Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, Malaise, Post-acute COVID-19 syndrome
Clinical narrative: Second covid-19 test which resulted as positive; Not feel well; Lack of effect; Post-acute COVID-19 syndrome; She started to "feel the effects" of what she thought was allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (She started to "feel the effects" of what she thought was allergies), COVID-19 (Second covid-19 test which resulted as positive), MALAISE (Not feel well), DRUG INEFFECTIVE (Lack of effect) and POST-ACUTE COVID-19 SYNDROME (Post-acute COVID-19 syndrome) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced HYPERSENSITIVITY (She started to "feel the effects" of what she thought was allergies) and POST-ACUTE COVID-19 SYNDROME (Post-acute COVID-19 syndrome). On 10-Oct-2021, the patient experienced COVID-19 (Second covid-19 test which resulted as positive), MALAISE (Not feel well) and DRUG INEFFECTIVE (Lack of effect). At the time of the report, HYPERSENSITIVITY (She started to "feel the effects" of what she thought was allergies), COVID-19 (Second covid-19 test which resulted as positive), MALAISE (Not feel well) and DRUG INEFFECTIVE (Lack of effect) outcome was unknown and POST-ACUTE COVID-19 SYNDROME (Post-acute COVID-19 syndrome) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, SARS-CoV-2 test: negative (Negative) Tested Negative for COVID-19. In October 2021, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID-19.         The concomitant history was not reported. The patient had given prescription for prednisone, but patient not consumed it, on 10-OCT-2021 patient not felt well and went to different urgent care, at that appointment patient had second COVID-19 test resulted in positive, also received a monoclonal antibody IV on 12-0CT-2021, patient continued to have symptoms and post COVID syndrome.; Sender's Comments: This spontaneous report concerns a 68 year old female patient with no relevant medical history who experienced the non-serious events of allergies (coded as hypersensitivity) (expected event) and malaise (unexpected). Later, the patient tested positive for SARS-Cov-2 (coded as COVID-19, an unexpected AESI) after being exposed to a COVID 19 positive patient at work. The events occurred approximately 6 months after the second dose and nearly 7 months after the first dose of mRNA-1273. Based on the current available information, lack of effect was considered as an additional event. The patient was treated with intravenous monoclonal antibody and continues to have post-COVID syndrome (a non-serious, unexpected event). Rechallenge was not applicable as the events happened after the administration of the second dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.