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Case Details (Sorted by Vaccination Date)

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VAERS ID: 274161 (history)  
Age: 12.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-03-16
   Days after onset:0
Entered: 2007-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB346AB / 0 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B011BA / 0 LA / IM

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

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

Write-up: Patient has hives at the site of the injections and on his upper bodya nd back. Had injections at 8am on 3-16-07 and was reported to the clinic at 4pm the same day.


VAERS ID: 274177 (history)  
Age: 48.0  
Gender: Male  
Location: New York  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-17
   Days after onset:0
Entered: 2007-03-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0959F / - LA / -

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

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

Write-up: Pain, swelling, erythema, ice Benadryl, Ibuprofen


VAERS ID: 274273 (history)  
Age: 17.0  
Gender: Female  
Location: North Dakota  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-03-18
   Days after onset:2
Entered: 2007-03-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1161F / 0 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Feeling cold, Feeling hot, 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Approx 20 min after vaccine pt felt dizzy, weak and blacked out. Caught by mother before falling to ground. Also felt hot. Taken home (was at grocery store). Felt slightly weak and then at 9 pm that night felt very cold and weak at 9pm. No rxn at injection site.


VAERS ID: 274409 (history)  
Age: 62.0  
Gender: Male  
Location: Washington  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-03-20
   Days after onset:4
Entered: 2007-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2690AA / 1 RA / IM

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

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

Write-up: Patient called day of shot to report pain, swelling and redness on right arm that extends from shoulder to about 2 inches from elbow. "It''s hard as a rock". No complaints of headache or fever but says feels kind of "fluish". Spoke to my supervisor who said suggest ice and ibuprofen. If no improvement or if swelling extends to fingers seek medical care


VAERS ID: 274552 (history)  
Age: 3.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2007-03-16
Onset:2007-03-22
   Days after vaccination:6
Submitted: 2007-03-22
   Days after onset:0
Entered: 2007-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1548F / 0 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Herpes zoster
SMQs:

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

Write-up: Zoster like rash 6 days after MMRV administration


VAERS ID: 274559 (history)  
Age: 0.13  
Gender: Female  
Location: California  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-03-22
   Days after onset:6
Entered: 2007-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2552AA / - LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1246F / - LA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE910AA/UF091AA / - LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1031-2 / - RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 847300A / - RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1166F / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Breast feeding, Faeces discoloured, Haematochezia, Mucous stools, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Stool was heme-occult positive and grossly positive on inspection of diaper with flecks of bright red blood.
CDC Split Type:

Write-up: Patient developed green, mucousy, bloody stools the night after receiving her first dose of Rotateq. She continued to have such stools for 3 days. Throughout this course she did not have fever, diarrhea, vomiting, or severe abdominal pain. She came into the office on the second day and the stool was tested and was heme positive. As the patient was exclusively breastfeeding, we asked mom to eliminated milk, soy, and wheat from her diet for presumptive allergic colitis. No other interventions were performed.


VAERS ID: 274570 (history)  
Age: 19.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2007-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 0 LA / IM

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

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

Write-up: Diarrhea, Nausea, headache


VAERS ID: 274627 (history)  
Age: 5.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-23
   Days after onset:6
Entered: 2007-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR APC2489AA / 4 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR AP20324 / 3 LA / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. MC0151U / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Full blood count normal, Oedema peripheral, Pain in extremity, Platelet count normal, Pyrexia, Skin warm, Tension
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: HAD CBC/PLATELETS, PT, PTT. ALL WNL
CDC Split Type:

Write-up: WOKE UP 03-17-07 WITH PAIN IN ARM, LG AMT OF SWELLING IN UPPER ARM AND SHOULDER. TENSE, HOT TO TOUCH, FEBRILE. TOOK TO ER FOR EVALUATION.


VAERS ID: 274679 (history)  
Age: 38.0  
Gender: Male  
Location: Maine  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-20
   Days after onset:3
Entered: 2007-03-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C264AA / 0 LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Injection site pruritus, Malaise, Oedema peripheral, Pain in extremity, Skin warm, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling, redness, hot to touch, swelling under arm (lymph gland), temp 99-100. General malaise. Pain in arm, itchy at sight.


VAERS ID: 274650 (history)  
Age: 1.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2007-03-16
Onset:2007-03-24
   Days after vaccination:8
Submitted: 2007-03-24
   Days after onset:0
Entered: 2007-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / -

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

Write-up: Developed a fever of 104.8 1 week after the MMR, Chickenpox, Hepatitis A vaccines. Treated him at home. Fever went down.


VAERS ID: 274789 (history)  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:2007-03-16
Onset:0000-00-00
Submitted: 2007-03-19
Entered: 2007-03-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS C2554AA / 4 RA / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB139BA / 1 RA / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 203262 / 3 LA / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0818F / 1 LL / -

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

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

Write-up: on 3-17-07 patient woke up in the AM with swelling redness and fever at injection site. On 3/18/07 swelling had gone down slightly.


VAERS ID: 274800 (history)  
Age: 25.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2007-03-16
Onset:0000-00-00
Submitted: 2007-03-19
Entered: 2007-03-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / - RA / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / -

Administered by: Military       Purchased by: Military
Symptoms: Body temperature increased, Injection site bruising, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Bruising and swelling in affected area. With warm temperature. (Left arm - swollen from shoulder to mid forearm).


VAERS ID: 274808 (history)  
Age: 2.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-19
   Days after onset:2
Entered: 2007-03-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 086821 / 2 RL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site erythema, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Pt developed "2/12" area of redness around injection site, was cranky, had fever. Now 3 days later area improving. Given Tylenol.


VAERS ID: 274838 (history)  
Age: 14.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-03-16
Onset:2007-03-18
   Days after vaccination:2
Submitted: 2007-03-26
   Days after onset:8
Entered: 2007-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52013AA / 0 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Oedema peripheral, Oesophageal obstruction, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: AZ0704

Write-up: Pt. received Tdap on 3/16/07. Some arm swelling 3/18/07. Had episodes of vomiting. Since that time has difficulty eating-feeling like stuck in esophagus. Father pointed to epigastric area. Relieved by antiacids & soft diet.


VAERS ID: 274964 (history)  
Age: 13.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2007-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 08005 / 0 - / IM

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

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

Write-up: Herpes Zoster of R upper chest & shoulder


VAERS ID: 274987 (history)  
Age: 0.5  
Gender: Female  
Location: California  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-22
   Days after onset:5
Entered: 2007-03-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B074AA / - RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE977AA / - LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08689B / - LL / -

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

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

Write-up: 1-5 cm firm, nodular, mobile swelling with pain to touch, no redness, no fever


VAERS ID: 275006 (history)  
Age: 1.02  
Gender: Female  
Location: Missouri  
Vaccinated:2007-03-16
Onset:2007-03-23
   Days after vaccination:7
Submitted: 2007-03-27
   Days after onset:4
Entered: 2007-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0654F / 0 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0094F / 0 RL / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO illness noted. No previous adverse reactions from vaccinations or allergies reported by mother. Temperature was 97.7. RN, BSN.
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per mother, As of 3/23/07 - child was "not herself." Then on 3/24/07 - child "...awoke with left cheek swollen and slightly purple." No fever or other rx reported by mother. As of 3/27/07 - mother stated that child''s cheek is now only slightly swollen. Typed by RN, BSN


VAERS ID: 275066 (history)  
Age: 34.0  
Gender: Female  
Location: California  
Vaccinated:2007-03-16
Onset:0000-00-00
Submitted: 2007-03-21
Entered: 2007-03-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0889F / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2720AA / - LA / IM

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

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

Write-up: Lymphadenopathy of axilla and supraclavicular.


VAERS ID: 275306 (history)  
Age:   
Gender: Male  
Location: Arizona  
Vaccinated:2007-03-16
Onset:2007-03-23
   Days after vaccination:7
Submitted: 2007-03-28
   Days after onset:5
Entered: 2007-03-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. PMH: Pityriasis, appendectomy, finger amputation. Allergies: none.
Diagnostic Lab Data: Labs and Diagnostics: CXT-normal. CBC and Chem. normal. HIV (-).
CDC Split Type:

Write-up: Reaction began 3/23/07 - "Little red bumps" on shoulder & chest. Had a few on back and leg - afebrile, no other symptoms. 3/16/07 Rec''d vaccine at Air force base. 04/09/2007 MR received for an ER visit for a c/o rash and a resolving local reaction to small pox vax. PE: macular papular rash noted on trunk mainly with a few lesions on arms and legs. Local reaction healing well per ID consult. Otherwise WNL. Discharged home on contact isolation. Principal DX: Reaction to Vaccinia vaccination.


VAERS ID: 275307 (history)  
Age: 1.26  
Gender: Male  
Location: Oregon  
Vaccinated:2007-03-16
Onset:2007-03-23
   Days after vaccination:7
Submitted: 2007-03-29
   Days after onset:6
Entered: 2007-04-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1281F / 0 - / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1586F / 0 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B53981E / 3 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, CSF culture negative, CSF test normal, Computerised tomogram normal, Convulsion, Drug screen negative, Intubation, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: URI / improved before vaccine
Preexisting Conditions: Mild underweight, no chronic issues. PMH: poor weight gain. NKDA.
Diagnostic Lab Data: CSF (-), CT scan (-), drug tox screen (-). Labs and Diagnostics: CXR showed mild volume loss but no acute infiltrates. ET tube in position. EKG-sinus rhythm. Labs: CSF clear with 2 WBCs and 1 RBC. CBC with WBCs of 35,200. Tox screen (-). Chem significant for sodium of 128, glucose 195 (possiblly related to seizure), creatinine 0.7. ABGs with initial pH of 7.14, pCO2 62, pO2 157
CDC Split Type:

Write-up: Seizure with fever - complex - required intubation secondary to apnea - No previous HX of seizures. 07/09/2007 MR received for o/n hospital stay 3/23-24/2007 after transport from another facility. Child initially presented for an episode of decreased tone, staring without focusing or tracking, emesis, and lip cyanosis. Child presented in previous hospital ER then had some retractions and a 15 second episode of apnea. Not responsive to pain, no gag, minimal corneal responsiveness. He briefly desaturated to 62 and 75%. At this point he was intubated and prepared for transfer. . Txd with anticonvusants for presumed seizure. Assessment: Presumed seizure in a previously normal child who had a prolonged period of unresponsiveness followed by apnea. ER record 4/11/2007 for a witnessed seizure with generalized motor activity with eyes rolling up, LOC and unresponsiveness. This episode included a fever of 101.6, transient stiffness, and a left gaze x 20 min after event. Admitted and treated for seizure. Clinical impression: Fever. Seizure.


VAERS ID: 275378 (history)  
Age: 1.26  
Gender: Female  
Location: Michigan  
Vaccinated:2007-03-16
Onset:2007-03-24
   Days after vaccination:8
Submitted: 2007-03-26
   Days after onset:2
Entered: 2007-04-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B040BA / 3 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0408F / 2 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0227U / 0 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Blood culture, Convulsion, Full blood count, Full blood count normal, Physical examination normal, Pyrexia, Urine analysis, Urine analysis normal
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: teething
Preexisting Conditions: none
Diagnostic Lab Data: Complete blood count, urinalysis, blood culture at outside hospital
CDC Split Type:

Write-up: High fever (104.7) and brief seizure 3/24/07, 8 days after vaccines given. CBC, urine normal. Exam normal.


VAERS ID: 275726 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-19
   Days after onset:2
Entered: 2007-04-06
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1182F / - - / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Current - Depression, frequent HA History - heart palpitation
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 101, heart palpitation, onset approximately 90 minutes after receiving MMR.


