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Case Details (Sorted by Vaccination Date)

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VAERS ID: 600930 (history)  
Form: Version 1.0  
Age: 0.26  
Gender: Male  
Location: Unknown  
Vaccinated:2011-04-11
Onset:2011-04-11
   Days after vaccination:0
Submitted: 2012-03-26
   Days after onset:350
Entered: 2015-09-21
   Days after submission:1274
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cough
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011079991

Write-up: This is a spontaneous report from a contactable nurse. A 3-month-old male patient (race unknown) received a dose of PREVNAR in the thigh via intramuscular route of administration on 11Apr2011. Past vaccine history included ROTARIX. Relevant medical history and concomitant medications were not provided. On 11Apr2011, the patient continuously coughed for 2 hours after PREVNAR was administered. The patients dad reported that he felt the cough was a cold symptom instead of a reaction to PREVNAR. Therapeutic measures taken in response to the event were unknown. The clinical outcome of the event at the time of the report was unknown. Follow-up attempts completed. No further information expected. Follow-up (10MAY2011): New information reported from a contactable nurse includes: patient age; patient gender; dose details for suspect product; and past vaccine history.


VAERS ID: 640148 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-11
Onset:2011-04-11
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:50
Entered: 2016-06-17
   Days after submission:1844
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M100130 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US32267

Write-up: Case number PHHY2011US32267 is a combined initial and follow-up spontaneous report received on 15 Apr 2011. This report refers to a 15 years old female patient. She was vaccinated with meningococcal vaccine (manufacturer and batch number unknown) on an unspecified date, when she was 12 years old and was given another shot of MENVEO vaccine (batch number: M100130) intramuscularly on 11 Apr 2011. On the same day of vaccination she experienced vomiting, fatigue and headache. The outcome of the event was reported as condition unchanged as of 14 Apr 2011. Following internal review of the data received on 15 Apr 2011, the following significant correction was done on 11 May 2011: The event "inappropriate schedule of vaccine administered" was deleted.


VAERS ID: 640192 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-04-11
Onset:2011-04-11
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:50
Entered: 2016-06-20
   Days after submission:1847
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 090901 / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US35723

Write-up: Case number PHHY2011US35723 is an initial spontaneous report received from a nurse on 18 Apr 2011. This report concerns a 16-year-old male patient. He was vaccinated with MENVEO (batch number: 090901, expiry date: Sep 2011) 1 DF, on 11 Apr 2011. The patient received only the Men CYW-135 liquid conjugate without the Men A lyophilized powder conjugate. No adverse reaction was reported following this drug administration error.


VAERS ID: 650806 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Oregon  
Vaccinated:2011-04-11
Onset:2011-04-11
   Days after vaccination:0
Submitted: 2016-08-29
   Days after onset:1967
Entered: 2016-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0552Z / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1608USA013445

Write-up: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient''s concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 11-APR-2011, patient received improperly stored VARIVAX dose 2, from lot # 0552Z (expiry date not reported). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.


VAERS ID: 635411 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-11
Onset:0000-00-00
Submitted: 2016-05-09
Entered: 2016-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA076DB / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Blood iron decreased, Chest pain, Chronic fatigue syndrome, Constipation, Dysmenorrhoea, Epistaxis, Feeling abnormal, Gluten sensitivity, Hot flush, Hypersensitivity, Hypoaesthesia, Insomnia, Melanocytic naevus, Menorrhagia, Mood swings, Nausea, Neck pain, Oropharyngeal pain, Paraesthesia, Peripheral coldness, Pharyngitis, Pyrexia, Scoliosis, Vitamin D decreased, Vulvovaginal disorder
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 02/2015, Benign bone neoplasm, Diagnosed with Desmoplastic fibroma in shoulder - cause unknown; Irritable bowel syndrome, Many years of IBS left immune system compromised; Immunodeficiency; Dyspepsia; Familial risk factor, Evidence of intolerance to heavy metals in parent
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2016061254

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of nausea in a 12-year-old female patient who received CERVARIX (batch number AHPVA070AA, expiry date unknown). Co-suspect products included CERVARIX (batch number AHPVA076DB, expiry date unknown) and CERVARIX (batch number AHPVA082CC, expiry date unknown). The patient''s past medical history included benign bone neoplasm (Diagnosed with Desmoplastic fibroma in shoulder - cause unknown), irritable bowel syndrome (Many years of IBS left immune system compromised), immunocompromised, indigestion and familial risk factor (Evidence of intolerance to heavy metals in parent). On 5th October 2010, the patient received the 1st dose of CERVARIX (parenteral) .5 ml. On 11th April 2011, the patient received the 2nd dose of CERVARIX (parenteral) .5 ml. On an unknown date, the patient received the 3rd dose of CERVARIX (parenteral) .5 ml. In November 2013, an unknown time after receiving CERVARIX, CERARIX and CERVARIX, the patient experienced gluten intolerance (serious criteria disability and other). On an unknown date, the patient experienced nausea (serious criteria disability and other), fever (serious criteria disability and other), allergy (serious criteria disability and other), anxiety (serious criteria disability and other), chest pain (serious criteria disability and other), chronic fatigue syndrome (serious criteria disability and other), cold hands and feet (serious criteria disability and other), constipation (serious criteria disability and other), foggy feeling in head (serious criteria disability and other), hot flushes (serious criteria disability and other), insomnia (serious criteria disability and other), iron low (serious criteria disability and other), mole of skin (serious criteria disability and other), mood swings (serious criteria disability and other), neck pain (serious criteria disability and other), nosebleeds (serious criteria disability and other), numbness of limbs (serious criteria disability and other), pins and needles (serious criteria disability and other), scoliosis (serious criteria disability and other), sore throat (serious criteria disability and other), throat infection (serious criteria disability and other), vulvovaginal disorder nos (serious criteria disability and other), vitamin D decreased (serious criteria disability and other), heavy periods (serious criteria disability and other) and painful periods (serious criteria disability and other). On an unknown date, the outcome of the nausea, fever, allergy, anxiety, chest pain, chronic fatigue syndrome, cold hands and feet, constipation, foggy feeling in head, gluten intolerance, hot flushes, insomnia, iron low, mole of skin, mood swings, neck pain, nosebleeds numbness of limbs, pins and needles, scoliosis, sore throat, throat infection, vulvovaginal disorder nos, vitamin D decreased, heavy periods and painful periods were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, allergy, anxiety, chest pain, chronic fatigue syndrome, cold hands and feet, constipation, foggy feeling in head, gluten intolerance, hot flushes, insomnia, iron low, mole of skin, mood swings, neck pain, nosebleeds numbness of limbs, pins and needles, scoliosis, sore throat, throat infection, vulvovaginal disorder nos, vitamin D decreased, heavy periods and painful periods to be related to CERVARIX, CERVARIX and CERVARIX. RA verbatim: Nausea, fatigue, constipation, fog, chest pain, pins and needles, sore throat, numb limbs, cold hands and feet, allergies, food intolerance, anxiety, insomnia, nosebleeds, scoliosis, neck pain, chronic fatigue syndrome, menstrual problems, fever, moles, mood swings, hot flushes, very low vitamin D levels, vaginal issues and persistent throat infection. Low iron and very low - unexplained. Not one health professional could explain her combination of symptoms. Psychological damage due to no diagnosis given. Patient had low immunity at time of injections - as this as given as a school roll out, girls were not looked at individually. Evidence of intolerance to heavy metals in parent. Seek Advice Details: Referred to different departments and consultants for individual problems including paediatrician, chronic fatigue syndrome specialist, oncology and dermatology. Heavy and painful periods - Microgynon prescribed. Gluten intolerant. Dermatology prescribed cream for vulval problems.


VAERS ID: 420863 (history)  
Form: Version 1.0  
Age: 1.05  
Gender: Female  
Location: Iowa  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-12
   Days after onset:0
Entered: 2011-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB446AA / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0907Z / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1103Z / 1 LL / SC

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

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

Write-up: SOME REDNESS AND FIRMNESS ON THE L LOWER THIGH


VAERS ID: 420898 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-12
   Days after onset:0
Entered: 2011-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B126AA / 1 LG / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Inflammation, Skin warm
SMQs:, Hypersensitivity (narrow)

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

Write-up: Shot was give immediately became warm to touch, inflammation more than the size of a quarter. Pt was given BENADRYL & MOTRIN per Dr.


VAERS ID: 420954 (history)  
Form: Version 1.0  
Age: 0.16  
Gender: Male  
Location: Alaska  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-13
   Days after onset:1
Entered: 2011-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B256CA / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1514Y / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E84462 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0997Z / UNK MO / PO

Administered by: Private       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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever (highest at 101.5 degrees F) x 12 hours - treated with TYLENOL.


VAERS ID: 420975 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-13
   Days after onset:1
Entered: 2011-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0956Z / 1 RA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD. 3001879 / UNK MO / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF803AB / 1 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Back pain, Hypoaesthesia, Neurological examination normal, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Called clinic at 6 P.M. stated numbness, tingling in Rt. foot. Seen in clinic 4/13/11, tingling in both feet. Neuro exam normal. Returned at 3:30pm stating arm very sore, back pain, continued numbness. Sent to Urgent Care.


VAERS ID: 420977 (history)  
Form: Version 1.0  
Age: 0.18  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-13
   Days after onset:1
Entered: 2011-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)

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

Write-up: Non stop crying $g 3 hrs.


VAERS ID: 420982 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-12
   Days after onset:0
Entered: 2011-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV274 / 2 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3872BA / UNK LA / UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR E1288 / 2 RA / UN

Administered by: Private       Purchased by: Military
Symptoms: Chills
SMQs:

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

Write-up: Pt reporting chills; 0.3 mg EPIPEN given. Decreased chills. BP prior 118/78, 18, 60, 97.9, 120 apical. VS after 100 apical.


VAERS ID: 420990 (history)  
Form: Version 1.0  
Age: 80.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1623Z / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Rash to R arm injection site~Pneumo (Pneumovax)~1~80.00~Patient
Other Medications: Aspirin, Zithromax, Rocephin, Cardura, Lopressor, Asmanex, eyedrops, Zocor, Albuterol, and Atrovent treatments.
Current Illness: None
Preexisting Conditions: COPD, HTN, CAD, Carotid artery disease, dyslipidemia. NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient complaining of soreness to the injection site with redness that is spreading around injection site.


VAERS ID: 421027 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:2
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0603Z / 2 RA / SC
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3543AA / 2 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3486AA / 1 LA / IM

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

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

Write-up: Clts was living with father, recently moved back to mother''s care. HD called provider for IMMs record at which time there was 1 sheet received, with 1 Gardasil recorded. There was only the 1 recorded on MICR. This RN administered HPV on 4/12/2011 as 2nd dose. There was a subsequent fax that came to the HD after clt''s visit that 3 doses of HPV vacc. recorded. The 4/12/2011 dose was then clts. 4th dose.


VAERS ID: 421028 (history)  
Form: Version 1.0  
Age: 49.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-04-12
Onset:2011-04-14
   Days after vaccination:2
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (TENIVAC) / SANOFI PASTEUR U3006EA / UNK LA / IM

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

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

Write-up: Left deltoid red, warm to touch and swollen to the size of an egg. Pt stated area was also burning. Pt given ice packs and told to take Tylenol or Motrin. If symptoms persisted or got worse to return to clinic or Emergency Department.


VAERS ID: 421030 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1395Z / 2 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915192 / 1 RL / IM

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

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

Write-up: Swelling and redness at site right leg, size about 4 inch


VAERS ID: 421031 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:2
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS M53108 / 1 RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB456AA / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3764AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR AC52B044CA / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Dysarthria, Paraesthesia oral, Tongue paralysis
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BICILLIN 2ML IM
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: TONGUE FELT STRANGE TONGUE MOVEMENT WAS WEIRD, VOICE SLURRED. GIVEN 0.3 MG OF 1:1000 EPI R ARM IM


VAERS ID: 421033 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Male  
Location: Missouri  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1312Z / 2 LA / SC

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

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

Write-up: Patient has red swollen area, size of an egg on the back of the left arm. No fever, no rash. Taking Advil.


VAERS ID: 421051 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB469AA / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U36688AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1498Z / 2 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Rash on left deltoid
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient has large rash on left deltoid warm to the touch, patient states it itches a lot. No fever or other complaints.


VAERS ID: 421054 (history)  
Form: Version 1.0  
Age: 1.36  
Gender: Male  
Location: Georgia  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:2
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB453BA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0602Z / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915702 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0996Z / 1 LL / SC

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

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

Write-up: Mom reports that a rash appeared on his buttocks approx 2 hrs. after vaccinations. Rash has progressed to being papular & pustular. It is diffuse in location, on lower extremities & diaper area & is red in color.


VAERS ID: 421057 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915383 / UNK LL / UN

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

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

Write-up: (L) leg at injection site with redness, swelling & warm to touch 1 day after vaccine given.


VAERS ID: 421060 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1354Z / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRICOR; HCTZ; L-Thyroxine; ZOCOR; Metformin; TOPROL XL; ASA 81
Current Illness: None
Preexisting Conditions: Had shingles last April (2010)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient describes adverse event as 2" long x 1" wide bump at site of injection. She states that the bump is red, hot, hard, & itchy (but not painful).


VAERS ID: 421061 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B178CB / 5 LA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0367U / 2 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: ROCEPHIN (4/07) -$g hives.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6 cm x 7.5 cm erythema with induration; non-tender to palpation; no warmth at site. Imm. administered 4/12/11; seen in office r/t reaction 4/14/11. Tx: ice pack to arm & Ibuprofen.


VAERS ID: 421092 (history)  
Form: Version 1.0  
Age: 0.35  
Gender: Female  
Location: Florida  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3783AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E94497 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1267Z / 2 MO / PO

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

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

Write-up: 4 mo old female who had PCV 13 IM in left anterior thigh and PENTACEL IM in right anterior thigh on 4/12/11. Within 24 hrs after vaccines mom noticed multiple bumps with redness on both thighs that spread superiorly. No problems breathing, no lip or tongue swelling, no itching, no fevers. Pt received these vaccines 2 months ago without problems.


VAERS ID: 421145 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Montana  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:2
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3516AA / 1 LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD skin test; AMBIEN; Vit D; EFFEXOR; RELPAX; VICODIN
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Returned to clinic two days post TDAP and placement of TST c/o (L) deltoid up into shoulder & down to hand hurting, not tingling, hurting able to move thumb to fingers open & close fist raise arm. Site without redness but approximately 3" x 3" raised warm to touch area over deltoid.


VAERS ID: 421195 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Kansas  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:2
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B172AA / 1 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0039AA / 2 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1024Z / 2 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1187Z / 2 LL / SC

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

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

Write-up: Redness and swelling at site of MMR injection. On 4-14-2011, site measured 31.2 as reported by Dr.; on 4/5 swelling down to 1 cm not red.


VAERS ID: 421242 (history)  
Form: Version 1.0  
Age: 1.13  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB362CA / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0550Y / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1703Y / 1 RA / SC

Administered by: Public       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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Mild, dry cough
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mother reported that her son developed hives. She states he had them the next morning after receiving his immunizations. She states the hives come and go and he had a total of 4 at one time. The baby has no other symptoms.


VAERS ID: 421275 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-18
   Days after onset:5
Entered: 2011-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U3497BA / 5 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0123 / 5 RA / IM

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

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

Write-up: Recieved 4 shots on 4/12/11, on 4/13/11 call rcieved that right arm was red and sore. On 4/16/11 patient seen in office and diagnosed with Right arm cellulitis at the Dtap site. Treated with antibiotic.


VAERS ID: 421283 (history)  
Form: Version 1.0  
Age: 46.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-15
   Days after onset:3
Entered: 2011-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1157Z / 1 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3874BA / 1 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pain
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pain, redness, swelling of arm and axilla.


VAERS ID: 421289 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Male  
Location: Utah  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-18
   Days after onset:5
Entered: 2011-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0564Z / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3819AA / 1 LA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD. 3001880 / 1 MO / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF803AB / 2 RA / SC

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache, Musculoskeletal pain, Non-cardiac chest pain, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: NKA, simvastatin for hypercholesterol, Naprosyn for arthritis, Lisinopril for Hypertension, Omeprazole for Hiatal hernia,
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: On 04/13/11 was outside and c/o chills and Headache. Took shower at 8:30 PM and temp. at 9:30 PM had 103 degree fever and went to bed. At 5:30 AM on 04/14/11 temp. 101 derees and took 2 Aleve tablets. Cont to c/o headache, fatigue and weakness throughout the day. Seen by MD on 04/15/11. MD stated exam showed no signs of an infection or other illness not related to vaccine. Recommended Pt increase amounts of Naprosyn. On 04/16/11 c/o swelling at upper half of body accompanied by pain. Severe pain at sternum and upper back between shoulder blades. 04/17/11 pain began to subside but continued to have some fatigue until this AM of 04/18/11.


