chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client complained of "nausea" at 2:36pm (5-6 minutes after receiving 2nd dose of Pfizer COVID-19 vaccine).  Baseline vitals were within normal range. Client was alert and oriented x4 and denied shortness of breath.  Client was placed in zero gravity chair and given a bottle of water.  Vitals at 2:46pm were within normal range.  At 3pm, client confirmed that "nausea has gone away".  Client was advised to follow up with PCP if symptoms return or worsen. Client released at 3pm with steady gate.
Ten days post vax, the pt experienced pain, redness, and swelling at the injection site, fatigue, back pain, fever, chills, flu-like symptoms, gastrointestinal symptoms, and diarrhea. An ER visit was required. The pt was treated with Decadron and Benadryl.
low grade fever, malaise, myalgias, arthralgias for 3-4 days after vaccination and mild malaise myalgias arthralgias continue now one month later
Stinging and burning in the upper arm. She applied cool compresses. During the night the arm began to itch in both the upper arm and lower arm. She had dizziness during the night. She developed nausea. She felt flushed. The arm has been sore. No vomiting. No documented fever during the night. But there is low-grade fever today.
Shortness of breath for months and later floating blood clot in the Aorta; blood thinners for 3 months and other tests; numerous hospitalizations prior to the discovery of blood clot.
Information has been received from a physician concerning a 8 year old male who in approximately 2001, 1-2 years ago, was vaccinated with a dose of varicella virus vaccine live. On 14Jul2003, the physician spoke with the parent after the pt "started with symptoms". It was reported that the pt had a mild case of varicella. Unspecified medical attention was sought and no treatment was required. A lot number was not available because a dr covering for the child's physician did not have the chart. No further pt information was available. No product quality complaint was involved. Additional information has been requested.
Fever 103 Shakes Complete body muscle cramps and aches even finger joints Tiredness  Extreme headache Nausea Since shot my periods have been very irregular! First heavy and twice a month then next month was only one day . Then had again in 20 days later.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 01-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
A physician reported the occurrence of an injection site reaction in a female child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 4/24/03, the subject received her fourth injection of infanrix (lot DTPA572A). On an unspecified date post-immunization, the subject developed an injection site reaction characterized by redness and warmth. As of 4/28/03, the outcome of the injection site reaction was unknown. The reporter considered the injection site reaction to be probably related to Infanrix administration.
5 days after receiving vaccine I developed flu-like symptoms.; Minor diarrhea; upset stomach; chills; fever that got up to 100 at first then 101 later.; This is spontaneous report from a contactable other healthcare professional. This 41-year-old female other healthcare professional (patient) reported that: A 41-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown) via unknown route of administration on 19Mar2021 10:30 (at the age of 41 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not have relevant medical history and concomitant medication. The patient did not have allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive any other medications within 2 weeks of vaccination. On 24Mar2021 14:30, the patient experienced 5 days after receiving vaccine patient developed flu-like symptoms, minor diarrhea, upset stomach, chills and fever that got up to 100 at first then 101 later. On 24Mar2021, the lab data included body temperature was fever that got up to 100 at first then 101 later and nasal swab test performed result was pending. Patient visited emergency room due to the events. No treatment was received for events. The patient did not have covid prior vaccination and tested for covid post vaccination. The outcome of the events was not recovered at the time of last observation.  No follow-up attempts were needed. No further information was expected.
Patient received Pfizer COVID-19 Bivalent Booster vaccine which was beyond the manufacturer recommended use time of 10 weeks at the refrigerated temperature. Staff has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 10 weeks. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule.
