Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscular weakness, Myalgia, Nausea
Clinical narrative: nausea; muscle pain and tenderness in both legs; Sharp pain, throbbing, sore and if you pressed down on leg/tenderness in both legs; weakness in both legs from thighs to calves all the way down to ankles; sore in his legs especially the thigh and calf area, down around ankles; tiredness/Chronic fatigue has gotten a lot worse; This is a spontaneous report from a contactable consumer(patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198, vaccine product manufacture date 24Feb2021 ) intramuscularly in arm (for route of administration: Caller stated the shoulder, caller forgot whether left or right, clarified as shoulder muscle. Caller thought it was in the left shoulder muscle but stated don't hold him to it. Caller said he was picturing himself sitting down, but didn't remember if its the right or left arm) on 17Mar2021 13:20 at age of 75-year-old at single dose for COVID-19 immunisation. Medical history included fibromyalgia, chronic fatigue, two bouts with cancer, heart attack, pneumonia years ago (He said it was 3 or 4 weeks in the hospital when the caller had pneumonia, Caller clarified he was in the hospital for at least 4 weeks and home for 3 or 4 weeks, that's how bad caller's pneumonia was. Also the fact the caller is 75 years old, so basically caller's age and immune system) and a lot of health issues. Other medical history included gastritis. When relevant family medical history was queried caller said it was just like caller said, the pain was just constant. He could not take any kind of Aspirin, Advil or anything like that because caller has severe gastritis. Caller may try something topical cream to see if it would help or not. Caller stated he had Atypical Neuralgia and had not taken anything for the leg pain. Caller's stomach was extremely sensitive to any type of medication. The only medication the caller took is for blood pressure. If he took any medication it hits his gastrointestinal system, musculoskeletal and central nervous system so he didn't take any prescribed medications other than Atenolol for blood pressure, once a day. Caller took Valium as needed for severe costochondritis, stated between the ribs was cartilage, the Valium was taken as needed. No further information provided. The patient's concomitant medications were not reported. Prior vaccinations included: the patient has had Prevnar 13 shots and had other, been a long time ago, had vaccinations in past for tetanus, Prevnar 13, pneumonia, normal flu shot every year that kind of stuff. Caller confirms he has not had any adverse event after a vaccination. No prior vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. Caller stated he knew better than to have any other vaccinations. It was days before that, it was like on a Sunday, caller got an allergy shot, but they said allergy shot was not considered a vaccination. It was an allergy shot for dust, mold, histamines. Caller stated he may have skipped the allergy shot, confirmed caller did not receive the allergy shot. Shot was for mold, histamines and pollen, not a vaccination. No vaccines for flu or Pneumonia or anything else. The patient had problems a week after the first shot of the Pfizer COVID 19 vaccine, which was already reported to Safety. She had severe muscle pain, soreness and weakness in both legs from thighs to calves all the way down to ankles; not just the typical muscle pain, tiredness, nausea that lasts a day or so. On 24Mar2021, she started experiencing muscle pain and it has gotten progressively worse. She was not sure if she will get the second shot but she would beyond the 42 days; it's been about 6 weeks and didn't have an appointment with her rheumatologist until June.The patient talked to a nurse in the FDA. The nurse said there was no time limit to receive second dose Pfizer COVID Vaccine. Although, when the vaccination first came out caller was told the second dose Pfizer COVID Vaccine should be given no more than 6-8 weeks and the nurse was telling the caller the second dose could be given months later. Caller's first question, if caller decided to go the second dose Pfizer COVID Vaccine was there any time frame between doses that the caller would have to start over again with the Pfizer Covid Vaccinations. Caller received the Pfizer Covid Vaccine on 17Mar2021 and was not sure if he will get the second dose because he was experiencing a little bit of a problem and was not sure if it is related to the Pfizer Covid Vaccine dose one or not, caller stated he would get to that. He has a couple doctors appointments, so if they rule it out. Severe muscle pain and tenderness in both legs: Caller reported he was having severe muscle pain and tenderness in both legs began about a week after receiving first dose Pfizer Covid Vaccine. He knew most of the shots they say that you may experience muscle pain nausea and all that. That's basically it. Caller stated it is a throbbing, sharp pain that was 24/7 and it begun happening within a week after got the first dose Pfizer Covid Vaccine. Experiencing muscle pain in both legs, to thigh to calves to the ankles, 24/7, not coming and going. Caller stated ever since a week from 17Mar2021 this has been happening from 24Mar2021 to the date of report. Severe muscle pain, soreness, weakness in both legs. If caller bends down, he had to put his arm on something to pull himself up. Sharp pain, throbbing, sore and if you pressed down on leg, made it even worse. If the leg was touched anywhere it was just really sore and tender and kind of like a sharp pain. Sharp pain wasn't as bad as the soreness. Extremely sore and tender 24/7 and hadn't stopped since 24Mar2021. About the time period it started and hasn't let up since then. If caller did any kind of work, trying to get muscles back in shape with exercise helps, but if caller did anything putzing around and pulling weeds, bending down exacerbates the problem. Any kind of activity exacerbates the problem greatly. Caller never had this kind of muscle pain. Severe muscle pain and tenderness in both legs: Caller reported he was sore in his legs especially the thigh and calf area, down around ankles not too bad. But the thigh and the calf muscles are extremely sore and painful. Caller sated has not gotten any better, if anything may have gotten a little worse. Same or maybe a little worse, honestly, when first came on just felt like a little bit of muscle pain. Initial onset to now it has gotten worse, it hadn't gotten worse in the last few weeks. The pain was bad lets put it that way. Caller guesses the biggest thing it has a major impact on is his quality of life. Caller has gotten different surgeries and stuff and been able to move on. However, with this the caller was lucky to be able to do anything for half an hour to an hour and then he just has to sit down. Caller stated it was having a major impact on caller's quality of life. Caller like to have gone but doctor ordered blood work, didn't want caller to be exposed. Caller was holding off going to emergency room, didn't want exposure of going to the emergency room. Pain was pretty bad but not to the point of screaming out of caller's mind. Severe muscle pain and tenderness in both legs: Caller reports throbbing sharp pain in both legs. Chronic fatigue has gotten a lot worse: Caller stated he does have chronic fatigue prior to receiving the Pfizer Covid Vaccine dose one. Chronic fatigue has gotten a lot worse after receiving the first dose Pfizer Covid Vaccine. Noticed two weeks after receiving the Pfizer Covid Vaccine caller felt the chronic fatigue more. Before, caller felt tired all the time, now caller is exhausted if caller does anything for half an hour to an hour, caller has to sit down and falls asleep for awhile. Chronic fatigue has gotten worse in conjunction with leg pain. The chronic fatigue worsening began maybe a couple weeks after receiving the first dose Pfizer Covid Vaccine. Caller stated you have to have Chronic Fatigue to understand. Everyone may be tired and if you want to call it a day they may go home and feel a little tired but with Chronic fatigue sleeping 8 hours a night, REM sleep, wake up and just feel totally exhausted. Some people were worse and can't get out of bed. He can at least get out of bed but Everything is an effort to move forward with chronic fatigue. Caller's Chronic Fatigue has gotten worse since receiving the Pfizer Covid Vaccine. Whether this is related or not, caller is not in a position to say. Caller states he can report the sequence of events as they happened and let the determination be made. Chronic Fatigue has gotten considerably worse. The outcome of the events was unknown.  No follow-up attempts are needed; No further information is expected.