chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Pfizer vaccine. She indicated she fainted after receiving some injectable during an ER visit once but she did not know the medication. She mentioned she was lactating. She was told to wait 30 minutes in the area after receiving the vaccine. Patient fainted at 11:33am, she indicated she experienced blurry vision, some dizziness and fainted. Associate indicated patient body got rigid before fainting. Patient was put in the floor, legs were elevated and gained consciousness slowly after a few seconds. She was accompanied by her husband. Code White was announced. Ambulance was called. Pharmacy Associate went to the area and took notes; patient was transferred to a chair. I went there, blood pressure was 136/91. She told me she was feeling a little better. Pharmacy Assistant came and did the report. Verified blood pressure again, was 114/88 before I went back to the pharmacy. She was better. Ambulance came at 11:59 am. Emergency Techs showed. Blood pressure was 110/88 and Blood Glucose 93. Patient decided to go to the Hospital in ambulance to make sure everything was normal.
My left armpit began to swell around 9:30pm the same day I received the shot. I woke up the next day and my armpit was still swollen and tender to the touch.
arm was sore, similar as previous vaccination; minimum swelling; soreness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No medical history information  was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-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 PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness). At the time of the report, PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was  not provided.   This case was linked to MOD-2021-294360 (Patient Link).
Tested NAAT positive for COVID 10/13/21 after being fully vaccinated.
One hour after the vaccine child had redness to left deltoid area. This progress until the next morning. Child also had headache, nausea, loss of appetite and axillary temp of 104 to 105 says mother. Took child to pediatrician who said it may be allergic reaction. No treatment given.
abnormalities/decline with her kidney function; This is a spontaneous report from a contactable consumer.  A 77 year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as a single dose at the age of 77 years old, for covid-19 immunisation. Medical history and concomitant medications were not reported.  Patient reports that she completed the full series of the Pfizer Covid 19 vaccine on 28Feb2021.  She references when she completed the series, nothing was known.  Patient went in for a normal checkup where she had blood work and a urine sample collected yielding abnormalities/decline with her kidney function. Patient did not share specifics of results or date of checkup. With the concern of initial decline in kidney function patient was referred to Nephrologist. Her physician thinks there is a chance that her decline in kidney function could have been related to the Pfizer Covid 19 vaccine. That numbers being out of whack were due to injection.  Evaluated if the M spike was dangerous to her. More testing has been completed including urine test, numbers are down after they were elevated. stated that after taking the Covid shot that she had issues with her kidneys. Stated that she was being looked at by nephrologist, had bloodwork and then had to see a specialist.  Stated that she had her last shot in February, saw her doctor in April who stated it may be due to injection. Stated that she noticed the issues with her kidneys after the second shot. The outcome of the events was not reported.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.           .                The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Swelling/knotting of the thigh muscles at injection site which lasted more than 3 weeks, redness, soreness, uncontrollable crying for more than two hours, lethargy lasting up to 3 days after injections.
1 hour after vaccination swelling in the hand, left hand, continued to increase and decreased over night - customer notified pharmacy morning after vaccination. Recommended doctor visit.
developed pain under left breast; It increased daily and formed a thick cord. The cord grew to extend to center of abdomen. Doctor confirmed it was an inflammed vein; Similar to Mondor's cord of the breast; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 24Feb2021 at 17:00 (at the age of 67-years old) as dose 2, single for covid-19 immunization. Medical history included open angle glaucoma, high cholesterol and chronic migraine The patient had known allergies with codeine, sulfa drugs, red dye used in pills. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL9264) administered in left arm on 04Feb2021 at 19:00 as dose 1, single for COVID-19 immunization at age of 67-year-old. Concomitant medications included atorvastatin calcium , propranolol, butalbital, caffeine, paracetamol (FIORICETTE)and Vitamin D [colecalciferol]. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Patient developed pain under left breast on 04Mar2021 after 2nd shot. Pain increased daily and formed a thick cord. The cord grew to extend to center of abdomen. Doctor confirmed it was an inflamed vein on 04Mar2021, similar to Mondor's cord of the breast. The patient underwent lab tests and procedures which included mammogram and ultrasound scan with unknown results on an unspecified date. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not taken for the events. The outcome of the events was reported as recovering. The case considered as non-serious. No follow-up attempts are needed. No further information is expected.
Pt has reported small blisters, about 16, all over her body (legs, knee, breast, axilla, back) that started as small itchy red bumps. She states they are itchy and has been using Benadryl cream on them. I instructed her to contact her physician to have them looked at to make sure they are not related to vaccine.
