chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date of Admission: 3/9/2022   Chief Complaint:  Low hemoglobin    Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 38y.o. male who presented to Emergency Department after he was seen by his primary care doctor who noted that the patient was anemic. Patient also had a reported syncopal event last Saturday which is why he saw his PCP.   Patient is known to the Gen. surgery team. Patient did undergo an EGD and colonoscopy on 10/19/2021 for anemia with general surgery and the patient was found to have H. pylori gastritis as well as a adenomatous cecal polyp. The gastroenterology team did evaluate the patient after this for possible endoscopic mucosal resection of the polyp and the patient underwent a repeat colonoscopy on 12/14/2021. GI team did note a large polyp Floyd neoplasm in the proximal ascending colon greater than 3 cm as well as a 1.5 cm pedunculated polyp in the midascending colon as well as internal hemorrhoids. Patient was not a candidate for endoscopic mucosal resection, and was referred back to surgery for resection. On 2/22/2022 patient underwent a laparoscopic right hemicolectomy which was uneventful. His postoperative course is uncomplicated with return of bowel function and he was subsequently discharged on 2/24/2022. Patient did undergo follow-up in office on 2/28 which patient was noted to be healing appropriately with return of regular bowel movements and tolerating a diet. He shouldn't did come to the general surgery office yesterday for staple removal. He was noted to be continuing to pass gas and have bowel movements.   Patient was seen and examined at the bedside in the emergency department. On presentation patient is hemodynamically stable and afebrile. A states that he was initially doing well postoperatively. Prior to his first postop appointment he states that he had an episode of multiple loose stools and had gotten lightheaded and had a near syncopal event however it resolved after food hydration and continued to do well subsequently following that. He does state that last Monday however he was having some tight right sided abdominal pain and significant bloating and which she had multiple episodes of emesis and felt significantly better. He reports that since then he is still have a tall crampy right-sided pain. He has been passing gas and having regular bowel movements. He denies any further episodes of emesis. He denies any blood in his stool. Currently denying any fevers or chills.   Patient is noted to have a mild leukocytosis of 12.1 as well as a hemoglobin of 7.0. His hemoglobin was last noted to be 9.4 on 2/23 prior to discharge from the hospital. Patients labs are otherwise unremarkable. Patient did undergo an acute abdominal series in which there was mildly dilated loops of small bowel with air-fluid levels. CT scan of the abdomen and pelvis was ordered revealing post-surgical changes near the right hemicolectomy anastomosis line with a air-fluid 4.3 cm fluid collection concerning for abscess with dilated loops of bowel favoring an ileus.
Information has been received from a consumer concerning a 13 year old granddaughter who, on an unspecified date was vaccinated with her second dose of GARDASIL (Lot #, site and route were not reported). Concomitant therapy included antibiotics (unspecified) for a cold and nasal spray (unspecified) for allergies. "Soon after receiving the shot", the patient experienced redness and soreness at the injection site. "This effect disappeared, but soon afterward a brown spot appeared at the injection site (like a birthmark), and is still present". The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested.
Pt recvd vax & exp hives, dizziness & lightheadedness; No further details were provided;
AUG94 noted lt flank pain w/inability to empty bladder; 15SEP94 appt w/MD for inc severity of pain to lt side;23SEP94 w/t100 orally;lower abd pain;1NOV94 shingles, no rash; 17NOV SOB, chest pain; allerg react;
Patient became faint and dizzy 10 minutes after receiving her first dose of the Moderna COVID-19 vaccination.  911 was called and she left in the ambulance to receive care at the ED.
Vomiting and screaming continually for about an hour. She is not keeping any formula down.
