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Case Details (Sorted by Age)

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VAERS ID: 513817 (history)  
Age: 22.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2013-10-22
Onset:2013-11-18
   Days after vaccination:27
Submitted: 2013-11-19
   Days after onset:1
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2014 / - - / IN

Administered by: Military       Purchased by: Military
Symptoms: Contraindication to vaccination, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test urine negative
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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:
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: Quantitative HCG this morning it shows 18743 units- approx 6 weeks
CDC Split Type:

Write-up: Patient had Quantitative HCG this morning it shows 18743 units- approx 6 weeks. By this calculation, patient was 2 weeks pregnant when she recieved the live influenza vaccine. On the day of vaccination the urine pregnancy test result was NEG.


VAERS ID: 513877 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-04-19
Onset:2013-04-20
   Days after vaccination:1
Submitted: 2013-11-19
   Days after onset:213
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV310 / 0 LA / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Rash, Skin discolouration, Skin reaction
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (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:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: I encountered a skin reaction. I had white circular spots around skin and shading areas on limbs (arms and legs).


VAERS ID: 514135 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-09-25
Onset:2013-09-25
   Days after vaccination:0
Submitted: 2013-11-20
   Days after onset:56
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / - UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (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:
CDC Split Type:

Write-up: I received the flu shot from a pharmacist and almost immediately felt sick and blacked out. I proceeded to lay down on the ground.


VAERS ID: 514442 (history)  
Age: 22.0  
Gender: Male  
Location: Texas  
Vaccinated:2013-11-05
Onset:2013-11-05
   Days after vaccination:0
Submitted: 2013-11-22
   Days after onset:17
Entered: 2013-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS Y9RX5 / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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: EMPLOYEE STATES THAT HE WENT TO SIT DOWN AFTER THE HEP B SHOT WAS ADMINISTERED. HE SAYS THAT 10 MINUTES LATER HE BEGAN TO FEEL LIGHTHEADED AND BEGAN TO SEE SPOTS. EMPLOYEE THAN NOTIFIED THE MSA. MSA HAD EMPLOYEE TO LIE DOWN ON BED AND BEGAN TO MONITOR EMPLOYEE. MSA APPLIED ICE PACKS TO THE NAPE OF NECK AND TO CHEST. AFTER 8 MINUTES OF LYING DOWN EMPLOYEE BEGAN TO FEEL BETTER AND TRIED GETTING UP. EMPLOYEE BEGAN TO INSTANTLY GET LIGHTHEADED AGAIN. MSA HAD EMPLOYEE TO LIE BACK DOWN AND CONTINUED TO MONITOR FOR AN ADDITIONAL 7 MINUTES. EMPLOYEE STATED THAT HE FELT FULLY RECOVERED AND RETURNED TO WORK.


VAERS ID: 514545 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-11-20
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA009317

Write-up: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL dose 1. The time gap between first and second dose was not reported. The patient received the second dose on 31-MAY-2013 and third on 26-JUL-2013. No adverse effects were reported. Additional information has been requested.


VAERS ID: 514589 (history)  
Age: 22.0  
Gender: Male  
Location: New York  
Vaccinated:2013-10-15
Onset:2013-10-18
   Days after vaccination:3
Submitted: 2013-11-25
   Days after onset:38
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1309401 / 0 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. H022280 / 0 RA / SC

Administered by: Other       Purchased by: Private
Symptoms: Cellulitis, Local swelling
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen arm on same side as shot. Pt dx with cellulitis. Abx successfully cured.


VAERS ID: 514708 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2013-11-20
Onset:2013-11-20
   Days after vaccination:0
Submitted: 2013-11-26
   Days after onset:6
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA009393

Write-up: This spontaneous retrospective pregnancy report was received from a physician refers to a 22 years old female patient. On 25-APR-2012, the patient received the first 0.5 ml dose of GARDASIL (Lot# unspecified), intramuscularly, location unspecified. On 25-JUL-2012, the patient received the second 0.5ml dose of GARDASIL (Lot# unspecified), intramuscularly location unspecified. The patient became pregnant (LMP unknown), and was in office on 20-NOV-2013, for routine visit after delivering baby in October 2013. Patient wanted to receive the third 0.5ml dose of GARDASIL (Lot# unspecified), intramuscularly location unspecified on 20-NOV-2013. No adverse effect was reported. Additional information has been requested.


VAERS ID: 514761 (history)  
Age: 22.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2013-11-14
Onset:2013-11-14
   Days after vaccination:0
Submitted: 2013-11-19
   Days after onset:5
Entered: 2013-11-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH949AB / 0 RA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: None
Preexisting Conditions: Amoxicillin; Clindamycin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Noticed rash/hives on chest. SOB. Chest pain. Went to ED. Treated for anaphylaxis (epi, nebs, BENADRYL). Began to feel better on 11/18/13.


VAERS ID: 514810 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2013-10-21
Onset:2013-10-22
   Days after vaccination:1
Submitted: 2013-11-07
   Days after onset:16
Entered: 2013-11-26
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UN873AB / 0 LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Headache, Hyperhidrosis, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 10/2011~Influenza (Seasonal) (no brand name)~UN~20.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Apples
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, chills, muscle aches, shortness of breath, fatigue, headache, extreme sweating, loss of appetite.


VAERS ID: 514927 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-11-15
Onset:0000-00-00
Submitted: 2013-11-27
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA007036

Write-up: This spontaneous report as received from a healthcare worker, certified medical assistant (C.M.A) refers to a patient of unknown age and gender. In approximately November 2011 reported as about 2 years ago the patient was vaccinated with the first dose of GARDASIL, injection (strength, dose, lot number and expiration date not provided). In approximately November 2012 reported as about 1 year ago the patient was vaccinated with the second dose of GARDASIL injection (strength, dose, lot number and expiration date not provided). On 15-NOV-2013 the patient came to office to receive the 3rd dose of GARDASIL. No adverse effect was reported. Additional information has been requested.


VAERS ID: 515033 (history)  
Age: 22.0  
Gender: Female  
Location: Ohio  
Vaccinated:2001-06-01
Onset:2005-07-29
   Days after vaccination:1519
Submitted: 2013-11-28
   Days after onset:3044
Entered: 2013-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Public       Purchased by: Private
Symptoms: Dizziness, Hepatitis B antibody negative, Hypoaesthesia, Migraine, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: ~Hep B (no brand name)~3~22.00~Patient|~Hep B (no brand name)~3~25.00~Patient|~Hep B (no brand name)~3~27.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This was the first time I received the HEP B vaccine as an adult. I had received this vaccine series a total of 3 times as an adults, and was told each time vaccine didn''t take but was safe to have again. After each time I had this vaccine all symptoms I had after first vaccine increased and new symptoms emerged leading to a diagnosis of Multiple Sclerosis (MS) a about 2years that was so progressed that I needed immediate infusion to try and reverse effects. Symptoms I started having after first vaccine: Migraines with dizziness with right facial hand and arm numbness that accompanied the migraine. These symptoms got worse after I received my second series in 2004 at clinic. I had a MRI of head that showed spots, they thought I might have MS. I was started a MS medication and the was told later that I didn''t I had my 3rd Hep B series maybe 3 years about which increased symptoms to syncope, vertigo severe migraines and the my confirmed Dx of MS


VAERS ID: 515180 (history)  
Age: 22.0  
Gender: Male  
Location: Michigan  
Vaccinated:2013-11-30
Onset:2013-11-30
   Days after vaccination:0
Submitted: 2013-11-30
   Days after onset:0
Entered: 2013-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13375P / - - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. H017759 / - - / SC

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen 800mg 1tid; Dicyclomine 20mg 1tid
Current Illness: No claim of illness
Preexisting Conditions: None
Diagnostic Lab Data: Unknown at this time
CDC Split Type:

Write-up: Approximately 10 minutes after immunization patient complainted of numb tongue. Gave 25mg diphenhydramine solution. 15 minutes complaint of slight nausea and could pass out. 5 minutes after that slight rash on neck. Called 911, gave another 25mg diphenhydramine solution. No change complaint of breathing issues no change in tongue numbness.


VAERS ID: 515316 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2013-11-27
Onset:2013-11-27
   Days after vaccination:0
Submitted: 2013-12-02
   Days after onset:5
Entered: 2013-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 0 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Blood pressure decreased, Hyperhidrosis, Loss of consciousness, Pallor, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring Claritin PRN Excedring PRN Ibuprofen PRN
Current Illness: NONE
Preexisting Conditions: Dysmetabolic Syndrome with history of Hypoglycemia Polycystic Ovarian Syndrome Hemicrania Migraine Scoliosis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Snycope /w brief LOC, tonic/clonic movements, decreased BP, pallor, diaphoretic Place on exam table in trendelenburg position. Monitored vital signs


VAERS ID: 515384 (history)  
Age: 22.0  
Gender: Female  
Location: Michigan  
Vaccinated:2013-11-15
Onset:2013-11-15
   Days after vaccination:0
Submitted: 2013-12-03
   Days after onset:18
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No ohter medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA007710

Write-up: This spontaneous report as received from a physician refers to a 22 year old female patient. On 15-NOV-2013 the patient was vaccinated with PNEUMOVAX23 25/0.5 Y, 0.5 ml, intramuscular. On 15-NOV-2013 the patient experienced redness around the injections site that spread down her arm and up her shoulder, severe vomiting, and fever. The patient sought medical attention by calling the physician. The patient was treated with Prednisone. The outcome of fever, redness around the injection site that spread down her arm and up her shoulder and vomiting was reported as not recovered/not resolved. Additional information has been requested.


VAERS ID: 515622 (history)  
Age: 22.0  
Gender: Female  
Location: Alaska  
Vaccinated:2013-11-23
Onset:2013-12-02
   Days after vaccination:9
Submitted: 2013-12-04
   Days after onset:2
Entered: 2013-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH4596AA / 0 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Oropharyngeal pain, Pain, Pallor, Rash erythematous, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypotonic-hyporesponsive episode (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: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Yellow fever vaccine given 11/23/13. Pine mono papular non-pruritic rash noticed on 12/2/13. Perio-lesion pallor prominent. Very "viral" looking. Associated with mild sore throat and achiness, which both improved by 12/4. No fever. No other meals or vaccine prior to rash eruptions.


VAERS ID: 515750 (history)  
Age: 22.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2013-10-08
Onset:2013-10-09
   Days after vaccination:1
Submitted: 2013-10-10
   Days after onset:1
Entered: 2013-12-05
   Days after submission:56
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003707 / - LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Inflammation, Skin warm, 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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s left arm had a large whelp (5 inches in diameter) that was circular develop. Area was warm to touch and slightly inflamed/red.


VAERS ID: 515802 (history)  
Age: 22.0  
Gender: Male  
Location: Virginia  
Vaccinated:2013-09-18
Onset:2013-10-02
   Days after vaccination:14
Submitted: 2013-12-05
   Days after onset:64
Entered: 2013-12-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / - UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR - / - UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Chronic kidney disease (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: UNK
Current Illness: UNK
Preexisting Conditions: The subject had no significant past medical history.
Diagnostic Lab Data: Troponin I, 29SEP2013, 0.700 NG/ML; ECG, 28SEP2013, Abnormal; Echocardiogram, 28SEP2013, Normal
CDC Split Type: 2013SA123586

Write-up: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013 with additional information received on 02 December 2013. A 22 year-old male subject with no significant past medical history was found to have unspecified acute pericarditis and acute idiopathic pericarditis 14 and 10 days respectively after the subject had received the following vaccines on 18 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number and site of administration not reported). On 28 September 2013, the subject was found to have an abnormal ECG and a normal echocardiogram. On 29 September 2013, Troponin I result was abnormal with highest record value of 07.00 ng/ml. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject''s outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.


VAERS ID: 515816 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2013-05-01
Onset:0000-00-00
Submitted: 2013-12-06
Entered: 2013-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Menstruation irregular
Preexisting Conditions:
Diagnostic Lab Data: Urine home pregnancy test (2013): positive
CDC Split Type: WAES1311USA010364

Write-up: This spontaneous prospective pregnancy report was received from a physician, concerning a 22 year old female patient with irregular periods. The patient had no known drug reactions/allergies. On 01-MAY-2013 and 19-JUL-2013, the patient was vaccinated with a first and second dose of GARDASIL, 0.5 ml IM, left arm; respectively. On 11-NOV-2013, the patient received the third dose of GARDASIL, 0.5 ml IM, Lot # H019206, expiration date on 03-APR-2015, left arm. It was reported that the patient who was recently vaccinated with her third dose of GARDASIL was pregnant (LMP: 15-OCT-2013; EDD: 22-JUL-2014). The patient had thought she was putting on weight so she took a urine home pregnancy test and it was positive. The patient went to the physician''s office to confirm the pregnancy. At the time of the report, the patient''s outcome and the relatedness between the suspect therapy and event were unknown. Additional information is not expected.


VAERS ID: 516464 (history)  
Age: 22.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2013-10-12
Onset:2013-10-12
   Days after vaccination:0
Submitted: 2013-12-13
   Days after onset:62
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA006026

Write-up: This spontaneous report as received from a nurse refers to a 22 year old patient. Nurse reported that patient of 22 years age was administered PROQUAD (inappropriate age) on 12-OCT-2013, subcutaneously. No adverse effects were reported. This case is linked to 1312USA005814 and 1312USA006027 due to same reporter link. Additional information has been requested.


VAERS ID: 516549 (history)  
Age: 22.0  
Gender: Female  
Location: Indiana  
Vaccinated:2013-10-16
Onset:2013-10-16
   Days after vaccination:0
Submitted: 2013-12-10
   Days after onset:55
Entered: 2013-12-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS L9R29 / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood immunoglobulin E normal, Pruritus, Rash erythematous, Rash macular
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA for Leiden factor
Current Illness:
Preexisting Conditions: Factor 5 Leiden
Diagnostic Lab Data: Latex IgE, negative, 10/17/16
CDC Split Type:

Write-up: Blotchy skin, "itching" scattered small red dots 4 hours after influenza vaccine. Rx with BENADRYL every 12 hrs. Office visit x2.


VAERS ID: 516678 (history)  
Age: 22.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-11-26
Onset:2011-12-01
   Days after vaccination:5
Submitted: 2013-12-16
   Days after onset:746
Entered: 2013-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0690AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test urine positive, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified); SINGULAIR; gemfibrozil; ADVAIR; Albuterol Sulfate
Current Illness: Hyperlipidaemia; Amenorrhoea; Asthma
Preexisting Conditions: Menstruation irregular
Diagnostic Lab Data: Positive; 10/2011, Human chorionic gonadotropin, Positive; 10/2011, Pregnancy test urine, Positive
CDC Split Type: WAES1112USA02028

Write-up: Information has been received from a Licensed Practical Nurse (L.P.N.) for a GARDASIL, a Pregnancy Registry product, concerning a 22 year old pregnant female patient with asthma, amenorrhoea and hyperlipidemia and none drug allergies who on 23-SEP-2011, and 29-NOV-2011, was vaccinated with a first dose of GARDASIL (route, expiration date and Lot # unspecified) and the second dose of GARDASIL, 0.5 ml, intramuscular (Lot # 668985/0690AA) (expiration date 30-JUL-2013). Concomitant therapy included prenatal vitamins (unspecified), gemfibrozil 600mg, montelukast sodium and ADVAIR. It was also reported expiration date that the nurse was not sure if the patient was still taking these medications or if they were discontinued when the patient discovered that she was pregnant. Subsequently, in approximately October 2011 the patient became pregnant (an urine pregnancy test, hcg beta quantitative). On an unspecified date, the patient experienced some spotting. No treatments was given for the events. The patient had sought medical attention during second prenatal office visits. At the time of report patient spotting was resolved. Follow-up information has been received from a Licensed Practical Nurse (L.P.N.) for a GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient with hyperlipidemia, no illness at the time of vaccination, with a history of irregular menstruation, who on 26-NOV-2011, (previously reported 29-NOV-2011), received the second dose of GARDASIL, 0.5 ml, IM, in the right deltoid region (Lot # 668985/0690AA). It was reported that the patient was still pregnant. Her last menstrual period was on approximately 19-OCT-2011 and her estimated delivery date was 25-JUL-2012 (previously reported as 07-JUL-2012). The reporter stated that on 01-DEC-2011, the patient experienced vaginal spotting. On an unknown date, the patient recovered from vaginal spotting. Follow up information received. The nurse was called who stated that she would look into the information to see if she could find anything and that if she could would call back but have not been heard from her. The case is lost to follow up. Additional information is not expected.


VAERS ID: 516728 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-22
Onset:2013-11-23
   Days after vaccination:1
Submitted: 2013-11-25
   Days after onset:2
Entered: 2013-12-16
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. H018184 / 1 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Rash
SMQs:, Anaphylactic reaction (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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash.


VAERS ID: 516749 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-01
Onset:0000-00-00
Submitted: 2013-12-16
Entered: 2013-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / SYR

Administered by: Other       Purchased by: Other
Symptoms: Headache, Injection site swelling, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEONORGESTREL/ETHINYL ESTRADIOL
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: AFTER THE SHOT, SHE DEVELOPED NAUSEA, BUT NO VOMITING. THEN PATIENT DEVELOPED BODY ACHES. ALSO DEVELOPED SWELLING AT THE INJECTION SITE. BODY ACHES, NAUSEA AND HEADACHE AT TIME OF ER VISIT (3-4 DAYS AFTER VACCINE). IMPROVED WITH BENADRYL/PAIN/NAUSEA MEDS.


VAERS ID: 516813 (history)  
Age: 22.0  
Gender: Female  
Location: Illinois  
Vaccinated:2013-12-16
Onset:2013-12-16
   Days after vaccination:0
Submitted: 2013-12-17
   Days after onset:1
Entered: 2013-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 LA / SYR

Administered by: Unknown       Purchased by: Other
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Tingling/Numbness in right thumb.


VAERS ID: 516902 (history)  
Age: 22.0  
Gender: Female  
Location: Oregon  
Vaccinated:2013-09-05
Onset:2013-09-05
   Days after vaccination:0
Submitted: 2013-12-17
   Days after onset:103
Entered: 2013-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / SYR

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

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

Write-up: Swollen red area ranging from elbow to injection site, hot to the touch. Lasted 4 days.


