chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired dose of ACT-HIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00663712) and transmitted to Sanofi on 30-Jun-2021.  This case involves a patient with unknown demography who received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On 30-Jun-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number was not reported) which was expired on unknown date via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "calling regarding ACTHIB. Caller stated that the vaccine is expired and was given to a patient today and would like to know their next steps. All were assisting other callers. Case placed in proxy for call back. Caller stated that she will be leaving the office soon and would like to contact provider".  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no 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.  There will be no information on the batch number for this case.
At 11:00 AM the day after receiving the vaccine, I started having an elevated resting heart rate of around 100-110 BPM and severe chills and a headache. When I walked, my heart rate increased to 130-140 BPM. I had to leave work at 1:30 PM due to the rapid heart rate. I thought I was having an anxiety attack. I got home and took my temperature and it was up to 100 F. I could not get out of bed. My fever spiked up to 103 F during the night. My heart rate remained around 90-110 BPM at rest and I continued to have chills. When my fever broke around 6 AM the next morning, my heart rate went back to normal at 65-70 BPM resting. I feel like the elevated heart rate and the fever were an adverse reaction to the vaccine and I'm unsure whether to get the second dose.  I continued to have fatigue and a headache for three days after the vaccine.
syncope - pallor, nausea, sweating, Had pt sit on floor and remove mask, gave water & stay for 30 min. Checked BP wnl before he left, with someone else driving.
Patient had a red, warm Lump starting  day after. It is painful. Still continues  today.
parosmia/ rotten/fecal smell; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic hay fever and sinusitis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included emtricitabine; tenofovir alafenamide (DISCOVY), bupropion (WELLBUTRIN), levocetirizine (XYZAL) and prednisone (MANUFACTURER UNKNOWN), all for unknown indication from unknown dates. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Mar2021, 4 days after receiving vaccine, the patient started to experience parosmia. There was an underlying rotten or fecal smell that persisted, and the patient could smell it everywhere. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the event parosmia. The clinical outcome of the event parosmia was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US020147, is an initial spontaneous report from the nurse received on 03 Oct 2014, with a follow up received from nurse on 16 Dec 2014. This report refers to a 48-year-old female patient. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14512P) at a dose of 0.5 ml intramuscularly on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination) in Oct 2014, the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further, the patient experienced red hot rash lasting for three to four days. The patient was hospitalized. The reporter stated that no long term reactions were noted in the patient. The outcome of the event red hot rash was complete recovery; outcome of the other events was unknown. The seriousness and causality of the events were not reported. Follow up received from nurse on 16 Dec 2014: updated patient demographics (patient age and gender), new event (red hot rash) and other clinically relevant information in the narrative. Following an internal review for the date received on 16 Dec 2014 a significant correction was performed: Seriousness criteria hospitalization was added.
Patient described having an inflammatory reaction around the injection site with swelling, warm to the touch, redness and irritation, about 5 inches in diameter. The adverse reactions began a few hours after receiving the vaccination.
Hives all over face, arms, torso and upper legs.Started on torso and moved up and out. Received a steroid shot at office and have taken Benadryl.
PATIENT PRESENTED TO CLINIC TO RECEIVE INFLUENZZA VACCINE HIGH DOSE AS INDICATED FOR AGE.  CLINIC STAFF ADMINSTERED THE FLU VACCINE FOR AGES 64 AND UNDER.
Day of vaccine felt fine - the next morning - early in AM developed splitting headache (similar to when had wisdom teeth removed) entire body hurt - felt extremely weak - felt paralyzed - difficult to move arms up and down  - difficult to get out of bed - fever 102 or greater - took two regular advil 200mg - remained sick like this for three full days - chills - lack of appetite - did drink room temperature water - consumed crackers and broth - felt like had bone pain - severe body aches - headache was severe -  prescribed flexeril and meloxicam by PCP
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 18-MAR-2013, the patient was vaccinated with a second dose of GARDASIL (lot number, expiry date, route and dose were not reported) who had received the first dose approximately on an unknown date in October 2011 9reported as over a year and a half ago). Additional information has been requested.
