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Found 606967 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

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VAERS ID: 513408 (history)  
Age: 11.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2013-11-15
Onset:2013-11-15
   Days after vaccination:0
Submitted: 2013-11-17
   Days after onset:2
Entered: 2013-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / -
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / -

Administered by: Private       Purchased by: Other
Symptoms: Erythema, Pain, Pruritus, 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: Zyrtec, Singulair, Flovent, Tylenol
Current Illness: Headache, sore throat
Preexisting Conditions: Allergies (environmental, antibiotics, ADHD meds, pineapple), Asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness, swelling, severe pain, itching.


VAERS ID: 513615 (history)  
Age: 11.0  
Gender: Female  
Location: Washington  
Vaccinated:2013-11-14
Onset:2013-11-14
   Days after vaccination:0
Submitted: 2013-11-18
   Days after onset:4
Entered: 2013-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. B12013 / 0 - / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 0 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / 0 LA / UN

Administered by: Private       Purchased by: Public
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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt fainted after receiving HPV. Pt rolled back onto exam table. No injury noted.


VAERS ID: 513651 (history)  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:2013-10-25
Onset:2013-10-26
   Days after vaccination:1
Submitted: 2013-11-18
   Days after onset:23
Entered: 2013-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2154 / 0 - / IN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 494G5 / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13014 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS B5X7M / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood creatinine normal, Blood urea normal, Coagulation test normal, Contusion, Haematocrit normal, Haemoglobin normal, Liver function test normal, Mouth haemorrhage, Petechiae, Platelet count decreased, White blood cell count increased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (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? Yes, 6 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None according to father.
Preexisting Conditions: No allergies or chronic illness per father. Loose tooth for a few days.
Diagnostic Lab Data: Platelets 2000 WBC 12.1, Hgb 11.9, Hct 35.1, coags normal, BUN, Creatinine, and Liver enzymes normal.
CDC Split Type:

Write-up: Per father: Child woke up in the AM before school and noticed bleeding from mouth. Had a loose tooth for several days but bleeding appeared more than usual. Over course of day in school bruising and petechiae were noticed. Took child to Urgent Care where platelet count was 2000. Transferred to Hospital for admission and treatment.


VAERS ID: 513803 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2013-11-18
Onset:2013-11-19
   Days after vaccination:1
Submitted: 2013-11-19
   Days after onset:0
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH852AA / - UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4886AB / 0 UN / IM

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

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

Write-up: Fever and muscle aches.


VAERS ID: 513888 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2012-11-13
Onset:2013-11-15
   Days after vaccination:367
Submitted: 2013-11-15
   Days after onset:0
Entered: 2013-11-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH9264A / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 0 RA / UN

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

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

Write-up: Mother called and stated that the nurse called her and told her the R arm where injection was given was red and swollen and seemed to be gettng worse. Mother referred to PCP or ER.


VAERS ID: 514036 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-13
Onset:2013-11-13
   Days after vaccination:0
Submitted: 2013-11-13
   Days after onset:0
Entered: 2013-11-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH891AA / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4633BA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4689AA / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood glucose, Gaze palsy, Tension, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (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: After admin of vaccines pt became tense, eyes rolled towards back of head, began to shake. Pt was laid down on table shaking stopped. Vitals taken. MD assessed pt. Pt kept in office for 30 mins. Orthostatic b/s done. OJ given. Ice pack placed behind pt''s neck. Pt d/c to home after stabilized.


VAERS ID: 514041 (history)  
Age: 11.0  
Gender: Female  
Location: Puerto Rico  
Vaccinated:2013-04-12
Onset:2013-04-12
   Days after vaccination:0
Submitted: 2013-11-20
   Days after onset:222
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B094AA / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H016761 / 1 LA / SC

Administered by: Private       Purchased by: Other
Symptoms: Convulsion, Loss of consciousness, Salivary hypersecretion, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE REPORTED
Current Illness: NONE REPORTED
Preexisting Conditions: NONE REPORTED
Diagnostic Lab Data: BP- 109/50, P-62, R-17, T-36.6
CDC Split Type: PR1013

Write-up: AFTER RECEIVING THE VACCINES THE PATIENT BEGAN SHOWING SIGNS OF CONVULSION, BECAME UNCONSCIOUS AND BEGAN TO SALIVATE WITHOUT VERBAL OR TACTIL RESPONSE. AFTER A SHORT PERIOD OF TIME SHE AWOKE. VITAL SIGNS WERE TAKEN: BP- 109/50, P-62, R-17, T-36.6.


VAERS ID: 514072 (history)  
Age: 11.0  
Gender: Male  
Location: Missouri  
Vaccinated:2013-01-16
Onset:2013-01-17
   Days after vaccination:1
Submitted: 2013-01-25
   Days after onset:8
Entered: 2013-11-20
   Days after submission:299
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 07749221A / - LA / UN

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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient arm was swollen and red, went to doctor and was prescribed BACTRIM.


VAERS ID: 514073 (history)  
Age: 11.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2013-10-21
Onset:2013-10-22
   Days after vaccination:1
Submitted: 2013-10-25
   Days after onset:3
Entered: 2013-11-20
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003532 / 1 LA / SC

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

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

Write-up: Localized redness and pain. No vesicle or fever.


VAERS ID: 514087 (history)  
Age: 11.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2013-10-28
Onset:2013-10-28
   Days after vaccination:0
Submitted: 2013-10-31
   Days after onset:3
Entered: 2013-11-20
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH921AA / 3 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR 33465 / 5 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Balance disorder, Dizziness, Headache, Immediate post-injection reaction, Laboratory test, Neurological examination, Nuclear magnetic resonance imaging
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

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: Albuterol
Current Illness: Had no illness.
Preexisting Conditions: RSD; Pain in arm.
Diagnostic Lab Data: Neurology eval.; MRI; Labs; Fluids; Pain meds.
CDC Split Type:

Write-up: Headache immediately after immunizations, dizzy, balance issues. Patient subsequently seen in ER for further eval.


VAERS ID: 514090 (history)  
Age: 11.0  
Gender: Male  
Location: Indiana  
Vaccinated:2013-11-14
Onset:2013-11-15
   Days after vaccination:1
Submitted: 2013-11-20
   Days after onset:5
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS KC2N2 / 0 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J14061 / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J002866 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4585AB / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Local swelling, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Recieved call from school nurse reporting left arm swollen and sore. Child was sent home with fever and vomiting also.


VAERS ID: 514265 (history)  
Age: 11.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2013-11-21
Onset:2013-11-21
   Days after vaccination:0
Submitted: 2013-11-21
   Days after onset:0
Entered: 2013-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4789AA / 6 LA / IM

Administered by: Private       Purchased by: Unknown
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: fever 104~Influenza (Seasonal) (FluMist)~~7.00~Patient
Other Medications: None known
Current Illness: None known
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Syncopal episode several minutes after flu shot in arm. Pt helped to floor by RN and mom. Juice given. Syncopal episode lasted seconds.


VAERS ID: 514431 (history)  
Age: 11.0  
Gender: Female  
Location: Colorado  
Vaccinated:2013-07-11
Onset:2013-08-13
   Days after vaccination:33
Submitted: 2013-11-22
   Days after onset:101
Entered: 2013-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021861 / 0 AR / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4594AB / 0 AR / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4617AA / 0 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test normal, Computerised tomogram normal, Confusional state, Dizziness, Electrocardiogram normal, Electroencephalogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging normal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Patient had an EKG, EEG, MRI, CT scan and blood work. Everything came back normal. There was no explanation for the seizure. The doctors could not determine whether or not she would experience another seizure.
CDC Split Type:

Write-up: Dizziness and confusion followed by a grand mal seizure. We have no family history of seizures.


VAERS ID: 514501 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-20
Onset:2013-11-21
   Days after vaccination:1
Submitted: 2013-11-22
   Days after onset:1
Entered: 2013-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH899AB / - RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 0 LA / IM

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

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

Write-up: Per mother redness and swelling LD noted 11/21/13 day after shots given, pt. in clinic 11-22-13 per mother swelling and redness have gone down.


VAERS ID: 514672 (history)  
Age: 11.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2013-11-22
Onset:2013-11-22
   Days after vaccination:0
Submitted: 2013-11-22
   Days after onset:0
Entered: 2013-11-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13421P / - LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fall, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10-15 minutes after administering flu vaccine 11 year old female became faint and dropped to floor. Responded immediately after and seemed fine with some nausea. Had pt transported for safety precautions. Mother was with child.


VAERS ID: 514687 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2013-11-21
Onset:2013-11-21
   Days after vaccination:0
Submitted: 2013-11-25
   Days after onset:4
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12092 / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C403AA / 0 RA / UN

Administered by: Private       Purchased by: Public
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? 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: (L) arm swollen, redness.


VAERS ID: 514705 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-06
Onset:2013-11-09
   Days after vaccination:3
Submitted: 2013-11-26
   Days after onset:17
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Headache
SMQs:, Retroperitoneal fibrosis (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: Pyrexia, She had a reaction on an unspecified date to an unspecified spinal meningitis vaccine when she was 4 months old.
Diagnostic Lab Data:
CDC Split Type: WAES1311USA006698

Write-up: This spontaneous report as received from a consumer refers to 11 year old female patient (consumer's daughter). The patient's medical history included severe fever on an unspecified date to an unspecified spinal meningitis vaccine when she was 4 months old. On 06-NOV-2013, the patient was vaccinated with GARDASIL (dose, route of administration, lot#/batch# were not reported). No concomitant medications reported. On 09-NOV-2013, the patient experienced severe backache which began 4 days after the administration of the vaccine. On 12-NOV-2013, the patient experienced severe headache. It was also reported that she had a reaction on an unspecified date to an unspecified spinal meningitis vaccine when she was 4 months old and required hospitalization in an unspecified hospital, for “a couple of days” on an unspecified date. There was no diagnostics studies performed. The outcome of severe headache and severe backache was reported as not recovered/not resolved. Additional information has been requested.


VAERS ID: 514735 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2013-10-19
Onset:2013-11-01
   Days after vaccination:13
Submitted: 2013-11-26
   Days after onset:25
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
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? 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: WAES1311USA010034

Write-up: This spontaneous report as received from a physician refers to 11 year (also reported as 11 or 12) old patient. On 19-OCT-2013 the patient was vaccinated with GARDASIL dose second (also reported second or third dose) (lot #/batch #, route of administration, dosage were not reported). No concomitant medication was reported. On 01-NOV-2013, the patient experienced seizure. The physician was unable to clarify this information or provide any further details other than he thinks the patient may have been seen in the emergency room. The outcome of seizure was reported as recovered/resolved. Upon internal review the event seizure was considered to be medically significant. Additional information has been requested.


VAERS ID: 514752 (history)  
Age: 11.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2013-11-18
Onset:2013-11-20
   Days after vaccination:2
Submitted: 2013-11-21
   Days after onset:1
Entered: 2013-11-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / - LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 22C9R / - RA / IM

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

Write-up: Mother refers patient presented redness, swelling in right arm and warm to touch.


VAERS ID: 514773 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2013-11-22
Onset:2013-11-22
   Days after vaccination:0
Submitted: 2013-11-22
   Days after onset:0
Entered: 2013-11-26
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021861 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4617AA / 0 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain upper, Crying, Hyperhidrosis, Moaning, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Pt. was super anxious about vaccines and was crying after her 3rd (HPV). She started sweating (1 min) and looked pale and crying louder/moaning. C/O stomach ache and wanting to vomit. I had pt rest on my shoulder and gave her water and took her shirt off. Brought some cool compresses. Took BP 2 times. Had pt wait in office x 30 min. We were so worried that we forgot to give FLUMIST. Pt r/s appt OTP for 11/26/13.


VAERS ID: 514828 (history)  
Age: 11.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2013-10-25
Onset:2013-11-19
   Days after vaccination:25
Submitted: 2013-11-26
   Days after onset:7
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Private       Purchased by: Other
Symptoms: Borrelia test negative, Extraocular muscle paresis, Facial paresis, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Ocular motility 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: No
Preexisting Conditions: No
Diagnostic Lab Data: Lyme Disease test negative
CDC Split Type:

Write-up: Right side of face weakness, mouth and eyes - Bell''s Palsy diagnosed.


VAERS ID: 514853 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-11-26
Onset:2013-11-26
   Days after vaccination:0
Submitted: 2013-11-26
   Days after onset:0
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4633BA / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Loss of consciousness, Syncope
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), Cardiomyopathy (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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. briefly had a fainting spell for 2-3 seconds regained consciousness immediately and is doing fine now.


VAERS ID: 514926 (history)  
Age: 11.0  
Gender: Male  
Location: Michigan  
Vaccinated:2013-11-19
Onset:2013-11-19
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:8
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 37R99 / 0 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021861 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U44180A / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Muscular weakness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Lower extremity weakness and syncope started 11-19-13 evening resolved on 11-22-13. No treatment.


VAERS ID: 514973 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-11-26
Onset:2013-11-26
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:1
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4789AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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: APAP
Current Illness: Axillary pain
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 12 hr after vaccine, pt had temp of 40 C. Myalgia, dizziness, and generalized weakness. F/up call in morning - fever cleared.


VAERS ID: 515003 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-27
Onset:2013-11-27
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:0
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J0099993 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4585AB / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4667AA / 0 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Clonus, Loss of consciousness, Tremor
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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 10 minutes of receiving his immunizations he lost consciousness and his hands/arms were shaking with his hands in a "clonic" position. Episode lasted less than 30 sec. - witnessed by RN and LVN.


