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Found 603291 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

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VAERS ID: 639069 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-05-16
Onset:2016-05-16
   Days after vaccination:0
Submitted: 2016-06-13
   Days after onset:28
Entered: 2016-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 0 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAR; omeprazole; VENTOLIN; melatonin
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA003747

Write-up: This spontaneous report has been received from a nurse practitioner via company representative referring to a 11 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies was unknown by the reporter. On 16-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9, injection (anatomical location of administration was not provided), with lot # L044479, expiration date 12-MAY-2017. Concomitant therapies included generic montelukast sodium (manufacturer unknown), omeprazole (manufacturer unknown), VENTOLIN and melatonin. On the same date, immediately after receiving vaccination, the patient felt faint and lightheaded (dizziness). The nurse practitioner reported that was unknown if she received a treatment for the event. Product quality complain was not involved. The reporter stated that was unknown if the patient sought medical attention, or need hospitalization or performed laboratory diagnostics, also was unknown if the event was life threatening or if the patient received an overdose. At the time of reporting the outcome of faint and lightheaded was reported as recovered on an unspecified date in 2016. The relatedness between the event and GARDASIL 9 was not reported. Lot number L044479 is an invalid lot number for GARDASIL 9 however is valid for ROTATEQ. Additional information has been requested.


VAERS ID: 639108 (history)  
Age: 11.0  
Gender: Female  
Location: Puerto Rico  
Vaccinated:2016-06-08
Onset:2016-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2016-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5228BA / - UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 54L57 / - UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Cellulitis, Inflammation, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Cellulitis of right upper arm. ER doctor prescribed Acetaminophen 500 and BENADRYL PO #10
CDC Split Type:

Write-up: Mother of the girl takes her to the ER since on June 8th the girl received some vaccines and a cellulitis developed on the right arm and where the doctor helped her due to complaints of pain and inflammation on the arm.


VAERS ID: 639234 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2016-06-08
Onset:2016-06-09
   Days after vaccination:1
Submitted: 2016-06-09
   Days after onset:0
Entered: 2016-06-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A15076A / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 541S7 / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, 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)

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

Write-up: Swelling, redness, warm to touch and pain when moving it. (L) arm. Cold compress, BENADRYL PRN itching, Ibuprofen PRN pain.


VAERS ID: 639236 (history)  
Age: 11.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2016-05-25
Onset:2016-05-25
   Days after vaccination:0
Submitted: 2016-06-09
   Days after onset:15
Entered: 2016-06-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M37316 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chills, Fatigue, Injection site erythema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy, cough, sneezing
Preexisting Conditions: Hypogammaglobulinemia, seizure, congenital pulm. stenosis
Diagnostic Lab Data:
CDC Split Type: CT201602

Write-up: Fever T102.6, redness at injection site, chills, fatigue.


VAERS ID: 639049 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2016-06-01
Onset:2016-06-02
   Days after vaccination:1
Submitted: 2016-06-14
   Days after onset:12
Entered: 2016-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER L016429 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5180AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5278AA / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Eye movement disorder, Fall, Muscle tightness, Nausea, Seizure, Skin warm, Syncope, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA106695

Write-up: Initial unsolicited report received from other non-healthcare professional (medical assistant) on 03 June 2016. This case involves 11-year-old male patient who was vaccinated with a first dose of ADACEL (batch number- U5278AA, expiry date- 25 February 2018) intramuscularly in right deltoid, first dose of MENACTRA (batch number- U5180AA, expiry date- 22 January 2017) intramuscularly in right deltoid and also received first dose of HPV (batch number- L016429, manufacturer- Merck) intramuscularly in right deltoid on 01 June 2016. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergy. Concomitant medications were not reported. On 02 June 2016, one day following the vaccination, the patient had experienced 3 mini seizures vs syncope episodes (according to ER record) and the patient was warm, nauseated and lightheaded and fell to the ground, the patient''s mother reported that patient''s eyes rolled up into head and arms and legs tightened up and were shaking. On 02 June 2016 in the evening, one day following the vaccination, patient vomited 3 times. On 02 June 2016 at 2:44 pm, the patient was seen at emergency room. Laboratory data and corrective treatment were not reported. On an unspecified date, the patient was recovered from events. Upon internal review the case was considered as serious because of important medical event mini seizures. List of documents held by sender: none. Sender''s Comments: Seizures may occur after administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This case is not sufficiently documented. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.


VAERS ID: 639408 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-09
Entered: 2016-06-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L026602 / - RA / IM
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M37315 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5185BA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5378AA / 0 RA / IM

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

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

Write-up: Full body hives x 4 days. Began 48 hours after vaccines administered.


VAERS ID: 639415 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2016-06-09
Onset:2016-06-12
   Days after vaccination:3
Submitted: 2016-06-15
   Days after onset:3
Entered: 2016-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 2 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanse 10 mg once daily
Current Illness: None
Preexisting Conditions: Double aortic arch s/p repair; ADHD
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Non pruritic rash surrounding injection site, no swelling, no pain, stable and not progressing.


VAERS ID: 639437 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-06-09
Onset:2016-06-10
   Days after vaccination:1
Submitted: 2016-06-15
   Days after onset:5
Entered: 2016-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M005714 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5392AA / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: AT THE TIME OF VACCINE NO ILLNESS NOTED.
Preexisting Conditions: ALLERGIC RHINITIS
Diagnostic Lab Data:
CDC Split Type:

Write-up: MOM OBSERVED SITE TO BE RED AND PUFFY.


VAERS ID: 639441 (history)  
Age: 11.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-08-03
Onset:0000-00-00
Submitted: 2016-06-15
Entered: 2016-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / -

Administered by: Unknown       Purchased by: Public
Symptoms: Asthenia, Dizziness, Pain
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: Depression, chronic back pain/nausea
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Unsure of when exactly event happened - child reports feeling weak/dizzy, body aches for about 1month after each vaccination.


VAERS ID: 640320 (history)  
Age: 11.0  
Gender: Female  
Location: Illinois  
Vaccinated:2016-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2016-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15020 / - RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 79744 / - LA / UN

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

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

Write-up: None stated.


VAERS ID: 640539 (history)  
Age: 11.0  
Gender: Male  
Location: Virginia  
Vaccinated:2016-06-06
Onset:2016-06-07
   Days after vaccination:1
Submitted: 2016-06-07
   Days after onset:0
Entered: 2016-06-15
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. 1020015 / - RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5058AB / - LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9NA32 / - LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Cellulitis, Injection site rash
SMQs:, Hypersensitivity (narrow)

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

Write-up: Cellulitis of upper limb, rash - lt arm deltoid - 4.5 cm x 7.5 cm in diameter, irregular borders. Tx: Cefdinir 250 mg/5ml oral susp. Take 8 ml qd PO with meals x 10 days.


VAERS ID: 640626 (history)  
Age: 11.0  
Gender: Female  
Location: Virginia  
Vaccinated:2016-06-14
Onset:2016-06-14
   Days after vaccination:0
Submitted: 2016-06-15
   Days after onset:1
Entered: 2016-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M003659 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5415AA / 0 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Eye movement disorder, Nausea, Postictal state
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)

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

Write-up: HPV vaccine and MENACTRA vaccine administered to patient. Patient felt faint and nausea approximately one minute s/p vaccine administration. Two RN''s witnessed eyes rolling back in and head and patient was postictal.


VAERS ID: 639584 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-12-11
Onset:2012-12-11
   Days after vaccination:0
Submitted: 2013-02-21
   Days after onset:72
Entered: 2016-06-16
   Days after submission:1210
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10051 / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US025103

Write-up: Case number PHEH2012US025103 is an initial spontaneous report received from a pharmacist on 11 Dec 2012 with follow-up received on 20 Jan 2013. The report refers to an 11-year-old male patient. The patient''s vaccination history included vaccination with MENVEO and was well tolerated. He was vaccinated only with MenCYW-135 component of MENVEO 0.5 ml (batch number: M10051, expiration date: Jan 2013) intramuscularly on left arm on 11 Dec 2012. Upon follow-up, parent information of incomplete vaccination and recommended repeat dose. No adverse events were reported. No further information was available. Follow-up received from a pharmacist on 20 Jan 2013. Therapy details, vaccination history and narrative updated.


VAERS ID: 639599 (history)  
Age: 11.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2016-06-15
Onset:2016-06-15
   Days after vaccination:0
Submitted: 2016-06-16
   Days after onset:1
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 0 RA / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ear discomfort, Malaise, Nausea, Syncope, Tinnitus, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Reported ringing/popping in ears and not feeling well; reached parking lot and reported still not feeling well but couldn''t describe how feeling. He reported nausea and fuzzy vision. Ended up fainting in parking lot of doctors clinic.


VAERS ID: 639611 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-24
Onset:2012-10-24
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:28
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11064 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US021584

Write-up: Case number PHEH2012US021584 is an initial spontaneous report received from a nurse on 24 Oct 2012 with a follow up information received on 24 Oct 2012. This report refers to an 11-years-old female patient. She was given only Men CYW lyophilized conjugate component of MENVEO (batch number: M11064, expiry date: Dec 2013) intramuscularly on 24 Oct 2012. No adverse event was reported following this administration error (Inappropriate preparation of medication). Follow up information received on 24 Oct 2012: Expiry date of vaccine administered.


VAERS ID: 639636 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-09-04
Onset:2012-09-04
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:78
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11053 / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018695

Write-up: Case number PHEH2012US018695 is an initial spontaneous report received from a health care professional on 05 Sep 2012 and a follow up received on 16 Oct 2012: This report refers to a male child. He was vaccinated with MENVEO (batch number: M11053 and expiry date: 28 Feb 2014) intramuscularly into his left arm on 04 Sep 2012. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. It was reported that vaccine was stable and okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up information received from a healthcare professional on 16 Oct 2012: Updated route and site of vaccination, and the reporter''s comment on administered MENVEO vaccine.


VAERS ID: 639642 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-06
Onset:2012-08-06
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:16
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11051 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US015768

Write-up: Case number PHEH2012US015768 is an initial spontaneous report received from a nurse on 06 Aug 2012. This case refers to an 11-year-old female patient. On 06 Aug 2012, she was vaccinated intramuscularly only with MenA lyophilized conjugate component of MENVEO (batch number: A11051) reconstituted with a sterile water; she did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. No adverse event has occurred following maladministration error.


VAERS ID: 639645 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-06-25
Onset:0000-00-00
Submitted: 2012-08-22
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11071 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: PHEH2012US013092

Write-up: Case number PHEH2012US013092 is an initial spontaneous report received form a nurse on 28 Jun 2012: This case refers to 11-years-old male patient. He was vaccinated with MENVEO (batch number: A11071 and expiry date: Dec 2013), at dose 0.5 ml intramuscularly on 25 Jun 2012. On unspecified date after vaccination, he experienced localized reactions at injection site as red swollen, hard and hot. The outcome and causality of the events was not reported.


VAERS ID: 639647 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2012-06-29
Onset:2012-06-29
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:54
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10133 / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US015690

Write-up: Case number PHEH2012US015690 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M10133) without being reconstituted with Men A component of MENVEO on 29 Jun 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.


VAERS ID: 639655 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2012-07-05
Onset:2012-07-05
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:48
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11033 / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US015692

Write-up: Case number PHEH2012US015692 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 05 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.


VAERS ID: 639656 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-07-16
Onset:2012-07-19
   Days after vaccination:3
Submitted: 2012-08-22
   Days after onset:34
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11033 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US014340

Write-up: Case number PHEH2012US014340 is an initial spontaneous report received from a medical assistant on 19 Jul 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he was vaccinated intramuscularly only with the MenCYW-135 component of MENVEO (batch number: M11033) on 19 Jul 2012 and did not receive the Men A lyophilized component. No adverse event was reported following the medication error.


VAERS ID: 639657 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2012-07-05
Onset:2012-07-05
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:48
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11033 / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US015693

Write-up: Case number PHEH2012US015693 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 05 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.


VAERS ID: 639658 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-11-27
Onset:2012-11-27
   Days after vaccination:0
Submitted: 2013-02-21
   Days after onset:86
Entered: 2016-06-16
   Days after submission:1210
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12009 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US024671

Write-up: Case number PHEH2012US024671 is an initial spontaneous report received from a nurse on 10 Dec 2012: This case refers to an 11-years-old male patient. He was vaccinated with MENVEO (batch number: M12009 and expiry date: Feb 2014), at dose of 0.5 ml intramuscularly on 27 Nov 2012. The MENVEO had experienced multiple temperature excursions. On 15 Nov 2012, the temperature reading of 34 F for unknown time, on 19 Nov 2012 and 26 Nov 2012, the temperature reading of 32 F for unknown time and reporter stated that, at 09:00am the temperature reading was 36 F respectively. Reporter stated that, she does not know if the vaccine was frozen at any time. No adverse reaction reported following this administration error (incorrect storage of drug).


VAERS ID: 639663 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-04
Onset:2012-10-04
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:48
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10130 / - UN / SYR

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US020068

Write-up: Case number PHEH2012US020068, is an initial spontaneous report received from a medical assistant on 04 Oct 2012. This report refers to 11 year old female patient. She was vaccinated only with the CWY-135 liquid component of MENVEO (batch number: X10130), intramuscular on 04 Oct 2012. No adverse event was reported following this administration error.


VAERS ID: 639668 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-31
Onset:2012-08-31
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:82
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018687

Write-up: Case number PHEH2012US018687 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with the follow-up received on 16 Oct 2012: This report refers to an 11-year female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the left arm on 31 Aug 2012 at 09:58 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination and time of vaccination.


VAERS ID: 639672 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-07-13
Onset:2012-07-14
   Days after vaccination:1
Submitted: 2012-11-21
   Days after onset:130
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10135 / - AR / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - AR / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US016490

Write-up: Case number PHEH2012US016490 is an initial spontaneous report received from a medical assistant on 20 Aug 2012 with a follow up information received on 04 Sep 2012: This report refers to 11-year-old male patient whose current condition included Penicillin allergy. He was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) along with BOOSTRIX (manufacturer and batch number: unknown) intramuscularly in same arm on 13 Jul 2012. On 14 Jul 2012 he experienced symptoms of swelling which was greater than 10 cm, redness, tenderness and warmth at vaccination site. The final outcome of the events was reported as complete recovery with a stop date of 16 Jul 2012. No further information about the seriousness and causality of the event was reported. Follow up information received on 04 Sep 2012: Patient demographics (height and weight), current condition, batch number, event (tenderness), event stop date and outcome updated.


