Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Sleep disorder, X-ray
Clinical narrative: Back pain has been more severe, increased back pain; Not feeling well, kind of of,feeling off; Weakness in legs for 3 weeks,general weakness,weakness in legs; Low appetite,low appetite; Shortness of breath; Rapid heartbeat; Dry cough; General weakness; Arm was sore,sore arm; Trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain has been more severe, increased back pain), MALAISE (Not feeling well, kind of of,feeling off), ASTHENIA (Weakness in legs for 3 weeks,general weakness,weakness in legs), DECREASED APPETITE (Low appetite,low appetite) and DYSPNOEA (Shortness of breath) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back pain (history of backpain due to fractures) and Fracture (history of backpain due to fractures). Concomitant products included GABAPENTIN, HYDROCODONE, DULOXETINE, METOPROLOL, CALCIUM, RESVERATROL, FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR), MACROGOL 3350 (MIRALAX) and MAGNESIUM for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced SLEEP DISORDER (Trouble sleeping) and MYALGIA (Arm was sore,sore arm). On an unknown date, the patient experienced BACK PAIN (Back pain has been more severe, increased back pain), MALAISE (Not feeling well, kind of of,feeling off), ASTHENIA (Weakness in legs for 3 weeks,general weakness,weakness in legs), DECREASED APPETITE (Low appetite,low appetite), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Rapid heartbeat), COUGH (Dry cough) and ASTHENIA (General weakness). On 10-Mar-2021, SLEEP DISORDER (Trouble sleeping) and MYALGIA (Arm was sore,sore arm) had resolved. At the time of the report, BACK PAIN (Back pain has been more severe, increased back pain), MALAISE (Not feeling well, kind of of,feeling off), ASTHENIA (Weakness in legs for 3 weeks,general weakness,weakness in legs), DECREASED APPETITE (Low appetite,low appetite), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Rapid heartbeat), COUGH (Dry cough) and ASTHENIA (General weakness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) Patient reported visiting a cardiologist for the shortness of breath and rapid heartbeat and a X-ray was ordered which came back fine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Follow up on 4th June 2021: Other Concomitant Medication provided was Vitamin K and Turmeric.  Follow up on 9th June 2021: Patient called in to report adverse events following vaccination. Patient received the first dose of Moderna Covid19 vaccine on 09Feburary2021 in left arm. Patient reported sore arm following the first dose starting 09Feburary and ending 10Feburary2021. Patient received the second dose of the Moderna Covid19 vaccine (Lot #: 003A21A) on 09March2021. Patient reported experiencing a sore arm and trouble sleeping following the second dose which began on 09March2021 and ended on 10March2021. Patient reported feeling off, low appetite, general weakness, shortness of breath, rapid heartbeat, increased back pain, weakness in legs that began a couple of days after the second dose; patient could not remember specific date. Patient reported those symptoms lasting four to five weeks; patient could not remember specific date. Patient reported experiencing a dry cough a couple of weeks after receiving the second dose that lasted for two weeks; patient could not remember specific start and end dates. Patient reported visiting a cardiologist for the shortness of breath and rapid heartbeat and a X-ray was ordered which came back fine. Patient consented to follow-up via phone with Safety Team. Patient consented to follow-up with  healthcare provider with Safety team.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added concomitant medication. Updated events. Added events sore arm (after 2nd dose),trouble sleeping having outcome Resolved. Also added events general weakness, rapid heartbeat and dry cough having outcome as unknown.