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Case Details (Sorted by Age)

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VAERS ID: 630123 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-03-30
Onset:2016-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2016-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L039093 / - UN / SC

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

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

Write-up: Warm, red, raised itchy welt.


VAERS ID: 630217 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-04-01
Onset:2016-04-01
   Days after vaccination:0
Submitted: 2016-04-01
   Days after onset:0
Entered: 2016-04-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG JEV15B84E / 0 UN / IM
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 584011A / 0 UN / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR L0353 / 0 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Nausea, Pyrexia, Rash pruritic, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Hospitalized? No
Previous Vaccinations: Rash~Rabies (RabAvert)~1~6.00~Sibling|Rash~Typhoid Vi Polysaccharide (Typhim Vi)~1~6.00~Sibling|Rash~Japanese Encephalitis (IXIA
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to egg
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Rash (diffuse, urticaria-type, pruritus) treated w/BENADRYL and prednisolone. Fever (102) treated w/TYLENOL. Nausea/vomiting (1x).


VAERS ID: 630740 (history)  
Age: 9.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2016-04-04
Onset:2016-04-04
   Days after vaccination:0
Submitted: 2016-04-08
   Days after onset:4
Entered: 2016-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. L023232 / 0 LA / IM

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

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

Write-up: Mild urticaria after imm. given 25 mg BENADRYL with resolution of sx after 15 minutes.


VAERS ID: 631702 (history)  
Age: 9.0  
Gender: Male  
Location: Ohio  
Vaccinated:2016-04-15
Onset:2016-04-15
   Days after vaccination:0
Submitted: 2016-04-15
   Days after onset:0
Entered: 2016-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. L023936 / 0 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. L030587 / 0 LA / SC
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 435P7 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: After vaccinations received, patient became dizzy, pale, and diaphoretic. Patient was placed in reclined position with feet elevated, cool compress applied to nape of neck, and patient felt fully recovered after 10 minutes.


VAERS ID: 631835 (history)  
Age: 9.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2016-04-15
Onset:2016-04-15
   Days after vaccination:0
Submitted: 2016-04-18
   Days after onset:3
Entered: 2016-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L019297 / 0 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: 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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nurse who gave pt vaccination states that pt was anxious.
Preexisting Conditions: Nurse who witnessed event states the pt''s mother knew of pt''s past medical hx of seizures. Pt had office visit with physician prior to receiving HPV vaccination, problem of seizures was removed.
Diagnostic Lab Data:
CDC Split Type:

Write-up: After pt. received shot, she stood up started moving around and proceeded to collapse mother caught her and laid her on the ground and pt bumped her head and went into a seizure lasting aprox 20-30 seconds, signs of breathing and pulse pt was turned to her side. Ambulance was called and pt was taken to Hosp.


VAERS ID: 632013 (history)  
Age: 9.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2015-10-16
Onset:2015-10-17
   Days after vaccination:1
Submitted: 2016-04-19
   Days after onset:185
Entered: 2016-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 4M4FS / - LA / IM

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

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

Write-up: LT DELTOID AREA WAS WARM TO TOUCH AND RAISED BELOW FLU INJECTION AREA.


VAERS ID: 633100 (history)  
Age: 9.0  
Gender: Male  
Location: Montana  
Vaccinated:2015-04-26
Onset:2015-04-26
   Days after vaccination:0
Submitted: 2016-04-26
   Days after onset:366
Entered: 2016-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L045956 / 2 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
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: HUMALOG
Current Illness: None
Preexisting Conditions: Diabetes Type 1
Diagnostic Lab Data:
CDC Split Type:

Write-up: Administered #2 dose of varicella too soon for age: previous dose of varicella given 02/04/2015 so this dose should have been given 05/04/2015 per CDC recommendations. Noted this when reviewing the records with client''s mother. Let her know that it was given early but that it is still considered valid.


VAERS ID: 634018 (history)  
Age: 9.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-04-27
Onset:2016-04-27
   Days after vaccination:0
Submitted: 2016-04-27
   Days after onset:0
Entered: 2016-05-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L043213 / 0 RA / UN

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

Write-up: Pt. went to school after receiving vaccine at office, two hours later began to have hives on various parts of body.


VAERS ID: 634661 (history)  
Age: 9.0  
Gender: Male  
Location: Indiana  
Vaccinated:2016-05-06
Onset:2016-05-06
   Days after vaccination:0
Submitted: 2016-05-06
   Days after onset:0
Entered: 2016-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M006139 / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Lacrimation increased, Skin tightness, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lacrimal disorders (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: Prednisone 2.5 mg every other day. Client also receives breathing treatments as needed.
Current Illness: None
Preexisting Conditions: Allergies to dairy, wheat, nuts. Also taking 2.5 mg of prednisone every other day for psoriasis. Child also has environmental allergies.
Diagnostic Lab Data: Client''s allergist was called and was advised to follow up with them for any further concerns.
CDC Split Type:

Write-up: After receiving PPSV vaccine client stated that his "cheeks felt tight and his throat felt scratchy". Eyes became watery. Client also had redness on his face, chest, back, and arms. Client was assessed by nursing staff and was seen by our on-site physician. Client was also given generic BENADRYL and was observed for 30 min after vaccination. Client''s redness did begin to subside following administration of BENADRYL and client reported that his throat and checks "felt normal" prior to leaving the clinic.


VAERS ID: 635133 (history)  
Age: 9.0  
Gender: Unknown  
Location: California  
Vaccinated:2015-11-06
Onset:2015-11-06
   Days after vaccination:0
Submitted: 2016-05-11
   Days after onset:186
Entered: 2016-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L024256 / - 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: WAES1605USA002641

Write-up: This spontaneous report as received from a health professional refers to a 9 year old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 635682 (history)  
Age: 9.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:2016-05-12
Onset:2016-05-13
   Days after vaccination:1
Submitted: 2016-05-13
   Days after onset:0
Entered: 2016-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L001336 / 1 RA / SC

Administered by: Private       Purchased by: Public
Symptoms: Dizziness, Feeling abnormal, Heart rate increased, Injection site swelling, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), 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: Multivitamin
Current Illness: None
Preexisting Conditions: Egg allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt became dizzy, vomited, passed out for "5 seconds" per mother. Heart rate elevated. Injection site swollen. Pt "feels funny". Mother pushed fluids, gave BENADRYL.


VAERS ID: 635728 (history)  
Age: 9.0  
Gender: Unknown  
Location: California  
Vaccinated:2015-11-10
Onset:2015-11-10
   Days after vaccination:0
Submitted: 2016-05-14
   Days after onset:185
Entered: 2016-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L024256 / - 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: WAES1605USA002609

Write-up: This spontaneous report as received from a health professional refers to a 9-year-old patient (gender was not reported). There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 636275 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-05-12
Onset:2016-05-12
   Days after vaccination:0
Submitted: 2016-05-12
   Days after onset:0
Entered: 2016-05-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L046887 / - UN / SC

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

Write-up: Red and swollen lt arm.


VAERS ID: 636294 (history)  
Age: 9.0  
Gender: Female  
Location: New York  
Vaccinated:2016-05-17
Onset:2016-05-17
   Days after vaccination:0
Submitted: 2016-05-19
   Days after onset:2
Entered: 2016-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS KZ4TJ / 3 LA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. L046507 / 2 RA / SC

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

Write-up: Swelling and redness to (R) arm. Dx: cellulitis. Cephalexin 250 mg/mL 10mL po TID x 10 days.


VAERS ID: 636707 (history)  
Age: 9.0  
Gender: Male  
Location: Michigan  
Vaccinated:2015-11-11
Onset:0000-00-00
Submitted: 2016-05-24
Entered: 2016-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2PY24 / - - / IM

Administered by: Private       Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
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: Vaccine Was Given In Error.


