Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vision blurred
Clinical narrative: uneven balance; blurry vision; dizziness; nauseous; Red spotty rash; red spots on her right leg which hurt; palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful; palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful; Chills worsened; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (uneven balance), VISION BLURRED (blurry vision), DIZZINESS (dizziness), RASH MACULAR (Red spotty rash), PAIN IN EXTREMITY (red spots on her right leg which hurt), PERIPHERAL SWELLING (palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful), PAIN IN EXTREMITY (palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful), CHILLS (Chills worsened) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 023A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced RASH MACULAR (Red spotty rash) (seriousness criterion hospitalization), PAIN IN EXTREMITY (red spots on her right leg which hurt) (seriousness criterion hospitalization), PERIPHERAL SWELLING (palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful) (seriousness criterion hospitalization). On an unknown date, the patient experienced BALANCE DISORDER (uneven balance) (seriousness criterion hospitalization), VISION BLURRED (blurry vision) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization), CHILLS (Chills worsened) (seriousness criterion hospitalization) and NAUSEA (nauseous) (seriousness criterion hospitalization). The patient was hospitalized from 18-May-2021 to 20-May-2021 due to BALANCE DISORDER, CHILLS, DIZZINESS, NAUSEA, PAIN IN EXTREMITY, PAIN IN EXTREMITY, PERIPHERAL SWELLING, RASH MACULAR and VISION BLURRED. At the time of the report, BALANCE DISORDER (uneven balance), VISION BLURRED (blurry vision), DIZZINESS (dizziness), RASH MACULAR (Red spotty rash), PAIN IN EXTREMITY (red spots on her right leg which hurt), PERIPHERAL SWELLING (palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful), PAIN IN EXTREMITY (palm was very swollen/  and then on her left palm was very swollen and very painful/ swelling on the left ball of hand that is very painful), CHILLS (Chills worsened) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/85 (High) went up to 150/85 and 92/50 (Low) went down to 92/50.         It was reported that after administering the first dose the patient had fever and sore left arm that same night and then the next morning she was fine. Then 3 days later, patient experienced body chills, backache, and headache. It was stated that every night for 2 weeks around 4-5 pm patient experienced a lot of body aches.   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. Patient was experiencing side effects since the first dose and the side effects have gotten worse since the second one.  No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.  the action taken with response to the drug is not applicable   This case was linked to MOD-2021-209338 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional document received on 08 JUN 2021 has Added reporter information updates, added concomitant drugs updated and events and seriousness criteria updated from non serious to serious; 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.