VAERS ID: 639684 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-25
Onset:0000-00-00
Submitted: 2012-11-21
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US017337

Write-up: Case number PHEH2012US017337 is an initial spontaneous report received from a nurse on 28 Aug 2012 with a follow up information received on 28 Aug 2012. This report refers to an 11-year-old female patient. The patient was vaccinated with MENVEO (batch number: M11082, expiry date: May 2014) 0.5 ml intramuscularly on 25 Aug 2012. On unknown date, the patient experienced tenderness, warmth and redness and swelling of 3 inches diameter at the injection site. The patient recovered from the events on 28 Aug 2012. Follow up information received on 28 Aug 2012: Reporter information updated.


VAERS ID: 639695 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-05
Onset:2012-10-05
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:47
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11050 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US020830

Write-up: Case number PHEH2012US020830 is an initial spontaneous report received from a physician on 11 Oct 2012. This case refers to an 11-year-old female patient. She was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: M11050) intramuscularly on 04 Oct 2012. She did not receive MenA lyophilized conjugate component of MENVEO. No adverse event was reported follow this drug administration error. No other information was available.


VAERS ID: 639697 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-06-15
Onset:0000-00-00
Submitted: 2012-08-22
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11071 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US012272

Write-up: Case number PHEH2012US012272 is an initial spontaneous report received from a nurse via sales representative on 19 Jun 2012 with a follow-up received on 10 Jul 2012: This report refers to a male child. His medical history included unspecified allergies. He was vaccinated with a dose of MENVEO (batch number: M11071 and A11071, expiry date: Dec 2013) intramuscularly on 15 Jun 2012. On an unspecified date, the patient experienced red firm swelling and itching on injection site. The patient was treated with AUGMENTIN. The outcome of the event was not reported and the causality was not assessed. Follow-up received from the nurse on 10 Jul 2012: Updated patient demographics, medical history and route and date of vaccination with MENVEO.


VAERS ID: 639699 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-06-25
Onset:0000-00-00
Submitted: 2012-08-22
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11071 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: PHEH2012US013093

Write-up: Case number PHEH2012US013093 is an initial spontaneous report received from a nurse on 28 Jun 2012: This case refers to 12-years-old male patient. He was vaccinated with MENVEO (batch number: A11071 and expiry date: Dec 2013), at dose 0.5 ml intramuscularly on 25 Jun 2012. On unspecified date after vaccination, he experienced localized reactions at injection site as red swollen, hard and hot. The outcome and causality of the events was not reported.


VAERS ID: 639700 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-06-22
Onset:2012-06-23
   Days after vaccination:1
Submitted: 2012-08-22
   Days after onset:60
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - AR / SC
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10134A / - AR / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US013201

Write-up: Case number PHEH2012US013201 is an initial spontaneous report received from a health care professional on 28 Jun 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M10134A) intramuscularly and GARDASIL (other manufacturer, batch number: not reported) through unspecified route in the same arm on 22 Jun 2012. On 23 Jun 2012 he developed redness and blisters at the vaccination site. It was reported that the symptoms were improved on an unspecified date. The final outcome was unknown. No further information was provided.


VAERS ID: 639733 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-03-27
Onset:2012-03-27
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:57
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11053 / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US007087

Write-up: Case number PHEH2012US007087, is an initial spontaneous report received from medical assistant on 28 Mar 2012 with a follow up received on 16 Apr 2012: This case refers 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were unspecified. He was received only partial dose of Men A lyophilized conjugate component of MENVEO (batch number: M11053) intramuscularly on to right arm on 27 Mar 2012, which did not reconstituted well with Men C, Y, W-135 liquid conjugate component and half of powder stuck to the bottom of the vial. No adverse reaction had occurred following this administration error. No other information was provided. Follow up received on 16 Apr 2012: Patient demographics updated (height and weight) and site of vaccine administration.


VAERS ID: 639734 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-03-22
Onset:2012-03-22
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:62
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Product reconstitution issue
SMQs:, Medication errors (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US007096

Write-up: Case number PHEH2012US007096 is an initial spontaneous report received from a nurse on 22 Mar 2012 with the follow-up received on 30 Apr 2012. This report refers to an 11-years-old female patient. Her medical history, past drugs, current conditions and concomitant medications was unspecified. It was reported that this patient received only the MenCWY-135 liquid component of MENVEO (batch number: not specified) intramuscularly on to unspecified site without reconstituting the Men A lyophilized conjugate vaccine component on 22 Mar 2012. The patient will return to clinic to receive full-dose of MENVEO. No adverse event was reported following this drug administration error. Follow-up received from nurse on 30 Apr 2012: Updated patient demographics (age, gender, date of birth, height and weight).


VAERS ID: 639739 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-04-10
Onset:2012-04-10
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:43
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10042 / 1 UN / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US008036

Write-up: Case number PHEH2012US008036 is an initial spontaneous report received from a nurse on 10 Apr 2012: This case refers to an 11-years-old female patient. Previously she was vaccinated with first dose of MENVEO (batch number: unknown) intramuscularly on 13 Oct 2011. She was also vaccinated with second dose of MENVEO (batch number: A10042) subcutaneously instead of intramuscularly on 10 Apr 2012. No adverse event was occurred following this administration error.


VAERS ID: 639748 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-31
Onset:2012-08-31
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:82
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AJ2108 / - - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018681

Write-up: Case number PHEH2012US018681 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the left arm on 31 Aug 2012 at 13:41 pm. She was also vaccinated with FLUMIST (other manufacture) on 31 Aug 2012. These vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error. Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.


VAERS ID: 639750 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-07-09
Onset:2012-07-09
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:44
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11071 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US013858

Write-up: Case number PHEH2012US013858 is an initial spontaneous report received from a nurse on 09 Jul 2012. This case refers to 11-year-old male patient. He was vaccinated with MenA lyophilized conjugate component of MENVEO (batch number: A11071) mixed with sterile water on 09 Jul 2012. He did not receive MENCYW-135 liquid conjugate vaccine component of MENVEO. No adverse event was reported following vaccination.


VAERS ID: 639751 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-11-18
Onset:2011-11-18
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:277
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10029 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US012262

Write-up: Case number PHEH2012US012262 is a combined initial spontaneous report received from a physician on 14 Jun 2012 with a follow up information received on 20 Jun 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 18 Nov 2011, he was vaccinated intramuscularly on to unspecified site with MENVEO (batch number: A10029) that was reconstituted and stored in the refrigerator for three to five days. No adverse event was reported following the medication error.


VAERS ID: 639754 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-05-15
Onset:2012-05-15
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:8
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10053 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US010286

Write-up: Case number PHEH2012US010286 is an initial spontaneous report received from medical assistant on 15 May 2012: This report refers to an 11-year-old male patient. He was given only the CYW-135 liquid component of MENVEO (batch number: X10053) intramuscularly on 15 May 2012. No other adverse reaction was reported following this administration error.


VAERS ID: 639756 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-05-04
Onset:2012-05-04
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:110
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10135B / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US009550

Write-up: Case number PHEH2012US009550 is an initial spontaneous report received from a health care professional on 04 May 2012 with a follow up information received on 21 May 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 04 May 2012, he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10135B) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported. He was scheduled for correct dose at next visit. Follow up information received on 21 May 2012: Patient demographics updated (age, date of birth, height and weight).


VAERS ID: 639761 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-06-18
Onset:2012-06-18
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:65
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10130 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US012493

Write-up: Case number PHEH2012US012493 is an initial spontaneous report received from a medical assistant on 19 Jun 2012: This case refers to 11-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10130), intramuscularly, without being reconstituted with Men A component on 18 Jun 2012. No adverse reaction occurred following this administration error.


VAERS ID: 639789 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-04-27
Onset:2012-04-27
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:117
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11053 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US009470

Write-up: Case number PHEH2012US009470 is an initial spontaneous report received from a nurse on 02 May 2012 with the follow-up received from a physician on 21 May 2012. This report refers to 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 27 Apr 2012 he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: A11053) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported following this administration error. The causality was reported as not suspected. Follow-up received from a physician on 21 May 2012: Updated patient demographics (age, height and weight) and causality (not suspected).


VAERS ID: 639796 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-04-17
Onset:2012-04-17
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:36
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10132 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US008746

Write-up: Case number PHEH2012US008746 is an initial spontaneous report received from a health care professional on 19 Apr 2012 with a follow up report received on 01 May 2012. This report refers to an 11-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 17 Apr 2012 she received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10132) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported. Follow up received on 01 May 2012: Patient demographics updated (age, height and weight).


VAERS ID: 639806 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-06-05
Onset:2012-06-05
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:78
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11053 / - AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site extravasation, No adverse event, Underdose
SMQs:, Extravasation events (injections, infusions and implants) (narrow), Medication errors (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US011418

Write-up: Case number PHEH2012US011418 is an initial spontaneous report received from a nurse on 05 Jun 2012: This case refers to 11-years-old female patient. She was vaccinated with MENVEO (batch number: M11053) at dose of 0.5 ml intramuscularly on 05 Jun 2012. But vaccine came out of the vaccination site during the injection resulting in less than 0.5 ml entering to the patient''s deltoid muscle. No adverse event was reported following this administration error.


VAERS ID: 639807 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-04-18
Onset:2012-04-18
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:35
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11032 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US008927

Write-up: Case number PHEH2012US008927 is an initial spontaneous report received from a consumer on 24 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 18 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: A11032) intramuscularly on to unspecified site and did not receive the MenCYW-135 liquid conjugate. No adverse reaction was reported following the maladministration.


VAERS ID: 639823 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-02-15
Onset:0000-00-00
Submitted: 2012-05-23
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 114030AA / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US004170

Write-up: Case number PHEH2012US004170 is an initial spontaneous report received from nurse on 16 Feb 2012 with a follow up received on 07 Mar 2012. This report refers to 11 years old male patient with a follow up received on 12 Mar 2012. The patient was vaccinated with MENVEO (batch number: 114030AA) intramuscularly on to right deltoid on 15 Feb 2012. The nurse stated that the patient received less than 0.5 ml of MENVEO. During administration, the patient squirmed and only part of the vaccine entered into patient''s arm. The patient received a redoes on 06 Mar 2012. In the follow up information it was reported that no adverse events were noted following administration error. Follow up received on 07 Mar 2012: Updated revaccination status of patient. Event recoded to vaccine underdose. Follow up received on 12 Mar 2012: Batch no and site of administration of vaccine updated, patient demographics updated, event recoded to drug administration error as the patient received a redose of MENVEO.


VAERS ID: 639839 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-04-18
Onset:2012-04-18
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:35
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10133 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US009829

Write-up: Case number PHEH2012US009829 is an initial spontaneous report received from a medical assistant on 08 May 2012: This report refers to an 11-year-old male patient. He was given only the CYW-15 liquid component of MENVEO (batch number: X10133) intramuscularly on 18 Apr 2012. No adverse event was reported following this administration error.


VAERS ID: 639843 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-03-16
Onset:2012-03-16
   Days after vaccination:0
Submitted: 2012-05-23
   Days after onset:68
Entered: 2016-06-16
   Days after submission:1485
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US006459

Write-up: Case number PHEH2012US006459 is an initial spontaneous report received from a pharmacist on 16 Mar 2012: This report refers to 11-year-old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on 16 Mar 2012. No other adverse reaction was reported.


VAERS ID: 639975 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-12-20
Onset:2012-12-20
   Days after vaccination:0
Submitted: 2013-02-21
   Days after onset:63
Entered: 2016-06-16
   Days after submission:1210
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11081 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US025324

Write-up: Case number PHEH2012US025324 is an initial spontaneous report received from a nurse on 21 Dec 2012: This report refers to an 11-year-old male child. He was vaccinated with two doses of MENVEO (batch number: M11081) intramuscularly on 11 Dec 2012 and 20 Dec 2012. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).


VAERS ID: 639977 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-01-24
Onset:2013-01-24
   Days after vaccination:0
Submitted: 2013-02-21
   Days after onset:28
Entered: 2016-06-16
   Days after submission:1210
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11077 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2013US003319

Write-up: Case number PHEH2013US003319 is an initial spontaneous report received from a nurse on 07 Feb 2013. This report refers to an 11-years-old male patient. It was reported that he received only MenCYW-135 liquid component of MENVEO (batch number: M11077) intramuscularly on 24 Jan 2013 and did not receive MenA lyophilized conjugate. No adverse reactions were reported following the maladministration.


VAERS ID: 640002 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-11-19
Onset:2012-11-19
   Days after vaccination:0
Submitted: 2013-02-21
   Days after onset:94
Entered: 2016-06-16
   Days after submission:1210
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A11051 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US023201

Write-up: Case number PHEH2012US023201 is an initial spontaneous report received from a medical assistant on 21 Nov 2012 with the follow-up received on 21 Nov 2012: This case refers to an 11-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A11051 and expiry date: 01 Apr 2014), intramuscularly without being reconstituted with Men A component on 19 Nov 2012. No adverse reaction reported following this administration error. Follow-up received on 21 Nov 2012; Updated vaccine expiry date (01 Apr 2014).


VAERS ID: 640003 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-09-13
Onset:2012-09-13
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:69
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X110077 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018215

Write-up: Case number PHEH2012US018215 is an initial spontaneous report received from a nurse on 13 Sep 2012. This report refers to an 11-years-old male patient whose medical history and concomitant medications were not reported. It was reported that he only received the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number X110077) intramuscularly and did not receive Men A lyophilized conjugate vaccine component on 13 Sep 2012. No adverse reaction was reported.


VAERS ID: 640017 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-09-04
Onset:2012-09-04
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:78
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10033 / - UN / SYR
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018882

Write-up: Case number PHEH2012US018882 is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to a male patient whose medical history, past drugs, current conditions and concomitant medications were not repotted. It was reported that he received a dose of MenA lyophilized conjugate vaccine component of MENVEO (batch number: A10033, expiry date: Sep 2012) reconstituted with MENACTRA on 04 Sep 2012. No adverse reaction was reported.


VAERS ID: 640020 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-08-22
Onset:2012-08-22
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:91
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10075 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US016632

Write-up: Case number PHEH2012US016632 is an initial spontaneous report received from a nurse on 22 Aug 2012: This report refers to an 11-year-old male child. He was given only the CYW-135 liquid component of MENVEO (batch number: M10075) intramuscularly on 22 Aug 2012. No other adverse reaction was reported following this administration error.


VAERS ID: 640031 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-31
Onset:2012-08-31
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:82
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4531AA / - UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B085BA / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Asthma; Gastrooesophageal reflux disease
Preexisting Conditions: 03/20/2012, Appendicitis
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018699

Write-up: Case number PHEH2012US018699 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with a follow up received on 16 Oct 2012: This report refers to a 11 year old female child. Her medical history included asthma, gastrooesophageal reflux disease and appendicitis on 20 Mar 2012. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) into the right arm, intramuscular, on 31 Aug 2012 at 10 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. Vaccine was stable and okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up received on 16 Oct 2012: Updated patient details, vaccination site, medical history and concomitant medications.


VAERS ID: 640034 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-09-04
Onset:2012-09-04
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:78
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB646AA / - UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B085BA / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018686

Write-up: Case number PHEH2012US018686 is an initial spontaneous report received from a health care professional on 05 Sep 2012: This report refers to an 11-year-old female child. Her medical history included of asthma. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in right arm on 04 Sep 2012. Concomitantly she was also vaccinated with Hepatitis A vaccine (manufacturer: not reported, batch number: AHAVB646AA) and Tdap (other manufacturer, batch number: AC52B085BA) intramuscularly on 04 Sep 2012. It was reported that MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. It was reported that vaccine was stable and was okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up information received from the healthcare professional on 16 Oct 2012: Updated site of vaccination of MENVEO, concomitant vaccines administered and medical history.


VAERS ID: 640035 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-09-04
Onset:2012-09-04
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:78
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B085BA / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018685

Write-up: Case number PHEH2012US018685 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the right arm on 04 Sep 2012 at 15:00 pm. Concomitantly, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B085BA) intramuscularly on 04 Sep 2012. The MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.


VAERS ID: 640036 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-08-31
Onset:2012-08-31
   Days after vaccination:0
Submitted: 2012-11-21
   Days after onset:82
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B085BA / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Drug hypersensitivity, Allergic to Amox and OMNICEF
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018683

Write-up: Case number PHEH2012US018683 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. Her medical history included allergic to Amox and OMNICEF. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the right arm on 31 Aug 2012 at 15:15 pm. Concomitantly, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B085BA) intramuscularly on 31 Aug 2012. The MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, medical history, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.


VAERS ID: 640037 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-16
Onset:2012-10-18
   Days after vaccination:2
Submitted: 2012-11-21
   Days after onset:34
Entered: 2016-06-16
   Days after submission:1302
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12013 / - RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US021289

Write-up: Case number PHEH2012US021289 is an initial spontaneous report received from a nurse on 19 Oct 2012 with a follow up information received on 19 Oct 2012. This report refers to an 11-years-old female patient. She was vaccinated with MENVEO (batch number: M12013, expiry date: Feb 2014) intramuscularly on to right arm on 16 Oct 2012. It was reported that she was presented to the clinic with a raised swollen, sore, reddened area on her right arm around the vaccination site that measures 12 cm by 15 cm on 18 Oct 2012. The physician prescribed her topical hydrocortisone and KEFLEX. The outcome of the event was reported as condition unchanged. No further information was available. Follow up information received on 19 Oct 2012: Expiry date of vaccine updated.


VAERS ID: 640048 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-05-20
Onset:2016-05-20
   Days after vaccination:0
Submitted: 2016-05-20
   Days after onset:0
Entered: 2016-06-16
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L040458 / 2 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 1 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L027591 / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Electrocardiogram normal, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: EKG done after fainting, Normal
CDC Split Type: NYC1600006

Write-up: Less than 1 minute after receiving vaccines, RECOMBIVAX HB, MMR and GARDASIL 9, pt fainted. Cardiac - Vasovagal.


VAERS ID: 640056 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-07-27
Onset:2012-07-27
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:26
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X11046 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US014989

Write-up: Case number PHEH2012US014989 is an initial spontaneous report received from a nurse on 27 Jul 2012: This report refers to an 11-year-old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11046) intramuscularly on 27 Jul 2012. No other adverse reaction was reported following this administration error.


VAERS ID: 640069 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-07-12
Onset:2012-07-13
   Days after vaccination:1
Submitted: 2012-08-22
   Days after onset:40
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / SYR
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11053 / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Joint swelling, Peripheral swelling, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US014130

Write-up: Case number PHEH2012US014130 is an initial spontaneous report received from a physician on 17 Jul 2012 along with a follow-up received on 08 Aug 2012: This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11053 and expiry date: Feb 2014) intramuscularly on to right arm along with GARDASIL (other manufacturer, batch number: 0555AE) on 12 Jul 2012. It was reported that he experienced swelling to the elbow and up through the shoulder and to the nipple on the chest on 13 Jul 2012. He was seen by physician on 16 Jul 2012 and was prescribed antibiotics (unspecified). The outcome of the event was reported as complete recovery of the patient. The causality was not assessed. No further information was available. Follow-up received from the physician on 08 Aug 2012: Updated suspect product information for GARDASIL, expiry date of MENVEO and outcome.


VAERS ID: 640075 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-06-29
Onset:2012-06-29
   Days after vaccination:0
Submitted: 2012-08-22
   Days after onset:54
Entered: 2016-06-16
   Days after submission:1394
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X11075 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US013369

Write-up: Case number PHEH2012US013369 is an initial spontaneous report received from a medical assistant on 02 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11075) intramuscularly on to unspecified site and did not receive MenA lyophilized conjugate on 29 Jun 2012. No adverse event was reported following the maladministration.


VAERS ID: 640386 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2016-06-16
Onset:2016-06-16
   Days after vaccination:0
Submitted: 2016-06-16
   Days after onset:0
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L037554 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A15078 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS B4SD9 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abdominal pain upper, Mydriasis, Pallor, Tremor, Unresponsive to stimuli
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: While pt was walking out of clinic after receiving the 3 vaccines below, mother stated pt was pale, requested to sit down, and while sitting up pt began shaking uncontrollably (mother stated not violently), pupils were dilated, pt unresponsive to mother calling his name. This episode lasted about 30 seconds. Nurse was called afterwards, pt c/o stomach hurting but feeling fine, juice/granola bar given, VS WNL, pt''s color returned to normal, pt aware of surroundings able to verbalize needs. UC/ER precautions given.


VAERS ID: 640521 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2016-06-14
Onset:0000-00-00
Submitted: 2016-06-14
Entered: 2016-06-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L037554 / - RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR M15097 / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 54LS7 / - RA / IM

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

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

Write-up: Dizziness, pallor and brief LOC for 20 seconds.


VAERS ID: 640767 (history)  
Age: 11.0  
Gender: Female  
Location: Nevada  
Vaccinated:2016-06-13
Onset:2016-06-15
   Days after vaccination:2
Submitted: 2016-06-16
   Days after onset:1
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z3X9 / - RA / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR L1597-1 / - LA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L035674 / - RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M003439 / - LA / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Eye redness/drainage; nasal drainage; mild fever; cough; headache
Preexisting Conditions:
Diagnostic Lab Data: Allergic reaction to vaccine, cellulitis
CDC Split Type:

Write-up: Red swollen area upper Left arm. Clindamycin, Diphenhydramine, Ibuprofen given.


VAERS ID: 639863 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-03-04
Onset:2011-03-04
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:87
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10030 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US19886

Write-up: Initial report received from a nurse on 10 Mar 2011: This patient was vaccinated with MENVEO (batch number X10030) on 04 Mar 2011. The patient was inadvertently administered 0.5 ml IM dose of only the MenCWY liquid conjugate component of 04 Mar 2011. No adverse event was reported since administration.


VAERS ID: 639867 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-03-18
Onset:2011-03-18
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:74
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M100031 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US22901

Write-up: Initial report received from a health care professional (nurse) on 18 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: M100031) 0.5 ml dose intramuscularly on 18Mar 2011. The patient received only the Men conjugate component of MENVEO that was reconstituted with another diluent. No adverse events were noted following this medication error.


VAERS ID: 639871 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-03-29
Onset:2011-03-29
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:63
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 1000022 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US26134

Write-up: Case number PHHY2011US26134 is an initial spontaneous report received from a nurse on 29 Mar 2011. This report refers to 11 years old female patient. She was vaccinated with MENVEO vaccine (batch number 100022) on 20 Mar 2011. The vaccine was given intramuscularly. She did not receive the MenA lyophilized conjugate component of MENVEO vaccine. No other adverse reaction was reported. The final outcome of the event was not reported. Follow-up report received from a nurse on 12 Apr 2011: The patient did not present any adverse event.


VAERS ID: 639889 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2010-08-13
Onset:2010-08-13
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:19
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 0900901 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US54226

Write-up: Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.


VAERS ID: 639909 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-03-09
Onset:2012-03-10
   Days after vaccination:1
Submitted: 2012-05-23
   Days after onset:73
Entered: 2016-06-17
   Days after submission:1486
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10126 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Injection site erythema, Local swelling, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US006671

Write-up: Case number PHEH2012US006671 is an initial spontaneous report received from a physician on 20 Mar 2012. This case refers to an 11-year-old male patient. He was vaccinated with MENVEO vaccine (batch number: A10126) intramuscularly on 09 Mar 2012. On 10 Mar 2012, he developed fever, dizziness and vomited once. He was seen in the doctor''s office on 12 Mar 2012. On examination he was found to have local swelling and erythema at the site of injection at the left deltoid. He had these symptoms over 2-3 days. He had recovered slowly on 13 Mar 2012. The causality was not reported. No other information was available.


VAERS ID: 639912 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-04-29
Onset:0000-00-00
Submitted: 2012-05-23
Entered: 2016-06-17
   Days after submission:1486
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US037523

Write-up: Case number PHHY2012US037523 is an initial spontaneous report received from a physician on 30 Apr 2012. This report refers to an 11-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that she received inadvertently two doses of MENVEO (batch number: not reported) intramuscularly on to unspecified site about one month apart on 06 Apr 2012 and 29 Apr 2012. No adverse reaction was reported following the maladministration.


VAERS ID: 639934 (history)  
Age: 11.0  
Gender: Male  
Location: Colorado  
Vaccinated:2016-06-16
Onset:2016-06-16
   Days after vaccination:0
Submitted: 2016-06-17
   Days after onset:1
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L037554 / - - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5187AA / - - / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 943Z5 / - - / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Induration, Mass, 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)

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: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Redness, swelling, hard lump on left arm.


VAERS ID: 639943 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-02-07
Onset:2011-02-07
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:112
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A100028 / - AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US13133

Write-up: Initial report received from a nurse on 16 Feb 2011: This patient was vaccinated with MENVEO (batch number A100028) 0.5 ml dose, intramuscularly on 07 Feb 2011. The patient received MENVEO lyophilized powder reconstituted with saline instead of liquid conjugate component 07 Feb 2011. No other information reported. Follow- up report received from a nurse on 08 Mar 2011: Patient demographic updated. This patient was vaccinated with MENVEO into deltoid.


VAERS ID: 640060 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2010-07-21
Onset:2010-07-21
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:42
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 091101 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US50129

Write-up: Initial report received from the health care professional (nurse) on 21 Jul 2010: On 21 Jul 2010, this child was vaccinated with an intramuscular injection of only the MenCWY conjugate of MENVEO (batch number: 091101), (dose: unknown) without being reconstituted with the MenA component. No adverse effects were noted following this administration.


VAERS ID: 640061 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-06-20
Onset:0000-00-00
Submitted: 2010-09-01
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 090901 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US41451

Write-up: Initial report received from a health care professional (medical assistant) on 23 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: 0.5 ml) intramuscularly on 20 Jun 2010. The lyophilized portion was not reconstituted. The patient had not yet received additional dosing with MENVEO. No adverse event was reported following this administration.


VAERS ID: 640073 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-07-21
Onset:2010-07-21
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:42
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 091101 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US50247

Write-up: Initial report received from a health care professional (medical assistant) on 21 Jul 2010: This child was vaccinated with only the MenCWY conjugate of MENVEO (batch number: 091101), (dose: unknown) intramuscularly, without being reconstituted with the MenA component. No adverse effects were noted following this administration.


VAERS ID: 640077 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2016-06-14
Onset:2016-06-15
   Days after vaccination:1
Submitted: 2016-06-17
   Days after onset:2
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5187AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5263AA / 0 LA / IM

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

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

Write-up: Redness on left arm, 7.5 cm slightly warm circular nodule, no streaking, no pus, little itching.


VAERS ID: 640083 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2016-06-06
Onset:2016-06-16
   Days after vaccination:10
Submitted: 2016-06-17
   Days after onset:1
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M003659 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood glucose increased, Glucose urine present, Pollakiuria, Type 1 diabetes mellitus, Urine analysis abnormal, Urine ketone body present
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High cholesterol; Family Hx: Diabetes and high cholesterol
Diagnostic Lab Data: Urine test on 6/16/16 showed ketones and glucose; Finger stick glucose was 339 in the office
CDC Split Type:

Write-up: HPV vaccine was received in April and June, and she was seen in our office on June 16th for frequent urination. Tests performed in the office indicate new onset Type 1 Diabetes.


VAERS ID: 640091 (history)  
Age: 11.0  
Gender: Unknown  
Location: Texas  
Vaccinated:2016-06-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5187AA / 0 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS U5278AA / 0 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site urticaria, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No known
Diagnostic Lab Data: Allergy or adverse reaction to the vaccine
CDC Split Type:

Write-up: Had a wheal raised 10 x 14 cm on the right upper arm, no fluctuance/no tender. Today was sent with hydroxyzine and hydrocortisone . Advised mother that if still worsening need to return to the clinic or ER. Warm compress. FU 3 days.