VAERS ID: 275770 (history)  
Age: 18.0  
Gender: Male  
Location: Illinois  
Vaccinated:2007-03-16
Onset:2007-03-19
   Days after vaccination:3
Submitted: 2007-04-04
   Days after onset:16
Entered: 2007-04-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2171AA / - - / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Blood amylase increased, Computerised tomogram normal, Lipase increased, Pancreatitis acute, Ultrasound scan normal
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient denied any medical history or illnesses at the time of vaccination. He had no known allergies and was not taking any other medications.
Diagnostic Lab Data: A CT scan of the abdomen was normal. Ultrasound of the gallbladder and pancreas was normal. Amylase was 400 on admission and lipase elevated at 2,500. MRCP was pending at the time of this report. records received 5/2/07-IgG 1700. CT scan brain normal. Abdominal xray normal. MRI abdomen sludge in gallbladder. normal MR of pancreas. NM Hepatobiliary imaging normal. US pancreas normal.Positive white cells in stool but shigella toxin negative. Clostridium difficle is negative. Salmonella pending but diarrhea is gone at discharge.
CDC Split Type: 200701016

Write-up: Initial information received from a health care professional on 02 April 2007. A 17-year-old male patient received a dose of Menactra, lot number U2171AA, administered intramuscularly on 16 March 2007. The patient had no reported past medical history. Approximately three to five days later, the patient developed chronic, intermittent abdominal pain. He was diagnosed with acute pancreatitis and was hospitalized on 29 March 2007. A CT scan of the abdomen was normal. Ultrasound of the gallbladder and pancreas was normal. Amylase was 400 on admission and lipase elevated at 2,500. MRCP was pending. At the time of this report, the patient remained hospitalized and had not recovered from the events. 05/02/07-records received from facility for DOS 4/9-4/13/07-DC DX:Resolving Diarrhea and Dehydration. Previously admitted one week prir for pancreatitis which resolved itself. Possible immunologic reaction to a possible Menactra shot administered five days before initial onset of abdominal pain and pancreatitis. Dehydration elevated lipases and amylases. 10 pound weight loss. Current medication includes Protonix.


VAERS ID: 275810 (history)  
Age: 43.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-03-16
Onset:2007-03-23
   Days after vaccination:7
Submitted: 2007-04-10
   Days after onset:18
Entered: 2007-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV103 / 5 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Chest discomfort, Pericarditis, Pharyngeal erythema
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Throat red, tightness in chestdiagnosis perio carditis


VAERS ID: 276088 (history)  
Age: 11.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-20
   Days after onset:3
Entered: 2007-04-12
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2141AA / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C25559AA / 5 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blister, Cellulitis, Pain, Pruritus, Pyrexia, Skin warm, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling 3/16/07 pt woke up 3/17/07 with blister, fever and arm warm to the touch. Pt given Tylenol for fever and pain per mom. Pt present today 3/20/07 with cellulitis 8/9 cm and sensitive to the touch. No fever noted. Pt given Keflex 250 PO Q 6 hr #21, Benadryl PRN itching.


VAERS ID: 276093 (history)  
Age: 1.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2007-03-16
Onset:2007-04-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2007-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB133AB / 0 LL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0951F / 0 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0918F / 0 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Parotid gland enlargement, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling right face. Parotid gland area.


VAERS ID: 276266 (history)  
Age: 49.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-03-21
   Days after onset:4
Entered: 2007-04-13
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C26900AA / - LA / IM

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

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

Write-up: Swelling, redness 12-15 cm circular area. Next day after immunizations, Painful red. Seen 5 days later, redness diminished Instr. Benadryl for comfort


VAERS ID: 276320 (history)  
Age: 9.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-03-16
Onset:2007-04-02
   Days after vaccination:17
Submitted: 2007-04-13
   Days after onset:11
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Atelectasis, Blood alkaline phosphatase normal, Blood amylase increased, Blood bilirubin, Blood creatinine increased, Blood potassium normal, Blood sodium normal, Blood urea increased, Body temperature, Chest X-ray abnormal, Exposure to communicable disease, Infection transmission via personal contact, Lipase normal, Mouth ulceration, Rash vesicular, Secondary transmission, Skin lesion, Varicella
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Acute pancreatitis (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acyclovir, cyclosporine, enalapril maleate, LASIX (FUROSEMIDE), penicillin (unspecified), prednisone, ZANTAC, BACTRIM
Current Illness: Liver disorder; Immune system disorder
Preexisting Conditions: Renal transplant; Varicella exposure
Diagnostic Lab Data: abdominal X-ray 04/02?/07 - normal, chest X-ray 04/02?/07 - left basilar atelectasis, body temp 04/02?/07 - afebrile, serum alanine 04/02?/07 55, serum alkaline 04/02?/07 222, serum amylase test 04/02?/07 86, serum aspartate 04/02?/07 85, serum blood urea 04/02?/07 50, serum creatinine 04/02?/07 1.93, serum lipase test 04/02?/07 72, serum potassium 04/02?/04 4.4, serum sodium 04/02?/07 144, serum varicella zoster 04/02?/04 - VZIGG and VZVIGM pending, total serum bilirubin 04/02?/07 0.2
CDC Split Type: WAES0704USA01192

Write-up: Information has been received from a physician concerning an immunocompromised 9 year old female post renal transplant patient (1998) with liver disease and no allergies whose brother was vaccinated on approximately 16-MAR-2007 with a dose of Varivax. Concomitant therapy included LASIX, penicillin (unspecified), BACTRIM, prednisone, ZANTAC, acyclovir, cyclosporine, and enalapril maleate (manufacturer unknown). On 02-APR-2007 the patient experienced abdominal pain and was hospitalized at that time. On 04-APR-2007, the patient developed Varicella lesions. The rash was vesicular and was over her face and trunk. The rash continued onto the extremities but to a lesser degree than compared to her face and trunk. She also had ulcers in her mouth, some of which were open. The patient was still having new lesions appear. There was no fever. The patient had an abdominal X-ray that was "normal" and a chest X-ray that reported left basilar atelectasis. The patient has "experienced significant incapacity due to the abdominal pain. " Laboratory test revealed sodium 144, potassium 4.4, BUN 50, creatinine 1.93, total bilirubin 0.2, amylase 86, lipase 72, alkaline phosphatase 222, ALT 55, and VZVIGG and VZVIGM were pending. As of 06-APR-2007, the patient continued to develop new lesions and the abdominal pain continued intermittently. The patient remained hospitalized. They were treating the patient with intravenous anti-virals until the lesions stopped occurring and became crusted over. Her current medications were also adjusted. It was noted that the patient''s brother did not have any lesions present. The patient also had a school exposure to chickenpox at the same time but it was not known until after the patient was hospitalized. The patient had no history of ever having chickenpox herself but has had a history of receiving VZVIG a couple of times in the past due to possible exposure to chickenpox. At the time of the report, the patient had not recovered. A product quality complaint was not involved. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the manufacturer vaccine VZV strain. Varicella, abdominal pain, and left basilar atelectasis were considered to be other important medical events and the event of abdominal pain was considered to be disabling by the reporter. Additional information has been requested. Additional information ws received from the physician who reported that the patient''s 22 month old (also reported as 12 months old) brother was immunized three weeks prior to the patient''s illness. A rash did not occur at the vacinee''s site of injection post vaccination and he had no reaction. A swab specimen was obtained from the patient on 06-APR-2007 from a vesicle lesion. On 02-APR-2007 the patient had abdominal pain and elevated liver transaminases. The patient did not have a fever. The patient developed a vesicular rash with many lesions on the face, mouth, trunk, and extremities. At the time of the report, the patient remained hospitalized. Additional information was received from a health professional who reported that the patient was discharged from the hospital during the week of 09-APR-2007. The PCR results for the specimen identified the presence of wild type virus. Varicella, abdominal pain, and left basilar atelectasis were considered to be other important medical events and the event of abdominal pain was considered to be disabling by the reporter.


VAERS ID: 276384 (history)  
Age: 0.17  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-03-16
Onset:2007-03-18
   Days after vaccination:2
Submitted: 2007-04-13
   Days after onset:26
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA03737

Write-up: Information has been received from physician concerning an 8-week-old female who on 16-MAR-2007 was vaccinated with a dose of Rotateq. The physician reported that on 18-MAR-2007, the patient developed vaccine induced rotavirus characterized by vomiting along with diarrhea which started on the morning 19-MAR-2007. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 276487 (history)  
Age: 69.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:28
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Medication error, No adverse effect, Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA03655

Write-up: Information has been received from a pharmacist concerning a 69 year old female who on 16, Mar 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) rather that varicella virus vaccine live (Oka/Merck) (MSD). It was reported that there was confusion with which vaccine the patient was supposed to get after she lost her prescription and both vaccines were on back order. Unspecified medical attention was sought. At the time of the report the patient had not had any adverse reactions. There was no product quality complaint involved. No further information was available. Additional information has been requested.


VAERS ID: 276490 (history)  
Age: 60.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:28
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA03763

Write-up: Information has been received from a registered nurse concerning a male over 60 years old who on 16, Mar 2007 was vaccinated in the forearm with a 0.65 ml dose if zoster vaccine live (Oka/Merck). Subsequently, the patient developed a rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 276491 (history)  
Age: 55.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-03-16
Onset:2007-03-17
   Days after vaccination:1
Submitted: 2007-04-13
   Days after onset:27
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0163U / - UN / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA03781

Write-up: Information has been received from a pharmacist concerning a 66 year old female with no known history or allergies who on 16-MAR-2007 was vaccinated SC in the left deltoid with a dose of Zostavax (lot# 656607/0163U). On 17-MAR-2007 the patient experienced redness, swelling, itching, warm to touch and tenderness at the injection site. The skin area is raised a little bit and the size of the area is the diameter of an apple. The patient has no pain. When pressure is applied to the injection site there is a lump that is felt. Unspecified medical attention was sought. No laboratory test were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is expected.


VAERS ID: 276902 (history)  
Age: 16.0  
Gender: Female  
Location: New Mexico  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:28
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal, Vaginal haemorrhage
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron (unspecified) 325 mg; vitamins (unspecified);
Current Illness: Pregnancy NOS (LMP=01/17/2007); Human papilloma virus infection; Anaemia; Cardiac murmur
Preexisting Conditions: Cholecystectomy
Diagnostic Lab Data: beta-human chorionic, positive; ultrasound, 5/31/07, normal; ultrasound, 10/21/07, normal; serum alpha-fetoprotein, 05/31/07, normal; Apgar score, 10/23/07, 8/9
CDC Split Type: WAES0703USA04967

Write-up: Information has been received from a Certified Medical Assistant for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus who on 11-JAN-2007 was vaccinated IM with her first dose of Gardasil, lot#655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of Gardasil. The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Additional information has been requested. Follow-up information received 4/16/08 from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 10/23/07. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Medications used during the pregnancy were prental vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 05/31/07 and 10/21/07 which were normal. A maternal serum alpha-fetoprotein screening (MSAFP) was performed on 05/31/2007 which was within normal limits. 07/08/2008 Initial and follow up information has been received from a Certified nurse manager for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus and a heart murmur and a history of gallbladder removal and 0 pregnancies who on 11-JAN-2007 was vaccinated IM with her first dose of GARDASIL, lot #655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of GARDASIL. Her LMP was 17-JAN-2007 (estimated date of delivery 24-OCT-2007). The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Follow-up information received from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 23-Oct-2007. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Her apgar score was 8/9. Medications used during pregnancy were prenatal vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 31-May-2007 and 21-Oct-2007 which were normal. A maternal serum alpha-fetoprotein screening was performed on 31-May-2007 which was within normal limits.


