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Case Details (Sorted by Vaccination Date)

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VAERS ID: 434065 (history)  
Age: 42.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:0
Entered: 2011-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1101901 / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)

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

Write-up: Patient experienced numbness and tingling in her tongue and toes. I asked the patient to sit down by the pharmacy so I could watch her and offered to call her physician but she declined. After 10 minutes I talked to her and she said she experienced this before when she took Zyrtec. I told her if the symptoms did not go away she should contact her physician immediately and she agreed.


VAERS ID: 434147 (history)  
Age: 14.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:0
Entered: 2011-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IJ
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IJ

Administered by: Public       Purchased by: Other
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Nausea, Sluggishness, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: convulsions~HPV (Gardasil)~1~14.17~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving the HPV vaccine by Dr. at 11:00am she informed my daughter and I that we could leave. As we were waiting to get picked up at 11:09am patient stated she felt "nauseous" and immediately passed out and went into convulsions (fingers, toes and back became stiff). I tried for a minute and a half to wake my daughter up but she was unresponsive. After lightly smacking her face a couple of times at 11:11am she came back and was very sluggish and unaware. A stranger carried her to the nearest entrance back into clinic where they placed patient in a wheelchair and checked vitals and blood pressure. No further treatment was given and Dr. advised my daughter and I to leave. I am now going to take her to the hospital for a blood test.


VAERS ID: 434153 (history)  
Age: 31.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:0
Entered: 2011-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB459BB / 0 RA / IJ
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1025Z / - LA / IJ
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1293Y / 0 RA / IJ

Administered by: Public       Purchased by: Public
Symptoms: Expired 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: n/a
CDC Split Type:

Write-up: vaccine expired on 9/9/2011


VAERS ID: 434157 (history)  
Age: 22.0  
Gender: Female  
Location: Oregon  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:0
Entered: 2011-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH460AA / - - / IM

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Electrocardiogram normal, Nausea, Rash
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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:
Current Illness: none known
Preexisting Conditions: none known
Diagnostic Lab Data: EKG negative
CDC Split Type:

Write-up: Pt received Fluzone at 2:40pm (lot #UH460AA exp. 06/30/2012). Returned approximately 10 minutes later complaining of shortness of breath & rash on chest. Pulse was 135, BP was 120/70 and SaO2 was 100%. Pt given 25mg Benadryl at 03:00pm and EKG monitoring was placed. At 3:40pm pt continued to feel SOB, given 0.3mg Epinephrine. Pt became nauseous, BP was 138/98, pulse was 123, SaO2 was 100%. Pt transported to ER at 3:45pm.


VAERS ID: 434183 (history)  
Age: 52.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-13
   Days after onset:0
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

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

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

Write-up: severe dizziness


VAERS ID: 434192 (history)  
Age: 55.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / UN
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Local swelling, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Local (L) upper ext. swollen, pain & pain down (L) arm to hand, swelling of hand.


VAERS ID: 434222 (history)  
Age: 49.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-13
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 04849211A / 25 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: THE PATIENT RECIEVED A SINGLE DOSE OF FLUZONE FROM A MULTIDOSE VIAL USING THE NEW PHARMAJET NEEDLE-FREE MACHINE ON FRIDAY, SEPTEMBER 9, 2011 AND BY SATURDAY HER ARM HAD A LARGE HOT RED RASH FROM THE SHOULDER DOWN ABOUT 6 INCHES AND IT WAS PAINFUL AND THE ACTUAL INJECTION SITE HAD A ROUND HARD LUMP ABOUT A CENTIMETER IN DIAMETER. THE RASH WAS GONE BY MONDAY BUT THE HARD LUMP WAS STILL PRESENT AT THE INJECTION SITE AND THE AREA WAS STILL HOT.


VAERS ID: 434228 (history)  
Age: 58.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT424AA / 14 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Pruritus, 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: ALLERGY TO SULFA DRUGS
Diagnostic Lab Data:
CDC Split Type:

Write-up: ITCHY, RED HIVES UNDER LEFT ARM AND ACROSS THE UPPER CHEST AREA


VAERS ID: 434229 (history)  
Age: 45.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100501 / - LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling hot, Oropharyngeal pain, Paraesthesia oral, Swollen tongue, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: After injection I felt warm then weak then dizzy. Approximately one hour after that my tongue began to swell and tingle. I became tachycardic, sore throat, some SOB & tongue cont to have some swelling & tingling. Took 2 MOTRIN 400 mg- BENADRYL Albuterol inhaler.


VAERS ID: 434232 (history)  
Age: 33.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 1 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: After patient left started coughing & had trouble breathing. This started about 30 minutes after the vaccine. She went to ER & received steroid shot. She saw her allergy doctor next day and was feeling little better.


VAERS ID: 434240 (history)  
Age: 40.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT425AA / - RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Chest discomfort, Dyspnoea, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN 24; FLONASE
Current Illness: None
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 1 1/2 hrs. after receiving FLUZONE client began to feel SOB, tightness in her chest, & throat edema. Her symptoms worsened & she went to an Urgent Care clinic. She was given epinephrine, prednisone, ZYRTEC & an inhaler.


VAERS ID: 434249 (history)  
Age: 50.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-13
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AB / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Headache, Rash, 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headaches within 3 hours and hives/rash within 8 hours post vaccination


VAERS ID: 434252 (history)  
Age: 72.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AB / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0895AA / - LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Influenza like illness, Insomnia
SMQs:

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

Write-up: Flu like symptoms. Unable to sleep.


VAERS ID: 434254 (history)  
Age: 75.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AB / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0895AA / - LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Influenza like illness, Insomnia
SMQs:

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

Write-up: Flu like symptoms. Unable to sleep.


VAERS ID: 434286 (history)  
Age: 44.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-13
   Days after onset:0
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AA / - UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Rash, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had rash & hives on most of body, including arms, legs & torso. Starting using po BENADRYL & hydrocortisone cream.


VAERS ID: 434289 (history)  
Age: 11.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-13
   Days after onset:0
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10051 / - UN / IM

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

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

Write-up: Pt called 9-14-11 to report of red itchy splotches in face area. Denied SOB, or trouble breathing or swelling in throat, nose area. Mom said gave BENADRYL last night & it seemed to help.


VAERS ID: 434311 (history)  
Age: 2.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501090P / 0 - / IN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nasonex 50mcg/ACT 1 puff everyday started 8/8/2011.
Current Illness: No
Preexisting Conditions: allergic to Omnicef
Diagnostic Lab Data: No further evaluation from specialist.
CDC Split Type:

Write-up: Rash on face and body.


VAERS ID: 434317 (history)  
Age: 36.0  
Gender: Female  
Location: Oregon  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1101101 / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Back pain, Bone pain, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Initial symptom was aching bone and joint pain in L acromion. This pain progressed over 12 hrs to include L clavicle, L neck, L scapula, L arm. At this time majority of the pain is in L acromioclavicular joint and L upper back. Pain increases great with lifting of L arm. Range of motion is mildly affected due to pain at this time.


VAERS ID: 434319 (history)  
Age: 66.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100512 / 0 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0566AA / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, 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: Gabapentin; Zolpidem; Diazepam
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient described red, swollen, itchy, warm sensation below site of injection.


VAERS ID: 434357 (history)  
Age: 0.51  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4027AA / 2 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH475AA / 0 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916599 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0920AA / 2 - / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Crying, Cyanosis, Hypotonia, Musculoskeletal stiffness
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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: Child cried, had perioral cyanosis, stiffened briefly and then fell limp in mom''s arms. Episode lasted under one minute.


VAERS ID: 434358 (history)  
Age: 40.0  
Gender: Male  
Location: Missouri  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501096P / 0 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM 20 MG
Current Illness: NONE
Preexisting Conditions: GERD TAKEN NEXIUM 20MG RX BY DOCTOR.
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: MODERATE SYSTEMIC ITCHING. PT GIVE 50MG OF BENADRYL STAT WHICH RELIEVED SX''S


VAERS ID: 434360 (history)  
Age: 59.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA673AA / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: No tests performed
CDC Split Type:

Write-up: Patient woke up, turned over and was unable to get out of bed because he felt so dizzy and nauseous. He contacted his physician and was evaluated and prescribed Meclazine (per patient).


VAERS ID: 434383 (history)  
Age: 11.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1005AA / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4056BA / 0 RL / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B058BA / 0 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0608AA / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Arm swollen, area hot to touch 3" x 3". KEFLEX 500 Bid, BENADRYL Bid Hydrocortisone Cr.


VAERS ID: 434386 (history)  
Age: 67.0  
Gender: Male  
Location: Oregon  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-14
   Days after onset:0
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT448AA / - RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / 1 LA / IM

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

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

Write-up: (L) biceps swollen & red.


VAERS ID: 434401 (history)  
Age: 15.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR - / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0786AA / 1 LA / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: fever and body aches


VAERS ID: 434409 (history)  
Age: 70.0  
Gender: Male  
Location: Utah  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. VO3822 / 1 - / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~Pneumo (Pneumovax)~~69.00~Patient
Other Medications: None
Current Illness: none
Preexisting Conditions: Type 1 Diabetes
Diagnostic Lab Data: Medical exam only on Sep 13th
CDC Split Type:

Write-up: Tremendous pain at injection site. I had the pneumonia shot once before in 2010 with relatively little pain. The pain was unbearable. It lasted till today 09/14/2011 and the medication Dr prescribed helped a great deal. The pain medication and other medications were Loritab, Meloxicam, and the equivalent of Claritin.


VAERS ID: 434412 (history)  
Age: 5.0  
Gender: Female  
Location: Alabama  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: allergic reaction~ ()~~0.00~Patient
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness n swollen with blisters


VAERS ID: 434443 (history)  
Age: 77.0  
Gender: Male  
Location: Oregon  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH452AB / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0630AA / 0 LA / IM

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

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

Write-up: Itching, redness, rash, mild pain.


VAERS ID: 434452 (history)  
Age: 20.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:0
Entered: 2011-09-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT443AA / - UN / IM

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

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

Write-up: Lightheadedness, shiver.


VAERS ID: 434460 (history)  
Age: 0.18  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-14
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B171BA / 0 LL / IM
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3913AB / 0 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916044 / 0 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0328AA / 0 - / PO

Administered by: Private       Purchased by: Public
Symptoms: No adverse event
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine
Current Illness: None
Preexisting Conditions: Preemie <2500mg
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given a PENTACEL and a KINRIX. No adverse reaction occurred.


VAERS ID: 444435 (history)  
Age: 4.0  
Gender: Female  
Location: Kansas  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-14
   Days after onset:0
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3916AA / 1 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915707 / 0 LL / UN

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

Write-up: 24hrs after injection, injection site red, swollen and itching. 4-5 inch area on left thigh was warm to touch.


VAERS ID: 434459 (history)  
Age: 1.32  
Gender: Male  
Location: Maine  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3662AA / 3 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB464AA / 0 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0903Z / 0 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Rash, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions: 8/29/11 otitis media
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mom says 24 hours after immunizations given, pt has rash, hives on his face and some wheezing. Mom brought pt to ER and was given DECADRON orally which helped and advised to use BENADRYL as needed.


VAERS ID: 434483 (history)  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:0
Entered: 2011-09-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB472BA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0963AA / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B072DA / 0 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1564Z / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Pt became light headed, dizzy and diaphoretic after GARDASIL was administered at 1420. Doctor notified and Pt was instructed to lay prone. Symptoms subsided at 1455.


VAERS ID: 434495 (history)  
Age: 39.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 465011A / 3 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Activities of daily living impaired, Carpal tunnel syndrome, Condition aggravated, Injection site pain
SMQs:, Dementia (broad), 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: Client received Rabies vaccines (3) in 2008 with no reported reactions.
Current Illness: None reported by client. This was a booster vaccine.
Preexisting Conditions: Client reports history of Carpal Tunnel in right hand
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Client reported painful injection site and a flare-up of her carpal tunnel symptoms in her right hand. Client reported reaction the morning after the injection and contacted her doctor who advised her to use a cool compress and take Ibuprofen for the pain. Client had pain to the point that she sould not go to work on 9/13/11 and 9/14/11.


VAERS ID: 434496 (history)  
Age: 46.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. UNKNOWN / 1 RA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Body temperature increased, Cellulitis, Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (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: none~ ()~~0.00~Patient
Other Medications: un
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling and redness in Right arm. Saw Doctor on 9/14 and was told to take Benadryl and ibuprofen. Saw Doctor on 9/15 was told she had cellulitis and was given oral antibiotics and a injection of antibiotics. She had a temperature.


VAERS ID: 434508 (history)  
Age: 0.19  
Gender: Male  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3929AA / - LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915703 / - RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0194AA / 0 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Crying, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)

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

Write-up: Swollen left thigh, inconsolable.


VAERS ID: 434517 (history)  
Age: 35.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3958BA / - RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Headache, Muscular weakness, Musculoskeletal chest pain, Neck pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Received a call from patient indicating that she had extreme body aches throughout body with more pain centered in her legs and ribs. She was unable to make a fist on 9/13 but, had improved slightly on 9/14. Follow up call made on 9/15 and she indicated that her body aches were improving but, remained with a lot of aching in her neck and c/o a headache that is unrelieved with Ibuprofen or Tylenol.


VAERS ID: 434523 (history)  
Age: 33.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-15
   Days after onset:1
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: No
Preexisting Conditions: 32 weeks pregnant
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pinpoint red dots on left arm and both lower legs


VAERS ID: 434529 (history)  
Age: 64.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Cough, Fatigue, Myalgia, Oropharyngeal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: sore throat 09/12/2011 PM sore throat, cough, sore muscles and joints, fatigue on 09/13/2011 AM


VAERS ID: 434532 (history)  
Age: 6.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Private       Purchased by: Public
Symptoms: Cough, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Nasal congestion, Rhinorrhoea, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Dementia (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: NONE
Current Illness: None
Preexisting Conditions: Red Dye, other then that NONE
Diagnostic Lab Data: There were no diagnostic testing done.
CDC Split Type:

Write-up: We left the doctors office and I brought patient back to school. He went to the lunch room and by then the site of the vaccine for Chicken Pox was swollen and hot, with a 4 inch diameter cicle of red around it. I went home (10 Minutes), got some ibprofen 150mg and had patient take that. I had asked the nurse if I should give him ibprofen becasue that is what I have been told in the past and she said no. So I didn''t give it to him then. In about an hour the swelling and redness was dissapearing. When I pick him up at daycare he was coughing and his nose was stuffy and clear liquid. Tuesday morning he didn''t feel well and was still coughing. Wendesday night he coughed all night and look and felt awful. I took him to the doctors Wednesday Sept 14th. She said he was having a reaction to the shot. Last night he didn''t cough all night, just a little. Today, Sept 15, he seems to be feeling ok, and the cough and stuffy nose is going away. I was told to report this reaction to you by my doctor.


