Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chills, Loss of personal independence in daily activities, Pulmonary physical examination
Clinical narrative: he couldn't do anything, he was out of commission/Unable to resume normal activities; Chills; weak; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 13Dec2021, this case contains serious adverse reaction(s) and all safety information is processed together.  This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 89 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in arm right, administration date 29Jan2021 13:15 (Lot number: EL9261) at the age of 89 years as dose 1, single and intramuscular, administered in arm right, administration date 19Feb2021 13:15 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "carotid artery clean out" (unspecified if ongoing), notes: 10 -12 years ago; "partially collapsed mitral valve" (unspecified if ongoing); "leaky pulmonary valve" (unspecified if ongoing); "leaky aortic valve" (unspecified if ongoing), notes: see's cardiac surgeon yearly for ascending & descending aorta to ensure not stretched/within limits; "Prostate cancer" (unspecified if ongoing); "Bladder cancer" (unspecified if ongoing); "Idiopathic thickening of the pleura" (unspecified if ongoing); "urostomy" (unspecified if ongoing), notes: 7-8 years now; "prostate and bladder but both have been removed" (unspecified if ongoing); "Hemorrhoidectomy" (unspecified if ongoing); "chemical stress test and a physical stress test" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN E [TOCOPHEROL] (ongoing); VITAMIN D3 (ongoing); CALCIUM (ongoing); OMEPRAZOLE (ongoing); BABY ASPIRIN; AMLODIPINE (ongoing); ROSUVASTATIN (ongoing). Past drug history included: Vioxx for hemorrhoidectomy, reaction(s): "sicker".  The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 30Jan2021, outcome "recovered" (2021), described as "he couldn't do anything, he was out of commission/Unable to resume normal activities"; CHILLS (disability) with onset 30Jan2021, outcome "recovered" (2021), described as "Chills"; ASTHENIA (disability) with onset 30Jan2021, outcome "recovered" (2021), described as "weak". Patient reported that after the first and second doses of the vaccine, within 24 hours he had reactions; untoward reaction, both doses, onset dates provided as 30Jan2021 and 20Feb2021. He further described that he has no allergies, but it was very unusual, when he got the shot, 24 hours later is when he began to have effects like chills and like he couldn't do anything to take care of himself, he struggled with this for 2-3 days. The chills were violent in beginning and he felt weak, this effect took 2-3 days to wear off for normal living. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; (Oct2021) normal, notes: fasting blood work; pulmonary physical examination: (2021) passed, notes: he has no trouble breathing but they are doing the test because it's age related. Therapeutic measures were not taken as a result of loss of personal independence in daily activities, chills, asthenia. The reporter (patient) considered the Pfizer product had a causal effect to the adverse events.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and possible causal association between suspect product BNT162B2 to the reported events loss of personal independence in daily activities, chills, asthenia cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.