Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: pneumonia; blood clot in lung; kidney stone; neurological injury (occipital neuralgia); Postherpetic neuralgia (PHN); nauseated; passed out; The vaccine did not prevent shingles as intended; severely debilitating case of shingles/herpes zoster/herpes viral infection/"awful, awful" case of shingles. She further described them as all over his chest and too painful to touch./ persistent strain of herpes zoster / shingles; postoccipital headache; codeine allergy; A week prior to that  Zostavax vaccination the patient received his Pneumovax vaccination; This spontaneous report as received from a physician via company representative (field employee) refers to a male patient of unknown age with hypertension and hypercholesterolemia. In 2011 (exact day unspecified) the patient was vaccinated with zoster vaccine live(ZOSTAVAX), one time, subcutaneously (dose and lot number not reported). Other suspect therapies included pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot number and route not reported), given about the same time (in 2011) as receiving zoster vaccine live(ZOSTAVAX) vaccine. On an unknown date, the patient developed a severely debilitating case of shingles. The physician reported that it was the worst case of shingles that they had ever seen in 30 years. The patient had also been travelling and it was upon his return that he developed shingles. There was unspecified treatment given for the event. The patient sought medical attention (doctor visit). There was no intervention required to prevent the seriousness criteria. There was no hospitalization. There was no PQC involved. The event was not life-threatening. The outcome of the event was unknown. Relatedness between the therapies and the event was unknown. Reporting physician considered shingles to be disabling.  Follow up information received with updates: this spontaneous report as received from a physician regarding a 69 year old male patient via Program. On 24-OCT-2011 the patient was vaccinated with zoster vaccine live (ZOSTAVAX), lot# 670542/0619AA expire date 26-JUL-2012 in left arm. Prior to this vaccine, on 17-OCT-2011 the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). It was reported that on 22-APR-2014, a program sample of the vesicle from the skin was obtained. The clinical data obtained was about differentiating rash unspecified or shingles. The specimen was obtained from the back superior lateral upper. It was described as received information is an 8x7x1 mm shave specimen of skin. Blanched and submitted in one cassette(s). It was confirmed to be herpes viral infections which consist with herpes zoster. It was noted that on an unknown date, the patient experienced herpes zoster. The patient was already on treatment (unspecified). On an unknown date the patient recovered from the above experience. It was also reported that the patient not had chickenpox or shingles on VZV exposure recently.  Follow up information was received from Registered Nurse. She reported that on unspecified date in 2011, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and one week later in October 2011, the patient received a dose of  zoster vaccine live (ZOSTAVAX). She stated also that on unspecified date, the patient developed "awful, awful" case of shingles. She further described them as all over his chest and too painful to touch. Nurse reported shingles were actually hardened. Patient had biopsy completed by a Dermatologist. The outcome of painful skin was unknown. Relatedness between the therapies and painful skin was unknown.  Follow up information has been received on 13-MAY-2014, The registered nurse stated that she had faxed over the information on the program questionnaire. The RN stated the patient received the zoster vaccine live (ZOSTAVAX) vaccine in 2011 (unspscified date). A week prior to that zoster vaccine live (ZOSTAVAX) the patient received his pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. The R.N was concerneed about "that in 2013, the company all of a sudden told them there needs to be at least 2 weeks between vaccinations of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster vaccine live (ZOSTAVAX)".  Follow-up information was received from a lawyer on 04-FEB-2020, regarding a case in litigation and refers to a 69-year-old male patient. In 2013 (conflicting with information received previously from program), the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 23-APR-2014, patient was treated by a healthcare provider for a blistering vesicular outbreak, which was diagnosed as shingles. Patient was prescribed gabapentin and acyclovir for management of his painful symptoms and chronic pain. On or about 21-FEB-2017, patient sought subsequent treatment from a healthcare provider for a blistering vesicular outbreak, which was diagnosed as herpes zoster. Patient was again prescribed gabapentin and acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).  Follow-up information was received on 22-JAN-2021 from a lawyer via a Plaintiff Fact Sheet, concerning the 69-year-old male patient (pt). Pt's medical history included chicken pox. He had never received varicella vaccine. He was a non-smoker. On 01-DEC-2013 (conflicting with information received previously from program), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in the left arm. The pt claimed that as a result of zoster vaccine live (ZOSTAVAX), he experienced shingles (herpes zoster), postherpetic neuralgia (PHN) and neurological injury (occipital neuralgia). Pt experienced severe pain on his left arm with temporary loss of movement of this arm for approximately 4 months. He first became aware of the injury on approximately 20-APR-2014. Pt saw the blisters, went to the doctor and asked him about it because he thought it was sun poisoning. Doctor did a biopsy and called 2 days later to let pt know it was shingles. Diagnosis of shingles was made by a physician on 20-APR-2020 and 24-APR-2020 and "shingles" gel (not specified), acyclovir and gabapentin were prescribed; diagnosis of PHN was made on 23-MAY-2014; and with occipital neuralgia on 21-FEB-2017. No test was performed by a Health Care Provider to determine if the rash 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. 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). In the 7 years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present, the pt received inpatient or outpatient care from health care providers for the following conditions: prostate problems (dates of care/treatment: 2007-2015), urology/prostate problems (dates of care/treatment: 2015-present), pneumonia (dates of care/treatment: 25-AUG-2019-December 2019), blood clot in lung (dates of care/treatment: 25-AUG-2019-December 2019). 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: high blood pressure (dates of care/treatment: 2000-present), prostate (dates of care/treatment: 2014-present), pneumonia (dates of care/treatment: 25-AUG-2019 to 05-SEP-2019), blood clot in lung (dates of care/treatment: August 2019 to April 2020). 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: valsartan (DIOVAN) (2000-present) for high blood pressure, tadalafil (2006-present) for kidney flow/prostate, prednisone (30-JUL-2012 to 09-AUG-2012) (pt did not recall the indication), azithromycin (15-NOV-2012 to 21-NOV-2012) (pt did not recall the indication), amoxicillin (19-NOV-2012 to 29-DEC-2012) (pt did not recall the indication), hydrocodone (+) acetaminophen (22-APR-2014 to 22-JUN-2014) for kidney stone, apixaban (ELIQUIS) (25-AUG-2019 to 01-APR-2020) for blood clot in lung, amoxicillin (+) clavulanate potassium (AUGMENTIN) (25-AUG-2019 to 05-SEP-2019) for pneumonia. The pt also received the following vaccinations: pneumococcal vaccine (manufacturer unknown) on 01-DEC-2013; diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in 2014; and influenza vaccine on 01-OCT-2019.   Follow-up information was received on 22-JAN-2021 via medical records. Pt was a former smoker (also reported as never smoker, conflicting information). Use of alcohol: 0-2 drinks per day. His concurrent conditions included high blood pressure. Surgical history included: adenoidectomy, tonsillectomy, urinary tract surgery (microwave of prostate, spermatocele) and vasectomy. Family history included cancer and diabetes mellitus. Pt's concomitant medications included tadalafil (CIALIS), valsartan (DIOVAN) and ascorbic acid. Office visit (OV) on 23-APR-2014: pt came with with a complaint of rash on left shoulder for about 1 week. It looked like shingles. "Shingles" gel (not specified), acyclovir and gabapentin were prescribed. OV on 30-APR-2014: pt still having pain up back of neck and into head, shingles in the C3-C5 dermatomes; present on the left side. He continued to have headaches present on the base of skull on the left. He used one dose of hydrocodone. There was a resolving zoster rash noted on the left C3-C5 dermatome, there were a few scattered erythematous lesions noted on the left flank area near the fourth and fifth thoracic dermatome. Assessment: herpes zoster. Gabapentin dose was increased.   Follow-up information was received on 25-JAN-2021 from the lawyer. In 2013, the pt was administered zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions. Subsequently, pt was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries.  Information received via medical records on 22-JAN-2021 contained additional adverse experiences: codeine allergy (22-APR-2013, outcome and causality unknown (UNK), nausea (23-APR-2014, outcome and causality UNK), passing out (23-APR-2014, outcome and causality UNK), Postoccipital headache (probably secondary to herpes zoster) (??-APR-2014, outcome and causality UNK).  Upon internal review, the events of blood clot in lung, pneumonia, kidney stone and passing out were considered to be medically significant.  All available medical records will be provided upon request.  The serious criterion of disability was deleted for shingles, since medical records did not confirm this information.  It has been determined that case # US-009507513-2003USA007278 is a duplicate of case # US-MERCK-1404USA013963. Therefore, case # US-009507513-2003USA007278 is being deleted from our files and the cases are consolidated into case # US-MERCK-1404USA013963.