chrisvoncsefalvay/vaers-outcomes huggingface dataset:
urinating blood. It progressed to clots; Hematuria; urinary tract infection; acute cystitis with hematuria; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2, via an unspecified route of administration, administered in Arm Left on 14Aug2021 11:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization/Covid Prevention. Medical history included microhematuria from an unknown date and unknown if ongoing and developed a keloid from getting the small pox vaccine on an unknown date. There were no concomitant medications. On 15Aug2021, the patient experienced urinating blood. it progressed to clots, hematuria, urinary tract infection and acute cystitis with hematuria. The events were assessed as serious (medically significant). The events resulted in Emergency Room visit and Physician Office visit. There were no prior vaccinations (within 4 weeks). The clinical course was reported as follows: Patient went to the emergency room. She was told her she had a urinary tract infection and was put on an antibiotic. She was convinced it was caused by the vaccine. She will be seeing a urologist for testing. She asked if she should get she get the second dose. The urologist told her to wait until she was scoped to see if anything was going on in bladder. Patient's height as 5 feet 2 and 7/8th inches. She had the shot on Saturday 14Aug2021 at 1130 am. The following morning she woke up feeling like she had a urinary tract infection. She started urinating blood. It progressed to clots. She went to the urgent care. They saw that the level was significant. After 36 hours she went to the urgent care. She was told to contact the doctors office. The office told her to go to the emergency room. She went to the hospital. They did the same test as the urgent care and had the same conclusion. Since age 21 she has had microhematuria. She sees a urologist every 6 months for testing. At the urgent care and hospital she had a kidney and bladder ultrasound. At the hospital they said she had acute cystitis with hematuria. The impression from the Kidney Renal Ultrasound was no hydro nephrosis or shadowing renal stones. The bilateral ureter jets were visualized. The kidneys are normal in echo texture. No evidence of hydro nephrosis or shadowing calculus. She was unable to find any information about someone having gross hematuria and if they should get the second dose. Her doctor will see if there is an underlying cause. This is not a normal reaction and should not have happened. The patient is apprehensive about getting the second dose. She found reports of other people having it from a creditable website. She does not have any details to provide. The patient underwent lab tests and procedures which included Kidney and Bladder Ultrasound: both normal in Aug2021. Therapeutic measures were taken as a result of urinary tract infection. The outcome of the event 'hematuria' was recovered in Aug2021 and outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11-13-05 in the AM pt noted left deltoid to be red, warm to touch, puffy and itchy. Pt. applied cold pack and anti-itch topical medicine.
Shooting pains in my head persist.  This is not a headache, but they are sharp pains at approximately 1-2 minute intervals.  Tuesday and Wednesday the pains were on both sides of my head.  Thursday the shooting pain continues on the right side at the same intervals.  Additionally,  the injection site is still red and swollen.    I  also had chills and total body aches for more than a day.  Please note that I weigh 108 pounds.  I assume that I received the same dose as a 150 lb. woman or  200 lb man.  Shouldn't weight be a consideration?
feeling sick; sore throat; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling sick"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose". Therapeutic measures were taken as a result of malaise, oropharyngeal pain, rhinorrhoea.  Additional Information: Age of patient: 52, unknown unit. The patient was feeling sick and she has second covid shot tomorrow. The consumer asked if it is ok if she gets it. She doesn't think it is Covid because she only has a sore throat and runny nose. She was on an antibiotic, asked if that will be an issue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the second dose of Moderna series too early. The first dose was administered on 4/30/2021. No adverse reaction/event noted during the immediate 15 minute post vaccination observation period.
Given vaccine that was beyond it's BUD of 7/22/2022 Patient is in the beginning of her third trimester of Pregnancy - due in November
Narrative:  Patient received 1st Pfizer COVID-19 vaccine on 3/16/21 and 2nd  dose on 3/30/21. [14 day interval between doses.] The interval between Pfizer doses in 21 days (However, 2nd doses administered within a grace period of 4 days earlier than the recommended date for the 2nd dose are still considered valid) Per guide for use of COVID-19 Vaccines (Recommendations for COVID-19 vaccine administration errors and deviations), Do not repeat dose if second dose administered fewer than 17 days (Pfizer-BioNTech) after first dose.
Saturday Jan.2 my left arm/shoulder area had a rash, itch, hot to touch and swollen.  It was a little painful. On Jan. 3 it was hotter, more swollen and more red. I called Medical Center and Dr instructed me to draw a circle around the red area if it got larger than the circle go to the ER. By that evening it did get larger but moved down my arm. It would decease from where it started, it had just moved. I decided to see my PCP the next day, she told me she would call me back. She put me on 10 days of Teplaxton, she stated she suspected cellulitis.
