Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Dizziness, Dysphagia, Muscular weakness, Oesophageal motility disorder
Clinical narrative: when I take an immunosuppressant, this has a possible interaction that reduces the effectiveness of my Oxycodone; Muscle weakness; weak; dysmotility; dizzy/ feels dizzy again; fever; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), ASTHENIA (weak), OESOPHAGEAL MOTILITY DISORDER (dysmotility), DIZZINESS (dizzy/ feels dizzy again) and PYREXIA (fever) in a 44-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Chronic pain (Past medical history of chronic pain treated with Oxycontin and Oxycodone). Previously administered products included for Drug use for unknown indication: Pfizer Bivalent (5th 10Sep2022 GJ2524 Pfizer Bivalent) on 10-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer Bivalent. Concurrent medical conditions included Immunocompromised (Patient was immunocompromised.) and Allergic reaction (Patient was allergic to things but can't remember what the are.). Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN) and OXYCODONE for an unknown indication.   On 24-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), ASTHENIA (weak), OESOPHAGEAL MOTILITY DISORDER (dysmotility), DIZZINESS (dizzy/ feels dizzy again) and PYREXIA (fever). On an unknown date, the patient experienced VACCINE INTERACTION (when I take an immunosuppressant, this has a possible interaction that reduces the effectiveness of my Oxycodone). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), ASTHENIA (weak), OESOPHAGEAL MOTILITY DISORDER (dysmotility), DIZZINESS (dizzy/ feels dizzy again) and PYREXIA (fever) had not resolved and VACCINE INTERACTION (when I take an immunosuppressant, this has a possible interaction that reduces the effectiveness of my Oxycodone) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever went higher this time 101.2 than with her other doses. and thinks her fever is almost gone it was last 99.1.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered VACCINE INTERACTION (when I take an immunosuppressant, this has a possible interaction that reduces the effectiveness of my Oxycodone) to be related. No further causality assessments were provided for MUSCULAR WEAKNESS (Muscle weakness), ASTHENIA (weak), OESOPHAGEAL MOTILITY DISORDER (dysmotility), DIZZINESS (dizzy/ feels dizzy again) and PYREXIA (fever).    Patient had reactions to catscan contrast. Patient may have psoriatic arthritis. Patient had 1st 11Feb2021 Lot#006M20A, 2nd 11Mar2021 Lot#047A21A, 3rd18Aug2021 Lot#091D21A, 4th 18Jan2022 016J212A. Patient had updated vaccine yesterday 24Sep2023 around 4:50PM EST.  After having Moderna vaccine her oxycodone working more and more. She had previously developed tolerance before the vaccine. She reported that pain medicine was making her sick and it was too strong and had not felt like that in a long time. Patient also reported that she read an article which did not had much information on interaction, but since Spikevax causes inflammation it could affect the medication. It was been around 24 hours. Patient just became concerned, more concerned when she was eating an early dinner and having trouble swallowing, having some muscle weakness, feeling very weak all day, more of a reaction this time than any other dose,.  Patient said that earlier she didn't seem to be breathing normally. Patient did a swallowing study once. A motility study where they put a tube down esophagus to check their swallowing which was before they had a procedure to help their GERD. It was a TIF procedure, done by endoscopy which showed she has some kind of dysmotility.   This case was linked to US-MODERNATX, INC.-MOD-2023-742308, US-MODERNATX, INC.-MOD-2023-741847 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2023: Significant Follow-up received: Reporter, Patient Date of birth, medical history, event and Concomitant medication updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741847:Same reporter, Different Patient US-MODERNATX, INC.-MOD-2023-742308:same Patient (Monovalent dose)