VAERS ID: 515038 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2013-10-30
Onset:2013-11-06
   Days after vaccination:7
Submitted: 2013-11-08
   Days after onset:2
Entered: 2013-11-27
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH921AB / 1 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021861 / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Dyskinesia, Eyelid function disorder
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (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:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient began to have changes in smile and when she closed right eye. Right eye would not close completely and right side of mouth would not move. She was treated with prednisolone 1 mg - 5 day treatment.


VAERS ID: 515042 (history)  
Age: 11.0  
Gender: Male  
Location: Washington  
Vaccinated:2013-11-18
Onset:2013-11-19
   Days after vaccination:1
Submitted: 2013-11-27
   Days after onset:8
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AE / 2 LA / IM

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

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

Write-up: Red, swollen (L) upper arm.


VAERS ID: 515047 (history)  
Age: 11.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2013-11-19
Onset:2013-11-19
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:8
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 3T549 / 0 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
SMQs:, Anaphylactic reaction (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: Amoxicillin; Selenium sulfide topical cream; Hydrocortisone topical cream
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Came into office on 11-22-13 and described redness and swelling at site of vaccine on left arm. Patient to continue with AUGMENTIN and to keep the area clean. Patient also came into office on 11-21-13 and described area as itching and painful to lift arm. AUGMENTIN given.


VAERS ID: 515048 (history)  
Age: 11.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2013-11-13
Onset:2013-11-14
   Days after vaccination:1
Submitted: 2013-11-27
   Days after onset:13
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Headache, 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: Listed on back
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had headache, rash on neck and back. Was told to give BENADRYL and TYLENOL per MD. Rash went away after giving BENADRYL per mom.


VAERS ID: 515037 (history)  
Age: 11.0  
Gender: Male  
Location: Oregon  
Vaccinated:2013-11-08
Onset:2013-11-12
   Days after vaccination:4
Submitted: 2013-11-29
   Days after onset:17
Entered: 2013-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2019 / 0 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4657AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4456AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain lower, Activities of daily living impaired, Appendicitis, Blood test normal, Dizziness, Ear pain, Headache, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pyrexia, Streptococcus test negative, Urine analysis normal, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: • 3 different blood samples drawn for tests between Nov 13 – 24 – all normal • Strep test (Nov 18th) - negative • Urine test (Nov 24th)– normal • MRI (Nov 25th) - normal
CDC Split Type:

Write-up: Nov. 12th (the 4th day after receiving the flu vaccine): • Strong headache, dizziness, vomiting, ear ache • The dizziness, vomiting, and ear ached lasted for a couple of days, and a headache continued. • He saw a doctor twice that week. Gave Tylenol that week. Nov. 18th • Stronger headache returned, along with vomiting, fever 101.5. The fever was for about 3 days. • Ibuprofen (didn't help) Nov. 21st • One doctor thought she found symptoms of “hand, foot, mouth” disease, but this diagnoses changed quickly. • Headache continues Nov. 24th • Persistent abdominal pain, lower right side • Didn't seem to have other symptoms of appendicitis, and that pain diminished the next day. • Headache continues • Prescribed naproxen (didn't help) • Ordered MRI – done Nov 25th – result “normal” Nov 26th • Headache continues • Gave “Migranal” nasal spray for migraine – made the headache worse • Gave 15 mg Toradol (IV) & 500 mg Depacon – headache intensity lessoned somewhat, from a “7” to “4.5”, but didn't get rid of it. • Prescribed further migraine medicine – Migrelief, Omega 3 fatty acids, vitamin D 2000, more Migranal, and Maxalt. (We didn't try the Maxalt since it's supposed to be given at the start of a migraine, and due to the conflict with Migranal.) Nov. 27th • Headache continues • Evaluated at OHSU ER. Discussed option of doing spinal tap, but didn't do that test yet. There was not a strong push for it, given the absence of other symptoms. • Gave Vicodin and nausea medicine Zofran. Helped somewhat, but headache still continues. • Referred to Kaiser neurologist after the Thanksgiving holiday Nov. 28th • Still using Vicodin. Seems to help some, but the headache continues, level 5 or 6 on his scale of 1-10. He has missed about 10 days of school. The headache continues. Each doctor has given the basic “neurological exam” – all have been normal.


VAERS ID: 515143 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-15
Onset:2013-11-15
   Days after vaccination:0
Submitted: 2013-11-15
   Days after onset:0
Entered: 2013-11-29
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002641 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 0 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal pain, Asthenia, Dizziness, Erythema, Generalised erythema, Nausea, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Dizziness, blurry vision, abd pain, weakness, redness face/body, nauseous.


VAERS ID: 515290 (history)  
Age: 11.0  
Gender: Female  
Location: Iowa  
Vaccinated:2013-11-22
Onset:2013-11-22
   Days after vaccination:0
Submitted: 2013-11-22
   Days after onset:0
Entered: 2013-12-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH909AB / 9 LA / IM

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

Write-up: Flu injection given. 5 minutes later pt. passed out. Pt was moved to exam table with elevated legs and observed for 15 minutes. Pt. exam by Dr. was normal. Pt. walked to parent vehicle without any problem.


VAERS ID: 515318 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2008-11-24
Onset:2008-11-24
   Days after vaccination:0
Submitted: 2013-12-02
   Days after onset:1834
Entered: 2013-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Pain
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
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: Pain.


VAERS ID: 515355 (history)  
Age: 11.0  
Gender: Male  
Location: Colorado  
Vaccinated:2013-12-02
Onset:2013-12-02
   Days after vaccination:0
Submitted: 2013-12-02
   Days after onset:0
Entered: 2013-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 1 RA / UN

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

Write-up: 12/02/2013, Fainting after HPV2.


VAERS ID: 515429 (history)  
Age: 11.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2013-05-09
Onset:2013-07-11
   Days after vaccination:63
Submitted: 2013-12-03
   Days after onset:145
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Abdominal discomfort, Abdominal pain upper, Anger, Fatigue, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Fatigue~Meningococcal Conjugate (Menactra)~1~11.33~Patient|Malaise~Meningococcal Conjugate (Menactra)~1~11.33~Patient|Nausea~Men
Other Medications: Prescribed Albuterol, but not actively taking at the time due to inactivity of asthma.
Current Illness: Texture Aversion, Asthma
Preexisting Conditions: Texture Aversion, Asthma
Diagnostic Lab Data: To Be Determined. I made the connection to the possibility that the nausea, stomach problems, fatigue and malaise COULD BE attributed to this drug November 15, 2013 and my child has yet to get to a specialist with her stomach just to SEE what could possibly be happening. I DO NOT EVER DISCOUNT THE FACT THAT THIS COULD BE COMING FROM THE MENACTRA VACCINE, HOWEVER IT COULD BE ULCERS OR OTHER PROBLEMS AS WELL. I do not think the fatigue and malaise are a result of her menstrual cycle trying to begin, which she actually has as of 11/22/2014.
CDC Split Type:

Write-up: Complaints of stomach ache began to occur off and on during this time. Add to this, as later determined after a period of 4 months of observation, that my child would be playing and running then all of a sudden have to stop and sit down and complain of being entirely exhausted, HAVING TO SIT DOWN TO REST. Also FREQUENT ANGER OUTBURSTS which could or could not be attributed to the child coming home from foster care after 70 days. THIS DRUG WAS ADMINISTERED TO MY CHILD AGAINST MY WISHES WHILE SHE WAS IN THE CUSTODY OF THE STATE.


VAERS ID: 515472 (history)  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2013-08-24
Onset:2013-08-24
   Days after vaccination:0
Submitted: 2013-12-03
   Days after onset:101
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 024011 / - LA / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F75398 / 1 RA / SYR

Administered by: Unknown       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Amnesia, Arthralgia, Back pain, Blood test, Computerised tomogram head, Disturbance in attention, Dysstasia, Headache, Influenza like illness, Joint instability, Lumbar puncture, Malaise, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal, Pneumonia mycoplasmal, Walking aid user, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: CT scan or the brain, a lumbar puncture, blood work 6 times, A full spine MRI, A brain MRI.
CDC Split Type:

Write-up: Flu like symptoms with no fever for 3 days. Tylenol for headaches. Then 1 month later oshe was on crutches with her knee buckling and low back pain. Then after 3 weeks it started to spread to her left knee, ankles and hips. She can''t walk or stand on her own so Dr sends us to Hospital for tests stayed 4 days. She now has severe joint pain from head to toe with headaches. They said she had micoplasma pneumonia and sent us home with a Z-pack. Went home in a wheel chair. 2 weeks later went back to hospital for a headache that lasted 6 days. Had a brain MRI they said was normal so we go home again. She can not go to school due to lack of concentration, memory loss and just overall doesn''t feel well so now she has been getting home instruction. Its now 7 weeks no walking and still in a lot of pain. We no longer see the Dr who gave her the shot.


VAERS ID: 515598 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2013-12-03
Onset:2013-12-03
   Days after vaccination:0
Submitted: 2013-12-04
   Days after onset:1
Entered: 2013-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UH4556AC / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UH4395AA / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D3
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient complained tightness of her throat. No difficulty breathing no edema noted, no rash or redness.


VAERS ID: 515636 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-12-03
Onset:2013-12-04
   Days after vaccination:1
Submitted: 2013-12-04
   Days after onset:0
Entered: 2013-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2019 / 0 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 4594AB / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4456AA / 0 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Decreased appetite, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Anorexia; sudden fever = 24 hours later = 102-103. Vomiting x 2 and arm soreness.


VAERS ID: 515627 (history)  
Age: 11.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2013-10-16
Onset:2013-10-17
   Days after vaccination:1
Submitted: 2013-12-02
   Days after onset:46
Entered: 2013-12-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006879 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Eye pain, Full blood count normal, Headache, Influenza virus test negative, Laboratory test normal, Lumbar puncture normal, Neck pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Arthritis (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: NASONEX; ZYRTEC
Current Illness: At time thought it was meningitis
Preexisting Conditions: Allergic rhinitis; Asthma; Migraines
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, headache and eye pain and neck pain - 24 hours after vaccine. Went to ER - normal lumbar puncture and CBC and chemistry rapid flu (-) in office.


VAERS ID: 515697 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2013-12-02
Onset:2013-12-03
   Days after vaccination:1
Submitted: 2013-12-05
   Days after onset:2
Entered: 2013-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4680AA / - LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4668AA / - RA / SYR

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1.5 x 3 cm area of faint erythema and induration and min tenderness (R) deltoid at site of DTAP injection.


VAERS ID: 515706 (history)  
Age: 11.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2013-11-20
Onset:2013-11-25
   Days after vaccination:5
Submitted: 2013-12-05
   Days after onset:10
Entered: 2013-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A13014 / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332BA / - LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site rash, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hx allergy to pork
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received MENVEO vaccine on 12/20/13. Developed rash at injection site on 11/25/2013. Rash also spread albows, nees, abdomen, hands. Itchy at times. No difficulty breathing. Pt referred derm and seen 12/7/13 and told by derm rash due MENVEO vaccine.


VAERS ID: 515723 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-12-05
Onset:2013-12-05
   Days after vaccination:0
Submitted: 2013-12-05
   Days after onset:0
Entered: 2013-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Dyskinesia, Heart rate decreased, Hypotension, Loss of consciousness, Syncope
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), Cardiomyopathy (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: Levoxothyrine.
Current Illness: None
Preexisting Conditions: Allergic to Amoxicillin, Congenital hypothyroidism
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fainting, jerking, loss of consciousness, low blood pressure (73/34), low heart rate (30s). Laid down, ice, rest.


VAERS ID: 515821 (history)  
Age: 11.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2013-10-20
Onset:2013-10-24
   Days after vaccination:4
Submitted: 2013-12-05
   Days after onset:42
Entered: 2013-12-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH719AC / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase normal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: (-) MRI spine/brain, L.P.; NL total CK
CDC Split Type:

Write-up: Progressive bilateral ascending muscular weakness - Guillain-Barre - hosp and rec IVIG. No resp. issues - in PT still recovering started 4 days after Var given.


VAERS ID: 515877 (history)  
Age: 11.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2013-12-03
Onset:2013-12-04
   Days after vaccination:1
Submitted: 2013-12-07
   Days after onset:3
Entered: 2013-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13011 / 0 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 35589 / 0 RA / UN

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

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

Write-up: Itching, swelling and good redness of left deltoid covering about 30 cm diameter area. Much improved (actually resolved) in 24 hours with 2 doses of Benadryl and within 18 hours of Keflex.


VAERS ID: 516140 (history)  
Age: 11.0  
Gender: Male  
Location: Kansas  
Vaccinated:2013-12-09
Onset:2013-12-09
   Days after vaccination:0
Submitted: 2013-12-10
   Days after onset:1
Entered: 2013-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH898AC / - LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS K555K / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13014 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 74AP3 / 0 RA / IM

Administered by: Unknown       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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash to upper chest, no hives or swelling of ears or lips, no difficulty breathing.


VAERS ID: 516164 (history)  
Age: 11.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2013-12-10
Onset:0000-00-00
Submitted: 2013-12-10
Entered: 2013-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4127AA / - RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine ordered by provider, took wrong vial out of fridge and gave to another nurse to administer pt. wrong vaccine given to nurse to administer.


VAERS ID: 516249 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2013-12-02
Onset:2013-12-03
   Days after vaccination:1
Submitted: 2013-12-05
   Days after onset:2
Entered: 2013-12-11
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4689AA / 0 LA / IM

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

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: Large local inflammatory reaction in both arms. Already resolving in size and intensity.


VAERS ID: 516286 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2013-12-03
Onset:2013-12-04
   Days after vaccination:1
Submitted: 2013-12-06
   Days after onset:2
Entered: 2013-12-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X12129 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site macule, Vaccination site warmth
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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Macular erythema thats warm to touch around site where vaccines were administered. 12 on diameter of erythema. No treatment required.


