Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | — | — |
She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; This spontaneous report was received from the consumer and refers to herself, a 62-year-old female patient. The patient's medical history included drug reactions/allergies to lisinopril and other unspecified medications. The patient's concurrent conditions included high blood pressure and high cholesterol. Historical drugs included lisinopril. Concomitant medications included Carvedilolo, Atorvastatin, Vitamin E, Vitamin D, and Acyclovir. On an unspecified date in February 2025 (3 weeks ago but the patient was unsur of the exact date), the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site lot # and expiration date were not reported) administered for prophylaxis. On an unspecified date in 2025, the patient experienced swelling in the arm that received the vaccine, irritation and a "raised" area around the site (vaccination site swelling; vaccination site irritation; vaccination site mass). She reached out to the pharmacy where she received the vaccine and she stated that she received a cortisone shot and has been taking benadryl. She reported the swelling has decreased but is not resolved. She also reported having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns (headache; fatigue; sinus disorder; hypersensitivity). She stated that she did not receive any patient education from the pharmacist at the pharmacy prior to or after receiving the vaccine. She stated that she was going to attempt to get in contact and make an appointment with a primary care provider today as her symptoms have not responded. Therefore, at the time of reporting, the patient had not recovered from the reported adverse events. No additional adverse event (AE) and no product quality compliant (PQC) was noted. No additional information was reported. The causal relationship between the reported adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received.
Blood pressure high; Drug allergy; High cholesterol
Medical History/Concurrent Conditions: Allergic reaction
Carvedilol; Atorvastatin; Vitamin E; Vitamin D; Acyclovir