Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / RA |
Arm was hot; The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle; Arm was itchy; Arm was really red; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot), EXTENSIVE SWELLING OF VACCINATED LIMB (The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle), VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE ERYTHEMA (Arm was really red) and VACCINATION SITE SWELLING (Arm was swollen) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 06-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 07-Oct-2025, the patient experienced VACCINATION SITE WARMTH (Arm was hot), EXTENSIVE SWELLING OF VACCINATED LIMB (The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle), VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE ERYTHEMA (Arm was really red) and VACCINATION SITE SWELLING (Arm was swollen). The patient was treated with Naproxen sodium (Aleve) in October 2025 at a dose of UNK UNK, bid and Ibuprofen in October 2025 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm was hot), EXTENSIVE SWELLING OF VACCINATED LIMB (The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle), VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE ERYTHEMA (Arm was really red) and VACCINATION SITE SWELLING (Arm was swollen) had not resolved. Concomitant medication use information was not provided by reporter. Patient received Aleve this week (presumably starting on 06-Oct-2025). The patient received the COVID vaccine on Monday, 06-Oct-2025, and had a reaction that the patient had never experienced before. The patient always received Moderna in the past and had never had any issues. Unfortunately, it was not known whether the patient received Spikevax or mNEXSPIKE (did not keep the paperwork because the patient never had any issues in the past). The patient started experiencing a reaction by Tuesday; the arm was really red, swollen, hot, and itchy. The reaction started from the site where the shot was administered and spread all across the top of the arm, all the way around over the bicep muscle. It improved somewhat but still had not resolved. The patient had been taking Aleve twice a day and still feels kind of itchy, though not as bad as it was 2 days ago. The patient went back to the pharmacy, and they advised taking ibuprofen, so she had been taking Aleve all week. The patient was not sure if she should go to ready care (urgent care). The patient did not have a regular PCP but agreed to seek advice from the pharmacist on duty at the pharmacy, as she was going to go to the store later at the time of reporting. They advised her to try to find out which vaccine was received (mNEXSPIKE or Spikevax) and call back with that information. The patient did not have a headache and was not sick to her stomach. It was unknown if the patient experienced any additional symptoms/events.