chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the vaccine around 3pm. At 7pm, my lower lip started to swell and go numb. It quickly spread to my face, tongue and neck. I jumped up when I realized what was happening so I could tell my husband in case it affected my ability to speak. I took an antihistamine and we waited on alert. If it had continued, I would have called 911 or gone to the ER. The progression stabilized and after several hours, I was able to dose sitting up. In the morning, it was improved but not gone. It lingered for over 24 hours.
violently ill; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (violently ill) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (violently ill). At the time of the report, ILLNESS (violently ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On an unknown date, reporters friend was violently ill.  It was reported that they were thinking this may have been a latent reaction. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
diaphoretic Narrative:  3/10/21 50 yr old male received Moderna covid vaccine 0.5ml lot#044A21A exp 8/31/21. Within 5 min of receiving vaccine, patient became pale, diaphortic, hypotensive...lost consciousness. Pt has a hx of allergic rhinitis GERD,obese,vit D defi.,chronic leukocytosis,mild emphysema. Pt called prior to arrival, pt was placed in reverse trandeleburg with almost immediate return of consciousness and color. he was given some water and crackers. was observed for 30 minutes in clinic and was cleared and exan by dr to go home. was able to walk to care free of symptoms.
Severe discomfort globally and extreme fatigue.  I could barely hold my head up and was very unsteady due to a sense of fatigue & weakness, when getting up from the bed to use the restroom.  It felt as though my skin was being pulled apart from the inside of my body starting at each hair follicle. Tight swaddling in a flannel sheet and bedrest x 36 hours was the only way I could get comfortable and find any relief. I did not take my normal medications x 48 hours after the vaccination and drank only water and herbal tea. I had no appetite x 36 hours. About 48 hours after the vaccination all symptoms cleared and I felt normal.
Patient was inadvertently given a 0.2mg dose as her 2nd dose and should have received a 0.3 mg dose due to age.  Per regulatory authority guidelines the 0.3 mg dose was administered immediately.
Fever, chills, body aches, headache, fatigue for 24-48 hours
breakthrough Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough Covid) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced COVID-19 (breakthrough Covid). At the time of the report, COVID-19 (breakthrough Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  company comment: non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after unspecified dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to nature of the event, unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after unspecified dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to nature of the event, unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
typical arm discomfort, by 1 week - 8/7/21 , was not feeling good, very weak and a lot of fatigue,  after the second shot that I received on 8/18/21 at Pharmacy, the fatigue intensified.   Muscle weakness started and proceeded to get to the point that I could lift my legs and upper arms got weak.    I finally went to the dr at the end of October and that is when they started bloodwork on. me to try to determine the issue.  Once my CK levels reached 8618 I was admitted into Medical Center (11/22/21).  I had a lot of bloodwork and other testing while in there.  Including a left thigh muscle biopsy.
The patient is presented today 07/02/2022 to receive her third those of reinforcement of vaccine against COVID-19 Pfizer, at the time being it was administered a pediatric vaccine had been prepared (5-11  years) and by mistake it was administered. The patient was contacted immediately which she indicated that she does not have any reactions.
Heart rate of 128bpm woke me up 5/28/2021 2:30am and lasted until around 9:00am. Had chest pain for the next two days and woke up 5/30/2021 around 4:00am with heart rate of 115bpm that lasted until 8:00am. Since then I?ve had on and off again chest pain/tightness/ flushed feelings/ and trouble breathing.
Patient received Moderna #1 vaccine after receiving Pfizer #1 vaccine the previous day.
