chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced vaso-vagal response immediately following injection. Eyes rolled back and he slumped over in chair. Made snorting sounds. Some tremors.  Sweating. Legs elevated. Chair reclined. Aroused after about 45-60 seconds. Alert and appropriate responses to questions. Acknowledged that he had not had anything to eat recently, nor had he had fluids. Ice chips offered. Assisted to wheelchair and transported to Obs for VS. Ice water and coke offered.
difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weakness; loss of weight; loss of appetite; my joints got pain; it's the pain at the injection site; Muscle pain; Fever; Nausea; Feeling unwell; Restless; congestion; dizzy; swollen; constantly using the bathroom, having bowel movements; peeing a lot; can't stand up; I can't get out of the bed; my legs are so weak; I can't even stand now; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via intramuscular route of administration in right arm on 01Jun2021 at 01:00PM as single dose for covid-19 immunisation. The patients medical history included large prostate, gold stones in 2014, high blood pressure, operation on Gall Bladder (gall stones that were in gall bladder in 2014). Concomitant medication included lisinopril (20 mg, 1xday) for blood pressure measurement. Patient had the Pfizer covid vaccine on 01Jun2021. Patient went to get the Moderna but he got the Pfizer. Nurse told him that everybody was different, and it work in different kind of ways and she said that once he got the vaccination to fight the COVID, it just maintains that. On 03jan2021, Patient did not get out of the bed, he became dizzy, weak, his legs were so weak, lost massive weight (dropped to 145kg/2 pound) and the pain at the injection site, feeling tired, had a headache, got muscle pain, had the chills, joints got pain, bone aches. He had a fever, nausea, congestion, feeling unwell, swollen, was restless and pain to walk. He did not stand up. Took tylenol (spoonful, once a day, orally) for the headache and the fever. Had also been using the bathroom a lot. his most recent weight was 135 after he took the shot at 1:00pm on 01Jun2021. On 22Jun2021 to patient has get the second one but did not feel like taking it. Patient did not had any prior vaccinations within 4 weeks. The outcome of the event cannot stand was unknown and other event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Gout like symptoms in left big toe, Treated with prednisone 10 day taper,  then followed with  Catizone injection 14 days later. The pain subsided after 14 days
within 10 minutes of receiving the vaccine, I felt a funny feeling over my entire body. I also felt like my heart was racing and I was going to pass out. I remained at the pharmacy for approx another hour, still not feeling well. EMS was called, checked my BP and heart rate, which was a little elevated. SBP 137, HR 90-low 100's. I did take some liquid benadryl while still at the pharmacy. After about an hour and a half to 2 hours, the feeling completely subsided. The symptoms began again today 4/9/21 at approx 1015am. I have taken another benadryl capsule.
Vaccine was incorrectly reconstituted with 0.8mL NS instead of 1.8mL by LPN. After incorrect reconstitution, 0.3mL of the vaccine solution was administered IM. Patient stayed in office for 15 minutes after administration. During that time, no adverse effects were reported by patient or noted by healthcare providers.
Overnight developed chills, body aches, nausea w/vomiting, headache.
Three days after vaccination my heart rate increased, and had a slight elevation in blood pressure. Then about 6 months later, started feeling heart palpitations and trouble taking in a deep breath. Had an EKG at the hospital where I work and it was abnormal. Went to my Cardiologist the next week where he ordered an Echocardiogram.  My Cardiologist ordered an Echocardiogram. By time I saw him my heart rate went down a little bit. The Echocardiogram showed that Parameters showed are consistent with abnormal left ventricular relaxation, grade 1 Diastolic disfunction.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received 3 vaccines, after vaccines were complete she said she didnt feel well and laid on table. BP 100/68 pulse 86 and oxygen was 100 at the time. Patient aroused and provided water
A report has been received from a Physician concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Nov-2012. The patient experienced RUNNY NOSE. The patient recovered from the event of RUNNY NOSE on an unspecified date. The report was considered to be non-serious. The reported physician causality between the event of runny nose with the FLUMIST to be yes. Summary of follow-up information received by AstraZeneca on 12-Nov-2012 from Physician: Reported causality added. Outcome of event runny nose changed from unknown to Recovered. Corrected report: Vaccine type added.