She received Moderna COVID vaccines on 12/30/20, 1/27/2021, and 10/30/2021. She presented to the ED of a local HCF with 2 days of vomiting, chest pain, cough, SOB, back pain and abdominal pain on 5/17/22. Her COVID test resulted in positive. She was also tested positive with non-covid Coronavirus 229E PCR and Influenza A H3 PCR. Her CT showed choledocholithiasis, and she was admitted for acute bronchitis and choledocholithiasis management on the same day. She was given steroids, Ceftriaxone, Oseltamivir, Zosyn. She had ERCP for gallstone. She was one point on 4L of oxygen. She was medically stable, not required supplemental oxygen, and she was discharge to the local skilled nursing facility on 5/25/22.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On an unknown date in 2016, the patient was vaccinated with a dose of 0.5 ml expired PNEUMOVAX 23 (lot# not reported with expiration date 06-JUL-2016) subcutaneous. No adverse effects were reported. Additional information has been requested.
High fever, accelerated heart rate, fully body aches, full body chills, & migraine. Symptoms lasted throughout the night & didn't fully recover till the next day after.
Pt is a 64 y.o. male one Eliquis with a history of CAD, DM, HTN, and TIA who presents to the emergency department for evaluation of shortness of breath. One week ago patient thought he had a cold, got worse, and tested positive for Covid-19. Patient arrives ambulatory but with shortness of breath. His main concern is that he might have gotten pneumonia from his mother. Yesterday his mother was admitted to the emergency department for pneumonia and since he was not getting that maybe he had pneumonia. When he was at home his finger oximeter read 88%. Patient denies a fever.
Information has been received from a licensed practical nurse (LPN) concerning a 73 yr old male with no known drug allergies who on approx 11Oct05 was vaccinated SC in the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot0578P). The LPN reported that on approx 11Oct05, within 24 hrs of vaccination, the pt developed severe swelling from his shoulder to elbow and a red, hot, painful right arm. Unspecified medical attention was sought and the pt was treated with a antihistamine and antibiotic. At the time of this report, the pt was recovering from his events. The LPN considered the severe swelling from shoulder to elbow and a red, hot, painful right arm to be disabling and other important medical events (OMIC). Additional information has been requested.
Beginning  the night of Oct 5, I felt extremely tired. On the morning of Oct 6, I still felt very tired, became groggy and feeling as though I may be coming down with the real flu in terms of tiredness. I left the meeting I was attending abt 10:40 am, and went home. I felt more and more tired. I laid down to nap and felt crushing  fatigue. I slept for 5 hours straight, awakened and had to struggle mightily to get out of bed. I again felt paralyzing fatigue. Since I live alone, I was afraid of falling asleep and never waking up. So I called 911 and was taken to the hospital.
Patient came in on 8/31/2020 to discuss a rash that he believes may be from the Fluad vaccine he received on 8/29/2020.  The rash is only on the left side of his body, specifically some on the left arm and on the left side of the trunk of his body from the waist to just below the armpit.
Extreme pain in right shoulder. Unable to move arm without excruciating pain. Pain was a 10 on a 1-10 scale.
Injection site pain lasting more than two hours; Fever; Body aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 11:00 (Lot number: FC3592) at the age of 61 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Bnt162b2 (lot number=FD8448, Administration time=11:00 AM, Dose number=1, Vaccine location=Left arm), administration date: 05Sep2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Injection site pain lasting more than two hours"; PYREXIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were taken as a result of vaccination site pain, pyrexia, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications, the patient received within 2 weeks of vaccination: Levothyroxine at 125 mcg daily. No known allergies. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. The patient was treated with Aleve for reported events.  No follow-up attempts are possible. No further information is expected.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by the reporter and no concomitant medication was reported.  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.; 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.
On Friday, 10-17-14, she was advised that she should get a pneumonia shot before being discharged.  She had one several years ago and thought they were good for 10 years.  She feels the shot was given "improperly, either not deep enough or that the nurse hit a bone or something."  By that evening she couldn't move her right arm (where it was administered), and it has been very painful.  It didn't bother her until that night, and she had to lift that arm with her other arm.  She had to use percocet to relieve the pain in her arm, which was worse than her post-op surgical pain.  She states that from her elbow to shoulder is currently the affected area.  She's never had problems with shots before; did have a pneumonia vaccine several years ago without incident. On 10/31/14, she was able to move her right arm, but was still feeling pain and reported no change since 10/17.
