Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Induration, Mass, Papule, Product dose omission issue
Clinical narrative: she broke out in a red rash all over her body; turned black and hard and had big splotches/scabs/bumps all over her body; turned black and hard and had big splotches/scabs/bumps all over her body; turned black and hard and had big splotches/scabs/bumps all over her body; scars and white scaly patches all over her body; scars and white scaly patches all over her body; hard black lumps on their feet,hand, private area,arm,back; hard black lumps on their feet,hand, private area,arm,back; symptoms have not resolved and have gotten worse; rash turned black; wait until these symptoms are gone before receiving the second dose; Itchy; Red spot; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), RASH MACULAR (Red spot), RASH ERYTHEMATOUS (she broke out in a red rash all over her body), INDURATION (turned black and hard and had big splotches/scabs/bumps all over her body) and SCAB (turned black and hard and had big splotches/scabs/bumps all over her body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, PRAVASTATIN SODIUM, ESCITALOPRAM OXALATE (ESCITALOPRAM [ESCITALOPRAM OXALATE]), AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, METOPROLOL, OXYBUTYNIN, ASPIRIN [ACETYLSALICYLIC ACID], APIXABAN (ELIQUIS), LISINOPRIL, MULTIVITAMINS [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and FISH OIL for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (Itchy), RASH MACULAR (Red spot) and RASH (Rash). On an unknown date, the patient experienced RASH ERYTHEMATOUS (she broke out in a red rash all over her body), INDURATION (turned black and hard and had big splotches/scabs/bumps all over her body), SCAB (turned black and hard and had big splotches/scabs/bumps all over her body), PAPULE (turned black and hard and had big splotches/scabs/bumps all over her body), SCAR (scars and white scaly patches all over her body), SKIN EXFOLIATION (scars and white scaly patches all over her body), MASS (hard black lumps on their feet,hand, private area,arm,back), SKIN DISCOLOURATION (hard black lumps on their feet,hand, private area,arm,back), CONDITION AGGRAVATED (symptoms have not resolved and have gotten worse), RASH (rash turned black) and PRODUCT DOSE OMISSION ISSUE (wait until these symptoms are gone before receiving the second dose). At the time of the report, PRURITUS (Itchy), RASH MACULAR (Red spot), RASH ERYTHEMATOUS (she broke out in a red rash all over her body), INDURATION (turned black and hard and had big splotches/scabs/bumps all over her body), SCAB (turned black and hard and had big splotches/scabs/bumps all over her body), PAPULE (turned black and hard and had big splotches/scabs/bumps all over her body), SCAR (scars and white scaly patches all over her body), SKIN EXFOLIATION (scars and white scaly patches all over her body), MASS (hard black lumps on their feet,hand, private area,arm,back), SKIN DISCOLOURATION (hard black lumps on their feet,hand, private area,arm,back), RASH (rash turned black), RASH (Rash) and PRODUCT DOSE OMISSION ISSUE (wait until these symptoms are gone before receiving the second dose) outcome was unknown and CONDITION AGGRAVATED (symptoms have not resolved and have gotten worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added patient address, concomitant drugs, events and change in vaccine drug start date. On 03-Aug-2021: Follow up received :Significant follow up-Different date of administration of vaccine.Detailed  events description hard black lumps on their feet, back, arms, hands, and private area.Event added.