chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy red rash with some swelling on her right arm and right leg above the knee.; Itchy red rash with some swelling on her right arm and right leg above the knee.; Itchy red rash with some swelling on her right arm and right leg above the knee.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy red rash with some swelling on her right arm and right leg above the knee.), ERYTHEMA (Itchy red rash with some swelling on her right arm and right leg above the knee.) and SWELLING (Itchy red rash with some swelling on her right arm and right leg above the knee.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PRURITIC (Itchy red rash with some swelling on her right arm and right leg above the knee.), ERYTHEMA (Itchy red rash with some swelling on her right arm and right leg above the knee.) and SWELLING (Itchy red rash with some swelling on her right arm and right leg above the knee.). At the time of the report, RASH PRURITIC (Itchy red rash with some swelling on her right arm and right leg above the knee.), ERYTHEMA (Itchy red rash with some swelling on her right arm and right leg above the knee.) and SWELLING (Itchy red rash with some swelling on her right arm and right leg above the knee.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Pt received Men B#2 on 4/26/19. Has 3 seizures with 24 hours of dosing was dx with seizures about 8 mo ago and having them q 7-10 d but significant increase in freq post second shot. Had Neg CT, Neg Shunt Series.
This spontaneous report as received from a certified medical assistant refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ZOSTAVAX lot # L029482 with expiration date: 06-NOV-2016 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
BLOOD PRESSURE SLIGHTLY HIGHER  THAN NORMAL; DIZZY AND LIGHT HEADEDNESS; SWOLLEN ARM; REDNESS; This spontaneous report received from a patient concerned a 65 year old female. 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 12:20 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced dizzy and light headedness. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced redness. On 02-APR-2021, the subject experienced blood pressure slightly higher than normal. Laboratory data included: Blood pressure (NR: not provided) 157/72. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and redness, and had not recovered from dizzy and light headedness, and blood pressure slightly higher than normal. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Patient became immediately nauseous with wretching for approx 20 min. Person was hoarse with rasping voice after nausea 98.8-92-20 140/84. Kept for 35 minutes until stable. 1/29/10: Call to patient at work. Ate supper last its without nausea.
Had Tdap on Friday. Arm was sore and warm. Saturday am, woke up and had severe pain in back, weakness in legs and felt like had a fever. Had to have someone help her walk, because felt so weak. By Sunday, was able to walk by self. Went to chiropractor Saturday am and today. About 90% better today as opposed to Saturday am.
3RD MODERNA COVID VACCINE GIVEN 5/6/22, #FM9553; pt had a positive COVID test at local Hospital; during that stay, diuretics were held and IV fluids given; pt dc'd to alternate State Hospital with frank anasarca and respiratory difficulty; was sent to Specialty Medical Center; diagnosed with combined acute congestive heart and acute renal failure; dc'd back to alternate State Hospital where pt passed away
Metallic taste in mouth 12 min after vaccine. Lasting on and off until that same night. I did not have any further metallic taste after it resolved that night
Patient presented to mass flu clinic at the Health Department on 10/15/2021. Vaccine lookup was completed and noted that Patient was behind schedule for MMR, Varicella, Hepatitis A, Tdap, Hepatitis B, and polio.  After administration, while  documenting immunizations into vaccine system client was searched by name and his birthdate. There were two records for the client, one under Patient's name and DOB and one under Patient's name and DOB. Family was then called to verify middle name that was under, Middle name, mother's maiden name, and DOB match client listed under Patient's in vaccine system. Client had previously received vaccines through Memorial and they had been documenting his immunizations under the wrong name in vaccine system. Client eventually established care at clinic where they documented immunizations under the correct name and DOB for client. Client had two records open in vaccine system with different last names. Both records contain the correct parent information and address. Client has received vaccines at both Memorial and Clinic and some documentation was done under the incorrect last name while some immunizations were documented under the correct name. Due to the client having two open records in vaccine system, client received a total of 4 MMR/Varicella vaccines, 3 Hepatitis A vaccines, and an additional Tdap vaccine.
