Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: this morning a little bit puffy; then last night I had a plaque on my lip; Blister come up on lip inside mouth; tested positive for COVID; started out with little welts up on my eyes/ Started getting swelling under eyes; This spontaneous case was reported by a patient and describes the occurrence of SKIN PLAQUE (then last night I had a plaque on my lip), LIP SWELLING (this morning a little bit puffy), LIP BLISTER (Blister come up on lip inside mouth), COVID-19 (tested positive for COVID) and URTICARIA (started out with little welts up on my eyes/ Started getting swelling under eyes) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2022 at 9:30 AM, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) 100 milligram three times a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2022, the patient experienced COVID-19 (tested positive for COVID) and URTICARIA (started out with little welts up on my eyes/ Started getting swelling under eyes). On 28-Aug-2022, the patient experienced LIP BLISTER (Blister come up on lip inside mouth). On 29-Aug-2022, the patient experienced SKIN PLAQUE (then last night I had a plaque on my lip). On 30-Aug-2022, the patient experienced LIP SWELLING (this morning a little bit puffy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Taking if needed. At the time of the report, SKIN PLAQUE (then last night I had a plaque on my lip) and COVID-19 (tested positive for COVID) outcome was unknown, LIP SWELLING (this morning a little bit puffy) and LIP BLISTER (Blister come up on lip inside mouth) had resolved and URTICARIA (started out with little welts up on my eyes/ Started getting swelling under eyes) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         Patient Ethnicity reported as Other white. No concomitant medications was reported.  The patient called and said that, if there was something else that need to do or (had incomplete sentence) or meant that, welts on the eyes gone down early up better than it was last night. It was reported that patient took two doses and two booster doses from Moderna. First dose was administered  about 2 years ago, maybe over a year ago, might be less than 2 years ago. Second dose 6 months after first dose. First booster about 6 months after second dose. Second booster over a month ago. Patient had no side effects from vaccine. Patient tested positive for COVID-19 had a sore throat, in the morning about 4:30 throat was sore back of throat swollen a little bit, had mild fever for 2 days. Throat was still irritated but no as bad. Patient stopped taking Paxlovid and does not want to take anymore. Expiry date of Paxlovid was reported as Mar-2023.  Company Comment: This spontaneous case concerns a 63-years-old male patient, with  medical history of Co-suspect product PAXLOVID who experienced the unexpected events of Covid-19 (AESI), lip BLISTER, SKIN PLAQUE, LIP SWELLING and other expected event unknown days after  4th. dose of  mRNA-1273 vaccine. On 25-Aug-2022, SARS-CoV-2 test Positive, had a sore throat, began with Paxlovid but stop it after first doses. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to MOD-2022-637551 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Significant follow up received: Event detail and narrative updated.; Sender's Comments: This spontaneous case concerns a 63-years-old male patient, with  medical history of Co-suspect product PAXLOVID who experienced the unexpected events of Covid-19 (AESI), lip BLISTER, SKIN PLAQUE, LIP SWELLING and other expected event unknown days after  4th. dose of  mRNA-1273 vaccine. On 25-Aug-2022, SARS-CoV-2 test Positive, had a sore throat, began with Paxlovid but stop it after first doses. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.