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From the 1/14/2022 release of VAERS data:

Found 5,973 cases where Vaccine is VARZOS and Serious and Submission Date on/before '2015-09-30'

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Case Details

This is page 8 out of 598

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VAERS ID: 288137 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2006-11-13
Onset:2006-11-14
   Days after vaccination:1
Submitted: 2007-08-15
   Days after onset:273
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0622F / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Biopsy skin abnormal, Blood glucose normal, Glucose tolerance test normal, Granuloma annulare, Pruritus, Rash, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZETIA; hydrochlorothiazide; SYNTHROID; SINGULAIR; ZOLOFT
Current Illness: Seasonal allergy; Penicillin allergy; Drug hypersensitivity; Hyperlipidaemia; Hypothyroidism; Anxiety disorder; Glucose intolerance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: skin biopsy 01/24/07 - left inner thigh - granuloma annulare; glucose tolerance test 01?/??/07 - negative; skin biopsy 01/24/07 - right cheek - results not reported; fasting blood glucose 01?/??/07 - negative
CDC Split Type: WAES0706USA01950

Write-up: Information has been received from a physician concerning a 66 year old white female with seasonal allergies, allergies to penicillin, DEMEROL, codeine and "fluoroquinolones", hyperlipidemia, hypothyroidism, anxiety disorder and glucose intolerance who was vaccinated SC in the left upper extremity with a first dose of Zostavax (lot # 652965/0622F). Concomitant therapy included hydrochlorothiazide, SYNTHROID, ZOLOFT, montelukast sodium and ezetimibe. There was no illness at the time of vaccination. Within 24 hours of vaccination the patient developed a rash which was persisted. The rash covers her face, both arms, the trunk of her body and the lower limbs. The physician mentioned that the patient complains of a little itching, but no pain was noted. The patient went to see a dermatologist and an endocrinologist. The dermatologist performed a biopsy on 24-JAN-2007 which a diagnosis of granuloma annulare was determined. The endocrinologist performed various tests including fasting blood sugar and glucose tolerance testing in regards to possible diabetes that were all negative. As of 11-JUN-2007, the patient was recovering. Additional information from the physician indicated that on 14-NOV-2006, in the am, the patient developed a diffuse erythematous palpable macular rash in the bilateral axilla, torso and bilateral groin with pruritus. The patient had a biopsy of the left inner thigh and right cheek. The left inner thigh biopsy showed granuloma annulare. At the time of the report, the patient had not recovered. The physician reported that another office administered the vaccine. It was reported that the patient had no adverse events following prior vaccinations. The physician considered the patient''s experiences to be disabling. Additional information has been requested.


VAERS ID: 288145 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: New York  
Vaccinated:2007-07-11
Onset:2007-07-13
   Days after vaccination:2
Submitted: 2007-08-15
   Days after onset:33
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0461U / 1 RA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Atrioventricular block second degree, Bradycardia, Cardiac pacemaker insertion, Electrocardiogram, Fatigue, Muscular weakness, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol MDI; Crestor; Abalide 150/12.5
Current Illness: None
Preexisting Conditions: Right bundle branch block, Hyperthyroid PMH: abnormal TSH, HTN, hyperlipidemia, asthma, psoriasis
Allergies:
Diagnostic Lab Data: EKG LABS: serial cardiac enzymes were neg.
CDC Split Type:

Write-up: Weak legs, fatigue, nausea, bradycardia. Patient taken to Urgent Care sent via ambulance to ER second degree to heart block pacemaker placed 7-13-07. 8/17/07 Received PCP medical records which reveal patient was in usual state of health on 7/11/07. Returned to office on 7/24/07 as f/u to hospitalization where pacemaker inserted secondary to bundle branch block. Had right pneumothorax while in hospital requiring chest tube. Dx w/COPD at hospital. 8/28/07 Reviewed hospital medical records which reveal patient experienced tiredness, fatigue, dizziness & worsened SOB over a few days. In ER found to be in complete heart block w/ventricular rate of 32. Admitted 7/13-7/20/07 & pacemaker inserted 7/13. on 7/14 developed right side chest pain & decreased breath sounds. DX: right pneumothorax. Chest tube placed 7/14 & had persistent but intermittent air leak, chest tube d/c on 7/20. FINAL DX: complete heart block; right pneumothorax; s/p pacemaker.


