Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Intraocular pressure test, Investigation, Ophthalmological examination, Physical examination
Clinical narrative: a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pain. He clarified he had a Percocet prescription leftover from his hospitalization in Nov2020. He said he took another dose of the Percocet the week before 31Jan2021 for pain in his knee from the fall he had in Nov2020. He said his eye doctor told him his dry eyes could be caused by the Percocet. He said his eye doctor prescribed lubricating eye drops (Refresh Optive Mega 3, UPC Number: 0023577330, Lot Number: T095, and Expiration Date: Aug2022), that he is to use in both eyes every hour, and an eye ointment in his left eye only at bedtime. He had been using crutches when he walks because of the problem with his right knee since he fell in Nov2020. He said on 06Feb2021, he took a shower, and when he went to get out of the shower, his right leg gave out. He said he didn't fall, but he couldn't walk afterwards. He said he went to the Emergency Room on 06Feb2021, and an x-ray and sonogram were done of his right knee. He said he was told he had another soft tissue injury like he had when he fell back in Nov2020. He said he was given a leg immobilizer to use. He said when he first fell in Nov2020, he originally fell on his left knee. He said he has had PT since being discharged from the hospital on 17Nov2020. He said he also had a pacemaker implanted while he was in the hospital in Nov2020. He said after his discharge from the hospital on 17Nov2020, he went to take shower at home on 18Nov2020 and his left knee gave out. He said he was able to lower himself to the floor in the shower stall, but he couldn't get out of the shower stall. He said he was left sitting on his left leg and he couldn't use his right leg. He said he finally got himself to bed, and iced his right knee because he sat on it for over an hour. He said the next day (19Nov2020), he couldn't walk and had to have an ambulance take him to Emergency Room. He said he hasn't had PT since 27Jan2021, and needs clearance from his doctor before he can restart PT. He said he has been without PT for 2 weeks now. He said on 06Feb2021 he was unable to get a MRI on his knee because he had too much swelling that would have made the MRI imaging cloudy. On 06Feb2021 he was due for his second COVID-19 Vaccine, so before he was discharged from the Emergency Room he was given his second COVID-19 Vaccine dose. He was using the Refresh Optive Mega 3 eye drops constantly now. He said he had no fever, but is more tired than in the past. He said the last couple of days he can sleep for hours, and wake up and feel like he can go right back to sleep. He said he and his cardiologist are concerned because since 27Jan2021, he has only been on Aspirin 81mg. He said he has 3 cardiac stents since Oct2020, and should be on dual therapy. He said he had a CT of his abdomen and pelvis while he was in the hospital. He said he has been off of Plavix since 27Jan2021, and can restart the Plavix until he has a cystoscopy. He wants to know if UTIs in men are common after getting the COVID-19 Vaccine, so he can decide if he should cancel the cystoscopy and restart his Plavix. The second COVID-19 Vaccine Lot number as EL9261 or EI9261. He stated the vaccine lot number was handwritten on his COVID-19 Vaccine immunization card and was difficult to read the handwritten vaccine lot number. The patient underwent lab tests and procedures which included bacterial sepsis: gram negative urinary tract infection on 28Jan2021. Clarified he had no pain, burning, or urgency with the UTI. He said he was told by the hospital he had gram negative rods in his urine, when he was started on the IV Ceftriaxone on 29Jan2021. He stated he has never had a UTI before. Clarified his body temperature is rarely 98.6 degrees, and is normally 98.2 degrees and he had never had shingles before. He said he had chicken pox as a young adult, and he only had 1 spot of chicken pox. He had never had dry eyes before. Reporter seriousness for fever, UTI, injection site pain, injection site redness, injection site puffiness, rash, shingles were medically significant. For other events were unspecified. The outcome of event injection site pain, injection site redness, injection site puffiness was recovered on 31Jan2021, dry eye, tiredness was not recovered, while the outcomes of other events were unknown.; Sender's Comments: Based on the temporal association and the known possible local reaction, a possible contributory role of BNT162B2 to the development of injection site pain, redness, and puffiness cannot be excluded. The other events are considered as due to underlying or intercurrent conditions and unrelated to the use of BNT162B2. 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-2021134924 same reporter/drug, different patient, similar event