Minor received the 2nd dose of Pfizer COVID Vaccine on 9/21/21. Initial 1st dose of Pfizer COVID Vaccine was administered on 9/16/21
Diagnosed as Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 12:00 (Batch/Lot number was not reported) at the age of 50-year-old as single dose for covid-19 immunisation. The patient was health and had no medical history. The patient had no known allergy. Concomitant medication included finasteride (PROSCAR); lorazepam; hydroxyzine.  There was no other vaccine in four weeks. The patient was diagnosed as Guillain-Barre syndrome on 24Feb2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was in hospitalization for 8 days. The patient had no COVID prior vaccination and had been tested post vaccination. The patient underwent lab tests and procedures which included covid (blood test): negative on 01Mar2021. Outcome of event was recovered with sequel in 2021. The patient received IVIG Infusion therapy for 5 days for event.   Information on the lot/ batch number has been requested.
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. It was reported that patient received the vaccine on friday and 6 hours later experienced headache. She always feels like that after receiving a vaccine, so she didn´t worry about it. Then on sunday she felt achy, and with headaches, so she took a covid test which came out positive. She was feeling horrible. No treatment information was provided.   Reporter did not allow further contact
Numbness / tingling / parasthesia in legs from toes through pelvis started about 24 hours post vaccination. Still continuing. Also experienced transient fever, headache, sore throat.
Supraglottitis secondary to SARS-CoV-2; Supraglottitis secondary to SARS-CoV-2; This literature-non-study case was reported in a literature article and describes the occurrence of EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) (seriousness criterion medically significant) and COVID-19 (Supraglottitis secondary to SARS-CoV-2). At the time of the report, EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) and COVID-19 (Supraglottitis secondary to SARS-CoV-2) outcome was unknown. Related      For mRNA-1273 (Spikevax) (Unknown), the reporter considered EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) and COVID-19 (Supraglottitis secondary to SARS-CoV-2) to be related.    Treatment and concomitant medications were not reported. Company comment This literature-non-study case concerns a 50-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of EPIGLOTTITIS and the unexpected non-serious AESI of COVID-19, which occurred after receiving a dose of mRNA-1273 vaccine. Onset date of vaccination and date of event were not provided; hence, latency cannot be assessed. Interval between doses was not reported. It was reported that patient experienced Supraglottitis secondary to SARS-CoV-2. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 50-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of EPIGLOTTITIS and the unexpected non-serious AESI of COVID-19, which occurred after receiving a dose of mRNA-1273 vaccine. Onset date of vaccination and date of event were not provided; hence, latency cannot be assessed. Interval between doses was not reported. It was reported that patient experienced Supraglottitis secondary to SARS-CoV-2. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a 42 year old white male who on 9/27/98 and 10/27/98 was vaccinated with the 1st and 2nd dose of Hep-b vaccine recombinant, respectively. "Immediately after getting the shot", the pt experienced extreme fatigue and lost his appetite. In December of 1998, the pt experienced a rash on the back of his head, elbows and wrists. The pt sought unspecified medical treatment. Additional information has been requested.
pt recvd vax & exp arthritis, arthralgias & stiffness in lt arm; reporter indicated that the pt was seen by an arthritis MD;
I develop a terrible cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient already took the first shot dose of the Pfizer the COVID-19 Vaccine and is about it is schedule on 21st for her second dose and sudden after the first shot she develops a terrible cough on an unspecified date, and she wonder if she should take the second one or give it some more time. In response to further probing, consumer stated, "No, I don't think so. Limited information was available over the call. The event outcome was unknown.  Information on the lot/ batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Patient with history of 3 COVID vaccines who admitted to hospital and had a positive COVID test.  Provider d/c note:  "82 YO female with PMH R parietal meningioma, multiple sclerosis who presents 12/13/22 via EMS from her care facility for ground level fall and altered mentation. Patient had gone missing and was found on the ground between an end table and her couch. Her son reporte she is usually independent, lives alone in apartment. Last contact via phone was 12/11 and she was not reporting any symptoms. On presentation she had leukocytosis and found to have e coli UTI. She was treated with a course of ceftriaxone. She was also found to have gall stones and general surgery was consulted who plans to schedule the patient for an elective cholecystectomy once urosepsis resolved. PT/OT determined the patient would benefit from a SNF. On screening she tested positive for COVID and required a 10 day quarantine at the hospital prior to discharge to the facility. During this time PT/OT reevaluated the patient and determined that she became strong enough to return home with homecare/therapies. She also had continually higher blood pressures, amlodipine was increased to 10mg. Patient should follow up with her pcp and general surgery in 1-2 weeks. "
death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified
I don't believe this is due to the vaccine but I was still recommended to fill this out.  I miscarried and my pregnancy ended in May. I got my first shot in February very early in my pregnancy when I wasn't aware I was pregnant. I then proceeded the get my second shot which at that I knew I was maybe 6 weeks into pregnancy.   I've never been pregnant before and the estimated date of delivery would have been November 2021.
