Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Extremely faint; Sweating profusely; Blurred vision /seeing white; Felt like she was going to drop to floor; Right foot felt as if it was tingling; Tip of toe of right foot felt numb/felt numbness starting from ankle to toe; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Extremely faint) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (Right foot felt as if it was tingling) and HYPOAESTHESIA (Tip of toe of right foot felt numb/felt numbness starting from ankle to toe). On an unknown date, the patient experienced SYNCOPE (Extremely faint) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating profusely), VISION BLURRED (Blurred vision /seeing white) and PRESYNCOPE (Felt like she was going to drop to floor). At the time of the report, SYNCOPE (Extremely faint), HYPERHIDROSIS (Sweating profusely), VISION BLURRED (Blurred vision /seeing white) and PRESYNCOPE (Felt like she was going to drop to floor) outcome was unknown and PARAESTHESIA (Right foot felt as if it was tingling) and HYPOAESTHESIA (Tip of toe of right foot felt numb/felt numbness starting from ankle to toe) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided. Treatment medications was not reported.   After 1 or 2 days of vaccination, her right foot felt as if it was tingling. Her tip of toe of right foot felt numb. Starting from ankle to toe she felt numbness. It was still there. It would not go away. Patient donated blood on Tuesday. After donation of blood despite fact that she had eaten lunch and had several glasses of water, patient became extremely faint. She was at a bookstore sat in a chair and started sweating profusely. She started having blurred vision and saw white and felt like patient was going to drop to floor. It was so scary and she had never experienced this before. The only thing that saved her was drinking cold water and after 30 minutes she could finally stand up & walk out the door. The patient was a healthy person with no underlying health issues and she did not take any medications. She deeply regret getting this vaccine because ever since she got the vaccine, her right foot felt dead - numb & tingling. She was told that she should go to primary care physician and get tests. At the time of this report, the patient was still experiencing numbness and tingling in her right foot and did not had time to go to the physician. She was just very unhappy that she got this vaccine because she had never had side affects to any vaccine like this. She was very discouraged by side affects associated with the vaccine, to the point that she was extremely reluctant to get her second dose.  Company Comment: This case concerns a 54-year-old, female patient with no relevant medical history, who experienced the unexpected event of syncope same day after blood donation The event occurred approximately 12 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk continued in company comment section.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received on 16-Sep-2021 that contains Events added case is Upgraded to serious. On 24-Sep-2021: Follow up received is NNI.; Sender's Comments: This case concerns a 54-year-old, female patient with no relevant medical history, who experienced the unexpected event of syncope same day after blood donation The event occurred approximately 12 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.