VAERS ID: 434587 (history)  
Age: 69.0  
Gender: Female  
Location: New Mexico  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / 0 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Injection site reaction, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NIASPAN; Gemfibrozil; Omeprazole; COMBIVENT MDI.
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. reported to pharmacy with rash around upper arm around the area of injection site. Rash was red and spotty - localized to right arm only.


VAERS ID: 434548 (history)  
Age: 64.0  
Gender: Unknown  
Location: New Jersey  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2011-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100121 / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0595AA / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dyspnoea, Infection, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Arm at site of injection swelled up - felt painful upon touch - and pt felt shortness of breath - still have pain & swelling in arm 5 days later - MD prescribed a 5 day course of KEFLEX 500mg qid.


VAERS ID: 434570 (history)  
Age: 4.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-15
Entered: 2011-09-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4122CA / 2 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1396Z / 1 LA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916599 / 3 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nothing
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On 9/12/11 pt. received shots around 3 o''clock, no reaction in office. Mom came in for TB results & showed us the reaction on both arms. Per mom patient had fever, gave TYLENOL. Dr saw pt on 9/14 & gave BENADRYL & TYLENOL. (L) arm 5 inch circle, (R) arm 3 inch circle.


VAERS ID: 434578 (history)  
Age: 27.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB982AA / 2 RA / IM

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

Write-up: 9/13/11 began with tenderness, slight swelling, pain to (R) upper arm, 9/15/11 red & warm to touch w/ numbness. 9/15/11 - a.m.: seen & treated by PCP - ice & MOTRIN.


VAERS ID: 434585 (history)  
Age: 5.0  
Gender: Male  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-16
   Days after onset:2
Entered: 2011-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B141BA / - RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0515AA / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0786AA / 1 LL / SC

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

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

Write-up: Right thigh - large induration area & tender to touch. Left thigh - smaller area induration & tender to touch. Low grade fever - cool compresses, MOTRIN, TYLENOL was given ZITHROMAX 200mg/5ml one tsp today 1/2 tsp next 4 days.


VAERS ID: 434592 (history)  
Age: 21.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-15
Entered: 2011-09-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501094P / - - / IN
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB227AA / - AR / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3561DA / - LA / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Drug administered at inappropriate site
SMQs:, Medication errors (narrow)

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

Write-up: Pt received TDAP in left forearm (medic administered injection as TB skin test).


VAERS ID: 434605 (history)  
Age: 41.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-16
   Days after onset:3
Entered: 2011-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / 1 - / IN

Administered by: Military       Purchased by: Other
Symptoms: Body temperature increased, Diarrhoea, Joint swelling, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: malaise~Influenza (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1~40.00~Patient
Other Medications: Wellbutrin, trazodone and Nortrel
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: ankle swelling, diarrhea, nausea, Temp of 100 F


VAERS ID: 434693 (history)  
Age: 68.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-12
Onset:2011-09-15
   Days after vaccination:3
Submitted: 2011-09-16
   Days after onset:1
Entered: 2011-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100101 / 0 LA / UN

Administered by: Other       Purchased by: Public
Symptoms: Dizziness postural, Headache, Hyperhidrosis, Nausea, Sneezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)

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

Write-up: Immunization given 9/12/11; sx began 9/15/11: nausea, headache, sweating but no fever; sneezing & dizziness on standing, naproxen relieves headache; ZOFRAN is not helping nausea.


VAERS ID: 434703 (history)  
Age: 69.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AA / 2 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1111Z / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril 20/25; SYNTHROID 75; Vit. D 1000 IU; Aspirin 81; Coenzyme QID; Fish oil
Current Illness: None
Preexisting Conditions: Hypertension; Hypothyroid; Hypercholes; DM
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Temperature per pt. Redness, swelling, pain at injection site. Symptoms better day 2. Tx TYLENOL/MOTRIN for fever & discomfort, warm compress to area.


VAERS ID: 434625 (history)  
Age: 11.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-15
   Days after vaccination:3
Submitted: 2011-09-17
   Days after onset:2
Entered: 2011-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501103P / 1 - / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3998AA / 0 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B062 / 0 LA / IM

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

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

Write-up: Diffuse swelling, warmth, tenderness, pruritis, erythema of entire upper left arm


VAERS ID: 434630 (history)  
Age: 1.58  
Gender: Female  
Location: Oklahoma  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-17
   Days after onset:5
Entered: 2011-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Military       Purchased by: Other
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (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: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Raised temperature (fever) lethargy, red swollen injection site, cranky (crying). 4 days later onset of high fever (over 103) and lethargy, crying, still red injection site. Fever continues (as does lethargy)


VAERS ID: 434718 (history)  
Age: 62.0  
Gender: Female  
Location: Delaware  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AD / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity, Rash papular, Sensation of heaviness
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D 50,000 IU q 2wks; CA 1200 mg; Flax seed; Fish oil; Multivitamin
Current Illness: None
Preexisting Conditions: Osteoporosis; Allergy codeine, LEVAQUIN, Prednisolone
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Flu shot given (R) deltoid approximately equal to 4:45 pm 9/12/11. Arm felt heavy afterward. Became increasingly painful by 8 pm. Pt. took TYLENOL without relief. Following day used ice & heat - no relief. 9/14 developed redness, warmth & itchy red papular/vesicular rash over (R) deltoid. Responded to MOMETASONE cream today. Rash less itchy. Still with pain (R) deltoid to (R) elbow & (R) scapula. Decreased ROM D/T pain. Now will try ADVIL & continue MOMETASONE for rash. T 98.5 B/P 112/74.


VAERS ID: 434690 (history)  
Age: 73.0  
Gender: Female  
Location: Iowa  
Vaccinated:2011-09-12
Onset:2011-09-17
   Days after vaccination:5
Submitted: 2011-09-18
   Days after onset:1
Entered: 2011-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0661AA / 0 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Petechiae, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (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: PREMPRO; Metoprolol tartrate; Flecainide
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dispersed petechiae and pruritis, treating with diphenhydramine started 09/17/2011.


VAERS ID: 434784 (history)  
Age: 63.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AB / 3 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Anxiety, Chest discomfort, Electrocardiogram, Feeling abnormal, Full blood count, Nervousness
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension; GERD; melanoma
Diagnostic Lab Data: CBC; Comp met; EKG; chest pressure
CDC Split Type:

Write-up: 6 hours after flu shot she developed nervousness, anxiety, head felt like it "cotton cloud".


VAERS ID: 434810 (history)  
Age: 1.26  
Gender: Male  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-19
   Days after vaccination:7
Submitted: 2011-09-19
   Days after onset:0
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Varicella post vaccine
SMQs:

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: Diffuse chicken pox outbreak all over body with pox on face, palms, groin, legs, arms.


VAERS ID: 434818 (history)  
Age: 45.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:7
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3947BA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test, Burning sensation, Feeling cold, Hypoaesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ibuprofen, pseudoephedrine, ortho tri-cyclen (birth control)
Current Illness: none
Preexisting Conditions: regular allergies to grass and dustmites
Diagnostic Lab Data: Had blood work in ER and oxygen/blood pressure monitor. Will have an MRI tomorrow on 9/20.
CDC Split Type:

Write-up: 5 min after shot felt a cold flush up left side of face. Went home, took Benadryl. Next morn, 9/13 woke up with numbness on left side of face and in leg. Called nurse for advice & was told to take Allegra. By noon numbness was still spreading and I was completely numb on left side from top of head to toes. Noticed numbness spreading from left side of face to nose. Left eye was numb above and below. Called nurse & told her we were coming now. I was told to go to the emergency room. Spent aftn there & was sent home to await MRI. Numbness spread to entire body that evening but was not as intense on right side. On 9/14 numbness started to wear off and I felt a burning sensation under skin that lasted thru the day. On 9/15 was just and itchy feeling on face and arms. It is 9/19 and I still have the itchy feeling on face & arms.


VAERS ID: 434939 (history)  
Age: 7.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:7
Entered: 2011-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH462AB / 6 LL / UN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1068AA / 1 RL / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0880Z / 0 RL / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Environmental allergies; Asthma; VSD
Diagnostic Lab Data:
CDC Split Type:

Write-up: See hospital summary.


VAERS ID: 434995 (history)  
Age: 73.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AB / 2 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1111Z / 0 LA / UN

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

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

Write-up: Right arm swelling and redness.


VAERS ID: 435010 (history)  
Age: 4.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-20
   Days after onset:7
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC203178DA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. 0037AA / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0548Z / 1 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Blood culture, Body temperature increased, Full blood count
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: CBC, BLOOD CULTURE
CDC Split Type: TX20110061PR

Write-up: PT PRESENTED IN CLINIC WITH 105.1 TEMP 9/13/11 PATIENT RECEIVING 4 YR VACCINES 9/12/11


VAERS ID: 435032 (history)  
Age: 51.0  
Gender: Female  
Location: Maine  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:7
Entered: 2011-09-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4088AA / - RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol; HCTZ; ASA; PROTONIX; WELLBUTRIN
Current Illness: None
Preexisting Conditions: Oxycodone; DARVOCET; PERCOCET; latex; Simvastatin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Significant swelling, redness, shoulder arm pain, fever to 104, stiff neck lasting approx 48 hrs.


VAERS ID: 435183 (history)  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:7
Entered: 2011-09-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3869AA / 2 RA / IM
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501103P / 0 - / IN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1575Z / 0 LA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E94498 / - LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0136AA / 0 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Adverse reaction, Diarrhoea, Nausea, Pallor, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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: Mother denied illness. Next day called to report of Thallasemia.
Preexisting Conditions: Thallasemia
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccines were given on 9/12/11 in the P.M. (1-4) clinic. The routine screening questions were asked. Mother denied illnesses and previous reactions. No contraindications to live vaccines were noted. Per mother child has thalasemia. This was not divulged during interview. On the evening of 9/12/11, he began to have symptoms. He experienced fever up to 104 degrees, which was controlled by TYLENOL and cooling measures. He was pale, and had nausea and vomiting along with diarrhea. This was from the evening of 9/12/11 until the evening of 9/14/11. On 9/15/11 he returned to clinic for a PPD reading and appeared well and without c/o. The parents felt he was OK. All of this per the mother.


VAERS ID: 435246 (history)  
Age: 4.0  
Gender: Male  
Location: Oregon  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-13
Entered: 2011-09-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1644Z / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0340AA / 1 LL / UN

Administered by: Other       Purchased by: Other
Symptoms: Musculoskeletal stiffness, Streptococcal infection, Streptococcus test, Streptococcus test positive
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: None
Diagnostic Lab Data: As above
CDC Split Type:

Write-up: Pt. developed stiff neck 16 hrs. after vaccine. Also had positive rapid strep. Treated with antibiotics.


VAERS ID: 435257 (history)  
Age: 12.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH464AA / 2 LA / IM

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

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

Write-up: Fever, headache and body aches started 9/12/11 - 9/13/11. Returned to school 9/14/11. Treated with antipyretic.


VAERS ID: 435278 (history)  
Age: 47.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0453AA / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt on ADVAIR
Current Illness: Pt did have breathing problems at the time
Preexisting Conditions: COPD
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt''s wife called on 9-13-11 & stated pt''s rt arm was hurting severely where he received his vaccine. He was unable to move his arm. Onset 9-12-11 at 10pm. Dr prescribed pain meds for the pain.


VAERS ID: 435282 (history)  
Age: 16.0  
Gender: Female  
Location: Virginia  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AD / - LA / UN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0984AA / 0 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 0 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3543AA / 0 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: X 2, 6 x 6 cm sized, erythematous, tender lesions to left upper arm after receiving Hep A, meningococcal & influenza vacin. to site 2 days ago. No hx of diff breathing, no swelling to throat/lips. Advised Rx with ibuprofen & cool compresses to site.


VAERS ID: 435286 (history)  
Age: 78.0  
Gender: Female  
Location: Nevada  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:1
Entered: 2011-09-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100121 / 0 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0933Z / 0 LA / UN

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

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

Write-up: Pt came back to primary w/ swollen left arm. Rph referred pt. to clinic, was given LEVAQUIN and steroid. Arm was swollen and red.


VAERS ID: 435298 (history)  
Age: 18.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:10
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0230AA / - LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 15692 / 0 LA / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Allergic to CEC, history of febrile seizures and asthma
Diagnostic Lab Data:
CDC Split Type: MS11020

Write-up: Patient complained of itching "all over" with a sparse rash on left forearm and right hand. Rash resembles mosquito bites.


VAERS ID: 435385 (history)  
Age: 65.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-14
   Days after onset:2
Entered: 2011-09-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AC / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Headache, Influenza like illness, Lethargy, Pain in extremity, Somnolence, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: On 9/12/11 about 5:30 pm received FLUZONE HD at 10pm patient states she woke with shakes because of chills and symptoms of freezing lasted about 20 minutes. She had tightness in her throat like she couldn''t breathe. Arm hurt from shoulder to elbow. On 9/13/11 she woke up with headache, no appetite, very lethargic & fatigued. Slept all day. On 9/14/11 she feels like she has flu.


VAERS ID: 435648 (history)  
Age: 1.74  
Gender: Female  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3998AA / 0 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC032AA / 1 RL / IM

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

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

Write-up: Swelling, warm, redness, temperature of 100.5 F. Tx: Cool compress. Child continues to play, and is acting normal and is walking with no problem.


VAERS ID: 435401 (history)  
Age: 72.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-18
   Days after onset:4
Entered: 2011-09-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acoustic stimulation tests normal, Asthenia, Balance disorder, Dizziness, Face and mouth X-ray normal, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Second day after shot I became achy, dizzy & had no energy. My equilibrium was terrible. This went on for one week. Sick to my stomach also. Went to the doctor the 3 day. Had a hearing test, facial xray & found nothing that would make me feel that way.


VAERS ID: 435418 (history)  
Age: 29.0  
Gender: Female  
Location: Oregon  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-23
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT481AA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3935AA / 0 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Axillary pain, Back pain, Musculoskeletal pain, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Pain & swelling in my arm pit shoulder, back. Treatment: antihistamine/ NSAIDS.


VAERS ID: 435434 (history)  
Age: 70.0  
Gender: Male  
Location: Indiana  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-18
   Days after onset:4
Entered: 2011-09-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

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

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

Write-up: Same symptom as wife. Did not go to the doctor. Dizziness & loss of energy.