VAERS ID: 276542 (history)  
Age: 40.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-03-27
   Days after onset:11
Entered: 2007-04-17
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV103 / 1 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Cardiac enzymes normal, Chest pain, Electrocardiogram abnormal, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness: None
Preexisting Conditions: None.
Diagnostic Lab Data: Card EVZ neg, EKG = SVT. Labs and Diagnostics: EKG initially normal (SR 60''s) then changed to ST 110-120''s with rare PACs. CXR normal. CK normal-37. CKMB and Troponin normal. Other labs unremarkable.
CDC Split Type:

Write-up: Pt c/o joint pain x 10 days and palpitations then 2 days worsening chest pain. 04/18/2007 VAERS report received with MRs enclosed. Record of ER visit 3/27/2007 for 10 day c/o intermittent fatigue and joint pains, palpitations with chest pain and pressure assoc. with SOB. (+) nausea. Clinical Impression: Chest Pain.


VAERS ID: 276601 (history)  
Age:   
Gender: Female  
Location: Missouri  
Vaccinated:2007-03-16
Onset:2007-03-16
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:122
Entered: 2007-04-17
   Days after submission:90
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0094F / 0 LA / SC

Administered by: Public       Purchased by: Other
Symptoms: Dyspnoea, Lip swelling, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Received MMR #1 on 3/16/07 reported few hours after receiving shot had "difficulty breathing, facial and lips swelling. Did not go to emergency room - was afraid.'' Per MD MMR titers done to check immunisations.


VAERS ID: 274406 (history)  
Age: 31.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2007-03-17
Onset:2007-03-17
   Days after vaccination:0
Submitted: 2007-03-19
   Days after onset:2
Entered: 2007-03-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB403BA / 1 RA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Palpitations, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Received hepatitis B vaccine Saturday evening 3-17-07 at approximately 6:30pm. Between 9:00 and 9:30p started having heart palpitation Sunday morning at approximately 7:00 am blurred vision, fainted. Transported to medical center - lab work, chest x-ray and EKG obtained - some PVCS noted (did not admit). Syncope episode around 1:30pm 3-19-07.


VAERS ID: 274431 (history)  
Age: 7.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-03-17
Onset:2007-03-18
   Days after vaccination:1
Submitted: 2007-03-21
   Days after onset:3
Entered: 2007-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1502F / 1 RA / SC

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

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

Write-up: Parent called the office on 03/19/07 to report a quarter sized red, warm, hard, painful area at the site of Varivax injection. Reaction began 03/18 PM, was resolving by the time of the phone call. She was not seen in the office. Doctor rec. cool compresses to the site. He requested that VAERS form be completed.


VAERS ID: 274480 (history)  
Age: 12.0  
Gender: Male  
Location: Louisiana  
Vaccinated:2007-03-17
Onset:2007-03-17
   Days after vaccination:0
Submitted: 2007-03-20
   Days after onset:3
Entered: 2007-03-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U2058AA / 0 LA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1620BA / 5 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1156F / 1 LA / SC

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

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

Write-up: Received Varicella vaccine left arm Subq. Before 12 noon on 3-17-07. At bed time- red area as big as a quarter. The next AM 3/18/07-4"x6" area red, hard, hot, swollen, painful and itching. 3-21-07-still red and painful and itching-but getting better.


VAERS ID: 274658 (history)  
Age: 0.16  
Gender: Male  
Location: Texas  
Vaccinated:2007-03-17
Onset:2007-03-20
   Days after vaccination:3
Submitted: 2007-03-20
   Days after onset:0
Entered: 2007-03-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE989AA / - RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0240 / - LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B36258F / - LL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1082F / - - / -
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U12170B / - RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse effect, Wrong drug administered
SMQs:, Medication errors (narrow)

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

Write-up: child had no adverse symptoms or symptoms. Child was given wrong immunizations Td instead of DTap for 2 months immunization.


VAERS ID: 276815 (history)  
Age: 13.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-17
Onset:2007-03-17
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:27
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA03681

Write-up: Information has been received from a nurse concerning a 13 year old female patient who on 17-MAR-2007 was vaccinated with a dose of Gardasil, lot #655619/1427F. The nurse reported that she noticed that the syringe was leaking, and she couldn''t quantify how much vaccine was received. She added that several minutes after the injection, the patient felt a bit faint, but recovered with no specific intervention. No further information is available.


VAERS ID: 276816 (history)  
Age: 13.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2007-03-17
Onset:2007-03-17
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:27
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA03686

Write-up: Information has been received from a registered nurse concerning a 13 year old female with no pertinent medical history and no drug reactions or allergies who on 17-MAR-2007 was vaccinated IM into the left deltoid with Gardasil (Lot #655619/1427F). The nurse reported the patient was administered an incomplete dose of Gardasil and soon after fainted. The nurse also reported that while she was administering the patient''s first dose of Gardasil she experienced some resistance in the plunger of the syringe. Before finishing the injection, some of the vaccine leaked out around the injection site. When the patient was informed of the problem and possibly of another injection she fainted. The patient fainted 3-5 minutes after the vaccine was administered. On 17-MAR-2007, she recovered quickly. The patient''s vital signs were taken and she was monitored for twenty minutes. The office received an e-mail from the patient''s father one hour after she left the office which stated that she had fully recovered. There were no laboratory diagnostic studies performed. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No additional information is expected.


VAERS ID: 279066 (history)  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-17
Onset:2007-03-17
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:58
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unk
Current Illness:
Preexisting Conditions: Unk
Diagnostic Lab Data:
CDC Split Type: WAES0704USA00868

Write-up: Information has been received from a nurse concerning her 15 year old daughter who on 17-MAR-2007 was vaccinated with a dose of Gardasil, IM. Concomitant medication was not reported. On 17-MAR-2007, the patient experienced pain at the injection site immediately after vaccination with Gardasil. The pain resolved by the end of the day. On 20-MAR-2007 (three days later), the pain came back and it was associated with nausea and fever. The patient sought unspecified medical attention. It was also mentioned that no other vaccinations were administered that day. The symptoms resolved after an unspecified time. Additional information has been requested.


VAERS ID: 364898 (history)  
Age: 75.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-17
Onset:2008-10-22
   Days after vaccination:585
Submitted: 2009-10-31
   Days after onset:374
Entered: 2009-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Herpes zoster, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

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

Write-up: I received an immunization for shingles in 2007- In 2008, while on an overseas trip, I came down with shingles in spite of the shot. I would like this to be recorded somewhere for statistical purposes, as a failure for the shot.


VAERS ID: 513109 (history)  
Age: 14.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-03-17
Onset:2007-11-05
   Days after vaccination:233
Submitted: 2013-11-14
   Days after onset:2201
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Hypothyroidism, Nuclear magnetic resonance imaging, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypothyroidism (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri Cyclen Birth control
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: MRI done several times and was diagnosed with Hypothyroidism in 2008 but levels returned to normal.
CDC Split Type:

Write-up: Pain in legs and joints, severe fatigue, short breath and Chronic Headaches, still experiencing all symptoms.


VAERS ID: 274846 (history)  
Age: 5.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-17
Onset:2007-03-18
   Days after vaccination:1
Submitted: 2007-03-26
   Days after onset:8
Entered: 2007-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Body temperature, Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling, Pyrexia, Scratch, Tenderness
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Body temperature 18Mar2007 37.4 deg C
CDC Split Type: B0462400A

Write-up: This case was reported by a sales representative and described the occurrence of cellulitis in a 5-year-old male subject who was vaccinated with Fluarix for prophylaxis. A physician or other health care professional has not verified this report. On 17 March 2007 the subject received unspecified dose of Fluarix (intramuscular, unknown). On 18 March 2007 the subject received unspecified dose of Fluarix (intramuscular, unknown). On 18 March 2007, 1 day after vaccination with Fluarix, the subject experienced cellulitis and allergic reaction with injection site redness and swelling (10 x 5 cm) as well as tenderness of hand and arm. He was also found to have a scratch on the skin as well as fever (37.4 deg C). The subject was hospitalised. At the time of reporting the events were unresolved. Additional information has been requested.


VAERS ID: 280166 (history)  
Age: 0.42  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-17
Onset:2007-04-30
   Days after vaccination:44
Submitted: 2007-05-31
   Days after onset:31
Entered: 2007-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 23177 / 2 - / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Brain scan abnormal, CSF culture positive, Chest X-ray normal, Convulsion, Cough, Hypotonia, Inflammation, Laboratory test, Lumbar puncture abnormal, Mechanical ventilation, Meningitis pneumococcal, Pallor, Pneumococcal bacteraemia, Pyrexia, Serology test, Status epilepticus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unk
Diagnostic Lab Data: Blood culture 19-May-2007 positive for Pneumococcus; CSF culture 19-May-2007 found Pneumococcus; Chest X-ray 19-May-2007 normal; Laboratory test 00-May-2007 Pneumococcus serotype result was pending 19-May-2007 Pneumococcus was determined to have normal sensitivity to antibiotics; Lumbar puncture 19-May-2007 found streptococci at direct examination. Scan brain 00-May-2007 found "pericerebral effusions" but no abscess
CDC Split Type: FRWYE702022MAY07

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 5-month-old male patient who experienced chronic cough, "pericerebral effusions", status epilepticus, convulsions, pneumococcal meningitis and pneumococcal bacteraemia. The patient received the third dose on 17-Mar-2007. Past therapies included 3 doses of Infanrix-Quinta on 22-Jan-2007, 24-Feb-2007 an 17-Mar-2007, concomitant to the third doses of Prevenar. Concomitant medications were not reported. On 30-Apr-2007, the patient started to develop cough with minor fever (no value precision). He received amoxicillin from 03 to 15-May-2007. On 18-May-2007, the patient developed more intense fever, pallor and hypotonia. On 19-May-2007, he was hospitalized for investigations of his chronic cough. On admission, the patient was found to have biologic signs of inflammation. Chest X-ray was normal. However, the patient underwent lumbar puncture, which found streptococci at direct examination. Cerebrospinal fluid culture found Pneumococcus. The patient was diagnosed with pneumococcal meningitis. Blood culture was positive for Pneumococcus (pneumococcal bacteraemia). Pneumococcus was determined to have normal sensitivity to antibiotics. After 48 hours of antibiotherapy, the patient experienced convulsions, and then status epilecticus. The patient was transferred to Intensive Care Unit, was intubated and received mechanical ventilation. Brain CT scan found "pericerebral effusions" but no abscess. At the time of reporting, the patient was still in Intensive Care Unit, and had not recovered. Pneumococcal serotype result was pending. No additional information was available at the time of this report.


VAERS ID: 274171 (history)  
Age:   
Gender: Male  
Location: Minnesota  
Vaccinated:2007-03-18
Onset:2007-03-18
   Days after vaccination:0
Submitted: 2007-03-18
   Days after onset:0
Entered: 2007-03-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2221AA / 0 LA / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B012AA / 0 LA / -

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Mydriasis, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Gave child Tdap then gave Menactra after 2nd med administered child stated he felt light headed. Stated his eyes weren''t focusing. Pupils dilated. called for assistance got Epi Pen. In those minutes child sat up said he was feeling better. Has been light headed before from blood drawn per child.


VAERS ID: 275202 (history)  
Age: 23.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2007-03-18
Onset:2007-03-18
   Days after vaccination:0
Submitted: 2007-03-20
   Days after onset:2
Entered: 2007-03-29
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB287BA / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Arthralgia, Contusion, Headache, Nausea, Pruritus, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Headache, nausea/vomiting, arthralgia, bruising, itching and hives.


