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Found 551167 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

This is page 304 out of 552

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VAERS ID:541093 (history)  Vaccinated:2014-08-25
Age:15.0  Onset:2014-08-25, Days after vaccination: 0
Gender:Female  Submitted:2014-08-25, Days after onset: 0
Location:Georgia  Entered:2014-08-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Unconscious and seizure like activity~Vaccine not specified (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0153780IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4657AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSN4L770IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0041551SCRA
Administered by: Public     Purchased by: Public
Symptoms: Eye movement disorder, Heart rate increased, Loss of consciousness, Muscle contractions involuntary, Opisthotonus, Seizure like phenomena, Snoring
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), Convulsions (narrow), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: After the 4th and final imm given, which was the HPV vaccine, client, who was placed on exam table and lying down during vaccine administration, her eyes rolled back and she made a deep snoring noise. Her back began to arch and her arms drew up and tightened like with seizure activity. Client was unconscious. Client had rapid pulse. After 30 sec or so, client came to and answered to her name. Cool rags were applied to her chest and forehead, she was fanned with paper RN had in her hand. A Coke was given to client once consciousness gained. After 2-3 minutes client stated she felt fine. She was observed 15-20 minutes after losing consciousness and walked out of Health Dept without assistance with her mother and 2 brothers. Mother states she has a history of passing out and having seizure like activity after vaccines or the sight of blood.

VAERS ID:541434 (history)  Vaccinated:2013-10-01
Age:15.0  Onset:2013-12-15, Days after vaccination: 75
Gender:Male  Submitted:2014-03-03, Days after onset: 78
Location:Georgia  Entered:2014-08-25, Days after submission: 174
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: 2014SE15123
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Influenza virus test positive
SMQs:
Write-up: A report had been received from a health Professional concerning a 15 years old male patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient had received nasal FLUMIST QUADRIVALENT started during Oct-2013. It was reported that a total of four of their patients received FLUMIST and later tested positive for the flu which started on 15-Dec-2013. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of tested positive for flu was unknown. The reporter assessed the event of tested positive for flu to be non-serious.

VAERS ID:541528 (history)  Vaccinated:2014-01-26
Age:15.0  Onset:2014-01-26, Days after vaccination: 0
Gender:Male  Submitted:2014-02-12, Days after onset: 17
Location:New Jersey  Entered:2014-08-25, Days after submission: 193
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: 2014SE10641
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BK2023 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. This case was related to the one of the 17 patients who had administered the expired FLUMIST. FLUMIST QUADRIVALENT (Intranasal) started on 26-Jan-2014. It was reported that the expired FLUMIST was administered to the patient on 26-Jan-2014. Lot number BK2023. Expiry date 20-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.

VAERS ID:541623 (history)  Vaccinated:2014-01-16
Age:15.0  Onset:2014-01-16, Days after vaccination: 0
Gender:Female  Submitted:2014-01-23, Days after onset: 7
Location:Unknown  Entered:2014-08-25, Days after submission: 213
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: 2014SE05391
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2124 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 15 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 16-Jan-2014. Inadvertently was given expired FLUMIST QUADRIVALENT which started on 16-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.

VAERS ID:541654 (history)  Vaccinated:2014-01-28
Age:15.0  Onset:2014-01-28, Days after vaccination: 0
Gender:Female  Submitted:2014-01-30, Days after onset: 2
Location:Unknown  Entered:2014-08-25, Days after submission: 206
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: 2014SE06841
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BK2063 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 15 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 28-Jan-2014. The patient received expired FLUMIST on 28-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.

VAERS ID:541876 (history)  Vaccinated:2014-01-15
Age:15.0  Onset:2014-01-15, Days after vaccination: 0
Gender:Male  Submitted:2014-01-23, Days after onset: 8
Location:Florida  Entered:2014-08-25, Days after submission: 213
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: 2014SE05359
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2091 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from an office manager concerning a 15 year old, male patient who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) was administered on 15-Jan-2014. The office manager reported that they gave expired FLUMIST QUADRIVALENT which occurred on 15-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.

VAERS ID:542193 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:2013-12-04
Gender:Male  Submitted:2013-12-09, Days after onset: 5
Location:Unknown  Entered:2014-08-25, Days after submission: 258
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: 2013SE89968
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2091 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The reporter mentioned that patient was accidentally given expired FLUMIST on 04-Dec-2013. The outcome of the event of WE ACCIDENTALLY GAVE EXPIRED FLUMIST TO A PATIENT is unknown. The report was considered to be non-serious.

VAERS ID:542224 (history)  Vaccinated:2013-12-10
Age:15.0  Onset:2013-12-10, Days after vaccination: 0
Gender:Male  Submitted:2013-12-11, Days after onset: 1
Location:Unknown  Entered:2014-08-25, Days after submission: 256
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: 2013SE90719
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Physician concerning a 15 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient received FLUMIST on 10-Dec-2013 that expired on 09-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.

VAERS ID:542420 (history)  Vaccinated:2014-01-09
Age:15.0  Onset:2014-01-09, Days after vaccination: 0
Gender:Male  Submitted:2014-01-10, Days after onset: 1
Location:Unknown  Entered:2014-08-25, Days after submission: 226
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2014SE02355
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BJ2156 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 14 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that an administration of expired FLUMIST QUADRIVALENT which started on 09-Jan-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.

VAERS ID:542456 (history)  Vaccinated:2014-01-14
Age:15.0  Onset:2014-01-14, Days after vaccination: 0
Gender:Female  Submitted:2014-01-14, Days after onset: 0
Location:Unknown  Entered:2014-08-25, Days after submission: 222
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: 2014SE03256
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BK2022 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 15 year old, female subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 14-Jan-2014. The patient received expired FLUMIST on 14-jan-2014. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.

VAERS ID:542457 (history)  Vaccinated:2014-01-15
Age:15.0  Onset:2014-01-15, Days after vaccination: 0
Gender:Female  Submitted:2014-01-15, Days after onset: 0
Location:Unknown  Entered:2014-08-25, Days after submission: 221
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: 2014SE03262
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2187 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Physician concerning a 15 year old, female subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 15-Jan-2014. It was reported by Physician that eight patients were received expired FLUMIST on 15-Jan-2014. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.

VAERS ID:542501 (history)  Vaccinated:2013-12-18
Age:15.0  Onset:2013-12-18, Days after vaccination: 0
Gender:Male  Submitted:2014-01-15, Days after onset: 28
Location:Unknown  Entered:2014-08-25, Days after submission: 221
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: 2014SE03414
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2187 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a Health Professional concerning a 15 year old, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 18-Dec-2013. MD reported that 8 people received expired FLUMIST. The outcome of the event of received expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.

VAERS ID:542524 (history)  Vaccinated:2014-01-14
Age:15.0  Onset:2014-01-14, Days after vaccination: 0
Gender:Female  Submitted:2014-01-15, Days after onset: 1
Location:Unknown  Entered:2014-08-25, Days after submission: 221
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: 2014SE03393
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BH2187 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A report has been received from a physician concerning a 15 year old, female subject, who had been receiving nasal FLUIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 14-Jan-2014. It was reported by physician that eight patients were received expired FLUMIST QUADRIVALENT on 14-Jan-2014. The outcome of the event of received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.

VAERS ID:541218 (history)  Vaccinated:2014-08-18
Age:15.0  Onset:2014-08-18, Days after vaccination: 0
Gender:Female  Submitted:2014-08-26, Days after onset: 8
Location:California  Entered:2014-08-26
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: SCOLIOSIS
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0087990IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: REDNESS AND SWELLING OF INJECTED AREA, ALSO WITH PRURITUS.

VAERS ID:541317 (history)  Vaccinated:2014-08-08
Age:15.0  Onset:2014-08-08, Days after vaccination: 0
Gender:Male  Submitted:2014-08-27, Days after onset: 19
Location:Oklahoma  Entered:2014-08-27
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: No test done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0092432UNLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Chills, Dehydration, Diarrhoea, Headache, Nausea, Sinusitis, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: HPV given 8-8-14 10:00 am. He went to bed at 9:00pm having chills and headache. Up all night with vomiting and stomach pain. 8-9-14 he took MOTRIN at 9:00 am rested all day, drank 7up. By noon he was feeling better. His symptoms of headaches, nausea, vomiting, diarrhea continue to come and go since August 8th. Went to PCP yesterday. Diagnosed with dehydration and sinus infection. IV fluids given at ER. Given zithromycin 3 day treatment.

VAERS ID:541331 (history)  Vaccinated:2014-08-19
Age:15.0  Onset:2014-08-19, Days after vaccination: 0
Gender:Female  Submitted:2014-08-20, Days after onset: 1
Location:Washington  Entered:2014-08-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1411101 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Neck pain
SMQs:, Arthritis (broad)
Write-up: Approximately starting at 9:00 pm 8/19/14 (day of vaccine), patient reported pain in neck radiating to engulf her head, causing a knife-stabbing like pain. She was taken to emergency room and while there pain subsided. She was not treated at the ER - per mother.

VAERS ID:541382 (history)  Vaccinated:2014-08-20
Age:15.0  Onset:2014-08-20, Days after vaccination: 0
Gender:Male  Submitted:2014-08-20, Days after onset: 0
Location:New York  Entered:2014-08-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0106680IMLA
Administered by: Private     Purchased by: Unknown
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)
Write-up: Became faint, passed out.

VAERS ID:541635 (history)  Vaccinated:2014-02-11
Age:15.0  Onset:2014-03-11, Days after vaccination: 28
Gender:Female  Submitted:2014-08-28, Days after onset: 170
Location:Virginia  Entered:2014-08-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0213460 LA
Administered by: Private     Purchased by: Private
Symptoms: Autoimmune disorder, Skin depigmentation
SMQs:
Write-up: Autoimmune/Skin depigmentation.

VAERS ID:541650 (history)  Vaccinated:2013-06-01
Age:15.0  Onset:2013-06-01, Days after vaccination: 0
Gender:Male  Submitted:2014-08-29, Days after onset: 454
Location:California  Entered:2014-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: SEVERE EMESIS ALL NIGHT REQUIRING IV MEDICATION''S AND FLUIDS TO BE ADMINISTERED IN EMERGENCY DEPARTMENT.

VAERS ID:541743 (history)  Vaccinated:2014-04-11
Age:15.0  Onset:2014-08-28, Days after vaccination: 139
Gender:Female  Submitted:2014-08-29, Days after onset: 1
Location:Virginia  Entered:2014-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: SAB~HPV (Gardasil)~1~15.33~Patient
Other Medications: NONE KNOWN
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: NONE AT OUR OFFICE. PARENT REPORTED NORMAL THYROID LABS THROUGH DERM
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0133241IMLA
Administered by: Private     Purchased by: Private
Symptoms: Alopecia, Thyroid function test normal, Vitiligo
SMQs:
Write-up: ALOPECIA, VITILIGO.

VAERS ID:541832 (history)  Vaccinated:2014-08-26
Age:15.0  Onset:2014-08-26, Days after vaccination: 0
Gender:Female  Submitted:2014-08-29, Days after onset: 3
Location:Alaska  Entered:2014-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient had no illnesses at time of vaccination that we were told of.
Preexisting Conditions: None
Diagnostic Lab Data: Complete neuro exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Dizziness, Dyspnoea, Neurological examination normal, Pallor, Palpitations, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: About 45 minutes after the vaccine patient reported starting to feel crummy, as the day went on symptom got worse, blurred vision, overall feeling of weakness, dizziness, feeling like it was hard to breathe, pale skin, heart thumping in chest and temples.

VAERS ID:541872 (history)  Vaccinated:2014-08-27
Age:15.0  Onset:2014-08-28, Days after vaccination: 1
Gender:Female  Submitted:2014-08-29, Days after onset: 1
Location:California  Entered:2014-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0097880IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0137341SCLA
Administered by: Private     Purchased by: Other
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt reported swelling, redness, and warmth to the back of her left upper arm where she received the injection. Pt also c/o fatigue.

VAERS ID:541913 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-01
Location:Ohio  Entered:2014-09-01
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: WAES1408USA016371
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: This spontaneous report was received from a physician via company representative refers to a 15 year old female patient. There was not pertinent medical history. On an unknown date the patient was vaccinated with the second dose of GARDASIL injection, 1 single shot, (lot number, expiration date, route and dosage were not reported). Concomitant therapy was not reported. The physician informed that on an unknown date within a month of receiving the second dose of GARDASIL the patient began experiencing severe shoulder pain. No adverse effects were reported with the first dose. The patient needed physical therapy as treatment for the adverse event, a magnetic resonance imaging (MRI) was performed as diagnostic study. The patient sought an unspecified medical attention for the adverse event. The reporter determined that the shoulder pain was significant disability or incapacity. Additional information has been requested.

VAERS ID:542528 (history)  Vaccinated:2012-12-20
Age:15.0  Onset:2012-12-20, Days after vaccination: 0
Gender:Female  Submitted:2014-09-01, Days after onset: 619
Location:Unknown  Entered:2014-09-01
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: WAES1408USA015991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report was received from a nurse refers to a 15 year old female patient. On 20-DEC-2012 the patient was vaccinated with GARDASIL (dosing regimen unspecified) dose 3. It was reported that nurse states on 20-DEC-2012 a patient was vaccinated with the third dose of GARDASIL too early. Patient was vaccinated with GARDASIL first dose 22-AUG-2012, second dose 25-OCT-2012 and the third dose of GARDASIL on 20-DEC-2012. Nurse states patient vaccinated at another health care facility. No adverse effects reported. The outcome of patient was vaccinated with the third dose of GARDASIL too early and no adverse effects reported is unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.

VAERS ID:542603 (history)  Vaccinated:2014-06-01
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-01
Location:Unknown  Entered:2014-09-01
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: WAES1409USA000390
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Local reaction, Pain
SMQs:
Write-up: This spontaneous report was received from a certified medical assistant refers to a 15 year old female patient. No medical history or concurrent conditions were reported. Approximately in June 2014, reported as 2 months ago, the patient was vaccinated with the third dose of GARDASIL, injection (dose, route of administration and lot number not provided). Co-suspect or concomitant therapies were not reported. Approximately in June 2014, reported as 2 months ago, the patient was vaccinated with the third dose of GARDASIL, injection (dose, route of administration and lot number not provided). Co-suspect or concomitant therapies were not reported. Approximately on 2014, the patient experienced pain and a localized reaction at the injection site after received the third dose of GARDASIL. At the time of the report, the outcome of the events was unknown. The causal relationship between GARDASIL and the events was unknown. Additional information has been requested.

VAERS ID:541919 (history)  Vaccinated:2014-08-27
Age:15.0  Onset:2014-08-28, Days after vaccination: 1
Gender:Female  Submitted:2014-09-02, Days after onset: 5
Location:South Carolina  Entered:2014-09-02
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: NONE
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K005083 IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4686AB IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSE5957 IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.K003405 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red warm area to LEFT arm at site of VARICELLA injection. Area sore to the touch. Mom took her to see MD. No treatment given per MD. Mom states the area was clear by the am 8/29/2014.

VAERS ID:541944 (history)  Vaccinated:2014-08-27
Age:15.0  Onset:2014-08-27, Days after vaccination: 0
Gender:Male  Submitted:2014-09-02, Days after onset: 6
Location:Minnesota  Entered:2014-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None known
Preexisting Conditions: None known
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0106680IMLA
Administered by: Public     Purchased by: Public
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea and small amount of vomit.

VAERS ID:542117 (history)  Vaccinated:2014-08-20
Age:15.0  Onset:2014-08-22, Days after vaccination: 2
Gender:Male  Submitted:2014-09-02, Days after onset: 11
Location:Nevada  Entered:2014-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None known
Preexisting Conditions: None known
Diagnostic Lab Data: CSF fluid - clear; WBC - 186; Protein - 90; Glucose - 57; Cryptococcus antigen - negative; Herpes simplex DNA - negative; CSF culture - negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0042040UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count increased, Cryptococcus test, Diplopia, Fungal test negative, Headache, Herpes simplex serology negative, Neck pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (broad), Arthritis (broad)
Write-up: Approximately 1 1/2 hours after receiving HPV vaccine developed headache. Next morning had fever, continued headache and neck pain. On 8/22 began vomiting, double vision. Has also been camping prior with bug bites.

VAERS ID:542231 (history)  Vaccinated:2014-08-09
Age:15.0  Onset:2014-08-16, Days after vaccination: 7
Gender:Female  Submitted:2014-08-28, Days after onset: 12
Location:Massachusetts  Entered:2014-09-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data: Parent asked that this event reported to VAERS
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0097880IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient had urticarial rash 1 week after GARDASIL vaccine 8/9/14; Rash 8/16/14. Mom had pictures on phone. Rash resolved at office visit 8-19-14. 15 year old female presents with c/ rash started 8/16 under arms trunk LE UE; very itchy; mom took pictures - c/w urticaria-hives on back and thighs; had GARDASIL vaccine 1 week prior to rash; no recent illness, no new foods, lotions or other known exposures; mom concerned b/c she read online other reports (from patients/families) of hives 1 week or more following GARDASIL vaccine.

VAERS ID:542257 (history)  Vaccinated:2014-08-18
Age:15.0  Onset:2014-08-18, Days after vaccination: 0
Gender:Male  Submitted:2014-08-18, Days after onset: 0
Location:Arkansas  Entered:2014-09-03, Days after submission: 16
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: AR1423
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS5324E1UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0133240UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM140230UNLA
Administered by: Public     Purchased by: Public
Symptoms: Dyskinesia, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: On 8-18-14 at approximty 11:15 AM patient had Rc''d HPV and began a jerking movement of arm, color was pale. He told me he "gets low blood sugar and had not ate." Mother had soda in purse. I called in admin we placed patient supine in floor, cool compress to back of neck and head, legs placed in chair. Holding his head he drank soda BP was 120/70 manual by RN. 10 min assisted Pt to chair after finishs soda. Patient started feeling well. Mother request to proceed with with MENVEO. After given patient walked to car.

VAERS ID:542943 (history)  Vaccinated:2014-08-30
Age:15.0  Onset:2014-08-30, Days after vaccination: 0
Gender:Unknown  Submitted:2014-09-06, Days after onset: 7
Location:Unknown  Entered:2014-09-06
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: WAES1409USA001222
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse via a company representative refers to a 15 year old patient of unknown gender. On 30-AUG-2014 the 15 year old patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.

VAERS ID:542847 (history)  Vaccinated:2014-09-02
Age:15.0  Onset:2014-09-02, Days after vaccination: 0
Gender:Male  Submitted:2014-09-02, Days after onset: 0
Location:Georgia  Entered:2014-09-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPIPEN
Current Illness: None
Preexisting Conditions: Peanuts; Nuts
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0015000IMLA
Administered by: Private     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)
Write-up: Pt experienced syncope after vaccine administration. Pt was altered for approx 1-2 min. Given water and laid with legs elevated. Refused juice or crackers. Vital signs stable.

VAERS ID:543109 (history)  Vaccinated:2014-09-08
Age:15.0  Onset:2014-09-08, Days after vaccination: 0
Gender:Female  Submitted:2014-09-09, Days after onset: 1
Location:Massachusetts  Entered:2014-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Dizziness~HPV (no brand name)~1~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Neck x-ray - negative findings, no concussive symptoms
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0016312IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Fall, Headache, Heart rate decreased, Loss of consciousness, Neck pain, Pallor, Syncope, X-ray normal
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: I administered the HPV vaccine (Lot: K001631 exp: Nov 6, 2016) to patient on September 8, 2014 in room. Patient was sitting on the exam table when I arrived to administer the HPV vaccine. I inquired if she would like to lie down on the exam table while I administered the vaccine due to past experiences of dizziness after HPV administration. Patient declined and reported that she did not like vaccines and would like to get it over with. Patient''s mother was in the room at the time of the vaccine trying to provide distraction to the patient during while I administered the vaccine. After vaccine was administered I inquired how she felt and patient reported that she felt well. I then answered two additional questions patient''s mother had and then proceed to leave the exam room with patient sitting on the exam table and mother in the room. About 1-2 minutes later a loud noise came from exam room. Myself, four additional nurses and Dr. immediately went to attend to patient. Patient was found on the ground with LOC for about 3 seconds. She became responsive with a complaint of head and neck pain. Ice, water, ADVIL (4 tsp PO) and rest for 20 minutes. Patient''s mother reported that patient was stepping down from the step stool and then fell to the floor. I remained with the patient for 10 minutes and returned every 5 minutes for 10 minutes thereafter. Patient was able to speak with myself and her mother during this time. With the assistance of another nurse, we sat patient up to a chair where she denied any new pain or discomfort. Dr. then completed a brief head and neck exam. Patient appeared to be tolerating the exam with a complaint of neck pain. I stepped out of the room leaving patient safely sitting in a chair with Dr., another nurse and her mother. I was soon called back into the exam room by another nurse who then called the paramedics. With this second syncopal episode patient LOC for about 6 seconds and was then responsive and able to accurately answer questions. Her rate and oxygen were monitored (HR: 43 and O2: 100%). Patient appeared pale and was given oxygen via facemask on 0.5 L. Her color quickly improved and heart rate increased. The paramedics arrived shortly after and took report from Dr. and care of patient, who was then transported to ER for neck imaging.

VAERS ID:543195 (history)  Vaccinated:2013-11-13
Age:15.0  Onset:2013-12-01, Days after vaccination: 18
Gender:Female  Submitted:2014-09-10, Days after onset: 282
Location:Ohio  Entered:2014-09-10
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: Patient has been treated by pediatrician, ENT, child neurologist, child psychologist. Has received multiple medications over the past 6 months including prednisone, amytriptyline, Topamax, Imitrex, plus 5 trips to the ER for acute migraine care.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Anxiety, Depression, Dizziness, Ear canal injury, Headache, Migraine
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad)
Write-up: Dizziness and headache occurred. Chronic migraines developed -- never had headaches before thought to have caused trauma to both inner ear canals. Ongoing migraines being treated by neurologist resulting in depression and anxiety.

VAERS ID:543403 (history)  Vaccinated:2014-07-08
Age:15.0  Onset:2014-07-08, Days after vaccination: 0
Gender:Unknown  Submitted:2014-09-11, Days after onset: 65
Location:California  Entered:2014-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA004555
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J009788 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 08-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.

VAERS ID:543405 (history)  Vaccinated:2014-07-01
Age:15.0  Onset:2014-07-01, Days after vaccination: 0
Gender:Unknown  Submitted:2014-09-11, Days after onset: 72
Location:California  Entered:2014-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA004553
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J-009788 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 01-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.

VAERS ID:543406 (history)  Vaccinated:2014-07-09
Age:15.0  Onset:2014-07-09, Days after vaccination: 0
Gender:Unknown  Submitted:2014-09-11, Days after onset: 64
Location:California  Entered:2014-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA004556
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J009788 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown). which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.

VAERS ID:543503 (history)  Vaccinated:2014-08-29
Age:15.0  Onset:2014-08-29, Days after vaccination: 0
Gender:Female  Submitted:2014-09-11, Days after onset: 13
Location:Unknown  Entered:2014-09-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Menstruation normal; 06/2014, Metrorrhagia; Menstruation irregular
Diagnostic Lab Data:
CDC Split Type: WAES1409USA002184
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0042040IMUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This spontaneous prospective pregnancy report as received from a nurse refers to a 15 year old female patient. The patient had a history of menstrual at regular intervals, but she had only "spotted" in "June 2014" without experiencing her regular menstrual period. On 29-AUG-2014 the patient was vaccinated with first dose of GARDASIL injection, 120Y, lot # K004204, Expiration Date 12-JAN-2017 (dose, frequency and route unknown). The patient discovered she was pregnant after she received her first dose of GARDASIL. Prior to receiving the dose of GARDASIL, the patient had been unable to void in the clinic, so routine pregnancy screening was not able to completed prior to administration of the dose of GARDASIL. The patient''s mother preferred for the patient to receive GARDASIL, so the dose was administered without pregnancy screening. The patient had a positive "home" urine pregnancy test on an unspecified date. The patient sought medical attention via consulting her pediatrician, who detected fetal heart tones by doppler (result not provided). The patient was estimated to be approximately 4 months pregnant, she was scheduled for an Ultrasound to determine the gestational age. The patient was not demonstrating any adverse effects, and she was offering any complaints. Outcome of the events was unknown. Additional information has been requested.

VAERS ID:543640 (history)  Vaccinated:2014-08-25
Age:15.0  Onset:2014-09-02, Days after vaccination: 8
Gender:Male  Submitted:2014-09-14, Days after onset: 12
Location:Maryland  Entered:2014-09-14
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea, fatigue that lasted for 11 days.

VAERS ID:544035 (history)  Vaccinated:2014-08-30
Age:15.0  Onset:2014-08-30, Days after vaccination: 0
Gender:Female  Submitted:2014-09-15, Days after onset: 16
Location:Unknown  Entered:2014-09-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOVENT; XOPENEX
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA000855
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from a licensed practical nurse refers to a 15 year old female patient with asthma. No other medical history or relevant past drug history was provided. On 30-AUG-2014, the patient was vaccinated with PROQUAD (Merck), (Lot # reported as K0065546, Expiration date: 17-OCT-2015) Injection. Lot number K0065546 is an invalid lot number for PROQUAD (Merck). Concomitant therapies included FLOVENT and XOPENEX for asthma. On 30-AUG-2014, patient was vaccinated with PROQUAD (Merck) because the facility did not have the individual "MMR" and varicella vaccines available and then it was noted in the package insert it was only to be used in patients through 12 years of age. No relevant laboratory testing has been performed. No other adverse event was known at the time of the report. Additional information has been requested.

VAERS ID:544126 (history)  Vaccinated:2014-09-16
Age:15.0  Onset:2014-09-16, Days after vaccination: 0
Gender:Female  Submitted:2014-09-17, Days after onset: 1
Location:Oregon  Entered:2014-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Private
Symptoms: Convulsion, Dizziness, Loss of consciousness, Pallor
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Became dizzy after vaccine- rested for about 8 min sat up and was feeling good then suddenly became pale- passed out and had a seizure.

VAERS ID:544233 (history)  Vaccinated:2014-09-17
Age:15.0  Onset:2014-09-17, Days after vaccination: 0
Gender:Male  Submitted:2014-09-18, Days after onset: 1
Location:New York  Entered:2014-09-18
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: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J01482 SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR4P724 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Hyperhidrosis, 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), Hypotonic-hyporesponsive episode (broad)
Write-up: After administering immunizations client became diaphoretic and when asked if he was okay he nodded yes X1 then was not responding well. Clt with difficulty understanding english and speaking as well as he is a foreign exchange student. Client''s fellow foreign exchange student did translate and client answered him appropriately. Ice was applied to clt''s back of head and HR 64 was lowered to the floor for precautionary reasons and was doing well then to a wheelchair and was able to get out of the wheelchair go around the car and get into the car and was joking around with his fellow student. Patient when returned home did share with his host mother that he had this same reaction from previous vaccinations.

VAERS ID:544308 (history)  Vaccinated:2014-09-17
Age:15.0  Onset:2014-09-17, Days after vaccination: 0
Gender:Male  Submitted:2014-09-18, Days after onset: 1
Location:Indiana  Entered:2014-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.K0009430IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0106680IMLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness, Pallor
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)
Write-up: Client passed out after giving vaccine, pale, dizzy but alert when coming to, client laid down for a few min. Gave water, BP 102/76, O2 98%, HR 81.

VAERS ID:544651 (history)  Vaccinated:2014-09-18
Age:15.0  Onset:2014-09-18, Days after vaccination: 0
Gender:Female  Submitted:2014-09-19, Days after onset: 1
Location:California  Entered:2014-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSLZ4S21IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0042052IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site vesicles
SMQs:
Write-up: Patient received GARDASIL vaccine in (L) upper arm. Patient developed small subdermal vesicle approx. 1 1/2" from injection site. Possible hive? Patient observed x 20 minutes and vesicle improved but did not resolve.

VAERS ID:544658 (history)  Vaccinated:2014-07-17
Age:15.0  Onset:2014-07-17, Days after vaccination: 0
Gender:Male  Submitted:2014-09-19, Days after onset: 64
Location:Arkansas  Entered:2014-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSYZ2F70IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0112720IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS<130530IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0137301SCLA
Administered by: Public     Purchased by: Private
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)
Write-up: Pt. given school immis x 4 at 2:25 PM. Mom states child had tightness of chest 15 min post injections. Went to Dr office, observed x 30 min and they gave him epinephrine inj.

VAERS ID:544565 (history)  Vaccinated:2014-09-19
Age:15.0  Onset:2014-09-20, Days after vaccination: 1
Gender:Female  Submitted:2014-09-21, Days after onset: 1
Location:Connecticut  Entered:2014-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Flu shot and HPV vaccine
Preexisting Conditions: No
Diagnostic Lab Data: Strep test -negative Flu test -negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Other
Symptoms: Dizziness, Influenza virus test negative, Local swelling, Nausea, Pruritus, Streptococcus test negative, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Itchy, swelling feet and hands, nausea, vomiting, dizzy, hives all over body face hand feet.

VAERS ID:544679 (history)  Vaccinated:2014-09-19
Age:15.0  Onset:2014-09-19, Days after vaccination: 0
Gender:Female  Submitted:2014-09-22, Days after onset: 3
Location:Arkansas  Entered:2014-09-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALST9J3M0IDLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061170IDRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM140550IDRA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Disorientation, Dyskinesia, Immediate post-injection reaction, Lethargy, Nausea, Retching, Urinary incontinence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: After shots were given - immediately Pt laid head in moms lap and began to make an odd noise - I jumped up and hugged patient around trunk and she jerked her head back and started to move uncontrollably. Moved all equipment away and eased patient to the floor and placed her feet up above her head. Mom helped to secure patients head and called for help of RN Administrator and she came and called for ambulance. Pt had incontinent episode and urinated in the floor while arms and legs and body violently moving and jerking in the floor. This went on for about 2 minutes and then patient sat straight up and was very lethargic and disoriented. Started to come around and was asked by RN CDNS if she had had anything to eat this a.m. and patient stated "pretzels". Pt started getting very nauseated and started dry heaves with no production. Ambulance arrived at approximately 9:08 AM patient was able to stand with assistance but was very weak and ambulance driver lifted the patient to the gurney and patient was placed on gurney and was taken to Medical Center for further evaluation.

VAERS ID:544775 (history)  Vaccinated:2014-09-15
Age:15.0  Onset:2014-09-22, Days after vaccination: 7
Gender:Male  Submitted:2014-09-23, Days after onset: 1
Location:North Carolina  Entered:2014-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Zyrtec and occasional albuterol
Current Illness: None
Preexisting Conditions: Seasonal Allergies/Asthma
Diagnostic Lab Data: Laboratory bloodwork submitted at Primary Care Physician. Awaiting results. Currently treating with Tylenol cold and flu, combined with Benadryl.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT576061IMLA
Administered by: Public     Purchased by: Private
Symptoms: Blood test, Headache, Muscle spasms, Muscular weakness, Nasal congestion, Pain in extremity, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe headache, muscle spasms in lower back, weakness in legs, running nose combined with congestion. Soreness particularly in the arm in which the dose was administered, beginning the following day.

VAERS ID:545353 (history)  Vaccinated:2014-09-03
Age:15.0  Onset:2014-09-07, Days after vaccination: 4
Gender:Male  Submitted:0000-00-00
Location:Oregon  Entered:2014-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; Valproic acid; levocarnitine; amlodipine
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU1187AA IMAR
Administered by: Other     Purchased by: Private
Symptoms: Injection site infection, Injection site reaction
SMQs:
Write-up: Flu shot was administered in the tricep area intramuscularly broke out a large reaction from elbow all the way up to back of deltoid. MD rxed AUGMENTIN for reaction/infection.

