Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: COVID-19, Dysgeusia, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Pfizer Covid Vaccine/Moderna: For about four or five days had severe pain in that arm and was not able to move arm up or down; lymph nodes in armpit were huge for day; Paxlovid: Everything taste metallic; Pfizer Covid Vaccine/Moderna: Covid positive got caller really, really bad/Pfizer Covid Vaccine/Moderna: Covid positive/had severe muscle weakness; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Paxlovid: Everything taste metallic), COVID-19 (Pfizer Covid Vaccine/Moderna: Covid positive got caller really, really bad/Pfizer Covid Vaccine/Moderna: Covid positive/had severe muscle weakness), PAIN IN EXTREMITY (Pfizer Covid Vaccine/Moderna: For about four or five days had severe pain in that arm and was not able to move arm up or down) and LYMPHADENOPATHY (lymph nodes in armpit were huge for day) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Smoker. Concurrent medical conditions included Major depressive disorder. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Major depressive disorder.   On 10-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-May-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 100 milligram twice a day. On 03-May-2022, the patient experienced COVID-19 (Pfizer Covid Vaccine/Moderna: Covid positive got caller really, really bad/Pfizer Covid Vaccine/Moderna: Covid positive/had severe muscle weakness). On 04-May-2022, the patient experienced DYSGEUSIA (Paxlovid: Everything taste metallic). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pfizer Covid Vaccine/Moderna: For about four or five days had severe pain in that arm and was not able to move arm up or down) and LYMPHADENOPATHY (lymph nodes in armpit were huge for day). At the time of the report, DYSGEUSIA (Paxlovid: Everything taste metallic) had not resolved, COVID-19 (Pfizer Covid Vaccine/Moderna: Covid positive got caller really, really bad/Pfizer Covid Vaccine/Moderna: Covid positive/had severe muscle weakness) and PAIN IN EXTREMITY (Pfizer Covid Vaccine/Moderna: For about four or five days had severe pain in that arm and was not able to move arm up or down) outcome was unknown and LYMPHADENOPATHY (lymph nodes in armpit were huge for day) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 04-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient was a smoker and at a higher risk of getting bad COVID-19 symptoms. with Paxlovid, everything tasted metallic which was in back of throat and kind of weird.    On 3 May2022, patient had really bad Covid symptoms and on 4 May2022, patient experienced severe muscular weakness.  Patient had recieved Flu vaccine around the same time when the patient had recieved the Moderna vaccine and stated that it was pretty bad idea to get the Flu vaccine while getting the Modrna vaccine as well.  Patient was taking Bupropion Wellbutrin and was told there could be an interaction because both Paxlovid and Bupropion Wellbutrin could mess with kidney. Company comment: This spontaneous case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The non-serious events of Dysgeusia and AESI of COVID-19 occurred prior to the administration of third dose of mRNA-1273, hence the events are assessed as not related to the administration of the product. The initial two doses of Pfizer were given approximately 6 months prior, the interval between the two doses is 22 days. It has been reported that the patient experienced severe arm pain and lymphadenopathy on her axillary area for 4-5 days. Details of concomitant medications, clinical course, treatment and outcome were not provided. The events have not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The non-serious events of Dysgeusia and AESI of COVID-19 occurred prior to the administration of third dose of mRNA-1273, hence the events are assessed as not related to the administration of the product. The initial two doses of Pfizer were given approximately 6 months prior, the interval between the two doses is 22 days. It has been reported that the patient experienced severe arm pain and lymphadenopathy on her axillary area for 4-5 days. Details of concomitant medications, clinical course, treatment and outcome were not provided. The events have not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.