chrisvoncsefalvay/vaers-outcomes huggingface dataset:
w/in 12 hrs p/Acel-immune/OPV vax pt exp febrile sz-t40.2 R; seen in ER; no tx initiated; pt recovered & was sent home; hx of poss seizure;
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M041080, expiration date 19-JAN-2019; lot #M041080, expiration date 06-OCT-2018) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). The vaccines and sterile diluent(STERILE DILUENT) were excursed under -9°C to 8°C for about 15 minutes. Digital data logger involved. No adverse events reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1707USA010624:
10 minutes post injection, pt reported "itching and tingling" to her lower lip that persisted. Dr. l notified and obtained verbal orders for Ceterizine 10mg by mouth x1 tablet and was given to pt who tolerated well. There was no signs or symptoms or redness or swelling, patient continued to speak full and clear sentences, denying any acute respiratory or cardiac symptoms. After 10 mins of ingestion of administered antihistamine, patient reported total resolution of her symptoms.
Covid arm.  Red, itchy circle at injection sight.  https://www.health.com/condition/infectious-diseases/coronavirus/covid-arm-rash-moderna
Pain in the injection site; a 6*3 inch red spot in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE ERYTHEMA (a 6*3 inch red spot in the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE ERYTHEMA (a 6*3 inch red spot in the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain and Vaccination site erythema, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site erythema and Vaccination site pain, at an unspecified dose and frequency and CORTISONE for Vaccination site pain and Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE ERYTHEMA (a 6*3 inch red spot in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe headache/pressure, facial flushing, pain to (R) arm-resolved gradually over 24 hrs.
Paroxysmal SVT x 24 hours.   Exertional dyspnea.  Dehydration.
Evening of 5/18/00, the pt stated she had chills and loss of appetite. Then on AM of 5/19/00 she reports nausea, chills, and moderate swelling at site of injection.
C/O- dizziness, transient  Action- Monitored in OBS area, released after 30 minutes with no complaints
Pt stated that when the tdap  vaccine was given she felt a sharp pain in her arm and then in the last 8 days since receiving the vaccine, pt states her pain is traveling up towards her neck/back.
Patient received the 2nd dose of COVID-19 by Pfizer (9/14/21) 15 days after their 1st dose (8/30/21).  This is earlier than the 4 day window.  No adverse events from the patient occurred following the 2nd dose.
pt tolerated vaccinations well, no complaint, stood up and exited exam room with no assist. Upon check out pt became "hot and dizzy". Pt fell at this time. Pt reports not remembering what happened. While being assisted by parent and  pt appeared to seize or "convulse". Father of patient stated did not appear to seize to him. Pt given cold cloth, snack and water. Assisted to rolling chair and moved to observation room. Pt sitting upright in chair and talking at this time. Pt observed for approx. 15 min. Pt ate and drank during observation. Reports feeling "fine" and able to leave. Pt walked with parent out of clinic. Pt encouraged to follow up with family physician.
some of the medication squirted out of the site into mouth and on lip with no adverse event; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a health professional.  This case is linked with case ID 2019SA290921 (Same reporter).   This case involves a 35-years-old female patient (staff member) who was exposed to  vaccine and reported some of the medication squirted out of the site into mouth and on lip (accidental exposure to product), while administering INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT] (lot number UJ255AA) to a patient. Staff member was sent for a bloodborne pathogen work-up per facility protocol.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was as actual medication error due to accidental occupational exposure to product.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Myalgia & Arthralgia  Narrative: Employee with chronic conditions, employee associates  vaccine with the potential of triggering exacerbation of known  rheumatoid arthritis.
