chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began to feel "off" and itchy after returning home from the flu vaccine. Looking at my arms I began get hives first down my left arm followed by my right arm, abdomen, chest, neck and back and eventually my face. I took a Benadryl. It seemed to relieve the itch and stopped spreading. About 3 hours post vaccine the Benadryl wore off and the hives began to get deeper red and raised to look like a sleeve with the worst area being my right side and arm. I called my primary Dr, spoke with her nurse who advised to use either an urgent care or Prednisone just to be safe in case things got worse. Headache began around 5pm. Took Motrin to relieve it. No further spreading but at around 8pm we noticed that I was void of all color in my face with the exception of the hives near my eyes. Pale skin and still having the hives, took a Prednisone and went to sleep around 10pm. Woke up around 7am with no "typical" side effects like sore arm, flu like symptoms but still have redness down both arms, back and abdomen with the hives.
Nurse vaccinated at a nursing home for flu vaccines. Per  nurse, "The owner of the nursing home facility filled out the flu forms prior to our arrival on scene and told us which of his patients required a flu shot." The patient received a flu vaccine previously for this season on 10/19/2021 per record. Therefore, the patient received an extra dose of flu vaccine this 2021-2022 season. Per nurse: the owner of the facilities, was notified on 12/14/2021 and the patient was doing fine. Per nurse, two attempts were made to speak with the owner of facility, but the owner was uncooperative and dismissive in the procedure to follow up and address the situation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 30Sep2023 to 04Oct2023 as Treatment of COVID-19. Patient did not had Known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322291 same patient, different drug/event;
fever; headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program. A 71-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 05Mar2021 14:30 (at the age of 71-year-old) at dose 1, single for covid-19 immunisation. Medical history included gout (Mentions predating treatment with vaccine, he has gout). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On 20Mar2021 the patient experienced fever and on an unspecified date in Mar2021 patient experienced headaches. Reporter reported that he had the first dose of the Pfizer COVID 19 vaccine 05Mar2021 at 14:30 PM in the left arm. He will be getting the second dose this Friday 26Mar2021. Reports he was fine for two weeks after the first dose; he was cutting the grass and playing pickup ball but then on Saturday he spiked a fever and the has continues Sunday, and today 22Mar2021. Reporter had some head-aches too, for the past couple of weeks. He is asking can he get the second dose if he still has the fever or should he reschedule it. Is it unusual for a fever to show up 2 weeks after the 1st dose. Verbatim and event description: Reporter took the first dose of the Pfizer Covid-19 Vaccine on (05Mar2021) and scheduled to get his second dose on (26Mar2021). He mentioned that he experienced fever after the first dose. Outcome of the event fever was not resolved, and headaches was unknown.   No follow-up attempts are possible. No further information is expected.
According to Medical assistant taking call:  Daughter called stating that father had received 2nd dose of Shingrix vaccine 7/10/2019, and he waited 30 minutes after for any reaction.  When patient got home, he collapsed and started to have a seizure, EMS were called and patient was take to Hospital.
This spontaneous report as received from a Medical assistant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX Lot number reported as "M036293" with expiration date on 17-AUG-2018 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 22 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines. The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006986: US-009507513-1703USA006985: US-009507513-1703USA006984: US-009507513-1703USA006983.
Pt called on 3/16/11 concerned about site reactions. They include hot to touch, hard bump and soreness. Suggested pt continue to take ibuprofen and hot/cold compresses.
Patient received pfizer covid vaccine. At first her left felt typically sore after vaccination but over the past week it has been gradually getting worse and now she feels a sharp pain from her upper shoulder arm that radiates down to her hand. She thinks it is due to the vaccine itself but there is also a possibility that it has been given incorrectly.  She is unable to lift her arm well and it is difficult to perform daily tasks. She is not experiencing any other type of symptoms or reactions (no shortness of breath, rash, etc). Patient was advised to see a doctor right away to see what is going on.
