis A, she developed an odd sensation in the left shoulder region radiating down to the elbow. Initially, this was a burning sensation which changed to tingling and then numbness in the distal forearms and fingers, right more than left. On some occasions the arms appeared cold , white, cyanosed associated with a tight feeling - as though a tourniquet had been applied. About twelve hours later, she developed tightness around the midriff (T8-T10 dermatome) associated with numbness and breathlessness. She reported to the Accident and Emergency d

VAERS ID:210766 (history)  Vaccinated:2003-08-28
Age:52.0  Onset:2003-08-28, Days after vaccination: 0
Gender:Female  Submitted:2003-10-17, Days after onset: 50
Location:Foreign  Entered:2003-10-22, 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: UNK
Current Illness:
Preexisting Conditions: Rheumatoid arthritis
Diagnostic Lab Data: UNK
CDC Split Type: WAES0310AUS00017
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0063N   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Malaise, Polyarthritis, Rheumatoid arthritis
SMQs:, Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: Information has been received from a physician concerning a 52 year old female with rheumatoid arthritis who on 8/28/03 was vaccinated with pneumococcal 23v polysaccharide vaccine. There was no significant concomitant therapy. On 8/28/03 the patient experienced swelling and pain in limb adjacent to injection site that became obvious in hour or two after injection and over next 24 hours she developed systemic symptoms (headache/malaise), (chills and rigors). Over the next few days, the patient developed rheumatoid arthritis - widespread polyarthritis (pain and inflammation) which settled only very slowly over the following several weeks (using anti-inflammatories). The patient has partly recovered from swelling and pain in limb, headache, malaise, chills and rigors, rheumatoid arthritis - widespread polyarthritis (pain and inflammation). The physician felt that the patient''s symptoms were related to pneumococcal 23v polysaccharide vaccine. The physician felt that the patient''s symptoms were disabling. Additional information is not expected. Follow up on 10/31/2003: "This is an amended report. The lot number has been added to the report. Additional information is not expected." Follow up 3/15/05: Patient''s outcome is unknown.

VAERS ID:212453 (history)  Vaccinated:2003-09-14
Age:52.0  Onset:2003-09-16, Days after vaccination: 2
Gender:Female  Submitted:2003-11-17, Days after onset: 62
Location:Foreign  Entered:2003-11-18, 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:
Diagnostic Lab Data: UNK
CDC Split Type: B0314374A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Influenza like illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of flu-like symptoms in a 52 year old female subject who had received Hepatitis B vaccine injection for vaccination. On 9/14/03 the patient received Hepatitis B vaccine (IM) at 20ug. Approximately 30 hours after receiving Hepatitis B vaccine, on 9/16/03, the patient experienced arthralgia, cephalea, fever, flu symptoms, and myalgia. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). On 9/29/03, the events resolved. The regulatory authority reported that the events were related to vaccination with Hepatitis B vaccine. No additional information is expected and this case has been closed.

VAERS ID:214436 (history)  Vaccinated:2003-12-15
Age:52.0  Onset:2003-12-15, Days after vaccination: 0
Gender:Male  Submitted:2003-12-19, Days after onset: 4
Location:Foreign  Entered:2003-12-29, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: E200303936
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEURH012 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic shock, Bradycardia, Erythema, Hyperaemia, Respiratory distress, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow)
Write-up: It was reported by a pharmacist on 12/17/03 that an adult man (age unknown) received his 3rd dose of thyphoid vaccine in December 03. Two hours after the injection, he experienced an anaphylactic shock with generalized erythema, respiratory distress and bradycardia. He was hospitalized for 24 hrs. The reporter had no more info. This case was reported to health authorities therefore a follow-up is awaited. File to be completed. A 15-day follow up report received 01/14/2004 adds: Follow-up on 01/05/2004 through health authorities: The 52-year-old man was vaccinated on 12/15/2003. He experienced, 1.5 hours after injection, diffused erythema, tachycardia, respiratory distress, feeling of thorax oppression, conjunctival hyperemia. His state improved after injection of adrenaline. Pt recovered (duration not reported).

VAERS ID:214942 (history)  Vaccinated:2003-08-06
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2004-03-09
Location:Foreign  Entered:2004-01-15, Days after submission: 54
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: B0318912A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME)UNKNOWN MANUFACTURER    
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER    
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Accommodation disorder, Asthenia, Hypoaesthesia, Muscle contractions involuntary, Myelitis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Ocular motility disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of myelitis in a 52 year old female patient who had received Hepatitis A vaccine injection. Co-suspect medication included Meningococcus vaccine Groups A + C and Polio vaccine. Concurrent medications included Rabies vaccine, Tetanus vaccine and diphtheria vaccine. The patient received Hepatitis A vaccine (IM). An unknown time after receiving Hepatitis A vaccine, the patient experienced weakness, numbness, muscle fasciculation and loss of proprioception. A scan confirmed the diagnosis as inflammatory myelitis. This case was assessed as medically serious (OMIC). The outcome of the events is unknown. This case was found to be a duplicate of B0322715A. As such, this case has been voided. B0322715A will be retained as the Case of Records for all future correspondence and submissions. Information from Annual Follow-up report states this report is a duplicate of B0322715A, and has been voided from the database.

