chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER OF 100.2F; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown) dose was not reported, administered on 13-JUL-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-JUL-2021, the subject experienced fever of 100.2f. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever of 100.2f was not reported. This report was non-serious.
Information has been received from a consumer concerning his 22-year-old daughter who was vaccinated with all three doses of GARDASIL (dose, route and lot number not reported) and the last dose was received in July 2007. There were no concomitant medications. Last week (on approximately 15-JUN-2009) the patient had a PAP test done and it came back positive for HPV (unspecified which type). The patient had sought unspecified medical attention. At the time of the report, the patient's status was not recovered. No further information is available.
About twelve hours after receiving my first covid-19 Pfizer/BioNTech vaccine I experienced chills, body aches and fever.  Fever initially went to around 101.  After initial few hours from onset, chills and body aches subsided.  Fever hovered around 100 for about 24 hours before returning to normal.  Overall symptoms lasted for about 24 hours after onset.   No medications were taken to relieve pain or fever and no medical attention was needed.
painful swollen lump devel in lt deltoid approx 1wk post vax;
patient was administered an expired ADACEL vaccine with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved a 38 year old male patient who administered an expired Adacel vaccine with no adverse event (Expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 30-Oct-2020, the patient received an expired a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Expired product administered) lot C5519BA.   No relevant laboratory data was provided.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Not Applicable.  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 Disclaimer: 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.
Evening of March 3rd, convulsive chills extreme fatigue, dizziness. Morning of March 4th, collapsed on bathroom floor after feeling nauseous. Very weak and very hard to push to standing position. Eye infection which I treated with hot compresses. I infection almost gone today March 8th. Teeth sensitivity, anxious and panicky, dizzy very tired, headache, swollen glands in neck, too dizzy to drive.
Ongoing arm pain and headache. Severe muscle aches and fatigue for 48 hours. Reporting because the material says symptoms should not last more than 24 hours. I am normally very active and healthy, and I was completely incapacitated for 48 hours. I still have ongoing arm pain and headache. This is third day.
This report described a 48 y.o. female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. Medical history included tobacco use. No concurrent conditions or concurrent medications were reported. The subject had no adverse experiences following receipt of previous vaccinations. She received no concurrent vaccines. The subject received Engerix-B on 10/24/01, 11/27/01, and 4/24/02. Lots of vaccine administered were ENG5239A4 (1st injection), 5242A4 (2nd injection), and 5262A4 (3rd injection). A titer measured on 6/24/02, 2 months after the 3rd injection of Engerix-B showed a value of "0" (10 being considered a protective level). The reporting nurse considered the non-response to be possibly related to Engerix-B administration.
Tinnitus High pitched constant. Onset 3 day post 2nd vaccination. Do not know if vaccine related or simply a coincidence.
The first dose of the Pfizer-BioNTech vaccine was given at the same facility on March 15, 2021 (Lot EN6208).   Noticed Oral Lichen Planus (OLP) flare-up on May 5, 2021 (mouth was sore).  While I have chronic lichen planus it had been dormant prior to that for many years.  The flare-up was widespread and I sought medical treatment with Dr on May 12th, 2021.  Unlike any of the previous OLP occurrences, she said that the lesions were the very extensive and widespread.  I was given Kenalog oral cream for application to the lesions.  I saw Dr again on June 7, 2021 and on July 28, 2021 to monitor and treat the lesions which still persist. I will see an oral surgeon next week for biopsy.
Red irritation in lateral area of left arm, forehead, nose and lateral nose area, with little red spots in front and lateral area of nose; Red irritation in lateral area of left arm, forehead, nose and lateral nose area, with little red spots in front and lateral area of nose.; Red irritation in lateral area of left arm, forehead, nose and lateral nose area, with little red spots in front and lateral area of nose; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 6N6198; Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:30 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's other medical history was reported as none. Patient had not any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ezetimibe, simvastatin (VYTORIN) and collagen (COLLAGEN) taken for an unspecified indication. On 03Mar2021 patient experienced Red irritation in lateral area of left arm, forehead, nose and lateral nose area, with little red spots in front and lateral area of nose. Therapeutic measures were taken as a result of Red irritation in lateral area of left arm, forehead, nose and lateral nose area, with little red spots in front and lateral area of nose allegra was taken as treatment by the patient. The patient was not diagnosed prior and since the vaccination with COVID-19. The clinical outcome of event was recovering.    No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated IM with her first 0.5ml 2 doses of GARDASIL (lot number not reported), more than a year ago, in approximately 2011, and was vaccinated IM with her third 0.5ml dose of GARDASIL (lot number not reported) on 12-JUL-2012. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. Additional information is not expected.
