Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 80777-0400-60 | IM / RA |
Muscular pain increased from upper arm to right lumbar musculatone; Muscular pain increased from upper arm to side of neck; Muscular pain increased from upper arm to right chest wall; Muscular pain increased from upper arm to right chest wall; Extreme muscle pain RT side; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Muscular pain increased from upper arm to right lumbar musculatone), NECK PAIN (Muscular pain increased from upper arm to side of neck), NON-CARDIAC CHEST PAIN (Muscular pain increased from upper arm to right chest wall), PAIN IN EXTREMITY (Muscular pain increased from upper arm to right chest wall) and MYALGIA (Extreme muscle pain RT side) in a 72-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777-0400-60) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Amoxicillin, Erythromycin and Ampicillin. Past adverse reactions to the above products included Drug allergy with Amoxicillin, Ampicillin and Erythromycin. Concurrent medical conditions included Asthma since 2021, Sleep apnea since 2020, Selective IgG immunodeficiency since 2014, Allergy to metals (Gold allergy), Allergy to antibiotic (Amoxicillin allergy), Allergy to antibiotic (Ampicillin allergy), Allergy to antibiotic (Erythromycin allergy), Food allergy (Limbrell allergy), Iodine contrast media allergy (Iodinated contrast), Adhesive tape allergy (Glue on tape), Allergy to silk (Silk suture), Osteoporosis and Drug allergy (Tymlos). Concomitant products included Raloxifene hydrochloride (Raloxifene) from 2022 to an unknown date for Osteoporosis. On 18-Sep-2025 at 2:00 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 20-Sep-2025 at 2:00 PM, the patient experienced BACK PAIN (Muscular pain increased from upper arm to right lumbar musculatone), NECK PAIN (Muscular pain increased from upper arm to side of neck), NON-CARDIAC CHEST PAIN (Muscular pain increased from upper arm to right chest wall), PAIN IN EXTREMITY (Muscular pain increased from upper arm to right chest wall) and MYALGIA (Extreme muscle pain RT side). The patient was treated with Paracetamol (Tylenol) for Muscle pain, at an unspecified dose and frequency and Methylprednisolone (oral use) for Muscle pain, at a dose of 4 milligram. On 23-Sep-2025, BACK PAIN (Muscular pain increased from upper arm to right lumbar musculatone), NECK PAIN (Muscular pain increased from upper arm to side of neck), NON-CARDIAC CHEST PAIN (Muscular pain increased from upper arm to right chest wall), PAIN IN EXTREMITY (Muscular pain increased from upper arm to right chest wall) and MYALGIA (Extreme muscle pain RT side) had resolved. Patient was also allergic to EKG leads. It was reported that patient was continuously taking Arnuity inhaler 100mg sip from 2021 for asthma. It was reported that patient had no soreness until 20-Sep-2025, 2:00 P.M. Then muscular pain increased from upper arm to right chest wall, right side of heart, right lumbar masculine, right side of neck and in the entire arm. Patient would scream loudly when tried to use muscle or joints involving muscles those were painful. She tried to control the pain with ice packs and Tylenol, but pain was too great and started wrenching. Patient ended up taking 4 mg methyl prednisolone orally and 6 hours later, she took 4 mg methyl prednisone. After that, pain became tolerable but it took the patient 4 days to recover. This case was linked to MOD-2025-789418 (Patient Link).
Adhesive tape allergy (Glue on tape); Allergy to antibiotic (Erythromycin allergy); Allergy to antibiotic (Ampicillin allergy); Allergy to antibiotic (Amoxicillin allergy); Allergy to metals (Gold allergy); Allergy to silk (Silk suture); Asthma; Drug allergy (Tymlos); Food allergy (Limbrell allergy); Iodine contrast media allergy (Iodinated contrast); Osteoporosis; Selective IgG immunodeficiency; Sleep apnea
Raloxifene