chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was vaccinated by Dr. As she was handing her dad, her sticker, she fainted. On the way to the floor, she bumped the top left part of her head. No bump or swelling. She states it is tender but not painful. She recovered from the faint immediately with return to full consciousness. A& O X3. She was moved to a lounge chair and laid back for 10 minutes, then to sit position, then attempted stand. On first attempt she still felt dizzy so she returned to a sit for 5 additional minutes. Then she was able to walk on own accord to observation area. She kept ice pack to head the whole time. She had a juice, water, and a piece of candy. She denied other s/s. Dad was offered a copy of incident report but left prior to completion. PHN will mail to family. RN PHN
As per pt report, "The next day after I got the vaccine I woke up about 2am and felt terrible. The next day or so and about a week or so after I got it, I would get winded. We live on the 6th floor and I was getting winded trying to go up the stairs. After I felt good enough to start back going to the gym, I would feel winded on the tredmil as well. This lasted for about a week".
bones have been hurting since taking the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (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 (Dose 2,Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1,Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: BONE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "bones have been hurting since taking the shot". Addition information: Patient took the booster 12Dec and his bones have been hurting since taking the shot. Reporter did not want him to take the booster but he took it and now he was in pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Stomach cramps, diarrhea. 8 - 10 episodes/day x 3 days.
Client did not receive full dose due to faulty syringe. Most of vaccine ran out around hub of needle and did not retract. syringe was a spring loaded retractable syringe.
2 days p/vax pt vomiting, t102-103 A; no appetite, diarrhea lasting 5 wks; 14JAN92 dx w/Werdnig-Hoffman disease @ hosp;
Syncope episode. Patient brought into room to lay down, BP checked, water given. Patient monitored from 20 minutes. BP returned to normal, patient stable.
Within 4 hours, headache began. 8:00 the 24th of Feb, severe headache, 4 hours later chills, accompanied by shivering uncontrollably, 100.4 degree temp, lasting 8 hours, tiredness accompanied and by 2:00 pm the next day, everything shut down like turning off a valve.  Arm really sore, radiating down to elbow also. Itches but better every day.
L Frontal lobe headache with eye pressure left. Visual disturbances described as floaties in bilat peripheral fields of vision. Occurred x 2 days. Subsided when started Benadryl.
Increasing headaches. Vision altered L eye not tracking 2 right eye. Balance off L pupil larger than right multiple muscle cramps.
Reaction 9-20-06 administered on 9-19-06 fever red raised bumps.
Patient developed R calf pain on 3/21/21.   Diagnosed with acute R calf DVT on 3/24.
I got cramps in my stomach.  I got right arm and right leg pain.  I could not move right arm and right leg for 16 hours.  I went to ER.  They did blood work, that my blood count was high.
Beginning about 24 hours after receiving the vaccine, began to develop high fever (max of 103), chills, malaise, fatigue, all body ache, and bad headache. Malaise, body ache, and HA had begun about 8 hours before that, but fever kicked in at the 24 hour point, and lasted about 8-10 hours, including heavy sweating in bed. Still some residual symptoms at 72 hours post vaccination, but fever, HA, myalgia, have receded. Should be noted that the exact same profile of symptomatology also occurred for the first dose of the vaccination series, but was not reported to VAERS at the time.
Woke up with blood on my bedsheets, I had a bloody nose sometime during the hours of midnight and 4am
Brain fog; Skin hypersensitivity- waves of painful prickling just under skin w/o rash, Headache, Fever; Skin hypersensitivity -waves of painful prickling just under skin; Painful prickling; Insomnia (inability to fall asleep); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0158) via an unspecified route of administration in the arm left on 19Apr2021 at 09:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included esophageal acid reflux (acid reflux), sulfonamide allergy (Sulfa drugs allergy) and seasonal allergy (various plants). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), metronidazole (MANUFACTURER UNKNOWN) and fluticasone (MANUFACTURER UNKNOWN), all for an unknown indication from unknown date and unknown if ongoing. On 19Apr2021 at 22:00, the patient experienced insomnia (inability to fall asleep). On 20Apr2021, 1 day after the vaccination, 8 hours duration after waking up, the patient experienced skin hypersensitivity- waves of painful prickling just under skin w/o rash, headache and fever. On 21Apr2021, two days after vaccination, the patient experienced brain fog. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) which was taken 8 hours post symptoms on 20Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia (inability to fall asleep), skin hypersensitivity- waves of painful prickling just under skin w/o rash, headache, fever and brain fog were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
aprox 12 hours after injection, started with fever. chills.  fatigue, body aches, fever went up to 100.4 at 3am, 2  200 mg ibuprofen were taken. was in bed until 12 pm next day, fever gone, but still fatigue headache for aprox. 24 more hours. Symptoms then went away by Sat. am.
She said her upper body broke out in a red rash 2 days after getting the flu shot. It lasted for 1-2 days then once it was gone, her body was itching for couple of days.
10cm x 9cm reddened, warm to touch with red streaks to left upper arm. Treated with Augmentin ES 600/5 bid x 10 days and Benadryl PRN.
After the vial puncture time limit; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the vial puncture time limit) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the vial puncture time limit). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the vial puncture time limit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vial was initially punctured on 14-SEP-2021 at 10:00 AM. Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-378312 (Patient Link).
After receiving the Tdap and PNEUMOVAX on 10/30/12 pt started to have body aches, headache, vomited x 1. Today 11/2/12 pt has a 101.9 fever and localized redness 10 x 20 cm on arm.
Developed fever 101 and flu within 3 days; whiny crying nonstop for 3-5 hours after 2nd day. Zombie like for 13 days after vaccine with no personality and no appetite. KP on call advised to give Motrin and said it did not sound like reaction to DTP. Vaccine paperwork listed all his symptoms as possible reaction symptoms.
Complete heart block due to newly-diagnosed sarcoid cardiomyopathy.  Diagnosis suggested by appearance on cardiac MRI (delayed enhancement of septal and apical myocardium), confirmed a few days later on finding non-caseating granuloma in peribronchial lymph node.  Treatment was same-day implantation of pacemaker + defibrillator followed by immunosuppression with high dose prednisone and mycophenolate.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.  The date of refrigeration is 07-Jul-2021.
Pt admitted to Hospital with a dissection of his descending thoracic aorta.  While there he developed acute respiratory insufficiency that required high flow oxygen therapy.  Concomitantly he was also noted to have a infrarenal aneurysm measuring up to 5.7 to 6 cm in diameter.  Radiology measurements were 5.4 cm but not deemed accurate because of the measurement technique.  He states he is now not smoking.  He is fatigued but otherwise slowly regaining strength.  His infrarenal aneurysm was not treated during that admission due to his other acute problems.  His thoracic aortic dissection actually appeared to be improving on subsequent CT imaging.
Severe pain and paresthesia in arm and armpit, that continued to worsen on 5/2/19.  The patient was advised to seek medical treatment
reported getting HPV despite receiving GARDASIL 9; reported getting HPV despite receiving GARDASIL 9; This spontaneous report has been received from a consumer via Company representative concerning a currently 26-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date (also reported as receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at the age of 19-years), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, administered as prophylaxis (frequency, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient reported experiencing Human papillomavirus (HPV) (Papilloma viral infection) despite vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Vaccination failure). Outcome of the events papilloma viral infection and vaccination failure was not provided. No additional information was provided.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event papilloma viral infection was not provided. Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event vaccination failure was related.   This was one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA006343:
This spontaneous report was received from a pharmacist via a company representative and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prevention, reconstituted with sterile diluent (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On unknown dates, the patients experienced shingles.     The outcome of the event and the causality between the event and suspect therapies were unknown. Product quality complaint was not involved. Additional information has been requested.
Very severe headache; Extreme muscle aches; Extreme stomach ache; Nausea; This is a spontaneous report from a contactable consumer, the patient. An elderly non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 19:00 as a single dose for COVID-19 immunisation. The patient's medical history included tuberculosis, the patient reported that she had come in contact with the tuberculosis (at the age of 13) and the tuberculosis became active at the age of 23 when the patient was in college and working and she had recovered with "scare tissue in the lungs". The patient also had high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included losartan (MANUFACTURER UNKNOWN) taken once a day from an unknown date for high blood pressure. The patient previously received atenolol and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left am on 19Mar2021 at 18:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 10:00, the patient experienced very severe headache (8 hours), extreme muscle aches, extreme stomach ache and nausea so bad that the patient almost went to the local emergency room. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very severe headache, extreme muscle aches, extreme stomach ache and nausea were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
The patient has complex symptoms which he notes began as declining health following the varicella zoster infection in Sep/Oct 1999. His question asking did the AVA cause his health to weaken, leading to the varicella zoster and subsequent symptoms over the next several years. Altered mental status, generalized pain, headache, malaise and fatigue NEC, symptom, nervous/muscskltl systems NEC.
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 01-MAR-2019, the patient was vaccinated with improperly stored M-M-R II (lot # R019684, expiry date: 09-JUL-2020 (also reported as 10-JUL-2020) for prophylaxis. Nurse has reported that M-M-R II was reconstituted with properly stored Sterile diluent. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was seven of nine reports mentioned in the report. Lot number R019684 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1903USA009054: Master case #.
At around 11PM on 2/24/21, I had a severe headache, fatigue, chills, nausea, muscle and joint pain, and felt feverish. At around 2AM, I had vasovagal syncope (I lost consciousness and then woke up covered in sweat). Directly after I regained consciousness, I vomited several times over the next couple of minutes. I drank water and took Tylenol to try and alleviate symptoms. After that, I no longer vomited or lost consciousness but I continued to feel feverish, had a severe headache, fatigue, chills off and on, nausea, and muscle and joint pain until around 4PM on 2/24/21.
Since the vaccine booster I had 4 consistent days of fever, and ongoing heart problems. My heart races/pounds/flutters/clenches at all hours of the day and I struggle to sleep or eat. Chest pain is constant and stomach can't hold food. I am seeing a cardiologist who has ordered tests but there are no results yet.
Pt received TDAP and 30 minutes later c/o scratchy throat and hives face red. Pt stated she has allergies but not to TDAP. RN and another employee spoke with supervisor and had another member of pt's team drive pt to urgent care for follow up. Pt has her own Epipen and brought with her in car to urgent care. Pt returned to facility at 3:30 but immediately drove home unable to get report from pt on what services she received from urgent care.
about 15 minutes after the shot the patient felt dizzy and fatigued, no change in vision or lightheadedness. rested a few extra minutes before heading out. said he felt like he was waking up from a nap.
Patient fainted prior to receiving vaccination and mom mentioned this has happened before. Patient was given snacks and water and waited because mom was adamant for her to get her flu shot. After receiving the flu shot, patient walked off and fainted again and came back to the pharmacy where she stayed for about 45 minutes. The pharmacist on Duty followed up with the patient later that evening and mom reported patient was ok.
t102;begins in the afternoon & lasts all evening comes down w/Ibuprofen;loss of appetite for a couple of days;irritable;28AUG96 to 3SEP96 fever last is recovering;
A report has been received from a Physician concerning a 7 month old, Male subject, who had been receiving FLUMIST (intranasal), 0.2 milliliters. Once/Single administration. FLUMIST (intranasal) started on 16-Nov-2013. The doctor reported an off label use after administration which started on 16-Nov-2013. FLUMIST (intranasal) was discontinued on 16-Nov-2013. The outcome of the event of off label use is unknown. The report was considered to be non-serious by the company physician.
Patient broke out with itchy, red rash on 05/29/2003.  Seen by our physician 05/31/2003 with diagnosis of "varicella".  Treated with Benadryl and Calamine lotion.
Tinnitus is now 24/7; hyperacusis; all making it difficult to complete my tasks; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hearing loss " (unspecified if ongoing), notes: hearing loss from about 12 yrs ago. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 02Jan2023, outcome "unknown", described as "Tinnitus is now 24/7"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 02Jan2023, outcome "unknown", described as "all making it difficult to complete my tasks"; HYPERACUSIS (non-serious) with onset 02Jan2023, outcome "unknown". The events "tinnitus is now 24/7", "hyperacusis" and "all making it difficult to complete my tasks" required physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus, hyperacusis, loss of personal independence in daily activities.  Additional information: It was reported that "The Covid booster I got in January has dramatically changed a hearing loss from about 12 yrs ago. Tinnitus was now 24/7 and hyperacusis was often in overdrive. The 2 printers, Eyecon counter, phones, customers, employees, AC unit, and soda machine were all making it difficult to complete my tasks. If I can't give you 100%, I won't give you anything. The CDC contacted me in April to discuss the entries in the VSafe app and encouraged me to send them a encouraged me to send them a VAERS report". It was unknown if patient had covid prior vaccination and if covid tested post vaccination. It was unknown if patient had other vaccine in four weeks.  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.
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 012H21B, 026C21A and 041B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 15-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021 at 9:40 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:42 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    No concomitant medication was provided. Date(s) of administration of vaccine were reported as  19-May-2022, 26-May-2022, 02-Jun2022, 07Jun2022 and 08-Jun-2022. The used vials were placed in the refrigerator on the same day of administration (26-May-2022). No temperature excursions were reported. No treatment medication was provided.