Reporte zur Charge NDC0069-1085-06

Symptomtext

Metallic taste in mouth; Pains in gastric area; Patient experienced recurrence of Covid positivity and symptoms.; Painful aches/tightness in arms and legs; Headache; Nausea; This spontaneous case was reported by a physician and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), ABDOMINAL PAIN UPPER (Pains in gastric area), COVID-19 (Patient experienced recurrence of Covid positivity and symptoms.), MYALGIA (Painful aches/tightness in arms and legs) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Previously administered products included for Drug use for unknown indication: Cephalosporins, Clindamycin and Heparin. Past adverse reactions to the above products included Allergy with Cephalosporins, Clindamycin and Heparin. Concurrent medical conditions included Hypertension, Chronic kidney disease and Thrombotic thrombocytopenic purpura. Concomitant products included LOSARTAN and OMEPRAZOLE from 01-Apr-2022 to an unknown date for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 16-Apr-2022, the patient experienced DYSGEUSIA (Metallic taste in mouth), ABDOMINAL PAIN UPPER (Pains in gastric area), COVID-19 (Patient experienced recurrence of Covid positivity and symptoms.), MYALGIA (Painful aches/tightness in arms and legs), HEADACHE (Headache) and NAUSEA (Nausea). On 10-May-2022, DYSGEUSIA (Metallic taste in mouth), ABDOMINAL PAIN UPPER (Pains in gastric area), COVID-19 (Patient experienced recurrence of Covid positivity and symptoms.), MYALGIA (Painful aches/tightness in arms and legs), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 17-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 30-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 04-May-2022, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had onset of metallic taste in mouth, painful aches/tightness in arms and legs, headache, nausea and pains in gastric area. This occurred after 7 doses of the Paxlovid and the medication was stopped. The symptoms slowly dissipated over approximately a week. On 17-Apr-2022 and 18-Apr-2022 patient symptoms were 95 percentage gone and testing was negative On 21-Apr-2022 patient had Covid symptoms recurred, though not as strongly as previously but symptoms were consisted of headache, cough, nasal congestion, sore throat, fatigue. On 23-Apr-2022 patient tested positive again and had fatigue and shortness of breath with exertion. On 30-Apr-2022 patient had again tested positive for Covid but weakly so and symptoms were receding but still present. On 04-May-2022 patient again tested negative for covid and had only residual symptom of fatigue was present. All Covid tests were home tests, except for 13-Apr-2022 testing took place in ER where patient went due to nausea, heavy chest. No treatment medication were provided. Company Comment: This is a spontaneous case concerning a 78-year-old female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the third dose of COVID-19 vaccine. The patient tested positive for COVID and was treated with Nirmatrelvir/Ritonavir. The COVID symptoms slowly dissipate and tested negative for COVID after 6 days. 3 days after the negative tests, the symptoms recurred (headache, cough, nasal congestion, sore throat and fatigue) and tested positive after 2 days associated with shortness of breath on exertion. 11 days after the second positive test, only residual fatigue was present and the test became negative. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the third dose of COVID-19 vaccine. The patient tested positive for COVID and was treated with Nirmatrelvir/Ritonavir. The COVID symptoms slowly dissipate and tested negative for COVID after 6 days. 3 days after the negative tests, the symptoms recurred (headache, cough, nasal congestion, sore throat and fatigue) and tested positive after 2 days associated with shortness of breath on exertion. 11 days after the second positive test, only residual fatigue was present and the test became negative. The benefit-risk relationship of mRNA-1273 is not affected by this report.