Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Cholecystectomy, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: fever; headache; She has horrible stomach issues which are increasing; Her last Moderna vaccine was 36 days ago (21Aug2023) instead of 60 days ago; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), HEADACHE (headache), ABDOMINAL DISCOMFORT (She has horrible stomach issues which are increasing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her last Moderna vaccine was 36 days ago (21Aug2023) instead of 60 days ago) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205F23) for COVID-19 prophylaxis.    Co-suspect product included non-company product TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Trigger thumb.    The patient's past medical history included COVID-19 in June 2020. Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   On 29-Aug-2023, the patient received dose of TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (unknown route) 1 dosage form. On 29-Aug-2023, received dose of TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 26-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her last Moderna vaccine was 36 days ago (21Aug2023) instead of 60 days ago). On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and ABDOMINAL DISCOMFORT (She has horrible stomach issues which are increasing). At the time of the report, PYREXIA (fever), HEADACHE (headache) and ABDOMINAL DISCOMFORT (She has horrible stomach issues which are increasing) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her last Moderna vaccine was 36 days ago (21Aug2023) instead of 60 days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: Positive.  For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previous Moderna vaccinations included, the patient received first dose on 15-Jan-2021, Batch/Lot number 025J20A, second dose received on 12-Feb-2021, Batch/Lot number 010M20A, third dose received on 25-Jan-2022, Batch/Lot number 066H21A, fourth dose received on 09-Jun-2022, Batch/Lot number 048L21A, fifth dose received on 30-Sep-2022, Batch/Lot number AS7164B and sixth dose received on 21-Aug-2023, Batch/Lot number A57643E.  The patient got SPIKEVAX last Tuesday on 26-Sep-2023. She stated she had fever and headache for two days and it went away and now they were coming back. She then stated that they never fully went away. Her last Moderna vaccine was 36 days ago (21-Aug-2023) instead of 60 days ago. She had horrible stomach issues which were increasing. Her gallbladder was taken out, so she assumes it was the pancreas and liver.   On 21-Aug-2023, she received Moderna and influenza at the same time. She stated she did not had reaction to any previous vaccinations.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Live follow-up information received included added Co-suspect of Kenalog steroid injection. On 02-Oct-2023: Live follow-up information received included non-significant information of reference numbers added.