Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat tightness, Tinnitus, Tremor, Vaccination site haemorrhage
Clinical narrative: sinuses aggravated; my upper arm was bleeding freely; heart palpitations, hot flashes condition aggravated; racing heart; puffy face; taste of the vaccine in her mouth; ringing in the ears; jittery; shaky; painful lower back; throat swelling; tight throat; chest tightness; hot flashes; weird; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (jittery), TREMOR (shaky), BACK PAIN (painful lower back), PHARYNGEAL SWELLING (throat swelling) and THROAT TIGHTNESS (tight throat) in a 61-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.     The patient's past medical history included Palpitations (Patient was having heart palpitations which ceased in early 2000-2001.) and Hot flashes (Patient was having hot flashes that had also been non-existent since about 2012.). Concurrent medical conditions included Drug allergy (Morphine and all it's derivatives, Naproxen, Nsaids), Hemangioma cavernous (this is a serious vascular birth defect, there is no treatment) since 23-May-1959 and Urinary tract infection. Concomitant products included MANNOSE, D- for Urinary tract infection.    On 24-Mar-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING JITTERY (jittery), TREMOR (shaky), BACK PAIN (painful lower back), PHARYNGEAL SWELLING (throat swelling), THROAT TIGHTNESS (tight throat), CHEST DISCOMFORT (chest tightness), HOT FLUSH (hot flashes), FEELING ABNORMAL (weird), SWELLING FACE (puffy face), DYSGEUSIA (taste of the vaccine in her mouth), TINNITUS (ringing in the ears) and PALPITATIONS (racing heart). On an unknown date, the patient experienced SINUS DISORDER (sinuses aggravated), VACCINATION SITE HAEMORRHAGE (my upper arm was bleeding freely) and CONDITION AGGRAVATED (heart palpitations, hot flashes condition aggravated). On 24-Mar-2021, PHARYNGEAL SWELLING (throat swelling), THROAT TIGHTNESS (tight throat), CHEST DISCOMFORT (chest tightness), SWELLING FACE (puffy face) and DYSGEUSIA (taste of the vaccine in her mouth) had resolved. On 25-Mar-2021, FEELING JITTERY (jittery) and PALPITATIONS (racing heart) had resolved with sequelae. At the time of the report, TREMOR (shaky), BACK PAIN (painful lower back), HOT FLUSH (hot flashes), FEELING ABNORMAL (weird), SINUS DISORDER (sinuses aggravated), TINNITUS (ringing in the ears), VACCINATION SITE HAEMORRHAGE (my upper arm was bleeding freely) and CONDITION AGGRAVATED (heart palpitations, hot flashes condition aggravated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       For bleeding arm, patient put band aid on it. No treatment medication was provided. Patient chose not to have the second vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter's address, reporter's email id, Patient's details, Allergies and past medical history, Concomitant products, Additional adverse events was added. On 22-Jun-2021: Follow-up received does not contain no new information; 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.