chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following Immunizations client sitting in waiting room reported "not feeling well". Head dropped to left side, became pale, went into deep sleep-snoring, was lowered to floor, 911 called. Mother then reported "not breathing". Within 10 secs had regained consciousness BP 122/82 Pulse 60-911 gave 02-sent to ER.  3/30/09 MR received for DOS 3/11/09 with dx: Syncope. Pt presented after episode of syncope which occured just after vaccination.  Pt felt lightheaded and dizzy and then LOC for ~ 5 minutes. Still reports dizziness at hospital. PE WNL. W/U (-).  D/C home.
Patient is immunocompromised with Krohns disease and immunosuppression medications. She had a total of 4 Pfizer medication, was wanting to try a Moderna Vaccine, she was given a full dose of Moderna 0.5 ml instead of a half dose of Moderna 0.25 ml booster for being immunocompromised. Patient left the area after being vaccinated. error discovered later in the day. Patient had no adverse reaction during her time at the mobile vaccine clinic that she attended.
Mild fever, runny nose, skin rash (resembles chickenpox) originating on abdomen, spread to limbs and face.
Pt admitted w/ covid PNA 15L high flow, recieving dexamethasone
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, ROTATEQ was stored under 32 F for 39.5 hours. Then on 03-DEC-2015 the patient was vaccinated with the improperly stored dose of ROTATEQ (lot # k007246, expiration date 17-MAR-2016, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of "data logger". This is one of several reports received from the same source. Additional information has been requested.
Nausea, vomiting, difficulty breathing, tight chest, injection site pain, body aches.
Patient under 65 received Fluad QIV; Arm pain; Injection site redness; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04834) and concerned a 53-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed injection site redness and arm pain. No corrective treatment was given for the events.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095 and 202006098 (the same reporter).  Company comment: A 53-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and vaccination site erythema. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 53-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and vaccination site erythema. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored GARDASIL (dose, route of administration and lot # were not reported). It was reported that the vaccine was exposed to 1C for 48 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed Visual Snow Syndrome. Started 2 days after receiving flu vaccine. Went to ophthalmologist to see a doctor who referred him to a Neuropathologist. Still has it. On Neurontin 300mg tid to try to lessen symptoms. Symptoms include blurry snowy vision as well as floaters and light distortion.
5/7/03: Pt complained of soreness, pain and tightness to left upper arm. Reddened area to left upper arm measuring approx 8 x 6 cm. Area hardened and warm to touch. 5/13/03: Small reddened area approx 1 cm to left upper deltoid region.
This case was reported by a consumer via call center representative and described the occurrence of weakness in a 73-year-old male patient who received Engerix B adult for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (in chest, and he had chemo and radiation that). The patient had a Family History of drug hypersensitivity (patient's mother and sister very sensitive to medications). Previously administered products included Engerix B adult with an associated reaction of asthenia (1st dose received on 26th June 2018, refer case US2018133497), Diovan with an associated reaction of rhabdomyolysis (rhabdomyolysis also caused by statins) and Hepatitis B vaccine with an associated reaction of therapeutic response decreased (received in 2008, antibody titers were low, refer case US2018GSK135695). Concurrent medical conditions included heart disease, unspecified (from radiation treatment), cardiac pacemaker insertion, tachycardia and drug hypersensitivity (very sensitive to medications). On 24th July 2018, the patient received the 2nd dose of Engerix B adult. On 24th July 2018, less than a day after receiving Engerix B adult, the patient experienced weakness, urine discoloration, dizziness, fatigue and feeling abnormal. Rechallenge with Engerix B adult was positive. On an unknown date, the outcome of the weakness, dizziness, fatigue and feeling abnormal were not recovered/not resolved and the outcome of the urine discoloration was recovered/resolved. It was unknown if the reporter considered the weakness, urine discoloration, dizziness, fatigue and feeling abnormal to be related to Engerix B adult. Additional details were provided as follows: Within 3 hours after vaccination, the patient experienced weakness, fatigue, dizziness, and lightheadedness. The patient did not drink much water and had very dark urine. The patient said he was trying to work on his boat and had been drinking a lot of water. When the patient went to the restroom, he noticed that his urine was very dark. The patient was not sure where that came from. As he drank two and a half bottles of water during the day, the urine got lighter and lighter when going to the restroom. On the day of reporting, the patient said he still felt as on the day of vaccination. Other than the discolored urine, the other effects had not resolved for him. The patient said that he felt like someone who had been beaten, no energy to do anything. The patient stated that he had heart problems, which could have some of the same symptoms. The patient did not think the vaccine might have been the cause of the issues.
