chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional on 07 December 2015. This case involves a 72-years old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI524AA, dose, dose in series and route of administration was not reported) in the left arm on 04 December 2015. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and denied any other vaccinations within four weeks of vaccinations. The patient's concomitant medications were not reported. On 04 December 2015, thirty minutes following the vaccination, the patient had developed metallic taste. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the event (after 1.5 day). List of documents held by sender: none.
Shortness of breath, feelings of having a fast-beating, fluttering, and pounding heart (some sweating also).
Report 20010058451 described itching in a 36 year old female who received hep B vaccine recombinant for prophylaxis of hep B. The vaccinee's husband is "positive" for hep B. Reportedly, the vaccinee had no known durg alleriges, no medical history, and took no concomitant medications. On 08/30/2000, the vaccinee received her first right deltoid "adult" dose of Engerix-B. Post vaccination on 08/30/2000, she experienced itching and a "slight" rash. These adverse events resolved.
This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Had migraines), FATIGUE (tired), NAUSEA (nauseous), PYREXIA (fever) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Had migraines), FATIGUE (tired), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MIGRAINE (Had migraines), FATIGUE (tired), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.    No concomitant medications reported by reporterNo treatment medications provided by the reporter. This case was linked to MOD-2022-455718, MOD-2022-455739 (Patient Link).
note - lot number difficult to be confident of last 3 digits dT sloppy handwriting.  I underwent major surgery 8 days after the 2nd dose (breast implant removal with abdominal fat grafting). My surgeon told me afterwards that he noted stringy clotting. I ended up needing blood thinners and 2 units of blood transfused, Also had to go back into surgery the next morning to address additional bleeding and received an additional 2 units of blood. I was kept on blood thinners for several days following the surgery.   I've never had a clotting/bleeding problem with any of my previous surgeries (of which there are quite a few different kinds), and did not have any clotting/bleeding problems when I had follow-up reconstruction surgery in July 2021.
Urticaria diffuse occurred 2-3 hrs after immunization administration. Tx included BENADRYL and DECADRON IM.
pt recvd DTP vax AUG86, OCT86,NOV86 & DEC87 & following 3rd vax NOV86 & 4th vax DEC87 devel lumps @ inject site; incision & drainage of 1 site cult neg; pt still has firm lumps;
per patient: experienced arrhythmia s and flu-like symptoms. Pt went to cardiologist but unaware if patient received any treatment there. Patient came in today 6/30/19 to let pharmacy know about the symptoms but he is ok now.
patient had severe swelling in the arm.  had some pain in arm day after shot.  about 4-5 days later, developing swelling around the muscle
Information has been received from a physician concerning a female (demographics not reported) who on an unspecified date was vaccinated intramuscularly in the deltoid with the first dose of Gardasil (Lot# not reported). Subsequently, the patient experienced numbness in lower arm and was unable to speak for 15-20 minutes post vaccination. Subsequently, the patient recovered after 15-20 minutes from the events. The physician did not consider the events to be serious, however did state that he did not plan to continue vaccinating the patient with the second and third doses of Gardasil. Additional information has been requested.
2 lot numbers of Daptacel vaccine (C1700AA and C1996AA). Redness, warm to touch around injection site. Redness, blotchy (large) lasting 4-5 days.
Recent admit for upper GI bleed and pneumonia (3/27/2021 to 4/7/2021), was receiving IV antibiotics, seen in the EC 4/15/2021 for cough and not admitted to the hospital, returned to EC 4/19/2021 for cough, now with some tinge and dark blood (streak), discharged home
After injection arm very sore, painful to lift for 2days. Quarter sized itchy red rash appeared near injection site 9 days after 1st dose
pt recvd vax & devel a pos Coomb's test following vax w/Hep B vax; MD indicated that the time interval between the vax & pos Coombs' test was greater than 3 months & therefore the result was inconvlusive & probably not related to the vax;
A report has been received from a health professional (nurse practitioner), who was also the mother of the patient via a medical representative, concerning a 15 year old male patient. Relevant medical history, concurrent disease and concomitant medication were not reported. On 08-Oct-2014, the mother administered FluMist Quadrivalent (influenza virus vaccine live, intranasal) 0.2 millilitres vaccine by nasal as a onetime dose for flu to her son. On 13-Dec-2014, the patient caught the flu, experienced fever, headache and a positive result for Influenza A. The patient also vomited, after received Tamiflu as a treatment. The outcome of the event of caught flu, fever, vomited, positive test for influenza A and headache was unknown. The report was considered to be non-serious by the company physician.
