Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Lymph node pain, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm pain; Also reports  joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest; Lymphadenopathy-Lymph node pain around left clavicle; Lymphadenopathy-Lymph node pain around left clavicle; This is a spontaneous report received from a contactable pharmacist (patient himself). A 52-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6205, Expiry date: Jun2021), via intramuscularly to the left arm on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history included Hypertriglyceridaemia ongoing. Concomitant medication included Fenofibrate. The patient previous vaccination included Shingrix used for shingles and experienced with sore arm. The patient lab test included Sar-cov-2 which was negative. Patient reported that he received his first dose of the Pfizer BioNTech covid vaccine on 26Feb2021. He is due for his second dose this Friday 19Mar2021. He is calling because he experienced lymphadenopathy- explains he experienced Lymph node pain/tenderness around his left clavicle. Caller clarified that the injection was on his left side. The pain/tenderness occurred the next day, 27Feb2021 and it was self limiting and it lasted about 5-7 days. He didn't think anything of it, everything else was ok, the arm pain resolved after one day. On 12Mar2021, he developed similar pain on the right side, but it was a more intense pain/tenderness and lasted maybe 4 days. He still experiences it, but less frequently. He is not sure if he is describing it correctly. During the afternoon, it gets a bit more tender. He doesn't feel it in the morning, but by the afternoon he notices the pain/tenderness. He did not know if there were any reports of contralateral lymphadenopathy (lymph node pain). He clarified that there is no redness or lump- he doesn't feel anything, even if he touches it there's no pain, but periodically there will be a shooting tenderness. He feels like it's getting better, but it is still persisting. He clarified that on the right side- he is experiencing pain near the axilla, underneath the arm next to the chest. He is waiting to see if it is improving and doesn't know how long he should wait. He stated that it wasn't that painful on the left side, it was just a little tender; he knew something was different. The pain wasn't always there. Sometimes there's a little pain on the left side still, but not as intense as the right side. The pain is there, it's not worsening but it is not improving. The patient also reports joint stiffness around neck and shoulder and describes discomfort as ongoing intermittent tenderness. The reporter reported events Lymphadenopathy-Lymph node pain around left clavicle, Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest to be serious due to Medically significant. The outcome of events was not recovered.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported events Lymphadenopathy, Lymph node pain and Tenderness. 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.