chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a company representative's son via a company representative and refers to an 18-year-old female patient with allergy to gelatin. No information regarding her medical history or concomitant medications was provided. On 24-MAY-2018, the patient was vaccinated with a dose of Oka/Merck VARIVAX injection (dose, route of administration, lot number and expiration date were not reported) as a part of vaccinations for school. On the same day, 10 minutes after the administration of the vaccine, the patient experienced facial and mouth itching and swelling. She was treated with an epinephrine injection and was subsequently sent to an emergency room. The outcome of the events was unknown. The relatedness between the events and Oka/Merck VARIVAX was not reported. Upon internal review, the events of itching and swelling face and mouth were considered to be medically significant due to treatment with epinephrine.
On April 22nd 2021 I got my first dose of the Pfizer Vaccine. I've had symptoms of muscle fatigue, heaviness and pressure in my chest, night sweats 3 nights a week for a month, and a headache for several months.
48hrs p/vax pt was fussy & crying alot; rash began 29JUL blotchy, non blanching esp on trunk  & elbows/knees large indurated area @ inj site - size of golf ball on 30JUL according to mom; resolving by 1AUG95;
Body ache; Fever; chills; exhaustion; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion). At the time of the report, MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
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.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: G53277) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EM9809), on 03Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "repaired mitral valve" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "known allergies: iodine in shellfish" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE (Alembic), start date: Jan2013; ATORVASTATIN APOTEX, start date: Jan2018; BAYER ASPIRIN, start date: Jan2013; B1, start date: Jan2018; MACUHEALTH, start date: Jan2021; CALCIUM;MAGNESIUM, start date: Jan1993 (Now Foods); VITAMIN D3, start date: Jan2003 (Now Foods); METHYL B12, start date: Jan2018 (Now Foods); multi vitamin & mineral, start date: Jan1993 (Now Foods). Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 17Aug2023 to 22Aug2023.  Clinical course: The patient developed throat congestion, fever, and body aches on 15Aug2023 and tested positive for covid the next day on two Flowflex home covid tests.
Within less than two weeks, I began to have intense symptoms of obsessive-compulsive disorder consisting of intrusive thoughts and sensations.  I continue to suffer from OCD.  I have recently been diagnosed with Chronic Inflammatory Response Syndrome  for which it is not unusual for individuals to have negative reactions to vaccination.    The result or outcome of the adverse events is this ongoing battle with OCD, decreased life satisfaction, and inability to function at prior levels .
onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52
C/o headache, muscle weakness, nausea, diarrhea & hand trembling.
Patient woke up with chills and sweat. That has resided but warm, red blotches have begun to appear on his arm, leg and one on stomach.
I  WAS SCHEDULED FOR SHINGLES  SHOT AT 11 AM,  WAS NOTIFIED AFTER CALLING CVS BACK AFTER A ONE RING CALL I WAS GIVEN THE PFIZER 1ST DOSE SHOT I WAS GIVEN PFIZER SHOTS  1. 6206 3/10/2021 AND 2ND #ER 8733 ON 03/31/2021. WON'T SHARE ANY OTHER INFORMATION WITH ME WAS A MISS COMMUNICATION.
PATIENT'S ARM IS SWOLLEN AND BRUISED. SHE HAS A KNOT ON HER ARM WHERE THE VACCINE WAS GIVEN 3 WEEKS LATER. THE BRUISE IS DIMINISHING AND SYMPTOMS ARE IMPROVING. THERE WAS NO STREAKING ON THE SKIN REPORTED BY THE PATIENT. BECAUSE OF THE DURATION OF THE KNOT WE HAVE OPTED TO SUMBIT THIS REPORT.
Syncope on 4/28/22. Injured L knee. Treatment consisted of ice, elevation and compression at home. Recovered over the next 12 weeks. Lingering intermittent sciatica, occasionally severe and disabling. Walking with cane occasionally required until 11/15/2022. In late May, early June patient experienced heart palpitations, premature ventricular contractions. Urgent Care arranged transport to ED
On 5/28/21 patient received a dose of the J&J Covid-19 vaccine incorrectly. The patient had asked for the Moderna Covid-19 vaccine, signed a consent form for a Moderna Covid-29 vaccine, and received a card that stated she received a Moderna shot. However in her chart it was entered that she received a J&J Covid-19 vaccine with a J&J lot number of 202A21A. Thinking she had received Moderna, the patient came back on 6/30/21 and received an actual dose of the Moderna Covid-19 vaccine. She thought that this was her second shot. We realized on  7/9/21 while looking through our records that there was an error. We spoke to all staff involved to understand what happened. Once we were able to piece together what happened the patient was informed on  8/2/21. Our Medical Director, spoke with her and reported the following: Reviewed that J and J is a solitary dose and did not require a booster.    Advised that I would not anticipate any harm from receiving both especially as we are now 5-6 weeks past the administration, but since the vaccines are under EUA and this would be a rare circumstance, there is not data about such.  Patient received information well.  Stated that the J and J was a "doozy" and she had side effects for 3 days.  Stated she did not have any side effects after the Moderna vaccine.  Stated she has been feeling good - went out of state and quarantined for 2 weeks after given the high rate of CoVID there.  She actually stated " I feel even better having had 2 shots now with this variant."  She told me she would be ready for her third shot whenever booster are advised.  She is requesting appointments for her oldest 2 children to receive the vaccine.  I will send that information to the vaccine scheduler.  She also needed an appt for her oldest to have a sports physical - I made that appointment.  She expressed concerns about her younger children being in school and unvaccinated and I empathized with her on the subject.    She did not have any questions or questions at the end of the conversation
Received vaccines listed below Mon 08/11/2003.  Presented to clinic then 08/14/2003 with report of redness and swelling onset day after vaccinations, and progressing since that time.  Today 3 inch (length) x 2.5 inch (width) area on left deltoid with redness, swelling, warmth, and tenderness.  Parent to take child to MD at once and call and report. 08/25/2003: Patient's left arm was reported to have become reddened and swollen one day after immunizations were given.  Mom stated that patient was taken into MD for evaluation, and was told that patient had an 'allergic reaction" to the immunizations.  Since three vaccines were administered in left arm, pediatrician was unable to distinguish which vaccine (if one, or all) may have attributed to the inflammation.  Patient's mother stated that patient was given Benadryl and Tylenol per MD's orders, and arm is better now.
