chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with VAQTA injection (dose, route of administration, lot number and expiration date were not provided). On the previous day, the VAQTA has been drawn up into a syringe by a physician. Then the physician transported the syringe with VAQTA to his home to administer the product to his child. He did not administer it. He transported the syringe with VAQTA back to the office and placed it in a refrigerator overnight. The VAQTA did not have any temperature excursions prior to being administered to the patient (before or after being drawn up the syringe). No product quality complaint was involved. Additional information has been requested.
Right thigh numb/swelling. 16cm x 16cm right anterior thigh. Since 8/4/16.
Chills, tired all over, tenderness + pain at the injection site- lasted for 2 hours.  Now still c/o redness, swelling + pain.
Dizziness leading to nausea all day. Redness around injection site.  Doctor guessed the injection inflamed sinuses, leading to vertigo.
My hands became sore a few hours after I took the vaccine. This effect is still on going , on and off, acompanied with the emergence of viens around my fingers. My hands will feel tight in a way that makes typing feel slightly uncomfortable.  My hands looked strained, and have viens going around the knuckles and joints of my hands. This still happens on and off randomly since the vaccine was administered. Hands were always a little vieny, but not like this. Vienyness/ tighness comes and goes... if i raise my hands, the veins go back to a normal relaxed state...
Approx. 1 1/2 hrs after injections, had chills and difficulty breathing "throat closed up". All vital signs stable at visit. Lungs clear, O2 100% SAT, B/P 100/80, HR 86, Temperature 99F. Given Benadryl 50mg, IM. Temperature recheck after 30 minutes at 101.6 and down to 100.3 after 1 hour, discharged on Tylenol q 4-6 hrs.
First shot triggered an anaphylactic response where my throat began to swell and close. I stayed for an hour-long observation because of this. Treated with two Benadryl tablets for 50mg total. Reaction subsided and no need to utilize EpiPen. Monitored symptoms for next week and only had pain and headache moving forward. No additional treatment required. Doses 2 and 3, stayed for 30 minute observations, no reaction.
Associated reported continued pain with limited range of motion to left deltoid on 3/31/08. Associate was given authorization on 3/31/08 to see medical provider of choice, and went to see above MD on 4/15/08. Medical diagnosis is bursitis.
Pt. developed facial numbness, numbness and tingling both feet , also numbness in lower back
got full on mouth cold sores; severe face rash; teeth hurting; This is a spontaneous report from a contactable consumer.   A 51-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: EW0168 and expiration date were not reported) dose 2, via an unspecified route of administration in left arm, on 14May2021 at 09:15 AM (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient medical history included jaw rewired 20 years ago. Concomitant medications were received (unspecified). The patient previously received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot number: EW0171) unspecified route of administration, administered in left arm on 22Apr2021 at 11:15 AM as single dose for COVID-19 immunization experienced her lower jaw and lower teeth began to hurt and legs got hives for a couple of days. The patient did not receive other vaccine in four weeks. The patient did not take vaccination prior to covid and not tested covid post vaccination. In May2021, the patient got full on mouth cold sores. She never got them in warm months, abreva always tamps it out in a day. But the cold sore so much bigger. Then a week later, she got and still have severe face rash. She never had this kind of rash in her life. The patient's cold sore and face rash and teeth hurting are still ongoing. The patient did not take any treatment for the events. The outcome o the events was not resolved.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with an expiration date on 01-JUL-2017) (route, dose and frequency were not reported). No adverse events were reported and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
07/23/2022 A few days after the second vaccine he woke up very happy and feeling normal however later that night he started to form gunk in his eye and since he had pink eye after his first vaccination we were familiar with it. Putting him down to sleep he was having a terrible time trying to sleep and on the 25th of July we decided to take him in to the doctor that day. We were advised that he did have pink eye in both eyes and a double ear infection again, and so he was given a new antibiotic called cefdinir to try out. He seems to have slept throughout the night okay.
pt recvd vax 30NOV95 & later discovered that she was pregnant;pt recvd 2nd dose of vax 2 wks p/conception;pt elected to undergo an abortion because of vax;No further details were provided;
Shingles type rash on chin and scalp very uncomfortable Three spots size varies between a dime size and quarter size.  Red swollen and painful - comes in waves of intensity.  Cold pack and  Advill seems to help.
