chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I just administered a First Moderna Covid-19 vaccine to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I just administered a First Moderna Covid-19 vaccine to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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 24-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I just administered a First Moderna Covid-19 vaccine to a 16 year old). On 24-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I just administered a First Moderna Covid-19 vaccine to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not complain of any other adverse events.   No concomitant medications were reported.  No treatment information was reported.
Marked uriticaria, hive formation and erythrodema of torso predominately and extending to head, neck and extremities. No respiratory involvement. Blood pressures stable.
nauseous; feel tired; This is a spontaneous report from a contactable consumer.   An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced nauseous on an unspecified date with outcome of unknown and patient stated "feel tired" on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results.     Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
states recv immun 1130AM & felt fine until about 7PM when started having lt side abd pain cont through noc & still w/ complaints this AM;states no inc temp or any other sx;referred to MD;23OCT97 MD felt episode d/t Coumadin not vax-pt OK no
she got a light case of covid in Jun2022.; she got a light case of covid in Jun2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Apr2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "she got a light case of covid in Jun2022.". Patient got all her Pfizer vaccines, primary and 2 booster doses. Last booster dose on 06Apr2022. However, she had COVID 19 infection in Jun2022. Caller disconnected prior to transfer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu-like symptoms:  Very tired, headache, body aches, especially in mid and lower back, and a low-grade fever.  This has lasted 5 days.
The day before I noticed symptoms, on 5/19. I needed a nap in the afternoon which is not normal for me. I also felt a bit warm, but I had been outside so I didn't think much of it. On 5/20, I noticed that I had an itchy ear that went down into my throat. I also felt a bit warm that night like I may have had a low grade temperature. If we had not been in a pandemic, I would not have thought anything of my symptoms. It hardly slowed me down, other than just feeling a bit fatigued. I took an at home Covid test on 5/21 which was positive. On 5/22, I went to the pharmacy for a PCR test which was also positive. My husband has a compromised immune system, he tested positive before I did and was prescribed PAXLOVID so when I tested positive, my husband's doctor also prescribed PAXLOVID for me. My symptoms never got worse than that itchy ear and a bit of fatigue and those have gotten progressively better.
Patient experienced flushing and tachycardia about 15 minutes after vaccine.  Patient was sent to urgent care for brief observation and found to be hypertensive as well.  Ultimately thought be a large component of anxiety after vaccination, and patient was discharged without complication.
Patient had a tonic seizure 6 days after getting the vaccine Records requested and received.  Treated at facility Hospital for seizure with twitching of arms and jerks of trunk, Keppra prescribed and now complains of photophobia. To see neurologist at Medical Center  02/09/07-records received and reviewed from Dr. for DOS 01/08/07. Neuro consult-Impression:First convulsive seizure coccurring rather spontaneously with no evidence at present underlying neurological pathology. That is based on her normal function before and after the episode, normal CT scan and EEG normal to include photic stimulation and continued normal neurological examination. Having some apparent side effects from Keppra. Diagnostic possibilities include at least 50% chance this will be a single seizure and therefore not epilepsy. In that case the immunization might at most had a very minor role to play as would also be true of mild sleep deprivation. The lack of breakfast that morning and she had been up from bed very long and only had a normal blood sugar in ER, it does not appear to be likely issue. Stop the Keppra. Follow up in 4 weeks.
I woke up the next day and I had a spot on my arm, that was maybe the size of a quarter it was a little bigger, It was red and hot and i thought it was a spider bite. I didn't feel very good I felt tired, IT progressed through the day I had a fever and the spot was growing every hour. And by 11 it was covering a quarter of my upper arm. And I called the doctor and I went in and they did some kind of test i cant remember what it was for but they thought it was an infection and they were following along with the have I been in a pond type direction. But I had not been swimming at all. So they were not sure what to make of it, my fever kept going higher like 102. I just felt very tired and the rash on my arm kept growing bigger they marked it with a sharper and it would grow and inch all the way around and kept growing an inch everyday for 3 days. My heart rate was low and it was hard to go about my day. They thought I could be going into shock and this was in the middle of COVID-19 and I didn't wanna go to the hospital so I kept seeing my doctor they gave me a shot and antibiotics and no matter what it would just keep growing and growing and then it just stopped. But I still had the fever and was tired. The biggest it was covered 3/4th of my arm and everything other than one spot was bright red and hot to the touch and after it stopped getting bigger I remained unwell for 10 days. And I started to feel a little better, I mean I wasn't getting worse and that was by day 7. And at this point there was no idea that it could be related to the shot because it happened so long after I got the shot and the injection site was still visible and the spot where the rash was, was lower than where I was injected
1/10 developed running nose, headache, cough, congestion, headache. no fever. last nasal covid test 1/9, pending result.
