chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Poor quality vaccine administered, Products were not good with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant patient of unknown gender who had poor quality vaccine administered, products were not good with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date poor quality vaccine administered to the patient, products were not good with no reported adverse event (poor quality product administered) (latency: same day).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
This patient received Hep A shot on 12/07/00. Starting 12/14/00 she has had episodes of hives (almost daily), starting on her face, and then covering the rest of her body. The physician has prescribed her with steroids and antihistamines. The patient's dad reports 12/28/00, hives continue.
Felt intense itching and burning to chin and neck, noticable bumps on skin of chin and neck.
2 vaccines administered to left deltoid area. On Wednesday. Pt presented to clinic on Friday, playful, afebrile but left deltoid area swollen, erythematous, hot to touch, from deltoid to above elbow.
chills; felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side; she had almost 110 temperature; she wasn't feeling good; felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side; fluish; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 31Oct2021 10:00 (Batch/Lot Number: FD0810) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced she had almost 110 temperature, chills, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, she wasn't feeling good, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, fluish on 01Nov2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature decreased:110 temperature on 01Nov2021. Therapeutic measures were taken as a result of she had almost 110 temperature, chills, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side.  No follow-up attempts are possible, no further information is expected.
Local pain, swelling, redness, chills, and diffuse myalgias, worsening over 2 days.
Pain in area up to 10/10 since the day vaccine was given. Patient states she is unable to comb her hair, move her arm, pain worse at night. Works as paralegal now out of work as can't type due to pain. No swelling or redness. She tried cold and hot compresses. Also describes numbness and tingling in fingertips when touched in L upper arm.
pt recvd vax;fever 101;large local rxn from shoulder to elbow;is asthmatic & condition is excacerbated now;bitten by stray dog which was not captured;pt saw dog in neighborhood since incident,appears well;last dose probably not be given;
Bad back (joint/muscle) pain (on and off); Freezing/shivering, rapidly changes to being warm; Very sore arm at injection site, feels like what I'd expect my arm to be dislocated as; Nausea off and on;  Have only taken tylenol q6h prn, have been heating up my bed with a heating pad prior to getting in to keep me warm, I feel like the heat can help alleviate some of the injection site pains
On 1DEC90 morning p/vax sore arms & shoulders states wife has to assist in dressing, unable to raise arms states no fever. Did not see MD, no lab work or xray.
Information has been received from a physician concerning a 4 yr old male who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt was previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced swelling and inflammation. The pt sought unspecified medical attention. Additional information is expected.
Patient came to Vaccination Clinic on 3/12/2021, filled out paperwork and stated it was his first vaccine. This writer went to document vaccine in patient's chart and noted it was actually patient's third vaccine.
expired dose administered to 2 patients; Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 2 patients) and PRODUCT STORAGE ERROR (Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 060H21A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.). On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 2 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 2 patients) and PRODUCT STORAGE ERROR (Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Vial did not undergo any temperature excursions.The patients have not reported any adverse reactions to the dose at this time. No treatment medication was reported
itchiness at injection site; lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE MASS (lump at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 025B21A) for COVID-19 vaccination.     Patient medical history was not provided by the reporter.  Concomitant products included HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE,DERMATITIS TOPICAL MEDICATION) and FLUCONAZOLE (FUNGUS PILL, FLUCONAZOLE) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE MASS (lump at injection site). On 30-Mar-2021, VACCINATION SITE MASS (lump at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment with topical nub was provided.   This case was linked to MOD-2021-148809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: No specific follow-up information recorded.
12/22/21 Pt calling stating she has an ov on 12/30 and states she cannot wait that long due to her symptoms of a deep cough w/ phlegm along with congestion. Pt calling asking if an Rx can be sent to her pharmacy before her ov on 12/30.  No further documentation
Approximately 10 minutes after vaccination, patient began jerking and passed out.  Patient was placed on the floor and vitals were taken which were  normal.  After approximately 10 minutes, patient was brought to sitting position and after a few minutes began jerking movements and felt faint.  After approximately 10 minutes, patient was walked to a chair but after a few minutes he again began jerking and felt faint.  Patient was returned to the floor.  Parents refused transport to the hospital.  Father helped patient to the car and he was placed in the back seat lying down.  Father stated he may take him to the ER if he seems like he needs it.
