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VAERS ID: 336079 (history)  
Age: 28.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2006-07-07
Onset:0000-00-00
Submitted: 2008-12-24
Entered: 2008-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH - / - UN / -

Administered by: Military       Purchased by: Military
Symptoms: Barium swallow normal, Biopsy intestine normal, Blood arsenic normal, Blood folate normal, Blood test normal, C-reactive protein normal, Computerised tomogram normal, Decreased appetite, Disturbance in attention, Dysphasia, Encephalopathy, Epstein-Barr virus antibody negative, Fatigue, Headache, Lymphadenopathy, Mastoid disorder, Memory impairment, Muscular weakness, Neck pain, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Oesophagogastroduodenoscopy, Oropharyngeal pain, Pyrexia, Red blood cell sedimentation rate normal, Restless legs syndrome, Rheumatoid factor negative, Serology negative, Sinusitis, Thyroid neoplasm, Tremor, Urine analysis normal, Viral infection, Vitamin B12 normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BCP
Current Illness: None
Preexisting Conditions: PCN--$ganaphylaxis
Diagnostic Lab Data: 11/10/06, Thyrotropin 0.3 mcIU/mL (0.36-3.72); 1/16/2007, Ceruloplasmin 42 mg/dL (18-53); 11/6/07; Nuclear AB Negative; Rheumatoid Factor <20 IU/mL (0-<20); ESR 8mm/hr (0-20); 12/6/07, Trlioothyronine Free, 4.27 (L) (4.3-7.5); Thyroxine Free 0.78 (0.58 1.64); 1/31/08, Reagin Ab Non-Reactive; 7/8/08, B. burgdorferi Ab 0.59 Index 0.00-1.09; Epstein-Barr Virus Capsid Ab IgG POS 1:160 (H); Epstein Barr virus Capsid Ab IgM Negative; Heterophile Ab Negative; 30 Apr 2008, RNA Extractable Nuclear Ab Negative Smith Extractable Nuclear Ab Negative; SS-A Ab Serum Negative; SS-B Ab Serum Negative; 28 Apr 2008, Vitamin B12 (Cobalamins) 518 pg/mL (180-914); Flotate $g20 ng/mL; Purkin Cell (YO) AB Screen: Negative; Nuclear Ab Negative; Trilodothyronine Fre
CDC Split Type:

Write-up: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM''s symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.


VAERS ID: 336172 (history)  
Age: 28.0  
Gender: Male  
Location: Montana  
Vaccinated:2008-10-15
Onset:2008-10-22
   Days after vaccination:7
Submitted: 2008-12-23
   Days after onset:62
Entered: 2008-12-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500543P / 3 - / IN

Administered by: Private       Purchased by: Private
Symptoms: Epistaxis, Rhinalgia, Scab
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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:

Write-up: 4th year getting FLUMIST and patient states this has happened every year, sore start to develop in both nostrils and then scab over. They bleed when nose is blown. Pain scale 0-10 (10 being highest) , patient rates at a 6-7. They last for 2/1/2 months and are painful the entire time.


VAERS ID: 336667 (history)  
Age: 28.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2006-05-01
Onset:2006-12-21
   Days after vaccination:234
Submitted: 2009-01-05
   Days after onset:746
Entered: 2009-01-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C455AA / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alpha 1 foetoprotein normal, Amniotic fluid index abnormal, Antibody test negative, Chlamydia identification test negative, Complication of delivery, Complication of pregnancy, Foetal disorder, HIV test negative, Labour complication, Oligohydramnios, Rubella immunity confirmed, Syphilis test negative, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AUGMENTIN; ALBUTEROL; FLOVENT; Prenatal Vitamins
Current Illness:
Preexisting Conditions: The patient had a history of body mass index (BMI) - 24, asthma, anemia, and mitral valve prolapse - grade I by echocardiogram. No history of tobacco, alcohol (ETOH) or drugs.
Diagnostic Lab Data: Alpha Feto Protein: 31/May/2006 - normal; Serology: 16/May/2006 - A+; antibody - negative; Rub - immune; Gr/Chlam - neg/neg; Syph IgG - neg; HIV - non-reactive. Ultrasounds performed: 31/May/2006 - normal singleton intrauterine pregnancy (IUP), 20/Jul/2006 - normal anatomy, and 21/Nov/2006 and 08/Dec/2006 - normal growth. Ultrasound performed: 15/Dec/2006 showed normal amniotic fluid index (AFI). Ultrasound performed: 21/Dec/2006 showed normal growth; low amniotic fluid index (AFI). Genetic Screen: 11/May/2006 - Cystic Fibrosis gene negative; 31/May/2006 - first trimester screening - negative.
CDC Split Type: 200804106

Write-up: Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor. A 28-year-old pregnant female with a history of body mass index (BMI) 24, Asthma, Anemia, and Mitral valve prolapse was found to have oligohydramnios 234 days after she had received a first dose of intramuscular left deltoid injection of ADACEL, lot number C455AA on 01 May 2006. She had no history of prior pregnancies, and no history of tobacco, alcohol (ETOH) or drugs. Concomitant medications included Augmentin (indicated for otitis), Albuterol, Flovent and prenatal vitamins. On 21 December 2006, an ultrasound revealed normal growth and a low amniotic fluid index (AFI). Pregnancy, labor and delivery complications occurred and the patient was diagnosed with Oligohydramnios at 40 (3/7) weeks; AFI - 6.6. The patient was induced with misoprostol, augmentation with Pitocin and artificial rupture of membranes (AROM). Fetal heart tones (FHT) decelerations to 100''s occurred with return to baseline after one minute throughout the active labor phase. During the second stage of labor, decelerations to 100''s occurred with no slow return to baseline, however delivery was imminent, so labor continued. The patient delivered a single live female infant vaginally on 22 December 2006 at 40 (4/7) weeks gestation weighing 3070 grams. A tight nuchal cord was reduced. The infant was handed to nursing, ICN was called due to no respiratory effort. Apgar readings were 2/5 at one and five minutes respectively. The infant was intubated briefly, then extubated. The infant had no congenital anomalies. The patient experienced a second degree laceration and urinary retention post-partum day zero. Her Foley was replaced, and then removed 24 hours later without further problems. The patient''s recovery status was not reported. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.


VAERS ID: 336710 (history)  
Age: 28.0  
Gender: Male  
Location: Utah  
Vaccinated:2007-12-01
Onset:2007-12-02
   Days after vaccination:1
Submitted: 2009-01-07
   Days after onset:402
Entered: 2009-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR Z1102 / - UN / UN

Administered by: Military       Purchased by: Other
Symptoms: Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: DEVELOPED STEVEN-JOHNSON SYNDROME~Smallpox (no brand name)~UN~23.00~Patient
Other Medications: VALTREX, CLARITIN, AVAREX
Current Illness: NO ACUTE ILLNESS.
Preexisting Conditions: STEVEN-JOHNSON SYNDROME
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PT SUFFERED FROM HIVES, RASHES AND A MILD GRADE FEVER FOR 7 DAYS FOLLOWING VACCINATION. THE PT RECEIVED TX WITH PREDNISONE AND RECOVERED WITHIN DAYS.


VAERS ID: 336882 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-01-05
Onset:2009-01-05
   Days after vaccination:0
Submitted: 2009-01-06
   Days after onset:1
Entered: 2009-01-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1376U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NADOLOL; AVIANE
Current Illness: None
Preexisting Conditions: Heart palpitations
Diagnostic Lab Data:
CDC Split Type:

Write-up: Migraine with auras, nausea and headache.


VAERS ID: 336913 (history)  
Age: 28.0  
Gender: Male  
Location: Virginia  
Vaccinated:2008-11-16
Onset:0000-00-00
Submitted: 2009-01-09
Entered: 2009-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 03149111A / - - / IN

Administered by: Military       Purchased by: Military
Symptoms: Incorrect route of drug administration
SMQs:, Medication errors (narrow)

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:

Write-up: SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE


VAERS ID: 336951 (history)  
Age: 28.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2009-01-10
Onset:0000-00-00
Submitted: 2009-01-11
Entered: 2009-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA197AA / 9 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2823AA / 2 LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2965AA / 2 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR A0394 / 4 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

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: Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Erroneously received two doses of Meningococcal vaccine


VAERS ID: 337332 (history)  
Age: 28.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2008-10-23
Onset:2008-10-23
   Days after vaccination:0
Submitted: 2009-01-14
   Days after onset:83
Entered: 2009-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chills, Cough, Dysphagia, Heart rate increased, Pharyngeal oedema, Pyrexia, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), 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), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin 24-one daily, Nexium 40mg-one daily
Current Illness: none
Preexisting Conditions: acid reflux, pvc''s, migraines, viral meningitis 3 weeks prior to flu shot
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Flushot given around 11AM? About 3 hours after flu shot-started coughing and had a "tickle" in my throat, cough became more frequent, then heart rate up to 100-110. Felt like my throat was swollen, trouble swallowing. Gave myself 50mg of Benadryl and cough began to subside about 30min after. Swollen throat began to feel better a few hours after Benadryl. Later that evening started with fever (102-103F) and chills. Took 650mg Tylenol. Cough had completely subsided by then and throat was much better. Felt completely fine in the morning (no fever, chills, coughing, swollen throat).


VAERS ID: 337438 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-05-12
Onset:0000-00-00
Submitted: 2007-11-29
Entered: 2009-01-15
   Days after submission:413
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER MIPFAV105 / - UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Local reaction, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Developed large local reaction to anthrax vaccine Erythema Start: 05/2007; Swelling Start: 05/2007; Pain Start: 05/2007


VAERS ID: 337845 (history)  
Age: 28.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2009-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER B04752 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hypoaesthesia, Hypoventilation, Mydriasis, Paraesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None prior to now~ ()~~0.00~In Patient
Other Medications: LAMOTRIGINL; CONEPRAZOLE; LITHIOM; L-THYROXINE; TOPOLINAX
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: W/in 30 seconds: tingling & numbness down arm to fingers. Then, blurred vision, dilated pupils, wain skin, light headedness, shallowed breathing. After 15-20 min, symptoms dissipated treatment. laid down, called 911(arrived)


VAERS ID: 338501 (history)  
Age: 28.0  
Gender: Female  
Location: Georgia  
Vaccinated:2009-01-26
Onset:2009-01-26
   Days after vaccination:0
Submitted: 2009-01-28
   Days after onset:2
Entered: 2009-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0453X / 1 LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2994BA / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Employee c/o headache, nausea, vomiting, fever, rash on arms, neck, chest, abdomen and pain and swelling at injection site.


VAERS ID: 338642 (history)  
Age: 28.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2008-09-16
Onset:2008-10-31
   Days after vaccination:45
Submitted: 2009-01-29
   Days after onset:90
Entered: 2009-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / OT

Administered by: Military       Purchased by: Military
Symptoms: Dermatitis
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MVI
Current Illness: None
Preexisting Conditions: PCN allergy PMH: acne, contact dermatitis 10/2008, chickenpox, shingles.
Diagnostic Lab Data:
CDC Split Type:

Write-up: SM developed erythematous, pruritic lesions at site of primary SPV inoculation approximately 6 weeks post vaccination. Symptoms: Dermatitis, focal. Evaluated by dermatology and felt that it was related to vaccine. Treated with DESONIDE. 2/3/09 Received VHC medical records of 1/22/09. FINAL DX: post vaccine dermatosis of unknown etiology following vaccination w/primary SPV Records reveal patient experienced normal site reaction & scab falling off after approx 30 days. Then developed erythematous pruritic bump at innoculation site within 2 weeks after scab fall off. Bump got larger & patient self treated w/topical antibiotic cream after approx 1 week w/improvement. Stopped treatment & bump enlarged. Tried using steroid cream until 1/2009 when developed into pimple. Saw MD for deployment clearance. Dermatology consult done & tx w/desonide cream.


