chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles. The patient told the doctor that he wanted his money back, as the doctor claimed that he would have had a worse case if he not had the vaccine. The reporter stated that the vaccine did not prevent shingles, as the patient had it pretty bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Body aches, fatigue for two days. On third day, developed periodic episodes of vertigo that lasted for 2 days.
The day after I received my Moderna booster shot on 11/10/2021, I began to hear ringing or buzzing in my left ear on the same side I had my shot. I also had a swollen lymph node on my collarbone and it was tender. That improved, but I have had the ringing/buzzing in my left ear ever since the booster shot. I went to an ENT specialist. She looked in my ear and did not see anything wrong. She recommended a hearing test and or possible MRI. I am interested to understand if this will go away, or if I need a hearing test and MRI. Can I be reimbursed for this cost and the cost to visit the ENT doctor? I have not had this issue before.
Upper arm very swollen, red, large red hot spot immediately below injection site.  Resolved by 4/1/2023 9:00 AM.
This study case was received from the investigator in a trial on 17 January 2013. A 20-year old (age stated on ECG report) male subject had received the following vaccinations on 23 February 2012: ACAM2000 (lot number, right arm and route not reported); anthrax vaccine (Manufacture name, lot number not reported); and Typhoid vaccine (Manufacture name and lot number not reported). At study visit 2 on 28 February 2012 the subject reported he had experienced the same night following the vaccinations on 23 February 2012 mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue. The symptoms worsened over 12 hours but the subject did not seek medical evaluation. The symptoms resolved completely the following day on 24 February 2012. An electrocardiogram on 28 February 2012 was normal and a rapid Troponin was completed as well; however the result was not available as the vial broke during processing. The subject was referred for follow-up care. Assessment: low suspicion myopericarditis. Relevant medical history included occasional chest pain (onset in 1999) and night palpitations (onset date unknown). The subject was reported as recovered on 24 February 2012. According to the Investigator, the events of mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue was considered important events and possibly related. Documents held by sender: None.
Delayed hypersensitivity reaction with severe full body urticaria now chronic with continued symptoms over 6 weeks Now requires chronic medications to control symptoms.
Patient  presented with arm redness and red streak along with arm swelling at injection site, two days after administration of routine 4 year old vaccine. Patient is being treated for cellulitis of left arm with Clindamycin 225 mg orally 3 times a day.
Vertigo and paresthesia occurred around 3 months after the mandated injection on 1/6/22 when I contracted COVID a second time.   The first time I contracted COVID,  prior to receiving the mandated vaccine, I only had flu-like symptoms.
This nurse, while administering vax, "inadvertently got the vax in her eye." Subsequently she experienced burning which went away and a headache.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient received Shingrix and experienced sore arm. The reporter consented for follow up. This case has been linked with US2020036850, for 2nd dose.
Chest pain, SOB and palpitations. Condition developed into a chronic Afib condition. see attached full report. Symptoms: Pain, chest NOS(786.50), Palpitations(785.1), Tachycardia NOS (785.0).
Stomach ache and cramps; Body aches; Chills; Fever; This is a spontaneous report received from a contactable health care professional, the patient. A 25-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 25 years), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 25 years), as a single dose for COVID-19 immunisation. The patient did not take other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested positive for COVID-19. On 18Mar2021 at 12:00, the patient experienced chills, fever, body aches, stomach ache and cramps. The patient did not receive any treatment for the reported events. The clinical outcome of chills, fever, body aches, stomach ache and cramps were recovering at the time of this report.  No follow-up attempts needed. No further information expected.
Left ankle swelled up with great deal of sensitivity, but no underlying injury. It went away suddenly after two days.; Left ankle swelled up with great deal of sensitivity, but no underlying injury. It went away suddenly after two days.; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2021 at 15:00 (Lot number: 33030BD)at the age of 51 year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0177; Route of administration: Unspecified; Anatomical site: Left arm; Administration time: 12:00), administration date: 17May2021, when the patient was 51 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0171; Route of administration: Unspecified; Anatomical site: Left arm; Administration time: 11:30), administration date: 26Apr2021, when the patient was 51 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 15:00, outcome "unknown", described as "dose number=3"; JOINT SWELLING (non-serious), HYPERAESTHESIA (non-serious) all with onset 27Dec2021 at 22:00, outcome "recovered" (29Dec2021), and all described as "Left ankle swelled up with great deal of sensitivity, but no underlying injury. It went away suddenly after two days". Therapeutic measures were not taken as a result of joint swelling and hyperaesthesia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer exercise induced asthma infertility" (unspecified if ongoing), notes: other medical history: Breast cancer exercise induced asthma infertility; "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Information has been received from a 62 year old female with "numerous reactions to other unspecified medication" who on 17-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included "many other unspecified medications". "Within 24 hours of vaccination", on approximately 17-DEC-2008 the patient experienced warmth, itching and a swollen band around her left arm near the injection site; the band was about three inches thick and felt like a big hives. No medical attention was sought. The patient planed to follow up with her physician's office later the morning of 19-DEC-2008 to determine what she could do to treat her symptoms. At the time of this report, as 19-DEC-2008, the outcomes were unknown. Follow-up information was received on 05-FEB-2009 from a physician who reported that the patient never reported any "adverse side effect" to the office. Additional information is not expected.
Nothing major, I experienced some very light dizziness afterwards and had to go to the bathroom to relieve my bowels  soon after the vaccine,  later I experienced some tiredness so took a nap . Pain in left arm at site.  Nothing serious.
A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from an office manager/health professional concerning a 28-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 21-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
evening & next day p/vax leg quite red, swollen; fever 101, crying off & on alot; called ER; next day states reacted to P in DPT never saw MD
Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated with Gardasil. Subsequently the patient experienced a worst condition then before of the papilloma virus. At the time of the report, the outcomes of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
The patient was administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The date moved to refrigeration was 15-Oct-2021.
My upper arm where the injection was administered, started to radiate pain up to my neck. I noticed at that time a painful lump at the front base of neck, right side. The pain started to increase throughout the day. The following morning, the injection site was red and inflamed. The pain persisted throughout the day, radiating  to my hand, all the way up to my neck. The injection site was swollen and red. On a scale of 1 - 10, my pain was at 8. The following day, the pain reached a 10, the swelling and inflammation had increased and I noted decreased muscle strength in my hand. This persisted throughout the night. It's now Monday morning, and with flexril, constant application of a heating pad, a topical Diclofenac gel, and twice daily dose of 800 mg of Motrin and 2 tyelnol over the course of the last 2 days, my pain is at a 7. The swelling has reduced at the injection site some, but the the redness has increased and so has the hardness of the site.
Left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2022 at 12:45 (Lot number: FK9893) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: JUNEL taken for contraception. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534, Anatomical location: Left arm), administration date: 01Jul2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EP7534, Anatomical location: Left arm), administration date: 23Jul2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Apr2022, outcome "recovering", described as "Left supraclavicular lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.   Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Patient appeared to pass out immediately after shot given. Eyes rolled back in head. She was taking rapid breaths. Said she did feel well after a few seconds. She says she felt hot, dizzy, and in a dream like state. Sat w/ptn. Gave OJ to drink. Took blood pressure. Was 84/55, pulse 71.
administered Engerix B adult instead of Twinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 67-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced wrong vaccine administered (Verbatim: administered Engerix B adult instead of Twinrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 The nurse reported that the administration of a pediatric dose of Engerix B instead of Twinrix to a 67 year old patient which led to wrong vaccine administered. The nurse asked for information regarding this situation. Then, the nurse confirmed that the patient received an adult dose of Engerix B but asked for information regarding the use of pediatric Engerix B in adults and mentioned they will continue with HepA vaccination to complete the HepA HepB dose (Twinrix). The nurse did not provide information about the Engerix B dose given (lot number and expiration date) nor patient initials. Permission to follow up was not requested.
Headache followed by nausea, vomiting for 10 hours. Dizziness for an additional 2 hours. Unable to keep anything down, including Tylenol with water.
10 year old H M, sitting in exam room with mother. Nurse carried on conversation with child prior to IZ. Child wanted to know what nurse was doing as she gave injection. Pt BP 114/78, Pulse OX 99%. Child briefly (less than 30 seconds) lost consciousness and slumped against mother. Doctor called. Before doctor entered room, child awakened and was surprised-conscious but uncertain of what had happened. Mother only spoke Spanish and interpreter helped calm mother down. Mom states child had not eaten all day, since early this AM. Child was in clinic for well child visit and received no other IZ's on this day. During episode, child's eyes closed, he slumped against Mom. He continued to breathe normally, pulse was normal. In less than 30 seconds, his eyes fluttered and he was awake. He was moved to exam table by nurse and doctor under his own power and laid quietly while BP, O2 done.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Mother called, mainly complained about hives all over patient body. Patient seems otherwise fine with normal breathing. Taking oral steroids to reduce symptoms
Information has been received from a physician concerning a 17 month old female who on 09-MAR-2006 was vaccinated SC with a 0.5ml dose of Varivax. On 20-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a physician referring to a female pregnant patient of unknown age. Medical history of the patient includes anemia. On 07-JUL-2014 the pregnant patient was inadvertently administered GARDASIL INJ 120 Y, 0.5 ml, intramuscular instead of TDap. No adverse effects noted. Concomitant therapies reported include prenatal vitamins. Lab diagnostic tests were unspecified. The patient was 32 weeks pregnant. The LMP was estimated as 24-NOV-2013 and EDD as 31-AUG-2014. The patient sought medical attention. The pregnancy outcome was outcome pending. The causality was unspecified. No PQC and IRRE reported. Additional information has been requested.
I got the Flu shot and Pneumonia shot in the same muscle in left arm, upper arm became red, hot, swollen, and itchy and painful. I could not lift anything or raise arm or sleep on left side for 3 days. After the 2 shots, I told a nurse friend of mine, who said one should not get the 2 shots in the same muscle in the same arm at the same time. I could not go dancing Fri and Sat night like I usually do because of pain when I move my left arm.
R thigh red with bruise @ site of immunization + swelling + erythema. Pt very fussy and difficult to console.
experienced reactivity (IgE type); Initial information received on 21-Mar-2022 regarding an unsolicited valid  serious case received from a pharmacist via call center.  This case involves an unknown age and unknown gender patient who experienced reactivity (ige type) while receiving vaccine influenza quadrival a-b vaccine [Fluzone qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Latex allergy.   On an unknown date, the patient received a  dose of suspect influenza quadrival a-b vaccine [fluzone qiv].(batch lot UI433AA;expiry date :23-Sep-2015)(unknown dosage strength, route of administration, formulation) in unknown administration site. for immunization.  On an unknown date the patient developed a serious experienced reactivity (ige type) (Type I hypersensitivity ) (unknown latency) following the administration of influenza quadrival a-b vaccine. This event was assessed as medically significant.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced reactivity (IgE type)).  At time of reporting, the outcome was Unknown for the event (experienced reactivity (IgE type).; Sender's Comments: Sanofi Company Comment dated (24-Mar-2022) This case involves an unknown age and unknown gender patient who experienced reactivity (ige type) while receiving vaccine influenza quadrival a-b vaccineAdditional information regarding condition at the time of vaccination, medical history, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.