VAERS ID: 421335 (history)  
Form: Version 1.0  
Age: 0.19  
Gender: Female  
Location: New Mexico  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-19
   Days after onset:6
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B252CA / 1 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH121AA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 913964 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0502Z / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Hives to arms/hands bilat. preceded by vomiting.


VAERS ID: 421349 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B051CB / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0965Z / 2 LA / UN

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

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

Write-up: That afternoon after vaccination, (the next day) child reports a swollen and red area on arm that is about 3 inches in diameter located in the back of the left arm where the varicella vaccine would have been given. So far, ice pack has been used, will see physician if there''s a larger concern.


VAERS ID: 421354 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3618AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0330 / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0665Z / 2 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1331Z / 2 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swelling, warmth, soreness on much of upper arm.


VAERS ID: 421361 (history)  
Form: Version 1.0  
Age: 1.02  
Gender: Female  
Location: Kansas  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB446AA / 1 LL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0405Z / 1 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1594Y / 1 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: No tests/Labs done
CDC Split Type:

Write-up: Approximately 24 hours after patient received the MMR, Varicella & Hep A vaccines she developed welts and reddened areas on her thighs, arms & buttock.


VAERS ID: 421394 (history)  
Form: Version 1.0  
Age: 76.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-04-12
Onset:2011-04-14
   Days after vaccination:2
Submitted: 2011-04-19
   Days after onset:5
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3819AA / UNK RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incisional drainage, Injection site discharge, Injection site induration, Injection site pustule, Injection site swelling, Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes Mellitus, HTN, GERD, hyperlipidemia, vascular insufficency with ulcers.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right upper arm swelling with a 1X1cm pustule with a 4cm induration all around. 10mL of pus drained with local swelling, then she was injected with 1% lidocaine, incision of 3cm vertical X 1cm lateral, inner loculations broken extending 4-5 cm radially, 10-20mL of fluid drained, packed with iodoform gauze. Instructed pt to return to clinic in 2 days to remove packing and check wound. Pt started on cephaxelin 500mg PO Q6H X 7 days; Bactrim DS 2 tab PO BID X 10 days


VAERS ID: 421403 (history)  
Form: Version 1.0  
Age: 64.0  
Gender: Male  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-19
   Days after onset:7
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1150Z / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Feeling hot, Local reaction, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Came History & Physical
Preexisting Conditions: Diabetes; Hypertension; Obesity; Arthritis; DM not well controlled
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Local reaction, swelling (L) arm. Mild local warmth. Seen by covering MD. Rx with BENEDRYL 50mg PO BID, Prednisone 10mg PO qd x 3d then 1/2 tab x 3d. Cold compresses. Ibuprofen 600mg Bid.


VAERS ID: 421420 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Georgia  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U3470DA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E01231 / 4 RA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0667Z / 2 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1278Z / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Hyperhidrosis, Nausea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Child became pale, clammy, diaphoretic, BP decreased, c/o dizziness, slightly nausea. VS taken, applied cool cloths, provided H2O.


VAERS ID: 421485 (history)  
Form: Version 1.0  
Age: 0.42  
Gender: Male  
Location: Oregon  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-20
   Days after onset:7
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC218250BA / 3 LG / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1485Y / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E80081 / 3 RL / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB156A / 3 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Heart rate increased, Pyrexia, Respiratory rate increased, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Convulsions, screaming as if scared or in pain, increased heart rate, quick breathing and fever. The symptoms lasted an hour except the fever, which lasted 2 more days.


VAERS ID: 421498 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-17
   Days after vaccination:5
Submitted: 2011-04-20
   Days after onset:3
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B056BB / 1 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Headache, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bell''s Palsy.~Tdap (no brand name)~1~52.00~Patient
Other Medications:
Current Illness: None; Bell''s Palsy
Preexisting Conditions: HBP
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt developed HA 2 days after Tdap given. In 4 days she developed right facial paralysis.


VAERS ID: 421517 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Herpes zoster, Injection site pruritus, Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: I received a ZOSTAVAX injection on 4/12/2011. On 4/13/2011 I experienced a red, bumpy, itching rash at the injection site that appears at this time to be a mild form of shingles.


VAERS ID: 421589 (history)  
Form: Version 1.0  
Age: 1.01  
Gender: Male  
Location: New York  
Vaccinated:2011-04-12
Onset:2011-04-20
   Days after vaccination:8
Submitted: 2011-04-22
   Days after onset:2
Entered: 2011-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB464AA / 1 RL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0254Z / 1 LL / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0469Z / 1 RL / -

Administered by: Unknown       Purchased by: Public
Symptoms: Crying, Erythema, Papule, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: rhinorrhea for 3 days
Preexisting Conditions: mild iron deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, crying, erythematous papules to legs, diaper area, face, and arms


VAERS ID: 421591 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-22
   Days after onset:9
Entered: 2011-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB453AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1280Z / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: Patient came into clinic to be examined by physician
CDC Split Type:

Write-up: Per mom, quarter sized area of redness around the site of injection. Looks blotchy, feels soft. Area of redness is slightly tender.


VAERS ID: 421603 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Male  
Location: Missouri  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-22
   Days after onset:10
Entered: 2011-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB459AA / 2 UN / IM

Administered by: Public       Purchased by: Private
Symptoms: Chest discomfort, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MO20111

Write-up: About 20 minutes after receiving injection, client felt dizzy and shortness of breath, pressure in chest. Called 911 and was taken to ER; treated with epinephrine and Benadryl.


VAERS ID: 421620 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-22
   Days after onset:10
Entered: 2011-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B067AA / 1 RA / IM

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

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

Write-up: Severe soreness at injection site, difficulty with overhead activities more than 1 week after injection.


VAERS ID: 421616 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-14
   Days after vaccination:2
Submitted: 2011-04-22
   Days after onset:8
Entered: 2011-04-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1362Z / 1 UN / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Venlafaxine; lovastatin; metformin; carvedilol
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. reported hard lump under skin at injection site. Not painful. Iced site. Raised welt, red, 3 inches x 1 inch size.


VAERS ID: 421853 (history)  
Form: Version 1.0  
Age: 69.0  
Gender: Female  
Location: Delaware  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:2
Entered: 2011-04-28
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1384Z / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Hyperaesthesia, Injection site vesicles, Vaccination site rash
SMQs:, Hypersensitivity (narrow)

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

Write-up: Patient developed rash (04/12/11) that spread to approximate 4 inch width with blister in center at vaccination site. It is painful to the touch but does not hurt.


VAERS ID: 421996 (history)  
Form: Version 1.0  
Age: 73.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-05-02
   Days after onset:20
Entered: 2011-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1490Z / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm became red all the way down to patient''s hand; swelling of arm also noted.


VAERS ID: 422192 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-04-28
   Days after onset:15
Entered: 2011-05-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B068AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1475Z / 2 RA / SC

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

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

Write-up: Right upper arm became red, hot, swollen where Varicella vaccine was given. Area of redness spread $g1 inch over 24hrs. Patient taken to Emergency Room & was diagnosed with staph infection/cellulitis per mom. Prescribed BACTRIM and KEFLEX for 7 days. Symptoms resolved 5 days after onset.


VAERS ID: 422194 (history)  
Form: Version 1.0  
Age: 0.51  
Gender: Male  
Location: Texas  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-05-04
   Days after onset:21
Entered: 2011-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3782AA / 3 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E84462 / 3 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1476Z / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Genital rash, Injection site pruritus, Injection site rash, Pruritus genital, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Cough no fever
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Herpes Simplex virus IGG & IGM - normal
CDC Split Type:

Write-up: Bumps to arms, legs, private area itches. On 4.15.11 rash getting worse. Seen in ER. Rash spreading saw Dr. on 4-18-11 was told it was a reaction from the shots.


VAERS ID: 422289 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-05-05
   Days after onset:22
Entered: 2011-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B139AA / UNK LA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 09197 / UNK RA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tuberculin
Current Illness: Unknown
Preexisting Conditions: There were no concomitant medications and no known relevant medical history. The subject had previously received FLUZONE with no adverse events, and had not experienced adverse events following other prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0923688A

Write-up: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR II (non-gsk); Merck; unknown; right arm given on 12 April 2011 at 10:00. Concurrent medications included Tuberculin (TB skin test) given on 12 April 2011. On 12 April 2011 at 10:00 the subject received a dose of KINRIX (.5 unknown, unknown, left arm) as the 4th IPV and 5th PV in the series. On 13 April 2011 (during the night, in the early hours of the morning), 1 day after vaccination with KINRIX, the subject experienced swelling injection site and hotness at injection site of a 10-12 centimetre area. The events occurred in the same arm as KINRIX was given (left arm) and were described as a "severe injection site reaction". The subject was seen in the pediatrician''s office on 13 April 2011 and was treated with Antibiotic. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow-up information was received on 03 May 2011. It was reported that the subject experienced cellulitis in addition to injection site swelling and hotness at the injection site. The events began 2 days after administration of KINRIX, on 14 April 2011 and resolved by 18 April 2011.


VAERS ID: 422357 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E55587 / UNK RA / IM

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

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

Write-up: 5x6 cm erythema & redness (L) upper arm.


VAERS ID: 422924 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Virginia  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-05-11
   Days after onset:29
Entered: 2011-05-16
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Seasonal allergies, urticaria of unknown etiology, last episode 4 years ago. No previous reactions to vaccines.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Onset of hives within couple hours of having second HPV vaccine, first on abdomen, then spreading throughout, somewhat itchy, but no resp symptoms. Developed additional and different hives the next day and some finger swelling, again no resp or GI symptoms. Able to drink and eat normally. On 14 Apr seen in primary care and in ER on 15 Apr when sxs did not resolve with BENADRYL. Given DECADRON IM in ER. No other exposures identified such as foods, chemicals, inhalations, or illness that might have caused the hives.


VAERS ID: 423462 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Female  
Location: Utah  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-05-15
   Days after onset:33
Entered: 2011-05-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Penicillin; Sulfa; Codeine (High B/P)
Allergies:
Diagnostic Lab Data: 3 other women (age 65+ who had booster) in my book club, experienced similar reactions.
CDC Split Type:

Write-up: During annual physical exam, doctor''s assistant administered pneumonia booster (original was 2001) to deltoid area (L) arm. Approximately 3 hours later & for 3 days, I experienced heat, redness, swelling on (L) arm.


VAERS ID: 424058 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Male  
Location: Montana  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-05-24
   Days after onset:41
Entered: 2011-05-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1455Z / 1 RA / SC

Administered by: Public       Purchased by: Private
Symptoms: Arthralgia, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrocodone for pain
Current Illness: Possible polymyalgia rheumatica
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unsure - unknown
CDC Split Type:

Write-up: Patient received ZOSTAVAX on 4-12-11. A day after he had rt. shoulder pain (had vaccine in RA) & then his hips hurt really bad. Went to Dr. - could be vaccine reaction/also thinks he could have polymyalgic rheumatica.


VAERS ID: 425044 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2011-04-12
Onset:2011-04-25
   Days after vaccination:13
Submitted: 2011-06-02
   Days after onset:38
Entered: 2011-06-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1393Z / 1 AR / SC

Administered by: Private       Purchased by: Private
Symptoms: Exposure to toxic agent, Full blood count, Idiopathic thrombocytopenic purpura, Nasopharyngitis, Platelet count decreased, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Vomiting
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: CBC -$g platelets 3000
CDC Split Type: NJ1103

Write-up: The child had vomiting within hours of admin. Had fever assoc with cold in 1 wk. Developed I.T.P. within 2 weeks (5/25/11). She also was exposed to pesticides during this time.


VAERS ID: 425055 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-06-09
   Days after onset:57
Entered: 2011-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 3 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Adverse drug reaction, Biopsy site unspecified normal, Blood aluminium increased, Laboratory test, Lymphadenitis, Pyrexia, Rash, Recurring skin boils
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pt. on tegretol, ? rash
Current Illness: None reported
Preexisting Conditions: Recently dx Bi-Polar, Asthma, ADD, Esophageal Reflux Obstructive Sleep Apnea
Allergies:
Diagnostic Lab Data: Elevated Aluminin Level, other lab levels came down after 3 weeks.
CDC Split Type:

Write-up: Clinical note from Dr. on 4/24/11. 17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness. Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis. Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc. Pt was then transferred to hospital for poss non-hodgkins lymphoma. Biopsy was neg. Pt. cont. w/ recurrent boils. Aluminin level was elevated to 12.


VAERS ID: 425938 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-12
Onset:0000-00-00
Submitted: 2011-06-16
Entered: 2011-06-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3553BA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None yet. Patient declined neuro eval because of cost.
CDC Split Type:

Write-up: Pain in upper posterior arm, started shortly after injection. Persisted for over 1 month & associated with weakness of arm. Pain persisting. Referred to neurology and P.T.


VAERS ID: 426184 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2011-04-12
Onset:2011-04-14
   Days after vaccination:2
Submitted: 2011-06-23
   Days after onset:70
Entered: 2011-06-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest tube insertion, Pneumothorax, Vaccine positive rechallenge
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA02625

Write-up: Information has been received from a physician concerning a 16 year old male who on unspecified date was vaccinated with the first dose of GARDASIL (lot# and route not provided), within 48 hours of the vaccination child developed a pneumothorax. On unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot# and route not provided), and within 48 hours of the vaccination child developed a pneumothorax again. Patient sought for medical attention by contacted the physician. Follow-up information was received from the physician who confirmed that the patient was hospitalized in an unspecified hospital for an unspecified duration. The patient had a chest tube placed in him while in the hospital. At the reporting time, the outcome of pneumothorax was unknown. The doctor seemed to think the patient would be ok. Additional information has been requested.


VAERS ID: 428700 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: New York  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-08-03
   Days after onset:113
Entered: 2011-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Public       Purchased by: Private
Symptoms: Chills, Cough, Fatigue, Malaise, Oedema peripheral, Pyrexia, Renal pain, Tremor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: I did not go to the hospital because I don''t have health insurance, but I felt ill for about a month after the vaccinaton
CDC Split Type:

Write-up: Extreme Kidney Pain, Tremors or shaking of the body, violent cough, fever, chills, feeling exhausted, very tired, swollen of feet.


VAERS ID: 429406 (history)  
Form: Version 1.0  
Age: 88.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-07-19
   Days after onset:97
Entered: 2011-08-03
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / 1 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lovastatin; vitamins (unspecified)
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02267

Write-up: Information has been received from a consumer reporting on herself an 88 year old female with no allergies or drug reactions reported who on 12-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) on the left arm (route and lot number not reported). Concomitant therapy included vitamins (unspecified) and lovastatin (manufacturer unknown). On 13-APR-2011, the consumer reported that experienced swelling on her left arm at the injection site. The patient sought medical attention by referred to Health care professional. The patient was treated with antihistamine. On 14-APR-2011, laboratories were performed (no results were provided). At the time of the report the outcome of the patient was unknown. Additional information has been requested.


VAERS ID: 433643 (history)  
Form: Version 1.0  
Age: 56.0  
Gender: Male  
Location: Utah  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-07-29
   Days after onset:107
Entered: 2011-08-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0993Z / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1104USA02085

Write-up: Information has been received from a nurse concerning a 56 year old male patient who on 12-APR-2011, was vaccinated with a dose of 0.5 mL PNEUMOVAX 23 intramuscularly, in the right arm (lot number 667445/0993z, Exp. 05-JAN-2012). On 14-APR-2011, the patient was seen in the doctor''s office with a severe headache. At the time of the report of the outcome of the patient was unknown. Follow up information has been received from a registered nurse concerning the patient with no illness at time of vaccination, who on 12-APR-2011 at 10:00 was vaccinated with a first dose of PNEUMOVAX 23. On 13-APR-2011 (previously reported as 14-APR-2011), the patient experienced 3 days of erythema upper arm, aching, fever < 100 degrees and moderate to severe headache. There were no Lab diagnostic/studies performed. The patient recovered on 16-APR-2011. No further information is available.


VAERS ID: 433261 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-07-18
   Days after onset:97
Entered: 2011-08-23
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB498AA / 1 UN / UN
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA113AA / 1 LA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1059Z / 2 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3765AA / 1 UN / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3874AA / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1377Z / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: The subject has no relevant medical history and no history of adverse events following previous vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0924841A

Write-up: This case was reported by a healthcare professional and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX (GlaxoSmithKline), MENACTRA (Sanofi), MMR II (Merck), ADACEL (Sanofi) and VARIVAX (Merck) all given on 12 April 2011. There were no concurrent medications. On 12 April 2011 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On the night of 12 April 2011, less than one day after vaccination with CERVARIX, the subject experienced headache, dizziness, nausea, arm pain, tactile fever and body weakness. At the time of reporting the events were improved. Follow-up information received on 13 May 2011 indicated that the events resolved.


VAERS ID: 440227 (history)  
Form: Version 1.0  
Age: 48.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-04-12
Onset:2011-04-18
   Days after vaccination:6
Submitted: 2011-10-26
   Days after onset:191
Entered: 2011-10-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1315Z / 2 RA / IJ

Administered by: Private       Purchased by: Other
Symptoms: Haemorrhoids, Lichen planus, Lichenoid keratosis, Pathology test, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Triamterene/HCTZ 37.5-25 TAB 1x Day Fish, Flaxseed, Borage Oil Omega 3,6,9 400MG 2x Day Potassium Gluconate 550 MG 2x Day Vitamin D3-1000IU 2x Day !!!!!!!!!!!!!!!! THE FIRST HEP B VACCINE WAS ACTUALLY ADMINISTERED ON 3/12/2011 BUT BOX 14
Current Illness: No
Preexisting Conditions: Allergic to Versed.
Allergies:
Diagnostic Lab Data: Core sample of one of the red bumps indicated Lichenoid dermatitis.
CDC Split Type:

Write-up: Small slightly raised red bumps appeared on underside of both arms, on torso and buttocks. Didn''t itch, nor have fluid in them. Bumps have lessened in redness but not dissipated completely as of 10/26/2011. Bumps appear to increase in redness if patient performs strenuous physical labor which causes him to sweat. No other symptoms. Dermatologist took sample and pathology identified it as lichen planus. On 9/21/2011, Dematologist prescribed one course of Minocycline 100MG 2x daily as a preventative measure while waiting for pathology results. Minocycline seemed to cause rash to lessen but not completely go away. Possible side effect of Minocycline was patient developed prolapsed internal hemorrhoid one week after beginning Minocycline treatment. This was the first time the Patient had a hemorrhoid and didn''t strain prior to hemorrhoid appearing. Dermatologist examined hemorrhoid and noted no signs of cancer and advised patient to schedule visit with family doctor if hemorrhoid didn''t heal. As of 10/26/2011 hemorrhoid has shrunk considerably.


VAERS ID: 442918 (history)  
Form: Version 1.0  
Age: 1.03  
Gender: Male  
Location: Utah  
Vaccinated:2011-04-12
Onset:2011-06-09
   Days after vaccination:58
Submitted: 2011-11-17
   Days after onset:161
Entered: 2011-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LG / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / 1 LG / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 LG / UN

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Blood test normal, Chest X-ray normal, Febrile convulsion, Pyrexia, White blood cells urine positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: stomach virus
Preexisting Conditions: Had surgery for inguinal hernia 7/2/10 that was noticed after his 8 week immunizations.
Allergies:
Diagnostic Lab Data: urinalysis, blood work, chest x-ray
CDC Split Type:

Write-up: Patient was feverish, administered Tylenol throughout the day which didn''t control the fever, causing a febrile seizure and the patient to stop breathing. Patient had no other symptoms of illness besides a fever of approx 104 when he arrived at the hospital. Was given a double dose of Tylenol and Ibuprofen upon arrival and diagnosis. All tests came back negative except for a few white blood cells in his urine.


VAERS ID: 446266 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Nebraska  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-12-08
   Days after onset:239
Entered: 2011-12-23
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B256CA / 2 LG / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 0042AA / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915572 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1526Z / 2 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Crying, Decreased appetite, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: The subject has no relevant medical history.
Allergies:
Diagnostic Lab Data: With the second dose of PEDIARIX, the subject had onset of fever on 13 April 2011, at 01:00. Temperature was 101.5 degrees F.
CDC Split Type: A0923409A

Write-up: This case was reported by a healthcare professional via a sales representative and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (Pfizer) and ROTATEQ (Merck) both given on 12 April 2011. There were no concurrent medications. On 12 April 2011 at 16:30, the 5 month old subject received 2nd dose of PEDIARIX at 0.5 ml in an unknown leg. On 12 April 2011, less than one day after vaccination with PEDIARIX, the subject experienced crying uncontrollably. A day later, on 13 April 2011, at 01:00, the subject developed a fever (101.5 degrees F). Loss of appetite was also reported with onset 13 April 2011. Fever remained unresolved at the time of reporting. Outcome for uncontrollable crying and loss of appetite was unknown. It was additionally reported that the subject experienced the same events of uncontrollable crying, fever and loss of appetite following the 1st administration of PEDIARIX at the subjects two month old check up. Dates of administrations, onset of events and outcome was not indicated. Follow-up information was received on 13 April 2011. Concurrent vaccination included pediatric Hib vaccine given on 12 April 2011.


VAERS ID: 460375 (history)  
Form: Version 1.0  
Age: 1.28  
Gender: Male  
Location: Wisconsin  
Vaccinated:2011-04-12
Onset:2012-06-07
   Days after vaccination:422
Submitted: 2012-07-25
   Days after onset:48
Entered: 2012-07-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3473AA / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction, Sleep disorder
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 3 doses of PENTACEL; lot number C3324AA received on 01 March 2010, C3404AA received on 04 May 2010 and C3451AA received on 12 July 2010.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201207013

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 two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3324AA received on 01 March 2010, lot number C3404AA received on 04 May 2010 and lot number C3451AA received on 12 July 2010 and one dose of DAPTACEL; lot number C3473AA received on 12 April 2011 (routes and sites of administration not reported). On 07 June 2012, the subject developed a paroxysmal cough with a whoop, approximately one year and two months after the last dose. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 July 2012, the subject''s cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.


VAERS ID: 474006 (history)  
Form: Version 1.0  
Age: 1.54  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-12
Onset:2012-08-27
   Days after vaccination:503
Submitted: 2012-11-07
   Days after onset:72
Entered: 2012-11-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3815AA / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction, Post-tussive vomiting
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 3 doses of PENTACEL; lot number C3294AA received on 10 December 2009, lot number C3541AA received on 26 January 2010, and lot number C3555AA received on 30 April 2010.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201210240

Write-up: Initial report received on 29 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL: lot number C3294AA on 10 December 2009, lot number C3541AA on 26 January 2010, lot number C3555AA on 30 April 2010, and lot number C3815AA on 12 April 2011 (routes and sites of administration not reported). The subject developed a cough on 27 August 2012, approximately 16 months after the last dose. Nine days later, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 12 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 September 2012, the subject''s cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.


VAERS ID: 592623 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-04-12
Onset:2011-04-14
   Days after vaccination:2
Submitted: 2011-05-06
   Days after onset:22
Entered: 2015-08-26
   Days after submission:1573
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (DECAVAC) / SANOFI PASTEUR U3399BA / 2 LA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1490Z / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Rash, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Leg pain around the knee
Preexisting Conditions: Tobacco abuse; Sutures of facial injuries after MVA; S/P laparoscopic bilateral inguinal hernia repair; Allergies: Cats
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Skin Rash and swollen, redness


VAERS ID: 617788 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-06-09
   Days after onset:57
Entered: 2015-09-22
   Days after submission:1566
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK LG / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site induration, Injection site rash, Injection site urticaria, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Therapy regimen changed, previously received PREVNAR at the age of 2 months (date not provided)
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011081745

Write-up: This is the first of three reports. This is an initial spontaneous report received from a contactable medical assistant. A 4-year-old female patient intramuscularly received a dose of PREVNAR13 on the leg as routine vaccination on 12APR2011. The patient also concomitantly received a dose of measles, mumps, rubella and chicken pox vaccine on 12APR2011. There was no relevant medical history. Past vaccines included PREVNAR which was given when the baby was 2 month old. No vaccines were given within 4 weeks. On 13APR2011, the patient developed hardening of skin at the injection site, and also hives, little bumps and warmth at the site of injection. The events did not require an emergency room visit. Treatment was not provided. At the time of the report the clinical outcome of the above events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.


VAERS ID: 614899 (history)  
Form: Version 1.0  
Age: 0.24  
Gender: Male  
Location: California  
Vaccinated:2011-04-12
Onset:2012-04-27
   Days after vaccination:381
Submitted: 2015-12-15
   Days after onset:1327
Entered: 2015-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B280AB / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH123AB / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E88942 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1200Z / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Abdominal pain, Aggression, Crying, Developmental delay, Listless, Loss of consciousness, Nervous system disorder, Screaming, Seizure
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), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: We noticed something was not quite right with our child at home immediately following birth. He was crying a lot. Once home he was screaming and we contacted the pediatrician and weye told it was colic. We continued with vaccinations on schedule. By around 1 year our child was having seizures when he would cry and it seemed like he was passing out. We contacted the pediatrician and we''re told he was spoiled and was throwing temper tantrums. We continued with vaccines on schedule. His seizures became more severe and I asked my doctor if it could be the shots and he told me absolutely not that my child was trying to get attention. We continued with vaccinations. On 04/27/2012 after his last set of shots he was very listless and his seizures were terrible. We decided to stop vaccines altogether. He still has seizures. He has some neurological issues and development issues.


VAERS ID: 422726 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-17
   Days after vaccination:5
Submitted: 2011-05-11
   Days after onset:24
Entered: 2011-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0870Z / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, C-reactive protein normal, Haematochezia, Incorrect route of drug administration, Intussusception, Ultrasound abdomen abnormal, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Ultrasound, intussusception of colon into colon sigmoideum; WBC count, normal values; Serum C-reactive protein, normal values
CDC Split Type: WAES1105USA01279

Write-up: Case of misuse (inappropriate route of vaccination) received from the Health Authorities on 03-MAY-2011 (reference number PEI2011013225). Case medically confirmed. An 8 week old male patient had received a first dose of ROTATEQ (lot number 668125/0870Z) IM on 12-APR-2011. Five days later on 17-APR-2011 he developed bloody stools and abdominal pain leading to hospitalization for an unspecified time. Intussusception of colon into colon sigmoideum was detected by sonography. Laboratory test showed normal values for serum C-reactive protein (CRP) and leukocytes. Volvulus and gastroenteritis were excluded. The patient had completely recovered on 18-Apr-2011. The event was considered as potentially life threatening by the reporter. Upon medical review the company judged relevant to code the misuse: "inappropriate route of vaccination" which was not coded by the CA. A lot check has been initiated. No further information is available.


VAERS ID: 423493 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-05-19
   Days after onset:36
Entered: 2011-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A20CA642A / 4 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein, Cellulitis, Injection site nodule, Lymphadenopathy, Neutrophil count, Pyrexia, Red blood cell sedimentation rate, White blood cell count
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 13Apr2011, 38deg.Celsius; Body temperature, 14Apr2011, 38deg.Celsius; C-reactive protein, 14Apr2011, 63; Erythrocyte sedimentation rate, 14Apr2011, 32/69; Neutrophils, 14Apr2011, 4150; White blood cells, 14Apr2011, 14900
CDC Split Type: B0718290A

Write-up: This case was reported by the foreign regulatory authority (# MA20110874) and described the occurrence of cellulitis in a 2-year-old female subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline). Medical history and concurrent medications, if any, were unspecified. On 12 April 2011, the subject received 4th dose of INFANRIXQUINTA (batch A20CA642, intramuscular, injection site unknown). On 13 April 2011, one day after vaccination with INFANRIXQUINTA, the subject presented with fever at 38 degrees Celsius and nodule at injection site. The subject received topical treatment with FUCIDINE. On 14 April 2011, fever persisted at 38 degrees Celsius and the subject presented cellulitis (on about 15 cm of diameter) on thigh without gathering. Reactional inguinal adenopathy was reported without sign of lymphangitis. There was no functional discomfort. White blood cells were at 14900, neutrophils at 4150, C-reactive protein at 63 and erythrocyte sedimentation rate at 32/69. The subject was treated with AUGMENTIN and GENTALLINE. Fever resolved in 24 hours and cutaneous signs resolved progressively. The subject was hospitalised. At the time of reporting, fever, cellulitis and nodule at injection site were resolved. Outcome of inguinal adenopathy was unspecified. According to the foreign method of assessment, the agency considered the causal relationship between vaccination with INFANRIXQUINTA and the reported events as probable.


VAERS ID: 424343 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Unknown  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:49
Entered: 2011-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20909001A / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA560A / UNK UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR E5260 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pallor, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 12Apr2011, 39.2deg C
CDC Split Type: B0722669A

Write-up: This case was reported by a regulatory authority (PL-URPL-OCR-20110511004) and described the occurrence of restlessness in a 4-month-old subject of unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline), DTPA vaccine (non-GSK) and IMOVAX POLIO (non-GSK). On 12 April 2011 the subject received unspecified dose of HIBERIX (intramuscular, unknown injection site), unspecified dose of DTPA vaccine (Non-GSK) (intramuscular, unknown injection site), unspecified dose of IMOVAX POLIO (intramuscular, unknown injection site). On 12 April 2011, less than one day after vaccination with DTPA vaccine (Non-GSK), HIBERIX and IMOVAX POLIO, the subject experienced restlessness, paleness of skin and fever (39.2 deg C). The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. No further information is expected, the foreign Regulatory Authority has provided us with all the available information for the time being, if they ever get any further they will send it to us. This case was considered closed.


VAERS ID: 424482 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Unknown  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-06-01
   Days after onset:50
Entered: 2011-06-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20909001A / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA560A / UNK UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR E5260 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pallor, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapy.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201103024

Write-up: Case received from the Health Authorities in a foreign country on 24 May 2011 under the local number 2011/0145 (HA''s number PLURPLOCR20110511004). A 04-month-old patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of IMOVAX POLIO (batch number E5260, site of administration not reported), an intramuscular dose of HIBERIX (other manufacturer, batch number A72CA560A, site of administration not reported) and an intramuscular dose of DTP vaccine (other manufacturer, batch number 20909001A, site of administration not reported) on 12 April 2011. On the same day at 20:00, the patient experienced fever at 39.2 degrees C, pallor of skin and restlessness. The patient recovered on an unspecified date. The case was reported as serious due to other medically important condition.


VAERS ID: 426290 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-06-27
   Days after onset:76
Entered: 2011-06-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0867Y / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Malaise, Rash macular
SMQs:, 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
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA02012

Write-up: Information was obtained on a request by the Company from the agency via a public case detail form (local reference # 2011MSDA1031) concerning a 58 year old female patient who on 12-APR-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (batch number N3032, lot number 665741/0867Y) intramuscularly. On 12-APR-2011 the patient developed flu like symptoms and swelling to injection site area within a few hours of vaccine administration and remained unwell for 5-7 days. Injection site developed a red, blotchy rash, which was painful and swollen for 5 days. The patient reviewed by GP and was fully recovered when reviewed on 28-APR-2011. The reporter felt that flu like symptoms, injection site swelling and injection site reaction (red, blotchy rash, which was painful and swollen) to be incapacity/disability. The agency considered that all the symptoms were certainly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 426454 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-06-29
   Days after onset:77
Entered: 2011-06-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA082CC / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Allergy test negative, Monoplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OILATUM; EMOLLIENT
Current Illness: Eczema
Preexisting Conditions: No other immunizations have been given.
Allergies:
Diagnostic Lab Data: Allergy test, no allergies
CDC Split Type: B0727537A

Write-up: This case was reported by a foreign regulatory authority (#GB-MHRA-ADR 21111272) and described the occurrence of arm paralysis in a 12-year-old female subject who was vaccinated with CERVARIX. Concurrent medical conditions included eczema. Concurrent medications included OILATUM AND EMOLLIENT. Previous vaccination history included two dose of CERVARIX and a dose of PEDIACEL on an unspecified date. On 12 April 2011 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular). On 13 April 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced arm paralysis. The regulatory authority reported that the event was disabling. On 16 April 2011, the event was resolved. Paralysis in left arm for 72 hours. No treatment.


VAERS ID: 426918 (history)  
Form: Version 1.0  
Age: 41.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-07-07
   Days after onset:85
Entered: 2011-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA667A / 4 LA / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER A83CA118A / 4 LA / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. NL35720 / 4 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein increased, Dyspnoea, Lymphadenopathy, Pyrexia, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 13Apr2011, 39deg C
CDC Split Type: B0731028A

Write-up: This case was reported by a regulatory authority (# FI-FIMEA-20110662) and described the occurrence of dyspnea in a 41-year-old female subject who was vaccinated with HIBERIX (GlaxoSmithKline), MENCEVAX ACWY and (non-GSK) PNEUMOVAX 23. On 12 April 2011 the subject received 4th dose of HIBERIX (intramuscular, left deltoid), 4th dose of MENCEVAX ACWY (subcutaneous, left deltoid), 4th dose of PNEUMOVAX 23 (intramuscular, right deltoid). On 13 April 2011, 1 day after vaccination with HIBERIX, MENCEVAX ACWY and PNEUMOVAX 23, the subject experienced dyspnea and fever (up to 39 deg C). On 14 April 2011, 2 days after the vaccination the subject experienced vaccination site reaction (which lasted for four days) on the right upper arm. The subject was hospitalised on 14 April 2011 with enlarged neck lymph node and CRP increased (188). The subject was treated with Cefuroxime IV for 3 days. At the time of reporting the events were resolved.