VAERS ID: 338725 (history)  
Age: 28.0  
Gender: Female  
Location: California  
Vaccinated:2009-01-15
Onset:2009-01-22
   Days after vaccination:7
Submitted: 2009-01-30
   Days after onset:8
Entered: 2009-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3001447 / 4 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Skin rash all over the body, mostly in the torso regions.


VAERS ID: 339162 (history)  
Age: 28.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2009-02-06
Onset:2009-02-06
   Days after vaccination:0
Submitted: 2009-02-06
   Days after onset:0
Entered: 2009-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0218U / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site pruritus, Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa, depakote, trazodone
Current Illness: none
Preexisting Conditions: NKA
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 0815 Hep B vaccine administered. 0845 Client still in building came to my office stating her RT arm was breaking in rash and itiching real bad. Denied any breathing difficulty. At 0847 administer diphenhydramine 1cc IM in LD. 0937 was taken home.


VAERS ID: 339305 (history)  
Age: 28.0  
Gender: Female  
Location: Colorado  
Vaccinated:2009-02-04
Onset:2009-02-05
   Days after vaccination:1
Submitted: 2009-02-09
   Days after onset:4
Entered: 2009-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0652X / 2 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVORA; Fluoxetine; DEMEROL
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt contacted clinic on 2/6/09 (injection given on 02/4/09) stating after third HPV injection she experienced mild swelling @ site with moderate pain and bilateral shoulder , elbow, and wrist join pain (no recent trauma noted), throbbing in (R) side down to fingers, cannot sleep on (R)Side.


VAERS ID: 339503 (history)  
Age: 28.0  
Gender: Female  
Location: Florida  
Vaccinated:2009-01-20
Onset:2009-01-31
   Days after vaccination:11
Submitted: 2009-02-12
   Days after onset:12
Entered: 2009-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1248X / - LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Hyperaesthesia, Induration, Mass, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: client returned to clinic 2/9/09 stating she noted small lump left tricep region appr. 10 days prior. reports area getting progressively larger. area appr. 25cm. slightly reddened, warm, sensitive to touch, hard. denies fever, other systemic signs/symptoms. referred to primary care provider. placed on antibiotics for 7 days with follow up visit scheduled 12/16/09.


VAERS ID: 339507 (history)  
Age: 28.0  
Gender: Female  
Location: Texas  
Vaccinated:2008-06-02
Onset:2008-06-04
   Days after vaccination:2
Submitted: 2009-02-12
   Days after onset:253
Entered: 2009-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1309U / - LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 40mm x 35mm area of "bruising", erythema right upper outer arm (area of injection site). No systemic symptoms.


VAERS ID: 339876 (history)  
Age: 28.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2008-06-06
Onset:0000-00-00
Submitted: 2009-02-13
Entered: 2009-02-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2888A / - RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthma, Caesarean section, Drug exposure during pregnancy, Gestational diabetes, Injection site swelling, Pregnancy test positive, Serology normal, Ultrasound scan normal, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR; ZANTAC; Prenatal Vitamins; TUBERSOL
Current Illness:
Preexisting Conditions: The patient denied any illnesses at the time of the vaccination on 28 April 2008. She has no known allergies, but does have a history of asthma, hypercholesterolemia, and "reflux". Obstetrical history includes one previous pregnancy that resulted in a spontaneous abortion at five months gestation. The patient had a negative home pregnancy test on 12 May 2008, a negative blood pregnancy test on 13 May 2008, and a positive home pregnancy test on 29 May 2008. The patient had not received any other vaccinations within four weeks of 28 April 2008. From new information received on 06 February 2009, it was clarified the patient delivered her first child at 20 weeks gestation and the baby subsequently died. The patient had no family history of con
Diagnostic Lab Data: Diagnostic tests/labs related to swelling at the ADACEL injection site: "None needed. Swelling lasted 1 day." Prenatal testing: an ultrasound performed in August 2008 was normal; 03 July 2008: Normal serologies; 20 August 2008, 10 September 2008, 30 October 2008, 04 December 2008 and 31 December 2008: normal ultrasound.
CDC Split Type: 200801836

Write-up: Initial report received on 02 June 2008 from a health care professional. A 28-year-old patient, had received a 0.5 mL intramuscular right deltoid injection of ADACEL (Lot number C2888AA), and a 0.1 mL intradermal left forearm injection of TUBERSOL (Lot number C2907BA) on 28 April 2008. The patient had past medical history of asthma (treated with ADVAIR), hypercholesterolemia and "reflux" (treated with ZANTAC). Past obstetrical history includes one previous pregnancy that resulted in a spontaneous abortion at five months gestation. The following day after receiving the ADACEL and TUBERSOL, the patient developed swelling at the ADACEL injection site. Treatments received and diagnostic tests performed were not provided. The subject recovered (date not reported). Subsequently on 29 May 2008, the patient did a home pregnancy test that was positive. At the time of this report no prenatal tests had been done. The date of the patient''s last menstrual period was reported as April 2008, and the expected date of delivery was unknown. 28 July 2008: Corrective version was created to remove the "no adverse effect" from the adverse event structure field, since the patient had developed swelling at the ADACEL injection site. Follow-up information received from a health care professional on 28 August 2008. For the adverse event "swelling at the ADACEL injection site", extent of swelling was reported to be minimal (less than nickel sizes), and resolved in one day. Follow-up information concerning the patient''s pregnancy was also reported. The date of the patient''s last menstrual period was reported as March 2008. Estimated date of delivery is 20 January 2009. The patient denied alcohol, drug or tobacco use. At the time of the report, the patient was reported to be healthy. It was reported that per the patient, things were going well with the pregnancy. An ultrasound was performed in August 2008 with normal results. Follow-up information was received 25 September 2008 from a health care professional. The reporter confirmed that the swelling at the injection site had resolved on 30 April 2008. Follow-up information received on 06 February 2009 from a physician. It was clarified the patient, who, had delivered her first child at 20 weeks gestation and the baby subsequently died. It was previously reported the patient had experienced a spontaneous abortion at 20 weeks gestation. Per the reporter, the patient has no family history of congenital anomalies. the date of the patient''s last menstrual period was amended by the reporter from 01 March 2008 to an unknown day in April 2008 with an expected date of delivery on 24 January 2009. The patient took prenatal vitamins during the current pregnancy. The date of vaccination for the ADACEL, and the date of TUBERSOL test was amended from 28 April 2008 to 02 June 2008 by the reporter. Regarding the current pregnancy, the patient did not smoke cigarettes, drink alcohol, or use any recreational drug during her pregnancy. The patient''s prenatal tests included serology tests on 03 July 2008 that were normal and ultrasounds that were normal on 20 August 2008, 10 September 2008, 30 October 2008, 04 December 2008 and 31 December 2008. The patient developed gestational diabetes with a body mass index of 32, a urinary tract infection that was treated with oral MACROBID 100 mg for seven days from 13 October 2008 to 20 October 2008, and exacerbation of her asthma from 24 June 2008 to delivery on 17 January 2009. The patient delivered via cesarean section at 39 weeks gestation a healthy live male baby with no congenital anomalies. The baby weighed six pounds 15 ounces (2.78kg). The Apgar scores were not provided. Pregnancy complications were listed as gestational diabetes and asthma; however the reporter ticked "no" for adverse events experienced since being vaccinated with ADACEL and receiving the TUBERSOL test. The recovery status of the gestational diabetes and exacerbation of asthma were not reported. The recover


VAERS ID: 339928 (history)  
Age: 28.0  
Gender: Male  
Location: Kansas  
Vaccinated:2009-01-20
Onset:2009-01-20
   Days after vaccination:0
Submitted: 2009-01-22
   Days after onset:2
Entered: 2009-02-18
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2770AA / 1 RA / IM
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0866X / 2 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0224X / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chest discomfort, Headache, Injection site swelling, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: PCN allergy
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash on (R) deltoid, fever, swelling at injection site, body aches, chest tightness, headache. Pt seen by PA at Medical Clinic on 1/22/09. Recommended Ibuprofen and Benadryl prn.


VAERS ID: 340385 (history)  
Age: 28.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2009-02-09
Onset:2009-02-10
   Days after vaccination:1
Submitted: 2009-02-17
   Days after onset:7
Entered: 2009-02-23
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1571X / 1 RA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2774AA / 0 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Erythema, Local reaction, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: None
CDC Split Type:

Write-up: Local reaction - mild redness, soreness


VAERS ID: 340398 (history)  
Age: 28.0  
Gender: Female  
Location: Alaska  
Vaccinated:2009-02-10
Onset:2009-02-10
   Days after vaccination:0
Submitted: 2009-02-10
   Days after onset:0
Entered: 2009-02-23
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0619X / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Discomfort, Induration, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: slight swelling and soreness~Pneumo (no brand name)~1~21.00~In Patient
Other Medications:
Current Illness: Cough
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Discomfort started around 2pm. Slight swelling. Hurts to move arm. Ibuprofen and ice the shoulder/arm. 2/13/09 doing much better.


VAERS ID: 340583 (history)  
Age: 28.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2009-02-14
Onset:2009-02-17
   Days after vaccination:3
Submitted: 2009-02-24
   Days after onset:7
Entered: 2009-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3032AA / - UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLACE, MOTRIN, VICODAN
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: ADACEL given 2/14 2/17 - arm puffy, warm to touch, redness around site and trailed down arm


VAERS ID: 341156 (history)  
Age: 28.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2009-02-18
Onset:2009-02-18
   Days after vaccination:0
Submitted: 2009-02-27
   Days after onset:9
Entered: 2009-03-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR V2803AA / 0 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1163X / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3057AA / 0 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site streaking
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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: none
CDC Split Type:

Write-up: PNEUMOVAX given IM Left deltoid on 2/18/09. On 2/19/09, pt returned to ofc with edema, pain and erythematous streaking from injection site down beneath axilla-streaking completely 1/2 way around his arm.


VAERS ID: 341747 (history)  
Age: 28.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2009-02-18
Onset:2009-03-05
   Days after vaccination:15
Submitted: 2009-03-15
   Days after onset:9
Entered: 2009-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3068AA / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Abdominal pain upper, Antinuclear antibody negative, Asthenia, Blood thyroid stimulating hormone normal, CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, Gait disturbance, HIV test negative, Headache, Hepatitis B antibody negative, Hepatitis C antibody negative, Hypoaesthesia, Injection site erythema, Injection site pain, Laboratory test normal, Lumbar puncture abnormal, Multiple sclerosis, Muscular weakness, Neck pain, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Pleocytosis, Rheumatoid factor negative, Sensory loss, Spinal cord disorder, Syphilis test negative, Viral test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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), Optic nerve disorders (broad), Demyelination (narrow), Malignant lymphomas (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levoxyl 50mcg, Vitamin D 1000 IU, Tamadol 50mg PRN, Bactrim DS, Zyrtec 10mg
Current Illness: None
Preexisting Conditions: Hypothyroidism (controlled), Obesity, Vitamin D Deficiency (mild/treated), Anxiety (mild), remote history of viral meningitis, status post L Ankle fracture (remote) PMH: smoker; daily alcohol. Allergy: PCN, rash. Family hx: Hashimoto''s, DM, HTN.
Diagnostic Lab Data: On hospital admission MRI of the T-Spine revealed abnormality from T5 to T10 consistent with myelitis but not diagnostic. LP showed lymphocyte predominant pleocytosis, elevated protein (74) and normal csf glucose (59). TSH was normal. Hepatitis B and C antibodies, HIV 1 and 2, HTLV, ANA, RPR, rheumatoid factor, all were negative. LABS: CT scan head WNL. MRI spine abnormal. CSF:WBC 573(H), RBC 724(H), protein 74(H), glucose 59(N), lymphs 89%(H), monos 11%(L), oligclonal bands 2. CMP WNL.
CDC Split Type:

Write-up: Vaccine administered as part of routine PEx 2/18/2009. Pt seen on 2/23/2009 with pain and redness in the vaccination site and neck soreness. She was treated with Bactrim DS BID and Zyrtec 10mg daily as well as OTC Ibuprofen PRN. On 3/7/2009 she presented to ER with burning pain in band like distribution in the upper abdomen and tingling in the lower extremities. Pt. was d/c''d home and returned the next day with HA, increased tingling and difficulty with ambulation. She was found to have decreased sensation below the umbilicus and R $g L lower extemity weakness. Pt was treated with IV steroids and had clniical improvement and was d/c''d from hospital when she was able to ambulate w/o assistance on oral prednisone. Further follow up is pending. 4/2/09 Received hospital medical records of 3/8-3/11/2009. FINAL DX: myelitis, etiology undetermined Records reveal patient experienced 3-4 days of burning sensation in band like distribution around upper abdomen, back pain, numbness/tingling of LEs, difficulty walking, throbbing frontal HA, N/V. Seen in ER on 3/7 & d/c. Returned because of increased s/s. Neuro consult done. Tx w/IV steroids. Strength improved & d/c to home on tapering steroids x 2 more wks w/neuro f/u. Follow-up: Patient has had 90-95% recovery of her initial symptoms (numbness and weakness) as well as marked improvement by MRI in spinal cord lesion. Pt is now diagnosed with Multiple Sclerosis and on treatment doing well thus far. Unclear whether the onset of MS was related to vaccination or not but certainly timing of events was very suspicious.


