chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after vaccine administration pt complained of chest pains--medical attention refused by patient, left store/clinic. Next day 4/1 pt states had pus from injection site and chest pain--took nitroglycerin and put neopsporin on injection site. Then on 4/4/22  patient states had red line down arm, pain and numbness in thumb, Patient squeezed thumb, thumbnail came off and puss came out of site as well. Patient then cleaned out wound on thumb  with rubbing alcohol, saline and neosporin and took an old antibiotic had at home (Amoxicillin 500mg). Contacted pfizer, pharmacy and MD. Patient self  administered neopsporin to site, rubbing alcohol, flushed with saline. Also took old rx for nitroglycerin  SL 0.4mg for chest pain and amox 500mg ..1 tab every 6 hours for 4 doses. Admits to taking 1 tylenol 650mg tab when thumb was hurting. as of 4/5/2022 patient arm/thumb feeling better. Does complain of swelling in feet and ankles. no further chest pains.  advised to contact/see md
Patient reported numbness in left arm (vaccinated arm) patient waited additional 10-15 min. No other symptoms. Patient went home, called patient at home 2 hr later vaccinated arm was ok.
She has swollen not swollen, Painful arm first; This is a spontaneous report from a contactable consumer (patient's mother). A 13-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 13-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced She has swollen not swollen, Painful arm first. No treatment was received. No prior vaccine within four weeks. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Case number PHEH2014US011570 is an initial spontaneous report from a consumer received on 05 Jun 2014. This report refers to a 69-year-old female patient. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1308201) intramuscularly on 13 Oct 2013. On the same day, post vaccination, her pulse slightly elevated and irregular. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported.
This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unkown age and gender. Medical history and drug reactions or allergies were not specified. On 27-AUG-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K005645, expiration date 17-OCT-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 43) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; This is a spontaneous report from a contactable other HCP (patient herself).  This 28-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, on 19Dec2020 at 15:00 at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant.  Relevant medical history included sinus tachycardia and obstructive sleep apnea.  Patient's Body mass index (BMI) is more than 35. No known allergies. Relevant concomitant medications included ibuprofen. The patient was vaccinated at Clinic, age at vaccination was 28-year-old. No other vaccine was received in four weeks.  Pre-vaccination and post-vaccination COVID tests were not performed. On 28Dec2020, at 12:30, the patient developed tenderness, redness, and swollen at injection site, approximately 2 inches by 1 inch in size. The patient was not treated for the events.  The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Complained of fatigue (sleeping all day), headache (occipitol in AM, relieved by Alleve), N- AMs, weakness.
This spontaneous report as received from a medical assistant refers to a 17 year old male patient. On 09-JUN-2014 the patient was vaccinated with a first dose of GARDASIL (dose, route, lot # and expiration date were not reported). The reporter stated that mother of GARDASIL patient told her that son developed a fever for three days and felt sick immediately after receiving first dose of GARDASIL on 09-JUN-2014. The patient did not take any medication for the treatment. The therapy with GARDASIL was continued. The outcome of the events was unknown. The patient did not seek any medical attention. The relatedness between the events and GARDASIL was not reported. No PQC (product quality complaint) was involved. Additional information has been requested.
My arm started to hurt the next day and for five days after. I developed a rash after two days on my neck, chest, trunk and the insides of my arm. I have gotten a similar rash post viral before. I had the rash for three days. I took Tylenol for the arm pain which was red swollen and hot.
Patient admitted to Hospital on 9/23/14 with admitting diagnosis of chest pain for observation. Confusion, fever and dyspnea.
Pt developed a 2.5" x 3" red, hot, swollen area at site of injection in left arm. Discoloration still faintly visible after 1 month. Pt treated with Cyrtex x qd x 5.
Pt states had IPV vaccine on Thursday 6/16/05 and she broke out with "hives" on 6/17/05 on stomach, back, buttocks, pubic area and legs. Stated they were little blisters. Had been using Benadryl and cortisone cream OTC. Nurse called and talked with pt on 6/27/05. On 6/20/05 she went to physician due to continued hives on stomach, back, buttocks, public area and lower extremities. Dr gave her a sample of Zyrtec 10mg po to take 1 tab po daily. Steted hives subsiding by 6/20/05. Nurse called Dr's office on 6/20/05 for reports of her office visit. Dr diagnosed scattered urticarial lesions primarily on the back.
shakes; cough; sore throat; arm was sore; diarrhea; fatigue; body aches from head to toe; fever of 101.1 degrees F; severe headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore) and DIARRHOEA (diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills). On 28-Feb-2021, TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills) had resolved. On 06-Mar-2021, PAIN IN EXTREMITY (arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 101.1 (High) fever of 101.1 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment for the events included Tylenol every 4 hours.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: initial additional
Patient fainted while on her way to the observation area after vaccination.  She quickly regained conscious, but was pale and in cold sweats.  Her extremities were very rigid.   We lay her on the floor.   EMT arrived within 10 minutes.    She was much relaxed, but still complained not feeling well, especially her stomach.   Patient was taken hospital for further checkup. I spoke to pt in the evening.  Pt is already home.  She is feeling fine.
