chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately dizzy lightheaded, loss of balance, arm is swollen, face is swollen, fever over 101, breathing issues, urine inconstancy, fainted, shaking, chills, sweating diahreah naseau rash
On 5/18/2020 developed small red spots around injection site. On 5/19/2020 developed varicella like rash per MD. MD at time did not feel it needed to be reported. Today mom requests.
Big red patch, itchy, hot, raised at vaccination site around noon on 8th day after shot.  Day 11 starting to fade.
Syncope 30 min after vaccine visit. 911 called - patient taken to E.D. Negative work-up so far. Cardiologist and Neurologist visits pending.
pt states that she noticed her arm was sore to touch, red, hot and itchy around the injection site.  Pt states she still has these systems and she has developed a lump as well.  She is going to call her PCP for medical advise.
Patient experienced hot, warmth and pain at injection site.  Pain spreading to shoulder and armpits.  Patient was in admitted to ICU.
Within 5 minutes red area around vaccine site, measuring approximately 3" x 2", facial flushing, macular erythemous eruption on the plantar surface of the feet, no wheezing, observed for 30 minutes, released to home.
Giving blood. Notified that my donation?s initial screening test for anti HCV was reactive.  They also did more testing and the results of the extra tests did not confirm the initial reactivity.  It does not show that I have a HCV infection.  It also said I can not donate blood anymore.
Rapid onset of violent nausea/vomiting, jitteriness, weakness, muscle and bone aching.
Within 2 weeks, the pt developed numbness in her arms and feet, as well as unspecified neurological symptoms. The pt is being seen by a neurologist.
Face and throat swelling, sore/tingling throat, skin redness (mostly face, neck and chest). Took 2 Benadryl, face/throat swelling and redness subsided within 8 hours.
Left arm where I had the injection had been sore from the 1st day but increase got more sore. Then on 12/6/2009 it started to swell a little bit and by 12/12/2009 it was really swollen and my shoulder hurt pretty bad and I had a lot of fatigue in my muscles (upper arms and thighs). Scheduled and appoint with my general practioner but was unable to get in until the 12/21/09 by 12/18 my arm was more swollen my shoulder pain was unbearable along with fatigue. By the 12/21 I could barely walk the stairs. On 1/4/2010 finally some blood work was done and my CPK was 1505 and they put me on steroids, but would not say it was the result of the flu shot. I have been in an out of the doctors offices, general prationers, rheumatoglist and still have an elevated CPK at 240 to date (3/17/2009).  I wanted to report this because I believe it is related to my flu shot and would like to know if anyone else has experienced this and if so how long will it take to be well again.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 10 MINS AFTER SHOT, PT REPORTED WEAKNESS IN ARM THAT RECEIVED SHOT AND NUMBNESS. PT SAID THEY WOULD FOLLOW UP IF IT CONTINUED.
She was vaccinated with first dose of regular influenza vaccine shot (by IM inj on Right arm) on 10th January. Within 6 hours of vaccine shot, she had pain on that went toward the elbow, whole arm was sore, silver dollar size swelling. 1/4 inch width, warm to touch, lasted for about a week.
Started wheezing and having difficulty breathing at approximately 8 Pm. Symptoms continued through the night and subsided by morning after several nebulizer treatments. Has history of asthma.
unwitnessed fall with suspicion of head trauma as the patient had some nasal bleeding unknown of the patient is on blood thinner or not.   Upon arrival to ED, patient was septic, tachycardic with heart rate around 114 beats per minute, febrile up to 38.7 C with otherwise normal blood pressure saturating 93% on room air.  Tested positive for COVID.  Noncontrast CT head no acute findings. admit as a case of sepsis secondary to COVID-19 pneumonia in a demented patient complicated by lactic acidosis, hypomagnesemia, dehydration/volume depletion.
Sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.   This case was linked to MOD-2021-248300 (Patient Link).
severe abdominal cramping/severity on unrelenting cramping that I am on the floor; diarrhea; vomiting/ everything emptying out and then start intense vomiting; felt "woozy" right after getting the vaccine; fatigue; I have GI issues like IBS kind of stuff; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration on 02Apr2021 16:20 as dose 1, single (at the age of 61-years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Apr2021, the patient experienced felt "woozy" right after getting the vaccine. On 03Apr2021 04:20, the patient experienced severe abdominal cramping/severity on unrelenting cramping that i am on the floor, diarrhea and vomiting/ everything emptying out and then start intense vomiting. On Apr2021, the patient experienced fatigue and i have gi issues like ibs kind of stuff. The outcome of all the events was unknown.     No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer who posted her daughter's experience on internet. On an unspecified date after her yearly visit the patient was vaccinated with a second dose of GARDASIL (Lot# unknown). The consumer reported that their doctor recommended it strongly. She stated that had taken 2 years for them to finally figure out what was wrong with her daughter. The consumer mentioned that a friend of her posted a video on a web site and that was how they learned of this. The consumer said that her daughter had been to numerous doctors including cardiologist, internal medicine, 3 neurologist, a couple of general practitioners and not one of them mentioned this could be the problem. The consumer stated "she has no life now because of the shot". The second dose was all it took. She mentioned that they want their daughter back. At the time of the report, the outcome of the patient was not reported. No further information is available.