VAERS ID: 435435 (history)  
Age: 75.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-17
   Days after onset:5
Entered: 2011-09-23
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, 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: None
Current Illness: None
Preexisting Conditions: No allergies; has asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient states 2 hours after vaccine, injection site was warm, red, itchy swollen, but went away. Reported 9/17/11 - 5 days after vaccine received.


VAERS ID: 435437 (history)  
Age: 63.0  
Gender: Male  
Location: Indiana  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-16
   Days after onset:3
Entered: 2011-09-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4090AA / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: allopurinol; LIPITOR; multivitamin tabs; metformin HCL; ACTOS; glyburide micronized; Vitamin C; ENABLEX; cranberry extract caps; lisinopril-HCTZ; DIOVAN HCT; ZESTORETIC; LANTUS SOLOSTAR; cephalexin; SILVADENE 1%
Current Illness: burn to bilateral legs, 3% of body
Preexisting Conditions: Uncontrolled diabetes, insulin depd; HTN; hyperlipidemia; neuropathy
Diagnostic Lab Data: Diabetes, uncontrolled insulin dept.; hyperlipidemia; neuropathy; HTN; H/O toe amputation
CDC Split Type:

Write-up: Pt had Tdap injection about 9:30pm. Early morning pt woke with sweatiness, dizziness. Got up & passed out for short time.


VAERS ID: 435439 (history)  
Age: 14.0  
Gender: Male  
Location: Georgia  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:1
Entered: 2011-09-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 50192P / 1 - / IN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0627AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0636AA / 2 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0413AA / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injected limb mobility decreased, 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: FLUMIST given same day
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Negative
CDC Split Type:

Write-up: Pt was given Varicella, HPV & Hep A vaccine on 9/12/11. Developed (L) arm swelling & redness upper bicep/deltoid to elbow. Worse yest. Seen today, got Ibup. swelling decreased, redness present. Sl tender lost full ROM.


VAERS ID: 435473 (history)  
Age: 46.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-23
   Days after onset:10
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AC / 0 LA / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 11742 / 0 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Vaccination complication
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:
Current Illness: HTN, GASTRITIS
Preexisting Conditions: HTN, GASTRITIS, DEPRESSION
Diagnostic Lab Data: ADVERSE REACTION TO PNEUMOVAX
CDC Split Type: TX20110063PR

Write-up: RED ARE W/ PERIMETER OF 4 1/2" X 3 3/4". RIGHT DELTOID AREA RED AND SWOLLEN. SHARP PAIN, FEVER.


VAERS ID: 435662 (history)  
Age: 1.31  
Gender: Male  
Location: California  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-23
Entered: 2011-09-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3916AA / 3 LL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0352AA / 0 RL / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOTRIN/TYLENOL
Current Illness: Fever of 103 max
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever ongoing on and off since immz were given.


VAERS ID: 435759 (history)  
Age: 0.51  
Gender: Male  
Location: Oregon  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-09-26
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3894AA / 2 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4149CA / 0 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916971 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0235AA / 2 - / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: Febrile seizure.


VAERS ID: 435795 (history)  
Age: 57.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-27
   Days after onset:15
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH438AA / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Joint range of motion decreased, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Patient is complaining of arm soreness, tingling, and decrease of range of motion, and it has lasted for more than two weeks after receiving shot.


VAERS ID: 435803 (history)  
Age: 47.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-27
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AB / - UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dyspnoea, Lip swelling, Oropharyngeal pain
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol 50mg QD
Current Illness: None
Preexisting Conditions: PCN; ZITHROMAX; No food; No environmental
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt received Influenza vax on 9/12/11 at about 10 am. Report sore throat, hard to breathe, lips swelling at 1:30pm. No local rxn at vax site. Rxn occurred about 2 1/2 hours after IZ. Went to UC at 730Pm, MD there doubts vaccine rxn.


VAERS ID: 435806 (history)  
Age: 31.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-09-22
   Days after onset:8
Entered: 2011-09-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH438AA / 0 RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0843AA / 0 LA / UN

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

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

Write-up: Patient had red, warm, swollen lump at injection site day after immunization. Lump progressively got harder, redder and more swollen in next 2-3 days. Pt felt sick and feverish. Was diagnosed with cellulitis. Given antibiotics. Recovered 10 days after injection. Site still sore and slightly red.


VAERS ID: 436152 (history)  
Age: 64.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-28
   Days after onset:15
Entered: 2011-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1174Z / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / - RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Laboratory test abnormal, Pyrexia, Sepsis, White blood cell count increased
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLIMARA; Probiotics (unspecified)
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: WBC count, eleva; Body temp, 101 F
CDC Split Type: WAES1109USA02267

Write-up: Information has been received from an office manager concerning a 64 year old female patient with allergic reaction to erythromycin and no pertinent medical history who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (lot number: 668009/1174Z, expiration date: 10-MAR-2012) into the right deltoid region, 0.5 ml. Secondary suspect vaccine included a dose of ADACEL into the right deltoid region. Concomitant therapy included CLIMARA and probiotics formula (unspecified). On 13-SEP-2011, the patient was seen by the physician. At that time, the patient presented with redness and swelling from her right shoulder to her elbow. On unspecified date, unspecified lab work was performed on the patient and it was determined that the patient''s white blood cell count was elevated and that the patient had a fever of 101F. The physician recommended that the patient go to emergency room. Patient drove herself to the emergency room and was admitted to the hospital until 15-SEP-2011. The patient was diagnosed with cellulitis and sepsis. At this time on 20-SEP-2011, the patient was still recovering. Additional information has been requested.


VAERS ID: 436219 (history)  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-27
   Days after onset:14
Entered: 2011-09-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B196BA / - RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0155AA / 1 RA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915707 / 4 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0341AA / 1 LA / UN

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

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

Write-up: Mother of pt stated redness, heat on (R) arm site of IZ, first noticed on afternoon of 9/13/11. At upper arm erythematous, hot to touch, not painful as reported by pt.


VAERS ID: 436269 (history)  
Age: 64.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-27
   Days after onset:14
Entered: 2011-09-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3927AA / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, 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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLIMERA; Multivitamins; Probiotic formula cap.
Current Illness:
Preexisting Conditions: The patient has an allergy to erythromycin and a history of anemia, skin cancer and osteoarthritis.
Diagnostic Lab Data: Not reported
CDC Split Type: 201109066

Write-up: Initial report was received from a health care professional on 20 September. A 64 year-old female patient with an allergy to erythromycin and a history of anemia, skin cancer and osteoarthritis had received on 12 September 2011 an intramuscular right arm injection of ADACEL, lot number C3927AA and an intramuscular right arm injection of PNEUMOVAX (Merck lot number not reported). The next day on 13 September 2011, the patient experienced redness, swelling, induration, hot to touch upper arm area of the right arm. The patient was diagnosed with cellulitis and was hospitalized for two days (dates not reported). Treatments were not reported. Concomitant medication included CLIMERA, Multivitamin and probiotic formula cap. Illnesses at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccines were reported as none. No further information was available at the time of the report. The patient''s outcome was not reported. Documents held by sender: none.


VAERS ID: 436372 (history)  
Age: 59.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-09-12
Onset:2011-09-16
   Days after vaccination:4
Submitted: 2011-09-17
   Days after onset:1
Entered: 2011-09-29
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Influenza, Pain
SMQs:

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

Write-up: Got a flu shot, 3-4 days later seems to have come down with the flu, full blown symptoms not just achy. Wondering if vaccine was not fully inactivated. Have not been out of house or had contact with anyone other than going to pharmacy to get flu shot for 7 days.


VAERS ID: 436355 (history)  
Age: 24.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-24
   Days after onset:11
Entered: 2011-09-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT440AA / 1 LA / IM

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

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

Write-up: Rash on left arm, resolved after taking 1 dose of ZYRTEC. Patient is pregnant.


VAERS ID: 436502 (history)  
Age: 71.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-12
Onset:2011-09-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2011-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AB / 0 LA / IJ

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

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

Write-up: Started to get rash on left breast then other breast, waist, then groin. However no rash at injection site. Pt went to PCP & inconclusive whether it was due to flu vaccine. Pt taking BENADRYL & hydrocortisone cream.


VAERS ID: 436534 (history)  
Age: 17.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-03
   Days after onset:21
Entered: 2011-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

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

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

Write-up: nausea, headaches and fever


VAERS ID: 436626 (history)  
Age: 72.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-03
   Days after onset:21
Entered: 2011-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH471AA / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site reaction, Neuritis
SMQs:, Peripheral neuropathy (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROZEREM 8MG, ULTRACET, MORPHINE SUL ER, MELOXICAM 15MG, LORAZEPAM 1MG,
Current Illness: none
Preexisting Conditions: chronic pain hyper cholesterolemia
Diagnostic Lab Data: unkown
CDC Split Type:

Write-up: severe neuritis radiating from the injection site up into the back of neck and lower skull


VAERS ID: 436644 (history)  
Age: 65.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-17
   Days after onset:5
Entered: 2011-10-03
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH452AB / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Feeling cold, Hyperhidrosis, Laboratory test, Muscular weakness, Nausea, Pruritus, Swelling, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (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: promethazine; REMERON; lorazepam; levothyroxine; NEXIUM; dicyclomine
Current Illness:
Preexisting Conditions: NKDA
Diagnostic Lab Data: Hospital ran test unknown
CDC Split Type:

Write-up: Cold, sweats, shaking, nausea, diarrhea, itching, swelling, weak leg.


VAERS ID: 436843 (history)  
Age: 25.0  
Gender: Male  
Location: Colorado  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2011-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501111P / 1 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Tremor, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

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

Write-up: "Shaking" - vertigo starting 13 Sept 2011 - Rx''d ANTIVERT - vomiting - quarters. Pt to call nurse this afternoon.


VAERS ID: 436970 (history)  
Age: 63.0  
Gender: Female  
Location: Nevada  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-06
   Days after onset:24
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA688AA / 1 RA / IM

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

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

Write-up: Flu vaccine given in right deltoid, the injection site is red, about 1/2 inch wide, slightly swollen, lump underneath and sore to use, vaccination was on 9/12/11 @ 3pm. It was fine for the first week then the soreness and the redness appeared.


VAERS ID: 437021 (history)  
Age: 18.0  
Gender: Female  
Location: Maine  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA670AA / 1 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB446AA / 0 RA / IM

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

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

Write-up: One day after HEP A & flu inj - rash on chest, back, & face. Headache. Steroid cream helps some.


VAERS ID: 437083 (history)  
Age: 5.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-30
   Days after onset:17
Entered: 2011-10-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT451AA / 6 LL / IM

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

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

Write-up: Patient awoke with a high fever 103, was given TYLENOL and still had 103 temp afterward, Pt. felt achy and had no appetite.


VAERS ID: 437106 (history)  
Age: 52.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:16
Entered: 2011-10-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AD / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain, Pain in extremity, Skin warm, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma; kidney disease; fibromyalgia; GERD; High cholesterol; migraines; arthritis; ASA; ZANTAC; VESICARE DONNATAL; tetanus
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day of shot: Mild pain, swelling, heat, small pink area; approx size of 10 year old palm of hand. Next day: Worse pain, larger area of swelling & heat & larger, darker pink area. Approx size of adult average woman hand, wrist to finger tip. Third day: Arm swollen & pain from elbow to shoulder, pink from middle upper arm to shoulder, skin hot, same symptoms more days, then began to clear up. Pinkness last to clear up - thirteen (13) days after flu shot administered.


VAERS ID: 437258 (history)  
Age: 76.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:11
Entered: 2011-10-06
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site pain, Mobility decreased, Neck pain, Pain in extremity
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: cortisone injection; TYLENOL; LIPITOR; PLAVIX; SYNTHROID; iron pill; ASA; losartan; pain patch for pain
Current Illness: None
Preexisting Conditions: Hypertension
Diagnostic Lab Data: None ordered
CDC Split Type:

Write-up: C/o pain going down left arm and shoulder to elbow & neck forearm at times. Unable to move arm due to pain after receiving flu shot. Went back to the doctor and pain meds given, but not relief after a week still having symptoms.


VAERS ID: 437292 (history)  
Age: 4.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-09-12
Onset:2011-09-16
   Days after vaccination:4
Submitted: 2011-09-26
   Days after onset:10
Entered: 2011-10-06
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B171FA / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1482Z / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 06448AA / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Aggression, Body temperature increased, Crying
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Mother reports elevated temperature x2 days. Then on fourth day child throwing tantrums then crying inconsolably, daily on daily basis.


VAERS ID: 438123 (history)  
Age: 32.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB204BA / 2 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Decreased appetite, Headache, Nausea, Oropharyngeal pain, Pyrexia
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, nausea, loss of appetite, sore throat, headache.


VAERS ID: 438164 (history)  
Age: 74.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2011-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100501 / 0 UN / IM

Administered by: Other       Purchased by: Other
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: Penicillin; IPV Dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: None


VAERS ID: 438227 (history)  
Age: 68.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-13
   Days after onset:31
Entered: 2011-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1101301 / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site reaction, Pain, Pruritus, Rash, Rash erythematous, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: On 10/12 she reported red bumps under skin, itching, sting, spreading on upper arms only. Might be flu shot. Same reaction happen when got flu shot last time.


VAERS ID: 438570 (history)  
Age: 0.3  
Gender: Male  
Location: Unknown  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-12
   Days after onset:30
Entered: 2011-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / - UN / UN
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Respiratory distress, Sleep apnoea syndrome, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (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: Unknown~Pneumo (Prevnar13)~1~0.00~Patient
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Premature baby; Born at 27 weeks; Respiratory distress, Sleep apnoea syndrome, first dose of PREVNAR-13 at 2 months of age
Diagnostic Lab Data:
CDC Split Type: 2011241481

Write-up: This is a spontaneous report from a contactable office manager. This reporter reported similar events in the same patient after the first dose of PREVNAR 13. This is the second of two reports. A 4-month-old male patient received the second dose of PREVNAR 13 on 12SEP2011. Additional suspect vaccines administered on 12Sep2011 included a dose of HEPATITIS B VACCINE, a dose of ROTATEQ and a dose of PENTACEL. Past vaccine history included the first dose of PREVNAR 13 administered on 11Jul2011 (at the age of 2 months) with similar events of respiratory distress, sleep apnea and cyanosis. Relevant medical history included premature, born at 27 weeks. Concomitant medication was not provided. On 12Sep2011 the patient experienced the same reactions as after the first dose: respiratory distress and apnea that was responsive to stimulation and was significant enough to turn the patient blue. The outcome of the events was unknown. The patient was referred to pulmonary for urgent appointment and further appointments will be considered. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.


