chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gardasil vaccine administered during well child physical on 8-18-15. Mother called clinic the following day at 12:47 reporting that child had fever, headache and vomiting starting in the middle of the night and woke up with the same. Mother did not have thermometer but gave Ibuprofen. Vomiting has ceased and fever has gone down. Tolerating fluids. Mother told to watch for increased fever, vomiting and go to medical care if worsens 8-21-15. Phone call to mother reports child  is well.
Joint pain and nausea followed  8 hours later by severe diarrhea and vomiting with sweating and dizziness. Nausea and fatigue continued for 2 and a half days.
Post IZ, the child's stool frequency changed and she became red in the face during bowel movements. On 4/25/00, a barium enema reportedly revealed intussusception. The child was taken to surgery. The mother reported that the intussusception corrected itself before the surgeon could observe it, the surgeon performed an appendectomy. The child was discharged from the hospital after approximately 5 days. As of 7/19/00, the child was very cranky and had difficulty sleeping at night.
Noticed swollen, heavy, red eyelid on left eye  accompanied by a headache within 6 hours of receiving vaccine. Took one tablet (recommended dosage) of Benadryl 30 minutes later. Swelling, pain, headache, and redness had all decreased within 12 hours, at which point I took another Benadryl tablet for good measure. 27 hours after the vaccination, symptoms seem to have subsided.
Day of the JNJ shot I had fever, chills, vomited, slept for 20 hours.   A few weeks after the shot I purchased an Apple Watch and it notified me that I had AFIB.  The AFIB progressively got worse, and in Sept 2022, I had an ablation.
Chills, 101.9 temp, nausea, fatigue, extremely sore arm, body and head ache
Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K010224, expiration date 13-MAY-2016, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with ZOSTAVAX (Merck) (lot # not reported). The physician stated that on an unspecified date, the patient received the vaccine on a Wednesday and by that Friday the patient developed pimples and blisters on her pubic area. The following week, the patient was given steroids (unspecified) as well as antibiotics (unspecified). At the time of the report, the patient's outcome was unknown. The patient sought medical attention at the physician's office. Follow up information has been received from the physician who reported that he had tried to contact the patient for additional information but the physician believed that the patient could have left the area and was unable to get any additional information. No further information is available.
Some of the information is missing due to her not realizing this was a possible side effect until much later, Her right eye started "weeping" and just keeps watering all day and night.  This happened 2 to 3 weeks after her second shot.  A few weeks later she had already scheduled Cataract surgery and thought she could just get that "Fixed" while the Dr. was in that area anyway.  That would not happen that way.  The Eye surgeon says if it was doing it before, then he had nothing to do with it, he has put her on Antibiotics and they had drops for her but 6 months later and it is still constant weeping.  No answer and nothing else has changed in her over the course of the last year.  Just the need to keep a towel or washcloth handy at all times.
Rash on arms/ Rash on chest/ Rash on neck; rash "all over"; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on arms/ Rash on chest/ Rash on neck) and RASH (rash "all over") in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), MONTELUKAST SODIUM (SINGULAIR), ESCITALOPRAM OXALATE (LEXAPRO) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash on arms/ Rash on chest/ Rash on neck) and RASH (rash "all over"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE us (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, RASH (Rash on arms/ Rash on chest/ Rash on neck) and RASH (rash "all over") outcome was unknown.            On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route for prophylaxis of COVID-19 infection.
Pt was supposed to get the second dose of Monovalent primary dose but was administered Bivalent booster 0.5ml.
Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylaxis in past and was anxious about experiencing it again. Pt moved away from waiting area to be evaluated by RN. RN Assessed pt. Lung sounds clear, Pt denies having difficulty breathing, O2 sat remained 98% or better for the duration. BP initially 141/89 while sitting with HR at 75. Pt laid down with feet propped on chair. Vital signs reevaluated 15 min later: O2 98%, BP 118/89, HR 77. Pt still reports itchy throat but does not have difficulty breathing. Contacted on-call physician, recommended pt be evaluated at ED or urgent care. Pt parent refused ambulance; opted to drive pt to ED for further evaluation.