VAERS ID:215918 (history)  Vaccinated:2001-12-01
Age:52.0  Onset:2004-01-01, Days after vaccination: 761
Gender:Female  Submitted:2004-02-02, Days after onset: 32
Location:Foreign  Entered:2004-02-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Urine culture and hemoculture for salmonella typhi were positive.
CDC Split Type: 200400367
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: It was reported through an health care professional that a 52 year old female pt presented with Typhoid fever. She was vaccinated by Typhim Vi 25 months ago.

VAERS ID:216820 (history)  Vaccinated:2003-08-06
Age:52.0  Onset:2003-08-10, Days after vaccination: 4
Gender:Female  Submitted:2004-03-09, Days after onset: 212
Location:Foreign  Entered:2004-02-25, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diftavax; Alpha tocopheryl acetate; Evening primrose oil; Ubidecarenone
Current Illness:
Preexisting Conditions: Back pain; Cesarean Section; Hypothyroidism; Post viral fatigue syndrome
Diagnostic Lab Data: Blood pressure: 159/93mmHg; C-reactive protein result <5; ESR 7mm/Hr; Electrocardiogram normal; Fundocscopy normal; Haemoglobin 15.5g/dl; Heart sounds normal; Platelet count normal; Pulse rate 93bpm; Thyroid stimulating hormone 5.80; Thyrox
CDC Split Type: B0322715A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS7706 IM 
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURERW02392   
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Balance disorder, Cough, Cyanosis, Dyspnoea, Fatigue, Feeling cold, Hyperhidrosis, Hypersensitivity, Hypertension, Hypoaesthesia, Injection site reaction, Laboratory test abnormal, Myelitis, Myoclonus, Nausea, Vasoconstriction
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: this case was reported by a regulatory authority and described the occurrence of myelitis in a 51 year old female subject who had Hepatitis A vaccine for routine immunization. Concurrent medical conditions included back pain, cesarean section, hypothyroidism, and post viral fatigue syndrome. Co-suspect medication included poliomyelitis vaccine. Concurrent medications included rabies vaccine, Mengivac, Diftavax, Vitamin E acetate, Evening primrose oil and Coenzyme Q10. On 8/6/03, the subject received a dose of hepatitis A vaccine (IM) at 0.5ml and poliomyelitis vaccine (route unknown). Three days later, on 8/9/03, the subject experienced injection site reaction. The subject developed an odd sensation in the left shoulder and then numbness in the distal forearms and fingers, right more than left. On some occasions arms appeared cold, white and cyanosed associated with a tight feeling as though tourniquet had been applied. On 8/14/03, the subject also developed vasoconstriction. On examination by a consultant neurologist, she was unsteady on walking. She had odd myoclonic type movement with slight flexion of the trunk and sometimes involving the arms. About 12 hours later, she developed tightness around the midriff associated with numbness and breathlessness. The following day, she slept all day and paraesthesia spread to both arms, elbows, abdomen and feeling cold and sweaty. Brachial neuritis was considered and further investigations performed. The movement she described and possibly the forced expiratory noise might have represented spinal myoclonus. She also developed shooting pains in both legs and apparently noticed fasciculations. She became nauseous, anorexic, developed an unproductive odd cough and unsteadiness of gait. She reported hypersensitivity to pin prick in right hand with reduced joint position sense on this side. There was also reduced pin prick over the trunk, particularly in a T5-T12 distribution on front and back. In the legs, tone was normal and power perhaps minimally reduced. Reflexes were p

VAERS ID:217399 (history)  Vaccinated:0000-00-00
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2004-03-08
Location:Foreign  Entered:2004-03-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: On 5/29/02: Left deltoid muscular biopsy: No necrosis nor regeneration of muscular fibers. Abundant macrophagic (CD68 positive) and mononuclear elements (Cd3 and L26 positive) infiltrates. gomori''s trichoma was normal. Predominant hypotroph
CDC Split Type: B0324927A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Fibrosis tendinous, Immune system disorder, Thyroiditis, Xerophthalmia
SMQs:, Corneal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Arthritis (broad)
Write-up: This case was reported by the regulatory authority and described the occurrence of autoimmune thyroiditis in a 52 year old female subject vaccinated with hep B vaccine for prophylaxis. At an unspecified date, the subject received injections of hep B vaccine. At unspecified date, the subject experienced polyalgia and polyarthralgia syndromes with xerophthalmia and auto-immune thyroiditis. On 5/29/02, left deltoid muscular biopsy showed lesions of macrophagic myofasciitis (MMF). This case was assessed as medically serious (OMIC).

VAERS ID:220956 (history)  Vaccinated:1992-06-13
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2004-05-19
Location:Foreign  Entered:2004-05-20, 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:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: In September 1998: Visucal and somesthesic evoked potentials: results leading to a possible polynodular sclerosis. Medullar MRI: suspect demyelinating areas. Spinal fluid examination: slight hyperproteinorachia with digoolonal increase of g
CDC Split Type: B0332960A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Fatigue, Laboratory test abnormal, Muscular weakness, Nervous system disorder, Neuropathy peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: This case was reported by a manufacturer legal department and described the occurrence of peripheral neuropathy in a 52 year old male subject who was vaccinated with Engerix B for hepatitis B prophylaxis. On 6/17/91, 8/15/91 and 6/13/92, the subject received an injection of Engerix B. It was reported that the subject presented very quickely after the last injection with a worsening of health condition. It was reported that the first significant symptoms occurred in 1995. On 9/24/98, peripheral neuropathy was diagnosed. On 10/21/03, an unspecified central nervous system disorder was also diagnosed. In 2004, the subject was disabled with a muscular weakness and fatigability of the lower limbs, instability and balance disorders. Follow up on 06/08/04 states: "On 06/17/91, the subject received the first injection of Engerix B. In 07/91 and on 08/15/91, he received an injection of Hevac B. On 08/18/92, he received a booster injection of Engerix B. It was reported that the subject presented very quickly (NOS) after the last injection with a worsening of health condition. It was reported that the first significant symptoms occurred in 1995. In 1998, he presented with sensory disorders at the four limbs and micturition disorders. In September 1998, visual and somesthesic evoked potentials gave arguments of multiple sclerosis. A medullar MRI evidenced two suspects demyelinating areas and spinal fluid examination revealed a slight hyperproteinorachia with digoolonal increase of gammaglobulin. On 09/24/98, peripheral neuropathy and multiple sclerosis were diagnosed. On 10/21/03, an unspecified central nervous system disorder (inflammatory type) was also diagnosed. In 2004, the subject was disabled with a muscular weakness and fatigability of the lower limbs, instability and balance disorders."

VAERS ID:229977 (history)  Vaccinated:2004-10-26
Age:52.0  Onset:0000-00-00
Gender:Male  Submitted:2004-12-02
Location:Foreign  Entered:2004-12-03, 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: NONE
Diagnostic Lab Data:
CDC Split Type: E200404299
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Malaise, Myalgia, Pyrexia, Red blood cell sedimentation rate increased, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Initial information received on 11/24/04. It was reported by a pharmacist that her husband, a 52 year old man who is a physician, was administered one month ago (10/26/04) a Typhoid vaccine, Hepatitis A vaccine, and Tetanus toxoid. Some days after vaccination, the man suffered malaise and myalgia during one week, and both of them disappeared after that time. Three weeks after vaccination, appeared fever only during the night and the rest of the day it keeps under 37C; since then, it repeats every night. Since the vaccination, the patient is suffering anorexia and loss of weight, but the is on a diet as well. Fever and anorexia have been considered as medically relevant (OMIC). Some tests have been done, but we don''t have the exact results. We just know that ESR is elevated, and that an abdominal echography is normal and cancer serologies are negative. Currently the patient is taking an oral cephalosporin since 11/23/04. Outcome is recovering. Further information is requested. Cases is incomplete.

VAERS ID:230228 (history)  Vaccinated:2003-09-02
Age:52.0  Onset:2003-09-02, Days after vaccination: 0
Gender:Male  Submitted:2004-10-08, Days after onset: 402
Location:Foreign  Entered:2004-12-09, Days after submission: 62
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: PJP200300722
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)EVANS VACCINESE33152GA IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Medication error
SMQs:
Write-up: A report was received from a health care professional on 9/2/03, concerning a 52 year old male vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter''s causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300721 and PJP200300723.

VAERS ID:230560 (history)  Vaccinated:2004-11-24
Age:52.0  Onset:2004-11-26, Days after vaccination: 2
Gender:Female  Submitted:2004-12-08, Days after onset: 12
Location:Foreign  Entered:2004-12-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Previous vaccination with DT vaccine 10 years ago.
Diagnostic Lab Data: CRP increased at 88. Leukocytosis with a majority of neutrophilic polynuclears.
CDC Split Type: E200404530
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEUR   LA
MEN: MENINGOCOCCAL (MENOMUNE)AVENTIS PASTEUR   RA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)AVENTIS PASTEUR   LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site inflammation, Laboratory test abnormal, Oedema, Pruritus, Pyrexia
SMQs:, Cardiac failure (broad), 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), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Initial report by HCP to manufacturer on 06-DEC-2004: It was reported that a 51-year-old woman was concomitantly administered on 24-NOV-2004 a Td-IPV vaccine on left arm, and Menonmune on right arm. On 26 Nov 2004, 48 hours post-vaccination, she presented with fever at 38, 9 degrees Celcius and with erythema and edema on her left arm. The pt was hospitalized on 28-Nov-2004 as erysipelas was suspected: she was administered antibiotics (Clamoxyl 6g/day) during 2 days. The inflammatory coating extended to the whole left arm (from injection site to the wrist), accompanied with pruritus. No adenopathy was found. See lab comments. On 30 Nov, erysipela was ruled out and antibiotics were stopped. Symptoms improved spontaneously and the pt recovered on 02-Dec-04. Further information awaited.

VAERS ID:234047