Missed second dose; COVID-19; A spontaneous report was received from a health care professional concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with COVID-19, missed second dose. Crosslinked case is MOD21-031684.  The patient's medical history was not provided.  Relevant concomitant medications were reported i.e., methotrexate, Prozac, lamictal, Ritalin.  On 05Jan2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273(lot/batch: 026L20A) intramuscularly in the left dominant arm for prophylaxis of COVID-19 infection.  Laboratory data was not provided.  Treatment details included steroids and  ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was reported that with help of steroids the patient felt better at the third week window.; Reporter's Comments: The event of COVID-19 was consistent with infection in pandemic set up.  Very limited information regarding these events has been provided at this time. The event of COVID-19 is assessed as not related to company product.
bleeding on her shoulder where she received the shot/have bleeding at site of injection; His daughter said ouch, so it hurt; This is a spontaneous report from a contactable consumer (patient's father). A 19-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 17Aug2021 at 02:43 (at the age of 19-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history allergic to mites and crabs. There were no concomitant medications. The patient had received MMRV when she was 3 months old and after that vaccine she developed high fever and crying because of the high fever. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered on 24Jul2021 (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that the patient went through bloodwork and analysis for one of the components in Pfizer and she showed fine and was not allergic to it. Patient had no vaccines 4 weeks prior to receiving COVID vaccines. The reporter reported that on 17Aug2021 at 02:43, patient had bleeding on her shoulder where she received the shot. She had not any adverse symptoms for the time being, but she did had bleeding at site of injection. When the Pharmacist injected the vaccine my daughter said 'Ouch, it hurts' and the Pharmacist took out the needle and caused bleeding in my daughter's left shoulder, I was shocked because the Pharmacist made a movement that was kind of strange and it caused the rupture of a cavity, she then proceeded to clean the bleeding, put pressure on it and put a band-aid on it (as treatment). Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
7 y/o patient was accidently given a booster dose (0.25ml) of the Moderna vaccine instead of a 1st pediatric dose (0.2ml) of Pfizer.
Tdap given SQ instead of IM patient had concerns about soreness/effectiveness. Rph contacted mfg to find out if re-admin. is necessary and they said no, it will still be effective.
Rash developed on upper body and arms 5/4/13 at 6:00 pm went to ER 5-4-13 at 11:30 pm. - Misdiagnosed. Went to ER 5-8-13 at 09:00 am - Diagnosed with varicella (rash only present on both thighs - 1 or 2 spots - on lower body/extremities) rash progressed to face and back. Severe case as noted by Dr.
Patient reports experiencing weakness in her legs the evening of vaccine administration. She claims it was so severe she was unable to get out of bed without assistance. She states there was a little improvement in her condition by the next morning and that she gradually returned to normal over the course of the next few days. Patient states she did not seek any medical help for her condition and is feeling fine at present.
I had pain in my shoulders and hips. I couldn't rest or pick something up off the ground. In bed I had to sit up. This was going on for two months before it was properly diagnosed. I was diagnosed with Polyrheumatica myalgia in May 2021. I was prescribed prednisone. After taking the prednisone I was pain free after 2 hours of receiving it. After the 3rd dose which was 9/25/2021 I had a PSA test and it was high. My doctor said he believes that the results was because of receiving the 3rd dose.
Breakthrough case admission after 4 vaccines Moderna 3/4/21 Lot# 030A21A;  Moderna 4/1/21 Lot# 025B21A;  Moderna 11/3/21 Lot# 077C21B;  Moderna 5/16/22 Lot# 059M21A
Information has been received from a woman working in a physician's office concerning a 12 yr old male, with high functioning autism, who on 31Oct96 was vaccinated with a first SC dose in the left arm of varicella virus vaccine live (lot618233/0781D). On 19Nov05 the pt started with runny nose with no fever. It was reported that there were lesions mostly on the trunk, chest and back with a few lesions on the face, arms and legs. There were greater than 100 lesions. Subsequently the pt recovered. Medical attention was not sought. Additional information is not expected. The pt's sister experienced chickenpox disease post vaccination following vaccination with varicella virus vaccine live (WAES0512USA00453).
