Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
weakness; pain on the arm; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (pain on the arm) and VACCINATION SITE SWELLING (injection site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concomitant products included Ibuprofen and Paracetamol (Tylenol) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (pain on the arm) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (pain on the arm) and VACCINATION SITE SWELLING (injection site swelling) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was taking ibuprofen and Tylenol for several years before ever having a Moderna vaccine. The patient had all Moderna COVID -19 vaccines since Moderna started them. She always had some side effects post vaccination like weakness, unable to go to work for few days, injection site swelling and pain on the arm, etc. She got very nervous while getting the COVID shots. She became nervous cause she got so sick from that. On 03-Oct-2025, the patient received 8th Moderna vaccine. Prior to that, she had received all 7 doses from Moderna. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789984, MOD-2025-789988 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. On 06-Oct-2025: Live significant follow-up received included patient's DOB was added, concomitant medications added, narrative updated and reference numbers were added. On 06-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. On 07-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added.
Ibuprofen; Tylenol