Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a salivary gland disorder; Sinus issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. Past drug history included: Botox injections, notes: Had the day before she had the vaccine but, has been having those for years. The following information was reported: SALIVARY GLAND DISORDER (non-serious) with onset 14Oct2024, outcome "not recovered", described as "Has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a salivary gland disorder"; SINUS DISORDER (non-serious) with onset 14Oct2024, outcome "not recovered", described as "Sinus issues". The events "has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a salivary gland disorder" and "sinus issues" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of salivary gland disorder. Therapeutic measures were not taken as a result of sinus disorder. Additional Context: Reporter not sure of exact name but, calling regarding Covid vaccine she had in Oct2024. Further clarified, referring to Pfizer Covid vaccine. Has been experiencing symptoms since the week after getting the vaccine. None of her physicians have been able to diagnose what it is and what it isn't. They are aware she had vaccine, just spoke to CDC, filed report, wanted to report through Pfizer as well. When clarifying symptoms that caller has been experiencing, she states, she has been diagnosed with having a salivary gland disorder. Had Covid vaccine 08Oct2024, the symptoms began after 7 days. Clarified, the specific symptoms she experienced, that lead to being diagnosed with having a salivary gland disorder, are xerostomia and hypersalivation, which is excess salivation, even though, xerostomia means dry mouth. Xerostomia, Hypersalivation: Outcome of events: Have stayed the same, 24/7, with no change. Treatment: No, they don't have any treatment for her. They have given her a few medications not tolerable, did not help in any way. Further clarified, was just that one dose Covid vaccine, which she had on 08Oct2024. Has other medical conditions. Had Botox injections the day before she had the vaccine but, has been having those for years. Test results: Has had extensive testing, lab tests, CT scan, ultrasound. Drove 8 hours to (redacted), to see specialist, a salivary gland expert. Was something they cannot diagnose or, what is causing the problem. They have no way to prove diagnosis of anything. Clarified, she is referring to diagnosis of salivary gland disorder. It just started over night, was not slow or progressive. One night she was fine then, next day, had this problem. Did have regular flu shot. When clarifying if same date as Covid vaccine, 08Oct2024, caller states, she is not 100 percent sure, thinks it might have been. She knew they were not combined, was 2 separate injections. No AE required a visit to the Emergency Room. AE require a visit to a Physician's Office? Has seen many doctors and specialists, Nurse Practitioners, pulmonologist; cannot even keep track. Not allergic to any previous vaccination, medications, food or other products. Patient had sinus issues started same day as the salivary symptoms. she is still experiencing now, coincide with the other conditions, also has it 24/7. Has no previous history of sinus problems. Outcome of event: Has stayed about the same. Treatment: No prescription medicines. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
FLU VACCINE VII
Test Name: CT scan; Result Unstructured Data: Test Result:Was something they can not diagnose or; Comments: what is causing the problem. They have no way to prove diagnosis of anything. Clarified, she is referring to diagnosis of salivary gland disorder.; Test Name: ultrasound; Result Unstructured Data: Test Result:Was something they can not diagnose or; Comments: what is causing the problem. They have no way to prove diagnosis of anything. Clarified, she is referring to diagnosis of salivary gland disorder.