chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 79 year old male with a history of stroke, anaemia, dementia, hypersomnia, alzheimer's disease, hypertension, sinus bradycardia, acute nasopharyngitis, vitamin b12 deficiency, low back pain and seborreic keratosis who on 12-JUN-2009 was vaccinated with the first dose of PNEUMOVAX  (lot# 662874/1125X). The following weekend on approximately 19-JUN-2009 the patient was treated in the Emergency Room for a left shoulder infection. The patient required surgery for the infection. At the time of the report, the patient recovered from left shoulder infection. The left shoulder infection was considered to be other medically important event. Additional information has been requested.
About 12 hours, post vax (DTAP), pt complained of leg pain, felt hot (no documented temperatures). Leg was noticed to be swollen and tender. Fever of 101-102F, the next day with swelling and soreness in leg and limping. Swelling persists after 48 hours.
Fever, fatigue, chills, headache, rapid heartbeat, dizziness and nausea. The headache and chills were severe.
I was deeply fatigue, achy like I had the flu and diarrhea and I believe  it triggered my illness because I did have to get on bigger dose of my medicine.
June 20 at 4 weeks after the vaccination, I began feeling very tired and lathargic.  june 26 i took my temperature at it was 101. for the next ten days I was in bed , eating very little, and foggy thinking. the worst part was the 103.5 temperature when I was not able to speak in a complete sentence without coughing .  I had trouble breathing and after a virtual appointment with my doctor was perscribed zpak and albuterol and cepcol. I was unable to sleep with my CPAP machine because I was coughing during the night in bed.  It was almost 3 weeks later when I was back to my normal self of eating ,   for the next 3 month (to day) I require exceessive sleep - 10 to 13 hours a night with 2 hour naps a couple times a week.  I have seem a sleep doctor and am pleased to report my CPAP machine settings are new and now functioning well so that I can sleep uninterrupted with the RESMED machine therapy.
Severe shoulder pain, inability to move shoulder because of pain, pain 8/10 on pain scale.
This spontaneous report as received from a nurse refers to a 25 year old female patient with allergy to penicillin, allergy to sulfa and unspecified symptoms prior to her first dose of GARDASIL. The patient had no pertinent medical history. On 10-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number were not provided). On 12-NOV-2012, the patient received of second dose of GARDASIL (dose, route, lot number were not provided). Concomitant therapies included COUMADIN, doxycycline and PRILOSEC. The nurse reported that the patient developed endocarditis after her second dose GARDASIL (Approximately  in November 2012) which required open heart surgery and a valve replacement. Also reported the patient developed unspecified symptoms on an unspecified date in November 2012. The nurse also mentioned the patient had 2 strokes (date unspecified) when she was hospitalized. The patient was hospitalized (date unspecified). The patient's outcome was reported as recovering. Endocarditis, open heart surgery, valve replacement, unspecified symptoms and 2 strokes were considered disabling, medically significant and life threatening by the reporter. Additional information has been requested.
Death within 48 hours of vaccine. Patient presented with high grade fever to 105 within 24 hours of vaccine. Seen at hospital on 6/17/04 (informant states); worked up, released from hospital ED 6/18/04. Fever and spots and pronounced dead.  Nurse follow up on 08/10/04 states: "Septicemia."
2-3 hrs p/inject, t102, inconsolable crying & dec feeding, marked swelling of rt thigh; pt screams until collapsed w/exhaustion then sleeps;
Red spots like measles on arms, legs, back but did not itch, no pain or throb. Didn't see reaction until day after and resolved within 5 days.
17 y.o. scheduled into Moderna vaccine clinic and was given 1st dose on 1/27/21.  Vaccinator did not recognize by DOB that patient was 17. (Age not specified on form).  EUA for Moderna COVID vaccine is for persons age 18 and older. Patient did not have any reaction to 1st dose of Moderna vaccine.  She returned to clinic on 2/24/21 for 2nd dose and it was recognized that she was 17.  On 2/23/21, COVID Pharmacist consulted about this same issue and pharmacist consulted with CDC/State officials at that time.  Per clinical considerations for the Moderna vaccine, 2nd dose of Moderna vaccine can be given to those 16-17y as off label use.  Mother and patient informed of EUA age cutoff for Moderna vaccine and re: clinical considerations/off label use.  Both gave verbal consent to patient having 2nd Moderna vaccine. 2nd dose given. No allergic reaction immediately following vaccine.
The health dept came to my place of employment and gave the vaccines.  I took the first dose and within a couple days my chest began bothering me.  After 1 week i was concerned enough to go get an ECG which showed normal, but the discomfort continued for a couple weeks.  I have also felt tired since receiving it..  Because of this I did not and do not intend to get the second dose.
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number reported as: M041514, expiration date on 11-OCT-2018 (Strength, dose number, route and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 6°F (Fahrenheit degrees) to 14°F (10 °F) with a time frame of 4 hours. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1705USA004665.
Following vaccinations patient began to feel warm and got dizzy. Distress button was pushed by MA staff. Immediate response by RN staff, MA staff, and providers. Lowered patient slowly and gently to the ground and elevated feet. Cold compress applied. Patient was orientated to person and place but did report fuzzy vision. Vitals taken. After approximately 10 minutes patient did improve and was able to sit up. He drank apple juice and continued to improve. Stayed for an additional 10 minutes with no further incidents.
AIDS; This spontaneous report received from a patient via social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "Your vaccine gave me aids" (coded as Acquired immunodeficiency syndrome (AIDS)). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of AIDS was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 14-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1:Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event. 20220126763 -Covid-19 vaccine ad26.cov2.s-AIDS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a registered pharmacist concerning a 40-year-old male with a history of recurrent shingles and no known allergies or drug reactions who was vaccinated on an unspecified date with a dose of Zostavax (Oka/Merck). Subsequently, the patient experienced an outbreak of shingles 6 weeks after receiving the vaccination. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. On an unspecified date the patient recovered from shingles. No product quality complaint was involved. Additional information is not expected.
Day after immunization, localized red bump at site of injection a little bigger than golf ball. Pt. requested MEDROL dose pak from primary MD.
site ached, swollen & redness; lasted 2-3 days; no prior vax;
Slight tingling in both calves when resting. Sensation goes away when moving.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that,  A 58-years-old male patient received bnt162b2 (BNT162B2, formulation solution for injection, Batch/Lot number was: 301458A) (at the age of 58 years old), dose 3 intramuscular, administered in deltoid right on 23Sep2021 09:00 as dose 3 (booster), single for covid-19 immunisation, historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6198, Expiration Date: Jun2021), dose 1 intramuscular, administered in left deltoid on 02Mar2021 as dose 1, single for covid-19 immunisation, historical vaccine, the patient took second dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6199, Expiration Date: Jun2021), dose 1 intramuscular, administered in right deltoid on 23Mar2021 as dose 2, single for covid-19 immunisation and influenza vaccine (FLU), intramuscular in left deltoid from 23Sep2021 (Batch/Lot number was not reported) to 23Sep2021, at UNK, single for immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that on 25Sep2021, patient experienced slight tingling in both calves when resting. Sensation went away when moving. No weakness or pain. This was actually third shot but that was not a choice on prior page. He did not experience any of those symptoms on prior two doses. Light tingling in both calves and both fore arms. Tingling was mild and transient. Sometimes just calves tingle, other times one or both fore arms tingles. Sometimes all limbs tingles. No rhymes or reason. Very transient. Becoming less apparent recently. Not received the treatment. The outcome for the event was recovering.  Follow-up attempts are completed. No further information expected.
hypertension; This case was reported by a consumer via call center representative and described the occurrence of hypertension in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced hypertension (serious criteria death). On an unknown date, the outcome of the hypertension was fatal. The patient died on 14th August 2020. The reported cause of death was hypertension.   It was unknown if the reporter considered the hypertension to be related to Shingrix.  Additional information was provided as follows: The case was reported by a friend of the patient. The patient received a dose of Shingrix in a pharmacy.  Two days later on 14th August 2020, the patient was found dead in his bed at his home. The cause of death was listed as hypertension. It was not known if the patient had a history of hypertension. No other details were known at time of report. The physician might be contacted for further details. The reporter who was a friend of the patient, did not wish to be known. ; Reported Cause(s) of Death: Hypertension
Donor completed donation without incident.  Donor then received Tetanus injection and waited at center for 15 minutes, stated felt fine.  Donor reported feeling dizzy while driving home, pulled over and recovered in 30 minutes.  Donor complained of soreness and muscle aching to left arm from shoulder to elbow for 24 hours.  Donor also experienced "migraine" headache lasting for 48 hours.  Donor stated recovered without incident 02/12/2005.
Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Health Professional, the patient.  A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm on 08Jan2021 at 13:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had sars-cov-2 test on 04Jan2021 which was negative. Concomitant medication taken within two weeks of vaccination included dexlansoprazole (DEXILANT). The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), left arm  on 19Dec2020 for COVID-19 immunization. The patient reported that he continued total body myalgias and weakness 11 days post injection. The events began on 11Jan2021. The events was reported as non serious. The patient did not receive treatment for the events. The clinical outcome of the events continued total body myalgias, and weakness was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19.
No adverse effects reported.; patient received unspecified dose of PEDVAXHIB that was improperly stored/experienced excursion on 5/10/2018; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  The reporter stated that unspecified dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) experienced temperature excursion on 10-MAY-2018 (time included more than 1 excursion). Then on 18-JUN-2018, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # N003536 and expiration date 02-NOV-2019 (strength, dose, frequency and anatomical location were unknown) for prophylaxis. The administered dose of the vaccine was stored with a temperature of 8.72 degrees centigrades for 1 hour and 35 minutes and multiple excursions (more than 1 excursion). There was a digital data logger involved. No adverse effect reported.
p/vax pt rt arm from elbow to deltoid area was red; swollen; ached; low grade fever; achiness; h/a; went to MD & possible Dx of cellulitis made;f/u pt stated felling fine; swelling gone; sl tenderness in rt arm;
This spontaneous report was received from consumer refers to 74 years old male patient with shingles concerning her husband. Approximately in 2011 about 3 years ago, the patient was vaccinated with ZOSTAVAX injection, one time vaccine (dose unit, lot # and expiry date, route unknown) to prevent shingles. On an unknown date, patient started and was undergoing chemotherapy. On 28-JAN-2014 patient has developed shingles. Patient sought medical attention. The outcome of shingles and received shingles vaccine 3 years ago and he was undergoing chemotherapy was unknown. No further information was provided. Additional information has been requested.
24yo  female with anovulatory vaginal bleeding and cramping x5 days which presented within 24 hours of receiving her 2nd dose Moderna COVID-19 vaccination on 06/09/2021. Patient describes her symptoms as if she is having a normal menstrual cycle.  This patient uses Nexplanon for contraception successfully without a menstrual cycle for the past 2 years.  Denies other urinary or vaginal symptoms, or possibility that she may be pregnant.  Although there is high suspicion that this is a COVID-19 vaccine side effect, I will evaluate for abnormal anovulatory uterine bleeding with labs and follow-up with ulatrasound if her symptoms do not resolve with time.    24yo female with left sided supraclavicular lymphadenopathy presenting within 24hrs of her 1st and 2nd dose of the Moderna COVID-19 vaccine.  Patient endorses waning symptoms after the first dose until she received the second dose at which point the lymph node came back.  Physical exam remarkable for one 1x1cm left sided supraclavicular lymph node tender to palpation.  Likely reactive lymphadenopathy.  I will treat with watchful waiting given reactive lymphadenopathy to include supraclavicular lymphadenopathy is a known side effect of the Moderna COVID-19 vaccine, and that patient's young age and lack of risk factors.  If persistent over several months I will re-evaluate the lymph node with imaging.
Area to back of Lt upper arm - red, swollen and warm to touch. Approx 7 cm x 6 cm and pt voices that it "aches and that it hurts."
Seriousness criteria other medically significant (OMIC). From initial information received on 4/27/2006 from a literature report, it was reported that a 5 month old male patient, who at 3 months of age had received budging fontanelle and irritability following first dose of diphtheria tetanus pertussis vaccine DTP 1, and first dose of trivalent oral poliovirus vaccine OPV 1, administration, received diphtheria tetanus vaccine DT 1, and a second dose of trivalent oral poliovirus vaccine OPV 2. The manufacturer, route and sites of administration were not reported for either vaccine. One day post immunization, the patient was found to have bulging fontanelle, irritability and fever. He did not require hospitalization, and did not have a CBC or lumbar puncture for CSF completed. His physical exam was normal, and he recovered one day after the onset of the adverse events. The patient subsequently received a second dose of DT 2 at age seven month and again experienced a bulging fontanelle without any associated symptoms. Reportedly there were no conditions or exposures eg steroids that could have explained the event of bulging fontanelle. Subsequent follow up determined that the patient was normal neurologically and developmentally. Case 200600970 captures the patients event at 3 months of age. The reporter of this event is the same as for cases 200600970 to 200600976, case 200600980 and 200601056.
Patient fell out of observation chair and become diaphoretic, weak, dizzy, and nauseated post vaccination. Assisted to chair and assessed blood pressure of being hypotensive at 74/40 and bradycardic at 54. Gave Zofran ODT and Benadryl PO w/ resolve to condition after monitoring for approx 30  min. Discharged to self under supervision of family member.
Arms were sore and swollen by the time he got home from vaccinations.  Both arms were involved.  Swelling continued and mom sought medical treatment on 11/16/2012 from primary doctor.  Reports both arms were swollen and red from shoulder to elbows.  Was given oral predisone and completely resolved.
Severe chills for approximately 8 hours beginning about 5 hours after the vaccine,  Low-grade fever  <101 Body aches and pains for about 24 hours Soreness at the injection site for more than 1 week I had Covid in June 2020.  The symptoms I experienced with the vaccine were very similar to those.  They were much shorter lasting, and I did not have the extreme fatigue that I had with Covid.  But the body aches were as bad. Thankfully, for a much shorter duration.   Symptoms were managed with OTC Extra Strength Tylenol.
Extreme stomach and abdominal pain, nausea, vomiting, diarrhea, chills, sweats, lower back pain, fatigue
pt passed out p/vax of DT booster & fell on floor sustained hematoma of scalp; ran high fever;
Extreme fatigue approximately 48 hrs Pain at injection site , mild, ongoing at 48 hrs Headache 4 hours after onset resolving the next day Mild, diffuse muscle aches and joint pain ongoing at 48 hrs
SERIOUSNESS CRITERIA: OTHER- MEDICALLY SIGNIFICANT.  Initial report was received 26 August 2008 from the patient's child, who is also a physician.  A 77-year-old female patient with an unknown medical history had received an injection of Yellow Fever vaccine, lot number VF307AB (lot number invalid) on 11 August 2008 and 11 days later, developed oral lesions and petachia.  Three days later on 25 August 2008, the patient developed hemoptysis and was evaluated at the emergency room.  Laboratory test results revealed her WBC and platelet counts decreased since 11 August 2008.  The patient was not hospitalized.  It was unknown if the patient had any illness at the time of vaccination.  At the time of the report, the patient had not recovered from the event.
Pain in his arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm) and PYREXIA (Low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth infection since an unknown date. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in his arm) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (Pain in his arm) and PYREXIA (Low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include antibiotics for tooth infection.   No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: FOLLOW-UP information received on 22-JUN-2021. Updated the events Pain in Arm and Low grade fever from unknown to Resolved.
pt recv vax 29APR99 & 4MAY99 began to exp severe bifrontal & vertex h/a associated w/pain in eyes;skin sensitivity describe as a pain;sweats & chills;dizziness;movement or rotation;fatigue;BP 100/68;resp 16;
pt recv vax; less than 24 hrs p/ vax starting running fever & PAR noticed child would become rigid & start shaking; she would yell for 10-15 sec as though uncomfortable;episodes lasted for about 5 days;
Information has been received from an office nurse concerning her now 11 year old daughter with significant allergies and allergic to antibiotics (names were unspecified) who was vaccinated with the second dose of VARIVAX (Merck) when she was 9 years old. After receiving the second dose of VARIVAX (Merck) the patient had a large local reaction at the injection site that went from the shoulder to the elbow. The nurse did not mention what arm the vaccine was given in. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.