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VAERS ID: 343766 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: California  
Vaccinated:2009-04-02
Onset:2009-04-02
   Days after vaccination:0
Submitted: 2009-04-08
   Days after onset:6
Entered: 2009-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3084AA / 2 LL / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF6Z0AB / 2 LL / SC
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B0475 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D26083 / 2 RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test, Cyanosis, Dyspnoea, Hypotonia, Loss of consciousness, Urticaria, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None 4/20/09-records received-PMH: eczema.
Allergies:
Diagnostic Lab Data: Blood, results not all in yet. Future skin/scratch tests. 4/20/09-records received-WBC 14.6, 26 neutrophils, 63 lymphocytes and 7 monocytes.
CDC Split Type:

Write-up: Within 10 minutes of receiving the vaccines, patient developed hives on his head and then experienced shortness of breath, wheezing and his lips turned blue. He went limp, losing consciousness. He went into anaphylactic shock, required an epi pen, oxygen, benedryl and then was taken in critical condition by ambulance to hospital. He was treated in the emergency room, had an IV placed in his head, several breathing treatments, more drugs and was then admitted to the hospital for three days. 4/20/09-records received for DOS 4/2-4/4/09-DC DX: Anaphylaxis. Allergic reaction. Ten minutes after receiving vaccines, developed hives on head and had trouble breathing turned blue and cyanotic around mouth and dusky all over, eyes rolled back and went limp and passed out. PE: wheezing, shortness of breath and labored breathing, rash erythema all over, cyanotic episode and hypertonia. Scratching all over.


VAERS ID: 343767 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Arizona  
Vaccinated:2008-08-25
Onset:2009-02-13
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2009-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAV8289BA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0843X / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 42624AA / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain lower, Computerised tomogram abnormal, Laparoscopy
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PMH: kidney reflux w/2 ureters on left.
Allergies:
Diagnostic Lab Data: CT LABS:WBC 15.0(H). CT scan abdomen/pelvis abnormal.
CDC Split Type:

Write-up: (Per mother), child went to ER 2-13-09 with LLQ pain had CT- Showed ovarian cyst was told by ER physician- was result of HPV immunizations. Laparoscopy for ovarian cyst 2-13-09. 4/10/09 Received hospital medical records of 2/13-2/14/2009. FINAL DX: ruptured left corpus hemorrhagicum; laparoscopy Records reveal patient experienced progressive left flank, nausea & LLQ abdominal pain x 1 wk. Taken to OR for laparoscopic surgery. Findings at the time of surgery include: ruptured corpus hemorrhagicum, blood clots in anterior & posterior cul-de-sac. Did well postoperatively & d/c to home next day.


VAERS ID: 343774 (history)  
Form: Version 1.0  
Age: 64.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2009-03-26
Onset:2009-03-27
   Days after vaccination:1
Submitted: 2009-04-08
   Days after onset:12
Entered: 2009-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1625X / UNK RA / SC

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

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

Write-up: Patient noticed red welt on site of injection the following day. In the afternoon around 3 pm. she experienced slight itch on left arm. The red welt on right arm grew to the size of a tennis ball in a few days. Ice was applied during this time. Left arm became very itchy and Pt saw a dermatologist on 4/1/09 and doctor confirmed she has shingles. Pt was given a week course of VALTREX and cream to apply. Symptoms resolved. Pt has no other complaints


VAERS ID: 343883 (history)  
Form: Version 1.0  
Age: 76.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-08-30
Onset:2009-01-26
   Days after vaccination:880
Submitted: 2009-06-24
   Days after onset:148
Entered: 2009-04-08
   Days after submission:77
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Herpes zoster, Myalgia, Pain, Varicella zoster virus serology positive
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: PENICILLIN allergy
Preexisting Conditions: Chickenpox
Allergies:
Diagnostic Lab Data: VZV strain, VZV WILD TYPE STRAIN.
CDC Split Type: WAES0901USA03661

