Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Disturbance in attention, Ear pain, Headache
Clinical narrative: Loss of concentration; small shingles outbreak/ persistent painful blistering rash on top of his head in his hair, on his face and in his ear/ diagnosed as herpes zoster; ears started "feeling funny"/ persistent painful blistering rash on top of his head in his hair, on his face and in his ear; The vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster; persistent painful blistering rash on top of his head in his hair, on his face and in his ear/ diagnosed as postherpetic neuralgia; This spontaneous report was received from a patient's wife and pharmacist and refers to 60-year-old (also reported as 56-year-old, conflicting information) male patient. The patient's concurrent condition included unspecified heart disease. The patient had no drug reactions or allergies. The patient's medical history and concomitant medications were not reported.   On 07-MAR-2015 (also reported as on Saturday), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) vial 19400 plaque-forming unit (PFU), lot # K016326, expiry date 24-DEC-2015 (dose, route of administration, application site were not reported) for the prevention of shingles/ vaccination/ to prevent shingles.   On 08-MAR-2015 (reported as the day after getting zoster vaccine live (ZOSTAVAX), also reported as by Sunday afternoon), his ears started "feeling funny". On the same day, he also experienced headache and shooting pains accompanied by a burning sensation, all of which occurred on his face without rash and redness. The patient had shooting pains, tingling and numbness on the left side of his face and had. The pharmacist believed it was a small shingles outbreak. The patient's wife reported that he developed shingles in the left side of his face. The patient contacted pharmacist due to the event. It was reported that he went to his physician and was given an unspecified steroid shot and a dose of steroids in pills due to shingles. The patient stated that he felt that the vaccine gave him shingles. There was no treatment given for the events. The outcome of shingles was reported as not recovered. The outcome of remaining events was not reported.  The patient considered the shingles to be related to zoster vaccine live (ZOSTAVAX). The relatedness between ears started "feeling funny" and zoster vaccine live (ZOSTAVAX) was not provided.  Follow up information has been received on 18-OCT-2019 from a lawyer, regarding a case in litigation and refers to a male patient. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date (reported as shortly after receiving vaccine), the patient developed a persistent painful blistering rash on top of his head in his hair, on his face and in his ear. In response to these symptoms, he presented to a physician, where he was diagnosed with herpes zoster and postherpetic neuralgia and remained under their care. As a result, the patient had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Follow up information has been received on 18-JAN-2021 from a lawyer via a Plaintiff Fact Sheet, regarding a case in litigation and refers to a 60-year-old male patient (pt). The pt never smoked or used tobacco products. He was diagnosed with chickenpox in approximately 1964, at the age of approximately 9 or 10 years old. He was never vaccinated with chickenpox vaccine. On 07-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in left arm, by a pharmacist at a pharmacy. The pt claimed to suffer following physical injuries caused by zoster vaccine live (ZOSTAVAX): shingles (herpes zoster) and postherpetic neuralgia (PHN). The pt suffered from pain which led to loss of concentration, loss of work. He had severe pain on the side of his face, head, neck and in his ear. The pt first became aware of the injuries as initially he noticed the pain at night of 07-MAR-2015, but the following day 08-MAR-2015 it got much worse. He first became aware of the injuries as within hours he began to experience pain in his hair, face and ear. It was painful to touch. The following day he broke out in bumps and sores in his hair, side of his face and ear. He was diagnosed with shingles and postherpetic neuralgia (PHN) by a physician in approximately March 2015. On an unknown date in March 2015, he was prescribed unspecified medication for nerve pain by a physician (could not recall name of medication). On an unknown date in March 2015, he communicated with a physician about whether the injuries were related to or caused by zoster vaccine live (ZOSTAVAX). He reported that he saw provider for shingles treatment and discussed injury. He stated that he did not know if any test to determine if the rash following vaccination with zoster vaccine live (ZOSTAVAX) was wild type or vaccine strain varicella zoster virus was ever performed by a healthcare provider. He was never told by any healthcare provider that he had vaccine strain varicella zoster virus. The pt claimed that zoster vaccine live (ZOSTAVAX) did not cause or aggravate any psychiatric/ psychological conditions other than pain, suffering and emotional distress, for which treatment was sought from a healthcare provider. The pt filed for social security due to retirement in 2019, which was granted. In the 7 years preceding his zoster vaccine live (ZOSTAVAX) vaccination to the present, the pt received inpatient or outpatient care from his primary care physician (PCP) (2005 to present). In the 7 years preceding zoster vaccine live (ZOSTAVAX) to the present, the pt required hospitalization or recurrent medical care and treatment or medication due to high cholesterol (2005 to present) and high blood pressure (2010 to present). In the 7 years preceding zoster vaccine live (ZOSTAVAX) to the present, the pt's prescription medications taken on a regular basis included: rosuvastatin for high cholesterol (2005 to present) and metoprolol for high blood pressure (2010 to present). The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Follow up information has been received on 18-JAN-2021 from pharmacy records, regarding case in litigation. On 07-MAR-2015, the pt was dispensed zoster vaccine live (ZOSTAVAX) 19400 PFU injection, quantity 1.  Upon internal review, the event of herpes zoster in his ear was considered to be medically significant.  It has been determined that cases # US-009507513-1503USA005428 and US-009507513-1503USA012042 are a duplicate case of case # US-009507513-1503USA004588. Therefore cases # US-009507513-1503USA005428 and US-009507513-1503USA012042 are being deleted from our files and the cases are consolidated into case # US-009507513-1503USA004588.