Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Condition aggravated, Erythema
Clinical narrative: COVID-19; Pseudo relapse of multiple sclerosis; exhausted; Chills all day and all night for 2 days; Fever; Extreme nausea; Joint pain; Headache; Sore arm; Couldn't eat anything; Arm was very red and one part was streaking down to armpit; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudo relapse of multiple sclerosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU SYRINGE and Shingrix. Past adverse reactions to the above products included Unable to walk with FLU SYRINGE and Shingrix. Concurrent medical conditions included Multiple sclerosis.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Mar-2021, the patient experienced NAUSEA (Extreme nausea), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills all day and all night for 2 days) and PYREXIA (Fever). In 2021, the patient experienced FEEDING DISORDER (Couldn't eat anything), ERYTHEMA (Arm was very red and one part was streaking down to armpit) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudo relapse of multiple sclerosis) (seriousness criterion medically significant) and FATIGUE (exhausted). The patient was hospitalized from 02-Jan-2023 to 05-Jan-2023 due to COVID-19. The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at a dose of 8 milligram. On 25-Mar-2021, CHILLS (Chills all day and all night for 2 days) had resolved. In 2023, COVID-19 (COVID-19) had resolved. At the time of the report, MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudo relapse of multiple sclerosis), FEEDING DISORDER (Couldn't eat anything), ERYTHEMA (Arm was very red and one part was streaking down to armpit), HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Sore arm), NAUSEA (Extreme nausea), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown and FATIGUE (exhausted) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 F fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  The patient recalls that her legs did not work for about an hour; she could not walk after first dose. She just stayed there until the legs worked again. It was a typical reaction for her to any vaccine. She also got it with Shingrix, the flu shot, everything.  Patient also had sore arm from the first vaccine.  Post second shot of Moderna, patient had chills all day and all night for 2 days, fever, extreme nausea, headache and joint pain. Patient also had multiple sclerosis and had pseudo relapse so patient could not use legs and arm. The amount of sickness was where patient could not walk or eat anything. Patient's arm was very red and one part was streaking down to armpit. Patient was alternating between chills and sweating. Patient had to hold something in order to walk.  On 12-Sep-2022, patient received Pfizer bivalent booster dose (last dose).  On 02-Jan-2023, patient was hospitalized for COVID till 05-Jan-2023. They told her she had a mild case. She received 2 antivirals alternately overnight, but she did not know what they were. She mostly felt exhausted with no appetite. She started out with a 102 F fever. She could not get up, so she called the ambulance.  Patient was trying to figure out if she needs another booster. Patient was scheduled for surgery beginning Sep-2023, so she wants to prepare before it.   Company comment: This is a Spontaneous case reported by a consumer, concerning a 74-year-old female patient, with relevant underlying condition of multiple sclerosis, who experienced the unexpected and serious (due to hospitalization) event of COVID-19, and the unexpected and serious (due to medically significant) event of Multiple sclerosis pseudo relapse. Multiple sclerosis pseudo relapse occurred after the second dose of mRNA-1273 vaccine. COVID-19 occurred approximately 13 months after the third dose of mRNA-1273 vaccine. As reported, after the second dose, patient experienced chills, fever, extreme nausea, headache and joint pain. She also had multiple sclerosis pseudo relapse, so she could not use legs and arms. She could not walk or eat anything. Regarding COVID-19, she had a mild case, and was hospitalized for 4 days. No information disclosed about diagnostic tests performed. At the time of the report, Multiple sclerosis pseudo relapse outcome was unknown, and COVID-19 had resolved. Underlying multiple sclerosis can present relapses as part of its natural history. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact information updated, NNI On 11-Aug-2023: Upon receipt of the follow-up information on 11-Aug-2023, it was identified that the information in cases MOD-2021-060436 and MOD-2021-060425 are pertaining to the same patient and same product. Hence the case MOD-2021-060425 will be retained for further follow-up and all the information from the case MOD-2021-060436 has been incorporated into the retained case MOD-2021-060425. The case MOD-2021-060436 will be nullified and deleted from the safety database.Follow-up received: Case was upgraded from non-serious to serious. Suspect details, additional events and narrative was updated.