VAERS ID: 275453 (history)  
Age: 22.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-03-18
Onset:2007-03-18
   Days after vaccination:0
Submitted: 2007-03-21
   Days after onset:3
Entered: 2007-04-03
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB086AA / - LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2632AA / 5 RL / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3001165 / 0 - / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE998AC / 0 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Body temperature fluctuation, Body temperature increased, Diarrhoea, Dizziness, Feeling cold, Gait disturbance, Headache, Pain, Pharyngolaryngeal pain, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None; BCP stopped 2 weeks earlier; had not started TB med at that time
Current Illness: TB
Preexisting Conditions: TB diagnosed 3/2; has Rx but has not started
Diagnostic Lab Data: None done
CDC Split Type:

Write-up: Took oral Typhoid 3/18 at 0400, 0800 feeling cold, shaking, generalized body aching and headache, T= 99; throat sore later, difficulty ambulating due to lack of energy; persistent dizziness, temperature rose during day; at 2030, in ER temp 103; no home care prior to ER, in ER, no care, no tests, no labs, no exam; was given Motrin x 3 tabs; released at 4AM, temp at that time = 99; on 3/19 at home lack of energy persisted, temp off/on up to 101, responded to Motrin; diarrhea and vomiting several times; missed work 3/20 due to continued symptoms; called our clinic and reported situation on 3/19; advised to d/c. Vivotif and continue home/symptomatic care.


VAERS ID: 275849 (history)  
Age: 15.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-03-18
Onset:2007-03-18
   Days after vaccination:0
Submitted: 2007-03-30
   Days after onset:12
Entered: 2007-04-09
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV: JAPANESE ENCEPHALITIS (JE-VAX) / SANOFI PASTEUR EJNZZ8A / 1 LA / SC
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 412011A / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Headache, Injection site pain, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: one week after # 2 JE and Rabies client''s aunt reported that client had a temp 100.5 po on Tylenol tue pm after #2 doses. site was tender but no red or inflamed. General malaise and headache also reported. Did not go to school for one day. Resolved.


VAERS ID: 277004 (history)  
Age: 82.0  
Gender: Female  
Location: New York  
Vaccinated:2007-03-18
Onset:2007-03-26
   Days after vaccination:8
Submitted: 2007-04-19
   Days after onset:24
Entered: 2007-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0988F / - LA / -

Administered by: Private       Purchased by: Other
Symptoms: Balance disorder, Blood creatine phosphokinase normal, Blood electrolytes normal, Muscular weakness, Myalgia, Somnolence, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin, Plavix, Nexium, Toprol XL, Lipitor
Current Illness: CHF, Hypertension, arthritis, hyperlipidemia, glaucoma
Preexisting Conditions: stent placement
Diagnostic Lab Data: Electrolytes - normal 3/26/07 CPK 42U/L records received 5/15/07-Labs: ESR 86, rheumatoid factor negative.
CDC Split Type:

Write-up: Leg weakness, muscle pain, somnolence, vertigo, unsteadiness 05/15/07-records received for DOS 3/26-3/31/07-Presented to ER with increased blood pressure weakness in legs. BP 210/106. Assessment Hypertension. R/O rhabomyois subsequently ruled out.HX of stent placement 2 weeks prior and returned 1 week later with complaints of arm pain. Developed coughing and weakness in both knees. Feels lightheaded. Sleeps all the time. DX:Acute hypertension, angiotensis-converting enzyme induced cough and somnolence. Clinical presentation highly consistent with PMR which may explain stiffness muscle discomfort and possible vertigo.


VAERS ID: 287677 (history)  
Age: 91.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-03-18
Onset:2007-03-18
   Days after vaccination:0
Submitted: 2007-07-30
   Days after onset:134
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: TYLENOL; cefepime; LOVENOX; PEPCID; LEVAQUIN; PHENERGAN injection; sotalol hydrochloride
Current Illness: Bacteraemia; Bladder cancer; Hospitalisation; Basal cell carcinoma; Arteriosclerotic cardiovascular disease; Arrhythmia
Preexisting Conditions: Cardiac pacemaker insertion; Aspiration; Pneumonia; Bacteraemia; Bladder cancer; Hospitalisation; Basal cell carcinoma; Arteriosclerotic cardiovascular disease; Arrhythmia
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA03631

Write-up: Information has been received from a Pharm. D. concerning a 91 year old male inpatient with possible bacteraemia, bladder cancer, basal cell carcinoma on his back, arteriosclerotic cardiovascular disease, and arrhythmia and a history of cardiac pacemaker insertion, and recent pneumonia and aspiration who on 04-MAR-2007 was vaccinated IM with a 0.5 mL dose of PNEUMOVAX 23 (656225/0070U). Concomitant therapy included LEVAQUIN, PHENERGAN INJECTION, sotalol hydrochloride, famotidine, LOVENOX, cefepime and TYLENOL. On 18-MAR-2007, the patient was vaccinated with another 0.5 mL dose of PNEUMOVAX 23 when he was re-admitted to the hospital. On approximately 18-MAR-2007, the patient''s right arm was red and swollen at the injection site. At the time of this report, the patient''s injection site redness and swelling persisted. Additional information has been requested.


VAERS ID: 285022 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2007-03-18
Onset:2007-06-06
   Days after vaccination:80
Submitted: 2007-07-18
   Days after onset:42
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Anencephaly, Drug exposure during pregnancy, Echography abnormal
SMQs:, Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Echography 06Jun2007 anencephaly
CDC Split Type: B0479039A

Write-up: This case was reported by a regulatory authority and described the occurrence of anencephaly in a foetus subject of unspecified gender whose mother was vaccinated with Twinrix for prophylaxis. The subject''s mother last menstrual period was on 01 March 2007. She did not present any allergy and she did not have other disease. On 18 March 2007 the subject''s mother received unspecified dose of Twinrix (intramuscular). On 6 June 2007 80 days after vaccination and at 14 weeks of pregnancy by last menstrual period, and echography showed foetus anencephaly. On 16 June 2007 the subject''s mother had an abortion. The regulatory authority reported that the events were clinically significant (or requiring intervention).


VAERS ID: 274400 (history)  
Age: 4.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-03-20
   Days after onset:1
Entered: 2007-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1985CA / 4 LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1209F / 0 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y10302 / 3 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1548F / 0 LA / IM

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

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

Write-up: Patient c/o L deltoid pain, the night of the immunization. Patient was seen in the office the following day. His left arm was swelling and erythema. DX with allergic reaction to ProQuad. Given RX for Keflex and OTC Benadryl. Return in 1 week.


VAERS ID: 274777 (history)  
Age: 14.0  
Gender: Female  
Location: New York  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-03-21
   Days after onset:1
Entered: 2007-03-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB143BA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 01870 / 1 LA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR AC52B014AA / 5 RA / IM

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

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

Write-up: rash-red spots with white centers all over.


VAERS ID: 274820 (history)  
Age: 0.17  
Gender: Female  
Location: Ohio  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-03-26
   Days after onset:7
Entered: 2007-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B090BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF051AA / 0 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH BO8674H / 0 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Convulsion, Dyskinesia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Keppra for seizures (0.5ml bid)
Current Illness: None reported
Preexisting Conditions: Hx of Seizures. PMH: Known hx. of seizures since 3 days of age, last seizure 19 days ago. Dacryostenosis. Allergies: none.
Diagnostic Lab Data: Labs and Diagnostics: UC (-), Blood cultures(-), CSF culture (-). CSF with 6 RBCs. CXR shows Peribronchial thickening. CBC with WBC 10.4, 567K platelets Hct. 27.1, Hgb 9.1.
CDC Split Type:

Write-up: Patient received regular 2 mo. immunizations on 3/19/2007. Mother reported a hx of seizures on vaccine administration questionaire form. Mother reported no illness on the day of vaccination and that child had received Hep. B vaccine at birth with no complications. Child received vaccine between 9am and 11am. Mother reports that approximately 3 hours post immunization, child developed a fever of 102 degrees and did have approximately 6-8 episodes of seizure activity with jerking motions in the infants body. Mom reports ambulance called and infant transported to Hospital and was admitted there x 3 days. Child stable at this time and home with Mom. Child''s pediatrician, per Mom, states no further immunizations for child until further notice. 03/28/2007 MR received for a 3 day hospitalization for fever and seizures on the evening of her 2 month vax. Child felt hot to touch, and had a decreased appetite. Infant had 6 seizures prior to ER visit. ER temp was 101.7''F rectally. PE: WNL except eyelashes coated with yello-green discharge. Treated with IVF and antibiotics. One brief seizure during hospitalization. Discharge DX: 1) Sepsis ruled out. 2) Seizure disorder. 3) Dacryostenosis.


VAERS ID: 274829 (history)  
Age: 48.0  
Gender: Female  
Location: Nevada  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-03-26
   Days after onset:7
Entered: 2007-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2631AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Cellulitis, Computerised tomogram, Convulsion, Fall, Head injury, Injection site pain, Loss of consciousness, Muscle twitching, Neck pain, Oedema peripheral, Pain, Respiratory distress, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: Appy 1984, Knee Arthroscopy, R hand Tenolysis. Allergies: Minocycline.
Diagnostic Lab Data: Labs and Diagnostics: CBC with WBCs of 13.5. US of shoulder (-) for abscess. CT head (-) for acute process. EEG (-) for seizure disorder. CT thorax showed mild basilar atelectasis. Blood cultures (-).
CDC Split Type:

Write-up: Pt received Tdap on Monday. Went to work that night although in pain. Took Tylenol with some relief. Took another Tylenol at end of shift and then went home and took a Percocet for the pain. Tuesday, called in sick and went to ER with arm swelling, temp 100.5, pain into neck from injection site. Dx with cellulitis and was hospitalized w/IV antibiotics. WBC''s elevated. Pt fell while in Er--she states they had given her Morphine and Phenergan and when she stood up she passed out and hit her head. She states she did NOT have a seizure but ER staff said she did. When she lost conciousness she had "twitching" in her legs and was incontinent. ER staff thought she might have had hypotonic respiratory distress and did a CAT scan to r/o PE. Pt states she is doing much better and most of the sx have resolved. 05/22/2007 MR received for 2 night hospital stay for c/o R shoulder rash which extends up to the neck. Admitted for tx of cellulitis, pt. had a seizure while OOB to the BR. Pt fell to the floor and her lower extremities began shaking. Incontinent of urine. Pt. c/o fever, chills, and R arm/shoulder pain increased with ROM. Pt also complained of SOB with decreased O2 sats-mildly hypoxic on RA. PE: WNL except R shoulder rash 8x5cm. Txd with Abx. Principal DX: Right shouder cellulitis. Hypoxic respiratory insufficiency. 2'' DX: Possible isolated seizure.


VAERS ID: 274977 (history)  
Age: 33.0  
Gender: Male  
Location: Alaska  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-03-22
   Days after onset:2
Entered: 2007-03-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

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

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

Write-up: On 20 Mar 07 I woke up with pain and redness. Over the next 24 hrs the redness had spread almost covering my entire upper arm and was hot to the touch and had signs of swelling around tricep and elbow. 21 Mar 07 I was seen in the ER and was given Benadryl.