VAERS ID: 640296 (history)  
Age: 9.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-04-30
Onset:2016-05-01
   Days after vaccination:1
Submitted: 2016-05-23
   Days after onset:22
Entered: 2016-05-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Injection site swelling, Red blood cell abnormality, Skin warm
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REMICADE
Current Illness: Not sick at this time
Preexisting Conditions: Inflammatory bowel disease (Crohn''s) diagnosed 10/6/2015
Diagnostic Lab Data: No
CDC Split Type:

Write-up: The vaccine was given in my son''s right arm. Everything was fine after the shot was given. It was later that night into the next day, his arm around the injection site swelled up a lot to his shoulder. It became red and hot to touch. Lasted about 4 days. Gave BENADRYL to treat it.


VAERS ID: 637355 (history)  
Age: 9.0  
Gender: Male  
Location: Florida  
Vaccinated:2016-05-28
Onset:2016-05-30
   Days after vaccination:2
Submitted: 2016-05-30
   Days after onset:0
Entered: 2016-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site plaque
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: No
Preexisting Conditions: Hearing defect, cochlear implant
Diagnostic Lab Data:
CDC Split Type:

Write-up: Indurated erythematous plaques in arm distal to administration site and pain.


VAERS ID: 637776 (history)  
Age: 9.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-12
Entered: 2016-06-01
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Angioedema, Cough
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2015057129

Write-up: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 9 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received Influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine, oral antihistamines, oral steroids, bronchodilators and ice pack. The outcome was recovered and the patient was referred to a pediatrician. Reporter''s comments: The attributed trigger was vaccine.


VAERS ID: 638913 (history)  
Age: 9.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2016-06-02
Onset:2016-06-03
   Days after vaccination:1
Submitted: 2016-06-03
   Days after onset:0
Entered: 2016-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 49LH2 / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Hypersensitivity, Pruritus, Rash
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? Yes
Hospitalized? No
Previous Vaccinations: ~Hep A (no brand name)~2~13.00~Sibling|~HPV (Gardasil 9)~1~13.00~Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received HAV vaccine 6/2/16 3 PM, went overnight to grandmothers home and woke up with rash "bumps" to legs and arms with c/o itching. Mom brought child to ER and doctor stated had allergic reaction. RX steroids.


VAERS ID: 640618 (history)  
Age: 9.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-05-27
Onset:2016-05-27
   Days after vaccination:0
Submitted: 2016-06-13
   Days after onset:17
Entered: 2016-06-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M000762 / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site erythema, Pain, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: Immediate erythema surrounding varicella injection site (appropriately 4" in diameter). (+) painful, swollen area marked-BENEDRYL given and iced region with some improvement in office. Child observed for 30 mins. Mom called about 2 hours later with concern of facial swelling, no resp sx''s and swelling self resolved.


VAERS ID: 641101 (history)  
Age: 9.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-06-08
Onset:2016-06-08
   Days after vaccination:0
Submitted: 2016-06-22
   Days after onset:14
Entered: 2016-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M003659 / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Inappropriate schedule of drug administration, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: PROAIR HFA; SINGULAIR; QVAR; Loratadine, ZYRTEC; BENADRYL
Current Illness: Drug hypersensitivity; Drug hypersensitivity; Chronic spontaneous urticaria; Asthma
Preexisting Conditions: Historical Drug, clindamycin, Drug Reaction: Drug hypersensitivity; Historical Drug, SULFA, Drug Reaction: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1606USA004852

Write-up: This spontaneous report as received from a registered nurse (also the patient''s mother and the company employee) refers to a 16 month old male patient. the patient''s concurrent conditions included asthma, chronic idiopathic urticaria, allergy to sulfonamides and allergy to clindamycin. On 29-MAR-2008, the patient was vaccinated with the first dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported). On 06-AUG-2008, the patient was vaccinated with the second dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported). The vaccines were administered within a shorter interval than it was recommended, but no adverse effects were reported. On 08-JUN-2016, the patient was vaccinated with the first 0.5 ml dose of GARDASIL 9 (lot # M003659, expiry date, 20-SEP-2017; route and site of administration were not reported). Concomitant therapies include PROAIR HFA, SINGULAIR, QVAR, loratadine (manufacturer unknown), ZYRTEC and BENADRYL. On 08-JUN-2016, a few hours after vaccination, the patient experienced stomach pain. On 09-JUN-2016 in the morning, the patient started vomiting. The patient did not seek medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of the stomach pain and vomiting was reported as recovered on an unknown date in June 2016. The relatedness between stomach pain and vomiting and VAQTA and GARDASIL 9 was not reported. Additional information has been requested.


VAERS ID: 640587 (history)  
Age: 9.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-06-23
Onset:2016-06-23
   Days after vaccination:0
Submitted: 2016-06-24
   Days after onset:1
Entered: 2016-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site warmth, Mobility decreased, Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: High fever, her whole body is hot, can barely move arm, huge rashy looking red splotch where shot was taken, hot to touch, will be taking her to emergency room after work today on 06/24/16.


VAERS ID: 640649 (history)  
Age: 9.0  
Gender: Male  
Location: Hawaii  
Vaccinated:2016-06-23
Onset:2016-06-24
   Days after vaccination:1
Submitted: 2016-06-25
   Days after onset:1
Entered: 2016-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LA / UN

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

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

Write-up: My son complained headache @ 12pm and it went away after eating lunch, then 6:30pm he was experiencing a severe headache, lying and feeling nausea. I called Dr. who gave him the vaccine yesterday and asked for his advise. I gave him Tylenol to reduce the headache. @7:00PM he vomited a lot and fell asleep right after that. He woke up @9:40pm and said headache got reduced yet still exist.


VAERS ID: 641577 (history)  
Age: 9.0  
Gender: Female  
Location: Vermont  
Vaccinated:2016-06-28
Onset:2016-06-28
   Days after vaccination:0
Submitted: 2016-06-29
   Days after onset:1
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M000995 / 1 LA / SC

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Dizziness, Fall, Foaming at mouth, Gaze palsy, Head injury, Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: fluoxetine; albuterol
Current Illness: No
Preexisting Conditions: Allergy, AUGMENTIN; anxiety; asthma; autism
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient was getting stickers after shot, Mom said patient didn''t respond to her question then patient reported feeling dizzy. Her body became stiff, eyes rolled back, her arms were stiff, foamy mouth and was unresponsive. She fell to the floor. Mom wasn''t able to catch her so she hit her head. Dr. arrived to evaluate and patient came to and was interactive and immediately oriented to where she was but anxious. Fam. history of petit mal seizures. Unclear if episode was syncope/vagal response or seizure, although would be very brief and without postictal phase if seizure. Full exam normal. Reassurance. F/U visit 6/29/16 diagnosed as syncope after vaccination.


VAERS ID: 641223 (history)  
Age: 9.0  
Gender: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-30
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Angioedema, Cough
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (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: Comments: None
Diagnostic Lab Data:
CDC Split Type: USSA2016SA117959

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, 2016SA117960, 2016SA117961, 2016SA117962, 2016SA117963, 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 a nine-year-old female patient who was vaccinated with a dose Trivalent Influenza Vaccine (batch number, dose, route and site of administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date, less than 30 minutes following the vaccination, the patient had experienced Anaphylaxis, Angioedema (eyelid) and cough. The patient required ER/doctor visit. Laboratory data were not reported. The patient received corrective treatment with epinephrine, oral antihistamine, oral steroid, bronchodilators, other (ice pack). On an unspecified date, patient was recovered from all the events. Upon internal review the case was considered as serious because of important medical event: Anaphylaxis. List of documents held by sender: none. Sender''s Comments: The reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. The patient had no medical history. Additional information including but not limited to the patient''s previous immunization history (i.e., previous immunizations and any adverse events following immunizations), concomitant medications, 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: 641438 (history)  
Age: 9.0  
Gender: Female  
Location: Michigan  
Vaccinated:2016-06-21
Onset:2016-06-23
   Days after vaccination:2
Submitted: 2016-06-30
   Days after onset:7
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Private       Purchased by: Private
Symptoms: Full blood count, Mononucleosis heterophile test, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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:
Current Illness: Mom had shingles; recent strep; possible viral URI in home
Preexisting Conditions:
Diagnostic Lab Data: Monospot, CBC
CDC Split Type:

Write-up: Syncope X 1; fever 101-103 at least 7 days.


