Sex: U
Vaccine: COVID19
Symptoms: Infection, Loss of personal independence in daily activities, Memory impairment, Muscle spasms, Myalgia
Clinical narrative: brain dysfunction; dysrhythmia; literally had to quit working because could not function; I got my second vaccine and my symptoms became much worse; weak; dizzy; Forgetful; I had quite severe cramps with muscle pains; I had quite severe cramps with muscle pains; Loss of taste and smell; Loss of taste and smell; I am having dizziness to the point where I am literally tripping over and specially; I can't see that is my eyes are closed or lights are off; a loop problem which was small irritation on finger tips; specially can't see that is eyes are closed or lights are off; joint pain; now had turned into a very pain full and persisting what appeared to be kind of infection; uncomfortable; was having all of the pain in my limbs, arms and thighs.; This is a spontaneous report from a contactable physician (patient). This 77-Year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 (Lot: EL3247) as single dose for COVID-19 immunisation and unspecified medication. Medical history included Myopathy, Sleep apnea diagnosed from 2006 (reported for 15 years ago, as of 02Apr2021), High cholesterol, Blood pressure high, first heart attack in 2010 and second heart attack in 2017, Trauma, Prostate enlargement from 2016, prostate enlargement that was biopsy that didn't have any cancer and some changes in PSA levels and then stating so on. But it was diagnosed about 5 years ago, acoustic neuroma. Concomitant drugs included tocotrienols nos at 200 mg, 1x/day, ascorbic acid (VIT C) at 2000 mg, 1x/day, pramipexole dihydrochloride (MIRAPEX) at 5 mg, ASPIRIN [ACETYLSALICYLIC ACID], lisinopril (NEOPRIL [LISINOPRIL]), Metoprolol at 50 mg, and aluminium sulfate, calcium acetate (BUROFIX) at 2.5mg. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at age of 77-year-old lot number: EK9231 for COVID-19 immunisation and experienced fatigue, not feeling well, muscle aches, dizziness. The patient got second vaccine on Jan 26th and symptoms became much worse. The patient literally had to quit working because could not function was weak, dizzy, forgetful, had quite severe cramps with muscle pains, had puzzling symptoms similar to long hour Covid patient, loss of taste and smell. The patient thought may have Covid. The patient got tested again for Covid the test result of the active disease came negative. And then got Covid antibody test to see if any way that even the test was negative, so the patient had the infection and now the patient was having side effects and that came negative. The patient saw the neurologist and brain specialist, had the Brain scan saw the cardiologist as was having dysrhythmia. The patient saw back and bone expert the orthopedic doctor because was having all of the pain in limbs, arms and thighs. The patient saw rheumatologist as it was causing a lot of muscle pain, joint pain and things. Now, all of them basically said that the organ they were checking had minor problems. The patient had prior heart attack but there was no sign to do in the way of heart attack and heart failure had previous acoustic neuroma radiated in brain and that used to cause a little bit of dizziness but it was pretty much gone away and now was having dizziness to the point where was literally tripping over and specially can't see that is eyes are closed or lights are off. The patient further stated, this is more disturbing. Since the patient had the symptoms, did returned to work briefly at the end of Feb and after 3 days of work had to quit. The patient was not up to functioning so it's about a month now still feel a very, very strong presence of this function brain dysfunction and muscle pain. The patient had a course of steroids during this time to see if that would help had number of things pain medications (Unspecified Medications) and so on but nothing really is demonstrating any real help. The patient was having a loop problem which was small irritation on finger tips and now had turned into a very pain full and persisting what appeared to be kind of infection. And that still since the second shot. Outcome of the events was unknown. Causality included the patient believed they are. And would say that because a lot of people have the similar but less side effects.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality 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 and on the conduct of the study 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.