chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the 2nd dose, I did get a pain in my arm. The next morning, I woke up and I started to get flu like symptoms, chills and fever. These symptoms lasted 24 hours and resolved. On 5/25/2021, I woke up at 7am, I was having difficulty standing and went to the bathroom to shave and noticed I could not hold my razor. I called 911 and tried to explain to the operator and realized I could not talk. The ambulance showed up within 5 minutes. They flew me to the hospital via helicopter and I went straight to an operating room at 11:15AM. They scan and found a clot in my brain. They did a catherization and removed the clot. I woke up at 2:20PM and was able to speak again. They doctor told me I had a stroke between my heart and brain. The surgery was successful and I was discharged on 5/27/2021 fully recovered from my stroke. I was prescribed an increased dose of atorvastatin 80 mg and I signed up for a stroke study.
PATIENT CALLED PHARMACY AT 10:40AM 6/29/2019 AND LEFT A MESSAGE INDICATING SHE HAD AN ADVERSE REACTION THAT STARTED AT 10:30PM ON 6/28/2019 AND LASTED ALL NIGHT UNTIL 5:00 AM 6/29/2019.. PATIENT INDICATED SHE WAS IN PAIN, COULD NOT TURN OVER IN BED, WAS SICK WITH FEVER AND CHILLS.
Initial injection site soreness, red, itchy, heat approx 3 inch in diam for 3 days. Delayed reaction on 4/7 heat, hard lumps, red, itchy. Consistently growing daily several inches. Currently 8 inches by 10 inches. Morning lighter and blotches, 2 hours later very red and solid, growth occurring in afternoon with increase of pain and itch, evenings uncomfortable and causing movement restriction. Swelling of arm, fingers lymph nodes next to left neck and part of neck.  Attempts at ice packs, over the counter cortisone creams and Benadryl resulting in little to no relief. Doctor prescribed prednisone course to be started today 4/14 and recommends discontinuing vaccine course, concerned about anaphylaxis if shot 2 is administered.
Patient received injection, became very nauseous and vomited, patient given diphenhydramine and was ok to leave after 15 mins.
Pain in shoulder joint radiating down arm. Ibuprofen, first doctor visit on 10/13/14, subsequent visits on 10/23/14 and 10/31/14. Pain still in left shoulder joint when raised above arm level and moved across body. Anti-inflammatory shot given on 10/31/14 along with Tramadol. Physical Therapy to start on 11/5/14. No relief after shot given on 10/31/14.
sz x 1 following vax; fever 101; pt exam day of sz dx febrile sz;
Patient received his routine allergy shot and a Hep-A and Varicella shot at 9:45 a.m.  We waited the alloted thirty minutes to see if he had any reactions, was checked out by provider at 10:15 a.m.  Everything seemed to be in order and then we left.  As we headed out to the car, patient said he felt a bit light headed.  When we arrived at the car, he circled it and seemed confused as to what to do.  I sat him down in his seat and proceeded to drive home.  However, about half a mile down the road, he complained of being dizzy and thought there was something in the road when the road was empty.  I turned around and went back to the clinic. He was seen immediately by provider, who took his blood pressure, oxygen levels, and listened to his heart and lungs.  Patient's vitals were fine, other than being dizzy, light headed, confused, pale, and fatigued.  A pediatrician came in to check him out.  The doctor felt he was okay.  The doctor recommended I take him home, give him lots of fluids for the day and keep patient cool for the day.  Patient rested that day.  He was slow that day and pretty much for the weekend.  We made sure he drank plenty of fluids and stayed cool. He feels fine.  The injection site is still sore.
BAD CHILD MEMORY; ANGER; NOT EATING ALOT; INSOMNIA; RINGING IN EARS; HYPERNESS; ANXIETY; HEADACHE; HEARD A CRACK IN KNEE; LOW BACK PAIN; ENHANCED LEFT KNEE PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heard a crack in knee. On 25-MAR-2021, the subject experienced low back pain. On 25-MAR-2021, the subject experienced enhanced left knee pain. On 26-MAR-2021, the subject experienced bad child memory. On 26-MAR-2021, the subject experienced anger. On 26-MAR-2021, the subject experienced not eating alot. On 26-MAR-2021, the subject experienced insomnia. On 26-MAR-2021, the subject experienced ringing in ears. On 26-MAR-2021, the subject experienced hyperness. On 26-MAR-2021, the subject experienced anxiety. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low back pain, had not recovered from enhanced left knee pain, anxiety, anger, headache, not eating alot, insomnia, hyperness, and bad child memory, and the outcome of ringing in ears and heard a crack in knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
About 10 seconds after receiving the shot he felt dizzy, nauseous, had to sit down.  Had dry heaves.
