chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 50-year-old female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult. On an unknown date, the patient received ENGERIX B adult and ENGERIX B adult at an unknown dose. On an unknown date, unknown after receiving ENGERIX B adult and ENGERIX B adult, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: The age at vaccination was not reported. In 1991, the patient received a complete hepatitis B series and in 1992, the patient received a booster dose. On an unknown date, recent the patient underwent for laboratory test which showed low titer for hepatitis B (decreased therapeutic response) and subsequently the healthcare professional intended to vaccinate the patient with a booster dose of ENGERIX-B, but the vaccine was not yet been administered. The healthcare professional did not had specific patient information.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ3277) for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EWG201), on 12Mar2021 as dose 2, single (Lot number: 6203), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8841) and as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 from 09Sep2023 till 13Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304837 same patient, different drug/events;
Patient states she received flu vaccine at 10 am on 10/3/09. At 12 N experienced some shortness of breath. Used albuterol inhaler. At 1 pm facial itchiness, eye puffiness. BENADRYL at 1 pm - symptoms improved. Dose repeated at bedtime. Some itchiness 10/4/09 am - BENADRYL repeated and symptoms resolved.
same thing as before heavy bleeding/menstrual cycle changed to heavy flows after the vaccine; After my second dose, my menstrual cycle was two weeks earlier; horrible menstrual cramps; lower back pain; migraines; Dose number=1 Administration date=19Mar2021/ dose number: 2 vaccine date:19Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EW0162) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild back aches" (unspecified if ongoing), notes: This never happens with me usually its none to mild back aches.; "birth control" (unspecified if ongoing), notes: Although I was on birth control pill and I always get my period on time. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product COVID 19, brand=Pfizer,, Lot number: EP7534,, Vaccine location=Left arm,, Dose number=1), administration date: 19Mar2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "my menstrual cycle was late two weeks", "had horrible cramps which never happens". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Mar2021, outcome "unknown", described as "Dose number=1 Administration date=19Mar2021/ dose number: 2 vaccine date:19Mar2021"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 27Mar2021, outcome "unknown", described as "same thing as before heavy bleeding/menstrual cycle changed to heavy flows after the vaccine"; POLYMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "After my second dose, my menstrual cycle was two weeks earlier"; DYSMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "horrible menstrual cramps"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "lower back pain"; MIGRAINE (non-serious) with onset 27Mar2021, outcome "unknown", described as "migraines". Therapeutic measures were not taken as a result of heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, back pain, migraine.  No follow-up attempts are possible. No further information is expected.
Pfiser booster lastest one 2022 taken nearly 3 weeks ago. I have been sick ever since. Nausea general weakness as well as shoulder neck and chest pain combined w shortness of breath. Fine beforehand no significant issues. Modana inoculations previously w no significant adverse effects. Every single one w never feeling ill afterwards. First tome w pfiser and dick as hell ever since
Pt presented for scheduled 1st dose of Moderna, upon completion of dose of Moderna, pt informed nurse that he had a 1st dose of Pfizer on 01/7/2021. Pt with no sign and symptoms of discomfort.
PATIENT HAD PFIZER COVID VACCINE Dose 1 date: 01/15/2021,  Dose 2 date: 02/05/2021, AND TESTED POSITIVE TO COVID.
Covid symptoms lasted for about a week I experienced tiredness, sleeping a lot, body aches, & mild headaches and also experienced vertigo as well.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 02-NOV-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669601/0138AA, expiry date 26-JAN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, fatigue, nausea, elevated heart rate, tightness in chest, shortness of breathe began in the evening on the day of my injection.  Symptoms are continuing on day 4, post vaccine. I am seeing my family doctor this afternoon.
Pt awoke 11/15/2001 with hives over entire body. Eyes swollen with "feeling of sand in eye" check out "itchy" feeling. Therapy in ER 11/17/01 with Benadryl 25 mg BID and Prednisone 20 mg BID times 3 days. 11/21/2001 rash "clear" and "feeling well".
Immediate reaction-pale, rapid heart rate. No treatment. Apparently recovered but transported to hospital for observation overnight. Admitted for 24 hrs. Some crying and agitation through the night. Mild diarrhea and crankiness after discharge. Essentially recovered.
I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
Grandmother reports child developed fever to 104.8 degrees at home with 24 hours after receiving vaccine.  Family took patient to nearest urgent care center where she was witnessed by staff having a seizure.  Diagnosed as febrile seizure related to immunization.  Fever developed 03:00 AM 09/20/2003;Seizure occurred at 09:23 AM 09/20/2003.
12 hours after my second dose I had fever for 24 hours that reached 102 Fahrenheit; headache/sporadic headaches; muscle/joint pain.; muscle/joint pain; General feeling of weakness; feeling sick; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Left arm on 09Apr2021 13:00 at the age of 31-years-old as dose 2, single for covid-19 immunisation at School or Student Health Clinic. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration, administered in Right arm on 19Mar2021 13:00 (at the age of 31-years-old) as single dose for covid-19 immunisation and experienced could not move his arm from the pain and the next morning he had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache. The patient previously took third dose of historical vaccine, HPV (HPV VACCINE, Batch/lot number: Unknown), administered in Left arm on 02Mar2021 at the age of 31-years-old as single dose for immunization. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. On 10Apr2021 at 03:00, the patient experienced 12 hours after his second dose the patient had fever for 24 hours that reached 102 Fahrenheit, with headache and muscle/joint pain, General feeling of weakness and feeling sick. For the next two days, the patient had some sporadic headaches only. Treatment received for the adverse events included Paracetamol. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit fever on 07Apr2021, Covid-19 (Saliva test) (sars-cov-2 test): negative on 07Apr2021. The outcome of event, fever for 24 hours that reached 102 fahrenheit was recovered on 11Apr2021 while other events were recovering.  No follow up attempts are needed. No further information is expected.
Patient's mother calls 8/9/04 to report teen has had persistent pain in right arm past vaccines given.
Arm hurt; Diarrhea; Knees hurt; Cold; Had a temperature; Lightheaded; Tired; Memory was worsened; This is a spontaneous report from a non contactable consumer (Patient) or other non-HCP.  A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Arm hurt, Diarrhea, Knees hurt, Cold, Had a temperature, Lightheaded, Tired and Memory was worsened. Additional Information: Consumer reported that she was connected to something last time that was to tell of certain symptom were ongoing out of one time happening and was somewhat disappointed and what she got for an answer. Her symptoms, had initial symptoms one day and after that had other things. She confirmed Pfizer Covid-19 vaccine. She stated that Well, she supposed to early to know how long this symptoms last and if more will appear because was put in some department last time and was not real happy with it. She was informed about the role of Pfizer drug safety. When she was probed for the experiences she had after the second shot, she stated that the first one was the day after the second shot and thought that all that was fairly normal. She was an arm hurt, diarrhea, my knees hurt, was cold and had a temperature. That was just the day after and then it was gone but the thing that have been continuing are, lightheaded it was there a day and then gone. May be a day or two very tired and then alright for little while and memory was worsened than that it was before. She stated that what she would like to know is the thing that she had in this product, has not been on the market long enough to know anything and was wandering if other people were having some of these same things. She had met two people that had the same thing that I have. When she was asked for further question stated, No and was given something else last time and they were to tell me some of the side effects. And she did not knew that the one they give her were an ongoing effect or just the first day affect and she was little bit disappointed in that because, she want to know if it was long term and we did not knew enough about this stuff to know, what was going to be happening or when it will disappear. She was informed about the medical information department and telephone number was shared. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as she was unwilling to share further information. Hence, further probing could not be done. Limited information available over the call. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021688857 Same reporter/drug/events, different patients
Itchy face, neck and upper chest.  Face is warmer on side that is the itchiest. Injection was at 11:14 am, symptoms started at 7:00 pm. I took 10 mg of Cetirizine Hydrochloride at 8:00 pm. It is now 9:27 and symptoms have subsided a bit.
Almost immediately began having heart palpitations. Strong fluttering. Continuous. Steady pulse. Lasted over 24 hours. Finally took one Benadryl. Had good night sleep. Woke feeling normal.
Hematologist/Oncologist: MD  Primary Care Physician at Discharge: MD Admission Date: 9/3/2022 Discharge Date: 09/14/2022   PRESENTING PROBLEM: Severe sepsis  [A41.9, R65.20] Altered mental status, unspecified altered mental status type [R41.82] Pneumonia of right lower lobe due to infectious organism [J18.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 80 y.o. patient with a past medical history significant for epilepsy 2/2 GBM s/p resection and course of Temodar with concurrent RT who presented to ED on 9/3 from SAR for symptoms of lethargy and AMS, found to be septic due to COVID-19 infection.  Pt recently admitted for new seizures and was discharged to SAR on 8/26.  prior to admit he was suspected to have missed doses of his anti-seizure meds. During his stay he was found to be having seizures again ( most likely secondary to missed medication) and his seizure meds were increased. Besides the covid he had a GNR Bacteremia that was eventually identified Brevabacillus species and ID directed abx.  He completed Zosyn while IP. He also experienced diarrhea and C. Diff was indeterminate, so he was treated with oral Vanco. He was stable to return to his assisted living and was discussing checking into Hospice, but had not made a decision on the day of DC.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA "10pk 25U/0.5ml SD LLok wCap Ped" which had a lot number of L013324 and expiration date on 24-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the VAQTA vaccine had one temperature excursion of 24 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Akinesia-dyskinesia sequence; Akinesia-dyskinesia sequence; Myopathy; Gastroesophageal reflux; Poor oral intake; Acute respiratory decompensation; Vesicular rash; Information has been downloaded from Agency (HQ3513310NOV2000).  This spontaneous report was received from a healthcare professional concerning to a 13 month old male patient with a ventricular septal defect, cardiomegaly, bronchospasm, lung disorder, pneumonia, cryptorchism and developmental delay. The patient's medical history included cardiac arrest. Concomitant therapies included ipratropium bromide, lansoprazole, prednisone, albuterol and metoclopramide.     On 22-SEP-2000 the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) (Lot No. reported as 0722J, upon internal validation determined to be valid for varicella virus vaccine live exp. date 24-OCT-2020), subcutaneous for immunisation. Other suspect therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (Lot No. 474-718) intramuscular injection and measles, mumps, and rubella virus vaccine, live (manufacturer unknown) (Lot No. reported as 1720J, upon internal validation determined to be valid for  measles, mumps, and rubella virus vaccine, live) (HSA) subcutaneous.  On 23-SEP-2000, the patient experienced acute respiratory decompensation (respiratory failure), rash vesicular and was hospitalized on an unspecified date. On an unknown date, the patient experienced akinesia-dyskinesia sequence (akinesia), poor oral intake (poor feeding infant), gastrooesophageal reflux disease, myopathy and akinesia-dyskinesia sequence (dyskinesia) and was hospitalized on an unknown date. The outcome of respiratory failure, poor feeding infant, gastrooesophageal reflux disease, myopathy, dyskinesia, akinesia and rash vesicular was unknown.  The causal relationship between the aforementioned events and suspect therapies was not reported.
Pain in left arm around injections site; The pain intensifies as I lift my arm up or stretch.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease, known allergy to nasal sprays and the patient was a breast cancer survivor. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received ciprofloxacin (CIPRO) for unspecified indication from unknown date and experienced drug allergy and received first dose of BNT162b2 (COMIRNATY; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021, as a single dose for COVID-19 immunisation. On 30Mar2021, since the second vaccine was administered, the patient experienced pain in left arm around injection site. It had been over a month now (at the time of reporting). The pain intensified as the patient lifted the arm up or stretched. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left arm around injections site and pain intensified patient as lifted the arm up or stretched was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Infant seen on 2-5-10 at about 3 pm for recheck of Bil Otitis with bil otorrea to PE tubes place on 1-8-10 with some cold. PE neg T99.3 Rx with Ceron DM icc PO TID. Received 3 IM injection. Developed 104 with seizure 2-6-10 1:30 AM see TCAA. 2.44 AM PS neg Rx: antipyretics. Pt had 2nd fever 105.2 2-7-10 or 2-9-10 PE neg.
Hospitalized 01/06/2022l; COVID-19 positive 01/06/2022; fully vaccinated   Admission Date: 1/6/2022 Discharge Date: Jan 8, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: SBO (small bowel obstruction) (HCC) [K56.609] Abdominal pain [R10.9] COVID-19 virus detected [U07.1]   HOSPITAL COURSE: 69-year-old female past medical history of Roux-en-Y gastric bypass in 2006 presented on 01/06/2022 with abdominal pain, nausea, vomiting, and CT findings showing dilation and wall thickening of the distal small bowel.  She was initially diffusely peritoneal on her physical examination.  She was treated with an NG tube, NPO, and multimodal pain regimen.  Her exam was very closely monitored.  Her labs were stable and showed no objective evidence of bowel ischemia; her lactic acid and white blood cell count remained within normal limits.  She was also found to have a chronic history of pain related to her previous Roux-en-Y and has had numerous previous visits with her bariatric surgeon at and has requested that her Roux-en-Y be reversed.  We stated to the patient this could not be performed during the current hospitalization, but she should follow-up with the bariatric surgeon regarding this.  Her exam improved on 01/07/2022 and she at started having some bowel function.  Her NG tube was removed she was trialed on clears.  This was advanced to full liquids on 01/08/2022.  She was discharged with instructions to follow up with her bariatric surgeon and with prescriptions for Tylenol.  All questions were answered.  The patient was comfortable with this discharge plan
#1 vaccine: 10 days after vaccine : fever, vomiting, diarrhea, arthritis, led to chronic iliac crest inflammation with pain lasting 6 weeks.  #2 vaccine: 1 week after #2 vaccine: swelling and redness and pain left elbow.  Treated at local facility , requiring incision and drainage and wic                            packing for continued draining.