Age: 47.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: SARS-CoV-2 test, Skin hyperpigmentation
Clinical narrative: epidermal hyperpigmentation to bilateral lower extremities,dense multiple dark brown macules; This spontaneous case was reported by a nurse and describes the occurrence of SKIN HYPERPIGMENTATION (epidermal hyperpigmentation to bilateral lower extremities,dense multiple dark brown macules) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 068H21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Concussion. Concurrent medical conditions included Rhinitis seasonal, Hypothyroidism, Migraine, Penicillin allergy, Sulfonamide allergy (Sulfa), Drug allergy (Compazine), Seafood allergy (Shrimp.) and Insect bite allergy (Vespids). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMANTADINE, LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and VITAMIN D NOS for an unknown indication.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form, second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced SKIN HYPERPIGMENTATION (epidermal hyperpigmentation to bilateral lower extremities,dense multiple dark brown macules) (seriousness criterion disability). At the time of the report, SKIN HYPERPIGMENTATION (epidermal hyperpigmentation to bilateral lower extremities,dense multiple dark brown macules) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2022, SARS-CoV-2 test: (Positive) Nasal Swab.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The race of the patient reported. The vaccination site for Dose 4 of Moderna and other doses of Pfizer vaccine was provided as Deltoid. Patient had received the most recent vaccine dose in hospital. Patient had received the treatment for the events and had visited the Dermatology for the same.  It was reported that the patient had not tested positive for COVID-19 vaccine prior to receiving the COVID-19 vaccine. Since the vaccination, the patient has been tested for COVID-19 reported as Yes. Company comment- This is a spontaneous case concerning a 47-year-old-female-patient with no relevant medical history who experienced the serious (disability) unexpected event of skin hyperpigmentation (reported as epidermal hyperpigmentation to bilateral lower extremities, dense multiple dark brown macules). A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on vaccination date. Four doses of TOZINAMERAN vaccine, given as first, second, third and fifth doses were given (revaccination with different COVID-19 vaccine and interchange of vaccine products). No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.