Sex: M
Vaccine: PNC20
Symptoms: Biopsy skin normal, Idiopathic urticaria, Incorrect route of product administration, Injection site swelling, Pruritus
Clinical narrative: 2 or 3 weeks later, I developed, like when a person has like irritations on the skin; had small bump, was itchy, then broke out into hives/ I reach my left hand under my right arm pit to my back and I felt that there was some elevations/ I will call them welts; Route of administration: intravenous; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2024 (Batch/Lot number: unknown) intravenous, in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B12 [VITAMIN B12 NOS]. Vaccination history included: Prevnar, administration date: 2010, for Immunisation. The following information was reported: SKIN IRRITATION (medically significant) with onset 2024, outcome "unknown", described as "2 or 3 weeks later, I developed, like when a person has like irritations on the skin"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 2024, outcome "unknown", described as "Route of administration: intravenous"; URTICARIA (medically significant) with onset 2024, outcome "unknown", described as "had small bump, was itchy, then broke out into hives/ I reach my left hand under my right arm pit to my back and I felt that there was some elevations/ I will call them welts". The events "2 or 3 weeks later, i developed, like when a person has like irritations on the skin" and "had small bump, was itchy, then broke out into hives/ i reach my left hand under my right arm pit to my back and i felt that there was some elevations/ i will call them welts" required physician office visit and emergency room visit.  Additional information: Patient stated that was the first time patient ever had in the place of the injection had created like a small little bump. It did not bother him much, a little bump. But 2 or 3 weeks later, he developed, like when a person has like irritations on the skin. It did not itch but he broke out in such a little. It was not shingles. He went to a Urgent Care (name not clarified) that night and they gave him a shot. That night he had hives, that was why he broke out and hives. Never had hives before. When he got there, they gave a shot (unspecified shot) in his butt and they gave him 2 medications to pick up that night and start taking the next morning. Then went that time, the next day those hives were gone but what has happened since then, about 2 weeks later, he was bathing and  reached his left hand under right arm pit to his back and felt that there was some elevations, so he asked his wife to come in and she took pictures. He would call them welts. He got an appointment and  went to a dermatologist and the dermatologist took 2 samples of those welts and they did not determine what caused that, it was like an idiopathy. But it was determined not to be cancerous. As concomitant medications patient was prescribed but never took a cholesterol medication Atorvastatin 20 milligrams. Indication of Atorvastatin: for high cholesterol. Regarding treatment patient stated that was given a shot the very night when he had the hives. A shot in his butt and they also prescribed 2 medications, that they wanted him to take beginning the next day and he got those, that same night and the very next morning started taking those just as prescribed.  Causality for "route of administration: intravenous" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.