chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first Moderna shot on March 24th. Just had a sore arm the next day.   April 2nd: Around 1pm at work I was starting to feel a headache coming on. By about 2-3pm it was worse and felt tired/drowsy. I ate supper then went to take a nap at 7:30pm. I woke up at about 10:30pm, checked the time and just felt out of it so I went right back to sleep.  April 3rd: I slept until my dog woke me at about 5:50am and felt pretty good, still minor headache and some chills. During the night I did feel some soreness in my arm that got the covid shot. After I showered I checked my arm and it was swelled up with a rash like redness maybe an inch in diameter. I was fine for most of the day enjoying the nice weather outside. Then about 6pm I started to feel the headache again and some chills. Went to bed at about 10:30pm, headache was bad, had the chills, started coughing some, and just didn?t feel normal, took some Tylenol to help through the night.  April 4th: Slept through the night fine, woke up with a mild headache and a sore throat. Had some dry coughs occasionally throughout the day, but was fine most of the day.  I did check my temperature throughout these past few days and all check were normal.  April 5th: Almost back to normal, still have a sore throat and cough. My arm rash near the shot area has gone away, just a little swollen.  April 6th: Back to normal health.
30 minutes after, severe soreness, 60 minutes after, severe nausea, 180 minutes after, fever spiked of 102. Symptoms subsided 360 minutes after vaccine.
Rash underneath armpit and neck, also rash on abd. Child taken to ER. Mother stating she was told it was a heat rash, but she will follow-up with MD.
Rapid, pounding heartbeat. Begin hours after vaccine.  Still occurring 32 days later.
patient was accidentally given a Pentacel vaccine instead of just DTAP/Ipol, no AE; 5 year old was given pentacel, no AE; Initial information received on 06-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five year old male patient who received 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ227AAA, Expiry date 23-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination instead of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE, on 29-Jun-2020 (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported Nurse stated that she read a story on her iPhone from the clinic about the patient who got clots after 3rd full dose of covid-19 vaccine of unknown manufacturer.  Company comment- This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, serious (medically significant) adverse event of special interest Thrombosis which occurred at an unknown time after vaccination with a third dose of mRNA-1273. A nurse stated that she read a story on her iPhone from the Clinic about someone who got clots after a 3rd dose of a Covid-19 Vaccine of unknown manufacturer. The outcome of the events was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.   This case was linked to MOD-2022-569119; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, serious (medically significant) adverse event of special interest Thrombosis which occurred at an unknown time after vaccination with a third dose of mRNA-1273. A nurse stated that she read a story on her iPhone from the Clinic about someone who got clots after a 3rd dose of a Covid-19 Vaccine of unknown manufacturer. The outcome of the events was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.
Discharge Provider: (name withheld) Primary Care Provider: (name withheld) Admission Date: 6/27/2022 Discharge Date: Jul 4, 2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia  Hypoxia  COVID-19    HOSPITAL COURSE:  a 54-year-old male with history of neuromuscular disorder, hypertension, DVT/PE on Eliquis, neurogenic bladder, RLS and OSA who presented with fever, cough and shortness of breath.  He initially presented to Hospital, where he was noted to be febrile tachypneic and hypoxemic.  He was placed on 6 L oxygen.  Labs showed a WBC count of 9.03, procalcitonin 0.08 lactic acid 2.7.  COVID was negative on film array, but positive on PCR.  Chest x-ray showed right-sided airspace disease, improved on the right, but worse on the left.  He was given IV vancomycin and IV Zosyn.  CT thorax without contrast was then done, and showed increasing moderate patchy airspace disease, concerning for worsening multifocal pneumonia.  Patient was transferred to Hospital for further care.   Upon admission, the patient was placed on nasal cannula oxygen.  He had rather rapid deterioration on the morning of 6/28, and was requiring 100% non-rebreather.  He was transferred to the intensive care unit at that time, and placed on high-flow nasal cannula.  He was started on Decadron 6 mg daily as well as IV remdesivir.  Infectious Disease and pulmonology services were consulted.  He was started on Bactrim DS 2 tabs three times daily due to concern for possible Pneumocystis pneumonia.  Pulmonology performed bronchoscopy on 06/29/2022.  Infectious Disease also recommended treatment with convalescent plasma, which could only be done at Hospital.  He was transferred to Hospital for this therapy.  His respiratory status had improved by time of transfer, and was felt appropriate for general medical floor at hospital. Patient was transferred to hospital where he received convalescent plasma, he was able to wean his O2 and he completed 7 days of zosyn and 5 days of remdesivir. Patient was started on 10 days of decadron before resuming his home O2. Bronchoscopy results were negative aside from COVID-19. Patient did require O2 with activity at the time of discharge. He also was continued on PJP prophylaxis per ID recommendation. Patient was instructed on signs and symptoms of when to return to the ER. He was then considered stable for discharge home. Patient was given a referral for the hospital at home program.