was sick for three days; pissed off had to pay to get sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and feeling irritated. On an unknown date, the outcome of the sickness and feeling irritated were recovered/resolved.   It was unknown if the reporter considered the sickness and feeling irritated to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:11-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient was sick for three days when the patient got the first shingle shot. The patient hope he or she would not that sick when get the second one. The patient also pissed off that had to pay to get sick. Additional Supportive Information: Follow up would not be possible since no contact details were provided.
ringing in my ear started while i was asleep. i think i woke up due to it. was difficult to get back to and stay asleep.  the next day, 4/20/21, it was only noticeable when it was quiet. that night, it was very faint and didnt disturb my sleep, from 11pm to 5am. woke up with ringing at that time and was in and out of sleep til 7am.  it was faint all day until about 7:30pm, now it may be as loud as it was when it started. it is 8:05pm at this time.
her arm was sore; she felt tired; achy; Arm blew up like a baseball: This diminished over the 1st and was hardly noticeable, by the 2nd it was gone.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2020 (Lot number: EJL685) at the age of 73 years as dose 1, single and administration date 12Jan2021 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore"; FATIGUE (non-serious), outcome "unknown", described as "she felt tired"; PAIN (non-serious), outcome "unknown", described as "achy"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Arm blew up like a baseball: This diminished over the 1st and was hardly noticeable, by the 2nd it was gone."  No follow-up attempts are possible. No further information is expected.
Received MMR 7/6/12. Measles rash 7/16/12.
Flu like symptoms for 12 hours after first vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after first vaccination) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after first vaccination). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patients symptoms lasted for 12 hours. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-336858 (Patient Link).
I experienced significant injection site soreness (but no redness) that started around 9pm day of vaccination. I was also fatigued feeling by 9pm but could not fall asleep most of the night. During the day 1/17/21 I was fatigued, mildly chilled and experience an achy neck and mid back which spread to lower back by midday and by the evening noticed some mild leg aches. All of the above symptoms had dissipated by morning on 1/18/21.
About 10 mintues after the vaccination while the patiet was waiting the 15 minute obvservation time, she complained about feeling nausea, and tingling and numbness running down her left arm. ( The left upper arm recieved the IM shot).  Patient stated she was feeeling  anxiety and was afraid her blood pressue was increasing.  She took a read on the automated personal health station and got a reading of 178/99.   Pulse 78    10mins later I took a reading using a  hand held blood pressure reader and got  175/98  pulse 74,  10min later  next reading was 176/89  pulse 68.  At this time I called for EMS to come and evaluate the patient  and her symptoms.   About 10 minutes after the last reading the EMS tech  took reading of 174/73 pulse unknown.  After their assetment of the patient and talking with the her daughter the patient refuse transport to the ER and was taken home by her daughter
Breakthrough case admission after 2nd vaccine. #1 Pfizer 4/14/21 Lot# EW0169 #2 Pfizer 5/5/21 Lot# EW0171
Received vaccine on 3-25-03. March 29th dime size reaction. 24 hours later 50x70 mm. Patient went to hospital 3-30-03, was treated with Benadryal liquid, client states had no symptoms other than reddness at the injection site.
Temp 37.4 degrees. Pulse 88. BP 98/62. Treated with KEFLEX 250/5mL 8 mls 30 day. Ibuprofen 100 mg chew tid prn. Came to see dr for fever and sore arm.
Moderna COVID-19 Vaccine EUA Received second vaccine around 9:30 AM, 3/16/2021. Minimal tenderness at injection site. Around 2:00 AM 3/17/2021 ( the day after the vaccine was administered), I awoke with entire body aches, low-grade headache which transitioned to a migraine by 8:00 AM, vascillated from chills to feverish, abdominal cramping without nausea, weakness/fatigue and lack of appetite.  These side effects began to lessen around 6:00 PM, though persisted until bedtime.  Slept through the night and awoke the next morning (3/18/2021) with a low-grade headache and muscle soreness.  March 18, 2021, I was able to go about my daily routine without disruption.
Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he felt at 3:27 during his 30min observation, patient report he felt "spacey" because he had not eaten since breakfast. EMT alerted PHN'S. 3:30 blood pressure 200/130, pulse 86, respirations 18, O2 93%. Patient was A&Ox4, denied headache, dizziness, swelling, tingling, altered vision. Medications: simvastatin, amlodipine, gabapentin, methocarbinol, vitamins. Medical conditions include kidney problems, hypertension, polycythemia, spinal fusing, chronic pain. Patient receives therapeutic phlebotomy and is 1 week overdue. 3:35 blood pressure 182/120, pulse 88, O2 99%, respiratory rate 20. 3:40 blood pressure 192/119, repiratory rate 24, paitent reported anxiety and lightheadedness, continued to deny headache, blurry vision. PHN called 911 at 3:42, offered Bendaryl to patient who declined. 3:50 911 assumed care, reported blood pressure 210/palpated and temp 101.1. Patient's partner arrived. Patient declined 911 transport at 3:53. Patient reported he would have his partner drive him to urgent care. Patient left with steady gait at 4:09.