VAERS ID: 276349 (history)  
Age: 21.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-03-19
Onset:2007-03-22
   Days after vaccination:3
Submitted: 2007-04-04
   Days after onset:13
Entered: 2007-04-16
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 1 LA / -

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

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

Write-up: on 3/22/07 broke out in rash on right arms, upper chest and neck itchy. on 3/23/07-examined and very faint macular rash on arms, neck, upper trunk, not urticaria


VAERS ID: 277638 (history)  
Age: 70.0  
Gender: Male  
Location: Florida  
Vaccinated:2007-03-19
Onset:2007-03-21
   Days after vaccination:2
Submitted: 2007-04-30
   Days after onset:40
Entered: 2007-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0163U / 0 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Deafness unilateral
SMQs:, Hearing impairment (narrow)

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

Write-up: Patient called and stated that he lost hearing in his left ear on 03/21/07. He went to see an ENT doctor on 03/27/07 and was given steroids. He reports his hearing is not improved at this point.


VAERS ID: 278324 (history)  
Age: 59.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-03-19
Onset:2007-04-21
   Days after vaccination:33
Submitted: 2007-05-02
   Days after onset:11
Entered: 2007-05-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2730AA / 0 LA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z1102 / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Aphasia, Blood pressure fluctuation, Eye movement disorder, Feeling hot, Flushing, Heart rate increased, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levaquin 750, Wellbutrin 300 Vitorin
Current Illness: None
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Aphasia, paraesthesia, (L) eye not blinking on closing. Intermittent flushing of face and feeling of warmth. Unstable B/P; rapid pulse


VAERS ID: 278336 (history)  
Age: 0.33  
Gender: Female  
Location: Michigan  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-05-07
   Days after onset:49
Entered: 2007-05-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2489AA / - RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF020AA / - RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08683C / - LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1232F / - - / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Flatulence, Muscle spasms
SMQs:, Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Reported by mom on 5/7/07 that pt have cramping and gas for 2-3 hours after vaccine. No diarrhea or blood in stool, no vomiting.


VAERS ID: 278379 (history)  
Age: 24.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-05-10
   Days after onset:52
Entered: 2007-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0188U / 0 LA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Cervical laser therapy
Diagnostic Lab Data:
CDC Split Type: WAES0704USA01265

Write-up: Information has been received from a registered nurse concerning a 24 year old female student (weight 113) who on 19-MAR-2007 was vaccinated with the first dose of Gardasil, IM in the left deltoid (Lot number 657006/0188U). Concomitant medication was not reported. On 19-MAR-2007 in the evening, the patient developed a rash on her neck and abdomen. There was not reaction at the injection site. The patient was treated with Benadryl. Subsequently on 30-MAR-2007, the patient recovered from a rash on her neck and abdomen. Follow-up from a dermatologist indicated that the patient had a medical history of laser treatment to the cervix and was on birth control pill concomitantly. The patient was seen in the office on 02-APR-2007 with multiforme rash of the torso and neck. The dermatologist reported that the patient indicated that the rash began the evening that the patient was vaccinated. The rash started 2 weeks before it was assessed by the dermatologist. The physician reported that the patient was treated with oral steroids to prevent serious criteria. The patient has recovered. The dermatologist reported that the multiforme rash was an other important medical event. Additional information is not expected.


VAERS ID: 279534 (history)  
Age: 13.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:56
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / - LA / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL TABLETS
Current Illness: Vasovagal reaction; Cold sores; Attention deficit/hyperactivity disorder
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA04859

Write-up: Information has been received from a physician concerning a 14 years old female student with no drug allergies, recurrent cold sores and Attention deficit/hyperactivity disorder who, on 19-MAR-2007 at 10:00 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Gardasil (Lot# 656741/12084). Concomitant vaccination included meninigococcal vaccine (unspecified) and concomitant therapy included ADDERALL. Subsequently, at approximately 10:05 the patient felt "funny" and briefly passed out (previosulsy reported as felt dizzy) and fainted. The patient fell to the floor. After falling the patient woke and was able to walk to the exam table and laid down for a while where she felt better. The physician reported that fainting was due to a vasovagal reaction. The patient then seemed ok and walked out of the office. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on 19-MAR-2007 recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 279000 (history)  
Age: 0.4  
Gender: Female  
Location: Georgia  
Vaccinated:2007-03-19
Onset:0000-00-00
Submitted: 2007-05-18
Entered: 2007-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS B066AA / 0 LL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0651F / 0 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0621R / 0 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08649F / 0 RL / IM

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

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

Write-up: Patient given Hepatitis A along with other vaccines.


VAERS ID: 279153 (history)  
Age: 12.0  
Gender: Female  
Location: Vermont  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-05-16
   Days after onset:57
Entered: 2007-05-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B12AA / 5 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1334F / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Nausea, Pyrexia, Rash macular
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Tdap - local red area right deltoid and blotchy also nausea, fever.


VAERS ID: 280241 (history)  
Age: 0.4  
Gender: Male  
Location: California  
Vaccinated:2007-03-19
Onset:2007-04-28
   Days after vaccination:40
Submitted: 2007-06-01
   Days after onset:34
Entered: 2007-06-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1237F / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception, Surgery
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: None PMH: GERD PMH: recurrent URI
Diagnostic Lab Data: Unknown; LABS: CXR, KUB, CBC, chemistries, UA, RSV, influenza A&B. Barium contrast SB follow through revealed possible malrotation.
CDC Split Type: WAES0705USA04003

Write-up: Information has been received from a certified medical assistant concerning a 6 month old male, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq (Lot# 654422/0607F and 656187/1237F) on 16-JAN-2007 and 19-MAR-2007, respectively. Concomitant therapy included Tylenol as needed. On 28-APR-2007 the patient was taken to the emergency room and was transported to another facility that was equipped to handle children. The patient was hospitalized and underwent surgery to correct intussusception. It was reported that a nurse mentioned that the child was seen on 21-MAY-2007 for a well check up and was still recovering at that time. It was noted that the patient was due for a third dose of Rotateq, but the physician decided not to complete the series. No product quality complaint was involved. No other information was provided. The patient''s intussusception was considered to be an other important medical event by the reporter. Additional information has been requested. A lot check has been requested. 6/14/07 Received medical records via fax from CDC which reveal patient experienced abdominal pain w/bilious emesis x 1 day. Seen at outlying ER where UGI films were neg & stool was + for occult blood. Admitted 4/20-5/2/07. Taken to OR for operative reduction of ileocolic IS & appendectomy. Progressed well & d/c to home. FINAL DX: Intussusception. 6/14/07 Received medical records of ER visit via fax from CDC which reveals patient experienced congestion, bilious vomiting, fever & crampy intermittent abdominal pain w/difficulty sleeping. Transferred to higher level of care.


VAERS ID: 282568 (history)  
Age: 37.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-04-24
   Days after onset:36
Entered: 2007-06-18
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB28BA / - RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2688A / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypokinesia, Injection site bruising, Musculoskeletal pain, Musculoskeletal stiffness
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD Parkdale lot# 30723
Current Illness:
Preexisting Conditions: No known allergies. Follow-up information received on 18 April 2007. The patient did not have any illness at the time of the vaccinations.
Diagnostic Lab Data:
CDC Split Type: 200700894

Write-up: A 37 year old, female patient (with no known allergies) developed a bruise at the injection site, stiffness in the left arm and pain the clavicle and left scapular area, approximately 8 hours after she received Adacel (lot number C2688AA) intramuscularly in the left deltoid on 19 March 2007. She also received Engerix B (GSK, lot number AHBVB28BA) intramuscular in the right deltoid and PPD (Parkdale, lot number 30723) in the left forearm on the same day. At the time of the vaccinations, she denied any illness and was not on any medications. She has difficulty lifting and states it is progressively getting worse. At the time of the report, she had not recovered. Follow-up information received on 18 April 2007. The patient did not have any illness at the time of the vaccination. The reporter left several messages to check on the patient, however she did not return the calls. As far as the reporter was concerned, the patient is recovered.


VAERS ID: 283730 (history)  
Age: 16.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:87
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0945F / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Inappropriate schedule of drug administration, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA03643

Write-up: Information has been received from a health professional concerning a 16 year old white female student (142 lbs., 61.25 in.) who on 19-FEB-2007 was vaccinated with Gardasil. The patient was vaccinated with the second dose of Gardasil on 19-MAR-2007, which was only one month post dose one. The patient had no illness on the day of vaccine administration. On 22-MAR-2007 the patient experienced symptoms of hives and feeling dizzy and sought unspecified medical attention. No laboratory/diagnostic tests were performed. Subsequently, the patient recovered from symptoms of hives and feeling dizzy. Additional information is expected.


VAERS ID: 284499 (history)  
Age: 26.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:87
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 0 - / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified), Estrostep
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA05245

Write-up: Information has been received from a healthcare worker concerning a 26 year old female with allergic reaction to Cipro who on 19-MAR-2007 was vaccinated with Gardasil 9Lot # 656049/0187U). Concomitant therapy included Estrostep and acne medication. On 19-MAR-2007 the patient experienced abdominal cramping, diarrhea, nausea, body aching and fatigue for 24 hours after receiving her first dose of the vaccine. The next day, 20-MAR-2007, the patient fully recovered from abdominal cramping, diarrhea, nausea, body aching and fatigue. Additional information has been requested.


VAERS ID: 282231 (history)  
Age: 52.0  
Gender: Female  
Location: Idaho  
Vaccinated:2007-03-19
Onset:2007-03-29
   Days after vaccination:10
Submitted: 2007-06-11
   Days after onset:74
Entered: 2007-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / - LA / -

Administered by: Private       Purchased by: Other
Symptoms: Chest X-ray, Computerised tomogram, Dyspnoea, Exocrine pancreatic function test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chest X-ray, PFT x 2, CT Chest
CDC Split Type:

Write-up: One wee after injection, having dyspnea, difficulty breathing normal temp, felt like breathing in smoke, after 3 weeks - went to the doctor - inhaler ordered, chest x-ray, PFT, CT Chest, Echocardiogram. Resolved in 1 1/2 months.


VAERS ID: 284695 (history)  
Age: 1.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:109
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0815F / - UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1335F / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Overdose, Wrong drug administered
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA01065

Write-up: Information has been received from a licensed practical nurse concerning a 12 month old female who on 19-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of ProQuad (lot# 654474/0815F). Concomitant therapy included Varivax (lot# 654756/1335F). The nurse reported the office confused the ProQuad with the MMR II in the freezer. The patient received a dose of ProQuad and a dose of Varivax during the same visit. The patient sought unspecified medical attention. No problems reported. Additional information has been requested. This is one of several reports from the same source.