VAERS ID:546000 (history)  Vaccinated:2014-09-11
Age:15.0  Onset:2014-09-11, Days after vaccination: 0
Gender:Female  Submitted:2014-09-29, Days after onset: 18
Location:Unknown  Entered:2014-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA006598
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report was received from a pharmacist refers to a 15 year old female patient. On 11-SEP-2014 the patient was inadvertently vaccinated with ZOSTAVAX. No adverse effects reported. The outcome was unknown. Additional information has been requested.

VAERS ID:545733 (history)  Vaccinated:2014-09-29
Age:15.0  Onset:2014-09-29, Days after vaccination: 0
Gender:Female  Submitted:2014-09-30, Days after onset: 1
Location:New Jersey  Entered:2014-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zrytec daily for seasonal allergies
Current Illness: No
Preexisting Conditions: Celiac Disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Headache, Lethargy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea, headache, lethargy, and mild fever.

VAERS ID:546366 (history)  Vaccinated:2013-06-17
Age:15.0  Onset:2013-07-08, Days after vaccination: 21
Gender:Female  Submitted:2014-08-13, Days after onset: 401
Location:Michigan  Entered:2014-09-30, Days after submission: 48
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Trazodone; WELLBUTRIN XL; WELLBUTRIN SR
Current Illness: None
Preexisting Conditions: Depression/anxiety and migraines
Diagnostic Lab Data: CT scan, MRI, EEG, Full blood work.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0213462UNAR
Administered by: Private     Purchased by: Other
Symptoms: Computerised tomogram, Cyanosis, Electroencephalogram, Eye movement disorder, Full blood count, Grand mal convulsion, Loss of consciousness, Nuclear magnetic resonance imaging, Tongue biting, Tooth fracture, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Generalized tonic-clonic seizures - approx 3 min w/20 minute recovery. - loss of consciousness - lips and jaw blue - whole body convulsions - eyes rolled back - bit sides of tongue - chipped tooth - loss of bladder control. Dates of seizures: 7/08/13 and 3/15/14. Diagnosis: Generalized seizure disorder of unknown origin.

VAERS ID:546755 (history)  Vaccinated:2014-09-23
Age:15.0  Onset:2014-09-23, Days after vaccination: 0
Gender:Female  Submitted:2014-10-01, Days after onset: 8
Location:Kentucky  Entered:2014-10-01
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0016312IMLA
Administered by: Public     Purchased by: Public
Symptoms: Fall, Syncope, Tooth fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: HPV #3 given per LPN on 9/23/14. Approximately 5 minutes after getting vaccine she fainted falling on floor and chipping two upper front teeth. Dentist was seen after. Pt will need permanent crowns for teeth.

VAERS ID:546817 (history)  Vaccinated:2014-02-21
Age:15.0  Onset:2014-02-21, Days after vaccination: 0
Gender:Male  Submitted:2014-10-01, Days after onset: 221
Location:Washington  Entered:2014-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: SULFAMIDE: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013075
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084232IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year old male patient, who was allergic to sulfamide and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 21-FEB-2014 at 2:50 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient''s parent did not call back. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.

VAERS ID:546823 (history)  Vaccinated:2014-01-20
Age:15.0  Onset:2014-01-20, Days after vaccination: 0
Gender:Male  Submitted:2014-10-01, Days after onset: 253
Location:Washington  Entered:2014-10-01
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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013078
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084232IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccination with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 20-JAN-2014 at 10:10 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents were going to consult with physician and declined to repeat vaccination. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.

VAERS ID:546212 (history)  Vaccinated:2014-01-28
Age:15.0  Onset:2014-01-28, Days after vaccination: 0
Gender:Female  Submitted:2014-10-02, Days after onset: 246
Location:Washington  Entered:2014-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Type 1 diabetes mellitus; Food allergy; Scoliosis; Drug hypersensitivity; House dust allergy; Attention deficit/hyperactivity disorder
Preexisting Conditions: Penicillin (unspecified), drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013100
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084232UNLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to am unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year-old female patient with attention deficit/hyperactivity disorder (ADHD), Diabetes Mellitus Type 1, scoliosis, who was allergic to penicillin, dust mites, and shellfish. It was not reported whether the patient had any other illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 28-JAN-2014 at 3:40 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was informed and declined to revaccinate. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown, although date of recovery was written as 18-APR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.

VAERS ID:546226 (history)  Vaccinated:2014-02-04
Age:15.0  Onset:2014-02-04, Days after vaccination: 0
Gender:Female  Submitted:2014-10-02, Days after onset: 239
Location:Washington  Entered:2014-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013101
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084231IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year-old female patient, who had no known drug allergy. The reporter stated that it was unknown if the patient had any illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 04-FEB-2014 at 3:30 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was informed and revaccinated on 22-APR-2014 at no charge. The reporter reported the outcome as recovered. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.

VAERS ID:546267 (history)  Vaccinated:2006-07-01
Age:15.0  Onset:2006-07-01, Days after vaccination: 0
Gender:Female  Submitted:2014-10-02, Days after onset: 3015
Location:Pennsylvania  Entered:2014-10-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: Dizziness, felt like she was going to faint.
Preexisting Conditions: None
Diagnostic Lab Data: MRIs; CT scans; ultrasound; lab work; bladder testing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Other
Symptoms: Abdominal pain upper, Appendicectomy, Attention deficit/hyperactivity disorder, Bladder scan, Cognitive disorder, Computerised tomogram, Cystitis interstitial, Emotional disorder, Food intolerance, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache, Hyperacusis, Hypotension, Laboratory test, Menstrual disorder, Mental impairment, Migraine, Nuclear magnetic resonance imaging, Ovarian cyst, Parosmia, Photophobia, Sleep disorder, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)
Write-up: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.

VAERS ID:546329 (history)  Vaccinated:2014-01-29
Age:15.0  Onset:2014-01-29, Days after vaccination: 0
Gender:Male  Submitted:2014-10-02, Days after onset: 245
Location:Washington  Entered:2014-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013055
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084232UNRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year old male patient, with no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 29-JAN-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Patient was going to consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.

VAERS ID:547059 (history)  Vaccinated:2014-02-04
Age:15.0  Onset:2014-02-04, Days after vaccination: 0
Gender:Unknown  Submitted:2014-10-02, Days after onset: 239
Location:Washington  Entered:2014-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA013058
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084231PO 
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempt to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report refers to a 15-year-old patient of unspecified gender. It was unkonwn if the patient had any allergies, conditions or illnesses at the time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection, batch/lot# J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 04-FEB-2014 at 4:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 4:00 PM). The patient was going to return to revaccinate at no charge. No adverse event was reported for the patient. Outcome was not reported by the reporter, although date of recovery was written as 27-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.

VAERS ID:546308 (history)  Vaccinated:2013-10-02
Age:15.0  Onset:2014-04-05, Days after vaccination: 185
Gender:Male  Submitted:2014-10-03, Days after onset: 181
Location:Texas  Entered:2014-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent; Flonase; Zyrtec
Current Illness: No
Preexisting Conditions: No conditions
Diagnostic Lab Data: 780.39 Convulsive seizure
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Private     Purchased by: Private
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)
Write-up: Patient had seizure.

VAERS ID:546475 (history)  Vaccinated:2014-10-02
Age:15.0  Onset:2014-10-03, Days after vaccination: 1
Gender:Female  Submitted:2014-10-04, Days after onset: 1
Location:Illinois  Entered:2014-10-04
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Headache, Malaise
SMQs:
Write-up: Woke up next morning with severe headache. Feeling sick when standing. No appetite in 2 days.

VAERS ID:546587 (history)  Vaccinated:2014-09-24
Age:15.0  Onset:2014-09-25, Days after vaccination: 1
Gender:Male  Submitted:2014-10-05, Days after onset: 10
Location:Virginia  Entered:2014-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI194AB IMLA
Administered by: Other     Purchased by: Private
Symptoms: Contusion, Haemorrhage, Injection site erythema, Injection site haematoma, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Soon after the patient reports significant bruising and more bleeding than was expected. Two days later the patient describes a redness and warmth about baseball-sized around the injection site. No fevers, no chills, no streaking and thus unlikely infection-related. It seems that it was just due to administration and the symptoms sounded like a hematoma. No treatment other than ice and rest was required. Patient''s mother also consulted their physician, who agreed with likely a hematoma and no infectious process.

VAERS ID:546778 (history)  Vaccinated:2014-10-03
Age:15.0  Onset:2014-10-06, Days after vaccination: 3
Gender:Female  Submitted:2014-10-06, Days after onset: 0
Location:Delaware  Entered:2014-10-06
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: Na
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Rash, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Hive like rash on upper forearm. Shoulder and lower arm feel sore. Uncomfortable to raise shoulder.

VAERS ID:547750 (history)  Vaccinated:2014-08-01
Age:15.0  Onset:2014-08-01, Days after vaccination: 0
Gender:Female  Submitted:2014-10-06, Days after onset: 66
Location:Mississippi  Entered:2014-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Physician stated he had completed many blood tests like "mono and thyroid" on unspecified dates in 2014, believing "there is something viral going on"; some tests were pending at the moment of this report while others "looked good" (tests, dates, exact results were not provided).
CDC Split Type: WAES1410USA002261
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Mononucleosis heterophile test, Thyroid function test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: This spontaneous report as received from a physician via company representative refers to a 15 year old female patient. The patient had no pertinent medical history or current conditions and no drug reactions or allergies. At the moment of this report, patient was not pregnant. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection, dose 1, 0.5 ml, intramuscularly, batch/lot # and expiration date not reported). There were no concomitant medications. Since an unspecified date in August 2014, after being vaccinated, the patient experienced less energy, more fatigue than normal, some dizziness and some shortness of breath. The patient sought medical attention. The physician reported that he had completed many unspecified blood tests like "mono and thyroid" believing "there was something viral going on"; at the moment of this report some unspecified tests were pending while others "looked good" (exact results, tests and dates were not provided). As treatment for shortness of breath, PROAIR and QVAR were prescribed on an unspecified date in September 2014 (also reported as since last week). The outcome of shortness of breath was reported as recovering/resolving due to the prescribed treatment. The outcome of the other events was reported as not recovered/not resolved. The reporting physician did not provide causality assessment for the events. Additional information has been requested.

VAERS ID:546972 (history)  Vaccinated:2011-04-25
Age:15.0  Onset:2011-04-25, Days after vaccination: 0
Gender:Female  Submitted:2014-10-06, Days after onset: 1260
Location:Unknown  Entered:2014-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Seasonal allergy; Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: A201105703
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Eye irritation, Headache, Mydriasis, Nausea, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of vomiting in a 15-year-old female subject who was vaccinated with CERVARIX. On 25 April 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 25 April 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced vomiting, headache and mydriasis. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 17 May 2011: Concurrent medical conditions included asthma and seasonal allergy. Lot number was provided. The vaccine was administered in right deltoid. On 25 April 2011, less than one day after vaccination with CERVARIX, the subject experienced vomiting, and mydriasis. On 26 April 2011, one day after vaccination with CERVARIX, the subject experienced headache, queasy, vision disturbance and irritation when opening the eyes. A blood test was performed and showed no abnormality. On 28 April 2011, the events were improved. On 6 May 2011, the headache and queasy recurred. Follow-up information received on 18 May 2011: Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 25 March 2011. This case has been linked to case B0718792A because it was a duplicate. All future correspondence will be submitted to B0716098A. Follow-up information received on 26 May 2011: The subject was treated with unknown (Infusion) and unknown (Unknown medication).

VAERS ID:547614 (history)  Vaccinated:2014-10-13
Age:15.0  Onset:2014-10-13, Days after vaccination: 0
Gender:Male  Submitted:2014-10-13, Days after onset: 0
Location:Indiana  Entered:2014-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS2A2KX0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSN434L1IMRA
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)
Write-up: Patient received his Hepatitis A vaccine then fainted after receiving his influenza injection. He has never fainted before. He did not eat breakfast this morning.

VAERS ID:550693 (history)  Vaccinated:2014-10-01
Age:15.0  Onset:2014-10-01, Days after vaccination: 0
Gender:Male  Submitted:2014-10-04, Days after onset: 3
Location:Rhode Island  Entered:2014-10-13, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI171AC0UNLA
Administered by: Other     Purchased by: Public
Symptoms: Grip strength decreased, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)
Write-up: After receiving vaccine, student stated he "couldn''t feel" his (L) arm and (L) hand. Able to raise (L) arm to chest level when asked, grasp was weak. BP 98/60 P 60. Incident occurred approx 1/2 hour after shot given. After another 30 minutes pt stated he had some feeling back in hand and arm. Parent took him to MD around 2pm. At this point he had recovered feeling/sensations in (L) arm and (L) hand. No further incidents reported from pt at this time.

VAERS ID:551790 (history)  Vaccinated:2014-08-06
Age:15.0  Onset:2014-09-09, Days after vaccination: 34
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2014-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness:
Preexisting Conditions: Allergy-Amox
Diagnostic Lab Data: EEG, normal; MRI, see notes attached
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0015001IMLA
Administered by: Private     Purchased by: Private
Symptoms: Clonus, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: 9/9/14 2:30A had generalized seizure with clonic movements of all extremities. Pt taken to ER by ambulance.

VAERS ID:551805 (history)  Vaccinated:2014-08-04
Age:15.0  Onset:2014-08-05, Days after vaccination: 1
Gender:Female  Submitted:2014-10-14, Days after onset: 70
Location:Pennsylvania  Entered:2014-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA; Allergic Rhinitis; H/o concussion
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4677AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4655AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Eye pruritus, Injection site pain, Injection site warmth
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)
Write-up: 08/04/14 Pt had vaccines in office in afternoon. 08/05/14 Patient woke and stated her eyes felt very itchy. She also felt SOB. She had to leave for work. She progressively got worse took CLAIRITIN with no relief. SOB became progressively worse Rt arm where ADACEL was placed was hot to touch and she denied throat closing. Was given in office Albuterol and felt improved. SOB was dissipating. Was D/C''d with albuterol MEDROL Pak. Called next day Pt states felt 90% better.

VAERS ID:548055 (history)  Vaccinated:2014-10-13
Age:15.0  Onset:2014-10-13, Days after vaccination: 0
Gender:Female  Submitted:2014-10-15, Days after onset: 2
Location:New Jersey  Entered:2014-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort 180 mcg per actulation breath activated, Xopenex HFA 45 mcg inhaler
Current Illness: No known
Preexisting Conditions: History of Asthma
Diagnostic Lab Data: Vital signs, pulse ox and blood sugar
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI172AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Blood glucose, Hyperhidrosis, Tremor, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: Diaphoretic, trembled, stated, "vision spotty". Did not lose consciousness.

VAERS ID:548077 (history)  Vaccinated:2014-10-13
Age:15.0  Onset:2014-10-14, Days after vaccination: 1
Gender:Male  Submitted:2014-10-15, Days after onset: 1
Location:Texas  Entered:2014-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSX9HM30IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pruritus, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: PATIENT DEVELOPED VERY ITCHY URTICARIA - SMALL BUMPS BEHIND HIS ARMS, ON HIS BACK, TORSO, CHEEKS.

VAERS ID:552290 (history)  Vaccinated:2014-08-30
Age:15.0  Onset:2014-09-02, Days after vaccination: 3
Gender:Female  Submitted:2014-09-22, Days after onset: 20
Location:Arkansas  Entered:2014-10-15, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURK1329 IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.K0056460SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4923BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)
Write-up: 9/2/14 Pt''s mother reported she heard screaming in her head. Pt seen by PCP and psych.

VAERS ID:548336 (history)  Vaccinated:2014-06-10
Age:15.0  Onset:2014-06-11, Days after vaccination: 1
Gender:Male  Submitted:2014-10-16, Days after onset: 127
Location:Arizona  Entered:2014-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0209011IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Patient came in for 3rd HPV on 9/30/14 and explained to nurse that one day after last shot he got a rash about 4 inches wide around injection site. The rash lasted for a few days and went away.

VAERS ID:549682 (history)  Vaccinated:2014-10-15
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-10-20
Location:Minnesota  Entered:2014-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CF2251 IN 
Administered by: Other     Purchased by: Private
Symptoms: Drug administration error
SMQs:
Write-up: Administration error. Pt received dose in nostril. RPH did remove clip and gave full dose in the nostril.