Nausea and Feeling Faint within 5 minutes of injection under required monitoring from the health department post vaccine. Patient was taken to an exam room and given sugary drinks / food with which symptoms rapidly improved. Patient reports likely cause of not eating much since breakfast. Blood pressure observed as normal after stabilization.
Mother stated fever of 104 degrees F, crying, whining and throwing up began about 12 hours after receiving DTaP and lasted about 6 hours.
The pt saw a physician on 04/23/2002 for left leg red, swollen with hive looking raised from hip to knee. Right leg had a less severe local reaction. Physician advised to give Benadryl and apply cook compresses.
24MAY93 mom reports very high shrieking cry lasting 2-3 days p/vax 24MAR93; MD saw pt on 7MAy93 for routine MD; mom reported inconsolable crying p/vax 24MAR93; requested only DT be given @ next immun scheduled for 24MAY93;
10 minutes after receiving vaccination: Symptom: Heart palpitations  Duration: 5 seconds   2 hours post inoculation: Symptom: mild lethargy, mild dizziness, and mildly disoriented  Duration: ongoing 12 hours post inoculation: Symptom: moderate lethargy and mental fogginess. Mild body aches, mild headache, mild joint pain.  Duration: ongoing
burning in my extremities, moved up to myback, neck, and head.I can barely tolerated any sun light as I feelburning sensation over my body.; I have been experiencing sensation similar to electricalsensations going thru my body; I was not able to sleep; I am not able to exercise, run, or do a lotactivities that I used to do on my own.My quality of life is diminished.; weakness are still with me daily.; I received my 2nd dose on 01/202/2021, in the next 24-48 hours I began experiencing tingling and burning in my extremities, moved up to myback, neck, and head.; Thesesensations and numbness andweakness are still with me daily.; This is a spontaneous report from a contactable physician. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 20Jan2021(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT INH) for unknown indication since unknown start date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Dec2020(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Jan2021, the patient received 2nd dose, in next 24-48 hours the patient began experiencing tingling and burning in extremities. Eventually tingling and burning moved up to the back, neck, and head. The patient was not able to sleep as he had been experiencing sensation similar to electrical sensations going thru in his body. The patient can barely tolerate any sun light as he felt burning sensation over his body. These sensations and numbness and weakness are still present in him daily. The patient was not able to exercise, run, or do a lot activities that he used to do on his own. The patient's quality of life was diminished. The events resulted in doctor or other healthcare professional (number of specialists) office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with ELAVIL, LYRICA and prednisone (MANUFACTURER UNKNOWN). On an unknown date, the patient underwent MRI (brain/spine), CT scan and blood work, but the results were unspecified. The clinical outcome of event tingling, burning sensation, numbness, weakness, not able to exercise, run, or do a lot activities that he used to do on his own, quality of life was diminished, similar to electrical sensations, not able to sleep was not recovered at the time of this report.  No follow-up attempts are needed; No further information is expected.
Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; This is a spontaneous report from a contactable consumer (patient).  A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in Left Arm on 08Apr2021 02:00 PM (at the age of 43-years) as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, via an unspecified route of administration, in Left Arm on 30Apr2021 02:30 PM as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension, depression from an unknown date and unknown if ongoing. The Patient was allergic to wellbutrin. Patient not had covid prior vaccination and patient had not undergone any covid tested post vaccination. Patient had not received any other vaccine in four weeks. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); cetirizine hydrochloride (ZYRTEC ALLERGY); propranolol hydrochloride (INDERAL LA) taken for an unspecified indication, start and stop date were not reported. On 01May2021 08:00, the patient experienced blotchy facial redness and puffiness, almost like hives, after both doses lasting two days. Patient had not received any treatment for the events reported. Outcome of events was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Patient fainted shortly after leaving immunization room. Told his mom he felt dizzy. I brought him back into immunization room, gave him some water to drink and a couple pieces of chocolate to eat. Was very pale but regained his color and wasn't dizzy after resting for about 10-15 minutes.
PATIENT RECEIVED MODERNA DOSE AT AGE 14. SHOULD HAVE RECIEVED PFIZER. PER CDC, DOSE DOESN'T NEED TO BE REPEATED.
On Sunday, June 1, he had a fever of about 100.5, but I thought nothing of it.  Gave him over the counter medicine for the fever.  Early morning Monday at 3am he woke up with a fever still and complained that his "legs hurt."  I gave him over the counter medicine for the fever.  Monday morning he slept very late, and woke up without a fever but feeling very tired and not himself.  He started to throw up around 2:30, and had several heaves over the course of a few minutes.  The last heave was a large amount of blood.  I called the pediatrician and they told me to take him to the ER.  He threw up one more time, bloody, on the way to the hospital.  Hospital admitted him and did xray to check for blockage since he had been constipated on Saturday.  He had a high fever.  Blood work showed platelets were low, and doctor said that since his platelets were low he probably tore his esophagus when he threw up which caused the blood.  Tuesday morning he started to develop a rash at the hospital.  The rash spread to his entire body, was circular and blotchy.  He continued to have very high fevers and low platelets at the hospital.  His lymph nodes near his appendix were also enlarged.  Hospital discharged him Friday, June 6 when his platelets started to increase and his fevers were low and controllable.  The hospital tested for many different viruses, and all came back negative.  I told the hospital and his pediatrician that I was researching and found a similar rash on children who had a reaction to the MMR vaccine.  Plus, if this were a virus why did no one else in the family show signs of this virus?  The hospital and pediatrician kept dismissing my thoughts that this was caused to the vaccine, and kept trying to point the cause elsewhere.  Doctor did repeat Parvo virus testing on Monday, June 16 along with CBC.  Repeat Parvo testing again came back negative and the CBC results were finally back to normal.
I developed Covid-19 symptoms on 10/12/21 (fatique, cough, nasal and chest congestion, fever).  I tested positive for Covid-19 10/13/21. I most likely was exposed to Covid-19 at my 50-year class reunion on 10/9/21.  Most of us were not wearing masks (150-200 people indoors).  walk-in clinic administered the Regeneron subcutaneous injection  anitbody treatment 10/13/21.  My fever reached 100.4 on 10/14/21 and returned to normal 10/15/21.  AS of 10/17/21 most symptoms are now gone except loss of smell and taste senses.
Chills all over the body, with no fever, warm to touch approximately 6pm.  Overall not feeling well.   Around 9:00pm right side of body began trembling and occurred for approximately 2 hours.
I felt I have cold, like colder; I was shaking and twitching kind of like, I mean big twitches, my arms were just twitching, my torsal was twitching, my head was going back and forth and I could not stop any of it; we could not get the arms to stop moving, I couldn''t warm up; I was shaking and twitching kind of like, I mean big twitches, my arms were just twitching, my torsal was twitching, my head was going back and forth and I could not stop any of it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Neuropathy peripheral" (unspecified if ongoing), notes: Verbatim: Neuropathy; "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia. Concomitant medication(s) included: GABAPENTIN; CELECOXIB; TIZANIDINE. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovering", described as "I felt I have cold, like colder"; MUSCLE TWITCHING (non-serious), TREMOR (non-serious), outcome "recovering" and all described as "I was shaking and twitching kind of like, I mean big twitches, my arms were just twitching, my torsal was twitching, my head was going back and forth and I could not stop any of it"; BODY TEMPERATURE DECREASED (non-serious), outcome "recovering", described as "we could not get the arms to stop moving, I couldn''t warm up".  Additional information: The patient after the second one, she got up about 4 in the afternoon about 12 hours later about 4 in the morning she woke up and felt that she had cold, like colder than ever had in her life but she did not had a fever and patient husband took her temperature twice. Patient stated that she was shaking and twitching kind of like, she mean big twitches, her arms were just twitching, her torsal was twitching, her head was going back and forth and she could not stop any of it. Patient stated it was just uncontrollable and she was breathing like she did not feel like she wasn't getting breath but that was just everything was uncontrollable they could not get the arms to stop moving, she couldn't warm up. Patient put heat blankets on and put 10 blankets on top but she couldn't get warm and it lasted about 4 hours. Patient thought she was going to die but her husband kept saying he had to take to you to the hospital but it was in winter and she said that she can't go outside, cannot go out from under of these blankets she just cannot. Patient stated that her husband sat up watching her for about 4 hours and this kind of ran away and she fell asleep.  Follow-up attempts are completed. No further information is expected.