VAERS ID: 516577 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2013-12-12
Onset:2013-12-13
   Days after vaccination:1
Submitted: 2013-12-13
   Days after onset:0
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332BA / 0 LA / IM

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

Write-up: Mother of patient was notified by school of child''s (L) arm w/ redness and swelling came to office for evaluation.


VAERS ID: 516580 (history)  
Age: 11.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2013-01-26
Onset:2013-02-09
   Days after vaccination:14
Submitted: 2013-12-13
   Days after onset:307
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. H010437 / 0 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016960 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4585AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4152AA / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H014194 / 1 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram, Dysarthria, Dysphagia, Headache, Mental status changes, Nuclear magnetic resonance imaging, Pain
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CT; MRI
CDC Split Type:

Write-up: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.


VAERS ID: 516585 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-12-02
Onset:2013-12-03
   Days after vaccination:1
Submitted: 2013-12-13
   Days after onset:10
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 4735D / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4618AA / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema
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: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type: TX130044PU

Write-up: Redness 20x18 left arm.


VAERS ID: 516699 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:2013-10-29
Onset:0000-00-00
Submitted: 2013-12-16
Entered: 2013-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2109 / 1 - / IN

Administered by: Other       Purchased by: Public
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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: None.


VAERS ID: 516722 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-12-11
Onset:2013-12-11
   Days after vaccination:0
Submitted: 2013-12-13
   Days after onset:2
Entered: 2013-12-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 2 LA / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Dizziness, Headache, Injection site pain, Pain in extremity, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Developed fever, tingling in extremities, bad headache, pain in both arms, pain over injection site and dizziness.


VAERS ID: 517153 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2013-12-17
Onset:2013-12-19
   Days after vaccination:2
Submitted: 2013-12-19
   Days after onset:0
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4597AB / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4655AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site swelling
SMQs:, Anaphylactic reaction (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: None
Current Illness: Mild cough/cold symptoms, afebrile
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Redness and swelling around injection site and spreading to underarm. Started on cephalexin 500 mg PO TID for 10 days on 12/19/13.


VAERS ID: 517268 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2013-12-10
Onset:2013-12-11
   Days after vaccination:1
Submitted: 2013-12-12
   Days after onset:1
Entered: 2013-12-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 7395G / 0 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Injection site rash, Lymphadenopathy, Pruritus
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: Fluticasone nasal spray
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bullseye rash around injection site swollen armpit/lymph nodes red, itchy.


VAERS ID: 517348 (history)  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2012-07-16
Onset:2012-07-16
   Days after vaccination:0
Submitted: 2013-12-20
   Days after onset:522
Entered: 2013-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B079CA / 0 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Body temperature increased, Headache
SMQs:, Neuroleptic malignant syndrome (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 known
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache and temperature elevated during the 36 hours after the vaccination. Temperaure was as high as 105F. Used Tylenol, Ibuprofen, and cool baths to control temperature.


VAERS ID: 517447 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-07
Onset:2013-11-07
   Days after vaccination:0
Submitted: 2013-12-23
   Days after onset:46
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (HEXAVAC) / SANOFI PASTEUR - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       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? 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: WAES1312USA006364

Write-up: This spontaneous report was received from a medical assistant via company representative refers to approximately 11 year old female patient. On 07-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # and dosage regimen unknown), meningococcal vaccine (unspecified) (lot # and dosage regimen unknown) and HEXAVAC (also reported as tdap) (manufacturer unknown) (lot # and dosage regimen unknown). On 07-NOV-2013, a few hours after administration of the vaccines the patient developed rash on her chest. Reportedly the rash resolved after 1 week (approximately 14-NOV-2013). Reporter''s causality was not provided. Additional information has been requested.


VAERS ID: 517556 (history)  
Age: 11.0  
Gender: Male  
Location: Hawaii  
Vaccinated:2013-12-21
Onset:2013-12-21
   Days after vaccination:0
Submitted: 2013-12-21
   Days after onset:0
Entered: 2013-12-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 7G47T / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, 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:
Current Illness: None
Preexisting Conditions: Allergies-Amoxicillin, sulfa drugs; Rhinitis; Childhood asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient blacked out for 4-5 seconds after administration of 2nd vaccination at 8:05am. He has high anxiety to needles and held his breath during immunization despite being reminded by father and Medical Assistant to keep breathing. He was in a sitting position leaning on father when incident occurred. We called his name and he began talking to us. We laid him down for 15 min post incident and gave him water and took BP. Pt left happy and alert. Vitals were normal.


VAERS ID: 517621 (history)  
Age: 11.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2013-11-19
Onset:2013-11-19
   Days after vaccination:0
Submitted: 2013-12-24
   Days after onset:35
Entered: 2013-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. BK2021 / 0 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 44445AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR E5957 / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (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 SEEN ON 11/22/2013 11:00 AM WITH A LARGE LOCAL REACTION ON RIGHT UPPER ARM FROM MENACTRA. AREA WARM, RED, AREA MEASURED 20 BY 12 CMS


VAERS ID: 517628 (history)  
Age: 11.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2013-12-10
Onset:2013-12-11
   Days after vaccination:1
Submitted: 2013-12-13
   Days after onset:2
Entered: 2013-12-24
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12127 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS N2K27 / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:

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: Atopic dermatitis; Multiple environmental allergies; Eczema
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Painful, warm swelling at vaccine site.


VAERS ID: 517959 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2013-12-24
Onset:0000-00-00
Submitted: 2013-12-30
Entered: 2013-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 0 RA / IM

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

Write-up: Diffuse skin rash.


VAERS ID: 518015 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-07-24
Onset:0000-00-00
Submitted: 2013-12-31
Entered: 2013-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010915 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H016912 / 2 RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, 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), Vestibular disorders (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: Menactra
Current Illness: Unknown
Preexisting Conditions: Anxiety, when she was informed that she would be receiving four vaccines
Diagnostic Lab Data:
CDC Split Type: WAES1312USA012517

Write-up: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL and VARIVAX. Information regarding dose, route and lot number was not provided. Concomitant therapies included MENACTRA and TDAP (manufacturer unknown). The nurse reported that the patient was very anxious when she was informed that she would be receiving four vaccines in a clinic visit on an unspecified date. When the patient received dose of GARDASIL, VARIVAX, MENACTRA, and TDAP, the patient became “dizzy and passed out.” The patient recovered fully, and the nurse attributed the patient's adverse experience to her own state-of-mind at the time of receipt of the four vaccine doses. The nurse stated that “her reaction wasn't unusual.” “Patient became dizzy and passed out” was determined medically significant upon internal review. Additional information has been requested.


VAERS ID: 518216 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-18
Entered: 2014-01-02
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram thorax abnormal, Cough, Fungal infection, Hypotension, Influenza A virus test positive, Myalgia, Pneumonia fungal, Polymerase chain reaction, Pulmonary mass, Pyrexia, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE92836

Write-up: A report from a literature source concerns an 11 year old female who received FLUMIST. The patient developed fever, cough, rhinorrhea, myalgia, and mild hypotension requiring hospitalization 12 days after LAIV receipt. Viral culture of a nasal swab had isolated the vaccine strain of influenza A virus on day 3 after vaccination but not on day 7. A nasal wash collected on day 13 at the time of onset of the symptoms was negative for influenza by DFA and culture, but influenza A virus was detectable by PCR. Insufficient RNA quantities prohibited further characterization. She was treated with antimicrobials and oseltamivir but remained febrile after 5 days of therapy. Multiple pulmonary nodules consistent with fungal infection were identified by computerized chest tomography on day 9 of hospitalization, and antifungal therapy was begun, fever resolved, and she was discharged from the hospital on day 11. The clinical impression at the time was probable fungal pneumonia. The event was judged to be possibly related to vaccination. Assessment of serious criteria of report: Hospitalization.


VAERS ID: 518386 (history)  
Age: 11.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2014-01-02
Onset:2014-01-02
   Days after vaccination:0
Submitted: 2014-01-03
   Days after onset:1
Entered: 2014-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AE / - LA / IM

Administered by: Public       Purchased by: Public
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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client fainted after injection given and bandaid was applied to injection site. No injury. Supportive treatment until awoke from faint.


VAERS ID: 518395 (history)  
Age: 11.0  
Gender: Female  
Location: Georgia  
Vaccinated:2013-06-01
Onset:0000-00-00
Submitted: 2014-01-04
Entered: 2014-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Skin papilloma
SMQs:

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: She now has a wart on her thumb and I just saw another one between her fingers. I''m not sure if the vaccine was the cause or if its just a coincidence....I''ve taken her to the Dr and they are now checking to see if the insurance will cover freezing it.


VAERS ID: 518407 (history)  
Age: 11.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2013-12-31
Onset:2013-12-31
   Days after vaccination:0
Submitted: 2014-01-04
   Days after onset:4
Entered: 2014-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - LA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Injection site atrophy, Injection site erythema, Injection site swelling, Oedema peripheral
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: He had the Tdap and meningococcal in his LA and HPV in his RA. His right arm did fine. By evening, his left bicep was swollen and red around the injection site. By the next morning, it was even larger and he had fluid building under his armpit. It continued to worsen throughout the day and by the evening the red portion covered all of his bicep and below and the swelling underneath the arm felt like a fluid filled balloon and almost made his armpit indistinguishable. I finally called our family physician on his cell that evening (he is a friend) and told him what was going on. I was already icing it regularly and giving him ibuprofen. He said that was really all I could do. I asked him if I should let the Health Department know the next day and he said that I could, but that they probably wouldn''t do anything about it. My concern was for the next time he has to have this vaccine (in 10 years) - I wanted the reaction documented because I won''t be with him when he receives it as an adult. On 1/2/14, I took him to the HD and let someone look at it - the injection site also looked sunken by then (similar to old small-pox types spots). She said this is "normal" and "occurs 50% of the time" with Tdap and that it is often bad in teens and adults. I knew this wasn''t entirely true, because his 2 older brothers didn''t have this reaction. Also, the hand-out did not have underarm swelling as an adverse effect or any reaction being 50% likely. She dismissed it as no big deal, but did say that his reaction was maybe a little worse than most. I will never allow 2 injections to be given in the same extremity again. Also, if this is common, someone should tell the parent to expect this reaction and definitely start icing and ibuprofen ahead of time. Either he had an atypical reaction and someone should have documented it - neither Dr. or other person at the Health Department made any notes of his reaction - or the paperwork needs to be redone to make a parent aware that this is normal and they should go ahead and start icing and ibuprofen as soon as they get home. I do have pictures of what his arm looked like on 1/1/13. Today (1/4/13) the swelling has gone down a lot, but it isn''t entirely gone. After looking at the next page, just to be clear: Left arm: Tdap & Meningoccal Right arm: HPV (I have no way of knowing the manufacturers since they didn''t even take my concern seriously. I just picked a manufacturer on the one and picked something so it would let me submit. You should really correct this issue as a parent has no way of knowing this information.)


VAERS ID: 518411 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2007-04-18
Onset:2007-05-08
   Days after vaccination:20
Submitted: 2014-01-05
   Days after onset:2434
Entered: 2014-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 4 / 0 LA / -

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain upper, Menstrual disorder, Oligomenorrhoea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None until afterwards she had to take Low-ogestral birth controll pills
Current Illness: No
Preexisting Conditions: She was born premature
Diagnostic Lab Data: Yes but the doctor has that on file. She has a new doctor.
CDC Split Type:

Write-up: Some severe pains in her stomach every so often but from there she had an abnormal menstrual cycle where she had bleed for 6 months straight and had to take birth control pills (which can cause cancer in her ovaries in her future) for two and a half years.


VAERS ID: 518494 (history)  
Age: 11.0  
Gender: Male  
Location: Ohio  
Vaccinated:2013-12-09
Onset:2013-12-20
   Days after vaccination:11
Submitted: 2013-12-26
   Days after onset:6
Entered: 2014-01-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / - - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR M12122 / - - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B097BA / - - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Lymphadenopathy
SMQs:, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: METROHEALTHESP20125822

Write-up: Enlargement lymph nodes on 2013-12-20. Clinician comment: Infra clavicular and epitrochlear lymph nodes. No fevers. Benign CBC.


VAERS ID: 518603 (history)  
Age: 11.0  
Gender: Female  
Location: Idaho  
Vaccinated:2013-12-30
Onset:0000-00-00
Submitted: 2013-12-31
Entered: 2014-01-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B149AA / 5 RA / UN

Administered by: Public       Purchased by: Military
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: Dtap was given instead for Tdap due to miscommunication of another nurse. No effects noted. Contacted agency. They advised pt would not need to received additional vaccination.


VAERS ID: 518656 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-01-29
Onset:2013-02-14
   Days after vaccination:16
Submitted: 2013-12-18
   Days after onset:307
Entered: 2014-01-07
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010649 / 0 RA / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN

Administered by: Other       Purchased by: Public
Symptoms: Anxiety, Crying, Depression, School refusal
SMQs:, Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROAIR HFA; DIMETAPP; FLOVENT; FLONASE; triamcinolone
Current Illness: None
Preexisting Conditions: Asthma; Obesity; Allergic rhinitis; Atopic derm.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On 12/16/13, the mother reported that days after each of the three HPV vaccines on 1/29/13, 4/2/13 and 7/31/13, the patient developed crying, school refusal and anxiety that lasted several weeks. After the dose # 1, patient presented to office on 2/19/13 reporting onset of crying 2/14/13. He was referred to behavioral health specialist and diagnoses with anxiety and depressive disorder.