Feeling unwell with pain in shoulder. At-home treatment with tylenol; feel okay; suddenly sick for 1 week with throw up, diarrhea, lack of appetite, fatigue, symptoms similar to bloodclot on left side of body, numbness in left foot for 1 month. At-home treatment for dehydration with Gatorade and coconut water; still fatigued for unknown reason 1 1/2 months later.
Subsequent to receiving vax pt developed a low fever, lasting several days. Pt was treated with Tylenol and in 2-3 days returned to normal activity.
Moderna COVID-19 Vaccine EUA Patient developed an itchy rash all over his body was told to use Benadryl and topical anti-itch cream.  He states that he is not having any pain or difficulty breathing.  I let him know that if he develops any swelling in face and throat, a fast heartbeat, or dizziness and weakness to go to the ER.  If the rash has not resolved in 2-3 days he needs to be seen by his PCP. He is scheduled to be seen by his PCP 5/25/21
my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 14:45 ( at the age of 40-year-old) as a single dose for COVID-19 immunisation at workplace clinic. Medical history included penicillin allergy (childhood). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 27Jan2021, at 12:00 the patient experienced my arm hurts, slight headache and cold sweat and did not last long at all (as reported). The patient did not receive any treatment for the events. The events were reported as non-serious. The outcome of the events my arm hurts, slight headache and cold sweat was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.
Have had extreme chronic hives since early December. If I do not take a great deal of antihistamines then it is unbearable. Was informed that this has happened with others who got the Moderna booster and it should go away in 6 weeks. It is going on 3 months with no end in sight. I will be attempting to do something more pro active at this point. Have had multiple visits and calls in an attempt to resolve and less the issue.
R57.9 SHOCK, UNSPECIFIED 9/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 9/29/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION R57.9 SHOCK, UNSPECIFIED 9/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 9/29/2022 ABNL ABDOMINAL ULTRASOUND
stomach ache; diarrhea; felt flushed; weak and tired; Endometriosis started hurting really bad; left arm was very, very sore; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), FLUSHING (felt flushed), FATIGUE (weak and tired) and CONDITION AGGRAVATED (Endometriosis started hurting really bad) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), FLUSHING (felt flushed), FATIGUE (weak and tired), CONDITION AGGRAVATED (Endometriosis started hurting really bad) and PAIN IN EXTREMITY (left arm was very, very sore). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), FLUSHING (felt flushed), FATIGUE (weak and tired), CONDITION AGGRAVATED (Endometriosis started hurting really bad) and PAIN IN EXTREMITY (left arm was very, very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details Naproxym, Tylenol.  Upon internal review on 04-Aug-2021, the age was corrected to 39 years.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.
reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 Vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (reaction). At the time of the report, VACCINATION SITE PAIN (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.
Area around inj inflamed and red area = total of approx 3 in in length. Warm and hard to touch.
On May 3, 2022 I had flu like symptoms. I had a sore throat first, then fever and cough. I contacted my doctor and Paxlovid was prescribed but it did not help. I took it for 4 days and stopped because of stomach issues. By the 5th day I was feeling better. On May 3 I tested negative for COVID. On May 4th, when I arrived home from flying I tested positive for COVID. I did a COVID test at home.  On May 10th 2022 I was feeling much better and back to 100% today.
Extreme arm pain and paresthesia of 3rd and 4th fingers on injection arm.  Inability to move left arm due to such extreme pain. I went to my doctors office a was prescribed a medrol dose pack. That helped but as soon as I finished the pack the symptoms returned.
DIZZINESS/LIGHT HEADEDNESS; BLURRY VISION; DIFFICULTY BREATHING; DISORIENTATION; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-JUN-2021 15:35 for prophylactic vaccination. The batch number is unknown and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness/light headedness, blurry vision, difficulty breathing, disorientation, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness/light headedness, blurry vision, difficulty breathing, headache and disorientation was not reported. This report was non-serious.
Day of injection patient complained of left arm pain rest of day.  Next day had headache, chills, body aches, and hives to arms and torso.  2 days later all symptoms resolved other than hives to left arm and face.  3 days later feeling well, but hives to legs.
RAPID HEART BEAT, HIGH FEVER, DIFFICULTY BREATHING, WHEEZING, PALENESS, PAINFUL SWELLING OF INJECTION SITE.
Itchy throat, cough, shortness of breath, rash across chest, large lump upper right arm.
Great soreness at injection location. The shot itself caused no discomfort. Pain started about 3 hours after injection. I had the same results after the first injection.
I just know that this particular shot has some bad side effect your arm swells and hurt; I just know that this particular shot has some bad side effect your arm swells and hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "I just know that this particular shot has some bad side effect your arm swells and hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter's Comments: ~~~