pt recvd vax;next day,tightened up;wound up like a toy & locked in,arms & legs stiff & could hardly get them to move;if bent over , would hurt cause so tight,a deep hurting;also chilled & ached all over, some h/a;lasted 2 1/2 days;took meds
Shot was given on 9.23. Patient experienced seizure in her bed on 9.26 around 1am.   Patient was alone when experienced seizure. Patient woke up by 7am and Patient had a terrible head ache and bed was wet.  No appetite for three days.  Felt similar symptoms from past seizure about 2 years ago (12/28/2017)  Called dr to schedule an appointment in December 2019 and took blood work last week, first week of October.
Autistic symptoms (toe walking appeared deaf, temper tantrums, loss of already acquired speech) Confirmed autistic on 8/29/00.
PAin, swelling, redness to the site. generalized itching that started soon after the injection. Pt visited Urgent care and was prescribed an antibiotic. pain and swelling decreased after three days, however, patient started to feel numbness in the arm going down to the fifth digit. PCP prescribed predisone for a potential pinched nerve from the swelling
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of unknown demographics who was vaccinated with a dose of ADACEL (lot number, expiry date was not reported) on an unknown date via subcutaneous route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate route of vaccination. It is not known whether the patient had any untoward experiences after administration. 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 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.
05/03/2021 I awoke and I had multiple joints hurting when I got up at 5:20 to go to work..During the day Monday, I had to take 1 turmeric pill for pain.   The pain went away.   Monday night I was extremely sleepey, and when I woke up to go to bed about 11:30 I notice some of the joint pain had came back esp the left arm. 05/04/21 , I noticed the area around the v site on the left arm had a red rash about 3x34" and a knot about the size of a golf ball raised and very hard.   Joints were hurting in L arm, legs, and right arm and wrist.   About 10 AM i took 1 ALEVE and within 2 hours the rash was almost gone on L arm at v site, and the swelling at the v site was also getting smaller.  Took 1 more ALEVE at the time point and I felt fantistic.   Same as today, great day, no pain.
localized rxn to DPT, Rt deltoid, apply ice, give APAP/observe. F/U w/ MD on 8May92 sooner if neccessary.
Pt reports day after having Tdap felt weak, slept for 2 hrs in evening which is unusual, awakened x 3 during night with drenching sweats; feels lightheaded, body aches, legs feel like "jelly", low grade fever, feels hot then clammy. Had night sweats 2nd night also.
2:30 gave injection. 2:40 Patient complained of being dizzy and nauseous. Laid patient down with wet cloth on head, gave water. 2:50 took blood pressure 100/52. Patient complains of shakiness. 3:05 No better took to urgent care. This is in follow-up to report (s) previously submitted on 1/16/2007.  Initial and follow-up information has been received from a health professional concerning an 17 year old female with no known allergies, who on 11-DEC-2006 at 2:30 PM was vaccinated intramuscularly in the right gluteal with the first dose of GARDASIL (lot # 653938/0954F).  There were no illnesses at the time of vaccination.  On 11-DEC-2006, at 2:40 PM, following vaccination, the patient complained of feeling dizzy, and nauseous (it was also reported that the patient felt weak).  The patient did not faint.  The patient laid down with a wet cloth on her head and was given water.  At 2:50 PM, the patient's blood pressure was noted to be 100/52 and the patient complained of shakiness.  At 3:50 PM, the patient had not improved, and was taken to an urgent care facility.  The patient was evaluated at the urgent care and released to home.  The patient subsequently recovered on 11-DEC-2006.  No further information is expected.
Aches  Exhaustion  Sore throat  Loss of appetite  Loss of taste/smell  Headache  Diarrhea  Stomach pain  Chills  Fever  Extreme swelling on left arm / injection site
developed shingles; This is a spontaneous report from a contactable Other HCP (patient). A 68-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 11Apr2021 at 15:15 (at the age of 67-years) as dose number unknown, single in the left arm for covid-19 immunisation. The patient medical history she just was diagnosed, no yet treated for shingles. Had chicken pox in 1953. The patient had known allergies to Bactrim, Cipro. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Apr2021, the patient experienced developed shingles. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for event with antiviral. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.