31 y/o female came in  Vaccine clinic for first dose of COVID-19 Moderna vaccine Lot# 013M20A. Patient received vaccine at approx. 3:00pm, walked to observation area to sit for 15 minutes at approx. 3:02pm. At approx. 3:08pm Nurse heard patients cell phone fall to the ground, nurse noticed patient leaning over to her right side and slumped over. Patients head was down and not responding to her name. Nurse heard patient making moaning noises, nurse held patient up and called her name, asked if patient had any disorders, after a couple minutes patient responded, lifted her head up and stated she didn't have any Seizures  disorders but does have a history of vasovagal reactions. EMS was called to the scene. Initial BP-90/46 P-51, O2-98%.  Patient denies any prescription meds or over the counter meds were taken prior to her vaccine. Per patient No history of any medical conditions. Water was given to patient, was A/O with EMS. Refused to be taken to ER/Hospital and Signed AMA.  EMS vitals 107/67, p-73 100%, last V/S bp-125/70, p-79, 100%
injection site reaction after 7 days ( arm swollen  hot to touch and itchy per patient)
12:40  pt c/o sweating nd nausea. placed in fowlers on stretcher where she proceeded to vomit small amt clear    liquid. Diaphoretic and felt better after vomiting. Lying down on stretcher with cold cloth to forehaed.    12:45 63 hr 18 R 97% O2  130/671255 feels better no nausea , skin warm and dry, tolerated H2O. Discharged home
The evening after receiving 2nd Covid vaccine my son developed chills.  The next day he was fatigued, left arm was sore from shot, headache, and muscle aches.  Day 3 in addition to the symptoms listed he developed chest pain. Day 4 the chest pain was so intense he asked to go to urgent care.  He said he could feel it was his heart and the pain was a constant.
Patient called reported injection site is red and slightly swollen, advised patient to monitor and seek medical attention if continues to worsen or shows signs of infection.
itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
pt recv vax 19DEC95 & next day devel a fever & an inj site rxn, characterized by redness, swelling & a sl raised area 1/2 inch below the inj site;area inc in size ( 1 1/2 x 1inc) w/no inflammation @ inj site;ER MD felt poss infect d/t vax;
Injection site pain lasting four days. Decrease in mobility of right arm lasting four days due to pain.
BP 50/32; lost conciousness; "fainting" was due to an acute allergy-related response to the yeast and/or other component(s)in the vaccine,; This spontaneous report was received from medical consultant and refers to a female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2006, the patientwas vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in approximately 2006, the patient experienced life threatening blood pressure(BP) of 50/32 (unit not provided), lost conciousness- "fainting" was due to an acute allergy-related response to the yeast and/or other component(s)in the vaccine,. At the time of reporting, the outcome of the events was not known.  The reporter considered lost conciousness to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered "fainting" was due to an acute allergy-related response to the yeast and/or other component(s)in the vaccine, to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The causal relationship between BP 50/32 and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.   Upon internal review, the event lost conciousness was determined to be medically significant. The reporter considered the event BP 50/32 to be Life Threatening.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 16-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Patient developed redness at the injection site and arm and complained of generalized itching. Benadryl 25 mg capsule given. Patient watched for 30 minutes and then left. Patient felt better after receiving Benadryl.
Received flu vaccine 1/25 in office. Started with redness/swelling a couple hours later. Was seen in urgent care 1/26 and started on BACTRIM. Has taken BACTRIM and BENADRYL last night and this morning. Mom concerned due to darker appearance at upper deltoid area. Redness extending now slightly below elbow. Painful to move, flex, or press on arm. Referred to ED on 1/27/18 for compartment pressures.
Flu like symptoms.  Nausea with vomiting.  Low grade fever of 100 for 3 days.  Aches, pains and chilling.  Nausea treated with Zofran.
5 or 6 hours after receiving shot I started having intense pain when I moved my arm. Very intense pain with movement or touch continued for about 18 hours. Most of my upper arm was one big irregular red welt, hot to the touch. It is now 47 hours since I received it, it is still red, hot & very tender to the touch, though it doesn't hurt so much to move my arm anymore. I got a flu shot in my left arm at the same time, that arm is ok.
