Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM / LA |
| RSV | RSV (MRESVIA) | MODERNA | UNK | — | — |
arm pain; discomfort; some body aches; tiredness/real tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DISCOMFORT (discomfort), MYALGIA (some body aches) and FATIGUE (tiredness/real tired) in an 83-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect products included Pre-filled Syringe injection for COVID-19 prophylaxis, mRNA-1345 (mRESVIA) for Respiratory syncytial virus infection prophylaxis and Pre-filled Syringe injection for Respiratory syncytial virus infection prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2-3 Pfizer COVID-19 vaccine doses); for COVID-19 prophylaxis: SPIKEVAX NOS (5 Moderna COVID-19 vaccine doses). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and SPIKEVAX NOS. On 20-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Jul-2025, the patient received dose of mRNA-1345 (mRESVIA) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose and Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced PAIN IN EXTREMITY (arm pain), DISCOMFORT (discomfort), MYALGIA (some body aches) and FATIGUE (tiredness/real tired). The patient was treated with Paracetamol (Tylenol) in 2025 for Discomfort, at an unspecified dose and frequency. In 2025, PAIN IN EXTREMITY (arm pain), DISCOMFORT (discomfort), MYALGIA (some body aches) and FATIGUE (tiredness/real tired) had resolved. The action taken with mRNA-1345 (mRESVIA) (Unknown) was unknown. Patient had no other vaccines within the past 4 weeks prior to the Moderna Spikevax, and patient had no medical conditions. The patient had 5 Moderna COVID-19 vaccine doses and 2-3 Pfizer COVID-19 vaccine doses in the past but had no further details. No concomitant medication was reported. The patient felt like she was overloaded with the COVID-19 vaccines, and she was spooked out and uncomfortable by having so many COVID shots. It looked like she was supposed to take another freaking shot. The patient was administered on 20-Jun-2025 in the left arm, where she had experienced significant arm pain, along with somebody aches and tiredness, and she was not prepared for this reaction. However, it was not as severe as the reaction to the RSV shot. She felt the discomfort was expected and suggested that the severity might depend on the person administering the shot or the injection site. It was worse than some previous shots, but referring to it as a little worse, but it was not terrible or horrible. She continued on that the pain from the reaction did not discourage her but referred it as gook and was referring to the vaccine. The patient received the RSV vaccine 10 days to 2 weeks after getting the Moderna Spikevax on 20-Jun-2025. Later confirmed that the RSV vaccine was administered on 01-Jul-2025. She experienced a more severe reaction to the RSV vaccine but noted that she did not remember all the details clearly. However, she had the same reactions with Spikevax for RSV but worse and mentioned she was exhausted. The patient did not remember exactly the details as it was too long ago but remembered it was way more severe than she had ever expected with RSV and hoped that Moderna would come out of a once in a lifetime COVID-19 vaccine like the RSV vaccine. It was unknown if the patient experienced any additional symptoms/events. Her experience of discomfort that lasted for two or three days which resolved on its own with the help of a couple of Tylenol, but she started taking after the first or second day.