VAERS ID: 427385 (history)  
Form: Version 1.0  
Age: 41.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-13
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:91
Entered: 2011-07-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72DA667A / UNK LA / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER A83CA118A / UNK LA / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0814Y / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: C-reactive protein increased, Dyspnoea, Local reaction, Lymphadenopathy, Pyrexia, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Serum C-reactive protein, 14Apr11, 188
CDC Split Type: WAES1107USA01155

Write-up: Case received from a nurse via the Health Authority on 04-JUL-2011 under the reference number FI-FIMEA-20110662. Case medically confirmed. A 41 year old female patient received a dose of PNEUMOVAX 23 (batch number NL35720, lot number 665603/0814Y) intramuscularly in right arm, a dose of HIBERIX (batch number A72DA667A) intramuscularly in the left arm, a dose of MENCEVAX AC (batch number A83CA118A) subcutaneously in the left arm on 12-APR-2011 and later on she developed pyrexia, dyspnoea, vaccination site reaction, lymphadenopathy and CRP increased. Reaction onset reported as 13-APR-2011. The day following vaccination the patient came down with fever of 39 degrees Celsius and experienced shortness of breath. 48 hours after the vaccination there was a local reaction on the patient''s right upper arm and it lasted approximately for 4 days. A swollen lymph gland was found on the patient''s neck (date not reported). On 14-APR-2011 the patient was referred to hospital. CRP level was 188 (no unit reported). She received treatment with cefuroxime 1.5 g intravenously for 72 hours. Date of discharge not reported. At the time of reporting, the outcome was recovered. No causality was reported. No further information expected. Other business partner numbers included: E2011-04189.


VAERS ID: 429010 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-05-29
   Days after vaccination:47
Submitted: 2011-08-05
   Days after onset:68
Entered: 2011-08-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ascorbic acid; Beta carotene; Folic acid
Current Illness: Pregnancy NOS (LMP = 15May11)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1108USA00229

Write-up: Case of pregnancy follow-up received from the Health Authorities agency on 28-JUL-2011 under the reference number 2011-02284 via the local site Sanofi Pasteur MSD. Case medically confirmed. A 23 year old female patient received a dose of MMR II (batch number not reported) on 12-APR-2011. Subsequently she became pregnant. Her last menstrual period was on 15-MAY-2011. The conception date was estimated to be 29-MAY-2011. Concomitantly the patient was taking folic acid, ascorbic acid and beta carotene. The patient was foreign origin. At the time of reporting the outcome was unknown. The case was considered as serious by the Health Authorities. The agency considered the event to be serious for the following reason: medically significant. Other business partner numbers include E2011-04686.


VAERS ID: 430495 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2011-04-12
   Days after vaccination:0
Submitted: 2011-08-19
   Days after onset:129
Entered: 2011-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Gastrointestinal disorder, Malaise, Nasopharyngitis, School refusal
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0739242A

Write-up: This case was reported by a physician and a health care professional and described the occurrence of gastrointestinal symptoms in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). It was unknown whether the subject had psychiatric disorders in the past. On 12 April 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid, lot number not provided). On 12 April 2011, less than one day after vaccination with CERVARIX, the subject experienced gastrointestinal symptoms. On 13 April 2011, the subject complained of malaise and anxiety and suffered from school refusal. The physician considered the events were disabling. The physician reported that although a follow-up investigation was requested because the adverse event was regarded as serious, follow-up was refused because the subject was attending another hospital. On 14 April 2011, the subject consulted another medical institution and a diagnosis of gastrointestinal cold was made, but she complained of symptoms and was sometimes absent from school and she received treatment for anxiety at another institution. The subject was suspected to have caught common cold and it affected on gastrointestinal. At the time of reporting, no symptoms were observed. The health care professional considered that anxiety was related to vaccination with CERVARIX. The causal relationship between gastrointestinal symptom and CERVARIX was unknown. No further information was available because the case was reported by healthcare center and follow up investigation was unavailable.


VAERS ID: 435345 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:0000-00-00
Submitted: 2011-09-22
Entered: 2011-09-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3742AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201108755

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3693). An adult female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number U3742AA, route and anatomical site of administration not reported) on 12 April 2011. On an unspecified date, the patient experienced not severe headache and vomiting. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The Ministry of Health classified the adverse events as AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 464753 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:0000-00-00
Submitted: 2012-09-11
Entered: 2012-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK10750 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Audiogram normal, Deafness neurosensory, Ear, nose and throat examination normal, Hypoacusis, Tinnitus, Tympanometry normal
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 04/20/2011, Audiogram; 05/18/2011, Audiogram; 04/20/2011, Ear, nose and throat examination; 04/20/2011, Tympanometry; 05/18/2011, Tympanometry
CDC Split Type: WAES1204USA00951

Write-up: Case received from a physician in a foreign country on 28-Mar-2012 and medically confirmed. A female patient born in 1996 had received the first dose of GARDASIL (batch number not reported0 on an unspecified date. One to two days after vaccination, the patient was found to have tinnitus and hypoacusis. She went to see an ENT specialist who confirmed those symptoms but no cause was found. At the time of reporting, the patient had recovered. Follow-up information received on 03-Sep-2012: The vaccine was administered via the intramuscular route in the right deltoid on 12-Apr-2011. The batch number was NN38230. The patient was 14 years old. Twenty-four hours post-vaccination the patient developed tinnitus in the right ear and right sensorineural deafness. On 20-Apr-2011 ENT examination was normal, tympanometry and audiometric test showed sensorineural deafness that involved frequencies from 4000 to 8000 Hz (30 db). She received corrective treatment with ginkgo biloba. The adverse reactions resolved in 3 weeks. On 18-May 2011 tympanometry and audiometric test were normal and the patient had fully recovered. The reporter considered the reactions as moderate and the case as non-serious. Upon medical review the company upgraded the case to serious due to deafness.


VAERS ID: 610708 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:0000-00-00
Submitted: 2015-09-28
Entered: 2015-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Chest pain, Chronic fatigue syndrome, Disturbance in attention, Dizziness postural, Fatigue, Food intolerance, Headache, Immune system disorder, Insomnia, Nausea, Pain, Petit mal epilepsy, Sleep disorder, Temperature regulation disorder, Vision blurred
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DICLOFLEX RETARD; melatonin; multivitamin; zonisamide
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015134682

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of absence seizure in a 13-year-old female patient who received CERVARIX. Concomitant products included DICLOFLEX RETARD, melatonin, Multivitamin and zonisamide. On 12th April 2011, the patient received CERVARIX (parenteral). In March 2011, an unknown time after receiving CERVARIX, the patient experienced absence seizure (serious criteria hospitalization, disability, GSK medically significant and other), chronic fatigue syndrome (serious criteria hospitalization, disability and other), chronic pain (serious criteria hospitalization, disability and other), dizziness on standing up (serious criteria hospitalization, disability and other), fatigue (serious criteria hospitalization, disability and other), headache (serious criteria hospitalization, disability and other), concentration impaired (serious criteria hospitalization, disability and other), nausea (serious criteria hospitalization, disability and other), blurred vision (serious criteria hospitalization, disability and other), anxiety (serious criteria hospitalization, disability and other), chest pain (serious criteria hospitalization, disability and other), temperature regulation disorder (serious criteria hospitalization, disability and other), immune system disorder (serious criteria hospitalization, disability and other), insomnia (serious criteria hospitalization, disability and other) and sleep disorder (serious criteria hospitalization, disability and other). In March 2014, the patient experienced food intolerance (serious criteria hospitalization, disability and other). On an unknown date, the outcome of the absence seizure, chronic fatigue syndrome, chronic pain, dizziness on standing up, fatigue, temperature regulation disorder, immune system disorder, insomnia and sleep disorder were not recovered/not resolved and the outcome of the headache, concentration impaired, food intolerance, nausea, blurred vision, anxiety and chest pain were not recovered/not resolved. It was unknown if the reporter considered the absence seizure, chronic fatigue syndrome, chronic pain, dizziness on standing up, fatigue, headache, concentration impaired, food intolerance, nausea, blurred vision, anxiety, chest pain, temperature regulation disorder, immune system disorder, insomnia and sleep disorder to be related to CERVARIX. Regulatory authority verbatim: Absence seizures (currently being investigated for auto immune epilepsy). Chronic fatigue syndrome (currently being investigated for postural tachycardia syndrome (POTS)). Chronic pain, dizziness on standing up, fatigue, headaches, and concentration impaired. Food intolerance, nausea, blurred vision, anxiety, and chest pains. Difficulty regulating body temperature, weak immune system, sleep problems, and insomnia. Hospital admission 6 months after reactions started and ongoing paediatric and neurology appointments.


VAERS ID: 731912 (history)  
Form: Version 2.0  
Age: 3.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-12
Onset:2014-03-20
   Days after vaccination:1073
Submitted: 0000-00-00
Entered: 2017-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER AA653AA / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER NN46280 / UNK UN / UN

Administered by: Unknown       Purchased by: 0
Symptoms: Coeliac disease, Diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT0095075131712ITA009749

Write-up: Information has been downloaded from Regulatory Authority (IT-MINISAL02-442772) on 19-DEC-2017, received from a consumer referring to a 3 years old female patient. On 03-JUN-2010, the patient was vaccinated with INFANRIX (lot# A21CA684A; dose, strength, route and expiration date unknown). And PREVENAR (lot# E44930; dose, strength, route and expiration date unknown). On 03-AUG-2010, the patient was vaccinated with PREVENAR 13 (lot# E28997; dose, strength, route and expiration date unknown). And INFANRIX HEXA (lot# A21CA796A; dose, strength, route and expiration date unknown). On 01-MAR-2011, the patient was vaccinated with INFANRIX (lot# A21CA844A; dose, strength, route and expiration date unknown). And PREVENAR 13 (lot# E87109; dose, strength, route and expiration date unknown). On 12-APR-2011, the patient was vaccinated with MENJUGATE (lot# AA653AA; dose, strength, route and expiration date unknown). On 12-APR-2011, the patient was vaccinated with M-M-RVAXPRO rHa (lot# reported as "NN46280"; dose, strength, route and expiration date unknown). All of the suspects were for prophylaxis. On 20-MAR-2014, the patient experienced coeliac disease and diabetes mellitus. The outcome of coeliac disease and diabetes mellitus was unknown. The causality between the suspects and the events was unknown.


VAERS ID: 420970 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-13
   Days after onset:0
Entered: 2011-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Chills, Influenza A virus test negative, Influenza virus test negative, Pyrexia, Streptococcus test, Streptococcus test negative, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Immune deficiency. Amoxicillin allergy.
Allergies:
Diagnostic Lab Data: Negative rapid strep, negative influenza A & B, negative urinalysis.
CDC Split Type:

Write-up: Onset of fever to 104 degrees & chills


VAERS ID: 420998 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-13
   Days after onset:0
Entered: 2011-04-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB A028A / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Flushing, Hypoaesthesia facial, Nausea, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None known
Preexisting Conditions: Pt stated hypertension
Allergies:
Diagnostic Lab Data: Unknown at this time
CDC Split Type:

Write-up: Patient returned post vaccine 2 hrs stating nausea, flushing approx 1/2 p. vaccine then stated she developed some numbness and tingling on facial area -$g to ER.


VAERS ID: 421017 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0894Y / 2 RA / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U3544AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Was also on Bactrim on time of injection.
Current Illness: had a healing abscess and was on Bactrim
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had headache night of 04/13/2011 which resolved. Noticed on day of 04/14/2011 to have full body rash. No difficulty with breathing, fever, or neuro symptoms. Gave Benadryl and discussed reasons to go to ER.


VAERS ID: 421032 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3298AA / 1 LA / IM

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

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

Write-up: redness, swelling, pain at injection site


VAERS ID: 421041 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3840AA / 1 RA / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pruritus, Tenderness
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: right otitis externa
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: swollen, red shoulder, mildly itchy and tender


VAERS ID: 421050 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Indiana  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1345Z / 1 AR / SC

Administered by: Other       Purchased by: Private
Symptoms: Dyspnoea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)

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

Write-up: Pt. turned white, had trouble breathing & almost passed out. Was transported to ER by paramedics. Was discharged from hospital with no known symptoms 30 mins later.


VAERS ID: 421058 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB464CA / 2 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3516AA / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B060BA / UNK RA / 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed whelps over most of her body. Reaction was a few hours after shot was given.


VAERS ID: 421065 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B178CB / 1 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E84461 / 5 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 34 week triplet preemie
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Moderate swelling and erythema down arm and into shoulder. Warm and hard to the touch.


VAERS ID: 421093 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB462BA / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3510AA / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B057EA / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1344Z / 2 UN / SC

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

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

Write-up: Approximately 11 1/2 mm red, raised, hard, itchy, painful area. Instructed to ice & give antihistamine and TYLENOL/MOTRIN for pain and swelling.


VAERS ID: 421115 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1150Z / 1 RA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3554AA / 1 LA / IM

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

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

Write-up: Pt c/o lump size between a walnut and a lemon at site of injection. Achy and painful. Advised pt per Dr. to ice the site, take TYLENOL or ibuprofen and BENADRYL as needed. Pt to call office if any new or persisting sx occur.


VAERS ID: 421134 (history)  
Form: Version 1.0  
Age: 0.64  
Gender: Female  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-15
   Days after onset:2
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LG / IJ
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LG / IJ
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LG / IJ
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

Administered by: Public       Purchased by: Other
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

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

Write-up: vomiting and diarrhea at night {3 nights after oral Rotavirus vaccination}


VAERS ID: 421142 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:1
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E88942 / 5 LL / IM

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

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

Write-up: Fever 102.0, Leg Pain, no swelling.


VAERS ID: 421146 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:1
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B178CB / 1 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB461AA / 1 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1412Z / 1 LL / SC

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

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

Write-up: Mother called 4/15/11 at 11:05am & states "(L) leg (outer thigh) red area (size of baseball). Warm to touch at injection site of KINRIX given on 4/13/11. Recommend BENADRYL 3/4 tsp bid x 1 week. Warm bath or compress & alternate cool compress for 5-10 min. TID. Also follow up on Monday or ASAP if site does not improve. Verbal understanding acknowledged.


VAERS ID: 421147 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B126AA / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0204 / 4 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1365Z / 2 RL / IM

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

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

Write-up: Right thigh to knee swelling, slightly red, warm to the touch. Treated with: AUGMENTIN 600/5 - 6cc Bid x 7 days. ATARAX 10/5 4cc every 6 hours.


VAERS ID: 421191 (history)  
Form: Version 1.0  
Age: 0.15  
Gender: Female  
Location: Illinois  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:1
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3742AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB477AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E63642 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0205AA / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)

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

Write-up: Inconsolable crying started within 30 minutes of vaccine injections, brief episodes of console. TYLENOL given about 3 - 4 hrs after injections. Crying much improved within 2 hours of TYLENOL. Swaddling helpful.


VAERS ID: 421196 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1167Z / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3461CA / 1 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3489AA / 1 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1499Z / 2 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)

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

Write-up: Whelps (R) deltoid at Tdap & MCV4 site & (L) arm where Ch. Px was given.


VAERS ID: 421161 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-17
   Days after onset:4
Entered: 2011-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0096N / 1 RA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3486AA / 1 LA / -

Administered by: Other       Purchased by: Private
Symptoms: Feeling abnormal, 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), Dementia (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD done on same date of vaccination
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx 20 sec after receiving Gardasil vacc patient stated felt funny, slumped over and passed out.


VAERS ID: 421183 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-17
   Days after onset:3
Entered: 2011-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1360Z / 1 LA / SC

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

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

Write-up: Administered ZOSTAVAX 4/13/11 - called pt to check 4/14/11. Came to pharmacy 4/17/11 at 2:20 pm. Area of injection red, swollen, warm & moving down towards elbow. Merck closed. RPh on duty will call Merck.


VAERS ID: 421233 (history)  
Form: Version 1.0  
Age: 0.9  
Gender: Female  
Location: Indiana  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-16
   Days after onset:1
Entered: 2011-04-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0330 / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI
Preexisting Conditions: 34th week gestation
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash on forehead. Rash on arms & legs.


VAERS ID: 421296 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-18
   Days after onset:4
Entered: 2011-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC2080178LB / UNK RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1089Z / UNK RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 915375 / UNK LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1183Z / UNK LA / SC

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

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

Write-up: Erythema, cellulitis bilateral biceps Rx Bactrim suspension and hydrocortisone ointment


VAERS ID: 421297 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:1
Entered: 2011-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915383 / 5 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC oral liquid 5mL QD; FLONASE nasal spray
Current Illness:
Preexisting Conditions: Autism; Allergic rhinitis; Severe overweight
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe swelling and redness of (L) upper arm at site of injection of "PREVNAR 13" vaccine for 48 hrs, since vaccine was administered on 4-13-11.


VAERS ID: 421309 (history)  
Form: Version 1.0  
Age: 0.37  
Gender: Female  
Location: Iowa  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B280AB / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1688Z / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E12400 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1477Z / 2 MO / PO

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

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

Write-up: Fever to 105 degrees rectally.