I'm a little late for my 2nd shot.; I had minor soreness in my arm from the injection.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (I had minor soreness in my arm from the injection.) and PRODUCT DOSE OMISSION ISSUE (I'm a little late for my 2nd shot.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced INJECTION SITE PAIN (I had minor soreness in my arm from the injection.). On 08-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I'm a little late for my 2nd shot.). At the time of the report, INJECTION SITE PAIN (I had minor soreness in my arm from the injection.) and PRODUCT DOSE OMISSION ISSUE (I'm a little late for my 2nd shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.
This spontaneous report as received from a consumer, a mother of a child via Stericycle Expert Solution (4420859). The reporter states that her child, a female of unknown age, had been administered the first dose of GARDASIL (lot # reported as J007354) on 14-OCT-2013 (information on dose and route not reported) and the second dose of GARDASIL (lot # reported as J007354) (information on dose and route not reported) on 31-JAN-2014. On unknown date the child started to have headaches for a month and GARDASIL and the events was not assessed by the reporter. Additional information has been requested.
colds or allergies; colds or allergies; runny nose; fever; loss of taste and smell; loss of taste and smell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Nasopharyngitis (non-serious), Hypersensitivity (non-serious) all with onset Oct2021, outcome "unknown" and all described as "colds or allergies"; Rhinorrhea (non-serious) with onset Oct2021, outcome "unknown", described as "runny nose"; Pyrexia(non-serious) with onset Oct2021, outcome "unknown", described as "fever"; Ageusia (non-serious), Anosmia(non-serious) all with onset Oct2021, outcome "unknown" and all described as "loss of taste and smell".  Additional information: It was reported that Caller had the 1st dose of the vaccine 3 weeks ago. A week after she got the vaccine, she thought that she had colds or allergies. She had runny nose, fever, loss of taste and smell and it is slowly returning now, and stuffy. Caller would like to know if this is colds, Covid or a reaction of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nausea; at the end she felt the gurgling and distress of her lower intestines; at the end she felt the gurgling and distress of her lower intestines; she experienced diarrhea for 45 minutes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included allergic to MSG (monosodium glutamate), allergic to soy, and allergic to NSAIDs. Concomitant medications were not reported. It was reported that she received the first dose of the Covid vaccine and within 14 minutes of administration, on an unspecified date, she experienced diarrhea for 45 minutes. She reports that it was so intense, and she would also experience waves of nausea. It was reported that she had one of the side effects with the Covid vaccine. It's listed diarrhea as one of side effects. She wanted to know when that is usually seen because she had the first shot and stayed the 15 minutes like she was supposed to and at the end she felt the gurgling and distress of her lower intestines on an unspecified date. She made it home and made it to the bathroom and had 45 minutes of intense diarrhea, like you would get with a colonoscopy prep. Also had a case of nausea since she had the intense diarrhea. She asked if it was typically seen with this vaccine or due to her nerves of getting the vaccine and being enclosed in a building for the first time in over a year or was it being in a room in line with 40-50 other people. She wanted to know when do this side effect was seen and does it occur within 15 minutes of the shot. She asked was it a side effect and if it was safe for her to get the second shot. She asked if diarrhea occurs 15 minutes or hours after receiving the Covid vaccine. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable patient reported for himself. A 72-year-old male patient received the second dose of PREVNAR 13, (lot S43277) on 17Oct2017 12:05 via an unspecified route at 0,.ml single dose, in the right arm for immunization, on the same date the patient also had received the first dose of Zoster, (lot M038350) for immunization in the left arm. On 16Jan2015 he had received the first dose of PREVNAR 13 from lot: J67643 in the right arm and previously, on 18Sep2007 a dose of PNEUMOVAX 23 (from lot#06984) and on 18Sep2012, other dose of the PNEUMOVAX 23 (from lot LOT#H013581). The patient had received Zoster vaccine 9 years ago and then he had mild shingles again. The patient also was on digoxin and COLUMADIN and taken off because his pacemaker is showing he does not have atrial fibrillation anymore. Concomitant medications included Aspirin at 325 mg on 10Aug2014 ongoing for blood thinner by mouth each night, benazepril HCL for blood pressure from 15Jan2001 and ongoing, at 10 mg, 1x/day, carvedilol since  15May2008 and ongoing for blood pressure and atrial fibrillation at 1.5mg 1 at breakfast and one at bedtime, BENADRYL for allergies at 25 mg, 1x/day since 20Aug2013 and ongoing, ALLEGRA for Allergies at 180 mg, daily since 20Aug2013 and ongoing, metronidazole topical cream at .75% rub on nose every morning and every night, to prevent the pointy nose, adult acne since 14Aug2008 and ongoing, SINGULAIR for sinus congestion since 20Aug2013 at 10 mg, daily and ongoing, PRILOSEC for Barrett's esophagus and acid reflux at 20 mg, daily since 31Oct2007 ongoing, ZOCOR at 20 mg, daily for cholesterol since 01Dec2005 and  ongoing, gabapentin for nerve pain caused by shingles on 17Oct2017and ongoing at 300 mg, 2x/day and VALTREX since 17Oct2017 and ongoing. Medical history included blood pressure diagnosed in 1994-1995, atrial fibrillation since Feb1994, cholesterol since 2002, spinal stenosis since Oct2016, allergies since he was a kids allergic to dust and cats and stuff like that, Barrett's esophagus found in 2002 or 2003, dual lead Medtronic's pacemaker (the latest was Sep2014, the first one lasted 12 years for atrial fibrillation, he has good plumbing, no stents. Took COUMADIN and Digoxin and he no longer takes it because they took him off of it because he is doing so well with his pacemaker),  Horseshoe kidney in the front, diagnosed at birth, it is a birth defect, blood thinner, acne, sinus congestion, acid reflux, post herpetic neuralgia. The patient received two doses of the vaccine and experienced who had some soreness around injection sites, upper arm area for 36 hours, the outcome was unknown. Follow-up (05Mar2018) Additional information receive from the same contactable patient includes information on concomitant medications. Event injection site pain added.
