chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 23 year old female with no allergies or medical history, and no illness at the time of vaccination, who on 27-AUG-2007 at 10:00, was vaccinated in the left deltoid with a 0.5mL first dose of Gardasil (Lot# 658222/0927U).  On 29-AUG-2007 the patient experienced visible condyloma.  It was noted that the patient had not had intercourse in five months.  The patient was seen at the office.  No laboratory diagnostics were performed.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
06/09/2021 Client presented to clinic for 2nd dose but wanted to ask questions first. He states about 24hrs after receiving the 1st covid shot, he has had headache ,ears hurt, and bumps and they bust open on his head. He showed me his head  several grape size bumps with scabs. The one on top of his head busted and ran down the back of his neck and he got the biggest one. He showed it to me it is a large bump the size of a large egg and is ozzing yellow/clear puss on the rt back of his neck. I told him I have not heard of that being a reaction, and he needs to go directly to his PCP or the emergency room. It could possibly be staff and it is urgent he see a Dr. today. Client states he has seen PCP. He was headed to the clinic to see if she would see him or send him to the ER. I will follow up with him on Friday morning to see if he received medical attention.
HYPOXIA 7/20/2021 CANCER METASTATIC TO BONE
Pt developed a generalized red rash consistent with measles; lip and cheek swelling consistent with mumps. Pt treated with Duricef and Zyrtec.
Within 224 hrs after immunization child had a fever of 105 would not bear weight on leg, examined no injection site reaction present.  Treated w/tepid baths and tylenol PRN. Mother report infant irritable, lethargic and regused to drink.
CDC reports: 4 mo infant developed fever to 99.6, local rxn @ inject site, pain in joints, screaming episode & hypotonia following DTP/OPV immunization.
stomach ache, and vomiting for more than two hours. forced fluids (water and popcicles, pepto bismal)he couldn't keep any of it down. no fever
reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the first dose) in a female 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (reaction to the first dose). At the time of the report, VACCINATION COMPLICATION (reaction to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD21-036558, MOD21-036629 (Patient Link).   Reporter did not allow further contact
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 week old patient of unknown gender (lot# J012588, expiration date 29-AUG-2015) (dose and route of administration not reported). This is one of several reports received from the same source. Additional information is not expected.
pt recv vax 16MAY97 & MAY97 pt exp weakness, nausea & lightheadedness which progressed to viral labyrinthitis;
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  This is a case of Expired Product Administered concerning a 65-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 65-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.On or about 02-SEP-2016, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 11-SEP-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
21 year old female with no significant past medical history who presents with 4 week history of progressively worsening vision, muscle spasms and paresthesias.  Pt. shares the above symptoms started immediately after receiving her first HPV shot in her right arm. Symptoms of progressive vision loss worsened to the point where she now has to wear contact lenses. She reports since receiving her contact lenses she notices continued worsening of vision, reports when the light are dim it is very hard for her to see. She endorses bilateral floaters as well. She reports an aching of bilateral eyes as if she has been staring at the computer screen for prolonged periods of time.  She shares bilateral tinnitus with muffled hearing bilaterally. She shares her muscle spasms that started 2 days after receiving the HPV shot started in her lower extremities and progressed upward to her arms. She denies muscle weakness or atrophy. They are associated with paresthesias that are worse in the evening and prompt patient to move her legs. Symptoms are improved with movement.  She reports 1 week history of palpitations after immunization as well that have since resolved. Durations 10 minutes occurring hourly. She denies headaches, weight loss, fever, chills, shortness of breath, cough, chest pain, recent travel. She has not been sexually active for 2 months LMP was 2 weeks ago.  She recently stopped Aubra, OCP, 1 week after her vaccination.   Social: non-contributory FHx: Brother wears glasses, Uncle: Thyroid dx.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she asked did the 2nd dose cause shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Right side of face is red and small blisters formed.  Right eye feels droopy and  slight headache.  Also red and swollen in left are where I received the injection.
chest cold; head cold; Poor appetite; Night sweats twice; Guts are messed up; Started with eyes; This case was reported by a other health professional and described the occurrence of chest cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest cold (serious criteria GSK medically significant), head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort. On an unknown date, the outcome of the chest cold, head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort were unknown.   It was unknown if the reporter considered the chest cold, head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix vaccine and experienced poor appetite, guts are messed up started with eyes, feeling like going to bug out of head, then went to head cold, chest cold and night sweats. The patient has not had flu in years and no fevers, really that he knows of.
I was given the PREVNAR 13 vaccine on 4/27/16. By 4/29 I had a horrible cough and was spitting out green phlegm. I started running a fever on 4/30. I have been back to the doctor several times since then. I was put on prednisone, LEVAQUIN and am using a nebulizer twice a day.
pt recv vax 10OCT97 & 22OCT97 pt devel about 20 vesicles on trunk & arms;MD noted that this was more attenuated than would be expected;22OCT97 pt also devel a raised red area about 3 to 4cm in diameter around the inj site;
Employee states that she began having abdominal cramping in the afternoon of 1/18 and rectal bleeding on 10/19 which increased on 10/20. Her husband called her GI physician on 10/20. Dr. called patient back and asked her if she had received the flu vaccine and asked if she had received the nasal spray.  He told her that the the vaccine caused the flare up.  Treatment increase Lialda, Begin Hydrocortisone enemas at night, begin PO Prednisone. Blood drawn on 10/21.