parents states  pt temp went up to 105 R; had difficulty breathing, tongue became swollen, devel a rash on chest & back; taken to hosp ER;
Narrative: 70 yo male with PMH of cirrhosis of liver, gallstone, neurocognitive disorder, angina, shoulder pain, depression, calcification of spleen, sleep apnea, CKD stage 3, OA, HF with reduced EF 20-25%, diabetes, diabetic peripheral neuropathy, and CAD passed away on 4/7/2021 under hospice care. Pt received the vaccine (while under hospice care) on 3/30/21, second dose of Moderna. He received first dose on 3/4/2021. Both doses were administered without complications. Most recent hospitalization is from 3/3-3/18/21 at the medical center for acute on chronic CHF exacerbation. He was sent to the nursing home after the hospitalization and was discharged to a community nursing home on 3/31/021. Pt passed away on 4/7/2021 at the community nursing home.
Patient received vaccines Hep A & Influenza in office in am without problems. Mom called approx 2 hrs. later and reported patient c/o stomach ache, fell to the floor, unresponsive, no movement & turning purple. Lasted approx 5 min & resolved. Looked well in office afterward.
Patient developed fever after vaccine and chest pain for 2 days. Findings concerning for acute pericarditis
Immediate (lasted 10 minutes) Racing Heart Rate / Tachycardia Dizziness (about to pass out) Nausea (about to be sick) Tunnel Vision   After Effects lasted 2hours Tunnel Vision Fatigue / Sudden Tiredness Cold / Pale Skin / Feeling Cold
was given after 30 day fridge life-Moderna verified that this was still okay to administer. No negative outcome
After receiving MMR shot, child developed fever (99 - 103 degrees); rash (chest, belly, sides, back, neck) that was raised, red and irritated; irritability, runny nose, cough, inability to sleep for 3 days; no appetite, diarrhea.  Brought child to doctors office on Saturday Feb 26 where we were told that it is a reaction to the vaccination.  Symptoms continue even today.
One day post vax pt noticed swelling, tenderness. Pt seen on 08/24/2000, noted redness, induration; pt treated for cellulitis vs allergic reaction. five days later redness and induration improving.
Hospitalized due to COVID-19; Reported per Moderna COVID-19 Vaccine EUA
Extreme pain, burning in upper R arm/starting a couple of weeks after vaccine. Diagnosed w/brachial neuritis. Doctor said "it will not improve" expect to get worse. Pain management /Nerve blocks. 03/20/07-records received from facility for DOS 10/22/04-8/9/05.C/O rash on right arm of 8 weeks duration. Rash itchy, red, irritated, painful, bleeds and is scaly.  PE:No primary lesions noted on right arm, classic triangular pick excoriation of upper right arm, several scabs from previous episodes of picking. DX: Xerosis which might cause some itching. Pruitis of unknown origin. Subsequent visit c/o burning sensation in arm and forearm, no weakness. in PMH:6/04 struck by a desk when a car broke through the window of her office and struck the desk pushing it into her. She suffered soft tissue injuries to the arm as well as pieces of glass which have been removed. DX:uncomfortable paresthesias and burning of the arm. On 8/9/05-DX: radiculopathic symptoms without definite evidence of a neurologic etiology.
6-9-15 Reaction brought to clinic attention area 10 x 10cm reddened-instructed to use ice-hydrocortisone cream and BENADRYL-returned to clinic 6-12-15 area increased in size remains red-SOLU-MEDROL given R.D.
patient is 17 years old and the first shot was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is 17 years old and the first shot was administered) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is 17 years old and the first shot was administered). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is 17 years old and the first shot was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details reported.
Acute respiratory failure with hypoxia. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
pt tested positive for COVID-19 on 8/4/21, sx of cough and SOB; presented to ED with hypoxia due to COVID pneumonia; experienced A Fib; worsening ARDS; placed on BiPap; transported to in-patient hospice; DNR; respiratory condition worsened and pt passed away in the hospital
I got blood clot in the legs. I think it started with surgery I needed but I am not sure. It seems I get new blood clots every time I take the vaccines. And my back seems to be getting weaker, with every vaccine I take. It is very concerning. I had surgery on my back and was recovering when I took the 2nd dose and it hasn't gone away and getting worse with every single vaccine.
THE BARREL DETACHED FROM THE NEEDLE AS I WAS FINISHING THE VACCINATION WHICH RESULTED IN LOSS OF VOLUME OF THE ADMINISTERED DOSE. AFTER CONSULTING WITH MY DM AND PHARMACY CARE COORDINATOR , I FOLLOWED PROTOCOL AND ADMINISTERED ANOTHER 0.3ML OF PFIZER VACCINE
Huge liquid filled blisters of entire upper arm around and below injection site from shoulder to elbow. Thickening or swelling and darkening tone of skin in same area. Burning sensation and itching.