VAERS ID: 640102 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-02-21
Onset:2011-02-21
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:98
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 024011 / - UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC5B048AC / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US31279

Write-up: Case number PHHY2011US31279 is an initial spontaneous report received from a nurse on 12 Apr 2011 with a follow up report from nurse on 03 May 2011. This report concerns an 11-year-old girl. She was vaccinated with MENVEO (batch number: 024011) 0.5 ml, intramuscularly on 21 Feb 2011. She concomitantly received BOOSTRIX (batch number: AC5B048AC) on 21 Feb 2011. She received only the Men CYW-135 liquid conjugate vaccine component of the vaccine and did not receive the Men A lyophilized conjugate component. No adverse event was reported following this drug administration error. Non significant follow up report was received on 12 Apr 2011: No new information was provided. Follow up information received on 03 May 2011: Patient demographics, vaccination details and concomitant vaccine updated.


VAERS ID: 640103 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-06-23
Onset:0000-00-00
Submitted: 2010-09-01
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 100002 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US42086

Write-up: Initial report received from a health care professional on 25 Jun 2010: This patient was vaccinated with only the liquid conjugate of MENVEO (batch number 090901), (dose: unknown) intramuscularly on an unspecified date. No adverse reaction had occurred following this administration. Follow up report received from a physician on 07 Jul 2010: The patient was vaccinated on 23 Jun 2010 and the batch number for MENVEO was reported as 100002.


VAERS ID: 640105 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-05-28
Onset:2010-05-28
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:96
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 100001 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US35401

Write-up: Initial report received from a health care professional (medical assistant) on 28 May 2010: This patient was vaccinated with MENVEO (batch number: 100001), (dose: unknown) intramuscularly on 28 May 2010, instead of combining the diluent component of MENVEO with the lyophilized component, the patient received only the diluent component of MENVEO. No adverse effects were noted after this administration.


VAERS ID: 640116 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-07-19
Onset:2010-07-19
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:44
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 100001 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US48102

Write-up: Initial report received from a health care professional (nurse) on 20 Jul 2010: On 19 Jul 2010, this child received 0.5 ml intramuscular dose of only the MenCWY component of MENVEO (batch number: 100001), instead of being reconstituted with the MenA lyophilized component. No adverse events were noted following this administration. Follow up report received from the health care professional (nurse) on 27 Jul 2010: The doctor''s office did not consider this incidence to be an adverse event and did not wish to provide any further information.


VAERS ID: 640117 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2010-06-14
Onset:2010-06-14
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:79
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 091001 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US39107

Write-up: Initial report received from a healthcare professional on 14 Jun 2010: This patient was vaccinated with MENVEO (batch number: 091001) intramuscularly on an unspecified date. The patient was inadvertently administered only the MenCYW-135 liquid conjugate component of MENVEO. No adverse event had occurred following this administration. Follow up information report from nurse received on 20 Jul 2010: The patient demographics were updated. This patient was vaccinated with MENVEO on 14 Jun 2010. The patient received only liquid portion of vaccine and advised to return for to receive powder-A (lyophilized) component of vaccine. The outcome of event was reported completely recovered on 14 Jun 2010.


VAERS ID: 640122 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-03-30
Onset:2011-03-30
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:62
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 090901 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US29939

Write-up: Case number PHHY2011US29939 is an initial spontaneous report received from a nurse on 04 Apr 2011 with a follow up received from a nurse on 26 Apr 2011. This report refers to an 11 year old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number 090901) intramuscularly) on 30 Mar 2011. NO other adverse reaction was reported. It was reported that the immunization would be repeated in two years. Follow up received on 26 Apr 2011: Updated information about patient demographics, batch number and dosage of the vaccine was provided.


VAERS ID: 640126 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-07-02
Onset:0000-00-00
Submitted: 2010-09-01
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 027011 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US46197

Write-up: Initial report received from a health care professional (medical assistant) on 13 Jul 2010: This patient accidentally received a 0.5 ml intramuscular dose of MENVEO (batch no: 027011) that was reconstituted with sterile water instead of lyophilized component on 02 Jul 2010. No adverse events were noted following this administration.


VAERS ID: 640134 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2010-07-14
Onset:0000-00-00
Submitted: 2010-09-01
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 100005 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US47323

Write-up: Initial information received from a health care professional on 16 Jul 2010: This patient received the MENVEO (batch number 100005, expiry date unknown), intramuscular on 14 Jul 2010. The patient not received the lyophilized conjugate component of MENVEO. No other adverse event was reported. The outcome of the event was not reported.


VAERS ID: 640142 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-06-28
Onset:0000-00-00
Submitted: 2010-09-01
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 029011 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: No adverse event, Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOTRIMIN ULTRA
Current Illness: Keratosis pilaris
Preexisting Conditions: 09/18/2008, Vesicoureteric reflux
Diagnostic Lab Data:
CDC Split Type: PHHY2010US42405

Write-up: Initial report received from a health care professional on 28 Jun 2010: This patient was vaccinated with MENVEO (batch no: 100005 (box)), (dose: 0.5 ml) intramuscularly on 28 Jun 2010. The patient was administered lyophilized component of the vaccine with sterile water instead of liquid conjugate component of the vaccine. The patient had no adverse events. No further information was reported. Follow-up report received from a health care professional on 07 Jul 2010: Batch number of vaccine was reported as 029011 (previously reported as 100005). This patient had a medical history of vesicoureteral reflux and was concomitantly using LOTRIMIN ULTRA topically for keratosis pilaris since 02 Feb 2010. The reporter stated that the patient didn''t experience any adverse event after administration of lyophilized component of the vaccine with sterile water instead of liquid conjugate component of the vaccine. The patient will be revaccinated with MENVEO in 2 months.


VAERS ID: 640147 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-06-28
Onset:2010-06-28
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:65
Entered: 2016-06-17
   Days after submission:2116
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 100005 / - AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US45910

Write-up: Initial report received from a healthcare professional on 09 Jul 2010: This patient inadvertently received a intramuscular dose of the liquid component (only) on MENVEO (batch number: 1000005) instead of being reconstituted with the lyophilized component. No adverse effects were noted following this administration. MENVEO that was not reconstituted with powder before administration and the lyophilized portion was not administered. No re-vaccination performed. No adverse event had occurred. Follow up information report from healthcare professional received on 30 Jul 2010: The patient demographics were updated. The outcome of event was unknown.


VAERS ID: 640815 (history)  
Age: 11.0  
Gender: Male  
Location: Kansas  
Vaccinated:2016-06-08
Onset:2016-06-09
   Days after vaccination:1
Submitted: 2016-06-10
   Days after onset:1
Entered: 2016-06-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15077A / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonidine; FLOVENT; STRATTERA; albuterol
Current Illness: None
Preexisting Conditions: ADD; Anxiety; Asthma; ODD
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Significant local swelling right deltoid and upper arm - prednisone and BENADRYL.


VAERS ID: 640830 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-17
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epistaxis, Platelet count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Lab values from days preceding nosebleeds and platelet count looked good
CDC Split Type: WAES1606USA006705

Write-up: This spontaneous report as received from a physician refers to a 11 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL 9, intramuscularly. On an unknown date the patient experienced recurrent nose bleeding after being administered GARDASIL 9. It was not reported which number shot was administered in the series. The physician had lab values from days preceding nosebleeds and platelet count looked good (dates and labs were unspecified). The patient contacted doctors'' office to seek unspecified medical attention. The outcome of recurrent nose bleeding and the causality between recurrent nose bleeding and GARDASIL 9 were not reported. Additional information has been requested.


VAERS ID: 640064 (history)  
Age: 11.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2016-06-17
Onset:2016-06-18
   Days after vaccination:1
Submitted: 2016-06-20
   Days after onset:2
Entered: 2016-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5271AA / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain upper, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, fluoride, and MVI
Current Illness: None
Preexisting Conditions: Recent removal of fish hook from foot; 5 day course of antibiotics Keflex 6/7/16 to 6/12/16; history of eczema, psoriasis, and allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Stomachache, rash to torso and arms.


VAERS ID: 640098 (history)  
Age: 11.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2016-05-26
Onset:2016-05-26
   Days after vaccination:0
Submitted: 2016-06-20
   Days after onset:25
Entered: 2016-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS Z9Z4Y / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol sulfate 90 mcg, budesonide 0.5m, montelukast 10mg tablet.
Current Illness: No
Preexisting Conditions: Bipolar disorder, anxiety, asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had hives and difficult breathing after getting vaccine.


VAERS ID: 640178 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-06-08
Onset:2010-06-08
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:85
Entered: 2016-06-20
   Days after submission:2119
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 091001 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US37387

Write-up: Initial report received from a nurse on 08 Jun 2010: This patient was vaccinated with MENVEO (batch number: 091001) unknown dose, intramuscularly on 08 Jun 2010. The patient only administered the diluent portion of MENVEO, rather than being reconstituted with the lyophilized portion. No adverse event occurred.


VAERS ID: 640195 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-28
Onset:2011-04-28
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:33
Entered: 2016-06-20
   Days after submission:1847
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10028 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US37917

Write-up: Case number PHHY2011US37917 is an initial spontaneous report received from a vaccines sales specialist (non health care professional) on 03 May 2011. This report refers to an 11 years old female patient. She was given only the CYW-135 liquid component of MENVEO (batch number M10028) intramuscularly on 28 Apr 2011. A few hours later, she received the fully reconstituted dose of MENVEO. No other adverse reaction was reported.


VAERS ID: 640200 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2010-05-24
Onset:2010-05-24
   Days after vaccination:0
Submitted: 2010-09-01
   Days after onset:100
Entered: 2016-06-20
   Days after submission:2119
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 100001 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010US34400

Write-up: Initial report received from a health care professional on 26 May 2010: This patient was vaccinated with MENVEO (batch no: CWY lot: 091991, A lot: 100001), (dose: unknown) intramuscularly on 25 May 2010. The patient was administered only the diluent portion of the MENVEO. No adverse event had occurred due to this inadvertent administration. Follow up report received from a physician on 23 Jun 2010: The patient was vaccinated with MENVEO on 24 May 2010. The patient will return for full vaccination.


VAERS ID: 640206 (history)  
Age: 11.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2016-05-16
Onset:2016-05-17
   Days after vaccination:1
Submitted: 2016-06-20
   Days after onset:34
Entered: 2016-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L048459 / 3 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: methylphenidate 30 MG CR capsule; sertraline (ZOLOFT) 50 MG tablet; Pediatric Multivit-Minerals-C (CHILDRENS MULTIVITAMIN PO)
Current Illness: None
Preexisting Conditions: Amoxicillin allergy; Diagnosis: ADHD, anxiety
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Vomited twice the morning after getting vaccine.


VAERS ID: 640302 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-08-29
Onset:2012-08-30
   Days after vaccination:1
Submitted: 2012-11-21
   Days after onset:83
Entered: 2016-06-20
   Days after submission:1306
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M11082 / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Pulmonary congestion; Wheezing; Attention deficit/hyperactivity disorder; Rhinitis allergic; Migraine; Asthma; Sleep disorder; Oppositional defiant disorder
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US099188

Write-up: Case number PHHY2012US099188 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 463810) on 01 Nov 2012. This report refers to 11-year-old male patient. The patient''s medical history included chest congestion, wheezing, attention deficit hypersensitivity disorder, allergic rhinitis, migraines, mild persistent asthma, sleep disorder and oppositional disorder. The patient was vaccinated with MENVEO (batch number: M11082) intramuscularly in left arm on 29 Aug 2012. On 30 Aug 2012, after the vaccination, the patient experienced itching, redness, swelling, fever, hardness and pain at the injection site. The outcome of events was reported as condition unchanged as of 31 Aug 2012.


VAERS ID: 640330 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2012-06-11
Onset:2012-06-13
   Days after vaccination:2
Submitted: 2012-11-21
   Days after onset:161
Entered: 2016-06-20
   Days after submission:1306
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1441AA / - RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10132 / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B075BA / - LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: 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)

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: PHHY2012US076889

Write-up: Case number PHHY2012US076889 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 457438) on 05 Sep 2012. This case refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: A10132) intramuscularly into his left arm on 11 jun 2012. On the same day he was also vaccinated with ADACEL vaccine (batch number: AC52B075BA, other manufacturer) intramuscularly into his left arm and VAQTA (batch number, batch number: 1441AA, other manufacturer) intramuscularly into his right arm. On 13 Jun 2012, the patient developed swollen red left arm. It was reported that there was a concern for cellulitis but was not confirmed. The final outcome was reported as completely recovered on an unspecified date. No other information was available.


VAERS ID: 640267 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-03-30
Onset:2011-03-30
   Days after vaccination:0
Submitted: 2016-06-21
   Days after onset:1910
Entered: 2016-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1437Z / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain upper, Back pain, Chest pain, Chills, Confusional state, Cystitis, Dizziness, Fatigue, Headache, Hyperhidrosis, Hypoaesthesia, Insomnia, Mental disorder, Muscle spasms, Nausea, Night sweats, Palpitations, Paraesthesia, Personality change, Photophobia, Pruritus, Pyrexia, Vaccination complication, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 01/2011, Surgery, twisted and necrotic ovary; 01/2011, Ovarian necrosis, required surgery
Diagnostic Lab Data:
CDC Split Type: WAES1606USA009195

Write-up: Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician''s advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient''s symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient''s mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient''s first injection of GARDASIL on 30-MAR-2011. The patient''s conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.


VAERS ID: 640369 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2016-06-20
Onset:2016-06-20
   Days after vaccination:0
Submitted: 2016-06-21
   Days after onset:1
Entered: 2016-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M007728 / 0 RA / SYR
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15123 / 0 LA / SYR
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5316AA / 0 LA / SYR

Administered by: Private       Purchased by: Unknown
Symptoms: Chest pain, Dyspnoea, Panic attack, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Patient developed chest pains, shortness of breath with tingling to her extremities about one hour after injection. Seen at ER, diagnosed with panic attack.