It was almost like cellulitis; Significant pain and swelling in the arm; Significant pain and swelling in the arm; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for three patients. This is 3rd of three reports.   A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. The vaccine was administered at reporting physician office. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced significant pain and swelling in the arm. The doctor reported "it was almost like cellulitis". Clinical outcome of the events was unknown at time of this report.  The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role towards the occurrence of significant pain and swelling in the arm like cellulitis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2019267621 same reporter/drug/event, different patient;US-PFIZER INC-2019267627 same reporter/drug/event, different patient
after pain and fever i developed a rash all over my body  travelling hives  that appear in different places of my body and face  still have head aches and rash after two weeks  was put on steroids and antihistamines but it doesn't go away
Pt presents today stating that 2 weeks ago she began with numbness/tingling in her fingers and it has progressed to all her fingers and toes. She states it is constant. When she puts her fingers in cold water it feels like she has put them in ice. No discoloration of the skin. She notes that 1-2 days prior to the numbness/tingling she did resistance yoga and she does have thoracic back pain around her bra-line on the R side. She did injure her back a few years ago and had to do PT, but it got better until recently. The patient also states that 1.5 weeks ago she went to the dentist and had a filling done and they gave her shots to numb her mouth, but since then the numbness has continued and her tongue is numb and she has tingling on the end of her nose as well as some intermittent lip tingling. She called the dentist and they prescribed her steroids, but she hasn't taken this as she was possibly exposed to brucella at work (she works at small animal hospital) from a dog about 3 weeks ago. She is waiting to hear from occupational health if they are going to treat her or not. Pt denies any fever, but states she isn't sure if the numbness/tingling is a sign of brucella and she has had some calf soreness as well for 4-5 days and isn't sure if this is maybe a sign of infection too.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2022 as dose 1, single (Lot number: GT2524) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing). Concomitant medication(s) included: CALQUENCE, start date: May2019, stop date: 29Nov2022; ELIQUIS, start date: Feb2018, stop date: 29Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: rebound tested positive 2 days after negative test; Positive, notes: rebound tested positive 2 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Known allergies was no. Paxlovid was taken on 29Nov2022 as Covid-19 treatment.
DTAP + IPV (Kinrix) given to patient instead of DTAP (Infanrix). No adverse s/s.
Onset of shingles on the right forehead and eye being treated with valacyclovir.  Ocular evaluation indicates no optic nerve involvement at this time.  Treatment is ongoing.
arm pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 08Feb2022 (Batch/Lot number: unknown) at 10 mg daily for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "fluctuating blood pressure", notes: since starting Lenvima (around 2/8/22) to a high of 144/73, 09 systolic is usually her baseline blood pressure per patient.; Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "increased urination"; Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "Abdominal pain", notes: described as a 2/10 pain scale, rating; Lenvima, start date: 08Feb2022, for Endometrial Cancer, reaction(s): "decreased weight". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional information: The patient reported that her blood pressure has continued to fluctuate. The patient also voiced that she planned to take a trip with her daughter before she gets married in the spring and got a COVID booster shot on 30Nov2022, since getting the booster she reported getting "really sick" with arm pain and fatigue. The patient's relevant history included previously reported fluctuating blood pressure since starting Lenvima (around 08Feb2022) to a high of 144/73, 109 systolic was usually her baseline blood pressure per patient. The patient also reported increased urination, abdominal pain described as a 2/10 pain scale rating, and decreased weight since starting Lenvima (around 08Feb2022), The patient voiced that she was also a Vegan (prior to Lenvima) and was receiving dietician consults to help her to eat more Protein and fats in her diet. Unknown if caused by Lenvima. C54.1 Endometrial Cancer diagnosis, 10mg Lenvima daily, Started 08Feb2022, taking with Keytruda. Date the event description was reported was 02Dec2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bloody diarrhea; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 13:00 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization. Patient has no medical history. Concomitant medication included ibuprofen. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. The patient experienced bloody diarrhea on 17Apr2021 10:00 with outcome of recovering.
lymph node swelling; pain in left armpit and a little above my left boob; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : FE3592 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 17Sep2021 12:00 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On 18Sep2021 the patient experienced lymph node swelling , pain in left armpit and a little above my left boob.The outcome of event was not recovered.
Information has been received from a healthcare student concerning an "over" 60 year old male who was vaccinated with a dose of Pneumovax 23.  Subsequently the patient experienced rash.  The patient is "on therapy", recovering from the rash.  Additional information has been requested.