Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052030 | IM / LA |
swelling and a large lump at the injection site/swelling at the injection site on her left arm; She had a little bleeding/she had a little bit of blood on the injection site following administration; has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed; swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin; she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.; She expressed apprehension that the injection might not have been administered correctly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling and a large lump at the injection site/swelling at the injection site on her left arm), VACCINATION SITE HAEMORRHAGE (She had a little bleeding/she had a little bit of blood on the injection site following administration), VACCINATION SITE BRUISING (has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed), VACCINATION SITE MASS (swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin) and PHOTOPSIA (she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna in 2021, Spikevax NOS in 2022, Spikevax NOS in 2023 and Spikevax 2024-2025 formula on 01-Oct-2024. Past adverse reactions to the above products included No adverse effect with Moderna, Spikevax 2024-2025 formula, Spikevax NOS and Spikevax NOS. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 22-Sep-2025, the patient experienced VACCINATION SITE SWELLING (swelling and a large lump at the injection site/swelling at the injection site on her left arm), VACCINATION SITE HAEMORRHAGE (She had a little bleeding/she had a little bit of blood on the injection site following administration), VACCINATION SITE BRUISING (has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed), VACCINATION SITE MASS (swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin), PHOTOPSIA (she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.) and ANXIETY (She expressed apprehension that the injection might not have been administered correctly). At the time of the report, VACCINATION SITE SWELLING (swelling and a large lump at the injection site/swelling at the injection site on her left arm) was resolving, VACCINATION SITE HAEMORRHAGE (She had a little bleeding/she had a little bit of blood on the injection site following administration), VACCINATION SITE MASS (swelling and a large lump at the injection site/initially a large, goose egg-like bump/swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin), PHOTOPSIA (she couldn't definitively say she felt lightheaded, she did experience seeing "stars," described as little flashes of light.) and ANXIETY (She expressed apprehension that the injection might not have been administered correctly) outcome was unknown and VACCINATION SITE BRUISING (has a bruise there/She observed swelling at the injection site on her left arm, which felt like a "big goose egg" under the skin, and a notable circular bruise also developed) had not resolved. The patient's age was reported as 65-and-a-half-years-old. The patient had not received any other vaccines in the past 4 weeks. She did not have life threatening medical condition and not on any prescription meds. No concomitant medications were reported. Immediately after receiving the injection, the patient noticed swelling at the injection site, which was unusual since she had never experienced such reactions from previous vaccines, including COVID-19 vaccines. She had received the Moderna COVID-19 vaccine every year since it first became available in 2021. She never had any reactions, swelling, or bruising from any vaccine in the past. The healthcare provider who administered the vaccine remarked that the swelling was strange and mentioned accidentally hitting a "fat pocket", raising her suspicion that the vaccine was not injected intramuscularly as intended. She was informed that she had a little bit of blood on the injection site following administration. After receiving the vaccine, she was nearly in tears as she recounted the experience to her husband. She expressed apprehension that the injection might not have been administered correctly, had a concern. Although she could not definitively say she felt lightheaded, she experienced seeing "stars," described as little flashes of light. That led to some worry, as she feared she might pass out, prompting her to sit down on the floor for a few minutes until the sensation subsided. Fortunately, she did not pass out or faint and felt fine afterward, aside from having seen the stars. That occurred within half an hour of receiving the injection. While she could not be certain if those symptoms were a reaction to the Moderna product, her suspicion was that the injection was not administered correctly and felt it was not done properly. Due to the mishap with how her injection was administered, she was asking how soon she should be re-vaccinated, or had there been studies done on re-vaccination for a patient in such a situation. Concerned about the competency of the pharmacy staff, she decided against returning there for a planned flu shot. Her most recent Moderna COVID-19 vaccination was administered at the same pharmacy on 01-Oct-2024. While she has primarily been vaccinated with Moderna, she might have also received a Pfizer vaccine on one occasion. Her pharmacist mentioned that if she received the vaccine, she would need to wait for 2 months. If it were a different vaccine, she would have to wait 3 months. She wanted to know if she could be re-vaccinated, and how long people were waiting between injections when getting re-vaccinated. She now had a bruise there, which was initially a large, goose egg-like bump, but the swelling had since gone down. She was very concerned about the level of protection. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live significant follow-up received included reporter's mail address updated, patient's DOB added, historical vaccine added, dose details of suspect (dose and anatomical location) updated, verbatim of events, narrative updated, and reference numbers were added.