chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mouth burning, rash on arms and upper torso. Pt. used Benadryl per her Dr. and seems to be getting better.
Large patch of erythema on (L) arm. From arm to top of shoulder. Heat/redness.
Information has been received from a pharmacist concerning an 11 yr old female with sickle cell disease who on in Sept 03 was vaccinated in the upper arm with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the child had received at least one dose in the past. Approximately 24 hrs after the vaccination, the pt developed a low grade fever and complains of neck pain. Apparently the pt was also down the shoulder and arm of the same side as the injection was administered. The physician was trying to rule out a reaction vs a sickle cell crisis. The outcome was unknown. Unspecified medical attention was sought, but no prescription drug treatment was required. No product quality complaint was involved. No other information or lot number available. Additional information has been requested.
Fainting episode; hit her head; High Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, for tolerance of 1st dose, refer case US2022AMR027150).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), head injury (serious criteria hospitalization), fever (serious criteria hospitalization) and fatigue (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, fever and fatigue were recovered/resolved and the outcome of the head injury was unknown.   It was unknown if the reporter considered the fainting, head injury, fever and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR027150  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was unknown. A couple days after receiving the second dose, the reporter stated that her friend experienced fatigue, high fever and fainting episode in which she hit her head and was subsequently hospitalized for a couple of days to get the fever down.  The patient continued with fever and fatigue for approximately 2 weeks, but did not experience any further fainting. The reporter provided limited information and did not wish to provide personal information. The reporter did not consent to follow-up. This case was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022AMR027150:same reporter
Red splotch approximately 2 inches long on injection site and tenderness. Appeared about a week after the first dose.
After my second shot of moderna vaccine,  my left arm (injection site) became very sore and then the next day, it spread to my left wrist and left breast. The wrist pain feels like stiffness that I cannot rotate my wrist and it?s affecting my range of motion on the area. It painful when I move it. Until today, the pain & stiffness is still present and it?s getting worse. I went to the doctor to get it checked and she told me to wear a wrist brace. The brace is not helping as the pain does not go away. My grasp is weak and cannot hold even just a glass of water. I?ve never had this problem before until I got the second shot of moderna.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:
pt recv vax & devel huge, itchy welts (2x2x6) on the stomach & back (which was red)--27 hr p/vax 3Pm on 10JUN97;51 hr post vax devel welts on arms;hydrocortisone cream was applied & MD was called;noted that hives w/itching & recommended DPH
Patient came into store today and showed us her reaction to the vaccine. At the injection site it is red, raised, and has a blister in the middle. Pt is calling MD in the morning to be evaluated.
Primary Care Physician at Discharge: MD  Admission Date: 7/10/2022 Discharge Date: 9/12/2022  PRESENTING PROBLEM: Unbalanced common AV canal [Q21.2] L-TGA, levo-transposition of great arteries with ventricular inversion [Q20.5] S/P right ventricle to pulmonary artery (RV-PA) conduit replacement [Z98.890]   Patient is a 7 y.o. male with heterotaxy syndrome and complex congenital heart disease including dextrocardia [I,L,L] with unbalanced left-dominant complete atrioventricular canal with hypoplastic right heart and pulmonary atresia, TAPVR, and bilateral SVC, s/p right sided bidirectional Glenn and 1.5 ventricular repair including atrioventricular canal repair, complex VSD patch, RV to PA conduit, RPA division, and fenestrated ASD closure in 2/2018. He also has a history of protein losing enteropathy, chronic diastolic heart failure, CLD/central sleep apnea, GERD, CKD, Hx thrombosis (occlusive IC thrombus), GDD, and functional asplenia and a recent admission for endocarditis with enterobacter cloacae via Karius test and completed a 4 week antibiotic course on 7/2/22.     He was readmitted on 7/10/22 for planned cardiac cath that was delayed due to AKI.  He underwent the cardiac cath for hemodynamic study on 7/14 that demonstrated significantly elevated pulmonary pressures with end diastolic pressure elevated to 20 mmHg and severe conduit stenosis with free conduit insufficiency and severe bilateral AV valve insufficiency.  Because of this, he went to OR on 7/28/22 for a redo sternotomy and replacement of his RV to PA conduit with a 21 mm pulmonary homograft with right and left atrioventricular valve repairs.    On 8/21, he tested positive for COVID with minimal symptoms (tested due to maternal illness.). He completed a 5 day course of Remedisvir per ID recommendations.