VAERS ID: 284758 (history)  
Age: 2.0  
Gender: Male  
Location: Arkansas  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-07-16
   Days after onset:118
Entered: 2007-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR U1735BA / 1 RL / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 117SF / 1 LL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Convulsion, Dyspnoea, Grand mal convulsion, Hallucination, Inflammation, Nuclear magnetic resonance imaging brain, Oedema peripheral, Personality change, Pyrexia, Sleep study, Tremor, Vaccination complication
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ending Clindamycin
Current Illness: No
Preexisting Conditions: 2 VSD''s (closed 6 months after birth). PMH: ? immune d/o, seizures x2 in past-grand mal, vascular ring, T&A 12/2006, VSD repaired, Apnea.
Diagnostic Lab Data: MRI of Brain and Spinal Cord and an all night sleep study. Labs and Diagnostics: Labs done 4/25/07: Immunology studies indicate normal immune cellular response to Tetanus, Diptheria, and Pneumococcal AB. F/U 5/29/07 Sleep study revealed mild obstructive sleep apnea. EEG showed no abnormalities. Brain MRI Normal for age with maxillary sinusitis. MRI lumbar spine-normal. MRI cervical and thoracic spine-negative. Pneumo titres similar pre and post vaccine. Tetanus and Diptheria antibody titres sugguest immunity. LR IgM low. LR IgA and IgG normal.
CDC Split Type:

Write-up: 3/20/07 1:30am: Hallucinating (Dr. said via telephone to proceed to Med. Center. Hallucinations continued with and without fever. At hospital the pt. became unable to walk or stand. The physicians agreed that he could be getting inflammation around his brain. He was sent by ambulance to another Hospital. He was there for only 2-3 hours and was released although he still had difficulty walking and was hallucinating without fever present. 30 min. after being released he had a grandmal seizure and was rushed by ambulance again to another hospital because he was having difficulty breathing. He continued to not be able to walk for 5 days. He continued to have seizure activity, fever, leg swelling, and personality changes for atleast 5 days after this. He had to be given Rectal Diastat to stop the grandmal seizure. We have had to have MRI''s of his brain and spinal cord and a sleep study after all of this. Those were normal which proves that he does not have a seizure disorder or tumor which could''ve caused these symptoms. It was an adverse reaction to the vaccinations. He continues to have personality changes which began after the vaccinations. He is not the same child. He even started biting us 2 days after the vaccinations. We have encountered 3 ER visits, 2 ambulance rides, 2 MRI''s, and a sleep study all because of this adverse reaction, not to mention the week that our whole family missed of work. 08/03/2007 MR received from PCP for several OVs beginning 4/23/2007 for F/U of sleep study and MRI for worsening of a seizure disorder with atypical characteristics such as hallucinations, ataxia, and bilateral lower extremity weakness. He additionally has had increased snoring s/p T&A. Assessment (4/23/2007): Seizure disorder, Hallucinations, Bilateral extremity weakness, Bilateral lower extremity ataxia, Recurrent URIs, Excessive Snoring, Sleep disturbance. 08/06/2007 MR received for ER visit 3/20/2007 for Febrile Seizure several hours after D/C from another facility. Rectal valium given by parents which stopped the seizure after ~20 seconds. Child had an unusual gait although other symptoms had improved. DX: Febrile Seizure. 09/04/2007 MR received for ER visit 3/20/2007 for c/o fever and hallucinations. PE (+) crusty rhinorrhea and upper airway noise upon auscultation of lungs. ER MD discussed w/ Immunology-no further testing recommended. Final DX: Fever. Hallucination. Additional ER visit for viral illness in 7/2007. 1/11/2010 My son continues to have tremors when he runs fever. In Nov. 2007 (the last time that he ran a fever) he had several episodes of tremors we had to rush him to the E.R several times. He never had these tremor episodes until after these vaccinations. These tremors began the day after the vaccination. These tremors are seizure activity. My son also complains of joint pain from time to time. Follow-up: Patient has a time back in August where he became unable to walk again. He could walk at times with difficulty. He began crawling again. It lasted about 3-4 days. I would like to be contacted to know what trends / links were found.


VAERS ID: 285794 (history)  
Age: 21.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-03-19
Onset:0000-00-00
Submitted: 2007-07-16
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 0 - / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ; ALLEGRA
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04335

Write-up: Information has been received from a health professional concerning a 21 year old white female with no medical history or allergies, who on 19-MAR-2007 was vaccinated intramuscularly in the right deltoid with a first dose of Gardasil (Lot # 655503/0012U). Concomitant therapy included YAZ and ALLEGRA. Subsequently, the patient experienced syncope. The patient had no illness at the time of the vaccination. It was noted that the patient had not eaten that morning. The patient had recovered on 19-MAR-2007. Additional information has been requested.


VAERS ID: 287687 (history)  
Age: 65.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-07-30
   Days after onset:133
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0959F / 0 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Chills, Erythema, Incorrect dose administered, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELAVIL; VASOTEC; meclizine; OMACOR; VIAGRA; DEMADEX; warfarin
Current Illness: Polyarthritis; Peripheral vascular disorder; Hypertension
Preexisting Conditions: Hyperlipidaemia; Nonspecific abnormal results of function study of liver
Diagnostic Lab Data: temperature measurement 03/19/07 fever
CDC Split Type: WAES0703USA03929

Write-up: Information has been received from a licensed practical nurse concerning a 65 year old retired male with no illness at the time of vaccination, polyarthritis, peripheral vascular disorder, hypertension and a history of non-specific abnormal liver function studies related to hyperlipidemia who on 19-MAR-2007 was vaccinated with a first dose of Pneumovax 23 (lot # 655290/0959F) 0.75 to 0.8 ml subcutaneously in the right tricep area at 10:30 AM. Concomitant therapy included enalapril maleate (MSD), warfarin, DEMADEX, amitriptyline hydrochloride (MSD), OMACOR, meclizine and VIAGRA. The nurse withdrew 1 ml. from a multi-dose vial of Pneumovax 23. During administration, the nurse realized the recommended dose, stopped administration of the 1 ml dose and 0.75 to 0.8 ml was administered to the patient. On 20-MAR-2007 (previously reported as 19-MAR-2007), the patient experienced chills and fever. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. Follow-up information was received from the licensed practical nurse. On 20-MAR-2007, the patient experienced fever, chills, muscle aches, and erythema of the right tricep. No diagnostic tests were performed. The patient was treated with rest, fluids, and TYLENOL. On 23-MAR-2007, the patient reported feeling much better and had recovered. No additional information is expected.


VAERS ID: 287692 (history)  
Age: 65.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-07-30
   Days after onset:132
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1005F / 0 LA / IM

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
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA05017

Write-up: Information has been received from a certified medical assistant concerning a 65 year old female who on 19-MAR-2007 was vaccinated, intramuscularly with a 0.5 mL dose of Pneumovax 23, (Lot #655500/1005F). There was no concomitant medication. On 20-MAR-2007 the patient developed injection site reaction that was red, swollen, and hot to touch, about one day after the Pneumovax 23 vaccination. The patient sought unspecified medical attention. The patient was treated with KEFLEX. No other symptoms noted. At the time of the report, the patient had recovered. Additional information has been requested. Follow-up received 08/06/2008 reported patient is retired female. Vaccinated in left deltoid with first dose of PNEUMOVAX. At the time of the report it was unknown if the patient recovered. Additional information has been requested.


VAERS ID: 287759 (history)  
Age: 25.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-03-19
Onset:2007-06-24
   Days after vaccination:97
Submitted: 2007-08-09
   Days after onset:46
Entered: 2007-08-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Muscle spasms, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC; PREVACID
Current Illness: Pregnancy NOS (LMP = 6/24/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 07/29/07 - no fetus/pregnancy; beta-human chorionic 07/23/07 - positive
CDC Split Type: WAES0708USA00038

Write-up: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 29-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F) injection 0.5mL IM left deltoid. On 19-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # 656372/0243U) injection 0.5mL IM left deltoid. Concomitant medication included ZYRTEC and PREVACID. The date of the patient''s last menstrual period was 24-JUN-2007. On 23-JUL-2007, the patient reported that she tested positive for pregnancy. On 29-JUL-2007, the patient sought medical attention for a miscarriage (the estimated date of delivery was 30-MAR-2008). On 29-JUL-2007, the patient arrived at the emergency room with complaints of bleeding and cramping. An ultrasound performed showed no fetus/pregnancy. Additional information was received from the registered nurse via telephone. It was originally reported that the miscarriage was life-threatening. The nurse clarified that it was not life-threatening to the mother but was unknown to the fetus as it was very early on in the pregnancy. The relationship of the miscarriage to Gardasil was unknown. Upon internal review, spontaneous abortion was considered to be an Other Important Medical Event. No additional information is expected.


VAERS ID: 289928 (history)  
Age: 0.3  
Gender: Male  
Location: Missouri  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-04-16
   Days after onset:28
Entered: 2007-08-29
   Days after submission:135
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2552A / 0 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. M5V0010F / 1 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1031 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH W8086708 / 1 RL / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prevacid
Current Illness:
Preexisting Conditions: GERD, possible heart murmur. First dose of Daptacel (lot# C2430AA) given on 17 January 2007, intra-muscular, into left thigh and experienced swelling of left foot and ankle only (approximately twice of normal size), lasted approximately 20 hours and received. Denied illness at vaccination time.
Diagnostic Lab Data:
CDC Split Type: 200700842

Write-up: A 4 month old male patient received on 19 March 2007 the second dose of Daptacel (lot # C2552AA), intra-muscular into the left thigh, IPOL (lot# Y1031) (corrected), subcutaneous into the left thigh; Comvax (Merck, lot# MSV0O1-F), into the right thigh; Prevnar (Wyeth, lot#086708) into the right thigh. The patient''s left foot began to swell. Treatment was not reported. The patient''s outcome was not reported. First dose of Daptacel (lot# C2430AA) given on 17 January 2007, intra-muscular, into left thigh and experienced swelling of left foot and ankle only (approximately twice of normal size), lasted approximately 20 hours and resolved. Denied illness at vaccination time. The patient''s medical history included gastroesophageal reflux disease (GERD) and possible heart murmur. The patient was taking Prevacid as concomitant medication. The events reported after first vaccination with Daptacel are captured is case 2007-00213. Follow-up information received on 12 April 2007. The patient received IPOL-Lot number Y1032. There was no treatment provided-no apparent distress. The duration of the symptoms was 20-24 hours, it was reported the patient was fine after that.


VAERS ID: 290522 (history)  
Age: 25.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-03-22
   Days after onset:2
Entered: 2007-09-13
   Days after submission:175
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB091BA / 2 LA / IM
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER Z0663 / - RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Renovascular disorders (broad)

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

Write-up: Pt reported to clinic with swelling of injection site, warmth and erythema with minor TTP. LROM of shoulder, no SOB, no CP, no MS changes.


VAERS ID: 291112 (history)  
Age: 1.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-03-19
Onset:2007-03-29
   Days after vaccination:10
Submitted: 2007-09-18
   Days after onset:173
Entered: 2007-09-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB148AA / 0 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1355F / 0 RA / SC

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

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

Write-up: Rash and fever. Time course: (10 days) after vaccine


VAERS ID: 292399 (history)  
Age: 75.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-03-19
Onset:2007-09-24
   Days after vaccination:189
Submitted: 2007-10-01
   Days after onset:7
Entered: 2007-10-08
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0015U / 0 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Herpes zoster
SMQs:

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

Write-up: H. Zoster 9/24/07


VAERS ID: 295805 (history)  
Age: 22.0  
Gender: Female  
Location: New York  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:227
Entered: 2007-11-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 2 UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chest pain, Costochondritis, Dyspnoea, Feeling jittery, Nausea, Pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~HPV (Gardasil)~1~22.00~In Patient
Other Medications: Nuva ring
Current Illness: None
Preexisting Conditions: None besides panic attacks
Diagnostic Lab Data:
CDC Split Type:

Write-up: 3/19 c/o reaction {chest pain treated in ER costochronditis; 5/21 no reaction per patient; 9/21/07 c/o reaction{SOB, nausea, jittery, generalized body pain 24 hours - resolved 3 doses given to patient


VAERS ID: 312294 (history)  
Age: 19.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-03-19
Onset:2007-05-19
   Days after vaccination:61
Submitted: 2008-05-13
   Days after onset:360
Entered: 2008-05-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Streptococcus identification test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified) 10 mg
Current Illness: Pregnancy NOS (LMP = 4/16/2007); Group B betahaemolytic streptococcal positive
Preexisting Conditions:
Diagnostic Lab Data: chest X-ray 01/28/08 right lower lobe pneumonia; cesarean section 01/28/08; respiratory rate 01/18/08 increased; vaginal Streptococcus positive
CDC Split Type: WAES0709USA00587

