Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
weakness; was achy; pain on the arm; usually get very ill/ get so sick from this; injection site swelling; the low grade temp; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (was achy), PAIN IN EXTREMITY (pain on the arm), ILLNESS (usually get very ill/ get so sick from this) and VACCINATION SITE SWELLING (injection site swelling) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concomitant products included Ibuprofen and Paracetamol (Tylenol) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN (was achy), PAIN IN EXTREMITY (pain on the arm), ILLNESS (usually get very ill/ get so sick from this), VACCINATION SITE SWELLING (injection site swelling) and PYREXIA (the low grade temp). At the time of the report, ASTHENIA (weakness), PAIN (was achy), PAIN IN EXTREMITY (pain on the arm), ILLNESS (usually get very ill/ get so sick from this), VACCINATION SITE SWELLING (injection site swelling) and PYREXIA (the low grade temp) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade. 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. The patient gets very nervous while getting the COVID shots. The patient became nervous cause she gets so sick from this. On 03-Oct-2025, the patient got 8th Moderna vaccine. Prior to this, patient 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-2025-789983 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live follow-up received contains non-significant information (reference numbers were added). On 06-Oct-2025: Live significant follow-up received: Patient's DOB was added, lab data was added, concomitant medication was added, additional events were added, and narrative was updated. On 06-Oct-2025: Live follow-up received contains non-significant information (reference numbers were added). On 07-Oct-2025: Live follow-up received contains non-significant information (reference numbers were added).
Ibuprofen; Tylenol
Test Name: temp; Result Unstructured Data: low grade