Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rash, SARS-CoV-2 test
Clinical narrative: Terrible rash, Rash under her eyes, Rash on her lower right leg and on the upper part of her left arm/Allergic reaction; Caller states that she tested positive for COVID-19 in January this year (2022); Caller states that she tested positive for COVID-19 in January this year (2022); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller states that she tested positive for COVID-19 in January this year (2022)), DRUG INEFFECTIVE (Caller states that she tested positive for COVID-19 in January this year (2022)) and RASH (Terrible rash, Rash under her eyes, Rash on her lower right leg and on the upper part of her left arm/Allergic reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 013M20A) for COVID-19 vaccination.     Patient stated that she has no allergies.  Concomitant products included PAROXETINE, LOSARTAN, AMLODIPINE, LEVOTHYROXINE, ALPRAZOLAM, MELOXICAM, ATORVASTATIN and VITAMINS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Caller states that she tested positive for COVID-19 in January this year (2022)) and DRUG INEFFECTIVE (Caller states that she tested positive for COVID-19 in January this year (2022)). On an unknown date, the patient experienced RASH (Terrible rash, Rash under her eyes, Rash on her lower right leg and on the upper part of her left arm/Allergic reaction). At the time of the report, COVID-19 (Caller states that she tested positive for COVID-19 in January this year (2022)) and DRUG INEFFECTIVE (Caller states that she tested positive for COVID-19 in January this year (2022)) outcome was unknown and RASH (Terrible rash, Rash under her eyes, Rash on her lower right leg and on the upper part of her left arm/Allergic reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that some months after second dose patient developed a terrible rash.  Patient explained that the rash started sometime this year, but she does not remember the exact time. She visited the dermatologist regarding this symptom and they gave them some creams to treat the rash. The creams helped a bit, she used them for 4 weeks. However she was still experienced symptoms and had this rash on her lower right leg and on the upper part of her left arm. She used to have rash under her eyes, but they disappeared. She thought symptoms might have appeared because she ate too much ice cream and made a reaction with the vaccine.  Company Comment:  This spontaneous case concerns a 79-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred on an unspecified date after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was also reported. Patient tested positive for COVID-19 approximately 10-11 months after administration of the same dose of vaccine. Patient received a Moderna COVID-19 vaccine for her first dose 28 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred on an unspecified date after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was also reported. Patient tested positive for COVID-19 approximately 10-11 months after administration of the same dose of vaccine. Patient received a Moderna COVID-19 vaccine for her first dose 28 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.