Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3044069 | IM |
headache; joint pain; muscle ache/a long reaction of a lot of muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle ache/a long reaction of a lot of muscle and joint pain) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3044069) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3044069) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient had been taking the Moderna vaccine whenever it has been available.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 11-Apr-2025, 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 11-Apr-2025, the patient experienced HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle ache/a long reaction of a lot of muscle and joint pain). The patient was treated with Paracetamol (Tylenol) from 2025 to 2025 at an unspecified dose and frequency and Ibuprofen (Advil) from 2025 to 2025 at an unspecified dose and frequency. In June 2025, HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle ache/a long reaction of a lot of muscle and joint pain) had resolved. Concomitant medication was not provided. It was reported that the patient had developed side effects such as headache, joint pain, and muscle ache following vaccination with Spikevax. These symptoms reportedly lasted for approximately two months. The patient was now inquiring about the differences between Spikevax and mNEXSPIKE for the 2025/2026 vaccination season, as he was considering options for his next COVID-19 vaccination. The patient wanted to confirm whether mNEXSPIKE contained a lower dose than Spikevax. It was explained that the patient had consistently received the Moderna vaccine whenever it was available, and the most recent dose had been administered in April Spikevax 2023 or 2024, depending on availability at the time. It was inquired about the differences between the earlier versions and the Spikevax 20252026 formulation. The patient wanted to determine whether there was something different about the Spikevax dose he had received, and whether similar differences existed in mNEXSPIKE that might explain or predict a similar reaction. It was noted that the basic ingredients appeared to remain consistent across the older vaccines, Spikevax, and mNEXSPIKE, and that the major differences seemed to lie in the mRNA sequence, dosage, and variant targeted. It was also asked whether the Spikevax dose patient received had the same dosage as previous vaccines or if it had been higher. They had been trying to understand whether the April dose had targeted a new variant and whether that could explain the prolonged muscle and joint pain he experienced for two months afterward. They were unsure if this reaction was a one-off event or a sign of how he might respond to future doses. Additionally, he had asked whether the body typically reacted to the variant encoded in the mRNA or to the other ingredients in the vaccine. He had expressed curiosity about whether the reaction was due to the mRNA variant or excipients, and whether non-mRNA vaccines might be a better alternative and also asked if Spikevax was simply a new name for the older vaccines and stated her belief that mNEXSPIKE had a weaker dosage. He had concluded that Spikevax might be the same as what had been available in 2022 or 2023, just under a new name. It was unknown if the patient experienced any additional symptoms or events. The patient had been advised by his healthcare provider to take Tylenol and Advil for two months. He had discontinued the medications once the symptoms had subsided. Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2025: Follow-up received and non-significant information includes medical history updated, updated reporter details and updated narrative.