Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: She got sick after each one of her covid vaccines; body aches; Patient was not feeling well; 2nd primary dose on 27-OCT-2021 and booster dose on 26-JAN-2022; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick after each one of her covid vaccines), PAIN (body aches) and MALAISE (Patient was not feeling well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ulcerative colitis.    Previously administered products included for Fibromyalgia: CYMBALTA; for Depression: CYMBALTA. Past adverse reactions to the above products included No adverse effect with CYMBALTA and CYMBALTA.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose on 27-OCT-2021 and booster dose on 26-JAN-2022). On an unknown date, the patient experienced ILLNESS (She got sick after each one of her covid vaccines) (seriousness criterion medically significant), PAIN (body aches) (seriousness criterion medically significant) and MALAISE (Patient was not feeling well) (seriousness criterion medically significant). At the time of the report, ILLNESS (She got sick after each one of her covid vaccines) was resolving and PAIN (body aches), MALAISE (Patient was not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose on 27-OCT-2021 and booster dose on 26-JAN-2022) outcome was unknown.            The patient had depression and fibromyalgia. Physician had prescribed Cymbalta for depression and to help with fibromyalgia.  No concomitant medication details were provided.  The reporter's causality with HUMIRA(ADALIMUMAB) for the event illness was reported as not reasonable possible and for events pain and malaise was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication details were provided.  Company Comment: This is a spontaneous case concerning  a  65-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Illness, Pain, Malaise and unexpected non-serious event of  Inappropriate schedule of product administration. The event Inappropriate schedule of product administration occurred on the same day after the third dose of mRNA-1273 Vaccine. On an unknown date the events Illness, Pain, Malaise. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Illness was resolving. While the events Pain, Malaise, Inappropriate schedule of product administration outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.   This case was linked to MOD-2022-624159, MOD-2022-623271 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a  65-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Illness, Pain, Malaise and unexpected non-serious event of  Inappropriate schedule of product administration. The event Inappropriate schedule of product administration occurred on the same day after the third dose of mRNA-1273 Vaccine. On an unknown date the events Illness, Pain, Malaise. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Illness was resolving. While the events Pain, Malaise, Inappropriate schedule of product administration outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.