Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
Patient thought she was having a reaction as she is allergic to preservatives, but did see there were no preservatives listed in the vaccine.; possible infection; This spontaneous report was received from a consumer and refers to a 69-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Rheumatoid arthritis. Historical drugs included adalimumab (Humira), rituximab (Rituxan), and Contrast media. Concomitant medications included atorvastatin calcium, amlodipine and atorvastatin (Amlodipine besilate (+) atorvastatin calcium), clonidine, levothyroxine sodium (synthroid), fexofenadine hydrochloride (Allegra), estriol, famotidine, calcium carbonate (Caltrate), ergocalciferol (Vitamin D), lactobacillus acidophilus (Acidophilus), folic acid, and prednisolone. On 09-Feb-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) (strength, formulation, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. On 09-Feb-2025, the patient initially had a minor irritation at the injection spot and couldn't sleep. On 10-Feb-2025 (Monday), the arm swelled up, her skin was very tight due to the swelling, the arm was hot & red (like a giant red hive) and was continuing to spread. The patient indicated she could not lift her arm. Therefore, patient went to her cardiologist on 11-Feb-2025 (Tuesday), as the swelling was almost under the arm. The cardiologist prescribed methylprednisolone (SOLUMEDROL) which worked until it wore off. The arm again became hot, red and swollen. The patient thought she was having a reaction as she was allergic to preservatives but did see there were no preservatives listed in the vaccine (Hypersensitivity). The patient was placed on cefalexin (KEFLEX) (500 m/4 times a day) in a case of an infection (infection unspecified (NOS) and prednisone (higher dose than currently taking). The patient sought medical attention and was to the emergency department. At the reporting time, the patient still had swelling (not recovered from hypersensitivity event). The outcome of the event of infection NOS was not provided. The causal relationship between the events with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Rheumatoid arthritis (gets monthly infusion and had her last done on 05-Feb-2025 (recently formed an antibody so HCP is taking her off it for now))
ATORVASTATIN CALCIUM; AMLODIPINE;ATORVASTATIN; CLONIDINE; SYNTHROID; ALEGRA; estriol Cream; FAMOTIDINE; CALTRATE; vitamin D; Acidophilus; Folic Acid; PREDNISOLONE; PREDNISOLONE