MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 547698 cases in entire database

Case Details (Sorted by Vaccination Date)

This is page 1709 out of 2191

Result pages: prev   1460 1461 1462 1463 1464 1465 1466 1467 1468 1469 1470 1471 1472 1473 1474 1475 1476 1477 1478 1479 1480 1481 1482 1483 1484 1485 1486 1487 1488 1489 1490 1491 1492 1493 1494 1495 1496 1497 1498 1499 1500 1501 1502 1503 1504 1505 1506 1507 1508 1509 1510 1511 1512 1513 1514 1515 1516 1517 1518 1519 1520 1521 1522 1523 1524 1525 1526 1527 1528 1529 1530 1531 1532 1533 1534 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1547 1548 1549 1550 1551 1552 1553 1554 1555 1556 1557 1558 1559 1560 1561 1562 1563 1564 1565 1566 1567 1568 1569 1570 1571 1572 1573 1574 1575 1576 1577 1578 1579 1580 1581 1582 1583 1584 1585 1586 1587 1588 1589 1590 1591 1592 1593 1594 1595 1596 1597 1598 1599 1600 1601 1602 1603 1604 1605 1606 1607 1608 1609 1610 1611 1612 1613 1614 1615 1616 1617 1618 1619 1620 1621 1622 1623 1624 1625 1626 1627 1628 1629 1630 1631 1632 1633 1634 1635 1636 1637 1638 1639 1640 1641 1642 1643 1644 1645 1646 1647 1648 1649 1650 1651 1652 1653 1654 1655 1656 1657 1658 1659 1660 1661 1662 1663 1664 1665 1666 1667 1668 1669 1670 1671 1672 1673 1674 1675 1676 1677 1678 1679 1680 1681 1682 1683 1684 1685 1686 1687 1688 1689 1690 1691 1692 1693 1694 1695 1696 1697 1698 1699 1700 1701 1702 1703 1704 1705 1706 1707 1708 1709 1710 1711 1712 1713 1714 1715 1716 1717 1718 1719 1720 1721 1722 1723 1724 1725 1726 1727 1728 1729 1730 1731 1732 1733 1734 1735 1736 1737 1738 1739 1740 1741 1742 1743 1744 1745 1746 1747 1748 1749 1750 1751 1752 1753 1754 1755 1756 1757 1758 1759 1760 1761 1762 1763 1764 1765 1766 1767 1768 1769 1770 1771 1772 1773 1774 1775 1776 1777 1778 1779 1780 1781 1782 1783 1784 1785 1786 1787 1788 1789 1790 1791 1792 1793 1794 1795 1796 1797 1798 1799 1800 1801 1802 1803 1804 1805 1806 1807 1808 1809 1810 1811 1812 1813 1814 1815 1816 1817 1818 1819 1820 1821 1822 1823 1824 1825 1826 1827 1828 1829 1830 1831 1832 1833 1834 1835 1836 1837 1838 1839 1840 1841 1842 1843 1844 1845 1846 1847 1848 1849 1850 1851 1852 1853 1854 1855 1856 1857 1858 1859 1860 1861 1862 1863 1864 1865 1866 1867 1868 1869 1870 1871 1872 1873 1874 1875 1876 1877 1878 1879 1880 1881 1882 1883 1884 1885 1886 1887 1888 1889 1890 1891 1892 1893 1894 1895 1896 1897 1898 1899 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958   next


VAERS ID:452358 (history)  Vaccinated:2012-03-23
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-23
Location:Florida  Entered:2012-03-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA673AA UNRA
Administered by: Private     Purchased by: Other
Symptoms: Cyanosis, Erythema
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Gave the flu shot on the right arm and in an instant it turned red and then it turned blue.

VAERS ID:452397 (history)  Vaccinated:2012-03-23
Age:11.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-23, Days after onset: 0
Location:West Virginia  Entered:2012-03-25, Days after submission: 2
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMLL
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101320IMRL
TDAP: TDAP (ADACEL)SANOFI PASTEURU4088AA0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Fall, Musculoskeletal stiffness, Skin discolouration, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Patient fainted & fell to the ground. Was slightly stiff in upper extremities, dusky in color. Episode lasted <2 minutes. 911 called patient sent to local E.R. Vomiting x1.

VAERS ID:452474 (history)  Vaccinated:2012-03-23
Age:69.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2012-03-25, Days after onset: 1
Location:Virginia  Entered:2012-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; LIPITOR; Fluoxetine; ESTRACE
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Area 8 x 8 cm erythema around site of inoculation 1 cm induration at the site of inoculation non fluctuant.

VAERS ID:452452 (history)  Vaccinated:2012-03-23
Age:58.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-26, Days after onset: 3
Location:Washington  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MACROBID; LEXAPRO
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNAR
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: After 3 days still have no relief from swelling, itching, redness & "hot spot" on my arm.

VAERS ID:452461 (history)  Vaccinated:2012-03-23
Age:13.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-26, Days after onset: 3
Location:Illinois  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none noted or reported
Preexisting Conditions: none noted or reported
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3899AA0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Dyskinesia, Musculoskeletal stiffness, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Client became unresponsive, had stiffening of head, neck and body with some jerking movements, lasted approx 15-30 seconds.

VAERS ID:452473 (history)  Vaccinated:2012-03-23
Age:3.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-26, Days after onset: 3
Location:Iowa  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MOTRIN at home
Current Illness: None
Preexisting Conditions: No - has tubes due to recurrent OM
Diagnostic Lab Data: CXR; CBC; BMP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B277AA1IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AA3IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522AA1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Chest X-ray, Febrile convulsion, Full blood count, Metabolic function test, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pt received vaccines around 11AM. Had febrile seizure around 9 pm. Transported by ambulance to local hospital. Temp 103.3 Had rec''d MOTRIN earlier in evening for leg pain & low grade temp approximately 100.

VAERS ID:452471 (history)  Vaccinated:2012-03-23
Age:60.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Male  Submitted:2012-03-27, Days after onset: 4
Location:Massachusetts  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diovan, Metformin, Vitamin D, Fish Oil
Current Illness: None
Preexisting Conditions: Type 2 Diabetic, High blood pressure, High Uric acid in blood
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH   LA
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Injection site joint pain, Injection site warmth, Mood altered, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: The severe pain on the shot location (left shoulder) gradually spread to the middle arm muscle in the evening. The pain locations were hot and lasted more than 3 days. The first day after the shot was in gloomy mood.

VAERS ID:452480 (history)  Vaccinated:2012-03-23
Age:1.4  Onset:2012-03-23, Days after vaccination: 0
Gender:Male  Submitted:2012-03-26, Days after onset: 3
Location:North Carolina  Entered:2012-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323AA3IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1310AA3IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF803833IMLL
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria within 24 hours of administration, without other exposure. Went to ER, given hydroxyzine Rx. Took BENADRY at home. Give prednisolone by PCP on day #3.

VAERS ID:452496 (history)  Vaccinated:2012-03-23
Age:0.3  Onset:2012-03-23, Days after vaccination: 0
Gender:Male  Submitted:2012-03-27, Days after onset: 4
Location:Texas  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: oral thrush, mild diarrhea
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC45158AA IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1482AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169771IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0041AE PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Inconsolable crying for 5-6 hours after administration.

VAERS ID:452544 (history)  Vaccinated:2012-03-23
Age:12.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Male  Submitted:2012-03-26, Days after onset: 2
Location:Massachusetts  Entered:2012-03-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: See attached.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4040AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3898BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0944AA1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Imms on 3/23/12. Abd. pain 3/24/12 --$g ER before midnight (discharge ZOFRAN). 3/25/12 --$g ER at midnight/admit 4 AM 3/26/12 IV fluids/PEPCID/Morphine. See attached admit & discharge summary.

VAERS ID:452546 (history)  Vaccinated:2012-03-23
Age:36.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Male  Submitted:2012-03-26, Days after onset: 2
Location:California  Entered:2012-03-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: The site is without abscess or fluctuance thus no culturing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1169AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009BA0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythemic, hot zone around injection sites. Also pain and fever. Fever seems abated for now. The zone is 11 cm x 9 cm x mild elevation. It is not fluctulent. Placed on KEFLEX and MOTRIN. Has follow-up.

VAERS ID:452574 (history)  Vaccinated:2012-03-23
Age:11.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Male  Submitted:2012-03-28, Days after onset: 5
Location:Indiana  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN qd; FLOVENT inhaler
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB518CA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0477AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4042AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B058AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncope about 2 minutes after administration of vaccines.

VAERS ID:452619 (history)  Vaccinated:2012-03-23
Age:4.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Pennsylvania  Entered:2012-03-28
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 reported
Preexisting Conditions: NKDA; NKFA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B140BA4IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1006AA1SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169740IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1147AA1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Child received immunizations on 3/23/12, booster shots for pre-school. Father came in 3/27/12 to report child had increased temp, 102 & redness & swelling (L) arm x2 days. He made appt to see PCP for 3/29/12. Tx: cool compress/warm compress, TYLENOL or MOTRIN. F/u PCP apt. 3/29/12.

VAERS ID:452655 (history)  Vaccinated:2012-03-23
Age:50.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-29, Days after onset: 6
Location:Washington  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Nontoxic multinodular goiter; migraines
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4136AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Palpitations, Pharyngeal oedema, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Received injection 3-23-12 at 9:18 am. Pt reports that evening her throat was swollen, had px in throat and chest - heart racing and palpitations. Developed a rash on her cheeks. Symptoms resolved that evening. Pt called 3-28-12 to report these sy. Has had no sy since.

VAERS ID:452693 (history)  Vaccinated:2012-03-23
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-29
Location:Arizona  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity, Rash, Skin discolouration
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Presented to clinic with c/o upper arm, shoulder neck pain with red, swollen posterior arm with 2cm wide x 3cm orange peal texture eruption IV ROCEPHIN x 3d; oral KEFLEX, PO acyclovir.

VAERS ID:452706 (history)  Vaccinated:2012-03-23
Age:1.1  Onset:2012-03-28, Days after vaccination: 5
Gender:Female  Submitted:2012-03-30, Days after onset: 2
Location:Massachusetts  Entered:2012-03-30
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: CBC; Electrolytes; BUN; Creatinine; Glucose: Hb; Stool culture; Hemoccult
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169213IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1065AA0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Blood creatinine, Blood culture, Blood electrolytes, Blood glucose, Blood urea, Culture stool, Diarrhoea, Full blood count, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea, vomiting x4 days, weight loss.

VAERS ID:452757 (history)  Vaccinated:2012-03-23
Age:47.0  Onset:2012-03-28, Days after vaccination: 5
Gender:Female  Submitted:2012-03-30, Days after onset: 2
Location:Georgia  Entered:2012-03-30
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: WOKE IN THE MORNING WITH SWELLING, REDNESS, AND TENDERNESS IN RIGHT UPPER ARM. HAD SOME TENDERNESS IN LYMPHNODES. TOOK TYLENOL.

VAERS ID:452753 (history)  Vaccinated:2012-03-23
Age:11.0  Onset:2012-03-27, Days after vaccination: 4
Gender:Female  Submitted:2012-03-30, Days after onset: 3
Location:California  Entered:2012-04-02, Days after submission: 3
Life Threatening? No
Died? Yes
   Date died: 2012-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Status post 2 recent spinal surgeries
Preexisting Conditions: Rett''s syndrome
Diagnostic Lab Data: Recent PICU stay d/c 2/28/12
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4043AD0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Intensive care
SMQs:
Write-up: 11 y/o female with Rett''s syndrome, scoliosis, has had 2 recent spinal surgeries (1/31/12 anterior, 2/8/12 posterior).

VAERS ID:452785 (history)  Vaccinated:2012-03-23
Age:4.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-26, Days after onset: 3
Location:California  Entered:2012-04-02, Days after submission: 7
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171AA4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB534CA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0853AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0835AA1SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left deltoid slightly swollen, warm to touch. Redness 4 x 4 1/2 inches. Per mother pt. scratching her arms. Ice pack applied & reminded mother to continue rubbing area & apply ice pack for 10-15 min every 2-3 hours to come back if no changes.

VAERS ID:452796 (history)  Vaccinated:2012-03-23
Age:49.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2012-04-02, Days after onset: 9
Location:North Carolina  Entered:2012-04-02
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB231AA2IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site pruritus, Injection site reaction, Muscle swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Itching and muscle swelling at injection site; still mild swelling on date of report (4/2/12).

VAERS ID:452824 (history)  Vaccinated:2012-03-23
Age:0.6  Onset:2012-03-23, Days after vaccination: 0
Gender:Male  Submitted:2012-04-02, Days after onset: 10
Location:Michigan  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR    
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH    
Administered by: Unknown     Purchased by: Other
Symptoms: Contusion, Crying, Dysphonia, Injection site haemorrhage, Insomnia, Pain, Pallor, Teething
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Parkinson-like events (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Bled at injection site, cried inconsolably. Nurse indicated bleeding is normal. Proceeded to cry throughout day/night. After 48 hours, baby continued to have regular inconsolable crying spells, could not sleep, seemed in pain. Pale bruise appeared over entire thigh. Crying spells lasted one week, culminating with a hoarse voice. Tried to discuss with doctor, message was not returned. Nurse indicated it was probably teething.

VAERS ID:452829 (history)  Vaccinated:2012-03-23
Age:0.3  Onset:2012-03-24, Days after vaccination: 1
Gender:Male  Submitted:2012-04-02, Days after onset: 9
Location:Oklahoma  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBYB976AA0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF611770UNLL
Administered by: Unknown     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives all over face that eventually spread through out the body within the next week. They were activated by touch to skin. Lasted 2 weeks. Used herbal remedies to cleanse system.

VAERS ID:452874 (history)  Vaccinated:2012-03-23
Age:1.0  Onset:2012-03-29, Days after vaccination: 6
Gender:Male  Submitted:2012-04-03, Days after onset: 5
Location:North Carolina  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: high fever~Measles + Mumps + Rubella (no brand name)~~12.00~Patient
Other Medications: None
Current Illness: None and had never been sick before.
Preexisting Conditions: None
Diagnostic Lab Data: Child has had various tests for influenza and rotovirus. All came back negative. Doctors refuse to believe this is related to vaccine. Child maintains fever at 7 days.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Influenza virus test negative, Pyrexia, Rotavirus test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: High fever of 103.8 lasting for over one week.

VAERS ID:452935 (history)  Vaccinated:2012-03-23
Age:14.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-23, Days after onset: 0
Location:Michigan  Entered:2012-04-03, Days after submission: 11
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: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA1SYRLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient turned pale, then fainted. Patient then layed on table/monitored for 30 minutes after injection. B/P taking after, then before she left.

VAERS ID:452952 (history)  Vaccinated:2012-03-23
Age:19.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2012-03-26, Days after onset: 2
Location:Pennsylvania  Entered:2012-04-03, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGESTIN FE 1/20
Current Illness: None
Preexisting Conditions: Positive PCN allergy; Psoriasis
Diagnostic Lab Data: 3-15-12 Student had MMR titers & Hep B surface antibody drawn for nursing clinical clearance. Rubella negative. MMR booster required. Hep B s Antibody negative. Series restarted.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC061AA3IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1640Z2SCRA
Administered by: Other     Purchased by: Private
Symptoms: Hepatitis B surface antibody negative, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Measles antibody, Mumps antibody test, Rubella antibody negative
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Student reports positive erythema, positive warmth, positive tenderness, increased edema at site of MMR injection - (R) deltoid that started 3-24-12 at 10:30-11:00 while trying to sleep. Tried Ibuprofen 400mg. Seen at Health Services on 3-26-12 at 3:15 p.m. T: 99.3. (R) deltoid positive edema, positive erythema, positive tender, positive warmth. Student reports improvement since 3-25-12. 3-29-12 11A re-examined. Eryth & edema almost resolved. No c/o pruritus or pain.

VAERS ID:453271 (history)  Vaccinated:2012-03-23
Age:0.4  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2012-03-30, Days after onset: 6
Location:Illinois  Entered:2012-04-09, Days after submission: 10
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR4204AA1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF753981IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1534AA1PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Frequent bowel movements
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Loose stools 4-5 times/day. Started day after ROTATEQ.

VAERS ID:453697 (history)  Vaccinated:2012-03-23
Age:43.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2012-04-13, Days after onset: 20
Location:Washington  Entered:2012-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PCN allergy; No other medical cond.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078BA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Local swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Local swelling, itching and redness developed next day. Tx with antihistamine & sx resolved over next 2-3 days.

VAERS ID:453853 (history)  Vaccinated:2012-03-23
Age:49.0  Onset:2012-04-01, Days after vaccination: 9
Gender:Male  Submitted:2012-04-05, Days after onset: 4
Location:Michigan  Entered:2012-04-17, Days after submission: 12
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 known
Diagnostic Lab Data: 4/4 ER - no temp, no SIB, no adenopathy, no swelling, BP 127/70 pulse 96, resp 16 temp 98.4, pulse ox 98% on room air.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0873AA SCRA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Nausea, Pain, Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: 9 days after receiving MMR developed urticarial rash. Patient also reports aches, pains, with chills & nausea started 11 days after vaccination. He is also reporting swelling in the throat and fever. Physician exam notes skin urticaria only. Patient has been using BENADRYL & CLARITIN, ranitidine added 4/4. Patient continues to feel symptoms at this time.