Patient started rash later on same day following the fever of 101F. Pt had rash on right arm and chest and was noticed on right leg yesterday as well.
tested positive for covid 19 infection on 24Aug2021/had the Covid virus 24Aug2021; tested positive for covid 19 infection on 24Aug2021/had the Covid virus 24Aug2021; This is a spontaneous report from a Program from a contactable other healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date as single dose, first dose via an unspecified route of administration on Jan2021 as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that he was fully vaccinated with Pfizer BioNtech covid 19 vaccine back in Jan2021. He tested positive for covid 19 infection on 24Aug2021. Patient stated that he was still having some side effects from decreased lung capacity however he had completed his required isolation and was back to work. Patient stated that he would like to know when it was safe for him to get his booster dose of the Pfizer Biontech covid 19 vaccine? Patient had the Covid virus 24Aug2021 and was asking how long to take the booster and what was the recommended month to get the booster shot. Patient stated that was what he really wanted to know and no one can answer. Patient stated it was too soon as he was still having side effects with his lung capacity, he was over the Covid for a little bit now. Patient was asking when it was safe for him to get it. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up. Based on the temporal association, a causal relationship between the events and BNT162B2 cannot be completely excluded. Of note, the efficacy of a drug varies from patient to patient and can be affected by different factors, and the mutated coronavirus strains would also alter the efficacy of the vaccine. The case will be reassessed when additional information becomes available.
A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), intramuscular, administered in Arm Right on 07Jun2021 20:00 (Age at vaccination 47 years) as dose 2, single, dose 1 intramuscular, administered in Arm Right on 17May2021 20:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient diagnosed with COVID-19). There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. On 01Aug2021, the patient experienced lack of efficacy. Patient was diagnosed with positive covid-19 test on 01Aug2021. Patient was not received treatment for event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021 Nasal Swab. Facility where the most recent COVID-19 vaccine was administered at pharmacy. Patient was visited to physician office. Vaccine Facility information available. Outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Per Federal Vaccinator: Client states she had pain and stiffness in left arm was seen at Urgent Care 2 weeks after vaccine for evaluation.
given expired dose of IPOL vaccine with no reported adverse event; Initial information received on 05-Apr-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 8 years old male patient who was given expired dose of ipol vaccine with no reported adverse event while receiving vaccine ipv (vero) [Ipol].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 05-Apr-2022, the patient received a  dose of 05.ml of suspect ipv (vero) formulation and strength unknown lot R1F972M via intramuscular route once in the left arm for Prophylactic vaccination.  On 05-APR-2022, same day, the patient was given expired dose of ipol vaccine with no reported adverse event (expired product administered). Site director is calling to ask for anything to watch out for in a pediatric patient who was given expired dose of IPOL vaccine. Site director mentioned that she knows that the vaccine should be repeated but wants to know any other details to provide to the parents and what to do moving forward.    Action taken: Not Applicable.  It was not reported if the patient received a corrective treatment for the event (given expired dose of IPOL vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event given expired dose of ipol vaccine with no reported adverse 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.
Food allergies of some sort - haven't pin pointed the food yet... Hives on face, swelling of eyes, hives on torso.
Pt immunized with Hep B vaccine #3 in the left deltoid around 5:30pm. Mom returned to clinic at 6.53pm, with a report that child was experiencing numbness in the left fourth and fifth finger as well as the outer/lateral edge of his left hand. All of this presented in the car ride home.
Right arm swelling, erythema, warmth. (large area) Treated with Sx care and Augmentin PO for poss cellulitis.
developed little raised mark at injection site; warm to touch; it's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (developed little raised mark at injection site), VACCINATION SITE WARMTH (warm to touch) and INJECTION SITE PAIN (it's sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (developed little raised mark at injection site), VACCINATION SITE WARMTH (warm to touch) and INJECTION SITE PAIN (it's sore). At the time of the report, VACCINATION SITE SWELLING (developed little raised mark at injection site), VACCINATION SITE WARMTH (warm to touch) and INJECTION SITE PAIN (it's sore) outcome was unknown. She developed little raised mark at the injection site that went away. But two weeks later, the mark is back.      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.   No Concomitant medication were provided No treatment were provided
declined to administer second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose an year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that, someone she knew was late for their second dose after forgetting about the second dose. The patient waited a year since the first dose.  The pharmacy reportedly declined to administer the second dose late. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
This Charge RN was not present on-site within the vaccine clinic during the following medical incident that per written report from vaccinating clinician, RN occurred 07/01/2022 at 1725 regarding patient. Patient received their First dose of pediatric Moderna COVID-19 vaccine (Lot#AS141B). Patient parent present during clinical moment. the RN Site Supervisor present on-site during the following incident.   Verbatim per, RN?s own handwritten incident report:  ?Parents were holding child during vaccination, child moved during administration and vaccine was seen in large drops rolling down left ant. thigh. After consulting w/ Site Supervisor & parents, parents confirmed they saw visible drops of vaccine & were worried less than ½ dose was likely given so they requested repeats dose in Right ant. thigh. Vaccine successfully administered in RAT @ 1730. PT observed standard time 15 m. and left accompanied w/ parents with no issue.?