VAERS ID: 342612 (history)  
Age: 28.0  
Gender: Female  
Location: Georgia  
Vaccinated:2008-06-01
Onset:0000-00-00
Submitted: 2009-03-13
Entered: 2009-03-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Formication, Smear cervix abnormal, Vaginal haemorrhage
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0902USA01481

Write-up: Information has been received from a 29 year old female consumer who in April 2008, was vaccinated with the first dose of GARDASIL. On June 2008, the patient received the second dose of GARDASIL. After receiving the second dose the patient began to experience abnormal vaginal bleeding, abnormal pap smears and the feeling of "bugs crawling on her skin". The symptoms had persisted since the second dose was administered. The patient called her physician office, but had not spoken with them yet. Additional information has been requested.


VAERS ID: 343393 (history)  
Age: 28.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-08-21
Onset:2007-08-22
   Days after vaccination:1
Submitted: 2009-03-04
   Days after onset:560
Entered: 2009-03-18
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB183AA / 0 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Electrocardiogram, Fatigue
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contraceptives
Current Illness: Unknown
Preexisting Conditions: The subject has a history of irregular heartbeat with negative cardiac work-up an no drug allergies. There is no history of adverse events following previous vaccinations.
Diagnostic Lab Data: An EKG was performed on an unspecified date (following the subject''s episode of dizziness) was negative.
CDC Split Type: A0717385A

Write-up: This case was reported by a healthcare professional and described the occurrence of dizziness in a 28-year-old female subject who was vaccinated with HAVRIX. Concurrent medications included oral contraceptives and concurrent vaccination included ADACEL given on 21 August 2007. On 21 August 2007 the subject received 1st dose of HAVRIX at 1 cc in the right deltoid. On 22 August 2007, 1 day after vaccination with HAVRIX (the following morning), the subject experienced dizziness while in the shower. The event resolved the same day with no treatment. The subject did go to her primary care physician regarding the dizziness. An EKG was performed, but was negative. On 4 March 2008 at 09:08, the subject received 2nd dose of HAVRIX at 1cc in the left arm. Six hours after vaccination with the 2nd dose of HAVRIX, at 15:00 on 4 March 2008, the subject developed severe fatigue that improved without treatment. The event had resolved by 5 March 2008. Both event s of dizziness and fatigue were systemic reactions. The healthcare professional considered the events were possibly related to vaccination with HAVRIX.


VAERS ID: 342774 (history)  
Age: 28.0  
Gender: Female  
Location: Texas  
Vaccinated:2009-03-25
Onset:2009-03-25
   Days after vaccination:0
Submitted: 2009-03-26
   Days after onset:1
Entered: 2009-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF471BA / 0 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Itching began about 2 hours after receiving vaccine. No local, injection site reaction. She took a Benedryl and was clinically stable when seen.


VAERS ID: 342816 (history)  
Age: 28.0  
Gender: Female  
Location: New York  
Vaccinated:2009-03-09
Onset:2009-03-09
   Days after vaccination:0
Submitted: 2009-03-26
   Days after onset:17
Entered: 2009-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF457CA / 1 LA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR D0251 / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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:

Write-up: Pt received Tdap + Typhoid 3/9/09 for pre-travel immunization. Within 10 min of receiving vaccine pt c/o pain + swelling L posterior deltoid. Pt. denied SOB, facial swelling, wheezing. V/S monitored, ice applied + pt. observed + assessed by HD.


VAERS ID: 342834 (history)  
Age: 28.0  
Gender: Female  
Location: Washington  
Vaccinated:2009-03-20
Onset:2009-03-20
   Days after vaccination:0
Submitted: 2009-03-24
   Days after onset:4
Entered: 2009-03-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF46UAA / 0 RA / UN

Administered by: Other       Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tubersol, Sanofi Pasteur, C2921AA, R forearm, 1 previous dose
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Diaphoresis and lightheadedness shortly after Tdap administration, resolved after 15 minutes. Fever 103 by history 18 hours after injection, lasted 2 days, also diaphoresis.


VAERS ID: 343377 (history)  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:1997-08-05
Onset:1997-11-08
   Days after vaccination:95
Submitted: 2009-04-01
   Days after onset:4161
Entered: 2009-04-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Artery dissection, Coordination abnormal, Discomfort, Dysstasia, Headache, Influenza like illness, Intensive care, Muscle strain, Muscular weakness, Neck pain, Pain, Pallor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: HTN, GERD, high cholesterol. Allergy: latex.
Diagnostic Lab Data: Unknown no data available
CDC Split Type:

Write-up: While attending graduate school, this 40 year old member reported receipt of hepatitis A #1, influenza, and typhoid vaccinations on 11/7/1997. Medical records show tetanus-diphtheria given 8/5/1997 not 11/7/1997. He remembers experiencing flu-like symptoms that evening that worsened the next day to resolve within 24 hours. Day 2 post vaccination (11/9/1997) he began to experience a dull ache to neck near base of skull. This discomfort gradually increased over the next 1 1/2 weeks until he was unable to rotate head side-side due to pain but he could shake it "yes" without pain. He denied any other symptoms (headache, n/v, muscular weakness, speech or visual disturbance). He presented to medical where he was treated for muscle strain and placed on muscle relaxer and MOTRIN. He took one "muscle relaxer" and developed a severe headache. He didn''t take any more and represented to medical where he was advised he was given a vasodilator instead of muscle relaxer. His medications were changed with resolution of all neck pain for 4 days. On Thanksgiving day he rapidly hyperextended his neck to "knock back a shot of whiskey" with family members at home when he suddenly "felt weird". He was reported to go pale, his coordination was off, and he had a headache. He was unable to stand due to muscle weakness and was assisted to the floor. He denied any paralysis, respiratory or visual complaints. He was taken to an emergency room, admitted and diagnosed with dissected cerebral artery. He remained in ICU for 1 week then in rehab for 3 weeks with full recovery except for mild residual pain/temperature deficit to his right side. He received his second hepatitis A vaccine 9/2 2005 with hepatitis B given 9/8/2005, 2/11/2006, 9/11/2006, and 3 influenza vaccinations (2005, 2006, 2007) with no adverse events. Symptoms: Gait abnormality, Weakness, Headaches, general, Inability to turn head (CN X1), Flu-like symptoms<96 hours, Pain. 4/14/09 Received medical records of 4/1/2009. FINAL DX: CVA/dissected cerebral artery Records reveal patient experienced flu-like symptoms after flu, hep A #1 & typhoid #2 vaccinations on 11/7/1997. (Had received Td on 8/5/1997.) Developed basilar HA 2 days s/p vax which increased over 10 days. Seen in clinic & given muscle relaxer for muscle strain. HA increased & meds changed w/complete resolution for 4 days. Then on Thanksgiving day, after neck hyperextension became pale, uncoordinated, HA, unable to stand & assisted to floor. Admitted to ICU x 1 wk w/dissected cerebral artery, then rehab x 3 wk w/full recovery except for mild residual pain/temperature deficit on right side. Received subsequent vaccines w/o adverse events.


VAERS ID: 343589 (history)  
Age: 28.0  
Gender: Female  
Location: Michigan  
Vaccinated:2009-03-31
Onset:2009-04-01
   Days after vaccination:1
Submitted: 2009-04-06
   Days after onset:5
Entered: 2009-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1117X / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pt had taken Prednisone 50mg x3 on 3/24 as a prep for an MRI.
Current Illness:
Preexisting Conditions: ASA - breathing difficulties PMH: HTN, asthma. Family hx: HTN.
Diagnostic Lab Data: LABS: WBC 20.0(H), neutros 17.7(H), US right arm abnormal w/significant soft tissue edema
CDC Split Type:

Write-up: 24hrs after shot pt had swollen, painful area at site, 1" red circle at site with rash around it. Syncopal episode on 4/1. Transported to hospital by ambulance. Admitted with diagnosis of cellulitis. Discharged 4/5/2009. 4/8/09 Received hospital medical records of 4/1-4/5/2009. FINAL DX: cellulitis right arm secondary to vaccination Records reveal patient experienced fever, chills, syncope w/LOC, twitching of right extremities & right arm injection site pain & redness x 2 days. Tx w/IVF & IV antibiotics. Markedly improved & d/c to home on continued oral antibiotics.


VAERS ID: 343594 (history)  
Age: 28.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2009-04-03
Onset:2009-04-04
   Days after vaccination:1
Submitted: 2009-04-06
   Days after onset:2
Entered: 2009-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF456BA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pain, Skin reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: ADVERSE SKIN REACTION
CDC Split Type:

Write-up: PT HAD A TDAP SHOT ON FRIDAY(04-03-09) AND SAT. HE HAD BODY PAIN & CHILLS.LEFT ARM WARM AND TENDER TO THE TOUCH. TODAY PT PRESENTED WITH A WARM ARM/NO PAIN JUST RED.


VAERS ID: 343687 (history)  
Age: 28.0  
Gender: Female  
Location: Texas  
Vaccinated:2008-05-16
Onset:2008-06-23
   Days after vaccination:38
Submitted: 2009-04-07
   Days after onset:288
Entered: 2009-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / - - / ID

Administered by: Military       Purchased by: Military
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery.


VAERS ID: 343810 (history)  
Age: 28.0  
Gender: Female  
Location: California  
Vaccinated:2009-04-08
Onset:2009-04-08
   Days after vaccination:0
Submitted: 2009-04-09
   Days after onset:1
Entered: 2009-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB3028A / 0 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR B0347 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mefloquine
Current Illness: None
Preexisting Conditions: Allergies, Eggs, wheat, corn (starches)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called 4/9/09 AM to notify us approximately two hrs after vacc. She felt "weak and with headache"; this morning after 15 min run she c/o sweats, chills, weakness and nausea. Patient referred to PMD if sx persist. Vacc given 4/8/09 PM.