VAERS ID: 518659 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-04-02
Onset:0000-00-00
Submitted: 2013-12-18
Entered: 2014-01-07
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010649 / 1 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Crying, Depression, School refusal
SMQs:, Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Crying for weeks~HPV (Gardasil)~1~11.00~Patient
Other Medications: PROAIR; FLOVENT; FLONASE
Current Illness: None
Preexisting Conditions: Asthma; Obesity; Allergic rhinitis; Atopic dermatitis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On 12/16/13 mom brought patient into office reporting anxiety and crying bouts lasting several weeks and triggered by going to school after each of three HPV doses 1/29/13, 4/2/13 and 7/31/13 seen 2/19/13 with onset crying 2/14/13 and school refusal. Behavioral health specialist diagnosed depressive disorder and anxiety and treated with REMERON 4/30/13


VAERS ID: 518662 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-07-31
Onset:2013-08-01
   Days after vaccination:1
Submitted: 2013-12-18
   Days after onset:139
Entered: 2014-01-07
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020002 / 2 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Condition aggravated, Crying, Depression, School refusal
SMQs:, Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Anxiety, crying for weeks~HPV (Gardasil)~2~11.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma; Allergic rhinitis; obesity; Depressive d/o; Anxiety
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 12/16/13 mom brought patient in to report anxiety/crying bout episodes lasting several weeks after each of three HPV doses on 1/29/13, 4/2/13 and 7/31/13. Seen on our office only once for this problem on 2/19/13 reporting onset of crying and school refusal beginning 2/14/13. Referred to behavioral specialist and note from 4/30/13 reports diagnoses depressive disorder and anxiety.


VAERS ID: 518677 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-08
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 1 UN / IM

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

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: WAES1312USA011532

Write-up: This spontaneous report as received from a certified medical assistant refers to a 11 years old female patient. On 16-AUG-2013 the patient was vaccinated with first dose of GARDASIL (lot # J006236 exp. date: 25-FEB-2016, dose, strength, site and route of administration not reported). On an unknown date in 2013 the patient experienced swelling, soreness, and tenderness at the injection site. When the patient informed the healthcare worker that she had the injection site reaction, she had already recovered (date not reported0. There was no treatment of the events. On 22-OCT-2013 the patient was vaccinated with second dose of GARDASIL (lot # J007354 exp. date: 20-FEB-2016, dose, strength, site and route of administration not reported). There were no adverse events reported after second dose of GARDASIL. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.


VAERS ID: 518738 (history)  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:2010-08-20
Onset:2010-08-28
   Days after vaccination:8
Submitted: 2014-01-08
   Days after onset:1229
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LG / SYR

Administered by: Unknown       Purchased by: Public
Symptoms: Arthralgia, Blood test, Bone scan, Chest pain, Cyanosis, Electrocardiogram, Electroencephalogram, Eye irritation, Headache, Loss of consciousness, Nuclear magnetic resonance imaging, Stomatitis
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Corneal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: EKG, MRI, blood work, bone scans, EEG
CDC Split Type:

Write-up: Joint pain, chest pain, headaches, mouth sores, irritated eyes, evolved to passing out, fingers turning blue, having new symptoms regularly.


VAERS ID: 518924 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-12-23
Onset:2013-12-24
   Days after vaccination:1
Submitted: 2014-01-10
   Days after onset:17
Entered: 2014-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006161 / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site vesicles
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: WAES1312USA012594

Write-up: This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's medical history included supraventricular tachycardia cardiac. Patient had no drug reactions/allergies. On 23-DEC-2003 the patient was vaccinated with VARIVAX dose 1 (dosing information, route of administration and lot # were not provided). On 23-DEC-2013 the patient was vaccinated with VARIVAX lot # J006161 (expiry date 20-MAY-2015) dose 2, 0.5 ml, subcutaneous. No concomitant medication was used. The patient's parents reported that the next day (24-DEC-2103) “18 hours later” a large vesicle was formed over the injections site. The physician documented that the vesicle was 4 cm in diameter and was full of clear fluid. The patient was recommended (Ibuprofen) and “compresses” for comfort. It was also reported that no treatment was given. The patient was seen in the office for a follow up visit on 27-dec-2013. And the vesicle was draining clear liquid and was beginning to crust. The nurse stated that the lesion “looked exactly like a chickenpox lesion”. The outcome of the event was reported as recovering/resolving. Additional information has been requested.


VAERS ID: 518929 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2014-01-08
Onset:2014-01-08
   Days after vaccination:0
Submitted: 2014-01-10
   Days after onset:2
Entered: 2014-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 0 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blood test, Electrocardiogram, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Child taking INH syrup 300mg po daily x 9 months for + quantiferon TB test.
Current Illness: No
Preexisting Conditions: None known
Diagnostic Lab Data: MD at the ER; performed EKG, obtain blood tests and gave IV fluids.
CDC Split Type:

Write-up: Was informed by parent that child was walking to main hospital building and fainted. Rapid Response Team at hospital call and child taken to ER for evaluation.


VAERS ID: 518955 (history)  
Age: 11.0  
Gender: Male  
Location: Ohio  
Vaccinated:2014-01-09
Onset:2014-01-09
   Days after vaccination:0
Submitted: 2014-01-09
   Days after onset:0
Entered: 2014-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332BA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cold sweat, Drooling, Dyskinesia, Fall, Gaze palsy, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: After pt received HPV he was sitting on bed and fell backwards and eyes rolled back, head and body jerking and drooling from (R) side of mouth. Episode lasted 10 - 15 seconds. Pt did not respond during that time when pt was finally able to respond he wasn''t sure what happened pt was pale and clammy. Dr assessed pt and kept pt in office x 1 hr 10 minutes.


VAERS ID: 518991 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-06-23
Onset:2006-06-23
   Days after vaccination:0
Submitted: 2014-01-11
   Days after onset:2759
Entered: 2014-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 AR / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Amenorrhoea, Headache, Insomnia, Menstruation irregular, Pyrexia, Sleep study, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Fertility 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Sleep test various doctor visits and various drugs its been years she is 18 and very irregular periods with months of no period at all.
CDC Split Type:

Write-up: Fever about an hour after injection then swelling headache and after a few weeks her periods became irregular and her started having insomnia. Then after two or three months her periods ceased all together.


VAERS ID: 519037 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-12-10
Onset:0000-00-00
Submitted: 2014-01-13
Entered: 2014-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / - RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 1 LA / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Adeno tonsillectomy; Tonsillar hypertrophy
Diagnostic Lab Data:
CDC Split Type: WAES1312USA012070

Write-up: This spontaneous report as received from a patient''s mother refers to a 11 year old female patient with none drug reactions or allergies. Pertinent medical history included tonsils and adenoids removal. In October 2013 (date unspecified) the patient was vaccinated with a first dose of GARDASIL (lot # J007354, expiration date 20-FEB-2016, injection (dose and route not provided). On 10-DEC-2013 the patient had administered in her left arm a second dose of GARDASIL (lot # J007354, expiration date 20-FEB-f2016, reported as which may had been from the recalled lot) injection (dose and route not provided). On the same day, 10-DEC-2013 the patient was vaccinated with an unspecified flu vaccine in her right arm which may had been AFLURIA (dose, route, lot number and expiration date not provided). No concomitant medication was reported. On 10-DEC-2013 the patient experienced pain at the left arm injection site. On an unknown date (in December 2013) the patient sought medical attention for the funny lump on her chin. The approximately 20-DEC-2013 reported as about one week ago, the patient sought medical attention for the funny lump on her chin. The funny lump was diagnosed as possibly a cyst or fatty tissue. No treatment was prescribed. No treatment was reported for the pain at her left arm injection site. The outcome of the pain at the left arm injection site was reported as resolved on an unspecified date in December 2013 and the site was at the time of report still a little swollen (onset date approximately in December 2013). The outcome of funny lump on her chin/cyst or fatty tissue was not reported. The relatedness between vaccination with GARDASIL and events was not reported. The patient did not recover from the event of vaccination site swelling at the time of this report. The relatedness between vaccination with AFLURIA and events was not reported. Additional information has been requested.


VAERS ID: 519051 (history)  
Age: 11.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2013-10-04
Onset:2013-10-04
   Days after vaccination:0
Submitted: 2014-01-13
   Days after onset:101
Entered: 2014-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Affect lability
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (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: Drug hypersensitivity
Preexisting Conditions: Amoxicillin; Drug Reaction: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1312USA012045

Write-up: This spontaneous report was received from a health care worker and refers to a 11 year old female patient. The patient did not have any concurrent condition and had history of drug reaction/allergy to amoxicillin. The reporter stated that a patient received her first dose of GARDASIL 90.5 ml, intramuscular, lot # J007354 exp. date. 20-FEB-2016) for immunization. The GARDASIL with this lot # was recalled. Soon after vaccination with GARDASIL, on 04-OCT-2013, the patient displayed emotional liability. The patient''s mother called the physician''s office and reported that the patient was laughing and crying and that her behavior was not right. The physician recommended that the patient should be seen in an Emergency Room (ER), but the patient did not go to the ER. None lab diagnostics studies were performed. The reporter called back the patient''s mother the next day and reported that the patient''s behavior had returned to normal. The patient recovered on 05-OCT-2013. The relatedness between GARDASIL, and events was not reported. Additional information has been requested.


VAERS ID: 519101 (history)  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:2013-09-18
Onset:2013-10-01
   Days after vaccination:13
Submitted: 2014-01-13
   Days after onset:104
Entered: 2014-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445AB / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332BA / 5 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Burning sensation, Loss of control of legs, Myasthenia gravis
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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11-9-13 to ER R/T legs "giving out" during a basketball game. Continued to have "burning" sensation and weakness through November. Referral to neurology, per neurologist, patient diagnosed with Myasthenia Gravis at the beginning of this month (Jan. 2014).


VAERS ID: 519114 (history)  
Age: 11.0  
Gender: Male  
Location: Kansas  
Vaccinated:2014-01-08
Onset:2014-01-09
   Days after vaccination:1
Submitted: 2014-01-13
   Days after onset:4
Entered: 2014-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AD / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: (Per Dad''s report). (Dad has had history of similar effect with Tetanus shot)
CDC Split Type:

Write-up: 01-09-14 developed increasing erythema, edema and pain to (L) deltoid - went to ER that PM for eval. Ibuprofen, ice and BENADRYL recommended and taken. On 1-10-14 f/u in clinic erythema, edema and discomfort increased - 1-11-14 f/u clinic visit edema and redness extended to (L) elbow. KEFLEX TID started PO. Client played a basketball game on 1-11-14. today on 1-13-14 mom reports it''s "much better".


VAERS ID: 519181 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-13
Onset:2014-01-13
   Days after vaccination:0
Submitted: 2014-01-13
   Days after onset:0
Entered: 2014-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 2 LA / UN

Administered by: Other       Purchased by: Public
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: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fainted in lobby approx 5 min after GARDASIL IZ. Taken back to room to rest on exam table x 10 min. Felt fine and left the clinic.


VAERS ID: 519228 (history)  
Age: 11.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2014-01-07
Onset:2014-01-08
   Days after vaccination:1
Submitted: 2014-01-14
   Days after onset:6
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4P724 / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003701 / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Blister, Erythema, Injection site warmth, Local reaction, Local swelling, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), 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: Local reaction; No lab
CDC Split Type:

Write-up: Rt arm became red and swollen, pt had fever and warmth at the sight in rt arm. Developed blisters on her skin and was seen at a clinic by APRN (convenient care).


VAERS ID: 519246 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-08
Onset:2014-01-10
   Days after vaccination:2
Submitted: 2014-01-14
   Days after onset:4
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AE / 0 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021861 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12130 / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4034AA / 0 RA / UN

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

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

Write-up: (L) deltoid redness, swelling/inflammation. Hot to area.


VAERS ID: 519273 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2013-11-07
Onset:2013-11-20
   Days after vaccination:13
Submitted: 2014-01-14
   Days after onset:55
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Disturbance in attention, Excessive eye blinking, Nervousness
SMQs:, Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unable to concentrate, seems nervous at times blinks eyes uncontrollably at times since.


VAERS ID: 519285 (history)  
Age: 11.0  
Gender: Male  
Location: Washington  
Vaccinated:2014-01-07
Onset:2014-01-07
   Days after vaccination:0
Submitted: 2014-01-14
   Days after onset:7
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / - LA / IM

Administered by: Other       Purchased by: Private
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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No symptoms, Flucelvax influenza vaccine indicated for 18 years old and over, vaccine adimistered to patient under 18.


VAERS ID: 519366 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-01-13
Onset:2014-01-14
   Days after vaccination:1
Submitted: 2014-01-15
   Days after onset:1
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12119 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J005726 / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Erythema, Nausea, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Low grade fever, nausea, felt short of breath, area very swollen, warm, red. All started 12-24 hrs after imm.


VAERS ID: 519412 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:2014-01-09
Onset:2014-01-10
   Days after vaccination:1
Submitted: 2014-01-15
   Days after onset:5
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Local reaction, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: Allergy to Amoxicilin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Local redness, soreness and slight edema.


VAERS ID: 519423 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-08
Onset:2014-01-08
   Days after vaccination:0
Submitted: 2014-01-15
   Days after onset:7
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4506AC / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Injected limb mobility decreased, Local swelling, Nausea, Pyrexia, Swelling face
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: Mother describes swollen arm from deltoid to elbow, redness, fever to 101.2, nausea, swollen cheeks. Unable to move left arm for 3-4 days.


VAERS ID: 519441 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-15
Onset:2014-01-15
   Days after vaccination:0
Submitted: 2014-01-15
   Days after onset:0
Entered: 2014-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH949AA / 0 LA / UN

Administered by: Other       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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt collapsed while in the arms of his mother. Pt was laid down on the ground gently (protecting the head). Was given cold compresses and fanned down. When he felt better we assisted him to a seat to rest. Was given vitamin H2O to drink. Recovered after approximately 30 minutes.


