Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed mood, Feeling of body temperature change, Irritability, Myalgia, Myocardial infarction
Clinical narrative: Information has been received from an 80 year old female patient with high blood pressure, thyroid disorder, lymphoma, allergy to Promethazine and Ketorolac, who on 06-MAY-2009 was vaccinated with once dose of ZOSTAVAX. Concomitant therapy included SYNTHROID, TOPROL and ATACAND. The patient stated that she had a weakened immune system and was given ZOSTAVAX and on the same day experienced weakness, pain in her calf and legs. The patient stated that she had shingles about twelve years ago. The patient did not seek medical attention. Follow up information was received from the consumer. She reported that she was experiencing "itching in my forehead and neck and a lot of hair breakage off". She believed the hair breakage was getting slightly better however, the itching was not improving. The patient stated she had a history of lymphoma, lymph disease, fibromyalgia and Parkinson's disease. She stated that she did not feel she was properly notified about the possible risks associated with the vaccine. Follow up information has been received from a physician concerning an 80 year old female with blood pressure high, hypothyroidism, lymphoma, allergy to Promethazine and Ketorolac, lymphatic disorder, fibromyalgia, Parkinson's disease, weakened immune system, urinary frequency, dysphagia, back pain, left ear pain, stress incontinence, acute bronchitis, abdominal pain, cerebrovascular disease, depression, gastrooesophageal reflux disease, myalgia, type 2 diabetes mellitus, mixed hyperlipidaemia, glycosuria, pain in hand, temporomandibular joint syndrome and Baker's cyst and a history of bad breath, diverticulitis, haematuria, irritable bowel syndrome and urinary retention who on 06-MAY-2009 was vaccinated with ZOSTAVAX. The patient was vaccinated at another facility but they had not contacted the physician regarding any adverse reaction. The patient assured the physician that she was "not convinced" that her symptoms had anything to do with the vaccine. The physician reported that the patient has chronic ongoing issues with her fibromyalgia. The physician noted that she seriously doubted that the patient had any adverse reactions. Follow-up information was received from the consumer who mentioned that she had multiple tests done so far including MRI (Magnetic Resonance Imaging) and CAT-scan (results not provided) to determinate what is causing her problems and "the doctors are bewildered". The reporter also mentioned that she had rash on her face, muscle pain and joint pain and her arteries were beginning to deteriorate. Follow up information has been received from the 80 year old female patient consumer who on 06-MAY-2009 was vaccinated with once dose of ZOSTAVAX, she reported that she experienced losing of hair, itching face and spine problems. She stated that her physician was looking because she has never suffered with problems with arteries, spine, nor joint and muscle pain. On an unspecified date, a blood work was performed with unknown results. At the time of this report the patient outcome was unknown. The patient also stated that she still had itching on her forehead and on her back. Follow up information has been received from a consumer who reported that she was vaccinated even though she had lymphoma, of which she recovered with chemo. She did not sign a form stating this information and possible side effects. The hospital and the physician have not any record, giving signed permission. Her medical records were available. She felt betrayed and also very sad. At her 81 years of age. She has some health problems but nothing like she is now facing. Viruses, MRI, labs, CAT scans have stated "I will require strong drugs - Codeine, methocarbamol. The cardiologist wanted to give me morphine for my pain. I call it screaming pain." She and her husband felt betrayed. This all started after the ZOSTAVAX vaccination. She was a very active 81 year old woman. The patient also reported that she did not require any assistance in her home. She loved to garden, fish, entertain and shop. The entertainment was shop. She was very ill with the cancer but never did feel handicapped. Now she has arterial disease and neuropathy spine. There were found since the injection, never before in tests. She was a proud person but now she would need assistance. She was using a cane, walker, and was having a handicap ramp built. She was looking into assisted living facilities and housekeeping. Shopping is torture for her. She reports extreme temperature changes to hot and cold. It is inhibiting her way of life. She can no longer exercise. Follow up information has been received from an 80 year old female consumer reporting on herself who stated that she developed an itchy area near her hairline after receiving ZOSTAVAX and that bumps developed in the area. Consumer reported that the rash had persisted for "quite some time" but she was unable to recall the date she received the vaccine or when the rash developed. Consumer denied pain at the site, but stated that she had been experiencing pain since the injection at an unspecified location. She stated that she would make an appointment with the physician and that she would seek treatment. At the time of reporting no treatment was given for this adverse event. Patient had not recovered from itchy area near her hairline, bumps developed in the area, rash and pain at an unspecified