Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: lungs also had some signs of inflammation; some enlargement of lymph nodes in the center of his chest; under the weather; flu like symptoms; mildly aching muscles; worn out feeling; First dose on 10FEB2021 and second dose after 42 days on 24MAR2021; sore arm; chest pain/a left upper chest pain which was worse with very deep; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONITIS (lungs also had some signs of inflammation), LYMPHADENOPATHY (some enlargement of lymph nodes in the center of his chest), CHEST PAIN (chest pain/a left upper chest pain which was worse with very deep), MALAISE (under the weather), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (sore arm), MYALGIA (mildly aching muscles) and FATIGUE (worn out feeling) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm) (seriousness criterion medically significant). On 24-Mar-2021, the patient experienced MALAISE (under the weather) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant), MYALGIA (mildly aching muscles) (seriousness criterion medically significant) and FATIGUE (worn out feeling) (seriousness criterion medically significant). 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 10FEB2021 and second dose after 42 days on 24MAR2021). In 2021, the patient experienced CHEST PAIN (chest pain/a left upper chest pain which was worse with very deep) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONITIS (lungs also had some signs of inflammation) (seriousness criterion medically significant) and LYMPHADENOPATHY (some enlargement of lymph nodes in the center of his chest) (seriousness criterion medically significant). In March 2021, PAIN IN EXTREMITY (sore arm) had resolved. On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 10FEB2021 and second dose after 42 days on 24MAR2021) had resolved. On 25-Mar-2021, MALAISE (under the weather), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (mildly aching muscles) and FATIGUE (worn out feeling) had resolved. In 2021, CHEST PAIN (chest pain/a left upper chest pain which was worse with very deep) had resolved. At the time of the report, PNEUMONITIS (lungs also had some signs of inflammation) outcome was unknown and LYMPHADENOPATHY (some enlargement of lymph nodes in the center of his chest) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) enlargement of lymph nodes in the center of his chest improved. and enlargement of lymph nodes (abnormal) enlargement of lymph nodes in the center of his chest.  lungs also had some signs of inflammation. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Around the end of June or early July, patient had some types of chest pain. This was a left upper chest pain which was worse with very deep breaths. This lasted from a Friday to a Sunday.  Doctor recommended him go to the emergency room. Did not find a reason for his pain and he was discharged. He has had follow up with his primary doctor and 2 appointments with a pulmonologist. He has had 3 negative COVID tests and a negative antibody test. He has not had any known history of COVID -19, myocarditis, or pericarditis.  Company comment: This case concerns a 69-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious events of pain in extremity, malaise, influenza like illness, myalgia, fatigue, chest pain, pneumonitis and lymphadenopathy. The events malaise, influenza like illness, myalgia, fatigue occurred approximately on the same after the second dose of Spikevax and chest pain, pneumonitis and lymphadenopathy, after the same dose of Spikevax (no date was provided). The rechallenge for pain in extremity and malaise was positive (reappeared after each administration). There is no information regarding the outcome of chest pain and pneumonitis, so rechallenge for these events is not applicable. Regarding lymphadenopathy, it is not stated if it was reevaluated after the third dose of the vaccine, so rechallenge is unknown. Inappropriate schedule of product administration was considered as an additional event. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-362028, MOD-2021-362099 (Patient Link).; Sender's Comments: This case concerns a 69-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious events of pain in extremity, malaise, influenza like illness, myalgia, fatigue, chest pain, pneumonitis and lymphadenopathy. The events malaise, influenza like illness, myalgia, fatigue occurred approximately on the same after the second dose of Spikevax and chest pain, pneumonitis and lymphadenopathy, after the same dose of Spikevax (no date was provided). The rechallenge for pain in extremity and malaise was positive (reappeared after each administration). There is no information regarding the outcome of chest pain and pneumonitis, so rechallenge for these events is not applicable. Regarding lymphadenopathy, it is not stated if it was reevaluated after the third dose of the vaccine, so rechallenge is unknown. Inappropriate schedule of product administration was considered as an additional event. The benefit-risk relationship of Spikevax is not affected by this report.