Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test positive, Blood urine present, Culture urine, Dizziness, Haemorrhage urinary tract
Clinical narrative: severe arm pain; Nausea; Dizziness; klebsiella pneumoniae, 50,000 to 100,000 cfu; Headache; Urine retention; blood and blood clots in her urine; blood and blood clots in her urine; tore or messed up a ligament in her hand; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in arm right on 31Mar2021 (at the age of 62-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included fibromyalgia from 1996 and ongoing, allergies from 1981 and ongoing, hypothyroidism and is pre-diabetic from 2012 and ongoing, Lyme disease from an unknown date and unknown if ongoing, concussion from Sep2019 to an unknown date, post-concussion syndrome from Sep2019 and ongoing , seasonal, food and chemical allergies from an unknown date and unknown if ongoing and had wisdom teeth extracted on an unknown date. The patient's concomitant medications were not reported. The patient previously took nalbuphine hydrochloride (NUBAIN) and experienced anaphylaxis. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EN6206), administered in right arm on 10Mar2021 for COVID-19 immunisation and experienced Face and ears became very flushed, red, and itchy, Headache, headache was more like a migraine/felt like a migraine, but worse, Post concussion syndrome was retriggered, not eating well and had lost some weight, feeling more worn out, she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction, flu like symptoms, achiness all over, pelvic pain and pressure, some burning during urination, did not have the energy level and stamina that she used to, blood in her urine and clots, she was not able to release the urine (urine retention), Nausea and Dizziness. About a week after receiving the second dose of the Covid-19 vaccine on 31Mar2021, she noticed the feeling again of retaining the urine. She was not swollen or anything and immediately went with increased fluids. The urine retention was not as severe at that point. It really showed up and intensified quickly with groin pain, pelvic pain, abdominal pain, and some back pain. She woke up the next morning after being doubled over in pain the night before and there was so much blood in her urine that she couldn't see any urine. Her urine was the darkest burgundy and the color of the darkest wine. She did not have anything in her urine the night before when she was doubled over in pain. She was increasing fluids and even drinking Propel for the electrolytes to make sure she was not making things worse. She woke up around 5 AM and felt so sick to her stomach. She had nausea the night before, but she was really nauseated the morning that she discovered blood in her urine. She woke up with severe nausea last Friday, 30Apr2021. Her doctor performed a urine culture. The urine culture returned positive for Klebsiella Pneumoniae with 50,000 to 100,000 CFU/mL on 30Apr2021. She does not have the urine culture results from her first doctor visit. Her friend is an RN that is administering the Covid-19 vaccine, was talking to company representatives and told the caller that she needed to call company to make a report and see if anyone else has experienced the same adverse events. Urinary retention came back in Apr2021 following her second dose of the Covid-19 vaccine on 31Mar2021. She can really go to the bathroom, but she is still feeling the abdominal and pelvic pressure as well as some burning and pain. Her symptoms are improving but not enough. It feels like she always has a full bladder still. She tore or messed up a ligament in her hand and she has been going to occupational therapy. She can't seem to be able to handle a pain level like she used to. It seems like pain is triggering her feelings of nausea and dizziness. Her body is not doing things well right now. The day before, of, and after getting the Covid-19 vaccine, someone suggested taking electrolytes before the second dose of the Covid-19 vaccine, so she drank Powerade. She was expecting the symptoms following the second dose of the Covid-19 vaccine to be a lot worse and they were a walk in the park in comparison. She had a mild headache the first day, 31Mar2021. She woke up in the morning of 01Apr2021 and her headache was gone. Following the second dose of the Covid-19 vaccine, she had severe arm pain. It felt like she was walking around with someone constantly punching her. She was moving her arm all around trying to get it to stop hurting. She saw blood and blood clots in her urine for over 24 hours. The blood and clots were lessening over the 24-hour time period. She probably saw in a 2-hour period at least 60 clots about the size of a quarter to a half dollar. The pain was excruciating. She was taking Phenazopyridine but is still feeling a sense of urgency, burning, and sometimes pain during urination. Her doctor did give her a prescription for phenazopyridine, but it was cheaper for her to buy over the counter and take the same dosage. She has been taking generic Macrobid, Nitrofurantoin Mono, 100 mg twice daily. It was dispensed in a pharmacy bottle. She is seeing a urogynecologist tomorrow, 06May2021. The patient underwent lab tests and procedures which included culture urine: unknown cfu on 26Mar2021 and culture urine: klebsiella pneumoniae, 50,000 to 100,000 cfu on 30Apr2021. The outcome of the event Headache was recovered on 01Apr2021 while of the rest was unknown. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported 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.