VAERS ID: 343838 (history)  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:2003-12-10
Onset:2004-01-01
   Days after vaccination:22
Submitted: 2009-04-10
   Days after onset:1925
Entered: 2009-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / SC
HEPAB: HEP A + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / IM
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR - / 0 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Activities of daily living impaired, Arthralgia, Electromyogram, Facial palsy, Feeling cold, Full blood count normal, Hypoaesthesia, Joint stiffness, Joint swelling, Laboratory test, Muscle twitching, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations: None~ ()~~0.00~Patient|None known~ ()~~0.00~Sibling
Other Medications: None at time of immunizations.
Current Illness: None.
Preexisting Conditions: Penicillin - following injection as infant, leg became red and swollen (reported to Patient by parent)
Diagnostic Lab Data: Most recent ESR and CBC (08 APR 2009) WNL. Rheumatology labs from facility drawn within past six months not in record. EMG results pending.
CDC Split Type:

Write-up: Administered first of six-series Anthrax immunization course on 10 DEC 2003. Also given #1 Hep A, #1 Hep B, Typhoid and Smallpox (smallpox not documented, but Patient describes process and procedures accurately). Approx. 4 weeks later, had sx of coldness, numbness, twitching L side of face. Lost expression on L side of face. Within six months, dx w/Bell''s Palsy at local facility and hospitalized. Given 2 gm Rocephin IV x approx. 6 weeks, during and post hospitalization. Sx gradually subsided, but still has occasional coldness, twitching of L side of face. Despite dx of Bell''s Palsy w/possible relationship to vaccines, was given second Anthrax immunization on 15 Sep 2004, along with #2 Hep B and #2 Hep A. Deployed in Oct. 2004. Beginning Oct/Nov 2004, began to experience stiffness, pain and swelling of ankles, feet, knees, hands, shoulders, elbows, lower back (sacrum). Symptoms ebb and flow but pain and swelling in knees, wrist, hands has gradually increased in intensity to average 7/10 pain level. Able to function fairly well with pain at 5-6/10 level, but not higher.


VAERS ID: 344149 (history)  
Age: 28.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2009-04-08
Onset:2009-04-09
   Days after vaccination:1
Submitted: 2009-04-14
   Days after onset:5
Entered: 2009-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD - / 0 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Hypoaesthesia oral, Rash
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO EVRA
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Peri-oral rash and slight numbness, no swelling of lips or tongues.


VAERS ID: 344188 (history)  
Age: 28.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2009-04-03
Onset:2009-04-03
   Days after vaccination:0
Submitted: 2009-04-06
   Days after onset:3
Entered: 2009-04-15
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB448AA / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient
Other Medications: LISINOPRIL; SULFAMETH-TRIMETH; TOPROL; APRIM; MOTRIN
Current Illness: None
Preexisting Conditions: Strawberries; Chronic bladder infections; hypertension; pulmonary hypertension; erythromycin; CODEINE; COMPAZINE; DARVACET; LORTAB
Diagnostic Lab Data:
CDC Split Type:

Write-up: Employee reports fever ranging from 100 degrees F - 103 degrees F and vomiting starting 4/3/09 through 4/4/09. Also reports body aches. No treatment needed.


VAERS ID: 344205 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-06-30
Onset:2008-07-11
   Days after vaccination:11
Submitted: 2009-04-15
   Days after onset:278
Entered: 2009-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / - LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery.


VAERS ID: 344300 (history)  
Age: 28.0  
Gender: Female  
Location: Florida  
Vaccinated:2008-09-16
Onset:2008-11-01
   Days after vaccination:46
Submitted: 2009-04-10
   Days after onset:160
Entered: 2009-04-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2532AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Abdominal pain, Abortion spontaneous, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Clinical Research Trial
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received FLUZONE vaccine on 9/16/08. November (date unknown) patient developed abdominal cramps & vaginal bleeding. OB/GYN evaluation revealed a spontaneous miscarriage.


VAERS ID: 344469 (history)  
Age: 28.0  
Gender: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-13
Entered: 2009-04-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2749AA / - RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: No adverse event
SMQs:

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:

Write-up: None stated.


VAERS ID: 344493 (history)  
Age: 28.0  
Gender: Unknown  
Location: Minnesota  
Vaccinated:2009-04-04
Onset:2009-04-09
   Days after vaccination:5
Submitted: 2009-04-20
   Days after onset:11
Entered: 2009-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / - UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Cardiac stress test, Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram, Fibrin D dimer normal, Heart rate increased, Metabolic function test, Pain, Troponin I
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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: 4/13/09: D Dimer: <200ng.ml (<230); Troponin I <0.010ng.ml; CK 40IU/L (30-200); CK-MB 0.3ng/ml (0-6.6); 4/13/09: CXR: no acute pulmonary disease identified; EKG: NSR. 4/17/09: Exercise Stress Test (Bruce): PMHR 97% (187), METS 18.2, 2 PVCs during recovery, Impression: neg.
CDC Split Type:

Write-up: Pt received SPV left arm on 4/4/09. On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10). He states that he felt like his heart rate was increased. He did not have SOB, N,V, diaphoresis, radiation of the pain. The pain was not affected by activity, position or deep breathing. Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes. Again, it was non positional, did not radiate, and the pt had no associated symptoms. He went to the VA ER on 4/13/09 where he had a negative work up and was discharged. The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable. Pt instructed to start taking MOTRIN 600mg qid with food. The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms: Chest Pain.


VAERS ID: 345303 (history)  
Age: 28.0  
Gender: Male  
Location: South Dakota  
Vaccinated:2009-04-27
Onset:2009-04-28
   Days after vaccination:1
Submitted: 2009-04-30
   Days after onset:2
Entered: 2009-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV164 / 2 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pain, Pyrexia, Vomiting
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Local site Reaction~Anthrax (Biothrax)~2~27.00~In Patient
Other Medications: Hydrocortisone Cream, Lisinopril, Atorvastatin
Current Illness: None
Preexisting Conditions: HTN, Hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, Chills, Bodyaches, Nausea, Vomitting, and local site reaction (redness, tenderness)


VAERS ID: 345305 (history)  
Age: 28.0  
Gender: Male  
Location: Texas  
Vaccinated:2009-04-28
Onset:2009-04-28
   Days after vaccination:0
Submitted: 2009-04-30
   Days after onset:2
Entered: 2009-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV171 / 7 RA / IM

Administered by: Military       Purchased by: Military
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)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: None
Preexisting Conditions: None, except patient has a hx of +reaction to TST (PPD) in the past; not under any treatment for TB or other illnesses at this time.
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Circumferential swelling and redness to right upper arm/deltoid, especially near area of vaccine administration, +pruritis, w/in the first 24hrs of vaccine administration. Symptoms subsiding by time of report. No medications given. No concurrent illnesses, other vaccines or other meds. Patient advised to avoid further anthrax boosters.


VAERS ID: 345341 (history)  
Age: 28.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2009-03-18
Onset:2009-03-18
   Days after vaccination:0
Submitted: 2009-04-21
   Days after onset:34
Entered: 2009-04-30
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Mobility decreased, Muscle injury, Muscle tightness, Nerve injury, Pain, X-ray
SMQs:, Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

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: 4/20/09- Had to see a specialist & he confirmed my pain is from the vaccination.
CDC Split Type:

Write-up: Unable to use my arm/shoulder, extreme pain & tightness. Unable to work due to some of the requirements of my job. I had X-rays taken & have been sent to physical therapy to try to repair the damage done to my muscle & nerve.


VAERS ID: 345575 (history)  
Age: 28.0  
Gender: Female  
Location: New York  
Vaccinated:2009-04-20
Onset:2009-04-23
   Days after vaccination:3
Submitted: 2009-05-04
   Days after onset:11
Entered: 2009-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3058AA / 0 LA / IM

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)

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:

Write-up: redness, pain and swelling at injection site


VAERS ID: 345615 (history)  
Age: 28.0  
Gender: Female  
Location: Maryland  
Vaccinated:2009-04-17
Onset:0000-00-00
Submitted: 2009-05-04
Entered: 2009-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 2 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. presented to GARDASIL clinic 7-22-08 to begin series. Completed series 4-17-09 after reporting LMP 3-26-09. Presented to health department for + pregnancy test 5-4-09.


VAERS ID: 345676 (history)  
Age: 28.0  
Gender: Female  
Location: California  
Vaccinated:2009-03-20
Onset:2009-03-20
   Days after vaccination:0
Submitted: 2009-04-27
   Days after onset:38
Entered: 2009-05-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVBB584AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Insomnia, Nausea, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVORA oral contraceptive
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Being followed at clinic
CDC Split Type:

Write-up: Pt reports 1 mo after receiving vaccine that beginning night of vaccination nausea and vomiting persisting X 2 weeks, SOB 24 hrs after vaccine, insomnia X 3 weeks and tremors lasting 30sec - 5 minutes during 3 weeks time. Sought tx at clinic at 3 weeks s/p vaccination. No tx provided.


VAERS ID: 345729 (history)  
Age: 28.0  
Gender: Female  
Location: New York  
Vaccinated:2009-03-13
Onset:2009-03-28
   Days after vaccination:15
Submitted: 2009-05-05
   Days after onset:38
Entered: 2009-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3068AA / - - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: 6/8/09 Hospital records and DC summary received DOS 4/03/09 to 4/17/09. Lyrica, Paxil, zolpidex, metoprolol, bactrim.
Current Illness: none
Preexisting Conditions: fibromyalgia. 6/8/09 Hospital records and DC summary received DOS 4/03/09 to 4/17/09. Anxiety and fibromyalgia. 6/9/09 ER records received DOS 4/3/09. Allergies to Cipro, prednisone. Panic attacks; fatigue; lupus. PPD (+).
Diagnostic Lab Data: unknown (done in Westchester Medical Ctr). 6/8/09 Hospital records and DC summary received DOS 4/03/09 to 4/17/09. LABS and DIAGNOSTICS: CBC - RBC 6.26 M/CM MM (H) HGB 15.1 g/dL H HCT 47.9% (H) MCV 76.5 fL (L) MCHC 31% (L). WBC 11.7 K/CU M (H) CHEM - ALT (SGOT) 27 U/L (H) Total Protein 9.2 g/dL (H) Albumin 5.9 g/dL (H) Glucose 117 mg/dL (H) Postassium 2.9 mEq/L (L) creatinine 0.5 mg/dL (L) Globulin 5.0 gm/dL (H). Urinalysis - Ketone 3+. Transthoracic Echocardiogram - WNL. Chest x-ray - bilateral opacities, atelectasis. Culture Urine - Escherichia Coli. Culture Respiratory (sputum) Staph Aureus. CSF - Protein 52 mg/dl (H) Protein Studies - IGA 326 mg/dL (H) Prothrombin Time 13.6 secs (H). EBV VCA IGG 5.62 (+) EBV Nuclear Antigen 4.91 (+). E
CDC Split Type:

Write-up: Guillain-Barre'' Syndrom 6/8/09 Hospital records and DC summary received DOS 4/03/09 to 4/17/09. Final Diagnosis: Guillain-Barre syndrome. Post vaccination transferred from another facility presenting with headache, photophobia, diplopia and generalized weakness. Complained of cervical pain, numbness and tingling in feet and hands. Areflexia. Trouble swallowing, facial diplegia, dysphonia. IVIg administered. Tachypneic. UTI. 6/9/09 ER records received DOS 4/3/09. Includes records of 2 prior visits to other urgent care centers. Assessment: Polyneuropathy, ascending weakness. Post vaccination presents to ER with headache, progressive weakness, double vision, head sensitive to touch, photophobia, nausea. Pain, ''pins and needles'' upper and lower extremities, unsteady gait, sensation decreased, DTRs decreased, patellar reflex absent. Symptoms worsening. UTI. Transfered to another hospital. 5/13/09 Rec PCP medical records of 3/13-4/3/09. Records reveal patient experienced nasal congestion, right eye tearing & tr urine protein on 3/13. RTC 4/3 w/weakness of LEs x few days, sent to ED for LP. 6/23/09 ICD-9 codes received. 3570


VAERS ID: 345991 (history)  
Age: 28.0  
Gender: Male  
Location: Georgia  
Vaccinated:2009-05-05
Onset:2009-05-05
   Days after vaccination:0
Submitted: 2009-05-08
   Days after onset:3
Entered: 2009-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF455BA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Allergy to vaccine, Dyspnoea, Pruritus, Urticaria, X-ray with contrast upper gastrointestinal tract
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Allergic reaction to ADACEL.
CDC Split Type:

Write-up: We gave him a shot by annual check up. And he had UGI. 90 minutes later after shot he start having hives, itchy, slight dyspnea. We brought him back to our office. Start O2 2l and call 911 to send him ER.


