Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cataract, SARS-CoV-2 test
Clinical narrative: undergo cataract surgery; This is a spontaneous report received from contactable reporter(s) (Physician).  A 68-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lymph node was removed", start date: Mar2020 (unspecified if ongoing), notes: In Mar2020, the lymph node was removed and I was diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma; "chronic lymphocytic leukemia/small lymphocytic lymphoma", start date: Mar2020 (unspecified if ongoing); "chronic lymphocytic leukemia/small lymphocytic lymphoma", start date: Mar2020 (unspecified if ongoing), notes: In Mar2020, the lymph node was removed and I was diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma; "I underwent 28 radiation treatments" (unspecified if ongoing). The patient's family history included: "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER taken for type 2 diabetes mellitus (ongoing); JANUVIA taken for type 2 diabetes mellitus (ongoing). Vaccination history included: Pneumonia vaccine booster (In Jan2020, I had a pneumonia vaccine booster and the next morning awoke with an enlarged lymph node the size of a squashed golf ball in my left armpit.), administration date: Jan2020, for Immunization, reaction(s): "enlarged lymph node"; Bnt162b2 (Dose 1), administration date: Jan2021, for Covid-19 immunization, reaction(s): "I did another Covid test and this time it was", "I did another Covid test and this time it was"; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 immunization, reaction(s): "I did another Covid test and this time it was", "I did another Covid test and this time it was"; Bnt162b2 (Booster Dose (Dose 3)), administration date: Aug2021, for Covid-19 immunization, reaction(s): "I did another Covid test and this time it was", "I did another Covid test and this time it was". The following information was reported: CATARACT (medically significant) with onset Apr2022, outcome "unknown", described as "undergo cataract surgery". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Normal; SARS-CoV-2 test: (unspecified date) Positive; (20Apr2022) Negative.  Clinical course: Reporter was forwarding a case of a patient who took a course of PAXLOVID for a recent COIVID infection. The patient was reporter neighbor and he shared his experience with reporter. Please note: he wanted to convey his positive experience with PAXLOVID, specifically and to express his gratitude to the company, however, he experienced some adverse reactions with exposure to PAXLOVID, including diarrhea and a burning sensation (NOS); taste perturbation, specifically metallic taste (verbatim); phlegm; and cough. Please see his account below. He also included his Physician's name (prescriber of PAXLOVID). As we discussed, below was a description of patient's recent experience with Paxlovid. Patient would like to share with you his recent excellent experience with Paxlovid. It was truly a remarkable treatment. Patient worked in the pharmaceutical industry in clinical research and regulatory affairs, including as a consultant, during his career for 34 years. He retired several years ago. His background medical history was that he was 68 years of age, had Type 2 diabetes mellitus taking Metformin ER - 2 x 500 mg tablets twice a day and Januvia 100 mg daily. In Jan2020, he had a pneumonia vaccine booster and the next morning awoke with an enlarged lymph node the size of a squashed golf ball in his left armpit. In Mar2020, the lymph node was removed and he was diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma. He underwent 28 radiation treatments to the axilla and sub pectoral areas and had 4 treatments with Rituxan. He was doing well with no recurrence of enlarged lymph nodes. His blood tests had been normal. He underwent immunization with the Pfizer Covid vaccines in Jan and Feb2021, and boosters with Pfizer vaccines in Aug2021 and Feb2022. On Sunday, 17Apr, his wife and he attend a holiday with neighbors. Also attending were their son, daughter-in-law and two grandsons. On Monday, 18Apr, our neighbor notified us that their son and daughter-in-law tested positive for Covid-19. In the afternoon on Tuesday, 19Apr, he experienced a slight frontal headache and sore throat for about an hour each. The next morning (Wednesday) he did a rapid Covid test because he was scheduled to undergo cataract surgery the next day on Thursday. The test was negative. His wife and he hosted our community gathering Wednesday evening with 35 people in attendance including the wife of the neighbors whose holiday we attended on Sunday. He hosted and interacted with most of the people. In addition to hosting, we worked very hard serving the dinner and cleaning up afterwards. During our drive home, he started feeling very tired and thought it was a result of the work done during the visit. he did another Covid test and this time it was positive. He notified the patient about the test result and his surgery was cancelled. The next morning (Thursday), his condition deteriorated very rapidly. He was amazed at how rapidly his condition went from bad to worse. he experienced very heavy sinus and chest congestion, chest/back pain near the lower left shoulder blade and a very productive cough with dark green phlegm. There was no headache, sore throat or fever. he felt terrible. he contacted his physician, and described his condition. He prescribed Paxlovid, benzonatate and albuterol inhaler. he took the first Paxlovid dose in the afternoon on Thursday, 21Apr. he experienced a strong metallic taste. The metallic taste occurred approximately 1. 5 hours after each dose and lasted for about 7 hours. he tolerated the medication very well. he began to feel better Friday afternoon. he experienced diarrhea with a burning sensation starting on Day 3 of Paxlovid. This persisted for a week. The phlegm became clear before the last dose which was taken Tuesday morning, 26Apr. The coughing persisted for a few days after the last dose. he tested negative for Covid on Wednesday, 27Apr. he strongly believe that if he was not prescribed Paxlovid, he would had been hospitalized and possibly placed on a respirator. he feel very lucky that he was immunized with the Pfizer Covid vaccines and treated with Paxlovid. Thank you for your efforts advocating vaccination and Covid treatments.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.