UTIs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTIs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTIs). At the time of the report, URINARY TRACT INFECTION (UTIs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.    Reporter did not allow further contact
His arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (His arm was sore) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (His arm was sore). At the time of the report, VACCINATION SITE PAIN (His arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
describes chest pain, waxing/waning, nonexertional, radiating to L axilla, increased abdominal bloating, gas which came on within hours to days after immunization and have persisted x2 months
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received Paxlovid from 21Sep2022 to 25Sep2022 for treatment of COVID-19
On 10/25/02 employee received flu shot in ER per above mentioned student under the guidance above listed Rn with reportedly correct technique and with sterile procedure. On 10/28/02 developed blister at injection site with redness and soreness. Emp had area drained in the ER and the next day debrided. No fever or other adverse reactions noted or reported by employee.
Patient's son reported that patient had a seizure on 3/5/21 after receiving the second Pfizer-BioNTech vaccine on 2/24/21.
Fever of 99.9, body aches, fatigue, headache, and severe lower back issues.  The back issues lasted for about two weeks and required the use of muscle relaxers and Ibuprofen.
Client  reported feeling dizzy at 2:57pm after COVID-19 vaccine administration at 2:38pm , reported "feeling itchy" and  redness in left forearm and headache 5/10.  Provided water and crackers. Benadryl 50 mg PO administered and icepack provided. Vital signs at 2:57pm 11/78 mmHg, HR 87, RR 18, Spo2 98%, 3:08pm: 114/76 mmHg, HR 81, RR18 3:15pm: 124/86 mmHg, HR 90, RR18, SPo2 98%. 3:21 pm: 112/82 mmHg, HR 92, RR 18 Call to 911 at 3:19 pm due to symptoms not improving and mother reporting slower response to questions.  Care transferred to paramedics at 3:28pm, transported to ER.
Second dose of Moderna vaccine was not stored properly. Recommended to get another dose of Moderna but had already transfered to another station and was recommended to get Pfizer since second Moderna was ineffective.
Patient received the vaccine in November and in December she started experiencing difficulty walking and talking tried to see a doctor unable to see a doctor until January.  Went to the emergency room in February with the following symptoms: unable to move legs, difficulty moving arms, trouble breathing, pain all over difficulty with speech, vision problems, headache, excessive thirst, fatigue. CT of head, MRI of head, ophthalmologist exam, MRI cervical and spine. Neurologist reported the following: Examination demonstrates features most consistent with a myelopathy.  We will obtain spinal MRI and repulse with steroid.  We will also check Lyme tier.  A post-vaccination myelitis or Miller Fisher syndrome is a consideration.  Cysticercosis is a possibility as well.  I will request hospital records as well.
Immediately after HPV9 vaccine. Pt reported "I'm going to pass out". Helped pt to lie down on bed and had mom call for help. Pt body became rigid, lost consciousness, labored, shallow breathing, strong carotid pulse. Urinated on bedding. LOC for apprx 1 min. When regained consciousness very tearful, disoriented, sleepy. Pt taken to hospital via ambulance.
It was received from a regulatory authority on 10/29/00, concerning an 88 year old pt who experienced cardiac failure and ventricular hypertrophy which led to death 16 days after receiving the Fluvirin vaccine on 10/1/02. The pt had a medical history of dementia, lower respiratory tract infection in June 2002, influenza and anaemia. The pt had been receiving the flu vaccination since 1993. On 10/17/02, 16 days after vaccination, the vaccinee developed an acute cardiac failure following left ventricular hypertrophy and subsequently died. A post mortom examination was performed and cardiac failure was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.
The day after the patient began to feel SOB, tight chest, and chest pain. Patient was hoping the symptoms would go away on their own but they have not. It has been 5 months and the symptoms have gotten worse. Patient has a hard time lying down, exercising, and daily activities without  having chest pain and SOB.
2 hours, post vax, pt experienced sweating, tingling of hands and altered sensorium. Given Medrol Dose-Pack with good response. Followed-up on 7/15/02
Narrative: presented to ER w/ c/o progressive weakness on 7/8/22 reporting symptoms started 2-3 days prior and getting progressively worse -- additional details provided in another section of this report. Patient received Shingrix and PPSV23 vaccines in different arms on 6/27.
The patient experienced no symptoms; on 5/18/2020 an improperly stored dose of GARDASIL 9 (lot S008151, expiration 11/20/2021) was administered to a patient; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 18-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S008151, expiration date 20-NOV-2021; dose detail and strength were not provided) intramuscularly for prophylaxis (product storage error). The temperature excursion included 27 fahrenheit degree for 3 hours. There was no previously temperature excursion. There was a data logger involved. The patient experienced no symptoms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
some arm soreness; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2020SA340519 and 2020SA346513.  This case involves female patient of an unknown age who experienced some arm soreness (pain in extremity), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious some arm soreness (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that he does not know which ones they got. The wife he said got a high dose flu vaccine but he does not know name.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.