chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender (previously reported as child) patient with no pertinent medical history reported. On 14-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 23-JAN-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
On 01/15/21, I received the vaccine. A short time later my heart began racing. In the night it was beating weird. I checked my vitals and my BP and heart rate were climbing. By the morning I was having chest pain and shortness of breath. My husband took me to the hospital. I was admitted for further testing and evaluation due to an abnormal EKG and labs with unstable vitals. I was discharged late afternoon/early evening on 01/16/21. I was ordered a cardiac event monitor and to see a cardiologist. My event monitor was reviewed by a cardiologist who referred my to Dr. in my local area. On 06/01/21, I had a consult with her. My EKG was abnormal and it is suspected that I have developed a cardiomyopathy. Further testing will need to be done to confirm.    After my first vaccine I was contacted by the Health Dept to inform me that I may be able to get the second vaccine due to the reaction that I had after the first. I was called the day prior to my appt and was told that their medical director reviewed and approved the second vaccine. Within an hour of leaving the health dept my heart was beating weird again.   Since a short time after the vaccine I developed a dry cough that I still have almost 6 months later. The cardiac issues have not dissipated as the medical professionals had hoped.
104 fever with hallucinations and severe uncontrollable convulsions for almost 24  hours
0950 - client c/o "weird sensation", sweating, pale, VS stable. Client was laid down on cot. Client stated he was feeling much better, and that "this happens with shots".  Client sat up, drank some water. VS Stable.  0950: 109/73, 56/min, 97%RA 0955: 131/88, 58/min, 98%RA
Patient called and stated that at about 9 pm the night of 10/9/20 some 5 1/2 to 6 hours after receiving her vaccines  complained of elevate blood pressure 126/103 and a rapid heart rate pulse rate of 176 after drinking some ice water within 30 minutes the symptoms subsided and went away. Patient rested comfortably the rest of the evening and into Saturday afternoon. The patient said that she is feeling just fine . I advised her to contact her physician and if this symptom occurred again to call 911 and seek medical attention.
lips/tongue numb, tingly, swollen dyspnea diaphoretic slight nausea after leaving clinic MJCH LESS INTENSE THAN PREVIOUS TWO REACTIONS
Severe edema and erythema of the thigh were vaccine was administered. Rx with Benadryl
Recurrent ear pain- drainage-brain fog-severe headaches - numbness in fingers - ringing in ears - light headedness
Appx 36 hour after shot had irregular heart beat.  Then extreme dizziness resulting me passing out .  After  regaining  consciousness, symptoms were gone.
This study case was received from the investigator in a trial on 27 September 2012. A 22 year-old male subject was found to have non-specific myocarditis 15 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 15 May 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 29.70 on 29 May 2012. ECG, and Echocardiogram results were not available. Treatment were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient is a 58 y.o. male with PMH follicular lymphoma s/p bendamustine/obinutuzumab, hypogammaglobulinemia s/p IVIG, hx of COVID-19 PNA (2/1/22) with subsequent cryptogenic organizing pneumonia (per 4/2022 surgical lung biopsy) who presents on 6/1/22 from Pulmonary Clinic with hypoxia, tachycardia, and chills.  Patient initially diagnosed with follicular lymphoma on 1/19/2021 and has been following with outpatient Hematology.  He was hospitalized 3/4/2022-3/12/2022 for COVID-19 pneumonia and has had a difficult course since then.  He was again hospitalized from 3/19/2022-3/27/2022 for persistent fevers felt to be related to COVID-19 and given his immunosuppressed status there is a possibly he is unable to clear the infection.  He was hospitalized again from 4/4/22-4/18/22 for acute hypoxic respiratory failure and is s/p bronch+BAL with extensive infectious workup which was unrevealing except for persistently positive COVID antigen.  Open lung biopsy on 4/12/2022 showed organizing for which the patient was started on steroids.  He was hospitalized again from 4/30/22-5/3/22 for recurrent fevers with negative infectious workup was discharged on prednisone and Bactrim prophylaxis.  He was hospitalized again from 5/13/22-5/15/22 when a single blood culture was positive for GPC (felt to be contaminant) and repeat blood cultures were negative.  Bactrim prophylaxis was changed to atovaquone for PJP prophylaxis.  The patient presents to pulmonary clinic follow-up today and was noted to be hypoxic, tachycardic, and experiencing chills.  Upon my evaluation the patient tells me he had a fever 102° F 2 days ago.  He continues to have intermittent chills throughout the day in addition to cold sweats.  Other symptoms include shortness of breath with activity and bilateral knee pain that started several days ago.  Early this morning he did have some chest pain which felt like dull ache under his left rib cage that lasted about 30 minutes.  Denies palpitations, dyspnea at rest, nausea, vomiting, hematemesis, cough, hemoptysis, abdominal pain, dysuria, hematuria, constipation, diarrhea, melena hematochezia.
The patient received her vaccine at 2:08 around 2:42 she fainted at a register, fell and hit her head.  According to the patient a the time of the event she didn't remember anything right before the event.  She did not remember doing anything different other than getting her shingrix vaccine about 30 min prior.
Resident was administered the Pfizer Covid-19 vaccine as her second booster shot. Consent obtained by family. Call from nursing home to report that resident had already received her vaccine at the hospital on 6/7/2022. Resident received addition vaccine on 6/10/22. No ill effects
Information has been received form a pediatrics office concerning an 8 year old white female with no allergies or medical history who on 11SEP1998 was vaccinated IM with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 02SEP2003 the pt experienced chickenpox. Recovery status is unknown. Additional info has been requested.
Tired, feeling hot, arm redness a little bigger than a quarter around injection site, swelling, body aches and headache.
When I went to bed the night of the vaccine (about 10 hours later), I had electric shock feelings throughout my body off and on during the night. I was fatigued for about two days, and then a little fuzzy in the brain for over a week.  About a week after the vaccine, my left hand began to be numb, mostly at night, but into the day. After about two weeks, the pinky and ring finger and the flesh along the side of the hand began to stay numb all of the time. A friend, whose brother is an ER doctor, told me he said it would go away, just give it time.  It is four months later and it hasn't. I have difficulty keyboarding and playing guitar/viola, as I have difficulty feeling my fingers touching the keys/strings.  I am going to a neurologist at the clinic in September to see if there is anything to be done.
Patient presented for second dose of vaccine. Patient wrote that he received Pfizer vaccine at his first dose but was mistaken and received Moderna. Pfizer given instead, monitored patient for any reactions, of which there were none. Patients provider aware as well as patient and patients mother.
This case was reported by a consumer (subject) and described the occurrence of swollen submandibular gland in a 40-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to ibuprofen, allergy to NEXIUM, allergy to PRILOSEC, codeine allergy and cold. Concurrent medications included Vitamins. On 15 October 2012 the subject received a dose of FLUARIX (details unknown). In 2012, about 2 weeks after vaccination with FLUARIX, the subject experienced swollen submandibular gland. The subject reported that she had a swollen submandibular gland on one side, but did not have pain. She had plans to see an ENT [Ear, Nose, Throat Physician] on Friday [16 November 2012], but had not received any treatment at the time of the report. She reported that the swelling started "about 2 weeks" after vaccination and that the swelling "started 2 weeks ago" and was still present. At the time of reporting the event was unresolved. The subject reported that the swelling was "not as big this year as it was last year". See case A1002313A for details regarding swelling last year.
Injection site pain, Injection site arm sore, feeling very tired, muscle aches, nausea, heartburn, sleeping,irritable
kidney pains, muscle paralysis, stiff neck, swelling inflammation of joints, h/a, nerve inflammatory spasm; numbness of rt arm; pain site of inj; back stiffening;
Fever (100.6), Headache, Body Aches.  Duration 24 hours.
Cold; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19). At the time of the report, NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive date - unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 75-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. On 31st May 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythema, blister and pain. On 8th June 2018, the outcome of the blister and pain were recovered/resolved. On an unknown date, the outcome of the erythema was recovered/resolved. The reporter considered the erythema to be almost certainly related to SHINGRIX. The reporter considered the blister and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. The day after the injection, the area about 5 to 7 inches below the injection site became red and sore. As the redness started to improve, the soreness also started to resolve. A blister about the size of a nickel developed within the redness. It took about 7 to 8 days for all symptoms to resolve. The registered pharmacist was transferred to MI on whether or not patient should receive 2nd dose based on her reaction to the first dose.
Dark urine; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) and EPINEPHRINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain). At the time of the report, CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment were provided
Pain @ injection site. pain to move arm. Pain did not relieve w/ OTC IBU OR ICe.
Information has been received from a physician concerning a healthy, white, 34-month-old female patient with no pre-existing allergies, birth defects or medical conditions, who was vaccinated on 19-Apr-2005, at the age of 12-months with an intramuscular first dose of varicella virus vaccine live (Oka/Merck) (lot# 649269/0986P). On 18-Jul-2007 the patient developed a rash, "small pimples" on her right forehead and scalp that gradually spread to her right eye lid. It was slightly itchy. The patient did not have any pain or a fever. On 22-Jul-2007 the patient was taken to a clinic and diagnosed with shingles. On the morning of 23-Jul-2007 the patient went to the doctor's office for follow-up, evaluated and sent to ophthalmology for a corneal exam. The patient was started on acyclovir. There were no diagnostic tests and laboratory data. No outcome is reported. No product quality complaint was involved. Additional information has been requested.
hives all over her body; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced hives all over her body (non-serious) on an unspecified date with an outcome of unknown.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
L leg 7x8cm area of erythema, mild induration-seen 2 days after Dtap given.
PATIENT WAS FINE WHEN HE LEFT THE PHARMACY. HE CALLED ABOUT AN HOUR LATER STATING THAT HE HAD SEVERE ABDOMINAL PAINS SUCH THAT HE COULD ONLY STAY ON HIS HANDS AND KNEES WITHOUT MAJOR DISCOMFORT. TRIED APAP AND NAUSEA MEDICATION AND THAT DID NOT WORK. HE CALLED BACK 2 HOURS LATER STATING THAT HIS CONDITION WAS NOT ANY BETTER. I ADVISED THAT HE MAKE HIS WAY INTO THE ER.
A needle went into the arm of a patient and needle fell off the syringe; A spontaneous report was received from a nurse, concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the needle went into the arm of a patient and the needle fell off the syringe  There were no medical history and concomitant medications provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   The reporter stated that a needle went into the patient's arm and the needle fell off the syringe. Both the needle and syringe were discarded, and the patient was vaccinated with a new needle a syringe. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, a needle went into the arm of a patient and needle fell off the syringe was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection and a needle went into the arm of a patient and the needle fell off the syringe. There we no reported adverse events after the vaccine was administered in this case of syringe issue.; Sender's Comments:
Patient became hypotensive, bradycardic and dizzy. During assessment pt had an episode of vomiting. Gave 4mg Zofran ODT with resolve to nausea/vomiting.
No additional AEs; Patient was given an expired ROTATEQ; This spontaneous report was received from a licensed practical nurse referring to a patient of unreported age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.    On 21-JAN-2022, the patient was vaccinated with first dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered) (lot number U007860, expiration date 14-JAN-2022; dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.         No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Nerve pain was in right arm / Pain started 48 hours after administration; This case was reported by a other health professional via sales rep and described the occurrence of nerve pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2021, the patient received the 1st dose of Shingrix. In February 2021, 48 hrs after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The reporter reported that, the patient received 1st dose of Shingrix and experienced nerve pain in right arm after 48 hours. The patient was consulting hand specialist. The reporter consented to follow up.
Sore throat, cough, malaise, runny nose.  Neck pain. Headache
13x8 cm region of erythema and edema, on left buttock began only 60-90 minutes after vaccine administered, BENADRYL, ice, CORTAID cream.
Small rash on upper left thigh; This is a spontaneous report from a contactable consumer (patient)  A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 02Jun2021 at 19:30 AM (Age at vaccination: 41 years old) as dose 1, single for covid-19 immunization at a hospital. Patient's medical history included: known allergies: Ibuprofen and the mental nickel from an unspecified date. Concomitant medication(s) included Telmisartan and ethinylestradiol/norgestimate (SPRINTEC), both taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. There were no other vaccines in 4 weeks, no Covid prior vaccination, she did not get tested for Covid post vaccination. Patient experienced small rash on upper left thigh 04Jun2021. Patient took unknown treatment which was advised by primary doctor regarding the issue. Outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
4/18/08 - recent JE, rabies.  On 4/25/08 received rabies #2 (Rabivert, Chiron).  On 4/29/08, received Japanese encephalitis #2.  On 4/30 pm, developed rash on wrists/arm.  Received Benadryl.  Improved.  Due to JE believed 2 hours received Rabies #3 by outside MD 5/16/08.  Developed shortness of breath, took Benadryl but by 5/18/08 went to ED.  Received Prednisone BID QD x 5days.
diverticulosis; pain at injection site; A spontaneous report was received from a consumer concerning a 70 year old male patient, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced diverticulosis and pain at injection site.  The patients medical history was not provided. No relevant Concomitant medications were reported.  On 02 mar 2021,prior to the onset of events, the Patient received the first of two planned dose of mRNA-1273(Lot number: 022M20A ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 02 mar 2021, patient experienced pain at the injection site and diverticulosis. The patient was admitted to Hospital on 02 mar 2021. No surgery performed. Discharged on 04 mar 2021.The event caused two days of hospitalization.   Treatment for the event included Amoxicillin . Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event diverticulosis and pain at injection site was not provided.; Reporter'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.
sojrnes; Multiple Sclerosis; Lupus; Mixed Connective Tissue Disease; Rhumatoid Arthritis; Raynauds; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single via an unspecified route of administration on an unspecified as dose 1, single for covid-19 immunization. Medical history included immunodeficiency. The patients concomitant medications were not reported. On an unspecified date, the patient experienced Sojrnes, multiple sclerosis, lupus, mixed connective tissue disease, Raynauds and rheumatoid arthritis. Because the patient on so many immunosuppressive medicines patient's rheumatologist wants patient to do a third Vax. Patient understand Pfizer going through clinical trials and patient would like to be part of it. The outcome of the events was unknown.  Information on the lot/batch number has been requested
This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 17-year-old, adolescent, female patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was eight of 10 reports. On 05-Apr-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as 185586 and 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as Incorrect product storage. As the patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the events was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Around 12 hours post-vaccine experiences severe chills for a couple of hours. Woke up around 8AM with headache, took an advil, passed out for an hour and have been fine since.