VAERS ID: 517228 (history)  
Age: 22.0  
Gender: Female  
Location: Illinois  
Vaccinated:2010-02-01
Onset:2010-09-01
   Days after vaccination:212
Submitted: 2013-12-19
   Days after onset:1205
Entered: 2013-12-19
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, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA006966

Write-up: This spontaneous report as received from a health care professional refers to a 23 year old female patient. On 01-SEP-2009, the patient was vaccinated with her first dose of GARDASIL (concentration, dose and lot number not reported). On 01-FEB-2010, the patient received her second dose of GARDASIL (concentration, dose and lot number not reported). It was reported that the patient had not yet received her third dose of GARDASIL. The reporter stated that no adverse effects have been observed or reported. Additional information has been requested.


VAERS ID: 517565 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-23
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Lymphadenopathy
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, Increased, Elevated sugar
CDC Split Type: WAES1312USA009394

Write-up: This spontaneous report as received from a registered nurse via a company representative refers to a currently 22 year old female patient. After competing her 3rd GARDASIL (lot # unspecified) (dose, route and location unspecified) for vaccine, the patient experienced swollen lymph nodes. The patient went to an unspecified Primary Care HCP, who reached out to her physician, who then referred patient to an unspecified Infectious Disease HCP. The reporter reported that a blood test discovered the patient had "elevated sugar" on an unspecified date. The patient had sought medical attention via went to Primary Care HCP. At the time of report, the outcome of the swollen lymph nodes and elevated sugar was unknown. Additional information has been requested.


VAERS ID: 517788 (history)  
Age: 22.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2013-11-27
Onset:2013-11-27
   Days after vaccination:0
Submitted: 2013-12-27
   Days after onset:30
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness
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: NONE
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: LIGHTHEADED AND DIZZY RIGHT AFTER SHOT WAS GIVEN, GAVE HER SOME WATER TO SIP AND SHE SAT FOR ABOUT 15 MINUTES AT THE PHARMACY


VAERS ID: 518218 (history)  
Age: 22.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2013-12-02
Onset:2013-12-04
   Days after vaccination:2
Submitted: 2014-01-02
   Days after onset:29
Entered: 2014-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Local reaction, Pain
SMQs:

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

Write-up: 22 y/o patient ref by Occ Hlth for eval of local rxn 48 hrs s/p receipt of Varicella #2 on 02DEC13 in LUE. "6"/10 pain on lifting Lt arm. No numbness or weakness in LUE. Also received Tdap in RUE on 02DEC13 w/o significant erythema, edema or warmth at Tdap injection site.


VAERS ID: 518284 (history)  
Age: 22.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2013-12-29
Onset:2013-12-29
   Days after vaccination:0
Submitted: 2014-01-02
   Days after onset:4
Entered: 2014-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4782AA / 1 AR / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Local swelling
SMQs:, 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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Epilepsy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. complaining of a red swollen arm.


VAERS ID: 518542 (history)  
Age: 22.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2009-04-08
Onset:2010-06-01
   Days after vaccination:419
Submitted: 2014-01-06
   Days after onset:1315
Entered: 2014-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0548X / 2 - / UN

Administered by: Public       Purchased by: Private
Symptoms: Crohn's disease, Gastrointestinal haemorrhage, Laboratory test, Type 1 diabetes mellitus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal premalignant disorders (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Crohn''s Disease~HPV (Gardasil)~UN~23.50~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Yes - I have medical records
CDC Split Type:

Write-up: I developed GI bleeding which grew worse over months. I was diagnosed with Crohn''s disease in July 2010. I was also diagnosed with Type 1 Diabetes in October 2010.


VAERS ID: 518563 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2013-12-19
Onset:2014-01-04
   Days after vaccination:16
Submitted: 2014-01-07
   Days after onset:3
Entered: 2014-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 0 LA / OT

Administered by: Military       Purchased by: Military
Symptoms: Pruritus, Rash
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Started as small bumps on hands and then developed into a rash on both hands. Rash is also located on right upper arms and both thighs with itching.


VAERS ID: 519452 (history)  
Age: 22.0  
Gender: Female  
Location: Vermont  
Vaccinated:2014-01-11
Onset:2014-01-12
   Days after vaccination:1
Submitted: 2014-01-13
   Days after onset:1
Entered: 2014-01-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J004387 / 0 LA / IM
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. J007207 / 0 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOFRAN; loratadine; gabapentin; VALIUM; CYMBALTA; Methotrexate; SINGULAIR; SEROQUEL; LIDODERM; JOLESSA
Current Illness: No acute illness
Preexisting Conditions: Rheumatoid arthritis; fibromyalgia; depression
Diagnostic Lab Data:
CDC Split Type:

Write-up: Raised erythematous welt on left bicep appeared 1 dy ago approx 1 dy after vaccinations. Treatment with CLARITIN 10mg BID and prednisone taper.


VAERS ID: 519482 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Papilloedema, Uveitis
SMQs:, Guillain-Barre syndrome (broad), Optic nerve disorders (narrow), Ocular infections (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA006201

Write-up: Information has been received from a literature article concerning a 22 year old female patient developed uveitis and papilledema, following administration of GARDASIL. The patient had as a pre-existing conditions elevated free T3. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 36z days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema and papillitis may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet''s disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.


VAERS ID: 519540 (history)  
Age: 22.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-16
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA006770

Write-up: This spontaneous report as received from a pharmacist refers to a 22 year old patient. Patient received dose 1 of VARIVAX (Merck) 0.5 ml, subcutaneous at the age of 1 years old in 1992. Lot number was not provided. In 2013 (reported as recently and at the age of 22 years old) the patient was vaccinated with VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous. Lot number was not provided. The pharmacist reported that the reason the patient received the dose of VARIVAX (Merck) was for nursing school. No adverse effect reported. Additional information has been requested.


VAERS ID: 519765 (history)  
Age: 22.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-04-05
Onset:2007-04-05
   Days after vaccination:0
Submitted: 2014-01-19
   Days after onset:2481
Entered: 2014-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 AR / -

Administered by: Public       Purchased by: Private
Symptoms: Migraine, Quality of life decreased
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bleeding at injection site. Flu like symptoms. Migraines.
Preexisting Conditions:
Diagnostic Lab Data: Dr that provided injection said there was no correlation but warning labels now have headaches and migraines listed as side effects.
CDC Split Type:

Write-up: Chronic migraines since 2007. Multiple neurology appointments and medication. Missed work and lessened quality of life.


VAERS ID: 519771 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-11
Onset:2014-01-11
   Days after vaccination:0
Submitted: 2014-01-20
   Days after onset:9
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Joint crepitation, Mobility decreased, Muscle strain, Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shooting pain in arm, extreme soreness and weakness in arm and shoulder, shoulder joint cracking, trouble lifting arms, muscle strain.


VAERS ID: 520451 (history)  
Age: 22.0  
Gender: Female  
Location: Georgia  
Vaccinated:2013-12-13
Onset:2013-12-13
   Days after vaccination:0
Submitted: 2014-01-23
   Days after onset:41
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH918AB / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Headache, Malaise, Nausea, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None/student recovered
CDC Split Type:

Write-up: Student reported "being sick, sleepy, dizzy, nauseated, headache" after receiving influenza vaccine on 12/13/13. Symptoms began, per student, in the afternoon after receiving the immunization. Lasted "until Sunday 12/15/13".


VAERS ID: 520472 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-01-20
Onset:2014-01-20
   Days after vaccination:0
Submitted: 2014-01-23
   Days after onset:3
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 1310001 / - RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J005081 / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J005723 / 0 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Pharyngeal oedema, Pruritus generalised
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), 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: Lisinopril
Current Illness: No
Preexisting Conditions: Drug Allergy - NOVOLOG and ZOLOFT
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling to injection site w/ redness. Patient stated throat started swelling. Itchiness all over body.


VAERS ID: 520706 (history)  
Age: 22.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-01-11
Onset:2014-01-20
   Days after vaccination:9
Submitted: 2014-01-24
   Days after onset:4
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV349A / 0 RA / IM
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 08849221A / 2 RA / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 0 LA / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR K1183 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Dysphagia, Dyspnoea, Headache, Injection site erythema, Injection site swelling, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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 (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Will followup with primary physician on 27 January.
CDC Split Type:

Write-up: Reports headache, sore throat, difficulty swallowing, feelings that can''t catch his breath, smallpox site very red and raised. Prescribed azithromycin for systemic symptoms.


VAERS ID: 520738 (history)  
Age: 22.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2013-09-03
Onset:2013-10-26
   Days after vaccination:53
Submitted: 2014-01-27
   Days after onset:93
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure increased, Blood test normal, Computerised tomogram, Electromyogram, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Muscular weakness, Plasmapheresis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Demyelination (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: numbness in hands,feet,mouth. Weakness to extremities~Influenza (Seasonal) (Fluvirin)~~22.00~Patient
Other Medications: Atenolol, Protonix, topiramate, Wffexor, ranitidine
Current Illness: None
Preexisting Conditions: Sulfa antibiotics
Diagnostic Lab Data: Blood work to rule out many things, EMG test, CT scan
CDC Split Type:

Write-up: Numbness to hands, feet, mouth. Severe weakness in legs, elevated blood pressure, trouble walking. EMG test was done to confirm GBS. Plasmapheresis treatments done with PCAD in place.


VAERS ID: 521032 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-01-27
Onset:2014-01-27
   Days after vaccination:0
Submitted: 2014-01-28
   Days after onset:1
Entered: 2014-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0849AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Expired drug administered
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: EXCEDRIN; Ibuprofen; IMITREX
Current Illness: Contraception; Migraine; Headache
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA012585

Write-up: This spontaneous report as received from a nurse refers to a 22 year old female patient with headaches and migraines. Per reporter the patient had no pertinent medical history and no history of drug reactions/allergies. On 27-JAN-2014 the patient was vaccinated with an expired dose of GARDASIL (lot # 0849AA; expiry date 23-JUN-2013), 0.5 ml, intramuscularly. This was the patient''s third dose of GARDASIL. Concomitant therapies included EXCEDRIN, ibuprofen, IMITREX and an unspecified birth control. After the patient received the third dose of GARDASIL, the patient became dizzy. The nurse reported that the patient sat and rested "for a second" after becoming dizzy and then "felt better". The patient outcome was reported as recovered. Additional information has been requested.


VAERS ID: 521058 (history)  
Age: 22.0  
Gender: Female  
Location: Oregon  
Vaccinated:2014-01-28
Onset:2014-01-28
   Days after vaccination:0
Submitted: 2014-01-28
   Days after onset:0
Entered: 2014-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4496AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, Asthenia, Convulsion, Dizziness, Hypotension, Injection site pain, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), 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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: BP 90/65 shortly after seizure
CDC Split Type:

Write-up: Pallor, weakness, hypotension, syncope, seizure, anxiety, nausea, dizziness, pain at the injection site.


VAERS ID: 521258 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-01-09
Onset:2014-01-09
   Days after vaccination:0
Submitted: 2014-01-30
   Days after onset:21
Entered: 2014-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA004782

Write-up: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On June 2009 the patient was vaccinated with 1st GARDASIL dose (dose, strength, route, indication and lot number were not provided). The 2nd dose of GARDASIL (dose, strength, route, indication and lot number were not provided) in August 2009. And the 3rd dose of GARDASIL (dose, strength, route, indication and lot number were not provided) on 09-JAN-2014. No adverse events reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.


VAERS ID: 521346 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-29
Onset:2014-01-29
   Days after vaccination:0
Submitted: 2014-01-30
   Days after onset:1
Entered: 2014-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1309801 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Headache, Heart rate increased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Nitrofurantion
Current Illness: Urinary tract infection
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: High fever (40 C), headache, fatigue, increased heart rate (122).


VAERS ID: 521489 (history)  
Age: 22.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2014-01-27
Onset:2014-01-29
   Days after vaccination:2
Submitted: 2014-01-31
   Days after onset:2
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J010396 / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Myositis, Nuclear magnetic resonance imaging abnormal, Pyrexia, Skin oedema, Ultrasound scan normal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vaccine given at private clinic. This report is being submitted by Hospital - Infection Prevention RN.
Current Illness:
Preexisting Conditions: History asthma and smoking.
Diagnostic Lab Data: WBC 19.1 on 1/29/14. MRI done 1/29/14: subcutaneous edema, possible myositis, no evidence of fasciitis. Ultrasound 1/29/14: no focal abscess. Managed by ID MD.
CDC Split Type:

Write-up: Left deltoid redness, pain, tenderness, fever began about 5 hours post injection. Fever up to 103. Admitted to hospital 2 days later with cellulitis, myositis, WBC 19,000. Treated with IV antibiotics, managed by ID consult.


VAERS ID: 521607 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-12-04
Onset:0000-00-00
Submitted: 2014-02-03
Entered: 2014-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: No other medications
Current Illness:
Preexisting Conditions: Multiparous, 39 weeks both; Pregnancy
Diagnostic Lab Data:
CDC Split Type: WAES1401USA013411

Write-up: This spontaneous prospective pregnancy report as received from a healthcare professional for GARDASIL, a Pregnancy Registry product, concerning refers to a 22 year old female patient. The patient had a history of 3 previous pregnancies and 2 live birth(s) of 39 weeks both, no preterm deliveries, no spontaneous abortion, no elective terminations and no fetal deaths were reported. There were no birth defects in previous pregnancies and no complications in previous pregnancies. On 04-DEC-2013, the patient was vaccinated with the third dose of GARDASIL, lot # J006850, expiration date 31-MAR-2016 (route was not provided). The patient''s last menstrual period was on 05-NOV-2013 and the estimated delivery date would be on 12-AUG-2014. The pregnancy outcome was unknown. Additional information has been requested.


VAERS ID: 521690 (history)  
Age: 22.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2014-02-03
Onset:0000-00-00
Submitted: 2014-02-03
Entered: 2014-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013777 / 0 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: Vasovagal~HPV (Gardasil)~1~22.25~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received the HPV quadrivalent vaccine. Lot#J013777. Exp date: 11Aug2016. Pt had a vasovagal episode afterwards.


VAERS ID: 521760 (history)  
Age: 22.0  
Gender: Male  
Location: Missouri  
Vaccinated:2014-01-15
Onset:2014-01-29
   Days after vaccination:14
Submitted: 2014-01-30
   Days after onset:1
Entered: 2014-02-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV349A / 0 UN / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 0 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J1629 / 0 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash throughout body (wrists, stomach, waistline, face, legs). Rash developed 15 days after vaccine.


VAERS ID: 522081 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-01-03
Onset:2014-01-05
   Days after vaccination:2
Submitted: 2014-01-06
   Days after onset:1
Entered: 2014-02-07
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC199AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 0 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Injection site erythema, Skin warm
SMQs:, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client received MCV4 - and HPV - both to (L) arm - Hept. B Rt. arm - came in today stated no pain, arm - warm to touch, redness to site.


VAERS ID: 522441 (history)  
Age: 22.0  
Gender: Male  
Location: Idaho  
Vaccinated:2014-01-31
Onset:2014-02-06
   Days after vaccination:6
Submitted: 2014-02-11
   Days after onset:5
Entered: 2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV349A / 1 RA / IM
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER VV04003A / 1 LA / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J1629 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Skin lesion
SMQs:, Anaphylactic reaction (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO KNOWN ALLERGIES, NO CHRONIC MEDICAL CONDITIONS
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT DESCRIBED THE APPEARANCE OF ROUND, RED LESIONS ON TRUNK, LEFT AND RIGHT ARM OF BODY.


VAERS ID: 522551 (history)  
Age: 22.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2014-02-06
Onset:0000-00-00
Submitted: 2014-02-06
Entered: 2014-02-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS X369K / 0 LA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. J014235 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4424AA / 0 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age, No adverse event
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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None. Pt needed MMR and varicella. Nurse found MMRV together and gave pt. MMRV (PROQUAD) is licensed for 12 year old and under. Next time will have separate injections. No symptoms occurred.


VAERS ID: 522978 (history)  
Age: 22.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-09
Onset:2014-02-07
   Days after vaccination:29
Submitted: 2014-02-18
   Days after onset:11
Entered: 2014-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / - - / OT

Administered by: Military       Purchased by: Military
Symptoms: Rash generalised, Rash pruritic, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Information is limited and listed above. Learned of patient via telemedicine. In the end, the consensus was that the rash was not related to the smallpox vaccine.
Current Illness: None
Preexisting Conditions: None known.
Diagnostic Lab Data: WBC 14
CDC Split Type:

Write-up: Developed widespread pruritic rash over chest, abdomen, back, scalp, forehead, and then arms and legs sparing the palms and soles. He was seen 4 days later, treated with Prednisone with improvement.


VAERS ID: 523152 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-20
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Decreased immune responsiveness
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA008801

Write-up: This spontaneous report was received from a Nurse refers to a 22 year old female patient. On an unkonwn date, the patient was vaccinated with VARIVAX (Merck) 0.5 ml subcutaneous and was also vaccinated with M-M-R II (dose, route and frequency was not reported). It was reported that on an unknown date, the result of unspecified tests on unspecified dates was that the patient did not have adequate immunity from VARIVAX (Merck) and M-M-R II. On an unkonwn date, the patient was administered with the third dose of VARIVAX (Merck) 0.5 ml subcutaneous. The outcome of the event did not have adequate immunity was unknown. The reporter did not provide the causality between the event and the suspect drugs. This case is linked to the case 1402USA009677 (same reporter link). Additional information has been requested.


VAERS ID: 523157 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-02-17
Onset:0000-00-00
Submitted: 2014-02-20
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / 0 AR / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 3 AR / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: M-M-R II
Diagnostic Lab Data:
CDC Split Type: WAES1402USA009677

Write-up: This spontaneous report was received from a Nurse refers to a 22 year old female patient. On 17-FEB-2014, the patient was vaccinated with fourth dose of VARIVAX (Merck) 0.5 ml subcutaneous in one arm and PROQUAD (Merck) (dose and frequency was not reported) instead of M-M-R II in the other arm. No adverse events were reported. No further information was provided. This case is linked to the case 1402USA008801 (same reporter link). Additional information has been requested.


VAERS ID: 523183 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-02-14
Onset:2014-02-14
   Days after vaccination:0
Submitted: 2014-02-20
   Days after onset:6
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11041 / - LA / IM

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

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

Write-up: Swelling, redness and fever to injection site.