VAERS ID:453964 (history)  Vaccinated:2012-03-23
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-18
Location:New York  Entered:2012-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuva Ring, multivitamin, vitamin d3, acidophillis
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNRA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Discomfort, Lethargy, Lymphadenopathy, Malaise, Myalgia, Nasopharyngitis
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: The day of the vaccine I experienced swollen lymph nodes under the left underarm. I developed a cold, and began to become lethargic and sick for one week. Since then, I''ve been experiencing chronic joint and muscle aches in my arms, shoulders, hands, lower back, neck, legs and feet. I''ve tried icing these areas and taking joint supplements, but the pain and discomfort will not abate. I''ve never experienced this chronic pain until after I began to take the Gardasil vaccine.

VAERS ID:454180 (history)  Vaccinated:2012-03-23
Age:17.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-04-23, Days after onset: 31
Location:Michigan  Entered:2012-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Atarax, Singulair and Zyrtec
Current Illness: NONE
Preexisting Conditions: Allergic to Sulfa Also, takes Atarax, Singulair and Zyrtec
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AB4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB492CA0IMRA
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA092AD0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0713AA1SCLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness at site of injection. By the next morning progression in redness and started getting harder. Red area about 3 inches in diameter on left back arm. Diagnosed with a cellulitis and was given oral antibiotics.

VAERS ID:456413 (history)  Vaccinated:2012-03-23
Age:  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-05-29, Days after onset: 67
Location:Unknown  Entered:2012-05-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA04657
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCAR
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site erythema, Injection site swelling
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a pharmacist concerning a female patient who on approximately 23-MAR-2012 ("2 months ago") was vaccinated SQ with a single dose of ZOSTAVAX (Merck) (lot # not reported) at the pharmacy. On approximately 23-MAR-2012 ("2 months ago") the patient developed redness and swelling at the site of injection. The patient had difficulty raising the affected arm which caused her to miss 2 days of work as a hospital nurse. The patient contacted her unspecified physician and was prescribed an unspecified medication. Subsequently, the patient fully recovered from the events on an unspecified date. Having difficulty raising the affected arm was considered to be disabling by the reporter. No further information is available.

VAERS ID:458383 (history)  Vaccinated:2012-03-23
Age:33.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-06-28, Days after onset: 97
Location:Texas  Entered:2012-06-28
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: DM II, Psoriatic arthritis, GERD
Diagnostic Lab Data:
CDC Split Type: TX120020PR
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1420AA0 LA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Injection site erythema, induration, pain with hive like rash running to inside arm and down arm; fever, chills, headache.

VAERS ID:459637 (history)  Vaccinated:2012-03-23
Age:  Onset:2012-03-23, Days after vaccination: 0
Gender:Unknown  Submitted:2012-07-17, Days after onset: 116
Location:Tennessee  Entered:2012-07-17
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:
CDC Split Type: WAES1207USA000775
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1 of LIQUID PEDVAXHIB on 09-FEB-2012 (lot # and dose not reported) and 44 days after on 23-MAR-2012 was vaccinated with dose 2 of LIQUID PEDVAXHIB (lot #, dose and route not reported). No other co-suspects and no concomitant medications were reported. No adverse effect was reported. Additional information has been requested.

VAERS ID:466745 (history)  Vaccinated:2012-03-23
Age:13.0  Onset:2012-04-09, Days after vaccination: 17
Gender:Female  Submitted:2012-09-27, Days after onset: 171
Location:California  Entered:2012-09-27
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: Biopsy of spot on calf, bloodwork negative for all other likely causes of erythema nodosum.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Biopsy skin normal, Blood test normal, Contusion, Erythema nodosum, Induration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Hard, bruise like spots appeared on legs. Continued to multiply on legs and existing spots darkened over the month. Erythema Nodosum was diagnosed 05/30/2012 with likely cause recent HPV injection.

VAERS ID:468967 (history)  Vaccinated:2012-03-23
Age:69.0  Onset:2012-04-12, Days after vaccination: 20
Gender:Male  Submitted:2012-10-02, Days after onset: 173
Location:Connecticut  Entered:2012-10-11, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.17066AA UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Diag. Guillain Barre Syndrome. Remains in hospital since April 13, 2012.

VAERS ID:474689 (history)  Vaccinated:2012-03-23
Age:38.0  Onset:2012-03-23, Days after vaccination: 0
Gender:Female  Submitted:2012-09-21, Days after onset: 182
Location:California  Entered:2012-10-17, Days after submission: 26
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: The subject had a positive PPD test in 1995. There was no history of adverse events following previous vaccinations. The subject was reported to be healthy.
Diagnostic Lab Data: UNK
CDC Split Type: A0971910A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076DA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Influenza like illness, Malaise, Nausea, Pain, Pyrexia, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a healthcare professional (occupational health nurse) and described the occurrence of flu like symptoms in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 23 March 2012 at 12:00 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. On 23 March 2012, 6 to 8 hours after vaccination with BOOSTRIX, the subject experienced flu like symptoms, body pain, nausea and low grade fever. The subject was treated with TYLENOL. The events were reported to be resolved as of 25 March 2012; however, the subject reported still having malaise, tiredness and a sleepy feeling the day prior to reporting. Outcome of these events was not reported. It was noted that the subject returned to work. The healthcare professional considered the events of flu like symptoms, body pain, nausea and low grade fever were probably related to vaccination with BOOSTRIX. Attribution of malaise, tiredness and sleepy feeling to BOOSTRIX administration was not known.

VAERS ID:516805 (history)  Vaccinated:2012-03-23
Age:20.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-17
Location:Utah  Entered:2013-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN; PRILOSEC
Current Illness: Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Urine pregnancy test (23-MAR-2012) positive for pregnancy; 2012, Ultrasound scan, any abnormalities prior to termination
CDC Split Type: WAES1203USA03203
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Exposure during pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a pharmacist for GARDASIL a Pregnancy Registry Product, concerning a 20 year old female with allergies (unspecified) and no drug reactions/allergies. On 13-JAN-2012 was vaccinated, with first dose of GARDASIL (lot # unspecified), 0.5 ml, injection, intramuscularly (IM). On 23-MAR-2012 the patient was vaccinated with the second dose of GARDASIL (lot # unspecified), 0.5 ml, IM. Concomitant therapy included omeprazole (manufacturer unknown) and CLARITIN taken as needed. On an unspecified date, the patient became pregnant. The patient mentioned after receiving the 2nd dose of GARDASIL that she did not have a period since December 2011. The patient was given a urine pregnancy test in the office visit on 23-MAR-2012 which was positive for pregnancy. No treatment was given. The patient''s Last Menstrual Period (LMP) was in December 2011 and her estimated delivery date (EDD) was 06-SEP-2012. At the time of report, the outcome was unknown. Follow up information has been received on 14-DEC-2013 from a pharmacist. It was reported that the patient terminated pregnancy electively at 20 weeks (in 2012). Fetal outcome was unknown. It was also reported that anatomy ultrasound prior to termination (date unknown) did not indicated any abnormalities. Relatedness between elective termination and GARDASIL was not assessed. Upon internal review elective termination was considered to be medically significant. Additional information is not expected.

VAERS ID:520046 (history)  Vaccinated:2012-03-23
Age:  Onset:2012-03-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-21, Days after onset: 669
Location:Unknown  Entered:2014-01-21
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: WAES1401USA008576
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1604AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 072477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 23-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA, expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:520060 (history)  Vaccinated:2012-03-23
Age:  Onset:2012-03-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-21, Days after onset: 669
Location:Unknown  Entered:2014-01-21
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: WAES1401USA008577
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1604AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 23-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 1604AA, expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:520944 (history)  Vaccinated:2012-03-23
Age:  Onset:2012-03-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-28, Days after onset: 676
Location:Unknown  Entered:2014-01-28
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: WAES1401USA009196
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:457025 (history)  Vaccinated:2012-03-23
Age:66.0  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2012-06-07, Days after onset: 75
Location:Foreign  Entered:2012-06-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA00062
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERH7221 SCUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0401Z SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (narrow)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (local reference # AUS/12/1065, OPR # 299548), concerning a 66 year old female who on 23-MAR-2012 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX 23 (lot# 668081/0401Z, batch # R2544). Other suspect therapy included a 0.5 ml dose of VAXIGRIP (batch# H7221) subcutaneously on the same day. On 24-MAR-2012 the patient experienced onset rapid atrial fibrillation and was hospitalized. The patient was treated with magnesium which was unsuccessful spontaneous reversion. Subsequently, the patient recovered from atrial fibrillation. The agency considered atrial fibrillation to be serious for the following reason: caused or prolonged inpatient hospitalization. The agency considered that atrial fibrillation was related to therapy with PNEUMOVAX 23 and VAXIGRIP. The original reporting source was not provided. Additional information is not expected.

VAERS ID:474103 (history)  Vaccinated:2012-03-23
Age:18.0  Onset:2012-04-27, Days after vaccination: 35
Gender:Female  Submitted:2012-11-14, Days after onset: 201
Location:Foreign  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: BUSCOPAN; cyclizine; loratadine; naproxen; omeprazole; acetaminophen; tramadol hydrochloride
Current Illness: Immunisation
Preexisting Conditions: Hypersensitivity; Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1211GBR005773
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ovarian cyst, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was received from the Health Authority on 07-Nov-2012. GB-MHRA-ADR 21902755. This case is not medically confirmed as it was reported by a consumer. A 18-year-old female patient received an injection of HPV vaccine (manufacturer unknown; lot no, dose, route and site of administration not reported) on 23-Mar-2012. She presented with ovarian cyst and pain on 27-Apr-2012 and she experienced syncope on 02-May-2012. Concomitant medications included BUSCOPAN, cyclizine, loratadine, naproxen, omeprazole, paracetamol and tramadol hydrochloride. The patient''s medical history included penicillin allergy and allergy to all tapes and plasters. At the time of reporting the patient was not recovered. This case was considered serious due to hospitalisation, disability and as an other medically important condition.

VAERS ID:474274 (history)  Vaccinated:2012-03-23
Age:18.0  Onset:2012-04-27, Days after vaccination: 35
Gender:Female  Submitted:2012-11-14, Days after onset: 201
Location:Foreign  Entered:2012-11-14
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: Omeprazole; Paracetamol; Tramadol hydrochloride; Cyclizine; Naproxen; Hyoscine butylbromide; Loratadine
Current Illness: Unknown
Preexisting Conditions: Allergy; Penicillin allergy
Diagnostic Lab Data: UNK
CDC Split Type: B0842435A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ovarian cyst, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-EYC 00095232) and described the occurrence of ovarian cyst in a 18-year-old female subject who was vaccinated with HPV VACCINE. The subject''s medical history included allergy and penicillin allergy. Concurrent medications included omeprazole, paracetamol, tramadol hydrochloride, cyclizine, naproxen, BUSCOPAN and loratadine. On 23 March 2012 the subject received an unspecified dose of HPV VACCINE. Approximately 35 days time after vaccination with HPV VACCINE, on 27 April 2012, the subject experienced ovarian cyst and pain. On 2 May 2012 the patient experienced syncope. The subject was hospitalised and the regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. MHRA Verbatim Text: Ovarian cyst, pain and syncope.

VAERS ID:484246 (history)  Vaccinated:2012-03-23
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-11
Location:Foreign  Entered:2013-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201301950
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER611853UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate in a foreign country who received the report from the Ministry of Health. A female patient (age reported as "29 years 7 months and 13 days old"), whose medical history and concomitant therapies were not reported, had received a dose of Rabies vaccine (manufacturer unknown, more than the fourth dose), lot number 61185, (route and anatomical site of administration not reported) on 23 March 2012. On an unspecified date post-vaccination the patient experienced hypersensitivity reaction up to 2 hours. The patient''s outcome was recovered with no sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:488004 (history)  Vaccinated:2012-03-23
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-27
Location:Foreign  Entered:2013-03-27
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: UNK
CDC Split Type: B0877217A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Juvenile idiopathic arthritis
SMQs:, Arthritis (narrow)
Write-up: This case was reported by a physician and described the occurrence of juvenile rheumatoid arthritis in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 September 2011, 14 October 2011 and 23 March 2012, the subject received 1st, 2nd and 3rd dose of CERVARIX (intramuscular, unknown injection sites and batch numbers). At an unspecified time after vaccination with 3rd dose of CERVARIX, the subject experienced juvenile rheumatoid arthritis and arthalgia. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.

VAERS ID:494957 (history)  Vaccinated:2012-03-23
Age:  Onset:2012-03-24, Days after vaccination: 1
Gender:Female  Submitted:2013-06-21, Days after onset: 454
Location:Foreign  Entered:2013-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, hypothyroidism
CDC Split Type: B0883280A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Hypothyroidism, Joint swelling, Juvenile idiopathic arthritis, Pain, Pain in extremity, Pyrexia, Thyroid function test abnormal, Thyroiditis chronic
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypothyroidism (narrow), Hyperthyroidism (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer and described the occurrence of juvenile idiopathic arthritis in a female subject aged between 10 and 19 years old who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 23 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 24 March 2012, 1 day after vaccination with CERVARIX, the subject experienced pyrexia and complained about arthralgia. At unspecified date, the body temperature declined shortly afterwards and the arthralgia disappeared. Several weeks after, the subject experienced pain in joint involving lower leg. On 16 April 2013, the subject visited the orthopedic department, the symptoms was considered to be attributable to excessive movement of the joints. The subject subsequently experienced radiating pain and visited the department of internal medicine. Based on the result of blood tests, a mild hypothyroidism was diagnosed. The subject was referred to a university hospital as a precautionary measure although no other abnormalities was found. The subject was therefore placed under observation. However, the subject experienced pyrexia and pain as well, which prevented her to go to school, a treatment for rheumatism was started. The subject received treatment with steroid, an antirheumatic drug and an analgesic for nearly one year. At the time of reporting, the subject did not experience irradiating pain, but she had mild pains including knee pain and finger pain but she was able to attend to school. Follow-up information received on 14 June 2013 by the consumer: The case was upgraded to serious. Concurrent vaccination included CERVARIX (GlaxoSmithKline) intramuscular; unknown given on 13 September 2011 and 14 October 2011 as 1st and 2nd doses. After vaccination, pyrexia occurred and pain and swelling occurred on the different location from day to day. On 09 May 2012, the subject experienced chronic thyroiditis. On 06 June 2012, a diagnosis of juvenile idiopathic arthritis was made. The reporter considered the events as clinically significant. The subject was treated with prednisolone for more than 1 year. At the time of reporting, fever and arthralgia was resolved. The outcome of pain in joint involving lower leg, irradiating pain, hypothyroidism, knee pain, finger pain, juvenile idiopathic arthritis, chronic thyroiditis and swelling was unspecified.

VAERS ID:524305 (history)  Vaccinated:2012-03-23
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-28
Location:Foreign  Entered:2014-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Menstruation Normal
Preexisting Conditions:
Diagnostic Lab Data: Unk
CDC Split Type: B0971674A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Loss of control of legs, Palpitations, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of control of legs in a 13-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). Historic vaccination included 1st and 2nd doses of CERVARIX, (GlaxoSmithKline) given on 10 August 2011 and on an unspecified date. On 23 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site and batch number). In Summer of 2012, approximately 3-4 months after vaccination with CERVARIX, the subject experienced loss of control of legs, swaying feeling, palpitations and tinnitus. The physician considered the events were clinically significant (or requiring intervention). The symptoms were most severe 2 weeks before menstruation and subsided during menstruation. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:538588 (history)  Vaccinated:2012-03-23
Age:7.0  Onset:0000-00-00
Gender:Male  Submitted:2014-08-01
Location:Foreign  Entered:2014-08-01
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: Body temperature, 39.9 degrees C
CDC Split Type: WAES1407CHN014364
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Erythema, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: This spontaneous report as received from an Agency refers to a 7 year old male patient. on 23-MAR-2012, the patient was vaccinated with a dose of PNEUMOVAX (lot # reported as R2377, expiration date 12-APR-2012) (route not reported). On an unknown date, the patient experienced convulsions, got a with a body temperature of fever (39.9 degrees C) and experienced red and swelling. Therapy with PNEUMOVAX was discontinued. At the time of the report, the patient''s outcome was unknown. Convulsions were considered to be medically significant by the Agency. The Agency assessed the case was serious because local regulation prescribed febrile convulsion was serious AEFI. Additional information is not expected. No patient''s and physician''s contact information was available. No FU information can be conducted.

VAERS ID:452423 (history)  Vaccinated:2012-03-24
Age:52.0  Onset:2012-03-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-26, Days after onset: 1
Location:Puerto Rico  Entered:2012-03-26
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: Penicillin; Aspirin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1103001 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1502AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient called to the pharmacy complaining that is experiencing a very painful in her arm and shoulder. She also said that the injection site is redness and heat and is red in a diameter of above 2 - 3 inches. Patient is taking APAP and is working at moment.

VAERS ID:452499 (history)  Vaccinated:2012-03-24
Age:5.0  Onset:2012-03-27, Days after vaccination: 3
Gender:Male  Submitted:2012-03-27, Days after onset: 0
Location:Massachusetts  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG150013IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling at injection site, Right Deltoid where DTaP was given. Treated with ice and Motrin.

VAERS ID:452586 (history)  Vaccinated:2012-03-24
Age:5.0  Onset:2012-03-25, Days after vaccination: 1
Gender:Male  Submitted:2012-03-26, Days after onset: 1
Location:Illinois  Entered:2012-03-28, Days after submission: 2
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: H/O Kawasaki disease
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0953AA1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0978AA1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received vaccines, Saturday 3/24/12, received call from mom stating that child woke up Sunday morning with right arm swollen from shoulder to elbow & warm. No fever. Evaluated in clinic on Mon 3/26/12. Positive warmth, erythema to mid-arm. Recommend ibuprofen & monitoring.