"My" menstrual cycle has increased since the vaccine. Prior to getting the vaccine, "my" cycle was average around 28 days now it has increasedto 32 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: AN6198) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 08Mar2021, since the vaccine, the patient's menstrual cycle had increased. Prior to getting the vaccine, her cycle was average around 28 days and it had increased to 32 days. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle had increased was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 23Mar2021 at 09:30(at the age of 30-years-old)as a single dose for COVID-19 immunisation.   No follow-up attempts are possible. No further information is expected.
Flush; Bruising on the site; Chills; Difficulty of breathing; Itchiness; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FLUSHING (Flush), DYSPNOEA (Difficulty of breathing), PRURITUS (Itchiness) and PAIN (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Ambien                                                         Sleepin Aid for Sleep disorder NOS.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and PAIN (Body aches). On 28-Jan-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and PRURITUS (Itchiness). On 29-Jan-2021, the patient experienced FLUSHING (Flush), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills). On 19-Jan-2021, PAIN (Body aches) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and DYSPNOEA (Difficulty of breathing) had resolved and FLUSHING (Flush), PRURITUS (Itchiness), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shooting pains in legs and arms; Restless legs; Severe dry mouth; constant thirst; Chills; Fever; Headache; Vertigo; Fog feeling; Almost felt like a bad hangover mixed with foodpoisoning; Almost felt like a bad hangover mixed with foodpoisoning; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8737) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. The patient received nature made daily vitamin for women within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 19:00, the patient experienced shooting pains in legs and arms, restless legs, severe dry mouth, constant thirst, chills, fever, headache, vertigo, in a fog feeling and almost felt like a bad hangover mixed with food poisoning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events shooting pains in legs and arms, restless legs, severe dry mouth, constant thirst, chills, fever, headache, vertigo, fog feeling, almost felt like a bad hangover mixed with food poisoning were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Patient developed a rash all over his back. Nurse at his college student health service administered 50mg BENADRYL
Initial information received on 08-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient who was inadvertently administered product that was too long in transit, TENIVAC. On an unknown date, the patient received a dose of suspect TENIVAC, Lot number, expiry date, dose not reported via unknown route in unknown administration site. It was a case of actual medication error due to incorrect product storage error. No adverse event was reported. 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. Documents held by sender: none.
Edema in arm and especially hand.  Very swollen like a balloon, non-pitting, still, one month since second dose of vaccine. Pain in lymph nodes under left arm..
Patient came in with wife with their vaccination card with completion of their first COVID dose on 03/02/2021.  They both stated that he needed to get his second dose based on the vaccination card not having the 2nd dose documented.  We also were told that her husband has dementia.  We verified with them that it was for his second dose due to not having proof of second dose and the Pfizer shot was administered.  When entering the data into our computer system, we got a rejection that states that patient's second dose has been billed for this patient.  When looking at patient's profile, it does show that a second dose was administered on 03/23/21. Therefore, the patient was given a 3rd Pfizer dose.  I spoke with his wife and she states that the only reason they came in was because the vaccination card for his 2nd dose was blank.  I contacted the CDC and was told to report with VAERS.  My district manager has been contacted and an incident report has been completed.  The district manager was going to talk to the patient's wife about the situation today on what to do next.
Rash around injection site, that is painful to touch. Fever chills headache and overall malaise
Rt arm (deltoid) swollen, no redness, huge knot approx half dollar in size, pain and warm to touch, shoulder pain, complaints of lightheadedness and nausea started approx 5/21/2005.
Pt complained of cold sores on lip and in nares.Pt has past history of cold sores. Pt to be treated with Valtrex 500mg bid
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case 2018SA248558. This case involves a 16 months old male patient who received vaccines ACT-HIB (lot U1945AAA via unknown route) on 13-Aug-2018, PREVNAR 13 not produced by Sanofi Pasteur (lot number not reported) via intramuscular route in the right thigh on an unknown date and DTAP not produced by Sanofi Pasteur (lot number not reported) via intramuscular route in the right thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was also reported that ACTHIB was used with sterile water. It was unknown whether adverse event occurred or not. 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.