Patient is fully vaccinated with Pfizer as of 02/26/2021. Patient received Moderna Vaccine as a third dose in series by error on 10/12/2021 at 1523 in RDeltoid. No signs or symptoms were noted by patient at time of administration. Patient was monitored in office for 30 minutes and sent home with instructions on adverse reactions. VAERS system was shown to patient to submit. Patient will be monitored via telephone by Medical Center Staff for 3 following days. Patient made aware and had no complaints or concerns at the time.
We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021)). On 07-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The assessment use date was 28 Apr 2021. Days post expiry was 9.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that a relative of her patient might have developed Guillain Barre after a flu vaccine. The Pharmacist did not mention which flu product was given.
Breakthrough case admission after 3 vaccines Pfizer 4/21/21 lot# EW0162;  Pfizer 5/13/21 lot# Ew0172;  Pfizer 01/20/22 lot# FL3198
3AM woke with severe HA, vomiting, diarrhea, vertigo, confused, fever noted by 8:00AM -up to 103 degrees. Resolved after 24hr & pt took 2nd dose & 925A 10/22 - 6pm HA onset. Then nausea fever 100.
Pt presented to the ED on 1/13/22 via EMS for complaints of chronic abdominal pain and alcohol withdrawal.  States he tested positive for COVID 3 days prior (1/10/22).  Admission unrelated to COVID-19 - patient remained asymptomatic while hospitalized.  Discharged 1/22/21
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 25-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
pt recv vax 17OCT96 & the following day pt devel mild osteoarthritis;pt reportedly has a sacroiliac hx & had surgery a few wk prior to vax;pt exp rt SI joint (?pain severe rxn for 24hr);severe sx, unable to bear weight rt hip;tx w/daypro
Rash at injection site arm was warm. Several days after this has pain in right arm felt like in the muscle.  Still have pain in the arm and two red spots on ly arm.
day four of asymptomatic COVID infection presenting today with shortness of breath.  Here, her oxygen saturation is 91% on room air with desaturation upon movement.
This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 12-AUG-2013, the patient was vaccinated with the first dose of GARDAIL injection (expiration date and lot number were not provided). On 07-AUG-2014, the patient was vaccinated with the second dose of GARDASIL injection (expiration date and lot number were not provided). There was not concomitant medication provided. Not adverse effects were reported. Additional information has been requested.
On 5/12/2021, he noticed a burning sensation in the lower extremities then he noticed a rash. The rash was on his arms, legs, and trunk.  He was seen at the Clinic and treated.  On 5/14/21, he reports that the rash has worsened so he returned to the clinic.  The rash does not itch and is not painful.     Diagnosis - Erythema Multiforme  TX - Prednisone taper dose x 8 days Follow up 5/17/2021
A non-serious spontaneous report of administration of expired dose of FLUMIST was received from a healthcare professional concerning a 36-month-old female. The product expired on 05-Feb-2010 and the patient received the expired product on 11-Feb-2010. There were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
SORE TO TOUCH; HARD AND KNOTTED; OVAL SHAPED; UNCONFIRMED FACE RASH; This spontaneous report received from a consumer concerned a male of unspecified age. 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 09-APR-2021 for prophylactic vaccination.  The Batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore to touch. On 09-APR-2021, the subject experienced hard and knotted. On 09-APR-2021, the subject experienced oval shaped. On 09-APR-2021, the subject experienced unconfirmed face rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore to touch, hard and knotted, and oval shaped, and the outcome of unconfirmed face rash was not reported. This report was non-serious.
Inappropriate schedule of vaccinereceived dose one of Shingrix and 2018 / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient did not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. No further information reported.