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Case Details (Sorted by Age)

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VAERS ID:564729 (history)  Vaccinated:2015-01-30
Age:11.0  Onset:2015-01-31, Days after vaccination: 1
Gender:Male  Submitted:2015-02-02, Days after onset: 2
Location:Connecticut  Entered:2015-02-09, 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: Multivitamins
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mom called within 24 hrs of vaccination to report 4-7 hive like areas on arm, smaller than dimes and raised; not at injection site further down arm; itchy when woke up; not itchy later in day as well as smaller without medicine. No other signs or symptoms. Played soccer this day.

VAERS ID:568290 (history)  Vaccinated:2013-04-24
Age:11.0  Onset:2013-04-24, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 306
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: PHEH2013US009706
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11047 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US009706, is an initial spontaneous report received from a nurse on 25 Apr 2013: This case refers to a 11-years-old male patient. He received only MENVEO vaccine (batch number: M11047) reconstituted with sterile diluent on 24 Apr 2013. He did not received MENVEO vaccine. No adverse reaction reported following this adminsitration error.

VAERS ID:568298 (history)  Vaccinated:2013-04-18
Age:11.0  Onset:2013-04-18, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 312
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: PHEH2013US009500
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX11079A IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B93BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US009500, is an initial spontaneous report received from a nurse on 25 Apr 2013 and a follow up received from a nurse on 16 May 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men C, Y, W-135 liquid conjugated of MENVEO vaccine, (batch number: X11079A) intramuscularly in her left deltoid, without being reconstituted with Men A component on 18 Apr 2013. On the same day she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B093BA) at a dose of 0.5 ml intramuscularly in her right deltoid. It was reported that the patient had no redness or swelling at the injection site. The reporter assessed this case as non-serious. Follow up information received from a nurse on 16 May 2013: Updated concomitant vaccination, site of MENVEO vaccination, seriousness, and confirmed that the patient had no vaccination site reactions.

VAERS ID:568302 (history)  Vaccinated:2013-04-04
Age:11.0  Onset:2013-04-04, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 326
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: PHEH2013US008349
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM102006 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US008349 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 04 Apr 2013. It was reported that the vaccine was at 33 to 36 F for 1 days and it was not frozen. No further information was provided.

VAERS ID:568331 (history)  Vaccinated:2013-04-18
Age:11.0  Onset:2013-04-18, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 312
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: PHEH2013US009414
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12013 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US009414, is an initial spontaneous report received from a physician on 23 Apr 2013: This case refers to an 11-years-old male patient. He received only MENVEO vaccine (batch number: X12013), intramuscularly without being reconstituted with Men A component on 18 Apr 2013. No adverse reaction was reported following this administration error.

VAERS ID:568344 (history)  Vaccinated:2013-01-30
Age:11.0  Onset:2013-01-30, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 390
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: PHEH2013US005287
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12006 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US005293 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 and a follow up received on 25 MAR 2013. This report refers to an adult male patient. He was vaccinated with MENVEO (batch numberM12006 and expiry date: 31 OCT 2014) intramuscularly at a dose of 0.5 ml on 30 JAN 2013. This vaccine had undergone temperature excursions. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that the MENVEO had a temperature excursion but the patient did not experience any adverse events as a result of the temperature excursion. It was reported that the patient will be revaccinated. Follow up information received on 25 MAR 2013: Confirmed that the patient did not experience any adverse event and will be revaccinated.

VAERS ID:568362 (history)  Vaccinated:2013-03-08
Age:11.0  Onset:2013-03-08, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 353
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: PHEH2013US007858
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:, Medication errors (narrow)
Write-up: Case number PHEH2013US007858 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 06 Mar 2013. This 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:568363 (history)  Vaccinated:2013-03-28
Age:11.0  Onset:2013-03-28, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 333
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: PHEH2013US007866
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:, Medication errors (narrow)
Write-up: Case number PHEH2013US007866 is an initial spontaneous report received from a health care professional on 03 Apr 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12009, expiry date: Feb 2014) at a dose of 0.5 ml intramuscularly on 28 Mar 2013. It was reported that the MENVEO she had received had been at 34 F for 12 hours and the vaccine was reported as not frozen. No adverse events were reported.

VAERS ID:568365 (history)  Vaccinated:2013-03-07
Age:11.0  Onset:2013-03-07, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 354
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: PHEH2013US007864
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:, Medication errors (narrow)
Write-up: Case number PHEH2013US007864 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This report refers to a female patient. Her medical history and concomitant medications were not reported. She was vaccianted with MENVEO (batch number: A12009, expiry date: Feb 2014) at a dose of 0.5 ml intramuscualrly on 07 mar 2013. it was reported that the MENVEO she had received had been at 34 F for 12 hours and the vaccine was reported as not frozen. No adverse events were reported.

VAERS ID:568367 (history)  Vaccinated:2013-04-08
Age:11.0  Onset:2013-04-08, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 322
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: PHEH2013US008326
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12025 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US008326 is an initial spontaneous report received from a nurse on 10 Apr 2013, with a follow-up received on 26 Apr 2013: This report refers to an 11-year-old female patient. She was given only Men CYW liquid conjugate component of MENVEO (batch number: X12025) intramuscularly on 08 Apr 2013 (at 3.48 pm). The liquid was not re-constituted with MenA powder component (she received only diluent portion of MENVEO vaccine). It was reported that she would be receiving full vaccine dose in next two months. No adverse event was reported following this administration error. Follow-up was received from a nurse on 26 Apr 2013: Patient gender (changed from male to female), vaccination time and information about revaccination schedule were updated.

VAERS ID:568375 (history)  Vaccinated:2013-03-26
Age:11.0  Onset:2013-03-26, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 335
Location:Unknown  Entered:2015-02-09, Days after submission: 350
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: PHEH2013US007327
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12004 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Dark circles under eyes, Dizziness, Immediate post-injection reaction
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Case number PHEH2013US007327 is an initial spontaneous report received from a medical assistant on 27 Mar 2013, with a follow-up received on 27 Mar 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12004, expiry date: Sep 2014) intramuscularly on 26 Mar 2013. On the same day immediately after vaccination, he experienced dizziness, decreased blood pressure and dark circles under his eyes. The reporter stated that the patient was kept in the office for 30 minutes after vaccination and his symptoms resolved, and then he was discharged from the office. The seriousness and causality were not reported. No other information was available. Follow-up was received on 27 March 2013: Expiry date of MENVEO was updated.

VAERS ID:568439 (history)  Vaccinated:2013-02-19
Age:11.0  Onset:2013-02-19, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 370
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: PHEH2013US010532
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:, Medication errors (narrow)
Write-up: Case number PHEH2013US010532, is an initial spontaneous report received from a medical assistant on 09 May 2013. This report refers to an 11-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 19 Feb 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:568458 (history)  Vaccinated:2013-06-05
Age:11.0  Onset:2013-06-05, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 264
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: PHEH2013US012628
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12094 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US012628, is an initial spontaneous report received from a nurse on 07 Jun 2013 with a follow-up received on 02 Jul 2013: This case refers to an 11-year-old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: M12094) reconstituted with sterile water, intramuscularly on 05 Jun 2013. He did not receive Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error. The nurse commented that there was no problem caused due to the medication error and the patient would be vaccinated with the correctly constituted MENVEO. Follow-up received from the nurse on 02 Jul 2013: Updated nurse''s comment.

