Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Inappropriate schedule of product administration, Malaise, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: All the COVID symptoms; difficulty breathing; Feeling sick in mid-October; losing a lot of weight; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick in mid-October), WEIGHT DECREASED (losing a lot of weight), SUSPECTED COVID-19 (All the COVID symptoms), DYSPNOEA (difficulty breathing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025320A and 0282A20) for COVID-19 vaccination.     The patient's past medical history included Non-Hodgkin's lymphoma. Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN for Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In October 2021, the patient experienced MALAISE (Feeling sick in mid-October) and WEIGHT DECREASED (losing a lot of weight). On an unknown date, the patient experienced SUSPECTED COVID-19 (All the COVID symptoms) and DYSPNOEA (difficulty breathing). The patient was treated with NAPROXEN SODIUM (ALEVE) for COVID-19, at an unspecified dose and frequency. On 01-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, MALAISE (Feeling sick in mid-October), WEIGHT DECREASED (losing a lot of weight), SUSPECTED COVID-19 (All the COVID symptoms) and DYSPNOEA (difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test..         It was reported that she tries to watch what she eats. Patient had mild COVID symptoms.  Patient started feeling sick in mid-October and started losing a lot of weight. She had all the COVID symptoms but kept testing negative for it. She had mild symptoms. She had difficulty breathing. She had no fevers. She apparently did have COVID because she must have had it for a while.   Company comment: This case concerns a 66-year-old, female patient with medical history of Non-Hodgkin's lymphoma and diabetes mellitus, who experienced the unexpected non serious event of suspected COVID 19 along with other non serious events. The patient also experienced Inappropriate schedule of vaccine administered. The events occurred approximately 8.5 months day after the second dose of mRNA-1273. As reported patient started feeling sick in mid-October and started losing a lot of weight. She had all the COVID symptoms but kept testing negative for it. She had mild symptoms. She had difficulty breathing and no fevers. Patient apparently did have COVID because she must have had it for a while, as reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403949 (Patient Link).; Sender's Comments: This case concerns a 66-year-old, female patient with medical history of Non-Hodgkin's lymphoma and diabetes mellitus, who experienced the unexpected non serious event of suspected COVID 19 along with other non serious events. The patient also experienced Inappropriate schedule of vaccine administered. The events occurred approximately 8.5 months day after the second dose of mRNA-1273. As reported patient started feeling sick in mid-October and started losing a lot of weight. She had all the COVID symptoms but kept testing negative for it. She had mild symptoms. She had difficulty breathing and no fevers. Patient apparently did have COVID because she must have had it for a while, as reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.