VAERS ID: 519460 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Retinitis, Uveitis
SMQs:, Retinal disorders (narrow), Ocular infections (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: WAES1401USA006204

Write-up: Information has been received from a literature article title as stated above concerning a 11 year old female patient developed uveitis and retinitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in this case. 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 apailledema. 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. 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 from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patients experience.


VAERS ID: 519514 (history)  
Age: 11.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2013-12-16
Onset:0000-00-00
Submitted: 2014-01-09
Entered: 2014-01-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2091 / - - / IN

Administered by: Public       Purchased by: Public
Symptoms: Expired drug administered, 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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.


VAERS ID: 519551 (history)  
Age: 11.0  
Gender: Male  
Location: Missouri  
Vaccinated:2013-10-25
Onset:2013-10-26
   Days after vaccination:1
Submitted: 2014-01-16
   Days after onset:82
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Full blood count, Headache, Insomnia, Metabolic function test, Mononucleosis heterophile test, Muscular weakness, Pain, Respiratory disorder, Sinus disorder, Streptococcus test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Arthritis (broad), Respiratory failure (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Buspirone 5mg 2x daily; Sertraline 37.5mg 1x daily; Flovent Inhaler 2 puffs in am and pm; Fluticasone nasal spray 2 inhalations daily
Current Illness: Cold Sore on Mouth
Preexisting Conditions: ADHD, Asthma
Diagnostic Lab Data: CBC, CMP, mono spot, another mono test, strep test.
CDC Split Type:

Write-up: Within a day or so if getting the injection. Patient began to experience numerous abnormal symptoms. These included, dizziness, body aches, joint pain, headache, fatigue, brain fog, trouble sleeping, weakness especially in legs, ongoing sinus and upper respiratory problems.


VAERS ID: 519582 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2014-01-08
Onset:2014-01-09
   Days after vaccination:1
Submitted: 2014-01-15
   Days after onset:6
Entered: 2014-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
SMQs:, 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: VYVANSE; RITALIN
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blotchy erythema upper (L) arm with swelling from (L) shoulder to elbow eval and tx ice to area BENADRYL P.O.


VAERS ID: 519625 (history)  
Age: 11.0  
Gender: Female  
Location: Georgia  
Vaccinated:2014-01-15
Onset:2014-01-16
   Days after vaccination:1
Submitted: 2014-01-16
   Days after onset:0
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS YG4XA / 2 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11051 / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Feeling hot, 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? 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: Localized redness, swelling, itching, warmth. Cold compress, BENADRYL, MOTRIN.


VAERS ID: 519693 (history)  
Age: 11.0  
Gender: Male  
Location: Maryland  
Vaccinated:2014-01-06
Onset:2014-01-07
   Days after vaccination:1
Submitted: 2014-01-14
   Days after onset:7
Entered: 2014-01-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12100 / 0 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B092FA / 0 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Burning feet syndrome, Pain in extremity, Rash generalised, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness: None
Preexisting Conditions: NAFLD; Obesity
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccines administered on 1/6/14, patient presented to office on 1/9/14 with generalized macula papular rash, pain/burning on bottom of feet. No treatment. Coming back for additional follow up on 1/16/14.


VAERS ID: 519713 (history)  
Age: 11.0  
Gender: Male  
Location: Washington  
Vaccinated:2014-01-09
Onset:2014-01-10
   Days after vaccination:1
Submitted: 2014-01-13
   Days after onset:3
Entered: 2014-01-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AC / 3 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 0 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 42B4N / 0 LA / UN

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

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

Write-up: (L) deltoid erythematous area approximately 4cm x 3cm with pain. No other s/sx. Outlined area return if worse or not improving. Erythema and pain tx with ibuprofen and cool compress.


VAERS ID: 519714 (history)  
Age: 11.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2014-01-02
Onset:2014-01-02
   Days after vaccination:0
Submitted: 2014-01-17
   Days after onset:15
Entered: 2014-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - AR / SYR
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - AR / SYR

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

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

Write-up: Blotchy rash appeared on arm within an hour of injection, BENADRYL/antihistamine and TYLENOL given immediately. It took about 2 days for it to away completely.


VAERS ID: 519750 (history)  
Age: 11.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2013-12-04
Onset:2014-01-03
   Days after vaccination:30
Submitted: 2014-01-18
   Days after onset:15
Entered: 2014-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER L4CR9 / 0 RL / UN
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER U4413A / 0 LL / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC520085BK / 0 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Guillain-Barre syndrome, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Guillain-Barre Syndrome confirmed with MRI at hospital
CDC Split Type:

Write-up: Limbs pain and weakness. Diagnosed with GBS on 1/8/14 by neurologist.


VAERS ID: 519774 (history)  
Age: 11.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-01-17
Onset:2014-01-17
   Days after vaccination:0
Submitted: 2014-01-17
   Days after onset:0
Entered: 2014-01-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AB / - LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / - RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4680AA / - LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4496AA / - LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Hypertonia, Injection site anaesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy
Preexisting Conditions: Hx allergies; The day of incident w pt irregular heartbeat
Diagnostic Lab Data: At ER
CDC Split Type:

Write-up: Pt had MCV4 and Tdap on LA was ok. Flu vac. and HPV on her RA. After the HPV vaccine c/o of numbness on Rt shoulder. Then fainted rt after, 1-2 min tonic movement O2 given after O2 100%. Partially still dizzy, went to ER for further evaluation.


VAERS ID: 519871 (history)  
Age: 11.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2014-01-16
Onset:2014-01-18
   Days after vaccination:2
Submitted: 2014-01-20
   Days after onset:2
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X13012 / 0 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 93279 / - LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth, Local reaction
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 4 cm local reaction around injection site - warm, pierchic red, (R) arm.


VAERS ID: 519882 (history)  
Age: 11.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2013-12-27
Onset:2013-12-28
   Days after vaccination:1
Submitted: 2014-01-16
   Days after onset:19
Entered: 2014-01-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2156 / 0 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4585AB / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332BA / 0 RA / IM

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

Write-up: Right arm pink changing to fiery red; swollen next day. Not itchy or painful.


VAERS ID: 519905 (history)  
Age: 11.0  
Gender: Male  
Location: Nevada  
Vaccinated:2014-01-14
Onset:2014-01-15
   Days after vaccination:1
Submitted: 2014-01-20
   Days after onset:5
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 47257 / - 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red, swollen arm.


VAERS ID: 519990 (history)  
Age: 11.0  
Gender: Female  
Location: Virginia  
Vaccinated:2014-01-14
Onset:2014-01-14
   Days after vaccination:0
Submitted: 2014-01-15
   Days after onset:1
Entered: 2014-01-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4169AA / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Blister, Laboratory test, Urticaria, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (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: ADDERALL XR
Current Illness:
Preexisting Conditions: Allergies - ibuprofen and sulfonamides
Diagnostic Lab Data: Per parent - no tests, labs done at ER
CDC Split Type:

Write-up: Per parent - "water blisters" on (L) arm about 2 hrs. after receiving the vaccine. Tdap was given in (L) arm. Patient then broke out in hives and blisters from her shoulders down to her feet. Patient was vomiting "violently" for about a half a hour. Patient was complaining of joint pain, especially in her legs. Mom gave patient 2 teaspoons of Children''s BENADRYL and took pt to the ER.


VAERS ID: 520169 (history)  
Age: 11.0  
Gender: Unknown  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-22
Entered: 2014-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction
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: WAES1312USA010864

Write-up: This spontaneous report as received from a registered nurse refers to an 11 year old patient of unknown gender. On an unknown date the patient was vaccinated with GARDASIL lot # J007354. Route, dose and frequency were not reported. On an unknown date the patient experienced injection site reaction. The nurse stated that she could vaguely recall a patient reporting an injection site reaction, but this patient was "eleven years old," and multiple vaccines were administered during that same office visit (date not reported). At the time of this call, the nurse did not have access to the patient''s information. The patient may have experienced an adverse effect to GARDASIL, lot # J007354. The nurse did not know for certain which vaccine the patient may have experienced an AE with. The outcome of injection site reaction was unknown. Additional information has been requested.


VAERS ID: 520177 (history)  
Age: 11.0  
Gender: Male  
Location: Virginia  
Vaccinated:2014-01-16
Onset:2014-01-16
   Days after vaccination:0
Submitted: 2014-01-21
   Days after onset:5
Entered: 2014-01-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 39TF5 / - LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A13017 / - LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS B5X7M / - RA / UN

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

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

Write-up: Severe redness, swelling and tenderness extending to shoulder and neck region in left arm.


VAERS ID: 520287 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2014-01-20
Onset:2014-01-22
   Days after vaccination:2
Submitted: 2014-01-22
   Days after onset:0
Entered: 2014-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J01272 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4680AA / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 3752B / 0 LA / IM

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

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

Write-up: 7.5x5 cm area - red and warm to touch. Non indurated swelling (L) arm around puncture site.


VAERS ID: 520328 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-22
Entered: 2014-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - 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: WAES1401USA004740

Write-up: This spontaneous report as received from a medical assistant refers to currently 11 year female patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 520496 (history)  
Age: 11.0  
Gender: Female  
Location: Oregon  
Vaccinated:2014-01-21
Onset:2014-01-22
   Days after vaccination:1
Submitted: 2014-01-23
   Days after onset:1
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H015537 / 2 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / 0 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H014194 / 1 LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Blister, Erythema, Local swelling, Pruritus, Skin warm
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient experienced red, raised, itchy area 14 cm, warm to touch, forming blisters. Treated for possible cellulitis / cephalexin 500mg 1 cap q 6 hrs.


VAERS ID: 520557 (history)  
Age: 11.0  
Gender: Female  
Location: Kansas  
Vaccinated:2013-10-08
Onset:2013-10-08
   Days after vaccination:0
Submitted: 2014-01-24
   Days after onset:108
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013977 / 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: WAES1401USA010903

Write-up: This spontaneous report as received from a consumer (patients mother) refers to her daughter (11 years old). the patient was vaccinated with GARDASIL injection first shot on 23-APR-2013, second sot on 25-JUL-2013 and third shot on 08-OCT-2013. No adverse effect reported. Additional information has been requested.


VAERS ID: 520599 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-01-23
Onset:2014-01-24
   Days after vaccination:1
Submitted: 2014-01-24
   Days after onset:0
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH918AB / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4612AA / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006806 / 1 LA / SC

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

Write-up: Heat, redness, and swollen on (R) arm injection site.


VAERS ID: 520620 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-04-01
Onset:0000-00-00
Submitted: 2014-01-21
Entered: 2014-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4418AA / - UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Bordetella test positive, Cough, Pertussis
SMQs:, Anaphylactic reaction (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: UNK
Diagnostic Lab Data: Blood test NOS, Unknown, Positive for pertussis
CDC Split Type: 2014SA007169

Write-up: This initial case was received from a consumer on 16 January 2014. Two cases of unidentified patients, who each experienced pertussis following administration of ADACEL, were reported by the same reporter. The other report is captured in case number 2014SA007170. An 11 year old female patient was vaccinated with "ADACEL" lot # U4418AA (lot number corresponding to MENACTRA in SP) in April of 2013, date not specified. The route, site of administration and dose were not reported. On an unreported date the patient experience coughing lasting for past 4 weeks. Blood work for each patient was positive for pertussis on an unreported date. The reporter stated that they do not have any cultures. The patient''s medical history and concomitant medications were not reported. The patient outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.


VAERS ID: 520651 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-01-06
Onset:2014-01-06
   Days after vaccination:0
Submitted: 2014-01-24
   Days after onset:18
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009788 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Haematoma, Local swelling, Muscle injury, Nerve compression, Pain in extremity, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FLONASE; MIRALAX
Current Illness: None
Preexisting Conditions: Bee sting allergy; NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt c/o pain after vaccination, swelling, redness, tingling and radiating pain traveling down arm to hand. Pt saw neurology - R/O''d nerve involvement. DX: by provider as prob muscle tear vs. hematoma with nerve pressure.


VAERS ID: 520708 (history)  
Age: 11.0  
Gender: Female  
Location: Colorado  
Vaccinated:2014-01-22
Onset:2014-01-22
   Days after vaccination:0
Submitted: 2014-01-24
   Days after onset:2
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / UN

Administered by: Other       Purchased by: Private
Symptoms: Abdominal pain upper, Erythema, Headache, Pain, Pyrexia, Skin discolouration, Upper extremity mass
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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: Allergies to sulfates, paraben, latex
Diagnostic Lab Data: School nurse indicated that several kids suffered same symptoms (most of them, on the next day also)...
CDC Split Type:

Write-up: HUGE swollen lump on arm, about the size of a large baseball (width), purple, RED, FEVERISH!!!, achy, sore, painful to touch. Also caused headache, tummy ache, possible diarrhea, and had to leave school early the day after.


VAERS ID: 520815 (history)  
Age: 11.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2013-11-25
Onset:2013-11-25
   Days after vaccination:0
Submitted: 2014-01-27
   Days after onset:63
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4658AA / 0 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS ZRY59 / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Pain in extremity, Tinnitus
SMQs:, Hearing impairment (narrow), Hypersensitivity (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: Fluticasone propionate
Current Illness: Leg pain; ringing in head
Preexisting Conditions: No known drug allergies; Allergic Rhinitis NOS
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt complained of leg pain and ringing in her head. Started immediately after vaccines and lasted 1 week. Symptoms have completely resolved.


VAERS ID: 520903 (history)  
Age: 11.0  
Gender: Male  
Location: Nevada  
Vaccinated:2014-01-24
Onset:2014-01-25
   Days after vaccination:1
Submitted: 2014-01-25
   Days after onset:0
Entered: 2014-01-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / - RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B088AA / - LA / IM

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

Write-up: Redness, itchiness, and swelling of the left arm. Necessitating ER visit 1 day after Tdap, MENACTRA, and HPV vaccination.