VAERS ID: 438810 (history)  
Age: 1.71  
Gender: Male  
Location: Arkansas  
Vaccinated:2011-09-12
Onset:2011-09-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2011-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3994AA / 3 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB509CA / 0 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH259AB / 3 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0346AA / 0 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E37117 / 3 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0338AA / 0 LL / SC

Administered by: Private       Purchased by: Public
Symptoms: Body temperature increased, Decreased appetite, Full blood count normal, Influenza virus test negative, Rash erythematous, Rash papular, Streptococcus test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC normal; strep negative; influenza A/B negative
CDC Split Type:

Write-up: Ten days after receiving DTaP, Hep A, Hib, MMR, PREVNAR, Varicella presented to office w/ 2d hx temp to 103, decreased appetite, diffuse erythematous papular rash.


VAERS ID: 438817 (history)  
Age: 63.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-10-13
Entered: 2011-10-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Bursa injury, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), 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: Autoimmune; Thyroid; Nerve damage from previous medication; Tinnitus; Sjogrens
Preexisting Conditions:
Diagnostic Lab Data: Exam at Dr''s ofc. determined damage to bursa in shoulder- will take months to heal.
CDC Split Type:

Write-up: Shot given strangely high upon arm at shoulder level- pain immediate, & continued to worsen. Went to MD now 1 mo later still cannot raise arm & arm in pain.


VAERS ID: 438877 (history)  
Age: 31.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-10-14
   Days after vaccination:32
Submitted: 2011-10-18
   Days after onset:4
Entered: 2011-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501094P / 4 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses reporteed at time of vaccination
Preexisting Conditions: No known allergies or medical conditions
Diagnostic Lab Data: Still in process
CDC Split Type:

Write-up: Guillain-Barre syndrome like symptoms.


VAERS ID: 439061 (history)  
Age: 78.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-05
   Days after onset:23
Entered: 2011-10-19
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AA / - LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? 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: Swelling of her arm where she got the shot; didnt hurt at all. Went to bed, in the morning swelling reduced and disappeared by next day. The swelling was in the upper part of arm.


VAERS ID: 439138 (history)  
Age: 79.0  
Gender: Male  
Location: New York  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-05
   Days after onset:23
Entered: 2011-10-19
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AA / - LA / IM

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

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

Write-up: Patient felt "completely drained" and next morning after sleeping, he felt fine.


VAERS ID: 439266 (history)  
Age: 66.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-10-10
   Days after vaccination:28
Submitted: 2011-10-17
   Days after onset:7
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Died? Yes
   Date died: 2011-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Gastric adenocarcinoma; CAD; COPD; Afib; HTN; AVR; Dementia; Seizure disorder; CHF
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439396 (history)  
Age: 0.47  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-21
   Days after onset:39
Entered: 2011-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C391AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916973 / 1 UN / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Blepharospasm, Body temperature increased, Crying, Dyskinesia, Excessive eye blinking, Neurological symptom
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (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: Child was given Tylenol for elevated fever.
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient experienced unconsolable crying for 2-2 1/2 hours. Mom reports that child was "flinching", turning head from side to side, elevated temperature 102-103 degrees F. Noted "eye twitching", other "neuorologic" signs & symptoms.


VAERS ID: 439583 (history)  
Age: 50.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-10-24
Entered: 2011-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR UH460AB / - LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3979CA / - LA / IM

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

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

Write-up: Pt received immunizations on 9/12/11. Called clinic on 10/11/11 reporting arm as still tender & use of arm. Appt scheduled for 10/12/11. Eval on 10/12/11 showed not redness, swelling, or warmth, normal ROM, but tender to palpation.


VAERS ID: 439803 (history)  
Age: 66.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-10-24
   Days after onset:41
Entered: 2011-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA675AA / 0 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Weakness and soreness of muscle.


VAERS ID: 440327 (history)  
Age: 10.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-13
   Days after onset:0
Entered: 2011-10-26
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501090B / 1 - / IN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1005AA / 0 LL / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B060BA / 0 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0706AA / 1 LA / IM

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

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

Write-up: 1" x 2" area of redness at injection site. Slight induration. Slight itching. Hydrocortisone cream. Warm/cool compress.


VAERS ID: 440371 (history)  
Age: 57.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-12
Onset:2011-09-24
   Days after vaccination:12
Submitted: 2011-10-27
   Days after onset:33
Entered: 2011-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA665AA / - RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0895AA / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Pruritus, 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: Itchy, scattered hives on both arms.


VAERS ID: 441256 (history)  
Age: 49.0  
Gender: Female  
Location: Alaska  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-11-03
Entered: 2011-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AB / - RA / IM
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS 4HABB223CA / 0 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. 0047AA / 1 LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3927BA / - LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Pain, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Ppatient presents to immunizations clinic on 2 November 2011. She reports that she has had pain above the injection site of left arm since the day of injection. She notes that it is worse over the past few days and now she has pain in her whole arm. She also notes swelling above her injection site on that side. No redness or induration. No fevers. No systemic symptoms suggestive of anaphylactic event. According to shot record, pt was given MMR and Tdap in that arm. Pt was referred to flight medicine for acute evaluation and treatment.


VAERS ID: 441944 (history)  
Age: 29.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-11-09
   Days after onset:58
Entered: 2011-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11034P / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Deep Muscle soreness after vaccination, worsening over time, so much so that by 10/19/11 was unable to complete lift, push or pull with Left arm without pain.


VAERS ID: 442081 (history)  
Age: 43.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-15
   Days after vaccination:3
Submitted: 2011-10-13
   Days after onset:28
Entered: 2011-11-09
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3561CA / - RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Body temperature increased, Dizziness, Flushing, Headache, Heart rate increased, Muscle spasms, Musculoskeletal stiffness, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Worsening of joint pain & temp, around 100, dizziness & near-fainting, increase in heart rate, facial flushing, headache, muscle spasms in neck & back -on-going. No treatment (stiff back & legs).


VAERS ID: 442263 (history)  
Age: 0.19  
Gender: Male  
Location: Illinois  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-11-07
   Days after onset:56
Entered: 2011-11-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3895AA / 0 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E79665 / 0 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1554Z / 0 - / PO

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

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

Write-up: (R) upper thigh became red & swollen, lower (R) leg became bright red & purplish. Baby cried inconsolably.


VAERS ID: 442590 (history)  
Age: 0.01  
Gender: Male  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-11-15
   Days after onset:64
Entered: 2011-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0480AA / 0 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Crying, Emotional distress, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt. recieved Hep B #2 10/10/2011 and the symptoms were worse. Mother did not notice that it could be related to the vaccine until the second vaccine was given and the baby cried for three days.
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Crying non-stop, fussy, unconsolable.


VAERS ID: 442601 (history)  
Age: 0.51  
Gender: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-11-15
   Days after onset:64
Entered: 2011-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LG / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 LG / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / PO

Administered by: Private       Purchased by: Other
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: Low fever~DT+IPV+Hib+HepB (no brand name)~1~0.17~Patient|Moderate Fever~DT+IPV+Hib+HepB (no brand name)~2~0.33~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Patient has since had another febrile seizure and is scheduled for a sleep deprived EEG 11/18/2011.
CDC Split Type:

Write-up: Patient had a high fever following 6 month immunizations. Also had a low grade fever after 2 month shots, a fever around 103 after 4 month shots but after 6 month shots temperature topped out at over 105 and patient ended up going into a febrile seizure and had to be taken to the ER.


VAERS ID: 443448 (history)  
Age: 47.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-09-12
Onset:2011-09-17
   Days after vaccination:5
Submitted: 2011-11-16
   Days after onset:60
Entered: 2011-11-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100801 / 2 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Audiogram, Deafness bilateral
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine; Insulin; Loratadine; ASA; Simvastatin; Clonazepam; Lisinopril
Current Illness: Chest pain
Preexisting Conditions: Diabetes; Depression; Hyperlipidemia; Hypothyroidism; Kidney disease
Diagnostic Lab Data: Audiogram
CDC Split Type:

Write-up: Patient reported complete bilateral hearing loss several days after receiving flu vaccine. Vaccine was given 9/12/11. Patient reported hearing loss on 9/19/11 that started on 9/17/11.


VAERS ID: 443609 (history)  
Age: 73.0  
Gender: Female  
Location: Utah  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-11-21
   Days after onset:69
Entered: 2011-11-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT437AB / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201111318

Write-up: Initial report was received on 10 November 2011 from a consumer who received the report from the patient. A female patient (age not reported) had received an INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time after receiving the vaccine, experienced a stroke and was hospitalized for ten days (dates not reported). Treatments were not reported. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.


VAERS ID: 443696 (history)  
Age: 67.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2011-11-28
   Days after onset:75
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0895AA / - LA / IM

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

Write-up: Red, Hot, Swelling, hard around injection site. Received Flu vaccination on 9/7/2011.


VAERS ID: 444007 (history)  
Age: 74.0  
Gender: Female  
Location: Maryland  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-11-30
   Days after onset:78
Entered: 2011-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR
Current Illness: None
Preexisting Conditions: High cholesterol
Diagnostic Lab Data: Has not been evaluated by a doctor.
CDC Split Type:

Write-up: Prolonged painful right arm, especially when twisting.


VAERS ID: 444185 (history)  
Age: 66.0  
Gender: Female  
Location: Alabama  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-12-01
   Days after submission:77
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH456AC / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 15 Unknown medications
Current Illness:
Preexisting Conditions: The patient had allergies to seafood, PCN (penicillin) and statin drugs.
Diagnostic Lab Data: Not reported
CDC Split Type: 201108626

Write-up: Initial report was received 13 September 2011 from a health care professional. A 56-year-old female patient who had known allergies to seafood, penicillin and statin drugs, had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number UH459AC on 12 September 2011, and on the day of vaccination she developed a stiff neck, fever of 103F and a headache. The patient called her physician''s office to report the symptoms and was instructed to go to the emergency room. She had not received any other vaccines during the four weeks prior to vaccination and she had no concurrent illness at the time of vaccination. Additional past medical history was not reported; however, the patient had been taking 15 concomitant medications which were unknown by the reporter. Outcome was not recovered. Documents held by sender: None.


VAERS ID: 445979 (history)  
Age: 70.0  
Gender: Male  
Location: Oregon  
Vaccinated:2011-09-12
Onset:2011-09-22
   Days after vaccination:10
Submitted: 2011-12-15
   Days after onset:84
Entered: 2011-12-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH460AB / 1 RA / SYR

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

Write-up: On 9/22, 10 days after injection, pt presents with rash approx 3 around, raised, red bumps, occasional pruritus. Pt reports rash did not occur until approximately 5 days post-injection. He has noted improvement over last 2 weeks. He did not use any creams/ointments.


VAERS ID: 446403 (history)  
Age: 42.0  
Gender: Male  
Location: Nevada  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:29
Entered: 2011-12-28
   Days after submission:78
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0630AA / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B074CA / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: From PCP note: He has had some chills and fever. He has a rash over leg and into groin. He had a PNEUMOVAX on the right side, and it is fine.


VAERS ID: 446746 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2011-11-23
Entered: 2011-12-30
   Days after submission:37
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10061 / 1 UN / IM
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SYR

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2011US06695

Write-up: Case number PHEH2011US06695 is an initial spontaneous report received from a health care professional on 29 Sep 2011: This report refers to an adult female. She was vaccinated with MENVEO (batch number: M10061 and expiry date: Sep 2012) intramuscularly and with Varicella vaccine (batch number and manufacturer: unknown) into the same arm on 12 Sep 2011. After vaccination the arm that had received the injections had swollen up to three inches larger in circumference than the other arm. This was her second dose of MENVEO, first dose was given on an unspecified date but she did not experience any reaction after the first dose. No further information was reported.


VAERS ID: 446628 (history)  
Age: 32.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-12
Onset:2011-11-17
   Days after vaccination:66
Submitted: 2012-01-03
   Days after onset:47
Entered: 2012-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA690AA / 0 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Feeling hot
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nurse administered flu vaccine at 2:30 PM. Patient had increased anxiety before shot was given. Nuirse had patient wait after administering flu vaccine and patient complained of feeling hot. Had patient remove sweatshirt and applied cold rag to back of the neck. Elevated patients legs. Patient was still feeling dizzy. Nurse placed patient on floor and elevated legs. Patient continued to complain of dizziness. BP 120/84, pulse 80, resp 24. Called EMS at 3:15 PM. EMS arrived at 3:25 PM. EMS assessed the patient and decided to take patient to the emergency room.


VAERS ID: 450129 (history)  
Age: 0.18  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2012-02-14
   Days after onset:155
Entered: 2012-02-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B256AA / 0 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF744AA / 0 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E23421 / 0 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB102A / 0 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Cyanosis, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: Born with inverted (R) foot - sees orthopedist
Diagnostic Lab Data:
CDC Split Type:

Write-up: Parent reports child had trouble breathing for 10-15 minutes with cyanosis, 2 hrs. post receiving vaccines. Told by phone by PP to go to Emergency. When they arrived child was better, and was discharged without treatment. Parent denies child had a rash, swelling or fever.


VAERS ID: 450195 (history)  
Age: 0.59  
Gender: Female  
Location: New Mexico  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:8
Entered: 2012-02-23
   Days after submission:156
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - UN / OT

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0013568

Write-up: A non-serious spontaneous report of oral administration of FLUMIST and inadvertent oral administration to 7 month old was received from a health professional concerning a seven-month-old female. On 12-Sep-2011, the patient received FLUMIST orally. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune''s FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.


VAERS ID: 450659 (history)  
Age: 2.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-16
   Days after onset:4
Entered: 2012-02-23
   Days after submission:160
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / - - / IN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0013563

Write-up: A non-serious spontaneous report of two doses of FLUMIST in the same day was received from a consumer concerning a 35-month-old female. Neither patient''s medical history nor concomitant medications were reported. On 12-Sep-2011, the patient received two doses of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune''s FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.


