chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In drawing multiple doses from the above multi-dose vial, this RN mistakenly attached 25g, 5/8" needles instead of the necessary 1" to 1 1/2" length. This means this client received a subcutaneous injection instead of the required intramuscular. This error involved two clients before it was caught. Both clients were called, no adverse effects were noted. Repeat influenza vaccine given today and charted. Will continue to monitor for any reaction.
pt recv 1st dose of vax, on 10jul92 devel abnl liver function tests;@ one point SGPT & SGOT elev & @ another point bili & LDH elev;did not seroconvert w/ 3rd dose;subsequently seroconverted p/ 3 oth doses;28feb94 lab eval showed nl liver fu
Ten minutes after the vaccination the patient called out that she didn't feel well.  I went to talk with her and she was experiencing dizziness and light headed to the point  she felt she was going to pass out.  She also had severe stomach discomfort to the point she thought she was going to have both diarrhea and vomiting.  We laid the patient down on a bench with her head supported and then called the paramedics. She was cold and sweating.  She said that both arms were tingling with an uncomfortable sensation and the left arm was also painful with pain radiating down from shoulder to hand.  She also said she couldn't move her hands very well and had a hard time gripping things.   The paramedics came after about another 10 minutes and checked out the patient.  All her vitals were ok, and the patients symptoms were improving.  She was still weak but she had someone there to take her home. The following day we called her and she said she didn't sleep and still felt sick (nausea, aches and pains, fatigue)
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt had to go to rest roomafter shot came back said he thought he past out with in 5 mins after the shot fell in bathroom he felt dizzy and past out hit back of head was red and had a bump was clammy and sweating gave pt water and something to eat like a granola bar and boost pt was hungry ambulance came in to check pt out told him ok to go was getting his color back but head hurt due to fall  called pt 2 hrs later better
Hospital Course:  Patient was admitted 2 days after having received his COVID-19 vaccine and had SIRS including hypotension.  Was believed to be a possible reaction to the vaccine.  He was admitted to the ICU and briefly he needed vasopressors.  The hypotension resolved and did not recur.  An echocardiogram showed that he had a moderate pericardial effusion, cardiology saw him and does not believe that this contributed to the hypotension.  He also thought his stools were dark however he has had quite dark stools for many years he told me, ever since he was started on iron pills.  He could not confirm whether or not the stools might be a little darker than usual for him and he also had 1 out of 3 stool occult blood test that were positive.  He has chronic anemia with the hemoglobin slightly lower than his baseline, so GI was consulted and an EGD was performed.  He does have Barrett's esophagus and GI discussed with him how he will need follow-up EGDs, and I reminded him of that as well.  Warning signs and alarm symptoms were discussed.  He was placed back on his Eliquis however he will not be taking the Effient medication.  This was based on recommendation from cardiology.  He will have lab work done and see his primary care provider within several days.  He will also have a video capsule test done and pick this up either today or tomorrow and follow-up in several days with GI.  Discussed going back on his low-dose Eliquis with GI.  Discussed with cardiology and GI and discussed with the patient the risks, benefits and alternatives.  He will watch for any signs of bleeding and stick with a low dose of Eliquis.
Started w significant pain and swelling at injection site approx 1 hr after dose. Followed by fatigue, nausea, headache. Vomited x 1. Overnight, struggled to sleep and had vivid dreams and sensation of not being certain whether awake or asleep. Shaking chills during the night followed by sweats but has not had fever. Exam with erythema and induration 5 cm diameter at injection site, otherwise nonfocal. Advised Ibuprofen, cool compresses to injection site, fluids, supportive care and close monitoring.
Excruciating and debilitating pain around knees starting from one leg to now both legs. Pt is unable to stand up or walk.
Chronic headaches persisting one month later.  Seen at my office on 7/16 for these headaches.
Patient complaint of fever, headache, leg pain, nausea, fatigue since 9/5/17 evening.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 Lot #: M020521, expiration date: 17-NOV-2017 and lot # M027552, expiration date: 04-FEB-2018 (strength, dose and route were not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Unknown. Unable to contact this case as he remains in ICU, admitted 05/09/2022.
