Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Somnolence, Vaccination site pain
Clinical narrative: fell asleep for about an hour or two; fatigue; soreness at the injection site; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (fell asleep for about an hour or two), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache) and CHILLS (chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (survivor, in remission patient had surgery in 2014, but status will be NED (No evidence detected)) from 2008 to 2014. Concurrent medical conditions included Follicular B-cell non-Hodgkin's lymphoma (stage 2 NHL, survivor, since 2019 chronic remission) since 2016, Immunocompromised since 2016, Visual impairment (visually impaired) since 07-Mar-2020, Food allergy (Red dye), Food allergy (blue dye), Hypertension (Had this for 30-40 years.), Vestibular abnormalities since 2021, Migraine and Allergy NOS (Had a long list of allergies.). Concomitant products included ATENOLOL for Blood pressure management, CLONAZEPAM for Migraine, LIOTHYRONINE SODIUM (LIOTHYRONIN), LEVOTHYROXINE SODIUM (UNITHROID), LOSARTAN POTASSIUM, VITAMIN D [VITAMIN D NOS], VITAMIN B [VITAMIN B NOS], MAGNESIUM CITRATE, CALCIUM CITRATE, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), CICLOSPORIN (RESTASIS), LATANOPROST, CARBOMER (REFRESH [CARBOMER]), ERYTHROMYCIN, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), MELATONIN and POLYETHYLENE GLYCOL [MACROGOL] for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Mar-2021, the patient experienced SOMNOLENCE (fell asleep for about an hour or two), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache) and CHILLS (chills). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at a dose of 500 milligram and Manual therapy (cool/icy compress on the site) for Vaccination site pain. On 04-Mar-2021, SOMNOLENCE (fell asleep for about an hour or two), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache) and CHILLS (chills) had resolved.            Current condition included blood pressure. Patient was currently being treated for vision impairment , however her treatment had been delayed due to the pandemic. Patient reported that she never had a fever after receiving the shots.  Concomitant medication taken by the patient included Acetaminophen.   This case was linked to MOD-2021-027528, MOD-2022-474724 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up was received and the patient demographics, medical history,vaccine information, concomitant medications  were  updated. Event fever was deleted as patient mentioned thatshe never had a fever after receiving the shots.