Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: Rebound of SARS-COV2 Symptoms; sense of dissociation; aggression; insomnia; diarrhea; headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of SARS-COV2 Symptoms), DISSOCIATION (sense of dissociation), AGGRESSION (aggression), INSOMNIA (insomnia) and DIARRHOEA (diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 042B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Chronic depression, Anxiety, Glaucoma and Drug allergy. Concomitant products included BUSPIRONE from 01-Jan-2022 to 21-May-2022, BUPROPION from 01-Jan-2022 to 21-May-2022, DULOXETINE from 01-Jan-2022 to 21-May-2022, VALACYCLOVIR [VALACICLOVIR] from 01-Jan-2022 to 21-May-2022, LATANOPROST from 01-Jan-2022 to 21-May-2022, ESTRADIOL from 01-Jan-2022 to 21-May-2022 and ACETAMINOPHEN from 08-May-2022 to 14-May-2022 for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced DISSOCIATION (sense of dissociation), AGGRESSION (aggression), INSOMNIA (insomnia), DIARRHOEA (diarrhea) and HEADACHE (headaches). On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of SARS-COV2 Symptoms). At the time of the report, COVID-19 (Rebound of SARS-COV2 Symptoms), DISSOCIATION (sense of dissociation), AGGRESSION (aggression), INSOMNIA (insomnia), DIARRHOEA (diarrhea) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that  six days after completing Paxlovid dosing and also while taking Paxlovid and for an additional 2 days, Patient experienced sense of dissociation, aggression, insomnia, headaches, diarrhea.  No treatment medications were reported  Company Comment: This spontaneous case concerns a 62-year-old, female patient with pre-existing chronic depression and anxiety, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred after approximately 7 months after receiving the third dose of mRNA-1273. She was initially treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid), along with intake of Acetaminophen. Six days after completion of treatment, the patient reported rebound of unspecified symptoms and tested positive again to the virus on rapid antigen test. Details on confirmatory testing done, medical consult and intervention administered after were not provided in the case. Non-serious events of Dissociation, Aggression, Insomnia, Diarrhoea and Headache were also reported on an unspecified date, within the same month of vaccination and during treatment with NIRMATRELVIR/RITONAVIR. The age of the patient and the ongoing COVID-19 pandemic remain as confounders for contracting the infection. Treatment with NIRMATRELVIR/RITONAVIR remains a confounder for the other events; while the pre-existing psychiatric conditions could be contributors to the dissociation, aggression and insomnia. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old, female patient with pre-existing chronic depression and anxiety, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred after approximately 7 months after receiving the third dose of mRNA-1273. She was initially treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid), along with intake of Acetaminophen. Six days after completion of treatment, the patient reported rebound of unspecified symptoms and tested positive again to the virus on rapid antigen test. Details on confirmatory testing done, medical consult and intervention administered after were not provided in the case. Non-serious events of Dissociation, Aggression, Insomnia, Diarrhoea and Headache were also reported on an unspecified date, within the same month of vaccination and during treatment with NIRMATRELVIR/RITONAVIR. The age of the patient and the ongoing COVID-19 pandemic remain as confounders for contracting the infection. Treatment with NIRMATRELVIR/RITONAVIR remains a confounder for the other events; while the pre-existing psychiatric conditions could be contributors to the dissociation, aggression and insomnia. The benefit-risk relationship of mRNA-1273 is not affected by this report.