chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given DTAP in right arm. Appears it was given into subcutaneous tissue vs. IM. Developed red, warm "quarter size" indurated area.
10cmx7cm area of erythema, swelling and warmth of injection site. Resolved with Benadryl.
Pt history thoracic neuritis recv trivalent influenza devel urinary retention, adm to hosp medical exam revealed normal vital sign, the lower limb had one fifth strength, dec reflexes, inability to stand independently, bladder distended
Pt was hospitalized on 4NOV90, 48 hrs p/immun w/fever of 103 & irritability, septic workup was performed, d/c on 6NOV90;
her temperature from 101.9; lethargic; feels bad all over; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 26Jan2021 18:10 as single dose for covid-19 immunization. On an unspecified date, she had a hard time reducing her temperature from 101.9, lethargic, and feels bad all over. Outcome of the events was unknown.   Referenced EUA Prescribing Information Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo for participants 56 years of age and older. Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). Information on the Batch/Lot number has been requested. Follow-up attempts are completed. No further information is expected.
Hives; Headaches; This case was reported by a consumer and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (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 hives and headache. The patient was treated with cetirizine hydrochloride (Zyrtec), prednisone, famotidine (Pepcid) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives and headache were unknown.   It was unknown if the reporter considered the hives and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was a reporter' sister. The patient was currently working and did not have the time right now. The reporter concerned because patient was highly reactive to new medications. The patient experienced hives and headaches. The physician prescribed the following 1 take prednisone as prescribed take 2 Zyrtec in the am, 1 pepcid in the afternoon, and 1 benadryl at night for about a month. The patient adviced to follow up if no resolution of symptoms or signs of bacterial infection warmth, redness, green discharge. The reporter enquired about what was the difference between this shingles vaccination and the other vaccines. The reporter consent to follow up.
Received the vaccine on 1/6/21. 1/12/21 discovered painful and very swollen supraclavicular lymph node. Ultrasound discovered 3 abnormal lymph nodes however bloodwork came back normal per my PCP.  Radiologist recommended biopsy of largest lymph node, PCP declined to do so.
Approximately 3 hours after vaccines patient was fussy. Diarrhea began 13 hours after vaccines, blood streaks were observed in diarrhea. Patient was seen in MD office on 8/8/07. Stool was (+) blood in stool. Patient well appearing, no distress, abdomen soft, non-tender. On 8/20/07 patient had blood in stool again dairy d/c's from diet on 8/23/07 blood still in stool. Patient seen 8/27/07 and MD ordered stool cs, KUB and start Florastor.  9/25/07 Reviewed pcp medical records which confirm RO dose & lot # as reported & reveal patient experienced good health on day of vax w/rash noted on head.  Became fussy, w/diarrhea, blood streaked stool & reduced oral intake next day & seen by pcp that day.  Exam at that time normal & felt to be probable milk protein allergy.  Continued to have intermittent loose, mucousy, blood streaked stools as of 8/20.  Referred for GI consult.  FINAL DX: colitis.
3am sleep depriving pain in left shoulder, chills.  April 1 day spiking temp between 99 and 101, nausea, chills, muscle pain, joint pain
2  days after second dosage the patient began to experience chest pain and shortness of breath at rest and worse with minimal activity-body aches--myalgias--headache
He noticed a hard lump in his bicep this morning and it appeared to be in a vein.  He went in to see his doctor and the doctor diagnosed him with a blood clot.  The doctor said it was in a superficial vein and didn't give him any treatment.  Told him to keep a watch on it and if it got swollen or turned red or he developed shortness of breath to come back in and be seen.
A non-serious spontaneous report of administration of expired FLUMIST was received from a pharmacist concerning an 11-year-old male. The patient's medical history included twin birth. No concomitant medications have been reported for this patient. The product expired on 27-Nov-2011. On 04-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Vaccine given at 10:35 am. Client monitored in office for 30 minutes post injection. Tolerated well, no reaction noted. Client returned to work.  At approximately 1:00pm client calls to inform she developed lightheadedness, nausea, and "puffiness" to bilateral eyes. At this time this nurse instructed client to contact PCP office as she has been instructed to not take Benadryl in past d/t developing a rash after taking. Client voiced understanding.  To client at 2:20pm. Client states she spoke with PCP office and they are unable to get her in until 11/30/21 at 08:00 am, and instructed her if s/s worsen or new sx. develop to be evaluated at ER. Client informs this nurse she has now noticed increased HR at rest. Client is home with mother. This nurse recommended for client to be seen at Urgent Care or ER for evaluation.
pt recvd vax & 24hrs p/vax pt exp swelling in foot & was found to have erythema nodosum;sx cont
Muscle spasms and tremors, nausea and severe chills, headache, bloody nose - per patient symptoms lasted 3 days required rest.
