Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Loss of personal independence in daily activities, Lymphadenopathy, Memory impairment
Clinical narrative: Can't drive; Almost passed out; Trouble sleeping because of pain; Pain in left arm after 1st dose / right leg pain on surface/pain in right arm; bad memory; can't stand; Tingling; Burns; Dizziness off and on after 1st dose; Can't sit; numb; Headache; Foggy brain; Unable to tolerate the medication; extreme fatigue/cant lay down for more than 2 hours; Bone pain/severe pain in front and back by collarbone; severe pain in back; severe chest pain; Swollen lymph node/supraclavicular adenopathy; Severe muscle pain in both arms; Extreme joint pain in both elbows after 1st dose / severe pain in both elbows/right shoulder/wrists; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness off and on after 1st dose), BONE PAIN (Bone pain/severe pain in front and back by collarbone), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't drive), PRESYNCOPE (Almost passed out) and INSOMNIA (Trouble sleeping because of pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine), Penicillin allergy (Bicillin LA), Iodine allergy (iodinated iodine), Fibromyalgia ("haven't had any real problem till 2 Mar 2021") since 22-Sep-2008, Chronic fatigue ("seems both had settled down till 2 Mar 2021") since 22-Sep-2008, Hypercholesterolemia since 14-Apr-2014, Supraclavicular retraction since 25-Mar-2021 and Rheumatoid arthritis (very very painful - same/ trying new medications) since 02-Mar-2021. Concomitant products included CYCLOBENZAPRINE from 30-Mar-2021 to an unknown date for Pain, GABAPENTIN and HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) for an unknown indication.    On 16-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 02-Mar-2021, the patient experienced MYALGIA (Severe muscle pain in both arms). 02-Mar-2021, the patient experienced ARTHRALGIA (Extreme joint pain in both elbows after 1st dose / severe pain in both elbows/right shoulder/wrists). On 25-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node/supraclavicular adenopathy). On 24-Apr-2021, the patient experienced CHEST PAIN (severe chest pain) and BACK PAIN (severe pain in back). On 26-Apr-2021, the patient experienced BONE PAIN (Bone pain/severe pain in front and back by collarbone). On an unknown date, the patient experienced DIZZINESS (Dizziness off and on after 1st dose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't drive), PRESYNCOPE (Almost passed out), INSOMNIA (Trouble sleeping because of pain), PAIN IN EXTREMITY (Pain in left arm after 1st dose / right leg pain on surface/pain in right arm), MEMORY IMPAIRMENT (bad memory), DYSSTASIA (can't stand), PARAESTHESIA (Tingling), THERMAL BURN (Burns), SITTING DISABILITY (Can't sit), HYPOAESTHESIA (numb), FEELING ABNORMAL (Foggy brain), DRUG INTOLERANCE (Unable to tolerate the medication), HEADACHE (Headache) and FATIGUE (extreme fatigue/cant lay down for more than 2 hours). The patient was treated with HYDROCODONE for Pain, at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form. On 19-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, DIZZINESS (Dizziness off and on after 1st dose), BONE PAIN (Bone pain/severe pain in front and back by collarbone), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't drive), CHEST PAIN (severe chest pain), BACK PAIN (severe pain in back), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph node/supraclavicular adenopathy), MYALGIA (Severe muscle pain in both arms) and ARTHRALGIA (Extreme joint pain in both elbows after 1st dose / severe pain in both elbows/right shoulder/wrists) had not resolved and PRESYNCOPE (Almost passed out), INSOMNIA (Trouble sleeping because of pain), PAIN IN EXTREMITY (Pain in left arm after 1st dose / right leg pain on surface/pain in right arm), MEMORY IMPAIRMENT (bad memory), DYSSTASIA (can't stand), PARAESTHESIA (Tingling), THERMAL BURN (Burns), SITTING DISABILITY (Can't sit), HYPOAESTHESIA (numb), FEELING ABNORMAL (Foggy brain), DRUG INTOLERANCE (Unable to tolerate the medication) and FATIGUE (extreme fatigue/cant lay down for more than 2 hours) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she used an over-the-counter sleep aid to help with her trouble sleeping due to pain. She also used a heating pad on both arms and took Epsom salt baths as well as a 1/2 bottle of an old prescription of hydrocodone to help with pain. She stated it "took the edge off", but never left. The pain moved from one side (of body) to the other or both. She reported it hurt non-stop in her muscles, bones and joints.  The patient has seen more than one doctor and says the doctor recommended she didn't get the 2nd dose. She has not received the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Additional events are added, concomitant drugs and allergies added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.