Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Peripheral swelling, Product dose omission issue, Pruritus, Pyrexia
Clinical narrative: lost her sense of taste; Arm swelling looked like a big welt and progressed to the size of a ping pong ball; not able to eat; no second dose received per primary care physician; dizzy; freezing despite 80 degree temp; fever; severe vomiting; chills; headache; left arm swelling like a pear; itchy arm; red arm; lost her sense of smell; severe night sweats, drenched in sweat; sickness; skin feels clammy; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second dose received per primary care physician), PERIPHERAL SWELLING (left arm swelling like a pear), PRURITUS (itchy arm), ERYTHEMA (red arm) and ANOSMIA (lost her sense of smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A07B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN HP) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling like a pear), PRURITUS (itchy arm), ERYTHEMA (red arm), ANOSMIA (lost her sense of smell), NIGHT SWEATS (severe night sweats, drenched in sweat), ILLNESS (sickness), COLD SWEAT (skin feels clammy), FEELING COLD (freezing despite 80 degree temp), PYREXIA (fever), VOMITING (severe vomiting), CHILLS (chills) and HEADACHE (headache). On 26-Mar-2021, the patient experienced DIZZINESS (dizzy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second dose received per primary care physician), AGEUSIA (lost her sense of taste), URTICARIA (Arm swelling looked like a big welt and progressed to the size of a ping pong ball) and FEEDING DISORDER (not able to eat). The patient was treated with PROMETHAZINE HYDROCHLORIDE at a dose of 25 mg three times a day and FLUOCINOLONE ACETONIDE (FLUOCINOLONE) at a dose of 1 dosage form. On 05-Apr-2021, PERIPHERAL SWELLING (left arm swelling like a pear), PRURITUS (itchy arm) and ERYTHEMA (red arm) had resolved. On 14-Apr-2021, NIGHT SWEATS (severe night sweats, drenched in sweat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second dose received per primary care physician) had resolved and ANOSMIA (lost her sense of smell), ILLNESS (sickness), COLD SWEAT (skin feels clammy), DIZZINESS (dizzy), FEELING COLD (freezing despite 80 degree temp), AGEUSIA (lost her sense of taste), URTICARIA (Arm swelling looked like a big welt and progressed to the size of a ping pong ball), FEEDING DISORDER (not able to eat), PYREXIA (fever), VOMITING (severe vomiting), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. primary care physician recommend patient not to take second dose due to her severe reaction.