VAERS ID: 450407 (history)  
Age: 35.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2011-09-12
Onset:2012-02-17
   Days after vaccination:158
Submitted: 2012-02-24
   Days after onset:7
Entered: 2012-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0306AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Abortion spontaneous~HPV (Gardasil)~UN~36.00~Patient
Other Medications: CYMBALTA
Current Illness: Pregnancy NOS (LMP = Unknown); Sulfonamide allergy
Preexisting Conditions: Abortion spontaneous complete; Uterine dilation and curettage
Diagnostic Lab Data: Beta-human chorionic, Positive
CDC Split Type: WAES1202USA03278

Write-up: Information has been received from a patient and a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 36 year old female patient with a history of one miscarriage and D&C (dilation and curettage) procedure while on prior therapy with GARDASIL (MSD, WAES 1202USA02959) and drug reaction/allergy to "sulfa" who was vaccinated with the first dose of GARDASIL, 0.5ml, IM., (lot number 666931/0337Z) on 02-MAR-2011, the second dose of with GARDASIL, 0.5ml, IM., (lot number 667930/1561Z) on 02-MAY-2011 and the third dose of with GARDASIL, 0.5ml, IM., (lot number 668554/0306AA) on 12-SEP-2011. The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. Concomitant therapy included CYMBALTA. Consumer reported that on 12-SEP-2011, she received the third dose of GARDASIL and on unknown date, also reported as "recently" became pregnant. Consumer stated that on 17-FEB-2012 she lost the baby again. Consumer reported that she contacted her physician. Pregnancy test, "blood work" and HCG (beta-human chorionic gonadotropin) levels studies were performed. The patient''s outcome was unknown at the time of report. Upon internal review, "lost the baby again" was considered to be other important medical event. Additional information has been requested.


VAERS ID: 450791 (history)  
Age: 0.52  
Gender: Female  
Location: Illinois  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2012-02-28
   Days after onset:167
Entered: 2012-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B256AA / 2 LL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4114BA / 0 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0235Z / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F13676 / 2 RL / UN

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Urticaria 48 hours post vaccination on 9/12/11. Was given BENADRYL.


VAERS ID: 451685 (history)  
Age: 58.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2012-03-06
   Days after onset:176
Entered: 2012-03-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0569AA / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Discomfort, Induration, Mass, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA03008

Write-up: Information has been received from a physician concerning a 58 year old female patient who on 12-SEP-2011, was vaccinated in the left deltoid with the third dose of RECOMBIVAX HB thimerosal free (lot# 669935/0569AA, expire on 01-NOV-2013). The physician reported that his patient had a delayed reaction to RECOMBIVAX HB after the third dose. The patient experienced "a fair amount discomfort at the time of the injection". Two weeks later "on 26-SEP-2011", the patient had increasing pain, swelling, induration at the shoulder ("6 cm lump"). There was no erythema, the patient was afebrile, but the area was slightly warm to the touch. There was not treatment given to the patient. At the time of the report, the patient had not recovered. The patient sought medical attention. Additional information has been requested.


VAERS ID: 456012 (history)  
Age: 2.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-09-12
Onset:2011-09-19
   Days after vaccination:7
Submitted: 2012-05-23
   Days after onset:247
Entered: 2012-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0048AA / 0 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Activities of daily living impaired, Conjunctivitis, Convulsion, Electroencephalogram normal, Epilepsy, Mobility decreased, Nuclear magnetic resonance imaging normal, Pyrexia, Red blood cell sedimentation rate increased
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conjunctival disorders (narrow), Ocular infections (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: nothing
Current Illness: none never had been really sick and never been on antibiotic
Preexisting Conditions:
Diagnostic Lab Data: MRI and EEG came back normal so they are hoping he with grow out of it but too early to tell what the prognosis will be.
CDC Split Type:

Write-up: First conjunctivitis then 2 days later high fever of 104 and 1 week after can''t even move joints in every part of body to the point he couldn''t get out of bed. Sed rate level was elevated and the week after that he has 3 seizures within 24 hours. Now he is diagnosed with epilepsy and is on heavy meds for it.


VAERS ID: 457070 (history)  
Age: 63.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-16
   Days after vaccination:4
Submitted: 2012-01-08
   Days after onset:114
Entered: 2012-06-09
   Days after submission:152
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AB / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B071CA / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash, erythema multiforme & urticaria pruritus.


VAERS ID: 458561 (history)  
Age: 9.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-09-12
Onset:2011-09-14
   Days after vaccination:2
Submitted: 2012-07-02
   Days after onset:292
Entered: 2012-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH456AA / 5 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: PROAIR inhaler; FLOVENT inhaler
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mom had taken picture of 4 in x 4 in hive 2 days after the vaccine given last September. Brought picture in today (7/2/12). Provider requested VAERS done. Hive lasted x 1wk no other c/o.


VAERS ID: 460376 (history)  
Age: 0.51  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-09-12
Onset:2012-06-16
   Days after vaccination:278
Submitted: 2012-07-25
   Days after onset:39
Entered: 2012-07-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3926AC / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Culture positive, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 2 doses of PENTACEL; lot number C3872AB received on 16 May 2011 and lot number C3911AA received on 25 July 2011.
Diagnostic Lab Data:
CDC Split Type: 201207014

Write-up: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 15-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3872AB received on 16 May 2011, lot number C3911AA received on 25 July 2011 and lot number C3926AC received on 12 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough with a whoop on 16 June 2012, approximately nine months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and positive culture on 20 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 July 2012, the subject''s cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.


VAERS ID: 464082 (history)  
Age: 16.0  
Gender: Female  
Location: D.C.  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2012-09-04
   Days after onset:358
Entered: 2012-09-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0318Z / 2 UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone; BACTRIM; NEXIUM; Ursodiol; PROGRAF
Current Illness: None
Preexisting Conditions: S/P Liver transplant secondary fulminant hepatic failure
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient developed low grade fever on 12SEP2011 with no associated signs & symptoms. Fever started a few hours after receiving her third GARDASIL shot. This resolved spontaneously the same day.


VAERS ID: 467781 (history)  
Age: 30.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2012-10-04
Entered: 2012-10-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA666CA / - UN / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3921AA / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Gestational diabetes, Gestational hypertension, Laboratory test normal, Maternal exposure during pregnancy, Ultrasound antenatal screen normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy
Preexisting Conditions: The patient''s medical history was not known. Follow-up on 24/Sep/2012: The patient had no family history of congenital abnormality.
Diagnostic Lab Data:
CDC Split Type: 201109163

Write-up: Initial report received from a health care professional on 22 September 2011. A 30-year-old female patient received dose 1 of an intramuscular injection (site not reported) of ADACEL, sanofi pasteur Ltd lot number C3921AA, on 12 September 2011. The patients'' weeks of gestation at the time of vaccination and the Estimated Date of Delivery were unknown. The date of the patient''s Last Menstrual was reported as 26 July 2011. The patient''s obstetrical history, current medical history and concomitant medication were unknown. The patient experienced no adverse event. The outcome was reported as unknown. Follow-up information was received from a health care professional on 24 September 2012. The patient developed gestational diabetes and hypertension during pregnancy. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient''s estimated date of delivery was 02 May 2012. Diagnostic testing included cystic fibrosis negative, AFPU negative and ultrasounds normal. A single male child was delivered at 39 weeks gestation by cesarean section on 23 April 2012. Apgar scores were 9 and 9 at one minute and five minutes respectively. Height was 50 cm and weight was 4 kg. Congenital abnormalities were reported as no. Documents held by sender: None.


VAERS ID: 479316 (history)  
Age: 0.51  
Gender: Female  
Location: California  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2012-12-27
   Days after onset:472
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 - / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Diet refusal, Injection site swelling, Insomnia, Pain, Pyrexia, Speech disorder developmental
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever for over 48 hours of 102F (tried children''s --Tylenol as prescribed on prior to vaccine and after the vaccine did not work). Pain anytime her leg moved. Wouldn''t sleep for more than 2 hours (7 days). Wouldn''t eat solids and often refused bottle (force fed fluids) for one week (7days). Swollen 2x the size at the injection site (lasted 4 days on day 5 swelling started to go down but wasn''t complete till day 7). Stopped babbling (said mom only) after vaccine (day of, baby talk) until 18 months (only says 1 word often knows how to say 4 others but only said them twice each). Possible disability, will be evaluated 1/3/13.


VAERS ID: 480790 (history)  
Age: 1.51  
Gender: Male  
Location: Colorado  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2013-01-09
   Days after onset:485
Entered: 2013-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LL / -

Administered by: Private       Purchased by: Private
Symptoms: Autism spectrum disorder, Irritability, Sleep disorder, Speech disorder developmental
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Meconium aspiration at birth
Diagnostic Lab Data: PDD-NOS (pervasive developmental disorder - not otherwise specified) - Autism spectrum disorder
CDC Split Type:

Write-up: Extreme irritability speech ability regression, sleep pattern disruption.


VAERS ID: 491130 (history)  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2013-05-07
Entered: 2013-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0410AA / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 09/12/2011, Human chorionic gonadotropin, Positive, 5 weeks gestation
CDC Split Type: WAES1109USA01366

Write-up: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 year old female with no pertinent medical history and no drug reaction or allergy who on 12-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # 670099/0410AA). Concomitant therapy included MENVEO, BOOSTRIX and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid on 12-SEP-2011. Urine pregnancy test was performed on12-SEP-2011. It was learned "later that day" that the patient was pregnant (positive 5 weeks gestation). Last menstrual date was on 03-AUG-2011 and estimated delivery date was on 09-MAY-2012. The patient did not seek medical attention. At the time of the report, no adverse effects were seen. Follow up information has been received from registered nurse. She reported that the Health Department had no information regarding the patient or her pregnancy outcome. She stated that the patient had only came in for her immunizations and had no forwarding medical provider information to give to follow up regarding her pregnancy care. Additional information is not expected.


VAERS ID: 524211 (history)  
Age: 24.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-12
Onset:2012-05-29
   Days after vaccination:260
Submitted: 2014-02-28
   Days after onset:640
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose abnormal, Caesarean section, Complication of pregnancy, Exposure during pregnancy, Haemoglobin decreased, Haemorrhage in pregnancy, Human chorionic gonadotropin positive
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis; Herpes simplex, Continuing
Preexisting Conditions:
Diagnostic Lab Data: Urine beta-human chorionic gonadotropin test (04-OCT-2011): positive; GBS: +, abnormal; Complicated antepartum course with a decreased haemoglobin to 9.2.
CDC Split Type: WAES1110USA02090

Write-up: Information has been received from a nurse practitioner (N.P.), for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with herpes simplex virus and no drug reactions or allergies who on 12-SEP-2011 was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). There was no concomitant medication. The N.P. reported that the patient had positive pregnancy test (by urine) on 04-OCT-2011. The N.P. stated that the patient was a few days pregnant when she received the vaccine. No adverse effects to report. The Last menstrual period (LMP) was 25-AUG-2011 and the Estimated Delivery Date (EDD) was 31-MAY-2012. The patient sought unspecified medical attention. At the time of the report, the outcome of the pregnancy was unknown. Follow up information has been received from the nurse practitioner concerning the 24 year old female patient. A girl baby was born via C-section on 29-MAY-2012 at 39 weeks and 5 days. The gestational blood sugar (GBS) performed positive (+) (also reported as "GBS+"). The patient had a complicated antepartum course with hemorrhage and decreased haemoglobin (HB) to 9.2 but was discharged in good condition on post-partum day 4. As far as she knew the baby was normal and healthy. There were no congenital anomalies or problems with the baby mentioned in the chart. The infant was a baby girl and weighed 4.425 kg. Apgar scores were 8 and 9. The outcome of the C-section was unknown. Upon internal review, C-section was considered as medically significant. Additional information is not expected.


VAERS ID: 543685 (history)  
Age: 80.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2011-09-12
Onset:2014-09-12
   Days after vaccination:1096
Submitted: 2014-09-12
   Days after onset:0
Entered: 2014-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5016AA / - RA / IM

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

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

Write-up: Pt received flu vaccine and then reported feeling dizzy at check out in front store to store associate. Pt was given a seat to sit in, was offered a call to 911 but denied it, had a cup of water and then left with husband. RPh called pt at home and she stated she was feeling fine.


VAERS ID: 434667 (history)  
Age: 5.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:3
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS AC20B176AB / - UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Craniocerebral injury, Hypertonia, 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), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0747420A

Write-up: This case was reported by a physician via regulatory authority (#147661) and described the occurrence of loss of consciousness in a 5-year-old female subject who was vaccinated with INFRANRIX-POLIO (GlaxoSmithKline), MMR vaccine (non-GSK). On 12 September 2011, the subject received unspecified dose of INFANRIX-POLIO (intramuscular, unknown injection site), unspecified dose of MMR vaccine (non-GSK), (intramuscular, unknown injection site). On 12 September 2011, less than one day after vaccination with INFANRIX-POLIO and MMR vaccine (non-GSK), the subject experienced loss of consciousness, cranial trauma and hypertonia nos. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-POLIO and MMR vaccine (non-GSK).


VAERS ID: 434766 (history)  
Age: 9.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-16
   Days after onset:4
Entered: 2011-09-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C3811AB / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Muscle twitching
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient fainted once before. Diagnostics showed no pathological findings.
Diagnostic Lab Data:
CDC Split Type: E201105433

Write-up: Case was received from a healthcare professional on 12-Sep-2011. Case is medically confirmed. A 9-year-old male patient received a booster dose of COVAXIS (lot-no. C3811AB) IM into the left upper arm on 12-Sep-2011. Immediately p.v., he presented with unconsciousness and twitching for five seconds. He was treated with oxygen and recovered. The same day, the patient was transmitted by an emergency doctor to hospital with suspicion of convulsion. It was reported that the boy fainted once before. Diagnostics at that time showed no pathological findings.


VAERS ID: 435276 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:10
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA147AA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Bed rest, Cold sweat, Dizziness, Pallor, Presyncope
SMQs:, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 12Sep2011, 84/60mmHg; Blood pressure, 12Sep2011, 105/50mmHg; Body temperature, 12Sep2011, 36.1deg. C.
CDC Split Type: B0748796A

Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature before the vaccination was 36.1 degrees Centigrade. On 12 September 2011, at 16:30, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 12 September 2011, at about 16:40, 10 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, cold sweat, lightheadedness and facial pallor. The subject''s consciousness was lucid and she experienced neither dyspnea nor rash. The blood pressures (BP) were 84/60 mmHg. She was followed up for observation on bed rest and the events gradually improved. Ten minutes later, BP were 105/50 mmHg. The physician considered the events were clinically significant (or requiring intervention). On 12 September 2011, at 17:20, the events were resolved. The physician considered the events were unrelated to vaccination with CERVARIX.


