Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Rheumatoid arthritis, Skin discomfort
Clinical narrative: rheumatoid arthritis; Very swollen upper arm; Wrist are swollen and they look very deformed; redness and my upper arm was swollen; itching; bilateral hand swelling.; fingers were swollen; pain; Her skin was so tight back to the finger till the fingertip; My skin was tightening from the back of the finger to the fingertip; I started developing joint pain in my shoulder, elbow, wrist and everywhere else / The pain is in my neck, shoulder, wrist and everywhere; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic stenosis" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "I had a previous ganglion on the wrist" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus; LISINOPRIL taken for hypertension; LEVOTHYROXINE taken for hypothyroidism; ZETIA taken for blood cholesterol increased; QUNOL LIQUID COQ10 taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose 1), administration date: 19Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2), administration date: 16Apr2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: SKIN DISCOMFORT (non-serious) with onset 25Dec2021, outcome "unknown", described as "Her skin was so tight back to the finger till the fingertip"; ARTHRALGIA (non-serious) with onset 25Dec2021, outcome "unknown", described as "I started developing joint pain in my shoulder, elbow, wrist and everywhere else / The pain is in my neck, shoulder, wrist and everywhere"; PARAESTHESIA (non-serious) with onset 25Dec2021, outcome "unknown", described as "My skin was tightening from the back of the finger to the fingertip"; PERIPHERAL SWELLING (non-serious) with onset 25Dec2021, outcome "unknown", described as "Very swollen upper arm; Wrist are swollen and they look very deformed"; PERIPHERAL SWELLING (non-serious) with onset 25Dec2021, outcome "unknown", described as "bilateral hand swelling."; PERIPHERAL SWELLING (non-serious) with onset 25Dec2021, outcome "unknown", described as "fingers were swollen"; PRURITUS (non-serious) with onset 25Dec2021, outcome "unknown", described as "itching"; PAIN (non-serious) with onset 25Dec2021, outcome "unknown"; ERYTHEMA (non-serious) with onset 25Dec2021, outcome "unknown", described as "redness and my upper arm was swollen"; RHEUMATOID ARTHRITIS (medically significant) with onset 25Dec2021, outcome "unknown". The events "rheumatoid arthritis", "very swollen upper arm; wrist are swollen and they look very deformed", "redness and my upper arm was swollen", "itching", "bilateral hand swelling.", "fingers were swollen", "pain", "her skin was so tight back to the finger till the fingertip", "my skin was tightening from the back of the finger to the fingertip" and "i started developing joint pain in my shoulder, elbow, wrist and everywhere else / the pain is in my neck, shoulder, wrist and everywhere" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: Positive, notes: rheumatoid arthritis panel blood tests which came back positive; lupus disease: Negative; Negative; X-ray: arthritis in my left wrist, notes: x-ray only on one hand and he noticed in the x-ray that there was arthritis in my left wrist. Therapeutic measures were taken as a result of rheumatoid arthritis, peripheral swelling, erythema, pruritus, peripheral swelling, peripheral swelling, pain, skin discomfort, paraesthesia, arthralgia.  Additional information: Pt liked to report an adverse event following the Pfizer COVID-19 vaccine. Pt had first dose of Pfizer COVID-19 vaccine on 19Mar2021 and the second one on 16Apr2021. Pt received my booster dose of Pfizer COVID-19 vaccine on 25Oct2021. Eight weeks after receiving the booster dose pt started developing side effects. After receiving the two primary vaccination series pt had no symptoms. However, pt went to do some antibody tests and there were no antibodies detected. Pt had a local reaction after receiving the booster dose, such as itching, a lot of redness and upper arm was swollen. It was very itchy for a few days. On holiday, pt developed a bilateral hand swelling. Pt fingers were swollen. Pt was in such a pain. Pt thought pt had carpal tunnel syndrome. When the doctor analyzed and assessed he did not see signs of carpal tunnel syndrome. Pt skin was tightening from the back of the finger to the fingertip. Pt had a previous ganglion on the wrist which was reassessed by the doctor. Upon reassessing the doctor found that pt had an arthritis on left wrist. Pt proposed warm heat and ibuprofen. Two weeks later, Pt started developing joint pain in shoulder, elbow, wrist and everywhere else. The doctor performed rheumatoid arthritis panel blood tests which came back positive. However, Lyme disease and lupus disease came back negative. Pt wanted to see specialist on the 09May but the pain was unbelievable pt also had to see a cardiologist in the month of Feb due to