VAERS ID: 521040 (history)  
Age: 11.0  
Gender: Male  
Location: Ohio  
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
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J004161 / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, 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: Fainting~Hep B (Recombivax HB)~2~11.00~Patient|Fainting and Vomiting~Hep B (Recombivax HB)~1~10.92~Patient|Fainting and Vomiting
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was reclined when vaccine given and remained that way for 15 minutes post vaccination without complaints of dizziness. Upon walking out of the clinic, he became pale and dizzy. Patient sat on the floor, was laid flat with feet elevated and cold compress applied to back of neck for relief. Remained in that position for 10 minutes after which patient felt fully recovered. Sat up, stood up, and ambulated out of office without further problems.


VAERS ID: 521055 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-21
Onset:2014-01-23
   Days after vaccination:2
Submitted: 2014-01-28
   Days after onset:5
Entered: 2014-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Private       Purchased by: Private
Symptoms: Bed rest, Dizziness, Headache, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Headaches, fever, vomiting, dizzy. Treated mostly with bed rest, limited ibuprofen for headache.


VAERS ID: 521180 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-02-22
Onset:2008-11-19
   Days after vaccination:271
Submitted: 2014-01-09
   Days after onset:1877
Entered: 2014-01-29
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1522U / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Biopsy site unspecified normal, Cholecystectomy, Colonoscopy normal, Gallbladder non-functioning, Oesophagogastroduodenoscopy normal, Type 1 diabetes mellitus, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Admitted to hospital on diagnosis of Type 1 diabetes, Hospital work up and treatment for stomach pain has included a cholecystectomy for an atonic gallbladder, now s/p colonoscopy and EGD with negative biopsies
CDC Split Type:

Write-up: Developed type 1 diabetes after first HPV and severe stomach pain with recurrent vomiting and weight loss x $g1 year after second.


VAERS ID: 521237 (history)  
Age: 11.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2014-01-28
Onset:2014-01-28
   Days after vaccination:0
Submitted: 2014-01-29
   Days after onset:1
Entered: 2014-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR A121009HX12100 / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4247AA / - LA / UN

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

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

Write-up: 24 hours post immunization patient presented with an 8.5 cm x 11 cm indurated area of erythema and warmth. Mild pain wiht moving (R) arm.


VAERS ID: 521264 (history)  
Age: 11.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2014-01-20
Onset:2014-01-23
   Days after vaccination:3
Submitted: 2014-01-30
   Days after onset:7
Entered: 2014-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR N2K27 / 0 RA / IM

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

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

Write-up: Pt. had a 3 inch erythematous area to (R) upper arm with 0.5 inch hematoma in the center.


VAERS ID: 521287 (history)  
Age: 11.0  
Gender: Male  
Location: Maryland  
Vaccinated:2014-01-16
Onset:2014-01-16
   Days after vaccination:0
Submitted: 2014-01-24
   Days after onset:8
Entered: 2014-01-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12003 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4612AA / - LA / IM

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

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

Write-up: Mother stated that the patient had rash on his left arm where the patient received his 11 year shot. Rash was from his upper arm to his left elbow. Localized rash according to mother. Mother applied ice to the site for the swelling and administer BENADRYL. Mother stated that the patient rash clear up by 1-20-14.


VAERS ID: 521333 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2014-01-27
Onset:2014-01-29
   Days after vaccination:2
Submitted: 2014-01-30
   Days after onset:1
Entered: 2014-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13051 / 0 RA / SYR

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Local swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), 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
CDC Split Type:

Write-up: Redness, swelling, some tenderness (R) upper arm (size 12 x 12cm). No relation to injection site.


VAERS ID: 521394 (history)  
Age: 11.0  
Gender: Unknown  
Location: South Carolina  
Vaccinated:2013-12-01
Onset:2013-12-01
   Days after vaccination:0
Submitted: 2014-01-31
   Days after onset:61
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Feeling abnormal
SMQs:, Systemic lupus erythematosus (broad), Dementia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA013391

Write-up: This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender who on approximately on December 2013 (within the last month or two), was vaccinated with the first dose of GARDASIL dose 1 (Dose, route and lot number was not provided). The reporter informed that the patient experienced that they "felt funny" and then had a seizure, after receiving the "eleven year old shots" which included the first dose of GARDASIL, "within the last month or two." The patient was sent to the Hospital, as per the office protocol. The patient did not required intervention to prevent serious criteria. At the time of the report the patient was well. The outcome of had a seizure, after receiving their first dose of GARDASIL and felt funny was unknown. Upon internal review, the event of seizure was considered as medically significant. The relationship between adverse events and GARDASIL was unknown. This is one of two reports from the same source. Additional information has been requested.


VAERS ID: 521413 (history)  
Age: 11.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2013-12-01
Onset:2013-12-01
   Days after vaccination:0
Submitted: 2014-01-31
   Days after onset:61
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Feeling abnormal, Urinary incontinence
SMQs:, Systemic lupus erythematosus (broad), Dementia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA014092

Write-up: This spontaneous report as received from a nurse refers to a 11 year old patient who in approximately December 2013 (within the last month or two), was vaccinated with the first dose of GARDASIL dose 1 (dose, route and lot number was not provided). The reporter informed that the patient experienced that they "felt funny" and then had a seizure, after receiving the "eleven year old shots" which included the first dose of GARDASIL, "within the last month or two." The patient urinated upon himself, during the seizure. The patient was sent to the hospital, as per the office protocol. The patient did not require intervention to prevent serious criteria. At the time of the report the patient was well. No further information was provided. The outcome of had a seizure, after receiving their first dose of GARDASIL, urinated upon himself, during the seizure and "felt funny" was unknown. Upon internal review, the event of seizure was considered as medically significant. The relationship between adverse events and GARDASIL was unknown. This is one of two reports from the same source. Additional information has been requested.


VAERS ID: 521437 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-01-22
Onset:2014-01-23
   Days after vaccination:1
Submitted: 2014-01-28
   Days after onset:5
Entered: 2014-01-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / - LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4612AA / - LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site scab, Injection site swelling, Injection site warmth, Nodule, Pain, Tenderness, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presents for ER follow-up. He was seen in clinic on 1/22 for his WCC and received Tdap and MENACTRA. He developed swelling and itching at the site 24 hours later. No fever. Was seen at medical center on 1/24 for pain and swelling. He was diagnosed with cellulitis and placed on Clindamycin and BENADRYL q8 hours. The swelling and pain is much improved. Per notes from medical center he presented to the ER 3 days after receiving vaccinations. Exam was notable for "large area of erythema, warmth, induration and tenderness to palpation to left upper arm over deltoid. Small scab to center from injection. No fluctuance. No drainage. Small nodule palpable to anterior aspect of axilla. Tender to touch." Ultrasound was performed with impression: Cellulitis without abscess.


VAERS ID: 521452 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-29
Onset:2014-01-30
   Days after vaccination:1
Submitted: 2014-01-30
   Days after onset:0
Entered: 2014-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4689AA / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Pain in extremity, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: Patient was evaluated by the Dr. If sx return to call back.
CDC Split Type:

Write-up: Patient received the Tdap vaccine on 1-29-14. He never developed a fever or any other sx. He slept fine. The next morning 1/30 he awoke with a sore arm 10 min later he felt dizzy, vomited, then fainted. He was fine the rest of the day.


VAERS ID: 521455 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2014-01-29
Onset:2014-01-29
   Days after vaccination:0
Submitted: 2014-01-29
   Days after onset:0
Entered: 2014-01-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 4 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Site reaction, redness, warmth pain.


VAERS ID: 521547 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-01-30
Onset:2014-01-30
   Days after vaccination:0
Submitted: 2014-01-31
   Days after onset:1
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH949AA / 0 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Feeling hot, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling with redness and feeling hot to area.


VAERS ID: 521635 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2014-01-22
Onset:2014-01-23
   Days after vaccination:1
Submitted: 2014-01-23
   Days after onset:0
Entered: 2014-02-03
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 0 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

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

Write-up: None stated.


VAERS ID: 521700 (history)  
Age: 11.0  
Gender: Male  
Location: Maryland  
Vaccinated:2014-01-31
Onset:2014-02-01
   Days after vaccination:1
Submitted: 2014-02-03
   Days after onset:2
Entered: 2014-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12132 / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4395AA / 0 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Injection site discharge, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Local reaction
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: FOCALIN XR
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Local reaction at injection site, minor swelling, warm to touch, pink in color. Located on left deltoid area. Per patient it doesn''t hurt any longer, only discomfort when touching. Pt given ibuprofen.


VAERS ID: 521798 (history)  
Age: 11.0  
Gender: Female  
Location: Virginia  
Vaccinated:2014-01-27
Onset:2014-01-27
   Days after vaccination:0
Submitted: 2014-02-04
   Days after onset:8
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J012963 / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4431BA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Nausea, Ultrasound abdomen abnormal, Urine analysis normal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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 being taken by patient. GERD well controlled with diet. No other Rx or otc meds given that day before the vaccinations.
Current Illness: No illness at all. This was a well child visit.
Preexisting Conditions: GERD
Diagnostic Lab Data: Abdominal ultrasound; urinlaysis - negative; glucose 117; Bun 15; SCr .7; Ca 10.1; Na 140; K 4.6; Cl 105; Co2 26
CDC Split Type:

Write-up: About 2 hours after receiving Tdap and Hep A vaccines (4:30 pm) my daughter started to feel nauseous. Two hours later she started having bad abdominal pain and vomiting. She vomited about 6 times and her abdominal pain had gotten worse before I took her to the ER at about 9:15 pm. She was given 1 dose of iv ondansetron, iv morphine, 30 cc of po Maalox and 1 liter of Normal Saline. An abominal ultrasound ruled out acute appendicitis and ovarian torsion while some debris was seen in the bladder. She had a urinalysis done that was negative. She never had a fever and that was documented at the ER and doctor''s office earlier in the day. She experienced relief about 20 minutes after the iv morphine dose. After ruling out other causes the ER assumed this was the beginning of a virus and sent us home with an RX for 4 doses of ondansetron (4mg po q6hr prn nausea) and warned us that she would probably could also have explosive diarrhea. The next day she was able to eat the diet recommended by the hospital and she did not have any virus symptoms. She did have some abdominal pain later in the week only after drinking milk. That seems to have subsided. She has recovered from the event. Considering the temporal relationship of the event and vaccine administration, and other causes ruled out, it''s difficult to rule out an association between the vaccine administration and this event.


VAERS ID: 521802 (history)  
Age: 11.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2013-02-08
Onset:2013-02-11
   Days after vaccination:3
Submitted: 2014-02-04
   Days after onset:358
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016238 / 1 UN / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Butterfly rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (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
CDC Split Type:

Write-up: Bright red rash on cheeks (mallar rash) for 2 weeks. No other issues.


VAERS ID: 522036 (history)  
Age: 11.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-02-03
Onset:2014-02-03
   Days after vaccination:0
Submitted: 2014-02-06
   Days after onset:3
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013277 / 2 LA / IM

Administered by: Public       Purchased by: Public
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None; Pt did pull arm away as nurse was giving vaccine
Preexisting Conditions: None known
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Pt pulled arm away from nurse as vaccine was being given. Mother reports arm red, swollen and sore, no fever.


VAERS ID: 522056 (history)  
Age: 11.0  
Gender: Male  
Location: Colorado  
Vaccinated:2014-02-04
Onset:2014-02-04
   Days after vaccination:0
Submitted: 2014-02-06
   Days after onset:2
Entered: 2014-02-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH910AA / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / 5 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Limb discomfort, Local reaction, Skin warm
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: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: MOC stated child c/o LA discomfort since the night of vaccination. She states that upper LA has two areas (one golf ball size, the other tennis ball size) that are red and warm to the touch. She states that this local reaction has progressively become more pronounced. Vaccines may have been given in opposite arms to what is noted below per MOC comment.


VAERS ID: 522155 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-02-07
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3941AA / - RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Expired drug administered, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Expired ADACEL was given to patient. No reaction. CDC was contacted - they said to re-administer. Parent wants to wait. Expired 1-18-2014.


VAERS ID: 522156 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-02-07
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3941AA / - LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Expired drug administered, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Expired ADACEL was given to patient. No reaction. CDC was contacted - they said to re-administer. Patient wants to wait. Expired 1-18-2014.


VAERS ID: 522176 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-02-04
Onset:2014-02-05
   Days after vaccination:1
Submitted: 2014-02-07
   Days after onset:2
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: 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:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: SWELLING OF INJECTION SITE WITH PRURITUS. SEEN THE NEXT DAY, RECOMMENDED COLD COMPRESS AND BENARYL 25 MG Q 6-8 HOURS PRN SCRATCHING.


VAERS ID: 522180 (history)  
Age: 11.0  
Gender: Female  
Location: Alabama  
Vaccinated:2011-02-16
Onset:2011-03-01
   Days after vaccination:13
Submitted: 2014-02-07
   Days after onset:1074
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1437Z / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Alopecia, Arthralgia, Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Laboratory test normal, Malaise, Memory impairment, Pain, Pain in extremity, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: After 3 years of tests, no diagnosis. All tests come back negative. Patient is so ill and fatigued that she is no longer able to attend school.
CDC Split Type:

Write-up: Joint pain, leg and body pain, auto-immune symptoms, losing hair, extreme fatigue, difficulty breathing, lung pain, chest pain, shaking, memory problems (brain fog), etc.


VAERS ID: 522211 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-05
Onset:2014-02-06
   Days after vaccination:1
Submitted: 2014-02-07
   Days after onset:1
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AE / 2 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12130 / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4170AA / 0 LA / UN

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

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

Write-up: (L) deltoid redness, pain.