VAERS ID: 288345 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Female  
Location: New York  
Vaccinated:2006-06-26
Onset:2007-07-05
   Days after vaccination:374
Submitted: 2007-08-16
   Days after onset:42
Entered: 2007-08-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Computerised tomogram abnormal, Condition aggravated, Convulsion, Facial paresis, Headache, Mass, Nervous system disorder, Vertigo
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: Breast cancer; Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: computed axial 07/05?/07 - 2 cm mass found in right frontal lobe
CDC Split Type: WAES0706USA04899

Write-up: Information has been received from a physician concerning his 61 year old white daughter with no allergies and a history of breast cancer 4 years ago and Non-Hodgkin''s lymphoma of the cervix 2 years ago who on approximately 12-JUN-2007 was vaccinated with a 0.65ml dose of Zostavax. Concomitant therapy included "ARAMIDEX". On approximately 16-JUN-2007, 4 days after vaccination the patient experienced vertigo with loss of balance and mild headache; no fever. The patient was seen by her physician who felt it was benign paroxysmal vertigo vs. post vaccination reaction. She was treated with an antihistamine. The patient''s oncologist had approved her of receiving the vaccine. No diagnostic laboratory tests were undertaken. At the time of report the patient''s symptoms were improving. A product quality complaint was not involved. Additional information has been received from the physician who stated that approximately 26-JUN-2007 the patient was vaccinated at her physician''s office and on 05-JUL-2007 patient experienced vertigo and balance difficulty. The patient had breast cancer from 2003 to 2007 and Non-Hodgkin''s lymphoma from 2005 to 2007. The patient''s oncologist cleared her before receiving vaccine. The patient was seen in her physician''s office and subsequently in ER for central nervous system symptoms; slight facial weakness and seizure like activity. A CT scan was done and a 2 cm mass was found in right frontal lobe. It was reported that the patient was recovering with treatment for possible recurrence of Non-Hodgkin''s lymphoma. At the time of report, the patient had recovered. The patient''s experience was considered to be disabling by the reporter. No further information is available.


VAERS ID: 288631 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-08-02
Onset:2007-08-06
   Days after vaccination:4
Submitted: 2007-08-21
   Days after onset:15
Entered: 2007-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-06
   Days after onset: 0
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: Cardiac disorder
Preexisting Conditions: Stroke PMH: mitral valve replacement; atrial fibrillation; pacemaker 8/2006; CVA; TIA; well controlled HTN; right cerebellar stroke; dental prophylaxis antibiotics; endometrial cancer; dyslipidemia; osteopenia; hysterectomy; seasonal allergies. Allergic to sulfa & quinidine.
Allergies:
Diagnostic Lab Data: Unknown LABS: last done 7/26/07, CBC & chemistry WNL. Glucose elevated 142. Digoxin WNL. PT/INR therapeutic.
CDC Split Type: WAES0708USA01838

Write-up: Information has been received from a pharmacy technician concerning a 75 year old (previously reported as "about 75 year old") female "in poor health" with heart problems and a history of stroke and other unspecified medical conditions who on 02-AUG-2007 was vaccinated with a dose of Zostavax. For an unspecified amount of time after vaccination the patient was observed for any reaction. The patient then left the pharmacy without any signs of an untoward reaction. Several days later the pharmacy technician read in the paper obituaries that the patient passed away on 06-AUG-2007. The cause of death was not reported. There was no product quality complaint involved. No further information was available. Additional information has been requested. 08/23/2007 Per email from FDA: A 75 y/o female in poor health with heart problem and a hx of stroke died 3 days after receiving Zostavax. Her name was in newspaper obituaries. She did not experience any immediate AEs after vaccination. Called Meck for follow up information including cause of death. 8/27/07 FDA obtained patient name & DOB from Merck. No autopsy was done. COD was intracranial hemorrhage. Merck will provide additional medical records. 9/7/07 Reviewed pcp medical records which reveal patient on chronic anticoagulant therapy for mitral valve replacement & was seen approx every 2 weeks for labs & eval. Weight & vital signs stable. 10/29/07 Reviewed Death Certificate which states COD as subdural hematoma with anticoagulation for valvular heart disease as contributing factor.


VAERS ID: 289354 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-08-29
Entered: 2007-08-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Varicella
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA04231

Write-up: Information has been received from a physician concerning a 65-year-old male who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently, on an unspecified date, the patient was admitted to the hospital with chicken pox. It was determined that the patient had "symptoms associated with acute varicella and not shingles." No outcome was reported. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 289355 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: New York  
Vaccinated:2007-06-15
Onset:2007-07-01
   Days after vaccination:16
Submitted: 2007-08-29
   Days after onset:59
Entered: 2007-08-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Drug hypersensitivity, Idiopathic thrombocytopenic purpura, Laboratory test, Platelet count
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin; atenolol; TRICOR; gemfibrozil; lisinopril
Current Illness: Drug hypersensitivity
Preexisting Conditions: Idiopathic thrombocytopenia, splenectomy
Allergies:
Diagnostic Lab Data: diagnostic laboratory - results not reported, platelet count - results not reported
CDC Split Type: WAES0708USA04473

