Age: 59.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Nausea, Peripheral swelling, Product administered at inappropriate site, Vitamin B12 deficiency
Clinical narrative: pain at injection site; swelling at injection site; muscle cramps; muscle aches; dizziness; nausea; Anxiety; vitamin B-12 Deficiency; hemochromatosis; intermittent chills; discoloration of arm at injection site; Itching at injection site/itching off and on at the injection site; swollen arm/swelling near her elbow; Shingrix vaccine was her third dose/She received the previous 2 doses; Shingrix was given in the middle of her upper arm, not in the deltoid muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   Previously administered products included Shingrix (received first dose in June 2022) and Shingrix (received second dose in August 2022).   On 24-MAY-2023, the patient received the 3rd dose of Shingrix (unknown arm) and TETANUS VACCINE. On 24-MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site itching (Verbatim: Itching at injection site/itching off and on at the injection site), swelling arm (Verbatim: swollen arm/swelling near her elbow), extra dose administered (Verbatim: Shingrix vaccine was her third dose/She received the previous 2 doses) and vaccine administered at inappropriate site (Verbatim: Shingrix was given in the middle of her upper arm, not in the deltoid muscle). On 25-MAY-2023, the patient experienced injection site discoloration (Verbatim: discoloration of arm at injection site), chills (Verbatim: intermittent chills), vitamin b12 deficiency (Verbatim: vitamin B-12 Deficiency) and hemochromatosis (Verbatim: hemochromatosis). On an unknown date, the patient experienced injection site pain (Verbatim: pain at injection site), injection site swelling (Verbatim: swelling at injection site), muscle cramp (Verbatim: muscle cramps), muscle pain (Verbatim: muscle aches), dizziness (Verbatim: dizziness), nausea (Verbatim: nausea) and anxiety (Verbatim: Anxiety).  The outcome of the injection site pain, injection site swelling, injection site discoloration, injection site itching, muscle cramp, muscle pain, chills, dizziness, nausea, swelling arm, vitamin b12 deficiency, hemochromatosis and anxiety were not resolved and the outcome of the extra dose administered and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site discoloration, injection site itching, muscle cramp, muscle pain, chills, dizziness, nausea, swelling arm, vitamin b12 deficiency, hemochromatosis, anxiety, extra dose administered and vaccine administered at inappropriate site to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site discoloration, injection site itching, muscle cramp, muscle pain, chills, dizziness, nausea, swelling arm, vitamin b12 deficiency, hemochromatosis, anxiety, extra dose administered and vaccine administered at inappropriate site to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The patient reported on 24 may 2023 she visited doctor and administered the unspecified product of tetanus vaccine and third dose of Shingrix vaccine. Soon after the administration f vaccines she stared experiencing injection site pain, swelling and discoloration. The patient had swelling near her elbow. She experienced intermittent chills, dizziness and nausea. All the symptoms were still ongoing, but they were not every day. The patient visited the neurologist and hematologist and she was diagnosed with vitamin B-12 Deficiency and hemochromatosis. The patient also suffered from the anxiety. It was unknown if the company considered the injection site pain, injection site swelling, injection site discoloration, injection site itching, muscle cramp, muscle pain, chills, dizziness, nausea, swelling arm, swelling, vitamin b12 deficiency, hemochromatosis, anxiety, extra dose administered and vaccine administered at inappropriate site to be related to tetanus vaccine. The patient received 3rd dose of Shingrix, which led to extra dose administered. The patient administered shingrix in middle of her upper arm instead in the deltoid muscle which led to vaccine administration at inappropriate site.  The reporter consented to follow up.