headache; body ache (lower back); slight fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 20Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Dose: 3 (BOOSTER)), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4 (BOOSTER)), for COVID-19 Immunization; Covid-19 vaccine (Dose: 5 (BOOSTER)), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "body ache (lower back)"; PYREXIA (non-serious), outcome "unknown", described as "slight fever".  Additional information: The patient did not tested covid prior vaccination. Side effects from covid vaccine: -headache -body ache (lower back) - slight fever note that she have not experienced these side effects since her second dose of the original vaccine in 2021. Usually do not react to boosters.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of VAQTA (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Twenty-four (24) hours after receiving vaccine patient developed fever, body aches, nausea, vomiting and diarrhea. These resolved 24 hours later.
sore arm; tiredness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm ) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm ) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm ) and FATIGUE (tiredness) had 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 had a sore arm and tiredness after the Moderna COVID vaccine and he was fine.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
The day before I tested positive for COVID-19 my husband was positive. I took a test the next day and it was also positive but I did not have symptoms until much later in the day. I was having body aches, headaches, a sore throat, a dry cough, and a low-grade fever. I also developed a heaviness on my chest with shortness of breath making it hard to breath. I did reach out to my health care provider, and they sent a cough medicine in for me. At this point I am still coughing, very tired and fatigued and recovering.
Discharge Provider: MD Primary Care Physician at Discharge: PA-C  Admission Date: 8/28/2022  PRESENTING PROBLEM: Acute on chronic respiratory failure with hypercapnia (HCC) [J96.22] Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC) [J96.21, J96.22]   HOSPITAL COURSE: Patient is a 77-year-old male with a history of significant comorbid conditions including end-stage chronic obstructive pulmonary disease, systolic congestive heart failure, chronic kidney disease as well as chronic respiratory failure with hypoxia and hypercapnia.  Patient was admitted to the hospital on August 28, 2022 for acute on chronic respiratory failure with hypoxia and hypercarbia in the setting of COVID-19 infection complicated by chronic obstructive pulmonary disease and congestive heart failure.  Patient was also noted to have acute kidney injury superimposed on chronic kidney disease.  The patient was admitted to the intensive care unit for treatment of respiratory failure with BiPAP.  Patient's hospital course was complicated by agitation, delirium and cardiac arrhythmia.  The patient struggled with the use of BiPAP which seemed to make him more agitated.  With the patient's condition failed to improve, patient's family elected to transition patient into comfort and hospice care.  This decision was made August 31, 2022. Patient was placed into comfort care order set with family at bedside.  Patient expired peacefully today September 1, 2022 at 11:09 p.m..  Family was at bedside and present.  Message sent primary care provider for notification.
Joint soreness, tiredness, ear ache eyes infected. I will never take another flu shot. I always have still have tiredness and infection.
Patient report left forearm swelling, slight redness and soreness.   Ice applied to forearm.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A male patient in the 4 decade received PREVNAR 13, at single dose and, influenza vaccine (FLU SHOT), both via an unspecified route of administration in the same arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient received both shots in one arm and experience soreness on an unspecified date with outcome of recovered. Clinical course was as follows. The gentleman was in his late 30's and got flu and PREVNAR 13 shot. Got both shots in one arm. The patient called the next day and reported soreness. The pharmacist could not determine which shot caused the soreness. He spoke to the gentleman the next day and he said that he didn't feel soreness at that time. The next day, he was fine. Information on the batch number has been requested.