chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax OCT94 & NOV94 devel psoriasis of the scalp & exp loss of hair;tx w/hydrocortisone cream;events resolved p/4months;
After the 2nd dose in evening, my arm was sore and I had flu like symptoms-chills, body aches and pains, low grade fever and I went to bed.  I called the pharmacy the next morning and was advised to take Tylenol and I felt better.  By 24 hours, most symptoms have resolved.   On 2/22/2021, I woke up with vertigo.  I was sitting down and I felt like I was falling over and extremely off balance.  The next day, it was slightly better, just a little dizziness and off balance.  I call my Internist and was advised to go to Urgent Care and  check for high blood pressure, dehydration and UTI.   Everything came back normal and the doctor as the Urgent Care said it may be allergy related and was prescribed Meclizine. I went to an ENT specialist on 3/5/2021 and did an "eply maneuver"  which help resolved the vertigo immediately and was taken off Meclizine.  I had another episode of mild vertigo and went back to the ENT and did another eply maneuver which help resolve the vertigo. I still had  moderate-severe light headedness afterwards which lasted til about middle of June.   I now get lightheaded intermittenly and it will come and go once or twice a week and was prescribed Allegra which seems to be helping.
get bad flu; Initial information was received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case from the non-health care professional.  This case involves patient with unknown demographics who experienced bad flu (influenza), while he/she received INFLUENZA VACCINE.   The patient get bad flu everytime when take it. The patient's medical history, medical treatment(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get bad flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  The outcome of the event was Unknown for bad flu.  There will be no information available on the batch number for this case.
Patient is a medical doctor.  .  patient reports at 10pm April 11, 2021 , he was reaching into a closet when his entire right side fell asleep/was numb.  He reports that sitting temporarily help relieve symptoms, however when he stood, symptoms returned. patient sought care at ER.  His BP was 183/110.  However, nothing was found to be wrong except B-12 level was low.  Patient reports that symptoms lasted 45 minutes.
Soreness in the left arm from 3 hours after shot. Headache and elevated temperature in the late afternoon and evening.  Fever and chills in the evening. Headache continued in the morning of April 20th. Took 200 mg ibuprofen, 50mg zinc and 2 tbsp elderberry.
Fever of approx 101 F; body chills; injection site pain; This is a spontaneous report from a contactable unspecified healthcare professional reporting for himself. This 45-year-old male patient received on 21Dec2020 13:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs and hypertension. Prior to vaccination, the patient was diagnosed with COVID 19. Concomitant medications were not reported. On 22Dec2020 03:00 am, the patient had fever of approximately 101 F, body chills, injection site pain. No treatment was provided. Outcome was not recovered. Information on the batch number has been requested.
pt was seen in hosp & 2 hrs p/receiving vax w/extensive hives; DPH administered; mom to call MD;
Rapid heartbeat lasted through evening, elevated during simply daily activities. Prescribed heart monitor. Awaiting test results.
ITCHING ALL OVER BODY; SWOLLEN LYMPH NODES; FLUSHING; HIVES ALL OVER BODY; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 to left arm, for prophylactic vaccination. Concomitant medications included montelukast for asthma. On 25-MAR-2021, the subject experienced itching all over body. On 25-MAR-2021, the subject experienced swollen lymph nodes. On 25-MAR-2021, the subject experienced flushing. On 25-MAR-2021, the subject experienced hives all over body. On 25-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: montelukast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, had not recovered from hives all over body, itching all over body, and swollen lymph nodes, and the outcome of flushing was not reported. This report was non-serious.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M021407, expiration date: 30-APR-2018; lot # M016193, expiration date: 24-APR-2018; lot # L038503, expiration date: 18-DEC-2017). The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours (cycles: 7 times). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Paroxysmal atrial fibrillation, treated with Eliquis and metoprolol succinate.
Pt called stating that she is having severe pain after her booster SHINGRIX vaccine today. States that she feels like it was given in the bursa or to close to the bursa. States that the pain is severe to the point that she can't move her arm. States that she got the injection by RN at 11:30 and the pain started at 12:45 with stiffness/pain that has escalated. States that it was given about 1.5 inches below the shoulder bone and she is concerned it is maybe to close to the bursa after speaking with her daughter who works in the health care field.