Write-up: Information has been received from a healthcare worker concerning a 78 year old female who was vaccinated with a dose of ZOSTAVAX (Merck). Four days ago the patient developed a shingles outbreak. The reporter stated that the office would be interested in the VZV analysis by PCR. The patient sought medical attention through an office contact. At the time of this report the patient was recovering. Follow up information received on 05-FEB-2009 from a herpes zoster questionnaire stated that the patient had chickenpox on 1935. It was also stated that the patient was vaccinated with a dose of ZOSTAVAX (Merck) on 30-AUG-2006, the rash did not occur within 42 days of the vaccination. The patient developed herpes zoster on 26-JAN-2009, other symptoms experienced by the patient includes fatigue, and ache in muscles, the maximum temperature experienced by the patient was 98.1. The pain was quantified as 5. It was unknown if the patient was recently exposed to chickenpox. At the time of this report the patient had recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine VZV strain. It was also stated that the patient had PENICILLIN allergy; the patient received the dose of ZOSTAVAX in left arm. The specimen was obtained on 02-FEB-2009 and sent to the laboratory on 03-FEB-2009, it was collected from a patient vesicle. The lesions were treated but not cured and were distributed in back, chest and in the left axilla. The sample of collection was collected on 02-FEB-2009. The sample was taken from a patient''s vesicle. The PCR results for the specimen from the patient''s vesicle identified the presence of Wild Type VZV. No further information is available. This is in follow-up to report (s) previously submitted on 3/27/2009. Follow up information received on 03-FEB-2009 from a herpes zoster questionaire stated that the patient had chickenpox on 1935. It was also stated that the patient was vaccinated with a dose of ZOSTAVAX on 30-AUG-2006, the rash did not occure within 42 days of the vaccination. The patient developed herpes zoster on 26-JAN-2009, other symptoms experienced by the patient includes fatigue, and ache in muscles, the maximum temperature experienced by the patient was 98.1. The pain was quantified as 5. It was unknown if the patient was recently exposed to chickenpox. At the time of this report the patient had recovered. The patient was enrolled in the Varicella Zoster Virus Idenification Program to identify VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. It was also stated that the patient had penicillin allergy; the patient received the dose of zoster vaccine live (oka/Merck) in left arm. The specimen was obtained on 02-FEB-2009 and sent to the laboratory on 03-FEB-2009. It was collected from a patient vesicle. The lesions were treated but not cured and were distributed in back, chest and in the left axilla. The specimen arrived in the laboratory on 05-FEB-2009. The sample of collection was collected on 02-FEB-2009. The sample was taken from a patient''s scab lesion (previously reported from a patient''s vesicle). The PCR results for the specimen from the patient''s scab lesion identified the presence of Wild Type VZV. The interpretation was: an adequate specimen, wild type strain. No further information is available.


VAERS ID: 343884 (history)  
Form: Version 1.0  
Age: 77.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-01
Onset:2009-01-22
   Days after vaccination:693
Submitted: 2009-03-27
   Days after onset:63
Entered: 2009-04-08
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1476F / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Blister, Erythema, Herpes zoster, Pain, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: calcium (unspecified); estrogens (unspecified); SYNTHROID; COUMADIN
Current Illness: SULFONAMIDE allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0901USA03665

Write-up: Information has been received from a nurse practitioner concerning a 77 year old female with SULFONAMIDE allergy and no known medical history who on 01-MAR-2007 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (lot # 656412/1476F) subcutaneous. Concomitant therapy included SYNTHROID, calcium (unspecified), COUMADIN and estrogens (unspecified). On 22-JAN-2009 the patient developed shingles. The patient developed painful red raised blisters on her shoulder blades on her back. The patient was given DARVOCET, VALTREX, and a cream for the treatment. No laboratories studies performed. The patient sought medical attention with the nurse. At the time of this report the patient was recovering. Additional information has been requested.


VAERS ID: 343886 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-27
Onset:2007-09-27
   Days after vaccination:0
Submitted: 2009-06-24
   Days after onset:636
Entered: 2009-04-08
   Days after submission:77
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0888U / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Chickenpox
Allergies:
Diagnostic Lab Data: body temp 01/??/09 98.1 degrees F -
CDC Split Type: WAES0901USA03668

Write-up: Information has been received from a registered nurse concerning a 77 year old female patient with no known allergies and no pertinent medical history, who on 27-SEP-2007 was vaccinated with ZOSTAVAX (Lot not provided). There was no concomitant medication. The patient developed (on an unspecified date) painful shingles around face, scalp and forehead. She also experienced shooting pain, chills and fever. She was prescribed VALTREX for the treatment. As of 26-JAN-2009 the patient hadn''t recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009. Follow up information has been received from a registered nurse and a completed questionnaire, concerning a 78 year old female patient with a history of chickenpox in 1938, who on 27-SEP-2007 was vaccinated with 0.5 mL the first dose of ZOSTAVAX (Merck) (Lot 658084/0888U) subcutaneously in the left arm at 2:15 pm. It was reported the patient had no illness at time of vaccination. The reporter stated a failure in the ZOSTAVAX (Merck) vaccine. On 26-Jan-2009, the patient developed shingles. The patient had a maximum of body temperature of 91.8 degrees F, with a pain degree of 5 (0 lest to 10 most), she also had trouble with vision and went to see the ophthalmologist. The nurse reported the patient had had no recent exposure to chicken pox or herpes zoster. A direct fluorescent antibody test was not done and no specimen was collected for PCR. On an unspecified date the patient recovered. Additional information is not expected.