Burning in digestive tract; Belching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoking", start date: 2021 (ongoing), notes: stopped smoking and then, Chantix was recalled and she started smoking again in 2021. The patient's concomitant medications were not reported. Past drug history included: Chantix, start date: 2021, stop date: 2021, for Smoking cessation, notes: Expiry Date: May2023, Dosage permanently discontinued. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: ER8733, Anatomical Location: left arm), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning in digestive tract"; ERUCTATION (non-serious) with onset 2021, outcome "not recovered", described as "Belching". The events "burning in digestive tract" and "belching" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not on any other vaccine 4 weeks prior to Pfizer vaccination. The patient had no AE(s) prior to Pfizer vaccination. The patient reported that she started smoking again after Chantix recall, she cannot remember the exact date, but started smoking again in 2021. She stated she was down to 2 cigarettes a day and alternating with 1 cigarette. She was up to 5 cigarettes a day now, depending on the day. She has had many tests for her digestive symptoms, unspecified and the doctors cannot make a diagnosis. This week she was having a digestive motility test. These events did not resulted in emergency room visit. She clarified these events occurred after stopping Chantix, and after she had the second Pfizer Covid vaccine, adult. Events Burning in digestive tract and Belching occurred at the end of May2022 or beginning of Jun2022. Belching still persisted.  No follow-up attempts are needed. No further information is expected.
Information has been received from a certified medical assistant (C.M.A.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. The reporting medical assistant reported that, since 02-JUL-2015, these patients were vaccinated with doses of RECOMBIVAX HB (lot # K021444, expiration date 17-SEP-2016; lot# K026666, expiration date 22-OCT-2016; dose and route not reported) which were exposed to temperatures outside of the recommended range on 02-JUL-2015. Among them, unspecified patients received RECOMBIVAX HB (lot# K021444, expiration date 17-SEP-2016) on 07-AUG-2015, 10-AUG-2015, 11-AUG-2015 and 13-AUG-2015. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
administered an expired ACT-HIB vaccine to a patient, with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 7-month-old male patient to whom administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for Immunisation.  On 13-Feb-2023, the patient received dose 3 at 0.5ml total of suspect HIB (PRP/T) VACCINE, Strength: standard (formulation: unknown) (Lot Number: UJ472AC, UJ472ACA; Expiration Date :2022-06-23, 2022-07-08) via intramuscular route in the left thigh for Immunization and on the same day administered an expired act-hib vaccine to a patient, with no reported adverse event (expired product administered).  It was reported that a nurse at the facility misread the expiration date on a vial of ACT-HIB of 23JUN2022 and believed that it didn't expire until 2023 so it was kept in the refrigerator. Caller asked for guidance on how to proceed in this situation. Caller asked if there was a waiting period for re-vaccination or if it could be done right away?   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  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 the 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.
Intern came to help out with the vaccines and processing them, at the store I was floating to. I took out the vaccine from the refrigerator to thaw. I indicated to her as such. But  there were 2 vials( 1 Pfizer+ 1 Moderna) left over from yesterday(12/13) sitting on the other side of the back counter, with a sticker on the bottom indicating the time and date. She thought I already prepared the vaccines and ready to go. So she started giving  vaccines from those vials.  After giving the 2 Pfizer and 3 Moderna vaccines, she realized that it was a bottle from yesterday. She alerted me as such .  None of the patients called back reporting any adverse effects. we reported to out patient care services manager and he is looking into more details
Complains of burning sensation on his tongue, noted 12-11-13, the day after he received three vaccines at this PCP appt. Flu, Pneumonia and Tdap vaccine. Describes the feeling as like he drank some hot coffee and burned his tongue but he has not. Today symptoms are slightly improving. Denies any difficulty swallowing or breathing. Eating small bites
This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received INFANRIX. Co-suspect products included PEDIARIX, ENGERIX B, FLUARIX and KINRIX. On an unknown date, the patient received INFANRIX at an unknown dose, PEDIARIX at an unknown dose, ENGERIX B at an unknown dose, FLUARIX at an unknown dose and KINRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, PEDIARIX, ENGERIX B, FLUARIX and KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information.
first dose on 2019, due to COVID not been able to receive the second; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient was not able to receive second dose of Shingrix due to Covid pandemic. The patient asked if he/she should just get the 2nd dose or should restart the series. Follow-up would not be possible as no contact details available.
patient got the flu shot.  i had her sit after the vaccine to make sure she felt fine like i do for all other patients. a few minutes later, the patient passed out from the chair in wiaitng area. she landed on her side and her face hit the ground as well. i had a tech call EMS while i took care of patient, after a few seconds she came to and was talking. EMS came, pt was treated by them. mom and boyfriend came to pharmacy. she walked herself out of the store and did not go to the hospital.
