Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Vaccination site discomfort
Clinical narrative: was in horrible pain for many many months/extreme pain; from the neck down to the fingers the patient could not move/it would take all day to move a little better; a feeling of uneasiness and not being comfortable at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was in horrible pain for many many months/extreme pain) and HYPOKINESIA (from the neck down to the fingers the patient could not move/it would take all day to move a little better) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stomach discomfort (patient was being treated for stomach/gut issues) since 2019, GERD since 2019, Hiatal hernia since 2019, Gluten intolerance (Gluten allergy), Seasonal allergy (Seasonal allergies) and Allergy to edible fungus (Mushrooms allergy). Concomitant products included VITAMINS NOS, PROBIOTICS NOS, TOCILIZUMAB (ACTEMRA), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CELECOXIB (CELEBREX), PREDNISONE and METHOTREXATE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN (was in horrible pain for many many months/extreme pain) (seriousness criterion hospitalization). In 2021, the patient experienced HYPOKINESIA (from the neck down to the fingers the patient could not move/it would take all day to move a little better) (seriousness criterion hospitalization) and VACCINATION SITE DISCOMFORT (a feeling of uneasiness and not being comfortable at vaccination site). At the time of the report, PAIN (was in horrible pain for many many months/extreme pain) and HYPOKINESIA (from the neck down to the fingers the patient could not move/it would take all day to move a little better) had not resolved and VACCINATION SITE DISCOMFORT (a feeling of uneasiness and not being comfortable at vaccination site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had never been tested for COVID-19 and had never felt any symptoms of COVID-19.  Concomitant medications also included supplements for stomach/gut health. The patient had allergic reaction with Actemra and hence no longer continuing it. The patient was on prednisone for 8 and a half to 9 months and no longer continuing it. The patient was no longer continuing Plaquenil.  No treatment information was reported.  The patient described the adverse event as rather extreme side effect and felt horrible pain after the first dose and it happened about 10-12 days after first vaccine administration.  The adverse events caused the patient to seek medical care (office visit, urgent care, emergency room and hospitalization).  It was unknown whether the patient experienced similar events in the past or not.  The patient had not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was not on any drug therapy prior to the vaccination and was a healthy person but recently the patient was just a sick person.  Company Comment:  This spontaneous case concerns a 64-year-old female patient, with no relevant medical history, who experienced the unexpected serious (hospitalization) events of Pain and Hypokinesia that occurred on an unknown date after receiving the 1st dose of mRNA-1273 vaccine. Patient felt horrible pain 10-12 days after first vaccination and could not move from neck down to the fingers and would take all day to move a little better. Clinical course and treatment details were not reported. The patient was not on any drug therapy prior to the vaccination and was a healthy person. At the time of reporting, the outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-529267, MOD-2022-528982 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64-year-old female patient, with no relevant medical history, who experienced the unexpected serious (hospitalization) events of Pain and Hypokinesia that occurred on an unknown date after receiving the 1st dose of mRNA-1273 vaccine. Patient felt horrible pain 10-12 days after first vaccination and could not move from neck down to the fingers and would take all day to move a little better. Clinical course and treatment details were not reported. The patient was not on any drug therapy prior to the vaccination and was a healthy person. At the time of reporting, the outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.