chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Chest Pain; Body aches; Vomiting; Fatigue; This is a spontaneous report from a contactable consumer. A 21-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Apr2021 at 12:00 hours as dose 1, single (at the age of 21-years-old) for COVID-19 immunisation. Patient had no medical history and no known allergies. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination. On 15Apr2021 at 23:45 hours, patient experienced severe chest pain, body aches, vomiting and fatigue. Patient received no treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache right after shot continuing into present time.  3 weeks later sore throat, congestion, loss of voice, fever, extreme chills, debilitating and extreme joint pain,swelling and heat in wrists, elbows, shoulders and knees, continuing into present time.  Weight loss. Have tried triamcinolone, solu medrol, high dose prednisone tapers, tylenol, ibuprofen.   Slight relief at times.  Have not been able to work for 3 weeks.  Limited movement in joints, decreased quality of life. Unable to get up from chair, toilet and bed easily.
Patient was administered dose at 8:36 am of Covid vaccine. Patient went to lab to have blood drawn and had syncopal episode at 8:56 am. Patient recovered and was sent home in stable condition.
Hives/urticaria in torso, neck, and arms. Ongoing at this time. Taking normal doses of Benadryl.
my last shot was 4/9/21 , in the last month or so , I get swollen feet, right leg pain , right heel pain , like pins and needles, prickly sensations, weak muscles , feel tired all the time, sometimes pain is unbearable, never had these symptoms before the shots, making me feel really afraid, I'll never be the same or unable to walk it's all my right side , vaccine was my right arm, I believe it's all caused from vaccine
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Pt reports Left Upper eyelid swelling the next day after her injection. She also states that her R upper eyelid also feels different.  She is concernced with VAERS. Was evaluated at the Clinic and tx started for potentially hordeolum of L upper eye
I had a sore throat and chills for 1 day and I went to get tested at pharmacy and was positive with COVID-19.  I didn't take Paxlovid that was given to me. The symptoms lasted about 3 days and then I felt better and feel good now.
difficulty with short-term memory; Initial information was received on 25-Aug-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a female patient (age was not reported) who had difficulty with short-term memory (memory impairment), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On 25-Aug-2020, the patient had (non-serious) difficulty with short-term memory (memory impairment), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Injection site is really high my arm. I am experiencing shoulder pain and limited mobility in my arm. Dose was today so will monitor.
possible heart attack; possible stroke; pacemaker was not working; overdue 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (possible heart attack), CEREBROVASCULAR ACCIDENT (possible stroke) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Pre-existing disease.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (overdue 2nd dose). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (possible heart attack) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criteria hospitalization and medically significant) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (possible heart attack), CEREBROVASCULAR ACCIDENT (possible stroke), COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) and PRODUCT DOSE OMISSION ISSUE (overdue 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information available.  The reporter mentioned that patient has lot of pre-existing medical conditions.She does not know name of current medications he is taking which is tons of them. Patient is currently in rehab center and Hospital where he is admitted did not give him vaccine since he received his 1st dose at Rite aid. Rehab center does not have vaccine in stock.  Limited information regarding the possible MI  and CVA and pacemaker problems have been provided at this time and a causal relationship cannot be excluded.  This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the possible MI  and CVA and pacemaker problems have been provided at this time and a causal relationship cannot be excluded.  This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Came in day after immun with vomiting (right after received flu vaccine) and next day, 1 loose stool, no fever. In daycare.
After booster shot, I had chest tightness, heart palpitations, high heart rate and lower than normal resting heart rate.  Had to have EKG which showed the lower resting heart rate and eco cardiogram.  Also, blood work showed elevated inflammation and high liver enzymes.
1 hour after shots - urticarial rash and ? gasping for air, seen in ED. Symptoms resolved in about 1 hour later. 1 dose BENADRYL given.
