chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inability to walk; sore throat; congestion; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; Rheumatoid arthritis; severe nerve pain; peripheral neuropathy; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; headache; fever; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included bronchiectasis, hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3); estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levaquin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on left arm as single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced inability to walk, fever, sore throat, congestion, headache, abnormal rh factor and elevated C-reactive protein and elevated sed rate all testings were negative for infectious disease process, rheumatoid arthritis, severe nerve pain, peripheral neuropathy. Before Mar19, she was completely independent and very active with no health problems beside brochialstasis for which she did inhalers. The patient was hospitalized for inability to walk, fever, sore throat, congestion, headache for 7 days. The patient underwent lab tests and procedures which included biopsy bone marrow: negative, C-reactive protein: elevated polymerase chain reaction: negative on 05Apr2021 Nasal Swab, red blood cell sedimentation rate: elevated, sars-cov-2 test: positive on 05Apr2021 Nasal Swab. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax 13MAR92 & expired on 14MAR92 @ 1235PM: pt had seizure prior to expiring;
Per ER report: pt presented to ER with headache at 1848 onset was 2 hours prior. He also had nausea and chills that began at the same time as the headache. He then started to have symptoms of periorbital numbness and tingling as well as numbness and tingling in his hands. Mild tachypnea was noted. Felt to be related to hyperventilation reaction. IV Phenergan 12.5mg and IV Benadryl 50mg were given. Pt. reported improvement and was discharged, pt and mom agreeable to discharge.
Pt RTC 5/29/13 830 am - Informed NP exp fast/irregular HR approx 24 hrs post vaccination of MENACTRA at the clinic. Resulted to ER Dx. Atrial fibrillation. Now Holter monitor in use to follow up with PCP and cardiologist.
Patient report left upper arm pain and soreness 4 weeks post injection.  She has tenderness to touch but no loss of left arm range of motion.  She report this persistant problem to employee health on 6/21/2006, when symptoms persisted.
Injection site swelling, a constriction feeling in the arm, hard lump occurred warmness. Used cold pack and gave BENADRYL.
4 inch in diameter red circle, raised slightly in areas with a few bumps around affected area. Hard and darker at center with purplish hue. No fever/chill/ body aches reported. Symptoms persisted since day after vaccination.
Patient came to the Pharmacy yesterday morning (June 20, 2021) around 10:00 AM. He said he received his first dose of Moderna at our pharmacy on May 25, 2021 and complains of shooting pain in his left arm where he received the vaccine, however he does not recall the exact spot where the vaccine was given. He reports not having a shoulder injury or pain prior to receiving the vaccine. Pharmacist and Pharmacy Technician were on duty that day and the patient said that the "female technician" was the one who gave him the shot. The patient reported feeling no pain when he received the vaccine, but days after receiving the vaccine he reported 10 out of 10 pain. This lasted a few days, then the pain subsided to a 5 out of 10. A few days after that, the patient reported the pain going back to a 10 out of 10 and it has been this way ever since. The patient came to the pharmacy with his left arm in a bent position and said he has been unable to extend it fully without causing a lot of pain. He said that even performing small tasks such as reaching over to his right shoulder causes him a lot of pain.
This was a telemedicine visit and I did not see patient's father during the patient's telemedicine visit: 21 year old patient states she received her 2d COVID-19 vaccine on 4/22/2021 and got the rash over posterior left thigh the next day.  Patient states the same thing happened when her father got his 2nd dose of the COVID-19 vaccine.  Patient states they both received the Pfizer brand of the COVID-19 vaccine.
Headache, Myalgia, SkinRash & NauseaVomiting Narrative:
Muscle twitching in leg, lip, and thigh.  Started the week of second shot.
Pale, limp, cold, "clammy" w/tremor of hands & feet; Onset 4 hrs post-inject; Lasted 4 hrs; Also had fever to 38C tx antipyretic & lasted at least 3 days;
After receiving the shot I had to be observed for 30 mins and 15mins into the observation I began to cough my throat felt as if there was something in in and tightness in my chest along with difficulty breathing. I did not note the length of time but a Doctor was called to listen to my lungs and I was offered some water. I continued to experience increased shortness of breath and  after using my Nebulizer and Inhaler with no result went to Urgent Care on 9/15/21
Information has been received from a physician concerning an approximately 2 month old patient who on approximately 25 Dec 2006 was vaccinated PO with a 2.0 ml dose of Rotateq. The physician reported that on approximately 25 Dec 2006, the patient developed blood in the stool. Unspecified medical attention was sought. A fecal blood occult test was performed (results not provided). Within a few couple days after onset, the patient's blood in stool resolved. Upon internal review, blood in the stool with determined to be an other important medical event. Additional information has been requested.
patient received expired Daptacel vaccine/ no side effects; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 22 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) on 03-Apr-2019.  On 03-Apr-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA, expiry date 23-Mar-2019 via unknown route in the left thigh.  It was an actual medication error due to expired vaccine used.  It was reported that patient received expired Daptacel vaccine on 03-Ap-2019 which got expired on 23-Mar-2019.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender- none.
