Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram, Fall, Feeling abnormal, Hypoaesthesia
Clinical narrative: with red streaks going down my arm; weak; with red streaks going down my arm; I could not get out of bed; I fell in the bathroom because my left leg was numb and hurting; I fell in the bathroom because my left leg was numb and hurting; I fell in the bathroom because my left leg was numb and hurting; my arm was swollen; Feeling bad; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Feeling bad), IMMUNISATION REACTION (I could not get out of bed), FALL (I fell in the bathroom because my left leg was numb and hurting), HYPOAESTHESIA (I fell in the bathroom because my left leg was numb and hurting), PAIN IN EXTREMITY (I fell in the bathroom because my left leg was numb and hurting), PERIPHERAL SWELLING (my arm was swollen), VACCINATION SITE STREAKING (with red streaks going down my arm), VACCINATION SITE ERYTHEMA (with red streaks going down my arm) and ASTHENIA (weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Hypertension and Anxiety. Concomitant products included AMLODIPINE BESILATE (NORVASC), SERTRALINE HYDROCHLORIDE (ZOLOFT), ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN POTASSIUM (COZAAR) and SIMVASTATIN (ZOCOR) for an unknown indication.    On 21-Apr-2022 at 11:45 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2022 at 3:00 PM, the patient experienced FEELING ABNORMAL (Feeling bad) (seriousness criterion hospitalization). On 22-Apr-2022, the patient experienced IMMUNISATION REACTION (I could not get out of bed) (seriousness criterion hospitalization), FALL (I fell in the bathroom because my left leg was numb and hurting) (seriousness criterion hospitalization), HYPOAESTHESIA (I fell in the bathroom because my left leg was numb and hurting) (seriousness criterion hospitalization), PAIN IN EXTREMITY (I fell in the bathroom because my left leg was numb and hurting) (seriousness criterion hospitalization), PERIPHERAL SWELLING (my arm was swollen) (seriousness criterion hospitalization) and VACCINATION SITE ERYTHEMA (with red streaks going down my arm) (seriousness criterion hospitalization). On 23-Apr-2022, the patient experienced ASTHENIA (weak) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE STREAKING (with red streaks going down my arm) (seriousness criterion hospitalization). The patient was hospitalized from 22-Apr-2022 to 24-Apr-2022 due to ASTHENIA, FALL, FEELING ABNORMAL, HYPOAESTHESIA, IMMUNISATION REACTION, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE ERYTHEMA and VACCINATION SITE STREAKING. At the time of the report, FEELING ABNORMAL (Feeling bad), IMMUNISATION REACTION (I could not get out of bed), FALL (I fell in the bathroom because my left leg was numb and hurting), HYPOAESTHESIA (I fell in the bathroom because my left leg was numb and hurting), PAIN IN EXTREMITY (I fell in the bathroom because my left leg was numb and hurting), PERIPHERAL SWELLING (my arm was swollen), VACCINATION SITE STREAKING (with red streaks going down my arm), VACCINATION SITE ERYTHEMA (with red streaks going down my arm) and ASTHENIA (weak) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2022, Computerised tomogram: result not reported Result not reported. On 22-Apr-2022, Magnetic resonance imaging: result not reported Result not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: This spontaneous case concerns a 68-year-old, female patient with relevant medical history of concomitant intake of Cozaar (losartan), Norvasc (amlodipine) and Zoloft (sertraline), who experienced the unexpected, serious (hospitalization) events of feeling abnormal, immunisation reaction (vaccination related malaise), fall, hypoaesthesia, pain in extremity, peripheral swelling, vaccination site streaking, vaccination site erythema and asthenia. The events occurred beginning 3 hours, 15 minutes and up to approximately 2 days after receiving the fourth dose of the mRNA-1273 vaccine. The patient started 'feeling bad' approximately 3 hours after vaccination. One day after vaccination, she could not get out of bed. The patient fell in the bathroom because of left leg numbness and pain. The patient again fell in the kitchen. She was then brought Emergency department. The patient also experienced swollen arm with red streaks going down the arm. It was reported that it was the patient's left arm and left leg that were affected. Magnetic Resonance Imaging and Computed Tomogram scan were done, however, the results were not provided. The patient was given intravenous fluids and pain medications (unspecified), and was subsequently admitted. Two days after vaccination, it was reported that the patient's strength on her left side was checked and it was found to be 'still real weak'. No further clinical information (including details about hospitalization) was available for medical review. The patient was discharged approximately 3 days after vaccination and the patient was able to walk again. It was also reported that the patient was still weak approximately 4 days after vaccination. The medical history of concomitant intake of Cozaar, which may cause the side effect of numbness, remains a confounder for the event hypoaesthesia. Of note, the concomitant medications (Cozaar, Norvasc and Zoloft) may cause dizziness/lightheadedness which may increase the risk of fall, and therefore, may also be confounders.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old, female patient with relevant medical history of concomitant intake of Cozaar (losartan), Norvasc (amlodipine) and Zoloft (sertraline), who experienced the unexpected, serious (hospitalization) events of feeling abnormal, immunisation reaction (vaccination related malaise), fall, hypoaesthesia, pain in extremity, peripheral swelling, vaccination site streaking, vaccination site erythema and asthenia. The events occurred beginning 3 hours, 15 minutes and up to approximately 2 days after receiving the fourth dose of the mRNA-1273 vaccine. The patient started 'feeling bad' approximately 3 hours after vaccination. One day after vaccination, she could not get out of bed. The patient fell in the bathroom because of left leg numbness and pain. The patient again fell in the kitchen. She was then brought Emergency department. The patient also experienced swollen arm with red streaks going down the arm. It was reported that it was the patient's left arm and left leg that were affected. Magnetic Resonance Imaging and Computed Tomogram scan were done, however, the results were not provided. The patient was given intravenous fluids and pain medications (unspecified), and was subsequently admitted. Two days after vaccination, it was reported that the patient's strength on her left side was checked and it was found to be 'still real weak'. No further clinical information (including details about hospitalization) was available for medical review. The patient was discharged approximately 3 days after vaccination and the patient was able to walk again. It was also reported that the patient was still weak approximately 4 days after vaccination. The medical history of concomitant intake of Cozaar, which may cause the side effect of numbness, remains a confounder for the event hypoaesthesia. Of note, the concomitant medications (Cozaar, Norvasc and Zoloft) may cause dizziness/lightheadedness which may increase the risk of fall, and therefore, may also be confounders.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.