Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dysphonia, Erythema, Headache, Malaise
Clinical narrative: Entire body turned bright red including eyes; Entire body turned bright red including eyes; burning sensation all over and hands tingling; closing of airway but not enough to restrict breathing/ swollen airway; just feeling sick instantly like flu with headache on back side of head; voice affected; burning sensation all over and hands tingling; just feeling sick instantly like flu with headache on back side of head; muscle aches but never actually vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Entire body turned bright red including eyes), OCULAR HYPERAEMIA (Entire body turned bright red including eyes), BURNING SENSATION (burning sensation all over and hands tingling), OBSTRUCTIVE AIRWAYS DISORDER (closing of airway but not enough to restrict breathing/ swollen airway) and MALAISE (just feeling sick instantly like flu with headache on back side of head) in a 58-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 03-Jan-2024, the patient experienced ERYTHEMA (Entire body turned bright red including eyes), OCULAR HYPERAEMIA (Entire body turned bright red including eyes), BURNING SENSATION (burning sensation all over and hands tingling), MALAISE (just feeling sick instantly like flu with headache on back side of head), PARAESTHESIA (burning sensation all over and hands tingling), HEADACHE (just feeling sick instantly like flu with headache on back side of head) and MYALGIA (muscle aches but never actually vomiting). 03-Jan-2024, the patient experienced OBSTRUCTIVE AIRWAYS DISORDER (closing of airway but not enough to restrict breathing/ swollen airway) and DYSPHONIA (voice affected). On 03-Jan-2024, ERYTHEMA (Entire body turned bright red including eyes), OCULAR HYPERAEMIA (Entire body turned bright red including eyes) and BURNING SENSATION (burning sensation all over and hands tingling) had resolved. On 04-Jan-2024, MALAISE (just feeling sick instantly like flu with headache on back side of head) had resolved. In January 2024, OBSTRUCTIVE AIRWAYS DISORDER (closing of airway but not enough to restrict breathing/ swollen airway), DYSPHONIA (voice affected), PARAESTHESIA (burning sensation all over and hands tingling), HEADACHE (just feeling sick instantly like flu with headache on back side of head) and MYALGIA (muscle aches but never actually vomiting) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient had no medical history, concomitant disease or risk factor.   30 minutes after taking vaccine following symptoms started- entire body turned bright red including eyes and burning sensation all over and hands tingling and closing of airway but not enough to restrict breathing and just felt sick instantly like flu with headache on back side of head and muscle aches but never actually vomiting. Redness and burning stopped within an hour and voice affected for 12 hours and feeling sick for about 24 hours. Then no more symptoms until 2 weeks and 2 days later the exact same symptoms occurred again including duration of symptoms with the exception of swollen airway.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment medication was reported.