VAERS ID: 346933 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2009-02-23
Submitted: 2009-05-14
   Days after onset:79
Entered: 2009-05-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Incorrect route of drug administration, Injection site mass, Pain in extremity, Underdose
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMBALTA
Current Illness: Paroxysmal supraventricular Tachycardia; Latex allergy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0904USA03961

Write-up: Information has been received from a consumer a 28 year old nurse with latex allergy and a history of paroxysmal supraventricular Tachycardia (PSVT) who on 23-FEB-2009 was vaccinated with a first dose of GARDASIL (IM, dose and lot number not reported) and her second dose on 23-APR-2009 (0.5ml IM/SQ, lot number not reported). Concomitant therapy included CYMBALTA (manufacture unknown). No other vaccines was administered at the time of GARDASIL vaccinations. The patient mentioned, that she received a portion of her second dose of the vaccine subcutaneous instead of intramuscularly. The patient stated that when the nurse administered the vaccine there was a "giant lump on her arm and some of the vaccine leaked out" and the administering nurse pressed her arm so that the vaccine would be absorbed (on 23-APR-2009). She also mentioned that after of the first dose of the vaccine, she developed soreness to the muscle of the arm later that the evening lasted for 3 days (on 23-FEB-2009). She also mentioned that she began her GARDASIL series at the age of 28 years old. No treatment was sought or required. The patient indicated that she fully recovered. No additional information was available. Additional information has been requested.


VAERS ID: 346615 (history)  
Age: 28.0  
Gender: Male  
Location: New York  
Vaccinated:2009-05-19
Onset:2009-05-19
   Days after vaccination:0
Submitted: 2009-05-19
   Days after onset:0
Entered: 2009-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / IM
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Dizziness, Fall, Head injury, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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: Allergy to Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: First a feeling of nausia. Sycope within minutes of the injections. Fell and hit head. Regained consciousness within a few minutes under care of the doctor. Slightly light headed and weak the rest of the day. Loss of appetite.


VAERS ID: 346739 (history)  
Age: 28.0  
Gender: Male  
Location: Arizona  
Vaccinated:2009-05-11
Onset:2009-05-20
   Days after vaccination:9
Submitted: 2009-05-20
   Days after onset:0
Entered: 2009-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV 155 / - RA / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04-003A / - LA / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR B0424-2 / - RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Incorrect drug dosage form administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions:
Diagnostic Lab Data: Site check 6-10 days after administration to see viability of vaccine
CDC Split Type:

Write-up: Patient recieved smallpox vaccine that was reconstituted with sterile water instead of 50% glycerin, and 0.25% phenol in Sterile Water. Patient does not have any adverse reaction site looks within normal limits.


VAERS ID: 346760 (history)  
Age: 28.0  
Gender: Male  
Location: Texas  
Vaccinated:2009-05-14
Onset:2009-05-14
   Days after vaccination:0
Submitted: 2009-05-20
   Days after onset:6
Entered: 2009-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF456AA / - RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Chills, Myalgia, Pyrexia, Sinusitis
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Deviated septum; allergic rhinitis
Diagnostic Lab Data: I think he developed a sinus infection unrelated to TDap.
CDC Split Type:

Write-up: Fever, chills, muscle aches.


VAERS ID: 346764 (history)  
Age: 28.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2009-05-19
Onset:2009-05-19
   Days after vaccination:0
Submitted: 2009-05-20
   Days after onset:1
Entered: 2009-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3097AA / 1 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Oedema peripheral, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

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: None
CDC Split Type:

Write-up: Vomiting- (R) arm- swollen, unable to move. Numbness in fingers, swollen hand.


VAERS ID: 347423 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:1998-01-01
Onset:2008-01-01
   Days after vaccination:3652
Submitted: 2009-05-15
   Days after onset:499
Entered: 2009-05-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, Varicella zoster serology negative
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS ( LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: serum VARICELLA ZOSTER ?/?/08 - not have immunity to VARICELLA
CDC Split Type: WAES0812USA04107

Write-up: Information has been received from a consumer concerning a 28 year old daughter who 13 years ago (1993) was vaccinated with a dose of VARIVAX (Oka/Merck). In 2008 a VARICELLA titer showed that her daughter did not have immunity to VARICELLA. Patient was vaccinated with VARIVAX (Oka/Merck) 13 years before becoming pregnant. As of 18-DEC-2008 the outcome of the patient was unknown. Additional information has been requested.


VAERS ID: 347502 (history)  
Age: 28.0  
Gender: Female  
Location: Ohio  
Vaccinated:2008-12-22
Onset:2008-12-31
   Days after vaccination:9
Submitted: 2009-05-15
   Days after onset:134
Entered: 2009-05-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1659U / 0 UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Infection, Inflammation, 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)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0901USA01608

Write-up: Information has been received from a nurse concerning a 28 year old female with no allergy who on 22-DEC-2008 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot# 659723/1659U). On 31-DEC-2008, the patient was seen in the office with swelling and pain at the injection site. The patient was prescribed KEFLEX and ADVIL. In follow-up, the nurse indicated that the patient received the first dose of VARIVAX (Oka/Merck) IM (lot# 659723/1659U) into the deltoid on 22-DEC-2008. She began swelling and "hurting" on 31-DEC-2008 at site of injection. On 02-JAN-2009, the area was tender to touch with 1.5 area of raised, redness, warmth. The patient was prescribed KEFLEX 500mg daily for 7 days on 02-JAN-2009 for inflammatory versus infection. On 09-JAN-2009, the patient recovered. In follow-up, the reporting nurse stated that the patient''s adverse events were not serious enough to require medical or surgical intervention to prevent disability or death. None of the experiences should be considered other important medical events, as she misunderstood what this classification meant. Additional information is not expected.


VAERS ID: 347785 (history)  
Age: 28.0  
Gender: Female  
Location: North Carolina  
Vaccinated:1998-10-31
Onset:2007-08-16
   Days after vaccination:3211
Submitted: 2009-05-15
   Days after onset:638
Entered: 2009-05-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Serum varicella zoster, 08/16/07, less than 0.91
CDC Split Type: WAES0805USA04744

Write-up: Information has been received from a nurse practitioner concerning a 37 year old female who on 28-SEP-1998 was vaccinated with the first dose of VARIVAX (Merck) and on 31-OCT-1998 was vaccinated with the second dose of VARIVAX (Merck). The patient had a negative titer on 16-AUG-2007 (less than 0.91, no units specified). No problems reported. It was not reported if the patient sought medical attention. Additional information has been requested.


VAERS ID: 347566 (history)  
Age: 28.0  
Gender: Female  
Location: California  
Vaccinated:2009-05-26
Onset:2009-05-27
   Days after vaccination:1
Submitted: 2009-05-27
   Days after onset:0
Entered: 2009-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B0475 / - LA / SC
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2820AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Joint range of motion decreased
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ortho tri-cyclen lo
Current Illness: fatigue due to undiagnosed condition
Preexisting Conditions: none
Diagnostic Lab Data: 5/29/09 Medical records received DOS 5/27/09. LABS and DIAGNOSTICS: CBC WNL. CHEM WNL. TSH WNL.
CDC Split Type:

Write-up: paresthesias of bilateral feet and lower legs, bilat forearms, R hand and inability to fully extend R index finger; started the morning after the vaccine; states she also feels weak; advised observation. 5/29/09 Medical records received DOS 5/27/09. PRIMARY DIAGNOSIS: Vaccines Allergic Reaction Post Vaccination - Woke up next morning with tingling in right hand, bilateral legs from knees down, and bilateral forearms. Arms and legs weak, difficult to walk. Finger nails are tender. Pain in index finger - cannot straighten. Substernal chest soreness.


VAERS ID: 347589 (history)  
Age: 28.0  
Gender: Female  
Location: Florida  
Vaccinated:2009-04-29
Onset:2009-05-01
   Days after vaccination:2
Submitted: 2009-05-27
   Days after onset:26
Entered: 2009-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B031AB / - RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Blood test, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ; FIORICET; Prenatal vitamins
Current Illness: LACTATION
Preexisting Conditions: MIGRAINE; The subject''s alcohol use was social and she was a non-smoker.
Diagnostic Lab Data: Blood work to test for rheumatoid arthritis may have been performed. A biopsy was not done.
CDC Split Type: A0783241A

Write-up: This case was reported by a healthcare professional and described the occurrence of joint pain in an adult female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of BOOSTRIX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced joint pain. The subject was seen by her primary care physician. At the time of reporting the outcome of the event was unspecified. Follow-up received from reporting healthcare professional on 22 May 2009: The subject was 28-years-old. The subject''s alcohol use was social and she was a non-smoker. Past medical history included migraines. Concurrent medications included Yaz, Fioricet and Prenatal vitamins (for lactation). On 29 April 2009, the subject received a dose of BOOSTRIX (0.5 mL, intramuscular, left deltoid). Two days after vaccination with BOOSTRIX, the subject experienced joint pain and redness at injection site. It was reported that blood tests may have been performed for possible rheumatoid arthritis. This case was assessed as medically serious by GSK. The outcome of the events was unknown. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. The healthcare professional considered that the events could also have been associated with medical history or a concurrent condition, and the subject''s physician was performing tests for rheumatoid arthritis.


VAERS ID: 348234 (history)  
Age: 28.0  
Gender: Female  
Location: California  
Vaccinated:2009-05-05
Onset:2009-05-05
   Days after vaccination:0
Submitted: 2009-05-07
   Days after onset:2
Entered: 2009-06-01
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 01144 / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 02194 / 0 RA / SC

Administered by: Other       Purchased by: Public
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tramaedol; Seroquel; Levothyroxine
Current Illness: None
Preexisting Conditions: Mild heart murmur; Migraines
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pain and area of redness over the skin at the site of injection 7 1/2 x 4 cm. No further reported problems as of 5/26/09.


VAERS ID: 348783 (history)  
Age: 28.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2009-06-04
Onset:0000-00-00
Submitted: 2009-06-04
Entered: 2009-06-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB583AA / - LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

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:

Write-up: None Stated


VAERS ID: 348961 (history)  
Age: 28.0  
Gender: Female  
Location: Georgia  
Vaccinated:2009-06-08
Onset:2009-06-09
   Days after vaccination:1
Submitted: 2009-06-11
   Days after onset:2
Entered: 2009-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0398X / 0 LA / IM
MM: MEASLES + MUMPS (MM-VAX) / MERCK & CO. INC. 1580X / - LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Glossitis
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: client received vaccines MMR, and Hep. B. on Monday 06/08/2009. Called today.Stated on Tues night tongue became sore and swollen. Still sore and swollen today. Took Benadryl yesterday. Advised client to take more Benadryl if needed and if tongue swells any more or if client experiences any difficulty breathing to go to ER immediately.


VAERS ID: 348972 (history)  
Age: 28.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2009-06-09
Onset:2009-06-10
   Days after vaccination:1
Submitted: 2009-06-11
   Days after onset:1
Entered: 2009-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0998X / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo Provera
Current Illness: None
Preexisting Conditions: Sickle Cell Trait
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 55 X 60 mm area of induration, warm to touch, erythematous


VAERS ID: 349030 (history)  
Age: 28.0  
Gender: Male  
Location: California  
Vaccinated:2009-05-15
Onset:2009-05-25
   Days after vaccination:10
Submitted: 2009-06-12
   Days after onset:18
Entered: 2009-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0487X / 0 LA / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site rash, Rash maculo-papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported.
Preexisting Conditions: None reported.
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Individual developed a maculopapular rash at the varivax injection site, on 5/25/2009.