patient stated she was having pain in arm from vaccine for a couple months. patient was recommended to go see pcp for further evaluation
RN 03/17/2023 09:43:04 AM >  Call placed to Pt she reports she is having extreme fatigue and  body aches from head to toes since her covid booster on Wednesday. Pt reports she had a fever of 101 on Thursday along with chills.No fever at this time.  Pt reports she is very nauseous and has mild sore throat.  She has taken extra strength Tylenol with little effect. Reports she "feels like shes dying" Pt reports zero side effects from last covid vaccines. Pt does have a NP, going out to the house at 10am. -To pcp any recommendation for pt or visiting np. (was going to have her come in but she is being seen at home) MD 03/17/2023 09:56:43 AM > Noted. Please have visiting NP to perform orthostatics for fluid assessment. Encourage fluids, antipyretics, and send for antiemetic if indicated after visit. Pls screen pt for Guillain-Barre-Syndrome and reprot adverse reaction if severe to system/ Ok to make telehelath visit with me for f/u next Wednesday or Thursday. Ty RN 03/17/2023 10:10:37 AM > Callplaced to pt direct extention given so NP may reach out to RN when she is in the home with pt, pt given phone visit for next week.  RN 03/17/2023 11:18:48 AM > Call recieved from Vsiting P.A she reports pt is not orthostatic, she wrote for Zofran. P.A  went over emergency symptoms that would require her to go to ER/call 911.   Pt in agreeement with plan and will contact office with any further difficulty. -FYI to pcp . 3/17/2023 - Home Visit NP orthostatics  Orthostatics 128/52 HR 60, lying  110/58 HR 68, sitting 130/58 HR 68, standing . 3/22/2023  telehealth PCP visit .#COVID-19 vaccine  Pt reports had COVID-19 booster Moderna  (BIONT 042H22A) administered 3/15/2023 at 1:00 pm. BY 5 pm that evening, shaking uncontrolably, very cold. Had profound bodyaches, pt was in bed for three straight days and very sick. Pt is still weak. Worse symptoms for 5 days until 3/21/2022 If she had known the booster would done that wouldn't have gotten it. Home visit NPs did orthostatic, was not severely dehydrated. Was offered IV and pt drank a lot of water and had Gatorade. Home visit NP found swollen lymph nodes. Has current lymph nodes and goin pain before. Pt taken Tylenol, hasn't picked up the Zofran yet because hasn't felt well enough to get out of bed. Will see her Cardiologist, NP next week as well, rescheduled on April 6 as was sick. She has a lot of discomfort around the pacemaker, will be 1 year next month. Denies CP, has chronic SOB with MDS, palpitations. Denies numbness or tingling at this time. It's been overwhelming since being diagnosed with pernicious anemia, MDS, and pacemaker.
Arm is very painful; Arm is swollen; The knot is about the size of a peach; The knot  is very warm; has been vomiting non stop; Was very disoriented; Could not make out a complete sentence; Had been feeling pretty sick; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had been feeling pretty sick), DISCOMFORT (very uncomfortable), VOMITING (has been vomiting non stop), DISORIENTATION (Was very disoriented) and SPEECH DISORDER (Could not make out a complete sentence) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless legs syndrome (Reported by patient that she takes medication for restless legs syndrome) and Insulin-dependent diabetes mellitus (Reported that patient is an insulin dependent diabetic and has an insulin pump). Concomitant products included AMITRIPTYLINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION COMPLICATION (Had been feeling pretty sick) and DISCOMFORT (very uncomfortable). On 16-Jan-2021, the patient experienced VOMITING (has been vomiting non stop), DISORIENTATION (Was very disoriented) and SPEECH DISORDER (Could not make out a complete sentence). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is very painful), VACCINATION SITE SWELLING (Arm is swollen), VACCINATION SITE INDURATION (The knot is about the size of a peach) and VACCINATION SITE WARMTH (The knot  is very warm). On 16-Jan-2021, VACCINATION COMPLICATION (Had been feeling pretty sick) and DISCOMFORT (very uncomfortable) had resolved. On 18-Jan-2021, VOMITING (has been vomiting non stop), DISORIENTATION (Was very disoriented) and SPEECH DISORDER (Could not make out a complete sentence) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is very painful), VACCINATION SITE SWELLING (Arm is swollen), VACCINATION SITE INDURATION (The knot is about the size of a peach) and VACCINATION SITE WARMTH (The knot  is very warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Blood glucose: 146 or 156 mg/dl (High) blood sugar was 146 or 156 in the morning( the patient couldn't remember) ) and started dropping .. On 19-Jan-2021, Blood glucose: 88 mg/dl morning -88mg/dl.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included acetaminophen.
