Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Panic attack
Clinical narrative: Panic attack, dry, metallic taste in mouth; Panic attack, dry, metallic taste in mouth; Panic attack, dry, metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (Panic attack, dry, metallic taste in mouth), DYSGEUSIA (Panic attack, dry, metallic taste in mouth) and DRY MOUTH (Panic attack, dry, metallic taste in mouth) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 048B21A and 048B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Lisinopril. Past adverse reactions to the above products included Allergy with Lisinopril. Concurrent medical conditions included Blood pressure high. Concomitant products included DILTIAZEM from 08-May-2013 to an unknown date, LOSARTAN from 02-Aug-2018 to an unknown date, FLUOXETINE from 15-Jul-2020 to an unknown date and BUPROPION from 05-Sep-2020 to 04-May-2022 for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022, the patient experienced PANIC ATTACK (Panic attack, dry, metallic taste in mouth) (seriousness criterion hospitalization), DYSGEUSIA (Panic attack, dry, metallic taste in mouth) (seriousness criterion hospitalization) and DRY MOUTH (Panic attack, dry, metallic taste in mouth) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to DRY MOUTH, DYSGEUSIA and PANIC ATTACK. At the time of the report, PANIC ATTACK (Panic attack, dry, metallic taste in mouth), DYSGEUSIA (Panic attack, dry, metallic taste in mouth) and DRY MOUTH (Panic attack, dry, metallic taste in mouth) outcome was unknown.            Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment medication information was provided. Device Date : 25May2022  Company Comment: This spontaneous case concerns a 45-year-old female patient, with relevant medical history of hypertension, with concomitant medications Fluoxetine, Losartan, and Diltiazem, who experienced the unexpected serious (hospitalization) events of Panic attack, Dysgeusia, and Dry mouth that occurred 4 months and 27 days after the 3rd dose of mRNA-1273 vaccine. Patient took Paxlovid but was discontinued after a day (reported as treatment for COVID-19 in this case but no information reported related to COVID-19 infection nor confirmatory test). Clinical course and treatment details were not reported. Hypertension could be considered as a risk factor for panic attack and dry mouth, and Paxlovid and concomitant Losartan, Fluoxetine, and Diltiazem could be confounders for dysgeusia, and Fluoxetine for dry mouth. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 45-year-old female patient, with relevant medical history of hypertension, with concomitant medications Fluoxetine, Losartan, and Diltiazem, who experienced the unexpected serious (hospitalization) events of Panic attack, Dysgeusia, and Dry mouth that occurred 4 months and 27 days after the 3rd dose of mRNA-1273 vaccine.Patient took Paxlovid but was discontinued after a day (reported as treatment for COVID-19 in this case but no information reported related to COVID-19 infection nor confirmatory test). Clinical course and treatment details were not reported. Hypertension could be considered as a risk factor for panic attack and dry mouth, and Paxlovid and concomitant Losartan, Fluoxetine, and Diltiazem could be confounders for dysgeusia, and Fluoxetine for  dry mouth. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.