VAERS ID:568465 (history)  Vaccinated:2013-06-11
Age:11.0  Onset:2013-06-11, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 258
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: PHEH2013US013228
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12025 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013228 is an initial spontaneous report received from a nurse on 14 Jan 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014), at a dose of 0.5 ml intramuscularly in the right on 11 Jun 2013. Reporter stated that the un-reconstituted MENVEO reached minus 1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from a nurse on 09 Jul 2013: Patient demographics (height and weight), site and date of vaccination updated.

VAERS ID:568467 (history)  Vaccinated:2013-06-13
Age:11.0  Onset:2013-06-13, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 256
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: PHEH2013US013237
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11082 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013237 is an initial spontaneous report received from a nurse on 14 Jun 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in the left deltoid on 13 Jun 2013. Reporter stated that the un-reconstituted MENVEO reached minus 1 degree Celsius at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from nurse on 09 Jul 2013. Patient demographics (height and weight), site and date of vaccination updated.

VAERS ID:568472 (history)  Vaccinated:2013-03-23
Age:11.0  Onset:2013-03-23, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 338
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: PHEH2013US011412
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS12013 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US011412 is an initial spontaneous report received from a health care professional on 22 May 2013, and with a follow up report received from nurse on 12 Jul 2013. This report refers to an 11 year old female patient. The patient''s medical history and concomitant medications were not reported. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 23 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. No adverse reaction was reported following maladministration. No further information was provided. Follow up report received from nurse on 12 Jul 2013. Updated patient demographics, batch number and vaccination date.

VAERS ID:568484 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-24
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: PHEH2013US013238
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11082 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013238, is an initial spontaneous report received from a nurse on 14 Jun 2013. This case refers to an 11-year-old female patient. her medical history and concomitant medication were not provided. She was vaccinated with MENVEO, batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in between 07 Jun 2013 to 14 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached-1 degree Celsius for atleast 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error.

VAERS ID:568485 (history)  Vaccinated:2013-06-12
Age:11.0  Onset:2013-06-12, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 257
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: PHEH2013US013240
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11082 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013240, is an initial spontaneous report received from a nurse on 14 Jun 2013 and a follow up report from the nurse received on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in the left deltoid on 12 Jun 2013. Reporter stated that, an un-reconstituted MENVEO reached-1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up report from the nurse received on 09 Jul 2013: The therapy dates of MENVEO vaccine and site of vaccination were updated.

VAERS ID:568487 (history)  Vaccinated:2013-06-11
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2014-02-24
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: PHEH2013US013241
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12025 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013241 is an initial spontaneous report received from a nurse on 14 Jun 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. It was reported that previous vaccinations were tolerated in the past. he was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 11 Jun 2013. Reporter stated that un-reconstituted MENVEO reached minus 1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from a nurse on 09 Jul 2013: Patient demographics (gender, height and weight), site and date of vaccination updated.

VAERS ID:568488 (history)  Vaccinated:2013-06-11
Age:11.0  Onset:2013-06-11, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 258
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: PHEH2013US013242
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12025 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013242, is an initial spontaneous report received from a nurse on 14 Jun 2013, with a follow-up received on 09 Jul 2013. This case refers to a 12-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014), at a dose of 0.5 ml intramuscularly into right thigh on 11 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached-1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow-up was received on 09 Jul 2013: Patient demographics, vaccination date and site was updated.

VAERS ID:568495 (history)  Vaccinated:2013-05-10
Age:11.0  Onset:2013-05-10, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 290
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: PHEH2013US010663
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS12023 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH213US010663, is an initial spontaneous report from a nurse on 13 May 2013. This report refers to an 11 year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number: 12023) subcutaneously on 10 May 2013. No adverse event was reported following this administration error.

VAERS ID:568608 (history)  Vaccinated:2013-07-08
Age:11.0  Onset:2013-07-08, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 231
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: PHEH2013US015423
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12025 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US015423, is an initial spontaneous report received from a medical assistant on 18 Jul 2013: This case refers to an 11 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X12025 and expiry date: Jan 2015), intramuscularly without being reconstituted with Men A component on 08 Jul 2013. No adverse reaction was reported following this administration error.

VAERS ID:568609 (history)  Vaccinated:2013-07-15
Age:11.0  Onset:2013-07-15, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 224
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: PHEH2013US015420
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12025 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US015420, is an initial spontaneous report received from a medical assistant on 18 Jul 2013: This case refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12025 and expiry date: Jan 2015), intramuscularly without being reconstituted with Men A component on 15 Jul 2013. No adverse reaction was reported following this administration error.

VAERS ID:568614 (history)  Vaccinated:2013-07-22
Age:11.0  Onset:2013-07-22, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 217
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: PHEH2013US015815
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12123 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US015815 is an initial spontaneous report received from a nurse on 23 Jul 2013. This report refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number; A12123) intramuscularly on 22 Jul 2013. It was reported that he received MENVEO that had been at less than 2 degree C for a 48-hours period time with the lowest temperature reading of minus 14 degree C. No adverse event was reported following the medication error.

VAERS ID:568626 (history)  Vaccinated:2013-04-01
Age:11.0  Onset:2013-04-01, Days after vaccination: 0
Gender:Unknown  Submitted:2014-02-24, Days after onset: 329
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: PHEH2013US015047
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS12013 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US015047 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an 11 year old patient (gender not reported). Medical history and concomitant medications were not reported. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 01 Apr 2013. It was reported that the patient possibly received Men A lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.

VAERS ID:568627 (history)  Vaccinated:2013-03-25
Age:11.0  Onset:2013-03-25, Days after vaccination: 0
Gender:Unknown  Submitted:2014-02-24, Days after onset: 336
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: PHEH2013US015050
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS12013 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US015050 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an 11 year old patient (gender not reported). Medical history and concomitant medications were not reporter. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 25 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.

VAERS ID:568630 (history)  Vaccinated:2013-07-09
Age:11.0  Onset:2013-07-09, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 230
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: PHEH2013US014762
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12025 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US014762 is an initial spontaneous report received from a medical assistant on 09 Jul 2013. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. It was reported that on 09 Jul 2013 he was vaccinated only with MenCYW-135 liquid conjugate of MENVEO (batch number: X12025) intramuscularly and did not receive the MenA lyophilized conjugate. No adverse event was reported following the maladministration.

VAERS ID:568637 (history)  Vaccinated:2013-06-28
Age:11.0  Onset:2013-06-28, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 241
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: Albuterol
Current Illness: Osteochoondrosis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2013US014363
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12025 IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  SYRUN
Administered by: Unknown     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US014363, is an initial spontaneous report received from a nurse on 02 Jul 2013, and with a follow up report received from nurse on 05 Aug 2013. This case refers to 11 year old female patient. Her medical history included Osgood-Schlatter''s disease. Concomitant medication included Albuterol for use when needed. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M12025), intramuscularly without being reconstituted with men A Component on 28 Jun 2013. On the same date he concomitantly received ADACEL (batch number: unknown). No adverse reaction was reported following this administration error. Follow up report received from nurse on 05 Aug 2013. Updated patient demographics, medical history, concomitant drugs and vaccination date.

VAERS ID:568642 (history)  Vaccinated:2013-06-20
Age:11.0  Onset:2013-06-20, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 249
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: PHEH2013US014196
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12118 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US014196, is an initial spontaneous report received from a nurse on 27 Jun 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO, batch number: M12118 and expiry date: Aug 2014), at a dose of 0.5 ml intramuscularly on 20 Jun 2013. Reporter stated that, MENVEO vaccine was stored at 4.6 F for 4 hours on 20 Jun 2013 and does not know if vaccine was frozen. No adverse event was reported following this administration error.

VAERS ID:568648 (history)  Vaccinated:2013-06-17
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-24
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: PHEH2013US013444
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12024 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013444 is an initial spontaneous report received from a nurse on 19 Jun 2013 with a follow-up received on 09 Jul 2013. This report refers to an 11-year-old female patient. Her past medical history and concomitant medication were not reported. She received only Men A lyophilized component of MENVEO (batch number: M12024, expired date: Dec 2014) reconstituted with a sterile diluent (not with Men CYW-135) intramuscularly on 17 Jun 2013. No adverse event was reported following medication error. The nurse reported that she would be re-vaccinated with the correctly reconstituted MENVEO. Follow-up received from the nurse on 09 Jul 2013: Updated patient demographics and information on re-vaccination.

VAERS ID:568653 (history)  Vaccinated:2013-06-07
Age:11.0  Onset:2013-06-07, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 262
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: PHEH2013US013267
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12024 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US013267, is an initial spontaneous report received from a nurse on 17 Jun 2013. This report refers to an 11-year-old male patient. He received only MENVEO conjugate component (batch number: X1224), intramuscularly without being reconstituted with MEN A component on 07 Jun 2013. No adverse reaction was reported following this administration error.

VAERS ID:568655 (history)  Vaccinated:2013-05-29
Age:11.0  Onset:2013-05-29, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 271
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: PHEH2013US012005
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 SCAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US012005 is an initial spontaneous report received from an office manager on 30 May 2013. This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: A11082) subcutaneously on 29 May 2013 and her arm became swollen at the injection site. No further information about outcome, seriousness and causality was reported.

VAERS ID:564536 (history)  Vaccinated:2015-02-02
Age:11.0  Onset:2015-02-02, Days after vaccination: 0
Gender:Male  Submitted:2015-02-04, Days after onset: 2
Location:South Carolina  Entered:2015-02-10, 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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1213AA1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU9678AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4825AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Cellulitis-swelling, hot to the touch, pain. Right arm.

VAERS ID:564541 (history)  Vaccinated:2015-02-02
Age:11.0  Onset:2015-02-03, Days after vaccination: 1
Gender:Female  Submitted:2015-02-06, Days after onset: 3
Location:West Virginia  Entered:2015-02-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to: Penicillins and erythromycin
Diagnostic Lab Data: Local reaction to vaccine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0650830IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4556AB0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4618AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration, Local reaction, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: No fever, 8 cm x 10 cm erythematous indurated area on 3rd day after vaccine was administered. Minimal erythema and warmth by 3rd day.

VAERS ID:568797 (history)  Vaccinated:2015-02-09
Age:11.0  Onset:2015-02-10, Days after vaccination: 1
Gender:Male  Submitted:2015-02-10, Days after onset: 0
Location:Texas  Entered:2015-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM140700IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS5DM3Y0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain at site of injection with marked erythema and swelling measuring 14 x 16 cm.

VAERS ID:568811 (history)  Vaccinated:2015-01-20
Age:11.0  Onset:2015-01-22, Days after vaccination: 2
Gender:Female  Submitted:2015-01-30, Days after onset: 8
Location:Florida  Entered:2015-02-10, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA; FLOVENT; fluticasone
Current Illness: No
Preexisting Conditions: Intermittent asthma; Sever''s disease; GERD
Diagnostic Lab Data: CBC; CPK; ASO; Anti DNase; Rapid Strep; LDH; CMP; (+) ANA; RF; ESR, 19; CRP; PT/PTT; Antiplatelet antibodies
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0234352SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Activated partial thromboplastin time, Anti-platelet antibody, Antinuclear antibody positive, Arthralgia, Back pain, Blood creatine phosphokinase, Blood lactate dehydrogenase, C-reactive protein, Full blood count, Metabolic function test, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity, Petechiae, Prothrombin time, Red blood cell sedimentation rate increased, Rheumatoid factor, Streptococcus test
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.

VAERS ID:564638 (history)  Vaccinated:2015-02-09
Age:11.0  Onset:2015-02-10, Days after vaccination: 1
Gender:Male  Submitted:2015-02-11, Days after onset: 1
Location:Arizona  Entered:2015-02-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0058810IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4834BC0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4965AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site discomfort, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Softball sized lump at injection site on Right arm. Discomfort at injection sites on both arms. Decreased with ice and ibuprofen temporarily through the evening. States just as bad on morning of 02/11/2015 as it was the day before.

VAERS ID:564860 (history)  Vaccinated:2015-02-02
Age:11.0  Onset:2015-02-04, Days after vaccination: 2
Gender:Female  Submitted:2015-02-05, Days after onset: 1
Location:Puerto Rico  Entered:2015-02-11, Days after submission: 6
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:
Diagnostic Lab Data: Cellulitis on the right arm- Cephalexine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K009482 UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4800AA UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS34EB5 UNRA
Administered by: Unknown     Purchased by: Public
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: According to mother, the right forearm has swelling, redness, warm to touch, and pain. We advised cold compresses.

VAERS ID:568826 (history)  Vaccinated:2013-08-28
Age:11.0  Onset:2013-08-28, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 180
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: PHEH2013US019082
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12093 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US019082, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to an 11 years old male patient. He was vaccinated with MENVEO, batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 28 Aug 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.

VAERS ID:568831 (history)  Vaccinated:2013-09-05
Age:11.0  Onset:2013-09-05, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 172
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: PHEH2013US019084
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12093 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US019084, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to an 11 years old male patient. He was vaccinated with MENVEO (batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 05 Sep 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.

VAERS ID:568842 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:2013-05-28
Gender:Male  Submitted:2014-02-24, Days after onset: 272
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: PHEH2013US021738
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021738 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to an 11-year-old male patient. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to left deltoid on 28 May 2013 (at 15:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). No adverse event was reported following the medication error. He was revaccinated on 26 Jul 2013.

VAERS ID:568889 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2015-02-11
Location:Unknown  Entered:2015-02-11
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: US2015GSK009240
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS5A425 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received INFANRIX (batch number 5A425, expiry date 27th February 2017). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: No adverse event reported.

VAERS ID:568895 (history)  Vaccinated:2014-12-12
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2015-02-11
Location:Unknown  Entered:2015-02-11
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: US2014GSK041304
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS907CM SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received INFANRIX (batch number 907CM, expiry date 27th February 2017). On 12th December 2014, the patient received INFANRIX .5 ml. On 12th December 2014, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: INFANRIX mistakenly given to an 11 year old female instead of BOOSTRIX.

VAERS ID:568927 (history)  Vaccinated:2013-12-05
Age:11.0  Onset:2013-12-05, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 81
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: PHEH2014US000524
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM13012 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US000524 is an initial spontaneous report received from a nurse on 03 JAN 2014. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he was only administered MenCYW-135 liquid component of MENVEO (batch number: M13012, expiry date: Sep 2014) at a dose of 0.5 ml intramuscularly and did not receive MenA lyophilized conjugate on 05 DEC 2013. No adverse reactions were reported following the maladministration.