Patient received dose of Tdap in clinic today. Pt's 5th dose of Dtap is counted as invalid. The patients 4th dose was administered on the patients 4th birthday. Per the CDC Recommended Schedule, stating: "Persons age 7?18 years not fully vaccinated* with DTaP:  1 dose Tdap as part of the catch-up series (preferably the first dose); if additional doses are needed, use Td or Tdap"., and per Guidance: "7-10 years of age: No DTaP or Tdap given after 4th birthday" (not stating ON 4th birthday and the patients 5th dose after 4th birthday being invalid), administered Tdap today.
Four days after the vaccine, I had a brownish vaginal discharge. It was only as I wiped myself after going to the bathroom. I am postmenopausal (LMP Jan 2019) so I contacted my GYN. It may have nothing to do with the vaccine but I have seen articles related to heavier periods & postmenopausal bleeding after the vaccine so that's why I'm mentioning this. I also had another day w/brownish discharge on 09/25/2021. I did use a vaginal moisturizer the night prior & again may not have anything to do with the vaccine but it was 27 days after the 1st incident.
28 y/o male ADSM is referred from a research site with c/o recent diarrhea, decreased appetite, dehydration and chest pain. Symptoms: Dizziness, chest pain, diarrhea, fatigue, malaise <60 days.
Numbness on left side of neck (same side shot was administered), numbness comes and goes throughout the day
patient experienced redness, itching, throat tightening, weird smells/congestion, stuffy ears, raw throat
This spontaneous report as received from a licensed vocational nurse refers to a 5 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 24-AUG-2015 at 11:37 a.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of PROQUAD (Merck) (subcutaneously, in right thigh, lot # K008185; dose and expiration date were not reported) that was improperly stored. On 24-AUG-2015 at 1:37 a.m., the patient was also concomitantly vaccinated with the first dose of KINRIX (intramuscularly, in left thigh, lot # 5412R; dose and expiration date were not reported), the second dose of HAVRIX (intramuscularly, in left thigh, lot # NK747; dose and expiration date were not reported) and with the fourth dose of PREVNAR 13 (intramuscularly, in right thigh, lot # J90528; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all scheduled correspondence was already received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 12Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm and on 11May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. 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 "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Jul2022 to 22Jul2022.
adacel was administered to the 78 years old female patient with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is cluster with cases 2023SA300771 and 2023SA300988.  This case involves a 78 years old female patient who was administered vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD); VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX); and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylactic vaccination (Immunization).  On 25-Sep-2023, the 78 years old female patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day) (Suspension for injection) (lot U7905AA) (expiry date unknown) (Frequency = once) (Strength = standard) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization.  It was reported that "Pharmacist states that ADACEL was administered to three 65 year old and higher patients."  Action taken: Not applicable.  Outcome: Unknown   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.
Diagnosis Plan 1. Exposure to COVID-19 virus  COVID-19 PCR   COVID-19 (SARS CoV-2,RNA Molecular Amplification)   See patient instructions.   MDM: Patient is a 49-year-old male presenting to the urgent care today requesting COVID-19 testing.  The patient started with fatigue last night and has developed a cough and headache over the course of the day.  He currently lives with 2 family members who are Covid positive.  On exam today the patient's vital signs are stable.  His resting pulse ox is 97%.  He does not report shortness of breath.  The patient has a reassuring physical exam at this time.  Today COVID-19 PCR swab was collected and sent to the lab.  We will call him with results.  I discussed with him the need to quarantine 10 days from the start of his symptoms in the event that he is positive.  I have also encouraged him to be rechecked if he would develop shortness of breath or chest tightness over the course of the next couple of days.  Patient is agreeable with the plan.