Lightheadedness random spells, heart palpitations, Chest pains, ringing in the ears
Patient began on June 3rd with pain in her right lower and foot, the leg and foot felt cool to touch and was discolored.
administered Adacel to a newborn baby instead of the Hep B/ no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 hour old (neonate) male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of the HEPATITIS B VACCINE (Wrong product administered).   The past vaccination and family history were not provided.  On 22-Jan-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], (batch number- U6511AQA, expiry date- 22-Oct-2021) via intramuscular route in right leg for immunization.  Concomitant medications included VITAMIN K for Immunisation.  It was a case of actual medication error due to wrong vaccine administered.  At the time of reporting no adverse event was observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Longitudinally extensive transverse myelitis, progressive worsening sensory changes in legs ascending to abdomen
Joint pain in my knees/pain in my wrists; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in my knees/pain in my wrists) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain in my knees/pain in my wrists). At the time of the report, ARTHRALGIA (Joint pain in my knees/pain in my wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.
headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt received polio vaccine 8/5/22 and that evening, he developed rash on B legs/buttocks Photos sent show red raised papular rash After a few days eczematous, very pruritic rash erupted and spread from legs to abdomen The abdominal rash has improved ; B legs still with rash and very itchy No reaction seen after first polio vaccine dose
No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old male patient on 05-FEB-2020.  On 02-MAY-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers. However, on receiving the patient's initials, date of birth and gender, this case was determined as valid.  This is one of the several reports received from the same reporter.
This spontaneous report as received from a nurse refers to unspecified number patients of unknown age and gender. No information on concurrent conditions and medical history was provided. On unknown dates, the patients were vaccinated with hepatitis B (recombinant) (manufacturer unknown). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
h/a, nausea, fatigue, stomach pain, poor appetite, dark urine, pruritic, jaundice, anorexic;elevated LFT, SGOT 73, SGPT 182, Bili 3.3 repeat 2NOV96 SGOT 30, SGPT 44, bili 1.0;
Received vaccine at an evening clinic.  Wakened next am with hives.  Resolved without treatment.  Only other complaint was feeling tired.
p/vax pt devel swollen glands, a few itchy vesicles & a low grade fever;pt sought medical attention & was dx w/chickenpox;
29JAN97 lt leg swollen hip to knee dec motion @ hip;knee mobile WNl;30JAN97 report by phone swelling down, pt walking no ortho consult, no redness;
6 days after vaccination, developed mild  poison ivy/chicken pox type irritations on both arms  and hands ending at shoulder. Reached worst stage 12 days after vaccination. Have never had poison reaction and was not exposed to any plants during this time. Irritation did not develop on palms. Itchy rash and small fluid filled blisters. Took Benadryl and used cortisone cream - started to subside.
Had 1st shot in Feb, i recently broke out; No knowing there was a 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: The patient self-reported this case. The patient stated that he/she received his/her 1st shot but not his/her second it there a cut off time. The patient had his/her 1st shot in February 2022, no knowing there was a 2nd shot. The patient was recently breaking out.  The patient asked when he/she should get his/her next shot. The patient also asked what a patient should do if their second dose of Shingrix was later than six months after receiving the first dose, how soon after GlaxoSmithKline had shingles could GlaxoSmithKline get vaccinated. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
SWELLING, RASH, ITCHINESS AND FEVER/HOT   5 days after injection. its now 13 days after injection and it s still red and itchy.
Patient experienced tingling in hands. Tingling sensation and numbness traveled to fingers. Patient then complained of tingling in lips. MD was trying to be contacted when tingling was in hands. Administered EPIPEN when reaction traveled to mouth, lips & 911 was called.
Myasthenia Gravis crisis. Not breathing issues but inability to move, trouble talking, moving and swallowing. Not acute but over a couple of weeks it was building until it got significant. Two or three weeks until it reached a peak which lasted for months and still not where she was before the additional dose of Moderna. Her body is super sensitive now. Colds and menstrual cycles much worse. Since the third dose IVIGs side effects have also been really bad for multiple days afterwards which wasn't the case before. She did fine with the first two doses but is not yet back to baseline condition prior to the additional dose she received in August. She received the .5ml and was vaccinated as immunocompromised due to her medications. Dates of the Doses were 02/03/2021, 03/03/2021, 08/25/2021.
Received the 1st dose at around 5pm on 1/21/21 - No immediate reaction. Slight soreness in right arm prior to going to bed that night. Next morning, 1/22/21, whole right shoulder became very tight and rigid. Took one Advil/Tylenol for symptomatic relief. Around 5 pm on 1/22/21, started getting body aches and chills, took an Advil/Tylenol for symptomatic relief. Took another set of Advil/Tylenol prior to going to bed at 11:30 pm on 1/22/21. All well the next day and thereafter.
Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified) via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after the first dose of vaccination the patient experienced headache. The outcome of events was reported as unknown at the time of report.  No follow up attempts are possible. No Information about Lot/batch number cannot be obtained.
Presented to outlying hospital with presumed MI. Arrived to tertiary center with EKG changes. Echocardiogram showed pericarditis with pericardial effusion. EF is preserved. Had unremarkable Cardiac Cath
Developed pneumonia; Symptoms included-fatigue, cough, wheezing, SOB, & leg/calf swelling.  Had symptoms for 3 weeks prior to death.  Cause of death listed on hospital records as COVID pneumonitis, with contributing factors of CAD, tobacco abuse, HFrER, CKD, and HTN.
flue like symptoms; body aches; headaches; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2022 17:00, the patient received Shingrix. On 17th July 2022 22:00, 5 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, general body pain and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The case was reported by the consumer for himself/herself. The patient received the vaccine yesterday (at the time of reporting) at 5pm. The reporter stated that by 10pm he/she was having flue like symptoms with body aches and headaches. The reporter asked was this normal. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Patient received 4 immunizations in the office at approx. 3:15 PM.  Mother called after hours at7:23 to report the child was grey/pale and limp.  No respiratory distress was reported.  Child sent to ER for evaluation.  Was then transferred to hospital for testing.  EEG and MRI were normal as was the child the next morning.  Neurology stated it might have been a seizure vs. a reaction to the immunizations.  No positive confirmation.  7/30/09 Hospital records received DOS 5/21/09 to 5/24/09. Assessment: Fever of unknown origin. Parent states child was crying as if he was in pain, pale, poor response to painful stimulus. Became limp, unresponsive. Heart rate 180. Fever. Nasal congestion. Minimal cough. Few bowel movements. Pale, ashen. Minimal left hemiparesis. Mild spasticity. Cortical fisting. Clonus ankles.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2593), via an unspecified route of administration, administered in arm left on 01Nov2021 10:00 (at the age of 50-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; influenza vaccine (FLU), via an unspecified route of administration from 01Nov2021 (Lot number was not reported), at unspecified dose for an unspecified indication. The patient medical history included mitral valve prolapse, high cholesterol and anemia. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 11:00 AM as dose 1 (Lot number: EN6207), and on 15Apr2021 11:00 AM as dose 2 (Lot number: EW0162) both was administered in left arm for covid-19 immunization. Vaccines were administered at the Pharmacy/Drug Store. On 01Nov2021 at 10:30am, severe skin itching and burning in arms, back, butt, thighs, and legs. These were all still occurring since Booster Shot and Flu Shot on 01Nov2021. The patient was also diagnosed with contact dermatitis on 07Nov2021 by hospital. The patient does not have known allergies not until the booster shot and flu shot on 01Nov2021. The events resulted in emergency room/department. Treatment received for the events was OTC Cortisone, and an upcoming appointment for burns/itching. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Info has been received from a 51 year old male pt with no past medical history and no known allergies, who in January 1997 and July 2002 was vaccinated with the 1st and 2nd doses of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. The pt reported that following the 2nd vaccination he had redness around the injection site which lasted for a day or two. At the time of this report, approx 6 weeks following the 2nd vaccination, there was still a faint quarter sized outline around the injection site, but it was not, swollen or itchy. The pt reported that "it just gives a slight outline about the size of a quarter" and he was told by his doctor that this was normal. Unspecified medical attention was sought. Additional info has been requested.
had chills about 18 hours after; felt cloudy in the head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EL3247) , via an unspecified route of administration at arm left on 09Feb2021 15:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included inflammatory bowel disease (IBS) from an unknown date. Not Pregnant at the time of vaccination. No allergies to medications, food, or other products.Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included plecanatide (TRULANCE) received within 2 weeks of vaccination. The patient historical vaccine included first dose of bnt162b2 (lot number=EL3247) on 19Jan2021 03:00 PM, at left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No symptoms after the first dose. After the second dose, had chills about 18 hours after and felt cloudy in the head, but was able to go to work and function. Adverse event start date was 10Feb2021 06:30 AM. No treatment received for the adverse event. Event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
Sorenessin the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sorenessin the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sorenessin the injection site). At the time of the report, VACCINATION SITE PAIN (Sorenessin the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.