Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Tearfulness, Tremor
Clinical narrative: Terrified of getting booster now; Chills; We either fell asleep or blacked out; Kind of blacked out; She had a really bad feeling/Thought she was going die/All of a sudden it hit her/Did not feel right/Thought we were both dying; Could not get up; Could not move her legs//Could not move from the waist down/ It was like she was paralyzed; Shaking with the chills; Confused/not thinking clearly; Terrible dream/Woke up with a terrible dream; Tears rolling down my face; Lots of weakness/no energy for 2 days; Hallucinated/Terrible hallucination of giant turtle chasing me; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (We either fell asleep or blacked out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Sulfa), Drug allergy (Alendronate), Blood pressure high and Cholesterol. Concomitant products included ATENOLOL and LOSARTAN POTASSIUM for Blood pressure high, ATORVASTATIN for Cholesterol, ESTRADIOL (YUVAFEM), CALCIUM, COLECALCIFEROL (CITRACAL [CALCIUM;COLECALCIFEROL]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 03-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021 at 8:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (We either fell asleep or blacked out) (seriousness criterion medically significant), PRESYNCOPE (Kind of blacked out), FEELING ABNORMAL (She had a really bad feeling/Thought she was going die/All of a sudden it hit her/Did not feel right/Thought we were both dying), MOBILITY DECREASED (Could not get up), HYPOKINESIA (Could not move her legs//Could not move from the waist down/ It was like she was paralyzed), TREMOR (Shaking with the chills), CONFUSIONAL STATE (Confused/not thinking clearly), ABNORMAL DREAMS (Terrible dream/Woke up with a terrible dream), TEARFULNESS (Tears rolling down my face) and CHILLS (Chills). In March 2021, the patient experienced HALLUCINATION (Hallucinated/Terrible hallucination of giant turtle chasing me). March 2021, the patient experienced ASTHENIA (Lots of weakness/no energy for 2 days). On an unknown date, the patient experienced FEAR (Terrified of getting booster now). At the time of the report, LOSS OF CONSCIOUSNESS (We either fell asleep or blacked out), HALLUCINATION (Hallucinated/Terrible hallucination of giant turtle chasing me), PRESYNCOPE (Kind of blacked out), FEELING ABNORMAL (She had a really bad feeling/Thought she was going die/All of a sudden it hit her/Did not feel right/Thought we were both dying), ASTHENIA (Lots of weakness/no energy for 2 days), MOBILITY DECREASED (Could not get up), HYPOKINESIA (Could not move her legs//Could not move from the waist down/ It was like she was paralyzed), TREMOR (Shaking with the chills), CONFUSIONAL STATE (Confused/not thinking clearly), ABNORMAL DREAMS (Terrible dream/Woke up with a terrible dream), TEARFULNESS (Tears rolling down my face) and CHILLS (Chills) had resolved and FEAR (Terrified of getting booster now) had not resolved.            Patient did not experience any adverse event with first dose of vaccine. After the 2nd dose, she was fine all day, she went to bed 9:30 pm and woke up at 11 pm. Had trouble returning to bed. Patient sat with no energy for 2 days. patient did not seek medical attention at the time of events. She just figured that she had a bad reaction. Her doctor had retired but she spoke to her nurse practitioner; the nurse practitioner told her to be very careful and recommended that she should not take the booster.She did not take any medication to alleviate any of her symptoms. Company Comment: This is a spontaneous case concerning a 70-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of loss of consciousness (either fell asleep or blacked out), with concurrent non-serious events of presyncope, hallucination, confusion and hypokinesia. The events occurred approximately on the same day after the second dose of mRNA-1273 vaccine and had recovered at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement   This case was linked to MOD-2021-402674 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow up received contains significant information, updated patient demographics, Medical history, added concomitant medications, events added and reporter causality updated.; Sender's Comments: This is a spontaneous case concerning a 70-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of loss of consciousness (either fell asleep or blacked out), with concurrent non-serious events of presyncope, hallucination, confusion and hypokinesia. The events occurred approximately on the same day after the second dose of mRNA-1273 vaccine and had recovered at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement