Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Tested positive for COVID 19/ Became sick; Nose is running; Aching all over the body; Fever 100.5 F after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose is running), MYALGIA (Aching all over the body), PYREXIA (Fever 100.5 F after 2nd booster) and COVID-19 (Tested positive for COVID 19/ Became sick) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Home test was positive) on 05-Jan-2022. Concurrent medical conditions included Immunocompromised and Asthma (uses Advair Discus inhaler). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.   On 06-Apr-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced RHINORRHOEA (Nose is running), MYALGIA (Aching all over the body) and PYREXIA (Fever 100.5 F after 2nd booster). On 28-Apr-2022, the patient experienced COVID-19 (Tested positive for COVID 19/ Became sick). At the time of the report, RHINORRHOEA (Nose is running), MYALGIA (Aching all over the body), PYREXIA (Fever 100.5 F after 2nd booster) and COVID-19 (Tested positive for COVID 19/ Became sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: positive (Positive) Home test was positive. On 28-Apr-2022, SARS-CoV-2 test: positive Positive. On an unknown date, Body temperature: 100.5 f Fever 100.5 F.         Patient received 5 doses of Moderna vaccine (3 primary doses and 2 booster doses). After the first 4 shots, patient did not have side effects.  No information on treatment medications was reported.  Company Comment: This is a spontaneous case concerning an 86-year-old male patient with medical history Asthma and unspecified Immunocompromised condition, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive test for SARS-CoV-2), 22 days after receiving a dose of mRNA-1273 vaccine. The patient experienced runny nose, body aches and fever 5 days after receiving the said mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Asthma and unspecified Immunocompromised condition remain as risk factors for the event. It should be noted that the dose was reported as fifth dose of mRNA-1273 however, there were no information regarding the previous four doses of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-539790 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up information received included: Significant information with updated Events and lab data.; Sender's Comments: This is a spontaneous case concerning an 86-year-old male patient with medical history Asthma and unspecified Immunocompromised condition, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive test for SARS-CoV-2), 22 days after receiving a dose of mRNA-1273 vaccine. The patient experienced runny nose, body aches and fever 5 days after receiving the said mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Asthma and unspecified Immunocompromised condition remain as risk factors for the event. It should be noted that the dose was reported as fifth dose of mRNA-1273 however, there were no information regarding the previous four doses of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.