VAERS ID: 523448 (history)  
Age: 22.0  
Gender: Female  
Location: Ohio  
Vaccinated:2014-02-14
Onset:2014-02-17
   Days after vaccination:3
Submitted: 2014-02-24
   Days after onset:7
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Abnormal behaviour, Cough, Dizziness, Headache, Heart rate increased, Lethargy, Oropharyngeal pain, Pharyngeal oedema, Pyrexia, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: hives, fever, dizziness, rapid heart rate, swollen face and throat, lethargy, cough~Tdap (no brand name)~1~22.08~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, headache, hives, sore/swollen throat, swollen face, behavior changes, light headed/dizziness, cough, rapid heart rate, lethargy.


VAERS ID: 523949 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2013-11-11
Onset:2013-11-11
   Days after vaccination:0
Submitted: 2013-11-25
   Days after onset:14
Entered: 2014-02-24
   Days after submission:91
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Underdose
SMQs:, 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: 2013SE86895

Write-up: A report has been received from a Pharmacist concerning a 22 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.


VAERS ID: 523744 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-01-16
Onset:0000-00-00
Submitted: 2014-02-25
Entered: 2014-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA003161

Write-up: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of currently 22 years old. The patient has a history of 4 previous pregnancies and 2 live births on 39 and 40 weeks from last menstrual period (LMP). No birth defects or no infant complications in previous pregnancies were present. On 16-JAN-2014 the patient was vaccinated with the third dose GARDASIL (lot # H020901, expiration date 05-JUL-2015). The patient became pregnant with LMP of 06-DEC-2013 and estimated date of delivery (EDD) of 12-SEP-2014. Initial exposure to GARDASIL was at 6 week(s). Additional information has been requested.


VAERS ID: 524140 (history)  
Age: 22.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-11-01
Onset:0000-00-00
Submitted: 2014-02-27
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1140AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypersensitivity, Mushrooms
Preexisting Conditions: Menstruation irregular
Diagnostic Lab Data: Unknown date: Pregnancy test. Positive.
CDC Split Type: WAES1111USA02867

Write-up: Information has been received from a healthcare worker for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with allergy to mushrooms and a history of irregular menses who on 01-AUG-2011 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL (lot number: 0626AA, expired date 23-JUN-2013). The patient had no known drug allergies. On 01-NOV-2011, the patient was vaccinated intramuscularly with 0.5 ml of the second of GARDASIL (lot number: 1140AA, expired date: 25-APR-2014), and the patient has been pregnant, pregnancy test was positive. The LMP was reported as 25-SEP-2011, estimated delivery date was on 01-JUL-2012. At the time of the reporting, the outcome of the pregnancy was unknown. The patient sought medical attention by office visit. Follow-up information was received from a nurse who stated that the patient was no longer a patient at the office. The patient''s last appointment was on 17-NOV-2011, and was transferred to other healthcare center. On 25-FEB-2014, a phone call was placed to the new healthcare center, a nurse stated that she had no record of the patient. Additional information is not expected.


VAERS ID: 524192 (history)  
Age: 22.0  
Gender: Female  
Location: Missouri  
Vaccinated:2014-02-27
Onset:2014-02-27
   Days after vaccination:0
Submitted: 2014-02-27
   Days after onset:0
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS FB3A3 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Oropharyngeal pain, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pain/Swelling at injection site w/ nodule~Pneumo (no brand name)~~24.00~Patient|Pain/redneess at injection site~Vaccine not spec
Other Medications: Oral antibiotic/ antibiotic eye drop for pink eye
Current Illness: Completed oral antibiotics as well as eye drops for pink eye 48 hours prior to injection
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient c/o throat constriction w/ soreness, increased anxiety. Oxygen and oral hydration were admin w/o c/o. Patient tolerated well.


VAERS ID: 524218 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-12-15
Onset:0000-00-00
Submitted: 2014-02-27
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1202USA00664

Write-up: Information has been received from a nurse practitioner for GARDASIL, Pregnancy Registry product, concerning a 22 year old female patient with no drug reactions or allergies and no pertinent medical history who on 10-OCT-2011, was intramuscularly vaccinated with a first, 0.5 mL dose of GARDASIL (lot # was not reported) in the left deltoid and on 15-DEC-2011, the patient was vaccinated with the second dose of GARDASIL lot# and dose were not reported), in the left deltoid. There was no concomitant medication. The nurse practitioner reported that the patient was vaccinated with 2 doses of GARDASIL and was pregnant (last menstrual period 27-NOV-2011, estimated delivery date: 02-SEP-2012, also reported as 09-SEP-2012). The patient was not experiencing any adverse effects or problems. Follow-up information has been received from a registered nurse. The nurse stated that the did not have any information regarding the patient. The patient transferred practices during her pregnancy and the physician''s office did not administer GARDASIL vaccination. No forwarding physician information was available at this time. Additional information is not expected.


VAERS ID: 524308 (history)  
Age: 22.0  
Gender: Female  
Location: Alabama  
Vaccinated:2007-02-23
Onset:0000-00-00
Submitted: 2014-02-28
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test, Depression, Fatigue, Glucose tolerance test, Hypoglycaemia, Intervertebral disc degeneration, Irritable bowel syndrome, Pain
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (broad), Hypoglycaemia (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: 5-hr glucose tolerance test; various blood tests
CDC Split Type:

Write-up: Progressive development of incapacitating fatigue, reactive hypoglycemia, IBS, chronic pain, degenerative disc disease, depression.


VAERS ID: 524366 (history)  
Age: 22.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2012-03-26
Onset:0000-00-00
Submitted: 2014-02-28
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 04/11/2012, human chorionic gonadotropin, positive N/A; 11-APR-2012, urine beta-humna chorionic gonadotropin test: Positive
CDC Split Type: WAES1204USA01927

Write-up: This spontaneous report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no pertinent medical history and no know drug allergies who on 26-MAR-2012 was vaccinated IM with a dose of GARDASIL (dose, route and lot# not reported). Other suspect therapy included ENGERIX-B. The patient''s last menstrual period was note as 28-MAR-2012 in the patient''s chart, but the nurse practitioner was not sure if that was correct. The patient came to the physician''s office on 11-APR-2012 for a normal annual exam. During the visit, it was discovered that she was pregnant, via urine pregnancy test. The patient was still pregnant. The estimated delivery date would be 02-JAN-2013. Follow up information has been received from a registered nurse who was able to access the clinic records for information concerning this pregnancy registry patient. The registered nurse stated that the patient had a prenatal appointment scheduled for 14-MAY-2012 and the patient never came in for the appointment. The registered nurse stated that the patient had been lost to follow up and they have no information to share. Additional information has been requested.


VAERS ID: 524550 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2013-10-02
Onset:0000-00-00
Submitted: 2014-02-25
Entered: 2014-03-04
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4567AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
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: PNV
Current Illness: None
Preexisting Conditions: Pregnant
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None noted or known reaction. Received Tdap x 2 10/2/13 and 1/23/14.


VAERS ID: 524737 (history)  
Age: 22.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2014-03-04
Onset:2014-03-05
   Days after vaccination:1
Submitted: 2014-03-05
   Days after onset:0
Entered: 2014-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG JEV12C10E / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4678AA / 0 LA / IM
RAB: RABIES (IMOVAX) / SANOFI PASTEUR J1391 / 0 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J1629 / 0 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Local swelling, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), 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: Multivitamin chewable gummy, gnc reloaded multivitamin gnc re-test booster supplement gnc re-mass protein shake
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt felt a pain inside his arm above the elbow at 1010am, he states he felt this pain a few times and then saw some swelling and redness to his arm. PT was given a Motrin and a Zyrtec prescribed by provider and also a ice pack was applied to the area.


VAERS ID: 524759 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-05-24
Onset:2013-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2014-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H018755 / 0 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Autoimmune disorder, Immediate post-injection reaction, Immunology test, Local swelling, Rash, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Nasal allergies
Diagnostic Lab Data: Auto immune
CDC Split Type:

Write-up: Right after the vaccination, I began to swell in my feet and face. Then, I developed rashes and hives. I still have these affects after 10 months I now have developed an auto immune disorder. I take herbs to help w/the symptoms of each. I never signed a paper before taking this. It was pushed to take it.


VAERS ID: 525351 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-08-26
Onset:0000-00-00
Submitted: 2014-03-10
Entered: 2014-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Pregnancy test (16-SEP-2011): positive for pregnancy; 09/16/2011, Pregnancy test, positive, positive for pregnancy N/A
CDC Split Type: WAES1112USA00324

Write-up: Information has been received from a nurse practitioner for GARDASIL concerning a 22 year old female patient with no medical history who on 26-AUG-2011, received her first dose of GARDASIL (Lot # not reported). On 16-SEP-2011, she tested positive for pregnancy. (It was also reported that the laboratory studies performed included pregnancy test on 03-AUG-2011 with no result). Her last menstrual period was on 03-AUG-2011. Estimate delivery date was 09-MAY-2012. The outcome of pregnancy was unknown. The patient sought medical attention by visiting office. Additional information is not expected.


VAERS ID: 525515 (history)  
Age: 22.0  
Gender: Female  
Location: Washington  
Vaccinated:2012-06-01
Onset:2012-07-01
   Days after vaccination:30
Submitted: 2014-03-11
   Days after onset:618
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV307 / 1 LA / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 1 RA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR G1541 / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule
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: None
Current Illness: No
Preexisting Conditions: Exercised-induced urticaria/anaphalyxis.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chronic local pink/red inflamed nodule measuring about 2.5 cm x 2.0 cm at site of inoculation right upper arm over deltoid.


VAERS ID: 525696 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-03-04
Onset:2014-03-11
   Days after vaccination:7
Submitted: 2014-03-13
   Days after onset:2
Entered: 2014-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021346 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA006157

Write-up: This spontaneous prospective pregnancy report was received from a Nurse practitioner refers to a 22 year old female patient. On 04-MAR-2014, the patient was vaccinated with first dose of GARDASIL lot # H021346 (Expiry: 01-OCT-2015) 0.5 ml, intramuscular. The LMP was reported as 05-FEB-2014. The EDD was estimated as 12-NOV-2014. On 11-MAR-2014, the patient was seen in the office and had a pregnancy test. The pregnancy test result read positive. No further information was provided. Additional information has been requested.


VAERS ID: 526395 (history)  
Age: 22.0  
Gender: Female  
Location: Alabama  
Vaccinated:2014-03-19
Onset:2014-03-19
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:2
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Pruritus, 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: Prozac
Current Illness: None
Preexisting Conditions: Allergic to Lorcet; Depression
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash described as "hives" to chest and stomach with itching. No other symptoms reported.


VAERS ID: 526442 (history)  
Age: 22.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2014-03-18
Onset:2014-03-18
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:3
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9E2GN / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H018455 / - RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Cellulitis, Injection site erythema
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: PPD
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt administered VARIVAX #2 sc right deltoid on 3/18/14. Later in evening pt noted redness at site. Had appt here to check this 3/19/14, then again on 3/20/14. As of 3/20/14 erythema present at site 7x8cm pt being treated for cellulitis with KEFLEX. 7 x 8 cm macular erythema at site.


VAERS ID: 526678 (history)  
Age: 22.0  
Gender: Female  
Location: Arizona  
Vaccinated:2013-09-09
Onset:2013-09-09
   Days after vaccination:0
Submitted: 2014-03-25
   Days after onset:197
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED R53907 / - LA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. H013399 / 0 RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Drooling, Hyperhidrosis, Laboratory test, Nausea, Pallor, Pruritus, Swollen tongue, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Humira, 40 mg. sub Q every two weeks; Benadryl PRN; Cymbalta 60 mg; Pentassa 600 milligrams; Uribel PRN; Vyvanse; Xanax PRN
Current Illness: Crohn''s Disease.
Preexisting Conditions: None
Diagnostic Lab Data: Was given Benadryl and steroids. All tests can be faxed.
CDC Split Type:

Write-up: Approximately 2-3 minutes following influenza and pneumococcal vaccine, pt. developed itching, throat tightness, tongue swelling diaphoresis, nausea, pallor and drooling. EMS called and transported to hospital.


VAERS ID: 527407 (history)  
Age: 22.0  
Gender: Female  
Location: Ohio  
Vaccinated:2014-03-25
Onset:2014-03-26
   Days after vaccination:1
Submitted: 2014-04-02
   Days after onset:7
Entered: 2014-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J014312 / - RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Rash generalised, Rash macular, Rash pruritic, Swelling face
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Heart arrhythmias; Amoxicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received RECOMBIVAX on 3-15-14. On 3-27-14 called office stating on 3-26-14 had swelling to face, blotchy itchy rash all over. Began taking BENADRYL P.O. 25mg.


VAERS ID: 527631 (history)  
Age: 22.0  
Gender: Male  
Location: Kansas  
Vaccinated:2014-03-24
Onset:2014-04-03
   Days after vaccination:10
Submitted: 2014-04-04
   Days after onset:1
Entered: 2014-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV365A / 0 UN / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04-003A / 0 UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J05201 / 0 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray normal, Dyspnoea, Monocyte count increased, Myocarditis, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Substance Abuse
Diagnostic Lab Data: Chest x-ray showed normal heart size. Non abnormal findings. Labs: CRP 5.8, ESR19, WBC 12.2, Monocytes 11.6
CDC Split Type:

Write-up: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.


VAERS ID: 527732 (history)  
Age: 22.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-04-04
Onset:2014-04-05
   Days after vaccination:1
Submitted: 2014-04-07
   Days after onset:2
Entered: 2014-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / 0 RA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft-100mg daily PO
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe itching, redness, swelling, and mass at injection site. Continues to get worse.


VAERS ID: 527750 (history)  
Age: 22.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2014-01-21
Onset:2014-01-21
   Days after vaccination:0
Submitted: 2014-04-07
   Days after onset:75
Entered: 2014-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Burning sensation, Cardiac disorder, Cardiac flutter, Chest X-ray normal, Computerised tomogram abnormal, Dyspnoea, Dysstasia, Electrocardiogram normal, Fatigue, Feeling abnormal, Full blood count normal, Gait disturbance, Headache, Impaired work ability, Initial insomnia, Metabolic function test normal, Muscular weakness, Musculoskeletal pain, Nerve conduction studies normal, Neuralgia, Pain in extremity, Paraesthesia, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Tingling, weird sensations in legs the night after the flu shot in September 2013~Influenza (Seasonal) (no brand name)~1~22.33~P
Other Medications: Aviane, Zyrtec, Flonase, Miralax, Multivitamin
Current Illness: Felt fine other than a little sinus trouble.
Preexisting Conditions: Allergies: grass, pollen, dust mites, cats, sulfa
Diagnostic Lab Data: NCV study was normal, chest x-ray normal, CT scanned showed a cyst in one of my maxillary sinuses (nothing to be concerned about), urinalysis was normal, EKG was normal, and CBC/BMP was WNL
CDC Split Type:

Write-up: The night after the hepatitis a vaccine I noticed my legs were tingling and felt very weird while I was trying to go to sleep. I went to sleep and got up the next day and went to work. My legs still felt very odd and weak. Over the next few days and weeks I experienced tingling, burning pain in my legs and arms. Around week 4 I noticed it felt hard to breathe. I would not be able to fall asleep at night because it felt like if I wasn''t awake to think to breathe I would stop breathing. My heart would also feel like it was fluttering or beating weird. I went to several doctors through out these 10 weeks because none seemed to take me seriously or really be knowledgeable about what this could be. I was so weak and didn''t have energy to do much. I had to stop working and only worked one hour every 30 days in order to keep my job. It was all I could do to go to school and come home. I have always enjoyed exercise and still have not exercised in over 10 weeks now. Between weeks 3-6 it got very hard to walk. I would notice myself using my hands to stand up out of a chair. I also had bad headaches during this time. I literally felt weird, tingling sensations in my head. It has now been over 10 weeks, and I still have nerve pain (burning, tingling), especially in my legs and butt area. I get tired very easily and feel weak still but am doing much better than I have been. I will get sharp pains in my shoulders or arms and legs occasionally too.


VAERS ID: 527828 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-04-03
Onset:2014-04-07
   Days after vaccination:4
Submitted: 2014-04-08
   Days after onset:1
Entered: 2014-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 4G7P2 / 0 LA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3000690 / 0 - / PO

Administered by: Public       Purchased by: Private
Symptoms: Vomiting
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Took oral Typhoid dose #1 4/3/14, dose #2 4/5/14, dose #3 4/7/14 and vomited pill up and 5 more times.


VAERS ID: 527851 (history)  
Age: 22.0  
Gender: Male  
Location: Virginia  
Vaccinated:2014-04-01
Onset:0000-00-00
Submitted: 2014-04-01
Entered: 2014-04-08
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AC / 1 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS PC525 / 1 RA / IM

Administered by: Military       Purchased by: Military
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.


VAERS ID: 528258 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-04
Onset:2014-04-04
   Days after vaccination:0
Submitted: 2014-04-12
   Days after onset:8
Entered: 2014-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1291AA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Local swelling, Neck pain, Pain in extremity, Paraesthesia, Sensation of heaviness, Skin discolouration, Ultrasound scan normal
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), 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: Hormonal contraceptives (unspecified)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 04/--/2014, Ultrasound scan, there were not blood clots
CDC Split Type: WAES1404USA006849

Write-up: This spontaneous report as received from a consumer refers to her 22 year old daughter with no pertinent medical history and no drug reactions or allergies. In approximately April 2014, "Monday or Tuesday", the patient was vaccinated with a dose of GARDASIL route and lot # not reported). Concomitant therapies included hormonal contraceptives (unspecified). The consumer reported that after receiving GARDASIL in April 2014, the patient experienced sharp shooting pains in her arm and neck. Her arm felt like dead weight and was discolored and swollen. The consumer also explained that the patient called the doctor on "Friday" (date unspecified) who advised her to visit the emergency room. The patient went to the emergency room the same day and was not admitted. The following Tuesday (date unspecified) the patient called the doctor once more because the symptoms were still persisting. The doctor advised the patient to go back to the emergency room. the patient went to the emergency room where they performed an ultrasound to check for blood clots and was not admitted. Result of the ultrasounds showed there were not blood clots. At the time of the report, the patient had not recovered and was experiencing tingling and swelling in her hand. The patient did not receive treatment for the adverse events. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 528468 (history)  
Age: 22.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-04-14
Onset:2014-04-14
   Days after vaccination:0
Submitted: 2014-04-14
   Days after onset:0
Entered: 2014-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS HK75L / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fall, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Gave pt flu shot, walked out of immunizing room and was talking to her then she staggered and started to fall to floor. I caught her and carefully laid her down and got her talking and had her rest.


