chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 30 minutes of receiving my vaccine, I became short of breath, dizzy and lightheaded. I went home instead of going to the hospital. The next day I was feeling extremely ill. I was feeling fatigue, shortness of breath and my nose started bleeding. The third day after my vaccine, I started to experience abnormal vaginal bleeding. It started as spotting, but became very heavy. My lungs felt like they were sticking together and it was hard to even walk up the stairs. A week later, I went to the ER. At the ER, they stated that I had tachycardia and they did blood work. They were worried they would have to perform a blood transfusion, but it did not happen. They wanted to admit me because of my rapid heart rate, to which they performed an echocardiogram, but I declined to be admitted due to the number of COVID-19 cases there. A pulmonary embolism was ruled out by D-Dimer and Chest X-Ray and I was discharged with extreme vaginal bleeding. Over the course of the next 4-5 months, Every single day, I have been experiencing shortness of breath. All of the toes on my right foot became purple about 4 months after my vaccine. It took about eight months for me to start to feel normal again.
I have Rheumatoid Arthritis. I did not have any reaction to the first dose but within two days of my second dose of the vaccine my joints started to ache. They started to ache and swell and I was very fatigued. Over time the problems with my joints became worse and Advil was not working like it usually does. My RA had not flared up for about two years. I consulted with my Rheumatologist after about a month because the pain was not improving. I was prescribed a tapering dose of prednisone which did not work for me. I took three rounds of the prednisone and the pain improved during the course of the steroids but it came back each time it wore off. Currently it has been six months and I am now on a stronger dose of prednisone and it is helping. It always takes a while to get my RA back under control after a flare-up.
This case was reported by a physician and described the occurrence of hepatitis b antigen positive in an adult subject of unspecified gender who was vaccinated with ENGERIX B, GlaxoSmithKline.  The subject's medical history included being bitten by a student.  On an unspecified date in 2008, the subject received 1st dose of ENGERIX B (unknown).  On an unspecified date in August 2009, within one to two weeks of vaccination with ENGERIX B, the subject had a positive laboratory test result for hepatitis b antigen.  A polymerase chain reaction (PCR) test was performed which showed a low positive result.  The reporting physician believes that a repeat laboratory test showed that the subject's positive hepatitis B antigens resolved and the subject's antibodies had increased as would be expected from the vaccine.   However, the reporting physician did not have access to the repeat laboratory results to confirm that the positive hepatitis B antigens had resolved, as he was being consulted on this report.  The physician stated that he had limited information to provide, as he learned of the event from his wife, who was employed by the school where the bite and subsequent vaccination and testing occurred.  At the time of reporting, the outcome of the event was unspecified.  The physician considered the event was probably related to vaccination with ENGERIX B, but stated that in his opinion the positive hepatitis B antigen result was just within the normal course of events after vaccination, and that the subject should not have been tested for hepatitis B antigen one to two weeks after receiving the vaccine.
Drug ineffective; 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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FE3594) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Lot number: N31m20a) for 1 day and as dose number unknown, single (Lot number: 045A21A) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "chronic pain/fatigue" (unspecified if ongoing); "chronic pain/fatigue" (unspecified if ongoing); "chronic inflammation" (unspecified if ongoing); "acute/recurring bronchitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Hyoscine, reaction(s): "Known allergies: Hyoscine", notes: Known allergies: Hyoscine. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08May2022) negative, notes: I had a negative test after finishing the course of this med on 08May2022 and a negative test on 09May2022; (09May2022) negative; (13May2022) positive, notes: I tested positive again on 13May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
feel a tiny bit of soreness; This is a spontaneous report from a contactable female consumer (patient) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Intramuscular on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Caller stated: "I received my first dose of COVID-19 vaccine today at noon. I did not know I had to Tell the vaccination provider about being on a blood thinner until After I received the IM injection. I feel a tiny bit of soreness but that's all." Outcome of the event was unknown.  Information about lot/batch number is requested.
No pain at injection site after administered until 8 hours post at which time injection site became very painful and swollen as well as feeling like I had COVID all over again with shortness of breath, severe body ache/fatigue/pain, nausea, abdominal cramping, diarrhea, loss of smell and taste, severe headache, chills/and sweating. These symptoms lasted 3 days. Afebrile throughout.
about 36 hrs p/vax pt noticed bumpy, red rash on arms & chest; 1 day later rash covered entire front of body & all of arms; was sl itchy; 2 different MD's said to take DPh & to never get tetanus;
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX. On 7th April 2018 11:35, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. In April 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporting nurse was the patient's wife. The patient received SHINGRIX vaccine on his left deltoid and experienced a sore arm. The patient had denied permission to contact their physician. This case was linked with US2018063411 (wife's case), reported by the same reporter.