VAERS ID:549095 (history)  Vaccinated:2014-10-20
Age:15.0  Onset:2014-10-21, Days after vaccination: 1
Gender:Female  Submitted:2014-10-21, Days after onset: 0
Location:Wisconsin  Entered:2014-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratadine
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Oxygen saturation below normal, recovered when supplied supplemental oxygen.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CH20640IN 
Administered by: Other     Purchased by: Private
Symptoms: Oxygen saturation decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)
Write-up: Syncopal event.

VAERS ID:553345 (history)  Vaccinated:2014-09-18
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-10-21
Location:Alaska  Entered:2014-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B225BA UNLA
Administered by: Public     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: KINRIX given to 15 year old.

VAERS ID:549320 (history)  Vaccinated:2014-10-14
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-10-14
Location:Colorado  Entered:2014-10-22, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN HFA; Vitamin D; Fluticasone propionate; Fexofenadine HCL
Current Illness:
Preexisting Conditions: Allergic rhinitis; Asthma Exercise Induced; Hyperlipidemia, mixed; Left nasal polyps; Overweight, pediatric, BMI 85.0-94.9 percentile
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI212AA2IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Incorrect dose administered
SMQs:
Write-up: Received lower dose than recommended by manufacturer.

VAERS ID:553550 (history)  Vaccinated:2014-02-01
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-10-22
Location:Unknown  Entered:2014-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, unknown not provided
CDC Split Type: WAES1410USA009995
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Dermatitis, Eczema, Metabolic function test, Pruritus, Pyrexia, Rash erythematous, Rash generalised, Staphylococcal infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from patient''s father concerning his son, a 15 year old male patient. Patient''s concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in February 2014 (also reported as March 2014), patient was vaccinated with first dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Approximately on an unknown date in August 2014 (reported as 2 and half months ago from 17-OCT-2014), the patient was vaccinated second dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Concomitant medications were not reported. On an unknown date in 2014 the patient experienced severe skin dermatitis and small red bumps after the first dose of GARDASIL. The reporter stated that initially the red bumps were only present on the hands, but now it was spreading throughout entire body and legs as well. The reporter also stated that itching was the real issue for the patient. On an unspecified date the patient has since developed the MRSA infection. The patient also has had fever when there was an infection present. The patient has also been diagnosed with Eczema. Patient has undergone full blood screening and metabolic lab test but results were not reported. The patient sought medical attention and had seen several doctors such as pediatric, dermatologist and primary cause physicians during this period. The patient has received various therapy treatments CORTISONE, Steroid based prescription creams, and over the counter topical creams without success (dose and manufacturers unspecified). The third dose of GARDASIL was not given yet. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.

VAERS ID:549492 (history)  Vaccinated:2014-10-20
Age:15.0  Onset:2014-10-21, Days after vaccination: 1
Gender:Female  Submitted:2014-10-23, Days after onset: 2
Location:Washington  Entered:2014-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS2G3J4 IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0123711SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema, itching, swelling at injection site (15 cm x 8 cm).

VAERS ID:549885 (history)  Vaccinated:2014-08-26
Age:15.0  Onset:2014-08-27, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Georgia  Entered:2014-10-24
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: GA1419
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURNOVM14031 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURPMC44902BA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.MSDK003422 SCLA
Administered by: Public     Purchased by: Private
Symptoms: Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient went to Dr''s office 03/27/14 reporting headache, nausea and fever of 101F.Called 08/27/14 temp decreased feeing better.

VAERS ID:553747 (history)  Vaccinated:2014-10-03
Age:15.0  Onset:2014-10-03, Days after vaccination: 0
Gender:Male  Submitted:2014-10-20, Days after onset: 17
Location:Massachusetts  Entered:2014-10-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluticasone; albuterol
Current Illness: None
Preexisting Conditions: Allergic rhinitis; Mild intermittent asthma
Diagnostic Lab Data: Hx of primary rabies vaccine in infancy
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV13A3ZE0IMRA
RAB: RABIES (IMOVAX)SANOFI PASTEUR500011A3IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Pt developed hives and slight difficulty breathing after receiving vaccines-went to ER for treatment. Treatment: prednisone, BENADRYL, ranitidine.

VAERS ID:550228 (history)  Vaccinated:2014-10-20
Age:15.0  Onset:2014-10-20, Days after vaccination: 0
Gender:Male  Submitted:2014-10-27, Days after onset: 7
Location:New York  Entered:2014-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU1200AB IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K003520 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4955AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Sweaty, felt faint.

VAERS ID:550288 (history)  Vaccinated:2014-10-01
Age:15.0  Onset:2014-10-05, Days after vaccination: 4
Gender:Female  Submitted:2014-10-27, Days after onset: 22
Location:Oklahoma  Entered:2014-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS4LY243IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pruritus, Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Client''s father stated that child started out with a rash on the arm where she got the shot, raised area about the size of a quarter and it itiched. Father reported that client had not taken any Benadryl or medication for the rash. No temp reported.

VAERS ID:553823 (history)  Vaccinated:2014-10-17
Age:15.0  Onset:2014-10-17, Days after vaccination: 0
Gender:Male  Submitted:2014-10-27, Days after onset: 10
Location:Unknown  Entered:2014-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA010488
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a 15 year old male patient. The patient''s medical history was not reported. On 30-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency, route and lot # were not reported). Concomitant medications were not reported. On 17-OCT-2014 the patient was vaccinated with second dose of VAQTA. No adverse effect was reported. No product complaint was reported for VAQTA. This case is linked to case # 1410USA013423 (same patient link). Additional information has been requested.

VAERS ID:553928 (history)  Vaccinated:2014-09-08
Age:15.0  Onset:2014-09-18, Days after vaccination: 10
Gender:Male  Submitted:2014-10-21, Days after onset: 33
Location:Massachusetts  Entered:2014-10-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0153782IMLA
Administered by: Private     Purchased by: Public
Symptoms: Activities of daily living impaired, Dizziness, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Mom called the following day to report that pt had a GARDASIL shot at his PE and was fine afterwards. He had eaten a snack before the shot as well. About 45 minutes later he felt dizzy and fainted in the car. When he got home he had a fever and stayed home the next day. He didn''t seem sick at all per mom.

VAERS ID:550521 (history)  Vaccinated:2014-09-30
Age:15.0  Onset:2014-09-30, Days after vaccination: 0
Gender:Female  Submitted:2014-10-28, Days after onset: 28
Location:Michigan  Entered:2014-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS145305 IMUN
Administered by: Public     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: After giving vaccine she fainted for about 5 seconds before she recovered and she was fine after.

VAERS ID:554051 (history)  Vaccinated:2014-10-23
Age:15.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-10-28, Days after onset: 5
Location:Unknown  Entered:2014-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA014412
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0042041IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 20-JAN-2014, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 23-OCT-2014, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # K004204 exp 12-JAN-2017) intramuscularly. No adverse effects were reported. Additional information has been requested.

VAERS ID:551072 (history)  Vaccinated:2014-10-27
Age:15.0  Onset:2014-10-28, Days after vaccination: 1
Gender:Male  Submitted:2014-10-29, Days after onset: 1
Location:Washington  Entered:2014-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS2G3J42IMRA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives

VAERS ID:551004 (history)  Vaccinated:2014-10-28
Age:15.0  Onset:2014-10-28, Days after vaccination: 0
Gender:Male  Submitted:2014-10-30, Days after onset: 2
Location:Michigan  Entered:2014-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time.
Current Illness: None
Preexisting Conditions: Allergic to penicillin; functioning heart murmur that has since closed
Diagnostic Lab Data: Not necessary
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Dyskinesia, Eye movement disorder, Feeling abnormal, Malaise, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainted. He was leaning against a wall and said he felt sick, then 30 seconds later he said he felt funny and started to faint. As he was going down his eyes rolled in the back of his head, a nurse caught him and laid him gently on the floor. His left hand seemed to seize up and he started to shake a bit. Another nurse came to hold his head, I told another nurse to get the Dr., and the nurse who caught him monitored his condition. Patient came out of it in about 30 seconds and had no memory of fainting. The Dr. & Nurses checked his vitals and they were within Normal range. Nicolaus had just come from school and had not eaten since lunch. The nurse game him a granola bar & water.

VAERS ID:554524 (history)  Vaccinated:2014-10-20
Age:15.0  Onset:2014-10-20, Days after vaccination: 0
Gender:Female  Submitted:2014-10-30, Days after onset: 10
Location:Illinois  Entered:2014-10-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Penicillins/Sulfa Drugs
Diagnostic Lab Data: Nl hand X-ray.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061241IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Discomfort, Dizziness, Erythema, Feeling abnormal, Flushing, Pain in extremity, Rash generalised, Swelling, Urticaria, X-ray limb normal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Flushed with slight hive-type rash about 15 minutes after injection. BENADRYL given with improvement. Discharged - increasing problem with redness and swelling with generalized rash late that night. Seen in ER with swelling. Given IV SOLUMEDROL w/ PEPCID. Discharged on oral prednisone. Lightheaded, achy joints and feeling foggy persisted with increased discomfort, pain in right hand persisting even 10 days after injection (carpal tunnel type).

VAERS ID:551684 (history)  Vaccinated:2014-10-30
Age:15.0  Onset:2014-10-31, Days after vaccination: 1
Gender:Female  Submitted:2014-11-03, Days after onset: 3
Location:Oklahoma  Entered:2014-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None apparent
Preexisting Conditions: Delayed puberty
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSCA77513IMLA
Administered by: Public     Purchased by: Other
Symptoms: Aphagia, Body temperature, Chills, Dizziness, Headache, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Arm swollen, hot and red at injection site. Also ran temp, chilling, nausea and dizzy. Also had headache. Unable to eat anything Friday, Oct 31st, but ate soup and drank liquids Friday. Felt better Sun PM.

VAERS ID:551975 (history)  Vaccinated:2014-10-14
Age:15.0  Onset:2014-10-14, Days after vaccination: 0
Gender:Female  Submitted:2014-10-20, Days after onset: 6
Location:North Carolina  Entered:2014-11-04, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CK20700IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061910IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4923BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Loss of consciousness, Somnolence, 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), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient was telling nurse how the HPV hurt more than the MENACTRA and then passed out and patient started shaking. Was passed out for a minute or two and then responsive to questions but very drowsy and laid down. Continue to monitor 30 mins with after injections.

VAERS ID:552029 (history)  Vaccinated:2014-10-28
Age:15.0  Onset:2014-11-02, Days after vaccination: 5
Gender:Male  Submitted:2014-11-05, Days after onset: 3
Location:Georgia  Entered:2014-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Vertigo for 3 days, seen in my office, rx meclizine.

VAERS ID:554869 (history)  Vaccinated:2012-11-21
Age:15.0  Onset:2012-11-21, Days after vaccination: 0
Gender:Male  Submitted:2014-11-06, Days after onset: 715
Location:Unknown  Entered:2014-11-06
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: Attention deficit/hyperactivity disorder; Asperger''s disorder
Diagnostic Lab Data:
CDC Split Type: WAES1410USA013053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0138310IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This spontaneous report as received from a medical assistant (also reported as health care worker) refers to a male patient of unknown age. The patient''s medical history included Asperger syndrome and attention deficit hyperactivity disorder. On 21-NOV-2012 the patient was vaccinated with GARDASIL dose 1 (lot # H013831 and expiry date 6-MAR-2015), 0.5 ml, via intramuscular route in the left arm. Other co-suspects and concomitant medication were not reported. On an unknown date the patient experienced dizziness on receiving dose 1 of GARDASIL while in the office. He was kept in the office for 30 minutes for observation and then was sent home. When he went home he experienced nausea and vomiting. There was no fever and diarrhea. He recovered 3 days later. The parent of the patient did not seek medical attention for the vomiting and nausea and only recently mentioned to the office what had happened. Also reported that the patient will not be receiving further doses of GARDASIL. Cancer and overdose was not reported. The outcome of dizziness, nausea and vomiting was reported as recovered/resolved. Causality was not specified by the reporter. Additional information has been requested.

VAERS ID:552713 (history)  Vaccinated:2014-11-07
Age:15.0  Onset:2014-11-07, Days after vaccination: 0
Gender:Male  Submitted:2014-11-07, Days after onset: 0
Location:South Dakota  Entered:2014-11-07
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: na
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURJ17270SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K00007371SCRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU4669AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chest discomfort, Hyperhidrosis, Pain in extremity, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)
Write-up: 10:00 am Patient sweating and pale. Cool packs to neck. Layed down, Elevated feet. 10:15am Complaints of left arm pain and chest discomfort. 10:17 Oxygen administered via nasal canula. 10:17 Ambulance contacted and client transported to the hospital.

VAERS ID:555491 (history)  Vaccinated:2014-09-26
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-10-31
Location:South Carolina  Entered:2014-11-10, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: M. pneumoniae IgG and IgM (negative); Viral culture wound (neg); HSV PCR wound (neg)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0028671SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0086521SCLA
Administered by: Other     Purchased by: Private
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Culture wound negative, Ear pain, Herpes simplex serology negative, Myringitis bullous, Polymerase chain reaction, Rash, Rash pruritic, Rash vesicular, Skin ulcer
SMQs:, Anaphylactic reaction (broad), Hearing impairment (narrow), Hypersensitivity (narrow)
Write-up: CC: Rash second MMR and Varicella received 9/26/14. Patient OV 10/10/14 with acute (L) ear pain. Dx''d bulbous myringitis and rx''d amoxicillin for infection triamcinolone for eczema. Returned 10/15/14 with itchy vesicular/ulcerative rash x 2 days.

VAERS ID:555759 (history)  Vaccinated:2012-08-17
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-12
Location:Unknown  Entered:2014-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 08/17/2012, Pregnancy test urine, Positive, Twice
CDC Split Type: WAES1208USA008735
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This spontaneous prospective pregnancy report as received from a Nurse Practitioner for VARIVAX (Merck), a Pregnancy Registry product, refers to a 15 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with VARIVAX (Merck) (lot # not reported) on 17-AUG-2012. It was reported that the patient may be pregnancy. The Nurse Practitioner did not know the date of the patient''s first dose of VARIVAX (Merck). The Nurse Practitioner provided a urine pregnancy test for the patient which was positive for pregnancy. The test was repeated and was found to be positive for pregnancy. No adverse experience has been reported or observed. No other co-suspects were reported. There were no concomitant medications were reported. The patient with an LMP of July 2012 ("late July") and EED of approximately 07-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought unspecified medical attention. Follow up information has been received on 11-NOV-2014. A phone call was placed to the reporting nurse who was no longer at facility. The facility was unable to share the patient information without a signed consent form. Reporter information has been updated. Additional information is not expected.

VAERS ID:556149 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-14
Location:Unknown  Entered:2014-11-14
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: WAES1411USA005001
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a 15 year old female patient. On an unknown date that patient was vaccinated with her first dose of RECOMBIVAX HB 5/0.5 mcrg/ml, dose/frequency: 0.5 ml (route and lot # not reported) at her birth, and the second dose three weeks later, with the third dose at six months after the first dose. No adverse effects reported. The outcome of event was unknown. Additional information has been requested.

VAERS ID:554126 (history)  Vaccinated:2014-11-12
Age:15.0  Onset:2014-11-15, Days after vaccination: 3
Gender:Female  Submitted:2014-11-18, Days after onset: 3
Location:Illinois  Entered:2014-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient had hives on both legs. I gave her Benadryl and she applied calamine lotion. This helped but they came back the following evening but worse. She took another Benadryl and applied more calamine and they have not returned.

VAERS ID:554442 (history)  Vaccinated:2014-11-06
Age:15.0  Onset:2014-11-06, Days after vaccination: 0
Gender:Female  Submitted:2014-11-19, Days after onset: 13
Location:North Carolina  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Postural orthostatic tachycardia syndrome
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CJ21301IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0094822IMLA
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Immediate post-injection reaction, Postural orthostatic tachycardia syndrome
SMQs:, Hypersensitivity (narrow)
Write-up: Pt has probable POTS which worsened immediately after receiving flu and HPV #3.

