chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of encephalopathy in a 11-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified) and Hepatitis B. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Hepatitis B (administration site and route unknown, batch number not provided). 2 days after vaccination with DTPa (with small D + P) and Hepatitis B, the subject experienced photophobia, progressive weakness, dizziness, incoherent speech, mental status changes and ataxia. Encephalopathy was diagnosed. This case was assessed as medically serious by GSK. After 1 day, encephalopathy was resolved. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
This spontaneous report has been received from a pharmacist via company representative regarding a female patient of unknown age. The patient's concurrent condition includes asthma. Concomitant medications were unknown. On 22-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L022262, Expiration date: 05-NOV-2016). Other suspect therapies included TDAP (manufacturer unknown) administered on the same day. On an unknown date in 2016, the patient experienced pneumonia. On 25-OCT-2016, the patient was admitted to an unspecified hospital for 5 days for the treatment of pneumonia. The patient had since recovered from pneumonia on an unknown date in 2016. The causality was not reported. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested.
booster; Tinnitus; anxious; desperate; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Oct2021, outcome "unknown", described as "booster"; TINNITUS (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Tinnitus"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxious"; FEELING OF DESPAIR (non-serious) with onset 2021, outcome "unknown", described as "desperate". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were taken as a result of anxiety.  Additional information: Caller is a Dentist. Caller stated he received his booster shot of the Pfizer Biontech COVID 19 vaccine adult formulation on 11Oct2021 and that 25 min after receiving the shot to now, present day, he was been experiencing tinnitus or ring in his ears persistently. He described it as been mainly on the right side and as really loud, with a high frequency and continuous sound. Caller also stated he was has gone to different Doctors and no one has treated him. He said he was anxious and he was considering acupuncture as alternative because he is desperate. Caller asked if there was any report this side effect and any possible treatment. Caller states he know Pfizer does lots of research and was wondering if we invented any medication to treat tinnitus.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sudden onset of left kne pain, swelling,, and stiffness within hours of having received the latest moderna Covid vaccine and the seasonal flu vaccine.
Headache, Myalgia, Fever & Diarrhea Narrative: Received the 2nd vaccine on 3/1/21 and yesterday started with symptoms of diarrhea, temp 101.5 fatigue, body aches. Reports has taken acetaminophin for discomfort. Reports that starting to feel better.
PATIENT TESTED POSITIVE FOR COVID-19 ON 10/1/2021 (BREAKTHROUGH CASE); PATIENT EXPIRED ON 10/3/2021
Spontaneous Peptic ulcer bleed; Left arm became sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PEPTIC ULCER HAEMORRHAGE (Spontaneous Peptic ulcer bleed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 211M28-9 and 022M20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure (Heart failure  7years ago ha sreolved by its own but was placed on entresto at that time), Cardiac disorder, Headache since an unknown date, General body pain and Left atrial appendage occlusion (to treat atrial fibrillation and prevent clots.) in 2019. Concurrent medical conditions included Edema legs (Fluid in feets), High cholesterol and Hypotensive (Mild hypotensive). Concomitant products included CARVEDILOL (COREG), HCTZ, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PARACETAMOL (TYLENOL) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm became sore). On an unknown date, the patient experienced PEPTIC ULCER HAEMORRHAGE (Spontaneous Peptic ulcer bleed) (seriousness criterion hospitalization). The patient was hospitalized from 24-Feb-2021 to 12-Mar-2021 due to PEPTIC ULCER HAEMORRHAGE. On 04-Feb-2021, PAIN IN EXTREMITY (Left arm became sore) had resolved. At the time of the report, PEPTIC ULCER HAEMORRHAGE (Spontaneous Peptic ulcer bleed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Consumer reported that she had a TEE (Transesophageal echocardiogram ) on  around 06 feb (exact date unknown).  Treatment medication included Eliquis twice a day.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-075255 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
8/9 - red mark from left arm to axilla  8/10 am - fever, chills, aches mostly at knees and ankles, numb all over - now: at fingers and toes only, stiff injection site, red rash at palms - on and off. 8/10 - vaccine site darkish. Hospitalized since 8/10.  09/17/2007 MR received for hospital DOS 8/10-12/2007 with DX of Post Smallpox vaccination reaction without evidence of any subsequent inflammatory demyelinating polyradiculopathy. Pt presented to ER with upper and lower extremity weakness, paresthesias, low grade fever and rash.   PE (+) weakness of upper and lower extremities, Palmar grasp decreased bilaterally.  DTRs brisk. Motor strength 3/5. Sensor exam with subjective numbness.  Circumferential rash at smallpox injection site.  Faint macular, papular palmar rash.  Pt improved during hospitalization and was D/cd ambulatory with only mild paresthesias.
This spontaneous report was received from a nurse concerning a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were  unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, swelling and itching appeared at injection site on left arm a full week after initial shot
Patient called 2/17/2021 to report he had a very stiff arm (unable to lift arm) and arm was very painful after injection 2/16/2021.  Patient took acetaminophen through the night and arm was still stiff and sore morning of 2/17/2021.  He required assistance doing his farm chores/work.
Exactly one week later, my arm was swollen, red, painful, and hot to the touch. The pain lasted 48 hours, and the redness, swelling, and warmth has lasted 48-72 hours right now.  The redness started off as blotchy and raised. Now it is a bit lighter in color but spread horizontally and is confined to my upper arm.
Initial misuse report received from a patient's mother to nurse on 02-Oct-2013. The 03-years-old patient had received FLUZONE (dose unknown) intramuscular (IM). No adverse event was reported. List of documents held by sender: none.
Patient developed small bruising/red area which progressed over 24 hrs to 1/2/ dollar size. Then progressed again to 2" wide by 4" long, 3/10 soreness, hot, sm swelling, itchy.
Daugher of patient called stating patient had a reaction to the pneumonia vaccine.  Patient in to the clinic.  Right arm with swelling at sight, heat, pain on abduction and to the touch.  Patient putting alcohol on site.  Swelling, heat, pain, and reddness with induration noted.  Patient instructed to take motrin and apply ice to site.
right sided upper arm swelling, slight redness, firm beneath injection site, with "tightness" from elbow to the shoulder with ROM/ movement
Fever, chills, severe nausea, rash on left arm, hand and face.
Several hours after being vaccinated my vaccinated arm became moderately sore.  The next day arm felt much better but I felt quite fatigued.  The fatigue only lasted one day.  Eight days after my vaccine I developed a large (approximately 3" in diameter)   oval red and swollen area on my arm. It lasted 3 days before clearing up.
Began breaking out in a rash over the next few days much worse than what it was prior to Dtap. Doctor confirmed eczema the following week.
Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tired, queasy stomach, headache, no appetite.  Thought I was doing better after 48 hours but had a relapse last night with fever and chest pains.  When I take a deep breath, feel pain in my chest.
Was diagnosed with Cellulitis/ "cellulitis or staff infection"/fever; She has experienced diarrhea; Severe adverse reaction/Unable to do anything for more than a week; Nausea; Injection site hot to touch; Information has been received from a 77 year old female patient. No medical history, concurrent conditions nor concomitant medications were reported. On 08-SEP-2019 (also reported as "unknown date"), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route, strength, lot number and expiration date not reported) for prophylaxis. In September 2019, the patient experienced a severe adverse reaction (adverse event), fever and the injection site was "hot to touch" (injection site warmth). On 09-SEP-2019 (also reported as "24 hours after vaccination"), the patient was seen by a registered nurse who diagnosed her with cellulitis (also reported as "cellulitis/staff infection"). The patient received treated with ondansentron hydrochloride (ZOFRAN) 8 mg and an unidentified "strong antibiotic". In September 2019, the patient experienced diarrhea and nausea but didn't know if it was due to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or the antibiotic. The patient reported she was "unable to do anything for more than a week" (adverse event) (conflicting information as report was received the same day of onset date). In September 2019, the patient saw a physician and was told to stop the antibiotic. The outcome of cellulitis, nausea, adverse event, injection site warmth and diarrhea was unknown.  The relationship between cellulitis, nausea, adverse event, diarrhea, injection site warmth and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, cellulitis was considered to be a medically significant event.
Patient complained of numbness in left cheek (under left eye socket to cheek bone area) which started approximately 30 minutes after the injection. After about 1.5 hours numbness eased but continued for about 3 hours total. Patient denied any weakness or paralysis in facial or arm muscles. No visual sign of drooping or irregular facial expressions, and grip was equal in both arms.
DIMINISHED HEARING IN BOTH EARS, DIZZINESS AND RINGING/BUZZING IN EARS AFTER 1 ST DOSE ADMINISTERED ON 6/15/2021. LOSS OF HEARING IN RIGHT EAR, TINNITIS AND VERTIGO AFTER 2ND DOSE ADMINISTERED ON 7/6/2021. PRIMARY CARE PHYSICIAN REFERRED TO ENT FOR TESTING. ON 8/5/2021 HEARING TEST PERFORMED BY AUDIOLOGIST SHOWED VERY LITTLE HEARING IN RIGHT EAR. ENT PRESCRIBED TREATMENT OF ORAL PREDNISONE FOR24 DAYS AND REFERRED FOR MRI. MRI SCHEDULED FOR 8/27/2021 AND FOLLOW UP WITH AUDIOLOGIST & ENT ON 8/31/2021.
2nd anthrax injection given on 1/25/03 in right arm. PT has redness and slight swelling from mid-arm to the elbow. Lymph nodes in armpit tender. Moderate hard know at site.
After receiving the injection and while walking the 75 yds to my parked car I experienced shortness of breath. This has continued, along with general tiredness,  and I have seen my primary care doctor who referred me to a cardiologist. Both reported low heart rate. I am seeing a Electrophysiologist tomorrow and expect to have pacemaker surgery.      I have heard anecdotally now of a relative who developed low heart rate after 2nd Moderna shot . I wonder if there is a relationship between low heart rate and the vaccine.?
if they have only received one shot of Shingrix and the time has past is over a year or more?; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received only one dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: if they have only received one shot of Shingrix and the time has past is over a year or more?). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-Jul-2023 The reporter asked that what patient should do if he or she had only received one shot of Shingrix and the time had past was over a year or more, the efficacy was with only a one shot series. No further information or clarification was provided. This was a sales representative submitted request and has the potential of being a duplicate report. It was being submitted out of an abundance of caution.  All available details had been submitted by medical information and medical information team had no further information available. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd shot of Shingrix, which led to incomplete course of vaccination.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter.
low level nausea; loose stools; not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. Medical history included immunodeficiency; patient should told the vaccinator if immunocompromised. But he didn't know this at that time, and no one asked him about it. The patient's concomitant medications were not reported. After vaccination, one of his co-workers tested positive for COVID, so he was exposed. Is this a problem with vaccine? After being exposed, patient had some low-level nausea, loose stools, and not feeling well. he didn't know if that was from the vaccine or if he had COVID because of exposure. The patient had COVID testing with unknown result in Jan2021. The outcome of events was unknown.  Information about lot/batch number has been requested.
Fatigue started 1 week after second injection.  Headache ( not a typical headache) lasted for 3 days so far. Not improved with usual meds ( Tylenol, Motrin, magnesium, caffeine).
Patient had JJ covid vaccine in March and came to get Pfizer vaccine because he thought the JJ vaccine is no longer effective.
Does have a mental illness problem, bipolar manic depression.; COPD; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "bipolar" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BIPOLAR DISORDER (medically significant), outcome "unknown", described as "Does have a mental illness problem, bipolar manic depression."; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (medically significant), outcome "unknown", described as "COPD"; COUGH (non-serious), outcome "unknown".  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-202201182963 same patient and event; different vaccine dose;US-PFIZER INC-PV202200032637 same patient, different vaccine dose and event;
Three days following my second vaccination, I started to develop chest pains, shortness of breath, and a dangerously high heart rate (confirmed by hospital and EMS). I was diagnosed with costochondritis and was instructed to take ibuprofen regularly. I still have flare ups and chest pains.
Pt vaccinated with DTP/OPV developed temp 100(R), excessive sleeping.
Moderna COVID-19 Vaccine EUA. Got 1st dose of Moderna shot on Wed. 03/03/2021 at 3:20 pm. That day my arm started hurting & I was fatigued so I went to bed about 5:30 pm and didn?t wake up at all until next day. Then, Sunday evening, 03/07/21, began to feel chills & body discomfort. By Monday morning around 8 am I began to feel fever of 99.5 & bodyaches. The fever got progressively higher on Tuesday & Wednesday, from 101.5 to 103.5 at the highest. Also, had intense bodyaches, headache, swollen lymph glands, nausea. Fever finally broke on Thursday, 03/11/21 by alternating Tylenol & ibuprofen tablets as advised by my local pharmacist. Also had to buy anti-nausea medication because felt like throwing up. I was feeling somewhat better by Friday, 03/12/21 (still felt tired & weak & had no appetite). I did not go to the Emergency Room at my local hospital due to the fear of picking up something else (virus/bug) while there.
pt reports onset of itching & erythema & raised areas p/scratching of 2wk duration;pt has notable dermographic/urticaria;no fever/myalgias,arthralgias or notable synovitis;did have viral illness 12FEB97 w/these sx;