Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: After his first shot he was knocked out for a couple of days; extreme fatigue and tiredness.; received second dose more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After his first shot he was knocked out for a couple of days), FATIGUE (extreme fatigue and tiredness.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose more than 36 days after the first dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Adrenal insufficiency and Fatigue. Concomitant products included HYDROCORTISONE for Adrenal insufficiency.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose more than 36 days after the first dose). On an unknown date, the patient experienced ASTHENIA (After his first shot he was knocked out for a couple of days) and FATIGUE (extreme fatigue and tiredness.). On 23-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose more than 36 days after the first dose) had resolved. At the time of the report, ASTHENIA (After his first shot he was knocked out for a couple of days) and FATIGUE (extreme fatigue and tiredness.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2021, SARS-CoV-2 antibody test: negative (Negative) IgM and IgA antibody tests for SARS-CoV-2 were negative, positive (Positive) Positive and negative (Negative) IgM and IgA antibody tests for SARS-CoV-2 were negative.         Treatment information was not provided.  company comment: This case concerns a 69-year-old, male patient with relevant medical history of Adrenal insufficiency maintained on hydrocortisone , , who experienced the non- serious un xpected event  of Asthenia  and expected event of fatigue  The event occurred on interval after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Additional event of Inappropriate of Product Administration was coded for this case.  The age and the medical conditional of Adrenal insufficiency  on steroids is considered as a confounder for this case.  The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow-up contains, Additional event and lab data added; Sender's Comments: This case concerns a 69-year-old, male patient with relevant medical history of Adrenal insufficiency maintained on hydrocortisone , , who experienced the non- serious un xpected event  of Asthenia  and expected event of fatigue  The event occurred on interval after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Additional event of Inappropriate of Product Administration was coded for this case.  The age and the medical conditional of Adrenal insufficiency  on steroids is considered as a confounder for this case.  The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.