VAERS ID:568937 (history)  Vaccinated:2013-12-31
Age:11.0  Onset:2013-12-31, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 55
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: PHEH2014US000526
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM13012 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US000526 is an initial spontaneous report received from a nurse on 03 Jan 2014: This report refers to an 11-year-old male child. He was given only MenCYW-135 liquid component of MENVEO (batch number: M13012 and expiry date: Sep 2014) intramuscularly on 31 Dec 2013. No adverse event was reported following this administration error.

VAERS ID:568945 (history)  Vaccinated:2013-10-28
Age:11.0  Onset:2013-10-28, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 119
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: PHEH2013US025552
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12094 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US025552 is an initial spontaneous report received from a health care professional on 05 Dec 2013. This report refers to an 11-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: M12094 and expiry date: 31 Aug 2014) at a dose of 0.5 ml intramuscularly on 28 Oct 2013, which was stored at 0 C for 250 minutes over a period of 63 days. No adverse event was reported following this administration error.

VAERS ID:568962 (history)  Vaccinated:2013-08-02
Age:11.0  Onset:2013-08-02, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 206
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: PHEH2013US016949
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12092 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US016949 is an initial spontaneous report received from a nurse on 08 Aug 2013. This report refers to an 11-years-old female patient. her medical history and concomitant medications were not reported. it was reported that she was vaccinated with MenCYW-135 liquid conjugate component of MENVEO (batch number: X12092 intramuscularly on 02 Aug 2013 without being reconstituted with MenA lyophilized conjugate. No adverse reactions were reported following the administration error.

VAERS ID:568964 (history)  Vaccinated:2013-08-07
Age:11.0  Onset:2013-08-07, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 201
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: PHEH2013US016944
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12013 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US016944, is an initial spontaneous report received from nurse on 07 Aug 2013. This report refers to an 11 year old female patient. Her medical history and concomitant medication was not reported. Nurse reported that the patient received MENVEO (batch number: X11042/A12013), at a dose of 0.5 ml subcutaneously on 07 Aug 2013. No adverse event was reported. No further information was provided.

VAERS ID:568974 (history)  Vaccinated:2013-08-07
Age:11.0  Onset:2013-08-07, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 201
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: PHEH2013US017767
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12132 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US017767 is an initial spontaneous report received from a physician on 19 Aug 2013 and a follow up report from the health care professional received on 23 Sep 2013. This report refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. On 07 Aug 2013, he was vaccinated only with an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: M12132) at a dose of 0.5 ml in the left deltoid region without being reconstituted with Men A lyophilized conjugate. It was reported that the patient was doing well and he would be re-vaccinated in the next vaccination schedule as there was no plan for a foreign travel at this time. No adverse reactions were reported following the mal-administration. Follow up report received from the health care professional received on 23 Sep 2013: The patient''s present condition was updated.

VAERS ID:568975 (history)  Vaccinated:2013-08-16
Age:11.0  Onset:2013-08-16, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 192
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: PHEH2013US017763
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12122 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US017763 is an initial spontaneous report received from a physician on 19 Aug 2013, with a follow-up received on 23 Sep 2013: This report refers to an 11-year-old male child. He was given only MenCYW liquid conjugate component of MENVEO (batch number: M12122) intramuscular on 16 Aug 2013, without being re-constituted with the powder component. The physician confirmed that patient would be revaccinated with the correctly constituted vaccine, as per the normal schedule. No adverse event was reported following this administration error. Follow-up received from a health care professional on 23 Sep 2013: Updated patient demographics and information about revaccination.

VAERS ID:568988 (history)  Vaccinated:2013-08-13
Age:11.0  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: PHEH2013US017740
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11032 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US017740 is an initial spontaneous report received from a nurse on 19 AUG 2013. This report refers to an 11 year old male patient. It was reported that MENVEO (batch number: M11032, expiry date MAR 2014) which reached to a temperature of 31.1 Fahrenheit for a brief but an unknown period of time and on the previous day to a temperature of 32 Fahrenheit for 24 hours was given to the patient via intramuscular route on 13 AUG 2013. It was reported that no adverse reactions reported following this medication error. No other information was available.

VAERS ID:569022 (history)  Vaccinated:2013-08-30
Age:11.0  Onset:2013-08-30, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 178
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: PHEH2013US018580
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12124 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US18580, is an initial spontaneous report received from a medical assistant on 30 AUG 2013, with a follow-up received on 30 AUG 2013. This case refers to an 11 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number M12124, expiry date: AUG 2014), reconstituted with diluent from Merck, intramuscularly on 30 AUG 2013. No adverse reaction was reported following this administration error. Medical assistant inquired whether the patient should revaccinate. Follow-up was received on 30 AUG 2013. Expiry date of vaccine was updated.

VAERS ID:569032 (history)  Vaccinated:2013-08-21
Age:11.0  Onset:2013-08-21, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 187
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: PHEH2013US018287
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US018287, is an initial spontaneous report from a physician on 27 Aug 2013. This report refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO, batch number: not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 21 Aug 2013, No adverse event was reported following this administration error.

VAERS ID:569037 (history)  Vaccinated:2013-08-22
Age:11.0  Onset:2013-08-22, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 186
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: PHEH2013US018020
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12098 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US018020, is an initial spontaneous report received from a nurse on 23 Aug 2013: This case refers to an 11 years old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: M12098) reconstituted with sterile diluent intramuscularly on 22 Aug 2013: No adverse reaction was reported following this administration error.

VAERS ID:569039 (history)  Vaccinated:2013-08-16
Age:11.0  Onset:2013-08-16, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 192
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: PHEH2013US017944
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12120 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US017944, is an initial spontaneous report received from a nurse on 22 Aug 2013. This report refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12120), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 16 Aug 2013. No adverse event was reported following this administration error.

VAERS ID:569054 (history)  Vaccinated:2013-09-03
Age:11.0  Onset:2013-09-03, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 174
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: PHEH2013US018949
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12092 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US018949, is an initial spontaneous report received from a medical assistant on 06 Sep 2013: This case refers to an 11 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12092), reconstituted with sterile diluent from Merck, intramuscularly on 03 Sep 2013. No adverse reaction was reported following this administration error.

VAERS ID:569057 (history)  Vaccinated:2013-06-13
Age:11.0  Onset:2013-06-13, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 256
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 medication
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2013US018851
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US018851, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to an 11 years old male patient. Past medical history and concomitant medicaton were not reported. He was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 13 Jun 2013. No adverse reaction was reported following this administration error.

VAERS ID:569062 (history)  Vaccinated:2013-09-16
Age:11.0  Onset:2013-09-16, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 161
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: PHEH2013US020254
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US020254, is an initial spontaneous report received from a nurse on 25 SEP 2013. This report refers to an 11-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being r4econsititut4ed with Men A lyophilized conjugate component on 16 SEP 2013. No adverse event was reported following this administration error.