VAERS ID: 522213 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-02-06
Onset:2014-02-07
   Days after vaccination:1
Submitted: 2014-02-07
   Days after onset:0
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR X12014 / - LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4612AA / - RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Cellulitis, Vaccination complication
SMQs:

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

Write-up: Cellulitis, complication of immunization.


VAERS ID: 522225 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-01-08
Onset:2014-01-08
   Days after vaccination:0
Submitted: 2014-01-08
   Days after onset:0
Entered: 2014-02-08
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS T3959 / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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: None
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Dizzy, fainted (approximately 1 sec) per mom after left the store.


VAERS ID: 522238 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-09-16
Onset:2013-09-16
   Days after vaccination:0
Submitted: 2014-02-10
   Days after onset:147
Entered: 2014-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002641 / 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: WAES1402USA002349

Write-up: This spontaneous report as received from a healthcare worker refers to an 11 year old male patient. On 14-MAY-2013 the patient was vaccinated intramuscularly with first 0.5 ml dose of GARDASIL (injection site and lot# not provided). On 15-JUL-2013 and 16-SEP-2013, the patient was vaccinated with second and third dose of GARDASIL respectively (injection site and lot# not provided). Third dose given early and no adverse effects were reported. Additional information has been requested.


VAERS ID: 522279 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2014-02-02
Onset:2014-02-03
   Days after vaccination:1
Submitted: 2014-02-10
   Days after onset:7
Entered: 2014-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH897AB / - LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
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: Guanfacine ER 2 mg, sertraline 25 mg, diphenhydramine 25 mg, amphetamine/dextroamphetamine XR
Current Illness: Psychiatric illness only
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 4" diameter red circle, warm to touch at injection site.


VAERS ID: 522288 (history)  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2014-01-29
Onset:0000-00-00
Submitted: 2014-01-31
Entered: 2014-02-10
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH921AA / - LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 99P59 / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS AX13012 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site oedema, Injection site pruritus
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: Well child visit
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: (L) upper arm, red, itchy, edematous. Dx ICD - 682.9 cellulitis and abscess. Rx KEFLEX 500mg bid x 10 days.


VAERS ID: 522367 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2008-06-19
Onset:2008-06-20
   Days after vaccination:1
Submitted: 2014-02-10
   Days after onset:2061
Entered: 2014-02-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1030U / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Hypersomnia, Injection site erythema, Injection site reaction, Injection site swelling, Loss of consciousness, Malaise, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (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: No other medciations
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA000323

Write-up: This spontaneous report as received from a consumer refers to her son, a 11 year old male patient. Patient had no pertinent medical history and no drug reactions/allergies. On 19-JUN-2008 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 658422/1030U, Exp date: 27-JUN-2009) (dose and route unspecified). No concomitant medication reported. On 20-JUN-2008, less than 24 hours later the patient started throwing up and became ill while at a soccer game. The consumer reported that her son left the soccer game and when her son got home he "passed out" and fell asleep. The consumer reported that her son slept for the next 24 hours. The consumer reported that when her son was sleeping she noticed that there was an injection site reaction at the site of the VARIVAX (Merck) vaccination that was described as a red, raised oval about 4 inches by 4 inches at the site of the VARIVAX (Merck) vaccination. The consumer reported that when her son woke up he felt better and within 4 or 5 days the injection site reaction resolved and her son was recovered (date unspecified). No treatment was given for the events and no lab diagnostics studies performed. Additional information is not expected.


VAERS ID: 522457 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-09-04
Onset:2013-10-27
   Days after vaccination:53
Submitted: 2014-02-12
   Days after onset:108
Entered: 2014-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020002 / 0 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Disability, Fatigue, Headache, Infectious mononucleosis
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
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: WAES1402USA004484

Write-up: This spontaneous report as received from a pharmacist via company representative refers to a 12 year old female patient (also reported as the pharmacist''s daughter). The patient did not have any pertinent medical history. On an unknown date in October 2013, the patient was vaccinated with a first dose of GARDASIL (route, dose, lot number and expiry date were not reported). On an unknown date in 2013, a couple of weeks later, after administration of GARDASIL the patient developed mononucleosis (disability) with a chronic headache (disability) and fatigue (disability). The pharmacist did not administer GARDASIL again and therapy with GARDASIL was discontinued. The outcome of the events mononucleosis, chronic headache and fatigue were unknown. The events mononucleosis, chronic headache and fatigue led to disability. Additional information has been requested.


VAERS ID: 522510 (history)  
Age: 11.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2014-02-10
Onset:2014-02-12
   Days after vaccination:2
Submitted: 2014-02-12
   Days after onset:0
Entered: 2014-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injection site nodule, 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:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heat, pain, swelling, knot at injection site.


VAERS ID: 522560 (history)  
Age: 11.0  
Gender: Male  
Location: Iowa  
Vaccinated:2014-02-11
Onset:2014-02-11
   Days after vaccination:0
Submitted: 2014-02-13
   Days after onset:2
Entered: 2014-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0231AA / 2 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Expired drug 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA006162

Write-up: This spontaneous report as received from license practical nurse refers to a patient of unknown age and gender. On 11-FEB-2014 the patient was vaccinated with expired dose of RECOMBIVAX HB with lot # 0231AA and expiry date 14-OCT-2013 (dose unit and route unknown). No adverse event was reported. The outcome of received a dose of expired RECOMBIVAX HB and no adverse event was unknown. No further information was provided. Additional information has been requested.


VAERS ID: 522861 (history)  
Age: 11.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2014-02-13
Onset:2014-02-14
   Days after vaccination:1
Submitted: 2014-02-17
   Days after onset:3
Entered: 2014-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J012963 / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015309 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13047 / - LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006693 / - LA / SC

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

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

Write-up: 7 INCHES X 4 INCHES WARM AND SIGNIFICANT ERYTHEMA.


VAERS ID: 522897 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2014-02-17
Onset:2014-02-17
   Days after vaccination:0
Submitted: 2014-02-17
   Days after onset:0
Entered: 2014-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009788 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13013 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9FS27 / 0 LA / IM

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

Write-up: Patient was in lobby waiting 15 minutes after imm. given when approx. 3 mins after imm was given he felt lightheaded and fainted. Was brought to back to be monitored. Waited 15 mins in room, and was okay to leave.


VAERS ID: 522954 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-12-04
Onset:0000-00-00
Submitted: 2014-02-18
Entered: 2014-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 0 LA / UN

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

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: WAES1402USA006145

Write-up: This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. On an unknown date, the patient was vaccinated with AFLURIA (dose, route and frequency was not reported) and first shot of GARDASIL (route and frequency was not reported) at the same time. On an unknown date, after receiving both the vaccines at the same time, the patient experienced swelling at the injection site. It was also reported that the patient had not yet received the second and third dose of GARDASIL. The outcome of the event swelling at the injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.


VAERS ID: 523040 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-01-30
Onset:2014-02-03
   Days after vaccination:4
Submitted: 2014-02-18
   Days after onset:15
Entered: 2014-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abnormal behaviour, CSF oligoclonal band, CSF test, Computerised tomogram head, Confusional state, Lethargy, Mental status changes, Nuclear magnetic resonance imaging brain, Somnolence, Speech disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KEPPRA
Current Illness: Headache; Myalgias; Decreased appetite for one month
Preexisting Conditions:
Diagnostic Lab Data: MRI; CSF studies; Oligomonoclonal bands in serum - collected at hospital
CDC Split Type:

Write-up: 1/30/14 - Received vaccine. 1/31/14 - Started KEPPRA because of history of seizure. First time seizure occurred was in week preceding vaccine, head CT was normal, patient was scheduled for brain MRI on 2/3/14. 2/4/14 Mom brought child into office - stating he had been behaving abnormally since night of 2/3/14 and deteriorating till time of visit. He was lethargic, falling asleep constantly, his speech was abnormal, no fever at the time, and was assessed as having altered mental status and transferred to hospital ER.


VAERS ID: 523075 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-02-13
Onset:2014-02-13
   Days after vaccination:0
Submitted: 2014-02-13
   Days after onset:0
Entered: 2014-02-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 1 LA / SYR
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 1 RA / SYR
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4G995 / 1 RA / SYR

Administered by: Private       Purchased by: Public
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fainted after shot. Monitor in office for 20 minutes.


VAERS ID: 523161 (history)  
Age: 11.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2014-02-18
Onset:2014-02-19
   Days after vaccination:1
Submitted: 2014-02-20
   Days after onset:1
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4561AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332BA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema, 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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Strawberry allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm swollen, red, warm.


VAERS ID: 523178 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2014-02-19
Onset:2014-02-19
   Days after vaccination:0
Submitted: 2014-02-20
   Days after onset:1
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - AR / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - AR / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: Fever, vomiting, headache over last 5 hours. Treatment so far is Advil and fluids. Dr visit later today.


VAERS ID: 523180 (history)  
Age: 11.0  
Gender: Female  
Location: Virginia  
Vaccinated:2014-02-03
Onset:2014-02-05
   Days after vaccination:2
Submitted: 2014-02-20
   Days after onset:15
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J011385 / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4430AA / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J011386 / 1 RA / SC

Administered by: Unknown       Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: None
Preexisting Conditions: H/o vaccine reaction to DTAP at a younger age
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash, redness and swelling at injection site. Diagnosed as cellulitis. Treated with antibiotics x 7 days.


VAERS ID: 523198 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-02-08
Onset:2014-02-11
   Days after vaccination:3
Submitted: 2014-02-20
   Days after onset:9
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4618AA / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Tenderness
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: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type: TX140006PU

Write-up: Edema and erythema right arm (MCV4) vaccine site 50x50. Tender to touch. Injection site feels warm.


VAERS ID: 523352 (history)  
Age: 11.0  
Gender: Male  
Location: Colorado  
Vaccinated:2014-02-17
Onset:2014-02-17
   Days after vaccination:0
Submitted: 2014-02-21
   Days after onset:4
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013277 / 2 RA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Chest discomfort, Decreased appetite, Dizziness, Fatigue, Nausea, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: After being in hot tub, developed chest tightness, dizziness, fatigue, and decreased appetite. Shortly after developed fever (103). Developed nausea and emesis (x10) around 3:00 AM on 02/18/2014. Treated with Advil and small sips of fluids at home. Came to urgent care at 9:52 AM on 02/18/2014 and was feeling well.


VAERS ID: 523447 (history)  
Age: 11.0  
Gender: Male  
Location: Virginia  
Vaccinated:2014-02-17
Onset:2014-02-18
   Days after vaccination:1
Submitted: 2014-02-24
   Days after onset:6
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4688BA / 0 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Diarrhoea, Lethargy, Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), 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? 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: Severe abdominal cramping/discomfort followed by diarrhea, vomiting, chills, lethargy, muscle aches, fever of 102.5 with Tylenol.


VAERS ID: 523460 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-14
Onset:0000-00-00
Submitted: 2014-02-24
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / - UN / SYR

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: WAES1402USA009564

Write-up: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages and genders. Nurse mentioned an unknown number of patients might have received GARDASIL injection (lot #, expiry date, dose and route unknown) that was improperly stored. No adverse symptoms reported. Additional information has been requested.


VAERS ID: 523483 (history)  
Age: 11.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-02-13
Onset:0000-00-00
Submitted: 2014-02-14
Entered: 2014-02-24
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J005081 / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / - LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4626AA / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4365AA / - RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Cellulitis, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Localized swelling of arm
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling and redness / cellulitis right arm.


VAERS ID: 523524 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2014-02-20
Onset:2014-02-20
   Days after vaccination:0
Submitted: 2014-02-24
   Days after onset:4
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - 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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA010823

Write-up: This spontaneous report as received from a nurse refers to 11 year old patient (gender unspecified). On 20-FEB-2014, nurse inadvertently administered ZOSTAVAX, subcutaneous (dose unspecified) to an 11 year old patient for vaccination. It was reported this would have been dose two of the patient''s VARIVAX (Merck). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.


VAERS ID: 523631 (history)  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2013-11-02
Onset:2013-11-02
   Days after vaccination:0
Submitted: 2013-11-04
   Days after onset:2
Entered: 2014-02-24
   Days after submission:112
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Exposure via direct contact, 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE81266

Write-up: A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. It was reported that patient received half of a dose of FLUMIST in one nostril and other half squired into his face and maybe in his eye which started on 02-Nov-2013. The outcome of the event of received half of a dose of FLUMIST in one nostril and other half squirted into his face and maybe eye is unknown. The report was considered to be non-serious.


VAERS ID: 523644 (history)  
Age: 11.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:0000-00-00
Onset:2013-10-22
Submitted: 2013-10-22
   Days after onset:0
Entered: 2014-02-24
   Days after submission:125
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2062 / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Exposure via direct contact
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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE77977

Write-up: A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient was administered into eye on 22-Oct-2013. The outcome of the event of ADMINISTRATION INTO EYE is unknown. The report was considered to be non-serious.


VAERS ID: 523710 (history)  
Age: 11.0  
Gender: Female  
Location: Montana  
Vaccinated:2013-12-03
Onset:2013-12-03
   Days after vaccination:0
Submitted: 2013-12-04
   Days after onset:1
Entered: 2014-02-24
   Days after submission:82
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2026 / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Expired 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE88710

Write-up: A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 03-Dec-2013. The patient was inadvertently given an expired dose of FLUMIST which started on 03-Dec-2013. The outcome of the event of inadvertently gave an expired dose of FLUMIST is unknown. The report was considered to be non-serious.


