chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 20 minutes after the vaccine, she came up to the pharmacy and said she had numbness/tingling in her left arm and face.  We observed her for about 25 more minutes and symptoms didn't seem to change.   The injection site looked normal.  She wasn't having any trouble breathing and was very talkative and active.  Told her if things progressed throughout the day to go see the doctor.
After receiving the first  COVID Pfizer vaccine at approximately 1pm- client developed hives around arms and chest at around 1:15 during the 15 minutes required observation period.  EMS on site called, client assessed, taken to the hospital for hives- the hives resolved once client transferred to the ER.
shingles outbreak - I do have a primary autoimmune deficit.  small blisters under right breast, itching, red - trailing laterally to rib cage, slightly feverish, fatigue. Will call my PA tomorrow. I have a prescription for valacyclovir and started taking it Friday the 22nd.
He became lightheaded approximately 1 min after vaccine administration, then extremely pale. Approximately 1 min later he lost consciousness, was shaking and snoring. He regained consciousness after approximately 15 seconds.
brain bleed; some pain in my head; This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 Immunization. Patient had an ER visit about a week ago in Aug and they said there was some sort of brain bleed or something. Patient had some issues like in Jul some pain in his/her head but then patient went to the ER like in Aug.This is all in 4 months of me having the last vaccination. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Information has been received from a nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unspecified. On 23-MAR-2016 the patient was vaccinated with improperly stored dose of PNEUMOVA 23 (lot # L040181, expiration date 18-APR-2017, dose unknown, intramuscular). The vaccine was stored under -0.4 degree centigrade (round to 0 degree centigrade) for a cumulative of 7 hours and 0.9 degree centigrade for a cumulative of 7 hours, 1.3 degree centigrade for 36 minutes, 1.4 degree centigrade for 1 hour, 1.6 degree centigrade for 42 minutes and 1.7 degree centigrade for 20 minutes. It was called because of a data logger. No adverse effects reported. Additional information has been requested.
My S/S occured <24hrs, right breast doubled in size. Hot to the touch with erythema, fever 101.6 and chills lasting 24 hours. Pain in chest/right breast not relieved by 800 mg motrin and Tylenol.  On 8/21/21 at 8am, went to ER.  At ER given IV cefazolin and ketorolac, and sent home with Norco and Naproxen. Referred to breast surgery for screening.  Ingredients in shot attacked a cyst in the right breast. The cyst was documented in imaging years prior, never problems noted with it. Pain lasted >1mo. Missed school, work, clinical and spent much time in bed due to pain that only Norco was helping.
Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs. The causality assessment remains as not applicable in this case.
Headache while idle, and once I move and walk around I have random migraine spikes that last from 1-30 seconds making it impossible to drive, walk, jog, exercise, go to work, exc.
I got the flu in the last 55 years, is the year I got /he flu shot; Initial information received on 12-Feb-2022 regarding an unsolicited valid non-serious case received from a patient via social media.  This case involves an adult patient of unknown gender who experienced I got the flu in the last 55 years, is the year I got /he flu shot while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, dosage form, frequency, route, administration site, batch number and expiry date) for immunization.  On an unknown date, the patient developed a non-serious event I got the flu in the last 55 years, is the year i got /he flu shot (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu in the last 55 years, is the year I got /he flu shot).  At time of reporting, the outcome was Unknown for the event I got the flu in the last 55 years, is the year I got /he flu shot.
Later the day after the vaccine I developed severe chills and a really bad sore throat.  I developed hives in my throat and mouth which cause hoarsness and was hurting really bad.  On that Monday I visited my PCP who prescribed an antibiotic which did help and took antihistimines also.  I developed a fever an was really tired and after about 3 day the symptoms subsided.  My arm was really sore for about 2 days also.
