chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On 31-DEC-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster).   On an unknown date (reported as "shortly after receiving vaccine"), the patient experienced Bell's Palsy. It was reported that the patient's symptoms had resulted in physical limitations not present prior to used zoster vaccine live (ZOSTAVAX). Also, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   At the time of the report, the outcome of facial paralysis was reported as not recovered/not resolved.    Upon internal review, Bell's Palsy was considered to be an important medical event, and due to severe and permanent personal injuries was also considered disabling.  The reporter considered Bell's Palsy to be related to Zoster Vaccine Live (ZOSTAVAX).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Pt experienced instant striking pain in right arm, wrist, and excruciating head pain. Soreness in arm and some leg pain. Went away the following day.
chance that a low-filled dose of Menveo could be administered to a patient; Menveo vial (liquid conjugate vial) that was empty out of the carton; Menveo vial (liquid conjugate vial) that was empty out of the carton; This case was reported by a nurse via sales rep and described the occurrence of intercepted drug administration error in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced intercepted drug administration error, manufacturing issue and pharmaceutical product complaint. On an unknown date, the outcome of the intercepted drug administration error, manufacturing issue and pharmaceutical product complaint were unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that one of the nurses at the clinic reported the following regarding two vials that came from the same carton in which one Menveo vial (liquid conjugate vial) that was empty out of the carton and there was no evidence of leaking into the carton, however she does not know if there was a crack in the vial or if the rubber stopper was pierced. One Menveo vial with a low fill and nurse said she was able to withdraw .25 or .3 ml after reconstitution. The syringe used was a 3 ml syringe with hashmarks marked for a quarter of a ml. The LPN stated that she has experienced a low fill volume before about a year ago and that product was discarded, which led to intercepted drug administration error, manufacturing issue and pharmaceutical product complaint. LPN does not know if air was injected into the vial, and stated no cracks or leaks were reported in the vial. LPN stated that there was a scant amount of liquid in the liquid conjugate vial, but nothing in the powder vial. LPN stated that the nurse "tried several times to get a larger volume out of the reconstituted vial, but was not able to get more than .25 to 3ml.
first dose in 2019, not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the second dose, which led to incomplete course of vaccination. Consent to follow up was denied.
Site swollen, raised, itchy, red and painful, size about 3 silver dollars.
Patient was given 1ML of Havrix- an adult dose, as opposed to 0.5mL(pediatric dose).  No adverse reactions reported as of now.
Injection site pain for 1 to 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection site pain for 1 to 2 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, PROGESTERONE, LISINOPRIL, FINASTERIDE, ESTRADIOL VALERATE, DUPILUMAB (DUPIXENT), ASPIRIN [ACETYLSALICYLIC ACID] and CANNABIS for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-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 VACCINATION SITE PAIN (Injection site pain for 1 to 2 days). At the time of the report, VACCINATION SITE PAIN (Injection site pain for 1 to 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: abnormal (abnormal) No immunity to COVID-19.         Treatment information was not provided.
Received TDaP vaccine at Employee Health on 6/9/2014 by Employee Health RN in (L) deltoid. Had chills, temperature of 103 and hot, red (L) arm with hives on arm the next day. Still feels a little sick but better.
facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated.  Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/06/21 pfizer,Lot#EL3246 2nd dose 01/27/21 Pfizer,lot#EL9262 Diagnosed covid positive:08/03/21 Symptom onset:08/03/21 Exposure:Travel Symptoms:Loss of smell/taste,congestion,sore throat,diarrhea,chills, sweating.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 04-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Feeling unwell began a few hours later. Tired, no energy,  body aches Woke up next morning feeling much worse. Fever started going up. Max measured was 101.7 Chills, body aches, headache, no energy, felt like I couldn?t even move. Stayed in bed all day.
Itchy arm for over a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm for over a week) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm for over a week). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm for over a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Swelling and itching to left deltoid 8/29/13 worse 8/30/13.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-DEC-2015 at 14:58, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.6 and 1.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt reported to Clinic next day complaining of an itchy burning scalp with no other symptoms. Pt stated that the reaction occurred while driving.
Information has been received from a physician concerning her 54 day old son with no known allergies or pertinent medical history who on 21-JUN-2008 was vaccinated orally with a first "full dose" of ROTATEQ vaccine live (human-bovine). Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine (manufacturer unknown), PREVNAR vaccine (CRM197) and Hib conj vaccine (OMPC) (manufacturer unknown). Subsequently, on 21-JUN-2008 the patient developed diarrhea. It was noted that the patient has 8-10 episodes a day since he received the vaccination. It was also noted that on 23-JUN-2008 the patient developed a decreased appetite. Medical attention was sought. There were no lab studies performed. The patient's pediatrician suggested that the patient be changed from soy formula to soy formula with fiber. It was noted that the patient's stools became more formed, but the frequency of the stools was the same. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information has been received from a physician concerning this 54 day old infant who developed "strong" diarrhea the day after vaccination. It was reported that there was no bleeding, but the patient still has diarrhea. At the time of the report the patient had not recovered. There was no product quality compliant involved. Additional information has been requested.
Left arm swelling, erythema, and induration to 8.5x9 cm.
Small Amount of Vaccine went in during adminstration; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Small Amount of Vaccine went in during adminstration) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced UNDERDOSE (Small Amount of Vaccine went in during adminstration). At the time of the report, UNDERDOSE (Small Amount of Vaccine went in during adminstration) had resolved. Not Provided      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.   Concomitant product details was not provided by the reporter. Treatment information was not provided. Post vaccination patient did not experience any Adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 23-JUL-2021, indicated patient experienced no adverse events after the vaccine was administered, no new information was received.
Mom noticed rash on child's torso, yesterday and extended to arms, legs, and face today: child cranky. Measles like rash over whole body and face today.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L029615, expiration date 15-MAY-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A 28-year-old male patient received vaccination with smallpox vaccine on an unknown date. The manufacturer and lot number of the vaccine were not reported in the literature reference nor was the date of vaccination. Fourteen days post-vaccination the patient presented to the emergency room with a four day history of chest pain described as positional, pleuritic, nonexertional and progressive, malaise, myalgias, fever and shaking chills. The symptoms became progressively worse over the following three days and the patient was admitted to the hospital with a suspected diagnosis of myopericarditis. On initial evaluation the patient was febrile with a fever of 39.2 degrees Celsius and had otherwise normal vital signs, cardiovascular examination and lung auscultation. The skin exam revealed acne scattered pustules on the scalp and upper back which the patient reported started a few days after vaccination. Initial laboratory data was remarkable for Troponin I of 0.16 mg/dL with normal creatine kinase (CK) and CK-MB. Electrocardiogram demonstrated diffuse concave ST elevation that was consistent with generalized epicardial injury. The patient was treated with nonsteroidal anti-inflammatory drugs and the pain did not worsen. A second set of Troponin I eight hours after admission was 0.63 mg/dL. An echocardiogram demonstrated normal ventricular function and no pericardial effusion. Chest x-ray was normal. Sedimentation rate was 30 mm/hr and C-reactive protein was 8.6 mg/dL. The patient was discharged after 24 hours and one week later was asymptomatic. A repeat electrocardiogram was remarkable for resolution of the diffuse ST elevation seen on admission and new T-wave inversions that were consistent with resolving pericarditis. No other information was provided. List of documents held by sender: None.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II subcutaneously (lot # L040961, expiry date 19-OCT-2017, dose, strength, dose number, vaccination site not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
102.9 degree fever off an on for about 18 hours after the first dose.  Subsided by 9am the morning after the vaccine.  Also, injection arm (non-dominant arm) incredibly sore to the point of not being able to raise it, but deep tissue massaging the site alleviated this symptom by 32 hours after vaccination.  Filling this out for data collection purposes.  Did not take any anti inflammatory or anti-fever medications to combat.  Simply sweated out the fevers and drank lots of water.
Queasy with diarrhea, chills, fever, achy all over, had to go to bed.  Had red rash on chest and stomach took Benadryl.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:30 as dose 5 (booster), single (Lot number: GH9694), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "known allergies: Cilantro" (unspecified if ongoing); "known allergies: Strawberries" (unspecified if ongoing). The patient took 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: I tested positive again after Covid 19 had resolved; Positive, notes: I tested positive again after Covid 19 had resolved. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid as COVID 19 treatment.
Patient called in stating: "About 3AM on 02/10/2021, he woke up with painful muscles, along with stiffening of muscles.  Lasting thru the rest of night,  and now states he is still just sore as if he had a bad fever.   Leg cramps are common, but this was more painful. "  Treatment suggested was to increase fluid intake and report back if any further problem.
Got hot and sweaty, shortness of breath for several hours; at 3:00 AM still short of breath, pain in left arm into my throat; tightness in throat; self-administered Flovent.  Shortness of breath got better so I could sleep. Throat was still tight in the morning. Took 1 Tylenol.  All symptoms are gone by end of 10/6/13.
About 10 minutes after the vaccinations "patient" complained of abdominal pain and nausea. 50mg of Benadryl po given. Vomited x2 complained of sore throat, itchy feet, watering eyes. Epinephrine 0.3 mg given. Complained of dizziness. 911 called. Patient was stable. EMT took to hospital ER. Mother took her to "another" ER also.
Light headedness.   Started 20-30 minutes after the vaccination and has persisted for 1 week without improvement.
May 21-May 23 I had fatigue, chills, I was hot/cold, upset stomach, dry mouth.   June 1 my left ear started fluttering when I lay on my right side in bed.  Noise/Sensation is so bothersome I can only sleep on my left side.   June 6 my ears started feeling blocked and I cannot hear as well and the dry mouth came back.   August 30 at night I started hearing ringing in my right ear.  This has happened a couple times over the last 2 weeks
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media concerned a patient of unspecified age and 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 not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-SEP-2021, the patient was diagnosed with suspected covid-19 infection (it had not been too bad) and suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210920261-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccine failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
local arm soreness for 4 days then the neck pain started it would come and go in severity, lasted over 10 days no relief from tylenol or motrin  at times very painful
Pt requested to receive Pfizer/ Comirnaty 2nd booster. Inadvertently administered Moderna as their second booster. Pt kept in clinic for 15 min, and no reactions were expressed or observed.
This patient had edema, erythema, and pain at the site of the injection. Erythema > 5cm diameter. Three patients who had the same lot # DTaP had this problem.
4/2/2012 child was taken to the hospital by EMS on arrival asystole. 3/15/2012 - ER visit oral thrush given Nystatin oral suspension.
Ankle & knee joint pain. Temp 101 degrees, Overall joint stiffness. Headache,. Muscle aches. Muscle stiffness, Pain & redness & swelling at injection site. Shivering. Extreme tiredness & weakness. Chills. Dizziness. General feeling of illness. Unable to function at normal level. Bedridden for 2 days.  Continued feeling ill for 7 days as symptoms decreased.