Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Feeling abnormal, Urinary bladder haemorrhage, Weight decreased
Clinical narrative: reaction to the nitrofurantoin mono-mcr; brain fog (which came and went); weight loss (lost 20 lbs); very little energy; bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gluten intolerance and Allergy to antibiotic (nitrofurantoin mono-mcr).   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-May-2021, the patient experienced FEELING ABNORMAL (brain fog (which came and went)), WEIGHT DECREASED (weight loss (lost 20 lbs)) and ASTHENIA (very little energy). In May 2021, the patient experienced URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced ADVERSE DRUG REACTION (reaction to the nitrofurantoin mono-mcr). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form and NITROFURANTOIN at a dose of 100 mg, 1 dose. In June 2021, URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) had resolved. At the time of the report, FEELING ABNORMAL (brain fog (which came and went)), WEIGHT DECREASED (weight loss (lost 20 lbs)), ASTHENIA (very little energy) and ADVERSE DRUG REACTION (reaction to the nitrofurantoin mono-mcr) outcome was unknown.            No relevant concomitant medications were provided. Patient  experienced the events within a week after receiving the second dose of the vaccine. Patient had visited the emergency room (ER) multiple times for the bleeding from the bladder and  tests were done.  It is stated that within a week, the patient experienced bleeding from the bladder, brain fog (which came and went), weight loss, which started shortly after second shot (lost 20 lbs), from start had very little energy (which was sporadic but had improved). This was not on 14-MAY-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-220964 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.