Developed a firm and moveable "cyst", 2 inches below antecubital crease on anterior forearm, same arm (right) as Anthrax immunization given. Cyst is currently 1/2 cm in size.
This spontaneous report as received from a pharmacist refers to a 86 year old male patient with high blood pressure. The patient had no drug reactions/allergies 3 or 4 years ago, in approximately September 2010, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided). Concomitant therapies included nifedipine (manufacturer unknown) and metoprolol (manufacturer unknown). The pharmacist reported that a patient was on dialysis after receiving a dose of ZOSTAVAX. The pharmacist did not know when the patient was placed on dialysis or why the patient needed the dialysis. It was unknown if the patient was on dialysis when the ZOSTAVAX was administered 3 or 4 years ago or if the patient's condition changed after the administration of the ZOSTAVAX. This outcome of dialysis was unknown. The relationship between ZOSTAVAX and dialysis was not reported. Additional information is not expected.
Post vax on 12/28/2000 the patient experienced chicken pox. He had a mild fever with about 20 lesions some of which were vesicular. Medical attention was not sought for the child. His outcome was not known. Additional information has been requested.
expired dose of Ipol was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (GMI) (Reference number- 00544923) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 5-year-old female patient who administered expired dose of IPV (VERO) [IPOL] (Expired product administered).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.   On 31-Mar-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) [lot R1B251N, expiry date: 13-Mar-2021] via an intramuscular route at a left arm for prophylactic vaccination.  It was a case actual medication error due expired product administered. [Latency: at the same time of vaccination].  It was reported that, a clinic was want guidance after an expired dose of Ipol was administered.  Product used : Used Still using product : No.  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Arm sore, Within hours Burning when urinating, very low energy and head felt foggy. Day five started  severe chills and sweats and low grade fever. Nausea, faint, diarrhea. Day 9 Glands in neck swollen hard to swallow. Day 13 back to the Dr, still have all symptoms. the severe chills are the only symptom that is better.
Worst headache I've ever had, exacerbated by bright lights.  Also with significant neck pain on movement and general body aches.  Almost like meningitis - if it had lasted any longer I would've gone to the ER.
states ran fever 4FEB93; presented today w/splotchy red (non-itchy) rash on upper arms & chest; t98.5 oral; BP 11070 & c/o dizziness; consulted w/MD who recommended DPh;
Pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetic, Hypertension, Myositis and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Pain at the site of the injection) outcome was unknown.            No concomitant medications reported. No treatment reported
13-year-old patient was administered the first dose of PROQUAD and VARIVAX series; No adverse effects; 13-year-old patient was administered the first dose of PROQUAD and VARIVAX series; This spontaneous report was received from a registered nurse refers to a 13-year-old patient of unknown gender and race. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medication.   On 30-JUL-2019, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration) (product administered to patient of inappropriate age); both vaccines were reconstituted with a sterile diluent all therapies were for prophylaxis (strength, dosage schedule, route of administration, lot number and expiration date were not reported). No adverse effect reported and there was no product quality complaint involved.
Narrative:  COVID infection following COVID vaccine series 01/06, Pfizer, dose #1 01/26, Pfizer, dose #2 11/19 COVID swab, result: detected 11/16 pt cc: chills, cough, diarrhea, fatigue, fever, muscle pain, nausea exposure: unknown 11/19 CXR impression: Low lung volumes. Mild streaky central perihilar and bibasilar airspace opacities, nonspecific but suggestive of given history of atypical pneumonia. Consider radiographic follow-up to resolution 11/19 SARS-COV-2 Variant Sequencing result: pending 11/26 clinically resolved
Child noted to have an area of about 10x5 erythema to upper, outer aspect of left arm. Mother reports that arm was very tender and had a larger area of redness & swelling.
