Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (had 2 Moderna doses and 2 boosters, got Covid, had symptoms /Covid-19/resurgence of Covid-19/Chills/Cough/Muscle aches/Headache/Diarrhea/Nasal congestion/runny nose) and EXPIRED PRODUCT ADMINISTERED (did get an expired dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 041C21A, 028L20A and 039K202A) for COVID-19 vaccination. The patient's past medical history included Headache from 23-Dec-2020 to 24-Dec-2020 and Cold symptoms from 23-Dec-2020 to 24-Dec-2020. Concurrent medical conditions included Allergy to molds, Grass allergy and Allergy to animal (Household pets). On 23-Dec-2020 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had 2 Moderna doses and 2 boosters, got Covid, had symptoms /Covid-19/resurgence of Covid-19/Chills/Cough/Muscle aches/Headache/Diarrhea/Nasal congestion/runny nose). On unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (did get an expired dose). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (had 2 Moderna doses and 2 boosters, got Covid, had symptoms /Covid-19/resurgence of Covid-19/Chills/Cough/Muscle aches/Headache/Diarrhea/Nasal congestion/runny nose) was resolving and EXPIRED PRODUCT ADMINISTERED (did get an expired dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-2 test: positive (Positive) Both nasopharyngeal and saliva, Rapid antigen test- Positive. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Nasopharyngeal, RT-PCR test- Positive. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Both nasopharyngeal and saliva, Rapid antigen test- Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. 0n an unknown date in 2022 at 10:15 AM, Patient received 4th dose of vaccine. The vaccine had expired the midnight before patient got it. Patient got COVID-19 and took Paxlovid as per physicians prescription, for 5 days, patient had terrible foul taste in mouth. Patient even lost weight due to gross taste. After 10 day of taking Paxlovid, felt much better. After that at work, patient get a cold and felt like patient was getting sick again. Patient took PCR test and was positive and took antigen test to confirm and it was also positive.  Patient reported Paxlovid 100 percent caused resurgence of COVID-19 and same thing happened with her husband. It was reported that patient had chills for 1 day, cough for 20 days which was still ongoing, muscle aches and Diarrhea for 2 days, headache for 3 days, and Nasal congestion/ runny nose for 10 days. Company comment: This spontaneous case concerns a female patient of unspecified age with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the fourth dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 However SARS-CoV-2 test was positive on 2-May-2022 (Both nasopharyngeal and saliva, Rapid antigen test- Positive) and on 17-May-2022 (Both nasopharyngeal and saliva, Rapid antigen test- Positive). Ongoing Covid-19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the fourth dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 However SARS-CoV-2 test was positive on 2-May-2022 (Both nasopharyngeal and saliva, Rapid antigen test- Positive) and on 17-May-2022 (Both nasopharyngeal and saliva, Rapid antigen test- Positive). Ongoing Covid-19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.