Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Oropharyngeal pain, Palpitations, Paraesthesia, Post-acute COVID-19 syndrome
Clinical narrative: Chronic fatigue; Long hauler; Sharp pain in head; Pressure on chest area, left arm; Racy heart; Dizziness worsened; Dyspnea worse; tingling; Numbness; sore throat; runny nose; Pressure around eye; brain fog; Muscle/joint pain; Muscle/joint pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Degeneration of cervical intervertebral disc (The cervical degeneration is not reported to be worsening or improving.) in 2017 and Osteoporosis (Osteoporosis is not reported to be worsening or improving.) in 2019. Concurrent medical conditions included Food allergy, Drug allergy, Long COVID since 06-Jun-2021 and Fibromyalgia since 2018. Concomitant products included BROMELAINS (SOLGAR BROMELAIN) and MULTIVITAMIN & MINERAL for an unknown indication.   On 29-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Chronic fatigue) (seriousness criterion hospitalization). On 14-Jun-2021, the patient experienced CHEST DISCOMFORT (Pressure on chest area, left arm). In June 2021, the patient experienced PALPITATIONS (Racy heart), DIZZINESS (Dizziness worsened), DYSPNOEA (Dyspnea worse), PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), OCULAR DISCOMFORT (Pressure around eye), FEELING ABNORMAL (brain fog), MYALGIA (Muscle/joint pain), ARTHRALGIA (Muscle/joint pain) and NAUSEA (nausea). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long hauler) and HEADACHE (Sharp pain in head). The patient was hospitalized from 14-Jun-2021 to 15-Jun-2021 due to FATIGUE. At the time of the report, FATIGUE (Chronic fatigue) and POST-ACUTE COVID-19 SYNDROME (Long hauler) had not resolved and CHEST DISCOMFORT (Pressure on chest area, left arm), PALPITATIONS (Racy heart), DIZZINESS (Dizziness worsened), DYSPNOEA (Dyspnea worse), PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), OCULAR DISCOMFORT (Pressure around eye), FEELING ABNORMAL (brain fog), MYALGIA (Muscle/joint pain), ARTHRALGIA (Muscle/joint pain), NAUSEA (nausea) and HEADACHE (Sharp pain in head) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  Patient describes that symptoms vary from time to time and that patient still experiences post exertional fatigue and consistent chronic fatigue daily. Concomitant medications Zahler Iron Complex, Nutri flair complex, Orgain protein powder. Treatment information was not provided  Company comment: This case concerns a 67-year-old female hospitalized with a serious unexpected event of fatigue, and nonserious post-acute COVID-19 syndrome, chest discomfort, palpitations, dizziness, dyspnea, paraesthesia, hypoaesthesia, oropharyngeal pain, rhinorrhea, ocular discomfort, feeling abnormal, myalgia, arthralgia, nausea, and headache. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-176735 (Patient Link).; Sender's Comments: This case concerns a 67-year-old female hospitalized with a serious unexpected event of fatigue, and nonserious post-acute COVID-19 syndrome, chest discomfort, palpitations, dizziness, dyspnea, paraesthesia, hypoaesthesia, oropharyngeal pain, rhinorrhea, ocular discomfort, feeling abnormal, myalgia, arthralgia, nausea, and headache. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.