VAERS ID: 640294 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2016-06-14
Onset:2016-06-16
   Days after vaccination:2
Submitted: 2016-06-22
   Days after onset:6
Entered: 2016-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 9X7LY / 0 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5260AA / 0 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 73D7R / 0 UN / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Cellulitis, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Increased swelling of arm. Diagnosed with cellulitis.


VAERS ID: 640348 (history)  
Age: 11.0  
Gender: Female  
Location: Georgia  
Vaccinated:2016-06-22
Onset:2016-06-22
   Days after vaccination:0
Submitted: 2016-06-22
   Days after onset:0
Entered: 2016-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A15097 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 54LS7 / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Dizziness, Fall, Slow response to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Patient received first Gardasil vaccine, Meningococcal and Tdap vaccines and stood up and told mother she felt dizzy; then fell to floor. She was placed in supine position. She was first slow to respond but then was oriented to her name, recognized her mother, and where she was located. VS on assessment was 110/80, HR 64 apical, respiration was even and unlabored. After several minutes, she was assisted to sitting position; was feeling less dizzy and given water to drink. She recovered more and then assisted to chair where she was now alert and oriented. She reported dizziness had subsided.


VAERS ID: 640637 (history)  
Age: 11.0  
Gender: Female  
Location: Illinois  
Vaccinated:2015-11-17
Onset:2015-11-19
   Days after vaccination:2
Submitted: 2016-06-24
   Days after onset:217
Entered: 2016-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. FJ2100 / - - / IN
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L007560 / - - / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Headache, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: None known
Preexisting Conditions: No known allergies; history negative for standard immunization screening questions.
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Headaches started 2 days after vaccines. A week later upon arising saw black spots, dizzy, could not see well. Laid down and symptoms resolved in one minute. Called ER and told to wait to see if symptoms reoccurred. Checked in with Dr''s. office. Currently has headache''s daily but only last about 5 minutes.


VAERS ID: 641323 (history)  
Age: 11.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2016-06-13
Onset:2016-06-14
   Days after vaccination:1
Submitted: 2016-06-20
   Days after onset:6
Entered: 2016-06-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15123 / 0 LA / IM

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

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

Write-up: Local inflammatory reaction consisting of redness/swelling/heat/induration measuring 11 x 12 cm over area of right deltoid/triceps.


VAERS ID: 641325 (history)  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2016-06-22
Onset:2016-06-23
   Days after vaccination:1
Submitted: 2016-06-24
   Days after onset:1
Entered: 2016-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M003011 / 0 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L043213 / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15097 / 0 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 74NT9 / 5 LA / UN

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

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

Write-up: 6/24 - Mom said (R) upper arm red and swollen, hard to touch. Mom drew a circle around the injection site - area larger. Advised per doctor to apply cool compress, give BENADRYL every 8 hours, site should improve over 48 hours/if red streak N/T seek emergent care.


VAERS ID: 641330 (history)  
Age: 11.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2016-06-23
Onset:2016-06-24
   Days after vaccination:1
Submitted: 2016-06-24
   Days after onset:0
Entered: 2016-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. M004116 / - LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15098 / - RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9Y57K / - LA / IM

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

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

Write-up: Redness (R) arm upon waking this morning. Pain and induration (L) arm, no fever.


VAERS ID: 641356 (history)  
Age: 11.0  
Gender: Female  
Location: Colorado  
Vaccinated:2016-06-15
Onset:2016-06-23
   Days after vaccination:8
Submitted: 2016-06-24
   Days after onset:1
Entered: 2016-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M011840 / 0 LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5259AA / - RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cellulitis
SMQs:

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

Write-up: Mild cellulitis at day 6-7 after administration of vaccine.


VAERS ID: 640703 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-27
Entered: 2016-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Blood pressure decreased, Injection site erythema, Injection site urticaria, Vaccination complication
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA12690

Write-up: Information has been received from the published literature article referring to a 11 year old male patient with no history of atopy. On an unknown date, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown), varicella virus vaccine live (manufacturer unknown), Tdap and meningococcal conj vaccine (unspecified) (dose, route and lot# were unknown). After vaccination (onset not documented), the patient experienced injection site urticaria and erythema and measured blood pressure decreased. The initial evaluation was performed in a clinic and the pediatrician provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with oral antihistamine. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.


VAERS ID: 640719 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-27
Entered: 2016-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Immediate post-injection reaction, Pruritus generalised, Rash generalised, Swelling, Tonsillitis, Urticaria, Vaccination complication
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis; Drug hypersensitivity; Asthma
Preexisting Conditions: Penicillin (unspecified), Drug hypersensitivity; fluconazole, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1606USA012692

Write-up: Information has been received from the published literature article referring to an 11 year old male patient with asthma and allergy to fluconazole and penicillins. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown), a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and a dose of meningococcal conj vaccine (unspecified) (dose, route and lot# were unknown). Immediately after vaccination, the patient experienced generalized urticaria, pruritus and rash, angioedema and swelling (tonsils). The initial evaluation was performed in a clinic and a family practice provider provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with epinephrine and parenteral steroid. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012693). Additional information has been requested.


VAERS ID: 640789 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-06-27
Onset:2016-06-27
   Days after vaccination:0
Submitted: 2016-06-27
   Days after onset:0
Entered: 2016-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 0 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Deafness, Dizziness, Loss of consciousness, Muscle twitching
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), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: No testing done. Although he is to have two more doses of Gardasil and I am unsure of any long term damage at this time. This was more than a vaso-vagal response.
CDC Split Type:

Write-up: My son reported feeling dizzy and could not hear about 10 minutes after Gardasil vaccine. He then lost consciousness for about 60 seconds. Woke up and lost consciousness again with twitching in arms and legs. Smell salts were used to help bring him to. I''ve brought him home with periods of dizziness but no loss of consciousness. I feel its important to report this because its direct correlation to the vaccine is indisputable. He has never had any reaction from any shots or blood draw.


VAERS ID: 641707 (history)  
Age: 11.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2016-06-13
Onset:2016-06-13
   Days after vaccination:0
Submitted: 2016-06-27
   Days after onset:14
Entered: 2016-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L038917 / 1 AR / IM

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

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

Write-up: Received HPV9 on 6/13/16. States it hurts to move left arm. Indicates area at deltoid. Mom has been using ice packs daily.


VAERS ID: 641725 (history)  
Age: 11.0  
Gender: Female  
Location: Washington  
Vaccinated:2016-06-14
Onset:2016-06-24
   Days after vaccination:10
Submitted: 2016-06-27
   Days after onset:3
Entered: 2016-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L024993 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5216AA / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 92N9B / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Arthralgia, Blood lactic acid, Full blood count, Hypoaesthesia, Injection site erythema, Injection site pain, Metabolic function test, Pain in extremity, Ultrasound joint, Urine analysis, Vaccination site swelling
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLINDAGEL .1%
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Shoulder ultrasound; CBC; CMP; UA; Lactate level, done 6/24/16.
CDC Split Type:

Write-up: 11 yr. vaccines given 6/14/16 at well exam. C/o redness, swelling to vaccine site (left arm) pain to site on 6/24/16. C/o pain to site w/cont. redness, swelling on 6/25/16 and (R) shin pain, (R) wrist pain, and numbness to (R) top on the foot. Seen at hospital ER 6/25/16. F/u here visit 6/27/16. Poss bug bite on top of (R) ft. Poss. puncture site noted on (R) ft.


VAERS ID: 640900 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2016-06-28
Onset:2016-06-28
   Days after vaccination:0
Submitted: 2016-06-28
   Days after onset:0
Entered: 2016-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M009377 / 0 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L048459 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5282BC / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U540688 / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Pt fainted and fell off of the exam table no additional injury noted. Pt with no complaints of pain prior to leaving the office approximately 20 minutes after incident.


VAERS ID: 641723 (history)  
Age: 11.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2016-06-27
Onset:2016-06-27
   Days after vaccination:0
Submitted: 2016-06-28
   Days after onset:1
Entered: 2016-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L048459 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A15078 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4R3MJ / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Fall, Malaise, Pallor
SMQs:, Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad)

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

Write-up: A few minutes after vaccines were given while waiting in exam rm, pt was sitting on exam table mom went onto to other exam room where sister is being seen-nursing staff heard a loud noise and saw pt slumped on the floor in the hallway. Looked pale, was stable after a few minutes able to drink water. Child doesn''t recall what happened. Remembered getting the shot but doesn''t remember going out of the room. She said she "felt sick after shots".


VAERS ID: 641728 (history)  
Age: 11.0  
Gender: Female  
Location: Illinois  
Vaccinated:2016-05-23
Onset:2016-06-09
   Days after vaccination:17
Submitted: 2016-06-17
   Days after onset:8
Entered: 2016-06-28
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L043213 / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5186AA / - LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS E735A / - RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Swelling, tenderness.


VAERS ID: 641176 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-06-21
Onset:2016-06-21
   Days after vaccination:0
Submitted: 2016-06-29
   Days after onset:8
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5252AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5406AA / 0 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: HEADACHE, FEVER OF 102 DEGREES FAHRENHEIT.


VAERS ID: 641205 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2016-06-29
Onset:2016-06-29
   Days after vaccination:0
Submitted: 2016-06-29
   Days after onset:0
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L024993 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5216AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5292AA / 0 RA / IM

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

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

Write-up: AFTER APROX 2 MIN. AFTER HPV VACCINE PT GOT OFF TABLE FELT DIZZY AND PASSED OUT.


VAERS ID: 641503 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2016-06-27
Onset:2016-06-27
   Days after vaccination:0
Submitted: 2016-06-29
   Days after onset:2
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15097 / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5267AA / 0 LA / UN

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

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

Write-up: (RD) and (LD) slight pain, hot, itchy after vaccine given.


VAERS ID: 641310 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-30
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Hypotension, Injection site erythema, Injection site urticaria
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA117963

Write-up: Initial unsolicited report received from the literature on 21 June 2016. This case is linked with 016SA117942, 2016SA117944, 2016SA117945, 2016SA117946, 2016SA117947, 2016SA117948, 2016SA117949, 2016SA117950, 2016SA117951, 2016SA117952, 2016SA117953, 2016SA117954, 2016SA117955, 2016SA117956, 2016SA117957, 2016SA117958, 2016SA117959, 2016SA117960, 2016SA117961, 2016SA117962, 2016SA117964, 2016SA117965, 2016SA117966, 2016SA117967, 2016SA117968, 2016SA117969. (Same literature). The following is verbatim from the article: Background: Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children. Objective: We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis. Methods: Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines. Results: We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95 percent CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a non-significant female predominance. Vaccine-specific rates included 1.35 (95 percent CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95 percent CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases). Conclusion: Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case involves an 11-year-old male patient who was vaccinated with a dose of Tdap (manufacturer unknown), a dose of MCV4 (manufacturer unknown), a dose of Varicella (manufacturer other) and a dose of Hepatitis A (manufacturer other) (batch number, expiry date, dose, route and site of administration was not reported for all the vaccines) on an unspecified date. The patient''s history of atopy was reported as none and other medical history was not reported. Concomitant medications were not reported. On an unspecified date, following vaccination, patient had injection site urticarial, erythema, measured low BP and anaphylaxis. It was reported that the patient went to clinic (Pediatrician). Other laboratory data was not reported. Patient''s corrective treatments included oral antihistamine. On an unspecified date, patient recovered from events. Upon internal review the case was considered as serious because of important medical event: Anaphylaxis. Documents held by sender: none. Sender''s Comments: This case refers to 11 years old male who had Anaphylaxis, following vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, simultaneously with MENINGOCOCCAL VACCINE, VARICELLA VACCINE and HEPATITIS A VACCINE. However, time to onset is not provided. Additional information including but not limited to the patient''s previous immunization history (i.e., previous immunizations and any adverse events following immunizations), concomitant medicati


VAERS ID: 641317 (history)  
Age: 11.0  
Gender: Female  
Location: Florida  
Vaccinated:2015-08-28
Onset:2015-08-29
   Days after vaccination:1
Submitted: 2016-06-30
   Days after onset:306
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. 738472 / - - / ID

Administered by: Unknown       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? Yes
Died? Yes
   Date died: 2015-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ADHD
Preexisting Conditions: Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 641428 (history)  
Age: 11.0  
Gender: Male  
Location: Ohio  
Vaccinated:2016-06-29
Onset:2016-06-29
   Days after vaccination:0
Submitted: 2016-06-30
   Days after onset:1
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M007728 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15122 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS KJ4MS / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness postural, Fall, Head injury
SMQs:, Accidents and injuries (narrow)

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

Write-up: RECEIVED GARDASIL 9, TDAP AND MENVEO THEN STOOD UP, BECAME DIZZY, FELL AND BUMPED LEFT TEMPLE ON WALL IN EXAM ROOM


VAERS ID: 641856 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2016-06-28
Onset:2016-06-29
   Days after vaccination:1
Submitted: 2016-06-29
   Days after onset:0
Entered: 2016-06-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / - UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: My 11 year old son had severe vomiting 12 hours after getting a first dose of GARDASIL 9. That''s not a serious side effect, but vomiting is not listed as a side effect for GARDASIL on its website or the CDC''s website. It may be possible that it''s a coincidence, but he was not ill prior and seems to be fine the next day.


VAERS ID: 641877 (history)  
Age: 11.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2016-06-28
Onset:2016-06-29
   Days after vaccination:1
Submitted: 2016-06-30
   Days after onset:1
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5155BA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5247BA / 0 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Local reaction, Pertussis
SMQs:

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

Write-up: Localized rxn to Imm (R) arm probable pertussis.


VAERS ID: 641879 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-06-29
Onset:2016-06-29
   Days after vaccination:0
Submitted: 2016-06-30
   Days after onset:1
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5260AA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U1558AA / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, Dizziness, Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Pt. here w/ father for nurse only visit for imm. Tdap and MENCATRA given. Pt was very anxious and immediately c/o pain (L) delt. Site bled but bandaid applied. I advised to wait 15 mins- When left office pt vomited and felt dizzy. Brought back into office and assessed by physician. Pt was stable after 30 mins.


VAERS ID: 641885 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2016-06-30
Onset:2016-06-30
   Days after vaccination:0
Submitted: 2016-06-30
   Days after onset:0
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M003659 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5259AA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS Z9Z4Y / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Chest pain, Dizziness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Developed chest pain, vomiting, and dizziness after vaccines were administered, 5 minutes after vaccines. Observed for 10 additional minutes. Normal Exam. Walked out of office on his own.


VAERS ID: 641636 (history)  
Age: 11.0  
Gender: Male  
Location: Indiana  
Vaccinated:2016-06-27
Onset:2016-06-28
   Days after vaccination:1
Submitted: 2016-07-01
   Days after onset:3
Entered: 2016-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal behaviour, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular, Skin tightness, Yellow skin
SMQs:, Cholestasis and jaundice of hepatic origin (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Extreme swelling at injection site. Raised; Redness all over upper arm; HOT to touch; Hard, Tight skin; Painful. 5pm when I got home from work; took him to a walk-in clinic to be seen; marked the red mark on the upper arm in pen, 8pm. 10pm, the redness had grown outside the marks, Marked again. When he woke at 7am, Wednesday, the redness had grown again and marked again. On Thursday, skin tones in face were blotchy and yellowish. Arm not as red, still HOT to touch and arm was about 3x harder than other arm in comparison. Felt tight. He has been taking Keflex 3 times a day since walk-in on Tuesday. His demeanor is off, did not play outside for a day and a half which is very out of character.


VAERS ID: 641741 (history)  
Age: 11.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2016-06-29
Onset:2016-06-29
   Days after vaccination:0
Submitted: 2016-07-01
   Days after onset:2
Entered: 2016-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5415AA / 0 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS HM4FY / 5 LA / IM

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)

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

Write-up: Red swollen left upper arm.


VAERS ID: 641785 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-06-30
Onset:2016-06-30
   Days after vaccination:0
Submitted: 2016-07-01
   Days after onset:1
Entered: 2016-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. M007728 / 2 LA / UN

Administered by: Military       Purchased by: Military
Symptoms: Drug administered at inappropriate site, Injection site swelling, Pain, Skin tightness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

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

Write-up: (L) upper arm localized swelling - tightness - pain. Shot was not given in the deltoid (visible shot mark close to shoulder).


VAERS ID: 641751 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2016-06-29
Onset:2016-06-29
   Days after vaccination:0
Submitted: 2016-07-01
   Days after onset:2
Entered: 2016-07-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M009116 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U525AA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5906AA / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal pain, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

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

Write-up: Vomiting and diarrhea with severe abd pain.


VAERS ID: 641696 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-05
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Blood pressure decreased, Injection site erythema, Injection site urticaria
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA117965

Write-up: Initial unsolicited report received from the literature on 21 June 2016. This case was linked to 2016SA117942, 2016SA117944, 2016SA117945, 2016SA117946, 2016SA117947, 2016SA117948, 2016SA117949, 2016SA117950, 2016SA117951, 2016SA117952, 2016SA117953, 2016SA117954, 2016SA117955, 2016SA117956, 2016SA117957, 2016SA117958, 2016SA117959, 2016SA117960, 2016SA117961, 2016SA117962, 2016SA117963, 2016SA117964, 2016SA117966, 2016SA117967, 2016SA117968, 2016SA117969. (same literature). The following is verbatim from the article: Background: Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children. Objective: We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis. Methods: Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines. Results: We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95 percent CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a non-significant female predominance. Vaccine-specific rates included 1.35 (95 percent CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95 percent CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases). Conclusion: Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case involves a 11-year-old male patient who was vaccinated with dose of Tdap, dose of MCV4, dose of Varicella and dose of Hepatitis A (batch number, dose, route and site of administration was not reported for all vaccines) on an unspecified date. The history of atopy was reported as none and other medical history was not reported. Concomitant medications were not reported. On an unspecified date, following vaccination, patient had anaphylaxis, Injection site urticaria and erythema, measured decreased blood pressure. It was reported that patient went to clinic (Pediatrician). Lab data was not reported. Corrective treatments included oral antihistamine. On an unspecified date, patient was recovered from events. Upon internal review the case was considered as serious because of important medical event: Anaphylaxis. Documents held by sender: none. Sender''s Comments: The reported symptoms are consistent with the diagnosis of anaphylactic reaction. Time to onset is compatible with the role of the vaccine. Additional information including but not limited to the patient''s previous immunization history (i.e., previous immunizations and any adverse events following immunizations), medical history, concomitant medication, vaccine details, and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be ruled out.


VAERS ID: 641920 (history)  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2015-07-21
Onset:0000-00-00
Submitted: 2016-06-23
Entered: 2016-07-05
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006960 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5020AA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5189AA / 5 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Immunosuppressant drug therapy, Morphoea, Pathology test
SMQs:

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

Write-up: Tdap, MENACTRA, and HPV given 7-21-15. Definitely had morphea Aug 2015. Don''t known if had before 7-21-15. Immunosuppressives started May 2016.


VAERS ID: 642015 (history)  
Age: 11.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-06-06
Onset:2016-06-07
   Days after vaccination:1
Submitted: 2016-07-02
   Days after onset:25
Entered: 2016-07-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5415AA / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AH4LF / 3 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Strattera
Current Illness: None
Preexisting Conditions: NKDA; Pt has a hx of ADHD
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Redness, warmth, itchy around injection sites the night after he was given the injection.


VAERS ID: 642024 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-06-03
Onset:2016-06-03
   Days after vaccination:0
Submitted: 2016-06-13
   Days after onset:10
Entered: 2016-07-05
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L024993 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5244AA / 0 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction, Nasal congestion, Oropharyngeal pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonidine
Current Illness: URI: no fever, Neg rapid
Preexisting Conditions: Hx: Intermittent asthma; BMI 99%; ADHD; Autism; OCD; Anxiety; Hx picking and self-mutilation
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 6/3/16- MENACTRA admin RA/IM at 2:17pm. That eve pt developed local itchiness, started scratching site over next day cont''d scratching, developed swelling, redness at site. Mom took to ER 6/4/16 night. ER tx''d for cellulitis and local rxn. 06/03/2016 c/o stuffy nose and sore throat. HPV and MCV due now. Other Imms UTD for age incl 2015 Flu Vac and TDaP. 06/06/2016 Walk in: Mom present swelling on his right arm. Imms UTD for age incl 2015 Flu, and TDaP. HPV #3 due 10/2016. 06/13/2016 Follow up: Local vaccine reaction and cellulitis. Imm''s UTD for age incl 2015 Flu, TDaP, MENACTRA.


VAERS ID: 642049 (history)  
Age: 11.0  
Gender: Male  
Location: Oregon  
Vaccinated:2015-10-15
Onset:2016-02-12
   Days after vaccination:120
Submitted: 2016-07-06
   Days after onset:144
Entered: 2016-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER L016428 / 2 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Laboratory test, Nuclear magnetic resonance imaging, Seizure, Seizure like phenomena
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: MRI''s, CT, video eeg (twice), blood work, lab tests
CDC Split Type:

Write-up: Seizures/seizure like activity.


VAERS ID: 642051 (history)  
Age: 11.0  
Gender: Male  
Location: Michigan  
Vaccinated:2016-02-11
Onset:2016-02-11
   Days after vaccination:0
Submitted: 2016-07-07
   Days after onset:146
Entered: 2016-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. L015460 / 1 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L019297 / 2 LA / IM

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

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

Write-up: No symptoms- pt. given adult hep A.


VAERS ID: 642090 (history)  
Age: 11.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:2016-03-30
Onset:2016-06-30
   Days after vaccination:92
Submitted: 2016-07-07
   Days after onset:7
Entered: 2016-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Numbness of vaccinated arm about 5 minutes after, convulsing of the bicep and/or tricep muscle for about 10 minutes, then distinct soreness for approximately two hours and mild soreness for 24 hours.


VAERS ID: 642112 (history)  
Age: 11.0  
Gender: Female  
Location: Maryland  
Vaccinated:2016-07-05
Onset:2016-07-06
   Days after vaccination:1
Submitted: 2016-07-07
   Days after onset:1
Entered: 2016-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5282AB / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5467AC / 0 LA / IM

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

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

Write-up: Received vaccines 07/05/2016. Mom called 07/06/16 evening and stated that patient''s arm is red and hot to touch where she received her shots. Spoke with ER dime sized, no fever or streaking. Just monitor. Call if any changes.


VAERS ID: 642114 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2016-06-28
Onset:2016-06-29
   Days after vaccination:1
Submitted: 2016-07-01
   Days after onset:2
Entered: 2016-07-07
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5259AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4990AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pain in extremity, 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), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: (R) arm localized swelling, redness 8 x 7 cm no treatment given. Recommend TYLENOL/Advil for pain.


VAERS ID: 642466 (history)  
Age: 11.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2016-07-07
Onset:2016-07-07
   Days after vaccination:0
Submitted: 2016-07-08
   Days after onset:1
Entered: 2016-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L013429 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5228BA / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS GS58R / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Back pain, Body temperature increased, Headache, Malaise, Neck pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VYVANSE 40MG ONE CAP PO DAILY; TRAZODONE 50MG ON TAB PO Q HS; INTUNIV 3MG ONE TAB PO Q HS
Current Illness: NONE
Preexisting Conditions: ADHD; ALLERGIC RHINITIS; SEVERE INSOMNIA; MOOD SWINGS
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: ELEVATED TEMP, HEADACHE, NECK PAIN, BACK PAIN, VOMITING, GENERAL MALAISE. ON 07/08/2016, PATIENT WAS EVALUATED IN THE CLINIC AND HER TEMP WAS 101.4 F. SHE WAS HAVING MILD HEADACHE, BUT NECK PAIN AND BACK PAIN WERE GONE. PHYSICAL EXAM WAS NEGATIVE FOR ACUTE INFECTION, THEN SHE RECEIVED BENADRYL 25MG INJECTION AND ORAL TYLENOL. SHE WAS DISCHARGED HOME WITH A PRESCRIPTION OF ORAL PREDNISONE 10MG TO TAKE FOR FIVE DAYS AND INSTRUCTIONS TO CONTINUE BENADRYL 25MG EVERY 8 HRS FOR 3 DAYS.


VAERS ID: 642505 (history)  
Age: 11.0  
Gender: Male  
Location: Idaho  
Vaccinated:2016-07-07
Onset:2016-07-07
   Days after vaccination:0
Submitted: 2016-07-08
   Days after onset:1
Entered: 2016-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS TS343 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5228BB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5298AA / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Lethargy, Pain
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort 05.mg/2mL inhalation 2 times daily as needed.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Lethargic, body aches, low energy.


VAERS ID: 642512 (history)  
Age: 11.0  
Gender: Male  
Location: Nebraska  
Vaccinated:2016-07-07
Onset:2016-07-07
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:2
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain upper, Chills, Dyskinesia, Headache, Nausea, Pain, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None yet, he fainted at the Dr office moments after the shot and is now having the other symptoms daily.
CDC Split Type:

Write-up: Intense pain and then fainting with some jolting, lost bladder control. Chills, headache, nausea, intense stomach pain the next night.


VAERS ID: 642514 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2016-07-08
Onset:2016-07-08
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:1
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Malaise, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Child felt fine during appointment. Received vaccine of Menactra in left arm with little pain and Trumenba in the right arm with a lot of pain that has continued to worsen thru the day & into the night. His right arm has swollen slightly near injection sight. And right shoulder is sore. Has pain moving his arm at all. In addition, he has become increasingly ill feeling. Developing a headache, nausea, & chills from 7:00 pm & it is continuing now at 1:30 am. I have given him 3 tsp. of Childrens liquid Advil every 6 hours without much relief. The pain has not let up, nor his other symptoms. He has been drinking water & ice chips throughout the evening. He feels so terrible right now after feeling fine going into his appointment to get these vaccines. They were the only 2 he received today. My son has not been sick in over a year! Until today. :(


VAERS ID: 642596 (history)  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2016-06-28
Onset:2016-06-28
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:11
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 0 UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Hyperhidrosis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA014535

Write-up: This spontaneous report as received from a patient''s mother and refers to a 11 year old male patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 28-JUN-2016, the patient was vaccinated with a first dose of GARDASIL 9 (strength, route of administration, lot # and expiration date were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (strength, dose and frequency, route of administration, lot # and expiration date were not reported) administered on the same day. On an unknown date in June 2016 (reported as several hours later) after getting the vaccination, the patient experienced vomiting that lasted about one hour, sweating and chills. There was not treatment given for the adverse events. There was no labs diagnostic performed. The reporter mentioned that her son had made a full recovery on 29-JUN-2016 (reported as of this morning). The patient''s mother contacted her son''s doctor. The relatedness between vaccination with GARDASIL 9 and meningococcal vaccine (unspecified) and the events was not reported. Additional information is not expected because the reporter refused to provide the physician''s demographics.


VAERS ID: 642617 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-04-20
Onset:2016-04-20
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:80
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA002639

Write-up: This spontaneous report as received from a certified medical assistant refers to an 11 year old female patient. No information regarding the patient''s medical history and concurrent conditions was reported. On 20-APR-2016 at 16:40, the patient was vaccinated at the private doctor''s office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the right arm (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.


VAERS ID: 642625 (history)  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2016-04-21
Onset:2016-04-21
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:79
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA002640

Write-up: This spontaneous report as received from a certified medical assistant refers to an 11 year old male patient. No information regarding the patient''s medical history and concurrent conditions was reported. On 21-APR-2016 at 16:58, the patient was vaccinated at the private doctor''s office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the left arm, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs, or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of the several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.


VAERS ID: 642637 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-04-19
Onset:2016-04-19
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:81
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USS002638

Write-up: This spontaneous report as received from a certified medical assistant refers to an 11 year old female patient. No information regarding the patient''s medical history and concurrent conditions was reported. On 19-APR-2016 at 12:39, the patient was vaccinated at the private doctor''s office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the right arm (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.


