Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Pain, Paraesthesia
Clinical narrative: got new blisters, an outbreak of blisters throughout his body / my whole body is blistered / now whole body is covered; over 100 in fever; chills; shortness of breath; sweats; Food sensitivities to flour, chocolate; lost his voice; phelgmy cough; runny nose; Got worse with Zyrtec / having a horrible reaction worse than his initial outbreak; he is having all kinds of reactions / he took Zyrtec and his body was like a lizard / bad reaction from Shingrix / having a horrible reaction; I had nausea; puked once; This case was reported by a consumer via call center representative and described the occurrence of blister in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number B4TT5, expiry date 10th April 2020) for prophylaxis.   Co-suspect products included cetirizine hydrochloride (Zyrtec) unknown for an unknown indication.   The patient's past medical history included sensitive skin, skin disorder, pruritus and blister. Concurrent medical conditions included shingles. Concomitant products included vitamin e, colecalciferol (Vitamin D3), thyroxine sodium (Levothyroxine), vitamins nos (Multivitamin) and ubidecarenone (Vitamin Q10).   On 13th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, the patient started Zyrtec at an unknown dose and frequency. On 15th March 2020, 2 days after receiving Shingrix and less than 2 weeks after starting Zyrtec, the patient experienced blister, fever, chills, shortness of breath and sweating. In March 2020, the patient experienced food intolerance, loss of voice, phlegm, runny nose, condition aggravated, adverse drug reaction, nausea and vomiting. On an unknown date, the outcome of the blister, fever, chills, shortness of breath, sweating, food intolerance, loss of voice, phlegm and runny nose were not recovered/not resolved and the outcome of the condition aggravated, adverse drug reaction, nausea and vomiting were unknown.   It was unknown if the reporter considered the blister, fever, chills, shortness of breath, sweating, food intolerance, loss of voice, phlegm, runny nose, condition aggravated, adverse drug reaction, nausea and vomiting to be related to Shingrix. It was unknown if the reporter considered the blister, fever, chills, shortness of breath, sweating, food intolerance, loss of voice, phlegm, runny nose, condition aggravated and adverse drug reaction to be related to Zyrtec.  Additional case details were reported as follows: The patient reported that he had an outbreak of shingles in February 2020. He was not recovered from shingles before getting the Shingrix vaccine on 13th March 2020. The patient said that prior to Shingrix vaccine he still had sensitivity to skin, chicken skin, some blisters on his skin that subsided and itching. Within 48 hours of getting the vaccine, the patient got new blisters, an outbreak of blisters throughout his body. The patient did not get it on his face. Within 48 hours he also experienced over 100 degree Fahrenheit in fever, chills, shortness of breath, sweats. After the Shingrix vaccine he also noticed that he had food sensitivities to flour, chocolate. He lost his voice in the last couple of days. During the conversation patient said that he had a phlegmy cough, runny nose His physician asked him to take Zyrtec and it got worse with Zyrtec. The patient stated he had all kinds of reactions. The patient was very errata so could not get any clarification. He stated he was having a conference call with his doctor today and just short of going to the hospital which he did not want to do. The patient called back because he wanted the package insert mailed to him and he wanted to know what medications he could have his doctor prescribe to stop his horrible reaction. He stated that otherwise he would end up having to go to the hospital. He stated that he took Zyrtec and his body was like a lizard. The patient had a horrible reaction worse than his initial outbreak. The patient was questioning whether to get second dose because it was worse than the initial outbreak he had, his whole body was blistered. His face and eyes did not get it, but his whole body blistered and had nausea, puked once. The patient stated he searched online and other patients also reported this.  The patient was angry and frustrated throughout call it was difficult to obtain additional details from caller, as he became more frustrated when specialist attempted to probe and clarify. The patient stated he already discussed this and reported to someone at Agency. The patient stated bad reaction from Shingrix and now whole body was covered and mentioned did not received information from previous calls. The patient did not provide any additional information pertaining to reaction.  The reporter did not consent to follow up. The outcome of the events blister, fever, chills, shortness of breath, sweating, food intolerance, loss of voice, phlegm and runny nose were reported as not recovered/ not resolved in the database however in source document, it was mentioned as recovering/resolving. This case had been linked to the case US2020AMR054583, reported by same reporter.