2/2/21; fever, body aches, chills, nausea, sore arm Patient is still very fatigues, but no fever
Daughter received flu shot on Monday 10/22 and broke out in hives and swollen eyes Friday morning 10/26. Gave BENADRYL and symptoms improved. Woke up at 1230 AM 10/29 with severe breathing problems and paleness. Called 911 and transported to medical center where she was treated for croup even though she didn't have typical croup symptoms. Released later that morning. Followed up with dr on 10/29 at 11:20am. Continued treatment with steroids and inhaler. Symptoms have resolved but do not believe her illness was the croup. I wanted to report this as a possible allergic reaction to the flu shot. She has a sulfa drug allergy.
Nausea, Fatigue, flushing Narrative:  Patient experienced 3 days of nausea, fatigue and flushing. Took over the counter Pepcid and Naproxen
her left arm is shaking.; This case was reported by a other health professional via sales rep and described the occurrence of tremor limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tremor limb. On an unknown date, the outcome of the tremor limb was not recovered/not resolved.   It was unknown if the reporter considered the tremor limb to be related to Shingrix.  This case was reported by a other health professional via sales rep and described the occurrence of tremor limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tremor limb. On an unknown date, the outcome of the tremor limb was not recovered/not resolved.   It was unknown if the reporter considered the tremor limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix month ago and left arm was shaking. The reporter consented to follow up. This was reported in an email to the field rep. by the physician assistant.   This was all the information she had.   The PA permitted follow up.
Patient received Pfizer booster dose.  Pharmacist recommended sitting for a few minutes.  Patient stated he was going to shop around for awhile.  Pharmacist was alerted about 10 minutes later that patient had passed out and fallen into an aisle of merchandise.  Store manager stayed with patient for a few minutes then walked him back to sit and relax in the pharmacy waiting area.  Patient had a few scratches on his hands and it appeared a small laceration inside his lower lip - pharmacist noted a little blood on the hands and mouth.  Patient was offered medical attention in form of an ambulance and he declined.  He was also offered water and declined.  Store manager sat with patient for approximately 3 - 5 minutes in pharmacy waiting area.  Pharmacist also checked in with patient and asked if he may have low blood sugar and suggested eating something just in case.  He denied ever having low blood sugar issues and agreed to get a protein bar just in case.  At this time, the patient did state that he gets "light-headed" when having blood drawn and has to make sure he eats, drinks and sits for 30 minutes afterwards.  This was not stated prior to receiving vaccination.  Patient stated he was feeling better and proceeded to walk around store and then leave shortly after.
off label use; Interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FL3198) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Feb2021 at 12:00 as dose 1, single (Lot number: 006U20A), in left arm, on 16Mar2021 at 12:00 as dose 2, single (Lot number: 003A21A), in left arm and on 19Oct2021 at 10:30 as dose 3 (booster), single (Lot number: O35C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing), notes: BPH; "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19"; OFF LABEL USE (medically significant), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) NEGATIVE; (15Sep2022) POSITIVE. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JAN-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R-II single 0.5ml dose (rHA, Lot # L007577, expiration date 05-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Soon after (a day or two) 2nd Moderna vaccine, an asthmatic bronchitis syndrome developed. Threated with prednisone, empiric Abx and symptoms lasted several weeks,
Information has been received from a health professional concerning a 20 year old Asian/Caucasian female with no reported medical history who on 21-DEC-2007 was vaccinated with her first dose of GARDASIL and on 19-FEB-2008 was vaccinated with her second dose of GARDASIL (Lot #659962/1740U) intramuscularly in the right deltoid at 1:00 pm. Concomitant therapy included DEPO-PROVERA. Immediately after injection the patient felt light headed and broke out into a cold sweat. She was followed up for 10 minutes. The patient felt better and was able to leave. Her reaction after her first shot was "similar". The patient's outcome after the second shot was unknown. No further information is available.
I started having right leg swelling. I noticed a small red spot on my medial side of my knee. I had this for about a week and then the swelling went down. A few days later, I had redness, skin was warm to touch, and hardness developing where the red spot was. I went to urgent care and the NP sent me to the ER for a possible blood clot. I had a venous study done in the ER and it was determined I had a superficial blood clot and was started on ASA 325 mg daily x7 days. I followed up with a vascular doctor and it was determined the clot was worse and had clotted all the way up the vein into my thigh. It remains superficial in nature at this time. I was started on Xarelto 10 mg  daily x1 month. I follow up with vascular in 1 month to make sure the clot is dissolving. I was instructed to Follow up with either the doc or go to the ER with worsening symptoms.
