chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PENTACEL was given incorrectly because at the end of the yesterday she found the powder portion and not the liquid portion with no adverse event; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves adult patient (unknown age and unknown gender) who received powder portion not liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product preparation issue (latency: same day).  At time of reporting, no adverse event reported.   It was reported "PENTACEL was given incorrectly because at the end of the yesterday she found the powder portion and not the liquid portion so she assumes the patient did not get the powder portion with the liquid portion."  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 the 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.  There will be no information available on the lot number for this case.
Given incorrect location - too anterior on upper arm leading to nerve pain that follows brachial plexus distribution.
Fever 101, complete body weakness not able to get up from sitting position without help, equallibirum off balance,  body aches
Patient experienced swollen red arm and flu like symptoms that began after receiving vaccine and lasted approximately 3 days. She did not seek medical treatment and recovered without the use of medication.
injection site red and enlarging; injection site sweling and enlarging; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient reported that he/she had Injection site red and swollen and enlarging 3 days after he/she received injection.  The patient asked as was that to be expected. Additional supportive information:  Follow up would not possible, as no contact details were available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: En5318), in left arm, on 21Feb2021 as dose 2, single (Lot number: En6203), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: Fe3592) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "reflux" (unspecified if ongoing), notes: reflux. Concomitant medication(s) included: AMLODIPINE; FLUOXETINE [FLUOXETINE HYDROCHLORIDE]; PANTOPRAZOLE; CELEBREX; ZOLPIDEM; VITAMIN D [COLECALCIFEROL]; VITAMIN E [TOCOPHEROL]; ZINC; COENZYME Q10 [UBIDECARENONE]; SAW PALMETO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Negative, notes: Negative test at 10 days; (May2022) Positive, notes: Positive at 12 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID relapse Negative test at 10 days Positive at 12 days with return of fever cough and nasal congestion. No known allergies.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162B2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Pt received immunization on 05/21/04 and on 05/24/04 site was really red and swollen, area was 10x9cm and 5x5cm.
1/17/2023:  Became unresponsive after walking back from an echochardiogram appointment. Received CPR and transported to the ED. ACLS was continued for 10 minutes approximately before ROSC, 3 doses of epinephrine were given. She was intubated and central line placed. Had another cardiac arrest for around 4 minutes despite multiple pressors started when patient was getting hypotensive.  Arrives to ICU on NE and epinephrine , diffuse B lines in all lung zones. IVC plethoric   Family reported DNR/DNI  status, changed to comfort measures. Patient expired on 1/18/2023. HOSPITAL PROBLEM LIST: 1. Resuscitated cardiac arrest 2. PEA cardiac arrest 3. Acute on chronic hypoxemic respiratory failure 4. Diffuse pulmonary edema on lung ultrasound 5. Acute on chronic RV failure 6. Severe biatrial enlargement 7. Right to left cardiac shunt 8. Pulmonary artery hypertension group 1&3 9. COPD-moderate 10. Tobacco use history 11. DM 12. Dementia
This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.   Company Comment: This is a literature report of myocarditis in an adult male after receiving the product. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-245527, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male after receiving the product. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Two hours after injection, great pain in my left knee. Knee had surgery on Sept. 29th, 2021 for meniscus tear. Attempted to wait out the pain to no avail. Continually worsened. Went back to Doctor. Drained a large amount of fluid and was given a cortisone injection.
Information has been received from a pre-school teacher concerning her male student who on 03-AUG-2005 was vaccinated with a first dose of MMR II 0.5 mL.  It was reported that recently the patient had a titer test performed and results showed that the patient had less immunity to mumps virus.  The patient sought unspecified medical attention.  Follow up information has been received from a pre-school teacher who reported that she did not have any additional information regarding this particular patient.  Additional information is not expected.
pain at the injection site and entire arm 1-2 days after vaccination and then again after 7 days (less intense then in the beginning). additionally, itching, swelling, rash and a dull feeling at the injection site after 7 days
Pt. was given 3 vaccines: MENVEO, TDAP, FLU shot on 1-5-12 and came back next day with cellulitis left deltoid area, redness right deltoid area. Pt. was prescribed KEFLEX 500mg 1 tab every 12 hr x 10 d and an appt. was scheduled for 1-20-12 for follow up.
Numbness in two fingers on left arm (ongoing for over one month after dose), rash on site of injection (ongoing for over one month)
pain and itchying over L cheekbone, HTN Solu-Medrol 125mg IVP, Benadryl 50mg IVP slowly, Lisinopril/HCTZ 10/12.5mg PO symptoms resolved in 2 hours of observation and management
18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of injection and neck.  Subsequently developed flu-like symptoms:  headache, fever(101F), chills, myalgias, arthaligias, fatigue that continued daily for several weeks.
pt recv vax 21JUN96 & 30JUN96 pt devel a varicella-like rash on stomach & chest w/over 100 lesions;pt recovered by 4JUL96;
Myalgia FATIGUE, LOW GRADE FEVER, CHILLS Narrative:   Other Relevant History:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 27Apr2021 as dose 2, single (Lot number: EW0170) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Nov2021 at 11:45 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; CIPRO [CIPROFLOXACIN HYDROCHLORIDE], start date: Jan2006. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
I did not have a severe reaction from either one of the shots.But with that said  I was quite miserable for about two days with the second shot. I have been extremely fatigued to the point where I cannot even get up for longer than about an hour a few times a day and walk around. I lost complete strength in my arms and legs, my brain seems to be misfiring. I can?t remember things I have a loss of smell that has not come back it seems to come and go. Rest and sleep does not help The chronic fatigue. I have also noticed an Extreme change in equilibrium and balance. The shoulder I got the injection in has felt like it has been dislocated, no matter how hard I try to stretch it out or to try to put it back into place it seems to be permanently dislocated. I had almost all of these symptoms before the vaccine but not to this extreme. I am almost unable to do anything at this point. I just want to know if there are others besides me that have the same symptoms in condition that I am suffering from I just want to know if this is normal for people that have had the pre-existing conditions that I have and if anybody else is out there experiencing this. I am a single mother of two kids and I can?t seem to get life back on a normal level, enough to function.
Got J&J vaccine @ 5:30 PM in R Arm. within 20 minutes felt sympathetic pain in my L arm @ same spot on L arm as R arm injection.   Went to bed at 10:30pm. woke @ 3AM feeling like I needed to move - got up for a drink and became aware of feeling like I spread  over my entire body - not exactly the same as chills and/or fever - literally felt like pepperminty cool burn/tingle all over whole body. Felt faintness w/waves of  nausea - had to squat twice like when you feel like you are about to faint/brown or black out so you feel the need to get close to the floor.  Had waves of abdominal cramps that felt like strong period cramps.   eyes feel dry - irritatingly dry - and I have not been wearing contacts.
Day 1 just normal effects as far as I know heavy eyes, super tired.  Day 2 a fever and sorness Every day since then fatigue and shotness of breath when over exerted. Arms and legs feeling heavy.  Eyes get really heavy,  double and foggy vision comes and goes. Sunday April 11 right arm muscles locked up,  tense and tight.  Monday April 12 legs feel really heavy,  feels like something pulling behind my knee caps.
Two months later, developed a persistent ache in left testicle lasting about 3 weeks. I do not think it is related to the vaccination.
On 07/08/2006 woke up with injection site redness, second hardness around site. 07/08/2006 around noon noticed fever 101 degrees, nausea, upset stomach, body aches stated she hurt all over.  Later in the day began diarrhea and vomiting, has had body aches and pain.  Nausea, vomiting, diarrhea and fever for 3 days as of today.  Injection site red, warm and hard redness extends down upper arm to elbow.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-AUG-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 19-APR-2016, the patient was treated for the onset of a rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient calls stating ever since I had those shots in the office I've been on the toilet with diarrhea, nauseated, abdominal discomfort - denies any fever but confirms bright blood in the stool.
Face became red , burning sensation, light puffy swelling feeling 20 min after shot. Zyetac given side effects went away. Returned 6 hrs later same symptoms benadryl given. No further issues
Patient was offered and administered Janssen COVID vaccine while admitted to the hospital. Following discharge, it was reported by a family member that patient had already received the two-dose Moderna series. Only one dose of Moderna was found in addition to the Janssen.
Began with headache and dizziness then progressed to nausea, vomiting, diarrhea, dizziness, and chills.
Starting evening after inject, stomachache and headache, and little sleep that night. Injection site is very tender, with no visible effects.
Information has been received from a registered pharmacist concerning a 15 month old male who was vaccinated with MMR and subsequently, the pt developed croup and sought medical attention. It was indicated that the pt's physician wants to place him on therapy with prednisone. At the time of this report, the pt's croup persisted. Additional information has been requested.
Hives on opposite arm (upper right arm); started evening of shot and patient called a week later; area is still itchy; she's used OTC aloe vera and alcohol, she started using benadryl 10/30/23
I exploded in boils all over my buttocks and in the crease with my thigh; have also found smaller noodles in the vulva, perineum and anus; have also found smaller noodles in the vulva, perineum and anus; have also found smaller noodles in the vulva, perineum and anus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 as dose 3 (booster), single (Lot number: 330308D) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HEDS" (unspecified if ongoing); "CLL" (unspecified if ongoing); "MDD" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "many issues with spine & skeletal anatomy" (unspecified if ongoing); "idiopathic retinopathy" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "known allergies: bee sting" (unspecified if ongoing); "Hidradenitis Suppurativa" (ongoing), notes: I have Hidradenitis Suppurativa and have been in remission for some time; "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; LITHIUM; PROZAC; TRIPHALA; XANAX; ZOLOFT. Past drug history included: Demerol for known allergies: Demerol; Tetracycline for known allergies: Tetracycline; Erythromycin for known allergies:Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Right), administration date: 08Jun2021, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0180, Location of injection: Arm Right), administration date: 29Jun2021, for COVID-19 immunization. Patient received vaccine at pharmacy or drug store. No other vaccine in four weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The following information was reported: FURUNCLE (disability) with onset 14Mar2022, outcome "unknown", described as "I exploded in boils all over my buttocks and in the crease with my thigh"; VULVAL DISORDER (disability), PERINEAL DISORDER (disability), ANORECTAL DISORDER (disability) all with onset 14Mar2022, outcome "unknown" and all described as "have also found smaller noodles in the vulva, perineum and anus". The events "i exploded in boils all over my buttocks and in the crease with my thigh" and "have also found smaller noodles in the vulva, perineum and anus" required physician office visit. Therapeutic measures were taken as a result of furuncle, vulval disorder, perineal disorder, anorectal disorder. Clinical course: It was reported that, she have Hidradenitis Suppurativa and have been in remission for some time. Soon after the booster, she exploded in boils all over her buttocks and in the crease with her thigh. She have also found smaller noodles in the vulva, perineum and anus. Those are not areas she ever had problems with - her disease expresses as Murphys boils to the inside of the thigh which appears unaffected.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post primary vaccination (Dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had fever (Dose number in series 2). Patient thought patient purchased the wrong Tylenol brand. Patient had Tylenol Cold & Flu Severe. Patient had Covid-19 shots and end up having fever. Patient thought this was a wrong Tylenol. Patient did not have a cold or flu, It was just the after effects of the Covid Shot (Dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Patient described dizziness starting at 11:30 pm last night (9/9/13) and lasting throughout the night "trouble with equilibrium". He also reported an enhanced sense of taste. "No cognitive compromise whatsoever" per the patient. Today 9/10/13 the dizziness is slowly resolving itself.
Red raised flat and raised bumps/rash on thighs front and back, knees, shins, ankles, and feet. Very small amount on back maybe 3-4 bumps
Patient says she has lost feeling in hand/tingling in the hand. She also complains of having issues with her right arm  when she lays on it, says it constantly feels like it "falls asleep" when she lies on it. She has since then followed up with her chiropractor and will also follow up with PCP.
TDaP(ADACEL, Boostrix), 7SY34, IM/LD, shoulder of 0.5 ml was given to me on 06/11/2021 ordered by Doctor wrongfully. A few days  after  the injection was feeling unusual, angry, irritable, argumentative, very talkative, anxious, panicking , feeling extremely cold as if I had thyroid disorders, issues with my male organs as if I had endocrine system issues,  Tinnitus, after all had been treated by urologist, Endocrinologist, Gastroenterologist, Podiatrist ect
Pain in arm, joints, nausea, shivering fever, sleeplessness, excessive urination
Headache,  fatigue,  muscle pain,  sore throat,  sinus congestion,  chest tightness (slight), dry cough.  Headache started 1/25/21. Others started 1/26/21 and progressively got worse. Went to urgent care on 1/26. Missed work on 1/26 & 1/27.