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| Age | Vaccine Count | Count | Percent |
| < 3 Years | 1 | 1 | 0.02% |
| 4 | 1 | 0.02% | |
| total | 2 | 0.04% | |
| 17-44 Years | 1 | 9 | 0.18% |
| 2 | 2 | 0.04% | |
| total | 11 | 0.22% | |
| 44-65 Years | 1 | 694 | 13.77% |
| 2 | 79 | 1.57% | |
| 3 | 15 | 0.3% | |
| 4 | 1 | 0.02% | |
| total | 789 | 15.65% | |
| 65-75 Years | 1 | 733 | 14.54% |
| 2 | 91 | 1.81% | |
| 3 | 17 | 0.34% | |
| 4 | 1 | 0.02% | |
| total | 842 | 16.71% | |
| 75+ Years | 1 | 577 | 11.45% |
| 2 | 59 | 1.17% | |
| 3 | 5 | 0.1% | |
| 4 | 1 | 0.02% | |
| total | 642 | 12.74% | |
| Unknown | 1 | 2,699 | 53.55% |
| 2 | 40 | 0.79% | |
| 3 | 13 | 0.26% | |
| 4 | 1 | 0.02% | |
| 9 | 1 | 0.02% | |
| total | 2,754 | 54.64% | |
| TOTAL | 5,040 | 100% | |
| Case Details |
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a 71 year old retired physician with no known allergies and hypercholesterolaemia who on 7/11/06 was vaccinated in the left arm with a dose of varicella zoster virus vaccine live. Concomitant therapy included ezetimibe. A couple weeks after vaccination on 7/27/06, the pt experienced tachycardia that was persisted. He was seen by a two cardiologists and had an echocardiogram done which did not show anything. Two EKGs were done and his HR was 110-120. He also reported that he was having a little shortness of breath occasionally,but didn''t think, it was related to vaccination. He did not have any other cardiovascular problems. The physician reported his sustained tachycardia to be potentially life threatening and disabling because he wasn''t sure if his tachycardia was self limiting and temporary or would cause additional problems. He reported that he was nervous when his HR was high for 2-3 weeks. His cardiologist recommended unspecified medication, however the physician refused to take any medication. As of 8/10/06 the physician reported that his heartrate was gradually slowing down, it was 90-100 which was better than before but still not back to normal. Four months prior to vaccination the pt scheduled knee surgery for 8/22/06. He explained that he would proceed with the surgery as long as his heart rate was back to normal. Additional information has been requested. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a male pt who on 9/9/06 was vaccianted with a dose of varicella zoster virus vaccine live. On 9/8/06 the pt was hospitalized with a rash. The was diagnosed with a zoster infection. No outcome was reported. No product quality complaint was involved. Additional information has been requested. | |||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Received Zostavax and flu vaccine on 10/11. Developed fever 102.4 documented on 10/18. Was admitted for IV fluids. No other obvious source found. Had recently been hospitalized and operated for small obstruction which made him susceptible to the dehydration factor. No infectious etiology found related to fever. Hospital and PCP MRs received documenting 73 yr old who presents 1 week s/p Flu and Zostavx immunizations with fever, dysuria, and not feeling well. Patient reports need to push on bladder to empty. Admitted to hospital for hydration and IV antibiotics. Impression: "Suspect UTI from inability to empty bladder well. Doubt reaction to Zostavax" Discharge DX: Fever, Dehydration, Hydronephrosis, BPH with outlet obstruction, concha bullosa, anemia, and past hx. of abd. incision dehiscence. | |||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes Write-up: This pt my brother received Zostavax and a flu vaccine on the same visit approx 7-10 days prior to developing a stroke. The stroke by MRI MRA was a complete occlusion of his R internal carotid artery with the MCA arterial distribution affected. Risk factors were hyperlipidemia but this was well controlled with statin Zocor 40 for years. No hypertension. No diabetes. Healthy life style, occasional daily cocktail, non smoker ever. Only prior medical history otherwise was a urethral stone two or three years ago. 02/27/07-records received and reviewed for DOS 11/5-11/8/06 DC DX: cerebrovascular accident secondary to carotid dissection on the right side. hyperlipidemia. Admitted with left sided facial droopiness. He had a right internal carotid artery dissection is hole. He still has cognitive impairment (mild), R facial droop. He wil never be able to believe Per 60 day follow up: Pt had a right internal carotid artery dissection. He had a large R MCA stroke. He has regained most use of left hand. He still has a large left lip droop. He has difficulty with speech, of math calculations and difficulty concentrating. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a medical assistant and an 89 year old female consumer with arthritis, increased cholesterol levels, coronary artery disease and shingles. since 9/28/1992 and a history of a mass in the right hand with surgery, gout, skin cancer on her face in 1984, cellulitis, cholelithiasis in 1978 and a heart attack in 1988 and 1989, she had angiogram in 1990 and a 30% double vessel occlusion. On 9/6/06 was vaccinated SC in the right arm with a dose of Varicella zoster virus vaccine live. There was no concomitant vaccinations. Concomitant therapy included Carbatrol, Allopurinol, Synthroid, Simvastatin, Spironolactone, aspirin and Tylenol. The pt thought that one shot of the vaccine would cure her shingles. It was noted that the pt was not experiencing pain from the injection site. the medical assistant also stated that the pt had pain from a previous shingles experience, however, the pain is reportedly worse since receiving the vaccine. The pt was worse later in the day and has interrupted the pts ability to sleep at night. It was reported that the pt did not experienced a rash. The pt had reported that she was previously seen by a neurologist, had acupuncture but nothing works for her shingles. About 3 weeks ago, on approx 10/16/06, the pt was experiencing severe pain in her back area after receiving varicella zoster virus vaccine live. At the time of this report, the pt had not recovered. It was reported that the pts experienced were disabling. Additional information has been requested. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a investigator concerning a 71 year old male with an enlarged prostate (April 2005) and an allergy to Sulfonamide who entered a study. On 29 Nov 2006, the patient was vaccinated SC in the deltoid with a 0.65 ml dose of varicella Zoster vaccine. Concomitant vaccination on 15 Nov 2006 included a dose of influenza virus vaccine (unspecified). On 29 Nov 2006, prior to vaccination with study therapy, the patient arose early and went exercising without having breakfast. The patient was then screened and vaccainted with Varicella Zoster vaccine. He was observed for 30 minutes and was released feeling well. The patient went home and had breakfast that consisted of eggs and cinnamon bread. Two hours post vaccination, the patient suddenly felt dizzy and nauseated followed by episodes of vomiting. The patient also experienced the sensation of numbness affection his arms, legs and neck. The patient felt clammy and looked pale to his wife who called the study site and spoke with the investigator and his primary care physician. The patient was taken by ambulance to the emergency room on 29 Nov 2006 for nausea, vomiting and vertigo. he was hospitalized for 24 hours in the emergency room and was discharged on 30 Nov 2006. The discharge diagnosis was rule out myocardial infarction with the additional diagnoses of benign paroxym/smal vertigo, dehydration, possible allergic reaction to varicella zoster vaccine. On 01 Dec 2006, the patient was called post release from the emergency department and he felt well. Again, he skipped breakfast and went to exercise. He arrived home to feel lightheaded and fatigues. He took a nap and felt better. On 04 Dec 2006, the patient was called again for an update. He rested over the weekend without further nausea or vomiting. He stated that he felt about 90 percent. Again, he exercised without breakfast and felt lightheaded. He stated the he has continued to have intermittent feelings of dizziness. The patient considered recovered on 30 Nov 2006. The patient''s nausea, vomiting and vertigo was considered to be other important medical events (OMIC). The reporter felt that the patients nausea, vomiting and vertigo was possibly related to vaccination with varicella Zoster vaccine. Additional information has been requested. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning an "over 60" year old female who in approximately December 2006, was vaccinated with a dose of ZOSTAVAX. Subsequently, 3-4 days after receiving ZOSTAVAX the patient developed numbness in her legs, lips and around her mouth, and a fever. The patient "could not walk" due to this event. The patient was referred to a neurologist to rule out Guillain-Barre Syndrome. The patient was also referred to an infectious disease specialist to determine if the event was vaccine related. At the time of the report the patient''s numbness had improved but she was still spiking a temperature of 100-101 degrees. Unspecified "blood work" was performed. The patient was discharged from the hospital after 11 days as an inpatient. There was no product quality complaint involved. No additional information was available. The reporter considered the patient''s events to be disabling and serious for hospitalization. Additional information has been requested. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a 65 year old female with no allergies or medical history who on 19-Dec-2006 was vaccinated with a 0.5 ml dose of varicella-zoster virus vaccine live. Concomitant therapy included cetirizine hydrochloride (ZYRTEC). On 19-Dec-2006, the patient experienced a headache after vaccination and was hospitalized. The patient recovered on 20-Dec-2006. No diagnostic laboratory test were performed. A product quality complaint was not involved. No further information is available. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information had been received from a consumer concerning his 62 year old wife with shingles around one of her ears, a penicillin allergy and a history of hysterectomy who was vaccinated in December 2006 with a dose of varicella zoster virus vaccine live. Concomitant therapy included medicine for diabetes, high blood pressure and cholesterol. Approximately twelve days after vaccination, she broke out with rashes and hives all over her body. She was hospitalized on 05 Jan 2007. She was currently still hospitalized. Unspecified laboratory test were performed, the results were not reported. The husband mentioned that approximately one month before his wife was vaccinated she had her first outbreak of shingles in the are around one of her ears. She had almost fully recovered from the shingles at the time she was vaccinated. At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested. | |||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning her 77 year old mother with a arthritis in her finger, osteopenia and no known drug allergies who in December 2006 was vaccinated SC with a 0.5 ml dose of Zostavax vaccine. Concomitant therapy included Celebrex, alendronate sodium and calcium (unspecified). Subsequently four to six days after vaccination, in December 2006, the patient developed sciatica. She was treated with oral steroids. As of 25-Jan-2007 the patient was recovering. The physician reported that her mother was still having some problems and was going to physical therapy. She explained that prior to vaccination, her mother was very healthy and active and exercised on a regular basis. It was noted that the patient had no rash. The physician considered the sciatica to be disabling and an other important medical event. Additional information has been requested. | |||||||||||||||||||||
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