Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Blood pressure measurement, Blood test, Chills
Clinical narrative: Feeling of sudden faint; Chronic fatigue for 10 weeks; Felt shaky inside; Blood pressure was up and down; Felt like bad flu bug; Lightheadedness; Weakness; Felt crappy; Lots of night sweats; Chills during the day; Nausea; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Feeling of sudden faint) and FATIGUE (Chronic fatigue for 10 weeks) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Migraine and Bladder disorder. Concomitant products included MIRABEGRON (MYRBETRIQ) for Bladder disorder, GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) and ELETRIPTAN HYDROBROMIDE (RELPAX) for Migraine, CICLOSPORIN (RESTASIS), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ESTRADIOL (ESTRACE) for an unknown indication.  On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Feeling of sudden faint) (seriousness criterion medically significant), FATIGUE (Chronic fatigue for 10 weeks) (seriousness criterion medically significant), NERVOUSNESS (Felt shaky inside), BLOOD PRESSURE FLUCTUATION (Blood pressure was up and down), INFLUENZA LIKE ILLNESS (Felt like bad flu bug), DIZZINESS (Lightheadedness), ASTHENIA (Weakness), VACCINATION COMPLICATION (Felt crappy), NIGHT SWEATS (Lots of night sweats), CHILLS (Chills during the day), NAUSEA (Nausea) and PYREXIA (Fever after 2nd dose). At the time of the report, SYNCOPE (Feeling of sudden faint), FATIGUE (Chronic fatigue for 10 weeks), NERVOUSNESS (Felt shaky inside), BLOOD PRESSURE FLUCTUATION (Blood pressure was up and down), INFLUENZA LIKE ILLNESS (Felt like bad flu bug), DIZZINESS (Lightheadedness), ASTHENIA (Weakness), VACCINATION COMPLICATION (Felt crappy), NIGHT SWEATS (Lots of night sweats), CHILLS (Chills during the day), NAUSEA (Nausea) and PYREXIA (Fever after 2nd dose) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Blood pressure measurement: up and down (Inconclusive) up and down. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that she had side effects several weeks after the vaccine and from the vaccine and stated that she does not want to get a booster. Side effects experienced by the patient was fever after 2nd dose for 2 nights, chills then was fine but on 07-Apr-2021, felt very tired after a trip as she flew on the plane but never got better after that. She stated that she had chronic fatigue for 10 weeks, nausea, lightheadedness and still has it, lost 5 pounds in weight, felt shaky inside at times that felt like too much caffeine was taken, lots of night sweats, chills during the day and felt like bad flu bug and after 3 weeks of that, she went to her primary care provider. Patient reported feeling crappy. She was then referred to an infectious disease specialist who did more blood work and everything was normal. The patient went Ear nose throat (ENT) specialist as she was having dizziness. Patient also reported experiencing fatigue and very weak and she had an episode of feeling of sudden faint and weakness that only happened one time. Her doctor told her it was not due to Corona virus disease (COVID) as she developed antibodies.  Treatment medication not provided.  The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: 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.; 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.