VAERS ID: 528668 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2014-04-16
Onset:2014-04-16
   Days after vaccination:0
Submitted: 2014-04-16
   Days after onset:0
Entered: 2014-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS M4FP4 / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Feeling hot
SMQs:, Guillain-Barre syndrome (broad)

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:
CDC Split Type:

Write-up: Patient began feeling hot and weak a couple minutes after vaccine was administered. EMS were called and while we waited her blood pressure was checked. It was 106/85.


VAERS ID: 528695 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-03-24
Onset:2014-03-24
   Days after vaccination:0
Submitted: 2014-04-17
   Days after onset:24
Entered: 2014-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, Exposure during pregnancy, Pregnancy test positive, Viral titre
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 03/24/2014, Pregnanct test, Negative; 04/11/2014, Pregnancy test, Positive; Viral titre, Negative
CDC Split Type: WAES1404USA007753

Write-up: This spontaneous prospective pregnancy report as received from a nurse practitioner states that a female patient was tested for varicella titers because patient works in healthcare. Nurse practitioner states results of varicella titers were negative ("not showing immunity") so patient was vaccinated with VARIVAX (Merck) subcutaneous 0.5 ml once (LOT # reported as H020673 EXP DATE November 2014) on 24-MAR-2014. Nurse practitioner states at the time of VARIVAX (Merck) vaccination, an unspecified pregnancy test was completed and results were negative. Nurse practitioner states patient was seen in office on 11-APR-2014 reported as today for a follow up visit and an unspecified pregnancy test was completed with positive results. Nurse practitioner states patient was near 5 weeks gestation which means at vaccination, she would have been near 3 weeks gestation. The patient became pregnant with an estimated LMP of 17-FEB-2014 and an estimated EDD of 24-NOV-2014. The patient sought medical attention, she did not receive any treatment and the patient was reported as doing well. The pregnancy outcome was pending. Additional information has been requested.


VAERS ID: 528986 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2014-04-15
Onset:2014-04-16
   Days after vaccination:1
Submitted: 2014-04-16
   Days after onset:0
Entered: 2014-04-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H010958 / 0 LA / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Local swelling, Pain, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient awoke this morning and noticed an area (now 4.5 cm) itching and burning. Area is painful to touch, warm, red and raised - localized only.


VAERS ID: 529361 (history)  
Age: 22.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2013-09-10
Onset:2013-09-15
   Days after vaccination:5
Submitted: 2014-04-25
   Days after onset:222
Entered: 2014-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - AR / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 0 AR / IM

Administered by: Private       Purchased by: Public
Symptoms: Hypoaesthesia, Migraine, Muscular weakness, Neurological symptom
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: speech loss~Measles + Mumps + Rubella (no brand name)~UN~2.00~Patient|encephalitis~DTP (no brand name)~UN~3.42~Sibling
Other Medications:
Current Illness: History of epilepsy, autism and bipolar disorder
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Numbness in feet, feeling in hands intermittent, migraine headaches, knee giving out, and other neurological issues.


VAERS ID: 529368 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-18
Onset:2014-04-18
   Days after vaccination:0
Submitted: 2014-04-25
   Days after onset:7
Entered: 2014-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA011923

Write-up: This spontaneous report as received from a physician assistant refers to a 22 year old female patient. On 18-APR-2014 the patient was supposed to receive her first dose of VARIVAX, but was inadvertently vaccinated with ZOSTAVAX. No adverse effects reported. Additional information has been requested.


VAERS ID: 529834 (history)  
Age: 22.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2014-04-25
Onset:2014-04-25
   Days after vaccination:0
Submitted: 2014-05-01
   Days after onset:6
Entered: 2014-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. J007209 / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ; clindamycin
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA014655

Write-up: This spontaneous report as received from a nurse refers to a non pregnant 22 years old female patient. On 25-APR-2014 the patient was accidentally vaccinated with a dose of ZOSTAVAX (subcutaneous, dose 0.5ml, lot # J007209, expiry date 20-SEP-2014) instead of VARIVAX (Merck). Concomitant therapies included YAZ and clindamycin. No adverse effect reported. There was no treatment given for the events. Additional information has been requested.


VAERS ID: 530050 (history)  
Age: 22.0  
Gender: Male  
Location: Michigan  
Vaccinated:2014-04-29
Onset:2014-05-01
   Days after vaccination:2
Submitted: 2014-05-02
   Days after onset:1
Entered: 2014-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. K001296 / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Rash
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: Bactrim DS
Current Illness: Lower lip abscess s/p I&D on 4/26/2014
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diffuse rash.


VAERS ID: 530180 (history)  
Age: 22.0  
Gender: Male  
Location: Maryland  
Vaccinated:2003-03-06
Onset:2003-03-15
   Days after vaccination:9
Submitted: 2014-05-01
   Days after onset:4064
Entered: 2014-05-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / 0 UN / ID

Administered by: Military       Purchased by: Military
Symptoms: Fatigue, Injection site scab, Myalgia, Pruritus, Rash erythematous, Rash generalised, Skin lesion, Skin plaque, Tenderness, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), 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? Yes
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: Patient reported being in good health while traveling. He was given his primary smallpox vaccine on 3/6/2003. No other vaccines given. Approximately 9 days later (3/15/2003) during his return trip home, he began to itch behind his left knee and noticed he had "large red dots" going up the back of bilateral legs, abdomen, back and lower arms. He described these dots as quarter/half dollar size flat, red raised lesions - "hives". He presented to medical and was sent to emergency room on 3/17/2003 and treated with ATARAX, ALLEGRA and ZANTAC. (These records unable to be located by medical record staff x3). On 3/18/2003 he presented to dermatology for follow up where providers documented "erythematous plaques on abdomen and lower back fading on comparison to yesterday''s exam. Lesions were no longer painful to palpation compared to when active". He was diagnosed with urticaria and instructed to continue with ZANTAC, ALLEGRA and ATARAX. He was then flown home. He advised symptoms resolved 2-3 days after treatment initiated and they have not re-occurred since. He also reported a normal take to SPV site with scabbing (no site swelling, streaking, lymphadenopathy, headaches, chest pain or shortness of breath). He did admit to feeling very fatigued with diffuse muscle aches 1-2 weeks after vaccination that resolved with use of MOTRIN/TYLENOL (began use after onset rash). He denied new clothing, soaps, detergents, lotions, uniforms/mustang dry suits, chemical or foods. He reported no further reactions with subsequent vaccinations (IE: influenza, Td, AVA, typhoid, YV, and hep B), medications, foods, etc since.


VAERS ID: 530251 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-05-02
Onset:2014-05-02
   Days after vaccination:0
Submitted: 2014-05-02
   Days after onset:0
Entered: 2014-05-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS GX2LA / 0 LA / UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J0513 / 0 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Feeling cold, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving HAVRIX, patient was dizzy and slumped over. Patient felt cold and turned pale. Patient was caught by clinician. Patient regained consciousness after a minutes. Patient remained in the pharmacy for 30 minutes for observation.


VAERS ID: 530365 (history)  
Age: 22.0  
Gender: Male  
Location: Georgia  
Vaccinated:2014-05-06
Onset:2014-05-07
   Days after vaccination:1
Submitted: 2014-05-08
   Days after onset:1
Entered: 2014-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS X3EL13 / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H019529 / 1 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Local swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), 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: PATIENT ALLERGIC TO PCN AND SULFA MEDICATIONS
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: LOCAL READNESS, SWELLING, ITCHING.


VAERS ID: 530452 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2014-05-08
Onset:2014-05-08
   Days after vaccination:0
Submitted: 2014-05-08
   Days after onset:0
Entered: 2014-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS JP44F / 1 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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: Seizure disorder controlled, no seizes in over 5 years
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Numbness to right side of face and right arm which is the arm that vaccination was placed.


VAERS ID: 530503 (history)  
Age: 22.0  
Gender: Female  
Location: Maryland  
Vaccinated:2014-05-06
Onset:2014-05-06
   Days after vaccination:0
Submitted: 2014-05-08
   Days after onset:2
Entered: 2014-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 540011A / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Eye swelling, Fatigue, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Nausea, Pyrexia, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies to PCN, Sulfa, Codein, Macrobid
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Approximately 2 hours after receiving vaccine, (L) shoulder/arm became warm, swollen, and red. Became nauseous, tired, "in a fog". She was sent home, napped for 3 1/2 hours, woke up with swollen eyes, (+) tactile fever, malaise. Went to ED. Given Naproxen, Diagnosed with "Drug Rxn" due to vaccine, and sent home.


VAERS ID: 530703 (history)  
Age: 22.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-05-05
Onset:2014-05-05
   Days after vaccination:0
Submitted: 2014-05-06
   Days after onset:1
Entered: 2014-05-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H018421 / 1 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 5 hours after SQ vaccine administered patient developed soreness, redness, raised, itchiness at injection site. No fever. (+) nausea. Ice applied to (R) arm, hydrocortisone and ADVIL PRN.


VAERS ID: 530636 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-05-03
Onset:2014-05-03
   Days after vaccination:0
Submitted: 2014-05-13
   Days after onset:10
Entered: 2014-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV349A / - LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema and pruritis to left shoulder (injection site) and abdomen noted 6.5 hours post-vaccination. Presented to clinic the following night with urticaria of the abdomen and BL arms. Patient was given 50mg of Benadryl in clinic and Zyrtec 10mg to take BID x 5 days beginning 05/06/2014.


VAERS ID: 530662 (history)  
Age: 22.0  
Gender: Male  
Location: Nebraska  
Vaccinated:2014-05-08
Onset:2014-05-08
   Days after vaccination:0
Submitted: 2014-05-12
   Days after onset:4
Entered: 2014-05-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J1629 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: 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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient started experiencing hives on his arms and chest the night the vaccine was received. The patient was directed to go to the emergency room where he received Benadryl and Prednisone.


VAERS ID: 530732 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-13
Entered: 2014-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Conjunctivitis, Cough, Measles post vaccine, Morbillivirus test positive, Neutralising antibodies, Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Rash generalised, Rhinitis
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Conjunctival disorders (narrow), Ocular infections (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Mitral valve prolapse
Diagnostic Lab Data: IgM/IgG index ratio (9 days after rash onset): 9.7; Measles-specific IgG activity (2 days after rash onset): intermediate (63%); Measles-specific IgG activity (9 days after rash onset): High; 2011, Neutralising antibodies, 81 miU/mL, 2 days after rash onset; 2011, Neutralising antibodies, 402 miU/mL, 9 days after rash onset; 2011, Polymerase chain reaction, Positive for measles RNA; genotype D4
CDC Split Type: WAES1405USA004782

Write-up: This literature marketed report as received from a physician refers to a 22 year old female patient (case 1 in article). During a measles outbreak in 2011 suspected patients and contacts were investigated. The 22 year old female patient (also referred to as the Index patient by the authors) was identified through routine surveillance at the Department of Health and Mental Hygiene. The patient''s medical history was only significant for mitral valve prolapse. The patient was vaccinated with MMR vaccine (manufacturer unknown) in 1991 and 1992, at 3 years and 4 years of age respectively. Strength, dose and lot number were unknown. On an unknown date in 2011 the patient developed a generalized rash, cough, conjunctivitis, coryza, sore throat, and subjective fever and presented to an emergency room for medical care, but was not hospitalized. Measles was confirmed by laboratory testing. The patient was positive for measles IgG and measles IgM antibodies 2 days after rash onset and 9 days after rash onset. Nine days from rash onset, IgM/IgG index ration was 9.7. Measles reverse transcription polymerase chain reaction from nasopharyngeal specimens was positive for measles RNA and genotype D4 was identified by sequencing, IgG activity was intermediate (63%) 2 days after rash onset and high (100%) 9 days after rash onset. Measles neutralizing antibody titer, measured by plaque reduction neutralization test, obtained from the index patient was 81 mlU/mL in serum collected 2 days after rash and 402 mlU/mL in the follow-up serum collected 7 days later. There was no travel during the incubation period and no known sick contacts. However, the index patient worked at a theater frequented by tourists. Duration of rash was 8 days. Patient outcome was not specified. Eight-eight exposed contacts aged 20-65 years were identified during the patient''s infectious period, of whom 66 (75%) had documentation of immunity, 10 (11%) were not immune to measles at the time of exposure, and 12 (14%) had unknown immune status. Four additional measles patients were identified among contacts of the index patient. Three of the secondary patients were healthcare workers at a clinic where the index patient received care and were exposed to the index patient on her day of rash onset. The other secondary patient was a coworker of the index patient and was exposed to the index patient 2 days prior to her rash onset. Two of the secondary patients had 2 documented doses of MMR vaccine (see linked cases 1405USA005754 and 1405USA005755) and 2 has prior positive measles IgG antibody results. An additional 231 contacts were identified as exposed to the secondary patients. No tertiary cases were identified among these contacts. Per the authors, this was the first report in which a person with a verified secondary vaccine failure despite receipt of two doses of MMR was demonstrated to be capable of transmitting disease to other individuals. The laboratory results of intermediate or high-avidity IgG antibody indicated that the index patient and all of the secondary patients has past immunologic experience with measles through vaccination or natural measles infection. However, the index patient''s relatively high IgM or IgG ration was typical of a primary response, whereas those of the 4 secondary patients were consistent with a secondary immune response. Despite high-activity IgG, the index patient did not develop the typical high neutralizing antibody titers that have been observed among previously immunized patients. The authors stated that the index patient''s lower neutralizing antibody titer after infection provides a biologically plausible explanation for her ability to transmit virus. The authors added that there were limitations to this evaluation. Although provider documentation of MMR vaccination was obtained, it was not possible to know about the quality of the vaccine received. Inappropriate storage conditions could alter the effectiveness of vaccine. It is possible


VAERS ID: 530737 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-13
Entered: 2014-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pyrexia
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:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA004060

Write-up: This spontaneous report as received from a registered nurse refers to a 22 year old female patient. Eight years ago, in 2008 the patient was vaccinated with the series of GARDASIL. The patient experienced nausea and fever after the third dose of GARDASIL. The patient reported the adverse effects with the third dose, but no adverse effects after the first and second dose of GARDASIL. The treatment for the patient was unspecified because the patient was not at their practice at the reporting time. On unspecified date, the patient recovered from nausea and fever. Additional information has been requested.


VAERS ID: 531249 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-05-02
Onset:0000-00-00
Submitted: 2014-05-14
Entered: 2014-05-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SYR
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 5400011A / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Nephrolithiasis
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2014US009685

Write-up: Case number PHEH2014US009685 is an initial spontaneous report from the nurse received on 09 May 2014. This report refers to a 22-year-old female patient. On 02 May 2014, she was vaccinated with RABAVERT (batch number: 5400011A) intramuscularly along with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN). On 05 May 2014, the patient went to the emergency room due to kidney stone. The patient was advised to continue with the RABAVERT remaining doses. The patient was doing fine and was unaware if it was related to RABAVERT. No other information was available.


VAERS ID: 531679 (history)  
Age: 22.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2014-03-05
Onset:2014-03-05
   Days after vaccination:0
Submitted: 2014-05-21
   Days after onset:76
Entered: 2014-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: 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: Vitamins (unspecified)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA004630

Write-up: This spontaneous prospective pregnancy report was received from a healthcare worker refers to 22 year old female patient who was 34 weeks pregnant at reporting time. There were no pertinent medical history or drug reactions/allergies. The last menstrual period (LMP) was approximately on 11-SEP-2013. On approximately 05-MAR-2014 the patient was inadvertently vaccinated with her first dose GARDASIL lot # J011272, expire date 21-APR-2016, (dose, route not provided) for immunization at 25 week gestation. Concomitant therapy included prenatal vitamins. The patient did not seek medical attention. The pregnancy outcome was unknown. Action taken with GARDASIL was not reported. Additional information has been requested.


VAERS ID: 531700 (history)  
Age: 22.0  
Gender: Male  
Location: Montana  
Vaccinated:2014-05-02
Onset:2014-05-15
   Days after vaccination:13
Submitted: 2014-05-15
   Days after onset:0
Entered: 2014-05-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3000741 / - - / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH675AA / - UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No treatment from Safeway. Patient had red rash bumps all over his body. His arms, legs, forehead and neck were covered with red rash bumps, and big red rash at injection site.


VAERS ID: 531796 (history)  
Age: 22.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2014-05-20
Onset:2014-05-20
   Days after vaccination:0
Submitted: 2014-05-22
   Days after onset:2
Entered: 2014-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD - / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pyrexia
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:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: CVAE0252014

Write-up: Nausea, slight fever.


VAERS ID: 532242 (history)  
Age: 22.0  
Gender: Unknown  
Location: New York  
Vaccinated:2014-03-06
Onset:2014-03-06
   Days after vaccination:0
Submitted: 2014-05-28
   Days after onset:82
Entered: 2014-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005661 / 0 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA012794

Write-up: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients'' identifiers were obtained. This report concerns one of the patients. On 06-MAR-2014 at 16:20, the 22 year old patient (gender not provided) was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 17, 26/20; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.


VAERS ID: 532548 (history)  
Age: 22.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-05-28
Onset:2014-05-29
   Days after vaccination:1
Submitted: 2014-05-30
   Days after onset:1
Entered: 2014-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J008522 / 3 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Inflammation, Pain, Skin warm, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Drospirenone-Ethinyl Estradiol (Ocella)
Current Illness: NO
Preexisting Conditions: Bee sting, Azithromoxin, Percocet allergies.
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Swelling, inflammation, redness, sore, warm to touch.


VAERS ID: 533032 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-05-09
Onset:2014-05-09
   Days after vaccination:0
Submitted: 2014-06-05
   Days after onset:27
Entered: 2014-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: BP, HR
CDC Split Type:

Write-up: Pt c/o dizziness after receiving Hep B vaccine. Pt put down on floor w/ supervisor assistance. At 1445, bp: 123/73, HR: 50. MD and supervisor was notified. At 1450, BP: 119/67, HR: 56. Pt denied any discomfort at this time, was able to eat and drink. Pt left ward w/o assistance at 1505.


VAERS ID: 533066 (history)  
Age: 22.0  
Gender: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2014-03-01
Submitted: 2014-06-05
   Days after onset:95
Entered: 2014-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy cervix abnormal, Papilloma viral infection, Smear cervix abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 04/03/2014, Biopsy, "High risk HPV"; 03/01/2014, Smear cervix, Abnormal; 03/01/2014, Smear cervix, Positive for HPV
CDC Split Type: WAES1405USA014840

Write-up: This spontaneous report as received from a medical assistant refers to a 22 years old female patient without any pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength and route were not reported). Secondary therapies were not reported. There was no concomitant medication. Medical assistant reported that patient that received GARDASIL on an unspecified date had a pap smear in March 2014 and the result of her pap smear was "abnormal" and positive to HPV. Medical assistant stated that the patient had a biopsy done on 03-APR-2014 and the result showed the patient was "high risk HPV". No treatment was given for the adverse event. It was reported that the patient sought medical attention by seeing the physician. Medical assistant reports that the patient will be having a repeat pap smear in "three months from March 2014". Additional information has been requested.


VAERS ID: 533115 (history)  
Age: 22.0  
Gender: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-05
Entered: 2014-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD - / 4 - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gastrointestinal disorder
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: CVAE0292014

Write-up: Gastrointestinal side effects.


VAERS ID: 533134 (history)  
Age: 22.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2014-05-19
Onset:2014-05-19
   Days after vaccination:0
Submitted: 2014-05-27
   Days after onset:8
Entered: 2014-06-05
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015378 / 0 LA / SYR

Administered by: Public       Purchased by: Private
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness: None noted
Preexisting Conditions: None noted
Diagnostic Lab Data: None health dept is aware of
CDC Split Type:

Write-up: 5-19-14 - GARDASIL vaccine given at local health dept. 5-27-14 - pt mother calls health dept to state patient has been reporting problems since "night of injection". S/S include rapid heart rate, no appetite, diarrhea and dizzy. Took her to local health clinic - no dx made, no treatment, s/s persist. I enc take her to E.R. and told her I would do VAERS. I not be able to contact pt or mother since 5-27-14. 3 attempts made.


VAERS ID: 533171 (history)  
Age: 22.0  
Gender: Male  
Location: California  
Vaccinated:2014-06-02
Onset:2014-06-02
   Days after vaccination:0
Submitted: 2014-06-06
   Days after onset:4
Entered: 2014-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J015868 / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: No
Preexisting Conditions: Keflex allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fevers up to 103, swelling pain and redness at the deltoid at the site of his injection.


VAERS ID: 533588 (history)  
Age: 22.0  
Gender: Female  
Location: Ohio  
Vaccinated:2014-06-03
Onset:2014-06-03
   Days after vaccination:0
Submitted: 2014-06-05
   Days after onset:2
Entered: 2014-06-11
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J015547 / 2 RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J007781 / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J002453 / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control injections q 3 mo.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Pt. advised to be seen by a doctor of symptoms worsen
CDC Split Type:

Write-up: Came to health dept 6/5/14 to report reaction. States redness and burning right after injection that got worse that night with onset of itching also. Worse the following day and today. Area on posterior (L) upper arm of redness measuring 2 1/2 inches x 3 1/2 inches which is firm and very warm to touch and painful. States nurse did say she was giving it "at an angle". Hx of chickenpox disease but needed for nursing sch.


VAERS ID: 533956 (history)  
Age: 22.0  
Gender: Female  
Location: Missouri  
Vaccinated:2014-06-13
Onset:2014-06-13
   Days after vaccination:0
Submitted: 2014-06-16
   Days after onset:3
Entered: 2014-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J007930 / - LA / SC

Administered by: Unknown       Purchased by: Private
Symptoms: Injection site reaction, Rash papular
SMQs:, 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: None ~ advised to take 50 mg Benadryl po every 6 hrs.
CDC Split Type:

Write-up: Employee alleges she developed linear papular rash distal to injection site (left deltoid) and proximally up to the shoulder region.


VAERS ID: 534292 (history)  
Age: 22.0  
Gender: Female  
Location: Georgia  
Vaccinated:2014-06-11
Onset:2014-06-12
   Days after vaccination:1
Submitted: 2014-06-18
   Days after onset:6
Entered: 2014-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS U4837AA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR N45BR / 5 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: History of sensitive skin. States brother had "bad reaction to MMR in the past that caused a rare blood disorder."
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash to neck and chest and face was puffy per patient. States she "took a Benadryl and symptoms faded." Right arm at injection site was red, swollen, and tender all the way to elbow. Swelling and redness worse on 06/13/14. Pt reported to health department. No rash or puffiness noted to face, neck or chest area. Right arm with redness, swelling, measured 48mm. Pt c/o tenderness. Told pt to put cool compress to area and take Motrin, if not allergies to Motrin. If swelling, redness worsens to report to doctor by 06/14/14. Call health department week of 06/16/14 to follow-up.


VAERS ID: 534326 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-06-04
Onset:2014-06-04
   Days after vaccination:0
Submitted: 2014-06-18
   Days after onset:14
Entered: 2014-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K001364 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA007913

Write-up: This spontaneous report as received from a pharmacist refers to a 22 year old, non-pregnant, female patient. On 04-JUN-2014 the patient was vaccinated with VARIVAX (Merck) (lot number reported as K001364) (dose and route were not reported). Concomitant medications were not reported. On 04-JUN-2014, the patient became white as a sheet and fainted for about 20 seconds, after receiving VARIVAX (Merck)." The pharmacist observed the patient for 25 minutes after she came to and the patient left the pharmacy on her own. Patient did not seek medical attention. The outcome of became white like a sheet was not reported. The outcome of fainted for about 20 seconds was recovered/resolved. The relationship between VARIVAX (Merck) and the events was not reported. Additional information has been requested.


VAERS ID: 534534 (history)  
Age: 22.0  
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-20
Entered: 2014-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pneumococcal infection
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA008367

Write-up: This spontaneous report was received from a physician refers to an approximately 22 year old male patient. The patient''s medical history included sickle cell disease. On an unknown date the patient was vaccinated with PNEUMOVAX23 vial, lot number, route, strength and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date (also reported as at unspecified time in the past) the patient developed a form of pneumococcal disease (type unspecified) about 7 months after received a dose of PNEUMOVAX23. The outcome of the event was unknown. Additional information has been requested.


VAERS ID: 534641 (history)  
Age: 22.0  
Gender: Male  
Location: Michigan  
Vaccinated:2014-06-16
Onset:2014-06-19
   Days after vaccination:3
Submitted: 2014-06-23
   Days after onset:4
Entered: 2014-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Military       Purchased by: Military
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatinine normal, Blood glucose normal, Blood urea normal, Chest pain, Chills, Dyspnoea, Haemoglobin normal, Neutrophil percentage, Oropharyngeal pain, Pain, Platelet count normal, Productive cough, Pyrexia, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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:
Current Illness: Unknown
Preexisting Conditions: unknown
Diagnostic Lab Data: Test on presentation to ER- Wbc-7.5, plt-202, hgb-14.7, neuts-70.6%, scr-1.1, glucose-104, ast-15, alt-16, bun-13, Temp-36.8, BP-126/67, RR-18, pulse ox-98, pain 6/10
CDC Split Type:

Write-up: sore thorat, yellow cough, hard to breath, checst hurt from coughing, chills and fever,


VAERS ID: 534690 (history)  
Age: 22.0  
Gender: Female  
Location: Missouri  
Vaccinated:2014-06-17
Onset:2014-06-17
   Days after vaccination:0
Submitted: 2014-06-23
   Days after onset:6
Entered: 2014-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3000764 / 2 - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Vaginal disorder
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: CVAE0332014

Write-up: Vaginal.


VAERS ID: 534803 (history)  
Age: 22.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2014-06-24
Onset:2014-06-24
   Days after vaccination:0
Submitted: 2014-06-24
   Days after onset:0
Entered: 2014-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J014219 / 2 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4327T / 0 RA / UN

Administered by: Military       Purchased by: Military
Symptoms: Feeling hot, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCP; DOXY; SINGULAIR; ZYRTEC; FLOVENT; Albuterol; Naproxen; EPI PEN
Current Illness: None
Preexisting Conditions: Asthma; Allergic rhinitis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt was given immunizations, stated she felt fine during the shots and had a conversation with the technician. Pt says she got up and left the immunization clinic and was walking to the waiting area. She says she remembers going to the door and feeling warm and once she got to the door she says she doesn''t remember anything else. Pt passed out in the waiting area. Pt was on floor, elevated legs, checked out by provider, vitals completed. Pt laid down for a little bit, sat her up and gave her some water to sip. Got her into chair and gave her something to eat. She hadn''t eaten anything prior.


VAERS ID: 535053 (history)  
Age: 22.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2014-06-27
Onset:0000-00-00
Submitted: 2014-06-27
Entered: 2014-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / - LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Wrong drug administered
SMQs:, Extravasation events (injections, infusions and implants) (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: PPD, Lot number 695669, ID, RA, 1 previous dose
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT WAS GIVEN ANTHRAX INSTEAD OF PPD IN THE LEFT FOREARM. PT HAS NOT EXPERIENCED ANY SYMPTOMS AT THIS TIME. HE HAS A LOCAL RED AREA AT INJECTION SITE WITH NO OTHER SYMPTOMS.


VAERS ID: 630382 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-10
Entered: 2014-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Measles, Measles antibody positive, Oropharyngeal pain, Polymerase chain reaction positive, Pyrexia, Rash, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: IgM/IgG index ratio (11 days after rash onset): 0.2; Measles-specific IgG avidity (3 days after rash onset): High (82%); Measles-specific IgG avidity (6 days after rash onset): High (70%); Measles-specific IgG avidity (11 days after rash onset): High (73%); 2011, Body temperature, 38.9 degrees C; 2011, Neutralising antibodies, 87.155 mIU/mL, 3 days after rash onset; 2011, Neutralising antibodies, 221.291 mIU/mL, 11 days after rash onset; 2011, Neutralising antibodies, 168.036 mIU/mL, 6 days after rash onset; 2011, Polymerase chain reaction, Positive for measles RNA
CDC Split Type: WAES1405USA005755

Write-up: This literature marketed report as received from a physician refers to a 20 year old patient of unknown gender (case 3 in the article). The patient had no pertinent medical history. The patient was vaccinated with a combined MMR vaccine (manufacturer unknown) in 1992 and 1996. Strength, dose and lot number were unknown. During a measles outbreak in 2011 suspected patients and contacts were investigated. A 22 year old female patient (also referred to as the index patient by the authors) was noted to have measles despite receipt of two doses of MMR through routine surveillance at the Department of Health and Mental Hygiene (see linked case 1405USA004782). Eighty-eight exposed contacts aged 20-65 years were identified during the index patient''s infectious period, of whom 66 (75%) documentation of immunity, 10 (11%) were not immune to measles at the time of exposure, and 12 (14%) had unknown immune status. Four additional measles patients were identified among contacts of the index patient. Three of the secondary patients were healthcare workers at a clinic where the index patient received care and were exposed to the index patient on her day of rash onset. The other secondary patient (the patient in this case) was a coworker of the index patient and was exposed to the index patient 2 days prior to her rash onset. The secondary patients had no epidemiologic links to any other patient with measles. These secondary patients had a generalized rash with onset between days 12 and 16 after exposure to the index patient. Two of the secondary patients had 2 documented doses of MMR vaccine and 2 had prior positive measles IgG antibody results. The patient is in this case is one of the 2 secondary patients with documented doses of MMR vaccine (for other patient, see linked case 1405USA005754). On an unknown date in 2011 the patient developed rash, sore throat and fever (38.9 degrees Celsius). Measles was confirmed by laboratory testing. The patient was positive for measles IgG and measles IgM antibodies 3, 6 and 11 days after rash onset. Eleven days from rash onset, IgM/IgG index ratio was 0.2. Measles reverse transcription polymerase chain reaction from nasopharyngeal specimens was positive for measles RNA. Sequencing for genotype was not done. IgG avidity was high 3, 6 and 11 days after rash onset (82%, 70% and 73% respectively). Measles neutralizing antibody titer, measured by plaque reduction neutralization (PRN) test, was 87.155 mIU/mL 3 days after rash onset, 221.291 mIU/mL 6 days after rash onset and 168.036 mIU/mL 11 days after rash onset. Duration of rash was 4 days. The patient was not hospitalized and there were no complications. Patient outcome was not specified. An additional 231 contacts were identified as exposed to the secondary patients. No tertiary cases were identified among these contacts. Per the authors, this was the first report in which a person with a verified secondary vaccine failure despite receipt of two doses of MMR was demonstrated to be capable of transmitting disease to other individuals. The laboratory results of intermediate or high-avidity IgG antibody indicated that the index patient and all of the secondary patients had past immunologic experience with measles through vaccination or natural measles infection. However, the index patient''s relatively high IgM to IgG ratio was typical of a primary response, whereas those of the 4 secondary patients were consistent with a secondary immune response. The 4 secondary patients all had an early and robust antibody response within a few days after rash onset, with PRN titers 6-60 times higher than those observed after primary infection with natural disease or following measles vaccination. Despite $g200 exposures identified through investigations following notification of the 4 secondary patients, no additional cases were detected. Per authors, this was in agreement with other published investigations describing a lack of transmission by documented cases of second


VAERS ID: 536466 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-04-10
Onset:2014-07-11
   Days after vaccination:92
Submitted: 2014-07-11
   Days after onset:0
Entered: 2014-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Blister, Rash erythematous
SMQs:, Severe cutaneous adverse reactions (broad), 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: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pin point red spots, as rash areas with raised bumps that are blistering and popping with fluid inside.


VAERS ID: 537409 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-07-17
Onset:2014-07-18
   Days after vaccination:1
Submitted: 2014-07-23
   Days after onset:5
Entered: 2014-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J013907 / 1 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Unknown
Current Illness: Denies
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed a reaction in the back of her left arm about the circumference of a pool ball. It was red, raised, hot to the touch, and tender. Dr told her to take Benadryl 25mg po every 6 hours (4 taken). Sat 07/19/14 reports lump doubled in size, painful adn hot. MD started her on Cephalexin 500mg BID which was started 7/20/14 AM. Ibuprofen and cold packs used for comfort. Low grade fever 7/19 of 99.3 x 24 hours. As of July 21, 2014, size had not decreased, warm to touch and tender, no fever.


VAERS ID: 537818 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-27
Entered: 2014-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J013555 / - RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amloidipine; Ferric sulfate; LISINOPRIL; OMEPRAZOLE; Albuterol, TYLENOL
Current Illness: Dysponea; Renal failure chronic; Hypertension; Dialysis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1407USA010923

Write-up: This spontaneous report as received from a nurse refers to a 22 year old patient. The patients pertinent medical history included dialysis, hypertension, end stage renal disease. No known allergies were reported to drugs. Concomitant therapies included amlodipine, ferric sulfate, LISINOPRIL (manufacturer unknown), OMEPRAZOLE (manufacturer unknown), albuterol and TYLENOL. On 19-MAY-2014 the patient was vaccinated with PNEUMOVAX23 lot # J013555 expiration date 02-MAY-2015, dose 0.5 ml, route intramuscular in the deltoid of right arm. Approximately on an unknown date in MAY 2014 (reported as with in 24 hours) the patient developed redness, warm to touch, swelling at the injection site of right arm. The nurse stated comfort measures of warm compress was recommended to patient and follow up with his health care provider. The outcome of redness, warm to touch, swelling at the injection site or right arm was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 537861 (history)  
Age: 22.0  
Gender: Male  
Location: Maryland  
Vaccinated:2014-07-27
Onset:2014-07-27
   Days after vaccination:0
Submitted: 2014-07-27
   Days after onset:0
Entered: 2014-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 011031A / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: FLUCELVAX administered, approx. 15 min later pt. complained about nausea, lightheadedness. I put pt. in safe area on floor. He recovered within 10 min. without further issues.


VAERS ID: 538149 (history)  
Age: 22.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2014-07-08
Onset:2014-07-21
   Days after vaccination:13
Submitted: 2014-07-22
   Days after onset:1
Entered: 2014-07-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J013730 / 0 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Cellulitis, Vaccination site swelling
SMQs:

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

Write-up: Patient reported swelling at sight of vaccine on 7/21. Patient then went to ER. Patient diagnosed with cellulitis and prescribed KEFLEX.


VAERS ID: 538400 (history)  
Age: 22.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2014-07-31
Onset:2014-07-31
   Days after vaccination:0
Submitted: 2014-07-31
   Days after onset:0
Entered: 2014-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4904AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Heart rate decreased, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: PPD
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Syncopal episode. HR decreased 45, BP 90/54, SaO2 98% diaphoretic at discharge. HR - 72 - BP 108/64 SaO2 100% back to baseline < 30 min.


VAERS ID: 538505 (history)  
Age: 22.0  
Gender: Female  
Location: Indiana  
Vaccinated:2014-08-01
Onset:2014-08-01
   Days after vaccination:0
Submitted: 2014-08-01
   Days after onset:0
Entered: 2014-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9E2GN / 0 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Dyspnoea, Hyperhidrosis, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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: No
Preexisting Conditions: PCN, Septra, Ceclor
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sweats, facial rash, difficulty breathing. Patent took Benadryl and was given Depo Medrol 80mg IM in the office.


VAERS ID: 538727 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-07-15
Onset:2014-07-16
   Days after vaccination:1
Submitted: 2014-07-25
   Days after onset:9
Entered: 2014-08-04
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blepharospasm
SMQs:, Dystonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 days after vaccine eye twitching (continuous).


VAERS ID: 538869 (history)  
Age: 22.0  
Gender: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-05
Entered: 2014-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 793JR / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Dizziness, Pallor
SMQs:, Anticholinergic syndrome (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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A few mins after administration of vaccine pt experienced lightheadedness and was pale and clammy. Had pt sit for several mins. We o/c checked BP 102/65. Felt OK to go home was with parent (mother). Called to follow up a hr later patient said she''s OK and lying down on couch.


VAERS ID: 539272 (history)  
Age: 22.0  
Gender: Female  
Location: Utah  
Vaccinated:2014-08-04
Onset:2014-08-05
   Days after vaccination:1
Submitted: 2014-08-07
   Days after onset:2
Entered: 2014-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS B457F / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015378 / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Immediate post-injection reaction, Pain in extremity, Pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (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? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: (R) arm - lot itchier and red bump. (L) arm just itched and not as much. Itching started approx 24 hours later itching stopped 8/7/14 - though has little bump. Hurt immediately and for 1 day - both arms, but more on (R) arm.


