Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: C-reactive protein increased, Fatigue, Headache, Immunoglobulins, Pain
Clinical narrative: extreme tiredness; trouble walking; legs are sore but not related to muscle or bone/legs are sore in her inner thigh area; Things like bending over, putting her shoes and socks on and going up steps are hard for her to do.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021), via an intramuscular route of administration (at the age of 57-years), on 13Feb2021 at 08:30 as dose 1,.single for COVID-19 immunisation and co-suspect as adalimumab (HUMIRA, Batch/Lot number was not reported), via an subcutaneous route of administration an unspecified date at unspecified dose for an unspecified indication and received apremilast (OTEZLA, Batch/Lot number was not reported), via an unspecified route of administration from Mar2021 to Jul2021, at unspecified dose for an unspecified indication. Medical history included ongoing asthma had maybe 15 years , allergy to vaccine from 2018 to an unknown date. The patient concomitant medications were not reported. The patient previously took pneumococcal vaccine and experienced cellulitis, Arm swelled up, pneumococcal vaccine and experienced fever. On 13Feb2021, the patient experienced extreme tiredness, trouble walking, legs are sore but not related to muscle or bone/legs are sore in her inner thigh area and things like bending over, putting her shoes and socks on and going up steps are hard for her to do. The adverse events resulted in physician office visit. After her first dose she experienced that same day, extreme tiredness, trouble walking, and leg soreness in her inner thigh area. He doctors told her it is not related to her muscle or bones. After her second dose the doctor did a lab test and tested her SED rate. It resulted at 60 and is supposed to be 5. Her inflammatory response is very high. She saw a rheumatologist and that doctor repeated the SED rate and it resulted an even higher number. The rheumatologist believes she has autoimmune disease. As of today, no one medically knows what to do with her. Caller asking do you know of any physicians that are dealing with symptoms of Covid-19 for example, has lower back pain and unable to do daily activities been reported after receiving the Pfizer Covid-19 Vaccine? Still having trouble putting shoes on going up steps. She was calling about the Covid 19 vaccine. She received the first dose on 13Feb2021 and that same day, later in the evening she was extremely tired and had trouble walking. Her legs are sore but not related to muscle or bone. Her legs are sore in her inner thigh area. Things like bending over, putting her shoes and socks on and going up steps are hard for her to do. She went to her doctor in Mar2021 and her sedimentation rate was 60 and it's normally supposed to be 5 so her inflammatory numbers were really high. Her doctor prescribed a steroid and referred her to a rheumatologist. The rheumatologist repeated the blood work and her sedimentation rate kept going up higher. The rheumatologist believed the caller has an autoimmune disease. The rheumatologist prescribed another steroid because the caller's legs were hurting again. The caller was signed up for Otezla but that medication takes a long time for approval from insurance so she was finally approved and took the Otezla. It was supposed to be in her system for 40 days to know if it's going to work. The Otezla did not work. She was prescribed another round of steroids and is now trying to get Humira. Her blood work now shows she is anemic. She has pain in her lower back. She does not think that her doctor know what to do with her. She has a full time job working with special education kids and she was very concerned over how can she go back to work. Her doctor wanted to prescribe an opioid but she does not want to take that and to become addicted to something like that. She was asking for some kind of direction or guidance. She is hoping to find a doctor that deals with adverse events from the Covid 19 vaccine. She wascalled the (name)and the CDC but no one can help her. She reports she used to work in housekeeping at Hospital. She had to quit because of the Covid 19 pandemic because she was immune compromised. She quit prior to receiving her Covid 19 vaccines. She received her second Covid 19 vaccine on 06Mar2021 in the right arm but was not 100% certain. Lot# EN6205, Expiry 30Jun2021, NDC not known. First Covid 19 vaccine information is in the suspect product field. When probing anatomical