VAERS ID: 349063 (history)  
Age: 28.0  
Gender: Female  
Location: Oregon  
Vaccinated:2009-06-12
Onset:2009-06-12
   Days after vaccination:0
Submitted: 2009-06-12
   Days after onset:0
Entered: 2009-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR U2883AA / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Chest discomfort, Nausea, Pallor, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

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:

Write-up: Tightness, in chest, pale, warm, nauseated. Cold packs were applied, she denied any difficulties breathing and recovered completely within a few minutes.


VAERS ID: 349399 (history)  
Age: 28.0  
Gender: Male  
Location: Oregon  
Vaccinated:2009-06-16
Onset:2009-06-16
   Days after vaccination:0
Submitted: 2009-06-17
   Days after onset:1
Entered: 2009-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB140AA / 2 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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: NONE
CDC Split Type:

Write-up: Patient was administered vaccine. Patient then began to have a vasovagal syncope reaction. Patient was immediately given oxygen. Patient was layed in the prone position with feet elevated and a cold compress a applied to the forehead. Vitals were constatntly monitored. Patient was stable and recovered quickly.


VAERS ID: 349412 (history)  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:1998-11-25
Onset:0000-00-00
Submitted: 2006-10-27
Entered: 2009-06-17
   Days after submission:964
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV048B / - UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Cognitive disorder, Computerised tomogram normal, Disturbance in attention, Fatigue, Headache, Insomnia, Libido decreased, Memory impairment, Neuropathy peripheral, Night sweats, Nodule, Nuclear magnetic resonance imaging abnormal, Pyrexia, Radiculopathy, Ultrasound scan normal
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: None 8/24/09 Medical records received w/PMH: lactose intolerance. Allergy: codeine (rash).
Diagnostic Lab Data: 8/24/09 Medical records received w/LABS: CT sinus c/w chronic sinus disease. CT chest c/w pulmonary nodules. CT abdomen WNL. Polysomnogram WNL. EMG/NCS WNL. MRI brain WNL. MRI c-spine w/degenerative changes C6-7.
CDC Split Type:

Write-up: Description: Had febrile illness within 24 hours for both vaccines. 1st episode required hospitalization. Developed chronic headaches after 2000 dose and also chronic fatigue, arthralgias. This developed into full CFS that has persisted to the present. See full summary. Symptom: Joint Pain, multiple joints. Symptom: Headache, general. Symptom: Insomnia. Symptom: Fatigue. Symptom: Cognitive deficiency. Symptom: Neuropathy. 08/24/09 Received medical & vaccine records. FINAL DX: chronic fatigue syndrome Records reveal patient experienced the following after the initial anthrax vaccine & aggravation of symptoms after subsequent vaccinations: alterations in memory, difficulty concentrating, muscle cramps, joint pain, chronic fatigue, paresthesias of left arm/leg, sleep disturbance, decreased sexual drive, erectile dysfunction, intermittent blurred vision, migraine HA, intermittent tinnitus, alternating constipation & diarrhea, pulmonary nodules, chronic rhinitis, C6 radiculopathy, chills, night sweats, extreme fatigue, . Multiple consults done. Follow-up: Was still symptomatic as of December 08 but have lost contact now.


VAERS ID: 349436 (history)  
Age: 28.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2004-08-27
Onset:0000-00-00
Submitted: 2005-03-15
Entered: 2009-06-17
   Days after submission:1554
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / - UN / SC
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS ENG5595B6 / - UN / IM
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arrhythmia, Axillary pain, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood electrolytes normal, Catheterisation cardiac abnormal, Chest discomfort, Chest pain, Differential white blood cell count normal, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Full blood count normal, Heart rate decreased, Intensive care, Myocardial infarction, Myocarditis, Neck pain, Troponin increased, Ultrasound Doppler abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Pt. Denies
Diagnostic Lab Data: 08/27/2004, EKG, NSR with left axis deviation; Echo, Borderline LV size with normal wall thickness and contractility. The estimated EF is 55%. Inferior/posterior basal non-borderline contractility, Normal valvular structure and movement, No atrial septal defect, Doppler shows mild mitral regurgitation, trace tricuspid regurgitation and pulmonary insufficiency; Cardiac Cath, normal coronary anatomy, normal left ventricular function, EF 54%; 08/28/04, EKG, Arrhythmias with brady rate (44-50); Labs: 8/27 at 1001, CBC with diff, lytes, WNL; CK-MB, 49.49; Troponin, 0.382; 8/27 at 1133; CK, 476; CK-MB, 22.6; Relative index, 4.7; 8/27 at 1410, CK, 530 CK-MB, 53.9 %; MB, 10.2; 8/27 at 2050, CK, 416, CK-MB, 36.3, %; MB, 8.7; 10/28 at 0718, Troponin,
CDC Split Type:

Write-up: 08/17/04 - received smallpox vaccine on his left upper arm (3 jabs)- denies any problems. 08/27/04 - onset 0600 while sleeping - bilat chest pain ("dull pressure-like" 5/10) radiating to bilat neck and bilat axillaries (did not radiate down to arms) - constant pain and pressure - denies SOB, palpitations, diaphoresis, or n/v - not pleuritic or positional- Pt. presented himself to ER - pain relieved with GI cocktail - Pt. given dx of "non ST segment elevation MI"-Pt. transferred from ER to ICU 08/28/04 - no cardiac sx''s during hospitalization - Pt. discharged from hospital in stable condition. 09/07/04- Pt. placed on temp medical suspension for two months (due to Pt. taking Cardizem). 09/27/04 - states had f/u appt. with Doctor, MD- states all his cardiac meds d/c''ed- no lab/ diagnostic tests ordered by Cardiologist. 10/15/04- patient seen by PCM-"Patient not fit to perform military duties (flight) from 10/15/04 to indefinite pending further notice and AMS" 10/19/04- "Patient deemed to be medically unfit for deployment. 10/26/04- Pt''s medical documentation received from MD. 10/28/04- Pt. seen in the clinic by his case manager- states has not had any cp or other cardiac sx''s since discharge from the hospital - letter sent to Dr. recommending 6wks cardiac f/u for Pt.- Pt. currently on med hold-scheduled to deploy in near future- Pt. would like to deploy ASAP. 11/01/04 - walk in received a copy of immunization record from Pt-copy of letter written to Doctor given to pt.- states has cardiology appt. in Dec 04 - importance of cardiac f/u reinforced - will reevaluate pt''s status after results obtained. 11/02/04- spoke with pt''s Case Manager, via phone- above plan of care reviewed. Symptoms: Chest pain start: 08/27/2004. END: 08/27/2004. Symptoms: Chest Heaviness Start 08/27/2004. END: 08/27/2004. 6/23/09 Medical records recieved DOS 8/17/04 11/28/04 Assessment: Probable acute myocarditis temporally associated with the receipt of the smallpox vaccine. Patient presented with bilateral (dull pressure like) chest pain radiating to bilat neck bilat axillaries. ICD-9 Codes: 272.4 Hyperlipidemia


VAERS ID: 349804 (history)  
Age: 28.0  
Gender: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-29
Entered: 2009-06-17
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, Laboratory test normal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory, ?/?08, titers were equivocal; diagnostic laboratory, 80?, titers were equivocal
CDC Split Type: WAES0804USA02851

Write-up: Information has been received from a physician concerning an approximately 28-year-old female with no medical history or allergies who as a child was vaccinated SC with the first dose of MMR. There was no concomitant therapy. Titers were listed as equivocal. In approximately 2003, the patient was vaccinated SC with a booster dose of MMR. There was no concomitant therapy. In 2008 the patient''s titers were also listed as equivocal. At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 350187 (history)  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-29
Entered: 2009-06-17
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA00612

Write-up: Information has been received from a nurse concerning an approximately 28 year old male student who was possibly vaccinated with MMR II and had negative titers for one of the components of MMR II. He did, however, had titers for the other two components. It was unknown which specific component was negative. The patient thought he had received one dose of MMR II but he had no documentation. Titers for measles, mumps and rubella immunity were performed. At time of the report the outcome of the patient was unknown. It was unknown if the patient sought medical attention. No further information is available.


VAERS ID: 350198 (history)  
Age: 28.0  
Gender: Female  
Location: Louisiana  
Vaccinated:1981-09-10
Onset:0000-00-00
Submitted: 2009-05-29
Entered: 2009-06-17
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: serum measles Ab, 0.98, negative; serum rubella IgG, positive; serum mumps Ab, positive
CDC Split Type: WAES0902USA02792

Write-up: Information has been received from a registered nurse concerning a 27 year old female who in 1981 was vaccinated with a first dose of MMR II, in 1997 was vaccinated with a second dose of MMR II and in 2006 was vaccinated with a third dose of MMR II. The patient has negative measles titer even after receiving 3 doses of MMR II. The patient has positive titer for rubella and mumps. No adverse effect reported. Follow up information was received. It was reported 28 year old (previously reported as 27 year old) female who was not a smoker was vaccinated with a first, second and third dose of MMR II on 10-SEP-1981, 20-JUN-1997 and 11-AUG-2006 respectively. The patient''s rubeola titer was 0.98 (equiv. result). No further information was available.


VAERS ID: 349670 (history)  
Age: 28.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2009-06-17
Onset:2009-06-18
   Days after vaccination:1
Submitted: 2009-06-22
   Days after onset:4
Entered: 2009-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3098AA / 0 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Influenza like illness, Injection site pain, Injection site rash, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

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:

Write-up: The morning after receiving the vaccine (06/18/2009) she woke up with severe body aches, felt like the flu, and Rt. deltoid warm and tender to the touch. The next day she noticed a raised rash distal to the injection site on the deltoid and still warm to the touch for three days following that. All symptoms gone as of 06/21/2009


VAERS ID: 350026 (history)  
Age: 28.0  
Gender: Female  
Location: Washington  
Vaccinated:2009-06-07
Onset:2009-06-16
   Days after vaccination:9
Submitted: 2009-06-24
   Days after onset:8
Entered: 2009-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV193 / 1 UN / UN
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER VV04003A / 1 RA / ID

Administered by: Military       Purchased by: Military
Symptoms: Antibody test positive, Herpes simplex serology negative, Lymphadenopathy, Rash erythematous, Rash maculo-papular, Rash pruritic, Skin hyperpigmentation
SMQs:, Anaphylactic reaction (broad), Vasculitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: oral contraceptives
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: 6/17/2009, HSV1/2 IgM/G both negative; VSV Ab, immune
CDC Split Type:

Write-up: 28 y/o female who presented as walk-in to clinic reporting development of itchy red rash over bilateral hands evening of 6/16/2009; possibly spreading up right forearm today. Received AVA#2 & repeat SPV (right deltoid) 6/7/2009. Initial SPV given 5/2/2009 resulted in equivocal take. She denied fever, chills, systemic symptoms; was well prior to & day of vaccinations; denied sick contacts, other environmental exposures, no prior hx eczema, atopic dermatitis, immunosuppression, or HSV; is otherwise well, not on medications; no known allergies to drugs, foods, latex, insect stings; she has had natural VZV infection in childhood. Pt was seen 6/17/2009 with non-urticarial patchy maculopapular rash over bilateral dorsal surfaces hands with faint erythema on palms, no vesicles; SPV site right deltoid consistent with major take/scab, no surrounding erythema, edema, or satellites, mild right axillary lymphadenopathy; treated with antihistamine & noted dramatic improvement within 24 hrs later. On 6/18 she reported similar but milder eruptions over bilateral dorsal feet & lateral ankles, but completely resolved by 6/19; as of 6/19 she reported mild hyperpigmentation over dorsal hands only - palms clear; no new eruptions; as of 6/23, no recurrence.


