chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 0: Vaccine was injected at around 4:15pm. There was injection site pain. By around 8pm, the injection site pain was spreading to upper arm and shoulder and was very painful. Day 1: At 3am I was woken up by the pain, which was much worse. I had a fever. Pain was in entire left arm, left hand, left shoulder, left armpit, side of left chest, and side of left neck. I also had muscle aches in my thighs and hips. This continued for all of day 1. Anytime I fell asleep, the pain would wake me up within an hour. Fatigue. Diarrhea.  Day 2: There was pain in my entire left arm, left hand, left shoulder, left armpit, side of left chest, and side of left neck. I had muscle aches in my back, to the point where lying in bed or sitting in a chair were not tolerable so I was on the floor with ice packs. (Muscle aches in thighs and hips from the previous day were gone.). Pain was still at a level where if I fell asleep the pain would wake me up within an hour. Fever was gone. Fatigue. Diarrhea.  Day 3: No more muscle aches. Moderate pain in left armpit, left shoulder, underside of left upper arm, side of left chest, side of left neck (burning intense pain when moving those areas, light pain when those areas are still). New symptoms on day 3 were headache and nausea. Fatigue. Day 4: No more muscle aches. Light pain in left armpit, left shoulder, underside of left upper arm, side of left chest, side of left neck. Headache. Fatigue. Day 5 - present (1.5 weeks later): Fatigue.
4/19/00, temperature was 102.1. Mom states he was fretful, cries out at intervals. Is taking plenty of fluids, no signs at IZ site. Vomited x 2 last few days. Saw MD and he put him on amoxicillin. On 4/21/00, pt was crying and fretful. Mom states excessive crying for 2-3 hours. Came to HD and temperature was 99.9F, not voiding. At visit, had no crying, playful and wants to be on floor. He is alert. On 4/24/00, child is doing well per mom.
fever, aches, joint pain, headache, nausea, chills, injection site pain up to shoulder, weakness, tired, diarrhea  Took Tylenol to sleep, most symptoms lasted from lunch time to bed time.  About 12 hours. Today, lingering tiredness, and aches.
Pt recvd vax & within 2 min p/vax exp swelling at site which continued to include upper arm of the elbow.Next day area hot,swollen & red.
Patient reported double vision lasting for approximately 3-5 minutes.  Patient placed in recumbent chair, Vital signs monitored and assessed by onsite provider.  Vital signs BP 140/80, P 82, R 20, SPO2 98%
This individual had donated plasma prior to being immunized with the Td vaccine.  Within less than 15 minutes after vaccination, the individual became dizzy.  The individual did not lose conscientious.  The individual recovered with minimal intervention.
Aprox. 6 hrs after immunization, face, neck, throat were swollen - at 6pm face red, felt hot, coughed with difficulty breathing and lethargy.  Took excedrin or ibuprofen (can't recall) slept sitting up.  This lasted until 2/13/06 - had TB skin test read and discussed those evnts with nurse - continued with coughing, mucous, throat, ear pain and reconnected on 2/24/06 with nurse who submitted report.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7533) and on 25Apr2021 as dose 2, single (Lot number: EW0172) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3(booster) , single (Lot number: 065F21A). The patient's relevant medical history included: "Tuburculosis 1995.", start date: 1995 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Neg, notes: Neg Antigen Test.
Patient is a 57 year old female with complaint of arm and shoulder pain. She does have pain out of proportion to the inciting injury. Her symptoms include hyperesthesia and report of temperature asymmetry and motor weakness and twitching. She does not have objective signs yet such as color changes. Diagnoses of CRPS and brachial neuritis were considered. She does not appear to have a rotator cuff pathology.
10 x 7 cm indurated, hyperpigmented noticed on (R) thigh on 11/7/14. Mom noticed it 1 day after vaccine given (10/17/14).
Had the usual AEs for a day after the second vaccine. Then on the third day started having electrical nerve pulses/shocks running along upper arm from injection site to elbow. home times it is hot, sometimes it is pain sometimes it is like I am receiving electrical pulse stimulation. Some days are worse than others. It is intermittent in length and severity and frequency. But it  occurs every day.
Local reactions at the site of injections/2 inch area erythema; This spontaneous case, initially received from other healthcare professional (nurse) on 11-Oct-2018, concerning a patient of unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A) and expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of 2 inches in the area at the site of injection which was considered as a local reaction.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.  This case: 201804408 was cross-linked to case 201804405 owing to the same reporter.  Non-significant case amendment (11-Oct-2018): The sentence On an unspecified date after vaccination, the patient developed erythema of 2 inches in area' was changed from to On an unspecified date after vaccination, the patient developed erythema of 2 inches in the area at the site of injection' in the narrative.; Reporter's Comments: A patient of an unspecified gender and age developed injection site erythema on an unspecified date after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to site-specific occurrence of the event.
