Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Illness, Inappropriate schedule of product administration, Oropharyngeal discomfort
Clinical narrative: horrible taste in her mouth, a nasty taste keeps sipping/taste is very strong in her throat; face is a little puffy; Tested positive for COVID, was fully vaccinated; has bad headache; Sick; taste is very strong in her throat; She got the booster early because she has the auto immune disorders; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick), OROPHARYNGEAL DISCOMFORT (taste is very strong in her throat), TASTE DISORDER (horrible taste in her mouth, a nasty taste keeps sipping/taste is very strong in her throat), SWELLING FACE (face is a little puffy) and COVID-19 (Tested positive for COVID, was fully vaccinated) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A, 026B21A and 001B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19.    She has a couple of auto immune disorders that were really bad a few years ago.  The patient's past medical history included Rash (Allergic to sulfa It was 15 years ago. She got a bad rash and itching) and Itching (Allergic to sulfa It was 15 years ago. She got a bad rash and itching). Concurrent medical conditions included Polyradiculitis, Guillain Barre syndrome, Sjogren's syndrome, Asthma and Drug allergy (NDC, LOT, EXP: Unknown It was 15 years ago. She got a bad rash and itching). Concomitant products included PREDNISONE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022 at 10:30 PM, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) UNK,2 pills Nirmatrelvir, 1 pill Ritonavir each dose. On 18-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the booster early because she has the auto immune disorders). On 05-May-2022 at 10:30 PM, the patient experienced TASTE DISORDER (horrible taste in her mouth, a nasty taste keeps sipping/taste is very strong in her throat). In May 2022, the patient experienced ILLNESS (Sick), OROPHARYNGEAL DISCOMFORT (taste is very strong in her throat), SWELLING FACE (face is a little puffy), COVID-19 (Tested positive for COVID, was fully vaccinated) and HEADACHE (has bad headache). At the time of the report, ILLNESS (Sick), OROPHARYNGEAL DISCOMFORT (taste is very strong in her throat), TASTE DISORDER (horrible taste in her mouth, a nasty taste keeps sipping/taste is very strong in her throat), SWELLING FACE (face is a little puffy), COVID-19 (Tested positive for COVID, was fully vaccinated), HEADACHE (has bad headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the booster early because she has the auto immune disorders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.         Patient ethnicity was reported. Patient was on Prednisone for a couple of years and just got off it a while back. When she put it in her mouth, she could taste it on her tongue but she could drink and then it would go away. Patient was tested positive and was sick and began taking Paxlovid last night and took some other pills. She stated it started yesterday when she took the first 3 pills. She took it last night at 10:30pm. As soon as she took it, she had that horrible taste. She took another 3 pills this morning at 10:30am and it was just horrible,It was horrible and she tried to sip something and ate a little and tried to get the horrible taste out of the mouth. when she went to the ER, she was not admitted to the hospital, and she was just in the Emergency room. She stated they did lab work and chest X-ray, and they gave her the medicine, the Paxlovid. She was supposed to take the medicine for 5 days, Lot It was either FY0319 or FYO319, patient stated she was not able to tell if it was a 0 or O. She stated it was handwritten on there and was not typed. Patient was fully vaccinated for COVID. Patient stated she had the Moderna COVID  vaccines. The reason she went to the emergency room was that she had a couple of auto immune disorders. She got the booster early because she has the auto immune disorders. Now, she has COVID and does not how because, she always masks up everywhere she goes.She stated she was just going to get some lemon drops for her throat, to help.She tested positive and was sick. Treatment information was not provided.  On unknown date in  May-2022: Chest X-ray and lab work was done with results not provided   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in