Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: upper bicep pain/soreness around upper part of bicep; tendonitis; lymphadenopathy; sore deltoid; This is a spontaneous report from a contactable Other Healthcare Professional (patient).  This 58-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EI0142, expiry date Mar2021), intramuscular once to the left deltoid, on 28Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 58-years-old. Medical history was none. Concomitant medications included an antihypertensive medication taking for several years. On 28Dec2020 the patient experienced side effects including sore deltoid (lasted for 2 days, Dec2020), and on 01Jan2021 the patient experienced upper bicep pain which he felt 5 days later (his friend said it may be lymphadenopathy).  The caller had the COVID vaccine on 28Dec2020, and from 28Dec2020 he had a sore deltoid for a couple days, but then almost a week later developed, he thought it was tendonitis, it was the upper part of his bicep, really he could not extend his arm all the way, it was so painful in that area, and it's still somewhat painful, but better. The sore deltoid was pretty much after the shot and into the next 48 hours, that went away, then he noticed this soreness around the upper part of his bicep, not until, probably, maybe 5 days later, on 01Jan2021. He was chatting with someone, who mentioned soreness in the underarm area, that person felt it was lymph nodes, so maybe, there is possibility, caller thought this was muscle pain, as it hurts when he tried to extend his arm, it does not hurt when sitting here, but when he extends, especially over his head, it is really quite painful but it's lessened, he thought it was a tendonitis, but it could be the lymph nodes active or enlarged, he is not sure, he has never noticed lymph node pain, so he never knew what it was.  Causality for soreness around upper part of bicep was reported as yes. He is pretty sure, since he has not done anything that aggravated that muscle, he can't think of anything, and it is in the general vicinity of the injection. States he is on an antihypertensive medication, but has been taking it for several years. He doesn't want to go through a report for the person he spoke to, who mentioned soreness in the underarm area, but it is interesting: the caller told him that had soreness, caller knows he also did report it, he reported it to Pfizer, actually he doesn't know if it was Pfizer or Moderna, but he reported it to whichever company, and said he thought was inflamed lymph nodes, so that was the first time he thought it was not muscle, but maybe the lymph node's reaction to vaccine, he has never experienced this kind of discomfort, he could not straighten his arm, as he would straighten the pain was at the upper insertion at the bicep, so that is where he came to this conclusion, his preliminary conclusions, he never thought it would persist this long. He thought, as time went by, it would be better tomorrow, and it has gotten better, but has not gone away.  Sore deltoid was reported as non-serious while soreness around upper part of bicep was reported as serious medically significant because it has persisted for so long, he would have not expected it to keep going on, but it is almost going on two weeks. Outcome of the event soreness around upper part of bicep, lymphadenopathy, and tendonitis was not recovered while the outcome of the sore deltoid was recovered in Dec2020. His second dose is scheduled tomorrow (14Jan2021) and wants to know if he can still take it.; Sender's Comments: There is a reasonable possibility that the events myalgia and lymphadenopathy were related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event tendonitis with BNT162b2 can not be fully 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.