Sex: F
Vaccine: PPV
Symptoms: Product use issue, Pruritus, Skin warm
Clinical narrative: chest tight; swelling on the left arm; had redness inside of arm/got worse the redness/on the elbow redness, up to the neck/under her arm/redness on her right elbow; caller stated this itched, was sore, and her arme felt hot; caller stated this itched, was sore, and her arme felt hot; caller stated this itched, was sore, and her arme felt hot; second pneumonia shot which was the pneumovax 23; affected her thinking/cannot think as well; Spontaneous information has been received from a consumer regarding an 81-year-old female patient. The patient had bladder infection recently and an unspecified thyroid disorder. She was taking as concomitant medications amitriptyline, 50 mg at night, unspecified variety of supplements, some of which were herbal, and some had oils in them, but she was unsure. She also took unknown vitamins and unknown thyroid medication. The patient had allergies to sulfonamide (reported as sulfa), codeine, cephalexin and ciprofloxacin.   On an unknown date in 2021 (reported as on last year), the patient received the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX 23) injection on her left arm (dose, route, lot # and expiration date were not reported) to prevent pneumonia. On 14-FEB-2022, the patient had a second dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX 23) on the top of the left arm (dose, route, lot # and expiration date were not reported) (product use issue) and she had a bad reaction from it. She received the vaccine early in the afternoon, and that evening around 20:00 she had swelling on the left arm, then she had redness inside of the arm "2 ½ by 7" at first but then the redness got worse, and her elbow has redness. The redness then went up the neck, then came down and spread a little under her arm. It was reported that this itched, was sore and her arm felt hot. The elbow of her right arm had also redness. At the time of reporting, these events had not gone away; therefore, the patient called her doctor's office and was told to allow 24 to 48 hours for response, so she called the pharmacist and he told her to take diphenhydramine (BENADRYL), so she got a box and took one dose. Latter she got a call from the doctor's office and the nurse said to her to take fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA D) twice a day and also an unspecified hydrocortisone cream. The patient also put on cortisone 10 anti-itch cream and the swelling on her left arm got better and it was not as big anymore. The patient took on pill of fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA D) last night on 24-FEB-2022 and one on 25-FEB-2022 in the morning (reported as this morning). On 25-FEB-2022, the patient stated her chest was tight and she still had itching, although the swelling was not as pronounced, but her left arm was still bigger than the other one. The patient felt it has affected her thinking because she cannot think as well (mental impairment). No laboratory diagnostics or studies were performed. The outcome for chest tight and mental impairment was not reported.  Upon internal review, mental impairment was considered to be medically significant.