Chills, fatigue, muscle aches, left arm redness pain  from  shoulder to fingers, fever  102.4, body very hot from abdomen to knees, feet and hands ice cold , unable to get out of bed, short term paralysis, after one hour fell out bed was unable to bear weight. Voice weak.
On the 25th, I woke up completely exhausted. On 12/26/2021 I woke up and I was very shaky and weak, no headache, it felt like I could not walk. I asked my doctor if this could be a reaction, and they stated it may. On 12/27/2021 I went to the doctor and saw that when I was walking I was extremely wobbly. Found that I was in A-Fib. Currently I still feel fatigued, and have low strength in my legs.
Fever: 101-104 Chills Nausea and vomiting Body aches Headache  Sore throat  Symptoms began at 9/10pm peaking at 11pm
patient receiving a double dose of the vaccine with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who received a double dose of the influenza quadrival A-B vaccine [Fluzone QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for prophylactic vaccination (Immunisation).  On 23-Oct-2023, the patient received double doses of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8144A; expiry date: 30-Jun-2024) via intramuscular route in the left and right arm for prophylactic vaccination (Immunisation) (extra dose administered) (latency: same day).  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.
Developed a fever over the weekend, up to 101 degrees F. Noticed a red rash at injection site that continued to grow over the weekend to cover an area about the size of a grapefruit. It was considerably enflamed.  Her PCP ended up calling in Rx for Clindamycin thinking some sort of cellulitis had developed.
Vomiting 1/8-9/22 Cold sore 1/10/22
10 year old given Pediarix; given Pediarix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: Registered nurse reported that the 10 year old patient was given Pediarix instead of Boostrix. At the time of reporting, the nurse did not have the lot number and expiration date and the information of what vaccines were given previously. The reporter consented to follow-up. Additional Supportive Information: The 10 year old patient was given Pediarix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. This was one of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022136461:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter
Information has been received from a registered nurse concerning a 44 year old white male physical education teacher, with no medical history and who's family history included a father who was allergic to sulfite or sulfa, who on 17-OCT-2006, at 3:15., was vaccinated with a first dose in the left deltoid of RECOMBIVAX HB (Lot# 653786/0107F). There was no illness at the time of vaccination. On 19-OCT-2006, at 8:00 a.m., the patient developed numbness in his left thumb which lasted until about 26-OCT-2006. There were no laboratory or diagnostic tests performed. Medical attention was sought. Follow-up information from a registered nurse indicated that after the vaccination with RECOMBIVAX HB in October, within a short time, on 17-OCT-2006, the patient had pain that started in his neck and radiated into his arm. He went to his family physician. The patient needed VICODIN to sleep. It was noted that the patient did not remember an injury. In October, he had weakness in his arm. His physician recommended that he go to neurologist or to an immunologist. The patient did not go either the neurologist or the immunologist. It was noted that the patient was not going to received more vaccinations. At the time of the report the patient said he had been experiencing left thumb into wrist weakness, that it was not rehabilitated prior to the injection, and that his feeling and grasp was up to 75% out of 100%. The patient's experiences were considered to be other important medical events by the reporter. The patient experienced brachial plexus neuritis and tightness between his fourth and fifth vertebrae following with a dose of MMR II (WAES# 0611USA01644). Additional information is not expected.
1st dose / in 2018 but did not receive 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date in 2018, 2 years ago from reporting day).   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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if to start the series. No further information was available. The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (missed dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke, Seizure and Bone marrow transplant. Concurrent medical conditions included Sickle cell disease NOS. Concomitant products included LAMOTRIGINE (LAMICTAL) and PREGABALIN (LYRICA) for Seizure.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved and PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient history updated.