Temp seen in clinic 10/08/2004. Sent to children's ER for further evaluation. All labs and all negative
07/16/02 received immunizations. 07/17/02 left arm at injection site: red, swollon, itiching, and "hot" to touch. child also naused. 07/18/02 child recovered. 07/19/02 family out of time not able obtain history of birth weight.
pt recvd vax & devel generalized hives & periorbital edema; pt was treated w/SC Epi, DPH & Pred; hives abated completely p/5 days;
Progress Notes Nurse Practitioner Cosign Needed Expand All Collapse All    2/4/2021    Patient:                                                                                    DOB:  11/21/1933  Date:  2/4/2021                                                                        MRN:      Subjective Patient is a 87 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience funny feeling in face, lightheaded and HA.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.         ALLERGY REVIEW OF SYSTEMS:   Funny feeling in facial area:     Previous Reactions: Levaquin    Objective    Vitals Vitals:   02/04/21 1505 02/04/21 1523 BP: (!) 172/81 (!) 184/75 Pulse:   (!) 102 SpO2: 95% 95%     Pt reports she is on Blood pressure medications and took these this am.     Physical Exam Constitutional:      Appearance: She is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)   Pt left at 15:40pm accompanied by husband.  FU with PMP regarding blood pressure      Electronically Signed 2/4/2021 3:44 PM
Injection at approximately noon on 2/4/21. Began feeling poorly with flu like symptoms about 11 PM Fitful Sleep.Extreme soreness at injection site. Awoke with fever (100.7), joint pain, nausea, lethargy. Took 400 mg of ibuprofen. Took "Nyquil" the next evening to help with symptoms. Fitful sleep and extreme sweating. Awoke Saturday feeling a bit better. Temperature (98.6) Rested all day. Better sleep Saturday night. Did not take any medication. Some sweating overnight. Awoke Sunday feeling better. Still not 100 percent Temperature 97.4.
NUMBNESS OF FACE, RASH. MD PRESCRIBED PREDNISONE FOR 7 DAYS.
pt rec'd grey cap pfizer vaccine after it was in the freezer for 22 days-they will be in at some point for a replacement vaccine
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Few days ago, in approximately October-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the arm. Concomitant therapies included influenza virus vaccine (manufacturer unknown) in a different arm on the same day as ZOSTAVAX. The arm that ZOSTAVAX was administered, the injection site was pretty swollen and itchy in approximately October 2013. The patient had sought medical attention via visit to pharmacy. The outcome was unknown. This is one of several reports from same source. Additional information has been requested.
PMH: deniesALL: deniesVS: 96%, HR 54, BP 98/64 (intiial)99%, 49, 110/75 (after 30 min and full recovery) Symptoms: This is Dose#216yM developed immediate dizziness, warm rush and darkening vision after injection that lasted about 3-5 minutes and improved without intervention apart from supine position. No medication given. Father reports pt has history of presyncope with blood donation. Assessment: slightly flushed appearing, complete sentences, coherent, alert and oriented. chest is clear, good air entry bilaterally, no respiratory distress or facial/oropharynegeal edema noted. Heart rate mildly decreased on auscultation but otherwise regular with normal S1S2. No distress. Treatment: none Patient observed for 30 minutes with snack and drink given. Symptom resolution and driven home by father. Patient is a high school athlete with slim build. Father reports heart rate is usually low/normal
Day after, extreme fatique.  3/20. Slight nausea. Ate cereal. Other food not appealing.  3/21. Injection area is hard, swollen. 6.5" x 3"
Smallpox vaccine was given on  28 Oct 2019. Patient is a 19Y/O male. He reported to Station with chief complaints of nausea and left jaw 2/10 pain. Patient denies diarrhea and vomiting. Patient was assessed and noted a swollen lymph nodes and a secondary reaction (smallpox) on his forehead. During the interview, patient stated that there are times that he is not actively washing his hands after replacing his bandage. Attending physician prescribed Ondansetron OPT 4mg. Pt was re-instructed on the post care of his smallpox vaccination site.
Possible allergic reaction to flu shot patient started breaking out with rash and hives one day after receiving flu shot.
Rash on legs, abdomen, and arms. None with significant fluids. No itch, afebrile. Recommended Aveeno bath and monitor rahs.
pt recvd vax;16dec95 arm swollen from elbow to arm pit;arm was grossly edematous, hard, red & itchy;inject site was oozing yellow fluid;also painful & stiff neck;to er on 17dec95;tx w/ duricef & ancef;
injection site warm; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site warm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site warm). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-008434 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Moderate to Severe Upper respiratory symptoms including : Cough, Phlegm/Sputum/Productive cough, Weezing, Fever, Fatigue, Nasal Discharge, Headache, night sweats, Ear Drainage, Difficulty sleeping.  I have had a previous COVID-19 infection resulting in mostly digestional issues.  Doctor has diagnosed me with Viral Upper Respiratory Infection, Currently on MethylPREDNISolone dose pack 4mg and Benzonatate 100mg to deal with symptoms. Symptoms still mildly present as of 10/25/2021.