VAERS ID:452620 (history)  Vaccinated:2012-03-24
Age:4.0  Onset:2012-03-25, Days after vaccination: 1
Gender:Male  Submitted:2012-03-26, Days after onset: 1
Location:Illinois  Entered:2012-03-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0953AA1UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0978AA1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt vaccinated in (L) arm on 3/24/12. On 3/25/12 received call from mom stating (L) arm was swollen from shoulder to elbow and was red & warm - no fever. Evaluated in clinic on 3/26/12 - and arm erythematous swollen to mid arm/no fever - Recommended observation & ibuprofen.

VAERS ID:452656 (history)  Vaccinated:2012-03-24
Age:26.0  Onset:2012-03-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-29, Days after onset: 4
Location:Rhode Island  Entered:2012-03-29
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078AA IMLA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Headache, Nausea, Neck pain, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pain swelling redness left arm neck pain, HA nausea fever treatment seen urgent care put on ZYRTEC 10mg. TYLENOL/ADVIL.

VAERS ID:452682 (history)  Vaccinated:2012-03-24
Age:45.0  Onset:2012-03-25, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 4
Location:South Carolina  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None. Have since taken 400 mg of ibuprofen on 4 separate occasions. Symptoms still occur even when not taking ibuprofen.
Current Illness: no
Preexisting Conditions: codeine, seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4104AA UNLA
Administered by: Public     Purchased by: Private
Symptoms: Heart rate increased, Heart rate irregular, Pulse pressure decreased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiac arrhythmia terms, nonspecific (narrow)
Write-up: I experienced short periods of rapid, shallow, and irregular heartbeat, usually lasting 10-20 seconds. Would occur in groups of 3 or 4. Has happened twice or three times each day, beginning the day after the vaccine was given.

VAERS ID:452922 (history)  Vaccinated:2012-03-24
Age:4.0  Onset:2012-03-26, Days after vaccination: 2
Gender:Male  Submitted:2012-03-26, Days after onset: 0
Location:Illinois  Entered:2012-04-03, Days after submission: 8
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: Red, swollen (L) arm after vaccines
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CAA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1004AA SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.121433AA SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Inflammation on left deltoid.

VAERS ID:453423 (history)  Vaccinated:2012-03-24
Age:51.0  Onset:2012-04-04, Days after vaccination: 11
Gender:Female  Submitted:2012-04-11, Days after onset: 7
Location:Texas  Entered:2012-04-11
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.09533AA SCLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Body temperature increased, Headache, Influenza like illness, Malaise, Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Malaise, flu like body aches, low grade temp and headache. Followed by a papular (1 mm papules) red rash on palms, then extensor surface of hands/knees/elbows (nowhere else). Somewhat pruritic. Bilateral arthralgias in joints, but mostly in hands.

VAERS ID:453855 (history)  Vaccinated:2012-03-24
Age:70.0  Onset:2012-03-24, Days after vaccination: 0
Gender:Female  Submitted:2012-03-29, Days after onset: 5
Location:Missouri  Entered:2012-04-17, Days after submission: 19
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0761AA0SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling at injection site - hard bump - patient running fever - itches.

VAERS ID:453869 (history)  Vaccinated:2012-03-24
Age:23.0  Onset:2012-03-31, Days after vaccination: 7
Gender:Male  Submitted:2012-04-17, Days after onset: 17
Location:Connecticut  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Negative blood cultures; CBC within normal limits
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV5050IMLA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE05490IMRA
Administered by: Military     Purchased by: Military
Symptoms: Axillary pain, Blood culture negative, Chest pain, Full blood count normal, Oedema peripheral, Pain in extremity, Viral infection
SMQs:, Cardiac failure (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Tracking my virus. Swollen sharp pain in arm, chest, armpit.

VAERS ID:453872 (history)  Vaccinated:2012-03-24
Age:34.0  Onset:2012-04-06, Days after vaccination: 13
Gender:Female  Submitted:2012-04-17, Days after onset: 11
Location:Connecticut  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3050IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC046BA0IMLA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 RA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11240IMRA
Administered by: Military     Purchased by: Military
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red itchy bumps started on my stomach on 6 Apr 12 and spread to my legs by 8 Apr 12. Was told to take 1 tablet of BENADRYL 3 times a day for 7 days.

VAERS ID:453873 (history)  Vaccinated:2012-03-24
Age:21.0  Onset:2012-04-02, Days after vaccination: 9
Gender:Male  Submitted:2012-04-17, Days after onset: 15
Location:Connecticut  Entered:2012-04-17
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3050IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE05490IMRA
Administered by: Military     Purchased by: Unknown
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Chest pain.

VAERS ID:457234 (history)  Vaccinated:2012-03-24
Age:4.0  Onset:2012-04-02, Days after vaccination: 9
Gender:Female  Submitted:2012-06-11, Days after onset: 70
Location:California  Entered:2012-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: OMNICEF; NASONEX; CLARITIN; Fluoride
Current Illness: Sinus infection
Preexisting Conditions:
Diagnostic Lab Data: Oligoarthritis; Labs and x-rays were done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4035AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG15003IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1405AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1273AA1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Arthritis, Joint swelling, Laboratory test, Limb discomfort, X-ray
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Legs felt silly, c/o Rt knee pain with swelling. Pt was given NAPROSYN.

VAERS ID:453045 (history)  Vaccinated:2012-03-24
Age:7.0  Onset:2012-03-24, Days after vaccination: 0
Gender:Male  Submitted:2012-04-05, Days after onset: 12
Location:Foreign  Entered:2012-04-04, Days after submission: 1
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:
CDC Split Type: PHHY2012EC028571
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS110122A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Epistaxis, Mouth haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Case number PHHY2012EC028571 is an initial spontaneous report received from a consumer (patient relative) via Novartis associate on 25 Mar 2012 and combines follow-up information obtained previous to reporting. This report refers to a 7-year-old male patient. Neither medical history nor concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 110122A and expiry date: Apr 2012) intramuscularly on 24 Mar 2012. He took acetaminophen in the afternoon and in the night, and experienced nose and mouth bleeding. The unspecified mouth bleeding had resolved within hours. Nose bleeding persisted til 8:00 am on 25 Mar 2012. After physical evaluation, her treating physician administered intravenous infusion of saline solution without vitamins (not specified). On 26 Mar 2012 patient experienced cough. Outcome was reported as condition recovered. Causality was not reported. No further information available.

VAERS ID:455452 (history)  Vaccinated:2012-03-24
Age:0.5  Onset:2012-03-24, Days after vaccination: 0
Gender:Male  Submitted:2012-05-11, Days after onset: 48
Location:Foreign  Entered:2012-05-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atopic dermatitis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0800670A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Condition aggravated, Cough, Decreased appetite, Dermatitis atopic, Diarrhoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a regulatory authority (# 163693) and described the occurrence of asthmatic cough in a 5-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent medical conditions included atopic dermatitis. Concurrent vaccination included pneumococcal vaccines (non-gsk) (Wyeth Labs, intramuscular, unknown injection site) given on 24 March 2012. On 24 March 2012, the subject received 2nd dose of INFANRIX (intramuscular, unknown injection site, batch number not provided). On 24 March 2012, less than one day after vaccination with INFANRIX, the subject experienced asthmatic cough, diarrhea, loss of appetite and dermatitis atopic aggravated. This case was assessed as medically serious by GSK. The subject was treated with hydration therapy, lactic-acid-producing organisms (Lactis fermentia) and Aerosol. At the time of reporting the outcome of the events was unspecified.

VAERS ID:455688 (history)  Vaccinated:2012-03-24
Age:0.4  Onset:2012-03-25, Days after vaccination: 1
Gender:Male  Submitted:2012-05-16, Days after onset: 52
Location:Foreign  Entered:2012-05-16
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 25Mar2012, 39.3deg.C
CDC Split Type: B0800575A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSYHIBC542B UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of upper respiratory infection in a 4-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 24 March 2012, the subject received an unspecified dose of HIBERIX (administration site and route unknown). On 25 March 2012, 1 day after vaccination with HIBERIX, the subject experienced upper respiratory infection and fever (39.3 deg.C). The subject was hospitalised and discharged on 30 March 2012. On 27 March 2012, fever was resolved. On 30 March 2012, upper respiratory infection was resolved. The physician considered the events were probably related to vaccination with HIBERIX.

VAERS ID:463987 (history)  Vaccinated:2012-03-24
Age:0.8  Onset:2012-06-09, Days after vaccination: 77
Gender:Male  Submitted:2012-09-04, Days after onset: 87
Location:Foreign  Entered:2012-09-04
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: Anti-HBsAg positive, Positive
CDC Split Type: B0826531A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B surface antibody positive, Hepatitis B virus test positive, Vertical infection transmission
SMQs:, Liver infections (narrow)
Write-up: This case was reported by a regulatory authority (# 2012M0609) and described the occurrence of Hepatitis B positive in a 9-month-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified) and ENGERIX B. Historic medications included Hepatitis B immunoglobulin administered on 9 September 2011, at birth. Subject''s maternal grandmother was Hepatitis B positive. Subject''s mother found out she was Hepatitis B positive during pregnancy (she never received Hepatitis B vaccine). The subject was breastfed. On 11 September 2011, the subject received 1st dose of Hepatitis B vaccine (intramuscular, unknown injection site), on 11 October 2011 and 24 March 2012 the subject received 2nd dose and 3rd dose of ENGERIX B (intramuscular, unknown injection sites). On 9 June 2012, 77 days after vaccination with ENGERIX B, routine tests were performed. The subject was Hepatitis B positive due to vertical infection transmission. The subject was HBsAg reactive. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was not hospitalized.

VAERS ID:484219 (history)  Vaccinated:2012-03-24
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2013-02-12
Location:Foreign  Entered:2013-02-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0866819A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B075AC0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a healthcare professional (National Immunization Program) and described the occurrence of hypotonic-hyporesponsive episode in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 March 2012, the subject received 1st dose of BOOSTRIX (administration site and route unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced hypotonic-hyporesponsive episode. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting, the event was resolved. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:519489 (history)  Vaccinated:2012-03-24
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2014-01-15
Location:Foreign  Entered:2014-01-15
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: UNK
CDC Split Type: B0959522A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Depressed level of consciousness, Hypotension, Mobility decreased, Somnolence
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of decreased consciousness in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline; intramuscular; unknown) given respectively on 20 September 2011 and 22 October 2011. On 24 March 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown injection site). At an unspecified time after vaccination with CERVARIX, the subject experienced feelings of weakness and could not strain the whole body at all when waking up in the morning. She complained of chills and could not move at all (decreased mobility) in the morning. She had low blood pressure in the morning, and she had decreased consciousness until around 10:00 AM. She became able to strain the body after 06:00 PM. She began to be late for school because she could not wake up in the morning even though she had adequate sleep. She was willing to go to school but could not control her body in contrast with her feelings. Only in December 2013, she could somehow manage to attend a class from the first period. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. It was doubtful whether these symptoms could be determined to be adverse reactions. Therefore the reporter didn''t provide the causal relationship to CERVARIX.

VAERS ID:553133 (history)  Vaccinated:2012-03-24
Age:14.0  Onset:2013-02-01, Days after vaccination: 314
Gender:Female  Submitted:2014-10-27, Days after onset: 632
Location:Foreign  Entered:2014-10-28, Days after submission: 1
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: JP2014JPN010343
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chronic fatigue syndrome, Fatigue, Headache, Hypotension, Learning disorder, Malaise, Orthostatic intolerance
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad)
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of chronic fatigue syndrome in a 14-year-old female patient who received CERVARIX (batch number AHPVA146BA, expiry date unknown), (batch number AHPVA148CA, expiry date unknown) and (batch number AHPVA161BA, expiry date unknown). On 20th September 2011, the patient received the 1st dose of CERVARIX (intramuscular). On 20th December 2011, the 2nd dose was an unknown dose. On 24th March 2012, the 3rd dose was an unknown dose. In February 2013, unknown after receiving CERVARIX, the patient experienced chronic fatigue syndrome (serious criteria clinically significant/intervention required), orthostatic intolerance (serious criteria clinically significant/intervention required), headache, hypotension, malaise, fatigue and learning disorder. On 20th October 2014, the outcome of the chronic fatigue syndrome, orthostatic intolerance, headache, hypotension, malaise, fatigue and learning disorder were not recovered/not resolved. The reporter considered the chronic fatigue syndrome and orthostatic intolerance to be related to CERVARIX. It was not reported if the reporter considered the headache, hypotension, malaise, fatigue and learning disorder to be related to CERVARIX.

VAERS ID:452989 (history)  Vaccinated:2012-03-25
Age:14.0  Onset:2012-03-25, Days after vaccination: 0
Gender:Female  Submitted:2012-03-26, Days after onset: 1
Location:California  Entered:2012-04-03, Days after submission: 8
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT499AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Within 10 seconds of vaccine pt turned white & fainted. She came to in about 10-15 seconds. Sitting at time of syncope so no injury. 1st BP 105/55 - wait 15 mins 2nd BP 117/96 -$g went home with father.

VAERS ID:453170 (history)  Vaccinated:2012-03-25
Age:26.0  Onset:2012-04-02, Days after vaccination: 8
Gender:Male  Submitted:2012-04-05, Days after onset: 3
Location:Connecticut  Entered:2012-04-06, Days after submission: 1
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: NYC1200005
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV305 UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A  UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11301 UNUN
Administered by: Military     Purchased by: Unknown
Symptoms: Injection site cellulitis, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: On 3/25 received small pox, anthrax typhoid vaccine. On 4/2 developed cellulitis at site of vaccination and non-specific generalized rash which began on the arms and travelled to thorax and legs, sparing hand/feet. Patient was vaccinated through work and seen at ER for the rash on 4/4/12.

VAERS ID:453871 (history)  Vaccinated:2012-03-25
Age:25.0  Onset:2012-04-03, Days after vaccination: 9
Gender:Male  Submitted:2012-04-17, Days after onset: 14
Location:Connecticut  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: GNC Vitamins; Fish Oil
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No tests performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3050IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11303IMRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Extreme swelling and redness, rash from arm to left breast.

VAERS ID:453875 (history)  Vaccinated:2012-03-25
Age:26.0  Onset:2012-04-09, Days after vaccination: 15
Gender:Male  Submitted:2012-04-17, Days after onset: 8
Location:Connecticut  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3050IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11300IMRA
Administered by: Military     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives = took BENADRYL.

VAERS ID:454795 (history)  Vaccinated:2012-03-25
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2012-05-01
Location:California  Entered:2012-05-01
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pyridostigmine Oral Syrup 2.5 mg (MESTINON) Glycerin (Pedi) Supp 1 Suppository (SANI-SUPP) POLY-VI-SOL Oral Drop 1 mL (Ped Multivitamin) DESITIN 40 % Topical Paste (Zinc Oxide-Cod Liver Oil) DRY SKIN MOISTURIZING/EU
Current Illness: This is a term infant delivered by c/s (repeat) to a mother with negative serologies, GBS positive, prenatal US with polyhydramnios and report of decreased fetal movements in the 2 weeks prior to delivery. Apgars of 4, 3, 6 respectively requiring PPV and chest compressions. Admitted to NICU. Noted to be hypotonic and poor suck and poor feeding and has also continued to have trouble with central apnea-like events and still requiring low flow oxygen. She is also being evaluated for possible GH def
Preexisting Conditions: ? carnitine deficiency
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG1068 IM 
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH916043 IM 
Administered by: Unknown     Purchased by: Other
Symptoms: Amino acid level normal, Ammonia normal, Blood cortisol normal, Blood creatine phosphokinase normal, Blood electrolytes normal, Blood growth hormone normal, Blood lactic acid normal, Bradycardia, CSF culture, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Carnitine decreased, Central venous catheterisation, Condition aggravated, Culture urine, Culture urine positive, Cytogenetic analysis normal, Electroencephalogram normal, Enterovirus test negative, Epstein-Barr virus test negative, Herpes simplex serology negative, Hypoglycaemia, Liver function test normal, Lumbar puncture, Miosis, Nuclear magnetic resonance imaging normal, Polymerase chain reaction, Postictal state, Pyrexia, Red blood cells CSF positive, Somnolence, Thyroid function test normal, Urinary tract infection, Urine analysis normal, Viral test negative
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials. There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it''s not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.

VAERS ID:463563 (history)  Vaccinated:2012-03-25
Age:72.0  Onset:2012-07-01, Days after vaccination: 98
Gender:Female  Submitted:2012-08-09, Days after onset: 39
Location:Unknown  Entered:2012-08-09
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: Oral herpes; Valacyclovir, Oral herpes
Diagnostic Lab Data:
CDC Split Type: WAES1207USA009031
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a currently 72 years old female consumer concerning herself with a history of recurrent cold sores and being prone to "fever blisters (prescribed valacyclovir) who on 25-MAR-2012 was vaccinated with a dose ZOSTAVAX (lot# not reported). Beginning around 01-JUL-2012 the patient had noticed that her left side of her lips felt "puffy." She reported that she had a history of being prone to "fever blisters," and she was prescribed valacyclovir by her dermatologist for "flare-ups." She was not taking valacyclovir at the time that she received ZOSTAVAX. She stated that since the beginning of July, when she noticed her lips feeling "puffy," she had consulted her primary physician. The patient started taking her valacyclovir when she began to experience the sensation of swelling of her lips. The doctor told the patient that the sensation she was experiencing in her lips could be as a result of ZOSTAVAX. The patient stated that she had not experienced a rash. No treatment was given for the event. At the time of reporting, the patient had not recovered. Additional information has been requested.

VAERS ID:487876 (history)  Vaccinated:2012-03-25
Age:10.0  Onset:2012-03-26, Days after vaccination: 1
Gender:Male  Submitted:2013-03-27, Days after onset: 366
Location:Texas  Entered:2013-03-27
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4287AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3947BA5UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0123511UNLA
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)
Write-up: Red - warm - swelling left deltoid.