PATIENT WAS WAITING THE 20 MINUTES POST VACCINATION . WITHIN 10 MINUTES OF SHOT, PATIENT FELT LIGHT HEADED, HAD HER EYES CLOSED. PARTIALLY RESPONSIVE. AFTER LYING ON FLOOR WITH LEG ELEVATED, PT FELT A LITTLE BETTER BUT  ALSO COMPLAINED OF LEFT LEG NUMBNESS. ON STROKING HER FOOT, PT HAD SENSATION. EMS WAS CALLED. PATIENTS VITALS WERE BP 80/60 AND BS 127 . PT WAS TAKEN TO HOSPITAL AS SHE STILL FELT LIGHTHEADED STANDING UP.
This spontaneous report was received from a licensed vocational nurse and refers to a 44 year old female patient. The patient had no concurrent conditions, pertinent medical history or drug allergies/drug reactions. On 09-MAY-2008, the patient was vaccinated with the first dose of MMR II (lot reported as 0Q85U, expiration date 02-FEB-2009) (route, strength were not reported). Concomitant medications included VALTREX. On 28-AUG-2012, the patient was tested for titers, which were found to be negative for the mumps component (mumps antibody test negative). Therefore, on 31-AUG-2012, the patient was vaccinate with a second dose of MMR II (lot reported as 0447AA, expiration date 28-MAR-2013) (route, strength were not reported). On 08-MAR-2016, the patient was tested again for titers, which were found to be "negative for titers for the mumps component only"(mumps antibody test negative). The nurse reported that the patient came back to the office for another dose of MMR II as vaccination against mumps was a requirement for her nursing school. The reporter indicated that on 14-MAR-2016, the patient received a third dose of MMR II (lot reported as L027431, expiration date 22-JUL-2017) (route, strength were not reported). There was no product quality complaint involved. At the reporting time, the outcome of mumps antibody test negative (28-AUG-2012 and 08-MAR-2016) was reported as not recovered/not resolved. Additional information has been requested.
I had first day vomiting and diarrhea day two fever over one hundred degrees day three was body aches day four the cough started and then days six my asthma started and got worse and worse and by day twenty I went to my doctor and right now we are day maybe thirty five days and I am starting to feel better after medications only.
Saturday, March 25, 2023, I got really tired that afternoon and felt weird. Sunday, I woke up and my chest felt like it was being crushed. I had overall lethargy and head congestion. I felt worse as the day went on and got a sore throat as well. I tested positive for COVID-19 and was prescribed PAXLOVID. I took 3 doses, but it made me throw up and the metal taste was horrible. I ran a fever for 9 days straight. Oxygen level was normal. The cough horrible. As of today, I have not regained my energy. On day 10 I had not fever and it has not returned. I still have the metal taste in my mouth as well.
Patient received pfizer vaccine ~4pm patient had no issues immediately after administration of vaccine. ~5-10 minutes after receiving vaccine daughter came running back to pharmacy stating her father had passed out. I immediately went to where father was. He had passed out on to floor. The daughter stated he hit his head  when he fall. When  I got to patient he was conscious but very lightheaded, calmy, sweaty, flushed and not coherent.  EMS was called . Patient while sitting on the floor after passing out, he passed out a second time for few seconds and arm withdrew in and he begin to shake but after few seconds laid straight on floor. Checked patient blood pressure  at 4:10pm it was 150/105, HR 45, o2 stat 97.  EMS arrived and he had began to come around 4:15pom BP had improved to 145/95. He did vomit ~4:15pm. EMS recommended patient go in to be checked out due to hitting head. EMS felt it was possible vasovagal response to vaccine. Patient went to hospital with EMS and was alert and aware and not as calmy .