VAERS ID: 642744 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-04-28
Onset:0000-00-00
Submitted: 2016-07-09
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA002645

Write-up: This spontaneous report was received from a certified medical assistant and refers to a 11 year old female patient. Information on the patient''s concurrent conditions, medical history or concomitant medications was not reported. On 28-APR-2016 at 10:26, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the left arm. On unspecified date, the vaccine that was administered to the patient has been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at time of vaccination. This is one of the several reports received from the same source. Additional information is not expected as all available information was obtained.


VAERS ID: 642815 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-04-16
Onset:0000-00-00
Submitted: 2016-07-09
Entered: 2016-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA002637

Write-up: This spontaneous report was received from a certified medical assistant and refers to a 11 year old female patient. Information on the patient''s concurrent conditions, medical history or concomitant medications was not reported. On 16-APR-2016 at 12:00 PM, the patient was vaccinated with GARDASIL 9 (lot # L044475, expiration date: 12-MAY-2017) dose 1, intramuscular in the left arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all available information was obtained.


VAERS ID: 642715 (history)  
Age: 11.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2016-07-06
Onset:2016-07-07
   Days after vaccination:1
Submitted: 2016-07-11
   Days after onset:4
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS KT54C / 0 RA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M011117 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15098 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9GE5D / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Decreased appetite, Dizziness, Fatigue, Moaning, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: He was too sick to take to the doctor. He is still recovering five days later.
CDC Split Type:

Write-up: High fever of 104.5, some shaking and moaning administered Motrin to reduce fever. Fever stayed above 103 for 48 hours, fever broke after 72 hours. Remained fatigued and light headed for another two days, has little interest in eating.


VAERS ID: 642834 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2016-05-01
Onset:2016-05-01
   Days after vaccination:0
Submitted: 2016-07-11
   Days after onset:71
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / SYR

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA012781

Write-up: This solicited report as received from a non-healthcare professional refers to a 11 year old female patient who was enrolled in a Market Research. Patient''s concurrent conditions, and medical history were not provided. Concomitant therapies included multiple unspecified vaccines administered on the same date. In approximately May 2016, the subject was vaccinated with first dose of GARDASIL (dose, route, lot # and expiration date were not provided). In May 2016, the patient experienced soreness at injection site (injection site pain). The patient recovered of the injection site pain 3 days after vaccination (approximately May 2016). The investigator considered the injection site pain to be related to GARDASIL. Additional information has been requested.


VAERS ID: 642878 (history)  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2016-07-05
Onset:2016-07-05
   Days after vaccination:0
Submitted: 2016-07-05
   Days after onset:0
Entered: 2016-07-11
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS F735A / - RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Eye swelling, Rash pruritic, Vaccination site urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Developed itchy rash and eye swelling a few hours after - TDAP vaccine given: taken to ER and required BENADRYL. No fever positive urticaria on deltoid muscle noted at site where vaccine given on Flu visit.


VAERS ID: 642908 (history)  
Age: 11.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2016-07-06
Onset:2016-07-06
   Days after vaccination:0
Submitted: 2016-07-11
   Days after onset:5
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR 9NA32 / - RA / IM

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

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

Write-up: Patient given Tdap - passed out 5 minutes after administration.


VAERS ID: 642909 (history)  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:2016-07-06
Onset:2016-07-08
   Days after vaccination:2
Submitted: 2016-07-11
   Days after onset:3
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A15097 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 5SR21 / 0 RA / IM

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

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

Write-up: Right arm red, swollen and warm to touch.


VAERS ID: 642915 (history)  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2016-07-11
Onset:2016-07-11
   Days after vaccination:0
Submitted: 2016-07-11
   Days after onset:0
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS KT54C / 0 LA / UN

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

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

Write-up: 1-2 minutes after he received shot he had syncopal episode and hit his head on window sill. He regained consciousness within few seconds. He BP was 60/40. He improved with lying flat and drinking water.


VAERS ID: 642917 (history)  
Age: 11.0  
Gender: Male  
Location: Nevada  
Vaccinated:2016-07-06
Onset:2016-07-08
   Days after vaccination:2
Submitted: 2016-07-11
   Days after onset:3
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / SYR

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

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

Write-up: Local swelling, pain at injection site.


VAERS ID: 642874 (history)  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:2016-07-08
Onset:2016-07-09
   Days after vaccination:1
Submitted: 2016-07-12
   Days after onset:3
Entered: 2016-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15069 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS X7DN3 / 0 RA / IM

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

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

Write-up: Redness, swelling, hot to touch, tenderness at injection site.


VAERS ID: 642925 (history)  
Age: 11.0  
Gender: Female  
Location: Illinois  
Vaccinated:2016-07-12
Onset:2016-07-12
   Days after vaccination:0
Submitted: 2016-07-12
   Days after onset:0
Entered: 2016-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. M014929 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR US468AA / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR US468AA / 0 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L023592 / 1 RA / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data: BP, 80/60, 97/68, 110/72
CDC Split Type:

Write-up: Patient passed out in the waiting room after vaccine administration.


VAERS ID: 642969 (history)  
Age: 11.0  
Gender: Male  
Location: Virginia  
Vaccinated:2016-07-08
Onset:2016-07-08
   Days after vaccination:0
Submitted: 2016-07-12
   Days after onset:4
Entered: 2016-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M005714 / 1 LA / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U5259AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5278AA / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain upper, Feeding disorder, Injection site erythema, Injection site pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VYVANSE; vitamin d3; valproic acid; trazodone; SINGULAIR; buspirone; DEPAKOTE; fluoxetine; guanfacine
Current Illness: no
Preexisting Conditions: H/O ADD, Seizures, Insomnia, Depression, Constipation, Asthma, Migraines - Followed by Specialists
Diagnostic Lab Data: Patient was seen in the ER on 07/10/16 and followed up in the office on 07/11/16 and improvement was noted
CDC Split Type:

Write-up: Patient complained of erythema, pain at injection site and was having difficulty eating and drinking due to stomach pain.


VAERS ID: 643073 (history)  
Age: 11.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2016-07-05
Onset:2016-07-05
   Days after vaccination:0
Submitted: 2016-07-13
   Days after onset:8
Entered: 2016-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Dehydration, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Developed fever 102.5, abd pain and vomiting for 3 days. Returned to office 7/7/16 for worsening abd pain, dehydration and sent to ED for IVF and to R/o appendicitis.


VAERS ID: 643076 (history)  
Age: 11.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2016-07-08
Onset:2016-07-08
   Days after vaccination:0
Submitted: 2016-07-13
   Days after onset:5
Entered: 2016-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M005714 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 45228BA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 54257 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type: PR1016

Write-up: The boy fainted a few fours after the vaccines being administrated.


VAERS ID: 643626 (history)  
Age: 11.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2016-07-12
Onset:2016-07-12
   Days after vaccination:0
Submitted: 2016-07-13
   Days after onset:1
Entered: 2016-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5244AA / 0 RA / IM

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

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

Write-up: Right deltoid, red swollen, at 5cm in diameter. (Local reaction only).


VAERS ID: 643301 (history)  
Age: 11.0  
Gender: Female  
Location: Georgia  
Vaccinated:2016-07-13
Onset:2016-07-13
   Days after vaccination:0
Submitted: 2016-07-14
   Days after onset:1
Entered: 2016-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L044475 / 0 LA / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U5228BA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS Z9Z4Y / 0 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Blood glucose, Deafness, Dizziness, Dyskinesia, Haemoglobin, Laboratory test normal, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

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

Write-up: Patient felt faint/ pale in color and she stated she could not hear. Patient had a slight jerk of movement and had to be laid down. Lab test were normal.


VAERS ID: 643542 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-06-19
Onset:2016-06-20
   Days after vaccination:1
Submitted: 2016-06-21
   Days after onset:1
Entered: 2016-07-14
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M003659 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5529AA / 0 RA / IM

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

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

Write-up: Localized reaction with increased swelling and redness on 6/20/16. Patient prescribed diphenhydramine and hydrocortisone 2.5% cream.


VAERS ID: 643553 (history)  
Age: 11.0  
Gender: Male  
Location: Colorado  
Vaccinated:2016-07-12
Onset:2016-07-13
   Days after vaccination:1
Submitted: 2016-07-14
   Days after onset:1
Entered: 2016-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15124 / 0 LA / IM

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

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

Write-up: Vaccine given 7-12-16. At 5pm 7-13-16, redness and swelling noted to injection site, left deltoid. Measured 3 1/2 x 6 cm. Presents to office 7-14-16 with increased redness and swelling measuring 10 x 11 cm. Mild itching, full ROM, denies pain.


VAERS ID: 643400 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-07-12
Onset:2016-07-13
   Days after vaccination:1
Submitted: 2016-07-15
   Days after onset:2
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15098 / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Syndactyly at left thumb; Amox allergy
Diagnostic Lab Data: Advised use of BENADRYL also
CDC Split Type:

Write-up: One day after MENVEO vaccine, mother noticed, red, raised firm area at right deltoid. 2 days after area larger, still firm, hard, warm to touch, area 8 cm. Given Prednisolone 15mg/5ml. Take 10ml x2days.


VAERS ID: 643442 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2016-06-28
Onset:2016-07-13
   Days after vaccination:15
Submitted: 2016-07-15
   Days after onset:2
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications administered on day of vaccine.
Current Illness: No
Preexisting Conditions: Autism, ADHD
Diagnostic Lab Data: CT Scan, MRI and EEG to be done
CDC Split Type:

Write-up: Complex partial seizure


VAERS ID: 643450 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-06-13
Onset:2016-06-14
   Days after vaccination:1
Submitted: 2016-07-15
   Days after onset:31
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UI291AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Axillary pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: USSA2016SA114797

Write-up: Initial unsolicited report received from a nurse on 16 Jun 2016. This case is linked to 2016SA114800 (same reporter). This case involves an 11-year-old male patient (one of the two boys) who was vaccinated with first dose of YELLOW FEVER VACCINE - US (Yellow Fever Vaccine) (lot number: UI291AA, expiration date: 20 Apr 2018, dose, route of administration not reported) in deltoid on 13 Jun 2016. The medical history incuding any allergies, illness at time of vaccination and concomitant medications were reported as none. It was unknown if any other vaccine administered to the patient within four weeks of suspect vaccine. On 14 Jun 2016, one day after vaccination, patient experienced pain in the axilla. The patient also had lymph node swelling that was obvious to the mother. The reporter planned to advise the mother to take the patient to see their pediatrician and have them evaluated for their symptoms. It was reported that patient required doctor visit. The lab data was reported as none. Corrective treatment was not reported. The outcome for the events was reported as unknown. List of documents held by sender: none.


VAERS ID: 643634 (history)  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2016-07-13
Onset:2016-07-15
   Days after vaccination:2
Submitted: 2016-07-15
   Days after onset:0
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS Z9Z4Y / 0 RA / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPI PEN Jr; famotidine; SINGULAIR; ZYRTEC
Current Illness: None reported
Preexisting Conditions: NKDA; ENVT: grasses, pollens
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Tdap vaccine was administered on 7/13/16. Provider reports localized swelling and tenderness. No abscess, fluctuance or redness. TYLENOL/ibuprofen. Cold compress to area.


VAERS ID: 643637 (history)  
Age: 11.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2016-07-14
Onset:2016-07-14
   Days after vaccination:0
Submitted: 2016-07-14
   Days after onset:0
Entered: 2016-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L026602 / 0 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: After administration of vaccine patient experienced syncopy BP 98/50 waited 15 minutes rechecked BP 92/60.


VAERS ID: 643648 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2016-07-12
Onset:0000-00-00
Submitted: 2016-07-15
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15078 / 0 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 2729X / 0 RA / UN

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

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

Write-up: Local reaction to vaccine BOOSTRIX. Mild erythema and tenderness.


VAERS ID: 643695 (history)  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-15
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA010995

Write-up: This solicited report has been received from an unspecified reporter. This report refers to a 11 year old female patient, enrolled in a market research. No information on patient''s medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, indication, lot# and expiration date were not reported). On an unknown day in May 2016, the patient experienced injection site pain. It was reported that the patient received multiple unspecified vaccines that day. The outcome of the event was reported as recovered 3 days after injection. The action taken with GARDASIL was reported as none. The reporter considered injection site pain to be related to GARDASIL. Additional information has been requested.


VAERS ID: 643666 (history)  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2016-07-08
Onset:2016-07-08
   Days after vaccination:0
Submitted: 2016-07-18
   Days after onset:10
Entered: 2016-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5185BA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9N74F / 0 LA / IM

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

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

Write-up: Patient is unsure if hives started on 7/08/2016 or 07/09/2016. Hives on arms, legs and abdomen. Seen at hospital on 7/15/16. Treating with oral Benadryl and Hydrocortisone cream. Referred to primary care physician.


VAERS ID: 643669 (history)  
Age: 11.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2016-07-14
Onset:2016-07-15
   Days after vaccination:1
Submitted: 2016-07-18
   Days after onset:3
Entered: 2016-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M01117 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5272AA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 7RJ9B / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prilosec- 20mg nightly
Current Illness: No
Preexisting Conditions: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Swelling, redness, warm to touch, painful.


VAERS ID: 643674 (history)  
Age: 11.0  
Gender: Female  
Location: Illinois  
Vaccinated:2016-07-15
Onset:2016-07-16
   Days after vaccination:1
Submitted: 2016-07-18
   Days after onset:2
Entered: 2016-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L0432103 / 1 LA / IM

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

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

Write-up: Swelling, redness, warmth.


VAERS ID: 643748 (history)  
Age: 11.0  
Gender: Female  
Location: Georgia  
Vaccinated:2016-07-18
Onset:2016-07-18
   Days after vaccination:0
Submitted: 2016-07-19
   Days after onset:1
Entered: 2016-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 7RJ9B / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Heart rate decreased, Seizure
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No known illness at the time of vaccination
Preexisting Conditions: History Vasovagal episode, tricuspid regurgitation, pulmonary stenosis
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient was given Tdap and less than a minute the patient had a seizure. The patient heart rate dropped into the 40''s. Patient was given an IV and EMT was called to transport the patient to the hospital.