VAERS ID: 641691 (history)  
Age: 9.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-05
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / 0 UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Computerised tomogram normal, Drug administered to patient of inappropriate age, Electroencephalogram normal, Neurological examination normal, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neurological disorder NOS; Non-Hodgkin''s lymphoma
Diagnostic Lab Data:
CDC Split Type: USSA2016SA116304

Write-up: Initial unsolicited misuse report received from the literature on 20 June 2016. Abstract Background: Approaches to improve the immune response of immunocompromised patients to influenza vaccination are needed. Methods: Children and young adults (3-21 years) with cancer or HIV infection were randomized to receive 2 doses of high-dose (HD) trivalent influenza vaccine (TIV) or of standard-dose (SD) TIV. Hemagglutination inhibition (HAI) antibody titers were measured against H1, H3, and B antigens after each dose and 9 months later. Seroconversion was defined as greater than or equal to 4-fold rise in HAI titer comparing pre- and post-vaccine sera. Seroprotection was defined as a post-vaccine HAI titer greater than or equal to 1:40. Reactogenicity events (RE) were solicited using a structured questionnaire 7 and 14 days after each dose of vaccine, and adverse events by medical record review for 21 days after each dose of vaccine. Results: Eighty-five participants were enrolled in the study; 27 with leukemia, 17 with solid tumor (ST), and 41 with HIV. Recipients of HD TIV had significantly greater fold increase in HAI titers to B antigen in leukemia group and to H1 antigen in ST group compared to SD TIV recipients. This increase was not documented in HIV group. There were no differences in seroconversion or seroprotection between HD TIV and SD TIV in all groups. There was no difference in the percentage of solicited RE in recipients of HD TIV (54% after dose 1 and 38% after dose 2) compared to SD TIV (40% after dose 1 and 20% after dose 2, p=0.27 and 0.09 after dose 1 and 2, respectively). Conclusion: HD TIV was more immunogenic than SD TIV in children and young adults with leukemia or ST, but not with HIV. HD TIV was safe and well-tolerated in children and young adults with leukemia, ST, or HIV. This case involves a 09-year-old male patient who was vaccinated with first dose of FLUZONE HD (batch number, dose, dose in series, site of administration were not reported) intramuscularly on an unknown date (in 2011-12) in the afternoon after recovery from sedation. The patient''s medical history included non-Hodgkin lymphoma and neurological disorder who underwent sedation for a routine imaging study before vaccination. Concomitant medications were not reported. On an unknown date, approximately 4 hours following the vaccination (6 hours after discharged), the patient had increased sleepiness or Grade 2 somnolence and was taken to hospital again and hospitalized for testing and observation. It was inappropriate age at vaccine administration, Drug use in unapproved population and off label use. Relevant laboratory test results included electroencephalography, CT scan, and neurological examination have been unremarkable. The patient''s corrective treatment was not reported. On an unknown date, the patient was recovered from the events (within 2-3 hours) and was discharged from the hospital. Documents held by sender: none. Sender''s Comments: This case refers to a 9 years old male child, a known case of non-Hodgkin lymphoma who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and 6 hours later experienced Grade 2 Somnolence. Time to onset is compatible with the role of vaccine. In this particular case, patient has history of neurological disorder (details not provided). Based on the available information, further investigations such as electroencephalography, CT scan, and neurological examinations were performed and had unremarkable findings (detailed results were not provided). In the absence of any alternative explanation and considering the positive temporal relationship, causality for the reported events with the suspect vaccine cannot be excluded.


VAERS ID: 641693 (history)  
Age: 9.0  
Gender: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-05
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Angioedema, Cough
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA117955

Write-up: Initial unsolicited report received from the literature on 21 June 2016. This case was linked to 2016SA117942, 2016SA117945, 2016SA117946, 2016SA117947, 2016SA117948, 2016SA117949, 2016SA117950, 2016SA117951, 2016SA117952, 2016SA117953, 2016SA117954, 2016SA117955, 2016SA117956, 2016SA117957, 2016SA117958, 2016SA117959, 2016SA117960, 2016SA117961, 2016SA117962, 2016SA117963, 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 a 9-year-old female patient who was vaccinated with a dose of TRIVALENT INFLUENZA VACCINE, (batch number, expiry date, dose, route and site of administration was not reported) on an unspecified date. Patient''s medical history and concomitant medications were not reported and allergic history was reported as none. On an unspecified date, less than 30 minutes following the vaccination, the patient experienced angioedema (eyelid), cough and anaphylaxis (anaphylactic reaction). It was reported that on an unspecified date, the patient required emergency department (pediatrician) visit. Lab data was not reported. Corrective treatments included epinephrine, oral antihistamine, oral steroid, bronchodilators and other (ice pack). On an unspecified date, the patient recovered from the events (also reported as "referred to pediatrician"). Upon internal review the case was considered as serious because of important medical event: anaphylaxis (anaphylactic reaction). Documents held by sender: none. Sender''s Comments: The reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. The patient had no allergic history. 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


VAERS ID: 642062 (history)  
Age: 9.0  
Gender: Male  
Location: Colorado  
Vaccinated:2015-08-11
Onset:2015-08-11
   Days after vaccination:0
Submitted: 2016-07-07
   Days after onset:331
Entered: 2016-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR K1513 / 0 RA / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain, Fatigue, Lethargy, Oropharyngeal pain, Pharyngeal erythema, Pharyngeal oedema, Pyrexia, Somnolence, Streptococcus test negative
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Diagnostic Lab Data: Test Date: 20150811; Test Name: body temperature; Result Unstructured Data: 105 degree(s)/Fahrenheit
CDC Split Type: USSA2015SA123729

Write-up: Based on additional information received on 14 September 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (patient parent) on 17-Aug-2015. A nine years old male patient, had received a first dose of IPOL (dose details, batch number: K1513-1, expiry date: 19-Sep-2016, route and site of administration were not reported) on 11-Aug-2015. There was no illness at the time of vaccination and there were no known allergies. Concomitant medications were not provided. It was reported that it was the first polio vaccine he ever had. On 11-Aug-2015, same day post-vaccination, the patient developed fever to 105 degree F; sore, red, swollen throat that was negative for strep throat test. He also experienced abdominal pain and lethargy and was sleeping more (like a nap in the afternoon) and felt tired. He was vaccinated at his own primary care physician''s office. Corrective treatments were not provided. The patient required ER/doctor visit. At the time of this report, the patient improved and his symptoms had resolved. He recovered from the above mentioned events on an unknown date. Documents held by sender: none. Follow-up information received from a physician on 14 September 2015. The patient received first dose of IPOL in right deltoid. A patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient''s pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were none reported.


VAERS ID: 642621 (history)  
Age: 9.0  
Gender: Male  
Location: Texas  
Vaccinated:2016-04-16
Onset:2016-04-16
   Days after vaccination:0
Submitted: 2016-07-09
   Days after onset:84
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: WAES1607USA002636

Write-up: This spontaneous report was received from a certified medical assistant and refers to a 9 year old male patient. Information on the patient''s concurrent conditions, medical history or concomitant medications was not reported. On 16-APR-2016 at 09:59, the patient was vaccinated intramuscularly in the right arm with his first dose of GARDASIL 9 (lot # L044475 and expiration date 12-MAY-2017, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and 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 source. Additional information is not expected as all required correspondence has been received.


VAERS ID: 642668 (history)  
Age: 9.0  
Gender: Male  
Location: Texas  
Vaccinated:2016-04-27
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 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: WAES1607USA002644

Write-up: This spontaneous report was received from a certified medical assistant and refers to a 9 year old male patient. Information on the patient''s concurrent conditions, medical history or concomitant medications was not reported. On 27-APR-2016 at 17:06, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the right arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34 F 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 several reports received from the same source. Additional information is not expected as all available information was obtained.