per pt states red hard, warm to the touch and itchy at the site of injection. Prednisone 20mg tab- take 1 po bid with food Diphenhydramine 25mg cap- Take 1 cap po qd 6-8 hrs prn
sore throat; muscle aches; dry hacking cough; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Mar2021, for COVID-19 IMMUNIZATION. The following information was reported: COUGH (non-serious) with onset 08Feb2023, outcome "not recovered", described as "dry hacking cough"; MYALGIA (non-serious) with onset 08Feb2023, outcome "not recovered", described as "muscle aches"; OROPHARYNGEAL PAIN (non-serious) with onset 08Feb2023, outcome "not recovered", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, myalgia, cough.  Additional information: No Known allergies, No other vaccine in four weeks. No covid prior vaccination, Patient had covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300064596 same patient, different dose and event;
cannot eat certain food; swallowing issues; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (swallowing issues) and FOOD INTOLERANCE (cannot eat certain food) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DYSPHAGIA (swallowing issues). On an unknown date, the patient experienced FOOD INTOLERANCE (cannot eat certain food). At the time of the report, DYSPHAGIA (swallowing issues) and FOOD INTOLERANCE (cannot eat certain food) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
mild fever about 9 pm. Higher fever and intense chills (teeth chatter) around 1 am which lasted about an hour.  Headache, dizziness, nausea persisted until approximately noon the next day, accompanied by continued mild fever.  Acetaminophen taken at 9 pm did not seem to have an impact on early fever.   When taken again around noon the next day, symptoms disappeared. No other symptoms presented on that day.
pt rcvd vax; pt was dx w/ mononucleosis; w/ 3rd dose pt devel relapse of mononucleosis w/ tonsillitis, swollen glands & there was a concern w/ liver damage; lab evaluation revealed pt was anti-HBs neg;
Soreness at the injection site.  I toll Advil 7 hours after the shot and went to bed.  The next morning, it was sore, so I took more Advil.
2" diameter site reaction with pain, itching, heat shortly after vaccination; per patient worsened on 5/10/18 overnight and patient seen in office today. Advised BENADRYL and cold compress and continue to monitor.
Tiredness, sore arm, fever, body aches, dizziness, nausea, lack of stability
Vaccine given 10/12/2004, on 10/15/04. Pt had very high fever and then had a seizure. Taken to hospital. Diagnosed with febrile seizure.
Pain on right side of face that comes and goes; This case was reported by a consumer via call center representative and described the occurrence of facial pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 12th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 20th April 2022, 8 days after receiving Shingrix, the patient experienced facial pain. On an unknown date, the outcome of the facial pain was not recovered/not resolved.   It was unknown if the reporter considered the facial pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: This case was self reported by patient. The patient reported that he received first dose of Shingrix dose on left arm and started to experience pain on the right side of his face that comes and goes. The patient reported that this was the location of a previous shingles case that occurred on the right side of his face about one year ago. The patient would like to hear from safety to see if similar cases have been reported and if he should do anything. The patient does not give permission to contact HCP (Health care professional).  The reporter did not consent to follow up.
I received this booster at a local pharmacy in the right arm on August 15, 2021.   It was my third Pfizer dose, and first booster.  I got Clear Cell Endometrial Cancer with first symptom showing up  Nov. 15th, 2021, exactly two months later.  I am MSI stable, if that is info of interest. As of now I am doing well following treatment of surgery, chemo, and brachytherapy.
After having the vaccination, she had soreness, pain and swelling. Feels like she going to choke, hard to swallow which she didn't have before the vaccine.
Received 1st dose on  May 2021 got 2nd dose on February 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2021).   In February 2022, the patient received the 2nd dose of Shingrix. In February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 18th Apr 2022 Reporter's Comments: The registered pharmacist reported that a patient who received 1st dose of Shingrix in May 2021 got 2nd dose in February 2022. It had been longer than 6 months since patient got first dose. Lot number and expiration date of second dose, patient's demographics asked but wasn't provided by health care professional.  Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule.
Headache, diarrhea, tired, body aches, pain and soreness in elbow of arm shot was administered.
Soreness arm and joint pain; Soreness arm and joint pain; This is a spontaneous report from a Pfizer sponsored program. An 85-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that her left was sore, she had soreness arm and joint pain not bad at all. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever, noc sweats, chills, h/a, body aches x 24 hr; onset 2AM 1JUL95;
I have had now several cardiac events of heart racing to greater than 180bpm with little to no exertion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, prev dose vaccine location=Right arm), for COVID-19 Immunization. The following information was reported: PALPITATIONS (medically significant) with onset 24Jun2022, outcome "not recovered", described as "I have had now several cardiac events of heart racing to greater than 180bpm with little to no exertion". The event "i have had now several cardiac events of heart racing to greater than 180bpm with little to no exertion" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (24Jun2022) heart racing to greater than 180bpm, notes: heart racing to greater than 180bpm; SARS-CoV-2 test: (28Jun2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of palpitations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.