Age: 53.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: soreness in arm; looks like shingles rash on neck; right quadrant of body beaten up/excruciating pain that crept up her shoulder/upper-right quadrant of my body has been beaten; pain in right side of spine; pain on right side of neck; pain right side of head; pain first started in her back; pain on shoulder where deltoid connects at neck; hurt like he, while it was injected, it burned going in; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis and thyroxine sodium (Levothyroxine) unknown for product used for unknown indication.   Concurrent medical conditions included visual impairment.   On 23rd February 2022, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2021-2022 season (intramuscular) and Levothyroxine at an unknown dose and frequency. On 23rd February 2022, immediately after receiving Shingrix, not applicable after receiving Influenza vaccine Quadrivalent 2021-2022 season and Levothyroxine and not applicable after starting Influenza vaccine Quadrivalent 2021-2022 season and Levothyroxine, the patient experienced injection site pain. On 25th February 2022, the patient experienced radiating pain, pain in spine, neck pain, headache, back pain and shoulder pain. On an unknown date, the patient experienced pain in arm and vesicular rash. The patient was treated with naproxen (Naprosyn). Levothyroxine was discontinued. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the radiating pain, pain in spine, neck pain, headache, back pain, shoulder pain and vesicular rash were not recovered/not resolved.   The reporter considered the injection site pain, pain in arm, radiating pain, pain in spine, neck pain, headache, back pain, shoulder pain and vesicular rash to be related to Shingrix. The reporter considered the pain in arm, radiating pain, pain in spine, neck pain, headache, back pain, shoulder pain and vesicular rash to be unrelated to Influenza vaccine Quadrivalent 2021-2022 season and Levothyroxine.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix 1st dose intramuscularly in the right deltoid and an unspecified flu (influenza) shot intramuscularly in the left deltoid at the same time on 23rd February 2022. The patient did not have the paperwork from the pharmacy thus she did not have the LOT/EXP nor did she have the name of which influenza shot she received. The patient provided the pharmacy's contact information, since they would have a record of the name of the influenza shot as well as the lot/exp of both vaccines. The patient stated that the Shingrix shot hurt like hell, while it was injected, it burned going in, the patient also experienced some soreness in her right arm and I was okay with that (the patient did not indicate how long after the shot the soreness began). It appeared that the arm soreness had resolved. On Friday 25th February 2022 the patient started experiencing excruciating pain that crept up her shoulder, she described that it was like if you bisected her head went down to just above the breast, straight across to the shoulder. The patient had the Shingrix shot in her right arm so the right-hand side of herh spine, the right-hand side of her neck, the right-hand side of her head, were killing her. The patient stated that when the pain first started in her back she thought it could be a side effect and the pain should be gone in a few days but it had been a week and it was not getting better, it was actually getting worse. The patient was taking Naprosyn, it was not helping, nothing was helping. The patient felt like the upper-right quadrant of her body had been beaten up. The patient wished it would stop because it hurt, the pain was really localized to her shoulder and where her deltoid connects at the insertion point at the neck. The reporter stated, she had developed this weird almost looking like shingles rash on her neck and offered to send pictures of the rash. The patient said it was not getting better. The patient attributed all side effect reported to Shingrix. The patient indicated that she did not currently plan to get the Shingrix 2nd dose. The reporter also did not believe that the side effects were due to the influenza shot or the Levothyroxine. The patient spoke to her physician about the side effects she was experiencing, he indicated that he did not think that levothyroxine was causing the event(s) because the pain was only on the right side of her body, however (to be prudent) he did advise her to discontinue the levothyroxine. The patient had not been in to see the doctor yet; his advice was given to her over the phone. The patient did not feel any of her side effects were due to Levothyroxine because they were getting worse and she was no longer on levothyroxine, the patient only took Levothyroxine for 2 days. The reporter consented to follow up. Note: Since there was a discrepancy in the structured field and narrative regarding causality of all the events in relation to Influenza vaccine and Levothyroxine and HUB was unable to clarify, we have captured reporter causality from the narrative description.