contracting covid; contracting covid; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (Unknown). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 at 18:00 as dose 1, single (Lot number: EN6208), in arm, on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm and on 22Nov2021 at 19:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 69 years, in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: When caller was 11 years old; "pericarditis" (unspecified if ongoing), notes: Back quite some time ago had pericarditis; "cardiac surgery" (unspecified if ongoing), notes: had cardiac surgery; "removing front 3rd of pericardium" (unspecified if ongoing), notes: ended up removing front 3rd of pericardium; "Flu", start date: Sep2017 (unspecified if ongoing), notes: Never used to get flu shot and then got flu in Sep2017. The patient took concomitant medications. Vaccination history included: influenza shot, administration date: 18Oct2021, when the patient was 69-year-old, for horrifically painful, reaction(s): "Immunization". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Aug2022, outcome "unknown" and all described as "contracting covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2022) Positive, notes: 7 of the 12 individuals tested positive for covid.  Clinical course: Reporter stated that she had covid the least consisting of a "very mild head cold that lasted 2 to 3 days and she was real tired for 4 days". Got flu shot which was the regular influenza shot on 18Oct2021, which was a bad shot, kind of jabbed caller with shot and caller's arms are very thin and ultimately was found out later due to problems with shoulder and upper arm, because hit the bone. But nothing to do with substance. Had gotten flu shots for 5 years and nothing bothered caller like this flu shot, horrifically painful, was told would hurt but to move and ice. Was given in the afternoon.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was probably about a week after I got the vaccine, I got a headache that wouldn't go away and about 5 days of intensity increasing I called the DR in order to receive medication. Tele visit with DR, prescribed butalbital acetaminophen caff 50-340. When I started taking that it was gone the next day. I also got two different rashes on my legs and they burned and itched and I treated that with some cream like cortisone cream and it eventually went away but it went away after about 1.5-2 weeks.
a lot of fever in the injection site/very very hot; real bad bump/swollen about 3 inches across; a lot of redness/very very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a lot of fever in the injection site/very very hot), VACCINATION SITE SWELLING (real bad bump/swollen about 3 inches across) and VACCINATION SITE ERYTHEMA (a lot of redness/very very red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a lot of fever in the injection site/very very hot), VACCINATION SITE SWELLING (real bad bump/swollen about 3 inches across) and VACCINATION SITE ERYTHEMA (a lot of redness/very very red). At the time of the report, VACCINATION SITE WARMTH (a lot of fever in the injection site/very very hot), VACCINATION SITE SWELLING (real bad bump/swollen about 3 inches across) and VACCINATION SITE ERYTHEMA (a lot of redness/very very red) outcome was unknown.            Patient stated that She didn't have any reaction to the first two shots at all, Concomitant information was not reported. Treatment information was not reported.
TC received from grandmother of child vaccinated on 8/21/02  reporting that pt had a fever of approx. 101-102 degrees on night of vaccination 8/16/02. She reports that pt has a fever only at night, and is fine during the day. Grandmother was advised to call private provider for follow-up to be sure sx were not from other illness rather than immunization.
Injection site noted to be pink with about a quarter sized lump, tender to touch. No treatment. Site is fading, lump about size of dime 11/1/04.
SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report for the following literature source(s): A 50-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (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), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: 20.4, notes: Day 1; 28.9, notes: Day 4; 22.3, notes: Day 9; 25.3, notes: Day 11; 34.5, notes: Day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Woke up with light sensitivity and head pressure.  Have had continued difficulty with foggy feeling, light sensitivity, and tingling in hands and face.  Not been able to think clearly for 3 weeks.
Information has been received from a registered nurse concerning an 81-year-old white female with hypertension and no known allergies who on 05/13/2003 at 10:30AM was vaccinated IM in the left deltoid with a second 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M - multidose vial).  There was no illness at the time of vaccination.  The patient received the first dose of pneumococcal vaccine 23 polyvalent in approximately 1995, also reported as 15 years ago, and had no reaction at that time.  On approximately 05/13/2003, 12 hours after immunization, the patient developed swelling, redness, and induration from the injection site down to the elbow.  The patient was treated with antibiotics and antihistamines.  It was reported that the patient is "better" and is recovering.  There was no product quality complaint.  Follow up information indicated that on 05/13/2003 at 18:00, within 12 hours of vaccination, the patient developed an erythematous, edematous rash in the affected arm.  The patient was prescribed antibiotics and antihistamines and was reported as "better".  It was noted that the patient recovered on 06/03/2003.  It was reported that the patient developed a rash after vaccination with one dose of tetanus vaccine 25 years ago.  The reporter also indicated that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed swelling, redness, and induration from the injection site down to the elbow (WAES # 0305USA01833 & WAES # 0305USA02389).  No further information is expected.
Dizzy and sensation that she was being choked with shortness of breath approximately 15 minutes after receiving vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of infection site pain in a 80-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3CG9P, expiry date 22nd June 2017). On 1st November 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 1st November 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site redness were recovering/resolving. The reporter considered the injection site pain, injection site warmth and injection site redness to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: At night of the vaccination day, the patient experienced injection site reaction, specifically injection site was sore, red and hot to touch. The redness was described as starting at injection site and moving down arm towards the crux of her elbow measuring 4 inches by 5 inches.