VAERS ID:569067 (history)  Vaccinated:2013-09-13
Age:11.0  Onset:2013-09-13, Days after vaccination: 0
Gender:Male  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: PHEH2013US019971
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12120 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US019971, is an initial spontaneous report received from a nurse on 20 SEP 2013 with a follow-up received from the nurse on 24 OCT 2013. This report refers to an 11-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12120), intramuscularly without being reconstituted with men A lyophilized conjugate vaccine component on 13 SEP 2013. No adverse event was reported following this administration error. The patient was re-called on an undetermined date and was given correctly re-constituted MENVEO vaccine. Follow-up received from the nurse on 24 OCT 2013. Updated information about re-vaccination.

VAERS ID:569104 (history)  Vaccinated:2013-08-29
Age:11.0  Onset:2013-08-29, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 179
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: PHEH2013US019090
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12092 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US019090, is an initial spontaneous report received from a healthcare professional on 09 Sep 2013. This report refers to an 11 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: A12092), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 29 Aug 2013. No adverse event was reported following this administration error.

VAERS ID:569112 (history)  Vaccinated:2013-05-13
Age:11.0  Onset:2013-05-13, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 287
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: PHEH2013US021723
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021723, is an initial spontaneous report received from a nurse on 16 OCT 2013. This report refers to 11-year-old female patient. She was vaccinated with MENVEO (batch number A11082) at a dose of 0.5 ml intramuscularly into left deltoid on 13 MAY 2013 (16:00). The reporter stated that MENVEO was stored in refrigerator that dropped to 32.6 F for less than one hour on 19 APR 2013 (vaccine compromised due to refrigeration malfunction). He was re-vaccinated with another dose on 26 AUG 2013. No adverse reaction was following this administration error.

VAERS ID:569115 (history)  Vaccinated:2013-05-14
Age:11.0  Onset:2013-05-14, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 286
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: PHEH2013US021741
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:, Medication errors (narrow)
Write-up: Case number PHEH2013US021741 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a an 11-year-old male patient. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 14 May 2013 (at 15:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. He had an appointment to received HPV vaccine therefore he will be receiving MENVEO at the same time.

VAERS ID:569119 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:2013-05-31
Gender:Female  Submitted:2014-02-24, Days after onset: 269
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: PHEH2013US021746
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021746 is an initial spontaneous report received from the health care professional on 16 OCT 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml, intramuscularly in the left deltoid on 31 MAY 2013 at 09:15 AM. It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). She was re-vaccinated on 10 SEP 2013. No adverse event was reported following this administration error (incorrect storage of drug).

VAERS ID:569122 (history)  Vaccinated:2013-05-17
Age:11.0  Onset:2013-05-17, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 283
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: PHEH2013US021749
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021749 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 17 May 2013. It was reported that the vaccine administered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was re-vaccinated on 27 Aug 2013. No further information was provided.

VAERS ID:569123 (history)  Vaccinated:2013-05-31
Age:11.0  Onset:2013-05-31, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 269
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: PHEH2013US021859
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021859 is an initial spontaneous report received from a nurse on 16 Oct 2013. This report refers to an 11-year-old female patient. Her medical history included seasonal allergies and allergy to amoxicillin. Her concomitant medications were not reported. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 31 May 2013. It was reported that the vaccine adminsitered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was re-vaccinated on 30 Aug 2013. No further information was provided.

VAERS ID:569126 (history)  Vaccinated:2013-10-10
Age:11.0  Onset:0000-00-00
Gender:Male  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: PHEH2013US022215
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11078 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product formulation administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US022215, is an initial spontaneous report received from a pharmacist on 18 Oct 2013 and follow up report from the pharmacist received on 22 Nov 2013. This report refers to a 12-year-old male patient. On 10 Oct 2013, the patient was accidentally vaccinated with only 0.5 ml MenCYW-135 liquid component of MENVEO (batch number: A11078) intramuscularly and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available. Follow up report from the pharmacist received on 22 Nov 2013: The report type changed from other to spontaneous. The patient details and MENVEO details were updated. The event changed from wrong solution used in drug reconstitution to inappropriate preparation of medication.

VAERS ID:569127 (history)  Vaccinated:2013-09-24
Age:11.0  Onset:2013-09-24, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 153
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: PHEH2013US022291
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12119 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US022291, is an initial spontaneous report received from the health care professional on 22 Oct 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12119) intramuscularly on 24 Sep 2013. It was reported that before administration, the vaccine was stored at 31.2 F for 12 hours. No adverse event was experienced following this mal-administration.

VAERS ID:569135 (history)  Vaccinated:2013-10-07
Age:11.0  Onset:2013-10-07, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 140
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: PHEH2013US021314
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.BJ2013 IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB703AA IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11081 IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B676BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021314, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to an 11 years old female patient. Past medical history was not reported. Concomitant vaccines included TDaP (other manufacturer, batch number AC52B676BA) and hepatitis A (other manufacturer, batch number: AHAVB703AA) and FLUMIST (other manufacturer, batch number M11081 and expiry date: 30 APR 2014) at a dose of 0.5 ml in the right arm intramuscularly on 07 OCT 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursion was 0 degree Celsius for may be 10-15 minutes and on 09 SEP 2013, the temperature excursion was 0.5 degree Celsius for many be 10-15 minutes. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error. Follow up report from the medical assistant received on 09 DEC 2013. The site of vaccination and concomitant vaccines were added.

VAERS ID:569141 (history)  Vaccinated:2013-09-04
Age:11.0  Onset:2013-09-04, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 173
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: PHEH2013US021327
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H621608 IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11081 IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021327, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to an 11 years old male patient. Past medical history was not reported. Concomitant vaccines included Tdap (other manufacturer, batch number: AC52B076BA) and GARDASIL (other manufacturer and batch number: H621608) on 03 SEP 2013. He was vaccinated with MENVEO (batch number: M11081 and expiry date: 30 APR 2014), at a dose of 0.5 ml in the right arm intramuscularly on 04 SEP 2013, which had temperature excursion below 2 degree Celsius. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error. Follow up report from the medical assistant received on 09 DEC 2013. The site of vaccination and concomitant vaccines were added.

VAERS ID:569145 (history)  Vaccinated:2013-05-17
Age:11.0  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: PHEH2013US021722
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11082 SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US021722, is an initial spontaneous report received from a nurse on 16 OCT 2013 with a follow-up received on 03 DEC 2013. This report refers to a 12-year-old female patient. She did not have any relevant medical history. Her vaccination status was up to date as per her records. She was vaccinated with MENVEO (batch number: A11082) at a dose of 0.5 ml into left deltoid arm on 17 MAY 2013 (09:30). The reporter stated that MENVEO was compromised due to refrigeration malfunction. She was revaccinated with MENVEO on 25 NOV 2013. No adverse reaction was reported following this administration error. Follow-up received from the nurse on 30 DEC 2013. Updated information on medical history, vaccination history and revaccination with MENVEO.

VAERS ID:569147 (history)  Vaccinated:2013-09-19
Age:11.0  Onset:2013-09-19, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 158
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: PHEH2013US022563
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX12120 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US022563 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 11-year-old female child. She was vaccinated with MENVEO (batch number: X12120) intramuscularly at 0.5 ml on 19 SEP 2013. MENVEO had undergone an excursion to zero degree Celsius for 16 hours; however the vaccine was not frozen. No adverse event was reported following this administration error.

