Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of COVID, Woke up this morning, 5/19/22, symptomatic, with congestion and cough.; 2 positive antigen tests today,; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (2 positive antigen tests today,) and COVID-19 (Rebound of COVID, Woke up this morning, 5/19/22, symptomatic, with congestion and cough.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F and 002M21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient medical history included left non-displaced humeral fx in January 2022.  The patient's past medical history included DVT. Concurrent medical conditions included Obstructive sleep apnoea syndrome (OSA), Asthma (mild asthma), Obesity (BMI determined obesity) and Food allergy (cashew, pistachio, hazelnut, pink,peppercorn). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from April 2022 to an unknown date, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL), DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN XR ER) from January 2018 to 06-May-2022 and ALBUTEROL SULFATE for an unknown indication.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 10-May-2022, the patient experienced COVID-19 (2 positive antigen tests today,). On 19-May-2022, the patient experienced COVID-19 (Rebound of COVID, Woke up this morning, 5/19/22, symptomatic, with congestion and cough.). On 14-May-2022, COVID-19 (2 positive antigen tests today,) had resolved. At the time of the report, COVID-19 (Rebound of COVID, Woke up this morning, 5/19/22, symptomatic, with congestion and cough.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 14-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking any other medications/products within 2 weeks of starting Previously receive a COVID-19 Vaccine. Reported Event: Rebound of COVID symptoms. First symptomatic and confirmed COVID positive 5/10/22; prescribed and started Paxlovid evening dose 5/10/22.Tested negative on PCR f/u test 5/14/22; Completed Paxlovid on morning 5/15/22. Negative antigen test on Tuesday 5/17/22. Woke up this morning, 5/19/22,symptomatic, with congestion and cough. 2 positive antigen tests was  today, 5/19/22. COMPANY COMMENT: This is an spontaneous case concerning a 53-years-old male patient with medical history of PAXLOVID from 10 to 15, May, 2022, left non-displaced humeral fx in January 2022, DVT, Obstructive sleep apnoea syndrome, Asthma, Obesity, Food allergy (cashew, pistachio, hazelnut, pink,peppercorn), concomitant products included CETIRIZINE, DEXTROMETHORPHAN, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE, DEXMETHYLPHENIDATE and ALBUTEROL SULFATE for an unknown indication who experienced the unexpected  (AESI) events of COVID-19 (1st episode) and COVID-19 (2nd. Episode) beginning 36 days after  receiving 4th  dose of  mRNA-1273 vaccine. On 10-May-2022, SARS-CoV-2 test: positive; On 14 and 17-May-2022, SARS-CoV-2 test: negative and on 19-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 53-years-old male patient with medical history of PAXLOVID from 10 to 15, May, 2022, left non-displaced humeral fx in January 2022, DVT, Obstructive sleep apnoea syndrome, Asthma, Obesity, Food allergy (cashew, pistachio, hazelnut, pink,peppercorn), concomitant products included CETIRIZINE, DEXTROMETHORPHAN, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE, DEXMETHYLPHENIDATE and ALBUTEROL SULFATE for an unknown indication who experienced the unexpected  (AESI) events of COVID-19 (1st episode) and COVID-19 (2nd. Episode) beginning 36 days after  receiving 4th  dose of  mRNA-1273 vaccine. On 10-May-2022, SARS-CoV-2 test: positive; On 14 and 17-May-2022, SARS-CoV-2 test: negative and on 19-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.