Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Herpes zoster, Migraine, Nerve injury, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a 62 year old female patient referring to herself. The patient's concurrent conditions included diabetes, colorectal cancer, enlarged heart, fatty liver disease, neuropathy, back pain, and allergic reactions to Ibuprofen, diazepam (VALIUM), Aspirin, Penicillin, Sulfa, Cephalexin, Tetracycline and other unspecified medications. The patient's medical history included several unspecified surgeries. On 12-NOV-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot number and expiry date were not reported) for prevention of shingles. Concomitant therapies included topiramate (TOPAMAX), pantoprazole sodium (PROTONIX), an unspecified hypertension medication and other unspecified medications. On approximately 07-JUN-2016 (reported as "Two weeks ago today"), a little red spot appeared on the patient's stomach which she originally thought was just a painful bug bite. The patient said that over time, the red spot began to blister and she then began to experience a painful burning sensation. It was reported that the red spots spread across her stomach to her side and back. The patient also reported that she experienced nerve damage and, as a result, she would experience pain for the rest of her life. The patient visited the nurse practitioner and a treatment with an unspecified antibiotic was given. No laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the time of reporting, the outcome of the events was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. All telephone call attempt for follow up information as of 19-JUL-2016 has been unsuccessful. Narrative has been updated. Information from voided case: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-NOV-2015, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles.  As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of her body. She did not have a shingles outbreak until on or about 01-JUN-2016.  As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and serious of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the Company's negligence, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. The outcome of the event was considered not resolved. Causality assessment was related. Information received on 04-FEB-2019 from a lawyer and female patient (pt) (Factsheet) regarding a case in litigation concerning a 62-year-old female patient (pt). The patient is a nonsmoker. Pt reported she never received the chickenpox vaccine. Medical history included diagnosed with chickenpox (1955, approx. age 8 years), Colorectal cancer (Dx 07-APR-2008; treatment: surgery), Hernia surgery (Type of hernia not specified, unknown if inpt or outpt) (OCTOBER 2010 and FEBRUARY 2011). In 2008, pt applied and was granted social security disability (Disability not further specified.) She received the following vaccinations (manufacturers unknown): influenza (FLU) vaccine approximately 2013 with the adverse reaction of throat started closing up; pneumonia vaccine (approximately 2013) with no reaction. On 12-NOV-2015, the pt was vaccinated with ZOSTAVAX as prescribed by her physician (Lot number and dose not reported) in her left arm at a pharmacy by an unspecified health care professional. The patient claimed she experienced the following physical injuries caused by ZOSTAVAX: Shingles (herpes zoster). She first became aware of the injury on approximately 01-JUN-2016 as she could visually see it in the mirror. On approximately 01-JUN-2016, the patient's healthcare provider/ nurse practitioner (NP) originally diagnosed the physical injury of rash and treated (not specified if inpt or outpt) the rash with over the counter (OTC) creams and lotions. On approx. 01-JUN-2016, in communication with the NP, about whether the rash was related to or caused by ZOSTAVAX, the pt reported as far as she could remember, the NP "said that the rash I had was Shingles caused by the Zostavax Vaccine". Following vaccination with ZOSTAVAX, a test was not ever performed by a healthcare provider to determine if the rash was wild type or vaccine strain varicella zoster virus and no health care provider ever told her that she had vaccine strain varicella zoster virus. The pt did not claim that her vaccination with ZOSTAVAX, caused or aggravated any psychiatric and/or psychological condition (other than pain and suffering and emotional distress) for which tx was sought from a healthcare provider. In the 7 years preceding the ZOSTAVAX vaccination to the present the pt received care/treatment (not specified if inpt or outpt) by healthcare provider/physician/surgeon from approximately 2010 to 2015 (No details provided.) The following are prescription medications the pt took on a regular basis in the 7 years preceding the ZOSTAVAX vaccination to the present: gabapentin 100 mg cap, 1-3 times daily (approx. dates of use 01-NOV-2018) for neuropathy/back pain, topiramate 25 mg cap 3 times daily approx. dates of use 10-DEC-2018 for migraines; pantoprazole once daily approx. dates of use 29-DEC-2018 for acid reflux, fluoxetine once daily approx. dates of use 29-DEC-2018 for depression and tinanzidine 3 times daily approx. dates of use 02 NOV 2018 for muscle relaxant/back pain. Upon internal review, the event nerve damage which would result in pain for the rest of the patient's life and the shingles outbreak were considered as disabling. Upon internal review, fluoxetine once daily for depression and Neuropathy were considered to be medically significant events. Additional information has been requested. It has been determined that case # US-009507513-1812USA003438 is a duplicate of case # US-009507513-1606USA011016.  Therefore, case # US-009507513-1812USA003438 is being deleted from our files and the cases are consolidated into case # US-009507513-1606USA011016.