Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Infarction, Intensive care, Ischaemic stroke, Pain, Pain in extremity
Clinical narrative: Ischemic Stroke/acute ischemic stroke/embolic stroke/evolving acute left frontotemporal lobe infract (right facial weakness, right face droop, facial palsy, M2 branch occlusion, unable to speak)/cva; hyperlipidemia/high cholesterol; claustrophobia; shingles (painful rash on right arm); The UDS was Positive for cannabinoids; feeding tube; CO2 22; Cl 112; CT angio neck and head/Fluid in the right maxillary sinus. Periapical lucencies associated with several remaining maxillary teeth, possible dental abscesses.; Periapical lucencies associated with several remaining maxillary teeth, possible dental abscesses.; WBC 13.5; PLT 105, 103, 101, 112; supraclinoid internal carotid artery stenosis; dysarthria; Expressive aphasia/dense expressive aphasia/lost his speech/he spent one moth in a rehabilitation center learning how to talk again; lost ability to swallow/he learnt how to swallow again/Dysphagia; atherosclerosis of aorta/Beam hardening artifact from bilateral shoulders/Calcified plaque in the carotid bulb and proximal ICA bilaterally/aortic calcification; The Zostavax vaccine caused me to still contract (reported as contact) the shingles virus; This initial spontaneous report was received from a lawyer via a Plaintiff Fact Sheet, regarding a case in litigation, concerning a 63-year-old male patient (pt). In 1959, when the pt was 7 years old, he was diagnosed with chicken pox. He never received chicken pox vaccine. He used to smoke cigarettes from 1963 to 01-NOV-1978, 2.5 packs per day. On 02-OCT-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in the right arm (lot#, expiration date, exact dosage and route of administration were not provided), as prescribed by the physician. The pt claimed that as a result of zoster vaccine live (ZOSTAVAX), he experienced ischemic stroke and expressive aphasia. Zoster vaccine live (ZOSTAVAX) vaccine caused him to still contract (reported as contact) the shingles virus. Seven months after he received the vaccine, he had a stroke. He lost his speech and the ability to swallow. He spent one month in a rehabilitation center learning how to talk and swallow again. The pt first became aware of the injuries on the night of 24-MAY-2016 at around 11pm. He stood up from the couch and started pacing and moving the tv remote from one hand to the other and he was unable to talk. His brother called 911 and the pt was taken by ambulance to medical center. He was told he was having a stroke. The pt first became aware of the injuries when he started getting a painful rash on his right arm. He went to the doctor and he was told it was shingles. Then, about seven months later on, he had a stroke. He lost his speech and ability to swallow. The pt was diagnosed with shingles on 22-OCT-2016 (conflicting information (date of diagnosis confirmed with medical record)). On 24-MAY-2016, he was diagnosed with ischemic stroke and expressive aphasia. As a treatment for the aforementioned injuries the pt alleged to have been caused by zoster vaccine live (ZOSTAVAX), he received following medications: tissue plasminogen activator (TPA), sodium chloride (both 24-MAY-2016); glucose (D50 WINS SUG), clopidogrel (PLAVIC), atorvastatin calcium (LIPITOR) (both from 24-MAY-2016 to 2019); chlorhexidine gluconate, ondansetron and paracetamol (ACETAMINOPHEN) (all three: 29-MAY-2016). On 22-OCT-2016, the pt asked his physician where the shingles came from, if he just took the vaccine. The physician mentioned the pt probably experienced shingles because of the vaccination. The pt did not know if any test was performed by a health care provider to determine if the rash following vaccination with zoster vaccine live (ZOSTAVAX) was wild type or vaccine strain varicella zoster virus. No health care provider ever told the pt that he had vaccine strain varicella zoster virus. The pt claimed that his receipt of zoster vaccine live (ZOSTAVAX) did not cause or aggravate any psychiatric and/or psychological condition(s) (other than pain and suffering and emotional distress), for which treatment was sought from a health care provider. In the 7 years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present, the pt received inpatient or outpatient care from the following health care providers: primary care physician (PCP) (dates of care: 2005 to 2015 and 2015 to present), physical speech therapist (dates of care: 29-MAY-2016 to unspecified date in 2016). The pt was diagnosed with the following medical conditions for which she required hospitalization or recurrent medical care and treatment or medication in the 7 years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present: severe obesity (dates of care: 28-SEP-2008 to present), high blood pressure and asthma (dates of care: 2010 to present), high cholesterol (onset, outcome and causality were not reported) (dates of care: 2015 to present) and osteoarthritis (the pt did not recall start date to present). In the 7 years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present, the pt had taken on a regular basis the following prescription medications: hydrocodone (the pt did not recall start date to present) as a pain relief, metoprolol tartare (the pt did not recall start date to present) as a beta blocker, Ventolin (2010 to present) as  a inhaler, clopidogrel (2015 to present) as a blood thinner (clopidogrel (PLAVIX) was also reported in medical record as a treatment for aortic atherosclerosis and ischemic CVA), atorvastatin (2015 to present) for cholesterol, losartan (2015 to present) for blood pressure and simvastatin (2015 to present) for high cholesterol. The outcome of the events was not provided. Reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Follow up (FU) information has been received on 26-AUG-2021 via a medical record regarding a case in litigation and refers to a male pt. The pt's surgical history included