Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052671 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z003579 | IM / LA |
INJECTION SITE WARMTH/feels warm to the touch; INJECTION SITE PAIN/some pain at the site of injection; Injection site erythema/The entire upper arm is red; INJECTION SITE SWELLING/The entire upper arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (INJECTION SITE WARMTH/feels warm to the touch), VACCINATION SITE PAIN (INJECTION SITE PAIN/some pain at the site of injection), VACCINATION SITE ERYTHEMA (Injection site erythema/The entire upper arm is red) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING/The entire upper arm is swollen) in a 77-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052671) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3052671) for COVID-19 prophylaxis and co-suspect non-company product included Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Previously administered products included for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included Allergy with Codeine. Concurrent medical conditions included Blood pressure high (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had high blood pressure), Arthritis (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had arthritis), GERD (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had GERD), Iodine contrast media allergy (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had iodine dye allergy), Drug hypersensitivity (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had codeine allergy) and Sleep disorder. Concomitant products included Celecoxib (Celebrex), Pregabalin, Citalopram hydrobromide (Celexa), Famotidine, Losartan potassium (Losartan), Apoaequorin, Colecalciferol (Prevagen) and Colestyramine (Cholestyramine) for an unknown indication. On 04-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 05-Oct-2025, the patient experienced VACCINATION SITE WARMTH (INJECTION SITE WARMTH/feels warm to the touch), VACCINATION SITE PAIN (INJECTION SITE PAIN/some pain at the site of injection), VACCINATION SITE ERYTHEMA (Injection site erythema/The entire upper arm is red) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING/The entire upper arm is swollen). At the time of the report, VACCINATION SITE WARMTH (INJECTION SITE WARMTH/feels warm to the touch), VACCINATION SITE PAIN (INJECTION SITE PAIN/some pain at the site of injection), VACCINATION SITE ERYTHEMA (Injection site erythema/The entire upper arm is red) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING/The entire upper arm is swollen) had not resolved. On Sunday, 05-Oct-2025, around noon, the patient noticed that the reaction started. It appeared on about half of the patient's upper arm. The reaction continued to worsen over the next few days. The entire upper arm became red, swollen and warm to the touch. The patient reported some pain at the injection site. Both vaccines had been administered in the patient's left arm, side by side. Patient was taking aqua peace for sleep. No treatment medications were reported.
Arthritis (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had arthritis); Blood pressure high (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had high blood pressure); Drug hypersensitivity (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had codeine allergy); GERD (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had GERD); Iodine contrast media allergy (As per patient on 07-Oct-2025 at 9:35 A.M, the patient had iodine dye allergy); Sleep disorder
Celebrex; Pregabalin; Celexa; Famotidine; Losartan; Prevagen; Cholestyramine