chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within minutes I felt the bursting radiation of sharp heat from my head to my extremities. I liken it to a firework in the sky in a round star formation. Palpitations in my chest area with a tightness. Sharp pains around my belly button and just hot flushing of my body. Later that day I displayed full-blown COVID-19 symptoms (I had last year April). Those symptoms lasted through Monday afternoon. Tuesday I woke up to a mouth full of ulcers, sensitive gums (I could barely brush my teeth, no flossing, and chewing was painful. I also developed fever blisters on my bottom lip mid-center and to the right.
This spontaneous case reported by a pharmacist, describes the occurrence of breast pain, chest pain, dizziness, chills and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced breast pain, chest pain, dizziness, chills, nausea and myalgia (muscle pain/underarm pain). At the time of the report, breast pain, chest pain, dizziness, chills, nausea and myalgia (muscle pain/underarm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
Nausea, vomiting, dizziness, 99.4 temperature, elevated blood sugar, arm pain, all on the day after the vaccine.  Stiff neck and arm pain on the 2nd day.
Severe Fibromyalgia attack until 3/5 Site redness, swelling, itching, still happening 3/9
Pt went home, slept for approx 4-5 hours, woke up with chills which lasted approx. 2 hours. Area of vaccine also bruised.
Vertigo and nausea started Sunday Jan 31 and has persisted. Worse in a.m. upon arising. Still have lingering symptoms.
HPI: 47 yo male who developed diffuse itchy rash two days ago, located mainly in the groin areas and both flanks. Rash worse with warm showers. He denies any associated systemic symptoms. No similar rash in the past. Denies change in cosmetics or laundry detergent. Symptoms better with use of topical hydrocortisone cream.   Physical Exam: GENERAL APPEARANCE: Healthy; alert and oriented X3; no acute distress SKIN: erythematous wheals distributed mainly along anterior belt line and gluteal clefts. Few papular lesions both flanks.   Assessment and Plan: (L50.9) Urticaria  (primary encounter diagnosis) Plan: predniSONE (Deltasone) 20 MG tablet Discussed with patient; recommend systemic steroid treatment. Follow up if symptoms worsen or fail to improve
I have trouble breathing, muscle aches, headaches, fever 104° f for 9 days, shakes, asthma attacks,  hives, feels like I'm breathing through water, bells palsy, trouble concentrating, chest pain, passing out, and severe pain in abdomen.
Patient given MMR in right thigh, PPD, DTaP and IPV on left thigh. Noted to have reaction in right thigh on 10/19/05. Here today. Positive redness and swelling 8x10cm.
Dizziness, clammy skin and dilated eyes, followed by a temporary ?black out?
Self reported vaccinated pt admitted to inpatient facility with covid infection. No info available on vaccine, i.e. type,, date, location, etc.
Pt's mom calling in regards to a red hot spot 1/2 the size of a softball.  According to mom it is on the right deltoid and he was given a Kinrix on that arm.  He c.o. itching and warm to touch and some discomfort. Mother called this am and was advised to use a cool compress on site, give Benadryl for the itchiness and Tylenol for the fever.  Advised her I would call back in pm.  Also advised her to mark the redness with a pen and if it get beyond that marking she is call me so she can come in to have him examined.  Mother states that would work.
received a booster of Menactra 20 days earlier on 03Jan2019 at a Vaccine Visit; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who vaccinated with 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6207AA via unknown route in the right deltoid on 03-Jan-2019.  It was a actual medication error case due to Inappropriate schedule of vaccine administered.  It was reported that received a booster of Menactra 20 days earlier on 03Jan2019 at a Vaccine Visit.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Within 1-2 minutes of receiving the Hep B injection, the patient became pale and vomited twice into the trash. Patient was given a few sips of water to rinse her mouth. Patient was monitored for further changes for about 15 minutes. Prior to walking out of the clinic, patients color was pink and she was acting normal per patients mother. Patient's mother was contacted approx. 8 hours after incident to check on the child. It was reported that the child appeared to be at baseline per mom. Mom did say that the child had vomited 4 times within 5 minutes after receving  the MMR vaccine on 6/21/2018 also.
varicella-like rash (diffuse) onset 10 days p/vax;
A 39 year old male patient, born on 11/15/1965, was vaccinated with the third dose of RabAvert (batch # 355011) IM on 7/28/05 after he had been scratched by a wild rabbit one week ago. On 7/11/05 the patient received his first dose of RabAvert and HRIG. In July 2005, the patient complained about numbness in hands, feet, face, and throat tightness. It was also observed that he showed paranoid behavior. We are awaiting further data. Seriousness criterion: medically significant (OMIC). Causality: unrelated.
Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.