VAERS ID:569154 (history)  Vaccinated:2013-10-25
Age:11.0  Onset:2013-10-25, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 122
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: PHEH2013US022747
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12119 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US022747 is an initial spontaneous report from the health care professional received on 28 Oct 2013. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO, (batch number: A12119) subcutaneously on 25 Oct 2013. On 28 Oct 2013, she experienced redness and swelling at the injected area. The outcome of the events reported as condition unchanged. The seriousness and causality of the events were not reported.

VAERS ID:569166 (history)  Vaccinated:2013-12-17
Age:11.0  Onset:2013-12-17, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 69
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: PHEH2013US026252
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12127 IMLA
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US026252 is an initial spontaneous report received from a medical assistant on 20 Dec 2013 with a follow-up received on 31 Jan 2014. This report refers to an 11-year-old male patient. Examination showed that he was a well-child. His concomitant medications were not reported. He received only Men A lyophilized conjugate component of MENVEO, (batch number: M12127), reconstituted with a sterile diluent instead of MenCYW-135 liquid component intramuscularly in to the left deltoid on 17 Dec 2013. No adverse reaction reported following this administration error. Follow-up received from the medical assistant on 31 Jan 2014: Updated patient demographics (weight and height), medical history and site of MENVEO application.

VAERS ID:564985 (history)  Vaccinated:2015-02-04
Age:11.0  Onset:2015-02-04, Days after vaccination: 0
Gender:Female  Submitted:2015-02-06, Days after onset: 2
Location:South Carolina  Entered:2015-02-12, 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: Allergy to OMNICEF
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU5058AA0IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEURU4998AB0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left arm with mild erythema and mild induration.

VAERS ID:569288 (history)  Vaccinated:2014-11-01
Age:11.0  Onset:2015-01-01, Days after vaccination: 61
Gender:Female  Submitted:2015-02-12, Days after onset: 42
Location:Oklahoma  Entered:2015-02-12
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: Drug hypersensitivity
Preexisting Conditions: Sports injury; BACTRIM, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1501USA009733
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy to vaccine, Drug hypersensitivity, Dyspnoea, Incomplete course of vaccination, Injection site pain, Nausea, Rash macular
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a field representative on 21-JAN-2015 concerning his daughter, an 11 year old female patient with allergy to BACTRIM. The patient''s pertinent medical history included sports injuries. Concomitant therapies included unspecified nasal steroids. The patient received her first dose of GARDASIL injection (strength, dose and lot# were not reported) in NOV-2014 (reported as "two months ago") and she fainted. After the patient received her second GARDASIL dosage on 20-JAN-2015, she complained of injection site pain, and later experienced shortness of breath, nausea and facial splotchiness. The representative called and discussed the patient''s symptoms with her physician, and the physician said to give ibuprofen as treatment. Since it appeared that the patient had an allergy to GARDASIL, she would probably not receive the third and final dosage. No lab diagnostics studies were performed. At the time of reporting, the patient still felt some nausea. The outcome of other events was unknown. Additional information has been requested.

VAERS ID:569327 (history)  Vaccinated:2013-02-12
Age:11.0  Onset:2013-02-12, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 377
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US003979
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12013 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case number PHEH2013US003979 is an initial spontaneous report from the health care professional received on 13 Feb 2013, with a follow-up received from a physician on 30 Apr 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12013) at a dose of 0.5 ml intramuscularly into left arm on 12 Feb 2013. On the same day, few hours after vaccination, he experienced a large swollen area on his left upper arm. On 13 Feb 2013, he consulted the physician and noticed swelling and redness of the left arm with size 164/6 cm. It was reported that swollen area was warm to touch and approximately 50mm across was painful. He received treatment with ATARAX and prednisone for the events. On 14 Feb 2013, the swelling and redness were barely visible. The final outcome of the events was reported as recovered. The seriousness and causality of the events were not reported. Follow-up was received on 30 Apr 2013: Patient demographics, vaccine information (batch number, vaccination dose, site of vaccination, events (swelling/ redness of left arm), treatment medication and outcome of the events were updated.

VAERS ID:569363 (history)  Vaccinated:2013-07-01
Age:11.0  Onset:2013-07-02, Days after vaccination: 1
Gender:Male  Submitted:2014-02-24, Days after onset: 237
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US014616
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12125 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US014616 is an initial spontaneous report from the physician received on 05 Jul 2013. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: M12125) via intramuscular route on 01 Jul 2013. On 02 Jul 2013, his injection site was warm to touch and swollen. His MD (reporter) saw the patient and treated him with an antibiotic. The outcome of the events was reported as decreased, but not completely resolved at the time of reporting. The seriousness and causality of the events were not reported.

VAERS ID:569366 (history)  Vaccinated:2013-07-08
Age:11.0  Onset:2013-07-08, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 231
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: Livedo reticularis
Diagnostic Lab Data:
CDC Split Type: PHEH2013US014822
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12097 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Case number PHEH2013US014822 is an initial spontaneous report received from a physician on 10 Jul 2013, with a follow-up received on 30 Jul 2013: This report refers to an 11-year-old male patient. His medical history included cutis marmorata diagnosed in new born and had complete resolution. He was previously vaccinated with MENVEO (batch number: unknown) on an unspecified date and was well tolerated. He was further vaccinated with MENVEO (batch number: M12097, expiry date: 20 Aug 2014) at a dose of 0.5 ml intramuscularly in to right arm on 08 Jul 2013 (at 2.00 pm). On the same day after vaccination, he experienced pain and lack of mobility in the arm. On 09 Jul 2013, he had swelling and could not raise the right arm. Patient went to a comp on 09 Jul 2013 but the physician did not know what he did there. His mother placed ice on the arm. He consulted his physician on 10 Jul 2013. Seriousness and causality of the events were not reported. Following an internal review of the data received on 10 Jul 2013, it was observed that verbatim swelling of the arm was erroneously coded to swelling. Therefore, it was correctly captured as extensive swelling of vaccinated limb, in the case. Follow-up was received on 30 Jul 2013: Patient demographics, medical history, previous vaccination information, vaccination dose and site were updated.

VAERS ID:569368 (history)  Vaccinated:2013-05-09
Age:11.0  Onset:2013-05-10, Days after vaccination: 1
Gender:Male  Submitted:2014-02-24, Days after onset: 290
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US014898
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10133 SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US014898 is an initial spontaneous report from the medical assistant on 11 Jul 2013, with a follow up received from the medical assistant on 05 Aug 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M10133) at a dose of 0.5 ml in the left arm on 09 May 2013 at 11:00 AM. On the same date, he underwent TB test in the right arm. next day morning (10 May 2013, after vaccination his left deltoid was very swollen, about 3 cm long at the injection site. It was reported that when the patient came back for follow up of the TB test, he had a very swollen deltoid. His physician (MD) advised to apply compresses on the arm. The outcome, seriousness and causality of the event were not reported. Follow up received from the medical assistant on 05 Aug 2013: Updated patient demographics, MENVEO batch number, dose and vaccination date and time.

VAERS ID:569369 (history)  Vaccinated:2013-06-15
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2014-02-24
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US015594
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11032 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Case number PHEH2013US015594 is an initial spontaneous report received from a nurse on 18 Jul 2013 with a follow up information received on 24 Jul 2013. This report reefers to an 11-years and 2-months old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: M11032, expiry date: not available) at a dose of 0.5 ml intramuscularly on 15 Jun 2013. His parent reported on 16 Jun 2013 that on unknown date he experienced itchiness, redness and swelling around the vaccination site. The outcome of the event was not reported. No further information was provided. Follow up information received on 24 Jul 2013: Batch number of the vaccine updated.

