chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reoccurrence of pre-existing crohn's disease; reoccurrence of pre-existing crohn's disease; diarrhea; vomiting; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction: "reoccurance of my pre-existing Chron's Disease"; Covid-19 vaccine (Primary immunization, manufacturer unknown), for COVID-19 immunisation. The following information was reported: CROHN'S DISEASE (medically significant), DISEASE RECURRENCE (medically significant), outcome "recovering" and all described as "reoccurrence of pre-existing crohn's disease"; DIARRHOEA (non-serious), outcome "recovering", described as "diarrhea"; VOMITING (non-serious), outcome "recovering". Clinical course: With the first booster, there was a reoccurrence of my pre-existing Crohn's disease characterized by Chronic pain in the ileocecal intenstinal area. It was painful enough to require my taking prednisolone (starting at 20mg) for about 6 weeks. With the next booster, the reaction has more severe about 12 hours following the shot. I also got diarrhea and vomiting lasting about a half hour. Then I improved over the next several hours. The latest booster also caused a worsening of arthritis in my hands along with the run-down feeling.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300080872 same patient and suspect drug/different booster # and AE;US-PFIZER INC-PV202300035909 same patient and suspect drug/different dose # and AE;US-PFIZER INC-202300006841 same patient and suspect drug/different booster # and AE;
Patient with a history of COVID19 infection. She reported onset of L arm numbness, tremor, and headache. Patient-reported that this was an exacerbation of her now chronic COVID19 symptoms. We discussed the next steps and follow up with COVID19 clinic if she so desired. She was discharged without incident with her husband as the driver.
09/13/22 presents to EC ED for "abdominal pain". PMHx of "Down syndrome and recent MI"
Tinnitus,   sore arm for five days ,  fever 102, tired three days.
Inflammation; Sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLAMMATION (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "Sickness". 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.
Injection site soreness - lasting days, flu like symptoms beginning the next day and lasting 48 hours, 101 fever beginning 12 hours post injection and lasting 30 hours managed by Tylenol. Fever re-emerged 3 times
Large welts around area of injection first seen, then itching developed in the scalp and arm area. Then hives and rash started to develop all over the body with it spreading to different areas on different days over the course of the next few days. Day 4 of the symptoms and it spread to my face and my lips and vocal cords are now swollen.
Swollen lymph nodes in the left armpit following the Pfizer booster - pain, itching, swelling, soreness. Not debilitating, but very uncomfortable and has persisted for two days so far.
fell; broke her hip; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 03May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's husband). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 18Mar2021 10:00 (Batch/Lot number: ER2613) at the age of 76-years-old female as single dose for covid-19 immunisation. Medical history included diabetes, pain and manic depression. Concomitant medication included metformin taken for diabetes from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for pain from an unspecified start date and ongoing; valproate semisodium (DIVALPROEX ER) taken for manic depression from an unspecified start date and ongoing; furosemide taken for an unspecified indication from an unspecified start date and ongoing; nitrofurantoin (NITROFURANTOIN MONO) taken for an unspecified indication from an unspecified start date and ongoing; vitamin D taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (EUTHYROX) taken for an unspecified indication from an unspecified start date and ongoing; alendronate sodium (ALENDRONATE) taken for an unspecified indication from an unspecified start date and ongoing; lisinopril taken for an unspecified indication from an unspecified start date and ongoing; potassium chloride taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine taken for an unspecified indication from an unspecified start date and ongoing. The patient fell and broke her hip 05Apr2021 and had to go to the hospital. He said now she is in a rehab center, so she couldn't get her second shot then, a few weeks later got she got her second shot. He said she had surgery for her broken hip and now she is in rehab. He said she left the hospital to go to rehab. She was in the hospital from 05Apr2021 to 10Apr2021. He said she was slowly improving. The outcome of the event fell was unknown, the outcome of the event 'broken hip' was recovering.
Lightheaded approximately 45 min after receiving 2nd Pfizer vaccine. Followed by intermittent vertigo throughout the week which continues at the time of reporting
Headache, dizziness, poor appetite, arm pain and swelling, fever, back and neck pain, tea color urine.