VAERS ID:556627 (history)  Vaccinated:2014-09-11
Age:15.0  Onset:2014-09-11, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-19, Days after onset: 69
Location:Unknown  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA008581
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 11-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556631 (history)  Vaccinated:2014-09-26
Age:15.0  Onset:2014-09-26, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-19, Days after onset: 54
Location:Unknown  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA006980
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and dates of vaccine administration) available at this time. No further information was available at this time of report. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 15 years old Adolescent. The patient was vaccinated with GARDASIL on 26-SEP-2014. Lot was reported as J015378, expiration date 09-APR-2016 for the vaccine GARDASIL. Additional information has been requested.

VAERS ID:556635 (history)  Vaccinated:2014-09-29
Age:15.0  Onset:2014-09-29, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-19, Days after onset: 51
Location:Unknown  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA008579
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 29-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556666 (history)  Vaccinated:2014-09-15
Age:15.0  Onset:2014-09-15, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-19, Days after onset: 65
Location:Unknown  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA008583
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556675 (history)  Vaccinated:2014-09-15
Age:15.0  Onset:2014-09-15, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-19, Days after onset: 65
Location:Unknown  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA006969
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiation date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556788 (history)  Vaccinated:2014-07-11
Age:15.0  Onset:2014-07-11, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-19, Days after onset: 131
Location:Unknown  Entered:2014-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA006989
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H020901 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 11-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported) and another dose of improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported) on 11-SEP-2014. No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:554764 (history)  Vaccinated:2006-06-01
Age:15.0  Onset:2006-06-01, Days after vaccination: 0
Gender:Female  Submitted:2014-11-20, Days after onset: 3094
Location:New York  Entered:2014-11-20
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: dizziness, headache~HPV (no brand name)~1~0.00~Patient|dizziness, headache~HPV (no brand name)~2~0.00~Patient
Other Medications: None
Current Illness: Dizzy, headache, later passed out at home. She had dizziness and headaches for almost a week. She continues to this day to have dizziness and headaches. She also has not been able to become pregnant. Her personality has changed and she has become aggressive versus her bubbly personality prior to her injections.
Preexisting Conditions: No birth defects, no allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal discomfort, Dizziness, Headache, Pallor
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Headache, dizziness, upset stomach, pale.

VAERS ID:554828 (history)  Vaccinated:2014-11-04
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-11-20
Location:North Carolina  Entered:2014-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CJ2004 IN 
Administered by: Other     Purchased by: Private
Symptoms: Hypersensitivity, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow)
Write-up: Patients mother said that patient developed a bad rash on his right cheek a few days after the vaccine was administered. They went to the MD to get it looked at and were given an antibiotic. They later went to the ER and the physician on duty told her it looked like an allergic reaction and prescribed an oral steroid.

VAERS ID:556831 (history)  Vaccinated:2014-07-14
Age:15.0  Onset:2014-07-14, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-20, Days after onset: 129
Location:Unknown  Entered:2014-11-20
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: WAES1411USA006990
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H020901 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556832 (history)  Vaccinated:2014-09-17
Age:15.0  Onset:2014-09-17, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-20, Days after onset: 64
Location:Unknown  Entered:2014-11-20
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: WAES1411USA007039
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 17-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556833 (history)  Vaccinated:2014-07-14
Age:15.0  Onset:2014-07-14, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-20, Days after onset: 129
Location:Unknown  Entered:2014-11-20
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: WAES1411USA006991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H020901 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556858 (history)  Vaccinated:2014-09-03
Age:15.0  Onset:2014-09-03, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-20, Days after onset: 78
Location:Unknown  Entered:2014-11-20
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: WAES1411USA008566
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J015378 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:555222 (history)  Vaccinated:2014-11-21
Age:15.0  Onset:2014-11-21, Days after vaccination: 0
Gender:Female  Submitted:2014-11-22, Days after onset: 1
Location:California  Entered:2014-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS011021A0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Flucelvax not approved by FDA for patients under 18. Flucelvax was inadvertently administered to this 15 year old patient. NO ADVERSE EFFECTS. Just reporting.

VAERS ID:555349 (history)  Vaccinated:2014-11-24
Age:15.0  Onset:2014-11-24, Days after vaccination: 0
Gender:Male  Submitted:2014-11-24, Days after onset: 0
Location:Louisiana  Entered:2014-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanse, 70 mg; Intuniv, 4 mg
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0 RA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 RA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea, general fatigue.

VAERS ID:557135 (history)  Vaccinated:2014-09-12
Age:15.0  Onset:2014-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:2014-11-24, Days after onset: 73
Location:Unknown  Entered:2014-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA008564
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J009002 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015 reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:556030 (history)  Vaccinated:2014-11-28
Age:15.0  Onset:2014-11-28, Days after vaccination: 0
Gender:Female  Submitted:2014-11-28, Days after onset: 0
Location:New Mexico  Entered:2014-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown.
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood pressure, oxygenation, and blood sugar were checked by EMTs.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT524080IMLA
Administered by: Other     Purchased by: Private
Symptoms: Blood glucose, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fainted approximately 10 minutes after receiving the vaccine.

VAERS ID:557885 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-28
Location:Unknown  Entered:2014-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA012999
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K009811 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: This spontaneous report was received from a certified medical assistant concerning to a 15 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.

VAERS ID:556306 (history)  Vaccinated:2014-11-04
Age:15.0  Onset:2014-11-04, Days after vaccination: 0
Gender:Male  Submitted:2014-11-20, Days after onset: 16
Location:Unknown  Entered:2014-12-01, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSGA22N IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Confusional state, Fall, Pallor, Staring
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: As the vaccine was being injected into patient''s arm, he started to drop forward. He had is eyes open in a blank stare. He slowly fell into my arms and his dad came to push him back into the chair. He had a blank stare on his face for another few minutes. Then his face lost all coloring and looked as if he had fainted. Then he recognized his surroundings but was confused. His confusion lasted for about 7-10 min and then he was back to normal.

VAERS ID:558179 (history)  Vaccinated:2014-11-04
Age:15.0  Onset:2014-11-07, Days after vaccination: 3
Gender:Male  Submitted:2014-12-01, Days after onset: 24
Location:Kansas  Entered:2014-12-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness: None
Preexisting Conditions: Seasonal/Environmental Allergies; Allergic to sulfa.
Diagnostic Lab Data: Pertussis nasal swab, positive - completed at Medical Center
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM140410UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Bordetella test positive, Cough, Pertussis, Rhinorrhoea, Sneezing, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: Pt. had runny nose, sneezing, cough that started aprox. 11-7-14. Cough got so bad he would vomit. Dx: on 11-14-14 and 11-16-14 with pertussis. Treated with Z-PAK, treatment started 11-14-14. (Not healed).

VAERS ID:556285 (history)  Vaccinated:2013-06-07
Age:15.0  Onset:2013-06-07, Days after vaccination: 0
Gender:Female  Submitted:2014-12-01, Days after onset: 542
Location:Unknown  Entered:2014-12-02, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLOFT
Current Illness: Unknown
Preexisting Conditions: 12/21/2011, Anxiety; 04/03/2013, Depression; KEFLEX, Hypersensitivity, causes rash; Thalassaemia beta
Diagnostic Lab Data: Urinalysis (07Jun2013) 4+ blood with leukocytes; EKG (07Jun2013) sinus tachycardia with a rate of 140 beats per minute; BP (07Jun2013) at 20:30: 138/55, no units provided, Heart rate (P) 136. BP (07Jun2013) at 22:00: 100/58, no unit provided, P 95. BP (07Jun2013) at 23:30: 106/57, no units provided, P 97. BP (07Jun2013) at 24:00: 86/54, no units provided, P 103. Respiratory rate (Unknown date) at 20:40: No respiratory distress noted. Repeat WBC (Unknown date): Result not provided. 06/07/2013, Blood albumin, 5.2 g/dl; 06/07/2013, Blood creatine, 0.0; 04/2013, Blood pressure, 103/74; 06/07/2013, Blood pressure, 138/88; 06/07/2013, Blood pressure, 100/58; 06/08/2013, Blood pressure, 98/49; 06/07/2013, Body temperature, 98.4 Fahrenheit; 06/08/2
CDC Split Type: 2013174424
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Anaphylactic reaction, Blood albumin, Blood creatine decreased, C-reactive protein increased, Cardiac monitoring, Chest pain, Electrocardiogram abnormal, Erythema, Headache, Incomplete course of vaccination, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Laboratory test normal, Lip swelling, Lymphocyte percentage decreased, Nausea, Neutrophil percentage increased, Palpitations, Paraesthesia, Platelet count increased, Sinus tachycardia, Skin warm, Streptococcus test negative, Urine leukocyte esterase positive, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This is a report from a study. A 15-year-old female subject received blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) on 07Jun2013 at 17:12 and presented with event acute anaphylactic reaction on the same day at 19:55. The reported subject''s medical history included allergy to KEFLEX, Beta thalassemia minor tract, anxiety and depression. Concomitant medication included ZOLOFT. On 07Jun2013 at 17:12, the subject received her first dose of blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) intramuscularly in her left arm. No acute reaction occurred within 30 minute. The patient stated she felt fine and was discharged at 17:45. She then went straight home, didn''t eat or drink anything and was not exposed to anything unusual. On the same day, around 19:55, 40 minutes prior to hospital Emergency Room arrival and 2 hours and 45 minutes after vaccination, the patient complained of lip swelling, heart racing, chest hurting, stomach ache with nausea. At 20:35, in the ER, the patient was found with upper lip slightly swollen, tachycardia, palpitations, chest pain, headache, tingling in hands, abdominal pain and nausea. Physical exam in the ER was notable for no respiratory distress. Vital signs on presentation: blood pressure (BP) 138/88 heart rate (HR) 140 20 respirations per minute, Temperature 98.4F. O2 Saturation was 99%. Repeat vital sings in the ER included BP 100/58, HR 95 at 22:00 and BP 106/57 HR 97 at 23:30. EKG indicated sinus tachycardia with a rate of 140 beats per minute. Relevant laboratory tests included WBC 23.3k/ul with neutrophils 85.1% and Lymphocytes 7.0%, normal serum chemistry, C-reactive protein 6.00 mg/dL, Serum albumin 5.2 g/dL, Rapid Influenza A and B negative, Rapid strep A test negative and Urinalysis was 4+ blood with leukocytes. The patient was treated with BENADRYL at 20:55, SOLUMEDROL at 21:10, ZANTAC at 21:12, all per IV and was put under cardiac monitoring. The patient was discharged home from ER on 08Jun2013 at 00:41. Upon discharge she was noted to be without pain with skin warm and pink. Discharge vital signs were BP 98/49, HR 95, RR 29, Temperature 98.4F, O2 Saturation 97.7. (Baseline BP in April 2013 was reported as 102/74). The patient was discharged on oral prednisone 40 mg for 5 days and diphenhydramine 25mg orally as needed. The subject received the first vaccination dose at visit 1, and then was withdrawn from the study prior to receiving any further vaccinations, so they did not complete the immunization schedule. The investigator considered the event acute anaphylactic reaction serious life threatening, and related to study drug but not related to clinical trial procedure and concomitant drug. On 14Jun2013 the blind code was broken by the Sponsor due to serious, related, unexpected event. Follow-up (31Oct14): new information includes: action taken changed from not applicable to permanently withdrawn. Follow-up (21Nov2014) New information includes: additional relevant lab tests from 07Jun2013.

VAERS ID:556343 (history)  Vaccinated:2014-11-05
Age:15.0  Onset:2014-11-06, Days after vaccination: 1
Gender:Male  Submitted:2014-11-25, Days after onset: 19
Location:New Jersey  Entered:2014-12-02, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061240UNRA
Administered by: Private     Purchased by: Private
Symptoms: Headache
SMQs:
Write-up: Headache - 24 hours after getting his HPV #1, 5:30 pm, 11/6/14. Had his HPV 5:45 pm, 11/5/14. Patient had no fever, no vomiting, no nausea. Headache relieved by taking MOTRIN 600 mg PO (didn''t take it regularly, only took if headache is intolerable). Headache lasted for 5 days. Headache located back of head and neck.

VAERS ID:556432 (history)  Vaccinated:2014-08-21
Age:15.0  Onset:2014-09-02, Days after vaccination: 12
Gender:Female  Submitted:2014-12-02, Days after onset: 91
Location:Nevada  Entered:2014-12-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: GILDESS FE 1/20 TABS
Current Illness: No. Perfect health.
Preexisting Conditions: None
Diagnostic Lab Data: Taken to the ER on 09/02/2014, CT scan showed stomach inflammation. Taken back to the ER on 09/04/2014, and again on 09/11/2014, stomach scope, HIDA scan. She has been sick for 3 months now, 10 different medications we are now looking at the Gallbladder, but the HIDA scan was inconclusive because they wasn''t acting right at the time and unable to fill.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0133240SYRRA
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEUR 0SYRRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Computerised tomogram abnormal, Gastritis, Headache, Hepatobiliary scan
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Severe abdominal pain, headache.

VAERS ID:558459 (history)  Vaccinated:2014-11-04
Age:15.0  Onset:2014-11-04, Days after vaccination: 0
Gender:Unknown  Submitted:2014-12-04, Days after onset: 30
Location:Unknown  Entered:2014-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1412USA002018
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H018948 SCRA
Administered by: Other     Purchased by: Other
Symptoms: Expired product administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 04-NOV-2014 the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, subcutaneously in the right arm (lot # H018948, expiration date: 18-OCT-2014). No adverse effects noted. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:557269 (history)  Vaccinated:2014-12-02
Age:15.0  Onset:2014-12-04, Days after vaccination: 2
Gender:Female  Submitted:2014-12-05, Days after onset: 1
Location:New Jersey  Entered:2014-12-05
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: Allergy to PERCOCET; Rash from ABILIFY
Diagnostic Lab Data: Past history of ovarian cancer Rx with chemo 1/13/to 5/13
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU5010AA IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K007264 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J011045 IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Ovarian cancer
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Malignant tumours (narrow), Ovarian malignant tumours (narrow)
Write-up: Left upper arm red and swollen and painful and warm 2 days after PNEUMOVAX - c/o pain and tenderness.

VAERS ID:557400 (history)  Vaccinated:2014-11-12
Age:15.0  Onset:2014-11-13, Days after vaccination: 1
Gender:Male  Submitted:2014-12-08, Days after onset: 25
Location:Florida  Entered:2014-12-08
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: None
Current Illness: None
Preexisting Conditions: Allergic rash to iodine 1/28/07
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI192AB0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0106680IMLA
Administered by: Private     Purchased by: Public
Symptoms: Blood urine present, Dysuria, Epistaxis, Pain, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Pt. started fever, body ache and pain on urination and blood in the urine on 11/13/14. Pt. was seen at ER on 11/13/14 night and was admitted at hospital from 11/14/14-11/16/14. Pt. is still being followed up by Nephrologist. Pt. still has blood in the urine and now has bleeding from the nose - started on 12/6/2014.

VAERS ID:558663 (history)  Vaccinated:2014-11-10
Age:15.0  Onset:2014-11-23, Days after vaccination: 13
Gender:Female  Submitted:2014-12-08, Days after onset: 15
Location:Georgia  Entered:2014-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies to sulfa
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0041550SCLA
Administered by: Public     Purchased by: Public
Symptoms: Dry skin, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: 11-24-2014 - 12:25 PM - client in clinic with her mother. Client hands and trunk of body shedding skin, very dry and skin from hands peeling off. Mom reports noticing the problem on 11-23-14. I visualized flaking of skin on palms and trunk area. No rash present.

VAERS ID:557826 (history)  Vaccinated:2014-12-10
Age:15.0  Onset:2014-12-10, Days after vaccination: 0
Gender:Male  Submitted:2014-12-10, Days after onset: 0
Location:Florida  Entered:2014-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hx of migraine headaches
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CK20561IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061170IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness right after shot was given. Had pt lay down for 20 minutes. Rechecked 02 sats. pulse and B/P which were all WNL.