Write-up: Information has been received through the Pregnancy registry concerning a 19 year old female patient, who on 19-MAY-2007 was vaccinated with a second dose of Gardasil. It was reported that the patient was 20 weeks pregnant. The patients last menstrual period was 16-APR-2007 and her estimated delivery date was 21-JAN-2008. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information was received on 24-MAR-2008 and 02-APR-2008. The patient delivered a baby boy on 28-JAN-2008 (weeks from LMP-40). The baby was born with pneumonia. He weighed 9 lbs. 2 oz. The baby''s pediatrician was called on 02-APR-2008. The nurse confirmed the patient had well visits and was seen multiple times during the month of February for pneumonia and what looked like abdominal pain. A request for Medical Records was faxed to the nurse to obtain the baby''s records. Follow up information received in the form of physician''s notes, indicated that on 28-JAN-2008, the infant first had a "vacuum attempt without success and positive meconium." The physician noted the infant was status post "C-section for failure to progress," and added that the mother was group B strep positive. After birth, the infant had an increased respiratory rate and "was on oxyhood overnight." The chest X-ray revealed right lower lobe pneumonia. Treatment in the hospital included IV ampicillin and gentamycin, and the infant "continued to do well with respiratory rate decreasing and 99% spO2 room air, feeding well." The infant was discharged on 02-FEB-2008 ("two days ago"). On 04-FEB-2008, the infant was seen in follow up at the physician''s office, and was "improving clinically" the physician''s assessment was pneumonia due to streptococcus, group B. Mild facial jaundice was documented. He was also diagnosed with diaper rash-candida, also noted as etoxicum rash; nystatin was prescribed, with follow up in 2 days. The infant was continued on AUGMENTIN. On 06-FEB-2008, the infant was seen by the physician and was improved clinically, with no jaundice noted and only mild etoxicum rash. On 14-FEB-2008, the infant visited the physician for a recheck, with notes of visiting the emergency department, 4 days earlier (10-FEB-2008), because he was "wheezing and crying uncontrollably." Treatment at the ED included Vaponeb, and he improved. At home, the mother used a nebulizer a few times. The physician indicated the infant had "cephalohematoma right posterior scalp." and also noted "well baby. Pneumonia resolved." On 22-FEB-2008, the infant was brought to the physician with "purple feet," and was also noted as being inconsolable, with pulling his legs up and crying. The physician indicated that infant had a "little color change with cold reassurance," and colic was diagnosed. Treatment included nutramagen movement, tight swaddle and white noise. The physician also noted the head had no abnormalities, lesions or masses. On 24-MAR-2008, the infant was brought to the physician with a runny nose and congestion, and reports that "he spits up almost every feeding." The diagnosis was "well baby" The infant was vaccinated with DTaP (+) poliovirus vaccine inactivated (+) tetanus toxoid (manufacturer not specified), HIB (manfacturer not specified), PREVNAR and ROTATEQ. The physician noted that the infant had no previous immunization reaction. Upon internal review, "C-section for failure to progress" was determined to be serious as an other important medical event. Additional information is not expected.


VAERS ID: 312421 (history)  
Age: 21.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2008-05-15
   Days after onset:423
Entered: 2008-05-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 2/14/2007); Specific allergy (drug)
Preexisting Conditions:
Diagnostic Lab Data: urine beta-human 03/19/07 posit
CDC Split Type: WAES0703USA03642

Write-up: Information has been received through the Merck pregnancy registry, for GARDASIL, from a physician concerning a 21 year old female with codeine allergy who on 19-MAR-2007 was vaccinated intramuscularly in the deltoid with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. Later that same day a urine pregnancy test was positive and the patient found out she was pregnant. (LMP: 14-FEB-2007; EDD: 21-NOV-2007). Unspecified medical attention was sought. On 09-May-2009, telephone follow up information was received from a nurse who reported that the patient miscarried at eleven weeks and three days. Upon internal review, miscarriage was considered to be an other important medical event. No further information is available.


VAERS ID: 315480 (history)  
Age: 1.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-03-19
Onset:0000-00-00
Submitted: 2008-05-16
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1511F / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Egg allergy, Peanut allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA00873

Write-up: Information has been received from a medical assistant concerning a 12 month old male with egg and peanut allergies and no other medical history who on 19-MAR-2007 was vaccinated intramuscularly in the thigh with a 0.5 mL dose of with varicella virus vaccine live (Oka/Merck) (lot# 656566/1511F). The patient later developed a rash around the injection site. On the same day, the patient was also vaccinated intramuscularly in the thigh with a dose of measles-mumps-rubella vaccine (MSD). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. The patient was reported as recovering. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 315506 (history)  
Age:   
Gender: Unknown  
Location: Texas  
Vaccinated:2007-03-19
Onset:2007-03-22
   Days after vaccination:3
Submitted: 2008-05-16
   Days after onset:421
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1306F / 1 - / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA01890

Write-up: Information has been received from a physician concerning a patient with no known allergies or pertinent medical history, who on 19-MAR-2007 was vaccinated SC with a second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 656079/1306F). Concomitant therapy included amoxicillin. On 22-MAR-2007, the patient had an injection site that was red and tender to touch after vaccination. Unspecified medical attention was sought. No labs were performed. Subsequently, the patient recovered. There was no product quality complaint. No further information was provided. Additional information has been requested. This is one of several reports from the same source.


VAERS ID: 317160 (history)  
Age: 1.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-03-19
Onset:2008-06-18
   Days after vaccination:457
Submitted: 2008-06-20
   Days after onset:2
Entered: 2008-06-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1280F / 0 RL / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1530F / 0 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Temp x2d x102.6-103, 4-5 red "bites" on trunk and inside of thighs.


VAERS ID: 318288 (history)  
Age: 20.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-03-19
Onset:0000-00-00
Submitted: 2008-07-03
Entered: 2008-07-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified); ibuprofen; PHENEGRAN (PROMETHAZINE
Current Illness: Hyperglycaemia
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08989

Write-up: Information has been received from a medical assistant, and a physician (through the patient''s mother) concerning a 22 year old female patient with hyperglycaemia who on 19-MAR-2007 was vaccinated intramuscularly with a first dose of 0.5mL GARDASIL (lot # not reported). On 14-MAY-2007 the patient was vaccinated with a second dose of GARDASIL (lot#657621/0387U); and on 11-SEP-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 657868/0523U). Concomitant therapy included ibuprofen, PHENERGAN and "NARCO" (therapy unspecified). The patient''s mother and the medical assistant reported that the patient experienced three seizures since receiving the GARDASIL, (timing for each seizure not specified). The mother also reported that the patient was scheduled to see a neurosurgeon. The medical assistant reported that on unspecified date, the patient recovered. Additional information has been requested.


VAERS ID: 325323 (history)  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2007-03-19
Onset:2007-05-01
   Days after vaccination:43
Submitted: 2008-08-14
   Days after onset:471
Entered: 2008-08-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Musculoskeletal pain, Pain, Rheumatoid factor negative
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness: Wart
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory, rheumatic tests negative; Lyme disease assay, negative; Epstein-Barr virus, negative
CDC Split Type: WAES0807USA03718

Write-up: Information has been received from a physician concerning a female who on 04-Oct-2008, 08-Dec-2006 and 19-Mar-2007 was vaccinated with first (lot# 653937/0637F), second (lot# 654389/0961F) and third (lot#657617/0384U) doses, respectively, of GARDASIL. Concomitant therapy included "experimental medication for plantar warts" (therapy unspecified). Physician reported that on 21-Jul-2007, the patient had reported that she had pain in the shoulder, hip, knee, and in general on and off since May 2007, 2 months after she had her 3rd dose of GARDASIL. Unspecified medical attention was sought by seeing her doctor. It was reported that on unspecified date the patient "saw her pediatrician, orthopedist, and rheumatologist. No additional information available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008. Initial and follow-up information has been received from a physician concerning a 19 year old female who on 04-Oct-2006, 08-Dec-2006 and 19-Mar-2007 was vaccinated with first (lot# 657617/0384D) doses, respectively, of GARDASIL by intramuscular injection. Concomitant therapy included "experimental medication for plantar warts", also reported as chemoprophylaxis. Physician reported that on 21-Jul-2007, the patient had reported that she had pain in the shoulder, hip, knee, and in general on an off since May 2007, 2 months after she had her 3rd dose of GARDASIL. It was reported that on unspecified date the patient "saw her pediatrician, orthopedist, and rheumatologist. Laboratory tests included rheumatic work up, lyme, EBV tests, which were all negative. It was also reported that patient underwent chemoprophylaxis for warts by a dermatologist around the time of complaint. At the time of this report, the patient''s events persisted. Additional information is not expected.


VAERS ID: 325770 (history)  
Age: 7.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-03-19
Onset:2008-09-13
   Days after vaccination:544
Submitted: 0000-00-00
Entered: 2008-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1494F / 1 RA / SC

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

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

Write-up: Papular rash on trunk, buttocks and legs. Complained of itching. Calamine lotion and Atarax prn.


VAERS ID: 483656 (history)  
Age: 75.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-19
Onset:0000-00-00
Submitted: 2013-02-06
Entered: 2013-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0015U / 0 LA / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA001139

Write-up: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 19-MAR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.


VAERS ID: 623429 (history)  
Age: 5.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-03-19
Onset:2007-03-23
   Days after vaccination:4
Submitted: 2016-01-25
   Days after onset:3230
Entered: 2016-02-02
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1143F / 1 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Diarrhoea, Dizziness, Ear infection, Lethargy, Muscle twitching, Pyrexia, Skin discolouration, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: 3-27-07, WBC = 2.8; 4-3-07, WBC = 3.9; 4-17-07, WBC = 4; 6-3-07, WBC = 5; 4 - CBC blood/labs - for low white blood cell count
CDC Split Type:

Write-up: High fever 104.5 four days after vaccination this continued to go up and down for 1 week. He was lethargic with fever. He had turned gray/greenish color and almost passed out - 6 days after vaccine. He had loose stools - low energy. His arm muscles were twitching with the fever. He had low white blood cell count. March 19, 2007 - varicella (VARIVAX) was administered - this was the only vaccine given at this well child appointment. March 23, 2007 - I called doctor''s office because of high fever 104.5, lethargy and his arm muscles were twitching - asked if this was a reaction to this vaccine. Doctor said it wasn't'' typical of the vaccine said to make an appointment to be seen. March 27, 2007 - office visit doctor said not typical of vaccine but she also said she didn''t know what was really going on. Doctor prescribed Amoxicillin in case there was something bacterial going on. (When I called to get these dates I was also told the doctor had a diagnosis of an ear infection in the right ear as the reason for prescribing the Amoxicillin. In my actual conversation with the doctor she said absolutely nothing about an ear infection, the only thing she said was she didn''t know exactly, but to try an antibiotic in case it was something bacterial - no mention of ear infection). March 27, 2007 ordered 1st of 4 labs/blood test. March 28, 2007 phone call w/results indicated very low white blood cell count - 2.8. Doctor changed diagnosis to "viral". April 3 and 4, 2007 labs and results of labs - white blood cell count at 3.9. April 17, 2007 3rd lab test - white blood cell count at 4.0. June 3, 2007 4th lab results white blood cell count. I also reported this situation to the Health Department. In the process of all of these weeks and months of doctor office visits and blood work/labs we also sought help from a chiropractor who also recommended a immune boosting standard process IMMUNUPLEX supplement which we gave our son during this time to help boost his immune system. To our knowledge he did make a full recovery from this event. This has been a very frustrating situation for our family. With all that happened the doctor''s office was in this denial that it had anything to do with this vaccine because "it didn''t happen within the "normal" time frame of when a person could react" - every body is different and every body reacts whenever it is going to react, just because it''s not "by the book" doesn''t mean that our experience had nothing to do with this vaccine. My son reacted at day 4 and we were told a reaction usually occurs 7-10 days after..."by the book", therefore "no connection" I beg to differ. Why did his white blood cell count go so dangerously low? Why the fevers?


