Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle discomfort, Muscular weakness, Thyroid function test
Clinical narrative: Elevated blood pressure; She has had ailments; Muscles went weak; Couldn't build up her body strength again/still has not recover her strength yet/feels like it sucked the life out of her body; Feels like something in her muscles/feels it in her body; Felt like her body was beaten up like coronavirus//Has been miserable ever since then; She's really tired/she's really tired/body is extremely tired all the time/she is still suffering from fatigue/could not get up for over 2 weeks/woke up tired; Feel worse/felt like she was about to die/really bad for her; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure), ILLNESS (She has had ailments), MUSCULAR WEAKNESS (Muscles went weak), FEELING ABNORMAL (Feel worse/felt like she was about to die/really bad for her), ASTHENIA (Couldn't build up her body strength again/still has not recover her strength yet/feels like it sucked the life out of her body), MUSCLE DISCOMFORT (Feels like something in her muscles/feels it in her body), FEELING ABNORMAL (Felt like her body was beaten up like coronavirus//Has been miserable ever since then) and FATIGUE (She's really tired/she's really tired/body is extremely tired all the time/she is still suffering from fatigue/could not get up for over 2 weeks/woke up tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had coronavirus at the end of January) in January 2021. Concurrent medical conditions included Thyroid disorder NOS.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FEELING ABNORMAL (Feel worse/felt like she was about to die/really bad for her) (seriousness criterion congenital anomaly). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure) (seriousness criterion congenital anomaly), ILLNESS (She has had ailments) (seriousness criterion congenital anomaly), MUSCULAR WEAKNESS (Muscles went weak) (seriousness criterion congenital anomaly), ASTHENIA (Couldn't build up her body strength again/still has not recover her strength yet/feels like it sucked the life out of her body) (seriousness criterion congenital anomaly), MUSCLE DISCOMFORT (Feels like something in her muscles/feels it in her body) (seriousness criterion congenital anomaly), FEELING ABNORMAL (Felt like her body was beaten up like coronavirus//Has been miserable ever since then) (seriousness criterion congenital anomaly) and FATIGUE (She's really tired/she's really tired/body is extremely tired all the time/she is still suffering from fatigue/could not get up for over 2 weeks/woke up tired) (seriousness criterion congenital anomaly). The patient was treated with VITAMIN B12 NOS for Adverse event, at an unspecified dose and frequency and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure), ILLNESS (She has had ailments), MUSCULAR WEAKNESS (Muscles went weak), FEELING ABNORMAL (Feel worse/felt like she was about to die/really bad for her), ASTHENIA (Couldn't build up her body strength again/still has not recover her strength yet/feels like it sucked the life out of her body), MUSCLE DISCOMFORT (Feels like something in her muscles/feels it in her body), FEELING ABNORMAL (Felt like her body was beaten up like coronavirus//Has been miserable ever since then) and FATIGUE (She's really tired/she's really tired/body is extremely tired all the time/she is still suffering from fatigue/could not get up for over 2 weeks/woke up tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Thyroid function test: abnormal (abnormal) abnormal.         Concomitant medications included unknown medication for  blood pressure medication and thyroid .  The concurrent condition of the patient was reported as Blood pressure.  The patient reported that she received the second dose administration of mRNA-1273 on either 14-May-2021 or 15-May-2021, she was unsure at the time of the report.  Company comment: This case concerns a 50-year-old female patient with medical history of COVID-19 and thyroid disorder who experienced non-serious unexpected events feeling abnormal, blood pressure increased, illness, muscular weakness, muscle discomfort and non-serious expected event of fatigue. The events occurred after the second dose of Spikevax however the exact time to onset was not provided. Rechallenge was not applicable. The events were consistent with the current understanding of the mechanism of action of the medication. Medical history of COVID-19 in January 2021 and concurrent condition of thyroid disorder remain confounders. The benefit-risk relationship of drug is not affected by this report   This case was linked to MOD-2021-321279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: The follow up document was received and had significant information. Upgraded the seriousness criteria. Added treatment medications, events. Updated the event outcome ( Unknown to not recovered).; Sender's Comments: This case concerns a 50-year-old female patient with medical history of COVID-19 and thyroid disorder who experienced non-serious unexpected events feeling abnormal, blood pressure increased, illness, muscular weakness, muscle discomfort and non-serious expected event of fatigue. The events occurred after the second dose of Spikevax however the exact time to onset was not provided. Rechallenge was not applicable. The events were consistent with the current understanding of the mechanism of action of the medication. Medical history of COVID-19 in January 2021 and concurrent condition of thyroid disorder remain confounders. The benefit-risk relationship of drug is not affected by this report