VAERS ID: 643514 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-07-12
Onset:0000-00-00
Submitted: 2016-07-15
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SYR

Administered by: Public       Purchased by: Public
Symptoms: Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergies to dust, milk, pet hair, others
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Since she got the shot, got pain in the arm, and after 3 days is getting painful rash under arm.


VAERS ID: 643640 (history)  
Age: 9.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2016-07-11
Onset:2016-07-13
   Days after vaccination:2
Submitted: 2016-07-15
   Days after onset:2
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5180AA / 0 RL / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. L034335 / 0 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Gait disturbance, Joint swelling, Movement disorder, Pain in extremity, Tenderness
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hereditary spherocytosis; Allergic gastroenteritis and colitis; Dysphagia unspecified; Cardiac murmur; Chronic otitis media; Vomits with soy.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mom called to report reactions to vaccine which includes left leg pain, left lower thigh and knee swelling, tenderness, limping, difficulty bending and straightening knee.


VAERS ID: 644504 (history)  
Age: 9.0  
Gender: Male  
Location: Indiana  
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
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 595MR / 0 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M011117 / 0 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. M004895 / 1 RA / SC
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS GS5BR / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Erythema, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 inch wide by 4 inch long reddened & warm area on the back of patient''s right arm, noticed while mother was bathing patient. c/o mild itching, denies pain. No treatment yet.


VAERS ID: 644627 (history)  
Age: 9.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-07-18
Onset:2016-07-18
   Days after vaccination:0
Submitted: 2016-07-23
   Days after onset:5
Entered: 2016-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K007975 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Expired product 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: WAES1607USA007664

Write-up: This spontaneous report as received from a medical assistant refers to a 9 year old patient of unknown gender. The patient''s pertinent medical history and concomitant medications were not reported. On 18-JUL-2016, the patient was inadvertently vaccinated with expired dose of VARIVAX (lot # K007975, expiry date 03-JUN-2016, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.


VAERS ID: 644918 (history)  
Age: 9.0  
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

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: None~ ()~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Adult formulas given HepA.


VAERS ID: 645437 (history)  
Age: 9.0  
Gender: Female  
Location: Michigan  
Vaccinated:2016-01-28
Onset:0000-00-00
Submitted: 2016-07-28
Entered: 2016-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 173906 / 0 UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Asked pt to follow-up with MD. No communication since then.
CDC Split Type:

Write-up: None known.


VAERS ID: 645724 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-07-29
Onset:2016-07-29
   Days after vaccination:0
Submitted: 2016-07-29
   Days after onset:0
Entered: 2016-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 392R1 / 4 LA / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR L14421 / 0 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L034730 / 2 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5257AA / 0 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M006729 / 1 LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Dyskinesia, 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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: After child received Tdap, IPV, Varicella, Hepatitis B and MMR she fainted in chair, Jerky movements noted for 10 seconds. Transitioned to floor until conscious and stable then transported to cot. Lift clinic 2 hrs later with parents.


VAERS ID: 645730 (history)  
Age: 9.0  
Gender: Female  
Location: Oregon  
Vaccinated:2016-07-25
Onset:0000-00-00
Submitted: 2016-07-31
Entered: 2016-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M006157 / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Contusion, Erythema, Induration, Local swelling, Pruritus, Skin lesion
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The day after vaccination the area was 2" raised, red and indurated. St became itchy and other similar lesion appeared. They look bruised after 24 hours. No vesicles.


VAERS ID: 645749 (history)  
Age: 9.0  
Gender: Male  
Location: Arizona  
Vaccinated:2016-07-26
Onset:0000-00-00
Submitted: 2016-07-26
Entered: 2016-08-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9927T / 1 LA / UN

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

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

Write-up: None reported.


VAERS ID: 646433 (history)  
Age: 9.0  
Gender: Female  
Location: Missouri  
Vaccinated:2015-10-29
Onset:0000-00-00
Submitted: 2016-08-04
Entered: 2016-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI496AB / - LA / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Blood glucose fluctuation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HUMALOG INSULIN PUMP
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Celiac disease
Diagnostic Lab Data:
CDC Split Type: USSA2015SA174243

Write-up: Initial unsolicited report received from a consumer on 29 October 2015. This case involves a (age unknown) female patient who was vaccinated with a [route and dose series not reported] dose of FLU VACCINE (batch number, expiry date and site of administration were not reported) on an unspecified date. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as diabetes and celiac disease. It was reported that, patient had received several flu vaccines over the past years. Concomitant medications were not reported. On an unspecified date, "1 to 2 weeks" following the vaccination patient experienced erratic blood sugars. Lab data and corrective treatment were not reported. The outcome of event was recovered. Follow up information received from physician on 30 November 2015. This case involves 09-years-old patient who was vaccinated with 0.5 ml dose of Flu vaccine (batch number: UI496AB, expiry date: 30-Jun-2016) in left deltoid on 29 October 2015. The batch number provided corresponds to the product INFLUENZA QUADRIVAL A-B VACCINE. Concomitant medications included HUMALOG insulin pump. List of documents held by sender: none.


VAERS ID: 646723 (history)  
Age: 9.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-08
Entered: 2016-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

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: WAES1608USA001929

Write-up: Information has been received from an office manager via a company representative referring to an about 9 or 10 year old female patient. There was no concomitant medication for the patient. The patient''s medical history and concurrent condition were unknown. On an unknown date, the patient was vaccinated with VARIVAX (strength, doses, lot#, expiration date and route were not reported) as chicken pox vaccine. In approximately 2012 (reported as around "9 or 10 years of age"), the patient developed shingles. The patient sought medical attention and treatment was given to the adverse event. The patient was recovered from shingles on an unknown date. The relatedness between shingles and VARIVAX was not reported. Additional information has been requested.


VAERS ID: 647082 (history)  
Age: 9.0  
Gender: Female  
Location: Michigan  
Vaccinated:2016-08-09
Onset:2016-08-09
   Days after vaccination:0
Submitted: 2016-08-09
   Days after onset:0
Entered: 2016-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS FY7FK / - LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L040960 / - LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M010485 / - RA / SC

Administered by: Other       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: No known
Preexisting Conditions: None reported / Immunization risk screen = negative
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child and guardian did not speak the language, uncle was assisting family. When uncle was asked to identify child, he gave the wrong name. Patient was given Pediarix instead of Tdap, IPV, HBV. Later identified during sister''s turn for vaccines. MCIR was corrected. No identifiable reaction by patient.


VAERS ID: 647654 (history)  
Age: 9.0  
Gender: Male  
Location: California  
Vaccinated:2016-08-12
Onset:2016-08-12
   Days after vaccination:0
Submitted: 2016-08-12
   Days after onset:0
Entered: 2016-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 7XR47 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Hyperhidrosis, Pallor, Posture abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Few seconds after given vaccine to patient, he started slumping down, with pale and sweaty face. Oxygen was administered, V/S take B/P 110/62, pulse 62, resp 20. Patient became alert and oriented X 4, but mother insisted that paramedic will called because of the paleness and sweaty appearance the patient. Paramedic was called and the patient was taken to Hospital for further evaluation.


VAERS ID: 648031 (history)  
Age: 9.0  
Gender: Male  
Location: Washington  
Vaccinated:2016-08-16
Onset:2016-08-16
   Days after vaccination:0
Submitted: 2016-08-16
   Days after onset:0
Entered: 2016-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AE735 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Panic attack, Skin discolouration
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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: CALLED 911 AND CAPTAIN SAID IT WAS MOST LIKELY PANIC ATTACK
CDC Split Type:

Write-up: PT COMPLAINED OF SHORTNESS OF BREATH, TURNED WHITE, WAS DIZZY AND ABOUT TO PASS OUT.


VAERS ID: 648595 (history)  
Age: 9.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2016-08-16
Onset:2016-08-17
   Days after vaccination:1
Submitted: 2016-08-18
   Days after onset:1
Entered: 2016-08-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M011117 / 0 RA / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Amox - allergies; eczema; and allergic rhinitis
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Developed rash on arm near injection site 24 hrs after receiving it. BENADRYL and hydrocortisone cream.


