Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: Diagnosed with a mild case of COVID pneumonia/ Tested Covid positive (rapid test) on May 6, 2022 and started Paxlovid on May 7.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Diagnosed with a mild case of COVID pneumonia/ Tested Covid positive (rapid test) on May 6, 2022 and started Paxlovid on May 7.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027121A, 032L20A, 054C21A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Prostatectomy. Concurrent medical conditions included HIV infection and Melanoma. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), VALACYCLOVIR [VALACICLOVIR], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), TADALAFIL (CIALIS), VITAMIN D [VITAMIN D NOS], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), FAMOTIDINE, VITAMIN C [ASCORBIC ACID], ZINC, CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM), BIFIDOBACTERIUM INFANTIS (ALIGN), ASCORBIC ACID, CALCIUM PHOSPHATE, LACTOBACILLUS NOS, VACCINIUM MACROCARPON (AZO CRANBERRY), BROMELAINS;QUERCETIN, VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]), LYSINE, ROSUVASTATIN CALCIUM (CRESTOR) and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 PNEUMONIA (Diagnosed with a mild case of COVID pneumonia/ Tested Covid positive (rapid test) on May 6, 2022 and started Paxlovid on May 7.) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 12-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 PNEUMONIA (Diagnosed with a mild case of COVID pneumonia/ Tested Covid positive (rapid test) on May 6, 2022 and started Paxlovid on May 7.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative; diagnosed with a mild case of COVID pneumonia. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    It was reported that the patient was taking other medications within 2 weeks of starting COVID-19 treatment. On 06-May-2022, the patient tested COVID positive (rapid test) and started Paxlovid on 07-May-2022. He re-tested himself on 13-May-2022 and was COVID negative (rapid test). That day, he was diagnosed with a mild case of COVID pneumonia (symptoms shortness of breath and cough). On 17-May-2022, he decided to retest himself and the rapid test was positive (he did two to be sure). He started to feel better each day and now he was less symptomatic (less shortness of breath and less coughing).  Company Comment: This spontaneous case concerns a 67-year-old, male patient with concurrent HIV infection and melanoma who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 pneumonia which occurred after receiving the fourth dose of mRNA-1273 vaccine. Patient tested positive for COVID-19 using a rapid COVID-19 test on the same day after administration of fourth dose of mRNA-1273. He was treated with Nirmatrelvir, Ritonavir (Paxlovid) for six days.  A repeat COVID-19 rapid test was performed 7 days after treatment showed negative result. Seven days after the fourth dose of mRNA-1273, he developed cough and shortness of breath and was diagnosed to have mild COVID-19 pneumonia. Two COVID-19 rapid tests were performed which showed positive result. Although patient reported improvement of symptoms, the complete clinical course, diagnostic evaluation, and treatment details were not provided in the report. Underlying immunodeficiency state is a risk factor for severe forms of COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-572754.; Sender's Comments: This spontaneous case concerns a 67-year-old, male patient with concurrent HIV infection and melanoma who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 pneumonia which occurred after receiving the fourth dose of mRNA-1273 vaccine. Patient tested positive for COVID-19 using a rapid COVID-19 test on the same day after administration of fourth dose of mRNA-1273. He was treated with Nirmatrelvir, Ritonavir (Paxlovid) for six days.  A repeat COVID-19 rapid test was performed 7 days after treatment showed negative result. Seven days after the fourth dose of mRNA-1273, he developed cough and shortness of breath and was diagnosed to have mild COVID-19 pneumonia. Two COVID-19 rapid tests were performed which showed positive result. Although patient reported improvement of symptoms, the complete clinical course, diagnostic evaluation, and treatment details were not provided in the report. Underlying immunodeficiency state is a risk factor for severe forms of COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.