VAERS ID:569370 (history)  Vaccinated:2013-07-12
Age:11.0  Onset:2013-07-15, Days after vaccination: 3
Gender:Female  Submitted:2014-02-24, Days after onset: 224
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US015772
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12011 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Case number PHEH2013US015772, is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: A12011, expiry date: Feb 2014) at dose of 0.5 ml intramuscularly on 12 Jul 2013. On 15 Jul 2013, her parent called and reported that, she experienced injection site of MENVEO was red and hot (exact date of onset of reaction was not known). The outcome, seriousness and causality of the events were not reported.

VAERS ID:569371 (history)  Vaccinated:2013-07-17
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2014-02-24
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US015777
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12011 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case number PHEH2013US015777, is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A12011, expiry date: Feb 2014) at dose of 0.5 ml intramuscularly on 17 Jul 2013. On 18 Jul 2013, his parent called and reported that, he experienced redness, heat and swelling at MENVEO injection site, low grade fever and headache (onset exact date of reactions was not known). The outcome, seriousness and causality of the events were not reported. Following an internal review received on 06 Aug 2013, the case number PHEH2013US016372 was identified to be a duplicate of PHEH2013US015777 and hence all the information from PHEH2013US016372 was merged into PHEH2013US015777 and the case PHEH2013US016372 would be deactivated.

VAERS ID:569372 (history)  Vaccinated:2013-07-17
Age:11.0  Onset:2013-07-18, Days after vaccination: 1
Gender:Male  Submitted:2014-02-24, Days after onset: 221
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US016332
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Case number PHEH2013US016332, is an initial spontaneous report received from a medical assistant on 30 Jul 2013. This report refers to 11 year 3 months old male child. He was vaccinated with MENVEO (batch number: unknown) at a dose of 0.5 ml intramuscularly on 17 Jul 2013. On 18 Jul 2013, he experienced localized red reaction at injection site. Outcome, seriousness and causality assessment of the event was not reported.

VAERS ID:569374 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:2013-07-17
Gender:Male  Submitted:2014-02-24, Days after onset: 222
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US016334
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site erythema, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case number PHEH2013US016334 is an initial spontaneous report received from a medical assistant on 30 Jul 2013 and a follow up report from the medical assistant received on 20 Aug 2013. This report refers to an 11-year-old male child. He was vaccinated with MENVEO, (batch number: unknown) at a dose of 0.5 ml intramuscularly in the arm on 17 Jul 2013 (at 9:15 am). On the same date, after vaccination he experienced localized red reaction at injection site, which later became as red swollen arm. On 20 Jul 2013, he recovered from the event. The event was reported as non serious. The causality assessment of the event was not reported. Follow up report from the medical assistant received on 20 Aug 2013: The vaccination site and date, event (red swollen arm), start date and outcome of the event and seriousness of the event were updated.

VAERS ID:569375 (history)  Vaccinated:2013-07-29
Age:11.0  Onset:2013-07-31, Days after vaccination: 2
Gender:Male  Submitted:2014-02-24, Days after onset: 208
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US016490
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12096 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US016490 is an initial spontaneous report received from a physician on 01 Aug 2013: This report refers to a male child. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: M12096) intramuscularly on 29 Jul 2013. On 31 Jul 2013, he experienced redness and swelling from the injection site to the elbow. No further information about seriousness, outcome and causality was reported.

VAERS ID:569378 (history)  Vaccinated:2013-09-04
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-24
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US020416
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US020416, is an initial spontaneous report received from a medical assistant on 27 Sep 2013. This case refers to an 11-years-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: not reported), at a dose of 0.5 ml intramuscularly on 04 Sep 2013. Within 48-hours after vaccination, she experienced redness, swelling and warmth to touch at the injection site. The seriousness, outcome and causality of the events were not reported.

VAERS ID:569379 (history)  Vaccinated:2012-07-01
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2014-02-24
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US020421
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHEH2013US020421, is an initial spontaneous report received from a medical assistant on 27 Sep 2013. This case refers to an 11-years-old male patient. past medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: not reported), at a dose of 0.5 ml intramuscularly, sometime in Jul 2012. Within 48-hours after vaccination, he experienced redness, swelling and warmth to touch at the injection site. The seriousness, outcome and causality of the events were not reported.

VAERS ID:569380 (history)  Vaccinated:2013-10-03
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-24
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: Lactose intolerance; Disaccharide metabolism disorder; Vitiligo; Oropharyngeal pain; Cough; Respiratory tract congestion; Headache; Lacrimation increased
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 110/70, Normal; Body temperature, 36.6 degrees C, Normal; Heart rate, 98, High, bpm; Oxygen saturation, 96%, Normal
CDC Split Type: PHEH2013US020956
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU4617AA IMUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUHB99AA SYRUN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12114 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Case number PHEH2013US020956 is an initial spontaneous report received from the medical assistant on 04 Oct 2013 with a follow up information received from the medical assistant on 05 Nov 2013. This report refers to a female child patient who was of 11-12 years of age. She had no recent injury, no allergic reactions and allergy to medications. She had a history of lactose intolerance, intestinal disaccharide deficiency and vitiligo. Her current conditions included sore throat, cough, congestion, headache and watery eyes and concomitant medications were not reported. Her vaccination history included administration of varicella virus vaccine (other manufacturer, batch number: not reported), MMR (other manufacturer, batch number: not reported) and HIB-PRP-T (other manufacturer, batch number: not reported) on 08 Nov 2002, DTaP (other manufacturer, batch number: not reported) and PCV13 (other manufacturer, batch number: not reported) on 31 Jan 2003, hepatitis A vaccine (other manufacturer, batch number: not reported), varicella vaccine (other manufacturer, batch number: not reported), DTaP (other manufacturer, batch number: not reported) and MMR (other manufacturer, batch number: not reported) on 23 Mar 2007, hepatitis A vaccine (other manufacturer, batch number: not reported) on 06 Aug 2009, H1N1 flu vaccine (unknown manufacturer, batch number: not reported) in 23 Nov 2009 and seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in 23 Dec 2009. She was vaccinated with 0.5 ml of MENVEO (batch number: A12114, expiry date: 31 Aug 2014) intramuscularly in the right arm on 03 Oct 2013. She also received influenza vaccine (other manufacturer, batch number: UHB99AA, expiry date: 30 Jun 2014) and Tdap (other manufacturer, batch number: U4617AA, expiry date: 22 Oct 2015) on the same date. On an unknown date after vaccination, she experienced lightheadedness and dizziness. Her vital signs were checked and were normal. Physical examination was done and the findings were normal. The events outcome was reported as complete recovery. The seriousness and causality were not reported. No additional information was available. Follow up information received from the medical assistant on 05 Nov 2013: Patient demographics (height and weight), laboratory data, vaccination history, suspect vaccines, site of vaccination, outcome of the event updated.