Covid 19; Covid 19; This is a spontaneous report from a contactable consumer (patient's brother). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 (at the age of 71-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included arthritis and high BP (blood pressure). The patient was not pregnant at the time of vaccination. Patient had no COVID-19 prior vaccination. Known allergies reported as unknown. Concomitant medication was not reported. The patient experienced no adverse reaction to the injection, however patient was presently in ICU (intensive care unit) on a ventilator with COVID-19. This was simply an information for knowledge. Adverse event started on 20Jul2021, adverse event resulted in, doctor or other health care professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient received treatment for adverse event. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events was not recovered.    Information about lot/batch number has been requested.
Pt came into the office to have his 1st  PPD of a 2-step placed for school. The pt's mother made me aware that the pt was seen in the office on 6/20/19 for a 18yr WCC and was given a Bexsero(2nd round) in his right deltoid and the pt had a reaction about 6-8 hr later. It started with redness in the deltoid area that grew larger, he was running a fever of 99.6, he was given ibuprofen and Motrin for the fever at home, he slept a lot the next day(roughly 15-16 hours) and his his arm still has a yellow discoloration and tenderness to it. He was not taken to the ER because the mother states "he has had a reaction previously and was told by the office that she was doing what needed to be done". I made Dr aware of the situation and he accessed the pt and gave the order to place the PPD step 1 and we made the pt and mother aware if he had any unusual reaction to this placement to please make us aware and for the pt to return on Friday morning to have it read.
Headache, chills, overall feeling of not feeling well, fever that topped out at 100.4, shivering, fatigue, joint pain in neck and shoulder.  Took Tylenol 600mg, 2 tablets at a time, 3 different times and bed rest the day after the shot.
1.5 hrs after injection, patient noted redness, mild induration, warmth, tenderness; defined 6cm x 4cm affected area.  No change in 3 days since injection; she presented to Health for assessment; site is defined, mild erythema, mild induration, tender. Recommended to apply cold pack, take ibuprofen as anti inflammatory, consult PCP and monitor, and return in 2 days 1/13/21 for update.   Advised that PCP may possibly want to prescribe antibiotics if no improvement/resolution (possible cellulitis? does not appear as such to date)..
Patient reported to me today 11/19/2021 via telephone call that 12 hours after she received the second dose of her Adult Hep B series that she experienced anaphylatic reaction. She states that she began having trouble breathing and that her heart began racing. She states that she then went to her local hospital ER where she was treated for an anaphylatic reaction. She believes the Hep B vaccine caused this allergic reaction.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time). This case was created for 4th of 8 adult patients by the reporter. No concomitant medications were provided by the reporter. Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and the vial was initially stored in refrigerator on 14-Jul-2022 and the vial were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 2-Aug-2022. No treatment information were provided.
pt was given vax @ approx 1PM & died @ approx 8PM:pt went into coma in afternoon & was rushed to hosp;
Possible seizer, unknown at this time, aprox 1hr and 20min after vac given. Passed away aprox 2hrs after vac.
Sep. 4 - 1:00am - shivering and muscle pain in both arms, both legs and lower back Sep. 4 - 7:00am - all symptoms except shivering continuing, large redness area ( 4" by 6") at injection site, feverish at redness area, lower back pain became more extreme (about a 6).   Treated with acetaminophen and heat  Sep. 4 - 6:00pm - muscle pain decreased a great deal (about a 2) Sep. 6 - 7:00 am - muscle pain basically gone - redness and fever at injection site almost gone
Only a few days after the vaccine, I broke out in Shingles across my mid-section. The Medical Group at the time did not evaluate whether it was related to the vaccine or not. Their focus was merely on treating the issue.
Soon after I had my first shot, the lymph nodes on my neck swole up and were painful. It happened within the 15 minutes that the med group had us wait after the shot. I reported it to the check out person, and they had me wait an extra 30 minutes. It didn't get worse during that time, and they told me to see a doctor if it didn't improve, and call 911 if it got bad. I don't remember how long it took to go back to normal, but I reported it on my vcheckin. In the Spring, my lymph nodes did the same thing, but NOT immediately after the second shot. I was seeing a doctor (who has since resigned) about another issue and mentioned it. She said it was just my lymphatic system doing what it is supposed to do. Continued. 18. It did go back to normal. About two weeks ago, it was really acting up. It started under my arms. I had surgery to chech a lump about 6 years ago, and the doctor cut a few nodes under my left arm. It isn't unusual for that area to swell, but my neck swelling only started with the first shot.  Swelling near my collarbone, jaw, outside throat. It made my neck so tight that it was a little hard to swallow. I was establishing care with a new doctor, so I told him that warm compresses were not helping the swelling. It was starting to go back down, but it felt like a fist coming out my neck and severe brusing on the same point. Of course, he said he had to press it. He told me it is my lymph nodes doing what they do--reacting to something that wants to make me sick. He suggested ibuprophen for the discomfort. Oddly, that same day, the vcheckin arrived asking about the shot. That is why I reported it.
