Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dyspnoea, Electrocardiogram T wave inversion, Fatigue, Heart rate abnormal, Hypotension
Clinical narrative: This spontaneous report as received from a 68 year old consumer (who is also a psychologist) refers to herself. The patient was vaccinated with ZOSTAVAX (dose, route and Lot# not reported) on 08-OCT-2012. No other co-suspects were reported. Concomitant medications included LEVOXYL, estradiol and NASACORT. On 08-OCT-2012 the patient experienced itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site. No treatment information was reported. The outcome of itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site was reported as not recovered/not resolved. The relatedness for itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site was not reported for ZOSTAVAX. Follow up information was received from the patient. The patient's current condition also included osteopenia, hypothyroidism and she cannot eat dairy. On 08-OCT-2012 the patient was vaccinated with ZOSTAVAX vial for her family history of shingles. Other suspect therapies included influenza virus vaccine (manufacturer unknown) (reported as unspecified flu shot) (dosage information unknown) on the same date. Concomitant therapies included estradiol patch and SYNTHROID. Immediately after vaccination on 08-OCT-2012, she developed soreness in left arm, which resolve in one day. However, she reported that her right arm got hot, swollen and itchy and the itching progressed to her right elbow on an unknown date. On 29-OCT-2012 (approximately, reported as 3 weeks post vaccination), her right upper arm developed pain (disability). This pain progressed to her right wrist (disability) on an unknown date in 2012. She stated it affected her ability to wash dishes. After a few months, she reported that localized symptoms decreased. However, on an unknown date, she developed systemic issues, including joint and muscular pain along with fatigue. She reported she could not even walk her dog. Beginning in spring 2013, she began is experience cardiac things (life threatening). She underwent stress tests and cardiac catheterization. Testing revealed no structural abnormalities or plague. On an unknown date in March 2013, she was admitted to hospital for left eye vision episode (hospitalisation) and was diagnosed with ocular migraine. During hospitalization in March 2013 she developed chest discomfort. Her EKG revealed T wave inverted. She stated she has electric abnormalities with rhythm issues on an unknown date in March 2013. Recently on an unknown date in 2014, her blood pressure and heart rate have had variability. Her baseline blood pressure was 110/60. She had been as low as 84/45. It was hard to put one foot in front of the other when blood pressure was that low. Her heart rate was 50 to 90 beats per minute. The patient also reported that a couple of weeks ago on an unknown date in 2014, she was admitted overnight to hospital due to lightheadedness, shortness of breath, nausea and pain in her back. She believes her symptoms are autoimmune-like. No diagnosis has been given to support at this time. She stated that she had multiple drug allergies and she has three pages of drugs that she is sensitive toward. It would be available upon request. The outcome of the event developed soreness in left arm was reported as recovered. The outcomes of the rest of the events were reported as not recovered. The causality of the events were unknown for ZOSTAVAX and influenza virus vaccine (manufacturer unknown). A product quality complaint (PQC) was not involved. Additional information has been requested.