VAERS ID:540377 (history)  Vaccinated:2012-03-25
Age:68.0  Onset:2012-03-25, Days after vaccination: 0
Gender:Female  Submitted:2012-04-05, Days after onset: 11
Location:Arizona  Entered:2014-08-19, Days after submission: 866
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0617AA1SCUN
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Site of injection - raised bump. Little redness. Referred to MD told to use cold compress and take BENADRYL.

VAERS ID:452494 (history)  Vaccinated:2012-03-26
Age:23.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 1
Location:Florida  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Spironolactone
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: First chills/shaking, then fever that lasted about 14 hours and peaked at 103 degrees.

VAERS ID:452497 (history)  Vaccinated:2012-03-26
Age:38.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 1
Location:Washington  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: nauseau, headache, vomiting~Hep B (Engerix-B)~1~38.00~Patient
Other Medications:
Current Illness: no
Preexisting Conditions: allergic to penicillin, sulfa, erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC046CA1SYRLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Fatigue, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Nausea, headache, dizziness, fatigue, vomiting.

VAERS ID:452515 (history)  Vaccinated:2012-03-26
Age:22.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 1
Location:Georgia  Entered:2012-03-27
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: Client stated that she has allergy (hay fever)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4104AA0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 3/27/12 I received a call from clients parent stating that her daughter had had a possible reaction to TDAP vaccine. Vomiting, fever, pain/swelling. Parent advised to have her daughter seek medical attention and apply ice to the area. See attached note (please). I received a call at 11am from parent of patient. She went into an explanation of the reaction that her daughter experienced yesterday evening receiving the TDAP vaccine 11am on 3/26/2012. Vomiting, fever, pain/swelling at the site of the injection. I advised parent that she should seek medical attention for her daughter as soon as possible, also apply ice packs to affected area.

VAERS ID:452530 (history)  Vaccinated:2012-03-26
Age:34.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-27, Days after onset: 0
Location:California  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, citalopram, lo-ogestrel
Current Illness: no
Preexisting Conditions: pollen/grass/tree allergies, dog/rabbit allergies, NO FOOD ALLERGIES
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Fine pruritic rash on all extremities and trunk.

VAERS ID:452547 (history)  Vaccinated:2012-03-26
Age:65.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-28, Days after onset: 2
Location:Maryland  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril; LEVOTHROID
Current Illness:
Preexisting Conditions: HTN; High cholesterol; Hypothyroid; All: Codeine; Morphine; Sulfa.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA0SCRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt c/o arm pain, redness & swelling at site of ZOSTAVAX injection. Pain at time of injection. Redness started 24 hrs later. 10x10 area of redness, warmth, & induration lateral Rt upper arm.

VAERS ID:452554 (history)  Vaccinated:2012-03-26
Age:39.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-28, Days after onset: 1
Location:Missouri  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril 10 mg 1 daily; SYNTHROID 50 mcg 1 daily
Current Illness: None
Preexisting Conditions: ROCEPHIN - anaphylaxis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU3748BA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Myalgia, joint pain, pain 6-8/10 all over.

VAERS ID:452561 (history)  Vaccinated:2012-03-26
Age:8.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-28, Days after onset: 2
Location:Florida  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TUBERSOL
Current Illness: JRA (childhood RA)
Preexisting Conditions: JRA (Juvenile rheumatoid arthritis)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT423AA3IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1786AA1IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site pain, Rash papular
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red, raised bump. Circle in shape. Area was sore x 2 days and becoming better on lt arm where flu shot given. PPD admin same arm.

VAERS ID:452581 (history)  Vaccinated:2012-03-26
Age:33.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-03-28, Days after onset: 1
Location:New Mexico  Entered:2012-03-28
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3079IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Mild swelling of the Left arm, redness and mild itching.

VAERS ID:452584 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-28, Days after onset: 1
Location:Pennsylvania  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Diagnostic Lab Data: None needed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B126BA4IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1333Y0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Accidental exposure, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Child was inappropriately given an HPV vaccine inadvertently. Child is 5 years old. When parent was notified the following day, mom reported that child complained of nausea. No further treatment was needed.

VAERS ID:452599 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:2012-03-28, Days after vaccination: 2
Gender:Male  Submitted:2012-03-28, Days after onset: 0
Location:Tennessee  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B172AA4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB513AA1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.164321SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF272914IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mother reported that left arm swollen from shoulder to elbow, red and hot to touch. Taken to see his PCP 3-28-12.

VAERS ID:452606 (history)  Vaccinated:2012-03-26
Age:35.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-28, Days after onset: 1
Location:Wisconsin  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None that she told me about. She also received a TB skin test on the same day, in the right forearm. Test was placed correctly.
Current Illness: Per questionnaire, client indicated that she is healthy today.
Preexisting Conditions: No known allergies, no medical condition indicated per client.
Diagnostic Lab Data: No lab testing was done at this time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0346AA SC 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B072AA IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1147AA SC 
Administered by: Public     Purchased by: Public
Symptoms: Injection site discomfort, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site reaction, Injection site swelling, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Yesterday, client noticed an itchy, rash on her right arm, where Varicella vaccine was placed on 3/26/2012. It an intact raised reddened round area 40mm X 50mm in diameter. She complains of discomfort and itching sensation. When asked, she denied any respiratory symptoms and did not notice the skin irritation right away. When she looked at it in the mirror, she was surprised how large it was.

VAERS ID:452608 (history)  Vaccinated:2012-03-26
Age:11.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-03-28, Days after onset: 1
Location:California  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: redness, swelling, pain~Measles + Mumps + Rubella (MMR II)~2~11.58~Patient|redness, swelling, pain~Varicella (Varivax)~2~11.58~P
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1229AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG15001SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0011AA1SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4052AD1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3899AA1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1274AA1SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Patient came in stated that his left arm was in pain. Nurse noted that the IM location was not red or swollen but the SQ was a little red. At 4:35 PM patient came in stating that his arms were in pain nurse noted that both left and right SQ sides are warm at the touch and swollen. Patient was given Motrin and advised to ice areas.

VAERS ID:452651 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-29, Days after onset: 3
Location:California  Entered:2012-03-29
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Vaccine reaction to DTaP noticed yesterday remained the same since onset no complaints noticed today at bath time 5.5 cm x 3.5 cm induration 5 cm x 4.0 cm redness.

VAERS ID:452658 (history)  Vaccinated:2012-03-26
Age:52.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-29, Days after onset: 2
Location:Florida  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: No
Preexisting Conditions: None NKA Healthy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU3768BA IMLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left deltoid with erythema, warmth, swelling c/o itching to site, pain to touch and on elevation and rotation of arm. Warm compress & Advil since 3/27/2012. Reported to OHS on 3/29/2012 erythema, induration 4" long x 3" wide, tender to touch. Still with discomfort on elevation and rotation. Tx with warm compresses & Advil, refused Benadryl 25 mg p.o. and topical cream.

VAERS ID:452662 (history)  Vaccinated:2012-03-26
Age:47.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 2
Location:New Mexico  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pain, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Raised Red rash area at site of injection with surroning redness. Some soreness. Does NOT itch.

VAERS ID:452665 (history)  Vaccinated:2012-03-26
Age:69.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-29, Days after onset: 2
Location:Unknown  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benazepril, Hydrochlorothiazide, ImDur, Lopressor, Pravastatin, Xopenex HFA.
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1786AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: LUE had swelling and redness.

VAERS ID:452673 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-03-29, Days after onset: 3
Location:California  Entered:2012-03-29
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Induration, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt. has vaccine reaction to Dtap. Pt. parents did not notice of the vaccine reaction. Induration noted. Child c/o pain, full range of movement. No redness 3.5 cm x 3.0 cm induration.

VAERS ID:452681 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-29, Days after onset: 2
Location:Arizona  Entered:2012-03-29
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Entire left thigh swelling, redness, induration.

VAERS ID:452741 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-03-30, Days after onset: 3
Location:North Carolina  Entered:2012-03-30
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: TGA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193BA0IMRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Within 48 hrs of KINRIX admin in patient''s right thigh, a serpiginous area of redness developed approx 1 in from the injection site, ie, the injection site was not within this area. The redness gradually resolved over the next 3 days, with no sequelae.

VAERS ID:452773 (history)  Vaccinated:2012-03-26
Age:12.0  Onset:2012-03-30, Days after vaccination: 4
Gender:Male  Submitted:2012-03-30, Days after onset: 0
Location:Minnesota  Entered:2012-03-30
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: ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586BA1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU3957CA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: 6 x 6 cm redness, induration (L) arm.

VAERS ID:452809 (history)  Vaccinated:2012-03-26
Age:59.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-02, Days after onset: 7
Location:Ohio  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: metformin; atenolol; ursodiol
Current Illness: cirrhosis of the liver; mitral valve prolapse; pre-diabetes
Preexisting Conditions: see box 18
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC046AA3IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB538AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Fall, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Patient had sudden episode of severe dizziness; "the room was spinning" and she fell onto couch. She started vomiting. Patient was taken to ED and was diagnosed with "severe vertigo". They gave her a medicine to take and it did help a little. She has had several episodes since then, but today, Monday, April 2, she states that she feels much better.

VAERS ID:452810 (history)  Vaccinated:2012-03-26
Age:12.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-04-02, Days after onset: 6
Location:South Dakota  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen prn Mecinex DM max prn
Current Illness: None
Preexisting Conditions: Allergies to Perfume and horses
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1380AA1SC 
Administered by: Private     Purchased by: Private
Symptoms: Chills, Dizziness, Erythema, Lymph node pain, Oedema peripheral, Pain in extremity, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Injection given 3/26/12. Next day arm was swollen red, painful. Posterior side of arm swollen, Tenderness in line nodes of L axial. Light Head & chilled. No fever. Itches.

VAERS ID:452817 (history)  Vaccinated:2012-03-26
Age:54.0  Onset:2012-03-29, Days after vaccination: 3
Gender:Female  Submitted:2012-03-29, Days after onset: 0
Location:Georgia  Entered:2012-04-02, Days after submission: 4
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1417AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Redness, warm to touch.

VAERS ID:452827 (history)  Vaccinated:2012-03-26
Age:67.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-04-02, Days after onset: 6
Location:Arizona  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure med - lisinopril 10 mg tab
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1600AA1UNLA
Administered by: Public     Purchased by: Other
Symptoms: Malaise, Oral herpes, Pain of skin, Tooth impacted, Toothache
SMQs:, Oropharyngeal infections (narrow)
Write-up: Top of my head was extremely tender to the touch; impacted wisdom tooth started aching; slight fever blister started on my lip but was gone by next day; just didn''t feel chipper.

VAERS ID:452830 (history)  Vaccinated:2012-03-26
Age:33.0  Onset:2012-03-28, Days after vaccination: 2
Gender:Female  Submitted:2012-04-03, Days after onset: 6
Location:California  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Pt had negative varicella titers prior to receiving vaccine.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Antibody test negative, Injection site rash, Pruritus, Rash, Rash maculo-papular, Skin lesion, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Localized rash at injection site on left deltoid with 4 to 5 maculopapular pruritic lesions. Tender to palpation. Lesions grew slowly larger and itchier.

VAERS ID:452847 (history)  Vaccinated:2012-03-26
Age:75.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-04-02, Days after onset: 6
Location:California  Entered:2012-04-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspir 81; PROVENTIL HFA; Calcium 500 + D; Vitamin D; LOTRISONE; SINGULAIR; Lisinopril; NEXIUM; MEVACOR; Gabapentin; Stool softener-laxative; BACTRIM DS; Loratadine
Current Illness: Arthritis knee
Preexisting Conditions: Pregabalin; Theophylline; Furosemide; Asthma NOS; Benign hypertension; cramp in limb; diabetes w neurologic manif; esophageal reflux; hypercholesterolemia; neuropathy in diabetes; obesity NOS
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4136AA IMAR
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash distal to immun. injection site.

VAERS ID:452885 (history)  Vaccinated:2012-03-26
Age:0.3  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 1
Location:California  Entered:2012-04-03, Days after submission: 7
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4074AA UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF62923 UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0679AA PO 
Administered by: Private     Purchased by: Public
Symptoms: Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Fever Tmax 102.2. Fussiness. Acetaminophen.

VAERS ID:452890 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:2012-03-28, Days after vaccination: 2
Gender:Female  Submitted:2012-03-29, Days after onset: 1
Location:Wisconsin  Entered:2012-04-03, Days after submission: 5
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171BA0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0953AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0834AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Reddened area to site of VARIVAX injection. Started itching - no BENADRYL given and then reaction developed. After using Ibuprofen, Children''s BENADRYL - reaction resolved.

VAERS ID:452902 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-27
Location:Arizona  Entered:2012-04-03, Days after submission: 7
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: NKA; NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300AA3IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1024Z1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0341AA1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Pt was due for DTaP/DT/Td vaccination but was given DTaP/Hep B/IPV instead.

VAERS ID:452912 (history)  Vaccinated:2012-03-26
Age:1.6  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-03-27, Days after onset: 1
Location:Idaho  Entered:2012-04-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Started on BACTRIM susp 3/26/12
Current Illness: Otitis Media
Preexisting Conditions: None
Diagnostic Lab Data: See ER report
CDC Split Type: ID12007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541CA1IMLL
Administered by: Private     Purchased by: Public
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever to 102.4 at 11 pm febrile seizure.

VAERS ID:452919 (history)  Vaccinated:2012-03-26
Age:37.0  Onset:0000-00-00
Gender:Male  Submitted:2012-03-26
Location:Kansas  Entered:2012-04-03, Days after submission: 8
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11024010IMUN
Administered by: Military     Purchased by: Military
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:452941 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-03-27, Days after onset: 1
Location:Washington  Entered:2012-04-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria 6 hrs after vaccine.

VAERS ID:452951 (history)  Vaccinated:2012-03-26
Age:14.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-03-29, Days after onset: 3
Location:Utah  Entered:2012-04-03, Days after submission: 5
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1843AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt. lost consciousness and fell in the waiting room. She immediately regained consciousness and is doing fine.

VAERS ID:453021 (history)  Vaccinated:2012-03-26
Age:18.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-04, Days after onset: 9
Location:Florida  Entered:2012-04-04
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1229AA2IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4019AA1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Fall, Loss of consciousness, Muscle rigidity, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: PATIENT''S COLORING TURNED PALE; PATIENT FAINTED; PATIENT BECAME RIGID AND POSTURED THEN BEGAN TO SLIDE DOWN SEAT. SECURED PATIENT FROM SLIDING TO GROUND. APPLIED COLD COMPRESS TO FOREHEAD & NECK AREA. FANNED. PATIENT RETURNED TO CONSCIOUSNESS AND STATED "I FEEL NAUSEOUS". PATIENT MOTHER STATED "I PASS OUT FREQUENTLY WHEN I EXPERIENCE PAIN. DR. TOLD ME I HAVE VASOVAGAL RESPONSE. GUESS SHE INHERITED IT FROM ME." PATIENT RESPONSIVE AND COLORING RETURNED TO CHEEKS. STATED "NOT NAUSEOUS ANY MORE. HYDRATED PATIENT WITH FRUIT JUICE. PATIENT STEADY UPON RISING AND AMBULATING. LEFT WITH MOTHER.

VAERS ID:453043 (history)  Vaccinated:2012-03-26
Age:61.0  Onset:2012-04-03, Days after vaccination: 8
Gender:Female  Submitted:2012-04-04, Days after onset: 1
Location:Pennsylvania  Entered:2012-04-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AVELOX --$g rash
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0744AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Erythema, Pain, Papule, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: CC: Rash upper chest, started 4/03/12 evening burning, itching, painful. Exam: B/L erythema with small papules C4 dermatome.

VAERS ID:453089 (history)  Vaccinated:2012-03-26
Age:1.5  Onset:2012-04-05, Days after vaccination: 10
Gender:Male  Submitted:2012-04-05, Days after onset: 0
Location:Iowa  Entered:2012-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURAC14B136BB0IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB541DA1IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0599AA0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1065AA0SCLL
Administered by: Private     Purchased by: Military
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: High fevers up to 106.7 rectal.

VAERS ID:453098 (history)  Vaccinated:2012-03-26
Age:0.2  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-05, Days after onset: 10
Location:California  Entered:2012-04-05
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4025AA IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC070AA IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH916977 IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB208A PO 
Administered by: Private     Purchased by: Other
Symptoms: Crying, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Fussiness, smiling less per mom (although smiling on exam) crying intermittently.

VAERS ID:453218 (history)  Vaccinated:2012-03-26
Age:35.0  Onset:2012-04-04, Days after vaccination: 9
Gender:Male  Submitted:2012-04-09, Days after onset: 5
Location:Texas  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec daily
Current Illness: no. Denied
Preexisting Conditions: PCN allergy
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC046AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0980AA0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site rash, Injection site vesicles
SMQs:, Hypersensitivity (narrow)
Write-up: Rash at injection site. On 4/9/12 examined by OHS and rash present at injection site with 7 vesicles.

VAERS ID:453223 (history)  Vaccinated:2012-03-26
Age:53.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-02, Days after onset: 7
Location:New York  Entered:2012-04-09, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; MOTRIN; LOVAZA; ACIPHEX
Current Illness: None
Preexisting Conditions: Allergic to KEFLEX; Amoxicillin; Sulfa
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURG10761IMRA
Administered by: Public     Purchased by: Private
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: Client states approx 3 hours after receiving the vaccine she had palpitations, client states she notified her PMD and took MOTRIN.

