Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19/ Running fever, congestion and body aches; Not working well and there is a lack of efficacy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid 19/ Running fever, congestion and body aches) and DRUG INEFFECTIVE (Not working well and there is a lack of efficacy) in a 61-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 26-Mar-2021, Pfizer (Dose 2) on 23-Apr-2021, Pfizer (Dose 3) on 11-Nov-2021, Pfizer (Dose 4) on 10-Jun-2022 and PFIZER BIONTECH COVID-19 VACCINE (Dose 6) on 24-Feb-2023; for COVID-19 prophylaxis: Moderna (Dose 5) on 06-Sep-2022. Past adverse reactions to the above products included No adverse effect with Moderna, PFIZER BIONTECH COVID-19 VACCINE, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Blood pressure high.    On 05-Dec-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-May-2024, the patient experienced COVID-19 (Covid 19/ Running fever, congestion and body aches) and DRUG INEFFECTIVE (Not working well and there is a lack of efficacy). At the time of the report, COVID-19 (Covid 19/ Running fever, congestion and body aches) had not resolved and DRUG INEFFECTIVE (Not working well and there is a lack of efficacy) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Reporter informed that the symptoms patient had since he got Covid were running fever, congestion and body aches. He had not recovered yet. Reporter believed that the last Moderna shot received by her husband was not working well and there was a lack of efficacy. Patient did not have any other vaccine in the 4 weeks before getting his last Moderna Shot. Treatment information was not reported.  Company comment:  This is a case concerning a 61-year-old, male patient vaccinated with 5 doses of Pfizer vaccine and two Moderna vaccines, with no relevant medical history, who experienced the unexpected non-serious events of COVID-19 and Drug ineffective which occurred about 5 months after the administration of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, used as a seventh dose. The patient had fever, congestion and body aches. Outcome reported as not resolved. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-768243 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2024: Live follow-up received and added quality complaint number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-768243:Wife case