VAERS ID: 648625 (history)  
Age: 9.0  
Gender: Female  
Location: Florida  
Vaccinated:2016-08-11
Onset:2016-08-11
   Days after vaccination:0
Submitted: 2016-08-19
   Days after onset:8
Entered: 2016-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS L4DF7 / 1 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR L15971 / 1 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L02873 / 1 RA / SC
TD: TETANUS DIPHTHERIA (TENIVAC) / SANOFI PASTEUR US251AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Limb discomfort
SMQs:, Medication errors (narrow)

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

Write-up: Vaccines inadvertently administered second set of catch up vaccines early. First set administered 7-28-2016. Telephone call to child''s father - through interpreter - revealed no adverse effects - denied fever. Some mild arm discomfort.


VAERS ID: 649196 (history)  
Age: 9.0  
Gender: Male  
Location: Michigan  
Vaccinated:2016-08-24
Onset:2016-08-24
   Days after vaccination:0
Submitted: 2016-08-24
   Days after onset:0
Entered: 2016-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 4P9M9 / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L043213 / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abdominal discomfort, Dizziness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Child was given 1st dose of Hepatitis A and HPV with dad present. Dad and child remained in waiting area for 15 mins prior to leaving. Child was eating ice cream and vomited one time and had lightheaded and dizziness. Dad brought child back to LHD. After lying down child felt that his stomach felt "a little better" and less lightheaded/dizziness. BP 128/79 and then 118/68. Dad declined to stay any longer at the LHD. Child was assisted into the sitting position and then into the standing position. Child felt that his stomach was feeling a little better and again less lightheadedness/dizziness. Dad felt that his child would feel better if he ate something and took child home.


VAERS ID: 649214 (history)  
Age: 9.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-08-22
Onset:2016-08-23
   Days after vaccination:1
Submitted: 2016-08-24
   Days after onset:1
Entered: 2016-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / - UN / SYR

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Healthy, no sickness
Preexisting Conditions: None
Diagnostic Lab Data: delayed adverse drug reaction
CDC Split Type:

Write-up: Redness, swelling and warmth around injection site.


VAERS ID: 649813 (history)  
Age: 9.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-01
Entered: 2016-08-25
   Days after submission:329
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Other       Purchased by: Other
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant drugs not reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2016SE14782

Write-up: A report has been received from a Health Professional concerning a 9 year old, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient received only one half of a dose in one nostril. The outcome of the event of patient received only one half of a dose in one nostril is unknown. The report was considered to be non-serious by the company physician.


VAERS ID: 649847 (history)  
Age: 9.0  
Gender: Female  
Location: Unknown  
Vaccinated:2016-03-02
Onset:0000-00-00
Submitted: 2016-03-04
Entered: 2016-08-25
   Days after submission:173
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drugs Not Reported
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: 2016SE25860

Write-up: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Yearly. FLUMIST QUADRIVALENT started on an unknown date. It was reported an expired dose of FLUMIST was given to a patient on 3/2/2016 that expired in February. No adverse events reported. The patient experienced took expired dose which started on 02-Mar-2016. The outcome of the event of took expired dose is unknown. The reporter''s description of the events was as follows: Nurse stated checklist stated: no asthma, heart, lung, kidney or live problems. No fever. No allergies. Received flu shot last year. The report was considered to be non-serious by the company physician.


VAERS ID: 649922 (history)  
Age: 9.0  
Gender: Female  
Location: Unknown  
Vaccinated:2016-02-17
Onset:2016-02-17
   Days after vaccination:0
Submitted: 2016-02-17
   Days after onset:0
Entered: 2016-08-25
   Days after submission:189
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / - - / IN

Administered by: Other       Purchased by: Other
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: Concomitant Drugs Not Reported
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: 2016SE17558

Write-up: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 17-Feb-2016. Nurse reported that she had administered an expired FLUMIST QUADRIVALENT to a 9 year old on 17-Feb-2016. The outcome of the event of administration of expired lot is unknown. The reporter''s description of the events was as follows: healthy child. The report was considered to be non-serious.


VAERS ID: 650992 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-08-22
Onset:2016-08-22
   Days after vaccination:0
Submitted: 2016-08-31
   Days after onset:9
Entered: 2016-09-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L039660 / 0 LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. L023232 / 0 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR M12311M / 0 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L032182 / 0 RA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5467AC / 0 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L046885 / 0 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

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

Write-up: Pt was behind on immunizations, was given what was due and behind on, after approx. 1/2 hr pt was still in wait room and started having SOB and wheezing. Was given O2 by mask, 25 mg BENADRYL and Albuterol TX. Pt was able to breath normally and was transferred to ER by ambulance for further eval.


VAERS ID: 653708 (history)  
Age: 9.0  
Gender: Female  
Location: Arizona  
Vaccinated:2016-08-18
Onset:0000-00-00
Submitted: 2016-08-24
Entered: 2016-09-07
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5272AA / 0 RA / IM

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

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

Write-up: Pt was given the wrong vaccine. Pt was given MENACTRA. She was to receive Hep A.


VAERS ID: 653101 (history)  
Age: 9.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2014-06-22
Onset:2016-08-19
   Days after vaccination:789
Submitted: 2016-09-13
   Days after onset:25
Entered: 2016-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L0433213 / 1 LA / SYR

Administered by: Public       Purchased by: Private
Symptoms: Arthralgia, Fatigue, Headache, Muscle spasticity, Myalgia, Nausea, Seizure, Tinnitus, Urine aluminium, Urine mercury
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: I asked for urine test for high mercury and aluminum
CDC Split Type:

Write-up: She has been to the ER twice with severe convulsions muscle pain ringing of ears nausea she was admitted to hospital with spasticity as her discharge reference she continues to struggle with severe joint pain headaches and fatigue.


VAERS ID: 653271 (history)  
Age: 9.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2016-09-13
Onset:2016-09-13
   Days after vaccination:0
Submitted: 2016-09-14
   Days after onset:1
Entered: 2016-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS Y4955 / 0 LA / IM

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

Write-up: Fever, site swelling, redness, tenderness and heat, nausea.


VAERS ID: 653311 (history)  
Age: 9.0  
Gender: Male  
Location: Texas  
Vaccinated:2016-09-14
Onset:2016-09-14
   Days after vaccination:0
Submitted: 2016-09-14
   Days after onset:0
Entered: 2016-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5587BA / - RA / IM

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

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

Write-up: Patient passed out a few minutes after shot administered.


VAERS ID: 653632 (history)  
Age: 9.0  
Gender: Male  
Location: Oregon  
Vaccinated:2016-09-14
Onset:2016-09-15
   Days after vaccination:1
Submitted: 2016-09-15
   Days after onset:0
Entered: 2016-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI657AA / 3 LA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. L050909 / 3 LA / SC

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

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

Write-up: Redness and swelling at site, approx size little bigger than a quarter, pt reports painful, area was marked and recommended TYLENOL and ice to site. Patient to report back if gets worse.


VAERS ID: 653892 (history)  
Age: 9.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2016-09-16
Onset:2016-09-16
   Days after vaccination:0
Submitted: 2016-09-16
   Days after onset:0
Entered: 2016-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3J3A9 / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness at time of vaccination noted by parent.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx. 5 minutes after giving vaccine mom called out from room stating pt. had fainted. Support Staff and provider assisted, gave pt. apple juice and monitored until pt. felt ok to leave clinic. Approx. 1 hour after pt. left clinic they came back because when in parking lot pt. began to vomit and wouldn''t stop.