VAERS ID: 643773 (history)  
Age: 11.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2016-07-18
Onset:2016-07-18
   Days after vaccination:0
Submitted: 2016-07-19
   Days after onset:1
Entered: 2016-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15122 / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS H5495 / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Dizziness, Fainting.


VAERS ID: 643794 (history)  
Age: 11.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2016-07-14
Onset:2016-07-14
   Days after vaccination:0
Submitted: 2016-07-19
   Days after onset:5
Entered: 2016-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M009377 / 0 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. :024993 / 0 LA / IM

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

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

Write-up: Pt reported redness and itching at and around the injection site.


VAERS ID: 643837 (history)  
Age: 11.0  
Gender: Female  
Location: Georgia  
Vaccinated:2016-07-11
Onset:2016-07-12
   Days after vaccination:1
Submitted: 2016-07-13
   Days after onset:1
Entered: 2016-07-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M010212 / 2 RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS J3GT5 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5228BB / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS Z9Z44 / 0 LA / IM

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

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

Write-up: Pain, swelling and rash at injection site-left deltoid.


VAERS ID: 643863 (history)  
Age: 11.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2016-07-13
Onset:2016-07-13
   Days after vaccination:0
Submitted: 2016-07-19
   Days after onset:6
Entered: 2016-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 49LH2 / 1 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L014415 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5186AA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4EK53 / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol inhaler PRN; loratadine PRN
Current Illness: None
Preexisting Conditions: Mild intermittent asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, vomiting, dizzy, fever for 2 days after vaccines. Mom used Ibuprofen and TYLENOL to treat fever. Fever resolved 7/15/16.


VAERS ID: 643865 (history)  
Age: 11.0  
Gender: Male  
Location: Michigan  
Vaccinated:2016-07-19
Onset:2016-07-19
   Days after vaccination:0
Submitted: 2016-07-19
   Days after onset:0
Entered: 2016-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS C9DA2 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5260AA / 0 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5288BA / 0 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Fall, Mydriasis, Pallor, Urinary incontinence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

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

Write-up: After 3 shots done went to discard mom noticed he was starting to go pale and falling. I turned and caught Pt. and layed him on table. Doctor was called in and evaluated Pt he had gone pale, urinated on himself and eyes dilated. Pt given juice sat up for a while till color came back, Pt. puked. Doctor checked him, and after a while he was ok to leave.


VAERS ID: 644018 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2016-07-18
Onset:0000-00-00
Submitted: 2016-07-20
Entered: 2016-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5282BB / 1 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5406AA / 0 LA / UN

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

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

Write-up: Erythema to injection sites.


VAERS ID: 644027 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-07-14
Onset:2016-07-14
   Days after vaccination:0
Submitted: 2016-07-15
   Days after onset:1
Entered: 2016-07-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5282BB / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Fall, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient received the meningococcal vaccine and was discharged from clinic. Within one minute after leaving room patient bump her on the wall and fell. Started to shake had her lay on her side about 5 minutes and then transferred her back to the room. Where she was kept in observation for 15 minutes. First fainting spell after vaccine.


VAERS ID: 644029 (history)  
Age: 11.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2016-07-16
Onset:2016-07-19
   Days after vaccination:3
Submitted: 2016-07-20
   Days after onset:1
Entered: 2016-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5244AA / 0 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5264AA / 0 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Fatigue
SMQs:

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

Write-up: Patient felt very tired after the vaccine. Patient instructed to lie down for 30 mins. Patient felt better and sent home with mom.


VAERS ID: 644071 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2016-07-18
Onset:2016-07-19
   Days after vaccination:1
Submitted: 2016-07-20
   Days after onset:1
Entered: 2016-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L026602 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15097 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 7B222 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blister, Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: EDEMA AND ERYTHEMA IN THE LT ARM; 1.5 CM BULLA ALONG THE OUTSIDE EDGE OF THE AREA OF EDEMA AND ERYTHEMA TOWARDS THE EDGE OF WHERE THE BAND AIDE WAS.


VAERS ID: 644087 (history)  
Age: 11.0  
Gender: Male  
Location: Arizona  
Vaccinated:2016-07-18
Onset:2016-07-18
   Days after vaccination:0
Submitted: 2016-07-20
   Days after onset:2
Entered: 2016-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L037554 / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15078 / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 2729X / 1 LA / UN

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

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

Write-up: Erythema and swelling of L upper arm approx 12cm x 10cm. Very warm to touch x2 days. Cephalexin RX given cellulitis.


VAERS ID: 644318 (history)  
Age: 11.0  
Gender: Male  
Location: Michigan  
Vaccinated:2016-07-20
Onset:2016-07-21
   Days after vaccination:1
Submitted: 2016-07-21
   Days after onset:0
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15125 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS K2D2T / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE 30 mg
Current Illness: No
Preexisting Conditions: Eosinophilic Esophagitis; Gastroesophageal Reflux Disease; Mild Intermittent Asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient complained of not feeling well after vaccines were administered 7/20/16. Vomited 5 x''s between 12:30 AM - 4:00 AM 7/21/16. Fever 101.7.


VAERS ID: 644338 (history)  
Age: 11.0  
Gender: Male  
Location: Missouri  
Vaccinated:2016-07-14
Onset:2016-07-15
   Days after vaccination:1
Submitted: 2016-07-21
   Days after onset:6
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A15098 / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS K2D2T / - RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal discomfort, Headache, Injection site rash
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

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

Write-up: Headache, upset stomach, localized rash at injection site.


VAERS ID: 644415 (history)  
Age: 11.0  
Gender: Female  
Location: Colorado  
Vaccinated:2016-07-18
Onset:2016-07-19
   Days after vaccination:1
Submitted: 2016-07-21
   Days after onset:2
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15124 / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 7RJ9B / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Induration, 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)

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

Write-up: Vaccines given on Monday, July 18, 4:48pm. Next day felt "yucky". Tuesday evening arm red, painful, swollen. Wed pm LA much more swollen, red, hot, only painful when pressed on. Seen in office today, July 21, 2016, "much less red and swollen,", per mother. Redness (L) arm measures 13.5cmx 11cm with induration


VAERS ID: 644450 (history)  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2016-07-21
Onset:2016-07-21
   Days after vaccination:0
Submitted: 2016-07-21
   Days after onset:0
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M005714 / - RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15079 / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 943Z5 / - LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Head injury, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: After receiving vaccines listed below, 15 minutes after, Patient had syncopal episode, hit back of head on wall and had seizure activity.


VAERS ID: 644455 (history)  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2016-07-19
Onset:2016-07-20
   Days after vaccination:1
Submitted: 2016-07-21
   Days after onset:1
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M011840 / - RA / SYR

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

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

Write-up: Large local reaction, redness, swelling at injection location on right deltoid.


VAERS ID: 644442 (history)  
Age: 11.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2016-07-12
Onset:2016-07-21
   Days after vaccination:9
Submitted: 2016-07-21
   Days after onset:0
Entered: 2016-07-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS C90A2 / - RA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M009116 / - LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5390AA / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 2E9JG / - RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema multiforme, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Erythema multiforme rash involving bilateral thighs.


VAERS ID: 644576 (history)  
Age: 11.0  
Gender: Female  
Location: Washington  
Vaccinated:2016-07-20
Onset:2016-07-22
   Days after vaccination:2
Submitted: 2016-07-22
   Days after onset:0
Entered: 2016-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5244AA / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9Y57K / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site cellulitis, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cat, Dog, Penicillin, dust, Pediasure products
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cellulitis around site of injection. Arm very painful and could not move the arm.


VAERS ID: 644578 (history)  
Age: 11.0  
Gender: Male  
Location: Nevada  
Vaccinated:2016-07-20
Onset:2016-07-21
   Days after vaccination:1
Submitted: 2016-07-22
   Days after onset:1
Entered: 2016-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U5390AA / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS B4G4G / 0 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Headache, Injection site rash, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Sleepiness/Headache/Rash at the injection site.


VAERS ID: 645139 (history)  
Age: 11.0  
Gender: Male  
Location: Alabama  
Vaccinated:2016-07-20
Onset:0000-00-00
Submitted: 2016-07-22
Entered: 2016-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M007764 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5282BD / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UI568AA / 0 RA / IM

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

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

Write-up: Induration and erythema on right lateral deltoid measuring 15cm x 8cm.


VAERS ID: 644595 (history)  
Age: 11.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2016-07-13
Onset:2016-07-15
   Days after vaccination:2
Submitted: 2016-07-24
   Days after onset:9
Entered: 2016-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQHIB: MENINGICOCCAL C & Y + HIB (MENHIBRIX) / GLAXOSMITHKLINE BIOLOGICALS 15125 / - UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS K2D2T / - UN / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Acupuncture, Anxiety, Depression, Diarrhoea, Inflammation, Nausea, Panic attack
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: Nutritionist and accupuncturist both diagnosed her with inflammation in her body and a liver that is working overtime trying to get rid of toxins in her body.
CDC Split Type:

Write-up: Patient started with diarrhea and nausea on Friday which soon turned into depression, anxiety and panic attacks that she has never experienced before. It is still ongoing and we are trying to treat her with alternative treatments such as supplements through a nutritionist and accupuncture.


VAERS ID: 644613 (history)  
Age: 11.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2016-07-21
Onset:2016-07-21
   Days after vaccination:0
Submitted: 2016-07-22
   Days after onset:1
Entered: 2016-07-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C478AA / 5 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L007560 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5560AA / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L043620 / 1 LA / SC

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

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

Write-up: Child in for immunizations. Nurse inadvertently drew up and administered Dtap instead of Tdap. No adverse events or problems noted with patient.


VAERS ID: 644637 (history)  
Age: 11.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2016-07-22
Onset:0000-00-00
Submitted: 2016-07-25
Entered: 2016-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5021AA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Pt was given an expired vaccine. Vaccine expired on 07/14/2016.


VAERS ID: 644919 (history)  
Age: 11.0  
Gender: Male  
Location: Virginia  
Vaccinated:2016-07-13
Onset:0000-00-00
Submitted: 2016-07-25
Entered: 2016-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 7447G / 0 RA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M005714 / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Adult formula given (Hep A).


VAERS ID: 645260 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2016-07-25
Onset:2016-07-25
   Days after vaccination:0
Submitted: 2016-07-25
   Days after onset:0
Entered: 2016-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M005714 / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5244AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U1567AA / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Fainting 1 min. after injection.


VAERS ID: 645269 (history)  
Age: 11.0  
Gender: Male  
Location: Vermont  
Vaccinated:2016-06-29
Onset:2016-06-30
   Days after vaccination:1
Submitted: 2016-07-01
   Days after onset:1
Entered: 2016-07-25
   Days after submission:24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L019297 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5186AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Pallor
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)

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

Write-up: 9 cm indurated warm local blanching area surrounding vaccine.


VAERS ID: 650135 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-05-04
Onset:2016-05-04
   Days after vaccination:0
Submitted: 2016-05-05
   Days after onset:1
Entered: 2016-07-25
   Days after submission:81
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M14133 / - UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient was given expired MCV vaccine on 5/4/16.


VAERS ID: 644752 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-07-26
Onset:2016-07-26
   Days after vaccination:0
Submitted: 2016-07-26
   Days after onset:0
Entered: 2016-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L043214 / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15076A / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UI543AA / 0 LA / IM

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

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

Write-up: Patient passed out and urinated.


VAERS ID: 644868 (history)  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2016-07-26
Onset:2016-07-26
   Days after vaccination:0
Submitted: 2016-07-26
   Days after onset:0
Entered: 2016-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR M15149 / 0 RA / SYR
TDAP: TDAP (ADACEL) / SANOFI PASTEUR 7RJ9B / 0 LA / SYR

Administered by: Public       Purchased by: Private
Symptoms: Blood test, Cough, Fatigue, Lethargy, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC as needed for seasonal allergies
Current Illness: NO ILLNESS AT TIME OF VACCINES
Preexisting Conditions: SEASONAL ALLERGIES
Diagnostic Lab Data: Hospital drew blood, check O2 levels, BP and heart rate.
CDC Split Type:

Write-up: 20 minutes after shots: Cough, child looked tired, slightly lethargic, child passed out for about 45 seconds to 1 minute. When he came to, he had no clue what happened and kept passing out. I rushed him to the ER where they treated him for syncope.


VAERS ID: 645267 (history)  
Age: 11.0  
Gender: Male  
Location: New York  
Vaccinated:2016-07-26
Onset:2016-07-26
   Days after vaccination:0
Submitted: 2016-07-26
   Days after onset:0
Entered: 2016-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 0 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M15098 / 0 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS Z924Y / 0 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Syncopal event.


VAERS ID: 644907 (history)  
Age: 11.0  
Gender: Female  
Location: Indiana  
Vaccinated:2016-07-27
Onset:2016-07-27
   Days after vaccination:0
Submitted: 2016-07-27
   Days after onset:0
Entered: 2016-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L024993 / - RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5460AB / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5406AA / 0 LA / IM

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

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

Write-up: Patient left office after getting vaccinated and passed out near the elevator. She quickly came to and Mom brought her back into the office.


VAERS ID: 645036 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2015-11-09
Onset:2015-11-09
   Days after vaccination:0
Submitted: 2016-07-27
   Days after onset:260
Entered: 2016-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L010596 / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA010107

Write-up: This spontaneous report as received from a licensed nurse refers to a 11 year old patient of unknown gender. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 645057 (history)  
Age: 11.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-01-11
Onset:2016-01-11
   Days after vaccination:0
Submitted: 2016-07-27
   Days after onset:197
Entered: 2016-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L007560 / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA009789

Write-up: This spontaneous report was received from a licensed practical nurse and refers to a 11 year old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2016 and on 14-MAR-2016, the patient was vaccinated with doses of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 645079 (history)  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2016-07-20
Onset:2016-07-20
   Days after vaccination:0
Submitted: 2016-07-20
   Days after onset:0
Entered: 2016-07-27
   Days after submission:7
Vaccin­ation