Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Vaccination site pain
Clinical narrative: pain from her shoulder to her elbow; she can't lift her arm because it hurts very much/ patient cannot lift her arm past her shoulder; she can feel the soreness where she got the shot; pain in her arm; The initial safety information received reported only non-serious adverse drug reactions. Upon receipt of follow-up information on 26Oct2021, this case now contains serious adverse reactions. Initial and follow-up information were processed together.   This is a spontaneous report from a contactable consumer (patient reporting for herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm on 30Apr2021 (batch/lot number: E28729) at the age of 48 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient worked for the cleaning industry and they encouraged her to get the vaccine. Patient received the vaccine at a Pharmacy/ Drug Store vaccination facility. Medical history included anxiety from an unknown date and ongoing, and pain from an unknown date. The patient had no family medical history relevant to AEs. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for anxiety from 2019 and ongoing; and paracetamol (TYLENOL) taken for pain from 09Apr2021 and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm, on 09Apr2021, 12:00 (batch/lot number: EP6955) at the age of 47 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced pain in arm and arthralgia described as "moderate pain/ pain was only from her shoulder to her elbow." The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no prior vaccinations (within 4 weeks) and no additional vaccines were administered on same date of the Pfizer suspect. The patient initially reported that when she got the shot, she noticed that she developed pain in her arm. She knew that people had said it would hurt, but her arm had been hurting since 30Apr2021. She had pain from her shoulder to her elbow since an unknown date. Lately, she can't lift her arm because it hurts very much. When she touches the area, she can feel the muscle, she can feel the soreness where she got the shot. Patient was very concerned, but she doesn't have an appointment with her doctor until 03Nov2021. It was further reported that the patient cannot lift her arm past her shoulder. It got worse the day after she got the vaccine and then it never decreased. The patient further reported that after her first dose on 09Apr2021, she had moderate pain, nothing serious. It wasn't until the second dose on 30Apr2021 that the pain increased severely, and it never went away. It gotten worse to the point that she can't move her arm without pain. The pain was only from her shoulder to her elbow. No investigation assessments and relevant tests were performed. The events did not require a visit to the Emergency room. The patient has not recovered from the events: pain in her arm (pain in extremity), pain from her shoulder to her elbow (arthralgia), and she can't lift her arm because it hurts very much/ patient cannot lift her arm past her shoulder (Joint range of motion decreased). Outcome of the event "she can feel the soreness where she got the shot" was unknown. The events pain in her arm (pain in extremity), pain from her shoulder to her elbow (arthralgia), she can't lift her arm because it hurts very much/ patient cannot lift her arm past her shoulder (Joint range of motion decreased) were reported as serious leading to persistent/significant disability/incapacity.  Follow-up attempts are completed. No further information is expected.