Shot was administered on Monday.  Itching and red rash broke out on Saturday.  Lasted about 3 days.  Used topical spray (Calamine Plus Itch Relief)
ADVERSE REACTIONS; This spontaneous report was received from a consumer via a newspaper article and concerned multiple patients.  The patients' weights, heights and medical histories were not reported. The patients received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration unspecified) on an unspecified date for prophylactic vaccination. Vaccination details were not reported. The batch numbers were not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced unspecified adverse reactions. It was not specified how many patients experienced reactions, but the staff at the site wanted to pause further vaccinations for the day "out of an abundance of caution".  The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Information has been received from a physician concerning a female who was vaccinated intramuscularly with three 0.5ml doses of GARDASIL (lot#, dates and site of administration not reported). Concomitant medication therapy included hormonal contraceptives (unspecified). Subsequently, the patient developed breakthrough vaginal bleeding (date not specified). It was reported that the patient also had "lip swelling" after she had "some dental surgery", it was unknown how long prior to the lip swelling the surgery was performed. The physician stated that the swelling may have been from a food allergy. There was no adverse event (AE) after the first dose, and it was unknown if these AEs happened at the same time or not, and if they occurred after the second or third dose of GARDSIL. Stool cultures had performed with no results reported. Unspecified medical attention was sought. The patient's lip swelling was reported as recovered, the outcome of breakthrough bleeding was unknown. The physician contacted during telephone follow-up could not supply the following information: (patient's name, date of birth, GARDASIL administration dates, lot#, concomitant vaccinations, AE onset dates, stool culture results and patient recovery status). The physician requested a call back in a few days and she needed to be in her office so that she could reference the patient's chart at that time. No further information is available at this time. Follow up information has been received from the physician concerning the 26 year old female with allergy to penicillin, polymycin, neomycin, bacitracin, and late allergies, migraine, temporomandibular joint syndrome, anxiety, back pain, anaemia, attention deficit disorder, abscess and lactose intolerance who on 08-DEC-2008, at 10 a.m., was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# 0152X) into the left arm. On 09-FEB-2009, at 9 a.m., she was vaccinated intramuscularly with the second dose of GARDASIL (lot# 0152X) into the left arm. On approximately 14-MAR-2009 the patient  developed lip swelling. Her lip swelling was at times part of the lip (mostly upper) but generally not the whole lip. This had continued and no cause had been found (including dental, parasitic, food allergies). On 07-JUL-2009 the patient came to the office and complained of post-coital bleeding for approximately 1 month. She was on birth control pills. Pregnancy test showed negative. Pap test in December 2008 was normal. Chlamydia & gonorrhea DNA test, dental X-ray test, stool culture test and beta-HCG test were all negative. Cervical polyp was seen on exam. There was no illness at the time of vaccination. At the time of reporting the patient was not recovered. On 09-JUN-2009, at 2 p.m., she was vaccinated with third 0.5ml dose of GARDASIL (lot# 661046/0546X) into the left arm. Follow-up information was received on 26-AUG-2009 from the physician's office. On 14-AUG-2009, the physician had an appointment with the patient and the patient had recovered from breakthrough vaginal bleeding and lip swelling. Additional information is not expected.
PT received pneumonia 23 vaccine & started to experience large swelling & rash/redness wrapping around top right arm area. Symptoms got larger through next day. PT saw provider & was released with meds.
Patient c/o pain in the arm in which he received the pneumonia vaccine injection (left arm) and reported to not being able to sleep that evening.  He reported his left deltoid muscle being sore and warm to the touch, with redness spreading down to above the elbow area.  The patient was instructed to take an OTC antiinflammatory and to ice his arm.
inadvertently given 0.25mL dose of FLUZONE QUADRIVALENT instead of the intended 0.5mL dose with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was inadvertently given 0.25ml dose of fluzone quadrivalent (INFLUENZA QUADRIVAL A-B VACCINE) instead of the intended 0.5ml dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Aug-2022, the patient received a dose of 0.25 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number:UJ879AB, expiration date: 30-Jun-2023, via intramuscular route in the left vastus lateralis as Immunization    On 26-AUG-2022 the patient was  inadvertently given 0.25ml dose of fluzone quadrivalent instead of the intended 0.5ml dose with no reported adverse event (incorrect dose administered by product) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently given 0.25mL dose of FLUZONE QUADRIVALENT instead of the intended 0.5mL dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient complains of reaction to the lower shot (Boostrix). Developed a hive for 2 weeks. When the redness disappeared, a patch of dry skin appeared. Dry skin patch has persisted for 1 month and there is a visible mark from injection site. Patient sought medical advice. treated with hydrocortisone cream with no relief.
Pt received flu vaccine on 11/14/16 to left arm early in the afternoon. Mother states area was red, warm and firm to the injection area also states child said it was sore. The area was noted to be slightly large than a 1/2 dollar coin. Ibuprofen was given for pain.
Patient received Pfizer COVID vaccine on 3/30/21 and 4/16/21. On 1/28/22, patient admitted to our inpatient facility (med/surgical unit) with acute encephalopathy likely secondary to AKI and COVID-19 virus infection. Patient was discharged home today (2/1/22).
Pt. had difficulty breathing and throat closing around 9:00 PM. Pt went to hospital and was given Benadryl and discharged. At 5:30 AM pt now complains of respiratory illness (10/4/13).
The patient experienced pain in her upper left arm.  She went to the doctor and was diagnosed with bursitis as the vaccine was apparently given too high in her arm.  Our pharmacy was alerted to this adverse event on 10/6/23. She was still experiencing some pain at the time of this form completion.
PT GIVEN FLU VACCINE 11/23/11.  PT CALLED 11/25/11 TO REPORT A 2" HARD SWOLLEN BRUISE IN THE AREA WHERE THE VACCINE WAS GIVEN (RT DELTOID).  PT DENIES ANY RASH ITCHING, DENY ANY OTHER SYMPTOMS.  PT STATES HE IS ON ASPIRIN THERAPY.  BRUISE AT INFLUENZA SITE, REDNESS AND SWELLING AT PNEUMOVAX SITE.