VAERS ID:557931 (history)  Vaccinated:2014-12-02
Age:15.0  Onset:2014-12-03, Days after vaccination: 1
Gender:Male  Submitted:2014-12-11, Days after onset: 8
Location:South Carolina  Entered:2014-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None Comment: this was his 7th flu vaccine, but only the 2nd time he had the Flumist according to his mother.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CK20576IN 
Administered by: Public     Purchased by: Public
Symptoms: Epistaxis, Malaise, Respiratory tract congestion, Skin warm, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Began complaining of "don''t feel well" the next day (Wednesday). On Thursday had congestion, throwing up, hot to touch, and had "white balls of" congestion with blood when he blew his nose. 7 days later he is "beginning to feel better".

VAERS ID:558292 (history)  Vaccinated:2013-06-06
Age:15.0  Onset:2013-08-01, Days after vaccination: 56
Gender:Female  Submitted:2014-12-16, Days after onset: 502
Location:South Carolina  Entered:2014-12-16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: Nerve Conduction Tests, Blood drawn numerous times, Bone Scan, Vein studies, Doppler scans, x-rays, MRIs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0213460IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blood test, Bone scan, Nerve conduction studies, Nuclear magnetic resonance imaging, Organ failure, Pain, Ultrasound Doppler, Venogram, X-ray
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad)
Write-up: Patient began complaining of aches and pains. They were unexplained and no injury found. By the September the pain became too much and her body began to shut down.

VAERS ID:558567 (history)  Vaccinated:2014-11-30
Age:15.0  Onset:2014-12-01, Days after vaccination: 1
Gender:Male  Submitted:2014-12-17, Days after onset: 16
Location:Unknown  Entered:2014-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Breathing difficulty~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: Albuterol
Current Illness: Penicillin allergy.
Preexisting Conditions: Asthma; Possible exercise-induced asthma
Diagnostic Lab Data: Blood test, Negative
CDC Split Type: 2014047002
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Asthma exercise induced, Blood test normal, Cold sweat, Condition aggravated, Crying, Decreased appetite, Dizziness, Dyspnoea, Mood altered, Nausea, Pallor, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This spontaneous consumer report (initial receipt 02-Dec-2014) concerns a 15 year-old male patient who had a penicillin allergy and a medical history of asthma as a child. His concomitant medication included albuterol. In Nov-2013, approximately 1 to 2 weeks following FLUMIST (batch number not provided), the patient experienced breathing difficulty and was prescribed an albuterol inhaler by a paediatrician. He thought that he had exercise-induced asthma after the FLUMIST administration. It lasted until the summer of 2014. He had many blood tests at the paediatrician''s office and with an allergist, but the tests were all negative and there were no reasons for the episodes identified. The paediatrician suggested the episodes may have come from anxiety. On 30-Nov-2014 at 12:00 hours, the patient intramuscular received AFLURIA (batch number not provided) 0.5mL. On 01-Dec-2014 at 21:30 hours, the patient experienced difficulty breathing, tachycardia, paleness, nausea, clamminess, feelings of fainting, decreased appetite and mood changes. They lasted for approximately one hour. He was a healthy, athletic, straight-A, funny person who felt debilitated with these episodes as they caused him to cry and appeared like a brick wall which was not typical to his mood and behaviour. His entire family received AFLURIA but only he experienced these adverse events. Outcome was not reported.

VAERS ID:558638 (history)  Vaccinated:2014-12-02
Age:15.0  Onset:2014-12-02, Days after vaccination: 0
Gender:Male  Submitted:2014-12-17, Days after onset: 15
Location:Georgia  Entered:2014-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1412USA007253
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.  IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Concussion, Fall, Head injury, Neurological symptom, Psychiatric symptom
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)
Write-up: This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. On 02-DEC-2014 the patient was vaccinated with GARDASIL (dose 1; route and dosage unknown; lot number reported as K0006124). Concomitant vaccine, administered on the same date included FLUMIST. The patient initially did not have any adverse reactions. However, four to five hours later, when the patient was at school, he fell to this knees and then fell backwards and hit his head "sustaining a concussion". The patient had psychiatric and neurologic issues that are ongoing. The patient was "being followed closely by a neurologist and a psychiatrist". The reporter believed the patient''s parents were given a "consult" with a division for infectious diseases. The patient sought unspecified medical attention. The outcome of hit his head "sustaining concussion" and he fell to his knee and then fell backwards was unknown. The outcome of the patient had neurologic issues and the patient had psychiatric issues was reported as not recovered. Lot number K0006124 is an invalid lot number for GARDASIL. Additional information has been requested.

VAERS ID:558726 (history)  Vaccinated:2014-11-01
Age:15.0  Onset:2014-11-03, Days after vaccination: 2
Gender:Male  Submitted:2014-12-18, Days after onset: 45
Location:Texas  Entered:2014-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness prior to vaccination
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Started with vomiting, then fever. Took to pediatrician. Vomiting and fever stopped after a couple of days. Then sore throat which has been persistent. Then, clogged nose and cough that hasn''t gone away.

VAERS ID:559136 (history)  Vaccinated:2014-12-18
Age:15.0  Onset:2014-12-18, Days after vaccination: 0
Gender:Male  Submitted:2014-12-22, Days after onset: 4
Location:Massachusetts  Entered:2014-12-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Atropine 15 eye ointment; Betimol 0.25% eye drops; dorzolamide 2% eye drops
Current Illness: None
Preexisting Conditions: Left eye retinal detachment
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.H011183 IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J002934 SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4975BA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J003706 SCLA
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)
Write-up: Patient had likely syncope v. seizure post vaccines. Sent to ER where determined to be syncopal event.

VAERS ID:559529 (history)  Vaccinated:2014-12-23
Age:15.0  Onset:2014-12-23, Days after vaccination: 0
Gender:Female  Submitted:2014-12-23, Days after onset: 0
Location:Florida  Entered:2014-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported by father of patient
Current Illness: None reported by parent
Preexisting Conditions: None reported by parent
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CL20260IN 
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS337A53IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061912IMLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Nausea, Pallor, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt had a vasovagal episode, felt dizzy, nauseous. Became very pale.

VAERS ID:559683 (history)  Vaccinated:2014-12-16
Age:15.0  Onset:2014-12-16, Days after vaccination: 0
Gender:Female  Submitted:2014-12-22, Days after onset: 6
Location:Unknown  Entered:2014-12-24, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1412USA010040
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a registered nurse refers to an adult 15 year old female patient. On 16-DEC-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant therapy was reported. On 16-DEC-2014 the patient inadvertently received adult doses of VAQTA, instead of pediatric doses. Nurse reports that the two patients are sisters. No adverse effect reported and there was no product quality complaint involved. The outcome of inadvertently received adult doses of VAQTA was unknown. This case is linked to: 1412USA009309 (same reporter). Additional information has been requested.

VAERS ID:559979 (history)  Vaccinated:2014-12-09
Age:15.0  Onset:2014-12-09, Days after vaccination: 0
Gender:Male  Submitted:2014-12-26, Days after onset: 17
Location:Unknown  Entered:2014-12-26
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: WAES1412USA005783
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a licensed practical nurse refers to a currently 15 year old male patient. Medical history and concurrent conditions were not reported. On 23-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiry date were not provided). On 04-OCT-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiry date were not provided). On 09-DEC-2014, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscular in the left deltoid. Nurse stated the patient was given his third dose early. No adverse effects reported. There was no concomitant medication. Additional information has been requested.

VAERS ID:560038 (history)  Vaccinated:2014-12-09
Age:15.0  Onset:2014-12-09, Days after vaccination: 0
Gender:Female  Submitted:2014-12-10, Days after onset: 1
Location:Unknown  Entered:2014-12-29, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Dizziness, Headache, Pyrexia, Viral infection, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: My 15 year old daughter received the first GARDASIL vaccine at about 1:30 pm on 12/9/14. By 5 pm she had a fever over 100 degrees and was dizzy, had trouble seeing and a severe headache. I had her eat some soup, take some MOTRIN and rest. At 5:30 am on 12/10, her fever had returned, and she still had a bad headache and only slight dizziness. I have kept her out of school for the day and am monitoring her symptoms. Upon calling her pediatrician''s office, I was informed that they have never seen these side effects and she probably just has a virus that came on at the same time.

VAERS ID:560026 (history)  Vaccinated:2014-10-21
Age:15.0  Onset:2014-11-24, Days after vaccination: 34
Gender:Female  Submitted:2014-12-30, Days after onset: 36
Location:Florida  Entered:2014-12-30
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Swelling from MMR/pain and redness
Preexisting Conditions:
Diagnostic Lab Data: Ulcerated colitis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSA7HC5 IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J009992 SCUN
Administered by: Private     Purchased by: Private
Symptoms: Colitis ulcerative, Colostomy, Computerised tomogram, Erythema, Immune system disorder, Nuclear magnetic resonance imaging, Pain, Rectal haemorrhage, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 3 ER visits/CAT scan/ colostomy/ MRI/ Flagyl med/ steroids/ 6 nights in hospital/ extreme bleeding from rectum/ immune system attacking it''s self/ morphine giving for pain.

VAERS ID:560074 (history)  Vaccinated:2014-11-13
Age:15.0  Onset:2014-11-14, Days after vaccination: 1
Gender:Female  Submitted:2014-11-19, Days after onset: 5
Location:Michigan  Entered:2014-12-30, Days after submission: 41
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM140680IMRA
Administered by: Private     Purchased by: Public
Symptoms: Burning sensation, Erythema, Pain, Peripheral swelling, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling of upper extremity, itching, pain, burning, redness.

VAERS ID:560367 (history)  Vaccinated:2015-01-02
Age:15.0  Onset:2015-01-02, Days after vaccination: 0
Gender:Female  Submitted:2015-01-02, Days after onset: 0
Location:Florida  Entered:2015-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0042041IMLA
Administered by: Private     Purchased by: Other
Symptoms: Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient was appeared fine after vaccine. She walked to her care with mom and seemed to have fainted. No one is sure if she lost consciousness. Pulse 92, respirations 20, B/P 120/60. She complained of headache and was transported via EVAC to hospital.

VAERS ID:564767 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-04-11
Location:Unknown  Entered:2015-01-02, Days after submission: 266
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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201308510
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
SMQs:
Write-up: Initial misuse report received from a healthcare professional on 25 July 2013. A 15-year-old patient (no other information was provided regarding the patient) had received DAPTACEL instead of ADACEL. No adverse event was reported. Documents held by sender: None.

VAERS ID:564784 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-04-11
Location:Unknown  Entered:2015-01-02, Days after submission: 266
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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201307140
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a 15-year-old patient was administered DAPTACEL. No adverse event was reported. List of documents held by sender: none.

VAERS ID:560532 (history)  Vaccinated:2015-01-02
Age:15.0  Onset:2015-01-02, Days after vaccination: 0
Gender:Female  Submitted:2015-01-05, Days after onset: 3
Location:New York  Entered:2015-01-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: flu like symptoms, dizziness, weakness, leg pain, fatigue, headache, stomach pain, nausea~HPV (Gardasil)~1~15.00~Patient
Other Medications: None
Current Illness: No illness, just recovered from bronchitis diagnosed on 12/17/2014
Preexisting Conditions: Allergic to cats, dogs dust mites. Asthma
Diagnostic Lab Data: So far: 2 neg flu tests and 1 neg strep test.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Abdominal pain upper, Asthenia, Crying, Discomfort, Dizziness, Eye colour change, Headache, Influenza virus test negative, Lethargy, Liver function test, Mononucleosis heterophile test, Nausea, Pain, Pain in extremity, Pyrexia, Restlessness, Streptococcus test negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pain in arm within an hour, severe headache, dizziness, uneasiness, weakness, lethargy, nausea, stomach pain, body aches, high fever started approx 12 after vaccine was administered (101 to 102.5) very hard to control fever with medication, would continue to rise even after taking Advil. Went back to doctor next morning and they did a flu test which was negative, said that she needed rest due to vaccine side effect. Fever continued, she woke up in middle of the night crying in pain, couldn''t get comfortable, everything hurt. Fever all day on Sunday January 04, 2014, called doctor''s emergency number Sunday night and he said give fluids and alternate Tylenol and Advil to bring fever down. Fever continued all night until 7AM on January 05, 2015. Still feeling lethargic and 102.2 fever at 10:30 AM, took Tylenol, fever still 102 at 11:30, went to doctor and took another flu test and it was negative, strept test negative. Doctor noticed her eyes looked yellowish so they did bloodwork to test liver and to test for Mono. It''s now 7:15 PM and she has 102.8 fever.

VAERS ID:564833 (history)  Vaccinated:2015-01-05
Age:15.0  Onset:2015-01-05, Days after vaccination: 0
Gender:Female  Submitted:2015-01-07, Days after onset: 2
Location:Georgia  Entered:2015-01-07
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: Allergy to chemicals
Preexisting Conditions: Diethyltoluamide, Allergy to chemicals
Diagnostic Lab Data:
CDC Split Type: WAES1501USA001358
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0094820IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Tinnitus, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: This spontaneous report as received from a medical assistant refers to a 15 year old female patient with drug reactions or allergy to diethyltoluamide (product reported as DEET). The patient had no pertinent medical history. On 05-JAN-2015 the patient was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular, lot # K009482, expiry: 06-MAR-2017. There was no concomitant medication. On 05-JAN-2015 within 30 seconds to 2 minutes after receiving GARDASIL the patient experienced ringing in both of her ears, became "hot and sweaty", became dizzy and her vision was blurred. The patient was still at physician''s office when the symptoms occurred. There was no treatment given for the events and no lab diagnostic studies were performed. The patient recovered from adverse events on 05-JAN-2015 within 5 to 6 minutes. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.

VAERS ID:564743 (history)  Vaccinated:2014-10-21
Age:15.0  Onset:2014-10-21, Days after vaccination: 0
Gender:Unknown  Submitted:2015-01-08, Days after onset: 79
Location:Unknown  Entered:2015-01-08
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: US2014GSK017262
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 15-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of Flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.

VAERS ID:564900 (history)  Vaccinated:1999-05-01
Age:15.0  Onset:1999-05-01, Days after vaccination: 0
Gender:Unknown  Submitted:2015-01-08, Days after onset: 5731
Location:Unknown  Entered:2015-01-08
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: WAES1501USA001851
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report was received from a licensed practical nurse refers to a 15 year old patient. On 17-APR-1999, 10-MAY-1999 and 04-NOV-2000, the patient was vaccinated with the first, second and third pediatric dose of RECOMBIVAX HB respectively. The nurse stated that the second dose was only 23 days. No adverse effects reported. Additional information has been requested.

VAERS ID:565052 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2015-01-12
Location:Unknown  Entered:2015-01-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: US2014GSK044935
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired product administered
SMQs:
Write-up: This case was reported by a nurse and described the occurrence of expired vaccine used in a 15-year-old patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided: This was one of the two cases received from the same reporter.

VAERS ID:561754 (history)  Vaccinated:2015-01-06
Age:15.0  Onset:2015-01-07, Days after vaccination: 1
Gender:Female  Submitted:2015-01-19, Days after onset: 12
Location:Missouri  Entered:2015-01-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Scalp pyogenic granuloma vs. keloid
Preexisting Conditions: Spherocytosis; innocent murmur; splenectomy
Diagnostic Lab Data: Dx at ICU with cellulitis-RA and Cx: negative sepsis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0094821IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU5020AA1IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J0133442IMRA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure decreased, Cellulitis, Culture negative, Erythema, Heart rate increased, Intensive care, Pain in extremity, Pyrexia, Skin warm, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: 1-8-15: fever 101, vomiting, increased HR, WBC-62K, decreased BP 80/60 (per ER) ICU. RA very sore after vaccines, red and hot to touch. Vaccines in question: right arm.

VAERS ID:562287 (history)  Vaccinated:2013-11-23
Age:15.0  Onset:2013-11-23, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 363
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003817
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010021A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003817, is an initial spontaneous report from a pharmacist received on 24 FEB 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A) intramuscularly on 23 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used an unapproved population".