17 year old received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
allergic reaction; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EP7534), via an unspecified route of administration, administered in left arm on 01Apr2021 at 14:00 (at the age of 64-years-old) as single dose for COVID-19 immunisation.  Medical history included high blood pressure (diagnosed with high blood pressure at age 40). Concomitant medications included losartan taken for hypertension, hydrochlorothiazide and carbinoxamine maleate (OMEGA 100) taken for an unspecified indication from 2018. The patient took also an unspecified multivitamin once a day form 1995. The patient experienced allergic reaction on 03Apr2021 with outcome of unknown. The patient reported that she had an allergic reaction to the first dose of the Pfizer COVID-19 vaccine and her pharmacist told her to take Benadryl to help prevent hives from happening with the second dose which was scheduled on 22Apr2021. Caller states she was calling to report that she broke out in hives after getting the Covid shot. She had a rash, after getting the Covid shot, on her hands. Caller states she started breaking out in hives on 03Apr2021, it was all over her body head to especially her torso which was super red and her arms. States there wasn't hardly a spot that wasn't covered in pimply hives. States her husband told he she looked like she got the measles. The patient stated that when she first broke out it was on her arms and underneath her bra. States she was taking Benadryl and Zyrtec and that she called her dermatologist and she had a skin rash on her hands and her dermatologist had given her a tube of medicine to use. Caller clarified this was before the vaccine and that had cleared up for a good say 3 months but now she has a rash, after getting the Covid shot, on her hands. It started on her hands and arms and under her bra. The patient put on the salve the dermatologist recommended Triamcinolone 1% was what she recommended for after the hives started. Hives was reported as worsened. The patient reported that she itched. The outcome of event allergic reaction was not resolved.
Difficult breathing; Cough; Body ache; Terrible headache; Fever; chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficult breathing), COUGH (Cough), MYALGIA (Body ache), HEADACHE (Terrible headache) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD and Breast cancer.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNEA (Difficult breathing), COUGH (Cough), MYALGIA (Body ache), HEADACHE (Terrible headache), PYREXIA (Fever), CHILLS (chills) and MYALGIA (Muscle pain). At the time of the report, DYSPNEA (Difficult breathing), COUGH (Cough), MYALGIA (Body ache), HEADACHE (Terrible headache), PYREXIA (Fever), CHILLS (chills) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
COVID-19 breakthrough. On Tuesday I had a headache and then I developed aches and chest discomfort. Right before I took the test I had a sore throat. I took two COVID-19 tests and they came back positive.
pt recv vax & devel redness & warmth to the inj site;no tx necessary;pt recovered;
pt recvd vax on 20JUL02 & pt states 3-4 days later noted severe knee pain w/pain & tenderness from knees down to toes; pt was unable to jog or climb stairs as usual; c/o tenderness rt elbow;
ADMINISTERED THE JANSSEN COVID 19 VACCINE TO PATIENTS MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; 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: 202A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administered the Janssen COVID 19 vaccine to subjects more than 6 hours after the first vial puncture, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered the Janssen COVID 19 vaccine to patients more than 6 hours after the first vial puncture and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to .
About 3 hours after receiving the vaccine in the morning, I developed a mild migraine which lasted the rest of the day (~8 hours). No treatment was taken.  I have a history of migraines and usually take Advil as treatment, but decided against it due to blood thinning concerns. The next morning I was completely fine.
I have experienced what seems like an excellerated cataract deterioration; I am also experiencing a high sensitivity to light.; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at age of 70-year-old on 27Feb2021 10:00 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. There were no concomitant medications. The patient previously took first dose of bnt162b2 at age of 70-year-old on 06Feb2021 10:30 in left arm for Covid-19 immunization. Patient had experienced what seems like an excellerated cataract deterioration on 01Mar2021. Patient was also experiencing a high sensitivity to light on 01Mar2021. Seriousness Criteria was disability. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded. Case will be reassessed when additional information is available.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 RAs, Ethics Committees, and investigators, as appropriate.
Pt complains of light headedness and dizziness after waving down staff.  Gave pt orange juice and crackers.  VSS and patient recovered quickly.  Patient stable and released from the vaccination site. Hx of sulfa and amoxicillin allergies (rash)
I just woke up with like a sore and itchy throat; I just woke up with like a sore and itchy throat; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Dec2020 at a singe dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient just woke up with like a sore and itchy throat on 24Dec2020. The patient was trying to get information if that is a possible side effect of that or if he should be worried about something else. The patient was due for the next shot on 13Jan2021. Outcome of the events was unknown. No treatment was given for the events.
This spontaneous report was received from a licensed practical nurse referring to a 15-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with an adult dose of VAQTA, strength: 50/1.0 U/ml, lot # N020503, expiration date 04-SEP-2018, for prophylaxis, instead of a pediatric dose. No adverse effect was reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On an unknown date since 12-FEB-2016 the patient was vaccinated with a dose of VAQTA (lot # K018181 with expired date 04-JUN-2017, dose and route were unknown), which was improperly stored. No concomitant therapy was reported. The vaccine was exposed at -16.99 degrees Celsius for 16.5 hours. This temperature excursion was not supported. No adverse effects reported. The reporter stated that there was no previous temperature excursion. Additional information has been requested.
