Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053115 | IM / RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
there was a black and blue spot where the vaccine was injected. That was the first time the patient noticed any discoloration or anything; soreness on her arm; pain in the arm and into the shoulder and upper neck; noticed a bruise that wasn't there before; The patient's shoulder was very tender and now it was up to her neck, behind her ears, up in the neck and it was from the place of injection, up into her shoulder and neck; pain in the arm and into the shoulder and upper neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (there was a black and blue spot where the vaccine was injected. That was the first time the patient noticed any discoloration or anything), VACCINATION SITE BRUISING (noticed a bruise that wasn't there before), TENDERNESS (The patient's shoulder was very tender and now it was up to her neck, behind her ears, up in the neck and it was from the place of injection, up into her shoulder and neck), NECK PAIN (pain in the arm and into the shoulder and upper neck) and VACCINATION SITE PAIN (soreness on her arm) in a 75-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3053115) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3053115) for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Seasonal asthma (It was not really severe and was seasonal.) and Osteoarthritis (It was not specified when the condition started. The patient did physical therapy for her osteoporosis in her back and was seeing an orthopedic doctor.). On 18-Dec-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In December 2025, the patient experienced VACCINATION SITE BRUISING (noticed a bruise that wasn't there before), TENDERNESS (The patient's shoulder was very tender and now it was up to her neck, behind her ears, up in the neck and it was from the place of injection, up into her shoulder and neck), NECK PAIN (pain in the arm and into the shoulder and upper neck) and ARTHRALGIA (pain in the arm and into the shoulder and upper neck). On 27-Dec-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced VACCINATION SITE DISCOLOURATION (there was a black and blue spot where the vaccine was injected. That was the first time the patient noticed any discoloration or anything) and VACCINATION SITE PAIN (soreness on her arm). The patient was treated with Arnica montana (Arnica) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (there was a black and blue spot where the vaccine was injected. That was the first time the patient noticed any discoloration or anything), VACCINATION SITE BRUISING (noticed a bruise that wasn't there before), TENDERNESS (The patient's shoulder was very tender and now it was up to her neck, behind her ears, up in the neck and it was from the place of injection, up into her shoulder and neck), NECK PAIN (pain in the arm and into the shoulder and upper neck), VACCINATION SITE PAIN (soreness on her arm) and ARTHRALGIA (pain in the arm and into the shoulder and upper neck) had not resolved. No concomitant medications were reported. The patient had no vaccines within last month apart from flu shot received on the same day as her COVID vaccine (18-Dec-2025). It was reported that the patient did not have any problems with the shots for several days - she was fine. Usually if she was going to have a reaction, she might have a little tenderness in the area on her arm. It was reported that, on day 9 after the shot (first symptoms appeared around Christmas day as it was bothering her), she started to have soreness on her arm and noticed there was a black and blue spot where the vaccine was injected. That was the first time she noticed any discoloration or anything. It was reported that, she thought maybe her symptoms were just starting a little late and noticed a bruise that was not there before. She then got concerned and it was reported 11 days after the shot. It was strange that she was having reactions, as she had numerous COVID shots, all Moderna and had no problems. She had COVID 3 times after she had the shots. It was reported that, the patient thought this was kind of unusual, her arm was so sore, and it was on her shoulder. Her shoulder was very tender and then it was up to her neck, behind her ears, up in the neck. It was from the place of injection, up into her shoulder and upper neck. She never had that happen with any shot she ever had. It was reported that, she was not feeling very well because her arm was very sore and it was recommended to take Ibuprofen, but she tried to avoid it because her blood pressure went up with it. They also recommended a topical lotion called Arnica Cream. They said that sometimes it alleviated the pain. She had put some on the evening when she went to bed so she could sleep better, and it helped. It was not something she had ever used before and was not sure if she could take it with Ibuprofen if she took an Advil with it. It was reported that, the patient's first guess was that it was probably the flu shot because she never had a reaction to any other COVID shots, just a little bit of tenderness but always immediately after the shot, 1 or 2 days after the shot and then it would just go away. It never happened that it was okay and then suddenly from out of nowhere, here it was hurting her 2 weeks later. Till date and the past couple of days, it was still very tender. It was reported that, the patient thought it was feeling better yesterday but it came and went. If she had to reach up, it bothered her on her shoulder. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-793037 (Patient Link).
Osteoarthritis (It was not specified when the condition started. The patient did physical therapy for her osteoporosis in her back and was seeing an orthopedic doctor.); Seasonal asthma (It was not really severe and was seasonal.)