chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents to the ER with complaint of rectal bleeding 2/1. Chest xray done at bedside, COVID test positive 2/1. On 2/2 patient sent to OR having EGD with possible intervention. Patient a/o/4, noted exspirtory wheeze in upper left lobe, iv infusing Caredizem gtt titrated too 5cc/hr, patient denies resp distress c/o of mouth dry and lips, no bleeding noted. On 2/2 patient returned from recovery a/o/4 skin warm and dry, vitals stable Cardizem infusing, happy about his status. 2/3 patient's HR remained elevated post metoprolol, but patient in stable condition and tolerated treatment. 2/4 patient discharged to home.
I have a history of untreated fibroids that were diagnosed in December 2019.  Because the coronavirus pandemic began in February 2020, elective surgeries were not allowed in my state.  My bleeding and blood clots were caused by the fibroids during menstruation.  On March 20, 2021, I received the Johnson & Johnson 1-shot COVID vaccine.  By March 26th, the blood clots that were coming out of my body were enormous.  They had NEVER been that large.  Being concerned, I immediately saw my doctor as soon as my period ended.  Today, I learned the J&J vaccine has been paused due to blood clots.   I believe that my blood clots became so large because I was given this particular vaccine.  WOMEN SHOULD BE ADVISED THAT IF THEY HAVE BLOOD CLOT CAUSING FIBROIDS, DO NOT TAKE THE JOHNSON & JOHNSON COVID-19 VACCINE.
Initial and follow up information has been received through the pregnancy registry from a certified nurse midwife concerning an 18 year old female, with no pertinent medical history, who in November 2006, was vaccinated with a dose of GARDASIL. In January 2006, the patient was vaccinated with a second dose of GARDASIL. On 20-MAY-2007, the patient was vaccinated with a third dose of GARDASIL. There was no concomitant medication. Subsequently, the patient became pregnant. In follow up it was reported that on 28-JUN-2007 patient had an ultrasound which was within normal limits. Prenatal lab testing was done, results not reported. The last menstrual period was 20-MAR-2007, with an estimated date of delivery was 25-DEC-2007. Ultrasound done on 28-JUN-2007 for date was reported to be within normal limits. Follow up information was received from a health care professional at the nurse midwife's office on 04-APR-2008. She reported that the baby was normal and healthy. The birthdate was 05-DEC-2007. She didn't have any more information. Follow up information was received from the doctor's office that on 07-DEC-2007, patient had a cesarean section for breech presentation and delivered 39 weeks from her last menstrual period. This information was conflicting with the previously reported information that patient had a normal delivery on 05-DEC-2007. Upon internal review patient's breech baby delivery which required a cesarean section delivery was determined to be an other important medical event. Additional information is not expected.
This non-serious spontaneous case, initially received from other healthcare professional (nurse) on 27-Mar-2018, concerning a 06-year-old, child, male patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, refrigerator was out of range for about 45 minutes and reached a maximum temperature of 48.6F and vaccine also underwent second temperature excursion. On 22-Mar-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195235, expiry date: 31-May-2018), which was exposed to 2 temperature excursions. It was reported that, no adverse effects were noted after the vaccination. The report was linked to case 201801298. Follow up report received on 24-Apr-2018: The dose (0.5ml), route of administration (intramuscular), anatomical location (deltoid) of suspect vaccine was added. The narrative was amended accordingly.
Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-039589 (Patient Link).
Approximately 15 hours after vaccination I awoke with severe pain of the left fourth toe, medial aspect of the proximal phalange.  There was a 3 mm pustule on a 1 cm erythematous base.  At the time I also had mild routine constitutional symptoms from the vaccine: fatigue, headache, vague malaise.  I had no fever.  The pustule progressed over the following 15-20 hours.  I was prescribed doxycycline 100 mg po bid and the pustule was incised and drained.  A wound culture was not sent, but the assumption was that S. aureus was the pathogen.  Over the next four days, the lesion resolved without complication.
Information has been received from a registered nurse concerning her daughter, an 11 year old female patient with no pertinent medical history and no known drug allergies, who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# not reported) and 20 minutes later developed a stiff neck while riding home from the doctor's office. There was no concomitant medication. The stiff neck resolved after the ride. On 23-DEC-2008, the daughter had a second dose of GARDASIL (lot# not reported) and within 11 days she developed a "constant cough and an enlarged lymph node at the cervical area". There was no concomitant medication. Patient was seen at the doctor's office. No abnormal labs. The cough lasted all of January and February and impeded in her basketball activity. She was given Z-PACK and TESSALON PEARLS but it did not help. She was also given Hydrocodone and TUSSIONEX that helped some days but made her drowsy. Both the cough and enlarged lymph nodes resolved by March. Additional information has been requested.
A 3 year old patient received Quadracel, no AE; Quadracel was administered to a 3 year old patient rather than Daptacel, no AE; Initial information was received on 15-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional  This case involves a three year old female patient who was administered 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5656AA, Expiry date 11-Aug-2021) once via intramuscular route in the left thigh for prophylactic vaccination on 15-Jul-2020 rather than DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. (product administered to patient of inappropriate age and wrong product administered)  The patient's past vaccination(s) included DIPHTHERIA VACCINE;HIB VACCINE;PERTUSSIS VACCINE ACELLULAR;POLIO VACCINE INACT;TETANUS VACCINE for prophylactic vaccination.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB); PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered.  The patient had no vaccinations since her 2 month series. She came in for catch-up vaccinations. As part of that vaccine series, Quadracel was administered rather than Daptacel.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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
Frequent fever and flu-like symptoms fall and winter 2000-2002. Joint pain, migrating. March 2002-Aug. 2002. Celebrex 4/15/02-8/1/02. Fatigue.
Headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to vaccination. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE (PROZAC)) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 13:00 hours, the patient experienced headache, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue, chills was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Received second dose of Moderna vaccine on 1/23/21, likely conceived on 1/24/21.  Lost pregnancy between 8-9 weeks with noted fetal bradycardia on during ER visit on 3/14/21 and no FHR on 3/18/21.
Rash on neck started 4 days after vaccine.  Rash worsened and hives broke out on entire face and neck on 5th day.
tenderness at site of injection; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (tenderness at site of injection) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 INJECTION SITE PAIN (tenderness at site of injection). At the time of the report, INJECTION SITE PAIN (tenderness at site of injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021: event details was updated.
p/vax pt exp T103-104.4; severe h/a; dizziness; weakness; pale; pt felt like top of head would burst; also had stuffy nose
Entire arm had swelling to R arm, R tender to touch, and veins were bulging on arm, and it was hot to touch and when pt bumps her arm, she experiences tenderness and swelling to entire R arm, no color change. Swollen more on Rt arm and upper half Rt forearm. No fever, no headaches, had URI x5 d, took TYLENOL only Loratadine given that day.
Patient received her 1st dose of Moderna vaccine at our pharmacy during a clinic for school employees. She is pregnant (unsure of weeks, but was visibly pregnant). She was asked if she had discussed the vaccine with her provider, which she said she had at length talked with several of the OB doctors that she sees and all recommended she receive. Patient understood risks/benefits and lack of data in pregnancy at this point, and comfortable receiving. No issues immediately following the vaccine and was brought to adjacent room for observation. Within 5-10 minutes, she reported feeling warm, flushed, light-headed. She took coat off, drank cool water, and the feeling revolved within next 5-10 minutes. She was able to leave pharmacy on her own as reported felt back to normal.
This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional case details were reported as follows: This case was reported by an Employee. The patient was a Pharmacist (unspecified demographics). The age at vaccination was not reported. The age group was not reported, but was captured adult as per vaccine indication. The pharmacist told employee that the pharmacist experienced painful arm after receiving SHINGRIX. The pharmacist told the adverse event to the employee in a conference over the weekend. No further information was available. It was reported that do not contact for additional information.
Immediate pain in entire arm, numbing of fingers, headache, flush cheeks and hot flashes. Fever set in later in the afternoon. 24 hours later body aches, headache, Fever of 102°
Nausea within minutes after injection, metallic taste and smell within an hour, slight full body muscle weakness and stronger muscle weakness at injection site within a few hours. All symptoms still present 11 hours after injection.
I had a sore arm for about two days, and it went away. I have always had mild constipation all my life. The gastrointestinal issues started in summer in 2022 and it progressively got worse. After I would eat within 30 minutes, I had extreme pain. My gastroenterologist recommended a colonoscopy, and nothing was found. I had a fecal elastase test in mid-January 2023, and it was determined that I have a pancreatic insufficiency, I lost about 10 pounds during this ordeal.
Myalgia, Fever, Fatigue, sinus congestion, rhinorrea Narrative:
Pt states she had pain in deltoid, scapula, trap and interscalenes, states it started after the surgery. Pt continues to have this pain 4 days out. Pt had two syncopial episodes at home, I spoke with her pcp and this is normal reaction for her to vaccines. Pt has had fever ranging from 101 to 104 for past 4 days since the second dose of her covid vaccine.
pt recv vax 22OCT97;approx 430-5PM reports lt arm began to swell & become painful 9PM;lt arm more swollen;hot & cold chills;fever;cont through noc;23OCt97 920AM saw pvt MD dx w/bacterial infect;
definite modified varicella documented exposure 14 days prior to onset;50-60 lesions most atypical;papules+ vesicles+ w/broad erythematous bases;papular pustules more than typical varicella lesions;crusts smaller also; 3+ pruritic;
Patient sustained a delayed hypersensitivity reaction to hyluronic acid filler injections in her tear trough. She was injected with Restylane-L on 2/23 and on 2/26 her right eye was red and itchy.  She was given theratears lubricating eye drops when the symptoms presented themselves, which made the redness go away within 2 hours.  After 24 hours all redness and itching was gone.