Write-up: Information has been received from a registered nurse concerning a 70 year old female with a history of xylocaine allergy, and a splenectomy after idiopathic thrombocytopenia, who in "mid June 2007" was vaccinated SC with a dose of Zostavax. Concomitant therapy included gemfibrozil, lisinopril (manufacturer unknown), Tricor, atenolol and aspirin. The patient was seen by the doctor on 25-JUN-2007 with a 4-5 day history of bruising. The doctor prescribed prednisone as treatment. Lab studies included blood work and platelet counts, results were not reported. The patient also received platelets on multiple occasions as an outpatient. The patient was diagnosed with idiopathic thrombocytopenia "17 days after vaccination." The patient saw a hematologist and an allergist. The patient recovered "about three weeks ago" on approximately 02-AUG-2007. No other information was provided. There was no product quality complaint involved. The reporter considered idiopathic thrombocytopenia to be serious, life threatening, and other important medical events. Additional information has been requested.


VAERS ID: 289551 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-07-31
Onset:2007-08-07
   Days after vaccination:7
Submitted: 2007-08-30
   Days after onset:23
Entered: 2007-08-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bacterial infection, Body temperature increased, Dehydration, Dermatitis, Fungal infection, Herpes zoster, Hyperlipidaemia, Hypokalaemia, Impetigo, Malaise, Myalgia, Red blood cell sedimentation rate increased, Renal failure, Sepsis, Superinfection, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sulfonamide allergy
Preexisting Conditions: PMH: HTN, hypothyroidism, dyslipidemia, incontinence, depression
Allergies:
Diagnostic Lab Data: body temp, 102 F; 8/7/07 Admit LABS: wound c/s (+) for strep. Sed rate 37 (H). WBC 4.1(L), neutros % 83.9 (H), lymphs % 4.8 (L), monos % 10.9 (H). MRI of brain,EEG & carotid US all WNL. Echocardiogram revealed possible vegetation but was WNL by cardiologist review. 9/14/07 Admit LABS: renal US WNL. Creatinine 1.7, BUN 28. Na 130.
CDC Split Type: WAES0708USA04462

Write-up: Information has been received from a physician concerning his mother, a 76-year-old female with sulfonamide allergy who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently, on an unspecified date, about 5 days post vaccination, the patient developed shingles on her lower right flank. The area was about 16"x8" in size. She also had a temperature of 102 degrees fahrenheit, malaise and myalgia. She went to her physician, and fainted in his office. she was hospitalized and diagnosed with shingles, impetigo and fungal super infection. It is also reported that the vaccination caused overwhelming sepsis and bacterial super infection. She was treated with anti-virals, anti-biotics, and anti-fungals. She was released from the hospital after 5 days. It is reported that she is still recovering. No product quality complaint was involved. Shingles, fungal super infection, and impetigo were considered to be disabling, immediately life-threatening and were thought to be other important medical events. Additional information has been requested. 10/26/07 Reviewed hospital nedical records which reveal patient experienced right sided back & shoulder pain followed by rash eruption c/w shingles. Seen by pcp when developed increased pain & cellulitis secondary to bacterial infection. Admitted 8/7-8/12/2007. Tx w/IV antibiotics & antivirals. ID consult done. Neuro consult done for near syncopal episode. Cardiology consult done. Improved & was d/c to home on continued oral antivirals & antibiotics. FINAL DX: shingles; secondary bacterial infection; electrolyte imbalance; HTN; near-syncope; GERD; fever. READMITTED: 9/14-9/16/2007 as direct admit from pcp offfice s/p labs revealed elevated creatinine. TX w/IVF. Diuretic d/c''d. FINAL DX: dehydration, resolved; hypokalemia, resolved; renal insufficiency secondary to dehydration, resolved; anemia, stable; GERD, hyperlipidemia; contact dermatitis (laundry detergent). 11/2/07 Received vax info from pcp & VAERS database updated w/same. Per 60 day follow up: I still have pain in my back where I had the outbreak of shingles. The discoloration on my back is getting a lighter color, but is not completely gone. Please advise me how I might recover the $200.00 I paid form y vaccines-my medical bills and medication was ver expensive.


