|
VAERS ID: |
264792 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Female |
Location: |
Unknown |
Vaccinated: | 0000-00-00 |
Onset: | 0000-00-00 |
Submitted: |
2006-10-13 |
Entered: |
2006-10-17 |
Days after submission: | 4 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other Symptoms: Syncope SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: UNK Current Illness: Preexisting Conditions: UNK Allergies: Diagnostic Lab Data: CDC Split Type: WAES0610USA03817
Write-up: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested. |
|
VAERS ID: |
264793 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Female |
Location: |
Unknown |
Vaccinated: | 0000-00-00 |
Onset: | 0000-00-00 |
Submitted: |
2006-10-13 |
Entered: |
2006-10-17 |
Days after submission: | 4 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
- / UNK |
UN / UN |
Administered by: Other Purchased by: Other Symptoms: Syncope SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: UNK Current Illness: Preexisting Conditions: UNK Allergies: Diagnostic Lab Data: CDC Split Type: WAES0610USA03818
Write-up: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested. |
|
VAERS ID: |
264950 (history) |
Form: |
Version 1.0 |
Age: |
57.0 |
Sex: |
Female |
Location: |
Wisconsin |
Vaccinated: | 2006-09-19 |
Onset: | 2006-10-03 |
Days after vaccination: | 14 |
Submitted: |
2006-10-16 |
Days after onset: | 13 |
Entered: |
2006-10-19 |
Days after submission: | 3 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0039F / 1 |
LA / IM |
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. |
0296R / UNK |
RA / SC |
Administered by: Other Purchased by: Other Symptoms: Chest pain,
Hypoaesthesia,
Lymphadenopathy,
Paraesthesia SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Current Illness: NONE Preexisting Conditions: Valve Proplase in distant past, neg heart cath 2 yrs ago. Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: 09/19/2006 MMR and HBV adm 1, 10/03/2006 swollen glands, numbness and tingling of arm and legs bilat. Pt called hotline and states she was told this was from the MMR. 10/15/06 chest pain. Pt wonders if this is related to immunizations. |
|
VAERS ID: |
264959 (history) |
Form: |
Version 1.0 |
Age: |
13.0 |
Sex: |
Female |
Location: |
New York |
Vaccinated: | 2006-10-16 |
Onset: | 2006-10-16 |
Days after vaccination: | 0 |
Submitted: |
2006-10-19 |
Days after onset: | 3 |
Entered: |
2006-10-19 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
0741F / 1 |
RA / IM |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0955F / 1 |
LA / IM |
Administered by: Private Purchased by: Private Symptoms: Bradycardia,
Coma,
Heart rate irregular,
Musculoskeletal stiffness,
Pallor,
Syncope,
Urinary incontinence SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: Scheduled for cardiac and Neuro follow up. LABS: IgG was only positive for Lyme dx which was considered negative. CDC Split Type:
Write-up: Administred VAQTA, then GARDASIL, immediately after GARDASIL child became unresponsive, stiff, pale about 30 sex. Child lost bladder control, pulse 46-55 after event, child alert and aware after events. 11/27/06 Received medical records from provider/reporter which reveal patient had LOC, tonic/clonic movements & loss of bladder control after received 2nd GARDASIL vax. HR was 46-55. This was the 3rd episode of LOC within a year (1st after tetanus shot, 2nd after finding a tick & 3rd after 2nd dose of GARDASIL). PCP recommended cardiac & neuro w/u. Received cardiac consultation which revealed final dx: probable fainting. Holter monitor was WNL. Awaiting neuro consult. |
|
VAERS ID: |
264992 (history) |
Form: |
Version 1.0 |
Age: |
15.0 |
Sex: |
Female |
Location: |
California |
Vaccinated: | 2006-10-16 |
Onset: | 2006-10-18 |
Days after vaccination: | 2 |
Submitted: |
2006-10-19 |
Days after onset: | 1 |
Entered: |
2006-10-19 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0637F / UNK |
RA / - |
TDAP: TDAP (ADACEL) / SANOFI PASTEUR |
C2572AA / UNK |
LA / - |
Administered by: Private Purchased by: Unknown Symptoms: Blister,
Eosinophil count increased,
Herpes simplex,
Herpes simplex serology negative,
Lip swelling,
Swelling face SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Current Illness: NONE Preexisting Conditions: Allergies: Diagnostic Lab Data: eosinophil count, 11/16/06, 11%; serum herpes simplex, 11/02.06, 5.6; HSV type1 and/or 2, 10/19/06, 11%; Herpes simplex virus, 10/19/06, negat. CDC Split Type:
Write-up: Received Tdap and HPV vaccine on 10/16/2006 noticed some blisters at the corner of mouth and swelling of lower lip on the evening of 10/18/2006 and facial swelling around eyes on 10/19/06. No fever, headache, dizziness or any GI symptoms. Information has been received from nurse manager in a physician''s office concerning a 15 year old female who on 16-OCT-2006 at 1600 was vaccinated in the right deltoid with the first dose of GARDASIL (lot # 653937/0637P). Concomitant therapy that day included DTP. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of BENADRYL. After raking BENADRYL the patient''s face and body swelling "went down". On 20-OCT-2006 it was reported that "the swelling became worse again". At the time of this report the patient had not recovered from the event. Follow up information was received from the patient''s physician which stated that on 18-OCT-2006 the patient developed blisters in the corners of her mouth and swelling of her lip and face and she was seen in the office. She was treated with acyclovir for possible herpes simplex. Laboratory results from 19-OCT-2006 included HSV type 1 and/or 2 was 11% and Herpes simplex virus culture was negative. On approximately 23-OCT-2006 the patient was considered to have recovered from these events. On 02-NOV-2006 the patient reported swelling on her face and lower lip again. Laboratory results that same day included serum herpes simplex type 1 IgG Ab 5.6 and a eosinophil count of 11%. The physician reported that the patient recovered from these events on an unspecified date. This report was identified from a line listing obtained on request by the Company. A 15 year old female with no pre-existing conditions was vaccinated in 16-OCT-2006, intramuscularly into the right arm with GARDASIL (lot#653937/0637F). Concomitant therapy that day included DTAP (Lot # C2572AA), vaccinated into the left arm (route unknown). The patient noticed on the evening of 18-OCT-2006, some blisters at the corner of her mouth and swelling of lower lip and facial swelling around her eyes ib 19-OCT-2006. There was no reported fever, headche, dizziness or any gastrointestinal symptoms. Additional information has been requested. |
|
VAERS ID: |
265013 (history) |
Form: |
Version 1.0 |
Age: |
23.0 |
Sex: |
Female |
Location: |
Kentucky |
Vaccinated: | 2006-10-09 |
Onset: | 2006-10-16 |
Days after vaccination: | 7 |
Submitted: |
2006-10-17 |
Days after onset: | 1 |
Entered: |
2006-10-20 |
Days after submission: | 3 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0688F / 1 |
RA / IM |
Administered by: Private Purchased by: Private Symptoms: Headache,
Injection site reaction,
Pruritus,
Thermal burn SMQs:, Anaphylactic reaction (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Lexapro, Effexor, Yasmin, HCTZ, Elmiron, Parida Plus, Claritin. Current Illness: Preexisting Conditions: Sulfa Allergy, Hypertension, Intestinal cystitis. Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: Localized reaction at injection site right del itching and burning beginning 7 day post injection, also headache. Txd symptoms with Benadryl, Tylenol, Hydrocortisone cream. |
|
VAERS ID: |
265107 (history) |
Form: |
Version 1.0 |
Age: |
20.0 |
Sex: |
Female |
Location: |
New York |
Vaccinated: | 2006-10-19 |
Onset: | 2006-10-19 |
Days after vaccination: | 0 |
Submitted: |
2006-10-19 |
Days after onset: | 0 |
Entered: |
2006-10-23 |
Days after submission: | 4 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0955F / UNK |
UN / IM |
Administered by: Unknown Purchased by: Unknown Symptoms: Asthenia,
Dizziness,
Hyperhidrosis SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: After receiving Gardasil vaccine #1 pt immediately became lightheaded, weak and sweaty. SX lasted approx 5 minutes. (OMIC). Per 60 day follow up: Patient received GARDASIL # 2 on 2/20/07, uneventful. |
|
VAERS ID: |
265305 (history) |
Form: |
Version 1.0 |
Age: |
21.0 |
Sex: |
Female |
Location: |
Florida |
Vaccinated: | 2006-10-16 |
Onset: | 2006-10-16 |
Days after vaccination: | 0 |
Submitted: |
2006-10-24 |
Days after onset: | 8 |
Entered: |
2006-10-24 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
UNKNOWN / 1 |
LA / IM |
Administered by: Unknown Purchased by: Unknown Symptoms: Difficulty in walking,
Muscle rigidity,
Syncope SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Ortho-tricyclene Low Current Illness: None. Preexisting Conditions: None Allergies: Diagnostic Lab Data: N/A CDC Split Type:
Write-up: According to my daughter, the following happened: 1. Shot was given between 1100-1115 am 2. Proceed to wait a few minutes with doctor in room and then went to check out 3. Between 1120-1125 am...she passed out in doctors office. 4. Day 2-4: tightness in muscles especially around lower legs. Also tigtness in arms, but not as bad as legs. 5. Hard time walking after first waking up in morning and gradually loosens up after she starts moving around. 6. I suggested to her to take a Tylenol to help with muscle tightness and to massage calves prior to getting out of bed to help loosen them up. |
|
VAERS ID: |
265338 (history) |
Form: |
Version 1.0 |
Age: |
1.03 |
Sex: |
Male |
Location: |
Michigan |
Vaccinated: | 2006-10-13 |
Onset: | 0000-00-00 |
Submitted: |
2006-10-17 |
Entered: |
2006-10-25 |
Days after submission: | 8 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR |
V2175HA / 1 |
UN / IM |
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHAVB099CB / 1 |
UN / IM |
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. |
0212R / 4 |
UN / IM |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0688F / 1 |
UN / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B22930D / 4 |
LL / IM |
Administered by: Private Purchased by: Public Symptoms: SMQs:
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: None Stated |
|
VAERS ID: |
265357 (history) |
Form: |
Version 1.0 |
Age: |
18.0 |
Sex: |
Female |
Location: |
Kentucky |
Vaccinated: | 2006-10-13 |
Onset: | 2006-10-20 |
Days after vaccination: | 7 |
Submitted: |
2006-10-25 |
Days after onset: | 5 |
Entered: |
2006-10-25 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HPV4: HPV (GARDASIL) / MERCK & CO. INC. |
0660F / 1 |
LA / IM |
Administered by: Unknown Purchased by: Unknown Symptoms: Injection site erythema,
Injection site pain,
Injection site swelling SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Other Medications: Current Illness: none Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: Approximately 7 days after HPV IM, L deltoid became very sore, painful to abduct. Nosig soreness at 24 hours after IM. On exam is tender deep in muscle and is enlarged. No surface redness. No induration. |
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