VOMITING; FEVER; ARM SORENESS AT INJECTION SITE; FAST HEART BEAT; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included patient had series of rabies vaccines last year., and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced fast heart beat. On 05-APR-2021, the subject experienced arm soreness at injection site. On 05-APR-2021 21:00, the subject experienced fever. On 06-APR-2021 02:00, the subject experienced vomiting. On 06-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, arm soreness at injection site, and fast heart beat. This report was non-serious.
pt says he developed high fever, sweats, diarhea, sore throat, cough, muscle pains and fatigue.  Pt is taking cold and flu meds along w/ Tylenol.  Pt no longer and fever but has been sick with for about 9 days.  Pt will contact PCP for medical advice.
My son has had chronic constipation with abdominal pain since administered the oral vaccine (Rotateq).  He has not been able to have a bowl movement without stimulation or laxitaves since that date.  His original bowl pattern was at least 4 - 5 large BMs daily. The patient was seen by a GI specialist on 2/6/09 and 2/26/09. The baby brest feed exclusively and the mother began a milk free diet on 2/6/2009 and soy free diet on 2/26/2009 to rule out food allergy. The stools were bloody with a lot of mucus. The baby had iuncresed reflux between 1/20/2009 and 3/31/2009. The U/S was normal on 1/26/2009. The last does of milk of magnesia was given on 2/25/2009 and a bowl movement occurred on 3/1/2009 (less mucus; noo blood).
Headache started at 4:oopm on Friday, July 23, 2021 and then light headed feeling.  Started sweating at 6pm. Started vomiting around 6:15pm and have continued vomiting through Sunday.  Patient took excedrin on Friday, for headache. Patient tried to take pepto bismol on Saturday and ant acids on Saturday, but she has had trouble keeping them down.  She  hasn't been able to keep food or drink down successfully until only a small amount of water on Monday, July 26, 2021.  She has been in the bed and is still very light headed as of 1:oopm Monday, July 26, 2021.
Went to primary care doctor on August 30th.  EKG showed I was in bigeminy.    I did not know that I was. No chest pain, SOB, or fluttering in my heart.  Dr. office referred me to a cardiologist.     I had a screening colonoscopy in March 2022, and no mention of PVC's at that time.
Approximately 1hour after vaccination began having stomach pain and bloating in the abdominal area. Stomach bloated abnormally. Later, during the evening had bloating to the face with redness, hands, fingers, legs, feet. My entire body swelled abnormally. By 5am I awaken to an entire swollen body. My left arm at the injection site was filled with unbearable soreness and pain to lift. Some light headed feelings. I called my Pulmonary and Primary. Went to hospital.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX on or about 28-NOV-2011 by a physician, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 23-JAN-2012, patient was treated by physician assistant for an ongoing painful rash which was diagnosed as shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Skin rash (hives) all over the top of my back; also experienced other typical side effects such as fever, nausea, fatigue, and muscle aches.
Red blister rash, wrist to elbow, right arm, vaccine was administered to upper arm, left arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (28Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 19Sep2022, treatment stop date was 23Sep2022 and indication was treatment of COVID-19. No known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a medical assistant concerning a 7 month old male with NKDA and no pertinent medical history, who was given 3 doses of ROTATEQ, 2 ml, and developed intussusception. The patient received his first dose on 16-APR-2008 (lot # 660291/1829U), the second dose on 16-JUN-2008 (lot # 660596/0211X) and the third dose on 31-JUL-2008 (lot # 660679/0407X). Concomitant therapy included PEDIARIX, ACTHIB, PREVNAR and DTaP (unspecified). The patient went to the hospital ER on 13-SEP-2008 and was then transported to another hospital and hospitalized with intussusception. The patient had a GI obstruction, surgical repair work on the intussusception, and his appendix was removed. The patient was in the neonatal intensive care unit. The medical assistant states she does not have the medical charts from the hospital, and does not know if the patient has been discharged from the hospital. However, the caller states she thinks the child is "recovering, getting better". Blood lab work and lots of unspecified tests were performed. No product quality complaint involved. Intussusception and appendix disorder were considered to be immediately life-threatening, disabling and other important medical events. A lot check has been requested. Additional information has been requested.  9/25/08-records received for DOS 9/13-9/21/08-DC DX: Colonic perforation. Presented to ED with current jelly bowel movements and emesis suggestive of intussusception. Open reduction intussusception with incidental appendectomy performed on 9/14/08-Subsequently developed severe abdominal pain associated with severe tachycardia.  Intubation. Returned to OR for exploratory lap, repair of colonic perforation. NG tube insertion. Recovered and discharged home.
On the day of the vaccine, I was tired, loss of appetite and achy.  No medications taken.  The next day, I had a pounding headache and bed ridden for 2 days. I had flu like symptoms-body aches, chills, and headache-lasted a few days. About a week later, left lymph node had a lump and was painful.  You went to the PCP, they did an ultrasound and on that day, my left lymph node was not inflamed and the ultrasound did not detect anything.   The next day, the left  lymph node swelled up and will come and go.  Every time it swells up, I can feel the pain.  It is also on the same side of the vaccine site (left arm).
patient had previously been given 3 doses of Bexsero.; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number A8X809A2, expiry date 21st May 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included bexsero (received first dose on 12th August 2020) and bexsero (received 2nd dose on 23rd September 2020).   On 21st June 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The patient received had previously received 2 doses of Bexsero vaccine and now received the 3rd dose which led to extra dose administered. Reporter consented to follow-up via e-mail.
Initial pregnancy report received from a healthcare professional on 16 April 2013. A 19-year-old female patient, had received intramuscular first dose of ADACEL vaccine batch number U4431BA (anatomical site of vaccination was not reported) on 16 April 2013. The patient was seen in emergency room for laceration on unspecified date. Patient's concomitant medications were not reported. The patient received vaccine during pregnancy. The patient's last menstrual period was unknown. The expected date of delivery (EDD) was reported as 11 June 2013. The patient did not experience any adverse event. List of documents held by sender: none.
mom states lt thigh became red, swollen & hard;gave DPH became better;mom denies rash doesn't know if there was fever;
Patient had two events that our pediatrician encouraged us to notify about.  First, on 4/15/2021 around 13:30, Patient stretched in class and fainted. He was unconscious about 30 seconds.  Second, beginning 4/15/2021 around 2100 he noticed a rash across his chest and down both arms. The rash is spreading to his abdomen and back today (4/16/2021). We saw a physician at his pediatric clinic this afternoon for evaluation.
diagnosed with covid 30Dec2020; diagnosed with covid 30dec2020; This is a spontaneous report from a contactable nurse (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration in right deltoid on 21Dec2020 13:45 at single dose for Vaccination.  There were no medical history and concomitant medications.  The patient was diagnosed with covid on 30Dec2020 with outcome of recovering.  The patient underwent lab tests and procedures which included COVID test: positive on 30Dec2020. The patient received the first dose of the covid vaccine on 21Dec2020, and was diagnosed with covid on 30Dec2020. The patient had COVID test on 30Dec2020 and received positive result of COVID test on 31Dec2020. He was scheduled for the second dose between 08Jan2021 and 11Jan2021. He asked if he should continue to get the second dose as scheduled in relation to the diagnosis of COVID. COVID: the patient still had chest congestion, but no fever without medication, no cough anymore. He was having cough, fever, loss of taste and smell, fatigue and malaise. Reporter seriousness for COVID: Not serious. Relatedness of drug to reaction/event:  Reaction assessed: COVID, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Unrelated. Verbatim event relatedness: Pfizer COVID-19 Vaccine: COVID-Unrelated.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and was diagnosed with COVID-19 on 30Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the diagnosed COVID-19 likely represents the pre-existing infection prior to vaccine use, and unrelated to BNT162B2.
Flu; Based on information previously received, the case assessed as non-case was reassessed as valid.  Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves male patient (demographics unknown) who had flu (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient had taken 1st and last flu shot, which was 30 years ago. He got the worst case of the flu he ever had before or after. He had the flu twice since he took the shot.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Initial solicited report received from an investigator in a trial on 02 March 2017. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 22 January 2016. On 22 February 2016, 31 days after vaccination the subject was diagnosed with Disease of pericardium, unspecified. On 08 February 2016, 17 days after vaccination the subject was diagnosed with acute myocarditis, unspecified. The lab data included 05 February 2016, the Troponin I was 1.45 (abnormal), on 02 February 2016, ECG was abnormal, on 03 February 2016 Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 22-year-old male who developed Disease of pericardium; unspecified and acute myocarditis, unspecified with favorable temporal association post vaccination with ACAM2000. Pericarditis and myocarditis are listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. The company has assessed the event as possibly related to study vaccine.
Diaphoretic, dizzy, nauseated. Pt drank water, and laid down on cot.
Patient went with her husband 10-12 days ago.  Patient developed cough, nausea, diarrhea, and weakness.  The patient and her husband were positive for COVID by a home test.  Patient saw her PCP who recommended home quarantine.  During the past 48 hours prior to hospital admission, the patient was more short of breath.