Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 4 | 6704983 | IM / LA |
severe pain in her inner thigh; severe headache; feel so ill; fell so uncomfortable; experiencing pain in the groin, specifically in the inner portion of her thigh; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel so ill), PAIN IN EXTREMITY (severe pain in her inner thigh), DISCOMFORT (fell so uncomfortable), GROIN PAIN (experiencing pain in the groin, specifically in the inner portion of her thigh) and HEADACHE (severe headache) in a 75-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 6704983) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1) in 2019; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 3) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. On 27-Sep-2025, the patient received fourth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced ILLNESS (feel so ill), DISCOMFORT (fell so uncomfortable) and GROIN PAIN (experiencing pain in the groin, specifically in the inner portion of her thigh). On 27-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced PAIN IN EXTREMITY (severe pain in her inner thigh) and HEADACHE (severe headache). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, ILLNESS (feel so ill), PAIN IN EXTREMITY (severe pain in her inner thigh), DISCOMFORT (fell so uncomfortable) and GROIN PAIN (experiencing pain in the groin, specifically in the inner portion of her thigh) had not resolved and HEADACHE (severe headache) was resolving. No concomitant medication was reported. It was stated that patient received the Moderna vaccine, which was her usual choice for the COVID-19 vaccine, on 27-Sep-2025. It was added that in the past, she had never any reactions or adverse effects, but this time, since the 27th, she had experienced a severe headache. Now, main concern was severe pain in her inner thigh, which she did not have before. It was mentioned that she had never any kind of problem like this before, and it all started after she received the vaccine, and it did not go away. She had been taking Tylenol, but it just did not go away. It was stated that she had received several COVID-19 vaccines, usually choosing Moderna. It was believed patient might have had at least three, and this was her fourth vaccine. It was then asked why she was having an adverse reaction to the Spikevax 2025-2026 when patient has been receiving the COVID-19 vaccine since 2019 without any adverse effects. It was inquired about what was in this vaccine that was causing her to feel so ill and uncomfortable. It was also asked how she could take away the pain in her thigh and whether it was one of the side effects, as the pain was so intense. It started with a severe headache, but now the headache was very minimal because she took Tylenol. However, the inner thigh pain, which started the day she got the vaccine, was bothering her the most, and it was just getting worse. It was also asked if Moderna vaccine could cause a blood clot. It was stated that she was 75 years old but very healthy. She had not been in the hospital in the last 10 years. It was then asked again if patient should be experiencing severe pain in her thigh, on the opposite side of where she received the injection. It was mentioned that she had the injection in her left deltoid and was now experiencing pain in the groin, specifically in the inner portion of her thigh, which was not there until she got the vaccine. It was stated that it felt almost like severe cramps, which was so painful that they made it difficult for her to go down the stairs. It was also asked how long this was supposed to last. Patient received the vaccine on 27-Sept-2025 and marked either 4 or 5 days since then. It was expressed the need to know why this was happening because patient always got any kind of vaccine that was protect her and had never experienced adverse effects like the ones she was having with Spikevax 2025-2026. hopes it would go away soon because she was very uncomfortable. It was unknown if the patient experienced any additional symptoms/events.