an aortic stenosis. He did not want me to take ibuprofen for some reason but when pt do not take it pt was in a lot of pain. The pain was in neck, shoulder, wrist and everywhere. Pt also had to take Prednisone for a five day regimen. Pt wrist was so swollen and looked very deformed. When the doctor looked at it, pt was surprised on how swollen and deformed it looked. Caller also tried to report online but it was very confusing for her. Caller stated and though it was a good thing that it was triggering my immune system. Pt believe pt had developed this symptom from the COVID-19 vaccine. Pt know it was gonna clean out on its own. Caller wants to know if these symptoms are associated with Pfizer COVID-19 vaccine. Caller was a female turning 71 years old soon.  Follow-up (14Apr2022): This is a spontaneous follow-up report from a contactable Nurse. This 70-Year-old female nurse (Patient) reported that: Updated Information Included: Reporter Information (Address in Slider 01) update. Patient Details (DOB, Age, Height, weight and Ethnicity) updated. RMH updated. Historical Vaccine updated. Lab data updated. Dosage regimen updated. New events updated. Concomitant drugs added.  Additional Information: Adverse Event: Transferring agent stated, So the caller had received the first dose on 19Mar2021 and second one on 16Apr2021, and the booster dose on 25Oct2021. There was couple of side effect, pt will go ahead and list them all if you like or if you want to speak to caller directly. Pt was going to be turning 71, she mentioned that there was no antibody detected after she received the two primary vaccination series (hence PC Filed Conservatively), after receiving the booster dose she had local reaction such as itching, a lot of redness, very swollen upper arm, very itchy for a few days. On Christmas day pt had bilateral hand swelling, finger was swollen, there was so much pain she thought she had Carpal tunnel syndrome, but the doctor said she does not. Her skin was so tight back to the finger till the fingertip, she had an accidental ganglion on her wrist which was evaluated by the Physician. The doctor found out that she has left arthritis in her wrist, they prescribed her warm heat Ibuprofen. 2 weeks later the joint pain went from the elbow, shoulder, and wrist and everywhere else, pt did some tests, and her rheumatoid arthritis came as positive. Pt had to see a specialist on the 9th of May. The pain was unbelievable she said, when she does not take the Ibuprofen, the pain was a lot worst and her wrist are swollen and they look very deformed. Nurse was informed about role of Pfizer Drug Safety and requested to probe. Anatomical site and Route of administration: Nurse Stated, The administration site was left upper arm and the symptoms occurred bilaterally in pt hands, progressed into my wrist and shoulder and neck. Nurse Stated, was treating with 800 mg of Ibuprofen not knowing what it was, thinking that it was just, pt had no idea that it was in hand, so pt was treating it with Ibuprofen. When pt went to see a doctor and pt had, pt went to an orthopedic because been working with the computers pt thought perhaps before retiring perhaps pt thought pt had Carpal tunnel, so pt went to an orthopedic and he said it definitely was not Carpal tunnel and he took an x-ray only on one hand and he noticed in the x-ray that there was arthritis in my left wrist. And he made that as after (voice not clear) by the way your x-ray showed you have arthritis in that wrist. So, he said to continue with the Ibuprofen for the pain and again that was only when it was in hand, but then it started progressing into the different areas, nothing (Unspecified Medications) was working. Concomitant medication: Nurse Stated, Zetia 10 mg Once a day for high cholesterol, and it was the generic form Ezetimibe (further not clarified if nurse was using the brand or generic, hence not captured in tab). Pt took CoQ10 product over the counter Qunol and it was a 100 mg and pt take that just for heart health, it was an over the counter product as supplement. Lab Test: Nurse stated, within last 2 weeks no, but pt did had rheumatoid arthritis panel performed in Feb or Mar. Nurse was informed about PDS. When confirmed if Nurse consumed Ibuprofen and experienced pain, Nurse Stated, Treated with 800 mg of Ibuprofen not knowing what it was. Pt thought pt had Carpal tunnel, orthopedic said it definitely was not Carpal tunnel. And he said that x-ray showed you have arthritis in that wrist. So, he said to continue with the Ibuprofen for the pain and again that was only when it was in my hand, but then it started progressing into the different areas, nothing (Unspecified Medications) was working.; Sender's Comments: Based on the available information a causal relationship between the reported events and suspected drug BNT162B2 cannot be 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.