No problem with the first shot. Came back 28 days later for the second. Fine the day of the shot, but then had a 102  fever when I got up the next day,  I didn't know what day of the week it was and had a good deal of trouble finishing  sentences. This period of  incoherence lasted for about 12 hours.
Hospitalized 11/29/2021; COVID-19 positive 11/29/2021; fully vaccinated.  BRIEF OVERVIEW: Discharge Provider: PCP Primary Care Provider: None Physician, MD Admission Date: 11/29/2021 Discharge Date: Dec 2, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Suicidal thoughts [R45.851] Alcoholic intoxication without complication (HCC) [F10.920] Alcohol abuse with withdrawal (HCC) [F10.139] COVID-19 [U07.1] Nausea & vomiting [R11.2] HOSPITAL COURSE: 38-year-old male with a past medical history significant for alcohol abuse as well as history of alcohol withdrawal who presented to the ER due to concern for impending alcohol withdrawal and desire to undergo detox. In the emergency department the patient was found have a positive Breathalyzer test and have a positive serum ethanol level.  As he was slightly tachycardic he was given lorazepam per his request.  He had also reported at that time of some abdominal discomfort that had started earlier in the day and he also had a cough and complained of some shortness of breath despite being on room air.  Patient's lab testing was remarkable for mildly elevated liver enzymes as well as a positive COVID-19 PCR test.  Patient was thought to warrant admission to the hospital for observation. The patient was quickly discontinued from benzodiazepines as he had no overt signs of alcohol withdrawal.  He remained on room air throughout his hospital course.  Discussing with the patient, he stated that he was quite concerned about his nausea which he states he has had for some time he normally takes famotidine and Zofran at home.  His abdominal exam was benign and imaging in the form of CT of the abdomen pelvis was obtained which showed no acute pathology.  Patient's labs remained stable with a particularly stable hemoglobin.  At this point, getting nausea was uncertain but upon evaluating the patient throughout the day, he notably had spent the majority of his time sleeping and did not have any issues with nausea until he was woken up. After informing the patient that he appears to be medically stable for discharge from the hospital, he became quite concerned about his disposition plan as he stated that he was homeless and had no place to go.  Help ensure a stable/safe discharge plan, medical social work was involved and the patient was able to be discharged to a facility where he could stay in isolation due to his COVID-19 status.  He was continued on famotidine and Zofran involved discharge from the hospital 12/2.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405 and 1310USA008406 (same reporter link). Additional information has been requested.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 51 years old male patient who still complains of pain in left arm, sore to touch and during movement, while he received vaccine ADACEL. The patients past medical history and family history were not provided. Concomitant medications included FLUARIX in left arm on unknown date (Batch number not provided). On an unknown date, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5829AB, expiry date 24-Nov-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious complains of pain in left arm, sore to touch and during movement (pain in extremity) one week following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Lab data was not provided. Final diagnosis was complains of pain in left arm, sore to touch and during movement. No corrective treatment was received. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for complains of pain in left arm, sore to touch and during movement. List of documents held by sender- none.
extremely large area of redness to the sight, originally treated as cellulitis and then Dr. said a reaction to injection.
Roughly 24 hours after receiving the vaccination, the site of injection was red/purple in color and visibly raised. The region was about the size of an egg. It was mildly itchy, and painful to the touch. It was also warm to the touch. Swelling went down over time, fully reduced about 24 hours after it was noticed.  Area remained red for another 24 hours and was slightly warm and then it transitioned to looking more like a bruise.
C/o pain, erythema, edema over vaccination site on right deltoid wiht erythema extending in a line to medial right axilla. Urticaric lesion medial to vaccination site. C/o pain (4/10 to 8/10 with palpation) over medial deltoid Pt states that sx's begain approx 3 days ago and increase in severity. T 99.7 post self administration of Advil (2 tabs). B/p 141/66 Rt arm sitting. P - 79
40 hours of general malaise, chills, fever, diaphoresis, sore throat, throat swelling, cough, burning sensation of lungs (briefly) mild LEFT CHEST dull ache (not nearly as bad as 1st vaccination, fatigue, nausea, nasal congestion, headache. RIGHT LOWER ABDOMINAL PAIN for 6 hours sharp stabbing and dull ache
HE STARTED SWEATING PROFUSELY BUT HE DID NOT PASS OUT. ON SITE EMS RESPONDED. VITAL LISTED BELOW. HE SLOWLEY RECOVERED AND WAS RELEASED TO HOME AT 503PM
4/12/21 Call from case to discuss symptoms she developed after receiving her first COVID vaccination, The case received the first Pfizer vaccination on 4/5/21 in her left arm. Later that evening, her left arm began to swell and was reddened. She also developed fever (tmax 100.9), chills, and back pain. These symptoms continued through 4/7/21 and by 4/8/21 they were much improved. However on 4/9/21 she developed a severe headache and chest/neck pain at night which continued through 4/11/21. Her symptoms have now resolved as of 4/12/21. Case states she had a reaction to both Flu and Pneumovax vaccines in the past where her arm would swell and she would feel very sick for a few days afterward. RN encouraged case to call her PCP as soon as possible to let them know about her reports of chest and neck pain over the weekend. Also, encouraged her to consult with her PCP about whether she should have the 2nd Pfizer vaccination. Case agreed to follow up with her PCP as soon as possible.
