Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vision blurred
Clinical narrative: had a faint; felt a pain in his heart; vision blurred.; swollen; It's like a rash or allergy/ bumps are on the back of my head and ears, in the right arm and above the waist; little bumps in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (had a faint) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (It's like a rash or allergy/ bumps are on the back of my head and ears, in the right arm and above the waist) and VACCINATION SITE RASH (little bumps in the injection arm). On 15-May-2021, the patient experienced SYNCOPE (had a faint) (seriousness criterion medically significant), CHEST PAIN (felt a pain in his heart) and VISION BLURRED (vision blurred.). On 14-May-2021, RASH (It's like a rash or allergy/ bumps are on the back of my head and ears, in the right arm and above the waist) had resolved. At the time of the report, SYNCOPE (had a faint), CHEST PAIN (felt a pain in his heart), VISION BLURRED (vision blurred.), PERIPHERAL SWELLING (swollen) and VACCINATION SITE RASH (little bumps in the injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Heart rate: "heart rate went up until 202-202 (while running)". On 15-May-2021, Heart rate: when he moves his heart accelerates.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 17-MAY-2021 patient went to ER, there they did a check and everything went normal. The patient said that while he he was at rest he was all normal but when he moved his heart accelerates (he felt a big difference). The patient mentioned that the previous allergy went away a week ago.  Treatment medication included cortisone cream.  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. Vaccination site rash and rash are consistent with the product known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY 2021 contains vaccine details and  newadverse event updated as syncope, chest pain and vision blurred. Outcome of the event rash was updated as resolved. On 21-May-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field.; 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. Vaccination site rash and rash are consistent with the product known safety profile.