Sever chills and body aches as well as fever reaching 101.8.  Profuse sweating.  Symptoms persisted for 24 hours and began to dissipate. Lingering less sever symptoms lasted beyond 24 hours (fatigue, chills)
PT c/o dizziness and chest discomfort 15 minutes after taking 2nd dose Pfizer. No shortness of breath noted.  No rash or swelling noted.  PT remains alert, oriented and talkative.  VS taken O2 Sat 100%, HR 72, RR-20, BP 110/70  PT stated that she didn't eat breakfast and was a little anxious prior to shot.  Mom gave food and water which PT tolerated well & stated she felt better.  PT monitored for additional 30 minutes and remains alert, oriented & talkative.  Vitals RR 18, HR 66, BP 110/70, O2 sat 100%.  No further c/o of dizziness or chest discomfort, PT cleared.  Parents instructed to seek medical attention if PT's symptoms return.  Parents verbalized understanding.  PT walking at steady gait & voices no concerns or questions.
After Covid vaccine(Moderna/ Pfizer) my periods stopped am I am in menopause in late 30's
1st day after chills, minor. 2nd day fatigue all day, swelling of face noticed by wife in the evening, moderate. Can not hear out of one ear. 3rd day, 4am get up to go to work. Still can't hear from one ear and my eyes are swollen almost shut face swollen. By 1100am it had gone down just a bit. Went see family doctor for assistance. He prescribed, Prednisone 20mg twice a day for three days. Benadryl 25mg every 6 hrs until swelling comes down.  There may be some breathing difficulty but it is so far very minor unless exertion happens, then it's noticable.
I had a sudden onset of double vision,  It occurred on 11/28/2021.  I went to the optometrist, the ER, and to the ophthalmologist.  I have no diagnosis for my condition.  No medical professional can tell me what caused the double vision.  To date, the double vision has not gone away.  I have no pre-existing health condition nor any recently diagnosed health conditions.  I am in overall very good health.  The only thing is that I took the covid-19 vaccination.
Itchy Rash.  Treated by patient's parent with Benadryl.  Patient became drowsy after Benadryl.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with thyroiditis and no known drug reactions/allergies who on 21-SEP-2011, was vaccinated with the first dose of GARDASIL (Lot #669285/0691AA; Exp. Date: 17-AUG-2013) (dose not reported), intramuscularly. Concomitant therapy included levothyroxine. The physician reported that on 21-SEP-2011, later after receiving the vaccine, the patient revealed that she was five days later for her menstrual period. On an unspecified date, urine pregnancy test was performed and it was confirmed the patient was pregnant. The patient last menstrual period was 15-AUG-2011. Estimated date of delivery would be 21-MAY-2012. Follow up information has been received from a Nurse practitioner. The reporter stated that she pulled the patient's chart and reported that the pregnancy was electively terminated. The causality of the event was unspecified. The action taken of the event with the suspect product was not applicable. The pregnancy outcome was elective termination. Additional information has been requested.
Patient has history of Hirschsprungs with surgical repair. Given the ROTATEQ on 4/30/12 was admitted with Ileus on 5/4/12 - Discharged 5/5/12 positive C-diff on stool test.
Patient was given Day 14 HDCV 1cc IM into right deltoid on 8/30/09. Reports of localized redness and swelling to area. Evaluated by MD on 9/2/09 at Lifetime Health AfterHours. Diagnosed with Cellulitis to injection site.
12 y/o client presented to HD Immunization Clinic for HPV #. A few moments after receiving vaccine, client experienced brief syncopal episode (1-2 seconds). MOC and RN held client upright in the chair, no fall or apparent injury. Client was aroused by MOC and RN talking to him. Upon waking, client sat in chair drinking juicebox and taking slow deep breaths. He sat in the chair for approximately 15 minutes talking to MOC and RN before stating he felt better and was ready to leave. Client declined to lie down, expressing preference to stay seated. At time of departure from the clinic, client had regained color, was alert and oriented, and walking independently.
L arm pain & swelling following immunization from injection site to hand.  15 weeks post administration left hand continues to swell, loses grip with grasp.