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 43-year-old female patient who received MENVEO (batch number X17054, expiry date unknown) for prophylaxis. On 28th August 2018, the patient received the 1st dose of MENVEO. On 28th August 2018, less than an hour after receiving MENVEO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), throat swelling and shortness of breath. The patient was treated with BENADRYL. On an unknown date, the outcome of the anaphylactic reaction, throat swelling and shortness of breath were recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction, throat swelling and shortness of breath to be related to MENVEO. Additional details were provided as follows: The patient had an anaphylactic like reaction which included throat swelling and shortness of breath within an hour after vaccination. The reporter stated that she was not completely certain if the patient was pregnant. She said initially that the patient was not pregnant. The pharmacist asked about administering the 2nd dose to the patient which has not happened till the reporting time. The pharmacist asked about diluting MENVEO or administering small amounts of MENVEO to desensitize the patient. The reporter stated that it has not been administered this way to the patient at time of reporting. The reporter did not consent to follow-up.
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old patient (gender not reported) who was vaccinated once with a 1.0 ml dose of IMOVAX RABIES (Batch number: N1L383M, expiration date: 26-Feb-2019) via intramuscular route in the right deltoid on 28-Jul-2018. This was a case of syringe issue and vaccine underdose as after drawing from the vial IMOVAX VACCINE started leaking between the needle during injection which was provided by company in kit. It was not reported whether the patient experienced adverse effects post vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 18-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose and route of administration were not reported; lot number N014946, expiration date 01-FEB-2019). On the same date, the patient received a second dose of the vaccine (dose and route of administration were not reported; lot number N014946, expiration date 01-FEB-2019). No adverse effects were reported. No product quality complaint was filed.
Anaphylaxis (Extreme dizziness, feeling of impending doom, rapid heart rate, trembling).
Within 5 minutes face and chest red.  Inside of mouth numb. Trouble swallowing,
Projectile vomiting accompanied by uncontrollable diarrhea that lasted for 24 consecutive, HELLISH hours...
pt had fever of 101, irritable, soreness & lump in shot location; treatment tempa every 4 hrs & cold compress;
LARGE AREA OF REDNESS APPEARED THIS MORNING (2/7/19) TWO DAYS POST INJECTION. THE PATIENT REPORTED NO PAIN, JUST SWELLING AND A SMALL PATCH OF ITCHINESS. TOLD PATIENT SHE COULD TAKE BENADRYL AND EITHER IBUPROFEN OR TYLENOL AND ALSO CALLED THE PHYSICIAN TO REPORT REACTION.
High fever, weakness, paranoid and confused. DIfficulty breathing, hoarseness, wheezing, dizziness, fast heartbeat. I went tit he ER and they drew blood. Then left me there to sleep. WhenI woke up they refered me to a clinic in my area. Student is still complaining for throbbing head, stiff neck, pain down her back in area of spine. Sore and stiff arem, nausea, muscle pain. Temp today 100.7 degrees. Has follow-up with Dr. Has slept some on nurses couch today waking up complainingof pain. 3/12/2009
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient was having rash the following day on the lower extremities, and swollen lympnodes
Client stated that about 1 hour after receiving the shot, she started to get pain up the neck and into the shoulder. Client stated headache for 4 days after the shot. Reported sore arm for abut 4 days. She reported no fever. Client reported achy body for 9 days; stated that her lower back was extremely sore and stiff. Client reported that she had confusion for 7 days after immunization. Client reported that she was sleepy for 2 weeks. Client stated that she had no redness in the arm that had the immunization.
painful itching started during the night around injection site, a week after receiving injection.  slightly swollen, red rash about 1 1/2 inches in diameter.  itching is continuous
100-102 fever 10 hours after vaccination. Diarrhea, vomiting, chills, headache, muscle aches
Pt was admitted to hospital on 11/15/2021 presenting with weakness Pt was tested for c-19 on 11/18/2021. Pt has been treated with Vatiamin c , Setrezine, Vitamin B-12, Ferra sulfate.