2nd shot Petechiae sever around both eyes within a few hours of injection, no trauma, coughing,  vomiting, vision became slightly cloudy after 48 hours.  Vomiting after 24hours briefly.  Body aches, dizzy, time perception off, 102 fever 2 days. Weakness and stomach discomfort bloating pain. Severe testicular pain.  1st injection  lot 026A21A 106 fever for 3 days, fever 4 days, symtoms 1 week, weakness, cold flashes, hot flashes, tingling, testicular pain, sleep issues, severe time skips and slow downs. Chest ache. Muscle aches.  Had covid-19 in July 2020 contracted via facility
Pt recvd DTP/OPV in the AM; c/o lt arm pain p/shot; apparently fainted during lunch; Was pale & eyes rolled back; Arms flexed against chest, legs were straight out was stiff, not limp; wanted to sleep; poss sz; initially whiney;
Initial unsolicited report received from a nurse on 31-Aug-2018. This case involves an eight-year-old patient (gender not reported) who was vaccinated with a dose of 0.25 mL of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient medical history and concomitant therapy not reported. It was as actual medication error due to vaccine underdose. It was unknown that any adverse event was 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.
Throat felt tight, reddened, swollen area around injection site, was seen in urgent care.
Large swelling, heat pain @ injection site and soreness same side shoulder; treated with elevation and active ROM; 18 hours post injection had large hives below the waist which decreased to smaller hive over the next 8 days; day five got sore, itchy eyes, hoarseness, mild headache and as the hives decreased they were replaced by general itching and fatigue; after day 8 I had a mild cough for two days; all Sx appeared resolved by day 10; NEVER had body swelling nor breathing difficulties, which is why I did not call my MD; unclear if I had faster heartbeat one night about day 3, or not; late term dizziness last days #8, 9.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER 8734), in right arm, on 21Apr2021 as dose 2, single (Lot number: Ew 0153), in right arm and on 30Dec2021 at 14:00 as dose 3 (booster), single (Lot number: 7J8757) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: Other medical history :High BP, former breast cancer pt,; "former breast cancer pt" (unspecified if ongoing), notes: Other medical history :High BP, former breast cancer pt,. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 04Aug2022, stop date: 26Sep2022; MUCINEX DM, start date: 26Sep2022, stop date: 29Sep2022; TYLENOL, start date: 25Sep2022, stop date: 30Sep2022. Patient known allergies reported as none.   The following information was reported: VACCINATION FAILURE (medically significant), 1 year 6 months 8 days 7 hrs after the suspect product(s) administration, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received treatment with paxlovid from 26Sep2022 to 30Sep2022 for COVID-19.
PATIENT WAS GIVEN THE PEDIATRIC DOSAGE OF 0.2 ML OF PFIZER. PATIENT REMAINED ON SITE FOR 15 MINUTES WITH NO REPORTS OF ANY REACTION.
This medically confirmed spontaneous report (initial receipt 17-Oct-2012) concerns a 39-year-old female patient. On 15-Oct-2012, the patient received AFLURIA (batch number: P59407A) injection intramuscularly in the deltoid. Within 24 hours after receiving AFLURIA, the patient developed an injection site reaction. The injection site reaction was described as a red, swollen, hot and itchy area at AFLURIA injection site. On 17-Oct-2012 the injection site reaction was about 4 cm in diameter and reported to be improving (still swollen, red and hot, but slightly smaller in size and with less itching). No lab diagnostic study was performed. The patient did not receive any treatment for the events. The event outcome was recovering.
A 35 year old female patient experienced mal-administration of RabAvert, injection site reaction with pain, pruritus, mass and malaise for pre-exposure prophylaxis. She received 1 dose of RabAvert 1ml ID to the left upper inner arm as a booster beginning 10/8/04 (lot number unavailable). Past medical history and concomitant medications were not provided. The patient (who was also a health care professional) received one injection of RabAvert on 10/8/04 and was aware that the clinic administered the injection ID instead of the approved route of administration of IM. She experienced the injection as painful. The injection was raised and red approximately 1.5cm in circumference and had a 2-3cm area around the raised area that was red. The injection site also itched and the patient felt some malaise since the injection was administered. The redness had not improved. Follow up information received on 10/14/04: The patient was not taking any concomitant medications and had no medical problems. The patient developed the injection site reaction and self-administered one dose of over the counter Benadryl 50mg. She had not sought the advice of a health care professional but was planning on returning to the clinic where she received the vaccine on 10/15/04. The events had improved 80% overall. She had no further malaise. The injection site was still red but only slightly raised in the center. The skin around the reddened raised itchy area became bruised and was still slightly bruised. Slight itching remained. (OMIC)