VAERS ID:453235 (history)  Vaccinated:2012-03-26
Age:62.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-29, Days after onset: 2
Location:Iowa  Entered:2012-04-09, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI
Preexisting Conditions: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1607AA0SCRA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: One day after shot erythema & induration developed.

VAERS ID:453250 (history)  Vaccinated:2012-03-26
Age:1.1  Onset:2012-04-04, Days after vaccination: 9
Gender:Male  Submitted:2012-04-05, Days after onset: 1
Location:Missouri  Entered:2012-04-09, Days after submission: 4
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1148AA0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site reaction, Injection site vesicles, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash with a few vesicles at injection site.

VAERS ID:453251 (history)  Vaccinated:2012-03-26
Age:44.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Company provide
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11033P0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Headache, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: I got a flu shot on Monday after that I began to have arm pain each day the pain got worse with tingle running down my finger and up my neck and headaches. Also (L) chest pain.

VAERS ID:453270 (history)  Vaccinated:2012-03-26
Age:74.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-03-30, Days after onset: 3
Location:Minnesota  Entered:2012-04-09, Days after submission: 10
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3984AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Chills, redness at site, 15 x 13cms redness around injection site, distal to site, erythema present, area hard & warm to touch.

VAERS ID:453272 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2012-03-27
Location:California  Entered:2012-04-09, Days after submission: 13
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: Pt. had febrile seizure 2 years ago - NOT vaccine related
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB972AA2IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB534AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH414AB3IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE09502SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0873AA1SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169760IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever 103, chills, nausea lasting 3-4 hrs. Returned to clinic for re-check, seemed well. Phone follow up next day - well.

VAERS ID:453365 (history)  Vaccinated:2012-03-26
Age:60.0  Onset:2012-03-30, Days after vaccination: 4
Gender:Female  Submitted:2012-04-04, Days after onset: 5
Location:New York  Entered:2012-04-11, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1198AA SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Papule, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Localize warmth, (rash on chest) arm, trace papules resolved by 4/3/12.

VAERS ID:453647 (history)  Vaccinated:2012-03-26
Age:21.0  Onset:2012-04-11, Days after vaccination: 16
Gender:Male  Submitted:2012-04-13, Days after onset: 2
Location:New Jersey  Entered:2012-04-13
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: no
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0OTRA
Administered by: Military     Purchased by: Military
Symptoms: Rash maculo-papular
SMQs:, Hypersensitivity (narrow)
Write-up: Maculopapular rash appeared on elbows and forearms, now extending to hands and several papules noted to knees, ankles, butocks, thighs - will start Benadryl for symptom control as of 04/13/2012.

VAERS ID:453693 (history)  Vaccinated:2012-03-26
Age:0.5  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-04-13, Days after onset: 18
Location:Virginia  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Testosterone enanthate 25 mg IM monthly x 3 months - injection #1 given the same day as the vaccines
Current Illness: none
Preexisting Conditions: anorchia
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323AA2IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH522AB2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF803802IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1346AA2PO 
Administered by: Military     Purchased by: Military
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Epidoses of prolonged, inconsolable crying within 72 hours of receiving vaccines.

VAERS ID:453757 (history)  Vaccinated:2012-03-26
Age:28.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-13
Location:Minnesota  Entered:2012-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVENTIL; VENTOLIN; ADDERALL; ZITHROMAX; CELEXA; FLEXERIL; ADVIL; MOTRIN; ATIVAN; naproxen sodium; ULTRAM
Current Illness: Diarrhea; yeast infection
Preexisting Conditions: PCN - hives; VICODIN - N & V; ADD; anxiety; headaches
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075AA IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Dyspnoea, Neck pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt had severe neck & arm pain on side of w/ vaccine; difficulty breathing.

VAERS ID:453856 (history)  Vaccinated:2012-03-26
Age:11.0  Onset:2012-03-29, Days after vaccination: 3
Gender:Female  Submitted:2012-04-11, Days after onset: 13
Location:Florida  Entered:2012-04-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: (R) arm red and itchy after Tdap given.

VAERS ID:453902 (history)  Vaccinated:2012-03-26
Age:29.0  Onset:2012-04-10, Days after vaccination: 15
Gender:Male  Submitted:2012-04-17, Days after onset: 7
Location:New Mexico  Entered:2012-04-17
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV307 UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A  UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG1124 IMUN
Administered by: Military     Purchased by: Military
Symptoms: Papule, Tenderness
SMQs:
Write-up: Papules on hands and feet. Both palmar and dorsal aspects. Associated with tenderness.

VAERS ID:453906 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:2012-03-28, Days after vaccination: 2
Gender:Male  Submitted:2012-04-04, Days after onset: 7
Location:Georgia  Entered:2012-04-17, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER04006AA UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG1068 UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0951AA UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0608AA UNLL
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left leg upper thigh hot, redness, swollen and hard. Pt went to ER diagnosis cellulitis.

VAERS ID:454041 (history)  Vaccinated:2012-03-26
Age:27.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-18, Days after onset: 23
Location:Texas  Entered:2012-04-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1215AA0SCUN
Administered by: Private     Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Headache, Nausea, Rash
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Had VARIVAX vaccine administered on 3-26-12 at about 9:00 am - a little after felt light head & headache late afternoon was nausea and lightheaded worsened. Was having difficulties breathing about 5:pm went home rested. Next day 3-28-12 at about 8:00 am came to notify symptoms to Occ Health - cont with difficulty breathing, rash to chest & (Lt) area = went to her MD was told had minor anaphylactic reaction not totally sore & was given ER work up - that same afternoon was better.

VAERS ID:454072 (history)  Vaccinated:2012-03-26
Age:3.0  Onset:2012-03-29, Days after vaccination: 3
Gender:Female  Submitted:2012-04-12, Days after onset: 14
Location:Arizona  Entered:2012-04-20, Days after submission: 8
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:
Preexisting Conditions: Spina bifida; hydrocephalus
Diagnostic Lab Data: Misfirings noted on EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1405AA0SCAR
Administered by: Private     Purchased by: Unknown
Symptoms: Convulsion, Electroencephalogram abnormal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Four days after given her first dosage of the MMR vaccine she had a twenty minute seizure that had to be stopped by paramedics giving her a shot. We were taken to the hospital and admitted.

VAERS ID:454143 (history)  Vaccinated:2012-03-26
Age:69.0  Onset:2012-04-01, Days after vaccination: 6
Gender:Female  Submitted:2012-04-20, Days after onset: 19
Location:Unknown  Entered:2012-04-23, Days after submission: 3
Life Threatening? No
Died? Yes
   Date died: 2012-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sulfonamide allergy; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1204USA02546
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1269AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Death
SMQs:
Write-up: Information has been received from a registered pharmacist concerning a 69 year old female patient with sulfa and amoxicillin allergies who on 26-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose and route not provided) (lot # 671144/1269AA, expiration date 05-NOV-2012). The pharmacist informed that the patient died approximately on 02-APR-2012 "around 1 week after receiving the ZOSTAVAX (Merck)". The pharmacist indicated that no adverse reaction was reported or any physical symptoms other than the death and that the patient did not seek medical attention. The cause of death was not provided. A lot check has been initiated. Additional information is not expected.

VAERS ID:454500 (history)  Vaccinated:2012-03-26
Age:0.2  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-23, Days after onset: 28
Location:Massachusetts  Entered:2012-04-27, Days after submission: 4
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: Unknown
Diagnostic Lab Data:
CDC Split Type: 201204126
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3928AA SYRUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF24141 SYRUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1240AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Crying, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Initial report was received from another manufacturer, who received the case from a health care professional, under manufacturer report number 2012081072 on 16 April 2012. A two-month-old female patient, with an unknown medical history, had received an injection of PENTACEL, sanofi pasteur Ltd., lot number C3928AA, PREVNAR 13, Pfizer, lot number F24141 and ROTATEQ, Merck, lot number 1240AA on 26 March 2012 (route, site and dose not reported). On 26 March 2012, the patient experienced extra puffiness, was crying excessively and had a fever. The patient''s rectal temperature on 26 March 2012 was 100.4 and on 27 March 2012 the patient''s rectal temperature was between 100.5 to 101. The patient was hospitalized on 27 March 2012 and was not discharged at the time of the report. The patient had blood work on an unknown date in March of 2012 while being hospitalized, however the results were unknown. The patient was recovering from the events at the time of the report. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient''s outcome was recovering (not recovered). Documents held by sender: None.

VAERS ID:455346 (history)  Vaccinated:2012-03-26
Age:1.1  Onset:2012-04-02, Days after vaccination: 7
Gender:Female  Submitted:2012-05-10, Days after onset: 38
Location:Florida  Entered:2012-05-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness at time of vaccine.
Preexisting Conditions: None.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Other
Symptoms: Dermatitis diaper, Irritability, Rash, Rash erythematous, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: She was fussy for at least 72 hours after her vaccines. She then woke up with a slight rash covering her entire torso, face, and slight in diaper area. I called the doctor and they said it was from her chicken pox vaccine. That is would pass in a week or so. It continued to worsen, and she continued to be fussy, not running a fever though. This later for a full 14 days an was what appeared to be a chicken pox rash without the pus. Raised red bumps covering body.

VAERS ID:455470 (history)  Vaccinated:2012-03-26
Age:67.0  Onset:2012-04-09, Days after vaccination: 14
Gender:Male  Submitted:2012-05-08, Days after onset: 29
Location:New York  Entered:2012-05-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic lymphocytic leukemia in remission
Preexisting Conditions:
Diagnostic Lab Data: WBC Ct 33,000; Punch skin biopsy (+) for varicella/zoster virus
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Biopsy skin abnormal, Blister, Herpes zoster, Insomnia, Malaise, Pyrexia, Rash pustular, Skin haemorrhage, Swelling face, Varicella, Varicella post vaccine, Varicella virus test positive, White blood cell count increased
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow)
Write-up: My father received the zoster/shingles vaccination after starting skin cancer treatment with EFUDIX. He developed chicken pox or disseminated shingles. Fever of 104 degrees F, extremely swollen face with eyes closed, pox on chest, back, arms and legs and hemorrhagic vesicles on face. WBC Ct 33,000. Malaise, insomnia.

VAERS ID:455530 (history)  Vaccinated:2012-03-26
Age:3.0  Onset:2012-04-18, Days after vaccination: 23
Gender:Male  Submitted:2012-05-15, Days after onset: 27
Location:New York  Entered:2012-05-15
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: Under Evaluation for Preschool Special Education Services
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4021AA3UNAR
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0830AA1UNAR
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain upper, Aggression, Diarrhoea, Dysphemia, Enuresis, Eye pruritus, Nightmare, Psychomotor hyperactivity, Rhinorrhoea, Screaming, Social avoidant behaviour, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: Stuttering; periods of screaming; spinning oneself; excessively playing with doors, lights and windows; diarrhea; nightmares; bed wetting; itchy eyes; runny nose; belly aches; social withdrawal; hitting others.

VAERS ID:456142 (history)  Vaccinated:2012-03-26
Age:1.5  Onset:2012-04-22, Days after vaccination: 27
Gender:Female  Submitted:2012-05-24, Days after onset: 32
Location:South Carolina  Entered:2012-05-24
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Multiple viral serologies, cultures, all negative for infectious etiology. MRI''s revealed necrotizing destruction of PONS
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4197CA1IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1542AA0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Acute disseminated encephalomyelitis, Apallic syndrome, Central nervous system necrosis, Decreased appetite, Endotracheal intubation, Intensive care, Lethargy, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Rash erythematous, Rash macular, Viral test negative
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hypersensitivity (narrow), Respiratory failure (broad)
Write-up: On April 22, 2012 pt developed fevers, decreased appetite, temp to 101.9, red, splotchy rash. Seen by MD & dx''d with possible Fifths disease. Rash subsided by 4/29 but fevers persisted. On 4/29 admitted to PICU with lethargy, intubated and eventually diagnosed with ADEM, necrotizing form currently in vegetative state.

VAERS ID:456439 (history)  Vaccinated:2012-03-26
Age:72.0  Onset:2012-03-28, Days after vaccination: 2
Gender:Male  Submitted:2012-05-21, Days after onset: 54
Location:Oklahoma  Entered:2012-05-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: AUGMENTIN; Ibuprofen; Naproxen; Erythromycin; Type II DM; Myasthenia Gravis; COPD; HTN
Diagnostic Lab Data: MRI and X-rays
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1198AA0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Local swelling, Mobility decreased, Nuclear magnetic resonance imaging, X-ray
SMQs:, Angioedema (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Unable to turn neck due to swelling.

VAERS ID:457103 (history)  Vaccinated:2012-03-26
Age:53.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-06-10, Days after onset: 76
Location:Georgia  Entered:2012-06-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  SYR 
Administered by: Public     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: INJECTION SITE PAIN AND REDUCED ROM-REPORTED TO OCC HEALTH X2 AND WAS TOLD UNRELATED TO VACCINE.

VAERS ID:457901 (history)  Vaccinated:2012-03-26
Age:4.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-06-21, Days after onset: 86
Location:Tennessee  Entered:2012-06-22, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis allergic
Preexisting Conditions: Croup
Diagnostic Lab Data: Magnetic resonance, 04/??/12, left femoral osteomyelitis; WBC count, 04/06/12, elevated; serum C-reactive, 04/06/12, elevated.
CDC Split Type: WAES1206USA02485
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1475AA3IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF654424IMRL
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Gait disturbance, Headache, Injection site pain, Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Pyrexia, White blood cell count increased
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Osteonecrosis (broad)
Write-up: Information has been received from a Registered Nurse (R.N.) concerning a 4 year old male patient, with rhinitis allergic and a history of croup and none drug reactions/allergies, who on 26-MAR-2012 was vaccinated with a dose of PEDVAXHIB (lot # 66775/1475AA, expiration date 11-NOV-2012), 0.5ml, IM in left thigh. Concomitant therapy included a dose of PREVNAR vaccinated on 26-MAR-2012 in right thigh. It was reported that on 27-MAR-2012 the patient developed a fever of 101 Fahrenheit with a headache. The patient''s parent called the office and was advised to administer MOTRIN or TYLENOL. On unknown date the symptoms resolved. On 05-APR-2012 the patient''s parents called the office to report the patient had developed fever, left thigh soreness and limping. Nurse reported that the patient was seen in the office on 06-APR-2012 and was found to have an elevated white blood cell count and C-reactive protein level. On the same day, 06-APR-2012, the patient was admitted to the hospital. On unknown date the patient had a magnetic resonance imaging (MRI) and was diagnosed with left femoral osteomyelitis. A peripherally inserted catheter was inserted and the patient was started on IV antibiotics (unspecified type). The patient was discharged from the hospital on 10-APR-2012. The patient continued IV antibiotics therapy at home. On 26-APR-2012 the antibiotics and peripherally inserted central cathered ("PIC line") were discontinued. On 26-APR-2012 the patient recovered. Left femoral osteomyelitis was considered to be disabling, immediately life-threatening and other important medical event by the reporting nurse. Additional information has been requested.

VAERS ID:458027 (history)  Vaccinated:2012-03-26
Age:0.4  Onset:0000-00-00
Gender:Female  Submitted:2012-06-22
Location:Oklahoma  Entered:2012-06-25, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CMP; CBC; Parents refused EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4075AA1IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0231AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF629231IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1554AA1PO 
Administered by: Private     Purchased by: Public
Symptoms: Convulsion, Full blood count, Metabolic function test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Seizure occurred 2 1/2 hrs after vaccinations.

VAERS ID:459229 (history)  Vaccinated:2012-03-26
Age:66.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-05-24, Days after onset: 59
Location:New Jersey  Entered:2012-07-11, Days after submission: 48
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history included thyroid, osteoporosis, HBP, GERD, Arthritis, Pinched nerve and concomitant medications were not reported. Illness at the time of vaccination: No
Diagnostic Lab Data: Not reported
CDC Split Type: 201204879
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Ear pain, Fatigue, Headache, Lymphadenopathy, Oropharyngeal pain, Pain, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial report received from a patient/consumer via healthcare professional on 07 May 2012. 12-0273. A 66-year-old female patient, whose medical history included thyroid, osteoporosis, HBP (high blood pressure), GERD, Arthritis and Pinched nerve and concomitant medications were not reported, had received a intramuscular dose of ADACEL vaccine in right deltoid (lot number U4046AA) on 26 March 2012. On 26 March 2012, the patient developed left arm was tender right after the injection. Bruising occurred and lasted 1 to 1.5 weeks. Lumps developed on the left side of her head. The patient had ear and throat pain. The visited to the physician and physician examined the patient and made diagnosis of clusters of lymph nodes on the left side. The patient also had complaint of headaches, a throbbing pain, which occur only left side of head. Patient also felt tired much of the time. The patient laboratory data included: none. The outcome of the events was reported as not recovered. Documents held by sender: none.

VAERS ID:460773 (history)  Vaccinated:2012-03-26
Age:65.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Female  Submitted:2012-08-01, Days after onset: 127
Location:Missouri  Entered:2012-08-01
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: Pertussis (about age 12, osteoporosis, Heartburn
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Cough, Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles, Mobility decreased
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Began with slight swelling & pain at injection site. Difficulty lifting arm above head. Lasted about a week. A couple weeks later there was itching, redness, and a lump at the site, lasting about a week, then subsiding. Another time, about 1 month post injection, the local reaction of itching, lump, redness resulted in clear fluid filled, pin head sized, blisters (reminded me of smallpox vaccination reaction). There is now a darkened area, nickel to quarter size, that has not gone away. During one flare-up there was a night time episode of a "croupy type" cough of short duration. The local reaction of itching, a palpable lump, some swelling, and redness, continues to occur at intervals of about 2 weeks, today, 4 months later.