VAERS ID: 421357 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914516 / UNK LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1493Z / UNK LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site discomfort, Injection site reaction, Muscle spasms
SMQs:, Dystonia (broad)

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

Write-up: Muscle spasm at injection site causing discomfort that developed $g 12 hrs after injection.


VAERS ID: 421366 (history)  
Form: Version 1.0  
Age: 0.41  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B249BA / 2 LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 19208 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E44520 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB036A / 2 MO / PO

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

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

Write-up: PEDIARIX, PREVENAR and HIBERIX, ROTARIX vaccines were given within 15 hours patient developed a temp of 102F and red hard quarter size area on left leg. Patient recovered.


VAERS ID: 421385 (history)  
Form: Version 1.0  
Age: 0.52  
Gender: Female  
Location: Alabama  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-19
   Days after onset:6
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 RL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Diarrhoea, Diet refusal, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: high fever~DTaP (no brand name)~2~0.33~Patient|high fever~DTaP (no brand name)~1~0.17~Patient
Other Medications: Augmentin, 1.2 tsp twice daily
Current Illness: She was completing a course of Augmentin to treat an ear infection. She had only 3 doses remaining at the time of vaccination and her pediatrician had already confirmed that the infection had cleared.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed a fever of 103 at 3:30 PM on the day of the vaccination. Fever of 102 and higher continued, despite treatment with acetaminophen and ibuprofen, for 3 days. Beginning around 7PM on the day of vaccination she also began vomiting and refusing to eat. On the second day after vaccination, she developed diarrhea. Vomiting, diarrhea, and low-grade fever (100.6 or lower) continued until the 5th day after vaccination (4/18/2011).


VAERS ID: 421417 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Female  
Location: Oregon  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-19
   Days after onset:5
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1490X / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfa; WELLBUTRIN; Albuterol inhaler; Vit D3; FLOVENT HFA; Loratadine
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Expanding redness/warmth at injection site 24 hours after injection.


VAERS ID: 421418 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-19
   Days after onset:5
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB910AA / UNK LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3561AA / 2 RA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Erythema, Injection site erythema, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Hep B & Tdap given 4/13/11 with one vaccine in each arm. On 4/14/11, patient experienced redness & itching in both arms. She walked into clinic on 4/19/11 because redness had increased. Presented with erythema in both upper extremities from mid deltoid to 1" below elbow. Treated with prednisone 40mg x 2 days, 30mg x 2 days & 20mg po x 2 days.


VAERS ID: 421466 (history)  
Form: Version 1.0  
Age: 51.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-20
   Days after onset:5
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1452Z / 1 LA / SC

Administered by: Public       Purchased by: Private
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Area of injection was hot, erythematous, painful, itchy and swollen. Patient went to PMD and received a cortisone injection.


VAERS ID: 421547 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-04-21
   Days after onset:6
Entered: 2011-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0182AA / 1 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3676AA / 1 LA / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B060CA / 1 RA / -

Administered by: Public       Purchased by: Public
Symptoms: Induration, Petechiae, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Patient developed petechiae, swelling with induration about 10 cm after Tdap in his right arm. On left arm developed a 12cm area of swelling and induration after recieving HPV and MCV4. Evaluated by attending MD here at the clinic. No other symptoms.


VAERS ID: 421665 (history)  
Form: Version 1.0  
Age: 1.02  
Gender: Female  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-25
   Days after onset:11
Entered: 2011-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Irritability, Pyrexia, Rash, Respiratory tract congestion, Restlessness, Sleep disorder, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I don''t know who the Manufacturer''s were. Please call Dr. for that info.
Current Illness: Getting over slight cold.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None at this point. We expect a full recovery, but plan to reconsider all vaccines in the future.
CDC Split Type:

Write-up: Rash, fever, irritability, restlessness, sleep problems, vomiting, congestions, wheezing, and general weakness.


VAERS ID: 421667 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-04-13
Onset:2011-04-24
   Days after vaccination:11
Submitted: 2011-04-25
   Days after onset:1
Entered: 2011-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV273 / 1 LA / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR W04003A / 1 LA / OT

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

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

Write-up: Noticed Pustular rash on chest and back 12 days after receiving smallpox vaccine. Discussed with HC and pictures sent. No fever, no itching, Dx Non-viral pustulous.


VAERS ID: 421738 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Indiana  
Vaccinated:2011-04-13
Onset:2011-04-26
   Days after vaccination:13
Submitted: 2011-04-26
   Days after onset:0
Entered: 2011-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B168AA / UNK RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1427Z / 2 RA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915671 / 5 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1468Z / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Blood amylase, Facial pain, Parotitis, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal infections (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Amylase 390
CDC Split Type:

Write-up: Parotitis. Left side facial pain and swelling.


VAERS ID: 421802 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-21
   Days after onset:7
Entered: 2011-04-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3838BA / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multivitamin
Current Illness: None
Preexisting Conditions: NKDA; No past medical hx
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Apr 14: 1 inch diameter bright red and raised area formed where shot was given. Temp 99.2, generalized achiness, chills, & fatigue. Apr 15: 2.25 inch diam. cherry red and indurated area at vaccine site. The site was approx. 1/4 inch raised. Temp 98.8 and site very painful & hot. Apr 16: 2.5 inch diameter maroon and even more indurated at site, hard and painful. Apr 17: redness subsided minimally. Apr 18: redness and induration minimally receded. Apr 19 - present: Sl. pink but palpable induration at vaccination site. I took pictures every day. Redness resolved however 3" diameter palpable "knot" persists.


VAERS ID: 421803 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-27
   Days after onset:14
Entered: 2011-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915671 / 1 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Irritability
SMQs:, 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), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: IMMEDIATE SORENESS-LATER THAT DAY LARGE INDURATION ON L THIGH OF 5 INCHES. WARM TO TOUCH, SWOLLEN-LASTED 4 DAYS. PT VERY IRRITABLE AND EMOTIONAL.


VAERS ID: 421828 (history)  
Form: Version 1.0  
Age: 51.0  
Gender: Female  
Location: New York  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-27
   Days after onset:14
Entered: 2011-04-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3554AA / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Induration, Joint range of motion decreased, Oedema, Pain, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D3; Lisinopril/HCTZ 20/25 BP
Current Illness: None
Preexisting Conditions: Allergic to penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 13x13 indurated warm fluctuant area w/ assoc. erythema, warmth, tenderness, decreased ROM secondary to edema & pain. 3 visits to clinic. Tx 1 gm ROCEPHIN IM then BACTRIM 875/105 BID x 10 d.


VAERS ID: 421866 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-28
   Days after onset:15
Entered: 2011-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB789BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal distension, Hepatomegaly, Injection site erythema, Injection site pain, Pyrexia, Underdose
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Blood transfusion; There were no concomitant vaccinations and no known concurrent medications. The subject had no known adverse events following previous vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0924671A

Write-up: This case was reported by a healthcare professional and described the occurrence of abdominal swelling in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included blood transfusion. On 13 April 2011 the subject received 1st dose of ENGERIX B (.5 ml, intramuscular, left arm). On 13 April 2011, less than one day after vaccination with ENGERIX B, the subject experienced abdominal swelling, injection site redness, injection site tenderness, intermittent fever, swollen liver and vaccine underdose (adult dose of ENGERIX B is 1 ml). The reason for the vaccine underdose was not reported. A healthcare professional visit on 13 April 2011 noted swelling around the liver. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting, the injection site redness and injection site tenderness were improved, the intermittent fever was unresolved, and the outcome of the abdominal swelling and swollen liver was unspecified. The vaccination course with ENGERIX B was discontinued. The healthcare professional considered the injection site redness and injection site tenderness were probably related to vaccination with ENGERIX B, the abdominal swelling was possibly related to vaccination with ENGERIX B, and the relationship of the intermittent fever and swollen liver was unspecified.


VAERS ID: 422046 (history)  
Form: Version 1.0  
Age: 1.54  
Gender: Male  
Location: New Hampshire  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-22
   Days after onset:9
Entered: 2011-05-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B118CA / 4 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB469AA / 1 RL / IM

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

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

Write-up: Patient received a DTAP #4 and a Hepatitis A #1 on 4/13/11. The mother is calling today 4/22/11 stating that within a minute of receiving vaccines his cheeks & side of his neck broke out in a rash. That lasted 3-4 minutes. The nurse was aware at that time. While in the car on their way home he was grinding his teeth & crunching his muscles. Mother reported this reaction to us on 4/22/11. Medical assistant reported to me that she did not see a rash on 4/13/11.


VAERS ID: 422481 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-09
   Days after onset:26
Entered: 2011-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG JEV09M40F / 1 LA / IM
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 460011A / 3 RA / ID

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

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

Write-up: Pain at injection site. Pain would shoot down arm when pressure applied to injection site. Pain has been present since day vaccine received.


VAERS ID: 422553 (history)  
Form: Version 1.0  
Age: 1.02  
Gender: Male  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-23
   Days after vaccination:10
Submitted: 2011-05-03
   Days after onset:10
Entered: 2011-05-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB464CA / 1 LL / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0036Z / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1492Z / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: CSF test normal, Convulsion, Differential white blood cell count normal, Full blood count normal, Pyrexia, Rash, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Neg CSF; Neg urine; Nl cbc with diff.
CDC Split Type:

Write-up: Pt received MMR, VARIVAX and Hep A on 04/13/11 8-9 days later, pt had a high fever, then started to seize. Seizure lasted for 1 hour. Pt was sent to ER where he continued to seize despite ATIVAN & other anticonvulsant therapy. He was shipped to another facility. Rash on torso 4/29/11.


VAERS ID: 422662 (history)  
Form: Version 1.0  
Age: 1.26  
Gender: Male  
Location: New York  
Vaccinated:2011-04-13
Onset:2011-04-18
   Days after vaccination:5
Submitted: 2011-05-11
   Days after onset:23
Entered: 2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0319Z / 3 RL / IM

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

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

Write-up: pt had fever for 4-5 days of 102.6 rash for 2-3 days and vomited


VAERS ID: 422688 (history)  
Form: Version 1.0  
Age: 1.09  
Gender: Male  
Location: Michigan  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-11
   Days after onset:28
Entered: 2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB464BA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0811Z / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1038Z / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed high fever, 103.F, and screaming uncontrollably.


VAERS ID: 422804 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Male  
Location: Delaware  
Vaccinated:2011-04-13
Onset:2011-04-18
   Days after vaccination:5
Submitted: 2011-05-13
   Days after onset:25
Entered: 2011-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / OT

Administered by: Military       Purchased by: Military
Symptoms: Dyspnoea, Dyspnoea exertional, Electrocardiogram ambulatory, Palpitations, Ventricular extrasystoles
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: Almost continuous palpitations for two nights, then sporadic but decreasing frequency ever since. Some shortness of breath with low level of exertion. Saw cardiologist and and have Holter monitor, having multiple PVCs, cardio says benign but is doing US today to check for carditis.


VAERS ID: 423030 (history)  
Form: Version 1.0  
Age: 53.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-04-13
Onset:0000-00-00
Submitted: 2011-05-16
Entered: 2011-05-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0211AA / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B069AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Erythema, Fatigue, Localised oedema, Pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Lumbar radiculitis; GERD; DM II; HTN; insomnia; VIT D def
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness, pain, edema, local area & generalized fatigue & arthralgia.


VAERS ID: 423031 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-04-13
Onset:2011-05-12
   Days after vaccination:29
Submitted: 2011-05-17
   Days after onset:5
Entered: 2011-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3783AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915383 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0197AA / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5/14/11 intussusception ileocolic. 5/16/11 recurrent intussusception.


VAERS ID: 424222 (history)  
Form: Version 1.0  
Age: 80.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-27
   Days after onset:44
Entered: 2011-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 145Z / UNK LA / SC

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

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

Write-up: fever, generalized aches and pains


VAERS ID: 424811 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-17
   Days after onset:4
Entered: 2011-06-06
   Days after submission:50
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1507Z / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None. Given prednisone taper for swelling by Dr.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccination given 4/13. Patient came into pharmacy 4/15 with redness, swelling and heat of about an inch to two inches around inj site. Advised BENADRYL & NSAID. Came back 4/17 after going to Dr. - swelling had travelled to elbow but redness & heat were gone.


VAERS ID: 428075 (history)  
Form: Version 1.0  
Age: 91.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-07-20
   Days after onset:97
Entered: 2011-07-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 10662 / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Gait problem; CAD
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: At site of injection, patient experienced swelling, soreness, redness, and warmth. Acetaminophen 650 MG Other, cephalexin 500 - Rx, but never too MG QID.


VAERS ID: 428357 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-04-13
Onset:2011-04-29
   Days after vaccination:16
Submitted: 2011-07-27
   Days after onset:89
Entered: 2011-07-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / UNK UN / ID

Administered by: Military       Purchased by: Military
Symptoms: Pericarditis, Troponin I
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had a medical history of chest pain, dizziness/fainting spells, shortness of breath, and asthma (include exercise induced).
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201105194

Write-up: This study case was received from the investigator on 21 July 2011. A 21-year-old male subject received on 13 April 2011 the following vaccinations: an injection of ACAM2000 (lot number not reported) and Anthrax vaccine (manufacturer and lot number not reported). The subject had a medical history of chest pain, dizziness/fainting spells, shortness of breath, and asthma (including exercise induced). The subject''s testing from 17 April 2011 reported an abnormal troponin I of 6.04 and an abnormal electrocardiogram (ECG). His echocardiogram results were not available. On 29 April 2011, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.


VAERS ID: 429405 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-07-19
   Days after onset:97
Entered: 2011-08-03
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK RA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEURONTIN; Levothyroxine sodium; REMERON
Current Illness: Neuropathy; Depression; Thyroid disorder; Gastric disorder; Drug hypersensitivity; Allergic reaction to antibiotics; Food allergy; Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1104USA02430

Write-up: Information has been received from a 40 year old female patient with neuropathy, depression, thyroid problem and stomach problem and who was allergic to aspirin, erythromycin, clindamycin; some food allergies as oysters and allergic to pollen; who "last Wednesday" (on 13-APR-2011) was vaccinated at the back of the right arm with a dose of ZOSTAVAX (Merck) (lot# not specified). Concomitant therapy included NEURONTIN, Mirtazapine (MSD), levothyroxine Na and "Platonix". The patient reported that the same afternoon after receiving the dose of ZOSTAVAX (Merck) (on 13-APR-2011), she experienced injection site reaction. Her right arm became swollen and really puffy, was itchy and red hot to touch. She stated she showed her Dad, who was pharmacist, and he told her to use cortisone cream (unspecified). The patient stated her arm was still swollen but she thought the cream was starting to help since the swelling had decreased somewhat, and the site was not as hot. She stated that she still had a ring of red at the site. No lab diagnostic studies were performed. Follow up information has been received from a female business staff from the physician''s office who stated that original patient''s adverse event could not be located. She had no new information about the patient''s adverse event. She also stated the patient did not get ZOSTAVAX (Merck) in the physician''s office. No further information is available.


VAERS ID: 433642 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-07-29
   Days after onset:107
Entered: 2011-08-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK GM / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Asthenia, Back pain, Dark circles under eyes, Dysstasia, Erythema, Eyes sunken, Flushing, Grip strength decreased, Headache, Pain in extremity, Skin warm
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonazepam; PROCRIT, SYNTHROID; GLUCOPHAGE; PROTONIX
Current Illness: Myelodysplastic syndrome
Preexisting Conditions: Drug hypersensitivity
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1104USA01944

Write-up: Information has been received from a 67 year old female consumer with myelodysplastic syndrome and no known drug reactions/allergies, who on 12-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). Concomitant therapy included PROCRIT, GLUCOPHAGE, SYNTHROID, PROTONIX and clonazepam. The consumer reported that on 12-APR-2011, within 5 or 10 minutes of receiving the dose of PNEUMOVAX 23, she had severe reaction. She had severe flushing of her face, and also her face was red and hot. The consumer also said that she experience weakness and inability to walk or stand. She could not hold a cup of water that she was given. The patient stated that she got the shot in her hip and said that she had severe pain in her back, on the same side as the injection was given. The patient also experienced a severe headache. The patient also reported that she developed black circles under her eyes. The patient sought unspecified medical attention. The patient was given cortisone shot to help her with the reaction. No labs diagnostic tests were performed. It was reported that after an hour or two the patient was able to drive herself home. At the time of the report, the patient still had some redness in her face and she thought she might had a dull headache, but none of the other symptoms. Follow up information indicated that on 13-APR-2011 (previously reported as 12-APR-2011) the patient was vaccinated with a dose of PNEUMOVAX 23 (lot umber not provided) and after she received the vaccine her eyes sunked in, turned black and she had a pain in her right arm. It was reported that the patient did not seek medical attention. No treatment was given for the adverse events. No lab diagnostic test were performed. The patient was reported as not recovered. Additional information has been requested.


