Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Tinnitus
Clinical narrative: now she can hardly get up and down out of chairs or turn her head because of the muscle pain.; has a hard time lifting her arms and turning her neck, or sleep; has a hard time lifting her arms and turning her neck, or sleep; muscle pain / pain came up into her shoulders and neck; She had tinnitus before but it worsened in the last week of Mar2021.; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 16Mar2021 09:45 (at the age of 69 years old) (Lot Number: EN6207) as 2nd dose, single for COVID-19 immunization. Medical history included ongoing tinnitus, she has had tinnitus for several years, maybe 3-4 years; ongoing high cholesterol, diagnosed 3 years ago, patient reported that her physician had been watching her cholesterol and it was kind of high, for awhile, she was going to watch her diet and this and that, but finally a friend's husband who is a pharmacist convinced her to try the pravastatin. Concomitant medication included pravastatin taken for high cholesterol from an unspecified start date (for 3 years) to May2021. The patient previously received the first dose of BNT162B2 (Lot Number: EN6202) on 23Feb2021 (the age of 69 years old) in left arm for COVID-19 immunization and had no reaction. Patient is a retired RN calling in regards to the Pfizer Covid-19 vaccine. Patient stated that she had no side effects, was fine, no problems, no nothing following both doses of the Covid-19 vaccine. Patient stated that she had the second dose of the Pfizer Covid 19 vaccine on 16Mar2021, at the end of the month, she started having muscle pain in the back of her thighs, especially when standing up. Patient stated in Apr2021 it progressed, she started getting more muscle pain, the pain started to spread to her groin and was more severe. Patient reported that in May2021 the pain came up into her shoulders and neck and has a hard time lifting her arms and turning her neck, or sleep because of the pain. Patient reported that she contacted her primary care physician who informed her that she could take Tylenol and Ibuprofen together to try to help with the muscle pain. Patient reported that the Tylenol and Ibuprofen helped during the day, but didn't take the pain away. Patient reported that she heard on the news that some long-term effects of the Covid-19 vaccine can be tinnitus, which she has and has gotten worse, and muscle pain. Patient reported that that is why she is concerned. Patient reported that she has been a healthy individual her whole life, and now she can hardly get up and down out of chairs or turn her head because of the muscle pain. Patient reported that her physician did draw lab work to see if her electrolytes are off. Patient reported that her doctor is supposed to contact her today, 04Jun2021, with the results of the lab work. Patient inquired if there have been reports of muscle pain and tinnitus developing weeks after receiving the Covid-19 vaccine. Patient reported that her physician informed her that she had not heard about these side effects of the Covid-19 vaccine. Patient reported that the muscle pain was medically significant and if it doesn't stop, it will be disabling. Patient reported that her grandchildren are visiting and she isn't able to pick up her 6 week old grandson because she doesn't have the strength in her arms to pick him up. Patient asked about the long-term side effects. Patient wanted to know if there are reports of muscle pain developing later and continuing for 2 months. Patient also reported that she had tinnitus before but it worsened in the last week of Mar2021, it was now getting louder. Patient reported that she did go and get her hearing tested. Patient reported that she knows there's no cure for tinnitus, but she talked with an audiologist who informed her that they have very high tech hearing aids now where they can tune in other noises to try to offset the tinnitus. Patient stated that one of the reasons she called Pfizer is because she thinks things like this that are happening to her and that it's very odd that she started getting muscle pains 2 weeks after the Covid-19 vaccine. Patient reported that if she told people about the side effects, they won't want the vaccine. Patient reported that if she would have known that the muscle pain and worsened tinnitus would be a side effect, she wouldn't have gotten it. Patient reported that she has so much pain during the day that it couldn't be worse than cancer. As for causality, patient reported that when she talks to her primary care physician on 04Jun2021 afternoon and sees that her electrolytes are off, she will attribute the muscle pain to an electrolyte imbalance, if her blood work comes back normal, she is going to blame the Covid-19 vaccine. Patient reported that there is no other reason for the muscle pain. Patient reported that there's nothing she's done to cause it, she hasn't gone out of the country, she still works part time, she runs around and sleeps at night, so this muscle pain is something that has happened since the Covid-19 vaccine. Patient stated that hopefully the blood work shows up and her electrolytes are off. As for pravastatin, patient reported that she knows that cholesterol medications can sometimes cause muscle cramps. Patient reported that she asked her physician if she could possibly be having a side effect to the Pravastatin after 3 years and her physician said that was highly unlikely. Patient reported that she is going off Pravastatin for a month to see if it could be the cause of the muscle pain. Patient reported that she has been off Pravastatin for a week and the muscle pain is getting more severe. Patient reported that her physician did draw blood work, but she will not have results until 3:20 PM today, 04Jun2021. The events muscle pain and tinnitus aggravated were considered serious per reporter with seriousness criteria-Other medically important condition. The adverse event muscle pain resulted in Physician Office. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events muscle pain and tinnitus aggravated cannot be excluded. The information available in this report is limited  and this case will be reassessed once 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.