VAERS ID:460869 (history)  Vaccinated:2012-03-26
Age:14.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-08-02, Days after onset: 129
Location:Unknown  Entered:2012-08-02
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:
CDC Split Type: WAES1207USA012108
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient was vaccinated IM on the right arm with the second dose of GARDASIL on 26-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-MAR-2012 the patient experienced loss of consciousness and fell in the waiting room. The patient regained consciousness and was doing fine. Upon internal review, loss of consciousness was considered medical significant. The original reporting source was not provided. Additional information is not expected.

VAERS ID:480802 (history)  Vaccinated:2012-03-26
Age:  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2013-01-09, Days after onset: 289
Location:Unknown  Entered:2013-01-09
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: WAES1301USA001679
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with no medical history and drugs allergies reported who on 01-AUG-2007, was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported). On 26-MAR-2012, was vaccinated with dose 2 GARDASIL (lot #, dose and route not provided). On 03-JAN-2013, was vaccinated with dose 3 GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that there was no adverse symptoms reported. Additional information has been requested.

VAERS ID:492880 (history)  Vaccinated:2012-03-26
Age:56.0  Onset:2012-03-29, Days after vaccination: 3
Gender:Female  Submitted:2012-06-11, Days after onset: 74
Location:Washington  Entered:2013-05-29, Days after submission: 352
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: Ibuprofen - rash
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)SANOFI PASTEURC4003AA1SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Agitation, Flushing, Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Agitation, fever and fever, flushing, swelling and erythema at injection site.

VAERS ID:524366 (history)  Vaccinated:2012-03-26
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2014-02-28
Location:Connecticut  Entered:2014-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 04/11/2012, human chorionic gonadotropin, positive N/A; 11-APR-2012, urine beta-humna chorionic gonadotropin test: Positive
CDC Split Type: WAES1204USA01927
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This spontaneous report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no pertinent medical history and no know drug allergies who on 26-MAR-2012 was vaccinated IM with a dose of GARDASIL (dose, route and lot# not reported). Other suspect therapy included ENGERIX-B. The patient''s last menstrual period was note as 28-MAR-2012 in the patient''s chart, but the nurse practitioner was not sure if that was correct. The patient came to the physician''s office on 11-APR-2012 for a normal annual exam. During the visit, it was discovered that she was pregnant, via urine pregnancy test. The patient was still pregnant. The estimated delivery date would be 02-JAN-2013. Follow up information has been received from a registered nurse who was able to access the clinic records for information concerning this pregnancy registry patient. The registered nurse stated that the patient had a prenatal appointment scheduled for 14-MAY-2012 and the patient never came in for the appointment. The registered nurse stated that the patient had been lost to follow up and they have no information to share. Additional information has been requested.

VAERS ID:534481 (history)  Vaccinated:2012-03-26
Age:  Onset:2012-03-28, Days after vaccination: 2
Gender:Male  Submitted:0000-00-00
Location:Unknown  Entered:2014-06-20
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: Sulfamethoxazole w/trimethoprim
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Absolute neutrophil count, 03/27/12, 12.4 mmol/L, 03/29/12, 8.9 mmol/L; C-reactive protein, 03/27/12, 4.30 mg/dL, 03/29/12, 5.30 mg/dL; Creatinine kinase, 03/27/12, 378 IU/L; ESR, 03/29/12, 18 mm/hr; Monocytes, 03/27/12, 0.9 mmol/L; Neutrophils, 3/27/12, 85.8%, 03/29/12, 84.0%; WBC, 03/27/12, 14.5 mmol/L
CDC Split Type: 486735USA
Vaccination
Manufacturer
Lot
Dose
Route
Site
ADEN_4_7: ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME)TEVA PHARMACEUTICALS34600017 PO 
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT424AA UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG1500 UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4097AA UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076BA UNUN
Administered by: Military     Purchased by: Unknown
Symptoms: Anaphylactic shock, Blood creatine phosphokinase increased, C-reactive protein increased, Monocyte count increased, Neutrophil count increased, Neutrophil percentage increased, Red blood cell sedimentation rate increased, Urinary tract infection, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. This report is regarding a 19-24 year old Male patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (ORAL) batch: 34600017, on 26-Mar-2012. From 27-Mar-2012 to 06-Apr-2012, the patient was administered SULFAMETHOXAZOLE W/TRIMETHOPRIM 800/160 mg per tablet for a urinary tract infection. On 28-Mar-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC and was hospitalized the same day. The patient was administered intravenous medications as treatment in the hospital. Lab tests: 27-Mar-2012, WBC: 14.5 mmol/L; 27-Mar-2012, Neutrophils: 85.8%; 27-Mar-2012, Absolute neutrophil count: 12.4 mmol/L; 27-Mar-2012, Monocytes: 0.9 mmol/L; 27-Mar-2012, Creatinine kinase: 378 IU/L; 27-Mar-2012, C-reactive protein: 4.30 mg/dL; 29-Mar-2012, C-reactive protein: 5.30 mg/dL; 29-Mar-2012, Neutrophils: 84.0%; 29-Mar-2012, Absolute neutrophil count: 8.9 mmol/L; 29-Mar-2012, ESR: 18 mm/hr. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: Unknown. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable; SULFAMETHOXAZOLE W/TRIMETHOPRIM - Dosage maintained. The patient''s medical history was not reported. The patient''s concomitant medication included INFLUENZA VACCINE (since 26-Mar-2012); DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (since 26-Mar-2012); MENINGOCOCCAL POLYSACCHARIDE (since 26-Mar-2012); HEPATITIS A VACCINE (since 26-Mar-2012); POLIOMYELITIS VACCINE INACTIVATED (since 26-Mar-2012). The patient''s past medication were unspecified. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). The Medical Monitor Assessment of Events: Causality of event OTHER ANAPHYLACTIC SHOCK, NEC in relation to Adenovirus is "No Reasonable Possibility". Event in relation to SULFAMETHOXAZOLE W/TRIMETHOPRIM is Probable. "Severity not assessed. Likely reaction to Sulfamethoxazole or Trimethoprim." ICD-9 code is confirmed.

VAERS ID:620225 (history)  Vaccinated:2012-03-26
Age:0.2  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-06-01, Days after onset: 67
Location:Massachusetts  Entered:2015-09-22, Days after submission: 1208
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: 2012081068
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3928AA IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF241410IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1240AA PO 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Irritability, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: This is a spontaneous report from a contactable nurse. This is first of the four reports from the same reporter. This nurse reported for a 2-month-old female patient who received the first dose of PREVNAR 13 via the intramuscular route, ROTATEQ orally, DTaP, PENTACEL via the intramuscular route on 26Mar2012 at 9:55 am. The relevant medical history and relevant concomitant medications were unknown. The nurse mentioned that the patient experienced extra puffiness, crying excessively, fever, and fussiness since 26Mar2012. The relevant laboratory data was unknown. The patient did not receive treatment for the events. The outcomes of the events extra puffiness and crying excessively were reported as recovering. The outcomes of the events fever and fussiness were reported as recovered on 26Mar2012. Follow-up (17Apr2012): New information received from a contactable physician included confirmation of events, route of administration of vaccine products, treatment details, outcome information, and additional adverse event of fever and fussiness with onset and resolution dates. Follow-up (23MAY2012) Follow-up attempts completed. No further information expected.

VAERS ID:452889 (history)  Vaccinated:2012-03-26
Age:17.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-03, Days after onset: 8
Location:Foreign  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Sertraline hydrochloride
Diagnostic Lab Data: UNK
CDC Split Type: B0792440A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
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)
Write-up: This case was reported by a pharmacist and described the occurrence of convulsion in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). At an unspecified time, the subject received 1st and 2nd dose of CERVARIX. Concurrent medications included ZOLOFT. On 26 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 26 March 2012, less than one day after vaccination with CERVARIX, the subject experienced convulsion. The subject was hospitalised. On 27 March 2012, the event was resolved. The pharmacist considered the event was unrelated to vaccination with CERVARIX.

VAERS ID:453097 (history)  Vaccinated:2012-03-26
Age:16.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-05, Days after onset: 10
Location:Foreign  Entered:2012-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 26Mar2012, 104/64mmHg; Blood pressure, 26Mar2012, 80/56mmHg
CDC Split Type: B0792731A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Loss of consciousness, Nausea, Presyncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Body temperature before the vaccination was 36.5 Deg.C. On 26 March 2012, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 26 March 2012, 20 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction with feeling queasy, aphose, loss of consciousness for several seconds and decreased blood pressure. The blood pressure lowered from 94./64 (BP before vaccination) to 80/56 mmHg. Respiratory discomfort, itching or other symptom was not observed. The blood pressure recovered to 104/64 mmHg 10 minutes later. Subsequently, the subject''s condition was maintained good. The physician considered the events were clinically significant (or requiring intervention). On 26 March 2012, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:453121 (history)  Vaccinated:2012-03-26
Age:13.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-04-05, Days after onset: 10
Location:Foreign  Entered:2012-04-05
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: UNK
CDC Split Type: B0792444A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMLA
MER: MEASLES + RUBELLA (MR-VAX II)MERCK & CO. INC.HF004 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Fall, Loss of consciousness, Presyncope, Syncope, Wound
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included measles/rubella vaccine (non-GSK, subcutaneous, right deltoid) given on 26 March 2012. On 26 March 2012, the subject received 3rd dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On 26 March 2012, 10 seconds after vaccination with CERVARIX, the subject experienced vasovagal reaction described as syncope with loss of consciousness. The subject fell forward to the floor which lead to contused wound on submaxillary region. The physician considered the events were clinically significant (or requiring intervention). No abnormality was found in vital signs. The subject regained consciousness after 10 seconds. At the time of reporting the outcome of the wound was unspecified. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:453673 (history)  Vaccinated:2012-03-26
Age:38.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-04-12, Days after onset: 17
Location:Foreign  Entered:2012-04-13, Days after submission: 1
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: Medical history of Pollinosis and allergy to antibiotic.
Diagnostic Lab Data:
CDC Split Type: E201202083
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3859A UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lip swelling, Pruritus, Rash pustular, Type IV hypersensitivity reaction
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Case was reported by a healthcare professional and forwarded from another company (Novartis Pharma GmbH, reference no. s2012DE02297) on 28-Mar-2012. Case is medically confirmed. A 38-year-old male patient (weight: 92 kg; height; 190 cm) with a medical history of allergy to pollen and antibiotics, received a dose of COVAXIS (lot-no C3859AD) into the left upper arm on 26-Mar-2012. Later on that day he presented with progressive swelling of the lower lip and itching pustules of the entire face. Allergic reaction type IV was suspected. The patient recovered on 27-Mar-2012. Case is closed. Upon internal medical review on 10-Apr-2012 the case was upgraded to serious (other medically important event/ progressive lower lip swelling).

VAERS ID:453769 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-04-16, Days after onset: 21
Location:Foreign  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0795465A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B191AF UNUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERA71CA449A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Cyanosis, Depressed level of consciousness, Oxygen saturation decreased, Pallor, Presyncope, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad)
Write-up: This case was reported by a physician via a regulatory authority (# 163253) and described the occurrence of vagal attack in a 5-year-old male subject who was vaccinated with INFANRIX-POLIO (GlaxoSmithKline), PRIORIX TETRA. On 26 March 2012, the subject received unspecified dose of INFANRIX-POLIO (intramuscular, unknown injection site), unspecified dose of PRIORIX TETRA (subcutaneous, unknown injection site). On 26 March 2012, less than one day after vaccination with INFANRIX-POLIO and PRIORIX TETRA, the subject experienced pallor, cyanosis, bradycardia, semi-conscious state, oxygen saturation (84%) and vomiting. The subject was hospitalised. The discharge diagnosis was a vagal attack. The subject was treated with oxygen, adrenaline, TRIMETON and flebocortid. On 27 March 2012, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-POLIO and PRIORIX TETRA.

VAERS ID:454896 (history)  Vaccinated:2012-03-26
Age:0.4  Onset:2012-03-27, Days after vaccination: 1
Gender:Male  Submitted:2012-05-02, Days after onset: 36
Location:Foreign  Entered:2012-05-03, Days after submission: 1
Life Threatening? Yes
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:
Diagnostic Lab Data:
CDC Split Type: 2012103195
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB225C1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF651891IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematochezia, Ileostomy, Intussusception, Lymphadenitis, Pyrexia, Surgery, Ultrasound abdomen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: This is a spontaneous report from a contactable physician from a foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2012012513. A 4-month-old male was vaccinated with the 2nd doses of INFANRIX HEXA (A21CB225C) and PREVENAR 13 (F65189) 0.5 ml single dose on 26Mar2012 in the tight intramuscularly. The first doses of INFANRIX HEXA and PREVENAR 13 administered on 16Feb2012 had been well tolerated. Information on preceding or concurrent medical conditions or medication was not provided. One day after vaccination, on 27Mar2012, the patient developed fever persisting until 29Mar2012. On 30Mar2012, the child had bloody stools and was hospitalized. Diagnosis of intussusception was confirmed by ultrasound. The infant underwent surgical reduction of the extended ileocoecal intussusception which was accompanied by lymphadenitis mesenterialis. An ileocoecopexy was performed. In addition, placement of an artificial bowel outlet connected to the small bowel (ileostomy) was required. The attending physicians were of the opinion that the events requiring hospitalization were life-threatening. The patient had not completely recovered at the date of reporting.

VAERS ID:454971 (history)  Vaccinated:2012-03-26
Age:44.0  Onset:2012-04-10, Days after vaccination: 15
Gender:Female  Submitted:2012-05-03, Days after onset: 23
Location:Foreign  Entered:2012-05-04, Days after submission: 1
Life Threatening? Yes
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: Unknown
Diagnostic Lab Data: bronchial culture, 10 000 CFU/ml, Streptococcus pneumoniae
CDC Split Type: WAES1204USA04566
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0269AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Culture positive, Pneumonia pneumococcal, Sepsis, Streptococcus test positive
SMQs:, Agranulocytosis (broad), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow)
Write-up: Case was received from the Health Authority on 25-APR-2012 (reference number PEI201212348). Case was medically confirmed. A 44-year-old female patient received a first dose of PNEUMOVAX 23 (lot number 670876/0269AA, batch number G005304), IM into the left upper arm on 26-MAR-2012, 15 days later, on 10-APR-2012, she presented with an acute pneumococcal pneumonia, ARDS and sepsis. The patient was hospitalised. In bronchial section about 10 000 CFU/ml streptococcus pneumoniae were detected. At the time of the reporting the patient had no recovered. According to the reporter the event was life-threatening. Other business partner numbers include E2012-02720. Priority lot check has been initiated. No other information is available.

VAERS ID:455127 (history)  Vaccinated:2012-03-26
Age:34.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-05-07, Days after onset: 42
Location:Foreign  Entered:2012-05-07
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:
CDC Split Type: PHHY2012FR036177
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10145 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Injection site inflammation, Injection site pain, Lymphadenitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Case number PHHY2012FR036177 is an initial spontaneous report received from a foreign Health Authority (PC20120186) on 27 Apr 2012: This report refers to a 34-year-old male patient with an unspecified medical history. No concomitant treatment was reported. He was vaccinated with MENVEO (batch number: M10145) intramuscularly on 26 Mar 2012. On the same day after vaccination he presented with inflammation (up to 5cm) and pain at injection site, lymphadenitis, fever and asthenia, leading to a three days work stop. Biological work up did not find any other etiology. Symptoms outcome was favorable within three days. The final outcome was reported as complete recovery of the patient without sequelae. The foreign Health Authority assessed the events as medically significant and the causal relationship with MENVEO as possible.

VAERS ID:455351 (history)  Vaccinated:2012-03-26
Age:0.2  Onset:2012-04-03, Days after vaccination: 8
Gender:Male  Submitted:2012-05-10, Days after onset: 37
Location:Foreign  Entered:2012-05-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Urticaria
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0800130A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Intestinal resection, Intussusception, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via regulatory authority (# 165434) and described the occurrence of ileocolic intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and INFANRIX. Concurrent medical conditions included urticaria. On 26 March 2012, the subject received an unspecified dose of ROTARIX (oral, batch number not provided) and an unspecified dose of INFANRIX (administration site and route unknown, batch number not provided). On 2 April 2012, the subject was treated with tinset for urticaria. On 3 April 2012, 1 day after treatment with tinset, 8 days after vaccination with INFANRIX and ROTARIX, the subject experienced ileocolic intussusception. The subject was hospitalised. A resection of intestine was performed. At the time of reporting the event was resolved with the following sequelae (intestine resection). The regulatory authority reported that the event was possibly related to vaccination with ROTARIX and INFANRIX.

VAERS ID:455383 (history)  Vaccinated:2012-03-26
Age:13.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-05-10, Days after onset: 45
Location:Foreign  Entered:2012-05-11, Days after submission: 1
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA01030
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN433802UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Fall, Gaze palsy, Head injury, Headache, Loss of consciousness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was received from a health care professional on 03-MAY-2012. This case was medically confirmed. A 13 year old female who was previously well received dose three of GARDASIL (lot # NN43380, batch # G014502) and an injection of BOOSTRIX (batch number not reported, other manufacturer), routes and sites not reported, on 26-MAR-2012, the same day as vaccination, the patient experienced slight dizziness and nausea. On 27-MAR-2012, one day post vaccination, the patient experienced a fainting episode. The reporter described faints/collapses. The dizziness and nausea occurred at school and lasted 3-4 hours. The fainting episode on 27-MAR-2012 lasted 1-2 minutes. According to the patient''s father, the patient complained of a sore head, her eyes started to roll in her head and she passed out. This had happened at school, at home and at judo class. The patient had fallen several times and hit her head. The attacks had become increasingly frequent (2-3 per day) and prolonged (20-25 minutes) over the six weeks prior to reporting. The patient was admitted to hospital twice for investigations and a third time having "passed out" for 90 minutes on 01-MAY-2012. Nothing abnormal had been found to date. At the time of reporting the patient had not recovered. The outcome of the nausea and dizziness were not reported. The patient had received PANDEMRIX on 01-FEB-2010. The events were considered to be serious due to hospitalisation. Other business partner numbers include E2012-02903. No further information is expected.

