chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via sales representative and described the occurrence of loss of hearing in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included viral meningitis. Concurrent medications included Gabapentin. On 23 February 2010 the subject received 1st dose of TWINRIX (unknown, left arm). On 28 February 2010, 5 days after vaccination with TWINRIX, the subject experienced loss of hearing, increased irritability and increased agitation. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the loss of hearing, increased irritability and increased agitation was unspecified.
9-18-12 at 2:15 received flu shot - intradermal - about 10 minutes later - chest tightness, SOB, hives, diff breathing, elevated BP was given BENADRYL & VENTOLIN - site of injection size of grapefruit, red raised & hot.
This spontaneous report was received from a medical assistant referring to a 16 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009212 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009212 is being deleted from our files and the case is consolidated into case # 1711USA003916 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Aching in right arm, then pruritus, then swelling. Went to ED immediately since she was at work when reaction began. In ED was given prednisone, Pepcid, Benadryl.
On 9/22, 10 days after injection, pt presents with rash approx 3 around, raised, red bumps, occasional pruritus. Pt reports rash did not occur until approximately 5 days post-injection. He has noted improvement over last 2 weeks. He did not use any creams/ointments.
It's been 2 weeks since I had the 2nd dose of the Moderna COVID vaccine.  During the first 2 days, I experienced 'typical' side effects--chills, fatigue, joint and muscle pain,  and a headache.  However, there is one effect that still lingers.  Ever since having the shot, I have had a stiff neck on the right side.   Where it's stiff, there is also a pinkish-purplish 'stripe' underneath the skin on my neck, which runs from my right ear to my clavicle.  It's a few centimeters wide.
got theshot and ended up getting it againsuspected vaccination failure; ended up getting it again.; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter knew a patient who got the shingles shot and ended up getting the shingles again. The reporter also asked what did you tell about the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. This case is one of 8 case, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166325:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter. US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter. US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
Initial report was received on 06 June 2011 from a consumer, who is also the patient's parent. This case involved the administration of the wrong vaccine. A three year-old male patient had received the vaccines in June 2011: an intramuscular injection of ADACEL, lot number C3486AA (site and exact date of administration not reported), IPOL (lot number, route and site of administration not reported), Hepatitis A (GSK lot number, route and site of administration not reported) and PREVNAR 13 (Pfizer lot number, route and site of administration not reported) and an unspecified amount of time after vaccinations the "child has changed". According to the mother, he is not listening, is more active and is easily distracted. She states the change is significant enough that family have noticed. The patient has not been evaluated by a physician. Treatments were not reported. The patient had no illness at the time of vaccination. Pre-existing conditions, other medications and adverse events following prior vaccinations were reported as none. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Patient developed a red, itchy, painful bump at injection site about 36 hours following immunization.
urinary tract infection is started and its painful; urinary tract infection is started and its painful; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection), URINARY TRACT INFECTION (urinary tract infection is started and its painful) and URINARY TRACT PAIN (urinary tract infection is started and its painful) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). On 23-Mar-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection is started and its painful) and URINARY TRACT PAIN (urinary tract infection is started and its painful). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) had resolved and URINARY TRACT INFECTION (urinary tract infection is started and its painful) and URINARY TRACT PAIN (urinary tract infection is started and its painful) outcome was unknown.            The patient was on unspecified concomitant medications. No treatment information was provided.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose unit, route, lot# and expiry date unknown). On an unknown date after administering with ZOSTAVAX the patient experienced the following adverse reactions, that have last for more than three months including crawling feeling underneath her skin, bad blood circulation, joint pain, heart palpitations, it was hard for her to breath, pressure in head and ears, tightness in her bones, she felt discomfort, spicy feeling in her fingers and nerve throbbing in her legs. On unspecified dates, she has seen many doctors and was currently wearing a heart monitor because of these symptoms. Physician asked for the following information: Have there been any reports of patients experiencing neuropathic or neuralgia symptoms after receiving ZOSTAVAX and was there any treatment. Physician also asked if a patient could develop post-herpetic neuralgia from the ZOSTAVAX vaccine. The outcome of hard for her to breathe, nerve throbbing in her legs, spicy feeling in her fingers, feels discomfort, tightness in her bones, pressure in her head and ears, heart palpitations, joint pain, bad blood circulation and crawling feeling underneath her skin was unknown. Additional information has been requested.