VAERS ID: 539476 (history)  
Age: 22.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-07-29
Onset:2014-07-30
   Days after vaccination:1
Submitted: 2014-07-31
   Days after onset:1
Entered: 2014-08-11
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4519AA / - LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K004544 / - LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Feeling hot, Injection site erythema, Local swelling, Pain in extremity
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient states she noticed redness and swelling on left arm and pain to touch 1 day after receiving Varicella vaccine. It has doubled in size and feels hot.


VAERS ID: 539572 (history)  
Age: 22.0  
Gender: Female  
Location: Delaware  
Vaccinated:2014-08-01
Onset:2014-08-02
   Days after vaccination:1
Submitted: 2014-08-11
   Days after onset:9
Entered: 2014-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3744L / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Numbness in extremities.


VAERS ID: 539656 (history)  
Age: 22.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2014-08-06
Onset:2014-08-06
   Days after vaccination:0
Submitted: 2014-08-12
   Days after onset:6
Entered: 2014-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA004186

Write-up: This spontaneous report as received from a licensed practical nurse refers to a 22 year old patient of unknown gender. On 06-AUG-2014 the patient was mistakenly vaccinated with a pediatric dose of VAQTA (route, dose and lot# not reported) instead of an adult dose of VAQTA. No adverse effects reported. Additional information has been requested.


VAERS ID: 539674 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-08-08
Onset:2014-08-08
   Days after vaccination:0
Submitted: 2014-08-12
   Days after onset:4
Entered: 2014-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives (unspecified)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA006425

Write-up: This spontaneous report was received from a physician via a company representative, concerning a 22 year old female patient. Medical history and concurrent conditions were not reported. On 08-AUG-2014, the patient was vaccinated with the fourth dose of GARDASIL (dose, lot number and expiration date were not reported), intramuscularly. Concomitant therapies included hormonal contraceptives (unspecified). The physician reported that an anonymous patient received a fourth dose of GARDASIL, on 08-AUG-2014, after already completing the three dose series of injections. The patient, who had had already completed the three dose series from her primary care office; however, she explained to her Obgyn (name and demographics unspecified)) that she had only had two doses of GARDASIL and was then given a forth dose, in error. The patient did not experience any symptomatic adverse reactions. Patient did not seek medical attention or received treatment for the adverse event. Additional information has been requested.


VAERS ID: 539852 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-10-31
Onset:0000-00-00
Submitted: 2014-08-13
Entered: 2014-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA008079

Write-up: This spontaneous report was received from a nurse practitioner refers to a 22 year old female patient. On 31-OCT-2013, the patient was vaccinated with GARDASIL, dose 2, 0.5ml, intramuscular. Concomitant therapy included "birth control pills" (unspecified name, dose and frequency). On an unknown date, the patient experienced dizziness and muscle aches after receiving the second dose of GARDASIL. The patient did not received treatment for the adverse event. The outcome of dizziness and muscle aches was unknown. Additional information has been requested.


VAERS ID: 539912 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-08-08
Onset:2014-08-08
   Days after vaccination:0
Submitted: 2014-08-14
   Days after onset:6
Entered: 2014-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA006480

Write-up: This spontaneous report was received from a nurse refers to a 22 year old female patient. On 08-AUG-2014 the patient was vaccinated with GARDASIL dose 2, 0.5ml, intramuscular in the patient''s left arm (lot # was not reported). It was reported that the patient got her first dose of GARDASIL on 08-AUG-2013 and the second dose, one year after she received the first dose GARDASIL. No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.


VAERS ID: 539946 (history)  
Age: 22.0  
Gender: Male  
Location: Oregon  
Vaccinated:2014-07-18
Onset:0000-00-00
Submitted: 2014-08-14
Entered: 2014-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J006954 / 2 UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Henoch-Schonlein purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), 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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diagnose with Henoch-Schonlein purpura by primary provider.


VAERS ID: 540035 (history)  
Age: 22.0  
Gender: Male  
Location: Arizona  
Vaccinated:2014-08-14
Onset:2014-08-14
   Days after vaccination:0
Submitted: 2014-08-15
   Days after onset:1
Entered: 2014-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS LSMN2 / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Nausea, Pain
SMQs:, Acute pancreatitis (broad), 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: NA
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: EMPLOYEE C/O OF NAUSEA AND BODY ACHING 6 HOURS AFTER IMMUNIZATION. MSA CALLED DR. AND SHE STATES IT COULD BE A NORMAL SIDE EFFECT TO THE IMMUNIZATION. EMPLOYEE STATES HE IS FEELING BETTER NOW (0900 8/15/14) EMPLOYEE ADVISED TO GO TO URGENT CARE IF SYMPTOMS GET WORSE.


VAERS ID: 540736 (history)  
Age: 22.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2014-08-21
Onset:2014-08-21
   Days after vaccination:0
Submitted: 2014-08-21
   Days after onset:0
Entered: 2014-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 145025 / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blister, Rash
SMQs:, Severe cutaneous adverse reactions (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blister appearing rash on both forearms; rash on right trunk area; family physician contacted; family physician recommended urgent care visit.


VAERS ID: 540782 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-08-05
Onset:2014-08-06
   Days after vaccination:1
Submitted: 2014-08-22
   Days after onset:16
Entered: 2014-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J014960 / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Injection site nodule, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Pertussis acellular vaccine (unspecified) Drug reaction: Lethargy and Pyrexia
Diagnostic Lab Data:
CDC Split Type: WAES1408USA005267

Write-up: This spontaneous report as received from a nurse practitioner refers to a 22 year old male patient. The patient had none pertinent medical history. The patient as an infant received unspecified acellular pertussis vaccine and had a reaction of fever and lethargy. The nurse practitioner reported that, on an unspecified date a patient was administe5red a dose of (Oka/Merck) VARIVAX subcutaneous (dose, , lot # and expiration date were not provided) and, on 05-AUG-2014, a second dose of (Oka/Merck) VARIVAX subcutaneous (dose was not provided) (lot # J014960, expiration date: 26-NOV-2015). The reporter stated that, on 06-AUG-2014, the patient experienced a 5 centimeter in diameter, tender, knot and induration at the site of (Oka/Merck) VARIVAX administration in posterior left arm. There was no treatment given for adverse event and no lab diagnostic studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and (Oka/Merck) VARIVAX was unknown. The patient sought medical attention at the office of nurse practitioner on 07-AUG-2014. Additional information has been requested.


VAERS ID: 541175 (history)  
Age: 22.0  
Gender: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-20
Entered: 2014-08-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 534011A / 0 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash maculo-papular
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed rash head to feet the day after received RABAVERT. Rash is isolated pink macules and papules. Itchy.


VAERS ID: 541219 (history)  
Age: 22.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-08-21
Onset:2014-08-21
   Days after vaccination:0
Submitted: 2014-08-26
   Days after onset:5
Entered: 2014-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5G943 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo Birth control shot obtained 8/20/2014
Current Illness: No
Preexisting Conditions: HPV
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site became tender, swollen, and warm to touch.


VAERS ID: 541256 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-26
Entered: 2014-08-26
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, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Titers for M-M-R(unknown date): Patient had titers for M-M-R drawn recently and the titers came back negative. Antibody test: Titers came back to negative not provided
CDC Split Type: WAES1408USA010606

Write-up: This spontaneous report was received from a registered nurse refers to a 22 year old females patients. On an unknown date the patient was vaccinated with M-M-R II (dose, lot # and route of administration was not reported). It was reported that patient had titers for M-M-R drawn on unknown date and the titers came back to negative. The reporter stated that the patient was revaccinated with M-M-R II on unknown date because of this. The outcome of titers came back negative was unknown. Additional information has been requested.


VAERS ID: 541455 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-08-05
Onset:0000-00-00
Submitted: 2014-08-28
Entered: 2014-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV381A / 0 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J12011 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN AT THIS TIME.
Current Illness: Patient could have potentially been pregnant at time of vaccine administration.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient could have potentially been pregnant at time of vaccine administration.


VAERS ID: 541677 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-08-27
Onset:2014-08-28
   Days after vaccination:1
Submitted: 2014-08-29
   Days after onset:1
Entered: 2014-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV374A / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site pruritus, 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? Yes
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: Patient had urticaria at both arm pits and itching at the injection site.


VAERS ID: 542028 (history)  
Age: 22.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-08-18
Onset:2014-08-18
   Days after vaccination:0
Submitted: 2014-08-29
   Days after onset:11
Entered: 2014-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Nausea, Pyrexia
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:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA013027

Write-up: This spontaneous report ws received from a physician via a company representative refers to a 22 year old female patient who was not pregnant. On 18-AUG-2014 the patient was vaccinated with PNEUMOVAX23, 1 single shot, Lot # reported as K004542, Expiration Date reported as: 19-AUG-2015 (dose and route of administration was not reported). On 18-AUG-2014 the patient developed fever, nausea, redness and pain near the injection site. Patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.


VAERS ID: 541896 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-03-01
Onset:2011-04-10
   Days after vaccination:40
Submitted: 2014-08-31
   Days after onset:1239
Entered: 2014-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 LA / -

Administered by: Unknown       Purchased by: Other
Symptoms: Antinuclear antibody positive, Bone pain, Central nervous system inflammation, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteonecrosis (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Painkillers, anti-inflammation pills
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: Autoimmune test aka ANA cell test shown positive
CDC Split Type:

Write-up: Painful pelvic bone, inflammation spinal cord, muscular weakness.


VAERS ID: 541899 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-08-31
Onset:2014-08-31
   Days after vaccination:0
Submitted: 2014-08-31
   Days after onset:0
Entered: 2014-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5J9E9 / 1 RA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Burning sensation, Injection site pain, Pallor, Sensation of heaviness, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Burning during injection, injection arm burning throughout day until reported, vomiting, tremor, pale, heavy but NOT difficult breathing.


VAERS ID: 542113 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-09-02
Onset:2014-09-02
   Days after vaccination:0
Submitted: 2014-09-02
   Days after onset:0
Entered: 2014-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Paraesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Dizziness, tingling in feet, fuzzy vision.


VAERS ID: 542151 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-08-31
Onset:2014-08-31
   Days after vaccination:0
Submitted: 2014-09-03
   Days after onset:3
Entered: 2014-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5J9E9 / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Diarrhoea, Dizziness, Migraine, Nausea, Pyrexia, Visual impairment
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), 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: NONE KNOWN
Current Illness: NO
Preexisting Conditions: NONE KNOWN
Diagnostic Lab Data:
CDC Split Type:

Write-up: DIZZINESS; NAUSEA; FEVERISH FEELING (TEMP NOT MEASURED); MINOR DIARRHEA; ONSET OF MIGRAINE HEADACHE, MINOR VISION DISTURBANCES.


VAERS ID: 542152 (history)  
Age: 22.0  
Gender: Female  
Location: D.C.  
Vaccinated:2014-09-03
Onset:2014-09-03
   Days after vaccination:0
Submitted: 2014-09-03
   Days after onset:0
Entered: 2014-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS EA3Z2 / - LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K003422 / - LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

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

Write-up: Immediately s/p vaccination, pt c/o dizziness. Put to lie supine on exam table, after 15 mins dizziness resolved.


VAERS ID: 542680 (history)  
Age: 22.0  
Gender: Female  
Location: D.C.  
Vaccinated:2014-09-04
Onset:2014-09-05
   Days after vaccination:1
Submitted: 2014-09-05
   Days after onset:0
Entered: 2014-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M14044 / - LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4689CA / - RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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 Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called clinic stating he woke up feeling feverish, advised to take Tylenol and rest


VAERS ID: 542821 (history)  
Age: 22.0  
Gender: Female  
Location: Utah  
Vaccinated:2014-04-10
Onset:0000-00-00
Submitted: 2014-08-26
Entered: 2014-09-08
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS 925P2 / 0 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. U4772AA / 0 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J000154 / 0 RA / SC
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 932Z9 / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003541 / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: 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:
CDC Split Type:

Write-up: Patient came to clinic on 8-26-14 for her second round of immigration vaccines. At this visit she stated she was 6 months pregnant and that she had been pregnant (thought had not known it at the time) on 4-10-14 when she received TDAP, Varicella, MMR, Flu and TWINRIX. She denies complication with her pregnancy at this time.


VAERS ID: 542842 (history)  
Age: 22.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2014-08-08
Onset:2014-08-20
   Days after vaccination:12
Submitted: 2014-08-21
   Days after onset:1
Entered: 2014-09-08
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K002922 / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: APRI; LAMICTAL; SINGULAIR; ADVAIR
Current Illness: None
Preexisting Conditions: Sulfa; coconut; shellfish, berries; nuts; casein; grasses; many other foods
Diagnostic Lab Data: None
CDC Split Type: TN14006

Write-up: 3cm circular erythematous edema at injection site, accompanied by nodularity and edema. Pt also reports sore throat and fever. All occurring within onset 12 days after vaccine administration.


VAERS ID: 542899 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-01-24
Onset:2013-02-11
   Days after vaccination:18
Submitted: 2014-09-08
   Days after onset:573
Entered: 2014-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test positive, Astrocytoma, B-lymphocyte count, CD4 lymphocytes normal, CD8 lymphocytes, Central nervous system inflammation, Central nervous system lesion, Condition aggravated, Convulsion, Craniotomy, Electroencephalogram abnormal, Gliosis, Haematology test normal, Headache, Herpes zoster, Herpes zoster meningoencephalitis, Immunoglobulins normal, Measles antibody positive, Natural killer cell count, Neoplasm, Nuclear magnetic resonance imaging brain abnormal, Oligodendroglioma, Pathology test, T-lymphocyte count normal, Varicella virus test positive
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vasculitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Herpes zoster, left-sided T6/T7 dermatomal rash, at 27 months of age
Diagnostic Lab Data: Body mass index (JUN-2012): normal; VZV antibody titer (20-SEP-2012): negative; 22-MAR-2013: positive; 25-MAR-2013: positive; Initial assessment (unknown date): negative; Nuclear magnetic resonance imaging (2013): small T2/FLAIR hyperintense and T1 mildly hypointense lesion (14x15x9mm) involving the cortex and adjacent subcortical white matter centered at the left inferior temporal sulcus. There was no associated restricted diffusion, hemorrhage, calcification, or contrast enhancement; Pathology test (18-MAR-2013): absence of tumor in the resected tissue, the cortex showed severe gliosis and diffuse microglial activation without microglial nodule formation. A chronic lymphocytic inflammatory infiltrate was present with a predominant perivas
CDC Split Type: WAES1409USA002689

Write-up: This literature marketed report as received from a other health professional refers to a 22 year old male patient. Further examination of his childhood medical records disclosed that his older sister had varicella when the patient was 6 months old. The patient did not have an obvious varicella exanthema at that time. However, at 27 months of age, the patient developed a left-sided T6/T7 dermatomal rash. He was seen by his pediatrician and a dermatologist at a clinic, both of whom documented in his medical record a clinical diagnosis of herpes zoster. The patient was not given any varicella vaccinations during his childhood. The patient was healthy with a normal body mass index when he completed his college education in June 2012. Because of a requirement for new employment in a hospital, he was serotested and found to have a negative varicella zoster virus (VZV) antibody titer on 20-SEP-2012. As per regulation, he received his first varicella vaccination (manufacturer unknown) on 11-DEC-2012 and his second vaccination on 24-JAN-2013. He did not recall any side effects of the 2 varicella immunizations. Between 11-FEB-2013 and 15-FEB-2013, he developed intermittent headaches, mainly in the left temporal area, and took ibuprofen to reduce pain. On 16-FEB-2013, he had a headache earlier in the day and, later, a seizure that was witnessed by another person in the same room. He was taken to a local emergency department, where an initial assessment was negative. On 19-FEB-2013, he was seen in follow-up by the neurology service; they found no remarkable findings but did order magnetic resonance imaging (MRI) and electroencephalography (EEG). The MRI demonstrated a small T2/FLAIR hyperintense and T1 mildly hypointense lesion (14 x 15 x 9 mm) involving the cortex and adjacent subcortical white matter centered at the left inferior temporal sulcus. There was no associated restricted diffusion, hemorrhage, calcification, or contrast enhancement. A routine EEG recorded 2 subclinical left temporal lobe seizures; levetiracetam (500 mg twice daily) was prescribed to prevent further seizure activity. Differential considerations favored a neoplasm, such as a low-grade astrocytoma or oligodendroglioma. On 12 March 2013, neurosurgeons performed an MRI guided left temporal craniotomy and resected the lesion. He recovered quickly and was walking within 3 days of surgery; he had no further seizures. On 18-MAR-2013, the initial pathology report indicated an absence of tumor in the resected tissue. However, perivascular inflammation was present, involving many small leptomeningeal vessels. This finding suggested that a viral etiology could have caused the gliosis. On 21-MAR-2013, the patient developed recurrent headache that continued for another week. Because of the recent history of 2 varicella vaccinations, VZV immunostaining was performed on the brain tissue and was interpreted as positive on 22-MAR-2013. On 23-MAR-2013, the patient initiated valacyclovir treatment 1000 mg 3 times daily, even though he was greatly improved symptomatically and had already returned to work. Subsequent hematologic screening studies on 25-MAR-2013 for a variety of autoimmune/rheumatology disorders were negative, but VZV serology was now positive. Serum immunoglobulin levels as well as absolute numbers of CD3+, CD4+, CDS+, CD19+, and CD16+CD56+ lymphocytes were within normal ranges. At a follow-up examination 1 year after the seizure episode, the patient was completely free of any central nervous system symptoms. Neuropathology Studies: After neurosurgical excision, the cortex showed severe gliosis and diffuse microglial activation without microglial nodule formation. A chronic lymphocytic inflammatory infiltrate was present with a predominant perivascular distribution, involving cortex and small leptomeningeal vessels. The infiltrate was composed predominantly of CD3+ cells and only a few CD20+ cells. The findings were consistent with an inflammatory reactive process a


VAERS ID: 543127 (history)  
Age: 22.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-09-09
Onset:2014-09-09
   Days after vaccination:0
Submitted: 2014-09-09
   Days after onset:0
Entered: 2014-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K00456 / 0 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Chest discomfort, Chest pain, Dyskinesia, Electrocardiogram, Eye movement disorder, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Administered Gardasil 0.5 ML IM in left upper deltoid while patient was sitting upright on exam table. Nurse walked to patient right side. Patient mumbled something, eyes rolled back into head and pt had a + LOC. Nurse called for assistance. Assisted pt to a lying position. Patient began having jerking movements of extremities x 5 seconds. Patient regained consciousness quickly and became alert and oriented to person, place and time. PA and MD made aware and assessed patient. Patient assisted to a sitting position after 15 minutes of lying down, he immediately complained of chest pressure and pain. EKG obtained. PA made aware of results. EMS called. Patient transfered to ER via EMS.


