Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test, Sinus pain
Clinical narrative: foggy brain; she had weakness; her glands in her throat was the size of a walnut; her sinuses felt like they were on fire all the way from her eyes to her ears,; She had stabbing body aches all over her body, l ke torture,; Lack of drug effect; Covid-19; Pain, her head felt like a vice/felt like a meat cleaver in her Forehead; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (foggy brain), ASTHENIA (she had weakness), THROAT TIGHTNESS (her glands in her throat was the size of a walnut), SINUS PAIN (her sinuses felt like they were on fire all the way from her eyes to her ears,) and PAIN (She had stabbing body aches all over her body, l ke torture,) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker (she quit smoking 4 years ago and got fat).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (foggy brain), ASTHENIA (she had weakness), THROAT TIGHTNESS (her glands in her throat was the size of a walnut), SINUS PAIN (her sinuses felt like they were on fire all the way from her eyes to her ears,), PAIN (She had stabbing body aches all over her body, l ke torture,), DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Covid-19) and HEADACHE (Pain, her head felt like a vice/felt like a meat cleaver in her Forehead). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 150mg tablet times 2 - 100mg tablet. At the time of the report, FEELING ABNORMAL (foggy brain) and ASTHENIA (she had weakness) had not resolved, THROAT TIGHTNESS (her glands in her throat was the size of a walnut), SINUS PAIN (her sinuses felt like they were on fire all the way from her eyes to her ears,), PAIN (She had stabbing body aches all over her body, l ke torture,) and HEADACHE (Pain, her head felt like a vice/felt like a meat cleaver in her Forehead) had resolved and DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, SARS-CoV-2 test: positive (Positive) positive for the Covid virus, with a home test.. On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) positive. The Regulatory Authority tested her with a swab test and she was positive..         The patient became symptomatic with the Covid virus and before started taking Paxlovid, the patient experienced pain, head felt like a vice, felt like a meat cleaver in forehead, glands in throat was the size of a walnut, sinuses felt like they were on fire all the way from eyes to her ears, had stabbing body aches all over body. The aptient had weakness and a foggy brain.  The patient had an improvement in all of Covid symptoms, 2 hours after started taking Paxlovid.  The patient was now fully recovered and all of symptoms are gone except for some weakness and foggy brain.  The patient had both doses and the booster of the Moderna Covid vaccine and got sick with the Covid virus. The Covid virus never got into lungs and stayed out of the hospital. Company comment: This spontaneous case concerns a 58-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273. The initial two doses of mRNA-1273 were given 9 months prior, the interval between the two doses is 33 days. Additionally, Drug ineffective was also reported. On April 23 and April 25, 2022, SARS-CoV-2 test was done which revealed positive results. It has been reported that the patient became symptomatic with the Covid virus and before started taking Paxlovid, the patient experienced pain, headache, cervical lymph node and sinusitis. The patient had improvement of all symptoms after taking Paxlovid and has now fully recovered except for body weakness and foggy brain. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273. The initial two doses of mRNA-1273 were given 9 months prior, the interval between the two doses is 33 days. Additionally, Drug ineffective was also reported. On April 23 and April 25, 2022, SARS-CoV-2 test was done which revealed positive results. It has been reported that the patient became symptomatic with the Covid virus and before started taking Paxlovid, the patient experienced pain, headache, cervical lymph node and sinusitis. The patient had improvement of all symptoms after taking Paxlovid and has now fully recovered except for body weakness and foggy brain. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.