Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, SARS-CoV-2 test, Taste disorder, Thrombosis
Clinical narrative: Blood clots; she also had terrible diarrhea and that began before the 2nd dose for the taste and terrible diarrhea/Paxlovid is the worst thing and was more God awful than covid and made her have the most horrible taste in her mouth; she also had terrible diarrhea and that began before the 2nd dose for the taste and terrible diarrhea.; Paxlovid Rebound; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 012M20A and D37E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 and DEXLANSOPRAZOLE for Reflux esophagitis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Reflux gastritis (Reflux), Thyroid disorder NOS (Did not know whether it was low or high thyroid, but it was for her thyroid.), Blood cholesterol abnormal (Cholesterol), Fibromyalgia and Clot blood (Blood clots). Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal, APIXABAN (ELIQUIS) for Clot blood, DULOXETINE HCL for Fibromyalgia, LEVOTHYROXINE for Thyroid disorder NOS, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, 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 started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 150mg times two 100mg pack (two in each pack) and DEXLANSOPRAZOLE (unknown route) 60 milligram once a day. On an unknown date, DEXLANSOPRAZOLE (unknown route) dosage was changed to 60 milligram. On 18-Aug-2024,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Paxlovid Rebound). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant), TASTE DISORDER (she also had terrible diarrhea and that began before the 2nd dose for the taste and terrible diarrhea/Paxlovid is the worst thing and was more God awful than covid and made her have the most horrible taste in her mouth) and DIARRHOEA (she also had terrible diarrhea and that began before the 2nd dose for the taste and terrible diarrhea.). At the time of the report, THROMBOSIS (Blood clots), COVID-19 (Paxlovid Rebound), TASTE DISORDER (she also had terrible diarrhea and that began before the 2nd dose for the taste and terrible diarrhea/Paxlovid is the worst thing and was more God awful than covid and made her have the most horrible taste in her mouth) and DIARRHOEA (she also had terrible diarrhea and that began before the 2nd dose for the taste and terrible diarrhea.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2024, SARS-CoV-2 test: Positive and Negative. On an unknown date, SARS-CoV-2 test: Negative and Positive.   The patient was calling about Paxlovid and she guessed that might be 2 to 2.5 weeks ago (which she was not sure), her husband contracted Covid. A couple days later, the patient tested negative and waited for 2 days and tested negative again and thought that she was alright. Then she got it and both of them lived with it. Patient stated that both she and her husband developed something called Paxlovid rebound or Covid rebound and the patient tested positive again and the patient had got it back again, so now it was recommended by the health department and the physician to call that in. The patient stated that she was still testing negative. Bothe the patient and the patient's husband were tested positive from the original. The HCP was a specialist of the kidney and the patient had two primary care physicians. The patient tested positive for Covid and they were all doing so many things, so she was not sure of the date of that but clarified on her calendar that she tested positive on 18-Aug-2024 and had symptoms the day or so before that but was still testing negative until 18-Aug-2024; she had a terrible headache, fever and sore throat but did not test positive until the next day after the symptoms began. Patient stated that the Paxlovid was the worst thing and was more awful than Covid and made her have the most horrible taste in her mouth and everybody said not to take it unless they had to, and the physician said that they needed to take it. Patient stated that the taste she experienced began after several hours of taking the Paxlovid and she also had terrible diarrhea and that experience began before the second dose for the taste and terrible diarrhea. She thought that she threw Paxlovid away and she had no lot number, expiry date or NDC to provide for it.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with a history of blood cholesterol abnormal, COVID-19, Thyroid disorder, Reflux esophagitis and Fibromyalgia, who experienced the serious (due to medically significant) unexpected, AESI event of thrombosis, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Patient received 3 doses of mRNA-1273 vaccine. It was reported that she took Dexlansoprazole 60mg for reflux and stopped that one but started it when she had Covid the first time and she got blood clots from it. She did not know if the blood clots were from the shots she had or the other thing. She took Eliquis 5mg twice a day for the blood clots. The outcome of the event was reported as unknown. Patient also experienced non-serious event of COVID-19 rebound approximately 3 years after 3rd vaccination with mRNA-1273 vaccine, was treated with Paxlovid, and experienced non-serious events of taste disorder and diarrhoea. Non-serious events of taste disorder and diarrhoea were assessed as not related due to alternative explanation (began after taking Paxlovid), and too long latency (approximately 3 years after third dose of mRNA-1273 vaccine). The mentioned medical history of blood cholesterol abnormal and COVID-19 remains as a confounder for event thrombosis. Paxlovid was considered as a co -suspect product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.