Two about 4 weeks apart; sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR211397).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain and drug dose administration interval too short. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and no reaction just sore first 2 days and dose was received earlier than the recommended interval 4 weeks apart, which led to shortening of vaccine schedule. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211397:same report, different dose
Within 1-2 minutes, post vax, pt complained of feeling funny. His nurse observed pale, clammy skin. No LOC noted. BP 102/48. Moved to exam room table via wheelchair. Legs were elevated. BP 98/60, pulse 66, resp 18, regular and unlabored. Continued to monitor for 20-30 mnutes. BP monitored freqently. At 14:10, BP 104/70, pulse 60, resp 16, drinking orange juice and states he is feeling better. At 14:15, BP 100/68, sitting up with legs dangling, pulse 64, resp 16. At 14:20, BP 100/60, pulse 70, while standing up. Voices no complaints and color is returning to face. No sweating noted. States "I'm OK". Sent home with mother and instructed to let us know if he has any more problems.
Fast heart beat - 10 minutes after vaccine (10/6/21) Sore and swollen arm (10/6/21) Vomiting and diarrhea, with loose, watery, mucus and bloody stools (10/7/21) Sore neck on right side, swollen lymph nodes  (10/7/21)
Patient given ZOSTAVAX in left upper arm 8/12/11. Patient came in 8/22/11 for appt with shingles on right leg. Patient's husband (caretaker) stated rash developed on 8/20/11.
Immediate soreness to injection site, around a little less than 24 hours I developed not just swelling but a very hard lump at the site of injection (not at my lymph nodes) that is quite large. Very very tender and unable to move arm much.
Mom states afternoon of Seasonal flu - 4-5-10 one eye swelled - next morning both eyes swollen - Took to M.D. states must be allergic to flu vaccine. Wednesday took child to eye doctor. Both eyes hemorrhaged - was placed on steroids.
Left arm tingling from neck to fingers, weakness, chest pain, muscle twitch. Evaluated by EMS-Refusal to transport.
Began with pain the evening that he received vaccine. Swelling began next day. Lasted about 48 hours. Pain and swelling began to improve on day 3. Erythema turned to yellow discoloration as swelling resolved.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "had breathing issues" (unspecified if ongoing), notes: Dates for had breathing issues: (From: Unspecified To: Unspecified). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization) with onset 25Jan2022, outcome "unknown", described as "acute respiratory failure"; PNEUMONIA (medically significant) with onset 23Dec2021, outcome "recovered with sequelae" (03Jan2022), described as "Pneumonia"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "could not get out of bed"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "stated that she has put on some weight since all of this started happening"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "hands are doing these twitchy things"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "something neurological going on". The patient was hospitalized for acute respiratory failure (start date: 25Jan2022, discharge date: 31Jan2022, hospitalization duration: 6 day(s)). The events "acute respiratory failure" and "pneumonia" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (23Jan2022) low; weight: (unspecified date) put on. Therapeutic measures were taken as a result of pneumonia. On 23Dec2021, patient was started on oxygen. She saw her doctor on 03Jan2022 and was put on antibiotics and steroids due to pneumonia. She went back home and had been off work the entire time. On 25Jan2022 that she went to the ER and was told that she was in respiratory failure. Her health dropped off so much she could not get out of bed and had to have her son come dress her. She does not know if the oxygen will permanent. She was hospitalized for acute respiratory failure and was diagnosed with pneumonia on 23Dec2021 but was not hospitalized and only went to the ER. She had breathing issues that started earlier on from that date. She did not recover from pneumonia and her condition was getting worst so she called her doctor back and asked for some more steroids and antibiotics. The lot number for bnt162b2 was not provided and will be requested during follow up.
flu; very sick; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza) and very sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had flu (influenza) and very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
pt recv vax 14AUG96 & 23JAN97 pt devel a rash consisting of more than 50 lesions, low grade fever, right ear pain, & lt ear infect;f/u info reported that the pt had a confirmed case of varicella & recovered on 1FEB97;
Per history by mother  -- After teen was roomed by the CMA, vaccines were given;  CMA left the room afterwards and teen told mother that she did not feel well, and spontaneously "passed out", hit her head on the wall and fell on the floor.    Per clinic team:  Teen's mother was screaming in the room and available team members responded.  Teen was found sitting on the floor, awake - started to speak "what happened?".  Team member asked if she was alright - teen reported " I am okay".
I received the vaccine at noon on Saturday. 12 hours later I experienced severe chills and body aches which lasted 12 hours. Late afternoon on Monday I began experience sharp pains on the left side of my head, in my left inner ear, my left temple, behind my eye and above my eye to the upper part of my left forehead. At one point in the evening, it hurt to move my eye . These pains have persisted. I took 800mg of Ibuprofen on Tuesday morning, which took away the sharp pain but there is still a dull pain/feeling of pressure behind and around my left eye and ear. The eye feels dry and sore when I blink. I called a doctor and they felt it could be a migraine. As someone who suffered from migraines in the past, it doesn't feel like one.