chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially developed low back pain in lumbar region, then over next 2-3 days, severe burning and electrical sensation into legs. Over next 24 hours, unable to walk. Also with bilateral facial weakness and slurred speech. Admitted initially to outside facility, then transferred here on 12/07/2010. Evaluation showed normal MRI, EMG consistent with moderate grade demyelinating peripheral neuropathy. Presentation thought consistent with Guillain-Barre. Five days of IVIG 24 GM (~0.5 g/kg IBW) administered.  Patient discharged after 7 days here to SNF with improvement, still with some motor deficits, facial weakness.
Information has been received from a dermatologist concerning her 20 year old "otherwise healthy" daughter with acne who on 08-MAR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included cephalexin (KEFLEX). On 10-MAR-2007, the patient developed a headache, "not feeling right", nausea, and fever. On 11-MAR-2007, the patient complained of generalized headache with "blurry vision" possibly attributed to the headache per the mother, chills, myalgias, and nausea. At the time of this report, the outcome was unknown. Additional information is expected.
Redness. Swelling. Tenderness to touch. Lasted 3 days.
Information has been received from a physician assistant concerning a female patient (age unknown), who, on unspecified date, was vaccinated with dose of GARDASIL.  Subsequently, the patient fainted and her tooth fell out.  The patient sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Patient received vaccine on 07/02/21. She complained of extreme fatigue and body aches for 72 hours following vaccination. In addition, patient broke out in severe fever blisters.
Extreme muscle soreness, raised welt which grew to approx 4" in diameter by 2nd day, hot to touch, slight fever. Administered OTC Children's liquid ibuprofen for pain and swelling every 4 hours as indicated on package instructions.
Developed severe rapid onset acid reflux disease that may or may not be related.  Some neurological symptoms that are still being investigated (trembling hands, single pupil dilation, bouts of passing out with extreme exhaustion after.   Again, this is probably not related but the more data you have, the better.
Pt was transferred from the ER with a history of diabetes mellitus post frequent falls. She had a left trimalleolar fracture, NSTEMI, and COVID pneumonia.
Severe soreness in left arm (arm both injections were put in)- Tightness in chest to the point I thought I was having a heart attack - Severe pain in back -  Chills - Fever
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL inj via gluteal intramuscular administration by unknown HCP. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received from the certified medical assistant (previously reported as nurse) referring to the 21-year-old female patient. There was no medical history and concurrent condition reported. On 16-DEC-2014 at 11:00, the patient was given the first dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015) (strength and dose not provided) intramuscularly in gluteus, not deltoid (drug administered at inappropriate site). There was no concomitant medication reported. Additional information is not expected because all follow ups requested to complete the case were received. Therapy information, AE term and narrative were updated.
apparent vaso-vagal reaction 5 to 10 minutes p/recvd DTP inject; pt became very pale, sweaty, appeared weak but did not lose consciousness, vomit, nor have a sz; pt taken to hosp ER;
About eight days after the vaccination, I started developing a rash around the injection site - a red ring. It does not itch or hurt. But I have been developing hives all over my body in different places and they are steadily increasing every day.
passed away from self inflicted injury; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTENTIONAL SELF-INJURY (passed away from self inflicted injury) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL SELF-INJURY (passed away from self inflicted injury) (seriousness criterion death). The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact; Sender's Comments: Patient died of an unknown cause from a self-inflicted injury nine days after receiving second dose of Moderna Vaccine. Very limited information regarding this event has been provided at this time.  Further information can not be requested.; Reported Cause(s) of Death: cause of death unknown
Patient presented on 9/22/06 with red swollen upper left arm. Erythema 12cmx8cm, induration 10cmx5cm. Warm and tender. Diphtheria Toxoid absorbed for adult use.
She broke out in a rash that had bumps under the skin and redness. It was on her cheeks and chest and arms and it itches. It was still there after a week and that's when she reported it to me. She wasn't even going to tell me but her husband made her tell me. She says she is sensitive to a lot of medication anyway.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant on 26-APR-2016 via a phone call. On 14-MAR-2016, patient was vaccinated with improperly stored GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested. Onset date, start date of product, patient demographics and the narrative was updated.
Severe chills and tremors, high fever(102), joint pain, general aching and sensitivity, lightening type pain in head periodically, sharp stabbing pains in temporal and ear areas, persistent headache, fatigue and brain fog. Lasted about 19 hours. Fever and aches returned 4/17 night, then again 4/18 night. Side effects far more severe than my actual COVID symptoms.
Information has been received from a physician concerning a 14 year old female patient who in approximately September 2008, "4-6 months ago" from the reporting date, was vaccinated with the first dose of GARDASIL, 0.5ml. No lot number was provided. Concomitant therapy included DTAP (unspecified). The physician reported that in approximately September 2008, "4-6 months ago" from the reporting date, the patient experienced warmth and dizziness. At the time of the report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Patient accidentally received a third bivalent booster. Patient received 2 primary series doses and 3 bivalent boosters total. No adverse event. This was an administration error.
When I first got the shot my arm was swollen and I had a fever. I also had body aches. When I got the second shot my arm hurt worse, but it went away. A couple weeks later now, I am not able to remember sentences or word choices. There are certain words that I can't remember to spell and I am a good speller.
Pinching feeling spread to both forearms; Weakness in both knees; Pinching feeling in right foot; Tingling to both feet/spread to both ankles and both calves,both hands involved; This spontaneous case was reported by a pharmacist and describes the occurrence of NERVE COMPRESSION (Pinching feeling in right foot), NERVE COMPRESSION (Pinching feeling spread to both forearms), PARAESTHESIA (Tingling to both feet/spread to both ankles and both calves,both hands involved) and ARTHRALGIA (Weakness in both knees) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Apr-2021, the patient experienced NERVE COMPRESSION (Pinching feeling in right foot) and PARAESTHESIA (Tingling to both feet/spread to both ankles and both calves,both hands involved). On 23-Apr-2021, the patient experienced ARTHRALGIA (Weakness in both knees). On 24-Apr-2021, the patient experienced NERVE COMPRESSION (Pinching feeling spread to both forearms). At the time of the report, NERVE COMPRESSION (Pinching feeling in right foot), NERVE COMPRESSION (Pinching feeling spread to both forearms), PARAESTHESIA (Tingling to both feet/spread to both ankles and both calves,both hands involved) and ARTHRALGIA (Weakness in both knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood glucose: abnormal (abnormal) Diagnosed her with paresthesia after completing a glucose test. On 24-Apr-2021, Thyroid function test: abnormal (abnormal) Diagnosed her with paresthesia after completing a thyroid blood test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was prescribed prednisone by their physician.  No Concomitant product use was reported.  The reporter was a pharmacist who was vaccinated with their first dose of Moderna vaccine and was breastfeeding their 13-month-old child at the time of receiving their vaccine. On 20-Apr-2021, the patient began to experience pinching feeling in their right foot, and then started to experience tingling to both feet. On 22-Apr-2021, the tingling spread to both ankles and both calves and on 23-Apr-2021 night, both hands and both knees were involved which the patient described as weakness in both knees. On 24-Apr-2021, the patient saw the Physician, who diagnosed the patient with paresthesia after completing a glucose and thyroid blood tests, and prescribed prednisone. Also, on 24-Apr-2021, the patient reported that the pinching feeling spread to both forearms.   This case was linked to US-MODERNATX, INC.-MOD-2021-090391, US-MODERNATX, INC.-MOD-2021-090153 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090391:Created for baby US-MODERNATX, INC.-MOD-2021-090153:Same reporter
patient stated she had large itchy rash that appeared a few days after vaccine and then went away after a day or two
Fatigue/Tiredness; Sleepiness; Both legs feeling week; Both knees are weak, right knee is not getting any better; Right knee is painful; Cannot walk right; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 02May2021 12:30 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes (states has been diabetic for several years) ongoing, lymphoedema from 2004 and ongoing (other conditions: Left arm), breast cancer from 2004 to an unknown date. Concomitant medication included dulaglutide (TRULICITY) taken for diabetes mellitus, start and stop date were not reported. Vaccination Facility received in Pharmacy. Patient reported on unknown date experienced fatigue, tiredness, sleepiness, both legs feeling week. on ninth day she has had pain in her knees. Her left knee is better but her right knee is not. She cannot walk right and she has never experienced this before. this was going to go away. What happens when I get the second dose how do I handle it. She has read that patients can had an arthritis flair-up. Is that possible. She does not had arthritis but should she had her doctor check her for it. Should I get the second dose. What would you recommend to someone who had pain on the arm- would you tell them to ice it. States that she got the vaccine last week on Sunday and is still having problems with her right knee. States she has to get the other one on 23May2021. Does not know what to expect. On 03May2021, states that both knees are weak, the right one was not getting any better. States it was painful and she cannot walk right. The outcome of the events joint injury, arthralgia, gait disturbance was reported as not recovered and while for other events was unknown.   No follow-up attempts are needed. No further information is expected.
Waited 15 minutes in clinic after vaccine. On the way home, notice slight numbness in left face and left side of neck. It never got worse and went away after approximately 2 hours.  Woke up in the middle of the night with a metallic smell.  Noticed metallic smell on hands, washed hands and this kept up the following day. Had a metallic taste in mouth that lasted all the following day.
Vanishpoint syringe as it retracted inside patient arms noticed a quarter to a half of vaccine splash out of arm and down patients arm. we administered Adult Pfizer vaccine.
Tested positive for COVID-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-374517 (Patient Link).
I started with a sore throat and fatigue and I first tested on 9/6/22 with a COVID-19 home test and it was negative and I tested again for COVID-19 with a home test on 9/7/22 and that was positive and was experiencing brain fog and I contracted my physician and she prescribed PAXLOVID for 5 days and I started it on 9/8/2022. I also had the dry cough and lost my sense of smell and taste. Today being the first day I kind of feel normal but I still have not regained my sense of taste.
This spontaneous report as received from a nurse refers to a patient of unknown age. Medical history and concomitant medication were not reported. On 26-FEB-2013 the patient was vaccinated with RECOMBIVAX HB (5/0.5 MCGR/ML) intramuscular (lotnumber unknown). On 14-MAR-2013, 17 days after onset of therapy the patient received the second dose on 14-MAR-2013 (Inappropriate schedule of vaccine administered). There was no adverse effect reported. Additional information has been requested.
Started getting achy and tired, then woke with 102.7 F. with bad body aches that lasted for about 36 hours. The next day she discovered swollen lymph node under arm.
Mild headache; mild nausea; chills; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration on left arm on 19Feb2021 at 11:45 (at the age of 58 years) as single dose for COVID 19 immunization. The patient medical history included sulfa containing medication allergy. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine sodium (LEVOXYL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 20Feb2021 at 08:00, the patient experienced mild headache, mild nausea, chills and general feeling of unwell. The patient did not receive any treatment to the event. The outcome of the events was recovered in 2021.
Excessive, bitter salivation Nausea Dizziness, faintness Chest pain- immediate Pressure feeling on sternum Extreme malaise 24 hours Severe chest pains next day  EMTs were called at the vwccine site, and I was strongly urged to go to the ER The Male EMTs apparently thought I had gas and was being " hysterical " - attention seeking only I had severe chest pains next day and phone Dr.
Client received 1st Hep-B and 2nd MMR at 14:15 and waited with mother in waiting room for 20 minutes with no reaction. Returned to health dept at about 15:05. Mother stated child began to experience a rash with itching. He was noted as having generalized redness, rash and hives over trunk, face and neck and pallor at nose and mouth. No SOB. Treated with Epinephrine 1:1000, 0.3ml given SC in left arm at 15:10. Benadryl 50mm given IM in left arm at 15:15. 911 was called and EMS transported to hospital for evaluation and treatment.
2nd and 3rd week had off and on mild headaches (but never have headaches otherwise) felt pressure in my head when bending over. 4th week developed ringing in the ears (tinnitus)...tinnitus has not resolved as of this submission
Immediately after injection, patient stated he did not feel well (like "something was surging through his body"), that he "felt flushed". Taken to hospital via ambulance (paramedic stated his blood pressure was high and suggested he be checked).
Vomiting stomach bile at 10am, 10:30am, 11:10am, 11:30am, 12pm, and 12:50pm. No nausea present. Drowsiness, partly due to vomiting.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA315983, 2018SA315982 and 2018SA315981 (same reporter). This case involves an 8 years old male patient who was vaccinated with FLUZONE HIGH DOSE 0.5ml (batch number: UJ000AB) rather than FLUZONE QUADRIVALENT 0.5ml in left deltoid on 18-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication case error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a physician concerning a 12 month old white female who on 12/8/99 was vaccinated SC with 1 dose of varicella virus vaccine live SC in the right thigh. On 12/15/99, the pt experienced injection site induration, erythema, inflammation, and 2 vesicles. An ER or physican visit was required. The pt recovered on 12/23/99.
Once again, as with the first shot (dated 2/3/2021) I got an itch on my arm in the area where the shot was given.  This time, however, it came about 11 hours after getting the vaccination.  It lasted about 4 or 5 days.
You can still get them. I had 2 shots/ suspected vaccination failure; You can still get them./had the worst case the drs had seen.; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had 2 shots still got shingles, had the worst case the doctors had seen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Left arm all the way down to hand excruciating pain Extreme headache 103.5 fever Chills Tiredness Whole body pain Change in taste and smell
Pt recv vax on 11/9/98; on 11/10/98 pt exp elevated liver enzymes
Pt sitting in chair in observation area. Pt appeared to be unresponsive. Pt was lowered to the floor. Upon assessment it was found that the pt was having a seizure. Pt was then rolled onto his left side. Pt then came to consciousness. On site EMS picked pt up off floor and put him into w/c. VS at that time, BP: 178/92, O2 sat: 98% on RA, HR: 66, RR: 16. Pt is now alert and oriented and verbal. Pt declined further assessment and transport to hospital.
Patients states that on Friday her arm swelled up and itched.  By Saturday the swelling had gone down but still itched.