THE SHOT WAS GIVEN AND THE PATIENT APPEARED PERFECTLY FINE BEFORE LEAVING THE IMMUNIZATION ROOM. THE FATHER RETURNED ABOUT 15 MINUTES LATER, CARRYING THE CHILD IN HER ARMS, SHE SEEMED RESPONSIVE AND ALERT. HER FATHER STATES THAT SHE WAS SEATED IN A CART AND HAD A SMALL SEIZURE AND SLUMPED OVER AND HER HEAD FELL TO THE SIDE OF THE SHOPPING CART. HE RAN IMMEDIATELY BACK TO THE PHARMACY TO LET US KNOW. THE FATHER SPOKE TO ME AS THE CHILD SAT ALERTLY IN THE CHAIR IN THE IMMUNIZATION ROOM. I HAD A PHARMCY INTERN CALL 911 WHILE I STAYED WITH THE CHILD. THE 911 OPERATOR HAD ME MONITOR HER BREATHING WHILE THEY HELD ON THE PHONE. HER FATHER ASKED IF HE COULD GIVE HER WATER. I TOLD HIM THAT WE SHOULD HOLD OFF ON FOOD AND WATER IN THE EVENT SHE HAS ANOTHER SEIZURE. WE CHECKED HER RIGHT ARM TO SEE IF THERE WAS A RASH BUT THERE WAS NONE. ALSO, I ASKED IF SHE HAD ANY PAIN ANYWHERE IN HER BODY BUT SHE SAID NO. THE 911 OPERATOR SAID THAT THEY WOULD BE SENDING AN AMBULANCE OUT TO US. WE RELAYED THIS INFORMATION TO THE FATHER AND HE CHOSE TO DECLINE HAVING AN AMBULANCE SENT OUT. I TOLD HIM TO MONITOR HER CLOSELY ESPECIALLY IN THE NEXT 24 HOURS AND TO TAKE HER TO THE EMERGENCY ROOM IMMEDIATELY IF HE NOTICES ANYTING OUT OF THE ORDINARY.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
I had severe headache, body ache, fever, and chills.  I had ulcers on my genital area.  I went to a dermatologist about the ulcers.  They tested for all STD, negative results on all of them.
Pt was given the Tdap in error at the age of 11.  Pt received the Tdap at his appropriate age last year at age 10.
This was reported by a lawyer and described the occurrence of mercury poisoning in a 7 year old male pt who received hep B vaccine recombinant and DTP/DTaP vaccine for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified this report. At an unknown time after receiving hep B vaccine, DTP/ DTaP vaccine, Hib and/ or MMR II vaccine, the pt experienced neurotoxic effects resulting in "severe" neurodevelopmental injuries. The events were attributed to mercury overdose and poisoning resulting from the thimerisol-component of the vaccines. The "multiple symptoms" of the pt's injuries "occurred and were first manifest no later than 1/1/01." According to the attorney, the pt incurred medical expenses and will continue to incur medical expenses in the future as a result of his injuries. The attorney also alleged that the pt suffered significant impairments in his ability to enjoy life, faces "significant obstacles to performing the tasks and activities of everyday living," and suffers "ongoing physical and mental distress." This case was assessed as medically serious (OMIC) by manufacturer.
freezing cold; arm hurt; covid arm; couldn't eat; couldn't sleep; fatigue; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat) and INSOMNIA (couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-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 FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat), INSOMNIA (couldn't sleep), FATIGUE (fatigue) and HEADACHE (massive headache). At the time of the report, FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat), INSOMNIA (couldn't sleep), FATIGUE (fatigue) and HEADACHE (massive headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283924 (Patient Link).
Large, red, hard area with streaking - Pt. dx. in ER with cellulitis - Parent reported (L) deltoid
Numbness in hand and legs; Cramps in hands and legs; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tetanus vaccine for prophylaxis.   On 8th April 2022, the patient received the 1st dose of Shingrix (intramuscular) and tetanus vaccine at an unknown dose and frequency. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced numbness and cramp. The patient was treated with magnesium (Magnesium Powder). On an unknown date, the outcome of the numbness and cramp were unknown.   It was unknown if the reporter considered the numbness and cramp to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's comment: This case was self reported by the patient.  The patient reported that received first dose of Shingrix vaccine on left arm. The patient was also administered with Tet vaccine in the right arm on the same day when patient got the Shingrix vaccine.  The patient reported that 1 or 2 months after the vaccine had numbness and cramps in hands and legs.  The patient reported that it was from below the knee.  The patient reported that using Magnesium powder and this had helped.  No all information was available.  Lot and expiration date were unknown.  No additional information was provided.  The reporter did not consent to follow up.
