Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Feeling abnormal, Memory impairment
Clinical narrative: After the second dose she refered experimenting a very nasty and unusual foggy mind/something was just not good; there was a big change in mind/Patient don´t remember and something was just not good; tiredness; Covid-19; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the second dose she refered experimenting a very nasty and unusual foggy mind/something was just not good), MEMORY IMPAIRMENT (there was a big change in mind/Patient don´t remember and something was just not good), FATIGUE (tiredness) and COVID-19 (Covid-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced FEELING ABNORMAL (After the second dose she refered experimenting a very nasty and unusual foggy mind/something was just not good), MEMORY IMPAIRMENT (there was a big change in mind/Patient don´t remember and something was just not good) and FATIGUE (tiredness). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (After the second dose she refered experimenting a very nasty and unusual foggy mind/something was just not good), FATIGUE (tiredness) and COVID-19 (Covid-19) outcome was unknown and MEMORY IMPAIRMENT (there was a big change in mind/Patient don´t remember and something was just not good) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: 101 101°F.         No concomitant medications were reported.  It was stated that patient received two doses of the Moderna COVID-19 vaccine a year ago. After the second dose patient referred experimenting a very nasty and unusual foggy mind, did not remember and something was just not good and tiredness, patient did not recognize herself. After the second shot there was a big change in mind it took more than a half year or maybe more to start getting back little by little.   After visiting a dentist last week from reporting, on Sunday evening patient was shivering and felt freezing cold.  Day before yesterday patient was tested for COVID-19 because patient started with fever of 101°F, sore throat and felt something swollen in throat, an unusual feeling and the test was positive. Patient was prescribed Paxlovid. Patient did not take the morning dose because just got the medication, asked if can start with the evening dose. should take it 9pm tonight and then 9 am tomorrow. Are the morning and the evening doses the same. The 2 medicines were taken together 2 times each day for 5 days. The doctor prescribed bromethazine, but patient did not want to take it because patient would already take Paxlovid.  Company Comment : This is a spontaneous case concerns 84-years-old female patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) that occurred in the context of second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. It was reported that after visiting to dentist, patient was shivering and felt freezing cold and tested for positive for COVID-19 with Body temperature of 101°F with a year before received mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. No additional information is available regarding vaccination schedule,medical history and concomitant medication received. The event outcome was unknown. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerns 84-years-old female patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) that occurred in the context of second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. It was reported that after visiting to dentist, patient was shivering and felt freezing cold and tested for positive for COVID-19 with Body temperature of 101°F with a year before received mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. No additional information is available regarding vaccination schedule,medical history and concomitant medication received. The event outcome was unknown. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement