Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, X-ray
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Penicillin. Past adverse reactions to the above products included Allergy with Penicillin.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: result not provided Result not provided.         Concomitant medication was not reported.  Patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  Device Date was reported as '29May2022'.  Company Comment: This spontaneous case concerns a 65-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 7 months after receiving the third dose of the mRNA-1273 vaccine. The patient took Paxlovid (nirmatrelvir, ritonavir) for 4 days only (25May2022 to 28May2022). It was reported that 1 day after taking Paxlovid, the patient woke up with a terrible feeling of throat swelling and intense throat pain (pain scale: 10/10). She had trouble breathing and wheezing, and could not lay down or the symptoms got worse. She gargled with salt water and took Tylenol (paracetamol) affording no relief of symptoms. She lost her voice and the swelling got worse. The following day, the patient went to the Emergency department. X-rays (unspecified) were done, however, the results were not provided. The patient was given an unspecified medicine to reduce the swelling. It was reported that the doctors did not consider an allergic reaction to Paxlovid. The doctors were concerned to stop the antiviral therapy but eventually the patient was told to stop taking the drug. The patient took Benadryl (diphenhydramine) which afforded relief from the throat swelling. Five days after the first dose of Paxlovid, the patient cannot speak beyond a whisper and the throat pain still continued. Additionally, the patient was also treated with Toradol (ketorolac), Duoneb (ipratropium bromide/salbutamol) and Decadron (dexamethasone). The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 7 months after receiving the third dose of the mRNA-1273 vaccine. The patient took Paxlovid (nirmatrelvir, ritonavir) for 4 days only (25May2022 to 28May2022). It was reported that 1 day after taking Paxlovid, the patient woke up with a terrible feeling of throat swelling and intense throat pain (pain scale: 10/10). She had trouble breathing and wheezing, and could not lay down or the symptoms got worse. She gargled with salt water and took Tylenol (paracetamol) affording no relief of symptoms. She lost her voice and the swelling got worse. The following day, the patient went to the Emergency department. X-rays (unspecified) were done, however, the results were not provided. The patient was given an unspecified medicine to reduce the swelling. It was reported that the doctors did not consider an allergic reaction to Paxlovid. The doctors were concerned to stop the antiviral therapy but eventually the patient was told to stop taking the drug. The patient took Benadryl (diphenhydramine) which afforded relief from the throat swelling. Five days after the first dose of Paxlovid, the patient cannot speak beyond a whisper and the throat pain still continued. Additionally, the patient was also treated with Toradol (ketorolac), Duoneb (ipratropium bromide/salbutamol) and Decadron (dexamethasone). The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.