Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Suspected COVID-19, Vaccine positive rechallenge
Clinical narrative: Felt like COVID symptoms / from when she had COVID in September 2020; Redness / at the injection site / second dose was worse; Swelling / at the injection site / second dose was worse; Pain at the injection site / second dose was worse; Arm was very / hot /  like fever in her arm at the injection site; Arm was very sore; Arm was very / red; Fever elevated fast from 99 to 100.5; Headache; Myalgia in her back, shoulders and lower back; Fatigued with a headache; Had to lay down; This case was reported by a consumer via call center representative and described the occurrence of suspected covid-19 in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (in September 2020). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received October or November 2020 (actual date was not confirmed), for tolerance refer case US2021AMR007263).   On 7th January 2021, the patient received the 2nd dose of Shingrix. On 8th January 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injection site warmth, pain in arm, erythema of extremities, fever, headache, myalgia, fatigue and activities of daily living impaired. On an unknown date, the patient experienced suspected covid-19. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, injection site warmth, pain in arm, erythema of extremities, headache, myalgia, fatigue and activities of daily living impaired were recovered/resolved and the outcome of the fever and suspected covid-19 were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site warmth, pain in arm, erythema of extremities, fever, headache, myalgia, fatigue, activities of daily living impaired and suspected covid-19 to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and her symptoms came on very quickly and were severe. She had redness, swelling and pain at the injection site. The second dose was worse.  Her arm was very sore, red and hot like she had a fever in her arm at the injection site for the second dose.  Her fever elevated fast from 99 to 100.5 and she had a headache and myalgia in her back, shoulders and lower back.  She was fatigued with a headache.  Her symptoms started 4 hours after vaccination, but all of the symptoms had resolved at the time of reporting.  She also claimed that she received the second dose of Shingrix on 7th January 2021 and her symptoms from the second dose actually started on Friday 8th January 2021, around 4 to 5:00 pm. She felt better by bed time but she did take Tylenol. She claimed that she was told by the Pharmacist to get her second dose of Shingrix two months after the first dose and they gave her a date of 28th December 2020 to return for the second dose. She waited past that date but got the second dose either in October or November 2020 but she could not confirm the actual date of the vaccination. She had to lay down and she claims that it felt like COVID symptoms from when she had COVID in September 2020.  Consented to follow up.   Reporting error received for this case and following correction was done: Re-challenge result was added in event screen for all events.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR007263:Same reporter