This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 08-JAN-2016, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (dose not reported, lot # L013188, expiration date 02-NOV-2016). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Hematoma at injection site on arm; This is a spontaneous report from a non-contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had hematoma at injection site on the arm. The adverse event resulted in emergency room/department or urgent care. It was unknown if the patient received treatment for the adverse event. The outcome of the event, hematoma at injection site on the arm, was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
half dose left out the syringe /  didn't receive full dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 13th April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 2021, from batch number G4CY5).   On 14th February 2022, the patient received the 2nd dose of Shingrix. On 14th February 2022, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: Registered pharmacist reported that, during administration of 2nd dose of Shingrix, half dose left out the syringe, so the patient did not receive full dose, which led to underdose. The reporter did not consent to follow up.
Moderate pain in lymphnodes; Moderate discomfort from in side elbow all the way to left flank/ Discomfort; Pain felt like severe bruising; Limited range of motion; Off-label use; Dose received: 3; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the deltoid left on 27Sep2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 29Sep2021 at 09:00, the patient experienced moderate pain in lymph nodes, moderate discomfort from in side elbow all the way to left flank, pain felt like severe bruising with limited range of motion. The events did not result in doctor/other health care professional office/clinic visit and 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 event moderate discomfort from in side elbow all the way to left flank were resolved on an unknown date in Oct2021 and moderate pain in lymph nodes, pain felt like severe bruising with limited range of motion were resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
received an expired dose; 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 70-year-old male patient who received Men B NVS (Bexsero) (batch number ABX06AA, expiry date 30-MAR-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: received an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5-Apr-2023 The reporter consented to follow-up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
4hr post vax pt off balance,unsteadiness cont for over 4months;a few days later paresthesia in feet,climbing to legs,fatigue,soreness,palpitations got forceful;tingling in tongue,arms;h/a,pain in sides,stomach
Respiratory infection; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. Medical history included COPD (chronic obstructive pulmonary disease) and disabled. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT) and tiotropium bromide (SPIRIVA).  The patient previously took paracetamol (TYLENOL) prior to the 1st dose. The patient got both doses of the Covid vaccine. He took Tylenol prior to the 1st dose and wanted to know if that would do anything to the vaccine. He was also on an antibiotic from Pfizer for a respiratory infection on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Tachycardia lasting approximately 6 hours, mild dizziness lasting 4 hours, muscle weakness (felt like my extremities were heavy), fatigue lasting 4 + hours.
Pt reported chills and severe muscle aches that night.  Also Heart palpitations but had his wife take his blood pressure and it was normal.  The next day was about 2/3 as bad and took about a week to feel back to normal
Pt had 103 fever for 3 1/2 days controlled with Tylenol. Had rash on face and arms. Really grumpy.
This spontaneous report was received from a currently 75 year old female patient who was referring to herself. The patient's concurrent conditions included chronic migraines and allergy to "Sulfa". In approximately April 2013 (reported as 3-4 years ago), after having the shingles virus previously, the patient was vaccinated with ZOSTAVAX, 19400 plaque-forming units (PFU) subcutaneously for prophylaxis (exact dose, lot number and expiration date were not provided). Concomitant therapies included zolmitriptan (ZOMIG). On 17-APR-2017, the patient's elbow started tingling and it was difficult for her to sit in a chair. The patient sought medical attention, as she saw the physician who diagnosed her with shingles again. The patient received a treatment of an unspecified antiviral, an unspecified pain medication and unspecified medicated lotion. The patient also stated that her shingles helped her in relieving the pain from her chronic migraines. There was no lab diagnostic studies performed. There was no product quality complaint involved in this case. The outcome of adverse events was reported as not recovered. The relatedness between adverse event and suspect therapy was not reported. Additional information has been requested.
ARM IS A LITTLE SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm is a little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm is a little sore was not reported. This report was non-serious.
Patient experienced immediate "throat closing" and generalized itching. Rash not seen. 25mg IV Benadryl given at 9:33 AM and Solumedrol 100mg IV given at 12:20pm.
Student returned to clinic on June 6, 2014, saw the nurse practitioner for headaches, losing focus, and soreness in left arm from HPV for 3 months ago. Per student pain worsened when she leans on her arm or if she lays on it.  No recent heavy lifting or trauma to arm.  Patient says she only does aerobic exercise. C/o that headache occurs 3-4 times per week for past 3 months. Helped by Advil. Patient got new glasses two months ago.   NP reports no swelling, bruising, redness, weakness, or muscle atrophy upon examination. Patient denies blurry vision, neck pain, nasal congestion, numbness, tingling or weakness. No MVA.  Patient reported that stress level has been increased lately b/c she had to take an exam and she isn't sure she passed, she has tried 3 times. Patient stated she doesn't drink much water and only eats 2 meals/day.  She has difficulty concentrating on her work and "took a friend's Concentra and it helped."  Patient wanted to know if she could get the medication.  Patient was referred to psychiatrist for evaluation of possible ADD or ADHD.  She is to increase water intake to at least 2 liters daily and eat 3 well balanced meals.  If arm pain persists advised to return to clinic and Xrays will be done to check for calcifications.