Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, X-ray
Clinical narrative: she tested positive for COVID; she tested positive for COVID; 4th dose got Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694, Expiration Date: Jun2023) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rare bone disease / Very rare genetic disease" (unspecified if ongoing), notes: can't process calcium, 5 DEXA scans: severe progression of what they thought was osteoporosis; "bone break last year / shoulder shattered" (unspecified if ongoing), notes: tripped over duvet and hit elbow but radiated up to shoulder and shoulder shattered; "pneumonia", start date: 2001 (unspecified if ongoing), notes: "twenty years ago when I had it done, after getting over the pneumonia, I had 1.5 times lung capacity"; "HPP" (unspecified if ongoing), notes: does not produce the alphaphosphatase enzyme; "impacted lungs" (unspecified if ongoing), notes: I had impacted lungs due to bronchitis; "bronchitis", start date: Jun2001, stop date: Sep2001, notes: viral bronchitis, lasted 4 months, Tetracyclines cleared it; "allergic to most families of antibiotics" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] taken for hypophosphatasia; STRENSIQ taken for hypophosphatasia. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022, outcome "unknown", described as "4th dose got Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "unknown" and all described as "she tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: first symptom onset; (21Sep2022) Positive, notes: first positive test; (01Oct2022) Positive, notes: still testing positive; X-ray: (unspecified date) lungs were clear. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Clinical course: After getting the last dose from Pfizer, patient tested positive for COVID. Her first positive test was 21Sep2022. She was exposed on 15Sep2022. She was at an event with a lot of people, and she was unmasked. She didn't have any side effects to the vaccines. She was just trying to get over COVID. She was continuing to quarantine. She has quarantined since 18Sep2022. She was concerned, as she was exposed to covid the day after having had her Bivalent vaccine dose, stated "'50-ish year' high school reunion... 16Sep2022 and 17Sep2022 was the exposure" and described it was a "super spreader event". She asked, if the Covid vaccine will be able to provide any protection. Patient was given with Paxlovid 21Sep2022 as treatment for the events. It was reported that the patient has a rare bone disease. It as a genetic disease. She has never been immunocompromised and has rarely got the flu.   Investigation results: For Compound BNT 162 Covid- 19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Adult 10 X 2.25 ml multidose; Lot-# (CR): GH9694. Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.