Uncontrollable shaking, muscle tremors, cramping of muscles in legs, calves and thighs,  generalized fatigue and body aches, fever 103, diarrhea, vomiting, extreme headache, extreme soreness in arm where injection was given with limited range of motion.  Egg size lump, bruising and rash at injection site.   Most all symptoms lasting 2 days.
heart attack; Initial information received on 22-Nov-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had heart attack (myocardial infarction) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, same day after vaccination, the patient developed a serious heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.; Sender's Comments: This case concerns an unknown demography patient who had myocardial infarction same day after vaccination with INFLUENZA VACCINE (from unknown manufacturer). The time to onset is compatible. However, more information on medical condition at time of vaccination, history and lab tests will be needed for further assessment. Based upon reported information, role of the suspect vaccine cannot be assessed.
Pt. developed red, warm, itchy rash on both lower extremities. No fever or any other systemic symptoms. Rash is still present.
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician via phone. This case is linked to case 2018SA237937, 2018SA237767, 2018SA237939. This case involves a 15 years old male patient who received 0.5 ml FLUZONE QUADRIVALENT (lot detail UI982AC, expiry date 30 June 2019) in left arm on 20 August 2018. This is actual medication error case due to Incorrect product storage as FLUZONE QUADRIVELANT given to patient after shipment of vaccine shipped on Saturday and not received until the following Tuesday. It was not reported if the patient experienced any 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. Documents held by sender: none.
This spontaneous report as received from a physician assistant refers to a 2 month old patient of unknown gender. On 08-DEC-2014 the patient was vaccinated with a dose of VAQTA, 50/1.0 U/mL injection, 0.5 ml, once, intramuscular. The patient received VAQTA instead of RECOMBVAX HB. No adverse effect was reported. Additional information has been requested.
I have had shoulder pain since the date of my COVID vaccination (April 8, 2021). At first I thought it was just a passing side effect of the vaccination, but the pain and discomfort have been persistent for the past 6 months. I have limited my activity with that arm/shoulder thinking it would help, but it has not. The pain in my shoulder is persistent and restrictive. The only time it does not hurt is when I attempt to immobilize it.
Low grade fever; Chills; Nausea; Body aches; Malaise for about 6 hours; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in left arm, administration date 14Dec2021 at 16:30 (Lot number: FD7218) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 26Mar2021, when the patient was 39 years old, and Comirnaty (DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 05Mar2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 16:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Low grade fever"; CHILLS (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Chills"; NAUSEA (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Nausea"; PAIN (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Body aches"; MALAISE (non-serious) with onset 15Dec2021 at 13:00, outcome "recovered" (15Dec2021), described as "Malaise for about 6 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Duration of the event of Malaise was reported as 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Fainted - no injury noted around 210pm - had not eaten reviewed VIS with mom & daughter (client).
Information has been received from a nurse in a physician's office concerning a 10 yr old male who on 03Jun96 was vaccinated with a dose of varicella virus vaccine live (lot 608666/0392B). Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. As of 11May05, he was recovering. No product quality complaint was involved. The nurse also reported that the pt's three other siblings developed chickenpox (WAES0505USA01477, 0505USA01835, and a 0505USA01837. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical facility/clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a medical facility/clinic (by an unspecified healthcare professional) for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX 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, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
burning in stomach, intense abdominal cramping, headache, chills, low-grade fever, duration of symptoms 24 hours.  Still have mild abdominal discomfort 24 hour later.
Patient states they are experiencing tachycardia per her smart watch.  Registering her at 120-130 BPM. Not experiencing chest pain or SOB. Patient reports a fever and chills. Per NP in the Health Clinic, patient should rest, drink lots of fluids, and go to the emergency room if they experience any chest pain or SOB.
Patient reported that the morning after she received her flu shot she awoke with her injection site raised, tender, and tough to the touch. She reported that a bruise approximate 2 1/2 to 3 inches in diameter had formed. She showed the bruise to her physician during the course of a regular appointment and he did not see any signs of infection. The bruise is improving but is still present 6 days after immunization. She says it is still a little sore to the touch and will follow up with her physician if it shows any signs of infection or does not continue to improve.
Information has been received from a physician concerning a female patient who on 23-JAN-2009 was vaccinated with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck).  The physician reported that on 23-JAN-2009 after the vaccination the patient experienced pain and erythema at the injection site.  The patient sought unspecific medical attention.  The patient recovered on 25-JAN-2009.  Additional information has been requested.
mom states pt began getting rash 10NOV92 p/getting vax; mom states was up all noc because of rash; mom states pt is not having difficulty breathing; seen by MD 11NOV92 w/rash (hives);
(L) arm sore immediately. 1 hr later hurt to move it. 4-6 hrs later quarter size hives under chin. Today, low grade fever with aches and pain and HA.