01/06/22 presents to Birth Center Triage for " scheduled induction". PMHx of "Gestational diabetes"
bradycardia; neuropathy; cardiovascular hypertensive crises; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BRADYCARDIA (medically significant), outcome "recovering", described as "bradycardia"; NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", described as "neuropathy"; HYPERTENSIVE HEART DISEASE (non-serious), outcome "recovering", described as "cardiovascular hypertensive crises"; TACHYCARDIA (non-serious), outcome "recovering", described as "tachycardia". Therapeutic measures were taken as a result of hypertensive heart disease. Patient received both doses of the Pfizer Covid 19 Vaccine back in Jan. He experienced devastating symptoms. He would have to double up on his blood pressure medication then after 3 or 4 days he would experience then also reported that he experienced. Things started to calm down in Nov. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a Registered Nurse refers to a 29 year old female patient. No pertinent medical history, drug reactions or allergies. In 1984, the patient was vaccinated with the first dose of M-M-R II (lot#, dose and route not reported). On 31-JAN-2013, the patient was vaccinated with a second dose of M-M-R II (subcutaneous injection) 0.5 ml (lot# H011907; exp. date: 03-JUL-2014). Concomitant medications included SPRINTEC. On 02-FEB-2013, the patient developed pre-auricular and post-auricular lymphadenopathy. No treatment was given. The patient was scheduled to be evaluated on 07-FEB-2013. The outcome of the event was reported as not recovered. The relatedness of the event with M-M-R II was not provided. Additional information has been requested.
Pt fainted approximately 5 minutes after receiving vaccine. Pt did not wait the full 15 minutes as advised by healthcare professional per decision of pt's guardian. Pt fainted after walking away but recovered in 15 seconds and did not have any long term injuries.
LUMP IN ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch 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 subject experienced lump in arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump in arm at the injection site. This report was non-serious.
This spontaneous report was received from a patient's wife and refers to a 73-year-old male patient. The patient did not have any pertinent medical history or any known drug reactions or allergies. On 15-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). The patient concomitant therapies included unspecified blood pressure and cholesterol medicine. On 16-DEC-2017, the patient developed redness, swelling and tenderness from his shoulder down to his elbow (also reported as "reaction to PNEUMOVAX 23. The patient did not seek medical attention, did not have any laboratory test performed and did not receive any treatment for the events. On 18-DEC-2017, the patient recovered form the events. The reporter considered the events to be related to PNEUMOVAX 23.
4 days after receiving 2nd dose of Pfizer COVID-19 vaccine, patient developed significant left-sided chest pressure, dyspnea, heart racing and was taken via EMS to hospital 11/21/21 and was admitted until 11/23. Had heart catheterization, echo, CXR, CTA that were suggestive of myocarditis. Was thought to be related to vaccination per patient's report/hospital.
Fainting. Patient fainted for about 30 seconds after immunization. Responsive and alert after fainting spell. Watched for additional time, gave water.
patient received a dose of Daptacel that was expired/ No AE; 5 year old received vaccine in thigh, no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who received 0.5 mL dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5206AA, expiry date 17-May-2019 via intramuscular route in the Left Quadricep on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included POLIO VACCINE (POLIO) right quadricep intramuscular) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (right vastus lateralis) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) (left vastus lateralis) for Immunisation.  It was a case of actual medication error due to expired vaccine used and Vaccine administered at inappropriate site.  It was unknown whether the patient had any adverse event.  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.
Kinrix that was administered to a 10 year old; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient who was 10 years old, received Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know if a Kinrix that was administered, count as a valid dose for tdap. No further details were provided.
Patient developed a 3 inX6 in rash approximately 12 hours after immunization. Rash is raised, red, and painful with no pustules present. Patient was advised to monitor for increased pain, fever, headache.  Patient was also advised to take antihistamines, ibuprofen, and topical corticosteroid to manage symptoms. We will follow up with patient in 3 days.
stomach cramps; nausea; vomiting; diarrhea; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.  A 32-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection), via an unspecified route of administration on 19Jul2021 10:30 (Batch/Lot Number: ew0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Other medications in two weeks: Birth control, prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. Patient stated that she had experienced nausea, vomiting and diarrhea since approximately 6 hours post vaccination. I also experienced chills, body aches and stomach cramps. The outcome of the events were recovering.
Received call to report patient developed hives and welts 24 hours after administration of Pfizer 5-11 Covid-19 vaccine. Stated this morning most of the welts and hives were gone.
Vomiting and diarrhea for 3 days starting 12 hours after dose given.
Pt here with mother. Pt received Meningococcal ACWY and HPV in right deltoid. This nurse went to Left deltoid and administered Meningococcal B in the left deltoid. Pt started drifting to the left and had passed out. This RN laid pt across bed and had seizure like activity with tonic arms and hands. That lasted about 3 seconds, during this time this RN has ammonia towelette under patients nose. 3 seconds later pt is restored consciousness. Water and crackers given. Pt able to verbalize name, DOB, and location. Blood pressure taken in left Arm. 139/71. Pt states to have not had much sleep last night, and had not ate breakfast this morning. Pt stayed in room with this RN for 15 minutes after episode, and also waited 15 minutes in the lobby. Mothers boyfriend came and got pt so pt would not have to drive. Flu vaccine not administered at this time.
There was no initial adverse event, there was no indication that I had had a vaccine except for the bandaid.  A little more than a month in, 07/12/2022, I tested positive for COVID-19. I have only had a scratchy throat.