VAERS ID:569414 (history)  Vaccinated:2013-02-08
Age:11.0  Onset:2013-02-08, Days after vaccination: 0
Gender:Male  Submitted:2014-02-24, Days after onset: 381
Location:Unknown  Entered:2015-02-12, Days after submission: 353
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: PHEH2013US003645
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10130 IMRA
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2013US003645, is an initial spontaneous report received form a nurse on 08 Feb 2013, and with a follow up report received on 12 Mar 2013. This report refers to 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M10130), at a dose of 0.5 ml IM into right arm on 08 Feb 2013 at 8:30 am. He received MenCWY liquid conjugate component only, instead of being reconstituted with MenA. No adverse reaction was reported. Follow up report received on 12 Mar 2013. Dose and site of vaccination updated.

VAERS ID:565152 (history)  Vaccinated:2015-02-12
Age:11.0  Onset:2015-02-13, Days after vaccination: 1
Gender:Male  Submitted:2015-02-13, Days after onset: 0
Location:Florida  Entered:2015-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No. Very healthy.
Preexisting Conditions: Hydrocephalus with shunt; sensory processing disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0061390SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cough, Injection site erythema, Nasal congestion, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Started coughing, signficant nasal congestion, then 15 minutes later scratching at scalp, hives on arms and chest, redness at site of injection.

VAERS ID:569535 (history)  Vaccinated:2015-01-23
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2015-01-27
Location:West Virginia  Entered:2015-02-16, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin pump
Current Illness: No
Preexisting Conditions: Diabetic
Diagnostic Lab Data: CT, labs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0061911IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4798AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram, Laboratory test, Local swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swollen area noted to (R) frontal area-denies injury-denies pain with palpation.

VAERS ID:565623 (history)  Vaccinated:2015-02-17
Age:11.0  Onset:2015-02-17, Days after vaccination: 0
Gender:Female  Submitted:2015-02-17, Days after onset: 0
Location:Colorado  Entered:2015-02-17
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: 911 called, transferred to Hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CL2127 IN 
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSBT24B2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0058810IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURK13302SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4929BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4690BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Slow response to stimuli, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Client received Tdap, IPV, Hep B, MCV4, Flumist and HPV4. After HPV4 was administered (which was the last vaccine that was administered, client had syncope episode, client responded within 15secs. Lowered client to floor, elevated legs, juice given. After 10 mins. client stated she was feeling better, asissted her to chair where she finished juice. 3:00pm client had another syncope episode, lowered her to floor and administered O2, client orinated but slow to respond. 911 called, Paramedics transferred client to the hospital.

VAERS ID:569615 (history)  Vaccinated:2015-02-16
Age:11.0  Onset:2015-02-16, Days after vaccination: 0
Gender:Male  Submitted:2015-02-16, Days after onset: 0
Location:Texas  Entered:2015-02-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sore throat; cough; 11 year old EPSDT
Preexisting Conditions: Asthma
Diagnostic Lab Data: Strep test done in house came out negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4975BA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4565AA0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Dyskinesia, Streptococcus test negative, Syncope, Trismus
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Dystonia (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncope, patient fainted, had jerking movement, his jaw locked. MCV4.

VAERS ID:569719 (history)  Vaccinated:2015-02-04
Age:11.0  Onset:2015-02-04, Days after vaccination: 0
Gender:Male  Submitted:2015-02-09, Days after onset: 5
Location:Wisconsin  Entered:2015-02-18, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 09/24/14 Bruise at site~HPV (Gardasil)~2~11.00~Patient
Other Medications: BENADRYL
Current Illness: None
Preexisting Conditions: Allergic to Amoclan
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0082132IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: GARDASIL 0.5 ml lot K008213 was administered on 02/04/15 to left deltoid. Mom called 02/09/15 to report his left arm became red, swollen and warm to touch at site of injection and spread quickly down his arm. She gave him BENADRYL on 2/4/15 and he was better. He''s had BENADRYL over weekend.

VAERS ID:566327 (history)  Vaccinated:2015-02-16
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2015-02-18
Location:Arizona  Entered:2015-02-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI191AA UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K006960 UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA14045 UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 10.5 x 7 cm area lat. proximal (R) upper arm sl. erythematous sl. swollen - not painful not causing LOM.

VAERS ID:569839 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2015-02-19
Location:Alabama  Entered:2015-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.K0048560IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4833CA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4939AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and redness at injection sites on left arm. Started 2 days after vaccines.

VAERS ID:566373 (history)  Vaccinated:2014-08-05
Age:11.0  Onset:2014-08-19, Days after vaccination: 14
Gender:Female  Submitted:2015-02-21, Days after onset: 186
Location:Florida  Entered:2015-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Food allergies - egg and melon
Diagnostic Lab Data: EMG, spinal tap, multiple neurological evaluations
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4799AA0IMRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERU4904AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Muscular weakness, Nerve injury, Neurological examination, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Demyelination (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Patient began experiencing severe limb pain for about 6-8 weeks which was accompanied by weakness which continued to develop over the next few months. Once the pain disappeared, she was left with nerve damage and extreme weakness. She was diagnosed with either Guillain Barre Syndrome or it''s more severe counterpart of CIDP. She underwent a spinal tap and multiple 8 hour IVIG treatments at the hospital. She is still currently undergoing neurology appointments, physical therapy and continued treatment. Symptoms originally started about 2 weeks after the vaccine and have continued over the last 6 months.

VAERS ID:566689 (history)  Vaccinated:2015-02-17
Age:11.0  Onset:2015-02-19, Days after vaccination: 2
Gender:Male  Submitted:2015-02-20, Days after onset: 1
Location:Arizona  Entered:2015-02-23, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Eczema - no treatment necessary since 2007
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU1207AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.K0042050IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4657AA2IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSL7J440IMLA
Administered by: Private     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)
Write-up: None stated.

VAERS ID:567058 (history)  Vaccinated:2009-07-16
Age:11.0  Onset:2009-07-24, Days after vaccination: 8
Gender:Female  Submitted:2015-02-25, Days after onset: 2042
Location:Oregon  Entered:2015-02-25
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dizziness; Nausea
Preexisting Conditions: None
Diagnostic Lab Data: TSH, Free T4 and Tilt test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2918AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3158AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Autoimmune thyroiditis, Blood thyroid stimulating hormone, Dizziness, Fatigue, Hypothyroidism, Nausea, Postural orthostatic tachycardia syndrome, Thyroxine free, Tilt table test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (narrow), Hyperthyroidism (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Dizziness, nausea, fatigue. Got hypothyroid Hashimoto''s and POTS shortly after (diagnosed).

VAERS ID:567168 (history)  Vaccinated:2014-10-27
Age:11.0  Onset:2014-10-31, Days after vaccination: 4
Gender:Male  Submitted:2014-10-31, Days after onset: 0
Location:Unknown  Entered:2015-02-25, Days after submission: 117
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: 2014SE83674
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CJ2129 IN 
Administered by: Other     Purchased by: Other
Symptoms: Influenza A virus test positive, Influenza like illness
SMQs:
Write-up: A spontaneous report has been received from a Health professional concerning a 11 year old male patient of unknown ethnicity. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. It was reported that the patient received FLUMIST QUADRIVALENT (intranasal) on 27-OCt-2014 at that office, and he came back on 31-Oct-2014 due to flu-like symptoms. Patient tested positive for Influenza A. Action taken was not applicable for FLUMIST QUADRIVALENT. The outcome of the events of tested positive for influenza A and flu-like symptoms was unknown. The events tested positive for influenza A and flu-like symptoms were considered to be non serious by the reporter.

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