After receiving the injection, within about 5 to 10 minutes patient felt dizzy and fell in his fathers arms.  Patient did not pass out but was dizzy, clammy, sweaty and pain in his left arm at injection site.   I called 911.  911 came within a few minutes since they are stationed across the street from us.  The EMT took his vitals. Vitals initially low at 88/55 then climbed back up to 102/68.  No fever.  Patient started to feel better.  EMT stated patient is ok and may have
Development of popular pustular rash over the back about a week after vaccination and continuing to worsen > 3 weeks after vaccination
Information has been received from a medical assistant concerning an 81 year old female who on 10/17/02, was vaccinated with pneumococcal vaccine 23 polyvalent (643782/0675M), in the left arm. On 10/18/02, in the morning, she called the physician's office with complaints of pain, left arm swelling, left arm redness and left arm itching. The medical assistant reported that the physician expressed a concern regarding the lot number and requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Right side of face and head: Gradual severe pain persisted for a number of days leading up to the onset of Bells Palsy-visited GP and neurologist and is on Prednisone and Valocyclovin now.  Hopefully recovering. The medical record received on 3/23/04 states weakness rt eye closure, numbness, difficulty speaking, eye tearing, taste diminished, headaches, and anxiety.
Patient broke out in rash to back, chest, and lt shoulder (injection given in Lt thigh SQ).
About 20 minutes after receiving the vaccine, the patient complained of congestion in her throat and  numbness of tongue and right side of face.   Patient was given 50 mg of Benadryl.   Numbness spread to arms.  After about 15 minutes, patient complained of feeling dizzy.  Patient was observed for about 20 minutes more. Symptoms did not progress.  Patient was advised to follow up with PCP. Spoke with the patient on 2/19/2021.  Patient stated that she was feeling much better.
Prolonged soreness at (L) delt vax site, with perceived numbness and weakness, no objective weakness.
Developed tiNNitis - Both ears 1 day after getting 2nd dose of Covid vaccine went to be evaluated on 10-1-21 BY Dr. After having my hearing checked he determined that my tiNNitus is most Likley from my 2nd Dose of Covid-19. but in his report to my primary Dr. Dr said it wasN't due to the vaccine! No treatment no pRedNisone only could give me ativAN which I refused. He did Not report the adverse reactioN To my Knoledge. Dr. Believed Dr.'s report so didn't report it. He said I could report it. So I am. I Have had Tinnitus Now for 1 yearand I believe it was caused by the Covid vaccine.
Patient was given the Covid Vaccine Booster. She was asked to wait 15 minutes after the vaccine. After 5 minutes patient and her son reported that she was feeling dizzy and unwell.  Pharmacist assured the patient is getting the proper treatment.  The pharmacist asked if the patient if she  likes to the hospital and she replied yes.  The pharmacist had both patient and her son sit down while made the call. The paramedics came and took the patient to the hospital of her choice.
became quite ill; This is a spontaneous report from a Pfizer sponsored program. A contactable Female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient became quite ill 3 days after receiving her first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Blue tinged skin around red pimple looking bumps 3 days after red lump appeared. fever of 102-103.4 up to 3 weeks after immunization. Painful to touch and warmer than rest of body. Hardened area (still to date) in injection site along with discoloration. Infant refuses to put full pressure of body weight on leg.
Currently pregnant at 18 weeks of pregnancy Shot administered at 9.20am in the left arm by pharmacist Signs of fever and chills started at 6pm Chills continued until 11pm (forehead temperature registered at 98 degrees) Sinus headache started at 10pm, remained until following day General feeling of malaise and fatigue 24 hours post-vaccine administration
Client complained of tightness in the throat region, eye puffiness and transient right arm urticaria.  On site MD recommended Benadryl but client declined. Client held for observation and symptoms resolved. Client released by MD in stable condition.
Diarrhea. Poo oily - oil floated on the water with poo. When you fart liquid come out yellow poo. Hands and feet pain (nerve bones pain). The pain last for a few seconds and sometime it last a long time. Hives.
Client received additional dose of Hep A vaccine and was observed for 15 minutes with no adverse effects noted.
This study case was received from the investigator on 27 August 2012. A male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 19 March 2010 an elevated Troponin, central laboratory level of 0.14 ng/ml (draw date 18 March 2010). The subject had a rapid Troponin I level on 18 March 2010 that was within normal limits (negative). An ECG on 09 April 2010 was normal. A repeat Troponin on 09 April 2010 was <0.10 ng/mL and according to the investigator was normal. The subject had no concomitant medications. No treatments were reported. No further information was available at the time of the report. The subject's outcome was recovered, no residual effects on 10 April 2010. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender.
swelling underneath arm; Could not lift arm; Fever; Chills; Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Shortness of breath in march2021 due to covid also tightness of chest and trouble breathing).   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (swelling underneath arm), MOBILITY DECREASED (Could not lift arm), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain/was very painful/could not lift arm/Swelling underneath your arm.) and HEADACHE (Headache) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. Treatment information was not provided.   This case was linked to MOD-2021-338784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant follow up (Additional event)
Vaccine appeared to be given slightly lower than deltoid muscle on arm. The injection itself did not cause pain but about 24 hours after receiving the vaccination patient reported that her hand became painful and numb. Patient reported she lost control of her hand for about a day or two. After a few days the pain subsided, and she regained control of her hand.