vaccination site was left deltoid. On the left shoulder across the back to the right shoulder was a small papular rash.  there was a small pustular lesion on the right anterior chest and on the right wrist. Vaccinated on 3-21-03 at HD. Take recorded on 3-27-03(vaccination lesion now scabbed over).  He then went to hospital where his father had been hospitalized and a rash was noticed (described as pimple on the back).  Called Health Dept. and was referred, who referred him to Dr. Dr. reportedly told him that he had not spread the virus to his back; also told him that he should avoid contact with other persons for a period of time to reduce any possible chance of transmitting vaccinia to tohers; gave him some type od anti-pruritic medication.  Approx. 3-4 days ago, developed diarrhea, which lasted 2 days. Yesterday he was tired, aching, sweaty, joint discomfort, felt hot at times (did not take his temp) possibly some nausea.  Denied vomiting or diarrhea.  Today still not feeling well with simialr symptoms, including apparent chilling. States he has had headache at times during past 2 weeks, which he attributes to sinuses.  It does not seem to be particularly bothersome.  Says the rash has kind of gone away.  It is less noticable than previously.  No areas of noticable erythema.  Told him it was possible his recent symptoms were due to a viral infection and might not be related to his vaccination. Recommended that he call his private physician's office, describe what he is experiencing and see if they want to evaluate him and see if they could see him.  Gave him my home phone number is case his physician had further questions.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 33 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID 19 Treatment from 07Sep2022 to 11Sep2022.
This spontaneous report as received from two healthcare workers refers to unspecified patients of unknown age. On 05-MAY-2014 between 8:50 a.m and 9:10 a.m, unspecified patients were vaccinated with ROTATEQ (strength, dose, lot#, expiration date were unknown) oral. It was reported that the patients received improperly stored ROTATEQ, it was exposed to 26.2F for 5.5 hours. One reporter reported that they believed the ROTATEQ was in recommended storage temperature when removed from refrigerator and administered, but they were not 100% certain so they included the products in the excursion information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Two hrs p/vax, child began to shake. Then ran temp of 104. Con't to shake & shiver throughout noc. Temp down p/Tylenol given. Seen by MD on 28FEB91.
Patient described that they felt like the room was "spinning," and felt "weak." Patient denied any shortness of breath, difficulty breathing, chest tightness, or itching/ flushing.  RN took vital signs at 1400, and were as follows:  155/99 mm Hg, 181 BPM, 26 BPM, and 100.5 F. RN took patient to a secluded area,  and  relaxation techniques (deep breaths, relaxation imagery, etc.) done RN. After relaxation techniques vital signs apical pulse 86 BPM.  Patient indicated she did not feel feverish at home, and no elevated temp. reported at screening station. Patient indicated that she was diabetic and had not eaten since the morning. RN instructed to eat a piece of candy.  Patient also indicated that they have high blood pressure usually, but could not identify approximate values.  Relaxation techniques continued. At 1435 vital signs were as follows:  131/68 mm Hg,  86 BPM, 20 BPM,  pulse oximetry 95%, 100.5 F. RN provided instructions to continue to monitor symptoms, and if worsen seek medical attention. RN provided information to rest, drink plenty of water, and take OTC medication as  clinically indicated.  Patient returned home.
1 1/2 days post vax devel arthralgias of shoulders elbows & knees improved w/Ibuprofen, but persisted @ time of report;
Heavy nose bleeds that are clotting from 2:00 am on Thursday 11/11/21 and Friday 11/12/21. Both days were 6 times each day. The bleeding stopped on Saturday at 9 am; thankfully. She was seen at hospital on Thursday 11/11/2021 and Dr. and the nurses listened to her heart and gave her. EKG and then sent her home. I will be taking her to see a ENT specialist following a video visit appointment with a physician from her primary doctor office.
an expired dose of ACTHIB was given to a patient with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 1 years old female patient who received an expired dose of Hib (Prp/T) Vaccine [Act-Hib], was given to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2023, the patient received an expired dose of suspect Hib (Prp/T) Vaccine (Powder and solvent for solution for injection), with no reported adverse event (expired product administered) (latency: same day) (strength: unknown) (lot: UJ836AA, Expiry date: 28-Oct-2023) via intramuscular route in unknown administration site for immunization.  No lab data reported.  Action taken : not applicable.  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.
Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in the right arm on 23Feb2021 23:30 at a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient did not received other vaccine in four weeks. The patient experienced acute appendicitis on 28Feb2021 00:00. The patient had an emergency open appendectomy. Outcome of the event was recovering. The patient was hospitalized for acute appendicitis for 4 days. Event serious due to hospitalization and life threatening. The event resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient was not diagnosed of COVID prior vaccination and has not tested for COVID post vaccination.
no adverse event; the patinet was inadvertently administered one dose of expired VAQTA; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.     On 14-AUG-2019, the patient was inadvertently vaccinated with one dose of expired hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml (lot # R022983, expiration date: 09-AUG-2019) for prophylaxis (expired vaccine used). No adverse effects reported. No further information provided.