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache.  Today, forth day, swelling going down still red, no headache and feeling better in general.  Took tylenol for headache and pain.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 77-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.  No treatment medications were reported.
my son went in for shots. on 12/26/2006. when he woke up on 12/27/2006. his arm and leg were swollen and bright red, and hot to the touch. i called the office on 12/27/2006 and was told thats normal because hes a large boy and to put hot compress on the sight. by that evening he was running a tep of 103.8 i gave him tylenol and his temp wouldnt go down. the redness on his arm and leg were bigger and he had blisters on his arm. i took him back to the dr on 12/28/2006 he was still running a temp. the dr informed me had an infection on the shot sights. i asked what shots were given where and he said it wasnt written down.i have no ideal what shots did this to him. the dr put him on antibiotics.and on hydroxyzine.
Woke up next day with sore arm and beginning of upper respiratory infection which turned into pneumonia.
feels sick all day; feels like she has a bug; cough; no strength; sore around injection site; headache; very tired; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels sick all day), MALAISE (feels like she has a bug), COUGH (cough), ASTHENIA (no strength) and VACCINATION SITE PAIN (sore around injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concurrent medical conditions included Diabetes mellitus and Hypertension. Concomitant products included Insulin fast acting for Diabetes mellitus, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced MALAISE (feels sick all day), MALAISE (feels like she has a bug), COUGH (cough), ASTHENIA (no strength), VACCINATION SITE PAIN (sore around injection site), HEADACHE (headache), FATIGUE (very tired) and NAUSEA (nausea). At the time of the report, MALAISE (feels sick all day), MALAISE (feels like she has a bug), COUGH (cough), ASTHENIA (no strength), VACCINATION SITE PAIN (sore around injection site), HEADACHE (headache), FATIGUE (very tired) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment include cough drops.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The follow-up was received on 26-APR-2021 and include NNI
patient got the first dose of Shingrix 1.5 years ago and has not had a 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1.5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got the first dose of Shingrix 1.5 years ago and has not had a 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The patient had not had a second dose of Shingrix yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
On 10/17/17--14 days after injection patient called and complained of arm soreness and tingling in fingers. Patient was advised to see her dr. Patient came into pharmacy 12/23/2017 stating she received prednisone from dr's visit and also seen ortho Dr--MRI showed up normal according to patient. Present time patient states arm feels much better.
Vomitting during nighttime sleep for 3 consecutive nights. Diarrhea during the same period of time. Vomitting stopped and began again during nighttime sleep one day after it had stopped.
a dose of FLUZONE HIGH DOSE QIV was given in error after patient had already received a dose this season with no reported adverse event; Initial information received from on 08-Nov-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 66-year-old male patient to whom a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] was given in error after patient had already received a dose this season with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included elasomeran (Moderna COVID-19 Vaccine) for COVID-19 immunisation.  On 11-Oct-2022, patient received influenza quadrival A-B high dose HV vaccine at an unknown dosing (lot number and expiry date: not reported) and on 08-Nov-2022, the patient received a suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UJ904AC, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.   On 08-Nov-2022 the a dose of fluzone high dose qiv was given in error after patient had already received a dose this season with no reported adverse event (extra dose administered, 28 days latency from the first therapy and same day latency from second therapy).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands.  Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red.  Injection site WNL.
Squirrel bite; This spontaneous case was reported by a consumer and describes the occurrence of ANIMAL BITE (Squirrel bite) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (She had squirrel bite today and she received Tetanus toxoid vaccine.) since 16-Mar-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ANIMAL BITE (Squirrel bite). At the time of the report, ANIMAL BITE (Squirrel bite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.