Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: resolution of symptoms on 5/13 and negative test; Retested and came back positive 5/18; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (resolution of symptoms on 5/13 and negative test) and COVID-19 (Retested and came back positive 5/18) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose no 2, batch no EN6201 and Location Left arm.) on 14-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech. Concurrent medical conditions included Fruit allergy (assorted). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and LEVOTHYROXINE for an unknown indication.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Retested and came back positive 5/18). On an unknown date, the patient experienced COVID-19 (resolution of symptoms on 5/13 and negative test). On 13-May-2022, COVID-19 (resolution of symptoms on 5/13 and negative test) had resolved. At the time of the report, COVID-19 (Retested and came back positive 5/18) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-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.   It was reported that the patient had dysgeusia within hours of taking paxlovid.   It was also stated that symptoms resolved on 13-May and tested negative. She stopped taking paxlovid on day 4, did not finish course. Rebound symptoms of coughing and congestion started on 17-May. She was retested and came back positive on 18-May.  No treatment information was reported.  company comment This spontaneous case reported by a pharmacist, concerns a 35 year old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of covid 19 Infection unknown days, after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received a dose with Pfizer vaccine about 6 months ago. Interchange of vaccine products was seen. Patient was treated with PAXLOVID from for 4 days from 10-May-2022 to 13-May-2022, for COVID-19 Infection. On 13-May-2022, SARS-CoV-2 test was negative. It was reported that the patient had dysgeusia within hours of taking paxlovid and was also stated that symptoms resolved on 13-May and tested negative. She stopped taking paxlovid on day 4, did not finish course. Rebound symptoms of coughing and congestion started after 4 days on 17-May. She was retested and came back positive on 18-May and was reported with an unexpected,  non serious event of COVID-19 (Retested and came back positive 5/18). Ongoing Covid 19 pandemia and incomplete course of Paxlovid treatment could be considered as confounders to the events. The first episode had resolved and the outcome of the second episode was unknown. 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 reported by a pharmacist, concerns a 35 year old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of covid 19 Infection unknown days, after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received a dose with Pfizer vaccine about 6 months ago. Interchange of vaccine products was seen. Patient was treated with PAXLOVID from for 4 days from 10-May-2022 to 13-May-2022, for COVID-19 Infection. On 13-May-2022, SARS-CoV-2 test was negative. It was reported that the patient had dysgeusia within hours of taking paxlovid and was also stated that symptoms resolved on 13-May and tested negative. She stopped taking paxlovid on day 4, did not finish course. Rebound symptoms of coughing and congestion started after 4 days on 17-May. She was retested and came back positive on 18-May and was reported with an unexpected,  non serious event of COVID-19 (Retested and came back positive 5/18). Ongoing Covid 19 pandemia and incomplete course of Paxlovid treatment could be considered as confounders to the events. The first episode had resolved and the outcome of the second episode was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.