location of her first Covid 19 vaccine she wants to say she received it in the left arm but was not 100% sure. She received the second vaccine in the other arm thinking maybe that would cure her. After receiving her second Covid 19 vaccine she reports her symptoms and side effects stayed about the same. When probing for medical history and concomitant medications she reports she does not think her medications are relevant, she has been on her medications for years. She reports the rheumatologist did an X-ray of her hips and her knees and her chest. She had an MRI done of her spine. The MRI was about 2 weeks ago. The chest X-ray was sometime last week. Her hips and knees were X-rayed on 10May2021. When probing for adverse events following other vaccines she reports she had an allergic reaction to the pneumonia vaccine. She states one doctor called it an allergic reaction but the emergency room doctor called it cellulitis. She reports her arm swelled up and she had a fever of 103 degrees Fahrenheit. That happened in 2018. NDC/Lot/Expiry not known. When probing for information regarding the Otezla, she reports she tried it maybe in Mar2021. She had to take it for 40 days before she could see results. She has been off of it for maybe 2 or 3 weeks now. Description of Product Complaint: Description of complaint: The caller was signed up for Otezla but that medication takes a long time for approval from insurance so she was finally approved and took the Otezla. It was supposed to be in her system for 40 days to know if it was going to work. The Otezla did not work. Caller stated that she would just like to add additional information to her previous encounter in case her Rheumatologists calls she would like her blood work information included in the file. Patient was speaking about the Pfizer COVID-19 Vaccine she had her first dose on 13Feb2021 and her second on 06Mar2021. She stated they are thinking that her pain that she was having is being cause by her blood being out of wack. Spontaneous report by a consumer of a 57-year-old female with events of non-serious trouble walking, things like bending over, putting shoes and socks on and going up steps were hard to do, allergic reaction to pneumonia vaccine/cellulitis, autoimmune disease, sedimentation rate kept going up higher, inflammatory numbers were really high, Otezla did not work, anemic, pain in lower back, arm swelled up, fever and legs hurting/legs were sore but not related to muscle or bone/legs were sore in inner thigh area with Humira (Adalimumab). On unknown dates, the patient experienced autoimmune disease, sedimentation rate kept going up higher, inflammatory numbers were really high, anemic, pain in lower back, arm swelled up, fever and allergic reaction to pneumonia vaccine/cellulitis. in 2018, the patient experienced allergic reaction to pneumonia vaccine/cellulitis. in 2021, the patient experienced Otezla did not work. on 13Feb2021, the patient experienced trouble walking, things like bending over, putting shoes and socks on and going up steps were hard to do and legs hurting/legs were sore but not related to muscle or bone/legs were sore in inner thigh area. Pfizer BioNTech covid-19 vaccine (Tozinameran) and Otezla (Apremilast) were also considered suspect. The patient underwent lab tests and procedures which included blood work: unknown results, sedimentation rate: 60 on unspecified date, body temperature: 103 fahrenheit on unspecified date in 2018, chest x-ray: unknown results on Jul2021, MRI of spine: unknown results on an unspecified date in Jul2021, knee x-ray: unknown results, hip x-ray: unknown results on 10may2021. The vaccine facility type was reported as university of toledo mass vaccination site for faculty members. The patient was taking Covid 19 vaccine to prevent the Covid 19 virus. The clinical outcome for the events was reported as not recovered.  Causality for HUMIRA: The reporter's causality for the event(s) of trouble walking, things like bending over, putting shoes and socks on and going up steps were hard to do onset 13Feb2021, allergic reaction to pneumonia vaccine/cellulitis onset in 2018, autoimmune disease, sedimentation rate kept going up higher, inflammatory numbers were really high, otezla did not work, anemic, pain in lower back, arm swelled up, fever, legs hurting/legs were sore but not related to muscle or bone/legs were sore in inner thigh area and allergic reaction to pneumonia vaccine/cellulitis unknown onset was not provided.  Follow-up attempts are completed. No further information is expected.