location. Follow up information has been received from an 80 year old female consumer who stated that there was still itching near her hairline which was intermittent, she still had bumps in that area and she stated that she was still having an itching in her nose after received ZOSTAVAX. Consumer stated that there was not pain, "it was just irritating". Follow up information has been received from a 80 year old female consumer who reported that she now has severe pain "all over her body" and that the pain is a "20" on a scale of "1-10". Follow up information has been received from an approximately 80 (previously reported as 80) year old female consumer. The consumer reported that the weekend of 04-FEB-2012, she was rushed to the hospital. She had a heart attack and was admitted to the hospital for four days. The consumer stated she was not able to have surgery (not further specified) because the physician told her she "would not make it through the surgery". Follow up information has been received from an approximately 80 year old female consumer. The consumer reported she was administered ZOSTAVAX while she had a lymphoma. The consumer reported she was admitted to the hospital on 03-FEB-2012 because she suffered a heart attack. The consumer reported she had no previous heart damage and suspected that the cause of her heart attack was because the ZOSTAVAX was administered "when it was not supposed to be given to her." She was hospitalized from 03-FEB-2012 through 06-FEB-2012 from the time she had her heart attack to the release date. The consumer reported she had not recovered and was told her "arteries stopped working" and could not have surgery because she was "at risk of dying". Follow up information has been received from an approximately 80 year old female consumer. The consumer reported on 27-FEB-2012 that "two weeks ago" she had a heart attack (the consumer previously reported she was hospitalized from 03-FEB-2012 through 06-FEB-2012 from the time she had her heart attack to the release date). The consumer stated "my heart is destroyed, my arteries are destroyed and my enzymes are off". Follow-up information was received from the patient's primary care physician in the form of a letter to the company (date of letter 27-FEB-2012). The physician stated the following in the letter: "I have not seen this patient in nearly two years. It came to my attention last fall that she felt her "scalp itching" was due to the ZOSTAVAX she was given at the local health department around two years ago. I wrote her a letter, recommending she come in so that we could determine the actual cause. She has not returned to my clinic, or any other clinic that I am aware of, to have any of her complaints evaluated as possibly being caused by a reaction to the ZOSTAVAX. Since last fall, it is my understanding that her list of complaints has increased. She has been followed by numerous specialists for her various complaints. It is worth noting that some of her complaints go back before her vaccination. I did review her history from old charts that were retrieved. Apparently, she was diagnosed with lymphoma I believe in 1983. She underwent treatment and has had no reoccurrence since then (30 yrs ago). I cannot find any actual operative report, oncology reports or laboratory reports regarding this diagnosis. There is no objective information supporting her claim that her pains, visual changes, bumps on her face, etc., are in any way related to this vaccination". Follow up information has been received by the consumer who reported that on 17-OCT-2011 her arm started hurting in the afternoon. She stated that "the big muscle at the top of her arm really hurt. She did not seek medical attention and no treatment was given for the event. At the time of the report the consumer's event persisted. She also reported she had hair loss, her body and head itch, few small bumps on face, and also had an "unusual in the night blue, green streaks of light would reach in her walls". She was also in severe pain, her muscles and bones also spine. Medical scans, magnetic resonance imaging (MRIs), vascular arteries scans prove it. The patient reported that she has been intervened by various medical personnel. The patient reported that her arteries were "found to be serious". The patient sought medical attention on 07-OCT-2009 and on 12-OCT-2009. Follow up information was received from a physician concerning the retired patient with no known illness at the time of vaccination. There were no known adverse events following prior vaccinations. This physician never saw the patient to assess any problems. The physician apparently gave the patient a prescription for the vaccine however it was not administered by the physician's office. The following list of pre-existing allergies, birth defects and medical conditions were provided by the reporter: "ICD: 729.1 (2005), 401.9 (2005), 564.1 (2005), 244.9 (2005), 332.0 (2005), 250.0 (2008), V13.5 (2008), 524.60 (2006), 530.81 (2008), 437.9 (2009), 789 (2009), 787.20 (2009), 724.5 (2009), 724.02 (2010), 611.71 (2011), 472.0 (2010) and V10.79 (1983)". Follow-up information was received from the consumer who reported she still experiences itching and tiny red bumps on her hips, shoulder, arms and around her hairline after she received ZOSTAVAX. The patient reported she experienced "burning on her back" during the night and cold cream was applied by her husband which provided her with some relief. No further information was provided. Additional information has been requested.