Information has been received from a physician concerning a 9 week old female with a history of reflux and a history of using AXID who on 16-AUG-2010 was vaccinated with a first dose of ROTATEQ (lot # 668124/0520Z). Suspect therapy on 16-AUG-2010 included RECOMBIVAX HB (lot # 666185/1493Y). Concomitant therapy included PENTACEL (lot # reported as C3580AA) and PREVNAR 13 (lot # reported as #69009). In the night of 16-AUG-2010 the patient experienced vomiting and spitting up. In the morning of 17-AUG-2010 the patient had an "acute life threatening event and stopped breathing and turned blue". The patient had a decrease in respiratory rate and oxygen. The patient was taken to the emergency room at a hospital and was admitted on 17-AUG-2010. The patient was given oxygen and also had secretions suctioned in the hospital. Upper GI showed normal anatomy. The patient was discharged from the hospital on 21-AUG-2010. At the time of the report, the patient had recovered. On 23-AUG-2010, the patient had a follow-up visit with the physician and was reported as fine. Vomiting, spitting up and stopped breathing were considered to be disabling and immediately life threatening. A lot check was requested. Additional information has been requested.
About 3 hours after receiving pt began experiencing a severe headache. Shortly after she developed nausea and dizziness. Denies vomiting but was not able to drink to eat anything for the nausea. She had to lay down in bed and was unable to get up until it resolved. Pt reports it resolved within 24 hours. She did not tell us about this until she returned today to receive her 2nd dosage. Despite the previous events, she opted to receive the 2nd Shingrix today.
pt recv vax 18APR96 & mom brought pt to clinic 22APR96 for eval of lt thigh;lt thigh (site of inj) appeared red & swollen approx 1" x 1";area was not painful to touch;pt able to move legs w/o diff & can bear weight on legs bilat;
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Potential AE due to doses administered from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Potential AE due to doses administered from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Potential AE due to doses administered from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Potential AE due to doses administered from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Moderna ordered date was 01-Nov-2021 and 15-Nov-2021 The BUD of the vaccines was reported as 01-Dec-2021 to 15-Dec-2021. No concomitant medications information was reported.  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They were preparing for a CDC audit and wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.   Reporter queried whether they need to take any action since they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment medications were provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports received from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K008333 and expiration date 10-MAR-2017, lot # M01116 and expiration date 17-JUN-2017, lot # reported as M015773 and expiration date 26-MAY-2017; exact doses and route of administration were not provided). It was reported that the vaccines were exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported.  This is one of the several reports received from the same source. Additional information has been requested.
Patient was accidently given the pediatric vaccine instead of the adult vaccine and will have to return to the office to receive the correct vaccine as the one received will be ineffective.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a fever for two days, a rash which lasted 4 days, diarrhea, vomiting, a headache and fatigue. The pt was treated with acetaminophen.
dizziness; blurred vision; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received first dose bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 14Jan2021 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced dizziness and blurred vision. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Nausea; Food intolerance; Smell also affected-lingering 10 days after vaccine admin; This is a spontaneous report from a contactable other Health Professional. A 18-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 25Feb2021 at 10:00 am (at the age of 18-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history includes Polycystic ovarian syndrome (PCOS), obesity and COVID-19, the patient had covid prior vaccination. The patient not tested covid post vaccination. No known allergies reported. concomitant medications includes Metformin and Oral contraceptive, which were received by patient in two weeks. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 04Feb2021at 04:00 pm (at the age of 18-year-old) as 1st dose, single dose for COVID-19 immunisation. The facility type for vaccine was Hospital. The patient was not received other vaccine in four weeks. On 01Mar2021, the patient experienced nausea and food intolerance. Smell also affected-lingering 10 days after vaccine administration. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with antiemetics. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
pt recvd vax & had t 104; 2 sz; 10 days post immun seen in ER;
Weakness on the left side of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "Weakness on the left side of the body". Clinical course: It was reported that the patient got the shot in the left side of the body. Weakness on the left side of the body came after the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient described "throat closing". Got diphenhydramine. Patient recovered in 15-30 minutes.
Pt woke up crying & was fussy, fretful all Fri & sat; extended arms & leg in spasm like or as if in pain about once q3hrs;