VAERS ID: 523711 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2013-09-16
Onset:2013-10-07
   Days after vaccination:21
Submitted: 2013-10-09
   Days after onset:2
Entered: 2014-02-24
   Days after submission:138
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2124 / - - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12120 / - UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS ACS2B099CA / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ear infection, Ear pain, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE74731

Write-up: A report had been received from a Health Professional concerning an 11 years old, male patient. The relevant history and concomitant drugs of the patient were not reported. The patient had received nasal FLUMIST QUADRIVALENT of batch number BH2124 on 16-Sep-2013. The patient also received Tdap and MCV4 vaccines on that day. The nurse reported that the patient had right ear pain on 01-Oct-2013. The patient was diagnosed with right ear infection on 01-Oct-2013. The patient was started on CIPRODEX drops - four drops to right ear two times a day. The patient started to experience a symptom of Bell''s palsy (right sided facial drooping) on 07-Oct-2013. Patient was seen in office on 08-Oct-2013. Doctor started him on ZITHROMAX 250 mg-two tablet, the first day, then one tablet for four days, Prednisone 20 mg tablet two tablet for seven days, one and half tablet for two days, then one tablet for two days then half tablet for two days and then one fourth tablet for two days. At the time of reporting, the event of patient''s right sided droop had not improved. The outcome of the event of right ear infection was unknown. The reporter considered the events of right ear infection and right sided facial droop to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 09-Oct-2013 from health professional: Event verbatim and coding for event of right sided facial droop/Bell''s palsy was updated. Reporter''s type patient was added. Reporter''s and patient''s details were updated. Concomitant drugs were added. Narrative was amended. Corrected report 20-Oct-2013: Manufacturer for suspect vaccine was added.


VAERS ID: 523747 (history)  
Age: 11.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2013-11-29
Onset:2013-11-29
   Days after vaccination:0
Submitted: 2013-12-06
   Days after onset:7
Entered: 2014-02-24
   Days after submission:80
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2029 / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Expired 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE90325

Write-up: A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 29-Nov-2013. Reporter reported that they administered expired FLUMIST/one of my staff members accidentally administered expired FLUMIST which started on 29-Nov-2013. The outcome of the event of administered expired FLUMIST/one of my staff members accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.


VAERS ID: 523884 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
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: 2013SE86911

Write-up: A report has been received from a Pharmacist concerning a 11 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. It was reported that the consumer was administered 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.


VAERS ID: 523889 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-11-11
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: 2013SE87093

Write-up: A report has been received from a Pharmacist concerning an 11 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril which started on 11-Nov-2013 at one of the mobile clinics. 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.


VAERS ID: 523914 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2013-11-27
Onset:2013-11-27
   Days after vaccination:0
Submitted: 2013-12-03
   Days after onset:6
Entered: 2014-02-25
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2027 / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Expired 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE88428

Write-up: A report has been received from a Pharmacist concerning an 11 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 27-Nov-2013. The pharmacist reported that inadvertently administered expired FLUMIST QUADRIVALENT to a patient on 27-Nov-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious. Summary of significant follow-up information received by AstraZeneca/MedImmune on 03-Dec-2013 from a Pharmacist: Product lot number ane expiry date added with updation of start date for FLUMIST. Event start date updated. Patient details updated. Reporter details updated.


VAERS ID: 523917 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-12-02
Onset:2013-12-02
   Days after vaccination:0
Submitted: 2013-12-03
   Days after onset:1
Entered: 2014-02-25
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2173 / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Expired drug 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE88410

Write-up: A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 02-Dec-2013. The medical assistant reported that six patients received FLUMIST quadrivalent that expired on 25-Nov-2013 on 02-Dec-2013. Not reporting any symptoms. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious by reporter.


VAERS ID: 523919 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-12-02
Onset:2013-12-02
   Days after vaccination:0
Submitted: 2013-12-03
   Days after onset:1
Entered: 2014-02-25
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2173 / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Expired 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE88526

Write-up: A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The health professional reported that patient received expired FLUMIST quad on 02-Dec-2013. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.


VAERS ID: 524049 (history)  
Age: 11.0  
Gender: Male  
Location: Rhode Island  
Vaccinated:2014-02-24
Onset:2014-02-25
   Days after vaccination:1
Submitted: 2014-02-26
   Days after onset:1
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445AB / 0 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Pain
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: None
Current Illness: None
Preexisting Conditions: School problems, learning disorder, math
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Redness and swelling of arm where vaccine administered. No systemic symptoms. Pain to touch.


VAERS ID: 524084 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-24
Onset:2014-02-24
   Days after vaccination:0
Submitted: 2014-02-24
   Days after onset:0
Entered: 2014-02-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / 0 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site reaction. S/P vaccination ice to area, Motrin as needed.


VAERS ID: 524092 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-18
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / - LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and need to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not have been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been indentify the 12 patients who administered HPV vaccine between the dates of 2/12 - 12/18/14 under lot number (J012212).


VAERS ID: 524093 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-18
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / - UN / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to clinic. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 12/18/14 under lot number (J012212).


VAERS ID: 524094 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-18
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).


VAERS ID: 524097 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-14
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).


VAERS ID: 524099 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-13
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / - LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to VFC. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).


VAERS ID: 524100 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-13
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to VFC. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).


VAERS ID: 524101 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-12
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to VFC. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).


VAERS ID: 524102 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-24
Onset:2014-02-25
   Days after vaccination:1
Submitted: 2014-02-26
   Days after onset:1
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / 0 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Injection site reaction
SMQs:

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: Injection site reaction. S/P vaccination, ice to area, Motrin as needed.


VAERS ID: 524107 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-10
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / - UN / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Incorrect storage of drug
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: Patient received vaccines exposed to the out of range temperature.


VAERS ID: 524118 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-27
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006732 / - RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (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:
CDC Split Type: WAES1402USA007622

Write-up: This spontaneous report was received from a medical assistant refers to a 11 year old child of unknown gender. Medical history was reported as none. No known drug allergy was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # J006732; expiry: 30-MAY-2015, dose: 0.5 ml (millilitres), subcutaneous in the right arm. Concomitant therapy was reported was none. On an unknown date the patient developed a rash at the injection site after administration of VARIVAX (Merck). The patients were evaluated in the office. No medical treatment was prescribed. The patient sought medical attention and had an office visit. The outcome of rash at the injection site was unknown. Causality assessment for the event was not provided. This case is linked to: 1402USA013049 (same reporter link). Additional information has been requested.


VAERS ID: 524205 (history)  
Age: 11.0  
Gender: Male  
Location: Kansas  
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH949AB / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / 0 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Dizziness, Hyporesponsive to stimuli
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: About 5-8 minutes after vaccine given became lightheaded, less verbally responsive. Placed in supine position, eyes closed not verbally responsive for 1-2 minutes. Gradually felt better, verbally responsive all sx resolved within 15 minutes.


VAERS ID: 524260 (history)  
Age: 11.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2014-02-24
Onset:2014-02-24
   Days after vaccination:0
Submitted: 2014-02-28
   Days after onset:4
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12104 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Diarrhoea, Erythema, Nausea, Swelling face, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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: some swelling~Tdap (no brand name)~UN~11.00~Patient
Other Medications: Singulair
Current Illness: Several allergies, asthma. Takes Singulair daily. Takes albuterol inhaler and neb treatments and Benadryl as needed
Preexisting Conditions: Asthma. Allergies to All nuts, sunflower seeds, Pineapples, Pulmacort, Ibuprofen
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling/Redness to face; hives 10:00AM treated with Benadryl. Later- went to ER d/t no improvement and now N/V/D received steroid injections and Zofran per mom.


VAERS ID: 524314 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-26
Onset:2014-02-28
   Days after vaccination:2
Submitted: 2014-02-28
   Days after onset:0
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13014 / 0 RA / IM

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

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

Write-up: Redness/swelling on R deltoid.


VAERS ID: 524348 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2014-02-26
Onset:2014-02-27
   Days after vaccination:1
Submitted: 2014-02-28
   Days after onset:1
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BN2195 / 0 - / IN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J005010 / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4700BA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site inflammation, Pain
SMQs:, Extravasation events (injections, infusions and implants) (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: Redness and severe inflammation to (L) deltoid arm muscle also c/o pain.


VAERS ID: 524396 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-02-26
Onset:2014-02-27
   Days after vaccination:1
Submitted: 2014-03-03
   Days after onset:4
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009788 / - LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4658BB / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4506BA / - RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, 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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: Allergy - Penicillins
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child received Tdap, MENACTRA and GARDASIL on 2/26/14. Mom noticed redness and swelling on 2/27/14 after playing baseball, some warmness to the touch also.


VAERS ID: 524412 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-02-26
Onset:2011-03-20
   Days after vaccination:22
Submitted: 2014-03-03
   Days after onset:1079
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1317Y / 1 - / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abnormal behaviour, Convulsion, Dizziness, Electroencephalogram abnormal, Fatigue, Headache, Myalgia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO ILLNESS AT TIME OF INJECTION... BUT THIS WAS FOR THE HPV INJECTION 2ND SHOT 2/26/2011 3RD SHOT 6/23/2011... AFTER HAVING 2ND SHOT ON 2/26/2011, MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, MUSCLE PAINS, AND BLURRED VISION AT TIMES
Preexisting Conditions: ADHD
Diagnostic Lab Data: PT. HAS SINCE HAD A FEW ABNORMAL EEG''S
CDC Split Type:

Write-up: MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, AND BLURRED VISION AT TIMES.


VAERS ID: 524433 (history)  
Age: 11.0  
Gender: Male  
Location: Oregon  
Vaccinated:2014-02-19
Onset:2014-02-19
   Days after vaccination:0
Submitted: 2014-03-03
   Days after onset:12
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Pyrexia
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of 102 that lasted for 18 hours and extreme soreness at injection site that lasted for 2-3 days.


VAERS ID: 524450 (history)  
Age: 11.0  
Gender: Female  
Location: Missouri  
Vaccinated:2014-02-11
Onset:2014-02-12
   Days after vaccination:1
Submitted: 2014-03-03
   Days after onset:19
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A13050 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 253B4 / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Lymphadenopathy, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pt.''s mom reported to Dr. on 02/27/14 during a sib O.V. that pt. ''developed approximately baseball size'' area of redness to RA after rec''ng vaccines in office on 02/11/14. Pt. was not brought to office; also reports pt. with 99 degree F temp at same time. No tx. Also reports pt. had ''swollen'' glands, but not enough to bring her in for, and dev. URI sx 1-2 days after that.


VAERS ID: 524480 (history)  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-02-26
Onset:2014-02-27
   Days after vaccination:1
Submitted: 2014-03-04
   Days after onset:5
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Rash erythematous, 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:
Current Illness: NONE
Preexisting Conditions: ALLERGIES
Diagnostic Lab Data:
CDC Split Type:

Write-up: CHILD NOTICED SMALL RED BUMPS EARLIER BY 10P MOM STATES CHILD COVERED IN HIVES. MOM CONTACTED PCP AND WAS TOLD TO GIVE CHILD HER ALLERGY MEDICINE, BY MORNING HIVES WERE GONE.


VAERS ID: 524676 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
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
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS A259X / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4657AA / 0 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS P572X / 0 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
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: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Redness with induration 5 x 6 cm and inflammation. On (R) deltoid region.


VAERS ID: 524744 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2014-03-03
Onset:2014-03-04
   Days after vaccination:1
Submitted: 2014-03-05
   Days after onset:1
Entered: 2014-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS T4MS9 / - RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AC / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U461788 / - LA / IM

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

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

Write-up: Patient with swelling, redness and tenderness to entire left deltoid area.


VAERS ID: 524755 (history)  
Age: 11.0  
Gender: Female  
Location: Alabama  
Vaccinated:2014-03-03
Onset:2014-03-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2014-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4610BA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4431BA / 0 RA / IM

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

Write-up: Pt arms swollen w/redness and warm to touch. Treated w/PO OTC Benadryl, Tylenol and Motrin.


VAERS ID: 525273 (history)  
Age: 11.0  
Gender: Female  
Location: Oregon  
Vaccinated:2014-03-06
Onset:2014-03-06
   Days after vaccination:0
Submitted: 2014-03-07
   Days after onset:1
Entered: 2014-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4561AA / 0 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time of immunizations, but started on Keflex after leaving Clinic.
Current Illness: Patient was being seen by FNP for a laceration on her left foot. Treated with Keflex.
Preexisting Conditions: None
Diagnostic Lab Data: To watch and observe and call/RTC for any further concerns or s/s of infection/reaction.
CDC Split Type:

Write-up: At 11:00am started w/arm itching, then after one hour it began to hurt and swell. The redness 10cmX8cm started this morning around 8am(03/07/2014).


VAERS ID: 525309 (history)  
Age: 11.0  
Gender: Male  
Location: Alabama  
Vaccinated:2014-03-04
Onset:2014-03-06
   Days after vaccination:2
Submitted: 2014-03-07
   Days after onset:1
Entered: 2014-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12092 / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Swollen arm~Tdap (Boostrix)~1~10.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Obesity; Obstructive sleep apnea
Diagnostic Lab Data: Referred to allergist
CDC Split Type:

Write-up: 3/6/14 (L) upper arm swollen and draining clear fluid. Given BENADRYL and Rx for prednisone.


VAERS ID: 525380 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2014-03-06
Onset:2014-03-06
   Days after vaccination:0
Submitted: 2014-03-10
   Days after onset:3
Entered: 2014-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4608A1 / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abnormal behaviour, Confusional state, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: High fever (102 F) starting 3/6/14 evening into 3/7/14. Still febrile today (3/10/14). Behavioral changes beginning 3/6/14; confusion 3/7/14. Cervical adenopathy.


VAERS ID: 525436 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-02-27
Onset:2014-02-28
   Days after vaccination:1
Submitted: 2014-03-11
   Days after onset:10
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021346 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 04593AB / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Loss of consciousness, Nausea, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Med