Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Malaise, SARS-CoV-2 test
Clinical narrative: started to experience symptoms of having COVID; not feeling well; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (not feeling well), CHILLS (Chills) and COVID-19 (started to experience symptoms of having COVID) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 031M20A and 013L20H) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza (given within 1 month prior to Moderna COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Allergy to animal (Cats), Hypertension (There was no recent change in status such as improvement or worsening.), Alcoholism (There was no recent change in status such as improvement or worsening.), Kidney failure (There was no recent change in status such as improvement or worsening.) and Unspecified functional disorder of stomach. Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE for Unspecified functional disorder of stomach.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced MALAISE (not feeling well) and CHILLS (Chills). On 30-Dec-2021, the patient experienced COVID-19 (started to experience symptoms of having COVID). On 17-Nov-2021, MALAISE (not feeling well) and CHILLS (Chills) had resolved. At the time of the report, COVID-19 (started to experience symptoms of having COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient did not seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience similar events in the past. No treatment had been given for his symptoms.  Company comment  This spontaneous case concerns a 75 year old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 (started to experience symptoms of having COVID) 44 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious events of Malaise and chills on the same day of receiving the vaccination. Previously administered product included the two primary doses with Moderna vaccine about 9 months ago and Influenza vaccine given within 1 month prior to Moderna COVID-19 vaccine. No adverse event with previous Moderna and Influenza vaccines were reported. On 29-Dec-2021, SARS-CoV-2 test was positive and started to experience symptoms of having COVID on the next day. The patient did not seek medical care. No treatment had been given for his symptoms. Details of symptoms, other labs, diagnostic tests were not provided. Concurrent medical conditions included Hypertension, alcohol use and kidney failure which along with ongoing Covid 19 pandemia could be considered as confounders. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.   This case was linked to MOD-2022-591122, MOD-2022-590911 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75 year old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 (started to experience symptoms of having COVID) 44 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious events of Malaise and chills on the same day of re3ceiving the vaccination. Previously administered product included the two primary doses with Moderna vaccine about 9 months ago and Influenza vaccine given within 1 month prior to Moderna COVID-19 vaccine. No adverse event with previous Moderna and Influenza vaccines were reported. On 29-Dec-2021, SARS-CoV-2 test was positive and started to experience symptoms of having COVID on the next day. The patient did not seek medical care. No treatment had been given for his symptoms. Details of symptoms, other labs, diagnostic tests were not provided. Concurrent medical conditions included Hypertension, alcohol use and kidney failure which along with ongoing Covid 19 pandemia could be considered as confounders. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.