chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Pt vaccinated with MMR became dizzy, had blurred vision, sweated profusely, started "going into shock", Given O2 & IV by paramedics, taken to Hosp.  Pt reports she was all right after 2 hours. Pt okay after 2 hrs.
Pain and itching at time of injection. I waited the 15 minutes and had no other reactions. Overnight there was swelling, increased pain, more itchiness and redness (about the size of a quarter) at the injection site. Treated it with Arnicare and Cortizone creams for about 3-4 days. All symptoms abated until Tuesday morning, 04/06/2021. Awoke to find a larger red welt (about the size of a half dollar), increased itchiness and slight painful swelling. Again treated it with Arnicare. The swelling and pain are gone, but the red spot and itchiness are still there.
Patient developed tense erythematous warm, swollen left arm from shoulder to elbow after pneumovax injection 06/11/2003 AM.  Reaction developed quickly, over 12-24 hours.
4hrs post inj, chills, nausea, fatigue, sweat that waxed & waned every 1-2hr for 24hr exactly 1600-1600) also w/stiff neck same side as inj;took compazine po x 2 doses & went home from work & slept;
Rapid and irregular heartbeat after retiring approx 10pm - continuing through the night keeping me awake
Per patient, cant lift arm up, forward or behind her. Says it is in constant pain. Had a dr appointment today and they did X-ray, gave a cortisone shot and recommends physical therapy.
This spontaneous report as received from a medical assitant, refers to a currently 11 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9,  (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA006354:
Red rash started one day after vaccines given 5.5 x 5 cm area of erythema to (L) post deltoid. No fever (100). No SOB, wheezing, cough, lip or tongue swelling or V/D.
Right deltoid sore, red and swollen. Temperature 98.5 sore to touch. Full range of motion in right arm and shoulder.
Asthma, Shortness of breath increased in severity by 4/15 or so. Has continued until present. I start to run out of breath when I reach the top of my stairs. I recover appx 3 min of rest. No increases in severity for the past 5 days. No fever, phlem, or mucus. Only breathlessness. Easier to sleep on an incline. (I must move too much in bed.)
I had a sore arm at the injection site. I was nauseous I felt a little weird and had stomach cramps. Those symptoms went on for about 2 days. I started itching very bad on back of my scalp. A couple days after that I started sweating really bad from head to toe. I have also had some tingly in my foot/leg. I had some swollen glands in my neck/throat area. I called my PCP she said I need to see an allergist before getting my 2nd shot, at this time I haven't received my 2nd vaccine.
severe h/a, diff focusing pain localized front to back top of head 12PM-8PM;
tested positive for Covid approximately 3 days after her second booster shot.; tested positive for Covid approximately 3 days after her second booster shot(throat irritation, feeling abnormal, nasal congestion); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8737), on 30Apr2021 as dose 2, single (Lot number: EW0169), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) and on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 05May2022, outcome "unknown", described as "tested positive for Covid approximately 3 days after her second booster shot(throat irritation, feeling abnormal, nasal congestion)"; VACCINATION FAILURE (medically significant) with onset 05May2022, outcome "unknown", described as "tested positive for Covid approximately 3 days after her second booster shot.". The patient underwent the following laboratory tests and procedures: COVID-19: (05May2022) Positive, notes: she tested positive for Covid approximately 3 days after her second booster shot. She said her symptoms were mild - scratchy throat, head fog, congestion. She feels ok but still testing positive so remains quarantined. She received the Pfizer Covid Vaccine.
07/30/2021 08/31/2021 dx covid 01/01/2021
Lay around, won't rollover or stand up, rash on body that was observed and went away in a few mins. No crawling.
The day after I received the vaccine I felt pain in my right leg. I went to a pain mangagement doctor and he ordered an ultrasound. It revealed that it was negative for a blood clot but it was an psuedo aneurism. I then had a CTA scan that revealed that it was a Popiteal  aneruism. The doctor does not know the cause of this but said that it could be a reaction from the vaccine.
Immunization shots 6/29/04: developed edema/ inflammation over left thigh 2 days after shot. Mother advised to apply ice, over a towel, and give Motrin. To RTC if fever or condition worsened.
Patient's son called and said she was achy, hot, and "loopy" the afternoon of the immunization.  She seemed confused; she prepared 6 cups of coffee instead of her normal one.  She was fine the next morning.
On Nov 25th visit to clinic client complained of less fetal movement.  Client was checked by ARNP.  ARNP thought she felt the fetus kick twice but could not get fetal heart tones.  Client was sent to triage for re-evaluation, fetus was found to have no fetal heart tones.  12/01/09:   OB Hospital records received for date of service 11/25 & 11/26/09.  Dx:  Intrauterine Fetal Demise at 35+3 weeks.  Assessment:  G1, P0 Presented with 2 week history of no fetal movement.  No cardiac activity or fetal movement on US, IUFD.  Admitted for induction of labor. SROM.  SVD, nuchal cord x 1,  thin meconium, no fetal heart tones. Apgars 0,0. Fetal hydrops.  Developed fever of 102.1.
Double vision for 1.5 days Vertigo for 2 days Pain in left side of body ongoing Injection site red and painful ongoing Heavier than normal menstrual period for a week and possibly effecting daughter with hers as well
I just didn't feel well in general after receiving the vaccine for a couple of days. I tested positive for COVID-19 in 11/2022. The night before testing, I was throwing up. I contacted my doctor and got a prescription for my nausea, but I never took it. I did take TYLENOL, stayed hydrated and rested for my symptoms. I found out I was pregnant in 10/2022. I am due in June.
Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old female patient who was inadvertently injected with Adacel rather than DTaP, while she received vaccines DAPTACEL and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD for Immunisation. On 08-Jun-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5792AA via intramuscular route in the left thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to wrong vaccine administered. (Other relevant tests included No lab data.) Final diagnosis was patient was inadvertently injected with Adacel rather than DTaP. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for patient was inadvertently injected with Adacel rather than DTaP. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
sore arm [after first two doses] After a day or two, the soreness went away.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was not reported by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.). At the time of the report, PAIN IN EXTREMITY (sore arm [after first two doses] After a day or two, the soreness went away.) had resolved.            No treatment medications provided by the reporter.     This case was linked to MOD-2022-475010, MOD-2022-475046 (Patient Link).
After the vaccination, I had a really high fever and I was shaking really bad and was vomiting and had headaches for a month.  Went to the doctor and they sent me for a CT Scan and it was normal.
Patient was accidentally given Modern vaccine, which is not approved for age 16. Pharmacist thought patient was going to be given Pfizer.  Unknown symptoms at this time and parents are aware of what happened and monitoring.
episodic RUE and RLE weakness.  c/o dizziness and near syncope.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: initial positive test; Negative, notes: being negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received Paxlovid as COVID 19 Treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
attempted to give vaccine via intradermal route - no weal noticed. gave vaccine subcutaneously.
This spontaneous report was received from a 62 year old female patient and refers to herself. The patient had an allergy to morphine (manufacturer unknown) and methadone. The patient's pertinent medical history was not reported. On 04-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX, 1 vial in the unspecified arm (strength, lot # and expiration date were not provided). The patient was vaccinated in an unspecified pharmacy by an unspecified pharmacist. The patient took unspecified medications. On 04-NOV-2015, the patient's arm (the one that received the vaccine) began to feel hot and swell. This arm continued to "hurt" her until pain in this arm prevented him from lifting her arm above the waist. She also became nauseous and got a headache. The pain in her arm extended up to her neck. The patient called the pharmacist who administered ZOSTAVAX, and was told to take BENADRYL as a treatment (unspecified dose). At the time of the report, the patient's arm was still tender to touch. The patient sought medical attention via calling the pharmacist. The outcome of the events was reported as recovering (also reported as "all of these symptoms lasted for 3 days"). The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports concerning the same patient. Additional information is not expected as there was no correspondence contact provided.
Information has been received from a company representatives daughter concerning a 17 year old female who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced dry patch patch around the injection site. At the time of the report, the outcome was unknown. Additional information is not expected.
- Body ache. - Headache. - Runny nose. - Sore throat. - No fever.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Vaccinated on left arm at 13:00. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache. Laboratory data included: Body temperature increased (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and chills. This report was non-serious.
sever abdominal cramps started at 6pm, followed by spurts of diarrhea. the cramps and diarrhea persisted about every 30 minutes until 4am.  lighter cramps and tingling abdomen persisted after every meal until Saturday 10/09/2021.
Patient received an extra infuenza vaccine, 2 total for 2014-2015 season, had 2 doses of influenza vaccine last year as well.
Pain around injection site followed by rash and swelling and redness beginning 24-48 hours later.
Patient received the booster dose of the Moderna COVID vaccine (011F21A) at 1626. At 1655, the patient reported to RN that she has nasal congestion, felt sweaty, and her eyes watered. Patient denied itching, difficulty breathing or swallowing. PHN approached to assess. Patient reported having a similar reaction previously after eating certain foods but was unable to name which foods. Vital signs: O2 97%, blood pressure 128/84, respirations 16, pulse 86. Patient reported allergies to sulfas, tetanus vaccine, opioids, codeine, and environmental allergies. Medications include estrogen and OTC vitamins. Patient denied medical conditions. At 1700, PHN administered Benadryl 50mg liquid, patient able to swallow without difficulties. Patient reported eyes watering had resolved. PHN educated patient on remaining for monitoring for 30min from time of Benadryl administration, to follow up with provider, and ER precautions including symptoms of anaphylactic reaction. Patient denied anxiety or fear of needles. At 1707, vital signs: respirations 14, O2 99%, pulse 70, blood pressure 126/78. At 1721, patient reported nasal congestion had resolved but she still felt sweaty but improving. Vital signs: respirations 14, O2 99%, pulse 70, blood pressure 126/78. At 1725, patient reported her symptoms had resolved and she wanted to leave against medical advice. Patient's accompanying family member would drive her home. At 1725, patient left walking with steady gait.
From initial information received on 3/12/03 from a registered nurse, it was reported that a 12 year old male child was vaccinated with IMOVAX RABIES, lot number U0595, given IM/site not reported and YF-VAX on 3/10/03. The lot number and route/site were not reported for YF-VAX. A few hours later, on the same day, the patient experienced a fever and chills lasting until noon the next day. Recovery status of the patient was not reported.
Patient requested flu vaccine and PNEUMOVAX 23 (Merck lot#N04564) be administered on 10-17. As per patient request both vaccinations were administered on left arm about 2 in. apart. About 2 days after vaccination patient called pharmacy stating  she had developed cellulitis, Upon speaking with primary care Dr. he informed me that patient had a mild cellulitis on left arm below the deltoid on the inward aspect of the arm. He treated with a course of antibiotics and would follow up with patient. Dr did not specify which antibiotics he had prescribed. He stated his expectation the cellulitis would clear up with this course. We spoke with patient about 2 days after she started antibiotics. As of last contact she was improving and would follow up with primary Dr.
Continued fatigue, body ache, headache, weird skin sensations (hypersensitivity), brain fog, a sense of unease, queasiness (lack of appetite), sore lymph glands and light sensitivity for seven weeks.
hard time trying to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time trying to sleep) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 14-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 INSOMNIA (hard time trying to sleep). At the time of the report, INSOMNIA (hard time trying to sleep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient takes medication for allergies.
fatigue occurred shortly after the injection headache presented a few hours after the injection and lasted 2 days about 12 hours after the injection I started having chills and did not sleep well due to "fever dreams;" I do not know if I had a fever for sure as I do not have a thermometer
Pt received adult Pfizer vaccine on 1/18/2022 and this vial was unfrozen on 12/17/2021 at 12pm.  The vaccine was good for 31 days according to Pfizer help line but vaccine was given on day 32, it was given 1 day after expired.
RA swollen the whole length of the Rt upper arm L elbow + use referred KINRIX and VARIVAX on this arm.
Vaccine should be administered subcutaneously, the vaccine was administered intramuscularly in error.
I tested positive for COVID-19 on 5/7/23. I had congestion, cough, sneezing headache, fatigue, chills, fever, and nausea. I contacted a doctor via telehealth and was prescribed ALAHIST and benzonatate. I am also taking vitamin C, zinc, and elderberry. I am still dealing with these symptoms at this time. I was unable to get PAXLOVID because it would interact with hydroxychloroquine. I am also taking vitamin C, zinc, and elderberry.
1/10/14 PNEUMOVAX 23 administered at 1030AM. At supper, pt arm hurt. After dinner, she couldn't move her arm - it felt like knives in her arm and it progressed to a "sumo wrestler" sized arm with a hot burning area. She received DECACRON IV and DEPOMEDROL IM.
A non-serious, spontaneous report of FLUMIST administered to a 56-year-old, has been received from a nurse concerning a 56-year-old female patient. The patient's medical history and concomitant medications was not reported. The patient received FLUMIST on 26-Oct-2009. The patient requested to have FLUMIST and informed the clinic during screening that she was "healthy." The administrator of the FLUMIST stated she failed to check age on consent form prior to giving FLUMIST. No adverse events were observed. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
patient received an expired vaccine Daptacel, no AE; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case involves patient (unknown demographics) who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site, On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 and Module VI of the 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.  Information on the batch number was requested.
Cheast pain, shortness of breath, sweating. Rest. No medications perscribed.
Lack Of Response- Information has been received from a registered nurse conerning a patient who in approximately 1999 was vaccinated with a first and second dose of varicella virus vaccine live.  Subsequently the patient's laboratory results indicated a lock of serocoversion.  it was indicated that this occurred with an additional patient (waes 000515811 as well.  Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to 2 patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (merck) (lot #, strength, dose, frequency and route unspecified). No adverse symptoms reported. The outcome of the events were unknown. This is one of several reports received from the same source. Additional information has been requested.