Child left MD office, became car sick & itchy w/in 15 mins. Mom immediately returned to office. Hives began to appear, then overall swelling. VERIPRED 20mg/ml 1 tsp given orally & DECADRON 4mg IM at 12:15. Observed x 2 hr while hives resolved. Home w/ ORAPRED ODT x 5 days & PRN BENADRYL.
Nausea, severe right sided hea ache, right arm swollen and extreme pain when touched or moved, pain down spinal cord resting in hips then knees and bone marrow of legs. Extreme fatigue. All has lasted 5 days since shot. Redness and swelling has spred down to elbow of right arm, sinuses stuffed up, chest pain from congestion.
Pre-Syncopal Symptoms of Dizziness, Vision changes and weakness with assisted collapse to floor after walking approximately 30 feet from clinic room to waiting room.  Pt was transferred to Wheel Chair then Gurney with assistance where he rested and was monitored for approximately 30 minutes. Symptoms subsided and Patient was ambulatory to leave clinic with his family friend who was driving.
Patient brought into Hospital via EMS d/t seizures on 06/05/2022.  CT angiography Chest w/ w/o contrast showed anomalous course of right subclavian artery tracks posterior to esophagus.  Mild atherosclerotic changes of thoracic aorta.  Images of upper abdomen: 11 mm nodule from the posterior aspect of right kidney, 7mm gallstone.  Atelectasis of left lower lobe, bronchial occlusion leading into small left chest pneumothorax, irregular calcified opacity lateral right upper lobe, infiltrate's in right middle lobe.  Patient tested positive for Covid-19 on 06/05/2022.  Patient was admitted to hospital, NGT was placed, was give IV heparin qtt, remdesivir, and steroids.  Patient went into respiratory distress and expired on 06/12/2022.
ONGOING RAPID HEARTBEAT; This spontaneous report received from a parent via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced ongoing rapid heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ongoing rapid heartbeat. This report was non-serious.
No additional AE details are available; administered an expired dose of VAQTA; This spontaneous report was received from a Nurse and refers to a 18-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-JUL-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) lot # T008698, expiration date 04-JUN-2021, dose of 0.5 milliliter (formulation, anatomical location and route of administration were not reported) for prophylaxis (expired product administered). No additional AE details were available. The outcome was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The patient started Paxlovid on 06Jul2022 for COVID-19 Treatment and stopped on 11Jul2022. Patient did not take any other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19  cannot be completely excluded.
little cough; nose might run; positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for Covid), COUGH (little cough) and NASOPHARYNGITIS (nose might run) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COVID-19 (positive for Covid). On an unknown date, the patient experienced COUGH (little cough) and NASOPHARYNGITIS (nose might run). At the time of the report, COVID-19 (positive for Covid), COUGH (little cough) and NASOPHARYNGITIS (nose might run) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications and treatment details reported.
The pt received a Toddler vaccine (pfizer Toddler), the vaccine when it was reconstituted  was mixed with 1.3 mls of diluent and the correct amount of diluent was supposed to be 2.2 mls of dilutent (saline)
Itching and rash approx. 20 min after receiving vaccination  Lips itching
Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including breast, under arms, legs, feet stomach.  Horrible headache that did improve with tylenol and ibuprofen taken at the same time. Body shakes and can't control body temperature.  Felt freezing cold but skin was very hot to the touch (according to my husband). Then, I started sweating and felt really hot and couldn't cool down.  Felt nauseous but no vomiting.    Could not sleep but felt very tired.  Today is now 48 hours after vaccine and body aches are gone but I am still extremely fatigued.
Presented with SOB, cough,nausea, aches, fatigue: +Covid 4 days PTA; fully vaccinated; admit with covid-19 PNA; TX with remdesivir, steroids, Vit D, zinc; d/c'ed home on room air
Five days after receiving the vaccine I noticed my eyes became blood red and very light sensitive. I had a headache above my eyes the lower half of my eyes were really blood shot. I made an appointment with my eye doctor to go in and fine out what was going on. I went in to see my eye doctor who diagnosed me with acute iritis to my right eye, he prescribed me a Prednisone Eye drop 1%. I have been using them for two weeks and am slowly being dosed down so that I can stop using them.
Injection was not fully inserted into my arm prior to meds being dispensed. Due to vaccine dripping down my arm, they recommended that I receive a 3rd shot. This was a Pfizer vaccine. It was supposed to be my second shot and I technically got a third. They said this was what the CDC website suggested they should do. They also recommended that I report it.