Welt that has lasted over a week, pain in the arm, extreme fatigue, fever of 101 for about 15 hrs, weakness
Nurse documented that a Hepatitis A adult dose was given, when a pediatric/adolescent dose should have been administered.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Mildly high blood pressure" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies Penicillin; sulfa; "Sulfa" (unspecified if ongoing), notes: Known allergies Penicillin; sulfa. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose , Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (1st booster dose , manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Apr2022) negative, notes: Fully recovered from Covid after five day course of Paxlovid; antigen test negative; SARS-CoV-2 test positive: (Apr2022) positive, notes: four days later symptoms returned and antigen test turned positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Fully recovered from Covid after five day course of Paxlovid; antigen test negative; four days later symptoms returned and antigen test turned positive again; sore throat, congestion, cough, fatigue. I'm on day 8 since symptoms returned -- improving slowly but still testing positive on antigen test  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low-grade fever, extreme irritability, trouble sleeping... lasting through post-vaccine day 11 at which rash appeared on face and trunk. Fever and irritability continued. Day 12, rash worsens, splotchy skin. Day 14 no fever, rash a bit better, but starts crying hysterically in pain and says (injection) leg hurts. Limps when walks. Seems better by Day 15.
Stroke; Transient Ischemic attack; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 1" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination; there were no known allergies. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE (DOSE 1; MANUFACTURER UNKNOWN), administration date: 26Mar2021, for COVID-19 immunisation. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (caused and prolonged hospitalization ("vaccine received during existing hospitalization"), disability ("or permanent damage"), medically significant, life threatening ("immediate risk of death from the event") with onset 09Jul2021, outcome "recovered with sequelae" ("recovered with lasting effects"), described as "Transient Ischemic attack"; CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization ("vaccine received during existing hospitalization"), disability ("or permanent damage"), medically significant, life threatening("immediate risk of death from the event") with onset 13Aug2021, outcome "recovered with sequelae" ("recovered with lasting effects"), described as "Stroke". The patient was hospitalized and prolonged hospitalization for transient ischaemic attack, cerebrovascular accident (hospitalization duration: 2 days). The events "transient ischemic attack" and "stroke" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasal Swab (SARS-CoV-2 test): negative, notes: post vaccination. Therapeutic measures were taken as a result of transient ischaemic attack, cerebrovascular accident which included apixaban (ELIQUIS).  Clinical course: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(10/12) Pain in the right cervical area it was like a muscle spasm that would not release.  Over all body aches and pains w/fatigue. Went to PCP  and had a few tests. At the end was given Baclofen for the muscle spasm issue. Was given a Chest X-ray and Blood work. They came back normal but a MRI was done and, with a spinal doctor, found I had worn out some of the cartilage on C3 and C4, and was referred to another doctor to consult about a  steroid injection between the two vertebrae (yet to see this doctor) Went to ENT doc for sinuses and such. Found no infection in inner ear. After hearing test was given a referral to an audiologist for hearing and balance.(yet to see audiologist)
Patient given dose of flublok when she needed typhoid vaccine. Pt reported she already had the flu shot for the season. No adverse reaction
Baby was found in crib unresponsive by a babysitter. She moved the baby to a couch until EMS arrived. Was placed in the crib at 2pm and found 1 1/2 hrs later. No fever or prodromal symptoms per the ER doctor. Unknown if Tylenol had been given. Was seen by private MD at 10am.  2/26/08 Reviewed autopsy report which states COD as undetermined.  Pathologic findings: tox results neg; pulmonary vascular congestion, mild, combined weight of lungs 132 grams; petechiae of lung pleura, mild; no evidence of significant natural disease, injury, active infection, congenital anomaly, malformation metabolic disorders or malignancy.
Post vax, the pt experienced a burning sensation and immediately a red welt appeared, which turned into a hard lump with 3 inch erythema. Reportedly the pt recovered from this experience.
Starting the day after the injection and the day after, my right arm was sore. Very much like when I get a flu shot. Then I felt nothing until 9 days after the Moderna injection when I noticed my arm was itching where the injection was given. Then I noticed it was slightly swollen, a little sore, and there is a redness on my arm about 3  3/4 x 4 3/4 inches. Doesn't itch as much now but the redness and slight swelling have been there about 4 days now.  I don't have a fever or pain. I feel fine except for the localized symptoms I listed. Is this normal?  Can I still take the second part of the vaccine?