Headache, Myalgia, Arthralgia, UrticariaPruritus & NauseaVomiting Narrative:
PT C/O  light headedness and tingling in arm c/o throat "feeling funny"  but stated it wasn't swelling. Reported "multiple allergies" after vaccine given but  not to interviewing nurse.  No breathing issues. Pt was speaking clearly and climbed over console in car to allow her husband to drive her.
Red circle semi rash looking around the injection site -  occurred three days after injection. No pain, no itchiness. Pt indicated that he applied some hydrocortisone cream prior to consult with RPh and the red spots have decreased.
Fever of 103F with shaking chills, severe generalized arthralgias and myalgias, persistent headache and mild nausea, beginning at about 20hrs post-rabies vaccine booster and lasting for about 8hrs for fever, and about 24hrs for other symptoms.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Post vax the patient developed a fever of 105F. The patient was treated with Motrin and Tylenol.
Patient described reaction as a welt located at the injection site that is one inch long and 3 inches wide extending into her armpit. The patient says the area itches and burns.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned more than 88 patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "88 +people have died from your fault vaccine!!!" It was unknown if an autopsy was performed or not.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211034004- COVID-19 VACCINE AD26.COV2.S- Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Starting 2 days after administration of my second COVID-19 vaccine and ending approximately 2-1/2 months after receiving the vaccine my heart would start racing at random times of the day, often several times a day. I run 5 miles 3-4 times a week and have no heart issues. I had a CT Heart scan that showed 0% plaque and am at very low risk of heart disease due to level of physical fitness and appropriate height/weight for my whole life. Several times my heart would start racing in the middle of the night and would wake me out of a sound sleep. The episodes took 30-45 minutes to resolve. Not only was my heart racing at rest (would reach 168 bpm at 0% activity level) but I also experienced a higher heart rate than normal during my 5 mile runs. My heart rate would get 20 bpm higher than it normally does during these runs.  This was very scary and I visited my physician, Dr., because I was worried that it was related to the vaccine and I also worried about long term heart problems as a result of the 2-1/2 month period where my heart was racing for no reason/at rest.
aches; soreness in the arm; a mild temperature of 99.2 degree F; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Feb2023 as dose 4 (booster), single (Lot number: GL1990) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "a mild temperature of 99.2 degree F"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was asking which vaccine he received and if the vaccine with LOT GL1990 was the RNA vaccine, and said he thought it's stronger. Reporter stated Pfizer GL1990, all its written down is Pfizer, and it looks like GL1990, it could be CL1990 that's why he was calling he was wondering which vaccine is this." Reporter shared that this was his "third one", received on Saturday 25Feb2023. He is experiencing mild side effects, including aches, soreness in the arm, a mild temperature of 99.2degree F, and fatigue. The reporter said also that he has had two boosters and two regular doses of the Pfizer covid 19 vaccines. The reporter asked how long the side effects last.  No follow-up attempts are possible. No further information is expected.
Physician called the pharmacy today asking us to fax over Shingrix vaccine history for patient. Upon checking patient's file, it was discovered that the patient received 3 doses when only 2 doses is needed. Patient came into the pharmacy asking for his first Shingrix vaccine on 9/30/2021 when he had his completed both his first and second dose in 2018. No side effects or reaction was resulted from the third dose.
Shot on Tuesday Wednesday woke up fever abs throwing up, felt better then Saturday woke up with shortness of breath and chest pains went to emergency room.
Pt reported "sore, red, warm, puffed out" area 2.5in x 4in "moving down on inside of arm."
Initial unsolicited report received from a registered nurse on 20 Sep 2016. This case involves two female patient's (age not reported) who were vaccinated with a dose of Fluzone QIV (Batch number- UT5627KA, expiration date: 30 Jun 2017, route of administration was not reported) intramuscularly on 20 Sep 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 20 Sep 2016, one hour following the vaccination, the patient had facial flushing, tingling in tongue and cheek and throat tightness. The patient's were sent for evaluation to the hospital. Relevant diagnostic tests/laboratory data were not reported. Patient's were treated with Benadryl and Zyrtec. The outcome of the events were unknown. Upon internal review, the company decided to consider the case serious because of important medical event cheek tightness, throat tightness, tingling in tongue and facial flushing. List of documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
local rxn fever by hx;pt seen in MD office & put pt on a steroid burst;