Harsh Body aches and chills...hand shook to the point where I couldn?t hold a pencil.  High 102 fever.  Dizziness
I developed a lump in my left axilla that I noticed on 2/8 (about 2 weeks) after my second COVID-19 vaccination. This lump has persisted and grown slightly larger since then.  It is now 4/20 (3 months after my second vaccination).
Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female patient who received Moderna's Covid-19 vaccine and had a stroke.  Patient's medical history included a mini stroke (5-6 years ago). Concomitant medication included blood thinners.  On 02 Feb 2021 at 4:30 pm, ten days prior to onset of the event stroke, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot/batch: unknown) for prophylaxis of Covid-19 infection.  On 11 Feb 2021, the patient had an event of stroke for which was hospitalized. The patient was on a lot of medications (not specified).   Action taken with second dose of mRNA-1273 in response to the event was not recorded.  The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. However, patient's elderly age and prior history of TIA are considered as risk factors.
expired dose of Shingrix was administered to a patient/ patient received an expired second dose of shingrix inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of Shingrix was administered to a patient/ patient received an expired second dose of shingrix inadvertently). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-NOV-2023 The reporter asked about the side effect if given expired shingrix to patient. The vaccine administration facility was the same as primary reporter. Office manager stated patient received an expired second dose of Shingrix inadvertently. The reporter confirmed an expired dose of Shingrix was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
Breakthrough COVID infection on 6/13/2022 with myalgias. Unknown symptom onset.
sore arm hours after shot; fatigue/tired; runny nose; coughing/slight cough; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm 05Feb2021 11:15 (82-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included diverticulitis (surgery), kidney cancer small area excised, and prostate cancer radiated. There were no known allergies. Concomitant medications in two weeks included allopurinol, fenofibrate, tamsulosin, and amlodipine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 15Jan2021 11:15 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On 05Feb2021 15:00, patient experienced sore arm hours after shot, fatigue, runny nose, coughing, no temperature the next day. Symptoms abated second day after shot. Still tired and a slight cough. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
BlurredVision, Dizziness, Myalgia, Fever, Diarrhea & Nausea Vomiting Narrative:
Week later - itchy rash, two inch diameter around vaccine site, still sore to touch - swollen painful lymph node left armpit
loss of energy; Nauseous; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (loss of energy) and NAUSEA (Nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced ASTHENIA (loss of energy). At the time of the report, ASTHENIA (loss of energy) outcome was unknown and NAUSEA (Nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: 150/119 (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab data: Red blood cell count - Low, B12 -Low, Iron -Low,
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history and concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of PEDVAX HIB (lot # J000360, expiration date: 25-OCT-2015 (also reported as 23-OCT-2015) (dose,  frequency and route of administration were unspecified) were inadvertently administered to the patients on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Complained of nausea, and feeling light headed. Turned very pale then got extremely flushed after. Complained of feeling warm and hot. Vision turned a little blotchy. Stayed for longer observation. Felt better when left vaccine clinic.
Patient is a 85 y.o. male patient of MD with history of coronary artery disease s/p bypass surgery LIMA to LAD and reverse saphenous vein graft to distal obtuse marginal 2006, nonsustained V. tach and atrial fibrillation, s/p ICD device, not on anticoagulation due to fall risk, Parkinson, diabetes mellitus on metformin, who presented to the emergency room with diarrhea, found to have AKI and COVID infection.   Patient was a history of Parkinson with a chronic generalized weakness, had 2 days history of weakness, fatigue, nausea, abdominal pain and subsequent diarrhea today, patient has mild cough, no shortness of breath, no phlegm production, no fever, no chills.  Patient fully vaccinated without booster   Acute kidney injury, on chronic kidney disease stage II Improved   Hallucinations and aggressive behavior Parkinson disease with behavioral disturbance Patient reported usual hallucinations due to his parkinson's  No hallucinations on 10/8 Consulted psych, appreciate input, started on olanzapine 2.5 mg daily for aggression and agitation, avoid halodol No hallucinations 10/12/22 Back to having hallucinations on 1/13 at night. Continue home Parkinson's medications, neurology consulted. Patient probably has poor long-term prognosis with advanced Parkinson's disease.  We will have palliative care evaluate the patient regarding goals of care.   Possible aspiration pneumonia Chest x-ray reviewed showing signs of aspiration pneumonia Has been started on IV cefepime, on discharge patient will be discharged on oral cefdinir. Diet modified per speech therapy: Ground/ NDD2, ground meats, Nectar thick liquids   Hypotension Resolved   Acute c-diff colitis, POA Continue p.o. vancomycin   Leukopenia Not sure about the etiology Can be due a combination of COVID and C-diff monitor     PVCs Hypokal and hypomag Replace and monitor Covid-19 Virus Infection-now out of isolation Date of onset of symptoms: 10/2/22 Symptoms present on admission: Diarrhea, decreased oral intake, nausea Date of covid positive test: 10/4/22 Vaccination status: vaccinated Imaging: Chest x-ray, pending Oxygen requirements on admission: 2 L  RA now Medical therapy: Dexamethasone, pateint is not hypoxic, stop dexamethazone Consultants following: None Anticipated special isolation end date: 10/14/22    Coronary artery disease s/p bypass surgery 2006 Aspirin, statin   Nonsustained V. Tach Atrial fibrillation S/p ICD device placement Continue 12.5 mg metoprolol twice daily Not on anticoagulation at home due to fall risk EF 57%   Diabetes mellitus, hold metformin given AKI and diarrhea Sliding scale insulin, diabetic diet   Acute metabolic encephalopathy Not sure about the etiology Colitis and COVID infection  Resolved   UTI Urine culture proteus susceptible to ceftriaxone Continue ceftriaxone   Dispo SNF
I had a mild case of myocarditis with elevated troponin levels highlighted in blood results.
