Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Femur fracture, Fibromyalgia, Headache
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) and consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 25Jun2021 (at the age of 71-year-old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated, she had a question that she had Pfizer shot last "Friday" afternoon, she knows that after have the vaccine get a lot of side effects. So, she had lot of dizziness "yesterday" (26Jun2021), but it was okay "today". She had pain on the injection site. She had taken the Pfizer but had a question regarding there was a lot of muscle pain but she just observing herself a little closer because she has a fibromyalgia and right "now", it has been severe. So, she was having a lot of pain anyways, but she main concern was, she scheduled for two MRI "tomorrow", should she call off going in a machine so soon after this. Someone told her, she should not do it for first 14 days or after, she means to go into the machine, she knows there was lot of stuff, but she just wants to be clear because she did not want to go in a machine you know like putting in all through her system, she already having problems. The reporter further stated, she was having the pain before but right "now", it was more intense, a little more intense but she was moving her arm very well, so it was not sore. I had two episodes of light headache "yesterday" (26Jun2021). The patient stated, it was going to take a while in walking and get to that because she does not have that, so that was going to take a while because she fractured both legs (hip and femur), so it takes more time for her to get to whatever that paperwork she need. She has a broken hip and a femur, right "now" she was dealing with. So, this was going to take a few minutes. she has a bone stimulator that she was supposed to wear. Since she got her 1st dose of the vaccine, she did not want to put it on because she did not want to intensify the pain. She needs information if it was okay to wear her bone stimulator after she received her 1st dose of the Pfizer vaccine. The patient stated, she was in a lot of pain. The patient further stated, "You" must wind up shortly as she need to go to the restroom and it was too long, she could not, it was going to take ten minutes with her broken leg. The patient said that what she was feeling right "now", she has some mild side effects and that can be expected. She had headache but she just taken some Tylenol (treatment) because she had headache. Her muscles are, still very, the pain was, she had muscle pain. Also, had some chills last "night" that was about it. She also had episodes of light-headedness. In her opinion, yes this was just a side effect for her. She had the card, and the card was put away in her wallet but like she said, it was going to take her a while to get it. So, if "you" want "you" can call back for a LOT number but "right now", she just need to try moving. So, not "right now", she must go now. The patient added, "I have a few other side effects but they are not severe, because I have a history of fibromyalgia, right now it's peak, so I'm in a lot of pain". The reporter did not specify any seriousness for the events. The outcome of the events was unknown. Information about lot/batch number is requested. Follow-up (27Jun2021): New information reported from a contactable nurse included: reporter information (consumer added), reaction data (description of the event Fibromyalgia worsened and pain added) and clinical course details.; Sender's Comments: The reported serious events femur fracture and hip fracture were most likely intercurrent condition, and unlikely causally related to the administration of the vaccine.   The vaccination may contribute to the fibromyalgia aggravated/pain, considering temporal relationship and immune effect of the product. 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.