Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Lung carcinoma cell type unspecified stage IV, SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: Hoarse voice; His weight has dropped; Stage 4 lung cancer; This is a spontaneous report from a contactable consumer or other non HCP (patient himself).  A 84-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration, administered in arm right on 25Oct2021 09:00 (Batch/Lot Number: FH8020) (age at vaccination 84 years) as dose 3 (booster), single for COVID-19 immunization. Additional vaccines administered on same date of the pfizer suspect: None. Medical history included ongoing lung cancer stage IV and he has never smoked. Family medical history included Stroke (Mother), Heart attack (father), Cancer (One of 9 children, doesn't think at this point he needs to get into all of that: different cancers). Concomitant medications included metoprolol, solifenacin, simvastatin, clopidogrel all taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration, administered in arm right on 24Mar2021 (Batch/Lot Number: ER8730) (age at vaccination 83 years) as dose 1, single and via an unspecified route of administration administered in arm right on 14Apr2021 (Batch/Lot Number: ER8731) (age at vaccination 83 years) as dose 2, single both doses for COVID-19 immunization and experienced sore throat after dose 2. Prior Vaccinations within 4 weeks was reported as none. AE(s) following prior vaccinations was none. He stated he did just fine with the other ones. On an unspecified date in 2021, patient experienced stage 4 lung cancer. On 25Oct2021 11:00, he experienced hoarse voice. On 25Oct2021, he experienced his weight has dropped. It was reported that he received his booster dose of the Pfizer vaccine this morning on 25Oct2021 @ 0900. At 1100 today on 25Oct2021 he noticed himself having a hoarse voice when talking and he wanted to know if it was going to go away in a day or a week or whatever. He reported to the agent that it has 50% improved and now getting better. He wanted to know if this could be a side effect from the vaccine. He was also recently diagnosed with stage 4 lung cancer although he has never smoked. He was unsure if this may have anything to do with it as well. He noted that now he was 80% better from 11:00 today on 25Oct2021. He wanted to confirm that his symptoms could be a possible side effect. Unsure if we may have any other consumers who may have had the same effect from the booster dose as what he was having currently. He has looked online and saw that his symptom may be a symptom to having COVID. He felt it was important for him to call and report this. He noted that you were now able to hear him when he speaks. Response received included a review of the Prescribing Information for <Pfizer COVID 19 Vaccine> did not find information regarding [hoarseness]. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. Pfizer cannot assess causality (i.e. cannot assess if what you described/are experiencing is associated with the <Pfizer COVID 19 Vaccine>). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. He stated he had second dose in April, so it was 6 Months later. He stated as he was talking, he noticed his voice was getting stronger, maybe it was just something temporary. He stated he was a little concerned because one of the symptoms of Covid 19 was a sore throat. He stated he would say it was 40-50% better now. He thinks by the end of the day it will be alright. Seriousness of the event Lung cancer stage IV was medically significant and other events was non serious. Adverse events did not result in physician office visit or Emergency room visit. The patient underwent lab tests and procedures which included COVID tests: negative, weight: dropped (he used to weigh 184) on an unspecified date in 2021. The patient did not receive any treatment for the adverse events his weight has dropped and hoarse voice. Relevant tests were none. The outcome of the event stage 4 lung cancer was not recovered, and other events was recovering.