was fine all day but then woke up at 2 AM with a mild fever (100.2); body aches; feel worn out; received flu shot and Pfizer Bivalent vaccine against Covid on the same date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 11:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2022 at 11:00 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 04Oct2022 at 11:00, outcome "unknown", described as "received flu shot and Pfizer Bivalent vaccine against Covid on the same date"; FATIGUE (non-serious) with onset 05Oct2022, outcome "unknown", described as "feel worn out"; PAIN (non-serious) with onset 05Oct2022 at 02:00, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 05Oct2022 at 02:00, outcome "recovered" (05Oct2022), described as "was fine all day but then woke up at 2 AM with a mild fever (100.2)". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient received flu shot and Pfizer Bivalent vaccine against Covid. He/she was fine all day but then woke up at 2 AM with a mild fever (100.2) and body aches. Today (05Oct2022) she/he just felt worn out but his/her fever was gone.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I got very severe pain in my right knee; after that very severe pain in my right knee and my left shoulder; the pain in the right knee was so bad; I couldn't walk like 4 days; I also had the chills for number of days; the pain in the left shoulder, very bad pain; not feeling well; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) dose 1 via an unspecified route of administration in Arm Right on 14May2021 (at the age of 69 years old) as dose 1 single for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date the patient experienced as, he got very severe pain in my right knee; after that very severe pain in my right knee and my left shoulder; the pain in the right knee was so bad; he couldn't walk like 4 days, he also had the chills for number of days, the pain in the left shoulder, very bad pain, not feeling well. Consumer stated that, he had  first Pfizer Covid-19 shot on 14May and for the first two days, he didn't have any symptoms but then he started, he got very severe pain in his right knee. After that very severe pain in his right knee and left shoulder. he got the vaccination on right shoulder but the pain in the right knee was so bad. he couldn't walk for like 4 days and its better now but he have and he have arthritis it normally gets pain like that chills the vaccine. he have arthritis but he don't get normally get pain like that, its better now. he also had the chills for number of days. The pain in the left shoulder, very bad pain. he stated from 3rd day he started experiencing sever right knee pain ( lasted 5 days) and unable to walk, left shoulder pain (received vaccine in the right arm) lasted about 2 days, chills and not feeling well. he stated he has ostomy and gets dehydrate easily. He stated he scared to deat to take second dose. patient received treatment some pain medication. Outcome of the event knee pain was recovered, while outcome of other events was unknown.  Information about lot/batch number has been requested.
On the same evening I received a flu shot in my right arm and the Pfizer booster in my left. I had already completed 2 rounds of pfizer vaccination in April of 2021.  On Friday night I began having some tightness in my chest, and the injection site from the booster was extremely painful. When waking up ok Saturday morning I was still in a lot of pain and noticed the lymph nodes in my left armpit were severely swollen. The lymph nodes in the left side of my throat were also a bit swollen.  The pain in my arm, chest, and lymph nodes has subsided a bit throughout Saturday, though I still have a significant lump under my arm.
Intended to give flumist intranasally; accidentally gave high-dose fluzone intranasally
Body ache; chills; little bit fever; redness under the injection site that is spreaded upto his elbow; swelling under the injection site that is spreaded upto his elbow; swelling has move down from the elbow to the arm area; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow) and INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow), INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) and SWELLING (swelling has move down from the elbow to the arm area). At the time of the report, MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow), INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) and SWELLING (swelling has move down from the elbow to the arm area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection at 12:30PM, 4PM Acute severe Right deltoid pain, constant, weakness of arm, unable to move right arm. 5pm pain continues along with spasms. Treated with NSAID/ICE. MD appointment the following day, diagnostic imaging and Vicodin and Motrin prescribed. Off of work due to inability to move arm. MRI pending.
