Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: He developed a small area of necrosis on the left temporal artery; and it felt like he could not hear; Caller states his temporal arteries were engorged, sensitive to touch; His blood pressure elevated to 170/95; He had the sensation of gauze or cotton in his ear; concerned he may be developing temporal arteritis; He woke up with a splitting headache; his temporal arteries were engorged, sensitive to touch; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised", start date: 1990 (ongoing), notes: Exposed to blood from a patient with HIV, and he turned positive for HIV, since the 1990s.; "Coronary artery disease", start date: 1990 (ongoing), notes: He had a history of coronary artery disease, and has 4 stents in his heart.; "Hyperlipidemia", start date: 1990 (ongoing); "Exposed to blood from a patient with HIV", start date: 1990 (unspecified if ongoing), notes: he turned positive for HIV, since the 1990s. Diagnosed HIV, but was currently undetectable.; "Caller states he has a history of coronary artery disease, and has 4 stents in his heart." (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot Number/Expiry Date: EN6202/unknown, Anatomical Location: left arm), administration date: 28Feb2021, when the patient was 69-year-old, for Covid-19 Immunization, reaction(s): "No"; BNT162b2 (Dose 2, single, Lot Number/ Expiry Date: Caller states as an E or L N6206, probably an E. Route, Anatomical Location: left arm), administration date: 21Mar2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "No"; BNT162b2 (Dose 3 (Booster), single, Lot Number/Expiry Date: EW0173/unknown, Route, Anatomical Location: left arm), administration date: 31Aug2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "No". The following information was reported: ARTERIAL DISORDER (medically significant) with onset 14Apr2022, outcome "not recovered", described as "Caller states his temporal arteries were engorged, sensitive to touch"; EAR DISCOMFORT (medically significant) with onset 14Apr2022, outcome "recovering", described as "He had the sensation of gauze or cotton in his ear"; CLUSTER HEADACHE (medically significant) with onset 14Apr2022, outcome "recovering", described as "He woke up with a splitting headache"; BLOOD PRESSURE INCREASED (medically significant) with onset 14Apr2022, outcome "recovering", described as "His blood pressure elevated to 170/95"; SUDDEN HEARING LOSS (medically significant) with onset 14Apr2022, outcome "recovering", described as "and it felt like he could not hear"; GIANT CELL ARTERITIS (medically significant) with onset 14Apr2022, outcome "not recovered", described as "concerned he may be developing temporal arteritis"; HYPERAESTHESIA (medically significant) with onset 14Apr2022, outcome "not recovered", described as "his temporal arteries were engorged, sensitive to touch"; NECROSIS OF ARTERY (medically significant) with onset 18Apr2022, outcome "not recovered", described as "He developed a small area of necrosis on the left temporal artery". The events "he developed a small area of necrosis on the left temporal artery", "and it felt like he could not hear", "caller states his temporal arteries were engorged, sensitive to touch", "his blood pressure elevated to 170/95", "he had the sensation of gauze or cotton in his ear", "concerned he may be developing temporal arteritis", "he woke up with a splitting headache" and "his temporal arteries were engorged, sensitive to touch" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 140/80, notes: his normal blood pressure; (14Apr2022) 170/95; Computerised tomogram head: (unspecified date) small area of necrosis on the left temporal artery; Red blood cell sedimentation rate: (unspecified date) normal. Clinical information: No Prior Vaccinations (within 4 weeks). Vaccine was not administered at Facility. Caller stated that he was a physician, and specified as paediatric psychiatrist. He took the fourth dose of the Pfizer Covid 19 vaccine. About 3 days, after his fourth dose of vaccine, he woke up with a splitting headache and his temporal arteries were engorged and they were sensitive to touch. He still had a headache but it was no longer a splitting headache. He had the sensation of gauze or cotton in his ear and it felt like he could not hear. Caller states it was not as pronounced as it was. His normal blood pressure was about 140/80 and his blood pressure elevated to 170/95. He decided to wait and see if the effects were transitory, but he was concerned he might be developing temporal arteritis. He went to the emergency room but was not admitted, just to get a SED rate, and a brain scan. The SED rate was normal, but his brain CT, had the recommendation to get a biopsy of the left temporal artery and would prefer him to have a neurological consult, because he developed a small area of necrosis on the left temporal artery. He went to the ED because he noticed a necrotic area on his temporal artery. He agreed to complete a report. Seriousness: Caller first states as serious, then later, documents as medically significant, because it could lead to other things.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.