Age: 68.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: I had, obviously discomfort at the injection site; the injection site was red and uncomfortable; rash running down my arm to the injection site to the elbow and it did not feel well; put me on antibiotic just because of concerns about possible infections; my arm remained very warm to the touch; also had headache; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Apr2024 as dose number unknown, single (Lot number: HL3888, Expiration Date: 30Jun2025) at the age of 68 years intramuscular, in right arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), on 24Apr2024 as dose number unknown, single (Lot number: T3Z7D) for diphtheria immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; MELOXICAM. The following information was reported: VACCINATION SITE DISCOMFORT (medically significant), outcome "not recovered", described as "I had, obviously discomfort at the injection site"; VACCINATION SITE ERYTHEMA (medically significant), outcome "not recovered", described as "the injection site was red and uncomfortable"; VACCINATION SITE RASH (medically significant), outcome "not recovered", described as "rash running down my arm to the injection site to the elbow and it did not feel well"; INFECTION (medically significant), outcome "unknown", described as "put me on antibiotic just because of concerns about possible infections"; VACCINATION SITE WARMTH (medically significant), outcome "not recovered", described as "my arm remained very warm to the touch"; HEADACHE (non-serious), outcome "unknown", described as "also had headache". The events "i had, obviously discomfort at the injection site", "the injection site was red and uncomfortable" and "my arm remained very warm to the touch" required physician office visit. The events "rash running down my arm to the injection site to the elbow and it did not feel well" and "put me on antibiotic just because of concerns about possible infections" required physician office visit and emergency room visit. Clinical course: Reporter was calling to report adverse event experience with (Prevnar 20: NDC number: 00005-2000-10). Patient had never had an issue with. Patient had obviously discomfort at the injection site which lingered and then, the injection site was red and uncomfortable initially but that feeling lingered and then a week after, she developed rash running down her arm to the injection site to the elbow and it did not feel well. So, she went to an urgent care facility to see a doctor, and doctor decided it would be prudent to put she on antibiotic (Cephalexin 500 milligram) just because of concerns about possible infections. Last week (based on 06May2024), patient started antibiotic and then three days after that her arm, during all this time, her arm remained very warm to the touch, three days after started the antibiotic, in the evening, one evening again, it was, it started getting warm again, it was uncomfortable and it was red and, so patient was still on antibiotic. Patient started the antibiotics initially the redness subsided and then it reappeared, three days after she was on that. It stayed red until she went to get on antibiotic, got on antibiotic, the redness had subsided, and in three days later, the redness reappeared. This morning (06May2024), she woke up and her arm was not normal again. Reporter stated she does not know what else, she was just trying to relay the information. Patient take Tylenol because she also had headache with it. Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site erythema, vaccination site rash, infection, vaccination site warmth, headache.  Causality for "i had, obviously discomfort at the injection site", "the injection site was red and uncomfortable", "rash running down my arm to the injection site to the elbow and it did not feel well", "put me on antibiotic just because of concerns about possible infections" and "my arm remained very warm to the touch" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).