This spontaneous report as received from a certificated medical assistant refers to a 14 year old female patient with no pertinent medical history and drug reactions/allergies. On 06-AUG-2014 the patient was vaccinated with the third dose of GARDASIL lot # H021861, Exp date: 09-OCT-2015, 0.5 ml, subcutaneous. No concomitant medication was taken. It was unknown when the patient received the first and second dose of GARDASIL. On 06-AUG-2014 the patient experienced tenderness, at the injection site after receiving the third dose of GARDASIL. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
Fever Arm Pain Narrative:  Pt had some arm pain on the day of the 2nd dose, 1/20/21. On Thursday morning 1/21/21 had a low grade fever and just felt miserable.  Symptoms improved 1/22/21. Missed work x 1 day. No known prior COVID infection   Other Relevant History:
PATIENT GOT THE PNEUMOVAX AND TEH NEXT DAY SHE HAD SIGNIFICANT SWELLING IN THE AREA. IT IS NOW STREAKING AROUND HER ARM. NO FEVER.
back pain; feeling bloated; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for herself that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient said that she was on her period right now and she was experiencing back pain and feeling bloated in Apr2021. Patient asked if she could take Midol. The outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Injection area became red and sore almost immediately after injection. By the next day, 24 hours later, the area had increased in size and became hard and painful. Patient noted her face was flushed and she felt as though she had a fever, but did not. 48 hours after the injection, the injection site was approx. a golf ball size, hard, red, warm to the touch lump that was burning painful and becoming pruritic. Patient, self, decided to seek medical attention when itching began to affect truck of body, face, and both arms. Patient was seen in the clinic where she works, and was prescribed a 7 day course of Prednisone and advised to continue to take Benedryl until improved. Swollen lump began to improved approx. 48 hrs after starting prednisone and benedryl. It took 1 week before area was completely back to normal and no longer visible.
31MAR97 t103, chills, dizzy, falling down, screaming @ noc, rash on chest pink;3APR97 went to ER, sleepy spells, staring, dec response, t96.2;CBC nl for 5hr, temp up to nl then below lethargic when temp dec;
No/Blood test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report from a contactable physician.  A 17-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), an unspecified route of administration, administered in Right Arm on 13Jun2021 at 12:00 as 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history included None. The patient had no known allergies. The patient's concomitant medications were not reported. Since the vaccination, the patient has tested for COVID-19.It was Unknown, if patient diagnosed with COVID-19 prior to vaccination. On 13Jun2021, after 1st Dose of vaccination, the patient underwent a covid test type post vaccination=Blood test, covid test name post vaccination, covid test result=Positive. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Congenital anomaly or birth defect]no days hospitalization: 4. The patient underwent lab tests and procedures which included blood test was positive on 13Jun2021 Blood test,sars-cov-2 test positive: positive on 13Jun2021 [{covid test type post vaccination was Blood test, covid test name post vaccination=covid test date was 13Jun/2021,covid test result was Positive. The outcome for the events was recovered/resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, whole body aches, headache and fatigue. Began around 1am and lasted for 24 hours.
Pain in back followed by vomiting and shortness of breath.  I used the inhaler I had from pneumonia and that helped breathing a little. By midnight I had chills, fever, more vomiting. At 1am on 11/1/2014 I had sever muscle pain.  11/1/2014 during the day I had a bad headache, nausea, chills and muscle aches.
No additional AE; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a 6-month-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #U007860, expiration date 14-JAN-2022; dose and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event. The outcome of expired product administered was unknown.
Patient was seen in immunization clinic to receive some vaccination. Patient is from a family and it is common for them to only receive certain vaccines and limit the amount of vaccines at one time below the recommended level. Patient received vaccines listed and this was only the second time she had received any vaccines. According to History and Physicals the patient was seen by the walk-in clinic for ear pain and not wanting to eat 3 days later but mom states that the problem started a couple hours after the vaccines were given. Patient was seen 2 days later by her family doctor which admitted her to the hospital with dehydration and possible strep, even though the patient was on antibiotics at this point.
My daughter was given Rotavirus as a shot in her leg, which makes it ineffective. It's supposed to be given orally.