VAERS ID: 432559 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: D.C.  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-08-04
   Days after onset:112
Entered: 2011-08-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Blood test, Dizziness, Electrocardiogram, Thinking abnormal, Urine analysis
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02290

Write-up: Information has been received from a registered nurse concerning a 15 year old female patient who on the afternoon of 13-APR-2011 was vaccinated with a dose of 0.5mL of GARDASIL (route and lot number not reported). On the morning of 14-APR-2011 while at school, the patient experienced changes in behavior and mentation. Nurse reported that the mother stated that teachers noticed the patient "acting goofy, giddy and laughing" and the patient''s mother noticed mentation changes. Nurse reported that patient''s mother took her daughter to the emergency room and the patient normalized there. An electrocardiogram, unspecified blood work and urinalysis were performed (results not reported) before the patient was discharged. At the time of the report, the patient recovered on 14-APR-2011. Additional information has been requested.


VAERS ID: 429631 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Male  
Location: California  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-08-14
   Days after onset:123
Entered: 2011-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH PCV13 / UNK LG / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Diet refusal, Lethargy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Low Weight, no medical reason why, will not eat properly, being tested for many different things all tests came back normal.
Allergies:
Diagnostic Lab Data: No tests. I was told this was all normal. Did What I could to keep fever down to avoid hopsitalization.
CDC Split Type: PCV13

Write-up: Extremely High Fever, Vomiting, Lethargic, Would Not Eat, would not drink.


VAERS ID: 434044 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:152
Entered: 2011-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0969Y / 2 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3474AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine 0.025 mg qd; Strattera 1 tab daily am; Seroquel 200mg 1 tab q am & 1 tab @ noon; Benztropine 0.5mg bid; Seroquel 50mg q am & 1 tab @ noon; Guanfacine 1 mg; citalopram 10 mg 1/2 tab q day in am; Seroquel 300mg @ bedtime.
Current Illness: Foster care giver denies any illness at time of vaccination.
Preexisting Conditions: Allergy to Abilify
Allergies:
Diagnostic Lab Data: Neither patient nor care giver recall him getting any lab or diagnostic tests.
CDC Split Type:

Write-up: Cephalgia; fever; vomiting. Care giver called CDC # on VIS and was told to seek medical care, so she took patient to ER. Patient recalls getting an IV. Care giver recalls being told patient''s reaction was due to shots to protect from viral illness.


VAERS ID: 439950 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-08-23
   Days after onset:132
Entered: 2011-10-21
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Incorrect drug dosage form administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US44954

Write-up: Case number PHHY2011US44954, is an initial report from a health care professional received on 25 May 2011. This report refers to a female child. The child received vaccination with MENVEO (batch number unknown) on 13 Apr 2011. The patient was administered only MenCYW-135 component (dilutant). No other information was reported.


VAERS ID: 455614 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2012-05-01
   Days after onset:384
Entered: 2012-05-15
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA096AD / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Amenorrhoea, Ovarian cyst, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: BACTRIM allergy; Epigastric pain; Sore throat
Preexisting Conditions: The subject had no other vaccines given on the same date as the CERVARIX. The subject had no concomitant medications.
Allergies:
Diagnostic Lab Data: Diagnostic ultrasound, 02Feb2012, right ovarian cy
CDC Split Type: A0965919A

Write-up: This case was reported by a healthcare professional and described the occurrence of amenorrhea in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included BACTRIM allergy, epigastric pain and sore throat. On 13 April 2011 at 14:30 the subject received 1st dose of CERVARIX (.5 ml, unknown route, right arm). In April 2011, less than one month after vaccination with CERVARIX, the subject experience amenorrhea and on 01 February 2012 experienced an ovarian cyst. The subject was administered the CERVARIX on 13 April 2011. In July 2011, the subject was seen by the healthcare professional and did not mention the amenorrhea. In November 2011, the subject was seen by the healthcare professional and the subject''s mother reported that the subject had not had her period since April 2011. The subject was referred to Obstetrics and Gynecology who found a right ovarian cyst on 01 February 2012 by ultrasound. At the time of reporting the outcome of the events was unspecified. The vaccination course with CERVARIX was discontinued. On 06 March 2012, updated lot number information was received from a safety review. The lot number was reported as AHPV096AD from the reporter; however, based on safety lot number review, the lot was updated to APVA096AD. Follow up information received from the healthcare professional on 14 March 2012. The healthcare professional reported that the subject experienced the events on 13 April 2011 and the events resolved on 05 February 2012. The healthcare professional noted that the events were not serious. According to the healthcare professional, the CERVARIX immunization series has been delayed until the subject''s parent decides to continue.


VAERS ID: 460364 (history)  
Form: Version 1.0  
Age: 1.88  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-13
Onset:2012-06-13
   Days after vaccination:427
Submitted: 2012-07-25
   Days after onset:42
Entered: 2012-07-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3618AA / 4 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 3 doses of PENTACEL; lot number C3289AB received on 05 August 2009, lot number C3545AA received on 12 February 2010 and lot number C3606AA received on 02 June 2010.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201207017

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 three-year-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 C3289AB received on 05 August 2009, lot number C3545AA received on 12 February 2010 and lot number C3606AA received on 02 June 2010 and one dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). On 13 June 2012, the subject developed a cough and paroxysmal cough without a whoop, approximately 14 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and negative culture on 28 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 July 2012, the subject''s cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.


VAERS ID: 464443 (history)  
Form: Version 1.0  
Age: 1.28  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-13
Onset:2012-07-09
   Days after vaccination:453
Submitted: 2012-09-05
   Days after onset:58
Entered: 2012-09-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3618AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 3 doses of PENTACEL; lot number C3542AA received on 01 March 2010, C3579AA received on 30 April 2010 and C3608AA received on 06 July 2010.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201208072

Write-up: Initial report received on 31 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-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 C3542AA received on 01 March 2012, C3579AA received on 30 April 2010 and C3608AA received on 06 July 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, approximately 15 months after the last dose. On 14 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 19 July 2012 for unknown duration. The subject was not hospitalized. At the time of final contact on 23 July 2012, the subject''s cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.


VAERS ID: 467188 (history)  
Form: Version 1.0  
Age: 1.53  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-04-13
Onset:2012-07-14
   Days after vaccination:458
Submitted: 2012-09-27
   Days after onset:75
Entered: 2012-10-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3618AA / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had previously received 3 doses of PENTACEL; lot number C3500AA received on 02 December 2009, lot number C3541AA received on 03 February 2010 and lot number C3591AA received on 07 April 2010.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201208817

Write-up: Initial report received on 19 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3500AA received on 02 December 2009, lot number C3541AA received on 03 February 2010 and lot number C3591AA received on 07 April 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed a cough in 14 July 2012, approximately 15 months after the last dose. On 21 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 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: 493969 (history)  
Form: Version 1.0  
Age: 1.32  
Gender: Male  
Location: Wisconsin  
Vaccinated:2011-04-13
Onset:2013-05-06
   Days after vaccination:754
Submitted: 2013-06-07
   Days after onset:32
Entered: 2013-06-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 3 doses of PENTACEL received on 18 February 2010, 21 April 2010, and 07 July 2010 (lot numbers not reported).
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201306501

Write-up: Initial report received on 30 May 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 4 doses of PENTACEL on 18 February 2010, 21 April 2010, 07 July 2010, and 13 April 2011 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 06 May 2013, approximately 2 years after the last dose, and a paroxysmal cough without a whoop on 06 May 2013. The subject also developed cold like symptoms on 05 May 2013 and post tussive vomiting and apnea (start dates not reported). Laboratory testing included positive PCR on 08 May 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 May 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 22 May 2013, the subject''s cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.


VAERS ID: 592752 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: New York  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2015-08-27
   Days after onset:1597
Entered: 2015-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508USA011808

Write-up: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient was vaccinated with his/her first dose, second dose and third dose of RECOMBIVAX HB (route, strength, lot# and dose were unknown) on 11-FEB-2011, 13-APR-2011 (inappropriate schedule of drug administration) and 23-JUL-2011 (inappropriate schedule of drug administration), respectively. No adverse effects were reported. Additional information has been requested.


VAERS ID: 617836 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-06-09
   Days after onset:56
Entered: 2015-09-22
   Days after submission:1566
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915373 / 5 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011073207

Write-up: This is a spontaneous report from a contactable nurse. This is fifth of five reports by the same reporter. This nurse reported on behalf of a 3-year-old female patient who received a 5th dose of PREVNAR13 (lot number915373), intramuscularly administered into the right arm on 13APR2011. The patient had no relevant medical/drug history. Drug allergies or relevant family history was denied. Concomitant medications were not reported. On 14APR2011, the patient experienced a reaction at injection site characterized by vaccination site redness and swelling. On an unspecified date, the patient also experienced vaccination site pain. The events did not result in a doctor visit. Relevant laboratory data was not provided. The status of therapy was unknown at the time of the report. Therapeutic measures taken in response to event were unknown. The patient recovered from the events. The nurse did not wish to be contacted for additional information. Follow-up attempts completed. No further information expected. Follow-up (28APR2011): New information reported from a contactable nurse includes: patient''s date of birth and gender, lot number, medical history, product details and event details leading to the additional codes of vaccination site pain, swelling and redness, event onset dates, and outcome.


VAERS ID: 648901 (history)  
Form: Version 1.0  
Age: 0.92  
Gender: Unknown  
Location: Unknown  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2016-08-23
   Days after onset:1959
Entered: 2016-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: waes1607usa012034

Write-up: This spontaneous report as received from a medical assistant refers to a 11 month old patient of unspecified gender. The medical assistant reported that the patient, who date of birth was 27-APR_2010, received the 1st dose of VARIVAX (confirmed Lot # 1105Z and exp., 25-AUG-2012) on 13-APR_2011 (dose unspecified), this was outside the recommendations per the VARIVAS prescribing information (inappropriate age of vaccine administration; product use in unapproved population). No adverse effects reported. No further information was provided. No product quality completed was involved. Additional information has been requested.


VAERS ID: 421476 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-20
   Days after onset:7
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Influenza
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0714082A

Write-up: This case was reported by a physician and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included influenza. On 13 April 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. On 13 April 2011, less than one day after vaccination with CERVARIX, the subject experienced fever and headache. The subject was hospitalised. On 14 April 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.


VAERS ID: 421560 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-04-19
   Days after onset:5
Entered: 2011-04-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Aphagia, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011081884

Write-up: This is a spontaneous report from a non-contactable physician via a company representative. A 4-year-old male patient received one dose of PREVENAR, Injection on 13Apr2011. Relevant medical history, past drug event and concomitant drugs were unknown. On 14Apr2011, the patient developed nausea, vomiting, abdominal pain and was unable to eat. At the time of this report, the patient was receiving treatment. The outcome of reported events was not recovered as of this report. No follow-up attempt possible. No further information expected. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR.


VAERS ID: 421650 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-22
   Days after onset:9
Entered: 2011-04-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E0060 / 4 AR / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant medical history. No other concomitant drug.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201102253

Write-up: Case received on 14 April 2011, follow-up information on 18 April 2011, from a healthcare professional in a foreign country, through local affiliates under local reference number CN2011034. A 24-month-old female patient, with no medical history, developed urticaria after receiving her fourth subcutaneous dose of ACTHIB (Batch number E0060-1) on the deltoid on 13 April 2011. There was no concomitant drug. On 13 April 2011, i.e. the day of immunization, the patient developed urticaria. She was examined by a doctor on 14 April 2011. A corrective therapy was administered on 14 April 2011. At the time of reporting, the patient did not recover. The patient was not hospitalized. This case was assessed by the reporter as serious due to medically important condition. Documents held by sender: none.


VAERS ID: 421708 (history)  
Form: Version 1.0  
Age: 0.24  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-25
   Days after onset:12
Entered: 2011-04-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Pallor, Respiratory arrest, Somnolence
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011085044

Write-up: This is a spontaneous report from a contactable physician via sales representative. A 12-week-old female patient received the first dose of PREVENAR 13, INFANRIX HEXA and ROTARIX for vaccination on 13Apr2011 approximately at 1 pm. PREVENAR 13 was administered in the left thigh and INFANRIX HEXA in the right thigh, both via intramuscular route of administration. ROTARIX was administered via oral route of administration. The patient did not have any relevant medical history. 2.5 hours after vaccination the patient''s skin colouration changed and the patient became pale with redness of skin. The patient had a big need of sleep and suddenly the patient experienced breathing arrest. After the patient was lifted up and shaken the patient''s condition normalised. The event was considered to be life-threatening. Since 15Apr2011 the patient''s breathing and heart were monitored via a monitor. Furthermore, it was reported that the patient received supply with vital fire. The patient recovered by 19Apr2011. The healthcare professional''s assessment of relatedness between the adverse event and the vaccines was possibly related. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.


VAERS ID: 421880 (history)  
Form: Version 1.0  
Age: 0.24  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-28
   Days after onset:15
Entered: 2011-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Apparent life threatening event, Erythema, Loss of consciousness, Pallor, Respiratory arrest, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0071146A

Write-up: This case was reported by a physician, via Pfizer Pharma GmbH, and described the occurrence of near miss sudden infant death syndrome in a 12-week-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline) and ROTARIX. Co-suspect vaccination included PREVENAR 13 (Pfizer). There was no relevant medical history. On 13 April 2011 the subject received 1st dose of INFANRIX HEXA (intramuscular, right thigh), 1st dose of ROTARIX (unknown formulation, oral), 1st dose of PREVENAR 13 (intramuscular, left thigh). After vaccination the subject was sleepy. On 13 April 2011, 2.5 hours after vaccination with INFANRIX HEXA, PREVENAR 13 and ROTARIX, the subject experienced near miss sudden infant death syndrome with pallor, loss of consciousness, skin red and stopped breathing. The physician considered the events were life threatening. After measures by the grandmother with lifting up and shaking, the subject regained consciousness and the conditions normalised. Since 15 April 2011 the subject was monitored for breathing and heart sounds. Additionally the subject received "supply with vital fire". On 19 April 2011, the events were resolved. The physician considered the events were possibly related to vaccination with INFANRIX HEXA, ROTARIX and PREVENAR 13.


VAERS ID: 422004 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-29
   Days after onset:16
Entered: 2011-05-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1007 / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Cyanosis, Fall, Heart rate decreased, Heart rate increased, Oxygen saturation decreased, Pain, Pallor, Presyncope, Stress, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history (including allergy), no concomitant therapies
Allergies:
Diagnostic Lab Data: 13/Apr/11 - 15:10; HR=20-30/min; 13/Apr/11 - 15:20; HR=60/min; SaO2=90-94%; 13/Apr/11 - 15:20 (after resuming oxygen administration); HR=90-100/min; SaO2=99-100%
CDC Split Type: 201102435

Write-up: Initial report received from a healthcare professional in a foreign country on 18 April 2011. Local reference number A201100328. A 4-year-old female patient, with no relevant medical history (including allergy), experienced vasovagal reaction on 13 April 2011, i.e. the day she received a subcutaneous dose of ACTHIB lot number G1007 in the left upper arm at 15:05. She had received PREVENAR on 06 April 2011. On 13 April 2011, after vaccination, the patient became dull and looked pale. During the clinical course, skin symptoms such as urticaria or wheezing were not observed. At around 15:10, i.e. 5 minutes after vaccination, the patient became dull and looked pale. During the clinical course, skin symptoms such as urticaria or wheezing were not observed. At around 15:10, i.e. 5 minutes after vaccination, the patient suddenly fell over and collapsed in the waiting room. The face was pale (lurid) and cyanosis was noted in the lips. Spontaneous breathing was observed. On auscultation, heart rate was slow (about 20-30/min). Chest percussion was performed but heart rate recovery was not obtained. Administration of 5 L/min of oxygen was initiated. At around 15:15, the patient got more color, cyanosis disappeared and crying occurred. At around 15:20, administration of oxygen was temporarily discontinued. Weakened crying and disappearance of redness of the skin were noted. Administration of 2 L/min of oxygen was resumed as heart rate decreased to about 60/min and SaO2 dropped to below mid 90''s. Then, the heart rate increased to 90-100/min and SaO2 to 99-100. At 15:40, the patient was taken to hospital by ambulance. Thorough examination was conducted at the hospital and no abnormalities were found. The patient returned home past 19:00. According to the physician, this case was serious and not related to ACTHIB. Physician''s comment: "the patient developed vasovagal reaction after receiving the vaccination of ACTHIB. This is considered to be caused by direct irritation of the vaccination. The event is not attributable to ACTHIB vaccine. Instead, the event was caused by stress and pain from vaccination. It is desirable that measures such as making the injection needle thinner are taken to reduce pain".