First dose: Hives; First dose: Body aches; First dose: Headache; First dose: Body had no energy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown and expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing AFib (Her Afib started like 5 years and 5 or 6 months ago), ongoing Water on her heart and lungs (She started having water on her heart and lungs about 17 years ago. If she had anything abnormal, she was supposed to go to emergency. Every year they do an echocardiogram and X-rays for her lungs to control it and make sure it had not increased). She was very allergic to a lot of stuff. The patient's concomitant medications were not reported (Other Products: No). Patient reported that she was taking some unspecified medications for Afib that include high blood pressure medicines.On an unspecified date in 2021, patient experienced first dose: hives, first dose: body aches, first dose: headache, first dose: body had no energy. Patient reported, due to the fact that she had Afib, today she was going to see her cardiologist. She happened to have an appointment from last year. He sees her twice a year, so she was hoping that he will find out what was wrong with her. She didn't remember her physician's phone number. She did not have contact information available for her physician. Her doctor told her that if she was completely short of breath due to the Afib she needs to go to the emergency room. Patient reported, with her first dose the reaction she had was very low. She had her vaccine on Wednesday, and her symptoms completely went away by Thursday mid-morning. She had body aches, hives, a headache, and her body had no energy. She had the vaccine on Wednesday, and by noonish the next day it was gone. Again stated, she had her first dose of the vaccine on Wednesday. She thinks it was 2 or 3 weeks prior to the second dose. She doesn't remember the exact date she had it. They took her card, and she has no NDC, lot, or expiration date for the first dose. They took that one and gave her the one she has. She takes medications for Afib that include high blood pressure medicines. The patient underwent lab tests and procedures which included X-rays for her lungs and echocardiogram: unknown results. There was no investigation assessment. The outcome of events was recovered on an unspecified date in 2021.  Additional information has been requested and will be provided as it becomes available
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
Extreme redness and swelling at site of vaccination. Extreme flu like symptoms. Warmth at site, painful. Started one hour post vaccination, lasting at least five days. Has taken ibuprofen and warm/cold compresses.
but not feeling well.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "but not feeling well.".  Additional information: It was reported that she will get the 2nd dose of Covid-19 Vaccine today 20Mar2021 but not feeling well. She wants to reschedule it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & devel flu-like sx, rash, nausea, vomiting & diarrhea; sx are unresolved;
One day 4 after injection itchy, red rash was noted on abdomen. By day 7 the rash covered arms, legs, and trunk. As of today, day 9, the rash remains unchanged.
Employee complained of pain, swelling, erythema on right deltoid, malaise, headache, aching in both lower legs. Fever (99 deg. F. for three days). Employee states took Advil, given Tylenol on 03/25/2002.
6 days after administration - broke out in a rash - around shoulders, under arm, then chest right side of body - jabby pains right shoulder - blistery. ER on 10/6.
PATIENT STATES THAT ARM IS VERY PAINFUL, NOT SWOLLEN NOR RED. PATIENT COULD NOT SLEEP BECAUSE OF THE PAIN. THE ARM APPEAR THE SAME BUT IS HURTING. PATIENT HAS AGREED TO WAIT ANOTHER DAY AND DETERMINE IF PAIN RESOLVES...
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (temperature before vaccine and after vaccine went up/temperature 100.4ºF after the first dose) and fatigue (tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 00SC21A) for COVID-19 immunization. Concomitant products included hydrochlorothiazide and lisinopril for an unknown indication. On May 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 13, 2021, patient experienced pyrexia (temperature before vaccine and after vaccine went up/temperature 100.4ºF after the first dose) and fatigue (tired). At the time of the report, pyrexia (temperature before vaccine and after vaccine went up/temperature 100.4ºF after the first dose) and fatigue (tired) outcome: unknown. Diagnostic results: On May 13, 2021, body temperature: 100.4ºF (high) after the first dose. On an unknown date, body temperature: 98ºF (high) before the first dose. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
No adverse reactions , child had duplicate records in system. 1st record under different name and the second record under another name , same name and DOB in our system. The DR used the name that matches our system to order the shots and did not realize the other record was for the same patient. the child needed only flu shot , but received additional 5 shots . Request sent to system to merge the records.
Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home
12 hours after injection, hives on arms and chest which resolved within hours; 24 hours after injection had blistering lesions of feet
not able to get out the bed she was having restless leg syndrome she couldn't even walk, she had bad pain on the right side of her leg and notice a mass on the inner part of her leg which was painful. she went to urgent care. the pain has been getting worse.
a patient received two doses of the Dtap-IPV portion of Pentacel vaccine without Act-hib powder, no AE; Initial information received on 09-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a nine month old male patient who received a 0.5mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTaP-IPV portion: lot CH3594 and expiry date: 22-Feb-2022 received) and (ACT-HIB portion: lot U6218AA and UJ015AA and expiry date: 26-Oct-2020) via an intramuscular route at an unknown administration site on Jan-2020 and Mar-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) Lot number: CH3594, expiry date: 22-Feb-2022 on Jan-2020 and (Lot number and expiry date) on Mar-2020 for prophylactic vaccination.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the patient possibly received 2 doses of the Dtap-IPV portion along with due to having a missing Dtap-IPV portion, with out Act-Hib powder of Pentacel in Jan-2020.  At the time of this 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 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.