VAERS ID: 435280 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:10
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143CA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy, Loss of consciousness, Muscular weakness, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0748001A

Write-up: This case was reported by a physician and described the occurrence of tonic convulsion in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Before vaccination, the body temperature was 36.7 deg.C. On 12 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 12 September 2011, 5 minutes after vaccination with CERVARIX, the subject experienced tonic convulsion and lost of consciousness. Epilepsy was suspected. After 15 seconds, she regained consciousness but a feeling of weakness persisted in the upper extremity of the inoculated site for a while but disappeared in approximately 30 minutes. The physician considered the events were clinically significant (or requiring intervention). On 12 September 2011, the events were resolved. The physician considered that possible epilepsy was related to vaccination with CERVARIX.


VAERS ID: 435542 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:11
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146BA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia
SMQs:, Haematopoietic erythropenia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0747977A

Write-up: This case was reported by a physician and described the occurrence of anemia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included influenza virus vaccine (manufacturer unspecified; route and injection site unknown) given on an unspecified date. On 12 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 12 September 2011, 2 minutes after vaccination with CERVARIX, the subject experienced symptom of anaemia. She was immediately laid down on the bed. 4 minutes after the blood pressure was measured, the symptom of anaemia had improved. The physician considered the event was clinically significant (or requiring intervention). On 12 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.


VAERS ID: 435546 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-23
   Days after onset:11
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0747967A

Write-up: This case was reported by a physician and described the occurrence of syncope in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included Influenza virus vaccine (manufacturer unspecified; route and injection site unknown) given on an unspecified date, after this vaccination the subject experienced the same event. On 12 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, injection site unknown, batch number not provided). On 12 September 2011, immediately after vaccination with CERVARIX, the subject experienced syncope and loss of consciousness. After she laid down, her condition recovered. the physician considered the events were clinically significant (or requiring intervention). On 12 September 2011, the events were resolved. The physician considered the events were unrelated to vaccination with CERVARIX.


VAERS ID: 435769 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-13
   Days after vaccination:1
Submitted: 2011-09-26
   Days after onset:13
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein increased, Platelet count decreased, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0749155A

Write-up: This case was reported by a physician and described the occurrence of platelets decreased in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site, batch number not provided) given on 12 August 2011. On 12 September 2011, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, unknown injection site, batch number not provided). On 13 September 2011, 1 day after vaccination with CERVARIX, the subject experienced fever. On 15 September 2011, 3 days after vaccination with CERVARIX, the subject experienced platelets decreased and CRP increased. The subject was hospitalised. At the time of reporting the outcome of the CRP increased was unspecified and the fever and platelets decreased were unresolved. The physician considered the events were related to vaccination with CERVARIX.


VAERS ID: 435927 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-27
   Days after onset:15
Entered: 2011-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146BA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Cough, Feeling abnormal, Nausea, Pallor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), 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: Scoliosis
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 12Sep2011, 88/50mmHg
CDC Split Type: B0749074A

Write-up: This case was reported by a physician and described the occurrence of anaphylaxis in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included scoliosis. The subject has not experienced first menarche yet. On 12 September 2011, at 16:18, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 12 September 2011, at 16:19, 1 minute after vaccination with CERVARIX, the subject experienced anaphylaxis. While the subject and her mother were receiving a post-inoculation explanation, the subject experienced cough, ill complexion and complained that she "felt like vomiting". Therefore, she was placed supine in bed. Blood pressure was 88/50 mmHg without bradycardia or arrhythmia. Her complexion returned to normal in about 15 minutes and she went home by bicycle 30 minutes after the inoculation. She again complained of poorly feeling on the way home and stopped by a nearby hospital to lie down and recovered from the symptom in about 10 minutes. On 13 September 2011, she felt well and went to school. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The physician considered the events were related to vaccination with CERVARIX.


VAERS ID: 436205 (history)  
Age: 3.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:17
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / 4 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Hyperhidrosis, Loss of consciousness, Pallor, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute otitis media; Cold; Contrast media allergy
Preexisting Conditions: Collapse unspecified; Eating disorder; High blood pressure; Respiratory syncytial viral infection; Sleep disorder; syncope; Tonsillectomy
Diagnostic Lab Data: UNK
CDC Split Type: B0750709A

Write-up: This case was reported by a nurse via regulatory authority (# NL-LRB-127609) and described the occurrence of fainting in a 3-year-old male subject who was vaccination with INFANRIX-POLIO (GlaxoSmithKline). The subject''s medical history included respiratory syncytial viral infection with 2 times collapse, high blood pressure (when he was a baby), eating disorder and sleep disorder between 1 and 3-years-old, syncope for 4 times and tonsillectomy. Concurrent medical conditions included cold at the morning of vaccination, acute otitis media regularly and contrast media allergy. Concomitant medication was not reported. No known past drug therapy. On 12 September 2011, the subject received 5th dose of INFANRIX-POLIO (intramuscular, administration site unknown, batch number not provided). On 12 September 2011, within minutes of vaccination with INFANRIX-POLIO, the subject experienced fainting following by lip cyanosis, vomiting, pallor and sweating. He was unconscious for a short while. He had only eat an apple until 12 am when the vaccine was given. This case was assessed as medically serious by GSK. He was laid down with his feet high. Wet clothes were used. On request of the parents, an ambulance was called but he was already conscious. On 12 September 2011, the events were resolved. The regulatory authority reported that fainting was probably related to vaccination with INFANRIX-POILO. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.


VAERS ID: 436478 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-30
   Days after onset:18
Entered: 2011-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146CB / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Immediate post-injection reaction, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 12Sep2011, 86/51mmHg; Blood pressure, 12Sep2011, 100/54mmHg
CDC Split Type: B0750365A

Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 12 September 2011, immediately after vaccination with CERVARIX, the subject experienced loss of consciousness and syncope. In addition, although the blood pressure had transiently decreased (from 100/54 mmHg before vaccination to 86/51 mmHg), it returned to normal. The physician considered the events were clinically significant (or requiring intervention). On 12 September 2011, the events were resolved in less than 1 minute. The physician considered the events were related to vaccination with CERVARIX.


VAERS ID: 436481 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-09-30
   Days after onset:18
Entered: 2011-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143CA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Epilepsy, Loss of consciousness, Presyncope, Syncope, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 12Sep2011, 36.7Deg. C.
CDC Split Type: B0747987A

Write-up: This case was reported by a physician and described the occurrence of tonic convulsion in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, lot number not provided). On 12 September 2011, less than one day after vaccination with CERVARIX, the subject experienced syncopal attack and vasovagal reaction. The physician considered the events were clinically significant (or requiring intervention). On 12 September 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow up information received on 20 September 2011: Body temperature before the injection was 36.7 degrees Centigrade. On 12 September at 17:05, 5 minutes after injection of first dose of CERVARIX (lot number: AHPVA143CA, left upper arm), the subject experienced afebrile tonic convulsion. She regained consciousness in 15 seconds. Feelings of weakness persisted in the upper extremity of the inoculated side for a while, but disappeared in approximately 30 minutes. According to the reporter, the causal relationship to CERVARIX for afebrile convulsion was unassessable but related to suspected epilepsy.


VAERS ID: 437092 (history)  
Age: 0.14  
Gender: Unknown  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-06
   Days after onset:24
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20909004D / - RA / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UVA10001 / - UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA640A / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Crying, Decreased appetite, Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0751934A

Write-up: This case was reported by a physician via a regulatory authority and described the occurrence of crying uncontrollably in a 2-month-old subject of unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline), DTP (A or W not known) vaccine (non-gsk) and Hepatitis B vaccine (non-gsk). On 12 September 2011, the subject received unspecified dose of HIBERIX (intramuscular, injection site unknown), unspecified dose of DTP (A or W not known) vaccine (non-GSK) (intramuscular, right arm) and unspecified dose of Hepatitis B vaccine (non-GSK) (intramuscular, injection site unknown). On 12 September 2011, 2 hours after vaccination with DTP (A or W not known) vaccine (non-GSK), Hepatitis B vaccine (Non-GSK) and HIBERIX, the subject experienced crying uninterrupted and reluctance to suck from the breast. The subject also developed injection site reaction in the form of mid edema and erythema of the right. The subject was hospitalised. The subject was treated with paracetamol. On 14 September 2011, the subject was discharged from the hospital in good general condition. At the time of reporting, the events were resolved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.


VAERS ID: 437136 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-06
   Days after onset:24
Entered: 2011-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP26080 / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Erythema, Hyperhidrosis, Hypotension, Nausea, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: blood pressure measurement, 12Sep11, 95/60; total heartbeat count, 12Sep11, 105 /min
CDC Split Type: WAES1110USA00037

Write-up: This case was received from the Health Authority on 26-SEP-2011. Agency reference number 2011-006753. This case was medically confirmed. A 16 year old female patient with no medical history or concomitant medications received the first dose of GARDASIL (batch number NP26080) 0.5 mls IM on 12-SEP-2011. On 12-SEP-2011, 2-5 minutes post vaccination, the patient experienced abdominal pain, nausea, sweating, blood pressure of 95/60, skin erythema, hypotension, pulse 105/min and tachycardia. The patient was given oxygen, an ambulance was called and the patient was transferred to hospital. The patient was given hydrocortisone and adrenaline as corrective treatment. The duration of the reaction was approximately 30 minutes and at the time of reporting the patient had recovered. The events were considered medically significant as they required intervention. Other business partner number included: E2011-05724. No further information is available.


VAERS ID: 437409 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-07
   Days after onset:25
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / IM

Administered by: Other       Purchased by: Other
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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Rash
Diagnostic Lab Data: UNK
CDC Split Type: B0751771A

Write-up: This case was reported by a consumer and described the occurrence of loss of consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included rash. On 12 September 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 12 September 2011, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness. The reporter considered the event as clinically significant (or intervention required). At the time of reporting, the outcome of the event was unspecified.


VAERS ID: 437648 (history)  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-09
   Days after onset:27
Entered: 2011-10-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA662A / 2 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E85639 / 1 LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Somnolence, Vaccination complication
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Apnoea attack, the infant was checked due to use of respiratory monitor suggestion; 1st dose of PREVENAR-13; 1st dose of INFANRIX IPV+HIB; 2nd dose of INFANRIX IPV+HIB
Diagnostic Lab Data:
CDC Split Type: 2011236267

Write-up: This is a spontaneous report from a contactable physician reported by the foreign Regulatory Authority (Regulatory Authority report number 81011) through the Medical Information Service. The National Institute of Pharmacy sent the reporting form entered by the vaccinating physician and the investigational form entered by the National Institute of Epidemiology. A 4-month-old male patient received the second dose of PREVENAR 13 (lot #E85639), along with the third dose of INFANRIX IPV+HIB (lot #A20CA662A) via intramuscular route of administration in the thigh, on 12Sep2011 at 11:00 hours. The patient had a relevant history of apnoeic attack at birth; the patient was examined and the use of respiratory monitor was suggested. Past vaccine history included two doses of INFANRIX IPV+HIB and 1 dose of PREVENAR 13 on unknown dates. On 12Sep2011, at 16:00 hours, the patient experienced sleepiness and lack of breathing and was hospitalized. After 2 days, the patient was discharged from the hospital. The course of events was reported as follows: On the day of immunization administered in the morning the patient has become sleepy in the afternoon and had lack of breathing. The physician detecting the event hospitalized the patient in children''s clinic, where after 2 days of monitoring the patient was sent home in good state with a diagnosis of vaccine reaction. The outcome of the events at the time of the report was recovered. The vaccine was obtained from central storage. The patient was vaccinated at the doctor''s office. The transport, storage and usage of the vaccine were adequate.


VAERS ID: 437666 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-10
   Days after onset:28
Entered: 2011-10-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA147AA / - RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0752516A

Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, right upper arm). On 12 September 2011, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness. The physician considered the event was clinically significant (or requiring intervention). On 12 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.


VAERS ID: 437709 (history)  
Age: 0.38  
Gender: Male  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:29
Entered: 2011-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA662A / - UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E85639 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Somnolence, Vaccination complication
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0754108A

Write-up: This case was reported by a regulatory authority and described the occurrence of apnea in a 4-month-old male subject who was vaccinated with INFANRIX-IPV/Hib (GlaxoSmithKline), (non-gsk) PREVENAR 13. On 12 September 2011 the subject received unspecified dose of INFANRIX-IPV/Hib (route and site unknown), unspecified dose of PREVENAR 13 (route and site unknown). On 12 September 2011, less than one day after vaccination with INFANRIX-IPV/Hib and PREVENAR 13, the subject experienced apnea and sleepiness. The subject was hospitalised for observation. After 2 days, he was discharged in a good condition. The events were assessed as a vaccine reaction. On 14 September 2011, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX-IPV/Hib and PREVENAR 13.


VAERS ID: 443819 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-11-28
   Days after onset:77
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146BA / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Bradycardia, Feeling abnormal, Immediate post-injection reaction, Injection site pain, Oxygen saturation decreased, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 12Sep2011, 70s/-mmHg; Oxygen saturation, 12Sep2011, decreased; Pulse rate, 12Sep2011, 30sbpm
CDC Split Type: B0747982A

Write-up: This case was reported by a physician and described the occurrence of vagal reaction in a 17-year-old female subject who was vaccinated with CERVARIX. On 12 September 2011 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular. Unknown site of injection, batch number not provided). On 12 September 2011, less than one day after vaccination with CERVARIX, the subject experienced vagal reaction. The physician considered the event was clinically significant (or requiring intervention). On 12 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Additional information received on 20 September 2011. On 12 September 2011, at 16:30, the subject received the second dose of vaccination with CERVARIX (right upper arm, lot number provided). On 12 September 2011, she experienced poor feeling immediately after the inoculation. Decreased blood pressure (70s), bradycardia (30s) and decreased oxygen saturation were noted. She was placed on bed rest with legs elevated and recovered within 30 minutes with intravenous drip infusion of fluid. Follow-up information was received on 16 November 2011. On an unspecified day after vaccination with CERVARIX, the subject experienced injection site pain. At time of reporting, the outcome of the event injection site pain was unknown. It was considered that the patient had had nervous control disorder as a predisposing factor and she experienced vasovagal reflex this time due to tension and pain caused by the inoculation of CERVARIX.


VAERS ID: 445453 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2011-12-14
   Days after onset:93
Entered: 2011-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0768672A

Write-up: This case was reported by pharmacist and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 September 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). On 12 September 2011, 4 to 5 minutes after vaccination with CERVARIX, the subject experienced syncope and loss of consciousness. One minute later, the subject regained consciousness. Subsequently, the subject was placed under observation for 30 minutes and no problem was observed. Therefore, she left for home. The pharmacist considered the events were clinically significant (or requiring intervention). On 12 September 2011, the events were resolved. The pharmacist considered the events were related to the action of injection of CERVARIX.