Flu like symptoms; Fever; Chills; Headache; Body aches during the night; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pyrexia (received 1st dose on an unknown date and had fever, refer case US2022AMR094576).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a month after receiving Shingles vaccine, the patient experienced influenza-like symptoms, fever, chills, headache and general body pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, headache and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, headache and general body pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR094576   Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient just got his/her second.  Both times the patient had flu like symptoms, fever, chills, headache, body aches during the night. The patient stated that but worth it if the vaccine helps. The patient got the vaccine because if reading all these comments. The patient was sorry everyone was going through the effects of shingles. The patient stated god bless. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094576:Same reporter
This spontaneous report as received from a pharmacist refers to patient of unknown age and gender. The patient was vaccinated with 0.65 ml SQ lot # (669746/0356AA, exp 09-JUN-2012) ZOSTAVAX expired dose on 02-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information is not expected.
Zoster given instead of HIB. Patient appeared fine. Realized when documenting vaccines that incorrect vaccine was given. Notified PCP.
felt tightening/tingling of face, perioral bilaterally within 15 minutes of administration. Was giving vaccine, waited 15 minutes in clinic and left. Got to car and then came back to report symptoms.  Monitored for 1 hour, evaluated by Family Medicine and Allergy Providers, BP 155/89 ; HR 82 and second BP 139/82; HR 78.
Night after vaccine had high fevers, treated with ibuprofen.  Low mouth intake, vomiting, no diarrhea, no dehydration.
pain in my left upper arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (pain in my left upper arm) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in my left upper arm). At the time of the report, PAIN IN EXTREMITY (pain in my left upper arm) 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.   No concomitant medications were reported. No treatment details were reported.
ADACEL accidentally being given to the wrong patient who is under 10 years of age with no reported AE; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a Non Healthcare professional.  This case involves a suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [ADACEL] accidentally being given to the wrong patient who is under 10 years of age with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine VLP RL1 9V (YEAST) (GARDASIL 9) and Meningococcal Vaccine A/C/Y/W CONJ (CRM197) (MENVEO) both for prophylactic vaccination.  On 05-Oct-2022, the patient who is under 10 years of age accidentally received a 2nd 0.5 ml  dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine with no reported AE (product administered to patient of inappropriate age), Suspension for injection (lot U7306BA, Expiry date- 11-Mar-2024, Strength- standard)) via intramuscular route in left deltoid for prophylactic vaccination (Latency- same day).  Action taken: not applicable.  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.
pt exp soreness in upper lt arm, burning in arm;reportedly pt exp heart palpitations 5wk p/vax;
rash appeared 10/18/99 on mostly uppe body & sporadically on lower extremities;rash is very itchy;
calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine; calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine". The patient underwent the following laboratory tests and procedures: infectious mononucleosis: unknown result, notes: they are currently waiting for their daughter's laboratory test result to see if she will test positive for mono.  Clinical course:Caller is calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine adult formulation. Caller said they are currently waiting for their daughter's laboratory test result to see if she will test positive for mono (mononucleosis) as well. Caller wanted to know if her daughter can still get the vaccine for 2nd dose after testing positive for covid and how long would they have to wait. Is report related to a study or programme Yes. Caller provided her telephone number. Caller clarified that her daughter had the first dose of Pfizer Covid-19 Vaccine and got Covid after that. Caller clarified that they do not know if the patient has mono yet, they are currently waiting on lab test results to see if she is positive for Mono. She verified that the patient needs to get her second dose of Pfizer Covid-19 Vaccine. Her question is if the patient does get a positive result for Mono, can she still get the second dose of Pfizer Covid-19 Vaccine. Is there a Product Complaint: Yes. Description of Product Complaint: Description of complaint: Patient had the first dose of Pfizer Covid-19 Vaccine and got Covid after that. Product strength and count size dispensed: Not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a 25 year old female patient without drug reactions or allergies. The patient's current conditions were not reported. The patient's medical history included: took trazodone, tretinoin cream and minocycline in the past and no drug reactions/allergies. On 23-OCT-2013, the patient was vaccinated with the first dose of GARDASIL 120 y (dose, route, lot and expiration date were not reported). On 06-FEB-2014, the patient was vaccinated with the second dose of GARDASIL 120 y (dose, route, lot and expiration date were not reported). On 06-FEB-2014, the reporter mentioned that the patient felt woozy after receiving her second dose of GARDASIL. The reporter stated that the patient remained in the office for a little while before going home and mentioned that the patient was recovered when she left the office. The patient did not received treatment for the event. No lab diagnostics were performed. Additional information has been requested.