Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Fatigue, Inflammation, Mental fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE (Mental fatigue / Brain fatigue), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), INFLAMMATION (Inflammation), COVID-19 (COVID-19) and FATIGUE (Fatigue extreme) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In February 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MENTAL FATIGUE (Mental fatigue / Brain fatigue), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), INFLAMMATION (Inflammation), FATIGUE (Fatigue extreme) and ARTHRALGIA (Joint pain). At the time of the report, MENTAL FATIGUE (Mental fatigue / Brain fatigue), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), COVID-19 (COVID-19), FATIGUE (Fatigue extreme) and ARTHRALGIA (Joint pain) outcome was unknown and INFLAMMATION (Inflammation) was resolving.    The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The reporter's causality for the events of Inflammation after COVID vaccination with HUMIRA (ADALIMUMAB) was a reasonable possibility. Company comment: This spontaneous case concerns a 59-years-old female patient with no medical history reported, who experienced the unexpected non-serious  event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. There was administration of Co-suspect product and non-company product ADALIMUMAB (HUMIRA) on unspecified date for unspecified indication. The Clinical course, and treatment details were not provided, and the event outcome was unknown.  Ongoing COVID-19 Pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a 59-years-old female patient with no medical history reported, who experienced the unexpected non-serious event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. There was administration of Co-suspect product and non-company product ADALIMUMAB (HUMIRA) on unspecified date for unspecified indication. The Clinical course, and treatment details were not provided, and the event outcome was unknown.  Ongoing COVID-19 Pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.