Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: soreness in the arm at injection site; fever/100.5 degree temperature/by the morning, the temperature was back to 99; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm at injection site) and PYREXIA (fever/100.5 degree temperature/by the morning, the temperature was back to 99) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Muscle strain on 15-Jan-2016, Biceps tendon rupture and Muscle disorder NOS. Previously administered products included for Asthma: DUPIXENT (Solution for injection 600 mg 1X and subcutaneous bed followed by 300 mg QOW (every other week)) on 01-Feb-2022. Past adverse reactions to the above products included No adverse event with DUPIXENT. Concurrent medical conditions included Asthma, Eosinophilic esophagitis and Bronchitis. Concomitant products included CEFUROXIME, METHYLPREDNISOLONE (MEDROL DOSEPAK), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL (VENTOLINE [SALBUTAMOL]), THEOPHYLLINE, CIPROFLOXACIN HYDROCHLORIDE, DEXAMETHASONE (CIPRO D), BUDESONIDE (PULMICORT), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) and THEOPHYLLINE (QUIBRON [THEOPHYLLINE]) for an unknown indication.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced VACCINATION SITE PAIN (soreness in the arm at injection site) and PYREXIA (fever/100.5 degree temperature/by the morning, the temperature was back to 99). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2022, VACCINATION SITE PAIN (soreness in the arm at injection site) and PYREXIA (fever/100.5 degree temperature/by the morning, the temperature was back to 99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 degree Celsius and 99 degree Celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Patient stated that she received her Moderna COVID vaccine booster shot last week (exact date unknown). She did not have a reaction to her original COVID vaccines. However, she had a reaction to the Moderna booster. After her Moderna COVID booster shot, she experienced soreness in the arm at the site of the Moderna COVID injection. She then had a fever, and woke up with a 100.5 degree temperature (exact date unknown). She took some Tylenol,and by the morning, the temperature was back to 99 degrees. The soreness in the arm continued. She took Tylenol again the next night, but then had another fever and a temperature of 100.5 again (exact date unknown). Her fever ran high for 2 nights, then subsided again the next day (exact date unknown). At the time of the call, the patients temperature is back to normal, and no more pain in my arm. The patients pharmacist instructed the patient to get her Theophylline levels checked regularly while on Dupixent (exact date unknown).