VAERS ID: 422005 (history)  
Form: Version 1.0  
Age: 37.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-04-29
   Days after onset:16
Entered: 2011-05-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was sensitive to vaccine injection though there was no severe relevant adverse event previously; when she received administered influenza vaccine, she felt mild pain. Unknown concomitant therapies.
Allergies:
Diagnostic Lab Data: no data
CDC Split Type: 201102464

Write-up: Initial report received from a consumer in a foreign country on 20 April 2011 through a pharmaceutical company under the reference number SK20110013. A 37-year-old female patient who was "sensitive to vaccinated injection" had received an intramuscular dose of ADACEL on 13 April 2011. On 13 April 2011, after the injection, the patient experienced pain, swelling, erythema at injection site and fever. On the weekend of 16 April 2011 to 17 April 2011, fever had disappeared and pain, swelling and erythema seemed to be alleviated. However, from 18 April 2011, pain worsened and the area of erythema increased. Pain, swelling, erythema at injection site continued for 1 week until the last contact date on 20 April 2011. The patient was sensitive to vaccine injection though there was no severe relevant adverse event previously; when she received administered influenza vaccine, she felt mild pain. According to the patient, the symptoms were serious considering the severity and duration. List of documents held by sender: none.


VAERS ID: 422132 (history)  
Form: Version 1.0  
Age: 0.18  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-03
   Days after onset:20
Entered: 2011-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS YHIBC084CA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cough, Pneumonia, Rash
SMQs:, Anaphylactic reaction (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0716293A

Write-up: This case was reported by a physician and described the occurrence of pneumonia in a 2-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 13 April 2011, the subject received unspecified dose of HIBERIX (.5 ml, intramuscular, unknown site of injection). On 13 April 2011, less than one day after vaccination with HIBERIX, the subject experienced rash. On 15 April 2011, 2 days after vaccination with HIBERIX, the subject experienced cough. On 19 April 2011, 6 days after vaccination with HIBERIX, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting, the events were unresolved.


VAERS ID: 422480 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-09
   Days after onset:26
Entered: 2011-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA123AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Decreased appetite, Feeling cold, Hypoaesthesia, Injection site discolouration, Injection site pain, Pyrexia, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 13Apr2011, 38Deg.C
CDC Split Type: B0714810A

Write-up: This case was reported by a physician and described the occurrence of skin discoloration in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 April 2011 the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 13 April 2011, less than one day after vaccination with CERVARIX, the subject experienced skin discoloration and fever. On 16 April 2011, the subject experienced anorexia. At the time of reporting, the events were improved. Follow-up information received on 27 April 2011: Previous and/or concurrent vaccination included CERVARIX (GlaxoSmithKline) given on 9 March 2011. Site of injection (left upper arm) was added. On 13 April 2011, during vaccination with CERVARIX, when the needle was intramuscularly inserted in the left upper arm, the subject had no numbness or no backflow of blood. But when the drug was infused, she experienced pain which was moderate. After coming back home, the subject experienced numbness, cold feeling, turning purple in the overall left upper limb (to the fingertips). The fingertips in the right hand also turned purple. During the night of 13 April 2011, the subject experienced pyrexia (38 Deg.C). On 13 April 2011, the subject also experienced anorexia. The physician considered the events were clinically significant (or requiring intervention). On 14 April 2011, the subject was afebrile, and the color of the limbs became normal. Between 16 April 2011 and 18 April 2011, as the subject persistently had anorexia, Sulpiride was administered. At the time of reporting, all the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 2 May 2011: The batch number was added.


VAERS ID: 422957 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-14
   Days after vaccination:1
Submitted: 2011-05-16
   Days after onset:32
Entered: 2011-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROLA086A1 / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0719004A

Write-up: This case was reported by a healthcare professional (National Immunization Program) via another manufacturer (Fiocruz) and described the occurrence of afebrile seizure in a 2-month-old male subject who was vaccinated with ROTARIX (Fiocruz). On 13 April 2011, the subject received 1st dose of ROTARIX (route unknown). On 14 April 2011, 24 hours after vaccination with ROTARIX, the subject experienced afebrile seizure and hypotonic-hyporesponsive episode. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved.


VAERS ID: 423061 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-19
   Days after vaccination:6
Submitted: 2011-05-17
   Days after onset:28
Entered: 2011-05-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Decreased appetite, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA02272

Write-up: Case received from the Health Authorities on 10-MAY-2011 under the reference number: ES-AGEMED-523951341. Case medically confirmed. An one year old male patient had received an injection of MMR II (batch number not reported, by intramuscular route, and site of administration not reported) on 13-APR-2011 and six days later, on 19-APR-2011, the patient presented with pyrexia. On 21-APR-2011, eight days after vaccination, the patient developed appetite absent and exanthema according to the Health Agency report. At the time of reporting, the patient had not recovered from these adverse events. Case reported as serious by the Health Authorities with other medically important condition as criteria. No further information reported. Case is closed. Other business partner numbers include E2011-02862.


VAERS ID: 424084 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-26
   Days after onset:43
Entered: 2011-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / 5 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0721509A

Write-up: This case was reported by a regulatory authority (# NL-LRB-120822) and described the occurrence of faint in a 3-year-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline). No known medical history or known past drug therapy. Concomitant medication was not reported. On 13 April 2011, the subject received 5th dose of INFANRIX-IPV (intramuscular, administration site unknown, batch number not provided). On 13 April 2011, 5 minutes after vaccination with INFANRIX-IPV, the subject experienced faint. He was pale, very quiet and silent but didn''t lose consciousness nor fell down. There was no swelling nor breathing difficulty. This case was assessed as medically serious by GSK. On 13 April 2011, the events were resolved spontaneously. The regulatory authority reported that the events were probably related to vaccination with INFANRIX-IPV. 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: 424342 (history)  
Form: Version 1.0  
Age: 0.12  
Gender: Unknown  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:48
Entered: 2011-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20909002B / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UVA09012 / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA639A / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypotonia, Hypotonic-hyporesponsive episode, Pallor
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0722665A

Write-up: This case was reported by a regulatory authority (PL-URPL-OCR-20110507004) and described the occurrence of hypotonic-hyporesponsive episode in a 6-week-old subject of unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline), DTPA vaccine (non-GSK) and hepatitis B vaccine (non-GSK). On 13 April 2011 the subject received unspecified dose of HIBERIX (unknown route, unknown injection site), unspecified dose of DTPA vaccine (Non-GSK) (unknown route, unknown injection site), unspecified dose of Hepatitis B vaccine (Non-GSK) (unknown route, unknown injection site). On 13 April 2011, less than one day after vaccination with DTPA vaccine (Non-GSK), Hepatitis B vaccine (Non-GSK) and HIBERIX, the subject experienced hypotonic-hyporesponsive episode, paleness of skin and muscle tone flaccid. The events lasted tens of seconds. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. No further information is expected, the foreign Regulatory Authority has provided us with all the available information for the time being, if they ever get any further they will send it to us. This case was considered closed.


VAERS ID: 424383 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-05-31
   Days after onset:48
Entered: 2011-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0867Y / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, 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
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA03276

Write-up: Information was obtained on request by the company from the agency via public case details form (local reference 2011MSDA0877, OPR281513), concerning a 70 year old female who on 13-APR-2011 was vaccinated within a dose (1 dose, 1 time) of PNEUMOVAX 23 (lot#665741/0867Y, batch#N3032) intramuscular. On 13-APR-2011 the patient developed pain and swelling, redness in patches of upper arm. The patient was treated with PANADOL, cool packs, marked edge of red warmth in case of spreading and flucloxacillin. The agency considered that pain and swelling, redness in patches of upper arm was possible related to therapy with PNEUMOVAX 23. Pain and swelling, redness in patches of upper arm was considered to be disabling by the agency. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 425262 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-06-10
   Days after onset:56
Entered: 2011-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED B090630501 / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dermatitis, Skin haemorrhage, Skin lesion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011028767

Write-up: This health authority report (initial receipt 01-Jun-2011) concerns a 40-year old female patient. On 13-Apr-2011 the patient received one dose of FLUVAX (batch number: B090630501) injection. On 15-Apr-2011 the patient developed a chronic inflamed lesion which bled profusely when knocked. The event has persisted with little change for the past 5 weeks. The event outcome was not recovered. Reporter''s comments: The reporter considered event certainly related to the suspect drug. The reporter coded ''injection site nodule'' as the Preferred Term. Batch record review of lot number 090630501 received on 06-Jun-2011 noted that all deviations related to the manufacture of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.


VAERS ID: 425932 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-06-22
   Days after onset:70
Entered: 2011-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA076EC / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0727134A

Write-up: This case was reported by a regulatory authority (# NL-LRB-122381) and described the occurrence of fainting in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Concomitant medication was not reported. No known medical history or past drug therapy. On 13 April 2011, the subject received 2nd dose of CERVARIX (intramuscular, administration site unknown). On 13 April 2011, 5 minutes after vaccination with CERVARIX, the subject experienced fainting and injection site warmth. This case was assessed as medically serious by GSK. She received chocolate and tea with sugar. On 13 April 2011, after 1 minute, she recovered. The outcome of injection site warmth was unspecified. The regulatory authority reported that the events were probably related to vaccination with CERVARIX. 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: 427485 (history)  
Form: Version 1.0  
Age: 46.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-06-14
   Days after vaccination:62
Submitted: 2011-07-14
   Days after onset:30
Entered: 2011-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090628702 / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011029112

Write-up: This health authority report (initial receipt: 04-Jul-2011) concerns a 46-year old male patient. On 13-Apr-2011 the patient received one dose of FLUVAX (batch number: 090628702) injection. On 14-Jun-2011 the patient had suspected vaccination failure. On 15-Jun-2011 he was diagnosed with influenza A on serology. The event outcome was not yet recovered. The reporter considered events to be serious (caused or prolonged inpatient hospitalisation) and possible in relation to the suspect drug.


VAERS ID: 433056 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-05-07
   Days after vaccination:24
Submitted: 2011-09-02
   Days after onset:118
Entered: 2011-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB203BD / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pelvic pain, Polycystic ovaries, Pregnancy test negative, Thrombosis, Ultrasound scan abnormal, Uterine dilation and curettage, Uterine haemorrhage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Abnormal vaginal bleeding; C-section due to arrested phase lab; Cellulitis (R) arm
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0943070A

Write-up: This female subject was enrolled in a study. On 03 March 2011 and 13 April 2011, the subject received the 1st and 2nd dose of TWINRIX. the subject''s past medical history included cellulitis right arm, abnormal vaginal bleeding, and C-section due to arrested phase labor (see case ids A0577220A, A0577220B, and B0510840A respectively for more details). On 07 May 2011, 24 days after the 2nd dose of TWINRIX, this 28-year-old subject experienced abnormal uterine bleeding. The subject was hospitalised. The subject was treated with dilation and curettage. The event resolved on 25 May 2011. The investigator reported the abnormal uterine bleeding as possibly related to TWINRIX due to the time elapsed between the application of the vaccine and the start of symptoms. Investigator comments: On 29 August 2011, during a clinic visit, the subject reported that on 07 May 2011, she started with transvaginal bleeding associated with blood clots and pelvic pain. She thought that it was a menstrual disorder because she was not using any birth control method. She persisted with bleeding, therefore, on 21 May 2011, she consulted to the emergency room of the local hospital. A blood pregnancy test was performed with negative result and a sonogram reported polycystic ovarian. Uterine dilation and curettage was performed on 23 May 2011 without complications. She was discharged on 24 May 2011 without home treatment. She reported to feel recovered on 25 May 2011. The medical chart will be reviewed as soon as possible. Diagnosis: Abnormal uterine bleeding.


VAERS ID: 434428 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-15
   Days after vaccination:2
Submitted: 2011-09-14
   Days after onset:152
Entered: 2011-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB470AE / 2 LG / UN

Administered by: Other       Purchased by: Other
Symptoms: Aspartate aminotransferase normal, Base excess, Basophil count increased, Blood bicarbonate, Blood calcium decreased, Blood pH normal, Blood potassium normal, Blood sodium decreased, C-reactive protein increased, Conjunctivitis, Diet refusal, Echocardiogram normal, Electrocardiogram normal, Eosinophil count increased, General physical health deterioration, Haematocrit decreased, Haemoglobin decreased, Immunoglobulin therapy, Infection, Kawasaki's disease, Lymph node pain, Lymphadenopathy, Lymphocyte count increased, Monocyte count increased, Neurological examination normal, Neutrophil count increased, Oedema peripheral, PCO2 normal, Pharyngeal erythema, Platelet count increased, Pyrexia, Rash, Rash maculo-papular, Red blood cell sedimentation rate increased, Rhinitis, Scarlet fever, Skin exfoliation, Skin warm, Thrombocytosis, Tonsillar disorder, Tympanic membrane hyperaemia, Ultrasound scan abnormal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Aspartate aminotransferase, 20Apr2011, 49.7U/l; Base excess, 20Apr2011, -1.1mmHg; Basophil count, 20Apr2011, normal; Basophil count, 27Apr2011, increased (absol; Blood bicarbonate, 20Apr2011, 23.1mmHg; Blood calcium, 20Aprl2011, 1.18mmol/l; Blood potassium, 20Apr2011, 4.5mmol/l; Blood sodium, 20Apr2011, 135.2mmol/l; Body mass index, 20Apr2011, 16.42; Body temperature, 20Apr2011, 38.8decC; C-reactive protein increased, 20Apr2011, 52.78; C-reactive protein increased, 20Apr2011, 64.5; C-reactive protein increased, 27Apr2011, 12.37; Echocardiogram, 20Apr2011, normal; Echocardiogram, 26Apr2011, normal; Electrocardiogram, 26Apr2011, normal; Eosinophil count, 20Apr2011, increased (absol; Eosinophil count, 23Apr2011, increased (absol; Eosinophil count, 27Apr2011, increased (absol; Erythrocyte sedimentation rate, 20Apr2011, 120 / not readab; Erythrocyte sedimentation rate, 27Apr2011, 68/110mm; Head circumference, 20Apr2011, 50.5cm; Hematocrit, 20Apr2011, 0.3; Hematocrit, 23Apr2011, 0.28; Hemoglobin, 20Apr2011, 6.2g/dl; Hemoglobin, 23Apr2011, 6.0g/dl; Lymphocyte count, 20Apr2011, normal; Lymphocyte count, 27Apr2011, increased (absol; Monocyte count, 20Apr2011, normal; Monocyte count, 27Apr2011, increased (absol; Neutrophil count, 20Apr2011, increased (absol; Neutrophil count, 23Apr2011, increased (absol; Neutrophil count, 27Apr2011, increased (absol; PCO2, 20Apr2011, 38.7mmHg; Platelet count, 20Apr2011, 374/ul; Platelet count, 23Apr2011, 409/ul; Platelet count increased, 27Apr2011, 523/ul; Ultrasound scan, 20Apr2011, neck: pathologic; Ultrasound scan, 26Apr2011, neck: improved; Weight, 20Apr2011, 13.3kg; Weight, 27Apr2011, 12.9kg; White blood cell count increas, 20Apr2011, 18.6/ul; White blood cell count increas, 23Apr2011, 14.1/ul; pH
CDC Split Type: D0072630A

Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2011028919) and described the occurrence of Kawasaki syndrome in 27-month-old male subject who was vaccinated with HAVRIX 720 Junior (GlaxoSmithKline). The subject was born spontaneously in the 40th week of pregnancy with a birth weight of 3800 g and a birth size of 51 cm as first child of healthy parents. Postpartal adaptation was normal and development up to now was age-corresponding normal. The subject has no underlying or concurrent medical conditions or other risk factors. Family anamnesis was normal. The subject received no concomitant medication. Up to now the subject has completely received all recommended vaccinations. All previous vaccinations, including first dose of HAVRIX 720 Junior (GlaxoSmithKline), given on 03 August 2010, have been well tolerated. On 13 April 2011 the subject received the second dose of HAVRIX 720 Junior (0.5 ml, unknown, unknown thigh). Approximately two days post vaccination with HAVRIX 720 Junior, on 15 April 2011, the subject experienced persistent high fever. Scarlatina (scarlet fever) was considered. The subject was treated with PENICILLIN for five days without success. Fever was still persisting. The subject experienced increasing deterioration of general condition with refusal to eat, skin efflorescence and edema on back of hands. On 20 April 2011 the subject was hospitalised for eight days. On admission to hospital the subject was in reduced general condition with fever of 38.8 degC. The skin was rosy and warm with maculo-papular exanthema with moderate sized spots on both cheeks and an emphasis towards the extremities but without petechiae. Skin turgor and skin care was good. Examinations of bones and joints were normal and showed free mobility both active and passive. The head was firm and of normal configuration. The muscles were normotonic and normotrophic. Otorhinolaryngologic examinations showed humid mucous membranes, severe throat erythema, no throat coating, severe redness of tonsils without coating, tympanic membranes both sides bland, no struma, and distinctly visible lymph nodes right cervical which were painful on pressure. Examinations of heart, lungs and abdomen as well as examinations of anogenital area were normal. Neurological examinations were normal and showed no signs of meningism, symmetric spontaneous motor function, no loss of cranial nerve function and normal pupil reactions. The subject was hospitalised for therapy resistant fever. Considering the symptoms, fever despite antibiotic treatment of more that five days, erythema of oral mucous membranes, polymorph exanthema, edema on back of both hands, cervical lymphadenopathy with lymph node size of more than 1.5 cm, and newly developed bilateral non-purulent conjunctivitis the subject was diagnosed with Kawasaki syndrome. Sonography of neck, performed on 20 April 2011, showed pathologic enlarged lymph nodes both sides with a maximal size of 30 x 23 mm (larger than 1.5 cm) but no signs of lymph node abscess formation. Laboratory parameters showed increased inflammatory parameters including increased white blood cell count with increased neutrophil and increased eosinophil count, as well as increased C-reactive protein (CRP: 52.78). Antibiotic treatment was discontinued. Treatment with normal immunoglobulins for three days and treatment with aspirin (ASS) as well as systemic treatment with PREDNISOLON for 24 hours for severe lymphadenopathy were started. On 24 April 2011 fever was resolved. Inflammatory parameters were improving. Sonography of neck, performed on 23 April 2011, showed enlarged and augmented, conglomerate-like arranged lymph nodes right with moderately hyperperfusion and without signs of necrolysis and augmented lymph nodes left of normal size of less than 1.5 cm. Echocardiograms, performed on 20 April 2011 and 26 April 2011, as well as electrocardiogram (ECG), performed on 26 April 2011, were normal and showed no signs of coronary involvement. On 27 April 2011 the subject was discharged from hospital in stable and ameliorated condition for ambulatory treatment at home. At the time of discharge from hospital the subject showed thrombocytosis and fine exfoliation of both hands. Conjunctivitis and exanthema were resolved. Cervical lymph nodes swelling was distinctly improved compared to admission to hospital but still visible at the right side. Symptoms of otorhinolaryngologic infection were improved to mild with improved tonsillar ring symptoms but mild rhinitis and slightly reddened tympanic membranes both sides. After about eight days, on 27 April 2011, Kawasaki syndrome was resolved. The outcome of initially suspected Scarlatina (scarlet fever) was unknown. The vaccination course with HAVRIX 720 Junior was discontinued. The reporting physician has not seen the subject since occurrence of the events and therefore the physician has no further information. The reporting physician stated that the causal relationship of the events to vaccination with HAVRIX 720 Junior stayed unsettled. No further information will be available.


