Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: fever; swelling in arm; some red spots; fatigue; sleeping constantly; trouble sleeping; anxious; needle phobia; push back his second vaccine by a month; had third dose; Painful; he was sick; arm hurt; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 61-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles accine (received 1st dose in September 2019). Concomitant products included alprazolam (Xanax).   In March 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain, malaise, pain in arm, fever, swelling arm, red rash, fatigue, somnolence, sleep disorder, anxiety, phobia, drug dose administration interval too long and extra dose administered. On an unknown date, the outcome of the pain, malaise, fever, swelling arm, red rash, fatigue, somnolence, sleep disorder, anxiety, phobia, drug dose administration interval too long and extra dose administered were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain, malaise, pain in arm, fever, swelling arm and red rash to be related to Shingles vaccine. It was unknown if the reporter considered the fatigue, somnolence, sleep disorder, anxiety and phobia to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and did not realize the 2nd dose vaccine appointment for the trial was a week later, so the patient had to push back the 2nd dose by a month, so they could wait for the shingles vaccine to take effects. The shingles vaccine was a terrible vaccine, painful and had severe reaction to them because it was injected into the muscle. The patient was sick as dog for few days. The vaccine was miserable, but was a believer in vaccine. No further information was provided. The patient reported that the study he was in, was a double-blind study, so the patient did not know for sure if received the vaccine or not, but he believes he received the vaccine because he had reactions, but they were not terrible.  The patient arm hurt for week after and was not bad and it was far less painful than the shingles vaccine was horrible. Then he had a fever a couple of times for a couple days and he did not feel ill. It's also unusual for him to get a fever for anything, and if he did not it's usually a retrograde fever. There was some swelling in his arm and some red spots, for about a week. It was particularly the pain and swelling and usually he did not get reaction to vaccines, except for the shingles vaccine.  No further information provided. The patient reported over the phone that when he had the third dose of vaccine, he had problems with severe fatigue. He was sleeping constantly. One night, he slept for 14 hrs. or some ridiculous amount. And that was the week following the injection. He noted on the trial application the different symptoms and put down he had a severe problem last night, and the doctor called him the next morning because Pfizer contacted them.  The doctor said he heard the patient had trouble sleeping. The patient told the doctor that he did not think it was related to vaccine. Another doctor changed a medication, and he has severe sleep disorders, so the patient said he was not concerned. No further information provided. The patient reported over the phone that he has severe needle phobia. Shots are not too bad, but bloodwork was different story. And the first bloodwork he ever had, the nurse missed, and he went through the roof.  The patient thought he couldn't do it and usually pops a Xanax before the bloodwork. It's that bad. The last couple of times he went for blood work it was better.He had to ask the nurse if she was done, and she was done for like five minutes. For his most recent blood work, he went from the appointment immediately to the pharmacy for round-two because he wanted to get deal with the two jabs in a single day. It was a terror, and still gets very anxious before his appointments, so he still pops a Xanax. No further information provided.