chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced significant swelling. The outcome of the event was unknown. The reporting physician assessed the event as related to TRUMENBA and he thought that it occurred pretty regularly. Follow-up (25JUN2015): Follow-up attempts completed. No further information expected.
screamed 20min then settled down p/being given APAP;a short time later noticed body shaking, x 60sec, afterwards was quiet;stomach had rippling motion like a caterpillar during breathing;pt never felt warm;refused formula that day took h20;
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, fatigue, shortness of breath, cough, sinus pain, nasal congestion, runny nose, chills Narrative:  Tested positive for COVID on 01/26/2021 and symptoms began 01/19/2021. Obtained care of Hospital and clinic. At time of second dose had not fully recovered from COVID and pneumonia. Past medical history asthma and heart condition. Fever 2/10/2021 and 2/11/2021. Headache and muscle pain 02/10/2021 through 02/15/2021. Fatigue onset 2/10/2021 and persisted. Shortness of breath, cough, sinus pain, nasal congestion, runny nose onset 02/11/2021 and persisted several days. Experienced chills and joint pain 02/10/2021 and 02/11/2021. Interviewed 03/29/2021 and she reports side effects of the vaccination have resolved however has lingering symptoms of COVID. Following her dose given 2/10/2021 she missed 1 day of work.
According to facility manager.  The patient was on dialysis but found unresponsive 2 hours after receiving the vaccine.  CPR was initiated, automated external defibrillator was used (shocked x2)- transported by EMS to hospital
Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after injection swelled. within a few hours unable to turn head without pain. From base of head to back was so sore and for 24 hours hard to turn head..
Administered FLUMIST with expiration date of 2/3/09 on 2/12/09. No apparent adverse event.
Started out as a small red rash around the injection site about 8-9 hours after the second injection (4/1/21). Now 4/3/21 the rash area has more than quadrupled in size and is continuing to spread. The whole area is swollen and hot to the touch.
Pfizer-BioNTech COVID-19 Vaccine EUA  Day After - Medium to Heavy Fatigue - Mild Body Aches - Soreness at Injection Point  Day 2 - Medium Fatigue - Soreness at Injection Point  Day 3 - Light Fatigue - Slight Swelling and Tenderness in Armpit (Lymph Node) of Injection Arm  Day 4 - Slight but Easing Swelling and Tenderness in Armpit (Lymph Node) of Injection Arm
patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion); patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) in a 63-year-old female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because  facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
VERY TIRED, DIZZY, WEAK.  FACE BECAME BRIGHT RED.  DURING EVENING LATER FEELING ITCHY ALL OVER BODY & HOARSENESS SET IN.  RASH ON BACK.
Patient received 2nd dose less than 24 days from 1st dose at only 23 days apart.
Pt received Pneumo vaccine PPSV23 on 12/21/17 @ 9am. Pt came in 12/22/17 @ 211pm with Swollen, red left upper arm with two raised areas. Pt states reaction started yesterday night. No difficulty swallowing at this time. Advised pt to go to Urgent Care and take BENADRYL for reaction.  Offered pt follow up appt with PCP on 12/26/17 and pt refused stating reaction resolved and is no longer an issue.
I received the shot Saturday at 1pm. The next day, late-afternoon Sunday, I experienced the expected flu-like symptoms: low fever (99.4 degrees F.), fatigue, aches, slight arm pain on left side, and fatigue. Monday morning (5/10) I woke up in a sweat; my fever had broken. But I had a slight headache and tinnitus. This headache and tinnitus has continued to the present day (5/17). Both have lessened in severity, and they were never crippling (I could still work and go about my business) but the constant, low-level pain is annoying. I also experience bouts of lightheadedness. Before the vaccine I had never had headaches or tinnitus.
This spontaneous report as received from an unspecified healthcare worker refers to a 16 year old patient (patient #414) of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Patient presented to emergency department with hyperglycemia, shortness of breath, and myalgias. She was found to be COVID-19 positive and was admitted to hospital for management of hyperglycemia. Patient was asymptomatic for COVID.
TURNED LIMP AND IRRITABLE X2 DAYS. NO CYANOSIS, NO SEIZURES,NO FEVER
BECAME LIGHT HEADED, NAUSEOUS AND HAD INCREASED HEART RATE ABOUT FIVE MINUTES AFTER INJECTION. AT 15 MINUTES FELT BETTER BUT NAUSEA AND ELEVATED HEART RATE CONTINUED.  FELT FINE OTHER WISE WITH ON OTHER SYMPTOMS.
