Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive) 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 nos. 027l21a and 047c21a) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination.    The patient's past medical history included Migraine, Factor II mutation (Prothrombin G2), Hidradenitis suppurativa (being treated with Remicade), Postural orthostatic tachycardia syndrome and Polycystic ovarian syndrome. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: Unknown. Obscured bybother product labelling Location of injection: Arm Left) on 15-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: ew0150 Location of injection: Arm Left) on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma and Environmental allergy.   On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, received fourth 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) at an unspecified dose. On 12-May-2022, the patient experienced COVID-19 (Covid-19 positive). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Covid-19 positive) 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 12-May-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: positive (Positive) positive and negative (Negative) negative.         No concomitant medication information provided.  About 6 days later patient woke up sick with a positive test.Before waking up sick the night before patient noticed leg pain and some congestion. Patient woke up sick with a runny nose, congestion, sore throat, body aches,breathlessness, and some fatigue. Patient believed that Change of taste caused by  paxlovid. The previous symptoms were when patient first tested positive were body aches, cough, scratchy throat, low fever, fatigue, breathlessness, and experienced diarrhea.  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 (Today is my first day being positive "again".) approximately 3 months after administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. It was reported that the patient took Paxlovid and was negative within 5 days. About 6 days later patient woke up with symptoms of runny nose, congestion, sore throat, body aches, breathlessness, and some fatigue and again tested positive for COVID 19. Further details regarding investigations, and treatment are not available. Patient received 2 doses of comirnaty COVID 19 vaccine and 1 dose of mRNA-1273 vaccine 11, 10 and 5 months respectively prior to the last dose (interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Non Significant Followreceived. No new pertinent information was added; 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 (Today is my first day being positive "again".) approximately 3 months after administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. It was reported that the patient took Paxlovid and was negative within 5 days. About 6 days later patient woke up with symptoms of runny nose, congestion, sore throat, body aches, breathlessness, and some fatigue and again tested positive for COVID 19. Further details regarding investigations, and treatment are not available. Patient received 2 doses of comirnaty COVID 19 vaccine and 1 dose of mRNA-1273 vaccine 11, 10 and 5 months respectively prior to the last dose (interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report.