Device issue / appears not to released needle; Strong burning sensation / pain during injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Strong burning sensation / pain during injection) and DEVICE ISSUE (Device issue / appears not to released needle) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (40 mg,1 in 2 wk). On 01-Apr-2022, the patient experienced INJECTION SITE PAIN (Strong burning sensation / pain during injection). On an unknown date, the patient experienced DEVICE ISSUE (Device issue / appears not to released needle). In 2022, INJECTION SITE PAIN (Strong burning sensation / pain during injection) had resolved. At the time of the report, DEVICE ISSUE (Device issue / appears not to released needle) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient had taken the Humira drug in the form of Solution for injection in pre filled pen. No treatment information was provided.
Lack of vaccine efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Lack of vaccine efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Organ transplant.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Lack of vaccine efficacy). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Lack of vaccine efficacy) outcome was unknown.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.
Pt received FluMist on 11/23/2004. She reports that on Friday 11/26, she developed profound myalgia, fever, chills, sore throat. On 11/27 she sought trmt from her personal physician.
Patient received a booster shot for Pfizer but was not over 16 years of age.
Case number PHEH2014US003967, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 and a follow up received from a pharmacist on 01 APR 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) which she tolerated well. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A, and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the right deltoid on 07 JAN 2014 at 16:45 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up received from pharmacist on 01 APR 2014: Updarted vaccination history, time and site of vaccination.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.
24-48hrs p/vax pt devel generalized rash & hives (urticaria) all over the body & wheezing noted upon admission to hosp;t101.2;rx atarax, hydrocortisone
has had the vaccine 2 times/Suspected Vaccination Failure; suffering from the shingles; horrific pain; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: has had the vaccine 2 times/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: suffering from the shingles) and pain (Verbatim: horrific pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that someone he/she knew had the shingles vaccine two times and she was now in isolation suffering from the shingles and was in constant horrific pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Soreness in arm - moved to shoulder - then neck - then across back to the other arm and shoulder. Could not move neck up or down or side to side. Congestion in chest. Still sick but can move neck some. Dr. gave methocarbamol 750 mg and levofloxacin 500 mg.
Pt states she got her vaccine in her left arm, and went to the waiting area. As soon as she got to the waiting area she felt like her throat was swelling. Denies SOB, changes in voice, or difficulty breathing. Pt states something similar happen after she got the flu shot this year and she took benadryl without issue. Pt was given a duoneb and 50 mg benadryl. Pt is feeling much better. VSS.
After the second vaccine I experienced fatigue, muscle aches, and a little fever that lasted for about a day. On September 13th I had developed a cough, a fever of 102.6 degrees, body aches, and I was very tired. I tested positive for covid on September 15th. I had lost my taste and smell for about a week. On September 18th I received the monoclonal antibody treatment. The next day I started to feel better, and my fever went down. About a week later, I got a urinary tract infection.
10/5/11 Received Shot at Elementary School at approximately 4:15 p.m. Felt immediate pain/ tingling/ numbness down left arm where shot was given into pinky and ring finger. Took two Advil at home. Called doctor at 6:30, after feeling weird sensation in left side of head, eye, nose, throat, almost an inflammation, swelling. Admitted to Hospital. Very high blood pressure, given CT of head, blood drawn, heparin. 10/5/11 - carotid artery scan, all symptoms the same 10/6/11 - stayed all day in hospital waiting for MRI, never scheduled so left hospital at 6:30 p.m. 10/7/11 - went to see my doctor, saw another doctor instead. She thought it was just a sensory neuropathy that would go away.  Got MRI of brain at 2:00 p.m. 10/8 & 10/9 - rested on weekend, had swelling of right foot toe joint near bunion, this went away by Monday, developed headache and pain in left jaw 10/11/11 - symptoms the same, saw Dr., she ordered more tests, prescribed Valtrex in case it might be shingles 10/12/11 -  symptoms the same, had cervical spinal brain MRI 10/14/11 -  Follow up with Dr., got blood work back, all normal but positive ANA, and positive anticardiolipin antibodies but indeterminate level.  Recommended I take 325 mg aspirin daily. 10/15/11 - same symptoms, worried that it may be in my right eye, but it wasn't 10/17 - Scheduled appointment with rheumatologist, his findings are not conclusive of an rheumatological or autoimmune problems. He didn't think I should take the aspirin. Will follow up with neuro on Nov. 3, follow up with Dr. on Nov. 7., taking Synthroid, Prilosec, Xanax, aspirin, Valtrex. VERY CONGESTED TODAY. 10/19 - Still feeling badly, right ear hurts like an infection  -started 10/10, and sore throat, called doctor.  Suggested I continue taking VALTREX and start antibiotics.  Several family members have autoimmune diseases including daughter who has lupus disease.
FEVER, FLU LIKE SYMPTOMS, ACHES PAINS, TIREDNESS AND SWELLING AT SITE OF INJECTION.
