Received Jun 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3042648 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y019157 | IM / LA |
Injection site reaction; Injection site vesicles; Injection site induration; Complaining of arm pain; Area was hard, red, induration present and large blister present (size of a quarter); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042648) for COVID-19 prophylaxis. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Concurrent medical conditions included Diabetes. Concomitant products included Amlodipine besilate, Benazepril hydrochloride (Lotrel), Atenolol, Insulin aspart (Novolog), Empagliflozin, Metformin hydrochloride (Synjardy), Esomeprazole magnesium (Nexium) and Tirzepatide (Mounjaro) for an unknown indication. On 18-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Apr-2025, the patient experienced VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. On 23-Apr-2025, the patient visited the clinic due to complaints of arm pain after receiving vaccines from the pharmacy. There was no fever, and pain occurred only when the area was palpated. Antibiotics were prescribed by the physician, and a follow-up was scheduled for 28-Apr-2025.
Diabetes
Lotrel; Atenolol; Novolog; Synjardy; Nexium; Mounjaro