8/13/21: presents to the ED with worsening shortness of breath.  Pt was in ED on 8-11-21 were he was diagnosed with COVID-19. Pt states his Sx started 7 days ago and over the last 2 days he has had worsening fever and SOB. He states he is unable to walk to the bathroom without getting SOB. He is currently taking prednisone and Azithromycin that he was prescribed. patient also complained cough, intermittent diarrhea, whole body ache from fever and poor oral intake. Pt states that he received the Johnson and Johnson COVID-19 vaccine on 07/29/2021. Diagnosed with: COVID-19 pneumonia 8/18/21: patient discharged. Admitted 8/13/21. Tested positive for Covid on 8/11/21. Diagnosed with covid 19 pneumonia and acute respiratory failure. Discharged to home on 8/18/21.
The vaccine administered was expired. The manufacturer was contacted and alerted of this event. They performed an analysis of the vial. The manufacturer determined that the vaccine had maintained the necessary activity to protect against COVID-19. Our Medical did not recommend the patient to be vaccinated again taking not consideration the findings from the analysis
The vaccine produced extreme fatigue, elevated heart rate, elevated blood pressure (150/90),  gastrointestinal pain, side pain, tingling in arms and feet, and being out of breath with any small physical effort such as walking from the bedroom to the bathroom.  These symptoms were most severe for 7 days after the shot.  In the second week I am now experiencing extreme itching in my hands, feet, arms, legs, and torso on and off throughout the day with hives that come and go.  My palms and bottoms of my feet turn red during these periods of itching.  GI symptoms are not as bad as the first week but are still there.  Fatigue is better but still present.  I am still very easily winded with normal physical activity and experience a racing heart beat as well.  My blood pressure is more normal now.
Initial and follow-up information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 21 year old black female with a history of 2 previous pregnancies, 1 full term delivery in 2005, and 1 elective termination, and no defects or complications in previous pregnancies, who on approximately 23-JAN-2007 was vaccinated with GARDASIL (lot # not reported) 0.5 mL IM. There was no concomitant medication. On 20-MAR-2008 the patient was vaccinated with a second dose of GARDASIL (Lot# 659962/1740U). The patient's last menstrual period was 08-MAR-2008, her estimated conception date was 22-MAR-2008, and her estimated delivery date was 13-DEC-2008. In follow up information was reported that on an unspecified date, the patient started prenatal vitamins, 1 dose, every day for pregnancy. On 12-MAY-2008, the patient started TERAZOL at bed time, 3 doses, for morning sickness. It was also reported that on 22-JUN-2008, a maternal serum alpha-fetoprotein test performed for routine, revealed negative results. On 30-JUN-2008 an ultrasound performed, to rule out any anomaly, with result 16 5/7 weeks. On 25-JUL-2008, the patient started PROMETHAZINE, 25 mg, every six hours, as needed, for morning sickness. Follow-up information indicated that the patient had left the practice and was being cared for by another health care professional office. Follow-up information was received which reported that the patient was no longer followed in physician's office. This is one of two reports from the same source.  Follow-up information was received which reported that the patient was no longer followed in physician's office. This is one of two reports from the same source. Additional information is not expected.
We both got flu shots at 10:15 am on 12/21/2004, and I took my wife to the clinic at 4:20 pm.  She had been having mild but increasing symptons for the previous one hour.  The nurse described the reaction as MODERATE.  They were hoarsness and wheezing; she was unable to take a deep breath through her mouth.  The treatment was nebulizer (?) breathing, with injections of a steriod and antihystamine.  We left the clinic at 6:30 pm with Methylpred 4MG PAK BARR and Diphenhydram 50MG perscriptions.
administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2022 at 2:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022 at 2:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The vial was initially stored in the refrigerator 07-Jul-2022. It was reported that time vial was first punctured 12-Jul-2022 at 12:33 PM and time of administration of vaccine 13JUL2022 at 2:54PM (booster dose). The vial was stored post puncture at room temperature. The vial did not undergone any temperature excursions. It was reported that the pharmacist did not have any information on the patient's primary series and the patient's first booster shot other than that all of the shots are Moderna Covid-19 vaccine shots. No treatment were reported.
pt recv vax 19JAN97 & had mild URI, T 100.2;fever to 101 on 20JAN-21JAN then awoke w/hive like rash extremities, face >trunk;allerg rxn;
Pt was receiving his seasonal flu vaccination and the administering technician resourced the correct dosage and vaccine in Immunizations Tool Kit (in both the green and pink section). After administering the dosage it was noticed that on the vaccination box it was advised that this vaccination (Afluria) is not to be given to children under the age of 5 years old. Parents of patient were notified and advised of warning signs to look out for. Parents were also educated on what to do if a fever develops.
He got a fever and he had other symptoms; This is a spontaneous report from a contactable other healthcare professional.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter stated she was calling because her boyfriend is getting the vaccine (Unspecified vaccine) and do not understand a lot of conflicting news articles and basically the last time he got the first dose, he got a fever and he had other symptoms. So, the reporter stayed away. He was afraid he might give the reporter something. Right now he is getting his second dose today. The reporter was asking if it was actually true that you put the Covid flu into the vaccine? So, like the reporter being exposed to it if she was around the patient. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Tingling in lower legs and feet. This has continued for months. It does seem to be an ongoing problem. Have not seen a doctor yet...
Nausea, vomiting, dizziness, site of MENACTRA was swollen and reddened.
Bell's palsy; hard time maintaining balance; constantly dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diabetic diagnosed 22 years ago; "quadruple bypass" (ongoing), notes: quadruple bypass diagnosed 22 years ago. There were no concomitant medications. The following information was reported: BELL'S PALSY (medically significant) with onset Mar2021, outcome "not recovered"; DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "constantly dizzy"; BALANCE DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "hard time maintaining balance".  Clinical course: Reported as, He stated that there are a lot of patients who have contracted Bell's palsy from the vaccine and his doctors have confirmed that his Bell's palsy was caused by the vaccine. The doctors did not have a solution. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. He developed Bell's Palsy after the first dose, stated the second and booster did not affect him. He clarified that he got the first shot in Mar2022, and the Bells Palsy started 6-7 days later. He stayed away from any medications within two weeks of the injection. He wanted to add that he was constantly dizzy, that he had fallen so many times, he was walking without a walker but walking very carefully.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5/6/99 pt  called clinic & c/o pain @ site;5/6/99 no redness, swelling, heat noted @ site;lt deltoid no edema;referred to PMD, inflammation rx Relafen;
Pt received the wrong age appropriate dose of the Moderna COVID-19 vaccine. Pt did not have any adverse reaction.
Got the vaccine and still got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine and still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2023 The case was received from the consumer interactive digital media. The reporter stated that he/she know people who got the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
fever; shivers/chills; headache; body aches; pain in ears; rapid heart beat so much so that it was hard to breath; chest and back pains like a heart attack; side pains; pain in the back of neck and stiff neck; throat hurt 06/08/2020 - dull headache still  remains and body pains
Died of a heart attack; A 3rd grader [just died of a heart attack after taking the booster]; On 16-DEC-2022, this serious, initial spontaneous safety report was received by Novavax from a consumer via social media monitoring.  A child of an unspecified race, age and sex was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 3 (reported as booster) on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the 3rd grader died of a heart attack after taking the booster (PT: Off label use) (PT: Myocardial infarction) (Serious: Death and Medically Significant).  At the time of reporting, the event outcome of Myocardial infarction was fatal and Off label use was recovered/resolved.  Lot number was not provided in the report.  ; Sender's Comments: This individual of an unspecified age and sex experienced: Myocardial infarction and Off label use after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Myocardial infarction was assessed as serious. The event Off label use was assessed as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.; Reported Cause(s) of Death: Heart attack
This is a spontaneous report from a contactable consumer. A child patient of an unspecified gender received PREVNAR 13 (lot: R75851), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.