Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052736 | IM |
arm/injection site soreness; numbness on arm up to shoulder and into armpit; light headed; nausea/feeling of wanting to vomit (not actually vomiting); headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm/injection site soreness), HYPOAESTHESIA (numbness on arm up to shoulder and into armpit), DIZZINESS (light headed), NAUSEA (nausea/feeling of wanting to vomit (not actually vomiting)) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052736) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Since late 2020 except for annual arm-injection site soreness for a day or two.). Past adverse reactions to the above products included Vaccination site pain with COVID-19 Vaccine. On 02-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 02-Oct-2025, the patient experienced VACCINATION SITE PAIN (arm/injection site soreness), HYPOAESTHESIA (numbness on arm up to shoulder and into armpit), DIZZINESS (light headed), NAUSEA (nausea/feeling of wanting to vomit (not actually vomiting)), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with Paracetamol (Tylenol) from 2025 to 2025 for Headache, at a dose of 4x daily. In 2025, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 06-Oct-2025, VACCINATION SITE PAIN (arm/injection site soreness), HYPOAESTHESIA (numbness on arm up to shoulder and into armpit), DIZZINESS (light headed) and NAUSEA (nausea/feeling of wanting to vomit (not actually vomiting)) had resolved. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. Within 2 hours, the patient started having a headache and arm/injection site soreness. Within 4 hours, she had arm soreness increased substantially. Within 6 hours, the patient had numbness in the arm up to the shoulder and in the armpit. Within 10 hours, patient had nausea, light headache, fatigue, and a feeling of wanting to vomit (not actually vomiting). Next morning, all the symptoms were there, and the patient stayed in bed all day due to nausea and light-headed. After 48 hours, the nausea and feeling of wanting to vomit were gone, but arm soreness and numbness still remained. 72 hours later, the numbness in the arm pit was gone, and injection site soreness started to subside. After 84 hours, the headache started to subside and numbness near the shoulder/upper arm started to dissipate, and fatigue. 96 hours later, the headache was gone, and injection site soreness was almost entirely gone (very slight with certain movements). After 106 hours, all symptoms were gone. That was the first time the patient had extensive side effects. The patient never had any reactions to Covid vaccinations since late 2020 except for annual arm-injection site soreness for a day or two. The patient never had a FLU shot along with a Covid-19 vaccination because if reactions happened, it was unknown which vaccination caused the reactions; and this year the patient had this reaction. The patient would wait for the annual flu shot in a few weeks to make sure the arm soreness and other reactions were totally gone. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Patient took Tylenol 500mg 4x daily to deal with headache for 3 days. Reporter causality was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790000 (Patient Link).