VAERS ID:455507 (history)  Vaccinated:2012-03-26
Age:13.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-05-14, Days after onset: 49
Location:Foreign  Entered:2012-05-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0799862A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B062AQ UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Fall, Gaze palsy, Head injury, Headache, Loss of consciousness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of fainting in a 13-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) GARDASIL. Historic vaccination included swine flu split dresden;GlaxoSmithKline;unknown;unknown given on 1 February 2010. On 26 March 2012, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown) and an unspecified dose of GARDASIL (unknown). On 26 March 2012, less than one day after vaccination with BOOSTRIX and GARDASIL, the subject experienced nausea and dizziness. After 3 to 4 hours, it was resolved. On 27 March 2012, 1 day after vaccination with BOOSTRIX and GARDASIL, the subject experienced fainting (1 to 2 minutes), passed out, sore and eyes rolling. At the time of reporting, fainting was unresolved. Fainting was more frequent, 2 to 3 times per day and more prolonged (20 to 25 minutes). The subject was hospitalised twice for investigations and was admitted on 1st May 2012 because she has passed out for over 20 minutes. She also hit her head on an unspecified number of occasions due to falling. The falls occurred in different settings such as school, judo and at home. The outcome of sore head, passed out, eyes rolling, head injury and fall was unspecified.

VAERS ID:455550 (history)  Vaccinated:2012-03-26
Age:0.2  Onset:2012-04-10, Days after vaccination: 15
Gender:Male  Submitted:2012-05-14, Days after onset: 34
Location:Foreign  Entered:2012-05-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no personal medical history and it was unknown if the patient had any family medical history. The patient took no concomitant medications and had no history of adverse events to prior vaccinations.
Diagnostic Lab Data:
CDC Split Type: 201204720
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH01250IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: 5'nucleotidase, Activated partial thromboplastin time prolonged, Alanine aminotransferase normal, Antibody test negative, Aspartate aminotransferase normal, Bilirubin conjugated, Blood albumin normal, Blood bilirubin normal, Blood bilirubin unconjugated increased, Blood cholinesterase increased, Blood fibrinogen, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood pH decreased, C-reactive protein increased, Cytomegalovirus test negative, Fibrin D dimer, Gamma-glutamyltransferase increased, Globulin, HIV antibody negative, Haemoglobin decreased, Hepatitis B core antibody, Hepatitis B e antibody, Hepatitis B e antigen, Hepatitis B e antigen negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C virus test, Herpes simplex serology negative, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, International normalised ratio normal, Mycoplasma test, PCO2 decreased, Petechiae, Platelet count decreased, Protein total normal, Prothrombin time shortened, Red blood cell count decreased, Rubella antibody negative, Scan bone marrow abnormal, Streptococcus test negative, Thrombin time abnormal, Total bile acids, Toxoplasma serology negative, Treponema test negative, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Liver infections (narrow), Asthma/bronchospasm (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Malignant lymphomas (broad), Respiratory failure (broad)
Write-up: Initial report was received from the local affiliate in a foreign country (local reference number CN2012048) who received the report was a company sales representative on 03 May 2012. A two-month-old male patient had received a primary dose one intramuscular injection in the left arm of IMOVAX POLIO, Sanofi Pasteur SA, lot number H0125-1 on 26 March 2012. On 10 April 2012, the patient experienced petechia all over the body skin, especially on the face and legs. On 12 April 2012, the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP) and admitted to the hospital. Corrective treatment included immunoglobulin, dexamethasone and prednisone acetate. Laboratory testing on 12 April 2012 included: blood gas analysis: pH 7.289, P CO2 19.3mmHg, P O2: 97.3mmHg, WBC 6.62*10^9/L, RBC 3.43*10^12, HBG 95g/L, PLT 5*10^9/L, INR 0.98, prothrombin time 1.28s, activated partial thromboplastin time 44.5s, thrombin time 18.9s, fibrinogen 3.02g/L, D-dimer 1.90g/ml, supersensitive CRP 1.03mg/L, IgA 0.2230g/L, IgG 10.399g/L, IgM 0.6945g/L, total bilirubin 16.6umol/L, DBIL 3.9umol/L, IBIL 12.7umol/L, total protein 65.9g/L, albumin 41.3g/L, globulin 24.6g/L, ALT 40U/L, AST 43U/L, GGT 56.8U/L, AKP 273U/L, cholinesterase 7335.8U/L, total bile acid 15.5umol/L, 5''-nucleotidase 2U/L, antistreptolysin O test 66.1 IU/ml, HIV antibody (-), HCV 0.07S/CO, syphilis antibody (-), pneumonia mycoplasma antibody (-), tubercle antibody (-). Laboratory testing on 16 April 2012 included: WBC 8.71*10^9/L, RBC 3.42*10^12, HBG 87g/L, PLT 300*10^9/L, HBsAg 0.00ng/ml, HBsAb 630.97IU/ml, HBeAg 0.00U/ml, HBeAb 0.49U/ml, HBcAb 0.990/,l, Pre S1 (-), CMV Antibody IgM (-), Rubella virus antibody IgM (-), Toxoplasma antibody IgM (-), HSV-I antibody IgM (-), HSV-II antibody IgM (-), Bone marrow picture suggested ITP. The patient recovered and was discharged from the hospital on 19 April 2012. The patient had no personal medical history and it was unknown if the patient had any family medical history. The patient took no concomitant medications and had no history of adverse events to prior vaccinations. The patient''s outcome was recovered. Documents held by sender: None.

VAERS ID:455709 (history)  Vaccinated:2012-03-26
Age:5.0  Onset:2012-03-27, Days after vaccination: 1
Gender:Unknown  Submitted:2012-05-16, Days after onset: 50
Location:Foreign  Entered:2012-05-17, Days after submission: 1
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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201204854
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3348AB IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Case received from the Health Authorities through the local affiliate on 08 May 2012 under the reference number PL-URPL-OCR-20120416005 (local reference number 2012-0135). A 05-year-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number C3348AB, on 26 March 2012. On 27 March 2012, i.e. the following day post-vaccination, the patient experienced rash at the injection site as well as injection site redness and oedema (at and around the injection site, around 10 cm in diameter), without pain and itching. The Health Authorities coded "rash injection site", "injection site redness" and "injection site oedema". The outcome was unknown. This case was reported as serious by the Has, i.e. as an important medical condition. Documents held by sender: none.

VAERS ID:456308 (history)  Vaccinated:2012-03-26
Age:11.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2012-05-25, Days after onset: 60
Location:Foreign  Entered:2012-05-29, Days after submission: 4
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA03351
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.G006569 UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN12450 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Feeling abnormal, Pallor, Petit mal epilepsy, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information was obtained on a request by the Company from the Agency (local reference number: AUS/12/0909, OPR No.: 298062) via a Public Case Detaile concerning a 11 year old female patient who on 26-MAR-2012, was vaccinated with a dose of GARDASIL (dose and route not reported) (lot number: NN12450, batch number; G005535). Other suspect therapy included hepatitis B virus vaccine (dose and route not reported) (batch number: G006569). On 26-MAR-2012, the patient didn''t feel normal. Legs started to shake. Looked pale. Continued to shake, advised she was having a "petit mal seizure". Seizures continued every few minutes. Treatment given for AE included oxygen., At the time of the report the patient''s outcome was not recovered. It was reported that the petit mal seizure was possibly related to therapy with GARDASIL and hepatitis B virus vaccine. The original reporting source was not provided. Additional information is not expected.

VAERS ID:456663 (history)  Vaccinated:2012-03-26
Age:42.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-06-01, Days after onset: 67
Location:Foreign  Entered:2012-06-01
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 abnormal, 26Mar2012, see narrative
CDC Split Type: B0804398A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Hepatic function abnormal, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# NL-LRB-136775) and described the occurrence of liver function disorder in a 42-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline) and ENGERIX B adult. On 24 August 2011, the subject received unspecified dose of HAVRIX adult (intramuscular, unknown injection site and batch number). On 26 September 2011, the subject received unspecified dose of ENGERIX B adult (1 ml, intramuscular, unknown injection site and batch number). On 26 March 2012, the subject received unspecified dose of HAVRIX adult (1 ml, intramuscular, unknown injection site and batch number). On 26 March 2012, less than one day after vaccination with last dose of HAVRIX adult and 6 months after vaccination with ENGERIX B adult, the subject experienced fatigue and liver function disorder. This case was assessed as medically serious by GSK. However, it could be possible that fatigue started before vaccinations. The abnormal liver function test result performed on 26 March 2012 was the motivation to notify this case. At the time of reporting the events were unresolved. The regulatory authority reported that the events were unlikely to be related to vaccination with HAVRIX adult and ENGERIX B adult. A diagnose was set but for reasons of privacy, the diagnose was not given to the regulatory authority. No further information was available, therefore the case has been closed.

VAERS ID:460648 (history)  Vaccinated:2012-03-26
Age:18.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Male  Submitted:2012-07-31, Days after onset: 127
Location:Foreign  Entered:2012-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 03/26/2012, Blood alkaline phosphatase, 238, High; 03/26/2012, Blood glucose, 13.9, High; 03/26/2012, Blood potassium, 3.2, Not Applicable; 03/26/2012, Blood pressure, 82/42, Low; 03/26/2012, Blood pressure, 94/46; 03/26/2012, Blood pressure, 112/57, Low; 03/26/2012, Blood pressure, 143/80, Not Applicable; 03/26/2012, 70, Not Applicable; 03/26/2012, Heart rate, 80, Not applicable; 03/26/2012, Heart rate, 65, Not Applicable; 03/26/2012, Heart rate, 56, Low; 03/26/2012, Oxygen saturation, 100%, Normal; 03/26/2012, White blood cell count, 10.5, Not Applicable
CDC Split Type: PHHY2012NO065037
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10008 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Blood alkaline phosphatase increased, Blood glucose increased, Blood potassium decreased, Cold sweat, Feeling hot, Hyperventilation, Hypotension, Pallor, Throat tightness, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Case number PHHY2012NO065037 is an initial spontaneous report from a health care professional via health authority (HA ref number: NO-NOMAADVRE-FHI-2012-14123) received on 27 Jul 2012. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of TWINRIX (other manufacturer, batch number: not reported) in 2008 and feeling of warmth and throat closure, hyperventilation, cold sweating and pallor following it. He was vaccinated with 0.5 ml MENVEO (batch number: M10008) via parenteral route through unspecified site on 26 Mar 2012. It was reported that he experienced strong reactions after vaccination with MENVEO. On the same day about one minute after the vaccination he experienced a feeling of warmth in the whole body. He became pale and experienced cold sweating. He had a feeling of throat closure and he was hyperventilated. His pulse rate was 65, 56, 70 and 80 (units not reported) on 26 Mar 2012. His blood pressure was 84/42 (units not reported) initially which became 94/46 (units not reported) after 10 minutes. The blood pressure values were 112/57 (units not reported) and 143/80 (units not reported) later. His blood alkaline phosphatase was 238 (normal values and units not reported), oxygen saturation was 100 percent, white blood cell count was 13.9 (normal values and units not reported) on 26 Mar 2012. He received ADRENALINE, SOLU-CORTEF and oxygen and was brought to hospital in an ambulance. He was in good condition when he reached hospital. In the hospital he received treatment with cetirizine and systemic prednisolone which was continued for three days. He was discharged the same evening after five hours observation. The course was quite uncomplicated. The adverse event that occurred after vaccination was interpreted as an anaphylactic reaction. The health authority assessed the events as serious. The events outcome was reported as complete recovery with a stop date of 26 Mar 2012 and the causality and assessed as suspected by the reporter.

VAERS ID:464024 (history)  Vaccinated:2012-03-26
Age:0.3  Onset:2012-05-07, Days after vaccination: 42
Gender:Male  Submitted:2012-09-04, Days after onset: 120
Location:Foreign  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Stool rotavirus antigen positi, 24May2012, positive
CDC Split Type: B0827481A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA482AE1PO 
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Failure to thrive, Psychomotor retardation, Rotavirus test positive, Weight gain poor
SMQs:, Depression (excl suicide and self injury) (broad), Neonatal disorders (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of failure to thrive in a 0-year-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included ROTARIX (GlaxoSmithKline) given in February 2012. On 26 March 2012, the subject received 2nd dose of ROTARIX (oral). On 7 May 2012, 42 days after vaccination with ROTARIX, the subject experienced failure to thrive (not getting on weight, stopped eating, decreased psychomotoric activity). The subject was hospitalised due to ongoing problems, diagnose after hospitalization was subject symptoms related to ingest. Symptoms of the gastrointestinal tract were not observed, but the stool sample of 24 May 2012 was positive for rotavirus. The subject was treated with CEREBROLYSIN. At the time of reporting, the events were improved. According to physician the event was coincidence but the subject''s mother believed in relationship with vaccination.

VAERS ID:474434 (history)  Vaccinated:2012-03-26
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2012-11-16
Location:Foreign  Entered:2012-11-16
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: Ophthalmologist examination, 15May2012, normal dilated
CDC Split Type: B0844176A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA742A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Congenital eye disorder, Ophthalmological examination normal
SMQs:, Congenital, familial and genetic disorders (narrow)
Write-up: This case was reported by a consumer and confirmed by a physician and described the occurrence of congenital eye disorder in an infant male subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline). Initial information received on 09 November 2012 from the patient and on 12 November 2012 by the physician were processed together. Medical history and concurrent medications were unspecified. On 26 March 2012, the subject received an unspecified dose of INFANRIXQUINTA (batch A20CA742A (recalled batch), route and injection site unknown). In April or May 2012, a right dermoid of limbus (coded congenital eye disorder) was evidenced. On 15 May 2012, at ophthalmological consultation, dilated fundus examination was normal. This congenital eye disorder had no effect on subject''s vision. This case was assessed as medically serious by GSK. At the time of reporting, dermoid of limbus was unresolved. The physician''s assessment was not provided.

VAERS ID:488050 (history)  Vaccinated:2012-03-26
Age:80.0  Onset:2012-03-26, Days after vaccination: 0
Gender:Female  Submitted:2013-03-29, Days after onset: 368
Location:Foreign  Entered:2013-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin; EUTIROX
Current Illness: Immunisation; Blood cholesterol increased; Hypertension; Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1204USA04322
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1462Z1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hyperpyrexia, Localised oedema
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case received from Health Authority (case n. 164009) through agency (local case n. IT182/12). Initial report received on 16-APR-12. Case medically confirmed. An 80 year old female patient was vaccinated on 26-MAR-12 with the second dose of PNEUMOVAX (batch n. NP32460) i.m., injection site not reported. The patient suffers from allergies (NOS) and she was concomitantly being treated with insulin and EUTIROX. On the same day she presented with hyperpyrexia and local edema. She was treated with cortisone cream and ice packs locally. The outcome is recovered on 30-MAR-12. The case is closed. Follow-up received from HA on 25-MAR-13: the patient was also concomitantly being treated with antihypertensives and cholesterol lowering drugs. The case was upgraded to serious by HA based on the IME (Important Medical Events) list and on the evaluated by the center. The case is closed.

VAERS ID:495376 (history)  Vaccinated:2012-03-26
Age:23.0  Onset:2012-09-19, Days after vaccination: 177
Gender:Female  Submitted:2013-06-27, Days after onset: 281
Location:Foreign  Entered:2013-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness: Unknown
Preexisting Conditions: Eczema; Psoriasis
Diagnostic Lab Data: Blood test, inflamed blood; Body temperature, 38.9
CDC Split Type: B0900152A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC221BA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test abnormal, Dizziness, Fatigue, Headache, Lethargy, Nausea, Pyrexia, Rash generalised, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (#GB-MHRA-ADR 22136460) and described the occurrence of fatigue in a 23-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included eczema and psoriasis. Concurrent medications included contraceptive. On 26 March 2012, 19 September 2012 and 25 October 2012 the subject received unspecified dose of ENGERIX B (1 ml, intramuscular). On 26 March 2012 and 19 September 2012 after vaccination with ENGERIX B, the subject experienced fatigue, nausea, headaches and dizziness. On 25 October 2012 after the third hep B vaccination, the subject experienced reactions as above plus fainting, body rash, high temperature and lethargy. On an unspecified date blood test shows inflamed blood cells. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Verbatim Text: Following the first two hep B vaccinations, patient experienced fatigue, nausea, headaches and dizziness. After the third hep B vaccination, the patient experienced reactions as above plus fainting, body rash, high temperature and lethargy. Medically significant details: blood test shows inflamed blood cells.

VAERS ID:452506 (history)  Vaccinated:2012-03-27
Age:4.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 0
Location:Florida  Entered:2012-03-27
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: Allergies = Milk; Eggs; Wheat
Diagnostic Lab Data: No tests done today
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184CA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0515AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1435AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Patient broke out in hives, had some shortness of breath, wheezing. Patient given steroid, BENADRYL and Neb.

VAERS ID:452523 (history)  Vaccinated:2012-03-27
Age:51.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 0
Location:Pennsylvania  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT472AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Dysphonia, Eye irritation, Ocular hyperaemia, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Parkinson-like events (broad), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Hoarsenes, red and irritated eyes, and wheezing.

