Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19, Hypoaesthesia, Paraesthesia
Clinical narrative: COVID 19; Moderna Covid vaccine allergy; Numbness of bilateral feet and hands / progressively worsened to include bilateral legs, hands and lower arms/Numbness of lips, and tongue; Tingling of bilateral feet and hands which progressively worsened to include bilateral legs,hands and lower arms/tingling of lips, and tongue; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID 19), HYPOAESTHESIA (Numbness of bilateral feet and hands / progressively worsened to include bilateral legs, hands and lower arms/Numbness of lips, and tongue), PARAESTHESIA (Tingling of bilateral feet and hands which progressively worsened to include bilateral legs,hands and lower arms/tingling of lips, and tongue) and ALLERGY TO VACCINE (Moderna Covid vaccine allergy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulpha), Allergy (Adhesives), Lupus syndrome, Asthma, Immune disorder (NOS), Raynauds, Breast cancer and Thyroid cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 29-Feb-2016 to an unknown date, LIOTHYRONINE from 22-Feb-2016 to an unknown date, CELECOXIB (CELEBREX) from 17-Sep-2021 to an unknown date and GUAIFENESIN from 14-May-2022 to 19-May-2022 for an unknown indication.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced HYPOAESTHESIA (Numbness of bilateral feet and hands / progressively worsened to include bilateral legs, hands and lower arms/Numbness of lips, and tongue) and PARAESTHESIA (Tingling of bilateral feet and hands which progressively worsened to include bilateral legs,hands and lower arms/tingling of lips, and tongue). On an unknown date, the patient experienced COVID-19 (COVID 19) and ALLERGY TO VACCINE (Moderna Covid vaccine allergy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) and ALLERGY TO VACCINE (Moderna Covid vaccine allergy) outcome was unknown and HYPOAESTHESIA (Numbness of bilateral feet and hands / progressively worsened to include bilateral legs, hands and lower arms/Numbness of lips, and tongue) and PARAESTHESIA (Tingling of bilateral feet and hands which progressively worsened to include bilateral legs,hands and lower arms/tingling of lips, and tongue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking other medications within 2 weeks of starting COVID 19 treatment. Patient went to ER for further work up.  Company comment: This spontaneous case concerns a 45 year old male patient with underlying medical history of Systemic lupus erythematosus, immune system disorder,Thyroid and Breast cancer, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred at an unspecified date after receiving a dose of mRNA1273 as first dose of COVID-19 vaccine. Patient went to the emergency room for further workup and was  subsequently treated with Paxlovid. Further details on the clinical course and diagnostic/laboratory test done were not provided in the case. The patient's underlying medical condition of systemic lupus erythematosus, immune system disorder, Thyroid and Breast cancer may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45 year old female patient with underlying medical history of Systemic lupus erythematosus, immune system disorder,Thyroid and Breast cancer, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred at an unspecified date after receiving a dose of mRNA1273 as first dose of COVID-19 vaccine. Patient went to the emergency room for further workup and was  subsequently treated with Paxlovid. Further details on the clinical course and diagnostic/laboratory test done were not provided in the case. The patient's underlying medical condition of systemic lupus erythematosus, immune system disorder, Thyroid and Breast cancer may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.