This case was reported by a pharmacist via sales rep and described the occurrence of restlessness in a male patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced restlessness, pain and headache. On an unknown date, the outcome of the restlessness, pain and headache were unknown. It was unknown if the reporter considered the restlessness, pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of SHINGRIX and experienced soreness, restlessness and headache at night. This case has been linked with case US2018GSK047416, reported by the same reporter.
This social media spontaneous report was received from a consumer, who made a post on 08-SEP-2018 that included a video. The title of the video was "manufactured crisis - HPV , hype and horror", in which a reporter mentioned information about an unspecified number of female patients of unknown age. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patients were vaccinated with GARDASIL for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). On an unspecified date, unspecified patients were going to have menopause (premature menopause) and infertility. (It was stated that those patients had  16 years old). Also, an unspecified number of patients experienced fatigue, could not breath, presented asthma, fell on the ground (fall),  experienced a seizure, loss of consciousness, depression, anxiety, had an ovarian dysfunction (ovarian disorder) and  presented a miscarriage. On an unspecified date, an unspecified patients died. The cause of death was not provided and it was unknown if autopsy was performed or not.  At the reporting time, the outcome of loss of consciousness, fatigue, asthma, fall, infertility, anxiety, depression, ovarian disorder, dyspnoea, premature menopause, seizure and abortion spontaneous was not reported. The reporter did not assess the relatedness between GARDASIL and the aforementioned events. Upon internal review, the events seizure, abortion spontaneous and loss of consciousness were determined to be medically significant.
pt recv vax in AM & was observed to have shaky movement of arms & legs & frothing;not post-ictal;did not lose consciousness;no fever;;seen in office nl exam; to f/u w/neuro;
Starting on the 8th day post vaccination, there is an itchy, raised/swollen spot at the injection site, roughly 1" in diameter. No further symptoms of an allergic reaction have occurred.
Flu-like symptoms; Her oxygen level dropped to 80mm Hg because she is asthmatic; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), OXYGEN SATURATION DECREASED (Her oxygen level dropped to 80mm Hg because she is asthmatic) and VACCINATION SITE SWELLING (Swelling at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthmatic (Reported but start date and stop date not provided).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), OXYGEN SATURATION DECREASED (Her oxygen level dropped to 80mm Hg because she is asthmatic) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), OXYGEN SATURATION DECREASED (Her oxygen level dropped to 80mm Hg because she is asthmatic) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details were not reported by the reporter.
Patient was brought to the local ER for c/o fever, cough and decreased responsiveness per his wife.  Patient was found to have Covid during testing.  Patient was hypoxic on arrival and was admitted with a diagnosis of Covid-19 and dementia for further evaluation and treatment.  Patient was discharged home 1/3/23 with Home Health.
A patient was accidentally given a half dose Moderna vaccine instead of the B12 shot he was scheduled for. The error was quickly noticed by the CMA who immediately notified the providers and office manager. The mistake was acknowledged to the patient by Dr with an explanation and apology. the safety of the shot was also reviewed. We notified the DOH and Dr who later spoke with the patient and explained the safety of the vaccine.
C/O swelling, redness and pain in L deltoid post receiving Td shot on 11/7/02-pain was not relieved by Tylenol or Ibuprofen-no further problems at this time.
Extreme fatigue; Joint pain; Low-grade fever  (101.1 F) which dropped to 100.3 F; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 11Apr2021 at 07:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Apr2021 at 07:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 01:30, the patient experienced extreme fatigue, joint pain, low-grade fever (101.1 F) which dropped to 100.3 F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event low grade fever which included treatment with acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of extreme fatigue, joint pain, low-grade fever (101.1 F) which dropped to 100.3 F was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had a lump in my right breast.  Mamogram and Sonofgram showed no problem.  I was told this is happening within 2 weeks of the vaccine.
Red slightly edematous (L) thigh 9 cm in diameter, hours after receiving Hep A #1.
SINUS PRESSURE; CHEST TIGHTNESS; CAN'T CATCH BREATH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with aura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced sinus pressure. On 14-JUL-2021, the subject experienced chest tightness. On 14-JUL-2021, the subject experienced can't catch breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure, chest tightness, and can't catch breath. This report was non-serious.
Vomiting (once at 1 am) Shaking and chills from 1 am until next day ( over 24 hours) Fatigue Joint pain Arm pain
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 27Jul2023 Batch/lot number: GK2931.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263865 same patient, different drug/event;
Couple days after it feels like a muscle cramp on the forearm. Also lost strength in the forearm
A month after the vaccine I went to the hairdresser for my birthday to have a new hairstyle. I discovered after I washed it that I had missing hair. I made an appointment with my dermatologist to have it looked at to confirm that I did have missing spots of hair. I had an appointment on 04/04/2023 who did confirm that I did have hair loss, but it is clearing up and growing back. I had started using steroid cream that I had at home on that patches before I was able to get in to help get the har to grow back