Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: pneumonia; COVID-19 (massive headaches, affected  sinuses, her throat was trash, not able to talk, very high fever, sick for 1 month); Patient got COVID-19; her cellulitis disappeared for a period of time after she received the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood disorder NOS (since 20 years back, she had blood disease/blood infection that kept coming), Cellulitis (cellulitis was an effect of the blood disease, got cellulitis in her leg constantly for 7 to 9 years) and Accident (In the past before the patient received the vaccine, she had an accident and got a blood infection). Concurrent medical conditions included Skin injury NOS (as a result of cellulitis in her leg constantly for 7 to 9 years, she had marks in her leg), Drug allergy (morphine), Drug allergy (NSAIDs), Blood pressure fluctuation (had blood pressure and was taking unspecified blood pressure medicine) and Thyroid disorder NOS (had thyroid and was taking unspecified thyroid medicine).   On 09-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2020, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (her cellulitis disappeared for a period of time after she received the Moderna COVID19 vaccine). On 11-Aug-2021, the patient experienced COVID-19 (COVID-19 (massive headaches, affected  sinuses, her throat was trash, not able to talk, very high fever, sick for 1 month)) and DRUG INEFFECTIVE (Patient got COVID-19). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and COVID-19 (COVID-19 (massive headaches, affected  sinuses, her throat was trash, not able to talk, very high fever, sick for 1 month)) had not resolved and DRUG INEFFECTIVE (Patient got COVID-19) and THERAPEUTIC RESPONSE UNEXPECTED (her cellulitis disappeared for a period of time after she received the Moderna COVID19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications included unspecified thyroid medicine and unspecified blood pressure medicine.In the past before receiving the vaccine, the patient had an accident and got a blood infection that kept coming back for the past 20 years. She had been getting cellulitis in her leg constantly for 7 to 9 years and because of this she had marks in her leg. She had cellulitis and it was an effect of the blood disease since 20 years ago but the Moderna COVID-19 vaccine was making it go away. Within 2 weeks of receiving the Moderna shot it was gone which lasted 2 years until about 1 month prior to this report, and it started coming back. She used many antibiotics to treat her condition but nothing help but the Moderna shot cleared up her cellulitis. She got COVID-19 on 11-Aug-2021 from a women that died from COVID and that women was not vaccinated. The patient became very sick. She experienced massive headaches, affected  sinuses, very high fever, sick for 1 month and her throat was trash and not able to talk.  Company comment: This spontaneous case concerns a 62 year old female patient with relevant medical history of cellulitis and blood infection, who experienced the unexpected serious (important medical event) event of Pneumonia and unexpected non serious AESI of COVID-19, about 11 months and 3 days after receiving the second dose of COVID -19 vaccination with mRNA-1273 vaccine. The interval between first and the second dose was 28 days and patient was diagnosed with COVID -19 about 11 months after the second dose which could be suggestive of Lack of efficacy. It was reported that the patient had an unexpected therapeutic benefit from mRNA-1273 vaccine for her cellulitis. Treatment details for pneumonia and COVID-19 were not available in the report. The outcome of the events was not resolved'. Medical history of blood infection could be risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-556422.; Sender's Comments: This spontaneous case concerns a 62 year old female patient with relevant medical history of cellulitis and blood infection, who experienced the unexpected serious (important medical event) event of Pneumonia and unexpected non serious AESI of COVID-19, about 11 months and 3 days after receiving the second dose of COVID -19 vaccination with mRNA-1273 vaccine. The interval between first and the second dose was 28 days and patient was diagnosed with COVID -19 about 11 months after the second dose which could be suggestive of Lack of efficacy. It was reported that the patient had an unexpected therapeutic benefit from mRNA-1273 vaccine for her cellulitis. Treatment details for pneumonia and COVID-19 were not available in the report. The outcome of the events was not resolved'. Medical history of blood infection could be risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.