Pt endorsed a swollen tongue several minutes after receiving the vaccine. Pt was given Benadryl IM and released.
Gums started swelling; lips got tingly; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; stretching of her throat; felt dry; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW 0162), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 10:28 (at the age of 47-years-old) as single dose for COVID-19 immunization at doctor's office/urgent care facility. Medical history included seizures, migraines and allergy to Anti-Fungal Medications. Concomitant medication(s) included sumatriptan succinate (IMITREX); calcium; lamotrigine (LAMICTAL), and multivitamin, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Apr2021 at 10:45, reaction started with stretching of her throat and felt dry. She drank some water. At 11:00 gums started swelling and her lips got tingly. Her hands, feet, tongue, and face got red and flushed. She was sent to the ER for observation. Since then she had been on 6 rounds of steroids to try to control the reactions. She had 7 additional reactions within the 9 weeks after the vaccine. She was still on 40 mg of Zyrtec and Pepcid a day to keep down the reaction. She has been to multiple doctors and nobody could figure what the vaccine did to her system. She asked to help her to stop these reactions. Seriousness criteria was reported as Disabling/Incapacitating. Events resulted visit to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Received treatment for the adverse event with Benadryl, Zyrtec, Steroids', and Pepcid. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: 6L0446), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 10Nov2023 to 14Nov2023. Clinical course: After taking the Paxlovid for 5 days, patient took a test the next day and it was positive and then 2 days later she started feeling sick.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300384571 same patient, different drug/event;
expired QUADRACEL was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Agency (Reference number- 00701102) and transmitted to Sanofi on 28-Jul-2021.  This case involves a five-year-old female patient who was vaccinated with the expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 28-Jul-2021, the patient received a fifth dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA, expiry date-18-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (same day).  At the time of 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 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.
Swelling of prostate causing inability to urinate.; Swelling of prostate causing inability to urinate.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 10Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and severe pollen allergy causing food allergy to melons and bananas. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Mar2021 at 02:00, the patient experienced swelling of prostate causing inability to urinate. Therapeutic measures were taken as a result of adverse event and included visit to emergency room/department or urgent care and treatment with a catheter. The clinical outcome of swelling of prostate causing inability to urinate was recovering at the time of this report.  Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
First dose was given on 1/04/2022 at the hospital where she delivered baby.  Second dose was given at 4:49pm on 3/3/2022. In the evening of 3/3/22 she felt overly tired. Her symptoms got worse on the morning of 3/4/22 including  throbbing headache, fever of 102, severe full body muscle pain, injection site pain.  She also reported her face got swollen (facial skin got tighter) and severe numbness arms and hands and tingling of fingers. Also, she is very dizzy and confused.
Patient received the vaccine 12/30/20, her reaction began 1 week later on 1/6/21 in the afternoon. Patient developed an itchy, red knot at injection site; 2 inches in diameter and warm to the touch. Patient still has the knot on her arm at the time I am reporting this. She has not taken any medication for it.
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, with reference number 2023SA055890 (Inquiry number # 01495388), was received by the partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from other health professional.  This case was considered non-valid due to no patient identifiers (temperature excursion only).   Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use." and Vaxelis was assessed as not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received on 23-FEB-2023, from a HCP. The case is maintained as non-serious and upgraded to valid.   The HCP confirmed that there were no adverse events following Vaxelis administration.  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis remained not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004562, MCM-004563, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Information has been received from the mother of a 20 year old female with no known medical history and no known drug reactions/allergies who "sometime in June" 2007, was vaccinated intramuscularly with a dose of Gardasil (lot # not reported). Concomitant therapy included unspecified "birth control pill". "Two to three weeks after first dose", the patient experienced three heat exhaustion episodes that included fainting since she began the Gardasil dosing schedule in June. The patient sought unspecified medical attention. The patient's three heat exhaustion episodes and fainting persisted. there was no product quality complaint involved. Additional information has been requested.
