Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: Flu-aches; She had tachycardia; Aching; About 10-12 hours after receiving vaccine, she had vomiting; Nausea; Low grade fever 99.2; Headache; She had tiredness/She spent a day in couch whole Wednesday.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-aches), TACHYCARDIA (She had tachycardia), PAIN (Aching), VOMITING (About 10-12 hours after receiving vaccine, she had vomiting) and NAUSEA (Nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039P21A, 039K20A and 103L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2000 and Heart rate abnormal (regular/irregular heart beat) since 2000. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) from 2000 to an unknown date for Blood pressure increased, MONASCUS PURPUREUS, UBIDECARENONE (CHOLEAST) from 2016 to an unknown date for High cholesterol, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) from 2021 to an unknown date for Macular degeneration, COLECALCIFEROL (VITAMIN D3 1000) from 2021 to an unknown date for Vitamin D decreased, ACETYLSALICYLIC ACID (ASPRIN) from 2010 to an unknown date for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 11:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-aches), TACHYCARDIA (She had tachycardia), VOMITING (About 10-12 hours after receiving vaccine, she had vomiting), NAUSEA (Nausea), PYREXIA (Low grade fever 99.2) and HEADACHE (Headache). 09-Nov-2021, the patient experienced PAIN (Aching) and FATIGUE (She had tiredness/She spent a day in couch whole Wednesday.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 09-Nov-2021, TACHYCARDIA (She had tachycardia) had resolved. On 11-Nov-2021, INFLUENZA LIKE ILLNESS (Flu-aches), PAIN (Aching), VOMITING (About 10-12 hours after receiving vaccine, she had vomiting), NAUSEA (Nausea), PYREXIA (Low grade fever 99.2), HEADACHE (Headache) and FATIGUE (She had tiredness/She spent a day in couch whole Wednesday.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: 99.2 (High) 99.2.         Company comment: This spontaneous case concerns an 81-year-old female patient with concurrent use of unspecified blood pressure medication, who experienced non-serious unexpected event of special interest (AESI) tachycardia. The event occurred 10-12 hours after the third, booster dose of the Moderna COVID-19 Vaccine (mRNA-1273). Reportedly, the event lasted 45 minutes and resolved afterwards. Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  Patient's concurrent use of blood pressure medication suggest cardiac disorder which can be a possible confounder, as well as patient's advanced age. The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-013023, MOD-2021-252963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow-up includes Patient demographics, Medical history, suspect dose 1,dose 2 information, concomitant medications, events start date, stop date and outcome, reporter causality were updated.; Sender's Comments: This spontaneous case concerns an 81-year-old female patient with concurrent use of unspecified blood pressure medication, who experienced non-serious unexpected event of special interest (AESI) tachycardia. The event occurred 10-12 hours after the third, booster dose of the Moderna COVID-19 Vaccine (mRNA-1273). Reportedly, the event lasted 45 minutes and resolved afterwards. Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  Patient's concurrent use of blood pressure medication suggest cardiac disorder which can be a possible confounder, as well as patient's advanced age. The benefit-risk relationship of drug is not affected by this report.