Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor, Urticaria, Vomiting
Clinical narrative: itching on her lower back; had hives from shoulders down to feet, noticed welts on waistband; skin rash/a little rash on her left feet; vomited; nausea (queasy); shaking chills, non shaking chills; had shake; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (had shake), PRURITUS (itching on her lower back), NAUSEA (nausea (queasy)), CHILLS (shaking chills, non shaking chills) and URTICARIA (had hives from shoulders down to feet, noticed welts on waistband) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no food allergies. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Dizzy (Cipro which made her dizzy). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1 batch number 025L20A) on 22-Jan-2021, Moderna COVID-19 vaccine (Dose 2 batch number 011A21A) on 26-Feb-2021, Moderna COVID-19 vaccine (1st booster batch number 033F21A) on 01-Nov-2021 and Moderna COVID-19 vaccine (2nd booster batch number 057M21A) on 02-May-2022; for Product used for unknown indication: Flu shot (flu shot in the fall of last year) in 2022, PFIZER BIONTECH COVID-19 VACCINE (1st bivalent very mild) on 26-Nov-2022 and PFIZER BIONTECH COVID-19 VACCINE (very mild) on 26-Nov-2022; for Drug use for unknown indication: CIPRO [CIPROFLOXACIN]. Past adverse reactions to the above products included Fatigue with PFIZER BIONTECH COVID-19 VACCINE; Headache with PFIZER BIONTECH COVID-19 VACCINE; and No adverse event with CIPRO [CIPROFLOXACIN], Flu shot, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Hypertension (HTN controlled with medicines).    On 02-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-May-2023, the patient experienced NAUSEA (nausea (queasy)) and VOMITING (vomited). On 09-May-2023, the patient experienced RASH (skin rash/a little rash on her left feet). On 10-May-2023, the patient experienced PRURITUS (itching on her lower back) and URTICARIA (had hives from shoulders down to feet, noticed welts on waistband). In May 2023, the patient experienced TREMOR (had shake) and CHILLS (shaking chills, non shaking chills). The patient was treated with PREDNISONE at a dose of still on it at the time of the call and TRIAMCINOLONE for Itching, at an unspecified dose and frequency. On 09-May-2023, NAUSEA (nausea (queasy)) had resolved. On 11-May-2023, URTICARIA (had hives from shoulders down to feet, noticed welts on waistband) had resolved. At the time of the report, TREMOR (had shake), PRURITUS (itching on her lower back), CHILLS (shaking chills, non shaking chills), RASH (skin rash/a little rash on her left feet) and VOMITING (vomited) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that hypertension was controlled with medicines. Patient did not had any concomitant vaccines administered with the 2nd bivalent booster. It was reported that patient was fine after getting the shot and no bruising was noted. On 16-18-May-2023 patient had shake and chills followed by non shaking chills after. Patient was treated with a prescription cream.