VAERS ID: 290353 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-09
Onset:2007-08-09
   Days after vaccination:0
Submitted: 2007-09-12
   Days after onset:34
Entered: 2007-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0883U / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angiogram, Blood pressure increased, Cerebral haemorrhage, Headache, Subarachnoid haemorrhage, Subdural haemorrhage, Visual field defect
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Accidents and injuries (broad), Hypertension (narrow), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paxil 20mg qd, Synthroid 112mcg qd,alprazolam .5mg prn (less than daily), ibuprofen 200mg prn (unknown frequency)
Current Illness: No
Preexisting Conditions: No known allergies; hypothyroidism, anxiety disorder PMH: HTN, hypothyroidism, depression.
Allergies:
Diagnostic Lab Data: see #7 LABS from ER: EKG revealed non specific ST-T wave changes. CT of head showed intracranial, SAH & SDH right occipital & CVA. CXR WNL. LABS from hospital: echocardiogram revealed LVH & left ventricular diastolic dysfunction. EEG WNL.
CDC Split Type:

Write-up: Approximately 4 hours after receiving Zostavax, patient develeoped sever headache & L visual field defect. Diagnosed with subacute hemorhage R occipital lobe, subdural and subarachnoid hemorhage aong the R cerepbral convexity. No ischemic changes, no acute injury, no abnormal enhancement. Normal CT angiographic study. Pt''s BP e;evated in hospital but no previous history of hypertension. TReated with observation, BP and pain medication. 9/18/07 Reviewed ER medical records which reveal patient experienced HTN (228/110 at home, 189/108 in ER), head pressure & lightheadedness, seeing spots. Transferred to higher level of care. 9/25/07 Reviewed hospital medical records which reveal patient experienced headache w/left sided visual defects. Admitted 8/10-8/15/2007. BP in outlying ER high. Neurosurgery, ophthalmology & neurology consults done. Medically managed & HTN controlled at time of d/c. HRT was d/c''d & patient started on Synthroid & Paxil FINAL DX: right occipital intracerebral hemorrhage w/adjacent SAH & SDH.


VAERS ID: 290451 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Nevada  
Vaccinated:2007-08-05
Onset:2007-08-05
   Days after vaccination:0
Submitted: 2007-09-12
   Days after onset:38
Entered: 2007-09-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Incorrect route of drug administration, Malaise, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLUCOTROL mg, lorazepam mg, oxybutynin mg
Current Illness: Urinary incontinence; Diabetes; Sleeplessness; Penicillin allergy; Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA00602

Write-up: Information has been received from a physician concerning a 75 white female with urinary incontinence, diabetes, sleeplessness and penicillin, codeine, Ambien allergies who on approximately 05-AUG-2007 (or 06-AUG-2007) was vaccinated IM with a single dose of Zostavax (Oka/Merck). Concomitant therapy included oxybutynin (02-AUG-2007 to 05-AUG-2007), Glucotrol XL (September 2006) and lorazepam (September 2006). On 06-AUG-2007, about 24 hours after vaccination the patient felt like she had achyness around the thorax and felt like she was going to get a shingles rash. It was reported that the patient felt achyness thoughout, had fever (on 07-AUG-2007), malaise and fatigue (on 06-AUG-2007) for 7 days and then felt ok. At the time of report the patient had recovered. The patient''s experience was considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 290452 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-08-27
Onset:2007-09-01
   Days after vaccination:5
Submitted: 2007-09-12
   Days after onset:11
Entered: 2007-09-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood culture, Blood culture negative, Nausea, Platelet count decreased, Thrombocytopenia
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: [therapy unspecified]
Current Illness: Hypertension
Preexisting Conditions: PMH: HTN, H. pylori, GERD, high cholesterol, arthritis
Allergies:
Diagnostic Lab Data: blood culture - no infection, platelet count 70000 LABS: Blood c/s neg. Urine c/s gram positive cocci. Phosphorous 1.7(L). LFTs elevated. CXR WNL. Platelets 71. WBC 5.7. Rapid strep neg. IgG 499 (L). IgM 361 (H). Varicella IgG & IgM (+)
CDC Split Type: WAES0709USA00813

Write-up: Information has been received from a physician concerning a 77 year old female with hypertension and no known allergies who on approximately 27-AUG-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant therapy included unspecified blood pressure medication. On an unspecified night (not the same night as the vaccination) after having dinner the patient developed nausea. The patient sought medical attention at the hospital and food poisoning was ruled out. Blood work revealed the patient had thrombocytopenia, platelet count 70,000 and blood culture revealed no infection. She was admitted to the hospital. The patient had no rash. The patient "is slightly getting better" since being admitted to the hospital. No further information was provided. There was no product quality complaint involved. The patient''s thrombocytopenia and nausea were considered serious for hospitalization. Additional information has been requested. 10/8/07 Patient demographics provided by CDC. 10/16/07 Reviewed hospital medical records which reveal patient experienced low blood pressure, nausea, vomiting, fever, fatigue, sore throat, dizziness, syncope. Exam revealed hypotension, throat erythema & vesicular lesions in mouth/throat. Admitted 9/5-9/8/2007. Tx w/IV antibiotics & antivirals FINAL DX: UTI, septic shock, acute renal failure, thrombocytopenia secondary to septic shock.


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