Age: 73.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Pain in extremity, Somnolence, Vaccination site pain
Clinical narrative: I cry easily; listless; I couldn't wake up, I was groggy all day/ I did sleep all day; sore in both arms; hurting; The Left side where I had the Covid-19 shot is tender to touch; depressed/ sad; This spontaneous case was reported by a patient and describes the occurrence of LISTLESS (listless), SOMNOLENCE (I couldn't wake up, I was groggy all day/ I did sleep all day), PAIN IN EXTREMITY (sore in both arms), PAIN (hurting) and CRYING (I cry easily) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU SYRINGE) for an unknown indication.    Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (EN5318) on 05-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (EN6201) on 26-Feb-2021, Pfizer (058F21A) on 10-Nov-2021, Flu shot in 2022 and Pfizer (GH9703) on 03-Oct-2022. Past adverse reactions to the above products included No adverse reaction with Flu shot, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, Pfizer and Pfizer. Concurrent medical conditions included Fibromyalgia (diagnosed while she was in her 50's).   On 05-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU SYRINGE) (unknown route) 1 dosage form. In 2023, the patient experienced DEPRESSED MOOD (depressed/ sad). On 06-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced LISTLESS (listless), SOMNOLENCE (I couldn't wake up, I was groggy all day/ I did sleep all day), PAIN IN EXTREMITY (sore in both arms) and PAIN (hurting). On 08-Oct-2023, the patient experienced CRYING (I cry easily). In October 2023, the patient experienced VACCINATION SITE PAIN (The Left side where I had the Covid-19 shot is tender to touch). At the time of the report, LISTLESS (listless), SOMNOLENCE (I couldn't wake up, I was groggy all day/ I did sleep all day), PAIN IN EXTREMITY (sore in both arms), PAIN (hurting), CRYING (I cry easily) and VACCINATION SITE PAIN (The Left side where I had the Covid-19 shot is tender to touch) outcome was unknown and DEPRESSED MOOD (depressed/ sad) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient takes no medication.  On 05-Oct-2023, she received Flu shot in the right arm and Spikevax in the left arm and slept pretty good Thursday night. On Friday morning, she could not wake up, was groggy all day, real listless, hurting, sore in both arms. It did not scare her but really felt good. Patient would eat something and felt sleepy and would sleep all day. She did not fall. She was thinking that she had a reaction. The left side where COVID-19 shot was given was tender to touch but the side of Flu shot, does not hurt. Had not reached out to HCP. During the call, the patient stated that she was sad and depressed but does not take anything.   This case was linked to US-MODERNATX, INC.-MOD-2023-745884, US-MODERNATX, INC.-MOD-2023-745980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745884:Husband's case US-MODERNATX, INC.-MOD-2023-745980:Sister-in-law's case