chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shot still got shingles. I was in hospital\ Suspected vaccination failure; shingles; sickest I have ever been; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and still got shingles. The patient was in hospital. The patient stated he/she had been battling shingles for little over two months. It has been the sickest ever been. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt. stated stiff neck on (L) side after administration of Y.F. There was a welt at injection site, she felt warm, tiredness and nausea. S/s started 05/02/14. S/s lasted 1 week and used TYLENOL.
I feel a annoying "electrical shock" when I move or position my left shoulder. And the shooting sensation tends to go halfway down my left arm and sometimes up as far as my neck. After a physical and I mentioned this, my doctor simply let me know that it shouldn't be an issue and if it gets worse come back and see me. And that visit was on Oct. 20 and I had my booster and flu shot. It seems it is persistent but has not gotten worse and is only situational if and when it "triggers" this sensation. I have not yet recovered from this issue.
Patient was given the adult dose of Covid19 instead of the pediatric dose. We spoke with the patients mom and she said she would monitor the patient and get in touch with her doctor if anything arises.
From initial info received on 7/30/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male pt (age unknown) received a TD ADS ADULT vaccination on an unspecified date. Lot number, route and site of administration were not reported. Unspecified time later, the pt developed a rash. No other info was reported. The pt's recovery was not reported.
severe pain, neuro deficits ongoing, mini-stroke months later, migraine, heavy and painful periods. symptoms not resolved
Pt experienced a fever up to 103; broke out with a rash; fussy. Medications given were Motrin, Tylenol and Benadryl.
Pt. had red, raised heated rash and welt at sight of injection. Pt. was unable to run or jog. Pt. developed bleeding gums and increased bleeding, decreased clot time starting 10/2015.
Numbness in face and hands; flush; blood pressure fluctuating; blotches on neck, arms,hands
Pain in L deltoid muscle at site of administration with limited range of motion with abduction of left shoulder due to pain. Radiates into left trapezius.
History of Present Illness 84-year-old male with history of hypertension, hyperlipidemia, solitary kidney presenting with weakness.  Patient reports 10 days of weakness, fatigue, decreased appetite and weight loss.  No fevers or chills.  No cough.  No chest pain or shortness of breath.  No abdominal pain.  Patient endorses urinary frequency but is only urinating a small amount when he goes.  No diarrhea.  Discharge Diagnosis Weakness, fatigue, loss of appetite-possibly related to covid 19 infection AKI 2/2 CKD stage III Covid-19 pneumonia Metabolic acidosis Hyperkalemia Paroxysmal atrial fibrillation Chronic lower extremity edema Hypertension CAD s/p CABG Anemia Solitary right kidney secondary to history of left nephrectomy for renal cell carcinoma Gout BPH  Hospital Course This is a 84-year-old male with past medical history of CKD, CAD status post CABG, right solitary kidney, anemia, hypertension who was admitted to a local Hospital on 12 8 for AKI. Nephrology was consulted for AKI and noted metabolic acidosis. Patient was on diuretic therapy for chronic lower extremity edema, diuretics were placed on hold and patient was placed on bicarb drip with noted improvement and resolution of metabolic acidosis. Patient's diuretics and lisinopril were stopped on discharge. Patient's hospital course was complicated by noted weakness, fatigue and loss of appetite and shortness of breath. Patient had informed he was exposed to Covid person outside hospital, was tested for Covid and noted to be positive. Infectious disease was consulted and chest x-ray was obtained which noted Faint left mid/lower lung pneumonia. Patient did not qualify for remdesivir therapy due to duration of onset of symptoms. He was placed on p.o. Decadron and oxygen supplementation. He was discharged to finish course of p.o. Decadron and remained on 2 to 3 L oxygenation. Toward the end of the hospital stay, patient was noted to go in and out of atrial fibrillation, this was felt to be new onset as no known history was noted. Cardiology was consulted. TSH was normal. Echocardiogram was unremarkable. He was started on Eliquis BID and metoprolol per Cardiology. Patient also noted to have impaired mobility and was evaluated by PT/OT who recommended SNF placement. Once medically stable he was discharged to . All other chronic conditions remained stable and no further interventions warranted.
Patient noticed pain in shoulder area around midnight 9/27/16.  The pain has spread from neck down to fingertips around 3 AM disturbed her sleep.
Headache 5-22-2013 till present. Dizziness 5-22-2013 till present. Chills 5-22-2013 evening only. Itching around neck 5-22-2013 to 5-25-2013. Itching around eyes and mattering till present.
Six hours after having received the 1st dose of the Moderna Covid 19 vaccine, I developed intense itching of my back and right shoulder. A day or two later, I began noticing hives that continue to spread and involve those same areas.
pt recv vax 09FEB95 & next day 10FEB95 pt exp irritability, listlessness, dec ur production, dehydration; refused to eat & drink, dec muscle tone, wanted to be held & was poorly responsive & became weaker; also poor weight gain ?metabolic p
12 year old female patient who was supposed to receive adacel but administered quadracel with no reported adverse event; 12 year old female patient who was supposed to receive adacel but administered quadracel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (reference number: 00706278) and transmitted to Sanofi on 02-Aug-2021.  This case involves a 12-year-old female patient who was supposed to receive DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] but administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [(wrong product administered) and (Product administered to patient of inappropriate age)].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) on an unknown date for prophylactic vaccination.  On 02-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: C5656AA; expiry date: 13-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination instead of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported).  It was case of actual vaccination error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported, "Nurse practitioner reports that the incorrect vaccine was given to a patient; the patient was supposed to receive ADACEL but the nurse administered QUADRACEL instead."  No adverse events were reported at the time of this report.   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.
(R) deltoid swollen, warm, red and hard to touch-client mother encouraged to seek help at MD or ER. No drainage noted at injection site.
Information has been received from a physician concerning a 20 year old female with Crohn's disease, sulfonamide allergy to nuts and environmental allergies who on 02-JAN-2008, 13-MAR-2008 and 25-AUG-2008, was vaccinated intramuscularly with her first, second and third 0.5 ml doses, respectively, of GARDASIL (Lot # of the third dose 659184/0843X). Concomitant therapy included ASACOL, SINGULAIR, ALLEGRA and 6-MP. On 25-AUG-2008, after receiving the third dose of GARDASIL, the patient developed a fever with a temperature of 102 degrees F. The patient was treated with MOTRIN and acetaminophen TYLENOL. At the time of the report, the patient was recovering from fever. Medical attention was sought via phone call. Additional information has been requested.
Exactly eight days after taking the vaccine my arm became really sore again and the lymph nodes under my arm swelled up and are painful to the touch. I have a rash on my arm like a red welt, but it does not itch, it is just sore.  On the affected arm my hand shakes and it feels weaker than my other arm.
received vaccine from vaccine that underwent a temperature excursion in the Freezer; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine from vaccine that underwent a temperature excursion in the Freezer).    No concomitant medication was provided.  The pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit.   No adverse events were reported.   Treatment medication was not provided by the reporter.
Left upper arm, injection site pain; chills; overall body aches;  fever off and on up to 100.2 which lasted approximately 36 hours. Treatment - Ibuprofen every 6 hours.
This spontaneous report was received from a nurse and refers to a 8 unspecified patients. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2015) (dose was not reported) which was stored improperly, exposed to 42F for 4 weeks. No adverse effects were reported. Additional information has been requested.
Large area of erythema, edema, & warmth at site of injection 20 cm x 15 cm with generalized edema of arm (L).
Rt leg very swollen, no edema, no erythema all of leg from thigh to ankle;
Information has been received from a physician assistant via a company representative referring to a 74 year old male patient. The patient had no drug reactions or allergies. No concurrent condition, medical history or concomitant therapy was reported. On an unknown date of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0467AE with expiration date of April 2013, 0.65 ml, once, subcutaneous). On the same day, an unspecified seasonal influenza vaccine was administered. On an unknown date in October 2013, the patient was sent for an audiogram for an unspecified reason. The audiogram showed sudden sensory neural hearing loss on the left and subsequent brain magnetic resonance imaging (MRI) (date unspecified) was negative for any abnormalities of the brain. No treatment was given to the patient. At reporting time, the patient had not recovered from sudden sensory neural hearing loss on the left. Upon internal review, the event sudden sensory neural hearing loss on the left was considered to be medically significant. Additional information has been requested.
Pt c/o itching, and oozing pus, a little red. Denies area being hot to the touch.
Client received Td and Zostavax vaccine on Tuesday June 17, 2008.  On June 18th  she noticed an itchy bump on her thorax, near her bra line.  June 19th she noticed 5 more spots that she described as blisters.  On June 20th she noticed more spots.  She called the Health District and was advised to see her doctor.  She did not have fever.  She did report redness, soreness and swelling at the site of injection.  She eventually developed 12 lesions spread over stomach, chest, shoulder and axilla.  There have been no new lesions since June 21st.  On June 23rd she reports they are still present but seem to be going away.  She reports no crusting or scabbing.  She did see her physician on June 20th.   She has a history of breast cancer. She has had no cancer meds since January.
lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Excruciating headache for 12 hours starting 3 hours after the vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via unspecified route of administration in right arm on 15Mar2021 at 09:45 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was reported as a cancer survivor. The concomitant medication included unspecified female hormones, thyroid medicine and vitamins. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since having the vaccine, the patient was not tested for COVID-19. On 15Mar2021 at 13:00, the patient experienced excruciating headache for 12 hours starting 3 hours after the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive treatment for the adverse event. The clinical outcome of the event headache was recovered on 16Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient had redness, swelling, and warmth at the injection site. She woke up in a sweat overnight on 8/23. On 8/24 she woke up, and injection site swelling was about 4 inches by 2 inches. She had a rash over entire upper body, which was warm and red, and was composed of large clusters. Temp was 99 degrees 1 hour after TYLENOL, 30 minutes after ibuprofen.
Very mild headache and mild chills that began around 3pm and got progressively more noticeable starting  around 7pm. I took advil around 9pm. I woke up the this morning (4/9/2021) and feel completely better.
Patient taken to ER for rash/hives on abdomen. Upon assessment at ER no hives noted at injection site, rash also noted on legs and upper arms. Patient given Benadryl 6.25mg and prednisone 15mg in ER and discharged.
Rash and right intercostal burning pain I got shingles after getting shingles shot terrible pain not a mild case!
The doctor ordered the "Meningo" vaccine for the patient. The medical assistant that was drawing up and administering vaccines that day thought the HIB vaccine was the same as the meningococcal vaccine because the manufacturer labeled the box as "Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate)." The medical assistant was not very familiar with how each vaccine box looked like and was confused by the label. The error was caught when a student volunteer that was entering vaccines into the online record realized that the Lot # of the vaccine administered did not correspond with the correct vaccine. The patient's guardian was notified and the patient returned the next week to receive the correct vaccine. Age of patient at time of event: 17 years 10 months.
Marked erythema w/small amts of pus from inject site; tx w/oral ATB & gradually resolved;
Feeling cold, involuntary muscle jerking, unable to move; feeling warm from head to toe Narrative:
Patient experienced a vasovagal response after receiving vaccination. Patient reported feeling like he was going to pass out, clammy, hot and appearance looked pale. Pharmacist assessed blood pressure and after about 30 minutes, patients appearance and symptoms improved.
ITCHING ALL OVER BODY; This spontaneous report received from a patient concerned a female of unspecified age. 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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching all over body was not reported. This report was non-serious.
Fever, chills, aches, pains, soreness in eyes, sore throat. Hands and arms trembling, dizziness. Everything lasted about 3 hours.
Started with pain, redness, swelling quite a bit and hard feeling. Progressed to becoming crazy itchy while also painful. From there it became body rash after a couple of days during which I was taking BENADRYL.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of VAQTA lot # K007827 (expiration date, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
1st shot was on Monday 4/12/21.  ( I had aches and didn't feel my best and rested a lot--was mild not a big deal)  Definitly on Thurs. 4/15/21 and on Friday I started having chest uncomfortable (breathing like sickness) and a dry cough kind of weird.  Wasn't sure if this is just strange side effects that I had to get through or who to call?   I cancelled my schedule and rubbed vicks on my chest and throat for 2 days and slept for  days in bed. I quoted Psalms 91 which protects against plague and pestilence.   I got better.  By Saturday, I felt better in my chest and cough gone!   I checked my fever (my friend texted me and told me to check my fever) and it was fine at. 4/17/21.  Since I did NOT have a fever on Saturday, I decided not to call my doctor.  Today 4/22/21, I felt much better except a mild runny nose and the rest is gone.
Minor soreness of top of left arm; This is a spontaneous report received from a contactable consumer, the patient. An 87-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 87-year-old), as a single dose for COVID-19 immunisation. Medical history included allergies(unspecified). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not tested positive for COVID-19 since having the vaccine. On an unspecified date in Mar2021, the patient experienced minor soreness in the top of the left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse event. The clinical outcome of the event pain in arm was resolved on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
PAIN AGGRAVATED; EXCESSIVE FLATULENCE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced pain aggravated, and excessive flatulence. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from pain aggravated, and the outcome of excessive flatulence was not reported. This report was non-serious.