VAERS ID: 654307 (history)  
Age: 9.0  
Gender: Female  
Location: Florida  
Vaccinated:2016-05-04
Onset:2016-05-04
   Days after vaccination:0
Submitted: 2016-09-20
   Days after onset:139
Entered: 2016-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L026553 / 1 LA / SC

Administered by: Other       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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1609USA009096

Write-up: Information has been received from a nurse practitioner referring to a 9 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. On 04-MAY-2016 at 15:00, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 654309 (history)  
Age: 9.0  
Gender: Male  
Location: Ohio  
Vaccinated:2016-09-08
Onset:2016-09-10
   Days after vaccination:2
Submitted: 2016-09-12
   Days after onset:2
Entered: 2016-09-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L026602 / 1 LA / UN

Administered by: Public       Purchased by: Public
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; ADDERALL
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain, redness, swelling at injection site. Patient received his HPV on Thursday 8/8/16, the following day woke up to pain redness, swelling. Warmth and swelling extended distally to injection site on 9/12/16. ER visit.


VAERS ID: 654785 (history)  
Age: 9.0  
Gender: Male  
Location: Louisiana  
Vaccinated:2016-09-21
Onset:2016-09-22
   Days after vaccination:1
Submitted: 2016-09-22
   Days after onset:0
Entered: 2016-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5598KA / 1 LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M027879 / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cyanosis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (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: ADHD
Diagnostic Lab Data: Ultrasound ordered
CDC Split Type:

Write-up: Forearm with prominent superficial vasculature, fingers blue.


VAERS ID: 655795 (history)  
Age: 9.0  
Gender: Male  
Location: Montana  
Vaccinated:2016-09-23
Onset:2016-09-24
   Days after vaccination:1
Submitted: 2016-09-27
   Days after onset:3
Entered: 2016-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AE735 / 0 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, 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: None
Current Illness: No
Preexisting Conditions: Penicillin allergy
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Leg at injection site warm and sore day after injection, had softball size red area around injection site by that night (mom outlined with black marker), redness had extended past outline a little bit by next morning. Brother had same vaccine at the same time with no reaction.


VAERS ID: 655724 (history)  
Age: 9.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-10-23
Onset:0000-00-00
Submitted: 2016-09-28
Entered: 2016-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2201AA / 0 UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eczema (EXEMA ALLERGIES.); Comments: None
Diagnostic Lab Data:
CDC Split Type: USSA2016SA149907

Write-up: Initial unsolicited report received from a consumer on 15 August 2016. This case involves a nine-years-old female patient who was vaccinated with a first dose of FLUZONE (batch number, expiry date, dose, site of administration were not reported) via intramuscularly on unspecified date. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as eczema allergies. Concomitant medications were not reported. On unspecified date, following the vaccination patient experienced large raised red area at the injection site with heat and pain. It was reported that patient visited to pediatrician who circled the area. The patient''s mother was instructed to call in about condition of the site as they were concerned about a blood infection. It was reported that it required patient to stay out of school. Lab data was reported as none. Patient received corrective treatment with ATARAX and patient''s mother was instructed to compress. On unspecified date, (few days later) patient recovered from event. Follow up report received from a nurse on 22 Sep 2016. It was reported that Based on information received from the reporter case was not medically confirmed (as vaccine was not administered in their clinic). List of documents held by sender: none.


VAERS ID: 656246 (history)  
Age: 9.0  
Gender: Male  
Location: Ohio  
Vaccinated:2016-09-20
Onset:2016-09-20
   Days after vaccination:0
Submitted: 2016-09-30
   Days after onset:10
Entered: 2016-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR - / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Diarrhoea, Headache, Injection site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Diagnostic Lab Data: Test Date: 20160920; Test Name: body temperature; Result Unstructured Data: 100 degree(s)/Fahrenheit
CDC Split Type: USSA2016SA175465

Write-up: Initial unsolicited report received from a consumer (Patient''s parent) on 21-SEP-2016. This case involves nine year old male patient who was vaccinated with a dose of Fluzone QIV (batch number and expiry date were not reported) via intramuscular route in left deltoid on 20-SEP-2016. Patient had no illness at time of vaccination and the pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Other vaccinations within 4 weeks of vaccination and other concomitant medications were not reported. On 20-SEP-2016, same day post vaccination by the evening, patient had developed symptoms of pain at injection site, stomachache, loose stools, vomiting, headache, shivering, and a temp of 100F. The patient''s laboratory data was reported as none. Corrective treatment was not reported. The events were still present and the outcome of the events was reported as not recovered. List of documents held by sender: none.


VAERS ID: 657557 (history)  
Age: 9.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-10-03
Onset:2016-10-04
   Days after vaccination:1
Submitted: 2016-10-04
   Days after onset:0
Entered: 2016-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI690AB / 1 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: 4 x 6 cm red edematous puritic area distal to injection site with 24 hrs of vaccine administration.


VAERS ID: 658000 (history)  
Age: 9.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2016-10-06
Onset:2016-10-06
   Days after vaccination:0
Submitted: 2016-10-07
   Days after onset:1
Entered: 2016-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. M028323 / 0 RA / 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:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling, pain, and redness to right arm, worsening the following day.


VAERS ID: 658279 (history)  
Age: 9.0  
Gender: Female  
Location: Kansas  
Vaccinated:2016-10-10
Onset:2016-10-10
   Days after vaccination:0
Submitted: 2016-10-10
   Days after onset:0
Entered: 2016-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED WT56407 / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? 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 FELL TO THE FLOOR, SHE HIT HER HEAD ON SIGNAGE ON THE WAY TO THE FLOOR, WHEN SHE CAME TO, WAS PALE AND COMMENCED VOMITING, EMT DISPATCHED AND ASSESSED, ALL VITAL WNL.


VAERS ID: 658301 (history)  
Age: 9.0  
Gender: Male  
Location: Iowa  
Vaccinated:2016-09-26
Onset:2016-09-28
   Days after vaccination:2
Submitted: 2016-10-10
   Days after onset:12
Entered: 2016-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI677AA / 7 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Full blood count normal, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol inhaler
Current Illness: none reported
Preexisting Conditions: bilateral hearing loss
Diagnostic Lab Data: ultrasound done of area - edema noted in area, CBC - WNL
CDC Split Type:

Write-up: Large area of confluent erythema with central injection area having slight induration. There is a clear geographic border where the erythema stops. No urticarial lesions noted. The whole area is warm to touch but not painful, no fluid collection seen, no abscess palpated. Not pruritic.


VAERS ID: 659190 (history)  
Age: 9.0  
Gender: Male  
Location: Idaho  
Vaccinated:2016-10-10
Onset:2016-10-11
   Days after vaccination:1
Submitted: 2016-10-12
   Days after onset:1
Entered: 2016-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI657AA / 0 RA / UN
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M018810 / 0 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Cellulitis, Erythema, Musculoskeletal pain, Oedema, Pain, Pain in extremity, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Gummy bits vitamins
Current Illness: None
Preexisting Conditions: Allergy to bee stings
Diagnostic Lab Data: (r) arm/shoulder cellulitis/poss. rxn to vaccine
CDC Split Type:

Write-up: Edema, erythema, pain of the (R) arm, shoulder and chest area.


VAERS ID: 659203 (history)  
Age: 9.0  
Gender: Female  
Location: Maine  
Vaccinated:2016-10-11
Onset:2016-10-11
   Days after vaccination:0
Submitted: 2016-10-13
   Days after onset:2
Entered: 2016-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 29PD2 / - RA / IM

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

Write-up: R upper arm, swelling, erythema hot to touch extended from shoulder to antecubital region. Cellulitis treatment - Cephalexin 250 mg/5ml 10 ml BID x 7 days.


VAERS ID: 659853 (history)  
Age: 9.0  
Gender: Male  
Location: Utah  
Vaccinated:2016-10-17
Onset:2016-10-17
   Days after vaccination:0
Submitted: 2016-10-17
   Days after onset:0
Entered: 2016-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 9335Y / - RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Nausea, headache.


VAERS ID: 660089 (history)  
Age: 9.0  
Gender: Female  
Location: Florida  
Vaccinated:2016-10-18
Onset:2016-10-18
   Days after vaccination:0
Submitted: 2016-10-18
   Days after onset:0
Entered: 2016-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC 186685 / 0 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Cough, Erythema, Local reaction, Peripheral swelling, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Large local reaction (L) arm - hot, red, swollen and tender. Cough - no wheeze.


