chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had J&J shot in April, then July 19th I had the first Pfizer shot, August 4th I started to breakout with a mild rash, then August 9th I got the second Pfizer shot and the next day the rash was more severe and I felt Flu?ish the next day the fatigue and rash became severe. By August 16th I had to go to my dermatologist as the rash covered my body and the itching was unbearable. My groin lymph nodes were swollen and very tender. I also had dry sore like  areas appear. The areas between  my thumbs and index fingers  had dry spots with dry flaky skin. My ears felt like they were infected and dry scales inside.
A 15 year old caucasian male patient was mistakenly administered Flublok instead of Fluzone, no AE; A 15 year old male patient was mistakenly administered Flublok instead of Fluzone, no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15 years old male patient who was mistakenly vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of FLUZONE [INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection,  , ] (lot numbers, expiration date for both the vaccines were not reported) via unknown route in unknown administration site for prophylactic vaccination on unspecified date (PT: wrong product administered; product administered to patient of inappropriate age).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency) and wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
This spontaneous report as received from a nurse refers to a female patient of age in her 50's. There was no medical history and no known drug reactions or allergies was reported. The patient was vaccinated with a dose of 1 ml of RECOMBIVAX HB (lot number reported as 1106AA and expiry date unspecified) given intramuscularly with first dose on 19-OCT-2011, second dose on 18-NOV-2011 and the third dose on 18-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in 2012, the patient experienced negative hepatitis B surface antibody titers. No treatment was given. The patient sought medical attention and visited the physician's office. The outcome of negative hepatitis B surface antibody titers was not recovered at the time of report. The relatedness for the event was unknown for RECOMBIVAX HB. The patient was in the process of repeating the 3 dose series of RECOMBIVAX HB. The case is linked to # 1209USA005863 and # 1210USA006251 (Due to same reporter link). Additional information is not expected.
The patient was given Proquad for her 2nd MMR vaccine by mistake, previously had positive varicella titer, pt notified of error and instructed to report adverse symptoms.
EXPIRED VACCINE ADMINISTERED TO 3 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients.  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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-OCT-2021, the patient experienced expired vaccine administered to 3 patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 3 patients was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017517.
Nurse roomed patient and obtained rapid strep and covid test after taking VS. I saw patient after that and discussed with patient and dad doing a rapid Flu test if rapid strep was negative. Patient and dad agreed, and I asked them twice, as it involved a third swab.  I left the room to check RS result and asked the nurse to do a flu test, if the rapid strep was negative, as he had been at a party with a lot of people, and they all had similar sx with fever. I went to the lab and told the lab assistant that I was going to do a flu test after confirming that his rapid strep was negative. When I came back to the room, the nurse was rolling down the patient's sleeve. I left the room with the nurse and asked her what she had just given, and nurse said his flu shot. I told her I ordered a flu test as the patient cannot get flu vaccines, due to his history of getting Guillain Barre following the flu vaccine in 2007. She then did the flu test and let patient leave. I called dad and told him the flu test was negative and explained what had happened. I asked if I should call mom and he said he would tell her.  Mom subsequently called back, and I explained to her what had happened as well.  I informed mom what to watch for if Guillain Barre were to recur i.e., weakness in legs or pain in fingertips or toes, any trouble breathing or irregular heart rate and to call immediately if noted or go to ER and that I would follow up with her after speaking in am. I have placed calls to discuss and am waiting for a call back after literature search. Received response from CDC 9/24/21 and GBS following flu vaccine is very rare. Furthermore, there has not been evidence of increased risk in GBS following immunization in people with history of GBS. The ACIP lists a history of GBS within 6 weeks after a previous flu vaccine as a precaution.
a little bit of a cough.; headache; runny nose; Aside from her taste and smell still being gone; Aside from her taste and smell still being gone/loss of taste; fogginess; Patient had since tested positive; Patient had since tested positive; patient likely had exposure on 22Dec2020; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient likely had exposure on 22Dec2020. She showed the first covid symptoms on 31Dec2020. Patient experienced loss of taste, headache, fogginess, runny nose, and a little bit of a cough on unspecified date. Patient received her first covid dose on 21Dec2020. The first dose likely helped her, she has rapidly gotten better and was feeling much better today. Aside from her taste and smell still being gone. The patient was scheduled to receive her second dose on 11Jan2021. Patient had since tested positive. Caller clarified that the patient didn't get a test until 03Jan2021. Outcome of events taste and smell still being gone was not recovered, and outcome of other events was unknown.   Information on batch/lot number was requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
no additional adverse effect reported; expired vaccine administered; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported.     On 08-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number S025133, expiration date 15-SEP-2020), as prophylaxis (expired product administered) (strength, dose, frequency, route of administration and anatomical vaccination site were not provided). No additional adverse effects were reported. The outcome of expired product administered and it's causal relationship with the vaccine were unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received as part of a pregnancy registry from a registered nurse concerning a 16 year old white female who on 17-AUG-2007, was vaccinated with her first dose of GARDASIL (lot# 658490/0802U), intramuscularly. On 18-OCT-2007 the patient received her second dose of GARDASIL (lot #658556/1060U), intramuscularly. The patient was given two doses of GARDASIL while she was pregnant. It was reported that on 27-NOV-2007 patient was treated 500 mg (two tablets) of ZITHROMAX for chlamydia. She was also started on prenatal vitamins on October 2007 1 tablet daily for pregnancy. No adverse events were reported. On 21-NOV-2007 the patient had a routine ultrasound that showed single IUC, 13 weeks and 5 days. The patient's last menstrual period was estimated to be 15-AUG-2007, " mid August" and her estimated date of delivery is 23-May-2008. In follow up telephone call the nurse reported that the patient delivered a healthy and normal infant on 12-MAY-2008 weighing 8 lb 1 oz "8-1" with apgars of 9/10. The baby's length was 20 inches long. No problem was reported. Additional information is not available.