coronary artery disease (CAD) percutaneous coronary angioplasty (2 stents placed), performed on 29-SEP-2008. The pt's historical condition included Bell's palsy, which resolved and chicken pox when he was younger. The pt was a smoker (conflicting information). His concurrent conditions included: knee degenerative joint disease (DJD) (osteoarthritis, advanced degenerative changes in cervical spine), neck and low back pain due to degenerative disk disease, severe obesity, diabetes mellitus type II (DM2) diet controlled, CAD, hypertension, asthma, ischemic cardiomyopathy. The pt's immunization history included: unspecified tetanus (+) diphtheria vaccine (25-FEB-2004), unspecified influenza split virus vaccine (21-NOV-2001, 17-NOV-2003 and 28-NOV-2007, 10-NOV-2010, 21-OCT-2013, 29-SEP-2014), unspecified influenza vaccine (22-OCT-2008), unspecified pneumococcal vaccine (manufacturer unknown) and tetanus (+) diphtheria (+) acellular pertussis (both 08-JUN-2015), influenza vaccine inact sag 3v (FLUVIRIN) (09-NOV-2015 and 21-OCT-2016). On 24-MAY-2016, the pt was brought in by ambulance to hospital for speech difficulty. The pt was in his usual health until 10:50 pm at home when his brother reported the pt stood up from couch and started pacing and moving a TV remote between his hands. He was unable to speak when questioned so brother called EMS. No right sided weakness except for right (R) sided droop. Initial National Institutes of Health Stroke Scale (NIHSS)=10 (could not answear either question, followed only 1 command, 2 facial palsy and dysarthria, 3 aphasia). Tissue plasminogen activator (TPA) was given at 11:55 pm, 23 minutes after arrival. Computerized tomogram (CT) showed M2 branch occlusion per teleneurologist and interventional neuroradiologist read. Family felt the pt had improved slightly since TPA. He was able to say daughter's name and could write to them on a pad but still expressive aphasia. The pt needed inpatient admission for treatment of acute ischemic stroke, which would require more than 2 midnights, and could not be managed as an outpatient. On 26-MAY-2016, the pt was transferred out of ICU to telem. On that day, ct head revealed evolving acute left frontotemporal lobe infract and no hemorrhagic conversion. Likely embolic phenomena. Patient with improvement in symptoms, but swallow evaluation failed thus with tube feeds, placed on 27-MAY-2016. Plan included: appreciate Neuro recs, continue clapidogrel (PLAVIX), PT/ST/OT and could resume blood pressure meds (losartan and metoprolol), atorvastatin calcium (LIPITOR). At the time of the visit, the pt;s medications included: losartan, metoprolol, simvastatin, ASA, furosemide (LASIX). On 26-MAY-2016, the pt had ct head without contrast performed, which revealed: There was patchy parenchymal hypodensity in the left frontal lobe and temporal lobe extending to the cortex which appears more conspicuous from previous exam suggest evolving acute infarct, no hemorrhagic conversion. There was calcification of intracranial arteries. Impression: evolving acute left frontotemporal lobe infarct, no hemorrhagic conversion. On 27-MAY-2016, the pt had chest X-ray performed (in regard to feeding tube placement), which revealed: Portable antero-posterior (AP) chest demonstrates an esophageal catheter that extended. On 29-MAY-2016, the pt was discharged from the hospital. On 22-OCT-2016, the pt presented at the office complaining of rash on the right arm and pain. He had deep burning pain on the right arm for the (last) 4 days, since 18-OCT-2016. On 21-OCT-2016, reported as yesterday, he noticed rash on the right arm. On that day he was seen by the provider and was given atorvastatin calcium (LIPITOR) prescription, as the provider thought the rash was a reaction to the medicine. Physical examination on 22-OCT-2016: right arm: group vesicles lateral arm. Assessment and plan: herpes zoster. Discussed diagnosis with pt, treatment, ways to prevent spread of infection. Plan: valacyclovir, acetaminophen. The pt agreed to cal primary care physician (PCP) if with no improvement or if worsening of symptoms. At the time of the visit, the pt's medication included: atorvastatin (LIPITOR), losartan (COZAAR), clopidogrel (PLAVIX), acetaminophen (MAPAP) and metoprolol tartare (LOPRESSOR). The outcome of the events was not provided. Causality assessment was also not provided.  Information received on 26-AUG-2021 contained the following events: claustrophobia (onset, outcome, treatment and causality were not reported), hyperlipidemia (onset, outcome, treatment and causality were not reported), fluid in the right maxillary sinus (onset: 24-MAY-2016, outcome, treatment and causality were not reported), fluid in the right maxillary sinus/periapical lucencies associated with several remaining maxillary teeth, possible dental abscesses (onset: 24-MAY-2016, outcome, treatment and causality were not reported) supraclinoid internal carotid artery stenosis (onset: 24-MAY-2016, outcome, treatment and causality were not reported), aortic atherosclerosis/aortic calcifications (onset: 24-MAY-2016, treatment: statin, BB, ARB, clopidogrel (PLAVIX), outcome, and causality were not reported), white blood cell (WBC) 13.5 (units not reported, onset: 24-MAY-2016, outcome, treatment and causality were not reported)), platelet (PLT) 112, 101, 103, 105 (units not reported, onset: 24-MAY-2016, outcome, treatment and causality were not reported)), carbon dioxide 22 (units not reported, onset: 26-MAY-2016, outcome, treatment and causality were not reported)), chloride (Cl) 112 (units not reported, onset: 26-MAY-2016, outcome, treatment and causality were not reported)), urinary drug screen (UDS) positive for cannabinoids (onset: 14-JUN-2016, outcome, treatment and causality not reported).  Upon internal review, the events of embolic stroke, feeding tube and supraclinoid internal carotid artery stenosis were determined to be medically significant.   All available medical records will be provided upon request.