LOSS OF TASTE; UNABLE TO WALK STRAIGHT; FLU-LIKE SYMPTOMS; HOT AND COLD CHILLS; HEADACHE; NAUSEA; FEELING HOT INTERMITTENTLY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 before 08:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feeling hot intermittently. Treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced unable to walk straight. On 12-MAR-2021, the subject experienced flu-like symptoms. On 12-MAR-2021, the subject experienced hot and cold chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced loss of taste. On 01-APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk straight, flu-like symptoms, and headache on 13-MAR-2021, had not recovered from nausea, and loss of taste, and the outcome of feeling hot intermittently and hot and cold chills was not reported. This report was non-serious.
received Maderna shot on 12/30/20 then one week later on 1/6/21 developed an allergic reaction on and near the injection site.   rash faded in a few days but did not resolve fully.  went to Occupational Medicine dept for exam and prescription to treat rash
I started having pain and discomfort from lipoma that was pre-existing and the shape of it started to change as well. I called my doctor and she referred me to a surgeon by the name at facility. I eventually had to have surgery to have it removed.
On April 1, 2021 I got my first dose of the COVID-19 EUA vaccination at  (Moderna, lot number: 028A21A) around 7pm (although my appointment was at 5:15pm but that's a whole different story about capitalism's inefficiency. About 30 mins after the vaccination I started getting a headache that turned into a migraine within the hour and did not respond to over the counter treatments (alieve, excedrine) nor did it respond to my second course treatments from the neurologist (as I get chronic migraines), such as triptans (imitrex, and today I tried amerge). I just wanted to report these symptoms to a) increase awareness of negative side effects in populations of the chronically ill and b) provide information that could alter the vaccination's preparation so others may not have to suffer the same side effects in the future.
Nausea vomiting shakes hot and cold weakness and muscle pain,  agitation, severe headache
This spontaneous report was received from a 82 year old female patient with depression and drug reactions or allergies to OTC cold medicines that contain epinephrine and some unspecified antibiotics reporting on herself. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included PARNATE. On an unknown date the patient experienced difficulty sleeping. The outcome of the event was not reported. Relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there is no consent to contact the reporter.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Since 18-SEP-2015 an unknown number of patients were vaccinated with PEDVAX HBI (lot # K015462, exp date 10-JUL-2017; lot # K025005, exp date 21-JUL-2017; lot # K019700, exp date 16-JUL-2017; lot # L014426, exp date 08-MAR-2018) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the several reports from the same reporter. Additional information has been requested.
symptoms began day after receiving Janssen CIVOD-19 vaccination. Symptoms include nausea, headache, body aches, light chest pain, chills. Taking Tylenol for relief of symptoms. Was seen at military sickcall for check up on 23 July 2021 at approximately 1100.
Slightly Higher Temperature; red blotches down arm of vaccine that itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Slightly Higher Temperature) and RASH MACULAR (red blotches down arm of vaccine that itches like crazy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Slightly Higher Temperature) and RASH MACULAR (red blotches down arm of vaccine that itches like crazy). At the time of the report, BODY TEMPERATURE INCREASED (Slightly Higher Temperature) and RASH MACULAR (red blotches down arm of vaccine that itches like crazy) outcome was unknown.     No treatment information was provided.  No relevant concomitant medications reported.
Patient developed swelling and redness from the injection site down to the wrist of the left arm. This occurred within 10 minutes of injection and was resolved with 50 mg of benadryl within 12 minutes after administration. All symptoms resolved and patient was counseled on signs of anaphylaxis.  Patient was observed for 15 additional minutes prior to being dismissed with husband.
Patient without symptoms, tested positive during response testing in an outbreak of COVID-19 in a homeless shelter
Case number PHEH2014US003800 is an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to a 16-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly at a dose of 0.5 ml on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Redness, swollen and induration or right arm 6cm x 4cm in size.
This spontaneous report as received from an office manager refers to a currently 14 month old (age at the earliest adverse event onset unknown) female patient with none concurrent conditions or medical history. Office manager reported that the patient needed skin testing for VARIVAX (Merck), M-M-R II and VAQTA. They did not have these vaccines available and the patient could not get any from her pediatrician as they were stated supplied. He requested some samples. The reporter stated, that the patient was vaccinated with a dose of VARIVAX (Merck) subcutaneous injection, VAQTA intramuscular injection and M-M-R II subcutaneous injection (dose, route of administration, lot#, expiry date unspecified for all) on an unknown date at another office. No concomitant medications were reported. Patient developed widespread hives on an unspecified date. Then, the patient was evaluated in the office on 25-APR-2014. She was prescribed unspecified corticosteroid medication and was administered a BENADRYL injection. On 26-APR-2014, the hives had resolved but the patient had developed lip and facial swelling. The patient's mother administered oral BENADRYL at home. The patient subsequently recovered on an unspecified date. No laboratory test were provided. The relatedness between events and suspect vaccines was not reported. Additional information is not expected.
The patient awakened on 02/04/2021 confused and disoriented.  Didn't know where or who he was and was taken to the hospital by ambulance and evaluated and admitted. BP by EMS was 220 systolic. He was diagnosed with hypertensive encephalopathy, but I suspect it may have been a Transient Global Amnesia.