When she got her vaccine for about 2 days starting that night she started getting feverish, chills, feeling light headed.  Went to bed and took Advil or Ibuprofen every 4 hours.   Was better the next morning and then continued that evening, and within 3 days that resolved.  On 8/19/21 she went to the UC because she had trouble swallowing and she saw a lump on her throat.  When she went in they set her up to call for an US as they felt something was going on but then felt it was due to dehydration.  They told her to drink water and suck on cough drops or salt water for the symptoms which she did and it went away in a few days.  Then on 11/28/21 is when she saw a red eye, though it was pink eye and it did not go away.  On 12/2/21 went to UC and it was episcleritis and was told to go to an Ophthalmic.  On 12/3/21 went to eye Dr. He told her that he was going to prescribe some drops, gave her prednisone and if it did not go away then call back.   Her was in pain, was having a pulsation on the left eye and her eye felt like it was so big underneath her eyelid that she could not sleep.    The biggest symptom she had started around August 8 - days after the vaccine, when she got out of bed to go to the bathroom felt like her whole body was really stiff, went to the gym a few days before and thought it may have been muscle soreness, and could not bend her knees to go to the toilet.  Previously she had worked out.  Over a period of time she noticed that her whole body was tired and stiff in the morning, and then around 11:00 AM it would improve.  She went on vacation in Mid December didn't work out, not to the gym and felt almost 100%.  Then she felt that was what it was.  When she came home on 12/26/21 she got COVID and after that the same symptoms came back, this time it was even worse.  She had COVID for 5 days, after that the muscle stiffness would not go away, and it stayed like that until she talked to her Dr on 1/26/22, she put in for blood work.  In the blood work she had a different tests and had an ESR and that came up higher than normal.  Then she also did an ANA, and checking to see if she had lupus or RA or MS because her symptoms sounded like that.  All came out negative, just one positive, and said to watch out for her symptoms.  Somewhere towards February she had no symptoms.  She again went back to work 3/7/22, and was traveling taking trains and got the flu.  When she got that on 3/8/22 all the symptoms came back again.  She got a sinus infection after that, given an antibiotic and once the antibiotic finished the symptoms still remain there.  Not as bad as it was, but limits her movement due to walking and uses the train and goes from to and not able to do that due to the stiffness in the mornings.   Told to keep diary on her symptoms and is supposed to contact her to see what she is to do, and feels that she is getting disabled.  She was given Meloxicam to use as needed.
I started feeling sick around 8:00 that evening - more than just sore. I ended up with fever of 102 by 11:00 or midnight; chills and burning up and what prompted me to call my doctor, in the middle of the night, I have a watch with heart rate monitoring and it had woken me up with signal of abnormal heartrate. It was over 130 (normal rate is between 55 and 60 during sleep ) and I had a telemed visit and Dr. said to take Ibuprofen after 24 hour mark. The only other side affect, my bladder side was feeling small and I had to pee every hour. Ibuprofen helped break the fever. The symptoms were resolved by about the following night. My stress level measured by my watch was back in the normal range after I woke up the second morning.
Ears started itching 8p, the day after the vaccine injection.  Woke up at 6:30a to see hive welts on underside of arm that had injection, along with hives on legs, right arm, upper chest and back.  Coughing and feeling of tongue and eyelid swelling started at 7:30a
Swollen arm, red welt, diarrhea, exhaustion, headache, slept 1.5 days By second day arm still swollen, red welt. No diarrhea, less tired.
Approx. 24 hours, post vax, the pt had an unprovoked, brief syncopal episode. She recovered fully. Work-up of episode has produced no etiology. (Syncope occurred at daycare in the AM of 2/21/01).
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 18-year-old male patient who received BEXSERO. Concurrent medical conditions included ulcerative colitis. Concomitant products included APRISO, REMICADE and VSL Probiotic Sachets. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sickness, diarrhea and astrovirus test positive. On an unknown date, the outcome of the sickness, diarrhea and astrovirus test positive were recovered/resolved. It was unknown if the reporter considered the sickness, diarrhea and astrovirus test positive to be related to BEXSERO. Additional details were provided as follows: The reporter was the mother of the patient. This was the report for the patient that was immune suppressed. In 2018, the patient received 2nd dose of BEXSERO. In 2018, the patient was sick for 24 hours and then it got better. Then the patient got horribly sick again and experienced severe diarrhea and came positive with astrovirus. This case has been linked to the case US2018051277 and US2018GSK056258 for another patient and linked to US2018051278 reported for the same patient.