Age: 72.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: bone pain; feeling flushed and exhausted; flu; lethargic; flare-up /extreme pain upon urination; feeling flushed and exhausted; burning sensation in my urethra; following the administration was similar to prior experiences -- lethargic and arm was sore; flare-up /body aches; flare-up /fever; being sick; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu), LETHARGY (lethargic), DYSURIA (flare-up /extreme pain upon urination), FLUSHING (feeling flushed and exhausted) and BURNING SENSATION (burning sensation in my urethra) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lethargic, Pain in arm and Chest cold from 25-Sep-2022 to 07-Oct-2022. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for an unknown indication.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Nov-2022, the patient experienced INFLUENZA (flu), LETHARGY (lethargic), DYSURIA (flare-up /extreme pain upon urination), FLUSHING (feeling flushed and exhausted), BURNING SENSATION (burning sensation in my urethra), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and FATIGUE (feeling flushed and exhausted). On an unknown date, the patient experienced BONE PAIN (bone pain) and ILLNESS (being sick). On 06-Dec-2022, INFLUENZA (flu), LETHARGY (lethargic), DYSURIA (flare-up /extreme pain upon urination), FLUSHING (feeling flushed and exhausted), BURNING SENSATION (burning sensation in my urethra), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and FATIGUE (feeling flushed and exhausted) had resolved. At the time of the report, BONE PAIN (bone pain) and ILLNESS (being sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient did ran a couple of negative Covid tests during the time he had the cold..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered INFLUENZA (flu), LETHARGY (lethargic), DYSURIA (flare-up /extreme pain upon urination), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches) and PYREXIA (flare-up /fever) to be related. No further causality assessments were provided for FLUSHING (feeling flushed and exhausted), BURNING SENSATION (burning sensation in my urethra), BONE PAIN (bone pain), ILLNESS (being sick) and FATIGUE (feeling flushed and exhausted).    Weight reported as 165 approx. Concomitant included Astragalus daily for build immunity. Patient had first dose on 07 Feb 2021 with batch number as 004MZDA, second dose on 07 Mar 2021 with batch number as 010AZIA, third dose on 09 Nov 2021 with batch number as 939905. Following the administration of the bivalent booster, the patient had flare-up speculation related to vaccine. He had flu shot for those over 65 at the same time. The day following the administration, the patient was lethargic with arm soreness. The first flare up was after three weeks later, when was feeling of coming down with flu shot. The patient had body aches, fever which last about 12 hours, lethargy and extreme pain upon urination. With the exception of the urination pain, all other symptoms disappeared within a few hours. The pain lasted for almost a week and subsided slowly over that period of time. After two weeks later, the patient had same experience.  He had never been diagnosed with/ tested positive for COVID-19. The event did not cause the patient to seek medical care. Unknown if the adverse event most likely caused by mRNA-1273. Unknown there any other potential causes. He did not experience a similar event in the past. He was at the tail end of a bad chest cold and got a flu shot at the same time as Moderna Bivalent vaccine The treatment medication was not reported.   This case was linked to MOD-2023-709453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2023: Follow-up received contains no new information. On 15-May-2023: Followup received and contains no significant information. On 16-May-2023: Follow-up information included no new information. On 16-May-2023: Event reported and narrative updated.