Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Diagnostic procedure, Diffuse large B-cell lymphoma, Fatigue, Lymphadenopathy
Clinical narrative: large diffuse B-cell lymphoma; swelling of lymph nodes; fatigue; vomiting; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Jun2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised patient" (unspecified if ongoing); "asthmatic" (unspecified if ongoing); "CLL" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2024, outcome "unknown"; DIFFUSE LARGE B-CELL LYMPHOMA (medically significant) with onset 2024, outcome "unknown", described as "large diffuse B-cell lymphoma"; LYMPHADENOPATHY (non-serious) with onset 2024, outcome "unknown", described as "swelling of lymph nodes"; VOMITING (non-serious) with onset 2024, outcome "unknown". The event "large diffuse b-cell lymphoma" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: three matted lymph nodes, notes: tests keep coming back as inconclusive including a biopsy of one of his very swollen lymph nodes but it turned out were three matted lymph nodes upon the biopsy; Diagnostic procedure: inconclusive to confirm diagnosis; Positron emission tomogram: inconclusive for a true lymphoma diagnosis. Clinical course: Caller spouse of the patient stated that, a male- 66 years old who has a "CLL" (Chronic lymphocytic leukemia) that had booster doses of Pfizer COVID-19 Vaccines on 08Jun2024 and 05Sep2024 the new formulation 2024-2025 at (Pharmacy name withheld) reported that after the booster shot her husband experienced swelling of lymph nodes, fatigue and vomiting. Caller stated that her husband's CLL might be transforming and might end up to be treated for large diffuse B-cell lymphoma, her husband had multiple diagnostic tests, these tests were inconclusive to confirm diagnosis and wanted to confirm if her husband's response to covid-19 vaccine might be a factor. Husband was recommended for chemotherapy. Caller also added that they have been getting Pfizer COVID-19 Vaccines ever since and it was their 7th booster, her husband was an immunocompromised patient. Caller would like to know if the vaccine might be contributing to her husband's symptoms because it has been transforming. Caller was seeking help for those who had experienced the same and if there were relevant information regarding her husband's situation/ experienced since her husband was undergoing inclusive diagnostic tests and wanted to figure out why his readings were coming back with these kinds of symptoms before putting her husband to a treatment that he did not need. Reporter stated, "They have been using the Pfizer vaccine (COVID-19 Vaccine), her husband and herself, their 'familians' in general. Recently her husband who was 66 years old and was asthmatic with CLL (Medical history), as he had been taking the boosters (Pfizer COVID-19 Vaccine), including one that he took on June 8th and another one on September, new one just came out, as he was taking these, his lymph node are swelling and she was calling to find out, he was having such strong reactions to the booster that he would need to be in bed and could can be vomiting, too fatigued to function for about 36 hours or so at a time. The reason that reporter was calling was not that they were not expecting those reactions but he had recently been to a doctor and they had him do a booster that just came out and they were concerned that his CLL might be transforming into diffused B-cell lymphoma but his tests keep coming back as inconclusive including a biopsy of one of his very swollen lymph nodes but it turned out were three matted lymph nodes upon the biopsy. Repoter's concern was that because even a PET scan came back was inconclusive for a true lymphoma diagnosis, she was wondering if it was possible that the vaccine and perhaps they were having other calls and they were aware that patients with CLL might be having these kinds of reactions because she did not want her husband to be concerned about being put on chemotherapy, if Pfizer knows something that needs to be part of the evaluation.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256302 same patient/product/events, different dose;