VAERS ID:452622 (history)  Vaccinated:2012-03-27
Age:2.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 0
Location:Texas  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient returned to the office approx. 15 minutes after getting Hepatitis A vaccine presenting with hives. 1 tsp of BENADRYL was given. Hives faded within 10 minutes.

VAERS ID:452538 (history)  Vaccinated:2012-03-27
Age:62.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-28, Days after onset: 0
Location:Massachusetts  Entered:2012-03-28
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: Allergies seasonal, cats, horses
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at injection site left upper arm noted the evening of 3/27/12. Pain with lifting arm up.

VAERS ID:452587 (history)  Vaccinated:2012-03-27
Age:5.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Female  Submitted:2012-03-28, Days after onset: 0
Location:Missouri  Entered:2012-03-28
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU3749AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1123AA1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1248AA1SCLL
Administered by: Public     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt broke out in rash. Mother is taking pt to be treated.

VAERS ID:452593 (history)  Vaccinated:2012-03-27
Age:8.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-03-28, Days after onset: 1
Location:Wisconsin  Entered:2012-03-28
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB534CA0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Dysphonia
SMQs:, Parkinson-like events (broad)
Write-up: Pt had hoarseness of voice at night after given called on call dr. was told to give BENADRYL & contact us. Child was hoarse next am and fine by afternoon.

VAERS ID:452597 (history)  Vaccinated:2012-03-27
Age:1.2  Onset:2012-03-28, Days after vaccination: 1
Gender:Female  Submitted:2012-03-28, Days after onset: 0
Location:Alabama  Entered:2012-03-28
Life Threatening? No
Died? Yes
   Date died: 2012-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Lissencephaly; Perimembranous VSD; PFO; seizures
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1586AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172433IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0979AA0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)
Write-up: Per parent, patient acting appropriately yesterday afternoon and last night - playful. Parent woke up around 4:15 am and child not breathing.

VAERS ID:452612 (history)  Vaccinated:2012-03-27
Age:1.8  Onset:2012-03-28, Days after vaccination: 1
Gender:Female  Submitted:2012-03-28, Days after onset: 0
Location:California  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aalso had hepatitis A vaccine on same date and time
Current Illness: No
Preexisting Conditions: Developmental delay; febrile seizures
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B140BA UNUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4149DB UNUN
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB533CA UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUH418AA UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF61177 UNUN
Administered by: Unknown     Purchased by: Private
Symptoms: Convulsion, Disorientation, Muscle twitching, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever to 101 and 6 brief seizures with twitching and disorientation over about half hour.

VAERS ID:452663 (history)  Vaccinated:2012-03-27
Age:29.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 1
Location:Ohio  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Seroquel, Abilify, Trazodone, clomipramine
Current Illness: no acute illness
Preexisting Conditions: schizophrenia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1489AA IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness at site progressing to redness around upper arm, tenderness, slight swelling.

VAERS ID:452671 (history)  Vaccinated:2012-03-27
Age:10.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Female  Submitted:2012-03-29, Days after onset: 1
Location:Michigan  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1404AA1SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema/edema (R) upper arm - 2 x 4 cm yesterday - 9 x 12 cm today. Given BENADRYL 25 mg TID. Returning tomorrow for recheck.

VAERS ID:452675 (history)  Vaccinated:2012-03-27
Age:51.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 1
Location:Illinois  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRAVASTATIN, ZITHROMAX ZPACK, POTASSIUM CHLORIDE, ASPIRIN, LIPITOR, HYDROCHLOROTHIAZIDE, AMLODIPINE-BENAZEPRIL.
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1520AA1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: HIVES. TO TAKE BENADRYL.

VAERS ID:452679 (history)  Vaccinated:2012-03-27
Age:61.0  Onset:2012-03-29, Days after vaccination: 2
Gender:Female  Submitted:2012-03-29, Days after onset: 0
Location:California  Entered:2012-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown to this pharmacist
Current Illness: none known
Preexisting Conditions: none known
Diagnostic Lab Data: If patient still has hot touch on Monday 4.1.2012, she has appt c dermatologist and will seek advise from dermatologist @ that time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0361AA0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site warmth
SMQs:
Write-up: Patient had unusual heat to site of injection- extremely hot to touch- compared to many other patients with injection site reaction.

VAERS ID:452694 (history)  Vaccinated:2012-03-27
Age:4.0  Onset:2012-03-29, Days after vaccination: 2
Gender:Male  Submitted:2012-03-29, Days after onset: 0
Location:Indiana  Entered:2012-03-29
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: Tomatoes
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B329BA2IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1321AA1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized reaction, redness, swelling, itching.

VAERS ID:452696 (history)  Vaccinated:2012-03-27
Age:0.2  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-03-29, Days after onset: 2
Location:Ohio  Entered:2012-03-29
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: Laryngomalacia; GERD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B326AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH483AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9181720IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB244A0PO 
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad)
Write-up: Very fussy then had several episodes of emesis that evening. By afternoon of next day was doing better. Treated with frequent small feeds of Pedialyte until was able to hold things down.

VAERS ID:452703 (history)  Vaccinated:2012-03-27
Age:24.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-03-30, Days after onset: 3
Location:Texas  Entered:2012-03-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: Hx of migraine headaches; last one in 2007
Diagnostic Lab Data: No labs done; meds given for inflammation; pain
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078BA IMRA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis, Inflammation, Migraine, Musculoskeletal stiffness, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Fever of 102, body chills, aches, hot, cold sweats, migraines, (neck stiff - 8 hours).

VAERS ID:452736 (history)  Vaccinated:2012-03-27
Age:1.2  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-03-30, Days after onset: 3
Location:California  Entered:2012-03-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB3IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.UNKNOWN3IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227203IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized swelling and redness on L thigh at injection site, minimal bruising first noticed 4 hours after injection.

VAERS ID:452750 (history)  Vaccinated:2012-03-27
Age:0.2  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-03-30, Days after onset: 3
Location:Georgia  Entered:2012-03-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AXID
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4142AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1522AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF753980IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1708AA0PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Decreased appetite
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Unconsolable crying, decreased appetite.

VAERS ID:452761 (history)  Vaccinated:2012-03-27
Age:31.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Female  Submitted:2012-03-30, Days after onset: 2
Location:Colorado  Entered:2012-03-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal discomfort, Asthenia, Chills, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever, chills, felt like throwing up (but did not), very weak, upset stomach.

VAERS ID:452776 (history)  Vaccinated:2012-03-27
Age:4.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 1
Location:Oregon  Entered:2012-04-02, Days after submission: 4
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: Amoxicillin; Asthma
Diagnostic Lab Data: Allergic reaction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA0UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1395Z1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0926AA1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Irritability, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Redness & swelling right arm & shoulder. Fever and fussiness.

VAERS ID:452826 (history)  Vaccinated:2012-03-27
Age:1.2  Onset:2012-03-31, Days after vaccination: 4
Gender:Female  Submitted:2012-04-02, Days after onset: 2
Location:Pennsylvania  Entered:2012-04-02
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1697AA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0601AA SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1410AA SCLL
Administered by: Unknown     Purchased by: Private
Symptoms: Cough, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: 5 days after MMR, varicella, and hepatitis A vaccines patient developed cough, wheezing, and fever. Mom attributes these symptoms to the vaccine and requested they be reported.

VAERS ID:452837 (history)  Vaccinated:2012-03-27
Age:45.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-04-02, Days after onset: 5
Location:Minnesota  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil - Omega 3; CENTRUM; Echinacea; meclizine prn
Current Illness:
Preexisting Conditions: NKA
Diagnostic Lab Data: CBC with diff, abnormal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB493AA1IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Differential white blood cell count abnormal, Erythema, Full blood count abnormal, Pain, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad)
Write-up: Redness, pain started 3/28/12. It progressively got worse, seen at ER on 3/31/12. DX (1) vaccination complication (2) cellulitis. Tx: BENADRYL Rx - KEFLEX - MEDROL Dose Pack, VICODIN, IV ROCEPHIN 3/31, 4/1 AND 4/2.

VAERS ID:452871 (history)  Vaccinated:2012-03-27
Age:0.2  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-04-03, Days after onset: 7
Location:Maryland  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEUR 1 LL
Administered by: Private     Purchased by: Private
Symptoms: Crying, Screaming
SMQs:, Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: High pitched screaming and crying. Inconsolable for hours.

VAERS ID:452908 (history)  Vaccinated:2012-03-27
Age:11.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-04-03, Days after onset: 6
Location:Illinois  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STRATTERA 40mg qday; LAMICTAL 75mgAM/100mgPM; COZAAR 50mg qhs; Milk of Mag 1tsp tid, XOPENEX prn, MVI, Fiber Gummis (4gm/day); VERAMYST qday; CLARITIN 5mg qday
Current Illness: No
Preexisting Conditions: Loeys-Dietz Syndrome; Autism; Seizure Disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1139AA1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4019AA0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large area of warmth, induration, erythema around site of Menactra administration (right deltoid).

VAERS ID:452918 (history)  Vaccinated:2012-03-27
Age:18.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-03-29, Days after onset: 2
Location:North Carolina  Entered:2012-04-03, Days after submission: 5
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 - here for a physical.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Hypersomnia, Pain, Paraesthesia, Pyrexia, Somnolence
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Note by Dr. 03/28/12. Became drowsy, achy, felt feverish. Slept most of the day and until 1pm the next day. Did not have fever when examined 3/28 tingling on bottom of his feet the next day - very mild.

VAERS ID:452948 (history)  Vaccinated:2012-03-27
Age:11.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-03-30, Days after onset: 3
Location:Minnesota  Entered:2012-04-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No known drug allergies; No other problems
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541AA1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1261AA0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA100530UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075AA0UNRA
Administered by: Private     Purchased by: Other
Symptoms: Hyperhidrosis, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fainted after injection. Patient was pale and sweaty. Patient revived in 15 minutes with feet elevated, ice applied to back of neck and 7-Up given.

VAERS ID:452968 (history)  Vaccinated:2012-03-27
Age:0.2  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-04-02, Days after onset: 6
Location:Oklahoma  Entered:2012-04-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4164AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF561770IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1512AA0PO 
Administered by: Private     Purchased by: Private
Symptoms: Hypotonia, Immunisation reaction, Pallor, Somnolence
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: On 3-27-12 at 1830 patient became limp, pale and somnolent for about 5 minutes, which spontaneously resolved. Then the episode reoccurred an hour later. Patient was taken to the ER. By the time of arrival skin color is back to normal. Patient was back to normal Dx: Reaction to immunization resolved. Sent home stable.

VAERS ID:453008 (history)  Vaccinated:2012-03-27
Age:48.0  Onset:2012-03-29, Days after vaccination: 2
Gender:Female  Submitted:2012-04-04, Days after onset: 6
Location:Kansas  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3769BA IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Arthralgia, Erythema, Feeling hot, Induration, Myalgia, Pain, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Redness, pain, warmth & swelling (hard to touch) about 2 days later. High fever (not measured about 102 degrees) - (aching muscle/joint ). Took ibuprofen. Local symptoms persisted. System rxn subsided in 72 hr.

VAERS ID:453015 (history)  Vaccinated:2012-03-27
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-04
Location:Missouri  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA4UNLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441AA0UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1310AA4UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0872AA1UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1249AA1UNLL
Administered by: Public     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None.

VAERS ID:453018 (history)  Vaccinated:2012-03-27
Age:36.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-04-04, Days after onset: 7
Location:Illinois  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HIV; GERD
Diagnostic Lab Data: Rapid flu & viral load for HIV while outpatient.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1489AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood HIV RNA below assay limit, Influenza virus test negative, Muscular weakness, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Note from provider: woke up 3/28 with fevers and body aches, temp 3/28 102 degrees F, 3/29 103 degrees F in office, legs felt weak, no neuro changes, no pain at injection site, labs drawn were negative. Patient called back 3/31 and stated symptoms were worse and going to ER.

VAERS ID:453035 (history)  Vaccinated:2012-03-27
Age:1.9  Onset:2012-03-27, Days after vaccination: 0
Gender:Male  Submitted:2012-04-04, Days after onset: 8
Location:California  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: inguinal and cervical node swelling~Measles + Mumps + Rubella (no brand name)~0~0.00~Patient|inguinal and cervical node swelling
Other Medications:
Current Illness: Enlarged lymph nodes from last vaccines
Preexisting Conditions: Hx of croup
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3957AA2SYRLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB481BB0SYRLL
Administered by: Private     Purchased by: Unknown
Symptoms: Inflammation, Lymphadenopathy
SMQs:
Write-up: Hyperinflammation of groin and cervical lymph nodes after injection. Swelling chronic $g 2 weeks. Enlargement noted from vaccines given in 2011 as well. Nodes < 10mm.

VAERS ID:453041 (history)  Vaccinated:2012-03-27
Age:0.5  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-30, Days after onset: 2
Location:Louisiana  Entered:2012-04-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough and wheezing
Preexisting Conditions: Bronchiolitis
Diagnostic Lab Data: Chest xray in ER
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4059AA2IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1455AA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172432IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Chest X-ray, Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:453124 (history)  Vaccinated:2012-03-27
Age:3.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-05
Location:Texas  Entered:2012-04-06, Days after submission: 1
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: Cellulitis and abscess of leg/vaccine reaction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF629234IMRL
Administered by: Private     Purchased by: Public
Symptoms: Abscess limb, Cellulitis, Erythema, Pruritus, Swelling, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Date of Service: 3/31/12. Two days after received PVC13 on the right thigh. Did not notice any redness or swelling until this AM. No pain. Itches a little. No fever. NO drainage. Ambulating well. Patient was Rx BACTRIM PO susp. 200mg 40/5ml. BENADRYL BID as needed. Motrin/Tylenol for pain.

VAERS ID:453155 (history)  Vaccinated:2012-03-27
Age:82.0  Onset:2012-04-01, Days after vaccination: 5
Gender:Male  Submitted:2012-04-08, Days after onset: 7
Location:Ohio  Entered:2012-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Synthroid Lisinopril Amlodipine Toprol xl Losartan hctz Aspirin Amaryl
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: MRI CT scan Carotid ultrasound EKG (3) Blood work Urinalysis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1267AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Hypoaesthesia, Nuclear magnetic resonance imaging, Ultrasound Doppler, Urine analysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Numbness of left side, head to toe.

VAERS ID:453167 (history)  Vaccinated:2012-03-27
Age:18.0  Onset:2012-04-04, Days after vaccination: 8
Gender:Male  Submitted:2012-04-08, Days after onset: 4
Location:Montana  Entered:2012-04-08
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: n/a
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Back pain, Lymphadenopathy, Neck pain
SMQs:, Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Throbbing pain in lower back up to cervical spine region. Low energy. Swollen lymph nodes in the posterior neck region.

VAERS ID:453237 (history)  Vaccinated:2012-03-27
Age:4.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 1
Location:Florida  Entered:2012-04-09, Days after submission: 11
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315DA3IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1006AA1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1275AA1SCLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and edema noted to (L) arm.

VAERS ID:453253 (history)  Vaccinated:2012-03-27
Age:1.5  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-03-29, Days after onset: 2
Location:Indiana  Entered:2012-04-09, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions:
Diagnostic Lab Data: Rapid RSV (-); Rapid flu (-); H/H = 12/34; WBC 10,000 with 58% neutrophils; 27% lymphs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC399AA3UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0741Z0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF120553UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1318Z0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Febrile convulsion, Influenza virus test negative, Lymphocyte percentage, Neutrophil percentage, Pyrexia, Respiratory syncytial virus test negative, White blood cell count normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Pt spiked a fever then had a febrile seizure about 6-8 hours after vaccines were given.

VAERS ID:453267 (history)  Vaccinated:2012-03-27
Age:11.0  Onset:2012-03-28, Days after vaccination: 1
Gender:Male  Submitted:2012-03-29, Days after onset: 1
Location:Illinois  Entered:2012-04-09, Days after submission: 11
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4002AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU3874BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1438AA1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Blister, Erythema, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Increased redness and development at 3x4 cm patch of clear vesicles on back of (R) arm. Sx develop 24 hours after vaccine. Redness progressed with 10 x 5 cm surrounding erythema with swelling.

VAERS ID:453257 (history)  Vaccinated:2012-03-27
Age:2.0  Onset:2012-03-29, Days after vaccination: 2
Gender:Female  Submitted:2012-03-30, Days after onset: 1
Location:Texas  Entered:2012-04-10, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS473011C0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site reaction, Rash maculo-papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mildly pruritic maculopapular rash at sites of immunoglobulin injection & rabies vaccines injection. Asked mom to give 2-5 ml of children''s BENADRYL every 8-10 hrs as needed.

VAERS ID:453285 (history)  Vaccinated:2012-03-27
Age:0.8  Onset:2012-03-28, Days after vaccination: 1
Gender:Female  Submitted:2012-04-10, Days after onset: 13
Location:New Hampshire  Entered:2012-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EKG - WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC090FA2IMLG
Administered by: Private     Purchased by: Public
Symptoms: Electrocardiogram normal, Hypotonia, Lethargy, Pallor, Presyncope, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Vasovagal reaction 28 hours following Hep B vaccine. Vomited at home & then 5-10 min later became limp, pale & lethargic. Pulse 160 RR 24.

VAERS ID:453298 (history)  Vaccinated:2012-03-27
Age:77.0  Onset:2012-03-27, Days after vaccination: 0
Gender:Female  Submitted:2012-04-10, Days after onset: 14
Location:Florida  Entered:2012-04-10
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1241AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: