Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hyperhidrosis, Pain in extremity, Prostate infection, Sleep disorder, Urine analysis
Clinical narrative: Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; lightheaded; Abdominal Discomfort; prostate infections; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Mar2021 at 14:30 (at the age of 54 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included benign prostatic hyperplasia (BPH) and cholesterol. The patient was diagnosed with BPH a few years back 2016 or 2017 and had a uralist in 2019 and that resolved his issues. The patient had been on no BPH meds and back to normal since that procedure. Co-suspect medication included atorvastatin (LIPITOR) from an unknown date to 01Apr2021 at 40 mg, 1x/day for blood cholesterol. On an unspecified date in Mar2021, the patient experienced prostate infections, and abdominal discomfort. On 25Mar2021, the patient experienced arm pain, and was lightheaded. He described the arm pain as he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5 inches above his wrist. On 31Mar2021, the patient experienced couldn't sleep, anxiety, sweat, urinating blood, and dark colored urine. The patient was concerned with the dark urine so he stopped taking atorvastatin, and called his physician who said he didn't need it anyhow. The patient visited the urologist office and was prescribed ciprofloxacin (CIPRO) as treatment for dark colored urine, urinating blood and prostate infection. On 06Apr2021, the patient experienced leukocytes in urine. Relevant lab data on 06Apr2021 included a urinalysis which resulted in leukocytes and blood +3. The action taken in response to the event dark urine with atorvastatin was permanently withdrawn. The outcome of the events prostate infection, and abdominal discomfort was recovered on an unspecified date in 2021. The outcome of the events arm pain, and lightheaded was recovered in 26Mar2021. The outcome of the events couldn't sleep, anxiety, and sweat was recovered on 01Apr2021. The outcome of the events urinating blood and dark colored urine was recovered on 06Apr2021. The outcome of the event leukocytes in urine was unknown.; Sender's Comments: Based on the current available information, the serious events Prostate infection, Blood in urine, and Urine color abnormal are most likely related to an intercurrent or underlying condition which is not related to the suspected drugs. Relevant medical history of benign prostatic hyperplasia (BPH) may provide a plausible explanation for the events.  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.,Linked Report(s) : US-PFIZER INC-2021450744 same patient/SD, different AE/dose