Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included ex-smoker (quit smoking over 15 years ago). Previously administered products included cortisone with an associated reaction of feeling hot, Penicillin with an associated reaction of coma (Penicillin put patient in a coma for two days when she was 7 years old.), Sulfa with an associated reaction of pruritus (with Sulfa, patient got an itching but that was 20 years before reporting), sulfa with an associated reaction of rash (with Sulfa, patient got an immediate rash but that was 20 years before reporting) and Influenza vaccine with an associated reaction of pain in extremity (received influenza vaccine on an unknown date, refer case US2021AMR018144). Concurrent medical conditions included blood cholesterol increased, coxarthritis, knee arthritis, borderline glaucoma (glaucoma suspect), gastroesophageal reflux disease, back pain and drug allergy (dexamethason). Additional patient notes included Ethnicity: latino. Concomitant products included famotidine, biotin, lansoprazole, lovastatin, cod-liver oil (Cod Liver Oil), xantofyl (Lutein), aloe barbadensis (Aloe Vera Gel), acetylsalicylic acid (Aspirin), glucosamine, chondroitin, zeaxanthin and latanoprost.   On 24th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 24th September 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 4 months after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device and an unknown time after starting famotidine and biotin, 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 Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient mentioned that the arm soreness was not even as bad as the flu shot. The patient stated when she get a flu shot her arm would be sore when she move it. The patient usually did not have issues with vaccines but she was going to make herself wait the 30 minutes due to her weird reactions. The patient could not take pain killers and lots of other medications including clindamycin;neurontin; gabapentin; carbamazepine; endocet; metoprolol; tamalor.  The pain medication issue happened in 2003 and the metoprolol issue happened in 2008. In January 2020, the patient got a spinal epidural at by an anesthesiologist. She had gone to an allergist prior to the spinal epidural to take a five hour test for allergy to dexamethasone and had a very mild reaction with face warming so she did get the spinal. She had no product or information to provide, lot or expiration for the dexamethasone she received. The patient did not have any product or information to provide NDC, lot or expiration for any of the painkillers or other medications she could not take. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR018144:same patient, same reporter, Flu shot