From provider note seen in March, 2022: In Sept 2021 she received her 1st Pfizer Covid vaccine in her right arm.  No issues the first 5 days or so.  She then developed pain in her right arm and then after about a week developed tingling, spasms that was present most of the day until about Dec.  She can also have leg spasms and paresthesias in her right leg with the same timeframe.    Currently happens about twice a week that lasts for about 30 minutes currently.  No weakness, loss of fine motor skills, gait disturbance, vision disturbance.  About 2 weeks after her injection she also had right sided facial drooping.  Would be worse after sleeping on that side.  She has no pictures of it.  However, she reported that co-workers clearly noticed.  This was present for a few months and has slowly improved and the facial drooping is no longer an issue.
Patient received Hep A #2 and after 5 minutes, she developed stiffening of arms & legs cold & unresponsive u/c lasted 30-45 seconds & recovered fully.
Provider was contacted by third party claiming to be family member of patient stating the day after vaccination, on September 15, 2022, patient complained of fatigue, chills and body aches.  Later that same day patient was found deceased in his car.  Cause of death is unknown to Provider at this time.
Headache, Myalgia, CHILLS, SWEATING Narrative:   Other Relevant History:
RHEUMATOID ARTHRITIS BREAK OUT; HAIR FALLING OUT; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total (first dose), administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from 22-DEC-2021 for moderate to severe rheumatoid arthritis, and moderate to severe chronic plaque. Age at time of vaccination 56 years old. No concomitant medications were reported.  On 27-APR-2022, the patient experienced hair falling out. On an unspecified date, the patient experienced rheumatoid arthritis break out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from hair falling out, and the outcome of rheumatoid arthritis break out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  20220601424-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis break out. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Narrative: Patient would like to report the side effects he experienced after receiving the MODERNA vaccine 04/15/2021. He reports 20 minutes after receiving the second moderna dose he had an extreme headache. Then he was bed ridden for 3 days with body aches, and soreness at the injection site. He also had erectile dysfunction for 2 weeks along with intermittent burning sensations throughout his body. He reports he had covid prior to getting vaccinated and his symptoms were near as bad then with the vaccine. Patient reports COVID positive Nov 2020. Symptoms: Symptoms: 1. Headache
I have gotten a bloody nose twice now, which has never happened to me before. First, last night and then this evening. Both times were when I was near hot water. I have felt very thirsty, and almost dehydrated--my lips are very dry but not chapped. I have been drinking more than a normal amount of water because of it but I still feel very dry.
Redness, swelling, burning in the arm. Following after...I had burning in the joints all throughout my body. My muscles felt very heavy and extremely fatigued, I saw spots, ringing in the ears, vertigo, depression, I thought I had bone cancer. I became pregnant with my second son in June 2016. I had very low white blood cell  count the entire pregnancy. At the 19 month checkup they found that my son had VUR. He was born 3 weeks early with stage 5 VUR. My pain and muscle fatigue has gotten worse. The littlest things can put me down for days. I have to completely change everything in order to get the energy and movement back that I had before the vaccine through plant based nutrition and detoxes. With my first pregnancy I had no complications and was full of energy. With my second after the vaccine I had insomnia along with all the other complications.
After the vaccination sharp pain in the arm. Late in the evening diarrhea started. The next day diarrhea became more severe. I started a brat diet. ( banana, rice, apple, and toast with plenty of fluids. By the following day the diarrhea ceased.
Pts liver function studies were reported to be very elevated approximately 10 days post vax. A lab test revealed negative hepatitis b titers. No further information is available.
Had the shot, still got it a year later/Suspected vaccination failure; Still got it; Had pain; nerve pain sometimes; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and nerve pain were not recovered/not resolved.   The reporter considered the vaccination failure, shingles, pain and nerve pain to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot, still got shingles a year later after the shot. The patient had pain, but no blisters or sores. The patient tool medication about a month, still experiencing nerve pain. The reporter denied for follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
loss total hearing in right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "loss total hearing in right ear".  Clinical course: Just loss total hearing in right ear. Read where Pfizer vaccine might cause this. I had all Pfizer Covid vaccinations and boosters. What do you know about this possibility?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Moderna vaccine DOSE 1 -on 2/13/2021 and DOSE 2 on 3/13/2021 then Pfizer vaccine DOSE 3 on 9/17/2021. The error occurred by giving Pfizer for dose 3 instead of Moderna.  I spoke with patient on 9/20 and she reports no symptoms since receiving her Pfizer vaccine on 9/17/2021. Of note, patient also received a high dose flu vaccine on 9/17/2021. She is tolerating vaccines well at this point.