VAERS ID: 660124 (history)  
Age: 9.0  
Gender: Female  
Location: Alabama  
Vaccinated:2016-10-06
Onset:2016-10-07
   Days after vaccination:1
Submitted: 2016-10-11
   Days after onset:4
Entered: 2016-10-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI5640KA / 0 LA / UN

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

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

Write-up: Approximately 5-6 cm x 3 cm area of erythema and slight swelling on left upper outer arm, no significant warmth, very minimal tenderness to palpation, no fluctuance, no urticaria. Seen later for worsening at an after hours clinic and 9 x 5.5 cm erythematous wheal on left deltoid, needle mark visible within wheal. Pt had full ROM of left arm.


VAERS ID: 660140 (history)  
Age: 9.0  
Gender: Female  
Location: Florida  
Vaccinated:2016-09-25
Onset:2016-09-29
   Days after vaccination:4
Submitted: 2016-10-12
   Days after onset:13
Entered: 2016-10-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain, Pyrexia
SMQs:, Acute pancreatitis (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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever, abdominal pain.


VAERS ID: 660522 (history)  
Age: 9.0  
Gender: Female  
Location: New York  
Vaccinated:2016-10-13
Onset:2016-10-13
   Days after vaccination:0
Submitted: 2016-10-19
   Days after onset:6
Entered: 2016-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2R654 / - LA / SYR

Administered by: Other       Purchased by: Private
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Opisthotonus, Pallor, Pupil fixed, Tooth injury, Trismus, Unresponsive to stimuli
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), Dystonia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Following discharge from the hospital, appointments were made with our pediatrician. Recommendations were made to consult with pediatric neurologist. Teeth required significant dental bonding, but originals were not found and composites were added. Unknown of nerve or root damage at this time, May take years to determine. Permanent fixtures not available until adulthood. Sleep-deprived EEG and MRI scheduled for 10/21/16 with follow up with neurologist 10/27/16. Missed some school. Released for school, but not physical activity at this point.
CDC Split Type:

Write-up: Moments after flu shot, while observing my younger child receive his shot, I turned to notice my daughter unconscious on the floor of the cafeteria where the shot was administered. Blood was pooling around her face. Her eyes were rolled back in her head. She was unconscious and unresponsive. Her jaw was clamped shut. Her back was arched with her chest forward. Her entire body was stiff. She was white. She was not breathing. 911 was called. She was unresponsive for nearly 30 seconds from when it was noticed she was on the ground. She jumped to her feet. She didn''t know who or where she was. She was solid white and her pupils hadn''t returned. We then realized that significant damage had been done to her teeth. The 2 front adult teeth were broken off. We were not able to find them. She was transported to Hospital of via paramedic level ambulance.


VAERS ID: 660556 (history)  
Age: 9.0  
Gender: Male  
Location: Michigan  
Vaccinated:2016-08-31
Onset:2016-09-02
   Days after vaccination:2
Submitted: 2016-10-20
   Days after onset:48
Entered: 2016-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9S54N / 0 LA / IM

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

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

Write-up: Swelling and hives on left arm/shoulder.


VAERS ID: 660580 (history)  
Age: 9.0  
Gender: Female  
Location: North Dakota  
Vaccinated:2016-10-19
Onset:2016-10-19
   Days after vaccination:0
Submitted: 2016-10-20
   Days after onset:1
Entered: 2016-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5686JA / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site swollen, red and hot. Injection was in the deltoid, swelling went down to forearm.


VAERS ID: 660799 (history)  
Age: 9.0  
Gender: Male  
Location: Indiana  
Vaccinated:2016-10-17
Onset:2016-10-17
   Days after vaccination:0
Submitted: 2016-10-19
   Days after onset:2
Entered: 2016-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3HA7D / 9 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Induration, Injection site induration, Injection site swelling, Injection site warmth, Peripheral swelling, Skin warm
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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Strep throat
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Significant swelling in left arm from proximal shoulder to below left elbow, indurated, warm, non tender. Treated with 12 day steroid course.


VAERS ID: 661092 (history)  
Age: 9.0  
Gender: Male  
Location: Illinois  
Vaccinated:2016-10-18
Onset:2016-10-18
   Days after vaccination:0
Submitted: 2016-10-20
   Days after onset:2
Entered: 2016-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5629MA / - LA / UN

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

Write-up: Lg oval shape red warm hard area on upper LT arm. Parents used ice packs Tuesday night with some relieve.


VAERS ID: 660863 (history)  
Age: 9.0  
Gender: Female  
Location: Georgia  
Vaccinated:2016-10-20
Onset:2016-10-21
   Days after vaccination:1
Submitted: 2016-10-21
   Days after onset:0
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / SC

Administered by: Other       Purchased by: Public
Symptoms: Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Lethargic, 101.9 fever.


VAERS ID: 661294 (history)  
Age: 9.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-06-30
Onset:2016-06-30
   Days after vaccination:0
Submitted: 2016-07-01
   Days after onset:1
Entered: 2016-10-21
   Days after submission:112
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Public       Purchased by: Other
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Pt. was given an unneeded dose of varicella vaccine. Age of patient at time of event: 9 years 6 months 24 days.


VAERS ID: 663992 (history)  
Age: 9.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-08-17
Onset:2016-08-17
   Days after vaccination:0
Submitted: 2016-08-24
   Days after onset:7
Entered: 2016-10-21
   Days after submission:58
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / - UN / UN

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

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

Write-up: An 8 and 9 yr. old received adult HEP A vaccine instead of Pediatric dose. Age of patient at time of event: 9 years 10 months.


VAERS ID: 660974 (history)  
Age: 9.0  
Gender: Female  
Location: Puerto Rico  
Vaccinated:2016-10-07
Onset:2016-10-07
   Days after vaccination:0
Submitted: 2016-10-24
   Days after onset:17
Entered: 2016-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS E97K2 / 4 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Anxiety, Dizziness, Dyspnoea, Erythema, Headache, Rash
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: PR1716

Write-up: Headache, redness of the face, rash, dizziness, difficulty breathing and anxiety.


VAERS ID: 660997 (history)  
Age: 9.0  
Gender: Female  
Location: Maryland  
Vaccinated:2016-10-17
Onset:2016-10-18
   Days after vaccination:1
Submitted: 2016-10-24
   Days after onset:6
Entered: 2016-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC 186111 / - LA / IM

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

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

Write-up: Child received Influenza vaccine on 10/17 at school based clinic. Child noticed redness at injection site on 10/18 while showering and reported to parent at 8pm. Site was reported to be red, swollen and warm to touch. Taken to Pediatric Urgent care and treated with Cephalexin TID for 7 days.


VAERS ID: 661817 (history)  
Age: 9.0  
Gender: Female  
Location: Ohio  
Vaccinated:2016-10-23
Onset:2016-10-23
   Days after vaccination:0
Submitted: 2016-10-26
   Days after onset:3
Entered: 2016-10-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3FK72 / 0 UN / IM

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

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

Write-up: Allergic type reaction, swelling (baseball size), redness, hot skin, no anaphylaxis signs.


VAERS ID: 661975 (history)  
Age: 9.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2016-10-19
Onset:2016-10-24
   Days after vaccination:5
Submitted: 2016-10-27
   Days after onset:3
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 4RX3D / 1 LA / IM

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

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

Write-up: Papular, erythemic, blanchable induration noted from L deltoid extending to L wrist. Most prominent in site of injection on L deltoid, diminishing distally. Worsened since 10/24/16. Pruritic in nature.


VAERS ID: 662060 (history)  
Age: 9.0  
Gender: Male  
Location: Kansas  
Vaccinated:2016-10-24
Onset:2016-10-25
   Days after vaccination:1
Submitted: 2016-10-27
   Days after onset:2
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI657AA / - RA / IM

Administered by: Public       Purchased by: Other
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: no
Preexisting Conditions: allergies. patient had received allergy injections prior to getting flu shot
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Redness/hotness at injection site. Large red area noted to right upper arm. Size measured at 6cm x 6cm. No pain or discomfort. No temperature. Patient treated with a 15mg dose of prednisolone syrup.