VAERS ID: 446218 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-22
   Days after vaccination:10
Submitted: 2011-12-22
   Days after onset:91
Entered: 2011-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM26350 / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA01827

Write-up: This case was received from the Health Authority on 13-DEC-2011 (2011-008453). This case was medically confirmed. A female patient of unknown age, and with no medical history or concomitant medication reported, received an injection of GARDASIL, (batch number NP26080, lot number NM26350), 0.5mL, I.M., on 12-SEP-2011. On 22-SEP-2011, 10 days post vaccination, the patient developed rash under her arms, a repeated headache and abdominal migraine. The patient did not receive any corrective treatment and was not undergoing any investigation. At the time of reporting the patient had not yet recovered (also reported as unknown). The events were considered to be serious (medically important). Other business partner numbers included: E2011-08040. No further information is available.


VAERS ID: 460542 (history)  
Age: 0.58  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2012-07-27
   Days after onset:319
Entered: 2012-07-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G9512 / 0 UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported personal and family medical history; No concomitant therapy
Diagnostic Lab Data: Not reported
CDC Split Type: 201207035

Write-up: Case received from the Health Authorities on 19 July 2012 under the reference number CN2012064 (HA''s number 342425111035201101165). A 07-month-old female patient, with no reported medical history and no concomitant therapy, had received her 1st primary dose of ACTHIB (batch number G9512-1, site of administration not reported) intramuscularly on 12 September 2011. On 12 September 2011, the patient developed fever at 38.7 degrees C. She was not hospitalized. She was recovered at the time of reporting. The case was reported as serious by a healthcare professional to the Health Authorities due to other important medical condition.


VAERS ID: 469047 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2012-10-11
Entered: 2012-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN12450 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210IRL005085

Write-up: This case was received from the Health Authority on 05-Oct-2012. Reference no. 2012-014591. This case is medically confirmed. A 13-year-old female patient with no reported medical history and concomitant medication, received the first dose of GARDASIL (Lot No. G005699, No expiry date, Dose 0.5 ml) intramuscularly on 12-Sep-2011 and second dose of GARDASIL (Lot no. NN40900, No expiry date, Dose 0.5 ml) intramuscularly on 09-Dec-2011. No reported information about site of administration for both doses. In late Nov-2011 or early Dec-2011, the patient experienced new onset of seizures on an unreported date. The patients corrective treatment include TEGRETOL. The reported stated that the patient''s third dose of GARDASIL was postponed. At the time of reporting the patient outcome was unknown. The authority considered this case to be serious as an other medically important condition.


VAERS ID: 492368 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2013-05-22
Entered: 2013-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA146AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Alopecia areata
SMQs:

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Body temperature
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0893248A

Write-up: This case was reported by a physician and described the occurrence of alopecia areata in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature prior to vaccination was of 36.6 deg. C. On 12 September 2011, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, left upper arm). In late September 2011, less than one month after vaccination with CERVARIX, the subject experienced alopecia areata. A circle with a diameter of 5 cm was observed on the temporal region of the head. In March 2012, subject''s hair was lost. The physician considered the event was disabling. On 24 April 2013, the event was improved.


VAERS ID: 503790 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2012-06-01
   Days after vaccination:263
Submitted: 2013-09-23
   Days after onset:479
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aphagia, Arthralgia, Asthenia, Bed rest, Blood test normal, CSF test normal, Diplopia, Dysgeusia, Eye pain, Facial neuralgia, Facial spasm, Fall, Fatigue, Gait disturbance, Headache, Hemiparesis, Insomnia, Loss of consciousness, Muscle spasms, Muscle twitching, Nausea, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Photophobia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 17Jul2012, No abnormalities; Nuclear magnetic resonance ima, 17Jul2012, No abnormalities; 17 July 2012 - Cerebrospinal fluid examination: No abnormalities
CDC Split Type: B0923187A

Write-up: This case was reported by a pharmacist and described the occurrence of adynamia in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced loss of sleep, pain, photophobia and taste disturbance. At the time of reporting, the events were unresolved. Follow-up information received on 12 September 2013: In 2012, the subject received CERVARIX (batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced loss of sleep due to pain, was dazzled by light and also experienced taste disturbance. The subject complained about the symptoms to the physician who had administered the vaccine, and was told that the symptoms were unrelated to vaccination with CERVARIX. She was transferred to another hospital and was treated with unspecified treatment (as outpatient). The reporter considered the events were related to vaccination with CERVARIX. Follow-up information received on 17 September 2013: The case was upgraded to serious. Concurrent vaccination included 1st and 2nd doses of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 22 February 2011 and 24 March 2011. On 12 September 2011, the subject received 3rd dose of CERVARIX (0.5 ml, intramuscular, unknown injection site, batch number not provided). In June 2012, 9 months after vaccination with CERVARIX, the subject began to complain of intense retro-orbital pain, diplopia, headache, cramp of limb, facial spasm, arthralgia and felt queasy. On 17 July 2012, 10 months after vaccination with CERVARIX, when the subject was about to get up at 7:00 in the morning, she could not put strength on the left side of the body at all and fell down. The subject immediately underwent Nuclear Magnetic Resonance Imaging in a hospital, which showed no abnormalities. The subject was hospitalized and also underwent examinations including a blood test and cerebrospinal fluid examination, which also showed no abnormalities. Thus, the subject was discharged from the hospital. On an unknown date, after the hospital discharge, the subject visited the hospital regularly for follow-up. The subject had symptoms such as twitching on the left side of the body, movement in the face like facial neuralgia, intense headache, queasy feeling, arthralgia, and retro-orbital pain (with diplopia and photophobia with flickering). The subject also had difficulty in walking at first. While the cause of the symptoms was unspecified, the subject was prescribed with Chinese herbal medicine. The subject was urgently brought into the hospital because the subject suddenly collapsed due to loss of consciousness, and visited the hospital at midnight for intense headache. But the subject was just placed on bed rest. The subject also had consultation in another hospital for the symptoms. On 18 July 2013, since the subject was unable to eat due to too much exhaustion (with headache, queasy feeling, and pain in the hands and feet) and had debility, the subject was hospitalized again. The subject was almost unable to go to school. AT the time of reporting, the adynamia, fall, walking difficulty were resolved with sequelae; the headache, queasy feeling, retro-orbital pain, diplopia, cramp in limb and arthralgia were unresolved and the outcome of other events was unspecified. The pharmacist considered the adynamia, fall, difficulty in walking, headache, queasy, sleep loss, pain, photophobia, taste disturbance, retro-orbital pain, diplopia, cramp of limb, and arthralgia were related to vaccination with CERVARIX. The relationship between the loss of consciousness, unable to eat, pain, debility, facial spasm and the vaccination with CERVARIX was not provided. The vaccinating physician, who was informed of the above, stated that


VAERS ID: 619666 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-10-01
   Days after vaccination:19
Submitted: 2015-12-16
   Days after onset:1537
Entered: 2015-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA129CA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Autonomic nervous system imbalance, Dizziness postural, Dyspnoea, Myalgia, Neuropathy peripheral, Night sweats, Peripheral coldness, Somnolence, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN175777

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of myalgia in a adolescent female subject who received CERVARIX (batch number AHPVA129CA, expiry date unknown) and (batch number AHPVA162AA, expiry date unknown). On 11th August 2011, the subject received the 1st dose of CERVARIX (intramuscular). On 12th September 2011, the 2nd dose was an unknown dose. On 29th March 2012, the 3rd dose was an unknown dose. In October 2011, several months after receiving CERVARIX, the subject experienced myalgia (serious criteria clinically significant/intervention required), arthralgia (serious criteria clinically significant/intervention required), autonomic dysfunction (serious criteria clinically significant/intervention required), weakness (serious criteria clinically significant/intervention required), sleepiness (serious criteria clinically significant/intervention required), shortness of breath (serious criteria clinically significant/intervention required), tachycardia (serious criteria clinically significant/intervention required), cold hands and feet (serious criteria clinically significant/intervention required), dizziness on standing up (serious criteria clinically significant/intervention required) and night sweats (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the myalgia, arthralgia, autonomic dysfunction, weakness, sleepiness, shortness of breath, tachycardia, cold hands and feet, dizziness on standing up and night sweats were not recovered/not resolved. The reporter considered the myalgia, arthralgia, autonomic dysfunction, weakness, sleepiness, shortness of breath, tachycardia, cold hands and feet, dizziness on standing up and night sweats to be related to CERVARIX. In October 2011, arthralgia in both hands developed after the vaccination, which extended to the lower limbs. In addition, myalgia was noted, which also extended to the whole body (upper and lower limbs, neck, scapular region, lower back and buttocks). The subject also experienced other autonomic nervous symptoms including weakness, sleepiness, feeling of dyspnoea, tachycardia, cold hands and feet, dizziness on standing up, and night sweats. As of 23 October 2015, the outcome of the symptoms was unresolved. Other possible etiological factor: None. The subject had no particular problem before the CERVARIX vaccination, and had no history of other drug use. As the symptoms met the College of Fibromyalgia Investigation preliminary diagnostic criteria for human papillomavirus vaccination associated with neuropathic syndrome (HANS), the causality between the symptoms and CERVARIX was highly suspected.


VAERS ID: 644078 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:2011-09-12
   Days after vaccination:0
Submitted: 2016-07-15
   Days after onset:1768
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cataplexy, Fall, Malaise, Narcolepsy, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: GB2016GSK099698

Write-up: This case was reported by a consumer via local affiliate and described the occurrence of narcolepsy in a 12-year-old female patient who received CERVARIX. On 12th September 2011, the patient received CERVARIX. On 12th September 2011, less than a day after receiving CERVARIX, the patient experienced narcolepsy (serious criteria GSK medically significant), cataplexy (serious criteria GSK medically significant), unwell, fall and sleepiness. On an unknown date, the outcome of the narcolepsy, cataplexy, unwell, fall and sleepiness were unknown. The reporter considered the narcolepsy, cataplexy, unwell, fall and sleepiness to be related to CERVARIX. Additional details were reported as follows: No information regarding the patient''s medical history, concurrent conditions or allergies was reported. The consumer reported that the patient felt unwell and within a day they noted something was very wrong. The patient started collapsing and falling asleep. The patient was subsequently diagnosed with narcolepsy and cataplexy. The consumer was certain that the events were caused by the CERVARIX vaccine. Consent for follow up was provided.


VAERS ID: 678204 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-12
Onset:0000-00-00
Submitted: 2017-01-11
Entered: 2017-01-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autism spectrum disorder, Dizziness, Dysaesthesia, Headache, Hypophagia, Insomnia, Movement disorder, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: JP2017JPN000645

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of physical deconditioning in a 14-year-old female subject who received CERVARIX. Concomitant products included CERVARIX. On 12th September 2011, the subject received the 3rd dose of CERVARIX (intramuscular). On an unknown date, an unknown time after receiving CERVARIX, the subject experienced physical deconditioning (serious criteria hospitalization), headache (serious criteria hospitalization), dizziness (serious criteria hospitalization), dysaesthesia (serious criteria hospitalization), oral intake reduced (serious criteria hospitalization), difficulty sleeping (serious criteria hospitalization), pain (serious criteria hospitalization), movement disorder (serious criteria hospitalization) and pervasive developmental disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the physical deconditioning, headache, dizziness, dysaesthesia, oral intake reduced, difficulty sleeping, pain and movement disorder were recovering/resolving and the outcome of the pervasive developmental disorder was unknown. It was unknown if the reporter considered the physical deconditioning, headache, dizziness, dysaesthesia, oral intake reduced, difficulty sleeping, pain, movement disorder and pervasive developmental disorder to be related to CERVARIX. [Clinical course] CERVARIX was administered from February 2011 to September 2011. In July 2012, the subject complained of physical deconditioning including headache, dizziness, an unexplainable sensation, difficulty in oral intake and difficulty sleeping. From 17 July 2012 to 26 July 2012, she was hospitalized in the reporting hospital. As of this report, she was not followed up at the hospital. [Reporter''s comment] It was impossible to assess the causal relationship between the physical deconditioning, headache, dizziness, an unexplainable sensation, difficulty in oral intake, difficulty sleeping, pain and movement disorder and CERVARIX. Other causative factor: The subject had pervasive developmental disorder. CERVARIX was administered from February 2011 to September 2011. It was an interval until the subject complained of physical deconditioning. The reporter considered that the events were unlikely the adverse reactions to CERVARIX. Yet, the subject''s parents suspected CERVARIX as the cause.


VAERS ID: 434251 (history)  
Age: 24.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-09-13
Onset:0000-00-00
Submitted: 2011-09-13
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH453AB / - UN / -

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

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

Write-up: headache, itchiness, rash


VAERS ID: 434260 (history)  
Age: 67.0  
Gender: Male  
Location: Alaska  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-13
   Days after onset:0
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR UT441AA / - LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Flushing, Hypotension
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure 88/53 mmHg after vaccine
CDC Split Type:

Write-up: Pt. became flushed, light headed, and felt like he was going to faint. Blood pressure was measured and was low. Pt. ate a snack, drank some orange juice, had a fan blowing on him, and rested in the pharmacy before leaving.


VAERS ID: 434410 (history)  
Age: 27.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:0
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / 0 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Pyrexia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No.
Preexisting Conditions: General allergies (e.g., hay fever) but not present at time of vaccine administration.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever; fatigue; headaches; dizziness; major soreness in arm; lack of focus; blurry vision. Adverse events still continuing by late evening, despite medication.


VAERS ID: 434416 (history)  
Age: 54.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER NDC49281038815 / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Grip strength decreased, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Started getting severe pains from shoulder to hand (like muscle pains)think that night but definitely by the next morning. Did some research on line this morning & other people had same problems. Only thing in common we had shot down very high on arm (never had shot done that high & never had this problem before in the 16 or so years of getting shots.
Preexisting Conditions:
Diagnostic Lab Data: Have not done anything yet & dont know what to do.
CDC Split Type:

Write-up: Severe pain from shoulder all the way down to my hand. Feels like muscle pain. I can''t pick up things & cant lift arm over shoulder with out severe pain. Please note I have been told I have a high tolerence for pain. Don''t know what to do & don''t know how long this will last. People on line who have had same issues after shots say it last for months. I already have limited use on right side due to lymph nodes being removed (breast cancer) now I can''t use my left. This pain is actually going up to my neck area on left side.


