Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19
Symptoms: Metabolic function test normal, Pyrexia, Urine analysis normal, White blood cell count normal
Clinical narrative: previous symptom from enlarged prostate worsening: difficulty urinating; previous symptom from enlarged prostate worsening: increased frequency of urination; persistent fever of up to 103°F; fatigue; mild headache; This spontaneous case was reported by a physician and describes the occurrence of DYSURIA (previous symptom from enlarged prostate worsening: difficulty urinating), POLLAKIURIA (previous symptom from enlarged prostate worsening: increased frequency of urination), PYREXIA (persistent fever of up to 103°F), FATIGUE (fatigue) and HEADACHE (mild headache) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No allergies to medications, food and other products. Patient not had COVID positive test or diagnosis.  The patient's past medical history included Mitral valve replacement (Condition was worsening.). Concurrent medical conditions included Enlarged prostate (Condition was worsening.) since 1990, Blood pressure high (Condition was worsening.), Hypercholesteraemia (Condition was worsening.), Dysuria (due to enlarged prostate) and Pollakiuria (due to enlarged prostate). Concomitant products included INFLUENZA VACCINE from 19-Sep-2022 to an unknown date for Flu prophylaxis, WARFARIN, ATORVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.    On 19-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced FATIGUE (fatigue) and HEADACHE (mild headache). On 22-Sep-2022, the patient experienced DYSURIA (previous symptom from enlarged prostate worsening: difficulty urinating), POLLAKIURIA (previous symptom from enlarged prostate worsening: increased frequency of urination) and PYREXIA (persistent fever of up to 103°F). The patient was treated with PARACETAMOL (TYLENOL) in September 2022 for Urination frequency of and Urination difficulty, at an unspecified dose and frequency and IBUPROFEN in September 2022 for Urination frequency of and Urination difficulty, at an unspecified dose and frequency. On 21-Sep-2022, FATIGUE (fatigue) and HEADACHE (mild headache) had resolved. At the time of the report, DYSURIA (previous symptom from enlarged prostate worsening: difficulty urinating) and POLLAKIURIA (previous symptom from enlarged prostate worsening: increased frequency of urination) outcome was unknown and PYREXIA (persistent fever of up to 103°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2022, Body temperature: persistent fever of up to 103°F. On 24-Sep-2022, Laboratory test: were all good, with no evidence of infection or other unusual reaction. and were all good, with no evidence of infection or other unusual reaction..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had previous doses of Moderna covid-19 vaccine -1st dose on 29-Jan-2021 (lot-012M20A and expiry date: 20-Jul-2021), 2nd dose on 26-Feb-2021 (lot-014M20A and expiry date: 12-Aug-2021), 1st booster dose on 22-Oct-2021 (lot-011F21A), 2nd booster on 02-Apr-2022 (lot-027L21A). It was reported that after bivalent booster, first couple of days patient only experienced minimum side effects, fatigue and mild headache. Patient spoke with his cardiologist and visited ER on 24-Sep-2022, but laboratory values and tests done to patient were all good, with no evidence of infection or other unusual reaction. Patient not experienced difficulty urinating and increased frequency of urination in the past.   This case was linked to MOD-2022-651184, MOD-2022-651186 (Patient Link).