VAERS ID: 543229 (history)  
Age: 22.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2014-08-01
Onset:2014-08-02
   Days after vaccination:1
Submitted: 2014-09-10
   Days after onset:39
Entered: 2014-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / IM

Administered by: Private       Purchased by: Other
Symptoms: Petechiae, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sumatriptan 100mg PO PRN migraine; Topiramate 25mg PO HS; Magnesium 200mg PO BID; Riboflavin 200mg PO BID
Current Illness:
Preexisting Conditions: History of migraines and inguinal hernia
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received their first dose of the Gardasil vaccine on Friday, 8/1/2014 and developed an unusual rash on 8/2/2014. The rash was petechial, periorbital, but only around the left eye, asymptomatic: non-painful, non-pruritic, no associated swelling, and not present anywhere also on the patient''s body. The rash had mostly resolved 2-3 days later. No treatment was given.


VAERS ID: 543319 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2014-09-10
Onset:2014-09-10
   Days after vaccination:0
Submitted: 2014-09-10
   Days after onset:0
Entered: 2014-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1411001 / 0 UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (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: Fluoxetine
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccine at workplace at 10:20 am and returned to desk. At 10:30 am patient collapsed at desk and fell to the floor. Patient stated that she felt dizzy prior to fainting. Patient laid on back in chair for about 15 minutes until she felt normal.


VAERS ID: 543356 (history)  
Age: 22.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-08-12
Onset:0000-00-00
Submitted: 2014-09-10
Entered: 2014-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Smear cervix, an unspecified strain of HPV
CDC Split Type: WAES1408USA014416

Write-up: This spontaneous report as received from a healthcare worker via field employee refers to a now 22 year old female patient. The patient was vaccinated with the first dose of GARDASIL, injection, (dose, route, lot # and expired date were not reported) on 04-AUG-2008. Concomitant therapy was not reported. The patient was performed pap smear. The patient was diagnosed with an unspecified strain of human papillomavirus (HPV) on an unspecified date prior to receiving the 2nd and 3rd doses of GARDASIL. The patient had a physician office visit for medical attention. Therapy with GARDASIL was continued. The outcome of adverse event was unspecified. On 30-JUN-2014, the patient was vaccinated with the second dose of GARDASIL. On 12-AUG-2014, the patient was vaccinated with the third dose of GARDASIL. Additional information has been requested.


VAERS ID: 543694 (history)  
Age: 22.0  
Gender: Unknown  
Location: D.C.  
Vaccinated:2014-08-25
Onset:2014-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2014-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006447 / 1 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4939AA / - LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K003422 / 1 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site pain, Nausea
SMQs:, Acute pancreatitis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain at site and nausea.


VAERS ID: 543695 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-09-10
Onset:0000-00-00
Submitted: 2014-09-12
Entered: 2014-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J013732 / 0 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Local reaction
SMQs:

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: Varicella titers in 2-3 months
CDC Split Type:

Write-up: Localized reaction: 5cm x 6cm no edema, erythema in circumscribed area.


VAERS ID: 543763 (history)  
Age: 22.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-14
Entered: 2014-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA003101

Write-up: This spontaneous report as received from other health professional refers to a 22 year old patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot no. unknown). No concomitant medication was reported. On an unknown date the patient was mistakenly administered a dose of ZOSTAVAX instead of a dose of (Oka/Merck) VARIVAX. No adverse effects were reported. The outcome of events was unknown. Additional information has been requested.


VAERS ID: 543702 (history)  
Age: 22.0  
Gender: Male  
Location: Missouri  
Vaccinated:2014-08-29
Onset:2014-09-12
   Days after vaccination:14
Submitted: 2014-09-15
   Days after onset:3
Entered: 2014-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K002924 / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Minor rash to face, legs, buttock. Employee was treated in Urgent Care.


VAERS ID: 543894 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-09-11
Onset:2014-09-13
   Days after vaccination:2
Submitted: 2014-09-15
   Days after onset:2
Entered: 2014-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K005797 / - LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Cellulitis, Local reaction
SMQs:

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

Write-up: Pt had localized reaction to left arm pneumococcal vaccine (PPV) - secondary cellulitis - tx at ER 9/13/14.


VAERS ID: 544025 (history)  
Age: 22.0  
Gender: Male  
Location: Virginia  
Vaccinated:2014-03-24
Onset:2014-04-04
   Days after vaccination:11
Submitted: 2014-09-14
   Days after onset:163
Entered: 2014-09-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / - UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR - / - UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Chronic kidney disease (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: Unknown
Current Illness: UNK
Preexisting Conditions: None
Diagnostic Lab Data: Troponin I, 05APR2014, 18.25 ng/ml; ECG, 03APR2014, Abnormal; Echocardiogram, 04APR2014, Abnormal
CDC Split Type: 2014SA121299

Write-up: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject''s outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.


VAERS ID: 544311 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-18
Entered: 2014-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015378 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Upper respiratory tract infection
SMQs:, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA002571

Write-up: This spontaneous report as received from a physician via a company representative refers to a 22 year old female patient. On 29-AUG-2014 the patient was vaccinated with GARDASIL lot # J015378, expiration date 09-APR-2016, intramuscular. The nurse reported to the representative, "the patient developed a lump on her neck on an unspecified date after receiving GARDASIL." Physician clarified that lymph node was not related to GARDASIL. It was related to upper respiratory infection. She stated patient did not have a reaction to GARDASIL. The outcome of lymph node/lump on neck and upper respiratory infection was reported as not recovered/not resolved. The patient sought medical attention. No treatment was given for the adverse events. No lab diagnostics studies were performed. Additional information is not expected. Physician declined any further contact regarding this report.


VAERS ID: 544338 (history)  
Age: 22.0  
Gender: Female  
Location: Utah  
Vaccinated:2014-09-18
Onset:2014-09-18
   Days after vaccination:0
Submitted: 2014-09-18
   Days after onset:0
Entered: 2014-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5G943 / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Feeling hot, Lethargy, Nervousness
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

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

Write-up: Patient is complaining of feeling lethargic, hot, and shaky about 25 minutes after vaccine. Symptoms lasting about 30 mintues with hot and shaky but is now resolved at 5:45 pm. Still is feeling lethargic about 1 hour later.


VAERS ID: 544504 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-09-17
Onset:2014-09-17
   Days after vaccination:0
Submitted: 2014-09-19
   Days after onset:2
Entered: 2014-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI185AA / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Rash erythematous
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: Portia
Current Illness: Small rash on lower body
Preexisting Conditions: N/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had small red bump which became bigger, approx. 20 cm diameter.


VAERS ID: 544515 (history)  
Age: 22.0  
Gender: Male  
Location: Michigan  
Vaccinated:2014-09-16
Onset:2014-09-19
   Days after vaccination:3
Submitted: 2014-09-19
   Days after onset:0
Entered: 2014-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI172AB / 3 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4963AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Local swelling
SMQs:, 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:
Other Medications: Iron 325mg-3x daily; Folate 1 mg 1x daily; Synthroid 100mg 1x daily; methotrexate 2.5mg 4 tabs weekly; flucinolone 0.01 topical 2x daily; Doxycycline Hyclate 100mg 1 tablet 2x daily.
Current Illness: NO
Preexisting Conditions: Appearing well
Diagnostic Lab Data: Cellulitis
CDC Split Type:

Write-up: Bump on left arm, pink around site and warm to touch.


VAERS ID: 544550 (history)  
Age: 22.0  
Gender: Female  
Location: Kansas  
Vaccinated:2014-09-20
Onset:2014-09-20
   Days after vaccination:0
Submitted: 2014-09-20
   Days after onset:0
Entered: 2014-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3744L / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Sluggishness
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: dizziness and sluggish after injection~Hep B (Engerix-B)~1~22.42~Patient
Other Medications: Ibuprofen daily for mensus, Equate brand allergy medication decongestant PRN for allergies
Current Illness: NO
Preexisting Conditions: Allergies to pollen.
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Approx 2 hours after receipt of 2nd of a series of 3 Hep B vaccines, employee felt dizziness and sluggish. Employee rested for approx 1 hour and symptoms are still present. Employee stated that she felt the same way from her 1st Hep B vaccine but did not realize it was a reaction from the vaccine until this event occurred. On the 2nd day after her 1st Hep B vaccine, employee stated her condition worsened and she felt nausea but did not vomit. On the third day after the first Hep B vaccine, employee made a full recovery.


VAERS ID: 544759 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-09-17
Onset:2014-09-18
   Days after vaccination:1
Submitted: 2014-09-23
   Days after onset:5
Entered: 2014-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2L752 / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4963AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Burning sensation, Injection site pain, Neck pain
SMQs:, Peripheral neuropathy (broad), 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: Zyrtec 10 mg daily as needed
Current Illness: One week of on and off chest pain
Preexisting Conditions: Cardiac Ablation in 2009 for SVT ... Patient has a milk and shell fish allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left shoulder pain that radiated to her anterior neck. Patient states that it was sharp and burning. She was treated with Ibuprofen 600 mg three times daily and instructed to put ice on the area of discomfort three times a day.


VAERS ID: 544808 (history)  
Age: 22.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2014-09-23
Onset:2014-09-23
   Days after vaccination:0
Submitted: 2014-09-23
   Days after onset:0
Entered: 2014-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI89AC / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Joint range of motion decreased, Muscle spasms, Musculoskeletal pain, Pain in extremity, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad), 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: UNKNOWN
Current Illness: None reported on screening document.
Preexisting Conditions: None reported on screening document.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain and cramping down left arm accompanied by some tingling. Limited range of motion due to pain in shoulder.


VAERS ID: 544875 (history)  
Age: 22.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2013-10-01
Onset:2013-10-15
   Days after vaccination:14
Submitted: 2014-09-24
   Days after onset:344
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Arthralgia, Back pain, Blood test, Muscular weakness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Pain in extremity, Sciatica
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Blood work, MRI lumbar spine, MRI of R hip
CDC Split Type:

Write-up: Sciatica, Low back pain, R hip pain, R leg weakness and major pain in leg.


VAERS ID: 545229 (history)  
Age: 22.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2014-09-18
Onset:2014-09-18
   Days after vaccination:0
Submitted: 2014-09-24
   Days after onset:6
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K009202 / 0 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Dizziness
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:
Current Illness:
Preexisting Conditions: Heart murmur
Diagnostic Lab Data:
CDC Split Type:

Write-up: A few minutes after injection, pt felt dizzy. Vital signs taken every 5 minutes until stable over 15 minutes. Waited additional 15 minutes sitting in waiting area.


VAERS ID: 545342 (history)  
Age: 22.0  
Gender: Female  
Location: Colorado  
Vaccinated:2014-09-10
Onset:0000-00-00
Submitted: 2014-09-24
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS EA3Z2 / 2 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site pain, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Upon administration, hurt more upon initial injection than previous. Site has continued to be extremely sore, resolved some, but now has become worse. When rotates arm has shooting pain down upper arm. Popping started 9/17.


VAERS ID: 545118 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-09-22
Onset:2014-09-23
   Days after vaccination:1
Submitted: 2014-09-25
   Days after onset:2
Entered: 2014-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) / SANOFI PASTEUR UT4982BA / 0 LA / ID

Administered by: Other       Purchased by: Other
Symptoms: Axillary pain, Discomfort, Insomnia
SMQs:

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: T 97.3F, no lymph nodes palpated
CDC Split Type:

Write-up: Laying on L side to sleep, felt pain to armpit, feeling for lymph nodes, did not find any one particular but discomfort seems more on the 3rd day.


VAERS ID: 546177 (history)  
Age: 22.0  
Gender: Female  
Location: Maryland  
Vaccinated:2014-09-23
Onset:2014-09-24
   Days after vaccination:1
Submitted: 2014-09-25
   Days after onset:1
Entered: 2014-09-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 759XC / - RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K003406 / 1 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site warmth, Local swelling, Skin warm
SMQs:, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Whole arm swollen after carrying child. Red, hard, hot from injection site to fingers (L) arm. Pt treated with ice and 400 mg MOTRIN PO, reaction resolved in approximately 15 min.


VAERS ID: 546602 (history)  
Age: 22.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-09-23
Onset:2014-09-24
   Days after vaccination:1
Submitted: 2014-09-30
   Days after onset:6
Entered: 2014-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 145005 / - RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Blood test, Fall, Muscle spasms, Pain, Walking aid user
SMQs:, Dystonia (broad), Accidents and injuries (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levocetirizine; MYZILRA; SINGULAIR; DYMISTA
Current Illness: None
Preexisting Conditions: NKA; recently had surgery to remove 2 screws from ankle that were pinching nerve
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu vaccine was administered on 9/23. Pt developed severe cramping in thighs on 9/24 upon exertion. Pain and cramping caused the patient to fall. She was then taken to the physician. The patient needed help walking. MD gave TORADOL injection and prescribed FLEXERIL 10 mg 1 TID. This reduced cramping so patient was able to walk without assistance. Cramping has reoccurred with exertion. Blood work performed 9/30.


VAERS ID: 545898 (history)  
Age: 22.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2014-09-22
Onset:2014-09-23
   Days after vaccination:1
Submitted: 2014-10-01
   Days after onset:8
Entered: 2014-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI191AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Induration, Local swelling, Pain in extremity, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Other Medications: Seasonique 0.15mg - 30mcg
Current Illness: None.
Preexisting Conditions: Pseudoephedrine
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Swollen, raised, hard, red circle around arm. Warm to the touch and painful.


VAERS ID: 546054 (history)  
Age: 22.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2014-10-01
Onset:2014-10-01
   Days after vaccination:0
Submitted: 2014-10-01
   Days after onset:0
Entered: 2014-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Public       Purchased by: Other
Symptoms: Dizziness, Flushing, Nausea, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizzy, light headed, flushed, nauseous and shaky.


VAERS ID: 546711 (history)  
Age: 22.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2014-09-30
Onset:2014-09-30
   Days after vaccination:0
Submitted: 2014-09-30
   Days after onset:0
Entered: 2014-10-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 2Y747 / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013277 / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Pt was fine came for physical determined she needed HPV shot #1. No Hx of GBS or allergies or seizures. Gave shot IM rt deltoid within 5 minutes she fell back on exam table and had 30 second seizure and then was alert again. Sent to ER for further evaluation.


VAERS ID: 546726 (history)  
Age: 22.0  
Gender: Male  
Location: Virginia  
Vaccinated:2014-10-01
Onset:2014-10-01
   Days after vaccination:0
Submitted: 2014-10-01
   Days after onset:0
Entered: 2014-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS 5JR7T / 1 RL / IM

Administered by: Military       Purchased by: Military
Symptoms: Dry mouth, Dysphagia, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
CDC Split Type:

Write-up: TWINRIX admin at 1126. Pt had dry mouth, shortness of breath difficulty swallowing approx. 10 min after. Pt has headache 3hrs after.


VAERS ID: 547211 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-08-20
Onset:2014-08-20
   Days after vaccination:0
Submitted: 2014-10-04
   Days after onset:45
Entered: 2014-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015378 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA001869

Write-up: This spontaneous report as received from a medical assistant refers to a 22 years old female patient. On 20-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot# J015378, expiry date: 09-APR-2016, dose, dose number, route of administration were not reported) that was improperly stored on 08-AUG-2014. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.


VAERS ID: 546524 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-10-01
Onset:2014-10-03
   Days after vaccination:2
Submitted: 2014-10-05
   Days after onset:2
Entered: 2014-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Swelling face
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Face swollen on both sides. So bad on right side entire eye swollen shut almost completely.


VAERS ID: 546740 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-09-18
Onset:2014-09-30
   Days after vaccination:12
Submitted: 2014-10-06
   Days after onset:6
Entered: 2014-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives appearing all over body, treated with Benadryl.


VAERS ID: 546880 (history)  
Age: 22.0  
Gender: Female  
Location: Illinois  
Vaccinated:2014-09-24
Onset:2014-09-24
   Days after vaccination:0
Submitted: 2014-10-07
   Days after onset:13
Entered: 2014-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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: Pain, myalgia~Influenza (Seasonal) (no brand name)~1~42.17~Patient
Other Medications: Ibuprofen
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain initially just at administration site. Vaccine inserted into left shoulder. Shoulder still is hurting with severe pain, taking NSAIDs to help, cannot lift anything heavy, and I have short range of motion without serious pain.


VAERS ID: 548699 (history)  
Age: 22.0  
Gender: Female  
Location: Kansas  
Vaccinated:2014-07-28
Onset:2014-07-28
   Days after vaccination:0
Submitted: 2014-10-08
   Days after onset:72
Entered: 2014-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J009165 / - RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA002964

Write-up: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified date, the patients were vaccinated with VARIVAX which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 22 year old female patient. On 28-JUL-2014 at 11:47 am, the patient might have been immunized with a dose of (Oka/Merck) VARIVAX lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.


VAERS ID: 547243 (history)  
Age: 22.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-10-03
Onset:2014-10-04
   Days after vaccination:1
Submitted: 2014-10-09
   Days after onset:5
Entered: 2014-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI196AE / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015378 / 2 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K001504 / 0 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol; Yaz
Current Illness: Moderate Major Depression
Preexisting Conditions: Asthma
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: 10/5/2014 @ 4:34pm pt. called c/o fever & muscle aches onset 18 hours after receiving vaccines. Educated on vaccine reactions. 10/6/2014 @ 8:21am pt. called MD office c/o redness & swelling to injection site of pneumococcal vaccine approx. 5-6 inches in diameter and fever of 102.9 with body aches. Pt going to Urgent Care. At 2:43pm pt calls informing MD in ER and being admitted to hospital.


VAERS ID: 547346 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-10-08
Onset:2014-10-09
   Days after vaccination:1
Submitted: 2014-10-09
   Days after onset:0
Entered: 2014-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI194AA / - RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K009107 / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (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:
Current Illness: No
Preexisting Conditions: HIV+
Diagnostic Lab Data:
CDC Split Type:

Write-up: L deltoid site red, hot, arm hurts, may have chills.