Pronounced irregular heartbeat, which has continued but is less frequent/severe now than right after I got the booster. I do not have health insurance so have not gone to a doctor. I made sure my affairs are in order for my kids (eg, filed a transfer on death for house and car).
pain; fever; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, fever and fatigue. On an unknown date, the outcome of the injection site pain, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient stated that received the first dose of the Shingrix vaccine in his right deltoid of the arm and had experienced injection site pain, fever and fatigue. Additional information were unspecified. The patient did not consent to follow up.
This spontaneous report was received from a male consumer of unknown age, who refered to himself. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for shingles prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). It was reported, that the vaccination failed and the patient had to have a booster vaccine in 60 days (vaccination failure). The outcome of the event was not reported. The causality for the event was not reported. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1809USA005291:
When patient was leaving the exam room she fainted and had jerking movement of hand and foot on one side. She lost consciousness and was caught by the medical assistant. When she regained consciousness both hands and fingers were numb and she was unable to move her fingers for a brief period. In addition, she was slow to regain awareness of where she was and what had happened - approx 2 minutes.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Fatigue, headache, ringing in my ears, decreased appetite, productive cough, sore throat, chills, daily fevers off 100 to 10. Pneumonia identified in the lingula--identified on x-ray report 6/15/2018, treated with LEVAQUIN x 10 days.
Vaccinated 7/12/04 , 1:45pm. Almost 12 hours later, developed fever, vomiting, dizziness. About 10-12 hours later the fever and vomiting were gone; dizziness was gone the following day.
Fri: Arm swelled and red and hot, where shot given (left arm). Sat Morn: moved down arm. I am hot then cold and sick and we have a hurricane. I put ice and took 2 Tylenol. I seep 2 hrs and none better. Sun: I go to ER and they give me a shot and Benadryl. Mon evening: start to feel better.
Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves a two months old male patient who was vaccinated with a 0.5 ml dose of PENTACEL lot number Liquid: expiry date: -U6138AB; expiry date: 30-Jun-2020 and powder: Lot U1952AB and expiry date 30-Jun-2020.; Carton: Lot U1952ABA and expiry date: 30-Jun-2020 in the right thigh on 15-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR administered in the left thigh and ROTATEQ via oral route for Immunisation. It was a case of an actual medication error due to inappropriate reconstitution technique. It was reported that the patient was administered the Liquid DTAP-IPV portion and didn't give/mix it with the Lypholized Powder ActHIB portion. It was not reported whether the patient experienced any adverse effects following the vaccination. 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. List of documents held by sender: none.
The site of injection (left arm near shoulder) started to hurt more than a broken bone, even if I didn?t move it, minblowing pain. The pain went away the following day. However, that shoulder joint still hurts at a certain place in my range of motion - the joint, not the muscle - and I?ve never had any symptoms in this arm in my life.  I can?t fully lift that arm in a certain direction without feeling joint pain.
Swollen left knee - reduced range of motion - pain - unable to sleep because of pain.  Steriod shot in knee joint resolved issue.
After Dose 1:  1 week later emergency surgery for pancreas and gall stones and flush. Hospitalized, given pain medicines. Taking anti-nausea, tylenol ibuprofen, and itinerol eye drops (for previous dry eyes), sustains eye drops,  After Dose 2: Could not use injection site arm because swelling/tingling, had chills, fever, nausea, vomiting for 2 days, subsided and then pain in the arm lingered for two weeks. Lingering headaches (migraines) and occasional nausea, heat rashes (unsure if from menopause).
injection site pain, induration that remains 1/6/2021 Narrative: Reported office to evaluation of pain at injection site that started 12/29/2020 and is still present 1/6/2021. Mild tenderness at left deltoid injection site with erythemia, warm to touch.
Pt returned to office approximately 2 hours after getting shots with rash - rash c/w hives/urticaria no resp distress - we gave him sq EPI (1:1000) 0.1cc x 1 - rash resolved - VSS. Pt d/c'ed on ATARAX.