VAERS ID: 350992 (history)  
Age: 28.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2009-05-05
Onset:2009-05-08
   Days after vaccination:3
Submitted: 2009-07-08
   Days after onset:61
Entered: 2009-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF471BA / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Blood electrolytes normal, Blood glucose normal, Chest X-ray normal, Dizziness, Full blood count normal, Liver function test normal, Loss of consciousness, Muscle spasms, Myalgia, Nausea, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia, Pyrexia, Red blood cell sedimentation rate normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: We arranged for her to have a left brachial plexus MRI performed. This showed a mild localized superficial bone marrow edema in the posterolateral aspect of the left humerus, swelling of the overlying soft tissues. This is most consistent with a localized inflammatory process. There is slightly increased fluid involving the subdeltoid bursa. There is no denervation, edema, or atrophy in the rotator cuff or the deltoid muscles. A chest x-ray was unremarkable. Her CBC, sedimentation rate, electrolytes, glucose, and LFTs were unremarkable.
CDC Split Type:

Write-up: She is a 28-year-old intern in biostatistics who is here with left upper extremity pain, post a TDAP shot that she got on May 5. She had just arrived, was working in Biostatistics as a summer intern, and had that shot given to her here in the left deltoid. Over the next few days, she had a lot of muscle aches that involved the upper left arm. Occasionally she would get lancinating sharp stabbing pains into her hands and her forearm. This pain in the arm went on, fairly severe and uncomfortable for about a week. About five to seven days into this she developed a fever, lightheadedness, nausea. This lasted for two or three days. The episodes of lightheadedness were where she would pass out. She was nauseated. That would last for 30 minutes or so and then get a little better but then come back, and this happened about four or five times per day for the two or three days that she had that. Then, the lightheadedness, fever, nausea passed, and she felt better. Associated with that lightheadedness she had a cramping pain several times a day that involved her left leg. About a week after the shot she felt that her left arm became weak. She noted that the pain changed. Rather than there being a constant pain she would notice pain when she would move the arm. When she would abduct her arm at the shoulder she would notice pain. She developed some symptoms in her left leg, some prickling and tingling in the left foot, but more of a cramping pain in the left calf that came several times over the two or three days that she had the fever-type of symptoms. Then, the lower limb symptoms subsided, and now she feels that she has some ongoing weakness in the left arm. She has a hard time pulling a door open. She has a hard time reaching over her arms. When she does these things, she gets pain in the upper arm, so it is not entirely clear if she is weak or whether it just hurts her to do these things. Her hands have been okay. She has no symptoms in the right upper extremity. She has no other symptoms in her lower extremities. She was seen by Dr., who discussed her case with me.


VAERS ID: 351199 (history)  
Age: 28.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2009-07-07
Onset:2009-07-07
   Days after vaccination:0
Submitted: 2009-07-13
   Days after onset:6
Entered: 2009-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C309744 / - RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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:

Write-up: c/o soreness of R arm, mild swelling near injection site, chills, sweats, body aches, nausea, mild erythema at injection site. Seen in clinic 7/9, vac administered R deltoid on 7/7. Rec. Tylenol or motrin, ice pack to arm, phenergan 25 mg po every 6 hrs prn nausea. Pt called back on 7/10, said feeling much better.


VAERS ID: 351205 (history)  
Age: 28.0  
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2009-06-30
Submitted: 2009-07-13
   Days after onset:13
Entered: 2009-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

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:

Write-up: Patient reports having an MMR vaccine 90 days before conception of pregancy. No complications from the vaccine were reported. Fetal sonogram detected a unilateral absent hand at 20 weeks gestation.


VAERS ID: 351307 (history)  
Age: 28.0  
Gender: Female  
Location: Nevada  
Vaccinated:2009-06-13
Onset:2009-06-15
   Days after vaccination:2
Submitted: 2009-06-25
   Days after onset:10
Entered: 2009-07-14
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2888AA / 0 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Headache, Induration, Joint swelling, Lymph node pain, Lymphadenopathy, Memory impairment, Pain, Swelling, Thinking abnormal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Current Metoporal 50 mg; Flonase
Current Illness:
Preexisting Conditions: Hypertension
Diagnostic Lab Data: Reviewed by Doctor at Hospital
CDC Split Type:

Write-up: Shot Saturday, swollen knot on right wrist Monday - painful. Swollen clavicular node and cervical nodes Wednesday- painful (Right). Swollen tissue in right shoulder and chest. Headaches almost everyday clouded thinking and slowed memory function.


VAERS ID: 351846 (history)  
Age: 28.0  
Gender: Female  
Location: Texas  
Vaccinated:2008-04-21
Onset:2008-04-21
   Days after vaccination:0
Submitted: 2008-09-09
   Days after onset:141
Entered: 2009-07-14
   Days after submission:308
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB448AA / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2899A / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lithium, LOMENTIL
Current Illness:
Preexisting Conditions: History of sulfa drug allergy and bipolar disorder. The patient had not received any other vaccines during the four weeks prior to receipt of ADACEL and Hepatitis B vaccines.
Diagnostic Lab Data:
CDC Split Type: 200801962

Write-up: This non-serious case was received from a health professional on 11 June 2008. A 29-year-old female patient, with a history of sulfa drug allergy and bipolar disorder, received an intramuscular left deltoid injection of ADACEL (lot number not known) on 21 April 2008. The same day, she also received an intramuscular right deltoid injection of Hepatitis B (manufacturer and lot number not known). Approximately 24 hours after vaccination, the patient complained of left shoulder pain. Three days later, the pain intensified, and at the time of the report was still ongoing. The patient had undergone unspecified testing, the results of which were not known by the reporter. She had been referred to an occupational medicine clinic for additional evaluation. Follow-up information was received 09 September 2008 from a health care professional. The patient had been vaccinated during a new hire physical and had received ADACEL, lot number C2899AA (expiration 09 May 2010) and a sixth dose of Hepatitis B, lot number AHBVB448AA (expiration 24 January 2010. The patient had not received any other vaccines during the four weeks prior to receipt of ADACEL and Hepatitis B vaccines. No additional information was provided at the time of the report.


VAERS ID: 351881 (history)  
Age: 28.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2009-03-30
Onset:2009-04-06
   Days after vaccination:7
Submitted: 2009-04-23
   Days after onset:17
Entered: 2009-07-14
   Days after submission:82
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1648X / - LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2844A / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3065 / - RA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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: not reported.
CDC Split Type: 200901491

Write-up: This non serious case was received on 06 April 2009 from a health care professional. A 28 year old female patient received ADACEL (lot number C3065, US lot number U2078CA), MENACTRA (lot number U2844AA) and RECOMBIVAX HB (manufacturer Merck, lot number 1648X) on 30 March 2009 at 4:00 PM. On 06 April 2009 at 3:15 PM the patient developed a 5.5 x 4.5 cm red, warm area with 2 cm indurated area to the right deltoid 10 cm below shoulder which was tender to touch. The patient was instructed to return to the office to visit with nurse practitioner, however the patient did not return. The recovery status was not known. List of Documents held by Sender: none.


VAERS ID: 351963 (history)  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:2008-09-23
Onset:2008-09-23
   Days after vaccination:0
Submitted: 2008-09-29
   Days after onset:6
Entered: 2009-07-14
   Days after submission:288
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0273 / - RA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2927A / - LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin; TUBERSOL
Current Illness:
Preexisting Conditions: No medical conditions. No known allergies. No illness at time of vaccination. No other vaccines given within the previous four weeks.
Diagnostic Lab Data: None.
CDC Split Type: 200802995

Write-up: A 28 year old male patient, with no medical history, received on 23 September 2008 a 0.5 ml right deltoid injection of IPOL (lot number "A0273"), a 0.5 ml left deltoid injection of ADACEL (lot number C2927AA), and a 0.1 ml left arm injection of TUBERSOL (lot number not reported). On the day of vaccination, the patient developed redness, swelling, firmness and itchiness at the right deltoid injection site. Corrective treatment was not reported. The patient had no illness at time of vaccination. Concomitant medication was a daily multivitamin and the patient received no other vaccines within the previous four weeks. At the time of the report, 26 September 2008, the patient had not recovered.


VAERS ID: 351418 (history)  
Age: 28.0  
Gender: Male  
Location: Virginia  
Vaccinated:2009-06-25
Onset:2009-07-03
   Days after vaccination:8
Submitted: 2009-07-06
   Days after onset:3
Entered: 2009-07-15
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / - LA / OT

Administered by: Military       Purchased by: Military
Symptoms: Blister, Cellulitis, Chills
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: No illness
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Chills x 3 days ago. Cellulitis 6.5 cm surrounding blister. Doxycycline 100mg 2X a day.


VAERS ID: 351627 (history)  
Age: 28.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2009-07-09
Onset:2009-07-13
   Days after vaccination:4
Submitted: 2009-07-15
   Days after onset:2
Entered: 2009-07-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB100AA / - UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / - UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR B0706 / - UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Cardiac enzymes normal, Chest pain, Decreased appetite, Dehydration, Diarrhoea, Dizziness, Fatigue, Full blood count normal, Laboratory test normal, Malaise
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D-Calcium Complex twice daily
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC, negative; CHEM 20, negative; Cardiac enzymes, negative
CDC Split Type:

Write-up: 28 y/o male ADSM is referred from a research site with c/o recent diarrhea, decreased appetite, dehydration and chest pain. Symptoms: Dizziness, chest pain, diarrhea, fatigue, malaise <60 days.


VAERS ID: 351707 (history)  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-13
Entered: 2009-07-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Body temperature increased, C-reactive protein increased, Chest X-ray normal, Chest pain, Chills, Echocardiogram normal, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Malaise, Myalgia, Myopericarditis, Pleuritic pain, Pyrexia, Rash, Rash pustular, Red blood cell sedimentation rate increased, Troponin I increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history not reported
Diagnostic Lab Data: temperature on initial evaluation in the Emergency Room: 39.2 degrees Celsius; Initial troponin I: 0.16 mg/dL; CK and CK-MB: both normal; ECG: diffuse concave ST elevation that was consistent with generalized epicardial injury; Troponin I eight hours post admission: 0.63 mg/dL; ECHO: normal left and right ventricular function with ejection fraction of 60%; no pericardial effusion; sedimentation rate: 30 mm/hr; C-reactive protein: 8.6 mg/dL; chest x-ray: normal
CDC Split Type: 200903015

Write-up: A 28-year-old male patient received vaccination with smallpox vaccine on an unknown date. The manufacturer and lot number of the vaccine were not reported in the literature reference nor was the date of vaccination. Fourteen days post-vaccination the patient presented to the emergency room with a four day history of chest pain described as positional, pleuritic, nonexertional and progressive, malaise, myalgias, fever and shaking chills. The symptoms became progressively worse over the following three days and the patient was admitted to the hospital with a suspected diagnosis of myopericarditis. On initial evaluation the patient was febrile with a fever of 39.2 degrees Celsius and had otherwise normal vital signs, cardiovascular examination and lung auscultation. The skin exam revealed acne scattered pustules on the scalp and upper back which the patient reported started a few days after vaccination. Initial laboratory data was remarkable for Troponin I of 0.16 mg/dL with normal creatine kinase (CK) and CK-MB. Electrocardiogram demonstrated diffuse concave ST elevation that was consistent with generalized epicardial injury. The patient was treated with nonsteroidal anti-inflammatory drugs and the pain did not worsen. A second set of Troponin I eight hours after admission was 0.63 mg/dL. An echocardiogram demonstrated normal ventricular function and no pericardial effusion. Chest x-ray was normal. Sedimentation rate was 30 mm/hr and C-reactive protein was 8.6 mg/dL. The patient was discharged after 24 hours and one week later was asymptomatic. A repeat electrocardiogram was remarkable for resolution of the diffuse ST elevation seen on admission and new T-wave inversions that were consistent with resolving pericarditis. No other information was provided. List of documents held by sender: None.