This spontaneous report was received from a consumer via Pfizer regarding a female patient of unknown age. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, 25 mcg/0.5 ml, for prophylaxis. On an unknown date, the patient had an allergic reaction to PNEUMOVAX 23. Ended up in ER. Her face turned bright red and puffy (It was also reported that she did not believe her face was puffy). The patient experienced puffiness in vaccinated arm, which went down to her elbow. She clarified the puffiness was only in her arm, explained her arm blew up, it was so fat and hurting. She had a topical cream from what her urgent care doctor gave her. The injection site was very tender. Her arm was tomato red and was crawling down her arm. The reporter wanted to know the difference between PNEUMOVAX 23 and PREVNAR 13. Outcome of the events were not reported. Causality of the events was related to PNEUMOVAX 23.
After receiving the Moderna booster,  I have had a headache,  dizziness and blurry vision for over a week.  This is horrible.
Dizziness, Nausea, lost feeling in legs, unable to use muscle in left leg for about 4 hours, weakness, headache, brief loss of memory.
Patient arrived to clinic with mom at 12:40 PM for Prevnar-13 (polysorbate protocol) and PEG testing. Negative COVID Screening, mother denied antihistamine use. Mom states that she had a fever on Sunday and Monday, she had 3 negative COVID tests. No fever today. Procedure explained and questions encouraged. Patient was alert, lungs clear, patient had a couple hives that resolved prior to testing.   Skin Prick Test done on back and interpreted in 15 minutes: Prevnar-13 (6mm/12mm) MiraLAX 1:100 (3mm/4mm), MiraLAX (3mm/5mm) MiraLAX 1:1 (3mm/4mm), histamine (13mm/40mm+) and control.   IDs not done to Prevnar due to positive SPT.  Discussed with attending and ordering provider; both agreed that due to the low positive results patient should receive split dose of Pfizer vaccine with observation.  Pfizer Lot # FK5618  First dose: 0.04mL administered in right deltoid at 2:55pm.  At 3:02pm pinpoint hive at injection site with mild erythema sounding, lung sounds clear. 3:14 pinpoint hive and erythema nearly completely resolved, lung sounds clear. 3:20pm small hive appears like small bubbles in line about 6-8mm long on right flank. MD examined patient, lung sounds clear. Per MD, antihistamine administered prior to second dose. Mom preferred loratadine to cetirizine due to past behavioral concerns. Loratadine 5mg administered at 3:27pm. 3:29pm flank hive had resolved.   Second dose: 0.16mL administered in left deltoid at 3:30pm. Within seconds of vaccine administration erythema on left shoulder and collar bone appeared. Resolved within 3-4 minutes. 3:30 hive on left bicep near elbow appeared. 3:45pm Hive on left flank of similar to right flank, small bubbles in a line 6-8mm long. 3:50 hive on left bicep have resolved. 4:10 erythema on right cheek appeared for 4-6 minutes and resolved. Lung sounds clear throughout observation. No further hives or erythema appeared for remaining observation time.   Patient was discharged at 4:30pm in stable condition after being examined by the MD. Patient was instructed to take Benadryl for any additional hives this evening and to take loratadine 5mg for the next couple of days. Mother is in agreement with plan and has no concerns at this time. Mom was instructed to go to nearest ED for any worsening or concerning symptoms, discussed signs and symptoms of anaphylaxis. Mom is comfortable with plan.
allergic reaction to the first dose of the vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced allergic reaction to the first dose of the vaccine on an unspecified date and she stated she knows she cannot get the second dose. The outcome of the event was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt tested 6/14 when she presented to Hospital because she could not bring down the high fever, was administered IV fluids, and received 3 shots, Azithromycin (antibiotic) & Decadron (steroid). Pt reported feeling weak, having an elevated pulse, & blood pressure drop to 71/54- was discharged when fever came down and BP was at 111/80.
6cmx7cm cellulitis with streaking and lymphangitis at site of smallpox vaccine on left deltoid.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patient was vaccinated with an incorrectly stored dose of VAQTA injection, lot # N005274 with expiration date 03-APR-2018 (dose, route and site of administration were not reported). VAQTA was stored in temperature 34 degrees Fahrenheit for 4 hours and 4 minutes. There was previous temperature excursion and the digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015612: US-009507513-1705USA015613: US-009507513-1705USA015614: US-009507513-1705USA015615: US-009507513-1705USA007801:
Pain in left arm where vaccine was given; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 12:00 (Lot number: Fa7484) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing), notes: Autoimmune hepatitis (currently in remission). Concomitant medication(s) included: GABAPENTIN; BENADRYL; ADVIL [IBUPROFEN]. Past drug history included: Penicillin, reaction(s): "Known allergies: Penicillin". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Aug2021 17:00, outcome "not recovered", described as "Pain in left arm where vaccine was given". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Pain in left arm where vaccine was given lasting more than a few days its been 21 days since the first dose was given. No other vaccine in four weeks. No COVID prior vaccination and not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.