VAERS ID:562295 (history)  Vaccinated:2013-12-13
Age:15.0  Onset:2013-12-13, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 343
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003824
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS004011A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2044US003824 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 and a follow up report from the pharmacist received on 18 MAR 2014. This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A, expiry date: 30 JUN 2014) at a dose of 0.5 ml intramuscularly in the left arm on 13 DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow up report from the pharmacist received on 18 MAR 2014: FLUCELVAX vaccination date, batch number, expiry date, dose and vaccination site were updated. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562299 (history)  Vaccinated:2014-01-05
Age:15.0  Onset:2014-01-05, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 320
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003829
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS006031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003829, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 15-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: June 2014) at a dose of 0.5 ml intramuscularly on 05 JAN 2014. It was reported that he did not experience any adverse reactions since the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.

VAERS ID:562302 (history)  Vaccinated:2014-01-18
Age:15.0  Onset:2014-01-18, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 307
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003832
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS006031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003832 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 18 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562307 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003836
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003836 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date in JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562312 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003809
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS004011A IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003809 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly on an unknown date in DEC 2013. No adverse event was reported following this administration error. No additional information was available. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562315 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003812
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003812 is an initial spontaneous report received from a consumer (parents) on 21 FEB 2014. This report refers to a 14 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: unknown), intramuscularly on an unknown date in JAN 2014. No adverse event was reported following this administration error. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562329 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003840
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003840 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a 15-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration: changed from listed to unlisted and added second indication as Drug use in unapproved population.

VAERS ID:562335 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:2014-01-02
Gender:Female  Submitted:2014-11-21, Days after onset: 323
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003853
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010031A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2044US003853 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow up report received from the pharmacist on 21 MAR 2014. This report refers to a 15 year old female patient. Her past vaccination history included seasonal influenza with was well tolerated. She was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly into her left arm at a dose of 0.5 ml on 02 JAN 2014 at 15:57 hours. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow up report was received from the pharmacist on 21 MAR 2014. The anatomical site of vaccination, vaccination history, time of vaccination and the reporter''s details were updated. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562336 (history)  Vaccinated:2014-01-09
Age:15.0  Onset:2014-01-09, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 316
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003854
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010031A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003854 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow-up received on 21 MAR 2014. This report refers to a 15-year-old female patient. She was vaccinated with seasonal influenza vaccines (manufacturer and batch number: unknown) on undetermined dates in the past which were well tolerated. She was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly in to the left arm at a dose of 0.5 ml on 09 JAN 2014. This vaccination with FLUCELVAX was an initial application of the vaccine. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow-up information received from the pharmacist in 21 MAR 2014. Updated information about application, vaccination history and site of administration of FLUCELVAX. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562338 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:2014-01-02
Gender:Male  Submitted:2014-11-21, Days after onset: 323
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003858
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS004011A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2044US003858, is a spontaneous initial report from a pharmacist received on 21 FEB 2014 with a follow up received on 21 MAR 2014. This report refers to a 15-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which was well tolerated. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A) at a dose of 0.5 ml intramuscularly into the left arm on 02 JAN 2014 at 14:40 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Follow up received from pharmacist on 21 MAR 2014. Updated vaccination history, vaccination time and site of vaccination of FLUCELVAX. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562340 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:2014-01-06
Gender:Female  Submitted:2014-11-21, Days after onset: 319
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003861
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010031A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2044US003861, is a spontaneous initial report received from a pharmacist on 21 FEB 2014, with a follow up received on 21 MAR 2014. This report refers to a 15 year old female patient. Past medical history and concomitant medication were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which was well tolerated. She was vaccinated with FLUCELVAX (batch number: 010031A) and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the left arm on 06 JAN 2014 at 17:00 PM. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow up received from pharmacist on 21 MAR 2014: Updated vaccination history, vaccination time and site of vaccination of FLUCELVAX. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as ''drug use in unapproved population".

VAERS ID:562397 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003974
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003974 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 15-years old male patient. His medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in JAN 2014. No adverse events were reported following the maladministration. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562447 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US004070
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS004011A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
SMQs:
Write-up: Case number PHEH2014US004070 is an initial spontaneous report received from a pharmacist on 26 FEB 2014. This report refers to a 15-year-old patient of unknown gender. The medical history and concomitant medication of the patient was not reported. On an unknown date in FEB 2014 (two weeks ago), the patient was vaccinated with FLUCELVAX (batch number 004011A) intramuscularly at a dose of 0.5 ml. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014 of the date received on 26 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.

VAERS ID:562458 (history)  Vaccinated:2013-11-30
Age:15.0  Onset:2013-11-30, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 356
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003776
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003776, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at 0.5 ml intramuscularly on 30 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562467 (history)  Vaccinated:2013-12-23
Age:15.0  Onset:2013-12-23, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 333
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003787
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003787 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 23 DEC 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562474 (history)  Vaccinated:2013-11-20
Age:15.0  Onset:2013-11-20, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 366
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2013US025228
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS009031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2043US025228, is an initial spontaneous report received from a nurse on 03 DEC 2013. This report refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 009031A and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 20 NOV 2013. No adverse event was reported following this administration error. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 03 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562481 (history)  Vaccinated:2014-01-07
Age:15.0  Onset:2014-01-07, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 318
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US000800
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US000800 is a combined initial and follow up spontaneous report received from a pharmacist on 07 JAN 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A) intramuscularly on 07 JAN 2014. No adverse event was reported following this medication error. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 JAN 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration " was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.

VAERS ID:562491 (history)  Vaccinated:2013-12-04
Age:15.0  Onset:2013-12-04, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 352
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2013US025315
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS006031A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2013US025315 is an initial spontaneous report received from a pharmacist on 04 DEC 2013 and a follow up report received from the pharmacist on 21 DEC 2013. This report refers to a 14-year-old female patient. She tolerated her previous vaccinations. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly in the left deltoid on 04 DEC 2013 (at 5:00 PM). No adverse event was reported following this medication error (inappropriate age at vaccine administration). Follow up report received from the pharmacist on 21 DEC 2013: Vaccination history added. Updated: FLUCELVAX vaccination site and time. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 31 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562516 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003751
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003751, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 16-year-old female patient. The patient''s medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly on an unknown date in DEC 2014. No adverse event was reported following this medication error. No further information was provided. Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.

VAERS ID:562528 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003655
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003655 is an initial spontaneous report from the nurse (also patient''s mother) received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on an unknown date in DEC 2013. No adverse event reported following this medication error (inappropriate age of vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562534 (history)  Vaccinated:2013-11-27
Age:15.0  Onset:2013-11-27, Days after vaccination: 0
Gender:Female  Submitted:2014-11-24, Days after onset: 362
Location:Unknown  Entered:2015-01-20, Days after submission: 57
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: PHEH2014US003626
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS004011A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US003636 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly at a dose of 0.5 ml on 27 NOV 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562542 (history)  Vaccinated:2014-01-11
Age:15.0  Onset:2014-01-11, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 314
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US001232
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US001232 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 15-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 13 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562546 (history)  Vaccinated:2014-01-11
Age:15.0  Onset:2014-01-11, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 314
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US001240
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US001240 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 15-year-old male adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Jan 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562549 (history)  Vaccinated:2013-12-10
Age:15.0  Onset:2013-12-10, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 346
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US001600
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US001600 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 10 Dec 2013. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562556 (history)  Vaccinated:2014-01-13
Age:15.0  Onset:2014-01-13, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 312
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US001602
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US001602 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 13 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562563 (history)  Vaccinated:2013-11-23
Age:15.0  Onset:2013-11-23, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 363
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003594
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS006031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003594, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 23 NOV 2013. It was reported that she did not experience any adverse reactions due to the maladministration (inappropriate age at vaccine administration). Following an internal review on AUG 2014, a significant correction was done for the information received on 20 FEB 2014. The BPI labeling of the event " inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562568 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-11-21
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003670
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003670 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown dale in JAN 2014. No adverse event occurred to the patient following this medication error. (inappropriate age of vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562573 (history)  Vaccinated:2013-12-06
Age:15.0  Onset:2013-12-06, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 350
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US003616
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010021A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
SMQs:
Write-up: Case number PHEH2014US003616, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 and follow up report received from the pharmacist on 18 MAR 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A, expiration date: JUNE 2014) at a dose of 0.5 ml intramuscularly in the right arm on 06 DEC 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Follow up report received from the pharmacist on 18 MAR 2014. The vaccination site of FLUCELVAX was updated. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562599 (history)  Vaccinated:2013-11-07
Age:15.0  Onset:2013-11-07, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 379
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2013US023984
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS008011A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2013US023984 is an initial spontaneous report received from a nurse on 12 Nov 2013 with a follow up information received from a health care professional on 16 Dec 2013. This report refers to a 16 years-old female patient. Her medical history and concomitant medications were not reported. her vaccination status was uptodate. This patient under 18-years of age was vaccinated with a 0.5 ml intramuscular dose of FLUCELVAX (batch number: 008011A, expiry date: 30 Jun 2014) intramuscularly in the left deltoid on 07 Nov 2013. No adverse event was reported following the maladministration. Follow up information received from a health care professional on 16 Dec 2013: Reporter information, patient demographics (gender), batch number and site of vaccination updated. Following an internal review on 18 Aug 2014 for the information received on 16 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562603 (history)  Vaccinated:2013-11-26
Age:15.0  Onset:2013-11-26, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 360
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2013US025054
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS0092031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2013US025054 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 0092031A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly on 27 Nov 2013. No adverse event was reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".

VAERS ID:562605 (history)  Vaccinated:2013-11-26
Age:15.0  Onset:2013-11-26, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 360
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2013US025056
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS0092031A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2013US025056 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 0092031A and expiry date: Jun 2014) at dose of 0.5 ml intramuscularly on 26 Nov 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562611 (history)  Vaccinated:2013-12-04
Age:15.0  Onset:2013-12-04, Days after vaccination: 0
Gender:Male  Submitted:2014-11-21, Days after onset: 352
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2013US025388
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS010021A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2013US025388 is an initial spontaneous report received from a pharmacist on 05 Dec 2013: This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 04 Dec 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 05 Dec 2013: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".

VAERS ID:562628 (history)  Vaccinated:2014-10-15
Age:15.0  Onset:2014-10-15, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 37
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US021089
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS015011A IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Case number PHEH2014US021089, is an initial spontaneous report from a pharmacist received on 16 Oct 2014. This report refers to a 15-year-old female patient. Her medical history and concomitant medications were not reported. On 15 Oct 2014, the patient inadvertently received an intramuscular dose of FLUCELVAX (batch number: 015011A) instead of FLUVIRIN (batch number: unknown). No adverse event was reported following this medication error.

VAERS ID:562656 (history)  Vaccinated:2014-09-29
Age:15.0  Onset:2014-09-29, Days after vaccination: 0
Gender:Female  Submitted:2014-11-21, Days after onset: 53
Location:Unknown  Entered:2015-01-20, Days after submission: 60
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: PHEH2014US019549
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Case number PHEH2014US019549 is an initial spontaneous report received form a Healthcare Professional on 29 Sep 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with a dose of FLUCELVAX (batch number: not reported) intramuscularly on 29 Sep 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).

VAERS ID:565522 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2015-01-20
Location:Unknown  Entered:2015-01-20
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: WAES1501USA005062
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Dizziness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This spontaneous report as received from a registered nurse via a company representative, refers to a 15 year old male patient. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a third dose of GARDASIL (dose, route, lot# and expiration date were not provided). Concomitant medication was not reported. On an unknown date, soon after administration of patient''s third dose of GARDASIL, his lips turned blue and he felt faint. The patient sought medical attention in an office. It was not known if the patient fainted or if he required medical treatment. The outcome of the events was not reported. Relatedness between the events and GARDASIL was not provided. Additional information has been requested.

VAERS ID:562012 (history)  Vaccinated:2015-01-21
Age:15.0  Onset:2015-01-21, Days after vaccination: 0
Gender:Female  Submitted:2015-01-21, Days after onset: 0
Location:Colorado  Entered:2015-01-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS3J9AM0IMLA
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSBT24B2IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURJ17273SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0162350SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4497AA4IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Dizziness, Dyskinesia, Fatigue, Loss of consciousness, Muscle rigidity, Nausea, Pallor
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), Dyskinesia (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: On January 21, 2015, client, age 15 years, received 5 vaccines including Tdap, IPV, Hepatitis A, Hepatitis B, and MMR. Approximately 1 minute after vaccines were complete, client became extremely pale, lost consciousness and became very rigid with some uncontrolled movements to bilateral arms. This episode lasted approximately 20 seconds, following which, client regained consciousness and was A/O x 3. Client remained very pale, dizzy, nauseous, weak, and tired following the episode. These symptoms gradually improved over the course of 5 minutes while client drank juice. Client was fully recovered after 5 minutes and ambulated to the waiting room, where she remained seated to wait an additional 15 minutes prior to leaving clinic. Clients color was completely restored and all other symptoms were completely resolved at the time client left clinic approximately 15 minutes following the episode.

VAERS ID:562894 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-10-31
Location:Unknown  Entered:2015-01-21, Days after submission: 82
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2013SA116489
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: Initial misuse report received from a healthcare professional on 01 October 2013. The 15 year old patient had received FLUZONE. Nurse reported that 0.25 ml vaccine was administered to patient instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.

VAERS ID:563058 (history)  Vaccinated:2013-10-01
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-10-31
Location:Virginia  Entered:2015-01-21, Days after submission: 82
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylphenidate
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2013SA133060
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH900AA0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4686AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial report received from the healthcare professional on 16-Dec-2013. A female patient age unknown, medical history and concomitant medications were not reported, had received MENACTRA (batch number U4686AA, expiry date unknown) and FLUZONE (batch number UH900AA, expiry date unknown) intramuscular on 11 November 2013. The patient was pregnant while receiving the both of the vaccine. The patient did not have any other adverse event while receiving vaccine. List of documents held by sender: none. Follow-up information received from healthcare professional on 15 January 2014. Father''s health status was reported as unknown. The patient did not have any family history of congenital abnormality. The patient''s last menstrual period was reported as 04 November 2014. The patient did not receive any treatment for infertility with no previous pregnancies. The patient received MENACTRA in left forearm. The patient received Methyl Phenidate 20 mg from 11 November 2013 to 12 December 2013 for ADD. The patient did not experience any non-serious adverse event. The patient carried only urine pregnancy test in office and will be going to an OB/GYN for prenatal care without any complications in pregnancy.

VAERS ID:562038 (history)  Vaccinated:2015-01-04
Age:15.0  Onset:2015-01-08, Days after vaccination: 4
Gender:Female  Submitted:2015-01-22, Days after onset: 14
Location:Maryland  Entered:2015-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No illnesses. Please note that vaccine administration was course of 4 pills taken orally every other day beginning on above date.
Preexisting Conditions: Allergic to peanuts and tree nuts; seasonal pollen allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30008480PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Skin rash appearing on front of neck, no treatment; rash spread to face and back of neck during following week. Completed course of oral vaccination on 1/10/2015.

VAERS ID:563362 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-10-31
Location:Unknown  Entered:2015-01-22, Days after submission: 83
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA045984
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: Initial misuse report received from a healthcare professional on 23 December 2013. The cases were received at GPV on 21 March 2014. A "15-month-old" patient (no information was provided regarding the patient) had received first dose of second dose series of FLUZONE 0.5 ml, on an unspecified date i.e. overdose. No adverse event was reported. List of documents held by sender: none

VAERS ID:562209 (history)  Vaccinated:2015-01-22
Age:15.0  Onset:2015-01-22, Days after vaccination: 0
Gender:Male  Submitted:2015-01-23, Days after onset: 1
Location:Arkansas  Entered:2015-01-23
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none~DTaP (Infanrix)~1~15.67~Sibling|none~Varicella (Varilrix)~1~15.67~Sibling|fainted~Meningicoccal Conjugate + Hib (Foreign)~1
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS4CY24 IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX14071 SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.K411485 SCLA
Administered by: Other     Purchased by: Public
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)
Write-up: Gave patient a MPSV4 without parents consent. Resulted in him passing out.

