Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Moderna Tested positive for Coronavirus/Cough/Flu/She still feels weak/Nose is still dripping/She feels more tired than expected) and VACCINATION FAILURE (Vaccination Failure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for Prevention. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milligram. On 06-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Moderna Tested positive for Coronavirus/Cough/Flu/She still feels weak/Nose is still dripping/She feels more tired than expected). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination Failure). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 06-Jul-2022 to 10-Jul-2022 for COVID-19 treatment, at a dose of 3 dosage form twice a day; PARACETAMOL (TYLENOL) for Illness, at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (CORICIDIN D [CHLORPHENAMINE MALEATE; PARACETAMOL; PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Flu and Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 (Moderna Tested positive for Coronavirus/Cough/Flu/She still feels weak/Nose is still dripping/She feels more tired than expected) and VACCINATION FAILURE (Vaccination Failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient was diagnosed on 06/Jul/2021 for positive Corona virus and was very healthy for 2 years. She felt weak. The patient knows she did not have severe case and wants to know how many days she will feel better. The patient would walk the dog and swim in pool and did yoga class. The patient felt more tired than expected. The patient would like to know how many days after taking Paxlovid will it take to feel better. She was diagnosed in the morning and picked up her prescription and started Paxlovid and took it right away. The patient took 3 tablets in the morning and 3 at night. Started 06/Jul/2022 and took it for 5 days. On 10/Jul/2022, that Sunday, was patient's last dose. The patient had been off 9 days. She was feeling better, and then showed on internet that some people might have a rebound, but she guessed it was like a flu and had a lingering weakness and a cough and it was identical to flu but more deadly. The physical symptoms were identical. Outcome depended on time of day. Early in morning, she was ok, and after walking dogs, she came home and started getting tired in the early afternoon. The patient sat down and took rest. The patient got 2 doses of Moderna COVID vaccine and did not get booster. The patient's physician wanted her to get booster now and she should have listened to him. The day dose was described as yellowish, and evening was silver. It was identical tablets though. The patient thought vaccine was injected in right arm. Dose was 100mcg/0.5ml. She just took for the duration of her illness right now, a couple of Tylenol, no ibuprofen. She was taking cough syrup at night and day. Cough improving and is not as congested and not coughing as much. The nose was still dripping like first signs of a cold. Company Comment: This spontaneous case concerns a 71-year-old female patient, with no reported medical history who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred 2 months and 21 days after receiving the second dose of mRNA1273. Vaccination failure is also a possibility in this case since the patient received the primary series of mRNA1273 at 33 days interval and the event COVID-19 started more than 15 days after the second dose of the vaccine. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) 3 tablets during the day and 3 tablets at night for 5 days. The patient completed the regimen and  felt better. 9 days later she started having lingering weakness and cough. The patient self medicated with acetaminophen (tylenol) and acetaminophen/chlorpheniramine (Corcidin-D). She reported that her cough was improving and she is not as congested however rhinorrhoea is still present. Additional details about the clinical course of the events and other diagnostic or imaging studies done were not provided. The patient's advanced age may be considered as a risk factor for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 71-year-old female patient, with no reported medical history who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred 2months and 21 days after receiving the second dose of mRNA1273. Vaccination failure is also a possibility in this case since the patient received the primary series of mRNA1273 at 33 days interval and the event COVID-19 started more than 15 days after the second dose of the vaccine. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) 3 tablets during the day and 3 tablets at night for 5 days. The patient completed the regimen and  felt better. 9 days later she started having lingering weakness and cough. The patient self medicated with acetaminophen (tylenol) and acetaminophen/chlorpheniramine (Corcidin-D). She reported that her cough was improving and she is not as congested however rhinorrhoea is still present. Additional details about the clinical course of the events and other diagnostic or imaging studies done were not provided. The patient's advanced age may be considered as a risk factor for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.