Received Mar 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
SIRVA; incorrectly administered Moderna vaccine into her shoulder joint, which was too high on her shoulder instead of her deltoid; This spontaneous case was reported by an other health care professional and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered Moderna vaccine into her shoulder joint, which was too high on her shoulder instead of her deltoid) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE. On 04-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 04-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered Moderna vaccine into her shoulder joint, which was too high on her shoulder instead of her deltoid). On 05-Sep-2024, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) had not resolved and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered Moderna vaccine into her shoulder joint, which was too high on her shoulder instead of her deltoid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 8-9 on 10-point scale. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered Moderna vaccine into her shoulder joint, which was too high on her shoulder instead of her deltoid) to be related and SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) to be not related. For Pre-filled Syringe, the reporter did not provide any causality assessments. The patient had no vaccines within the past 4 weeks. No concomitant medications were reported. It was reported that, the patient had SIRVA after receiving and incorrectly administered Moderna vaccine into her shoulder joint, which was too high on her shoulder instead of her deltoid. The next day and for months after she was unable to use her arm and in pain 8-9 on 10-point scale. That resulted in severe pain (9/10) from her neck to her fingertips the following day, rendering her arm unusable. Over the past 19 months, she had 2 cortisone injections, surgery to remove her bursa, synovial membrane, debridement, and a capsule release, 3 plasma injections, a tenotomy and 17 months of physical therapy, yet she remained in chronic pain. It was reported that, she emphasized that her condition was due to incorrect vaccine administration rather than the vaccine itself, highlighting the preventability of SIRVA. It was unknown if the patient experienced any additional symptoms/events.
Test Name: pain scale; Result Unstructured Data: 8-9 on 10-point scale