Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have been getting occasionaly readings of 182/96, 144/78 etc, and then back to normal; The patient states that she did not receive the second dose of the moderna COVID-19 vaccine because she was scared as an adverse event; Feeling tired/continuing fatigue; Ringing in ears describes it as a constant, high pitched tone; panic attacks due to the loudness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in ears describes it as a constant, high pitched tone), PANIC ATTACK (panic attacks due to the loudness), BLOOD PRESSURE FLUCTUATION (I have been getting occasionaly readings of 182/96, 144/78 etc, and then back to normal), FATIGUE (Feeling tired/continuing fatigue) and INTENTIONAL PRODUCT USE ISSUE (The patient states that she did not receive the second dose of the moderna COVID-19 vaccine because she was scared as an adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included GERD on 01-Jan-2015. Concurrent medical conditions included Allergy (Food), Allergy (peanuts) and Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LANSOPRAZOLE from 04-Jan-2018 to an unknown date for GERD, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 03-Jan-2018 to an unknown date for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TINNITUS (Ringing in ears describes it as a constant, high pitched tone), PANIC ATTACK (panic attacks due to the loudness) and FATIGUE (Feeling tired/continuing fatigue). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (I have been getting occasionaly readings of 182/96, 144/78 etc, and then back to normal) and INTENTIONAL PRODUCT USE ISSUE (The patient states that she did not receive the second dose of the moderna COVID-19 vaccine because she was scared as an adverse event). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 31-Mar-2021, PANIC ATTACK (panic attacks due to the loudness) had resolved. At the time of the report, TINNITUS (Ringing in ears describes it as a constant, high pitched tone) had not resolved, BLOOD PRESSURE FLUCTUATION (I have been getting occasionaly readings of 182/96, 144/78 etc, and then back to normal) had resolved and FATIGUE (Feeling tired/continuing fatigue) and INTENTIONAL PRODUCT USE ISSUE (The patient states that she did not receive the second dose of the moderna COVID-19 vaccine because she was scared as an adverse event) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had taken dose 2 with no information detail.  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.  This report also refers to a case of Intentional product use issue for mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Significant Follow up added - New event added On 02-Aug-2021: Fu information received patient information, dose information, concomitant drug strength ,event outcome were added.; 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.  This report also refers to a case of Intentional product use issue for mRNA-1273.