VAERS ID: 351766 (history)  
Age: 28.0  
Gender: Male  
Location: Alabama  
Vaccinated:2009-07-10
Onset:2009-07-10
   Days after vaccination:0
Submitted: 2009-07-16
   Days after onset:6
Entered: 2009-07-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0265X / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR UE111AA / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B031AB / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0052Y / 4 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Body temperature increased, Chills, Fatigue, Orthostatic intolerance, Tremor, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: Patient had urinalysis test conducted.
CDC Split Type:

Write-up: Pt recieved four shots right arm (Meningococcal, TDaP, MMR, and Varicella). Had Hyperimmune response with shaking, chills, and temp of 100.6. Pt refused IV fluids. Brought back to the clinic and found to have a temp of 103.1 and positive orthostasis. Given 1 gm of IM Rocephin, medrol dose pack, prn tylenol, po bactrim, cool compresses, quarters for 24 hours. Pt stated he feel better, but still has mild fatigue and chills, but temp improved to 99.3.


VAERS ID: 352463 (history)  
Age: 28.0  
Gender: Female  
Location: Ohio  
Vaccinated:2009-07-14
Onset:2009-07-14
   Days after vaccination:0
Submitted: 2009-07-22
   Days after onset:8
Entered: 2009-07-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF / 0 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Asthenia, Body temperature increased, Chills, Computerised tomogram, Dysgraphia, Hypoaesthesia, Laboratory test, Lumbar puncture, Nasopharyngitis, Nuclear magnetic resonance imaging, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Hypothyroidism
Diagnostic Lab Data: MRI; CAT Scan; Labwork; Spinal Tap
CDC Split Type:

Write-up: Initially cold, chills, achy, arm pain T 99.4. By 7/16/09 progressive loss of strength both arms T increase 100.4. Saw MD 7/17/09 sent pt to ER for testing CT, X-Rays, MRI, Spinal Tap, Labwork all testing inconclusive yet numbness and weakness persisted. By 7-22-09 hands improved some difficulty writing yet seems to be resolving.


VAERS ID: 352742 (history)  
Age: 28.0  
Gender: Male  
Location: Virginia  
Vaccinated:2009-07-27
Onset:0000-00-00
Submitted: 2009-07-27
Entered: 2009-07-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB583AA / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

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:

Write-up: None Stated


VAERS ID: 352818 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-09-20
Onset:2006-09-20
   Days after vaccination:0
Submitted: 2009-07-23
   Days after onset:1037
Entered: 2009-07-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV107 / - UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OCPs
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: SM developed redness, swelling, pain, induration at site of ANTHRAX injection. Symptoms resolved within 72 hrs. Symptoms: Erythema, Edema @ injection site 30-50 mm, Swelling, Pain.


VAERS ID: 353068 (history)  
Age: 28.0  
Gender: Female  
Location: Arizona  
Vaccinated:2009-07-28
Onset:2009-07-29
   Days after vaccination:1
Submitted: 2009-08-03
   Days after onset:5
Entered: 2009-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1677X / 2 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cough, Nasal congestion, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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: Mild ulcerative colitis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Had sore throat nasal congestion cough with mid epigastric pain - pain for 2 days - sore throat 2 days - nasal congestion cough persist.


VAERS ID: 353187 (history)  
Age: 28.0  
Gender: Male  
Location: Delaware  
Vaccinated:2009-08-01
Onset:2009-08-01
   Days after vaccination:0
Submitted: 2009-08-05
   Days after onset:4
Entered: 2009-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV217 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain upper, Asthenia, Cold sweat, Feeling hot, Haematemesis, Headache, Insomnia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: 8/24/09-records received- Labs WNL. ALT 108 and AST 41, A/G ratio 1:1, lymphocyte % 63.3.
CDC Split Type:

Write-up: I received an anthrax shot at 0830 on 01AUG09. As lunch time drew near, I began getting a terrible headache. I ate lunch and the headache persisted. I then started to have stomach pain and broke into a cold sweat. At 1530, I drove home and vomited violently. I noticed blood in the vomit. After vomiting again, my wife drove me to the hospital. I vomited again 3 hours later. I spent the night in the hospital on an I.V. I was not able to attend my drill on Sunday due to doctor''s orders. I was also extremely weak from the vomiting and lack of sleep. I was in drill status on 01AUG09 when the incident occurred. I am still quite weak today, 04AUG09. In addition, on 01AUG09, I had a physical fitness test immediately before receiving the anthrax shot. I was still hot and sweating. 8/25/09-ED records received for DOS 8/1/09-DX-Headache, vomiting. C/O headache, vomiting, feeling dizzy. 9/28/09 ICD9 codes received: 784.0, 787.03, E948.8


VAERS ID: 353242 (history)  
Age: 28.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2009-07-27
Onset:2009-07-28
   Days after vaccination:1
Submitted: 2009-08-05
   Days after onset:8
Entered: 2009-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF471BA / - LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Erythema, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Redness to upper arm fever 102 degrees-103.9 for 3 days pain in upper arm. Took TYLENOL and BENADRYL.


VAERS ID: 353245 (history)  
Age: 28.0  
Gender: Female  
Location: Texas  
Vaccinated:2009-08-05
Onset:2009-08-05
   Days after vaccination:0
Submitted: 2009-08-05
   Days after onset:0
Entered: 2009-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U2591DA / - RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blood glucose increased, Blood pressure increased, Chills, Drug exposure during pregnancy, Dyspnoea, Muscle rigidity, Pain in extremity, Paraesthesia, Speech disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness:
Preexisting Conditions: NKA
Diagnostic Lab Data: BP, 130/88; RBS, 120; Temp 98 degrees; NST reactive
CDC Split Type:

Write-up: 28 yo girl presented to clinic at 4:05 pm stating began feeling tingling over all of body, difficulty speaking, chills, pain to bilateral hands since 3:00pm. Pregnant 33 weeks. ENC-09/20/09. While at clinic, pt began to be unable to speak. Continued pending to hospital. Well, difficulty forming words, began with difficulty breathing arms became very rigid, Also hands very rigid. Pt denied pain. No pain to vaccine site. Pt was placed on NST (non stress test) which showed baby reactive with FHR 150''s. Pt was transported to VRMC via ambulance at 4:30pm


VAERS ID: 353278 (history)  
Age: 28.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2009-07-23
Onset:2009-07-24
   Days after vaccination:1
Submitted: 2009-07-27
   Days after onset:3
Entered: 2009-08-06
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3249AA / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Full blood count normal, Headache, Influenza serology negative, Injection site pain, Muscular weakness, Nausea, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC = normal; Influenza A + B = negative
CDC Split Type:

Write-up: Chills, muscle weakness, body aches, fever, soreness at injection site, headache and nausea reported by patient. Onset of S/S 24 hours after administration per patient evaluated at Urgent care clinic on 7-25-09.


VAERS ID: 353653 (history)  
Age: 28.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-09-02
Onset:2008-09-02
   Days after vaccination:0
Submitted: 2009-07-30
   Days after onset:331
Entered: 2009-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Erythema, Incorrect route of drug administration, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: diabetes; Osteomyelitis; Anxiety disorder; Hospitalisation; Diarrhoea; Vomiting; Dehydration
Preexisting Conditions:
Diagnostic Lab Data: total blood O2, 09/02/2008, 90%
CDC Split Type: WAES0809USA00337

Write-up: Information has been received from a pharmacist concerning a 28 year old female patient with diabetes, osteomyelitis and anxiety disorder who on 02-SEP-2008, while hospitalized for vomiting, diarrhea and dehydration was vaccinated with a dose of PNEUMOVAX (lot # not provided) by the intravenous route. After the PNEUMOVAX was given IV the patient had a red face, her oxygen went down to 90% and she developed chest pain. At the time of the report the patient had not recovered. The pharmacist reported that the patient''s hospitalization was not prolonged because of her reaction to PNEUMOVAX vaccine. No further information is available. Additional information has been requested.


VAERS ID: 353858 (history)  
Age: 28.0  
Gender: Female  
Location: Michigan  
Vaccinated:2009-08-11
Onset:2009-08-12
   Days after vaccination:1
Submitted: 2009-08-12
   Days after onset:0
Entered: 2009-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 000000 / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Arthralgia, Mobility decreased
SMQs:, Parkinson-like events (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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: none, allergy to pen and sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: no fever, but pain from the shoulder joint to wrist of the arm the inj. was given. difficult to lift coffee cup the next morning. pain is a 7 on a scale of 1-10 when moved a 2 when at rest. have never had this pain before from other td inj. will rest it, due to no ins, and i know it will pass.


VAERS ID: 353928 (history)  
Age: 28.0  
Gender: Female  
Location: California  
Vaccinated:2009-07-22
Onset:2009-08-10
   Days after vaccination:19
Submitted: 2009-08-12
   Days after onset:2
Entered: 2009-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB340AA / - LA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3001583 / - - / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF437AA / - LA / SC

Administered by: Private       Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Rash / Urticaria appears 2 days after completion of oral typhoid vaccine. Patient started oral vaccine or at home on 8/1/09.


VAERS ID: 355297 (history)  
Age: 28.0  
Gender: Female  
Location: Colorado  
Vaccinated:2008-10-17
Onset:2008-10-17
   Days after vaccination:0
Submitted: 2008-10-30
   Days after onset:13
Entered: 2009-08-13
   Days after submission:287
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Other       Purchased by: Private
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007293

Write-up: A non-serious, spontaneous report of "gave half of vaccine" was received from a nurse concerning a 28 year-old female subsequent to FLUMIST. The nurse reported she did not remember to remove the clip from the FLUMIST pre-filled syringe and thinks that she only gave one half of the vaccine. There were no additional events to report after follow-up on day thirteen after vaccination. The patient was re-vaccinated. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 30-Oct-2008 and incorporated into the narrative: telephone contact received; no adverse events occurred and the patient was re-vaccinated.


VAERS ID: 355319 (history)  
Age: 28.0  
Gender: Male  
Location: Georgia  
Vaccinated:2008-10-17
Onset:2008-10-17
   Days after vaccination:0
Submitted: 2008-11-03
   Days after onset:17
Entered: 2009-08-13
   Days after submission:282
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - - / OT

Administered by: Military       Purchased by: Military
Symptoms: Incorrect route of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007292

Write-up: A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician (patient''s father) and a combat medic concerning a 28-year-old male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST bottle. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.


VAERS ID: 355608 (history)  
Age: 28.0  
Gender: Female  
Location: Michigan  
Vaccinated:2008-11-07
Onset:2008-11-07
   Days after vaccination:0
Submitted: 2008-12-18
   Days after onset:41
Entered: 2009-08-13
   Days after submission:237
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500544P / - UN / -

Administered by: Other       Purchased by: Other
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (broad)

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: MEDI0007645

Write-up: A spontaneous non-serious report of administration to pregnant female has been received from a health care professional concerning 28 year old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. No obstetrical history was available. On 07-Nov-2008, the patient received FLUMIST and subsequently discovered she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.


VAERS ID: 355813 (history)  
Age: 28.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2009-01-26
Onset:2009-01-26
   Days after vaccination:0
Submitted: 2009-05-12
   Days after onset:105
Entered: 2009-08-13
   Days after submission:93
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500568P / - UN / OT

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0008128

Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 12-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.


VAERS ID: 355816 (history)  
Age: 28.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2009-01-26
Onset:2009-01-26
   Days after vaccination:0
Submitted: 2009-05-12
   Days after onset:105
Entered: 2009-08-13
   Days after submission:93
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500568P / - UN / OT

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0008131

Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.


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