11-12 days p/vax onset of morbilliform rash w/fever to 101;progressive to petechial rash & irritability required complete w/u;blood/urea/CSF analysis & cult & hosp;dx BOM, pneumonia, anemia, thrombocytopenia, neutropenia, oral candidiasis
Information has been received from a RN concerning a pt who on 05/31/00 with varicella vaccine. On 06/13/00 the pt developed a varicella like rash on her upper back and neck and it was noted that 14 days post-vaccination, the pt was covered from head to toe. The pt's parents do not know if exposure to wild type virus occurred. the reporter indicated that a vesicular fluid specimen and a swab will be sent for analysis. the pt sought unspecified medical attention. Follow up information received from the RN indicated that the PCR analysis was negative for varicella zoster virus. It was reported that the pt has recovered.
Per patient, visible swollen "gland" at neck near collarbone; hurts to the touch and when move around. Also feels swollen in armpit (not visible), and hurts when touch and when move around. Advised patient to follow up with doctor.
couldn't move her arm; Joint pain; chills; Fever came fast and gone away fast; really dry mouth; fall feeling throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), DRY MOUTH (really dry mouth), OROPHARYNGEAL DISCOMFORT (fall feeling throat), HEADACHE (headache) and ARTHRALGIA (Joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease since 2000.    On 27-Jan-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (headache). On 27-Jan-2021 at 5:50 PM, the patient experienced DRY MOUTH (really dry mouth) and OROPHARYNGEAL DISCOMFORT (fall feeling throat). On 28-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), ARTHRALGIA (Joint pain), CHILLS (chills) and PYREXIA (Fever came fast and gone away fast). On 27-Jan-2021 at 8:30 PM, DRY MOUTH (really dry mouth) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), OROPHARYNGEAL DISCOMFORT (fall feeling throat) and CHILLS (chills) outcome was unknown, HEADACHE (headache) and ARTHRALGIA (Joint pain) had not resolved and PYREXIA (Fever came fast and gone away fast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medications were not reported.    Treatment for the events included Aspirin next day of the shot on 28 Jan 2021.
09-12-08 530 PM Dizzy, Diaphoretic, painful in arm all the way down to wrist within minutes after vaccine ->lay down for 10 minutes felt better. 10 minutes later called office to report she had passed out while driving. Advised to go to the ER -
cold, clammy, pale, nausea, shivering, rigidity-unaware of surroundings;feet elevated-epi given pt responded;
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. In January 2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). Subsequently, on 05-NOV-2015 the patient was vaccinated again with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) leading to an inappropriate schedule of drug administration. Additional information has been requested.
Sore, scratchy throat, runny nose, headache, body aches, head cold feeling. Started the exact whole day after 2nd vaccine shot. I was fine and not having any symptoms of anything before vaccine injection was given.
OSTEOPOROSIS OF SPINE AND DETERIATION OF HIP BONE AT 40 YEARS OLD WITH ALL SECONDARY CAUSES RULED OUT. ANTHRAX VACCINE GIVEN BETWEEN 11/98-10/99 (5 OUT OF SERIES OF 6) CANCELLED BEFORE 6TH  COULD BE ADMINISTERED.  CONSISTANT WITH DOCUMENT DESCRIBING ADVERSE REACTIONS FOR THE ANTHRAX VACCINE.
The patient developed a high fever, flu like symptoms, aches, nausea and sinusitis.
Urticaria/ hives developed about 15-20 mins after administration of DTap, IPV, MMR vaccine. plus eye, facial swelling, itching spreading to entire body.
Spontaneous Urticaria (hives) all over body. Severe rash and itching with no previous sensitivity or reactions prior. Rash seems to appear randomly and will move around the body without warning. It is aggravated by heat.
felt like broken shins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt like broken shins".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 82 y.o. male with history of DM2, HTN, HLD, COPD, prior DVT, prior lower GI bleed presented to the Medical Center as a transfer from another facility with COVID 19 infection and atrial fib/flutter with RVR.   Acute respiratory failure with hypoxia COVID-19 Severe Sepsis (POA) Date of onset of symptoms: 1/6/23 (+) test on 1/9/23  Special isolation end date: 1/16/23 Met SIRS on admission; presumed viral Vaccinated, boosted (last booster >1yr ago) O2 needs; RA on admit, has needed HFNC since -- did briefly tolerate oxymizer on 1/21 Medical therapy: decadron (last dose 1/19) IV lasix changed to oral Pulm started another course of steroids on 1/22, currently on a wean and plan to taper down over next 5 days on discharge.  Home O2 eval- qualified and staff assisting in arranging home O2.    A flutter RVR History of PAF s/p watchman Tachycardia, 140s  EKG with A flutter RVR  H/O ablation 2014 for PAF Echo repeated; moderate LVH, normal EF,mild pHTN  Weaned off cardizem gtt  On metoprolol and amiodarone Continue eliquis   HTN BP stable Continue increased dose of metoprolol Hold home valsartan/hydrochlorothiazide 2/2 AKI, resume outpatient after PCP follow up if needed Diuresis as above   NIDDM2 Hold home glyburide  Cover with SSI, lantus Lantus decreased further due to low glucose   AKI on CKD Baseline Cr around 1.3 Cr 1.8 on 1/13 Improved, Cr 1.2 on 1/28
chills started around 9:45pm lasting thru the night, also developed a fever and headache.  Felt very fatigued till about 2:30pm on 5/26/2021