VAERS ID: 439660 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-10-21
   Days after onset:191
Entered: 2011-10-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB720AP / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0984Y / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pallor, Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA02635

Write-up: This is a spontaneous case report received from an agency (Mfr Control # SIJAZMPNCPHV2011SI0131-363) and concerning a 6 year old male patient who received a dose of MMR II (lot # 665683/0984Y, batch # NL50430) along with the first dose of ENGERIX-B (batch # ARBVB720AP) on 13-APR-2011. 3 minutes after the vaccines were administered the patient experienced tonic convulsion and pallor. The reaction abated spontaneously after 15 to 20 seconds. The child was afterwards observed in outpatients setting. Reaction did not reappear, complete recovery was reported as outcome. No data was provided on the child''s medical history. Tonic convulsion and pallor were considered to be other important medical events by the agency. The agency felt that tonic convulsion and pallor were possibly related to vaccination. This was originally reported by a physician. No further information is available.


VAERS ID: 440684 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2011-10-28
   Days after onset:198
Entered: 2011-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB720AP / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER NL5043 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pallor, Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0756752A

Write-up: This case was reported by a physician via a regulatory authority (# SI-JAZMP-NCPHV-2011SI0131-363) and described the occurrence of tonic convulsion in a 6-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and MMR vaccine (non-gsk). The subject''s medical history was not reported. On 13 April 2011, the subject received 1st dose of ENGERIX B (administration site and route unknown) and an unspecified dose of MMR vaccine (Non-GSK) (unknown). On 13 April 2011, 3 minutes after vaccination with ENGERIX B and MMR vaccine (Non-GSK), the subject experienced tonic convulsion and pallor. This case was assessed as medically serious by GSK. On 13 April 2011, after 15 to 20 seconds, the events were resolved.


VAERS ID: 445405 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-13
Onset:0000-00-00
Submitted: 2011-12-13
Entered: 2011-12-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Borrelia test negative, CSF test normal, Central nervous system lesion, Dysphagia, Encephalopathy, Grip strength decreased, Inability to crawl, Motor dysfunction, Muscle spasms, Nuclear magnetic resonance imaging brain abnormal, Oropharyngeal spasm, Somnolence, Speech disorder, Strabismus, Viral test negative
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ocular motility disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Diagnostic laboratory test, 28Apr11, Viral test: Negative; magnetic resonance imaging, 28Apr11, Nuclear: periventricular white-matter laesions (see narrative); magnetic resonance imaging, Several unspecified laesions.; serum Borrelia burgdorferi antibody test, 28Apr11, Negative; cerebrospinal fluid analysis, 28Apr11, No anomalies
CDC Split Type: WAES1112USA00875

Write-up: Case received from the Health Authorities on 02-DEC-2011, under the reference number NL-LRB-130046. Not medically confirmed. Initial source was a consumer. Case reported as serious by the agency (criterion: hospitalization disabling). A 15-month-old female patient had received a dose of MMR II (number in series not reported, lot number and site of administration unknown) and a dose of NEISVAC-C (dose in series and batch number not reported) on 13-APR-2011 in the local Childhood Immunisation Programme. No information reported on concomitant medication. On 27-APR-2011, the patient experienced encephalopathy, unspecified with latency of 14 days after the vaccination. The patient had no medical history. Clinical course reported by the agency: The patient experienced multifocal neurologic laesions with a multiphasic clinical pattern, initially suspected for acute disseminated encephalomyelitis (ADEM), however no ascribed to an unknown immunologican condition or viral infection. The condition manifested itself two weeks after the administration of the vaccines (also reported as 14 weeks). Symptoms presented with strabismus, drowsiness and loss of motor function in the left upper and lower extremities and left facial musculature. Initially the patient''s condition improved after corticosteroid therapy, however this was followed by two additional paroxysms. Magnetic resonance imaging (MRI) revealed several inspecified lesions. Patient partially recovered with persisting disability (swallowing, speech function, grip and crawling) impaired due to bilateral spasm, including oropharyngeal involvement. Patient''s condition was now gradually improving with significant impairment remaining however due to multifocal neurologic laesions, due to an unknown inflammatory encephalopathy possibly viral encephalitis; initial suspicion for ADEM had been abandoned. Upon medical review the company judged relevant to code the following adverse events: "strabismus", "drowsiness", "motor dysfunction", "multiple disabilities", "spasms", which were mentioned by the agency in the narrative but not coded. The patient was hospitalized. Physical findings and lab test results: 28-APR-2011: Nuclear Magnetic Resonance Imaging (NMRI): periventricular white-matter laesions diffuse restriction mesencephalon right and left thalamus. No clues for a specific viral pathogen. 28-APR-2011: cerebrospinal fluid (CSF) test: no anomalies. Borrelia burgdorferi serology: negative. Viral test: negative. Treatment and clinical course: the adverse reaction was treated with methyl prednisone. Multi episodal clinical course. Only partial recovery. Causality assessment: possible (plausible time interval, adverse event linked to MMR II vaccination, however no clinical clues towards a BMR infection). Concluding summary: encephalopathy: multifocal neurologic laesions, due to an unknown inflammatory encephalopathy, possibly viral encephalitis, initial suspicion for ADEM had been abandoned. Patient outcome: the adverse event "encephalopathy, unspecified" was reported by the agency as "recovered with sequelae". Comment reported by the agency: preliminary report due to ongoing diagnostic process. The events were considered to be disabling by the agency. Other business partner numbers included: E2011-07696. No further information is available.


VAERS ID: 451210 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:0000-00-00
Submitted: 2012-03-03
Entered: 2012-03-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 109303 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Thrombocytopenic; Thrombocyte count 30000
Allergies:
Diagnostic Lab Data: Platelet count, 140, At time of recovery. Unit and reference value unknown
CDC Split Type: PHHY2011AR50838

Write-up: Case number PHHY2011AR50838 is an initial spontaneous report from Health Authority (Ministry of Health) received on 07 Jun 2011, with follow-up received on 26 Jul 2011, and with a follow up received from the quality assurance department (reference number: 114468) on 28 Feb 2012. This report refers to a 1-year-old male child. Medical history included thrombocytopenia with thrombocyte count 30000. He received AGRIPPAL Junior (batch number 109303) on 13 Apr 2011. He was also vaccinated with MMR vaccine and Hepatitis A virus vaccine (VHA) on an unspecified date. Eleven days after vaccination, he experienced idiopathic thrombocytopenic purpura which led to hospitalization on 24 Apr 2011. The event outcome was reported as recovered after 48 hours. At time of recovery platelet count was 140 (unit and reference value unknown). Based on the batch review report, it was stated that the concerned AGRIPPAL Junior vaccine batch number 109303 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received on 26 Jul 2011: updated medical history, vaccination date, other vaccinations and hospitalization date. Follow up information received from the quality assurance department on 28 Feb 2012: Updated batch review report.


VAERS ID: 483784 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2012-04-13
   Days after vaccination:366
Submitted: 2013-02-08
   Days after onset:301
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bronchiolitis, Exposure during pregnancy
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1205USA02147B1

Write-up: This infant case was received from the Health Protection Agency on 03-May-2012. REF 0542. This case is linked with maternal report E2012-02918. This case is medically confirmed. A male patient received MMRVAXPRO (batch number NL07080), transplacentally, on 13-Apr-2011. The patient''s 31 year old mother was found to be pregnant with an EDD of 07-Jan-2012. Her LMP was not reported. The patient''s mother did not experience any adverse reaction following vaccination. The patient''s mother was susceptible to measles (from her clinical history) and was immunised for holiday travel. The patient''s mother had four previous pregnancies of which two went to full term with no birth defects, one was an elective termination and one ended in a miscarriage (at an unknown gestation). The patient''s mother had no pregnancy complications or illnesses, no diagnostic tests and no labour complications. The patient was born weighing 8.5lbs (3.86kg) at 39 weeks gestation. The patient had no congenital anomalies diagnosed at birth. The infant possibly had blocked tear ducts but this was not definitely diagnosed. The patient outcome was not reported. Follow up received on 31-Jan-2013: This case has been upgraded to serious. The patient was admitted to hospital with an episode of bronchiolitis on 13-Nov-2012.


VAERS ID: 492405 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2011-04-13
Onset:2011-04-13
   Days after vaccination:0
Submitted: 2013-05-22
   Days after onset:770
Entered: 2013-05-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bone pain, Dermatitis, Dyspnoea, Eczema, Inflammation, Insomnia, Lymphadenopathy, Mass, Muscle disorder, Pruritus, Rash, Sensation of heaviness, Spinal pain, Suicidal ideation, Urticaria, Visual acuity reduced, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Suicide/self-injury (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013036105

Write-up: This health authority report (initial receipt 07-May-2013) concerns a male patient. On 13-Apr-2011, the patient received one dose of influenza vaccine (batch and brand unspecified) via intramuscular injection. On the same day, the patient complained of aching bones at the base of skull, legs feeling heavy like they are weighed down, pain in the spinal cord from the cervical area to the lumbar area, pain in the left humerus bone, especially in the area below which the vaccination was given. The pain was the cause of many sleepless nights and continued for months. Also suffered with unusual breathing sensation like breathlessness behind the shoulders; not chest pain, but an unusual symptom which GPs (general practitioners) could not understand. Dimming of vision and subsequent decrease in vision, collapsing when walking due to leg leaden-ness, muscles in upper arms disappearing, swelling of lymph nodes under armpits. Suicidal thoughts, pseudo dermatitis, skin rashes with excessive itching, like infected hives and inflammation over the entire body, individual lumps ascending from the ankles upwards the legs, the arms, the shoulders, the back, the abdominal area, diagnosed with eczema on 21-Sep-2011. The health authority also coded preferred terms sleep disorder, myalgia, gait disturbance, and injection site pain. The event outcome was not yet recovered. Reporter''s comments: The reporter considered events possible in relation to the suspect drug.


VAERS ID: 421049 (history)  
Form: Version 1.0  
Age: 1.08  
Gender: Female  
Location: Michigan  
Vaccinated:2011-04-14
Onset:2011-04-14
   Days after vaccination:0
Submitted: 2011-04-14
   Days after onset:0
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3783AA / UNK RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB464AA / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1014Z / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915383 / UNK LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1321Z / 1 RL / SC

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

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

Write-up: Soon after Imms given urticarial rash over neck area only. No progression noted, on observation for 15 min. BENADRYL 4ml given. Clear chest, no distress, no fever on exam before child left the office. Advised Mom to call us at the clinic if rash progresses or still concerned. An oncall Dr. would call her back. RN called Mom at 5:30pm, rash all gone, didn''t repeat BENADRYL at home.


VAERS ID: 421046 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: Guam  
Vaccinated:2011-04-14
Onset:2011-04-14
   Days after vaccination:0
Submitted: 2011-04-15
   Days after onset:1
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV275 / 6 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3819AA / 1 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR E0302 / 2 LA / IM

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

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

Write-up: 2 ERYTHEMATOUS BANDS WITH MILD EDEMA DISTAL TO INJECTION SITES, PRURITIC. TOP BAND MEASURED ~3CM IN WIDTH, BOTTOM 2CM IN WIDTH. PT WAS GIVEN 12.5 OF BENADRYL IM WITH RESOLUTION OF SYMPTOMS


VAERS ID: 421067 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2011-04-14
Onset:0000-00-00
Submitted: 2011-04-14
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0710Y / 3 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVIL prn
Current Illness: None
Preexisting Conditions: AUGMENTIN; prednisone; overweight; hypertriglyceridemia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No adverse rxn. Pt received one xtra MMR she did not need. Pt record indicated need for #2 MMR & NP didn''t check other site in EMR that had record of all previous immunizations that is clearly read only scanned the flow sheet in order to interpret # 2 MMR had been given 6/20/2003.


VAERS ID: 421070 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2011-04-14
Onset:2011-04-15
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

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

Write-up: dizziness


VAERS ID: 421187 (history)  
Form: Version 1.0  
Age: 1.49  
Gender: Male  
Location: Illinois  
Vaccinated:2011-04-14
Onset:2011-04-15
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3380AA / 4 LL / IM

Administered by: Other       Purchased by: Public
Symptoms: Erythema, Injection site reaction, Rash papular, Skin lesion, Skin plaque
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash noted morning after administration. Rash first noted close to injection site. At first fine red papules on left upper thigh, then spreading to trunk, then appearance of red raised plaques and target lesions on trunk.


VAERS ID: 421190 (history)  
Form: Version 1.0  
Age: 0.33  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-04-14
Onset:2011-04-15
   Days after vaccination:1
Submitted: 2011-04-15
   Days after onset:0
Entered: 2011-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3738AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915572 / 2 RL / IM

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

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

Write-up: Rash noted on both thighs where PREVNAR & PENTACEL given had bandaids over site.


VAERS ID: 421154 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-04-14
Onset:2011-04-14
   Days after vaccination:0
Submitted: 2011-04-16
   Days after onset:2
Entered: 2011-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain lower, Decreased appetite, Insomnia, Malaise, Pyrexia, Sleep disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Nasonex, Patanase, Rhynatan
Current Illness: none
Preexisting Conditions: non-allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Following administration of Prevnar 13, child showed signs of malaise in the afternoon post-administration, did not eat or sleep well that night, and woke the next morning to a temperature of 101.9 and complaints of lower abdominal pain. Alternating doses of childrens'' Tylenol and Motrin were administered throughout day two. However, child continued to be febrile, with fever rising to 102.9, then 103, with continued and more frequent complaints of abdominal pain, lack of appetite, and disturbed sleep up to this time (approximately midnight on day two).


VAERS ID: 421244 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-04-14
Onset:2011-04-14
   Days after vaccination:0
Submitted: 2011-04-15
   Days after onset:1
Entered: 2011-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0776Y / 2 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3438AA / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B056BB / 1 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0841Z / 2 LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Hunger, Hypotonia, Posture abnormal, Somnolence, Tremor
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt became limp after receiving 4 vaccines. Became limp, slumped down in chair & body began trembling. Called for help. Attempted to stop pt from sliding out of chair. Pt regained composure, reports he is fine, he felt med. go through his body & got sleepy. Help arrived, father arrived. Both deny hx of seizures. Pt denies any other help (referred to E.R.), states he is hungry, & left with father. Received VIS with instructions.


VAERS ID: 421248 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Utah  
Vaccinated:2011-04-14
Onset:2011-04-14
   Days after vaccination:0
Submitted: 2011-04-18
   Days after onset:4
Entered: 2011-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Public       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain upper, Activities of daily living impaired, Asthenia, Balance disorder, Decreased appetite, Dizziness, Dysphonia,