Headache, Fever, Chills, Joint Pain, Kidney Region Soreness, Lethargy, Confusion and Difficulty in Expressing Thoughts  Very similar to Malaria "type" symptoms without ringing in the ears.   (Had malaria in 1997)   Symptoms tempered by 40% day two.
pt recvd vax 2MAR94 & cried non stop for almost 3 hrs; temp was not taken ut reported as low grade; mom stated pt is OK this AM x/redness & tenderness to lt leg;
I had a headache, fatigue, dry cough, postnasal drip. I went to the local Urgent Care, they tested me for COVID-19 and strep throat, both tests came back negative. I was diagnosed an upper respiratory infection, I was advised to drink was liquid, get plenty of rest. I did take Mucinex to help once I started experiencing postnasal drip. It took about two weeks before I started feeling like my normal self
Pt c/o left arm 3-4" red swollen area - following Tdap given on 4-29-10. (+) warmth, resolved by 5/6/2010.
overall "odd" feeling throughout my entire body; Right leg numbness; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK4176, first dose) solution for injection intramuscular in the left arm on 04Jan2021 at 12:00 (at the age of 38-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included migraines, PFO with closure, stroke, PNA (pneumonia) in 2002 and Covid on an unknown date. Concomitant medications included ASA and ibuprofen for headaches. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The evening of the initial injection (04Jan2021 at 17:00) the patient had an episode of right leg numbness and an overall "odd" feeling throughout my entire body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was provided for the events odd feeling and right leg numbness. The outcome of the events odd feeling and right leg numbness was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
I came home after the vaccine, had dinner and went to bed as usual. When I got up I had diarrhea and vomiting that went on all day. The next day I woke up to fever and chills along with the vomiting and diarrhea that lasted another three days. I was unable to get to the doctors office as I live alone.
This is 1 of 4 hosp employees to exp hypotension w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;
SOB; Dizzy/ Lightheaded; This is a spontaneous report from a non-contactable pharmacist. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration in the left arm on 05Jun2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced shortness of breath (SOB) and dizzy/ lightheaded that were resolved in 1 hour. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events shortness of breath (SOB) and dizzy/ lightheaded was resolved on an unknown date in 2021, after the duration of 1 hour.  No follow-up attempts are possible. No further information is expected.
severe swelling at injection site for 24 hours; pain at and around the injection site; loss of appetite; trouble sleeping, waking every 2 hours; fever between 99-100 degrees; rash(small to medium size red bumps) starting at back of neck spreading to face and scalp
1/17 Diffuse rash - Varicella like dry scaly, back, arms. 1/20 improving.
Arm soreness, 18 hours after vaccine with SOB, CP, fever 99. took Ibuprofen. Numbness to left side of face and hand approx. 36 hours post vaccine, that resolved in 10 hours approx. 48 hours after the vaccine. Lung pain resolved within 72 hours of the vaccine
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA286233, 2018SA286243, 2018SA286240, 2018SA286245, 2018SA286244 and 2018SA286242. This case involves a patient (age and gender were not reported) who experienced local redness and swelling that warm to the touch, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (frequency once) lot U1982AA via unknown route and administration site. On an unknown date, 48 hours of post vaccination the patient developed a non-serious events of local redness and swelling that warm to the touch following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also mention that the location of reaction is right below the injection. Details of lab date was not provided. Final diagnosis was local redness and swelling that warm to the touch. It was not reported if the patient received a corrective treatment. The patient outcome was reported as unknown. List of documents held by sender: none.
Severe pain in back and chest. Itchy bumpy rash on back and left breast and spreading. Today my feet are swollen. It's been 2wks since shot and I'm not getting better.
This patient received a dose of the 5-11 COVID vaccine on 3/31 that was diluted on 3/30. According to the information from Pfizer and the CDC and in my discussion with Dr., we resolved that it is reasonable and safe to offer a replacement dose for the vaccine.  The timing will be at the discretion of the patient's family. The relative effectiveness of the vaccine greater that 12 hours after dilution cannot be guaranteed though it is possible that some effect was retained.  We are confident that there is no additional risk of harm associated with getting an expired dose of the vaccine. There is no evidence suggesting a risk greater than any other vaccine.
Patient presented w/ cough, fever, myalgia, weakness and joint pain of unknown duration to ED. Tested positive for COVID-19 by PCR on 7/21/21. Received Pfizer vaccines on 1/6/21 and 1/28/21.