Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: leg did have to get stitches; fainted in the shower; felt a little dizzy; fell to the ground/collapsed/fell over again; hit my knee on the tile; beyond dizzy/took me a half hour to get up; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainted in the shower) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SYNCOPE (fainted in the shower) (seriousness criterion medically significant), DIZZINESS (felt a little dizzy), FALL (fell to the ground/collapsed/fell over again), JOINT INJURY (hit my knee on the tile) and DIZZINESS POSTURAL (beyond dizzy/took me a half hour to get up). On an unknown date, the patient experienced LIMB INJURY (leg did have to get stitches). At the time of the report, SYNCOPE (fainted in the shower), DIZZINESS (felt a little dizzy), FALL (fell to the ground/collapsed/fell over again), JOINT INJURY (hit my knee on the tile), DIZZINESS POSTURAL (beyond dizzy/took me a half hour to get up) and LIMB INJURY (leg did have to get stitches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The first shot she didn't have a reaction. On 12Feb2021, she felt a little dizzy after she got up in the morning. Then she fainted in the shower. She collapsed and fell to the ground. She never fainted in her life. She hit her knee on the tile and crawled out of the shower. But she fell over again because she was beyond dizzy. It took her a half hour to get up. She states it was a very weird fainting experience. The leg did have to get stitches. She states she lives alone. She states she has no major illnesses. She goes to the gym all the time.  She doesn't take any medications, except one for thyroid. The patient states that she doesn't know what to do now. She is concerned about taking the booster shot. She wants to know if she can take a Pfizer vaccine. Consent given for safety to contact the patient and her HCP. Treatment details were not provided.; Sender's Comments: This case concerns a 83 year-old, female with no relevant medical history, who experienced the unexpected events of syncope (and other non serious events). The event occurred approximately 1month and 2 days after the first dose and 2 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Event "syncope" Was auto-upgraded to serious by Auto-IME tool, but based on info avail and medical judgment the event was reassessed as non-serious.