had the shot have shingles now light case/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot have shingles now light case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and now experienced light case of shingles. The patient stated that Shingles vaccine did not stop you from getting the shingles but would not be as bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Moderna COVID-19 Vaccine EUA. On fifth morning after receiving my second injection, I awoke with an irregular red rash around the injection site and minor itching. By evening, the rash had disappeared but there was a noticeable bordered area on my upper left arm, where the shot had been given, which looked like illustrations of "Covid Arm" in internet news stories. On the sixth morning after the injection, it was barely noticeable, although there was still minor itching.
An incorrect dose of Pfizer COVID-19 vaccine was administered to this patient. A pediatric 5-11yr vial was used in error. MA was intending to draw up infant vaccine doses. Ped (5-11yr) vial was reconstituted with 2.2mL of diluent. (The amount used to reconstitute infant vials). This resulted in 10 syringes being drawn up of an incorrect dose of 6.9mcg/0.2mL dose. The syringes were then labeled with light blue infant labels and placed back into the refrigerator in the location of the (PEDS) (5-11yr) vials, where the vial was pulled from. The lot information for the vial used (Ped 5-11yr) was recorded on those stickers. An incorrect dose was then administered to this patient. No known issues. Dr. spoke with patients mother. Patient is doing well.
Pt recv vax on 1/26/99; on 2/5/99 pt exp vax site pain to shoulder and neck, unable to move arm, rt arm tender to palpate, unable to sleep, unable to dress, swollen rt arm; tx=Darvocet (w/ no resolve), Vicodin, Prednisone
4 hours after receiving the vaccine this patient developed diffuse hives which significantly improved with Benadryl after approximately 4 hours and completely resolved after 2 days. He has a many year history of a few episodes like this per year without identifiable trigger but has had no episodes for approximately 10 years while on daily Zyrtec (until this recent episode occurred).
Breakthrough COVID  first vax 3/31.   62 y/o female presents with complaints of SOB. Pt states that she is normally on O2 as needed and for the last 2 days, she has experienced worsening SOB and cough needs to be on 2L O2 all the time via nasal cannula.  Pt states she had fever, chest pain, and orthopnea.  Lives with boyfriend both vaccinated. Still hospitalized on this date
Information has been received from a nurse concerning a female who on 06-OCT-2010 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 665924/0930Z, expiration date 17-JUL-2011). Subsequently the patient developed adverse events of 3 to 4 inch swelling at injection site, rash and edema. The patient's 3 to 4 inch swelling at injection site, rash and edema persisted. The patient sought unspecified medical attention. The nurse reported that for two patients that vaccination was their first vaccination of PNEUMOVAX 23. It was also reported that the route of vaccination was IM for one patient and SC for two patients. The nurse requested a lot check. A lot check was initiated. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released.
This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a male patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 2nd dose of SHINGRIX. On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced muscle soreness. On 21st May 2018, the patient experienced lethargic. On 22nd May 2018, the patient experienced pustular rash. On an unknown date, the outcome of the muscle soreness and lethargic were recovered/resolved and the outcome of the pustular rash was recovering/resolving. The reporter considered the muscle soreness and lethargic to be related to SHINGRIX. The reporter considered the pustular rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 21st May 2018, 1 day after receiving SHINGRIX, the patient was lethargic. On 22nd May 2018, 2 days after receiving SHINGRIX, the patient developed chest rash with pustules that look like shingles. In 2018, the muscle soreness and lethargy had resolved. The patient reported that, the rash had improved some but it was present at the time of reporting. The patient declined to provide his address or physician information. The patient provided address to pharmacy only. The patient had denied permission to contact their physician.