VAERS ID: 343887 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Female  
Location: Ohio  
Vaccinated:2009-01-20
Onset:0000-00-00
Submitted: 2009-03-27
Entered: 2009-04-08
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1417X / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin 81 mg; calcium (unspecified) (+); chondroitin sulfate sodium (+); NEXIUM; NEURONTIN; ACTONEL; ZOCOR; vitamins (unspecified)
Current Illness: Arthritis; Drug hypersensitivity; Glaucoma; Hiatus hernia; Hyperlipidaemia; Seasonal allergy
Preexisting Conditions: Helicobacter pylori infection; Breath shortness
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA03677

Write-up: Information has been received from a registered nurse (also reported as certified medical assistant) concerning a 71 year old female patient with hiatus hernia, seasonal allergy, ibuprofen causes shortness of breath, glaucoma, arthritis and hyperlipidaemia and a history of helicobacter pylori infection that had been corrected who on 20-JAN-2009 was vaccinated intramuscularly into the right arm with a 0.65ml dose of ZOSTER vaccine live (Oka/Merck) (Lot #663196/1417X). Concomitant therapy included ACTONEL, aspirin, calcium (unspecified) (+) vitamin D (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate, vitamins (unspecified), NEURONTIN, NEXIUM and simvastatin (MSD). The medical assistant reported that after vaccination (on unspecified date) the patient experienced a local reaction to the right arm. The area was red, warm and slightly raised area that was 2 by 1 and 1/2 inches. The patient was told to apply a cool compress to this area. The patient sought medical attention by phone on 23-JAN-2009. At the time of reporting the patient was recovering This is one of two cases from the same source. This is a consolidation of two reports concerning the same patient. Additional information has been requested.


VAERS ID: 343889 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Idaho  
Vaccinated:2009-01-23
Onset:2009-01-23
   Days after vaccination:0
Submitted: 2009-03-27
   Days after onset:62
Entered: 2009-04-08
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA03902

Write-up: Information has been received from a physician concerning a female patient who on 23-JAN-2009 was vaccinated with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck). The physician reported that on 23-JAN-2009 after the vaccination the patient experienced pain and erythema at the injection site. The patient sought unspecific medical attention. The patient recovered on 25-JAN-2009. Additional information has been requested.


VAERS ID: 343890 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2009-01-09
Onset:2009-01-24
   Days after vaccination:15
Submitted: 2009-03-27
   Days after onset:61
Entered: 2009-04-08
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1710X / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Blister, Herpes zoster, Varicella virus test positive
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVISTA; vitamins (unspecified)
Current Illness: Osteopenia; Cholesterol
Preexisting Conditions: Chickenpox
Allergies:
Diagnostic Lab Data: VZV strain, 01/10/09, VZV wild type strain
CDC Split Type: WAES0901USA03955

Write-up: Information has been received from a Master of Science in Dentistry and a Physician concerning herself, a 61 year old female patient with pre-osteoporosis and no know drug allergies, who on 09-JAN-2009 was vaccinated with a "single dose" of ZOSTER vaccine live (Oka/Merck) (lot # not provided). Concomitant therapy included, vitamins (unspecified) and EVISTA. On 24-JAN-2009 the patient developed a "shingles rash that is about 2 inches by 4 inches in the left hand side of the belly". It was reported that the patient had received in November 2008 a shot of influenza virus vaccine (unspecified). Patient sought medical attention by seeing her physician. No lab diagnostic studies were performed. At the time of this report the patient had not yet recovered. Follow up information received on 29-JAN-2009. Patient called back and reported that the "rash never developed into fluid-filled blisters but rather pimple-like". The rash is improving and she is not experiencing severe pain or pruritis. Follow up information was received from a physician who reported that the patient had a history of cholesterol and chickenpox when she was a child. The patient had no recent exposure to chickenpox or herpes ZOSTER. The patient was vaccinated with ZOSTER vaccine live (Oka/Merck) (Lot no. 663673/1710X) SC, 0.65 mL into the right arm. The physician stated that the patient did not develop the event (shingles) at the site of the injection. The patient had pain quantified as 0 in a 0-10 scale and did not present other systemic symptoms. The patient recovered from the event. The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. On 30-JAN-2009 the lesion sample was collected. On 04-FEB-2009 the sample arrived to the laboratory and the DNA was amplified. The PCR results confirmed that the VZV strain was related to a wild-type. The specimen was adequate. It is unknown the specific site where the sample was collected from. A photo of the lesion was taken. No further information is available.


VAERS ID: 343891 (history)  
Form: Version 1.0  
Age: 87.0  
Gender: Female  
Location: Colorado  
Vaccinated:2009-01-09
Onset:0000-00-00
Submitted: 2009-03-27
Entered: 2009-04-08
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Shingles
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA03956

Write-up: Information has been received from a registered pharmacist concerning an 87 year old female patient with recurrent shingles (about every two months) who on 09-JAN-2009 was vaccinated with one dose of ZOSTER vaccine live (Oka/Merck) SQ. Since receiving the vaccine, the patient continued to develop shingles about every three months. The patient had contacted the pharmacist for medical attention. Additional information has been requested.


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