Initial information received from a consumer (pharmacy technician) on 08 October 2012. A female patient in her 50's (age and date of birth not reported) received a dose of Tetanus Toxoid Adsorbed Preservative-free, lot number U3919AA, intramuscularly in the left deltoid on 02 October 2012. The patient had no past medical history and no known allergies. Following administration of the vaccine, the patient immediately felt faint and developed redness and pain in the left arm. The arm continued to be sore and painful. The patient was hospitalized from 03 October 2012 through 08 October 2012 and was diagnosed with cellulitis at the site. The patient was discharged on ZITHROMAX. Her arm continues to be sore and painful with a "knot" at the site. The patient had not recovered at the time of this report. Documents held by sender: none.
Narrative:  Patient experienced RLE DVT within3 weeks of receiving the Janssen COVID-19 vaccine. Patient also with thrombocytopenia at time of diagnosis. Of note patient with bladder carcinoma on chemo. DVT possibly cancer associated vs vaccine-related and the thrombocytopenia is common with chemo (gemcitabine + carboplatin). Patient was started on apixaban therapy for DVT.
Patient came in for Moderna Bivalent Booster (0.5mL). It was discovered the next day that the patient had received the Primary Series Moderna product (0.5mL) instead. They had already received their first two doses and booster. Patient was called 6 times, but we are still unable to contact. We will continue to attempt to contact the patient. The MD office was notified and per CDC guidance, the patient will wait 60 days and then we recommend to receive the Bivalent Booster.
This case was reported by a healthcare professional via a sales representative and described the occurrence of antigenemia in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). It was reported that approximately one month after the subject's 1st vaccination with TWINRIX, she experienced antigenemia. No additional information was reported.
The same day post vax, this pt experienced a rash form the injection site (upper arm) to the elbow. The pt recovered from the injection site rash overnight. She did not experience any other symptoms. No further information is available.
Chicken pox blister appeared on my chest and was very itchy. Also had the usual symptoms of overly tired, achy, dizziness.
21 y.o. female normally healthy who arrived by to the emergency department for Post COVID-19 vaccination reaction.  Patient states approximate 5 minutes after the vaccine, she started to feel lightheaded and nauseated.  She does notice the sensation of throat irritation, but denies any shortness of breath or difficulty breathing. Denies any tongue/lip/airway swelling, abdominal pain, new rash/pruritus, diarrhea, emesis, fever/chills, chest pain.  She has no history of anaphylaxis or use of EpiPen.  No significant allergic reactions in the past  Initial reevaluation approximately 30 minutes after arrival, patient status unchanged.  She still felt lightheaded and nauseated with a sore throat.  No new rashes, shortness of breath, difficulty breathing.  Her voice was normal, and did not report any new GI symptoms.  Heart rate was 109 with one half fluids given thus far.   On reevaluation 2 and 3 hours after arrival, patient's heart rate normalized into the 60s?70s, she was asymptomatic.  She was slightly fatigued from the Benadryl.  She felt safe to go home.    Follow-up call a few days later and patient was doing fine with no symptoms.
The patient describes pain in the shoulder since receiving the Shingrix vaccination. She has trouble lifting her arm and cleaning house. She says her doctor has done x-rays and will do an MRI.
-extreme fatigue started 4 hours after the dose, 2 1/2 weeks later better but not resolved -irregular welts: 10 of varying sizes on anterior trunk, antecubital fossa and lateral leg just above the knee. Raised, red, hot to touch, improved in a week, have not faded in 2/12 weeks. - October 13 in afternoon:  --palpitations: lasted 2 1/2 weeks, better not gone, quite intense, occurred at rest, without dizziness -- tightness of breathing, no wheezing, occurred at rest, better in 2 weeks, then only occurring with minimal exertion (walking across a room) --muscle aches, headaches, chills, low grade fever (99.5 was highest) off an on for 2 weeks, but not completely resolved at 2 1/2 weeks -- weakness: lack of energy, was able to pick up usually daily items and climb stairs to the 3rd floor, but that drained my energy, increased shortness of breath and palpitations. - hoarse voice started at 2 weeks and has not resolved.
back pain, Head ache, nausea and vomiting, States Fever but temp normal.
Provider asked the LPN to administer a covid vaccine.   There was no order in the chart.  The patients father was upset about the wait time and yelling at staff.  The LPN got in a hurry and drew up the vaccine, administered it and did not do her vaccine double check .
had covid test that was positive on 10-17-22 and admitted at hospital 10-17-2022 discharge was ordered 10-23-22 deceased at Rehab facility on 10-28-22
resting heart rate fluctuating between 94-127; running a fever 100.5; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (resting heart rate fluctuating between 94-127), PYREXIA (running a fever 100.5) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE ABNORMAL (resting heart rate fluctuating between 94-127), PYREXIA (running a fever 100.5) and HEADACHE (headache). At the time of the report, HEART RATE ABNORMAL (resting heart rate fluctuating between 94-127), PYREXIA (running a fever 100.5) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment details were not provided.    Reporter did not allow further contact
Rec'd Tdap as indicated, 1 week later (6 days) came in w/complaint - redden area, warm to touch, tight - compress advise, Without resp. distress noted.
Whole left side pain from head to calf. Temp at 104 for 16hrs. Headache, ears ringing, stomach pain, strong pain left leg left side of thigh. Felt like a bus hit my left side. Severe fatigue. Congestion.