Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: tested positive for Covid in 12 May 2022 and started Paxlovid same day; Around the incision rising on size of a portabella mushroom and the top was fire red; Around the incision it was real red and itchy; Around the incision it was real red and itchy; Arm hurt; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid in 12 May 2022 and started Paxlovid same day), VACCINATION SITE PRURITUS (Around the incision it was real red and itchy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Around the incision rising on size of a portabella mushroom and the top was fire red) and VACCINATION SITE ERYTHEMA (Around the incision it was real red and itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 011M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included GERD and Anxiety. Previously administered products included for Product used for unknown indication: pneumonia shot and INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE and pneumonia shot. Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (Around the incision it was real red and itchy), PAIN IN EXTREMITY (Arm hurt) and VACCINATION SITE ERYTHEMA (Around the incision it was real red and itchy). On 13-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Around the incision rising on size of a portabella mushroom and the top was fire red). On 12-May-2022, the patient experienced COVID-19 (tested positive for Covid in 12 May 2022 and started Paxlovid same day). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 12-May-2022 for COVID-19, at a dose of 3 pill in the morning and 3 pill in the afternoon; GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In November 2021, VACCINATION SITE PRURITUS (Around the incision it was real red and itchy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Around the incision rising on size of a portabella mushroom and the top was fire red) and VACCINATION SITE ERYTHEMA (Around the incision it was real red and itchy) had resolved. At the time of the report, COVID-19 (tested positive for Covid in 12 May 2022 and started Paxlovid same day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Weight: lost some weight Lost some weight as she can't eat.         Patient Ethnicity, Other. Concomitant medications were not reported. On 12 Nov 2021, patient took Moderna booster. That night her arm hurt and around incision it was real red and itchy. Next morning, she woke up, there was a rising on her the size of a portabella mushroom and top was fire red. She put Benadryl on it. It went away just as fast as it came on her left arm. Tested positive for COVID on 12 May 2022 and started Paxlovid same day. Horrible taste in her mouth started out kinda being like when you bite into a lemon white part, that became more intense as she took the drug, it was horrible. She kept taking it, but it was nauseating.She states with her taste, now that she has finished the medication she still can't taste and that concerns her, she couldn't smell before. States that not being able to taste, she knows if something in her mouth was salty, she has to spit it out, thinks her taste was on and off. The way she feels is worse than before she took the Paxlovid. She had no energy and a lot of congestion. The urgent care said to treat her symptoms and she took Muci Company comment-This spontaneous case concerns a 66-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 approximately 6 months after receiving the third dose of mRNA-1273 vaccine. She was tested positive for COVID-19 virus test as on 12th May2022. It was reported that patient was treated with Paxlovid for Covid-19 from 12th May2022. Patient had received initial two doses of mRNA-1273 vaccine with an interval of 28 days. Patient also had non serious events of Pain in extremity, Vaccination site swelling, Vaccination site erythema and Vaccination site pruritus after 3rd dose. Outcome of the event covid-19 was unknown. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-579942 (Patient Link).; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 approximately 6 months after receiving the third dose of mRNA-1273 vaccine. She was tested positive for COVID-19 virus test as on 12th May2022. It was reported that patient was treated with Paxlovid for Covid-19 from 12th May2022. Patient had received initial two doses of mRNA-1273 vaccine with an interval of 28 days. Patient also had non serious events of Pain in extremity, Vaccination site swelling, Vaccination site erythema and Vaccination site pruritus after 3rd dose. Outcome of the event covid-19 was unknown. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.