Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-1 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid-19) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A21A, 003A21A and 013A21A) for COVID-19 prophylaxis. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. The patient's past medical history included Sinus infection and Hypercholesterolaemia. Concomitant products included ATORVASTATIN for Hypercholesterolaemia. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In April 2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On 13-Jul-2022, the patient experienced COVID-19 (tested positive for covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-Jul-2022 to 17-Jul-2022 for COVID-19 treatment, at a dose of Three tablets twice a day by mouth. At the time of the report, COVID-19 (tested positive for covid-19) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2022, SARS-CoV-1 test: (Positive) He was first diagnosed with COVID. On 27-Jul-2022, SARS-CoV-1 test: (Positive) Positive. On 31-Jul-2022, SARS-CoV-1 test: (Negative) Negative. It was reported that during the time he took Paxlovid, he had mild symptoms described as a funny taste in his mouth and he did have rebound Covid where he lost his sense of smell and taste. He had symptoms of COVID on 12-Jul-2022, he started taking Paxlovid on 13-July-2022, around 4 PM in the afternoon. Funky taste started the first day, he described it as soapy grapefruit, but more in the back of his mouth, it permeates through his sinuses in back of his mouth. He could not get rid of it with water or food. It was all the time, it was intermittent. It was reported that patient had a brain fog when attempting to remember dates for when he resumed statin intake. Company Comment: This spontaneous case concerns of a 63-year-old, male patient with a body mass index (BMI) of 32, who experienced an unexpected, non-serious AESI COVID-19 approximately 7 months after receiving a booster dose of mRNA-1273 vaccine. His symptoms started 216 days after receiving a booster dose, followed by a positive COVID-19 test and Paxlovid treatment the next day. He noted loss of taste and smell approximately 3 days after treatment.  Patient tested positive with COVID-19 for a 2nd time 10 days after completing Paxlovid. On the 14th day post Paxlovid treatment, patient tested negative with COVID-19. Patient's sense of smell and taste came back on an unspecified date. Relevant medical history included hypercholesterolaemia. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart, followed by a booster dose of mRNA-1273 vaccine and a dose of Pfizer's COVID-19 vaccine. Patient's high BMI and an underlying hypercholesterolaemia could be considered predisposing risk factors to COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow up received contains - Quality Complaint No. added; Sender's Comments: This spontaneous case concerns of a 63-year-old, male patient with a body mass index (BMI) of 32, who experienced an unexpected, non-serious AESI COVID-19 approximately 7 months after receiving a booster dose of mRNA-1273 vaccine. His symptoms started 216 days after receiving a booster dose, followed by a positive COVID-19 test and Paxlovid treatment the next day. He noted loss of taste and smell approximately 3 days after treatment. Patient tested positive with COVID-19 for a 2nd time 10 days after completing Paxlovid. On the 14th day post Paxlovid treatment, patient tested negative with COVID-19. Patient's sense of smell and taste came back on an unspecified date. Relevant medical history included hypercholesterolaemia. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart, followed by a booster dose of mRNA-1273 vaccine and a dose of Pfizer's COVID-19 vaccine. Patient's high BMI and an underlying hypercholesterolaemia could be considered predisposing risk factors to COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.