Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test, Taste disorder
Clinical narrative: Everything taste funny; Confirmed Covid-19 infection; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Confirmed Covid-19 infection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    Concurrent medical conditions included Allergy to antibiotic (Augementin). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for an unknown indication.   On 06-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In 2022, the patient experienced COVID-19 (Confirmed Covid-19 infection) (seriousness criterion medically significant). In July 2022, the patient experienced TASTE DISORDER (Everything taste funny). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-Jul-2022 to 11-Jul-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Confirmed Covid-19 infection) had not resolved and TASTE DISORDER (Everything taste funny), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 11-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 21-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On 22-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         On an unspecified date in 2022, patient had confirmed covid-19 infection with dose number in series 2. Patient was administered Paxlovid for Covid-19 treatment from 06 Jul 2022 to 11 Jul 2022. On an unspecified date in Jul 2022, patient reported everything tasted funny while taking Paxlovid. On 21 Jul 2022, patient felt sick and took home covid test and back to positive again.  Causality for the events of Confirmed Covid-19 infection, confirmed clinical vaccination failure and everything taste funny with Janssen covid-19 vaccine was related  Device date was reported as 22-Jul-2022.  Company Comment: This spontaneous case concerns a 41-year-old female patient, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI Covid19, after receiving a dose of mRNA-1273 (second dose in a Covid19 vaccination schedule).  The patient was treated with Nirmatrelvir/Ritonavir (Paxlovid) for Covid19 around 8 months after mRNA-1273 vaccination.  She reported that everything tasted funny while taking Paxlovid.  Around 10 days after Paxlovid treatment, she felt sick again and tested positive on a home covid test.  Additionally, she previously received 1 dose of Covid19 Janssen as primary dose (interchange of vaccine products/revaccination with different Covid19 vaccine).  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2022: Follow-up received on 18 Aug 2022-Event added, event seriousness updated, concomitant medications and Narrative part updated.; Sender's Comments: This spontaneous case concerns a 41-year-old female patient, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI Covid19, after receiving a dose of mRNA-1273 (second dose in a Covid19 vaccination schedule).  The patient was treated with Nirmatrelvir/Ritonavir (Paxlovid) for Covid19 around 8 months after mRNA-1273 vaccination.  She reported that everything tasted funny while taking Paxlovid.  Around 10 days after Paxlovid treatment, she felt sick again and tested positive on a home covid test.  Additionally, she previously received 1 dose of Covid19 Janssen as primary dose (interchange of vaccine products/revaccination with different Covid19 vaccine).  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.