Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; Moderna COVID vaccine [Dose: 3, Dose: 4 & Dose: 5] / Pfizer COVID vaccine [Dose: 1 & Dose: 2]; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old female patient received bnt162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EKS783), in left deltoid and on 07Feb2021 as dose 2, single (Lot number: EN5318) at the age of 54 years, in left deltoid, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: which is not severe; "atrial fibrillation with episode of RVR", start date: 03Jan2020 (unspecified if ongoing), notes: Very well controlled, exists, but hasn't any sustained bouts or RVR; "Sleep apnea", start date: Mar2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Nov2021, outcome "unknown", described as "Moderna COVID vaccine [Dose: 3, Dose: 4 & Dose: 5] / Pfizer COVID vaccine [Dose: 1 & Dose: 2]"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Aug2023, outcome "not recovered" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) probably 33; SARS-CoV-2 test: (19Aug2023) positive, notes: Caller tested positive for Covid on 19Aug2023; (28Oct2023) positive, notes: Tested positive this Saturday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported as, Sleep apnea is weight related, the patient stated yo-yos, clarifying when the patient was thin has no sleep apnea, when the patient is obese has sleep apnea, The patient stated obese at this time so has sleep apnea. The patient tested positive for Covid on 19Aug2023, and finished course of Paxlovid 24Aug2023. Now the patient is 2.5 months out and has had a new exposure, the patient did mention this is not a rebound. Tested positive this Saturday, however day 0 was on Friday. Then had a new exposure, exposure date was most likely 24Oct2023 or 25Oct2023, day 0 when the patient started having symptoms was 27Oct2023 and tested positive 28Oct2023. The patient was looking for information on retreatment which the agent assisted the patient with. The patient stated has not had the new 2023 omicron booster yet, clarified the patient had the others before that, clarified the patient has had every other dose that the patient should have had. Has had a mixture of the Moderna COVID vaccine and Pfizer COVID vaccine. Clarified has had 5 total doses. Provided product information from vaccination card. 1st dose: Time: During the day, maybe midday. 2nd dose: Time: During the day. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Interchange of vaccine products, drug ineffective and COVID-19 cannot be ruled out.