a kid was vaccinated with VARlVAX and had a localized reaction; The reaction was red swollen; The reaction was red swollen; hot to touch area; cellulitis at the shot location; This spontaneous report was received from an office manager referring to a 1-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 09-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliters, subcutaneous, lot number T022314, expiration date 30-JUN-2022 for vaccine series.        On 09-MAR-2021, the patient had a localized reaction. The reaction was severe and had to be treated with antibiotics. The reaction was a red swollen, hot to touch area on the left thigh, 4 cm wide that required medical attention (injection site reaction, vaccination site cellulitis, injection site warmth, injection site inflammation and injection site erythema). Caller reported she had been doing this for 30 years and had never seen anything like it. Caller reported the reaction was coming from a specific lot number of VARlVAX, and was sure was not the diluent because it had been used to reconstitute other vaccines and no such reactions had been seen.      The outcome of injection site reaction, vaccination site cellulitis, injection site warmth, injection site inflammation and injection site erythema was reported as not recovered. The causal relationship between varicella virus vaccine live (oka/merck)(VARIVAX) and the events was not reported.; Sender's Comments:  US-009507513-2103USA006614:
Per patient's mom - patient complained about being very warm then lost consciousness for a few seconds. I was notified about the patient shortly after. symptoms: warmth, grogginess, pale, no recollection of walking from the IMZ area to the bench time: occurred within 5 minutes after injection outcome: approximately 10-15  minutes later, patient was noticeably better, smiling and left with her mom. Notes: Mom refused 911 said she'll monitor her daughter. Patient claimed this happened after blood drawn not too long ago.
Arm pain at the injection site that progressively has moved into shoulder area. Left hand tremors started and have progressed to arm. Patient noticed both eyes quiver at peripheral which has resolved. Has been seen by PCP, Neurologist, Chiropractor, Hematologist.
Pt presented to our office on 11-1-16 with a scattered rash on back, arms, legs and head. The rash had erythematous macules to papules and vesicles.
severe case of flu symptons ..fever,aches sweating chill nausea   sleeping   lasting at least 24 hours
Within 30 mins of taking vaccine, patient felt fine but throat was "tingly". Voice is hoarse, almost as if she was screaming. No soreness or pain - just loss of voice.  Took tylenol and drank plenty fluids. Hasn't felt ill at all.
Small rash on left under arm; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 17Mar2021 at 09:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. The patient was allergic to talc. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 19Mar2021, the patient had small rash on left under arm. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse event. The clinical outcome of event rash on was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Pt BIBA to ED with lower extremity weakness and pain.  CT angio showed occlusion of the aorta and branching vessels.  Pt expired.  It was noted that she received the Moderna COVID vaccine six hours prior to presenting to the ED.
Urine turned neon yellow; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX) for an unknown indication from an unknown date and unknow if ongoing. On 21Apr2021 at 20:30, the patient urine turned neon yellow later that night. The next day, patient's urine was still a bit yellow now, but much less than before. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of adverse event. The clinical outcome of the event urine turned neon yellow was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
21yo Active Duty female Navy Sailor currently deployed to UAE reports to Fujairah Detachment medical clinic with c/o bottom lip swelling x 96hrs, which began about 24 hours post receiving the J&J vaccine on 16May21 in Jebel Ali, UAE. Pt denies any pain, tingling, or numbness but does report a throbbing sensation in the lip. Pt denies any dyspnea, SOB, dysphagia, or difficulty eating/drinking. Pt states there is also a blister like red spot on the middle of the lip. Pt denies any fever, body aches, fatigue, n/v, or other skin lesions. Pt denies any history of cold sores/herpes labialis. Pt denies having anything like this from a vaccine in the past. No history of medication, food, or environmental allergies. Pt also reported HA, stomach ache, and feeling weak for 24 hours after vaccination then resolved, but lip then swelling began and persisted prompting medical evaluation. Provider prescribed 25mg Benadryl which significantly decreased the lip swelling over the following 6-8 hours.
full body and face rash (described as hives), decreased PO intake with perceived choke/gag and facial swelling;  no V/D, no SOB;  and low grade fever
as i was giving the pneumovax-23, patient stated that her muscle twitched. next morning, she woke up and it really hurt. during the day, it started to get very red and inflammed and it hurt. saturday morning (11-16) she stated her arm was all red and swollen from her shoulder to down past her elbow. she went to urgent care where the doctor diagnosed her as having cellulitis/staph infection. they put her on bactrim ds. she is feeling much better now.