Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Tested positive for covid on 5/10; had symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid on 5/10; had symptoms) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose 1, Batch number EW0151, Location of injection: Left Arm.) on 12-Apr-2021, Pfizer / BioNTech (Dose 2, Batch number EW0173 and Location of injection Left arm) on 03-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Ehlers-Danlos syndrome, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome, Chronic migraine, Autoimmune disorder NOS (l kely autoimmune condition), ADHD, Obsessive-compulsive disorder, Obstructive sleep apnea syndrome and Fruit allergy (Pineapple). Concomitant products included EPTINEZUMAB (VYEPTI [EPTINEZUMAB]) from 17-Dec-2020 to an unknown date, BOTULINUM TOXIN TYPE A (BOTOX) from 23-Aug-2021 to an unknown date and TOPIRAMATE (TROKENDI XR) for an unknown indication.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced COVID-19 (Tested positive for covid on 5/10; had symptoms). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid on 5/10; had symptoms) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient started experiencing symptoms on 09 May 2022, Patient tested positive again and symptoms worsened. Overall symptoms from COVID reported as chest pain, shortness of breath, cough, sneezing, congestion, chills, fever. Paxlovid eliminated chills and fever. Device Date was reported as 24 May 2022  Company comment: This spontaneous case concerns a 27-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 5 months after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Symptoms (chest pain, shortness of breath, cough, sneezing, congestion, chills and fever) started on 9-May and tested positive for COVID 19 on 10-May. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 15-May. Patient tested negative on 16-May. Symptoms recurred 5 days later which worsened after 2 days and again tested positive for COVID 19. Patient received 2 doses of Tozinameran vaccine about 7, and 8 months respectively prior from the last dose (interchange of vaccine products noted).  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 27-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 5 months after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Symptoms (chest pain, shortness of breath, cough, sneezing, congestion, chills and fever) started on 9-May and tested positive for COVID 19 on 10-May. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 15-May. Patient tested negative on 16-May. Symptoms recurred 5 days later which worsened after 2 days and again tested positive for COVID 19. Patient received 2 doses of Tozinameran vaccine about 7, and 8 months respectively prior from the last dose (interchange of vaccine products noted).  The benefit-risk relationship of mRNA-1273 is not affected by this report.