VAERS ID: 662088 (history)  
Age: 9.0  
Gender: Female  
Location: Washington  
Vaccinated:2016-10-21
Onset:2016-10-22
   Days after vaccination:1
Submitted: 2016-10-27
   Days after onset:5
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI690AA / - LA / IM

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

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

Write-up: 4 inch area of redness and swelling at injection site, patient was reportedly more tired after vaccine than normal.


VAERS ID: 662312 (history)  
Age: 9.0  
Gender: Female  
Location: California  
Vaccinated:2016-10-12
Onset:2016-10-13
   Days after vaccination:1
Submitted: 2016-10-27
   Days after onset:14
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UO658AA / 12 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Strep Gp A Ag, IA w/Reflex, Throat, Negative; Beta Strep Gp A Culture, Throat, Negative
CDC Split Type:

Write-up: Patient recvd influenza vaccine 10/12/16 came in office on 10/17/16 with c/o patient has fever, sore throat and vomited once. A strep culture was done results were negative.


VAERS ID: 662526 (history)  
Age: 9.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2016-10-25
Onset:2016-10-26
   Days after vaccination:1
Submitted: 2016-10-28
   Days after onset:2
Entered: 2016-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 4A2E2 / - LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site reaction, Pallor, Rash papular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: (L) anterior thigh 23 cm x 8 cm bright erythematous, blanching, papular rash. No streaking, warmth, TTP, or edema. No treatment.


VAERS ID: 666841 (history)  
Age: 9.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2016-08-19
Onset:2016-08-26
   Days after vaccination:7
Submitted: 2016-10-28
   Days after onset:63
Entered: 2016-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. L037968 / - RA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1610USA010287

Write-up: This spontaneous report as received from a nurse practitioner (patient''s mother) via company representative refers to a 9 year old male patient. Patient''s pertinent medical history, concurrent condition and concomitant medication were not known. No previous drug reactions/allergies were reported. On 19-AUG-2016, the patient was vaccinated with PROQUAD (lot # L037968, expiry date 29-MAR-2017) via injection in the upper right arm (strength and dosing details were unknown). About one week after the vaccination (approximately on 26-AUG-2016), the patient experienced red bumps on his face and forehead. The patient was seen by an unspecified eye doctor. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 663017 (history)  
Age: 9.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2016-10-25
Onset:2016-10-26
   Days after vaccination:1
Submitted: 2016-10-26
   Days after onset:0
Entered: 2016-11-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI678AA / - LA / SYR

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

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

Write-up: Erythema, swelling, tenderness (4" in diameter) of left arm at site of injection.


VAERS ID: 663186 (history)  
Age: 9.0  
Gender: Female  
Location: Texas  
Vaccinated:2016-10-24
Onset:2016-10-25
   Days after vaccination:1
Submitted: 2016-10-26
   Days after onset:1
Entered: 2016-11-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI669AB / - RA / IM

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

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

Write-up: Rec''d vaccine 10/24/2016. After band aid removed on 10/25/2016 noted a blister and redness at site. Measured 1 x 1/2 cm erythema and blister. No streaking. DX as local reaction.


VAERS ID: 663513 (history)  
Age: 9.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2016-11-02
Onset:2016-11-02
   Days after vaccination:0
Submitted: 2016-11-02
   Days after onset:0
Entered: 2016-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3J3A9 / 4 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Dizziness, Dyspnoea, Oxygen saturation decreased, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (broad)

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

Write-up: PT GOT FLU VACCINE AT SICK VISIT AFTER GETTING VACCINE PT WENT OUT TO LOBBY AND GOT DIZZY AND FELT WEAK. WE BROUGHT HIM BACK TO EXAM ROOM AND O2 SATS WERE 82, HE HAD A RAPID RESPIRATORY RATE AND HARD TIME BREATHING. WE HAD TO ADMINISTER OXYGEN THERAPY AND GIVE MULTIPLE NEBULIZER TREATMENTS. PT COULD NOT MAINTAIN OXYGEN SATS ON ROOM AIR SO WE HAD TO CALL EMS FOR TRANSPORT TO CLOSEST ER.


VAERS ID: 664228 (history)  
Age: 9.0  
Gender: Male  
Location: Nebraska  
Vaccinated:2016-11-03
Onset:2016-11-04
   Days after vaccination:1
Submitted: 2016-11-05
   Days after onset:1
Entered: 2016-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 7K45B / 0 RA / IM

Administered by: Private       Purchased by: Public
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC; multivitamin
Current Illness: None
Preexisting Conditions: Allergies: Cashews, fish, walnuts, cats, dogs, grass, mold, ragweed, trees, weeds; Birth Defects: None; Conditions: allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed site tenderness, swelling, redness and warmth that started the day after the immunization was given, the symptoms gradually worsened, patient called the office back to report symptoms on 11/5/16 and was scheduled an appointment to be seen. Patient ordered AUGMENTIN antibiotic for treatment of reaction.


VAERS ID: 664633 (history)  
Age: 9.0  
Gender: Female  
Location: Michigan  
Vaccinated:2016-10-26
Onset:2016-10-26
   Days after vaccination:0
Submitted: 2016-11-02
   Days after onset:7
Entered: 2016-11-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5587BA / - LA / IM

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

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

Write-up: Vaccine administered 10/26/16 (L) deltoid. 12 hrs after developed redness, swelling, pain, itching. At 48 hrs post vaccine0redness neck to elbow (L) arm. At 55 hrs post vaccine-redness midline chest. Neck and LUE to elbow. Reports low grade fever.


VAERS ID: 669075 (history)  
Age: 9.0  
Gender: Female  
Location: Florida  
Vaccinated:2016-10-18
Onset:2016-10-18
   Days after vaccination:0
Submitted: 2016-11-07
   Days after onset:20
Entered: 2016-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M015290 / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1610USA013311

Write-up: This spontaneous report was received from a medical assistant and refers to a 9-year-old non-pregnant female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She was not taking any concomitant medications. On 18-OCT-2016, the patient was vaccinated with a dose of VAQTA lot # M015290, expiration date 20-SEP-2017 (dose, route of administration and anatomical location were not reported) to prevent HepA. On 18-OCT-2016, five minutes after receiving VAQTA, the patient experienced fainting. On the same day (reported as one minute later), the patient recovered from fainting. The patient sought medical attention by contacting physician but there was no treatment given for the adverse event. No lab diagnostics studies were performed. The relatedness between fainting and VAQTA was not reported. This was one of two reports received from the same reporter. Additional information has been requested.


VAERS ID: 664872 (history)  
Age: 9.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2016-11-02
Onset:2016-11-02
   Days after vaccination:0
Submitted: 2016-11-09
   Days after onset:7
Entered: 2016-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M004318 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hyperhidrosis, Intensive care, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Liver transplant; Gastrointestinal tube insertion
Diagnostic Lab Data: Body temperature (02-NOV-2016): fever
CDC Split Type: WAES1611USA002956

Write-up: This spontaneous report as received from a medical assistant refers to a 9 year old male patient. The patient''s medical history included liver transplant and gastric tube replacement. There was no information about the patient''s concurrent conditions or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M004318, expiration date: 12-OCT-2017 (exact dose, route of administration and anatomical location were not provided). On 02-NOV-2016, the patient experienced swelling, fever and body sweats after vaccine administration. The patient was admitted to the hospital on the same date and on 03-NOV-2016, during the night he was transferred to intensive care unit (ICU). At the time of the report, the patient had no lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. The reporter considered the events to be life threatening. Additional information has been requested.


VAERS ID: 665067 (history)  
Age: 9.0  
Gender: Female  
Location: Georgia  
Vaccinated:2016-11-07
Onset:2016-11-08
   Days after vaccination:1
Submitted: 2016-11-10
   Days after onset:2
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS EM5X5 / - RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling redness warmth upper extremity.


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