Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, Pain in extremity, Vaccination site pain
Clinical narrative: her husband's pain is more in his right elbow and right shoulder/pain is more like a joint pain; right arm pain started with the COVID-19 Vaccine injection site/pain is in his right (dominant) arm; husband is experiencing a sore arm, husband's arm has been sore as worsened; This is a spontaneous report from a contactable nurse.  A 86-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via intramuscular route of administration, administered in Arm Left on 03Feb2021 14:15 as single dose for covid-19 immunization. Medical history included was none. Concomitant medication was not reported. Upon follow-up (16Mar2021): it was reported that, first dose of Pfizer covid-19 was shot on an unspecified date at 14;15 PM via intramuscular route of administration in right arm of Batch/Lot number: EL9269. She said her husband's arm has been sore for 8 days. Her husband's arm has been sore for 8 days was reported as worsened. She said her husband tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his sore arm, and pain was in his right (dominant) arm, the pain was more in his right elbow and right shoulder, and her husband's pain is more like a joint pain. She said her husband has a high tolerance for pain, and normally doesn't take anything for pain. She said her husband can't put his jacket on because he is unable to lift his arm due to the pain in his right elbow and right shoulder. She said her husband has been trying everything, and nothing seems to help his right elbow and right shoulder pain much. Clarified her husband's right arm pain started with the COVID-19 Vaccine injection site and then the pain moved into his right shoulder and then into his right elbow. Reported her husband had a CAT scan of his head and neck on 01Feb2021 checking for blood clots. She said the results of the Head and Neck CAT (Computerised tomogram) Scan were normal. Reported her husband's second COVID-19 Vaccine dose is scheduled for 24Feb2021. The reporter classified the event husband is experiencing a sore arm and husband's arm has been sore as worsened as disability and other events was not reported and assessed the causality between the event husband is experiencing a sore arm and husband's arm has been sore as worsened the vaccines as Related. Upon follow-up, it was reported that, the patient has a very sore arm for about 8 days but then it resolved and no trouble since then. His second shot did not have much of a reaction and both are fine now. Therapeutic measures were taken as a result of husband is experiencing a sore arm and husband's arm has been sore as worsened and included treatment with ADVIL at a dose of 200 mg (Lot Number: W36210, Expiration Date: Nov2019), TYLENOL, at a dose of 500mg, hot packs and old packs. Upon follow-up (16Mar2021), the outcome for the events were recovered on 11Feb2021.  Follow up (16Mar2021): This is a follow-up spontaneous report received from a contactable nurse includes, updated information about the first dose of Pfizer vaccine, route of administration for the second vaccine and the outcome for the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering temporal relationship and known safety profile, the reported pain in arm was likely causally related to the vaccination with BNT162B2. The case will be reassessed should additional information become available.  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.