Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Blood test, Body temperature, Dizziness, Drug hypersensitivity
Clinical narrative: Arthritis; Digestive system was not working well; After second booster shot had hypersensitive reaction; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), GASTROINTESTINAL DISORDER (Digestive system was not working well), DIZZINESS (Light headedness) and DRUG HYPERSENSITIVITY (After second booster shot had hypersensitive reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 064H21A, 047B21A and 008B21A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) tablet for Hyperthyroidism.    Patient was very sensitive to chemicals.  The patient's past medical history included Abstains from alcohol and Dislocation of vertebra (Problem with spine where vertebra on neck went out of place by 25 percent off of the normal position) in 2019. Previously administered products included for Product used for unknown indication: CLAVULANIC ACID, Sulfa (sulfonamide derivatives) and ACCUHIST LA. Past adverse reactions to the above products included Allergy with ACCUHIST LA and CLAVULANIC ACID; and No adverse event with Sulfa. Concurrent medical conditions included Diabetes since 2005, Non-smoker, Sulfonamide allergy (Sulfa drug allergy manifested by skin turns bright red, temperature increased 104.4 F), Drug allergy (Ace inhibitors allergy), Allergy to antibiotic (Sulfonamides derivatives allergy), Allergy to antibiotic (Clavulanic acid allergy), Drug allergy (Accuhist LA tablet allergy) and Food allergy (Preservatives allergy). Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) and INSULIN GLARGINE (LANTUS) for Diabetes, METOPROLOL for Heartbeats irregular.   In 1980, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 milligram. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 137 microgram. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 150 microgram. On 14-Jun-2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 137 microgram. On 01-Jun-2022, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced ARTHRITIS (Arthritis), GASTROINTESTINAL DISORDER (Digestive system was not working well) and DRUG HYPERSENSITIVITY (After second booster shot had hypersensitive reaction). At the time of the report, ARTHRITIS (Arthritis) had not resolved and GASTROINTESTINAL DISORDER (Digestive system was not working well), DIZZINESS (Light headedness) and DRUG HYPERSENSITIVITY (After second booster shot had hypersensitive reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood test: results not reported results not reported. On an unknown date, Body temperature: 104.4 (High) Temperature increased 104.4 Fahrenheit.         It was reported that in 2005 patient experienced Diabetes and in 2019 problem with spine where the vertebrae on neck went out of the place by 25 percent off of the normal position. The patient used to feel very tired and after second booster shot patient had hypersensitive reaction.  The reporters causality for the event of light headedness and Digestive system was not working well very tired with was a reasonable possibility, causality for the event Arthritis was no reasonable possibility and causality for event after second booster shot had hypersensitive was not provided with co-suspect with Synthroid.  No treatment medication was reported by patient.  Company comment: This spontaneous case concerns a 57 year old female, with current condition of diabetes mellitus and underlying medical history of dislocation of vertebra, who experienced the unexpected, non-serious adverse event of special interest Arthritis, which occurred at an unspecified date after receiving the fourth dose of mRNA1273. Further details regarding the clinical course  were not provided. The patient's concurrent diabetes mellitus may be considered as a risk factor for arthritis and her underlying medical history of dislocation of vertebra may be in relation to arthritis as well. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 57 year old female, with current condition of diabetes mellitus and underlying medical history of dislocation of vertebra, who experienced the unexpected, non-serious adverse event of special interest Arthritis, which occurred at an unspecified date after receiving the fourth dose of mRNA1273. Further details regarding the clinical course  were not provided. The patient's concurrent diabetes mellitus may be considered as a risk factor for arthritis and her underlying medical history of dislocation of vertebra may be in relation to arthritis as well. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.