Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy breast, Body temperature, Headache, Pain in extremity, Prostatic specific antigen
Clinical narrative: fever; mild headache; Just a bit of a sore arm with second one; This is a spontaneous report from a contactable consumer (patient) in response to Non-HCP letter sent in cross reference case that included. A 76-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL8982) via intramuscularly in right arm on 05Feb2021 at 09:00 (at age of 76-years-old) as single dose for COVID-19 immunisation. No prior vaccination within 4 weeks. Medical history included high cholesterol, from 2012, patient was being treated for high blood pressure. In 2018, had 3 events on A-fib (but none lasts 2 years) and has 2 conditions/ occasional Afib/ left bundle branch block was hospitalised and treatment was given and was fine now. In 2019 had IMRT (intensity modulated radiation therapy) for prostate cancer 2 yrs ago, doing well now. Patient was on medication for high blood pressure, a beta blocker for Afib and high cholesterol. Patient was diagnosed with low grade prostate cancer in 2016 and was on "active surveillance" for 2 years then has 29 sessions of intensely modulated radiation therapy and PSA has dropped to 1.6 so far so good. Swelling decrease soreness in left breast, lumps that are sore (ongoing), no hospitalisation and treatment was received. Surgery on left breast (excision of lumps); type of surgery: In-patient (local anesthesia) surgery to remove lumps and severe bruising of left breast following surgery. Surgery was not planned prior to taking the product. Past drug included spironolactone (25 mgs daily) for nearly a year and developed some sore spots/lumps in left breast and diagnosis was gynaecomastia. Patient was off of it and started on a different drug. Because he had prostate cancer was confirmed enough to have a biopsy and then a surgical excision of two of the lumps. They both tested benign. No family medical history relevant to event was reported. Patient had previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot/ batch number: EK4176) via intramuscularly in left arm on 15Jan2021 (at age of 76-years-old) as single dose for COVID-19 immunisation and had no side effects. No Prior vaccination (within 4 weeks). On 06Feb2021 (mid-day on second day of vaccination) patient experienced mild headache and fever that only went to 99.5 lasted a few hours. On unspecified date in 2021, patient had just a bit of a sore arm. Events does not require a visit to emergency room and physician office. Lab test on an unspecified date included body temperature measurement was 99.5, PSA (Prostatic specific antigen) has dropped to 16 and biopsy of left breast, needle biopsy of sore spot on left breast was performed and results was negative for cancer.  The outcome for event mild headache and fever was resolved in Feb2021 and for other events was unknown.  Any additional information: I was on your drug spironolactone (25 mgs daily) for nearly a year. I developed some sore spots/lumps in my left Brest. Dr. (name withheld) said it could be one if this drugs side effects. He took me off of it and started me on a different drug. Because I had prostate cancer was confirmed enough to have a biopsy and then a surgical excision of two of the lumps. They both tested benign. The diagnosis was Gynaecomastia.  No follow-up attempts are possible. No further information is expected.