VAERS ID: 548561 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2014-09-30
Onset:2014-09-30
   Days after vaccination:0
Submitted: 2014-09-30
   Days after onset:0
Entered: 2014-10-09
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T51708 / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Cough, Headache, Injection site pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: flu like symptoms~Influenza (Seasonal) (no brand name)~UN~21.00~Patient
Other Medications: MIRENA
Current Illness: None
Preexisting Conditions: Penicillin (hives)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever - 105.2 degrees F. Pt reports (+) chills, cough, headache, pain at injection site started about 5 hours ago. Pt. treated with TYLENOL 1000 mg and ibuprofen 800 mg.


VAERS ID: 549612 (history)  
Age: 22.0  
Gender: Male  
Location: Idaho  
Vaccinated:2014-10-11
Onset:2014-10-11
   Days after vaccination:0
Submitted: 2014-10-11
   Days after onset:0
Entered: 2014-10-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 160234 / - AR / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 59D74 / - AR / IM

Administered by: Military       Purchased by: Military
Symptoms: Incorrect dose administered
SMQs:, Medication errors (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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: None.


VAERS ID: 549616 (history)  
Age: 22.0  
Gender: Male  
Location: Idaho  
Vaccinated:2014-10-11
Onset:2014-10-11
   Days after vaccination:0
Submitted: 2014-10-11
   Days after onset:0
Entered: 2014-10-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 160234 / - UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS N45BR / 0 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Incorrect dose administered
SMQs:, Medication errors (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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: None.


VAERS ID: 550789 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-10-01
Onset:0000-00-00
Submitted: 2014-10-12
Entered: 2014-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015378 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA002854

Write-up: This spontaneous report as received from a medical assistant refers to a 22 year old male patient. No information about medical history, drug reactions and allergies was specified. On 01-OCT-2014 the patient was vaccinated with temperature excursion supported GARDASIL injection (lot # J015378, expiry date: 09-APR-2016, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. The patient did not seek medical attention. There was no product complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005587). Additional information has been requested.


VAERS ID: 547623 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2014-10-10
Onset:2014-10-11
   Days after vaccination:1
Submitted: 2014-10-13
   Days after onset:2
Entered: 2014-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 141207 / - LA / IM

Administered by: Unknown       Purchased by: Private
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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic Rash / Hives.


VAERS ID: 548221 (history)  
Age: 22.0  
Gender: Male  
Location: Alaska  
Vaccinated:2014-10-14
Onset:2014-10-16
   Days after vaccination:2
Submitted: 2014-10-16
   Days after onset:0
Entered: 2014-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV387A / 3 LA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR K1200 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site oedema, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Member began to have erythema and edema to location of injection. Site is now warm to touch and extends 4-5cm in width and 3-4cm in height. Treatment: Per overseeing provider - use of Tylenol or Motrin and Benadryl at night before sleep to alleviate symptoms.


VAERS ID: 552302 (history)  
Age: 22.0  
Gender: Female  
Location: D.C.  
Vaccinated:2014-10-10
Onset:2014-10-14
   Days after vaccination:4
Submitted: 2014-10-16
   Days after onset:2
Entered: 2014-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4689CA / - LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K006139 / 1 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Varicella post vaccine
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: LEXAPRO; Multivitamin; Lorazepam; MIRENA
Current Illness:
Preexisting Conditions: Asthma; generalilzed anxiety d/o
Diagnostic Lab Data:
CDC Split Type:

Write-up: Low grade fever. "Chicken pox spots" 3 in x 2 in. Redness to injection site. Soft induration and redness blanches.


VAERS ID: 552334 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2014-10-16
Entered: 2014-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Anxiety, Inappropriate schedule of drug administration
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Craniocerebral injury; Anxiety; Cetrizine, Hypersensitivity; Amoxicillin, Hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1410USA004897

Write-up: This spontaneous report as received from a 23 year old female consumer refers to herself. Current condition included drug reactions or allergies to amoxicillin and cetrizine. The patient''s medical history included anxiety and traumatic brain injury. The patient reported that on 08-AUG-2011 she received first dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown in upper right arm) and second dose on 11-JUN-2013 and she received third dose on an unknown date in September 2014. Concomitant medications were unspecified by reporter. On an unknown date in 2014, the patient developed anxiety and stomach cramp after third dose of GARDASIL. Patient also stated that "she was trying to get pregnant". The patient also stated that she called nurse (name and contact information were unknown) regarding this and she was advised to take a fourth dose by Nurse. There was no treatment given for the event. The outcome of the events was unknown. The causality for the events anxiety and stomach cramp was unknown. No additional information adverse event information was provided. Additional information has been requested.


VAERS ID: 552393 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-10-14
Onset:2014-10-14
   Days after vaccination:0
Submitted: 2014-10-16
   Days after onset:2
Entered: 2014-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA007939

Write-up: This spontaneous report as received from a consumer (patient''s mother) refers to a 22 year old female patient with no drug reactions or allergies and with no medical history. The patient received two vaccinations of GARDASIL injection administered intramuscularly (strength, dose, lot# and expiry date unspecified). The patient went to her gynecologist on 02-OCT-2014 and received a dose of GARDASIL. She then went to her pediatrician on 14-OCT-2014 (reported as "yesterday"), for a physical and the pediatrician administered another dose of GARDASIL. Concomitant therapies included SINGULAIR. The patient suffered from pain in her arm after the injection (since 14-OCT-2014). She was not experiencing any other symptoms. The patient sought medical attention via calling the doctors office back. No treatment was given for the event and no laboratory test were performed. The outcome of pain in her arm was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.


VAERS ID: 548413 (history)  
Age: 22.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-09-08
Onset:2014-09-10
   Days after vaccination:2
Submitted: 2014-10-17
   Days after onset:37
Entered: 2014-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV387A / 2 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
SMQs:

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: None performed or necessary
CDC Split Type:

Write-up: Intense induration, erythema, tenderness to palpation occurring in the area circumscribing the anthrax vaccination area approx. 10 cm in diameter covering entire deltoid area, no fluctuance or signs of abscess. Pt provided Benadryl, given education, followed closely. Site improved following day and resolved without further intervention necessary. Two unplanned visits to clinic. This was shot 3 of Anthrax series. Pt never had any systemic symptoms and had not had this kind of a reaction prior to this one.


VAERS ID: 548453 (history)  
Age: 22.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2014-10-16
Onset:2014-10-16
   Days after vaccination:0
Submitted: 2014-10-17
   Days after onset:1
Entered: 2014-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI190AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Pain, Pain in extremity, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Large welt, approximately 4.5 inches long with pain upon moving arms.


VAERS ID: 548610 (history)  
Age: 22.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2014-10-16
Onset:2014-10-17
   Days after vaccination:1
Submitted: 2014-10-17
   Days after onset:0
Entered: 2014-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T55907 / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
SMQs:, Extravasation events (injections, infusions and implants) (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: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: TENDER AREA AROUND VACCINATION SITE, WARM FEEL LIKE. UPON EXAMINATION, THERE IS A 2 INCHES RED AREA AROUND VACCINATION SITE, TENDER AND HARD.


VAERS ID: 548727 (history)  
Age: 22.0  
Gender: Female  
Location: Utah  
Vaccinated:2014-10-18
Onset:2014-10-18
   Days after vaccination:0
Submitted: 2014-10-18
   Days after onset:0
Entered: 2014-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. K003533 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Cold sweat, Feeling hot, Lethargy, Nausea, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Biotin
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: No
CDC Split Type:

Write-up: Patient is complaining of feeling hot, clammy, nauseas, lethargic, and shaky 30 minutes after vaccination. States that she is still feeling lethargic and shaky one hour later. All other symptoms have resolved.


VAERS ID: 548792 (history)  
Age: 22.0  
Gender: Female  
Location: Kansas  
Vaccinated:2014-10-08
Onset:2014-10-09
   Days after vaccination:1
Submitted: 2014-10-20
   Days after onset:11
Entered: 2014-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI196AE / 0 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J011799 / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site erythema, Local swelling, Pain, Pyrexia, Tenderness
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Unknown
Current Illness: NONE.
Preexisting Conditions: ASTHMA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client has fever of 102, body aches, swelling of Rt. arm increasing diameter of Rt. upper arm approx 2 inches, erythema only to Rt. upper arm, and decrease limb mobility. Client saw her Dr. on the afternoon of 10-10-14 to have him check for allergic reaction. No treatment given. Client recovered with mild tenderness to Rt. arm on 10-14-14.


VAERS ID: 548799 (history)  
Age: 22.0  
Gender: Male  
Location: Michigan  
Vaccinated:2014-10-09
Onset:2014-10-09
   Days after vaccination:0
Submitted: 2014-10-17
   Days after onset:8
Entered: 2014-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI198AA / - RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Dyspnoea, Flushing, Palpitations, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: None
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA140268

Write-up: Initial case received on 10 October 2014 from a healthcare professional. A 22 year old male patient was vaccinated intramuscularly with FLUZONE on 09 October 2014 into the right deltoid, batch number UI198AA. Twenty minutes after vaccination, the patient experienced shortness of breath, heart palpitations and flushing. The patient went to the urgent care clinic and was treated with EPIPEN, BENADRYL and steroids. The patient was transferred by ambulance to the emergency department where he was treated with unspecified fluids. The symptoms waned and the patient requested to leave before being evaluated and left the hospital at 9:00 PM on 09 October 2014 which was 4 hours and 40 minutes after receiving FLUZONE vaccine. The patient reported on 10 October 2014 that the previous symptoms have resolved but he has tingling in his arms. The patient had no known allergies and was not ill at the time of vaccination. Concomitant medications and laboratory tests were not reported. The patient outcome is unknown. Documents held by sender: None.


VAERS ID: 549623 (history)  
Age: 22.0  
Gender: Female  
Location: Georgia  
Vaccinated:2014-10-15
Onset:2014-10-15
   Days after vaccination:0
Submitted: 2014-10-20
   Days after onset:5
Entered: 2014-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI185AA / 0 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site inflammation
SMQs:, 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:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had a red, inflamed 1 1/2 inch diameter circular area around the injection site that was.


VAERS ID: 549329 (history)  
Age: 22.0  
Gender: Female  
Location: Colorado  
Vaccinated:2014-10-14
Onset:2014-10-14
   Days after vaccination:0
Submitted: 2014-10-14
   Days after onset:0
Entered: 2014-10-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI212AA / 2 RA / IM

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

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: Received lower dose than recommended by manufacturer.


VAERS ID: 549733 (history)  
Age: 22.0  
Gender: Female  
Location: Maryland  
Vaccinated:2014-10-22
Onset:2014-10-22
   Days after vaccination:0
Submitted: 2014-10-22
   Days after onset:0
Entered: 2014-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T50807 / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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:
Current Illness: Snuffy nose
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Syncope following flu vaccine. Patient sat down and recovered within 10 minutes.


VAERS ID: 549378 (history)  
Age: 22.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-09-18
Onset:2014-09-18
   Days after vaccination:0
Submitted: 2014-10-23
   Days after onset:35
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1410801 / - LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), 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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Participant began vomiting 2 hours after receiving vaccine. Very nauseous. Stated that she ate lunch after receiving vaccine.


VAERS ID: 549382 (history)  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2014-10-20
Onset:2014-10-20
   Days after vaccination:0
Submitted: 2014-10-23
   Days after onset:3
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K004204 / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Rash generalised, 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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives and Rash all over body.


VAERS ID: 549986 (history)  
Age: 22.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2014-10-15
Onset:2014-10-17
   Days after vaccination:2
Submitted: 2014-10-24
   Days after onset:7
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Military       Purchased by: Military
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Ascending numbness bilat arms, no paralysis.


VAERS ID: 550007 (history)  
Age: 22.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-10-18
Onset:2014-10-20
   Days after vaccination:2
Submitted: 2014-10-25
   Days after onset:5
Entered: 2014-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Diarrhoea, Headache, Nausea, Pain, Rhinorrhoea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Other Medications: Lo estrin fe 1.5/30
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diarrhea, nausea, body aches, headache, runny nose, low temperature. Ongoing at this time.


VAERS ID: 553797 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-26
Entered: 2014-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K001504 / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA012342

Write-up: This spontaneous report as received from a registered nurse via a company representative refers to a currently 22 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (injection, lot # K001504, expiry date 28-MAR-2015, dose and route were not provided).. On an unknown date the patient experienced cellulitis after receiving PNEUMOVAX 23. The patient sought medical attention by office visit on an unspecified date. The outcome of the event was not provided. Additional information has been requested.


VAERS ID: 550233 (history)  
Age: 22.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-10-24
Onset:2014-10-24
   Days after vaccination:0
Submitted: 2014-10-27
   Days after onset:3
Entered: 2014-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 09949211A / 3 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Back pain, Body temperature increased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe muscle pain and low back pain with temp elevation lasting 3days gradually subsiding.


VAERS ID: 550313 (history)  
Age: 22.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-10-08
Onset:2014-10-13
   Days after vaccination:5
Submitted: 2014-10-27
   Days after onset:14
Entered: 2014-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / - LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), 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: SPRINTEC; VITAMIN D
Current Illness: NONE
Preexisting Conditions: ASTHMA; ALLERGIC TO PINEAPPLE, DUSTMITES, CATS, GOOSE DOWN
Diagnostic Lab Data:
CDC Split Type:

Write-up: PAINFUL/SORE SHOULDER, NUMBNESS AND TINGLING THROUGHOUT ARM AND HAND.


VAERS ID: 551102 (history)  
Age: 22.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-10-30
Onset:2014-10-30
   Days after vaccination:0
Submitted: 2014-10-30
   Days after onset:0
Entered: 2014-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5G943 / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Abdominal pain, Feeling of body temperature change, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NA
Preexisting Conditions: Employee states she was diagnosed with allergies to fruits and vegetables during childhood but has continued eating fruits and vegetables to help minimize the allergic reactions.
Diagnostic Lab Data:
CDC Split Type:

Write-up: At 12:05pm employee with complaints of abdominal cramping (pain scale 7 or 8, with 10 being highest) and seeing occassional spots with peripheral vision; Temp 98.9. At 12:44 employee rates abdominal cramping at a 6, peripheral vision spots no longer present; compliants of being hot and cold.


VAERS ID: 551512 (history)  
Age: 22.0  
Gender: Female  
Location: Maryland  
Vaccinated:2014-10-30
Onset:2014-10-30
   Days after vaccination:0
Submitted: 2014-10-30
   Days after onset:0
Entered: 2014-10-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 7329G / 0 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Crohn''s Disease
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt within one minute of FLUARIX being administrated experience severe shortness of breath and was given one dose of Epipen 0.3 mg and responded well.


VAERS ID: 553461 (history)  
Age: 22.0  
Gender: Female  
Location: Illinois  
Vaccinated:2014-11-11
Onset:2014-11-12
   Days after vaccination:1
Submitted: 2014-11-13
   Days after onset:1
Entered: 2014-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K007262 / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K006137 / 1 LA / SC

Administered by: Unknown       Purchased by: Private
Symptoms: Feeling hot, Induration, Peripheral swelling
SMQs:, Cardiac failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zolpidem Tartrate, Symbicort, Paxil, Nasonex, Flomax, Bupropion HCL
Current Illness: Sinusitis and seasonal allergies
Preexisting Conditions: Allergies: grass pollen, molds, tree pollen, dogs/cats/horses; Medical Hx: allergic rhinitis, asthma, PTSD
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling with firmness and warmth 4.5cm x 5.5cm to right arm.


VAERS ID: 553585 (history)  
Age: 22.0  
Gender: Female  
Location: Virginia  
Vaccinated:2014-10-27
Onset:2014-10-28
   Days after vaccination:1
Submitted: 2014-11-13
   Days after onset:16
Entered: 2014-11-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 45HX7 / 0 LA / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (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: Sulfa
Diagnostic Lab Data: Patient, tx and PE
CDC Split Type:

Write-up: Received flu vaccine 10-27-14. Awoke with pruritic rash 10-28-14. Concentrated in (L) axillae, antecubital fossa and under breast. Treated with topical antifungal and steroid without relief. Then antibiotics and oral steroid.


VAERS ID: 553606 (history)  
Age: 22.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-10-29
Onset:2014-11-04
   Days after vaccination:6
Submitted: 2014-11-14
   Days after onset:10
Entered: 2014-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 552011A / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Paraesthesia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Generic OCP
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Lab tests pending; Neurology referral pending
CDC Split Type:

Write-up: Onset of tremor right hand and arm for 20 minutes. Recurrent until present in right arm, then developed tremor in left arm/hand and left leg. No nausea, dizziness, headache. No weakness, numbness. Did have some ''tingling'' in right arm/hand.


VAERS ID: 555112 (history)  
Age: 22.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2014-11-18
Onset:2014-11-20
   Days after vaccination:2
Submitted: 2014-11-21
   Days after onset:1
Entered: 2014-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS ZE4G7 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4327T / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K002923 / 0 RA / SC

Administered by: Public       Purchased by: Private
Symptoms: 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contraceptive
Current Illness: Denies
Preexisting Conditions: Denies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client reports left arm swelling at injection site sates now size of her palm and "feels hot".


VAERS ID: 555167 (history)  
Age: 22.0  
Gender: Female  
Location: Iowa  
Vaccinated:2014-10-28
Onset:2014-10-28
   Days after vaccination:0
Submitted: 2014-11-21
   Days after onset:24
Entered: 2014-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / SYR

Administered by: Public       Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness, Pain in extremity, Paraesthesia, Rotator cuff syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (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:
CDC Split Type:

Write-up: Severe pain in left shoulder around injection site. Limited mobility of left arm, tingling in left hand, weakness and sharp pains throughout arm and left shoulder around deltoid. Damage to rotator cuff on left shoulder.


VAERS ID: 556934 (history)  
Age: 22.0  
Gender: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-11-21
Entered: 2014-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Viral titre decreased
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Varicella virus test, lower than normal titers
CDC Split Type: WAES1411USA009839

Write-up: This spontaneous report as received from a physician via a company representative refers to a 22 year old male patient. On unknown dates the patient was vaccinated with 2 separate doses of VARIVAX (Merck) (strength, dose, injection site and lot # not reported). On an unknown date the patient was found to have lower than normal titers after the 2 doses of VARIVAX (Merck). The outcome of event was unknown. The causal relationship was not reported. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 556517 (history)  
Age: 22.0  
Gender: Male  
Location: Kansas  
Vaccinated:2014-11-26
Onset:2014-11-26
   Days after vaccination:0
Submitted: 2014-12-03
   Days after onset:7
Entered: 2014-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3000843 / 0 - / PO

Administered by: Public       Purchased by: Private
Symptoms: Abdominal pain upper
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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe stomach cramping.


VAERS ID: 557055