weird symptoms; right ear started hurting bad/pain has been coming and going; swooshing sound; ended up being my heart rate which I could hear in my head; ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), TINNITUS (swooshing sound), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), TINNITUS (swooshing sound), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection). At the time of the report, FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection) outcome was unknown and TINNITUS (swooshing sound) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced some weird symptoms since receiving the vaccine. A couple of days after the first dose her right ear started hurting bad. This was accompanied by a swooshing sound, which ended up being her heart rate which she could hear in her head, tinnitus and was worse with lying down, sitting or stress. The patient was treated for an ear infection with sulfatide or cephalosporin. The patient had vexing and weeing kind of pain. She also has had headaches which have been continuous since then feeling like pressure in her head. She has seen an ENT specialist and neurologist who did MRIs showing no brain tumor or blood flow issues. She saw neuro yesterday who concluded that her symptoms were due to intercranial hypertension. She is now scheduled to get a spinal tap on 14SEP2021.   This case was linked to MOD-2021-307252 (Patient Link).
PT WAS GIVEN MMR ,HEPATITIS A, HEPATITIS B,. HAD A  REACTION OF A VERY FINE RASH AND ITCHING WITHIN 5 MINUTES OF GETTING THE VACCINES AND WAS GIVEN 50MG OF BENADRYL IM.
1-7-11 Father of this teen reports rash on face, back and stomach that appeared the morning after the flu vaccine. Reports rash seems to be getting worse. Encouraged him to take her to doctor. 1-13-11 Talked with pts dad, rash has resolved. Did not see a doctor and required no treatment.
Pt was hospitalized for treatment of smallpox vaccine adverse reaction-cellulitis-12 days post vaccination. Pt c/o left shoulder swelling, redness at vaccination site, fever, chills, "loose stools," vomiting, headache, light-headedness, body aches, and dry cough for 3 days. Pt was hospitalized for 5 days, then was discharged. Pt is now fully recovered. Pt left before VAERS could be filed. VAERS form created from inpatient medical records.
Patient had papular rash 8/29 which developed pinpoint blisters. Had low grade fever about 100 8/30-8/31. Presented 9/6 for well child visit. Rash blanchable with pin point scabs scattered chest, trunk, ext. Gave immunization on 9/6. Patient had fever to 101.7 evening on 9/6 then developed petichiae in AM 9/7 started on chin spread to abdomen, chest extremities. Admitted to hospital. Rule out meningococcemia. Leucocytosis.
received an expired dose of QUADRACEL, with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who received an expired dose of quadracel, with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation and strength not reported; lot C5763AA and expiry date: 26-Aug-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 22-Sep-2022, (latency: same day) the patient received an expired dose of quadracel, with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was 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 guidelines. 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.
short of breath; aching so bad again; was still short of breath, getting worse, aching so bad again; choking; got as cold as ice; throat was real swollen; started itching terribly; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration on 06Jan2021 single for COVID-19 immunization.  Medical history included hypertension and had 4 heart attacks. The patient's concomitant medications were not reported.  The patient just had the Covid 19 Vaccine first shot. After the shot he went to the dining room to get some lunch. He was reading since 'calculative'. He started itching terribly. Onset date for started itching terribly was reported as 06Jan2021. He got as cold as ice. He started getting real short of breath, he was choking but he managed to get them out of his throat. His throat was real swollen and choked. He went back to the clinic and the Nurse took him straight to the emergency room. He was there in his wheelchair freeze in and crawling himself, struggling to breathe for almost 25 minutes before the Nurse finally came in and helped him get him on the stretcher. She took his time, she got the IV started and gave him a steroid a shot and Benadryl. He did not know the dosage and some capsules. He did not know why the capsules and he was still struggling for a while but he found day tough for about an hour. When he came too he was still short of breath, getting worse, aching so bad again. He was struggling to breathe, he was still having some breathing problem, some choking and aching. The events was still short of breath, getting worse, aching so bad again were serious as hospitalization. Laboratory work: Work was normal. The COVID Test was negative. The outcome of events short of breath and started itching terribly was not recovered while for other events were unknown.
Varicella-mild/moderate eruption, diffuse on 7/25-7/26/03.