I had the Tdap shot. Shortly after my speech was getting slurred and still is. I've seen a neurologist, had 2 cat scans and MRI all kinds of blood tests and they cannot seem to find anything that is causing this. I even had my teeth pulled on the bottom and had a bottom denture put in. They thought it may be that I got an allergy to my partial which was made from Chronium and Cobalt which I found I am allergic to when I had my knee joint replaced; but that hasn't helped. Thought after a while that maybe it was the Tdap shot. Doctors cannot find anything else. I did not have it repeated, because they informed us that some people had reactions after the second shot. I'm not sure of the date of the shot. Asked the doctor about this and he made no comment 8/30/07-records received for DOS ranging from 12/13/05-6/25/07-Dysphagia. vaccine given on 12/13/2005. Second on 7/31/06-routine visit no complaints. 2/24/07-C/O thick tongue, trouble with speech. 2month HX of increasing tongue thickening sensation. PE tongue swollen no other focal neuro symptoms. Sinus congestion in the past few months. Antibiotics helped temporarily. Slight decreased nasolabial fold on left side.  Tongue swelling improving.  Tongue swelling returned in 3/15/07-Assessment tongue swelling most likely due to allergy. Sinusitis. Borderline HTN. 5/25/07-C/O persistent dysarthric speech and intermittent dysphagia. Cough. Saw allergist and has allergies to multiple metals.  Has decided to replace dental plate which contains metal. Depression with anxiety
Given TDAP 10-10-10. Developed red, warm, swelling & pain at injection site. Returned for re-check, diagnosed with cellulitis s/p injection. Given Rx for KEFLEX 500mg 1 TID X 10 days.
Stroke in right parietal lobe and right temporal lobe on May 27, 2021 Left upper extremity numbness and paralysis Visual and hearing disturbances word problems and mental confusion. 4 days in hospital
FLUBLOK QUAD was adminstered instead of FLUZONE QUAD to a pediatric patient.
Information has been received from a nurse practitioner concerning a 41 year old patient who in July 2010 (reported as "12-JUL-2010"), was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). In July 2010 (reported as "11 or 12 days after VARIVAX was given"), the patient experienced a rash with vesicles at the injection site. The patient had not recovered yet and no other information was available from the caller. Additional information has been requested.
My son began getting a fever, raised red bump at injection site (warm to touch), loss of appetite, runny nose, coughing. We brought him in 5 days later after the fever continued and symptoms did not alleviate. They said it was a virus and dismissed that the symptoms could have started from the shots and said it was not from the shots. My son lost weight and had an oral aversion in fear of not breathing from plugged nose and/or runny nose. He had a loss of appetite and that first night and slept long periods unlike his normal breastfeeding habits. Had to pump milk to feed him because he was so lethargic for 2-3 days. I just realized you can report these since they doctors office did not take our concerns seriously. Now these vaccines are not valid from improper storage.
02/10/2022, I thought I had allergies. I had a runny nose, sore throat and a little bit of cough. I took coricidin HBP.  02/11/2022, I started to get congestion. On 02/12/2022, I told my husband I needed to get tested for COVID. 02/13/2022 I tested positive for COVID using a rapid test. On 02/16/2022, I called my doctor because I got a sinus infection. She told me to use Mucinex and she ordered an antibiotic for my sinus infections. 02/22/2022, I had a PCR test and it came back positive. I was told to stay home for 5 days. On 03/02/2022, I started feeling better. I took another rapid test and it came back negative. I am still left with fatigue. I need to take a nap mid day. During the evening, when I go to bed I smell cigarettes and I am highly allergic to cigarette smoke. I live alone and no one is smoking around me. At night I need to spray perfume on my pillow so I cant smell it. 04/04/2022, my doctor ordered bloodwork and everything came back normal.
Received  the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location.  Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb.  A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist).   My neck got stiff and I was really tired.  The symptoms lasted about 4 hours.    When I woke up this morning the left side of my face and jaw still do not feel 100%.  My left eye is watery.  I'm very tired.
Burning sensation at time of injection (left deltoid) - site x 2 days - weakness in left arm on day  3 or 4 -> unable to left arm fully - progressively worse - saw PCP - XR/sonar normal - went to ER first week of October - Diagnosed: Reaction to flu shot - > referred to neurologist - "Brachial plexus neuritis" - started PT - EMG/NCS 10/23/11 - started improving.
Nine days after adverse effect of headache, body ache, tiredness typical with Shingrix, I went in for a routine blood panel for annual physical.  The PSA test came in abnormal; twice any previous reading.  I will see a Urologist soon to check but have learned that an infection can cause abnormal readings.  Any history of Shingritz  causing an abnormal PSA test?
The patient developed soreness, redness and itching at the site of the injection within hours of administration.  Several hours later he developed shortness of breath, arthralgias, myalgias, chills, sweats that worsened for 1 week and slowly decreased over 3 weeks.  The myalgias and arthralgias have never completely resolved and he continues to have arthralgias and myalgias now over 14 months later.
Hives and Dermatoghraphia that started 10 days after booster shot. The appear all over the body including face, ears and scalp, they do not go away no matter what. Symptoms ease after taking one Zyrtec a day but always return after 24 hours. Mine has been on going for more than two weeks now.