Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
white thrush in the mouth worsened; irritability; tiredness; chills; nausea; feeling unwell; decreased appetite; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Mar2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; fluticasone propionate (FLUTICASONE PROPIONATE HFA) at 1x/day (unk, 1x/day). The patient's relevant medical history included: "cast" (unspecified if ongoing); "sprained hand" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Mar2025, outcome "unknown"; DECREASED APPETITE (non-serious) with onset Mar2025, outcome "unknown"; MALAISE (non-serious) with onset Mar2025, outcome "unknown", described as "feeling unwell"; IRRITABILITY (non-serious) with onset Mar2025, outcome "unknown"; NAUSEA (non-serious) with onset Mar2025, outcome "unknown"; FATIGUE (non-serious) with onset Mar2025, outcome "unknown", described as "tiredness"; ORAL CANDIDIASIS (non-serious) with onset 29Mar2025, outcome "not recovered", described as "white thrush in the mouth worsened". The action taken for fluticasone propionate was unknown. Additional information: Patient regarding the Pfizer COVID vaccine. After receiving a booster dose, Patient developed a white thrush in the mouth. Patient wanted to know if this was a reported side effect from the vaccine. Patient also mentioned to have experienced chills and tiredness after the injection. A review of the Prescribing Information for Comirnaty did not find information regarding white thrush. As the Prescribing Information did not include all adverse reactions that had been reported or that may occur, asked to consult with healthcare provider about what patient was experiencing. Patient was in a cast, had a sprained hand so phone was on speaker. Patient had the Pfizer booster, patient then clarified the booster was the COVID-19 vaccine mRNA, Pf, Pfizer, 30mcg/0.3mL, IM 91320 CPT(R). Patient received the vaccine on Wednesday, 26Mar2025. Had call handler heard from anyone else if they have gotten thrush in their mouth after getting the booster. Patient had experienced that, later confirmed patient had experienced thrush in mouth, and was asking if that had been a side effect for anyone else other than patient. Another possibility was that patient did take an inhaler, initially provided as Flovent, which could cause thrush, but patient rinses mouth every time takes, every day. Could be possible the COVID vaccine lowered patient immune system and that inhaler caused the thrush. Patient had a bit of a reaction to the COVID vaccine. Inhaler information: Patient clarified the inhaler was a new one, rather than Flonase, patient then corrected and confirmed rather than Flovent, it was fluticasone propionate HFA inhalation aerosol, manufacturer was Prasco. Patient used to have Flovent, may be the generic instead of Flovent. This was the one patient had been taking now for a couple of years, confirmed the fluticasone propionate HFA inhalation aerosol, patient just noticed did not say Flovent on it anymore, there was a label across things, confirmed a pharmacy label, but the fluticasone propionate HFA inhalation aerosol had been for the last four refills. No longer had Flovent to provide any information, but was also was fluticasone. Had thrush in mouth this weekend on 29Mar2025. Indication: On medical records was time for 6th booster. Concomitant products: Just regular medications patient had been taking for years, nothing new that would have caused anything different. Declined to provide additional information, saying there was nothing pertinent. Medical conditions: Patient stated the other side effects patient had from the most recent dose of the COVID vaccine were nausea, feeling unwell, decreased appetite, and irritability. Clarified and confirmed patient was diagnosed with sprained hand the same day as getting the COVID vaccine, was right arm, so got vaccine on left arm. Patient stated had two more symptoms patient remembered after being on hold, after most recent COVID vaccine injection patient also had chills and tiredness. No Investigations reported. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Cast application; Hand sprain
FLUTICASONE PROPIONATE HFA