Age: 69.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Insomnia, Neuralgia, Pain in extremity, Peripheral swelling
Clinical narrative: delayed due to COVID-19 pandemic; was delayed due to supply shortage; arm only feels a little itchy; could not sleep at night; Severe Nerve Pain; right arm was minorly sore; red; hot; swollen; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-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.   Previously administered products included Shingrix (received her 1st dose 3 years ago from the reporting date). Concurrent medical conditions included fibromyalgia.   On 19th October 2021 15:30, the patient received the 2nd dose of Shingrix (intramuscular) and the 2nd dose of Influenza vaccine Quadrivalent 2021-2022 season (intramuscular) .5 ml. In October 2021, 12 hrs 30 min after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced erythema of extremities, skin warm and swelling arm. On 19th October 2021, the patient experienced pain in arm. On 20th October 2021, the patient experienced nerve pain and difficulty sleeping. On 21st October 2021, the patient experienced itchy upper limbs. On an unknown date, the patient experienced social problem and product supply issue. The patient was treated with non-drug therapy (Warm Compress) and paracetamol (Tylenol). On 20th October 2021, the outcome of the pain in arm was recovered/resolved. On 21st October 2021, the outcome of the erythema of extremities, skin warm, swelling arm and nerve pain were recovered/resolved. On an unknown date, the outcome of the itchy upper limbs was not recovered/not resolved and the outcome of the difficulty sleeping, social problem and product supply issue were unknown.   The reporter considered the pain in arm, erythema of extremities, skin warm, swelling arm, nerve pain, itchy upper limbs and difficulty sleeping to be related to Shingrix. It was unknown if the reporter considered the pain in arm, erythema of extremities, skin warm, swelling arm, nerve pain, itchy upper limbs and difficulty sleeping to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The case was reported by the patient. The patient received her Shingrix in left arm and Flu shots in different in right arms, on Tuesday of last week from the day of reporting on 19th October 2021 at 3:30PM. The patient was not able to provide the product name or manufacturer's information for the Flu vaccine. Consumer believed the adverse events were likely due to the Shingrix shot.  2nd Shingrix dose was delayed due to supply shortage caused by hurricane and the COVID-19 pandemic.   The patient's right arm was minorly sore through the next day from vaccination, however, it became red, hot and swollen starting late wednesday (noon through evening) and into Thursday noon (12:00 to 1:00 PM).  The patient suffered from fibromyalgia that trigger chain reaction all over her body when she experienced pain and as a result, she suffered from severe nerve pain throughout her body, she could not sleep at night. Less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm, 1 day after nerve pain and difficulty sleeping and 2 days after itchy upper limbs. The patient did not have this reaction with her first Shingrix dose.  The patient used warm compress and tylenol to remedy her symptoms, she states no immediate action needed to be taken.  Her symptoms resolved as of Thursday noon on 21st October 2021 and her arm only feels a little itchy at this time. The reporter consented to follow up. The case had been linked with US2021AMR223908 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223908:same reporter