Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM / LA |
pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm; bursitis; 12 hours later left shoulder felt like it was on fire; started loosing my range of motion in left arm; lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (bursitis), BURNING SENSATION (12 hours later left shoulder felt like it was on fire), HYPOKINESIA (started loosing my range of motion in left arm), ARTHRALGIA (lot of pain) and PRODUCT PREPARATION ERROR (pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Partial tear of muscle (cannot receive the booster in my right shoulder because I have a partial tear). On 30-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. In 2024, the patient experienced BURSITIS (bursitis), HYPOKINESIA (started loosing my range of motion in left arm) and ARTHRALGIA (lot of pain). 2024, the patient experienced BURNING SENSATION (12 hours later left shoulder felt like it was on fire). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm). The patient was treated with Cortisone acetate (Cortison) on 24-Mar-2025 at an unspecified dose and frequency and Manual therapy (used ice packs to try and cool it down) for Burning sensation. At the time of the report, BURSITIS (bursitis), BURNING SENSATION (12 hours later left shoulder felt like it was on fire) and PRODUCT PREPARATION ERROR (pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm) outcome was unknown and HYPOKINESIA (started loosing my range of motion in left arm) and ARTHRALGIA (lot of pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed had Frozen Shoulder. Concomitant medication was not reported. It was reported that patient went to the Pharmacy to receive the Moderna Covid Booster. The pharmacy was quite busy, and the pharmacist told, she had to retrieve the Covid booster from the freezer. The pharmacist must have waited about 10 to 15 minutes before she administered the booster into left arm. Patient sat there for about 15 minutes and then went on with day. 12 hours later her left shoulder felt like it was on fire. She used ice packs to try and cool it down. Then she started losing range of motion in left arm. Patient made an appointment with an Orthopedic because the range of motion in left arm was pretty bad. The orthopedic sent to PT for four weeks and had an MRI. The MRI showed she had Frozen Shoulder. Then she made an appointment with an Orthopedic. That Orthopedic told that she had Bursitis, not Frozen Shoulder. But throughout all this time she was in a lot of pain. The Orthopedic recommended a Cortisone Injection. Using an ultrasound he gave the Cortisone Injection. Patient had relief immediately and it had lasted about 7 months. It was Oct-2025 and returned to the Orthopedic for another Cortisone Injection. The injection lasted until Oct-2025. The point she was making was the Pharmacist was in too much of a hurry and administered the booster in the wrong spot or too soon after she retrieved from the freezer. Also because of the constant pain patient was unable to receive the booster this year on her left shoulder. She could not receive the booster in her right shoulder because she had a partial tear. So, no Covid Booster this year. Patient find PT did not help and the Orthopedic said any kind of surgery would help. Patient had X-Rays and MRI. She had an appointment with Orthopedic in Nov-2025 to have another injection. She still had a lot of pain. Range of motion had returned. It was unknown if the patient experienced any additional symptoms/events. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2025: Follow up received with non-significant information includes treatment drug details added.
Partial tear of muscle (cannot receive the booster in my right shoulder because I have a partial tear)
Test Name: MRI; Result Unstructured Data: showed had Frozen Shoulder