Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Moderna Covid Vaccine: Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Moderna Covid Vaccine: Covid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Epilepsy (mild) since October 2016 and Thyroid disorder NOS. Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Epilepsy, PARACETAMOL (TYLENOL) for Sore throat, LEVOTHYROXINE for Thyroid disorder NOS.   On 05-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) three pills twice a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Moderna Covid Vaccine: Covid). At the time of the report, COVID-19 (Moderna Covid Vaccine: Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On 08-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient probably had Covid before 04 Jul 2022, but she tested positive on 04 Jul 2022. On Sunday, she had the same symptoms and thought she had the flu. Then Monday, 04 Jul 2022, tested positive. Patient  did not know how many days had that before the fourth. Patient friend told about Paxlovid, so caller called doctor and doctor prescribed Paxlovid. Caller had to take morning pills. After that morning, patient had two more days of Paxlovid. Patient started that at nighttime. Patient had not taken morning pills yet. Caller talked to neurologist who told to take Paxlovid while on Keppra. The neurologist said to continue Keppra. The patient had seizures but been under doctor care. The other thing that patient had a horrible sore throat during that time. The doctor said patient could take Tylenol to relieve the sore throat, so patient was been on Tylenol. Patient had three boosters. She had 2 Covid vaccines and then all 3 boosters. Patient was totally vaccinated. Caller clarified that caller tested positive for Covid on 08 Jul 2022, at home again. Caller clarified that her Covid vaccines and boosters were Moderna. Patient was healthy and had no tolerance for being sick.No treatment medication was reported.  Company Comment: This spontaneous case concerns a 66 year old female patient with no relevant medical history reported , with reported  co-suspect non-company product  NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19,  who experienced Non-serious , unexpected , AESI of Covid 19 which occurred on an unknown date  post vaccination with a dose of mRNA-1273 vaccine. This patient reported  that   she had a horrible sore throat  . She was advised by her doctor to take Tylenol to relieve the sore throat, so she has been on Tylenol . She had 2 Covid vaccines and then all 3 boosters which were all Moderna as she reported.  She was  totally vaccinated. She wondered why she got this. She tested positive for Covid 19 test using a home kit on July 4  and took  Paxlovid  and  later on 8-07-2022 ( on the 4th day of Paxlovid treatment  )   she tested positive again using the home kit test. Outcome of the event was unknown. The age of this patient  and  the ongoing Covid 19 pandemic are considered as confounders for the event Covid 19 . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66 year old female patient with no relevant medical history reported , with reported  co-suspect non-company product  NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19,  who experienced Non-serious , unexpected , AESI of Covid 19 which occurred on an unknown date  post vaccination with a dose of mRNA-1273 vaccine. This patient reported  that   she had a horrible sore throat  . She was advised by her doctor to take Tylenol to relieve the sore throat, so she has been on Tylenol . She had 2 Covid vaccines and then all 3 boosters which were all Moderna as she reported.  She was  totally vaccinated. She wondered why she got this. She tested positive for Covid 19 test using a home kit on July 4  and took  Paxlovid  and  later on 8-07-2022 ( on the 4th day of Paxlovid treatment  )   she tested positive again using the home kit test. Outcome of the event was unknown. The age of this patient  and  the ongoing Covid 19 pandemic are considered as confounders for the event Covid 19 . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.