Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: Potassium decreased; Calcium decreased; Magnesium low; Bad reaction to COVID shot; Painful feet; Menstrual flow excessive; Peripheral arthritis; Swelling of feet; Inappropriate schedule of vaccine administered; Iron low; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Bad reaction to COVID shot), BLOOD POTASSIUM DECREASED (Potassium decreased), BLOOD CALCIUM DECREASED (Calcium decreased) and BLOOD MAGNESIUM DECREASED (Magnesium low) in a 44-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) for Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis (Chronic plaque psoriasis) and Psoriatic arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second 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) UNK Citrate free. In 2021, the patient experienced IMMUNISATION REACTION (Bad reaction to COVID shot) (seriousness criterion hospitalization) and BLOOD IRON DECREASED (Iron low). On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced BLOOD POTASSIUM DECREASED (Potassium decreased) (seriousness criterion hospitalization), BLOOD CALCIUM DECREASED (Calcium decreased) (seriousness criterion hospitalization), BLOOD MAGNESIUM DECREASED (Magnesium low) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Painful feet), HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive), ARTHRITIS (Peripheral arthritis) and PERIPHERAL SWELLING (Swelling of feet). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to BLOOD MAGNESIUM DECREASED, then for 2 days due to BLOOD CALCIUM DECREASED, BLOOD POTASSIUM DECREASED and IMMUNISATION REACTION. The patient was treated with APREMILAST (OTEZLA) at an unspecified dose and frequency. In 2021, IMMUNISATION REACTION (Bad reaction to COVID shot) had resolved. At the time of the report, BLOOD POTASSIUM DECREASED (Potassium decreased) had resolved, BLOOD CALCIUM DECREASED (Calcium decreased), BLOOD MAGNESIUM DECREASED (Magnesium low) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown, BLOOD IRON DECREASED (Iron low) and HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) had not resolved and PAIN IN EXTREMITY (Painful feet), ARTHRITIS (Peripheral arthritis) and PERIPHERAL SWELLING (Swelling of feet) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium: bottomed out. On an unknown date, Blood iron: low. On an unknown date, Blood magnesium: low. On an unknown date, Blood potassium: bottomed out.         No medical history was reported by the reporter.  The patient had low iron levels due to monthly period flow was high iron infusion was done about in 2016 and started getting low in beginning of 2021. The patient had bad reaction to covid shot four days later ended in hospital. She was in hospital for two days. Her potassium and calcium bottomed out. Adverse event Information provided by her not related to covid vaccine. She started Otzela on 20-Sep-2021 physician wants patient on both medications and swelling was now going down and pain was subsiding. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 44-year-old female patient, with relevant medical conditions of psoriatic arthritis and chronic plaque psoriasis, who experienced the unexpected and serious (due to hospitalization) events of Immunisation reaction, Blood potassium decreased, Blood calcium decreased and Blood magnesium decreased, which occurred related to primary vaccination of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for psoriatic arthritis. Patient was hospitalized for 2 days and treated with Otzela. The events of Immunisation reaction, Potassium decreased, Calcium decreased and Pain in extremity were considered unrelated to the mRNA-1273 vaccine per the reporter's assessment. conditions of psoriatic arthritis and chronic plaque psoriasis remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up report receive included lab data and events added and event outcome updated; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 44-year-old female patient, with relevant medical conditions of psoriatic arthritis and chronic plaque psoriasis, who experienced the unexpected and serious (due to hospitalization) events of Immunisation reaction, Blood potassium decreased, Blood calcium decreased and Blood magnesium decreased, which occurred related to primary vaccination of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for psoriatic arthritis. Patient was hospitalized for 2 days and treated with Otzela. The events of Immunisation reaction, Potassium decreased, Calcium decreased and Pain in extremity were considered unrelated to the mRNA-1273 vaccine per the reporter's assessment. conditions of psoriatic arthritis and chronic plaque psoriasis remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.