Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Pain in extremity, Periarthritis, X-ray
Clinical narrative: Arm is hurting/it's hurting me and I am in pain; inflammation in my arm; I been in a lot of pain on my left shoulder; I have a frozen shoulder; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left deltoid (reported as left shoulder) in a hospital facility on 27Apr2021 18:45 (Batch/Lot Number: EW01510) (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no prior vaccination within four weeks. Medical history included breast cancer from 2003 to an unknown date. Concomitant medication included unspecified multivitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular administered in left deltoid on 04Apr2021 06:52PM (Batch/Lot Number: EW0151) (at the age of 56-year-old) for covid-19 immunization and experienced left (L) shoulder pain and flu shot on unspecified date in Jan2021 for immunization. The patient reported that her arm was hurting, had inflammation in her arm, it's hurting her and she was in pain which was getting worse and she got scared. It was further stated that patient's had been hurting since she got the covid19 vaccine shot. She didn't think anything of it but now it was getting worse and she made an appointment to go and see the orthopedic, she just went to the Doctor today and she saw and they took X-ray and everything looks normal but Doctor just told her to report it because there been "several patients" (Further not clarified) before that they had the same problem. She have inflammation in her arm and she never felt like it, nothing happen to her but it was only been hurting since she got the second vaccine. When paraphrased the concern, patient stated, "Yes, it's been hurting me, I didn't know, I am getting worse and worse and got scared, so I had my appointment reconstructive orthopedic and he asked me like did you get hurt? I said it is been hurting since I got my shot, he gave me a prescription for physical therapy and then he said for X-ray, it looks like I dont have anything broken or anything like that, it could be the (Covid Vaccine) that chemical (not clarified) they put in me because I never had any medical problem. I have been all in a lot of pain." On 08Oct2021, the patient reported that she has been in a lot of pain on her left shoulder since on unspecified date in Apr2021. She never has any problem until she received the Pfizer vaccine. She has a frozen shoulder and no, she did not get hurt on unspecified date in 2021. She was in extreme pain everyday. On 03Nov2021, the physician reported that the patient did provide information regarding the reported adverse events with the use of the product. The physician consider the Pfizer product has a casual effect to the adverse events. The physician considered the left shoulder pain as serious due to persistence significant disability/ incapacity. The events left shoulder pain, arm is hurting, and inflammation in arm required physician office visit. Therapeutic measures were taken as a result of shoulder pain which included Naproxen. The patient had not yet recovered from events left shoulder pain, arm is hurting, and inflammation in arm while other event was unknown.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of event arthralgia cannot be totally excluded.  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 RAs, Ethics Committees, and Investigators, as appropriate.