Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dry skin, Pruritus, SARS-CoV-2 test
Clinical narrative: 2nd COVID-19 diagnosis; skin became itchy (2nd dose); dry skin (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (2nd COVID-19 diagnosis), PRURITUS (skin became itchy (2nd dose)) and DRY SKIN (dry skin (2nd dose)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 018B21A) for COVID-19 vaccination.  The patient's past medical history included COVID-19 (Diagnosed with COVID-19 sometime after the first Moderna vaccination.) in April 2021. Concurrent medical conditions included Seasonal allergy (Seasonal allergies), Asthma (Patient reported that it started many years ago. Recent change in status: Worsening), Heart disorder (Heart patient. Start date was prior to Moderna vaccines. No change in status recently.) and Diabetic (Start date was prior to Moderna vaccines. No change in status recently.).  On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Apr-2021, the patient experienced PRURITUS (skin became itchy (2nd dose)) and DRY SKIN (dry skin (2nd dose)). On an unknown date, the patient experienced COVID-19 (2nd COVID-19 diagnosis). At the time of the report, COVID-19 (2nd COVID-19 diagnosis), PRURITUS (skin became itchy (2nd dose)) and DRY SKIN (dry skin (2nd dose)) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.  No concomitant medication was reported. The patient reported after receiving the second Moderna COVID-19 injection her skin became itchy. The patient mentioned it could have been due to dry skin and not the Moderna injection. The patient was tested positive for COVID + test or diagnosis and stated that the patient was diagnosed with COVID-19 sometime after the first Moderna vaccination. Reportedly, the patient was again diagnosed with COVID-19 sometime after the second Moderna vaccination. It was also reported that the patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine and had not experienced a similar event in the past. No treatment information was provided.  Company Comment: This case concerns a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 on unspecified days after the second dose of mRNA-1273 vaccine. Since the onset date for Covid-19 is not provided, Lack of efficacy cannot be concluded. Ongoing pandemic could be confounding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-548556, MOD-2022-548565 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 on unspecified days after the second dose of mRNA-1273 vaccine. Since the onset date for Covid-19 is not provided, Lack of efficacy cannot be concluded. Ongoing pandemic could be confounding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.