Inj of flu vaccine with incident 10/21/2006 left arm noted blister at injection site, 1/2 inch blister reddened border, mildly inflamed non tender no discomfort, swelling or fever.
Fever (low-grade) sore throat, weakness in legs, dizziness. Symptoms beginning within hours of vaccine. Taken to ER and treated fever- dx- unknown sent home. 11/13 feeling better today.
She got her vaccines, had no initial reaction, was fine, went home and went about her business.  Then on 10/1/23 she went to get up and coul dnot walk.  Every muscle were so painful, felt like somebody beat her up.  Her legs, back of her legs, her arms and she could not even touch her body the pain was so bad.  She went to go to the bathroom and itr was painful as it hurt to sit on the toilet due to the pain in the bakc of her legs.  She could not stretch her arms or anything.  She went to bed as she had chills.  She tried to get up and just satyed in bed.  Monday the same thing, she started moving her legs, moving her arms, stretching.  Wednesday she was better, yesterday she was better, and today she is better.  She took Naproxen this morning to help with the discomfort, and hopes that this helps.  She is out and driving but was afraid that her legs were going to to out.  Her legs were contracting, and the pain was severe.  She took some Tramadol on Tuesday and had to do something as she could not stay like that.  She did call her doctor and they could not see her until 11/7/23.  She did not want to go to the hospital.  She had no appetite for 3 days whatsoever.  The 3rd day she ate some bread, she had breakfast and dinner yesterday and now is feeling better.  She did have a slight headache, but that has gone, and she did have some diarrhea that lasted for the 3 days as well, that has improved now as well.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June into July"), unspecified number of patients received unspecified doses of ROTATEQ (orally; dose, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Upper left arm swollen, tender to touch, slightly itchy and red circle approximately 4.5 inches in diameter. No action taken at that time. Late Friday night became more painful and red, muscle tight in bicep area.
chills, fever of 101.2°, vomiting , headache, dizziness & nausea
HCP called to state that the patient was given VARIVAX after a TE event.; No additional AE reported; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported). (Product storage error). The administered dose underwent a temperature excursion, but parameter where not reported. It was unknown if any previous temperature excursion happened. No additional adverse event was reported.    This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA007002:MSD US-009507513-2303USA006967:MSD US-009507513-2303USA006931:MSD US-009507513-2303USA006933:MSD US-009507513-2303USA007031:MSD US-009507513-2303USA006940:MSD US-009507513-2303USA007041:MSD
Pt received vaccine and waited 30 minutes post-vaccination due to list of allergies/intolerances to medications/vaccines. After leaving vaccine clinic, Pt developed weakness and dizziness and returned to COVID Vaccination Clinic to report symptoms.  Vitals signs taken: 238/101 HR 87BPM, O2 97%; Emergency Responders called to transport Pt to ER for evaluation; BP 217/100 on recheck.
it nearly killed her; like a heart attack; vaccine reaction; further described as throwing up; chest pain; This spontaneous report refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, route, lot# and expiration date were not provided). She stated it nearly killed her (near death experience) and she further described as throwing up (vomiting), chest pain and almost like a heart attack (myocardial infarction). The outcome of near death experience, chest pain, vomiting, vaccination complication and myocardial infarction was unknown.     The reporter considered vaccination complication, myocardial infarction, chest pain, vomiting and near death experience to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown) as she considered the reaction was caused by an ingredient in the vaccine but she did not know much about that.  Upon internal review, myocardial infarction and near death experience were considered medically significant events.
Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.
pt recvd vax 27DEC93 about 1130AM; 8PM on 27DEC had t103, convuls-little jerks, body rigid;
unexplained infant death;autopsy finding of hydronephrosis & renal insufficiency not felt to be r/t pt death;
Patient had nausea and vomiting after the shot.We offered to seek medical attention and patient refused and stated that she feel nausea before with another vaccine and felt better after some time. After  20 min she started feeling better and  went home.
Rash (7/10/19@12:00); Influenza-Like Illness (7/10/19@12:00)