VAERS ID: 276753 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-03-20
   Days after vaccination:1
Submitted: 2007-04-18
   Days after onset:29
Entered: 2007-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - LA / -

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Leukoencephalomyelitis, Migraine
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0052939A

Write-up: This case was reported by a physician and described the occurrence of acute disseminated encephalomyelitis (ADEM) in a female subject of unknown age who was vaccinated with Twinrix adult for prophylaxis. On 19 March 2007 the subject received the third dose of Twinrix adult (1 ml, unknown). Approximately one day post vaccination with Twinrix adult, on 20 March 2007, the subject experienced migraine-like headache. Approximately three days post vaccination with Twinrix adult, on 22 March 2007, the subject was hospitalised for an unknown period of time. In hospital, the subject was diagnosed with acute disseminated encephalomyelitis. The subject was treated with high-dose Kortison. At the time of reporting the subject still showed hemihypesthesia left from face to foot. At the time of reporting acute disseminated encephalomyelitis with hemihypesthesia were unresolved.


VAERS ID: 282755 (history)  
Age: 1.17  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-04-03
   Days after vaccination:15
Submitted: 2007-06-22
   Days after onset:80
Entered: 2007-06-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: platelet count 4000
CDC Split Type: WAES0706USA02452

Write-up: Information has been received from a health authority concerning a 14 month old male with no particular medical history who on 19-MAR-2007 was vaccinated with an intramuscular dose of MMR II. The batch number was not reported. On 03-APR-2007, 15 days after vaccination, the patient developed thrombocytopenic purpura with platelets at 4000 (date not specified). The patient was hospitalized. He received corrective treatment with injection of polyvalent immunoglobulins. The patient''s purpura resolved within a week. This case is closed. Other business partner numbers included: E2007-03823 and LL0700156. Additional information is not expected.


VAERS ID: 282756 (history)  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-03-26
   Days after vaccination:7
Submitted: 2007-06-22
   Days after onset:88
Entered: 2007-06-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02639

Write-up: Information has been received from a health professional concerning an approximately 27-year-old female who on 19-MAR-2007 was vaccinated with a dose of MMR II. On 26-MAR-2007 the patient developed pericarditis. Case is medically confirmed. The outcome is not reported. It is unspecified if medical attention was sought. Pericarditis is considered to be an other important medical event. Other business partner numbers included L07-00274, E2007-03830. Additional information is not expected. The case is closed.


VAERS ID: 290497 (history)  
Age: 20.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-09-13
   Days after onset:178
Entered: 2007-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Liver function test abnormal, Transaminases increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Liver function test 2007 altered; Transaminases 2007 increased
CDC Split Type: D0054492A

Write-up: This case was reported by a physician and described the occurrence of increased transaminases in a 20-year-old male subject who was vaccinated with Twinrix adult, GlaxoSmithKline. On 19 March 2007 the subject received the first dose of Twinrix adult (1 ml, unknown). Less than one year post vaccination with Twinrix adult, on an unknown date in 2007, the subject experienced change in liver function tests with increased transaminases. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.


VAERS ID: 303710 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-06-24
   Days after vaccination:97
Submitted: 2008-01-25
   Days after onset:215
Entered: 2008-01-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1466F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspartate aminotransferase increased, Bacteria urine identified, Blood creatinine increased, Blood iron decreased, Cytomegalovirus test, Epstein-Barr virus antibody negative, Febrile infection, Granulocyte count increased, Haematuria, Headache, Hypotension, Laboratory test abnormal, Lymphocyte count decreased, Nausea, Nuclear magnetic resonance imaging normal, Photophobia, Red blood cells urine positive, Serology test, Splenomegaly, Transferrin decreased, Ultrasound abdomen abnormal, Urine analysis abnormal, Urine iron decreased, Vomiting, White blood cell count increased, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic urinalysis test 27Jun07 macrohematuria; diagnostic laboratory test 28Jun07 20.42 mg/dl increased; diagnostic urinalysis test 28Jun07 leuko 25/OL, ery 10/OL, some bacteria; magnetic resonance imaging 28Jun07 inconsipicuous; abdominal ultrasound 28Jun07 slightly increased spleen; WBC count 28Jun07 17,800; lymphocyte count 28Jun07 11% decreased; serum aspartate aminotransferase 28Jun07 209 U/ml slight increased; serum creatinine 28Jun07 1.45 mg/dl increased; blood granulocyte count 28Jun07 82% increased; urine iron test 28Jun07 8 microg decreased; clinical serology test 28Jun07 no indication for acute infection EBV, cytomegaly, borrellia negative; transferrin saturation 28Jun07 3.2% decreased;
CDC Split Type: WAES0801USA04437

Write-up: Information has been received from a gynecologist, concerning an 18 year old female patient with no reported pertinent medical history, who on 19-MAR-2007 was vaccinated with the first dose of Gardasil (lot #654948/0903F; batch NE35170), and on 18-JUN-2007 with the second dose of Gardasil (lot #1466F; batch NF15720). On 24-JUN-2007, she developed a febrile infection with a headache, nausea, and vomiting (one episode), photophobia, and affinity to hypotension. Treatment included azithromycin (Zithromax) and mefenamic acid (Parkemed). On 27-JUN-2007, a macro hematuria was reported. On 28-JUN-2007, the patient was hospitalized. Treatment during hospitalization included infusions with Ringer lactate and multi-vitamins (Omnibionta) to stabilize the circulatory disorder, as well as metoclopramide (Paspertin) drops, pantoprazole sodium (Zurcal) and "Ulsal". Antibiotic therapy was changed to ceftriaxone (Rocephin), 2 g, IV. Laboratory findings included: 27-Jun-2007: diagnostic urinalysis test, macrohematuria; 28-Jun-2007: white blood cell count, 17,800; 28-Jun-2007: blood granulocyte count, 82%, increased; 28-Jun-2007: blood lymphocyte count, 11%, decreased; 28-Jun-2007: diagnostic laboratory test "CRG", 20.42 mg/dl, increased; 28-Jun-2007, serum creatinine test, 1.45 mg/dl, slightly increased; 28-Jun-2007: urine iron test, 8 mcg, clearly decreased; 28-Jun-2007: transferrin saturation, 3.2%, decreased; 28-Jun-2007: serum aspartate aminotransferase test, 209 U/ml, slightly increased; 28-Jun-2007: clinical serology test, no indication for acute infection EBV, cytomegaly, borrelia negative; 28-Jun-2007: diagnostic urinalysis test, leuko 25/OL, ery 10/OL, some bacteria; 28-Jun-2007: magnetic resonance imaging (cerebrum and "lumbal punction inconspicuous"); 28-Jun-2007: abdominal ultrasound, slightly increased spleen. Meningitis was excluded, and the cause of infection was not clarified. On 01-JUL-2007, the patient was discharged from the hospital. The patient recovered on an unspecified date. This case is closed. Other business partner numbers include: E2008-00406.


VAERS ID: 305206 (history)  
Age: 6.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2008-02-19
   Days after onset:337
Entered: 2008-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0609F / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: antimicrobial (unspecified) 19?Mar07 - Unk
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp $g39 degC; Temperature higher than 39 degC
CDC Split Type: WAES0802BRA00019

Write-up: Information has been received from a physician concerning a 6 year old male who on 19-MAR-2007 was vaccinated with Pneumovax 23. On approximately 19-MAR-2007 the patient experienced fever (over 39 degrees Celsius), application site oedema, application site redness. The patient''s father contacted a physician (Pediatric) who recommended that the patient should be hospitalized. On the hospital was diagnosed application site cellulitis. On approximately 19-MAR-2007 was started antimicrobial therapy. The patient remained hospitalized for 4 days receiving antibiotic therapy. Subsequently, the patient recovered from fever, application site oedema, application site redness and application site cellulitis. The hospital physician felt that fever, application site oedema, application site redness and application site cellulitis were related to therapy with Pneumovax. Lot number 654608/0609F. No further information is available.


VAERS ID: 321977 (history)  
Age: 1.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2008-08-12
   Days after onset:512
Entered: 2008-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autoimmune thrombocytopenia, Blood product transfusion, Coagulopathy, Ecchymosis, Eosinophil count increased, Eosinophilia, Expired drug administered, Kaolin cephalin clotting time normal, Ophthalmological examination normal, Petechiae, Platelet count decreased, Platelet transfusion, Purpura, Pyrexia, Thrombocytopenia, Thrombocytopenic purpura, White blood cell count, White blood cell count normal
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: ophthalmological exam, 03Apr07, normal, Fundis Oculi; WBC count, with hypereosinophilia of 2700/mm3, 03Apr07, 16000/mm3; platelet count, 03Apr07, 4000/mm3; thrombocytopenia-Biological check-up; kaolin cephalin clotting time, 03Apr07, normal, Cephalin; platelet count, 07Apr07, 124000/mm3, thrombocytopenia
CDC Split Type: WAES0808USA00129

Write-up: Information has been received from a physician concerning a 12 month old male patient who on 19-MAR-2007 was vaccinated with a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (HSA) (batch number not reported). Subsequently, On 03-APR-2007, i.e. 15 days post-vaccination, the patient was hospitalized due to ecchymotic purpura all over his body. At clinical examination, the patient had good health status, no hepatosplenomegaly and no adenopathy. Otorhinolaryngology examination and other examinations were normal. Biological check-up found thrombocytopenia at 4000/mm3, leukocytes of 16000/mm3 with hypereosinophilia of 2700/mm3. Cephalin coagulation time and fundus oculi were normal. There was no hemorrhagic complication. Corrective treatment with perfusion of polyvalent immunoglobulin 1g/kg was given. Outcome was quickly favorable and on 07-APR-2007 the patient''s count had further increased to 124000/mm3. On 07-APR-2007 the patient was discharged with a diagnosis of acute immunological thrombocytopenic purpura. Upon internal review on 01-AUG-2008, this case was a misuse because the vaccine administered had expired since 6 months. Follow-up information received from a lawyer on 31-JUL-2008: The patient developed petechiae one hour after receiving a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (batch number not reported) on 19-MAR-2007. He was hospitalized in the evening and received platelets transfusion. It was reported that it was "difficult to find veins, due to blood coagulation." In early April 2007 the patient was hospitalized for acute immune and petechial thrombocytopenic purpura on the entire body. The patient developed chronic febrile state on an unspecified date. The vaccine MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) had expired in September 2006. The patient received an unspecified number of doses of PENTAVAC and PREVENAR (other manufacturer) during the first months of infancy. Other business partner numbers included E2008-07307.


VAERS ID: 352514 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-03-19
Onset:0000-00-00
Submitted: 2009-07-24
Entered: 2009-07-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information reported.
Diagnostic Lab Data:
CDC Split Type: E200906037

Write-up: Initial case was reported as non-serious on Foreign Health Authority''s web page in line listing of AEs after vaccinations in year 2007. The case was screened by foreign agency on 17-Jul-2009. The case was upgraded to be serious according to the internal rules. It was reported that a 17-year-old girl (birth date and initials not reported) was vaccinated with IMOVAX POLIO (batch number, route and site of administration not reported) on 19-Mar-2007. She experienced convulsions on unspecified date after the vaccination (cessation and duration not reported). Agency has coded the case to be unexpected, non-serious with MedDRA code "convulsions". The outcome is not reported. There is no more information. The case is closed.


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