dementia; This is a spontaneous report received from contactable reporter(s) (Nurse).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEMENTIA (medically significant), outcome "unknown". Phone call seeking assistance with Prevnar 20 for the patient. The reporter stated the patient had a little bit of dementia. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Dementia is considered not related to PREVNAR 20 use but more likely due to underlying medical conditions.  More information such as relevant medical history, concomitant medications, patient demographics, event details including onset date are needed for meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Case number PHEH2012US022377 is an initial spontaneous report received from a consumer on 12 Nov 2012. This case refers to a 58-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 05 Oct 2012. On 06 Oct 2012, she began having symptoms of pain and difficulty moving arm which progressively got worse to point where she could not move arm without severe pain. She saw her primary care physician and was given prednisone and DUEXIS. On 02 Nov 2012, she saw her orthopedic physician and had an x-ray (result not reported). She was given cortisone injection into the right shoulder. Her orthopedic physician stated that she could have nerve or muscle problem or frozen shoulder. She stated that she still has symptoms as of 12 Nov 2012 and was scheduled for an MRI. No other information was available at the time of this report.
Patient developed a large red mark at injection site that was raised and itchy. There was no swelling, hives or other rash, fever, or trouble breathing.
Pt had vaccinations on 8/24/17. Dad reports that pt developed an itchy rash on entire body on 8/27/17. Did not appear to be like a chickenpox rash. It resolved within 24 hours. No fever. On 8/28/17, child had swollen eyes and some redness on skin under her eyes. The child went out of town on 8/25/17 and returned on 8/28/17. The swelling and redness around eyes have come and gone from 8/28 through today 8/29/17. Dad brought pt in today to report symptoms. He had given pt CLARTIN last night. Denies any fever, malaise or other symptoms. No current rash. Still has mildly swollen eyes. She is smiling, talkative and in no distress. Instructed dad to take child to her pediatrician. He agreed to do so.
Local pain, rash on arm, progresses to palpitations, N/V, HA, diarrhea later the same day.
Small bowel small bowel intussusception with acute gastroenteritis and dehydration with abdominal pain and low grade fever 100.7 .admitted for IVF and observation, repeat US the next day was normal. Pt went home 8/8/19.
Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, clavicle and neck.
cancer blown out of nowhere; portal vein thrombosis; strokes.; This is a spontaneous report from non-contactable healthcare professionals (one is a physician assistant).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated that just Tuesday, they shipped out three cardiomyopathies, and a blood clot. On 27Sep2021, the patient on the floor just died and the reporter just pronounced him a second ago. The patient got his shot and literally two weeks later, the patient ended up with cancer blown out of nowhere, a portal vein thrombosis like and got strokes in 2021. The patient died on 27Sep2021.  It was not reported if an autopsy was performed.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events cancer, portal vein thrombosis and strokes cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: portal vein thrombosis; cancer blown out of nowhere; strokes.
Within several hours the muscular pain traveled all the way down my arm to my hand; I experienced pain and cramping. Ibuprofen helped. By 10pm I began feeling fluish: headache, other muscular aches, very fatigued and chilled (by the morning of the next day). Still feeling like I have the flu by 9am on 7/3.
CLIENT CAME IN APPROX 5 PM FOLLOWING DAY WITH A 50 CENT SIZE REDNESS AND SWELLING TO UPPER BACK AREA OF LEFT ARM. STATES SHE WENT TO SCHOOL NURSE DURING THE DAY AND APPLIED ICE PACK. ADVISED CONTINUING COOL COMPRESS FOR 24 THEN TO USE WARM COMPRESS.
I did not have an adverse reaction to the vaccine. I picked up my new eyeglasses and I could not see. I went back to the office for another test, and I am referred to an ophthalmologist and that appointment is in April.
Mother & child report swelling & redness on left arm 6/29/11 with pain. Gave him several doses of ibuprofen & put cold compresses. Reports swelling is down today. Client's left arm slightly swollen with pink area over about half of upper arm. Tender to touch & still sore. Client to take ibuprofen, BENADRYL and continue with cold compresses 15 min at a time.
extra dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th November 2019) and Shingrix (received 2nd dose on 19th February 2020).   On 7th October 2021, the patient received the 3rd dose of Shingrix. On 7th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient an accidentally received 3rd dose of Shingrix, which led to extra dose administered. No symptoms reported The reporter consented to follow up.
Headache; fever; body ache; diarrhea; malaise; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, fever, general body pain, diarrhea and malaise. On an unknown date, the outcome of the headache, fever, general body pain, diarrhea and malaise were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, general body pain, diarrhea and malaise to be related to Shingrix.     Additional Information: GSK receipt date: 31-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received first dose of shingrix vaccine 31 hours prior to the reporting.  He/she still had headache, fever, body ache, diarrhea, malaise. The patient stated that this was no fun.  .
Confusion, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,   Stomach felt like it was sore.   Narrative:   Other Relevant History:
Drowning; He didn't feel well; This is a spontaneous report from a contactable consumer (patient's wife). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in left arm on 05Mar202113:00 (Lot Number: En6198) as single dose for COVID-19 immunisation. Medical history included hypertensive cardio disease, remote myocardial infraction. No COVID prior vaccination. No known allergies. No COVID was tested post vaccination. There were no concomitant medications. No other vaccine was received in four weeks. The patient didn't feel well Saturday on 06Mar2021 12:00 AM, went surfing Sunday morning on 07Mar2021 as usual for the last 60 yrs. He was in excellent shape and surfed every day. At about 7am the reporter received a phone call that the patient had been pulled from the water unresponsive. But what the reporter didn't understand was he had his arm over his board. But his face was in the water. The reporter realize he drowned but something happened before that. The events resulted in Emergency room/department or urgent care. It was unknown if patient received treatment for events. The patient died on 07Mar2021. An autopsy was performed that revealed drowning. The outcome of event didn't feel well was unknown.; Reported Cause(s) of Death: Drowning; Autopsy-determined Cause(s) of Death: Drowning
pt had soreness in rt leg, restless noc & has not been what mom describes as self; does not want to bear weight on rt leg; sleep disturbance; join pain & achiness; crying, irritable, refused to walk;
Mom called to the clinic and stated pt had red rash/hives for 2-3 days, post vax. Denies pain and no fever.
Elevated kidney functions. I had normal labs drawn April 7,2021. On July 21,2021 I had labs drawn and my labs showed elevated abnormal creatinine level. I also had elevated protien in my urine. I have never had my blood creatinine at 1.25 and 1.29 and I have never had elevated protien in my urine.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 (EN6201) Pfizer Dose 2 (EN6199) COVID Positive 12/19/21  12/19/21: A 79-year-old female with past medical history of COPD  not on home oxygen, hypertension the stage IIIB CKD, status post recent AAA repair at clinic in July 2021 comes to ED complaining of generalized weakness.  Patient states that she has not been feeling well for almost 3 weeks.  Had diarrhea for almost 2 weeks, multiple episodes of loose stools, but it has resolved about a week ago.  She does have loss of appetite and poor oral intake.  Denies vomiting or abdominal pain.  Does have some chronic cough, mostly nonproductive.  Patient states she is always short of breath due to COPD, nothing worse now.  Denies fever or chills or dysuria or hematuria.  Patient is vaccinated against COVID-19, had 2 doses, but not the booster.  Denies sick contacts.   On arrival in the ED, she was afebrile, vital signs stable and pulse ox was 91% on room air.  Abdomen acute series was done, reported as no abnormality.  Blood work is unremarkable except for stable renal function and chronic anemia.  With ambulation her oxygenation dropped in the ED, placed on 2 L oxygen by NC.  COVID-19 rapid antigen and influenza a are tested positive.  She has not received any treatment in the ED.  12/22/21: 79-year-old woman who presented to the emergency department with complaints of worsening generalized weakness and malaise, resolved diarrhea, cough.  Oxygen saturation was noted to drop to hypoxic levels with ambulation however chest x-ray demonstrated clear lung fields.  COVID-19 PCR was positive, influenza A antigen screen was also positive.  She was started on supplemental oxygen, treated with Tamiflu and parenteral steroid therapy.  Renal function precluded administration of IV remdesivir, low-dose anticoagulation was initiated on account of elevated D-dimers.  Clinical response was favorable with gradual improvement in oxygen requirements, generalized weakness and malaise.  She was evaluated by Physical therapy and cleared for discharge home with home health services.  Oxygen walk for home determination done prior to discharge revealed that she did not meet criteria for home oxygen.  She is in stable medical condition at the time of discharge.
Around 2:25 PM client head dropped/appeared to slump forward after last shot given. 2 jerks/seizure-like activity observed in Rt arm & chest. Pt "came to" and on inquiry verbalized "feeling week". Complexion pale, sitting in chair, legs raised and transferred to stretcher. Vitals on stretcher at 2:33 PM - B/P 113/75. Pulse 58. Pulse Ox 97%. Pt transferred to EMS squad after vitals. Complexion improved, pink on EMS transfer out of bldg.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Almost fainted, but was still responsive. Stood up from chair after vaccine, got dizzy and fell on her knee, vision and hearing went in and out for a second. Knee got scraped, not badly, a little bit of blood, gave her a bandaid. Helped her sit on the floor, gave her water and snack, she was weak, but recovered within 30 minutes.She thought it was because she had been so anxious about the vaccine. She eventually left once she felt a lot better and was walking normally with her friend.
Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of RECOMBIVAX HB. The nurse reported that a serology testing showed that the patient had a positive hepatitis B surface antigen test. The nurse stated that she was gathering information on whether there could be a false positive HBsAg for a certain time period after receiving RECOMBIVAX HB. Additional information has been requested.