Received May 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | — | LA |
a swollen band about 1/2"" went around my arm; itching; a small 1"" knot on the inside of my arm; my left arm was red; Information has been received from FDA (agency# 2889789) on 26-May-2026. This Spontaneous report referred to a 70 -year-old Female patient. The patient's medical history included Sulfa allergy. The patient's past medications were not reported. The patient's concomitant medication included Rosuvastatin (Rosuvastatin), Jardiance (Empagliflozin), Vitamin d (Vitamin d nos), Multivitamin (Vitamins nos) and calcium. On 25-Feb-2026, the patient was vaccinated with the first dose of Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) (dose, route, strength, lot and expiration date were not reported) in the left arm for prophylaxis. On 03-Mar-2026, also reported as 6 days after the shot, the patient's left arm was red (Erythema), had a 2"" round knot that was itching (Pruritus, Limb mass). On 05-Mar-2026, also reported as two days later, the knot left, the redness spread five inches and a swollen band about 1/2"" went around the patient's arm (Peripheral swelling), along with less itching. In Mar-2026, reported as 36 hours later, the band went away (Peripheral swelling was considered as recovered) and the patient had a small 1"" knot on the inside of her arm. On 15-Mar-2026, also reported as 18th day from shot, the patient's arm was fine (considered as recovered from Erythema, Pruritus and Limb mass). The action taken with Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) was Not applicable. Causality assessment was not provided.
Medical History/Concurrent Conditions: Sulfonamide allergy
Multi vitamin; Rosuvastatin; Jardiance; Vitamin D