Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: Racing heartbeat; Shortness of breath; It feels really abnormal; Headache; Anxious; Really weak; Felt like she had the flu but worse; Chills; Muscle aches; Received the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Really weak), INFLUENZA LIKE ILLNESS (Felt like she had the flu but worse), HEART RATE INCREASED (Racing heartbeat), DYSPNOEA (Shortness of breath) and ANXIETY (Anxious) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cerebral palsy, Bipolar disorder and Generalized anxiety disorder. Concomitant products included LITHIUM, LAMOTRIGINE (LAMICTAL), LORAZEPAM, DARIFENACIN and LEVOCETIRIZINE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the vaccine more than 36 days after the first dose). On 07-Aug-2021, the patient experienced ASTHENIA (Really weak), INFLUENZA LIKE ILLNESS (Felt like she had the flu but worse), CHILLS (Chills) and MYALGIA (Muscle aches). On 16-Aug-2021, the patient experienced ANXIETY (Anxious). On an unknown date, the patient experienced HEART RATE INCREASED (Racing heartbeat), DYSPNOEA (Shortness of breath), FEELING ABNORMAL (It feels really abnormal) and HEADACHE (Headache). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the vaccine more than 36 days after the first dose) had resolved. In August 2021, ASTHENIA (Really weak), INFLUENZA LIKE ILLNESS (Felt like she had the flu but worse), CHILLS (Chills) and MYALGIA (Muscle aches) had resolved. At the time of the report, HEART RATE INCREASED (Racing heartbeat), DYSPNOEA (Shortness of breath), ANXIETY (Anxious), FEELING ABNORMAL (It feels really abnormal) and HEADACHE (Headache) outcome was unknown.            Patient reported that she had reservations in getting the second dose because of the heart condition. Patient had chills, really weak, muscle aches, felt like she had the flu but worse. It went away in 2 days and she was fine and she did not take any medication. On an unknown date, patient started experiencing racing heartbeat, shortness of breath. Patient went  to ER and in the ER she was informed that her heart might had pounded because she was anxious. She had anxiety issues in the past and it did not feel like this.  Patient felt little better when she woke up the next morning. However, it came back that afternoon and it felt really abnormal.   Patient took Birth control pill (details were not provided).  Patient wanted to know if this was abnormal and if she could consult a cardiologist.  No treatment information was reported.  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.  However, more information is required for further assessment. Follow up is expected.   This case was linked to MOD-2021-290992 (Patient Link).; 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.  However, more information is required for further assessment. Follow up is expected.