Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Immunisation reaction, Myalgia, Pain, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (woke up severely depressed / more depressed that can ever recall having been), IMMUNISATION REACTION (very severe negative reaction / reaction frightened him because it was intense), PAIN (pain) and MYALGIA (muscle ache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 032L20A, 023M20A and 939905) for COVID-19 vaccination. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]) for Enlarged prostate, METOPROLOL for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNISATION REACTION (very severe negative reaction / reaction frightened him because it was intense). On 04-May-2022, the patient experienced DEPRESSION (woke up severely depressed / more depressed that can ever recall having been), PAIN (pain) and MYALGIA (muscle ache). At the time of the report, DEPRESSION (woke up severely depressed / more depressed that can ever recall having been), IMMUNISATION REACTION (very severe negative reaction / reaction frightened him because it was intense), PAIN (pain) and MYALGIA (muscle ache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: result not provided yet result not provided yet. Patient information includes- Height 5'9", No Allergies were reported. Patient did not had COVID positive test or diagnosis. Medical History includes: HX relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were provided. Patient received first 2 primary doses of Moderna and the 1st booster dose; and for none of those he experienced any side effects (doesn't recall the facilities for these doses). He got his 2nd booster dose on Tuesday 3May2022 afternoon and wants to report a very severe negative reaction he had. On Wednesday patient woke up severely depressed, almost suicidal, more depressed that can ever recall having been, he was unable to get out of bed which is totally unlike him since he's a very physically active person. He eventually got out of bed at 10:30 am to use the bathroom, he had no appetite, had muscle ache and pain, couldn't do anything for the entire day, couldn't eat, couldn't get out of bed, couldn't be interested in anything. This reaction frightened him because it was intense, so he went out to report it to the pharmacy in which he got the vaccine; he says they couldn't care less and just told him they think he might have had COVID-19 and then the vaccine just pushed him to the edge. He got tested but doesn't have the results yet. On 5May2022, he states feeling good. He clarifies he never had a reaction to any shot before, including all the Moderna vaccines prior to this one. No Treatment drug information was provided.