Chest cramps, chest tightness, and chest pressure. Brain fog for days. Chest cramps have subsided but still notice a little tightness still there
This spontaneous report as received from a pharmacist refers to a female patient of unknown age.    On 10-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M020902 for prophylaxis. On 10-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. No adverse event was reported. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007378:
unable to use their arm as it was still swollen and painful; unable to use their arm as it was still swollen and painful; unable to use their arm as it was still swollen and painful; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that since getting the second shot in their left arm they had been unable to use their arm as it was still swollen and painful. The reporter's doctor stated she had seen another patient who had a long-term reaction to the vaccine like that of the reporter. The clinical outcomes of unable to use their arm as it was still swollen and painful were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JAN-2022, the patient experienced some minor sinus congestion since this afternoon and tested positive for Covid 19 today (binax home test) (suspected clinical vaccination failure, and suspected covid-19 infection). Laboratory data included: COVID-19 rapid POC (Point of care) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The report was associated with product quality complaint number: 90000210323.; Sender's Comments: V0 20220107754-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Left deltoid injection site tender with redness and slight edema, extending down arm and toward bicep. Treatment: Tylenol, ice pack application X 24 hours and then heat. Follow-up in clinic within 48 hours to assess.
Pt is diabetic. Sugar was 200 at time of vaccine and dropped to 30 one hour later. Caused automobile accident.
Significant high fevers (>102) along with rigors, headaches, muscle ache, fatigue, night sweats.  Tlaxcala 102.8. Symptoms have persisted for 18 days post injection and remain ongoing.  Fevers are cyclic and occur approximately every 8-12 hours. Fevers are not responsive to Tylenol, NSAID. Fever duration 4-5 hours.
Thick Tongue, itching face, head, arms legs, increased temperature, headache, muscle pain
Pt. received the 1st dose COVID vaccine (Pfizer, Lot# EW0191, Exp. 09/30/2021) at 1210 in the L arm. At 1218, client reported he has "a racing heart rate and is feeling really nervous" Observer. Observer provided translation. Observer reported findings to Co-Lead who immediately assessed client, transferred client to zero-gravity chair, and provided him with a bottle of water. The patient was A&O to person, time, place, and situation. No loss of consciousness or dizziness occurred. At 1220 vitals were taken by observer with BP 148/98 in R arm laying down, HR 98, O2 Saturation 98%, and RR 20. At 1225 client reported that he was feeling better but had a "dry throat". Co-Lead assessed throat and observed no swelling. Client denied swelling or any trouble swallowing. At 1228 the patient denied numbness, tingling, or shortness of breathe. Client denied taking medication, denied any significant medical history, and has NKDA. Client reported to Co-Lead that he has a history of anxiety including a racing heart rate and feelings of nervousness. Client has no hx of fainting or dizziness with other vaccines or needles. At 1230 client said he was feeling better and his heart was no longer racing and his "throat feels fine now". Client continued to take sips of water. Vitals at 1250 were BP 128/88 in R arm laying down, HR 76, O2 Saturation 98%, and RR 18. At 1255 client was stable and Co-Lead educated about V-safe information, ER precautions, and when to follow up with PCP. Patient ambulated with even and symmetrical gait when leaving site at 1305.
4PM began crying-screamed-high pitch for 3-4hrs, t103;taken to ER they examined & gave pt a double dose of APAP;mom became upset but temp did come down & pt finally went to sleep; leg sl swollen @ site;otherwise ok
No additional AE; HBP called to report administering PROQUAD to a patient after a temperature excursion.; This spontaneous report was received from ''HPB'' and refers to a 5-year-old patient of unknown gender. The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, valid lot #X007086, expiration date: 04-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 5.7F, for 8 hours. Previous temperature excursions were not reported.
Dizziness from about an hour and a half after injection.  Inability to walk steadily because of it.  the day after the vaccine I called my doctor and the on-call DR. responded recommending an over-the-counter anti-dizziness medicine that started with an "A. " I live alone so I ordered what seemed to be its aquivilantnMeclinzine 12.5 mg.  I did not receive it until Monday 2/15. I took it at  1:29 pm and did not feel any effect until around 5:30 when I started to feel druggie and drowsy.  I laid down and slept most of the night waking at 6:00 am still having the same symptoms. It is 3:14  Tuesday 2/16 and I am still feeling druggie and drowsy.  I am going to call my doctor tomorrow if I do not feel any better. I am not going to take any medication until then.
3hr post vax pt devel to 104;pt had brief episode tonic-clonic generalized movements lasting 1-2min;neurological exam p/that was nl;