VAERS ID: 434448 (history)  
Age: 32.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11053P / 3 UN / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: unknown
Preexisting Conditions: not to our knowledge
Diagnostic Lab Data: Being evaluated at the time this report is being submitted and I do not know what diagnostic tests will be ordered at this time.
CDC Split Type:

Write-up: bilateral leg weakness


VAERS ID: 434468 (history)  
Age: 45.0  
Gender: Female  
Location: Virginia  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:1
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

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

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

Write-up: Pt noticed redness with TTP to left deltoid today 15SEP11. Pt was seen by Occ Hlth for tx.


VAERS ID: 434502 (history)  
Age: 79.0  
Gender: Male  
Location: Nevada  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1105P1 / 0 AR / IM

Administered by: Public       Purchased by: Private
Symptoms: Injection site pruritus, Injection site rash, Pruritus, 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: CRESTOR; Indapamide; Warfarin; Colestipol gran; Prednisolone ophth; Amiloride; Lansoprazole
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed itching/swelling day of administration symptoms include itching and rash in area of injection about the size of playing card.


VAERS ID: 434504 (history)  
Age: 31.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH454AC / 0 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Malaise, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: losartan, hydrochlorothiazide
Current Illness: None
Preexisting Conditions: Hypertension
Diagnostic Lab Data:
CDC Split Type:

Write-up: 09.13.11 approximately 3 hours post vaccination developed chills, light headedness, fever, malaise, myalgia. Initiated ibuprofen 600 mg po every 4-6 hours. 09.14.11 symptoms continue with stomach cramps and diarrhea. 09.15.11 symptoms continue less severe.


VAERS ID: 434513 (history)  
Age: 14.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3779AA / 0 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Fatigue, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever started 7 hr after immunization & peaked at 102 degrees (15 hrs after immunization). Tingling both legs from 3-11pm on 9/13. Pt reported being very tired from 11 am-3pm on 9/13 slept overnight & felt fine on 9/14.


VAERS ID: 434516 (history)  
Age: 87.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH452AB / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF glucose normal, CSF protein increased, CSF test normal, Mental status changes, Red blood cells CSF positive
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: digoxin, finasteride, propranolol, warfarin, acetaminophen, furosemide
Current Illness: None identified
Preexisting Conditions: allergy to codeine (reaction unknown) atrial fibrillation, glaucoma, osteoarthritis, benign prostatic hypertrophy
Diagnostic Lab Data: CSF 9/15: clear, colorless fluid, 1 RBC, 59 glucose, 71 protein
CDC Split Type:

Write-up: Vaccine administered at 2PM. Patient developed acute mental status change around 9PM. Patient admitted to Medical Center and worked up for possible meningitis. CSF has been clean thus far in treatment, patient''s mental status moderately improved on 9/15.


VAERS ID: 434518 (history)  
Age: 47.0  
Gender: Female  
Location: California  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA611AA / 3 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0213AA / 0 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (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: HEADACHE
Preexisting Conditions: H/O STROKE DEPRESSION
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PAIN, SWELLING, AND REDNESS TO LEFT ARM


VAERS ID: 434528 (history)  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:1
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0786Z / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3778AA / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Urticaria
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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cetirizine 10 mg daily DDAVP 0.2 mg HS Clotrimazole 1% cream (site other than immunization site)
Current Illness: No
Preexisting Conditions: Sulfa allergy (TMP/SMZ) - itchy rash
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Redness, swelling, discomfort, pruritis, localized urticaria (6 inch diameter surrounding Menactra injection site). No associated respiratory complaints.


VAERS ID: 434533 (history)  
Age: 30.0  
Gender: Female  
Location: Alaska  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-15
   Days after onset:2
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR - / 10 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Local swelling, Pain, Skin warm
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Swelling on shoulder, hot to the touch, pain


VAERS ID: 434534 (history)  
Age: 92.0  
Gender: Male  
Location: Arizona  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-15
   Days after onset:0
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. UH439AB / - LA / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: pt denied
Preexisting Conditions: not assesses
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt returned to clinic. Told practitioner that he visited the ER on 9/14/11 as the site of pneumonia vaccination was red and swollen, staes that ER treated him with antibiotic for infection at site, at this time 9/15/11 10 am site L arm is erythematous from site of injection L deltoid extending down to L wrist, slight edema in this extremity, no warmth or induration at site, pt denies having a fever, states that he is on blood thinner medication.


VAERS ID: 434535 (history)  
Age: 90.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-15
   Days after onset:0
Entered: 2011-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0614AA / - LA / UN

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

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

Write-up: pt spouse came by the clinic and states that his wife developed severe redness and swelling at injection site


VAERS ID: 434623 (history)  
Age: 32.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-17
   Days after onset:4
Entered: 2011-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4104AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Tenderness, Urticaria
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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: Levaquin, okra, green peppers
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Severe swelling at injection site with pain and subsequent overlying hives and axillary tenderness.


VAERS ID: 434719 (history)  
Age: 67.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-17
   Days after onset:4
Entered: 2011-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U3696BA / - RA / IM

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

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

Write-up: Redness and swelling of right upper arm at injection site with slight itching. Patient said it started the same day of injection on 9/13/11 and was enlarging still when she reported to me at clinic on 9/15/11. Treated with cold compresses, OTC Hydrocortisone cream and oral BENADRYL 25-50 mg. She reported improvement on 9/16/11.


VAERS ID: 434633 (history)  
Age: 68.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2011-09-13
Onset:2011-09-17
   Days after vaccination:4
Submitted: 2011-09-18
   Days after onset:1
Entered: 2011-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Ear pain
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ear ache~ ()~~0.00~Patient
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type: 1962407002

Write-up: For the first time in my life, since childhood, I am having intermittent stabbing ear ache. Painful.


VAERS ID: 434684 (history)  
Age: 12.0  
Gender: Male  
Location: Tennessee  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-19
   Days after onset:4
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0607Z / 1 RA / SC

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

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

Write-up: Pt was given varicella SQ in his (R) arm. Pt had pain & redness at site within first 30 mins of injection. Since then redness & swelling & pain have worsened.


VAERS ID: 434728 (history)  
Age: 67.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:6
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AA / - RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Chills, Hot flush
SMQs:

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: Type 2 Diabetes, Hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:

Write-up: Alternating feelings of chills and hot flashes for 8-9 hours. Patient did not report temperature readings. Resolved without treatment.


VAERS ID: 434820 (history)  
Age: 67.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-19
   Days after onset:5
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH439AC / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cough, Fatigue, Headache, Influenza virus test negative, Malaise, Pain, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ACTOPLUS MET; Glipizide; Lisinopril
Current Illness: None
Preexisting Conditions: Diabetes type 2
Diagnostic Lab Data: Rapid Flu test done in office - negative
CDC Split Type:

Write-up: Patient received Flu vaccine 9/13/11, started feeling ill 9/14/11 with fever, aches & fatigue. Improved by 9/16/11. Then Mon. 9/19/11 came into office with fever 103.1, vomiting, achiness, fatigue, headache, cough.


VAERS ID: 434827 (history)  
Age: 67.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-19
   Days after onset:4
Entered: 2011-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH459AB / 0 LA / IM

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

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

Write-up: Patient came to the pharmacy on 9-19-11 and showed red spots & blotches all over her body. They are very itchy and seem to be spreading. Claims this started after the flu shot. Advised BENADRYL & cortisone, then go see doctor.


VAERS ID: 434948 (history)  
Age: 7.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-14
   Days after onset:0
Entered: 2011-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH455AB / 5 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0978Z / 0 RA / IM

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

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

Write-up: (R) arm red, hot, swollen from shoulder -$g elbow. Tender to touch. Fever 101 degrees. Difficulty raising (R) arm. Hives on (R) arm. Symptoms developed the day after receiving vaccines. BENADRYL & MOTRIN for symptoms.


VAERS ID: 434909 (history)  
Age: 66.0  
Gender: Male  
Location: California  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-16
   Days after onset:1
Entered: 2011-09-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH457AA / - RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Joint swelling
SMQs:, Anaphylactic reaction (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: 201108655

Write-up: Initial report was received on 15 September 2011 from a health care professional. A 66-year-old male patient had received an intramuscular right deltoid injection of FLUZONE HIGH-DOSE, lot number UH457AA on 13 September 2011 and two days later his right knee became red and swollen. He was evaluated by a physician and prescribed prednisone. Laboratory and diagnostic test data was reported as "none". Concurrent illness, concomitant medications and past medical history were reported as "none". Outcome was unknown. Documents held by sender: None.


VAERS ID: 434921 (history)  
Age: 56.0  
Gender: Female  
Location: D.C.  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-20
   Days after onset:5
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Other       Purchased by: Public
Symptoms: Dermatitis infected, 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: Levothyroxine Lexapro Vitamins -- A,D,E, B-complex, multivitamin, calcium+D.
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives (itchy, small round bumps) appeared at upper inner thigh area. Each day for the next four days more hives appeared, spreading down legs past the knees and up the torso to waist line, with a few single bumps appearing on upper arms, ankles, arm pits, and shoulder blades. Hives are still present, but being controlled by Claritin (AM), Benadryl (PM), and Betamethasone Dipropionate cream (.05%) because I cannot take Prednisone. Also taking Cephalexin 25 MG as some appear to be infected.


VAERS ID: 434938 (history)  
Age:   
Gender: Female  
Location: New York  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-19
   Days after onset:5
Entered: 2011-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11065P / - LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3719AA / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: zolpidem; HCTZ; MIRALAX; metoprolol; simvastatin; ramipril
Current Illness: None
Preexisting Conditions: Penicillin-rash; diabetes Type 2; HTN; GERD
Diagnostic Lab Data: Blood cultures at ER visit pending
CDC Split Type:

Write-up: Onset of symptoms 12-24h after vaccination of fever 102 degrees F, chills, rigors - swelling, erythema, pruritus at vaccination site progressively worsening - emergency room visit - treated with antibiotic.


VAERS ID: 434992 (history)  
Age: 18.0  
Gender: Female  
Location: Iowa  
Vaccinated:2011-09-13
Onset:0000-00-00
Submitted: 2011-09-14
Entered: 2011-09-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B277AA / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3780AA / 0 LA / IM

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

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

Write-up: None.


VAERS ID: 434993 (history)  
Age: 70.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-19
   Days after onset:6
Entered: 2011-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100101 / - LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Oedema peripheral, Pruritus, Rash
SMQs:, Cardiac failure (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa, penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm & hand swelling. Rash & itching. Patient went to Dr. & had arm wrapped & patient took BENADRYL.


VAERS ID: 435065 (history)  
Age: 16.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-09-13
Onset:0000-00-00
Submitted: 2011-09-19
Entered: 2011-09-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA113AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0602AA / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Injection site induration, Injection site pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Local erythema & induration, intense pruritus (L) upper arm. Rx antihistamines.


VAERS ID: 435066 (history)  
Age: 23.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-15
   Days after onset:1
Entered: 2011-09-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT441AA / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0322Z / 0 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cellulitis, Headache, Injection site haematoma, Injection site pain, Injection site swelling, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 12 hours sore "felt bruise" about 18 hours pain swelling "hives" at site only, c/o HA. Went to ER 0200 9/13 - hives "cellulitis" appearance.


VAERS ID: 435067 (history)  
Age: 32.0  
Gender: Female  
Location: Maryland  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:7
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH462AA / - RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0387AA / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3927AA / - LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chills, Dizziness, Erythema, Movement disorder, Pain in extremity, Pyrexia, Skin warm, Toxicity to various agents
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Vestibular disorders (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? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergic to penicillin, vancomycin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received 3 injections - experienced fever, chills, dizziness that night. Also very red, hot (R) arm requiring dr''s visit on 9/16 though no treatment rendered. Dx "toxic" reaction to shots. Painful to touch, hard to move arm in general. Redness spread from baseball sized 9/15 - patchy redness all over 9/16. Dr took pictures of arm.


VAERS ID: 435098 (history)  
Age: 4.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-21
   Days after onset:7
Entered: 2011-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B196BA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1396Z / 2 RA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916005 / 0 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0670AA / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea, Skin warm
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Broken out with rash from neck down to top of knees front and back, looked like polka dots some were raised. Fever was not taken but mom states really hot to touch. Gave him childrens Motrin a few minutes after 6 am. Fever broke a while later. The rash lasted 24 hours. Once fever free rash went away.. since this day runny nose and cough. Has started headstart on the 15th of Sept. His Dr was called on 9-15-11 and was told to bring him right away, once mom arrived with shot record from health dept drs office refused to see child told him to take him to the health dept that the child received shots at.


VAERS ID: 435234 (history)  
Age: 14.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:9
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0636AA / 0 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3848AA / 0 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3979DA / 0 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Bee Stings
Diagnostic Lab Data:
CDC Split Type: MS11018

Write-up: Patient had a "knot" in right deltoid after vaccine administration.


VAERS ID: 435236 (history)  
Age: 14.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 2011-09-22
   Days after onset:9
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0636AA / 0 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3848AA / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3979DA / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: N/A
CDC Split Type: MS11019

Write-up: School nurses says patient had hives and itching about 20-30 minutes after administration of vaccines.


VAERS ID: 435339 (history)  
Age: 67.0  
Gender: Female  
Location: Virginia  
Vaccinated:2011-09-13
Onset:0000-00-00
Submitted: 2011-09-22
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH436AC / - AR / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Inflammation, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt said her arm was inflamed & swollen below the vaccination site up to her elbow, pain, redness, hot to the touch.


VAERS ID: 435462 (history)  
Age: 12.0  
Gender: Female  
Location: Kansas  
Vaccinated:2011-09-13
Onset:2011-09-15
   Days after vaccination:2
Submitted: 2011-09-16
   Days after onset:1
Entered: 2011-09-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0407AA / 0 LA / SC

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

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

Write-up: Hives began 9/15/11 in AM - treated with BENADRYL.


VAERS ID: 435684 (history)  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-09-13
Onset:2011-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0886Z / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0118AA / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Asthenia
SMQs:, Guillain-Barre syndrome (broad)

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

Write-up: About 1 hour after vaccinations, lt. arm became weak & developed all body weakness. 4 days after vaccinations her body weakness much improved.


VAERS ID: 435406 (history)  
Age: 67.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-22
   Days after onset:8
Entered: 2011-09-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0662AA / 0 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 24 hrs after vaccine red goose egg - hot at the site - itching - over the next week the swelling & itching spread around & down the upper arm. Ice helped. Lasted 8 days - also scalp itched after several days.


VAERS ID: 435443 (history)  
Age: 52.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2011-09-13
Onset:2011-09-14
   Days after vaccination:1
Submitted: 2011-09-20
   Days after onset:6
Entered: 2011-09-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0661AA / 0 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema,