Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve block, Pain, Paraesthesia, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a 65 year old female patient refers to herself. Patient had drug reaction/allergies to morphine. On unknown date, (reported as "about two and a half years ago" in 2012) patient received a dose of ZOSTAVAX 1 injection, (dose, lot number, expiry date and route of administration were not provided) for prevention of shingles. Concomitant therapy included amlodipine. On 30-SEP-2014, the patient experienced shingles outbreak starting with shoulder blade pain and followed with an excruciating pain tingling and an extreme tiredness. On 04-OCT-2014 the patient experienced symptoms that mimicked a heart attack, due to those symptoms, patient was hospitalized for 2 days (04-OCT-2014 and 05-OCT-2014). On 06-OCT-2014 patient felt tingling and saw a blistering rash, which started in the middle of her back and continued to spread to the front right side going into her breast area. No lab diagnostic studies were performed. Patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. Relatedness between events and vaccination with ZOSTAVAX was not reported. Follow up information has been received on 11-NOV-2014 by the consumer stated that on 12-AUG-2014, she received  dose of ZOSTAVAX, lot 0257AE, expiry date 15-MAY-2013 (dose and route were not reported) for prophylaxis. Follow up information has been received from the patient via other company Pfizer. The patient stated that she had the ZOSTAVAX vaccine two years ago (reporter previously as 12-AUG-2012) and she currently had shingles for two months (previously reporter as onset date on 30-SEP-2014). The reporter stated that she got such a non-typical response that it took them eight days to figure out it was the shingles and at that point patient was already been hospitalized.  Patient was hospitalized on 04-OCT-2014 and stayed in the hospital for 3 days (discharged on 06-OCT-2014,previously reported as 2 days, with discharge date of 05-OCT-2014); at the hospital they thought it was a heart attack because she had no rash and had only an incredible, incredible heart pain and all they could think of was heart. She was totally non-functioning /has been out of work for two months  and now, she was taking opioids.  The patient stated that she would be going for a nerve block to try to stop the pain. At the time of the report, the patient had not recovered from "shingles" and she was totally non-functioning/she has been out of work for 2 months. The patient's outcome regarding "symptoms that mimicked a heart attack/they thought it was a heart attack/incredible heart pain" was unknown. The event of she was "totally non-functioning/she has been out of work for 2 months" was considered to be disabling. Upon internal review, the event of "symptoms that mimicked a heart attack/they thought it was a heart attack/incredible heart pain" was considered to be serious due to other important medical event, whereas the event of "totally non-functioning/she has been out of work for 2 months" was assessed as disabling. Follow up information has been received from the patient on 08-DEC-2014. Patient stated that she had been out of work for 2 and a half months. This week (approximated date December 2014) she would be starting 'scrambler therapy' where they redirect her pain thought process. She had Postherpetic Neuralgia (PHN) (onset approximately in 2014),that was treated with a nerve block procedure (approximately in 2014). The outcome of the event Postherpetic Neuralgia was unknown.  The causality between the event and zoster vaccine live(ZOSTAVAX) was not reported. Physician did not wish to be contacted. Follow up information has been received from a patient on 06-MAR-2015. She stated that she has been still experiencing Postherpetic Neuralgia and due to her "shingles outbreak" after receiving ZOSTAVAX she lost 12 pounds within a few weeks. The patient also provided the name of the other physician for the correspondence contact. The outcome of Postherpetic Neuralgia was not recovered/not resolved and the outcome of "she lost 12 pounds" was unknown. The causality between the events and ZOSTAVAX was not reported. Follow up information has been received from consumer on 12-MAR-2015. She stated that pregablin (LYRICA) did not help her shingles pain. Legal issue was involved and sent to Legal. No other information was provided. Information has been received on 09-JUL-2018 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2012 at a hospital, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for a vesicular outbreak which was diagnoses as herpes zoster or shingles.  As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles,  the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. It has been determined that case number US-009507513-1807USA003716 is a duplicate of case number US-009507513-1410USA006534. Therefore, case number US-009507513-1807USA003716 is being deleted from our files and the cases are consolidated into case number US-009507513-1410USA006534. Additional information has been requested.