VAERS ID:565818 (history)  Vaccinated:2015-01-06
Age:15.0  Onset:2015-01-06, Days after vaccination: 0
Gender:Female  Submitted:2015-01-23, Days after onset: 17
Location:California  Entered:2015-01-23
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: WAES1501USA008982
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0069601UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This spontaneous report was received from a health professional via company representative and refers to a 15-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 23-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (dose and anatomical location were not reported, lot # J011272, exp. date was not reported). After the vaccination the patient offered no complaints. There was no concomitant therapy. On 06-JAN-2015, the patient was vaccinated with the second dose of GARDASIL (dose and anatomical location were not reported, lot # K006960, exp. date was not reported). On 06-JAN-2015, in the evening, the patient experienced dizziness, nausea and headache. The patient''s mother informed her physician that the patient sought medical attention in an unspecified emergency department of an unspecified facility. The patient was not admitted to the hospital and the reporter did not know if the patient received any treatments while in the emergency department. The patient recovered from the adverse events on an unspecified date, approximately in January 2015. The relatedness between vaccination with GARDASIL and the events was not reported. Additional information has been requested.

VAERS ID:565843 (history)  Vaccinated:2015-01-20
Age:15.0  Onset:2015-01-21, Days after vaccination: 1
Gender:Female  Submitted:2015-01-23, Days after onset: 2
Location:Florida  Entered:2015-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL
Current Illness: No
Preexisting Conditions: Nickle allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.K0079731SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site warmth
SMQs:
Write-up: Cellulitis, that is moderate, well demarcated, on the (RT) tricep, warm to touch, Measured 9 cm x 5 cm.

VAERS ID:565858 (history)  Vaccinated:2015-01-20
Age:15.0  Onset:2015-01-20, Days after vaccination: 0
Gender:Female  Submitted:2015-01-23, Days after onset: 3
Location:Oregon  Entered:2015-01-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Mom states when pt was a baby her thigh swelled~Vaccine not specified (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA/none
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAZ5400IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0058810IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR9683803IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.K0207531SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA140570IMRA
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)
Write-up: Redness and swelling at injection site.

VAERS ID:564012 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-10-31
Location:Unknown  Entered:2015-01-26, Days after submission: 87
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014SA044852
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Initial misuse case was received from a health care professional on 25 October 2013. Cases were received on 21 March 2014 at GPV. A 15-year-old patient whose demographic details, medical history and concomitant medications were not reported received a dose of FLUZONE Intradermal on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an incorrect product. Laboratory investigation were not reported. No adverse event was reported. Lit of documents held by sender: none

VAERS ID:564046 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-10-31
Location:Unknown  Entered:2015-01-26, Days after submission: 87
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA046099
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Initial misuse report received from a healthcare professional on 16 January 2014. The cases were received at agency on 21 March 2014. It was reported that 15-year-old patient had received FLUZONE ID inadvertently. The patient experienced 3-4cm of erythema. List of documents held by sender: none.

VAERS ID:564231 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-10-31
Location:Unknown  Entered:2015-01-26, Days after submission: 87
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014SA008483
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Initial misuse report received from a health care professional on 08 January 2014. A 15-year-old patient had received FLUZONE HD. It''s an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none

VAERS ID:562985 (history)  Vaccinated:2015-01-21
Age:15.0  Onset:2015-01-22, Days after vaccination: 1
Gender:Female  Submitted:2015-01-28, Days after onset: 6
Location:South Carolina  Entered:2015-01-28
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: ECZEMA
Diagnostic Lab Data: UNDER TREATMENT AND PROGRESSIVLY RECUPERATING
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0084092IMRA
Administered by: Military     Purchased by: Military
Symptoms: Lethargy, Mobility decreased, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: PAIN, SWELLING, FEVER, LETHARGIC, GUARDING ARM, UNABLE TO MOVE ARM.

VAERS ID:566253 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-04-17
Location:Unknown  Entered:2015-01-28, Days after submission: 286
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unk
Current Illness: Unk
Preexisting Conditions: The patient had received a dose of ADACEL in September 2010. No other information was provided.
Diagnostic Lab Data: Not reported
CDC Split Type: 201307085
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Extra dose administered, No adverse event
SMQs:
Write-up: Initial misuse report received from a healthcare professional on 06 June 2013. A 15-year-old patient had received a dose of ADACEL in September 2010 and then received again last week. No adverse event was reported. List of documents held by sender: none.

VAERS ID:566728 (history)  Vaccinated:2015-01-09
Age:15.0  Onset:2015-01-13, Days after vaccination: 4
Gender:Female  Submitted:2015-01-29, Days after onset: 16
Location:California  Entered:2015-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RETIN A; Minocycline
Current Illness: None
Preexisting Conditions: Penicillins and amoxicillen allergy; Acne; Depression; Anxiety
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV13037E0IMLA
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS556011A0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Blood test normal, Swelling, Tenderness, Thyroiditis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypothyroidism (broad), Hyperthyroidism (broad)
Write-up: 1/13/15 pt. had tenderness and swelling along cervical and supraclavicular lymph node locations. 1/14/15 pediatrician diagnosed "thyroiditis" inflammatory. Blood work was all WNL. 1/28/15 Mother calls to report thyroiditis has resolved. No specific treatment.

VAERS ID:563470 (history)  Vaccinated:2015-01-29
Age:15.0  Onset:2015-01-29, Days after vaccination: 0
Gender:Female  Submitted:2015-02-03, Days after onset: 5
Location:Florida  Entered:2015-02-03
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: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0072640IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Muscle spasms, Musculoskeletal stiffness, Pallor
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), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: BECAME PALE, PASSED OUT, ARMS BECAME STIFF AND FLEXED IN A SPASM FOR ABOUT 20- 30 SECONDS. BREATHING WAS HEAVY. AFTER THIS TIME SHE BREATHED NORMALLY, BECAME LIGHT HEADED AND AWARE, AND REMAINED WHITE AS A SHEET. SHE WAS PLACED SUPINE WITH HER FEET ELEVATED WITH A COOL MOIST CLOTH OVER HER FOREHEAD. SHE BECAME MORE AWARE AND COHERENT OVER THE MINUTES AND IN ABOUT 10 MINUTES STARTED TO HAVE SOME COLOR IN HER CHEEKS. SHE REMAINED IN THE ROOM FOR ABOUT 20-30 MINUTES AND THEN WAS ABLE TO WALK OUT WITH NORMAL VITAL SIGNS

VAERS ID:563576 (history)  Vaccinated:2013-08-22
Age:15.0  Onset:2013-08-23, Days after vaccination: 1
Gender:Female  Submitted:2015-02-03, Days after onset: 529
Location:Florida  Entered:2015-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cephalexin 500 mg capsules to treat Folliculits
Current Illness: Slightly swollen left inguinal node. Folliculitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AGRIFLU)NOVARTIS VACCINES AND DIAGNOSTICSBH21730IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0062360IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4594AB0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0037001SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pain
SMQs:
Write-up: Parent reported the patient had body aches for one week.

VAERS ID:567931 (history)  Vaccinated:2015-01-19
Age:15.0  Onset:2015-01-19, Days after vaccination: 0
Gender:Female  Submitted:2015-02-04, Days after onset: 16
Location:California  Entered:2015-02-04
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: WAES1501USA010501
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Discomfort, Headache, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This spontaneous report as received from a registered nurse via field representative refers to a 15 year old female patient of unspecified ethnicity (nurse niece). On 19-JAN-2015, the patient was vaccinated with her first dose of GARDASIL (lot #, batch #, expiration date, dose, route of administration and indication were not provided) in the pediatrician''s office. In the evening of 19-JAN-2015, the patient experienced shakiness, headaches and "uncomfortable reaction". The patient sought medical attention. The pediatrician was contacted on the following day, 20-JAN-2015. No treatment was given to the patient, however, the pediatrician stated that the patient should not receive any further doses of GARDASIL in the future. Action taken with GARDASIL was not reported. The outcome of the events was not reported. Relatedness between GARDASIL and the events was not provided. Additional information is not expected. It was reported that the physician could not be contacted.

VAERS ID:563988 (history)  Vaccinated:2015-02-03
Age:15.0  Onset:2015-02-03, Days after vaccination: 0
Gender:Female  Submitted:2015-02-05, Days after onset: 2
Location:California  Entered:2015-02-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS797K7 IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4875AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient was underage for the vaccine given- reports pain at injection site.

VAERS ID:568272 (history)  Vaccinated:2015-02-06
Age:15.0  Onset:2015-02-06, Days after vaccination: 0
Gender:Female  Submitted:2015-02-06, Days after onset: 0
Location:New Mexico  Entered:2015-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pale/lightheaded~HPV (Gardasil)~1~15.00~Patient|Pale/lightheaded~HPV (Gardasil)~2~15.00~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0058812IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Head discomfort, Pallor, 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)
Write-up: Pale, lightheaded, pt states "pressure in her head" and syncope after HPV #3. Dose 1 and 2 pt felt lightheaded and appeared pale, felt fine after 20 minutes.

VAERS ID:568243 (history)  Vaccinated:2014-10-22
Age:15.0  Onset:2014-12-05, Days after vaccination: 44
Gender:Female  Submitted:0000-00-00
Location:Utah  Entered:2015-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Blood test; HBLA blood; MRI C spine; MRI Brain
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0015021IMRA
Administered by: Private     Purchased by: Private
Symptoms: Autoimmune disorder, Blood test, Chest X-ray, Fall, Headache, Neck pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
SMQs:, Accidents and injuries (narrow), Arthritis (broad)
Write-up: First GARDASIL shot given 7/21/14. Second shot 10/22/14. 6 weeks she had full blown symptoms of neck, head all over body pain, falling down. Have done blood, MRI, chest X-ray etc. Saw doctor almost daily saw a pediatric neurologist. Diagnosis: Autoimmune reaction.

VAERS ID:564387 (history)  Vaccinated:2013-05-24
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2015-02-09
Location:Tennessee  Entered:2015-02-09
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Private
Symptoms: Autoimmune disorder, General physical health deterioration
SMQs:
Write-up: There was no adverse event immediately following the injection. Instead, there was a general decline in health and well being beginning 3-4 months after vaccination. I suspect the vaccine contributed to a generalized Autoimmune response.

VAERS ID:568349 (history)  Vaccinated:2013-02-25
Age:15.0  Onset:2013-02-25, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 364
Location:Unknown  Entered:2015-02-09, Days after submission: 350
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: PHEH2013US005306
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12013 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: Case number PHEH2013US005306 is an initial spontaneous report received from a medical assistant on 25 Feb 2013 with the follow-up received on 25 mar 2013. This report refers to a 15-year-old female patient. it was reported that she was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M12013, expiry date: 28 Feb 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 23 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. it was reported that MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported. Follow-up received on 25 Mar 2013: Updated reporter comments.

VAERS ID:568368 (history)  Vaccinated:2013-03-20
Age:15.0  Onset:2013-03-20, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 341
Location:Unknown  Entered:2015-02-09, Days after submission: 350
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: PHEH2013US007861
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12009 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: case number PHEH2013US007861 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to a 15-yer-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A 12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 20 Mar 2013. The reporter stated that the administered MENVEO was stored at 34 F for 12 hours, but was not frozen. No adverse event was reported following this drug administration error.

VAERS ID:568440 (history)  Vaccinated:2013-03-14
Age:15.0  Onset:2013-03-14, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 347
Location:Unknown  Entered:2015-02-09, Days after submission: 350
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: PHEH2013US010540
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11072 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: Case number PHEH213US010540, is an initial spontaneous report received from a medical assistant on 09 May 2013. This report refers to a 15-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11072 and expiry date: Jun 2014) at dose of 0.5 ml, intramuscularly on 14 Mar 2013, which was stored below 36F. The vaccine reached 34.5F multiple times since 07 Feb 2013 for collective total times of 9-hours and 20-minutes. No adverse event was reported following this administration error.

VAERS ID:568449 (history)  Vaccinated:2013-04-26
Age:15.0  Onset:2013-04-26, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 304
Location:Unknown  Entered:2015-02-09, Days after submission: 350
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: PHEH2013US010669
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12002 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:
Write-up: Case number PHEH2013US010669, is an initial spontaneous report received from a nurse on 09 MAY 2013, and a follow up received from the nurse on 09 MAY 2013. This report refers to 15-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X12002, expiration date: OCT2014) intramuscularly on 26 APR 2013. She received only MenCWY-135 liquid conjugate component, instead of being reconstituted with MenA lyophilized conjugate vaccine of MENVEO. No adverse reaction was reported. Follow up information received from a nurse on 09 MAY 2013: Updated expiration date of MENVEO.

VAERS ID:568894 (history)  Vaccinated:2014-01-07
Age:15.0  Onset:2014-01-07, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 48
Location:Unknown  Entered:2015-02-11, Days after submission: 352
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: PHEH2014US001298
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11081 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:
Write-up: Case number PHEH2014US001298 is an initial spontaneous report received from a pharmacist on 14 JAN 2014. This report refers to a 15-year-old male patient. His medical history and concomitant medications was not reported. Erroneously he received only Men A lyophilized conjugate component of MENVEO (batch number A11081), reconstituted with a sterile water instead of MenCYW-135 liquid component intramuscularly on 07 JAN 2014. No adverse reaction reported following this administration error.

VAERS ID:569014 (history)  Vaccinated:2013-08-13
Age:15.0  Onset:2013-08-13, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 195
Location:Unknown  Entered:2015-02-11, Days after submission: 352
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: PHEH2013US017313
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12092 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:
Write-up: Case number PHEH2013US017313, is an initial spontaneous report received from a medical assistant on 13 AUG 2013. This report refers to a 15 year old male patient. His medical history and concomitant medications was not reported. Medical assistant reported that the patient received Men A component of MENVEO (batch number: M12092) intramuscular that was reconstituted with Merck diluent reported as sterile water on 13 AUG 2013. No adverse event was reported. No further information was provided.

VAERS ID:569068 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-24
Location:Unknown  Entered:2015-02-11, Days after submission: 352
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: PHEH2013US019963
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12092 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: Case number PHEH2013US019963, is an initial spontaneous report received from a medical assistant on 20 SEP 2013. This report refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12092), intramuscularly on an unspecified date, which was exposed to temperature up to 51F for a time of 90 minutes on 19 SEP 2013. No adverse event was reported following this administration error.

VAERS ID:569108 (history)  Vaccinated:2013-09-13
Age:15.0  Onset:2013-09-13, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 164
Location:Unknown  Entered:2015-02-11, Days after submission: 352
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: PHEH2013US019556
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12102 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:
Write-up: Case number PHEH2013US019556, is an initial spontaneous report received from a nurse on 16 Sep 2013, with a follow-up received on 25 Oct 2013. This report refers to a 15-year-old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: M12104/4434AA) reconstituted with sterile water intramuscularly at a dose of 0.5 ml into left deltoid on 13 Sep 2013. She did not receive the Men C, Y, W-135 liquid conjugate component of MENVEO. Patient had no adverse event following medication error. Follow-up was received on 25 Oct 2013: Patient demographics, vaccination site, batch number and information that no adverse event was experienced were updated.

VAERS ID:569116 (history)  Vaccinated:2013-05-01
Age:15.0  Onset:2013-05-01, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 299
Location:Unknown  Entered:2015-02-11, Days after submission: 352
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: PHEH2013US021734
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: Case number PHEH2013US021734 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This reports refers to a 15-year-old female patient. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 01 May 2013 (14:00). It was reported that the vaccine administered was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. Her parents declined to revaccinate with MENVEO.

VAERS ID:564751 (history)  Vaccinated:2015-01-29
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2015-02-12
Location:New York  Entered:2015-02-12
Life Threatening? No
Died? Yes
   Date died: 2015-02-06
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bilateral lower Abdominal pain
Preexisting Conditions: Aspergers
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CL2126 IN 
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain, Culture urine negative,