Sex: F
Vaccine: VARZOS
Symptoms: Haemoptysis, Pain in extremity, Plicated tongue, Stomatitis, Swollen tongue
Clinical narrative: sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Keflex with an associated reaction of oral candidiasis, Biaxin with an associated reaction of rash, Sulpha with an associated reaction of myalgia and Morphine with an associated reaction of nausea. Concomitant products included esomeprazole magnesium (Nexium), gabapentin and estrogens conjugated (Premarin).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix injection a couple of years before reporting and experienced sore arm. The patient received unspecified BioNTech COVID Vaccine. The patient got the Pfizer vaccine and was getting the second one on 21st February 2021. They did not get her the vaccine card. She just knew it was Pfizer BioNTech COVID vaccine. The unusual side effects she experienced were deep fissures in her tongue, sensitivity in her tongue, and sensitive pallet. She had a reddish sensitive pallet. She was spitting blood for 4 hours before she realized she had fissures in the tongue. She could not contribute it to anything except she had the vaccination. She noticed it 3 nights after the vaccine. The fissures could have been developing, but she did not examine it until it started bleeding. Her tongue was examined frequently during the year by her dentist and her doctor. She got the vaccine on 31st January 2021. The symptoms could have started between 31st January 2021 and she noticed the bleeding on 3rd February 2021. It was before six or so when she got the injection and she was spitting blood about 6PM on 3rd February 2021. The bleeding lasted for 4 hours and she was about to go to emergency room , but the bleeding stopped. She had not bled again. The fissures were not cleared. The entire tongue had groves they were deep. There were still fissures there. Her pallet was still sensitive but it was not bleeding. It was red and the doctor told to use a Q-tip to apply hydrogen peroxide. That was all she suggested. Some days the fissures seem more irritated. Her dentist looks at her tongue closely twice a year. She saw the dentist in December and saw her primary care doctor in January. All labs were good. She hopes this did not happen with the second dose. She would say her tongue was slightly swollen. It was not preventing her from breathing, but the swelling was from the fissures. She get rashes from medications. She did not take the medications anymore.  The reporter consented to follow up. For tolerance of 2nd dose of shingrix, refer case US2021AMR045165.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR045165:same patient