Case previously recorded as MA2009-6446. Initial case report received via Med Com from a health care professional on 30 NOV 2009: A 3-year-old patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. unknown) i.m. on 30 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-008951.
Reaction from injection site down to elbow redness and swelling; Reaction from injection site down to elbow redness and swelling; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Reaction from injection site down to elbow redness and swelling". Additional information: Reaction from injection site down to elbow redness and swelling. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (severe nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (severe nausea). At the time of the report, NAUSEA (severe nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Full body rash - started as hives and ultimately turned into full body rash. Within 5 hours after shot my entire body was covered and completely red/swollen. This rash lasted for a little over a weak.
Moderate to Severe Swelling, red, hard, and hot to the touch, some mild blistering near center of spot, diameter of swelling 3 inches and increasing still a day later, treatment so far nothing but monitoring.
Stating many details to help determine whether or not this is not vaccine related: onset of red and blistery rash, similar to a contact dermatitis with no known new contact substances; rash started on upper front torso, spread to folds under breasts and downward to abdomen and around to lower back; over several days spread to upper arms, elbow pits and below; next to shoulder areas and knee pits; 01/11/2021 the rash is still spreading slowly, itchy and inflamed, while parts of the original rash have begun to scab and heal. Due to holidays and level of inflammation and blistering, cosmetic surgeon recommended and PCP called-in 7-day round of Keflex to curb possible infection in breast creases beginning 12/26/2020. Taltz dose dates were 12/11/2020 and 01/08/2021. Breast augmentation 11/13/2020 (no adverse reaction to surgical tape, stitches or staples in this or prior procedures).
now I'm losing the cornea and cant see out of it.; now I'm losing the cornea and cant see out of it.; I've had shingles four times and had all the shots, they do mot work for me/ Suspected vaccination failure; I had them in my right cornea in November of last year and that was a transplanted cornea and now I'm losing the cornea and cant see out of it.; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had four times) and corneal transplant.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2020, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced unilateral blindness (serious criteria GSK medically significant) and corneal disorder. On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown and the outcome of the unilateral blindness and corneal disorder were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unilateral blindness and corneal disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received all the doses of Shingles vaccine and they did not work for him/her. The patient stated that he/she had shingles in his/her right cornea and that was a transplanted cornea and at the time of reporting, he/she was losing the cornea and could not see out of it. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
light headedness to the point of feeling like passing out; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age (Age: 71; Unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced: light headedness to the point of feeling like passing out (non-serious) in Feb2021. The clinical course was reported as follows: The patient reported that during the 15 minutes after receiving the injection, he was fine. Thirty minutes post vaccination, while driving home, the patient experienced light headedness to the point of feeling like passing out. The patient had to pull over on the highway. The feeling lasted about an hour before subsiding. The patient stated that after an hour and a half after receiving the injection, the light headedness was mostly gone. The clinical outcome of the event was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient experienced a high fever, headache, and malaise 3 days after immunization that prompted ED visit at hospital.
Fever - 100.8 degrees, shaking, chills, headache, fatigue, nausea- 24 hours Fever - 99.8 degrees, headache, fatigue, nausea - 48 hours Headache, fatigue - 5 days
approx 11hr p/vax pt found limp & unresponsive, color pink;taken to ER, given 02, had gradual recovery;next day pt looks fine
10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard.  I was short of breath and had nausea and a headache.  This lasted for 1.5 hrs. then I laid down.  As I was falling asleep I couldn't shake a scary "vision: I was having of myself like my eyes turning bright blue and electricity going through my body and my body ascending into the air.  I had nightmares all night.  I have never had hallucinations or whatever that was.  And nightmares are rare for me.  I woke up fine on day 2, just a stiff sore arm.  Day 3 I was fine.  Day 4 I am developing an itchy, bumpy, rash on my right arm at site of injection and around it.  I reported this online on my health chart and will go in if I keep getting strange reactions.
pt described itching @ area of inj on lt deltoid then turned red & became edematous approx 3" diameter;p/several min itching & redness subsided, swelling dec w/in 45min;pt states feels a little lightheaded but nothing else;
feeling really shaky; very dizzy; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 at 12:30 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included vestibular dysfunction. The patient's concomitant medications were not reported. On 12Mar2021, the patient started feeling really shaky and very dizzy. The patient stated she has been dealing for 40 years with "pre-existing vestibular dysfunction" and she wanted to know if there had been any complaints about Pfizer second shot causing "excessive dizzy, shaking, type of feeling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Profuse sweating. Dizziness. Shakiness, unsteady on feet.
she is feeling sick today; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Dose 1 manufacturer unknown.), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, Dose 2 manufacturer unknown.), for Covid-19 immunization; Covid-19 vaccine (First Booster dose (Dose 3), Manufacturer unknown.), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 12May2022, outcome "unknown", described as "she is feeling sick today".  Additional information: she mentioned that she is gone with her second dose of Pfizer COVID-19 Booster yesterday and she is feeling sick today and she would like to know if we can get her some recommendation of what is the next step for her to do."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CT abdomen pelvis reported acute pyelonephritis. Admitted for further evaluation treatment. Discharged to home. ED to hospital admission within 6 weeks of receiving the COVID vaccine.