Initial unsolicited misuse report received from a nurse (consumer) on 16 June 2015. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of PENTACEL (batch number C4879AB, expiry date 10 September 2016, dose, dose number, route and site of administration were not reported) on 16 June 2015. On an unspecified date, nurse was removing ACTHIB component vial of PENTACEL from box and upon removing vial from box she sustained several small lacerations to the palm of her right hand. It was reported that patient had performed first aid measures of cleaning area to remove glass shards. Patient had no excessive bleeding and her hand was fine and stated that she did not require bandaging or any other treatment. Product complaint PC 291071 filed for broken vial of PENTACEL, thus there was a product physical issues and it was also a case of occupational exposure to drug. Laboratory investigations were not reported. At the time of this report, patient had recovered. Documents held by sender: none.
Heart fluttering; Lymph Nodes in right armpit were sore; Skipped heart beats; Lymph Nodes in right armpit were sore and went into my upper arm; This serious initial spontaneous safety report from RA was received by Novavax on 16-SEP-2022 from a consumer.  A female of 48 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 dose 1 in right deltoid on 25-AUG-2022. The following medical history was reported: Drug hypersensitivity to Codeine and Steroids, Supraventricular tachycardia and Cardiac ablation in MAR-2021. No concomitant medications were reported.  On 26-AUG-2022, 2 days after vaccination, the individual experienced lymph nodes in right armpit were sore (PT: Lymph node pain) and went into my upper arm (PT: Pain in extremity).  On 02-SEP-2022, 9 days after vaccination, the individual experienced heart fluttering (PT: Cardiac flutter) (Serious: Medically Significant) and skipped heart beats (PT: Extrasystoles).  At the time of reporting, the event outcomes of Lymph node pain  and Pain in extremity were recovered/resolved and event stop date was 30-AUG-2022, Cardiac flutter was recovered/resolved and event stop date was 04-SEP-2022, Extrasystoles was recovered/resolved and event stop date was 06-SEP-2022. No additional information was provided.; Sender's Comments: This 48  year-old female experienced: Cardiac flutter, Lymph node pain, Pain in extremity and Extrasystoles after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Cardiac flutter was assessed as serious. The events Lymph node pain, Pain in extremity and Extrasystoles were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events were assessed as Possible.
Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid.; Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid.; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumonia shots  (They also had whatever pneumonia shots are recommended for those over 80.), for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid. ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Pfizer Covid Vaccines, Pfizer Covid Boosters, Pfizer Bivalent Vaccine- have had all the Pfizer Covid Vaccines and Boosters and still got Covid. He was diagnosed on Monday and started Paxlovid on Monday night. He has not noticed any medical issues, discomfort or bleeding.  Patient stated that he and his wife have had all Pfizer Covid vaccines and booster with the last booster in November. They also had whatever pneumonia shots are recommended for those over 80.  They mask and take precautions but still got Covid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
A spontaneous, non-serious events of fever, runny nose and general flu-like symptoms were reported by a physician involving children of unknown ages subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. The patient's have received FLUMIST. The physician reported that "I've noticed that the kids I've given FLUMIST have had some side effects such as fever and runny nose or general flu-like symptoms". No further information was available. The outcome of the events, fever, runny nose and general flu-like symptoms, was unknown.
This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M006708, expiry date: 02-JUN-2018 and lot # M013639, expiry date: 15-SEP-2017 (dose and route not provided). The vaccines were exposed to unspecified multiple previous excursions since March 2016 and a current excursion in July for 15 days exposed to a minimum of 27 degree Fahrenheit and maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
RED AND WARM AREA UNDER UPPER ARM APPROXIMATELY 8 INCHES FROM INJECTION SITE.
First 1-7 days: local swelling, mild erythema, warm to touch, tenderness, approximately 1-1.5 inches in diameter at injection site.  Mostly resolved approximately 1 week post-vaccination.  12 days post vaccination a large rash was noted, approximately 4-5 inches in diameter; significant erythema with a darker red ring encircling a lighter red  center. Hot to touch. Mild tenderness.  13 days post vaccination started cephalexin for suspected mild cellulitis. 14 days post vaccination (day of filing this report): rash seems to be improving but has not resolved.
bfever x 1 day after her second covid vaccine injection; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of injection on 08Apr2021, at 54-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history included ongoing malignant neoplasm of breast from an unspecified date. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient stated that she had a fever x 1 day after her second covid vaccine injection on 09Apr2021. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.