chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine was administered outside of the clinic - reported by patient   ACUTE RESPIRATORY FAILURE 6/29/2021 ANEMIA DUE TO ANTINEOPLASTIC DRUG  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/30/2021 ANEMIA DUE TO ANTINEOPLASTIC DRUG  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/29/2021 ANEMIA DUE TO ANTINEOPLASTIC DRUG  ACUTE RESPIRATORY FAILURE 6/29/2021 MALIGNANT PLEURAL EFFUSION  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/30/2021 MALIGNANT PLEURAL EFFUSION  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/29/2021 MALIGNANT PLEURAL EFFUSION  ACUTE RESPIRATORY FAILURE 6/29/2021 ABNL CERVICAL PAP  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/30/2021 ABNL CERVICAL PAP  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/29/2021 ABNL CERVICAL PAP
PT RECEIVED EXTRA DOSE OF TETANUS CONTAINING VACCINE . PREVIOUS DOSE OF TD GIVEN 9/27/21
fever 101.9F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101.9F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (fever 101.9F). At the time of the report, PYREXIA (fever 101.9F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: (High) 101.9F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 10 year old male with no medical history who on 14-APR-2000 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 632370/1462J). Secondary suspect therapy included a first dose of MMR II on 14-APR-2000. The two vaccinations were given in different arms. On 28-JAN-2009 the patient experienced chickenpox. The patient came into the physician's office to be diagnosed. No relevant lab tests were performed. It was reported that they are unsure if the patient will be getting the booster of VARIVAX (Oka/Merck). As of 05-FEB-2009, the patient's outcome was unknown. This is one of several reports received from the same source. The patient's sibling also experienced an adverse event following vaccination (WAES # 0902USA00865). Additional information has been requested.
Rapid heartbeat; had hearing problem; Very fatigued and weak; Very fatigued and weak; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (Rapid heartbeat), ASTHENIA (Very fatigued and weak), HYPOACUSIS (had hearing problem) and FATIGUE (Very fatigued and weak) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included AFib (She also has a history AFIB).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Very fatigued and weak). On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heartbeat), HYPOACUSIS (had hearing problem) and FATIGUE (Very fatigued and weak). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Very fatigued and weak), HYPOACUSIS (had hearing problem) and FATIGUE (Very fatigued and weak) outcome was unknown and HEART RATE INCREASED (Rapid heartbeat) 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. No concomitant and treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up was received on 23-APR-2021. Additional event- hypoacusis added.
Patient came to clinic for flu vaccine. Pt qualified for Fluzone High Dose Influenza Vaccine. Patient checked in correctly per protocol, patient consented for vaccine and filled out consent correctly per protocol. Vaccine prepared correctly and labeled correctly per protocol. (COVID/Flu Clinic Supervisor). Ordered vaccine correctly and handed consent to MA and had MA repeat back order to verify correct vaccine was being given. MA went to do a task by his work station . MA had left Pfizer-BioNTech vaccine on work table.  MA administered COVID-19 Pfizer Bio-NTech vaccine in left deltoid. Patient received COVID-19 Vaccine in ERROR. Patient notified. Patient was educated about vaccine and all questions answered. Patient given vaccine information handout. Patient received  COVID-19 vaccine. This was her 4th dose. Previous doses and lot numbers 02/03/2021 EL9269, 02/24/2021 EN6203, 08/23/2021 FC3183. All vaccines were Pfizer-BioNtech. This fourth does was FF2587.  Patient was observed for 60 minutes for adverse side effects, no adverse side effects detected or reported by patient. Patient was discharged in stable condition. Patient instructed to RTC or the ED if any questions or concerns. Medication error reported to Pfizer Manufacturer. Pfizer did not have current data or research regarding fourth dose administration. Medical director made aware. Rendering Provider made aware. No further actions or orders received by medical for that patient. Supervisor made aware. Director of Operations made aware.  Plan for process improvement in place.
On 11/19 I started with a patchy rash. It is transient, showing up in different parts of my body and each latch disappearing after a couple hours. It is intensely itchy, flat, red. If I scratch, it swells. I was seen by walk-in care twice and prescribed prednisone which reduced but didn't resolve symptoms. Then I saw an allergist who determined it to be dermatographia urticaria. He had me start Zyrtec four times daily, famotidine 40mg twice daily, hydroxyzine 25mg. Symptoms improved but did not stop. I had follow up three weeks later. He said that blood testing did not indicate a specific allergen factor and could not determine etiology of continued rash. He continued the prior regimen of meds and added singulair once daily on 1/6/22. Symptoms have improved but not completely resolved. Now as each dose of Zyrtec wears off I start to have small red, itchy areas but much less intense itching and no swelling.
Immediately after my vaccine I became disoriented and had to sit down for about 30 minutes. Felt bad that night and woke up in the middle of the night with a bad headache. I took Tylenol and it helped a little. Two weeks later I started getting Vertigo, it was so bad I could barely function. It's lessened over time. Now I get these episodes every couple of months. It's still off and on.
patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.  The date of refrigeration of the vial was 19-Aug-2021.
This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. On an unkown date the patients was vaccinated with the first dose of M-M-R II (lot # not reported) (dose and route not reported). The reproter reported "they did not feel well after receiving their 1st dose of M-M-R II". The outcome of the event was unknown. Causality assessment was not provided. It was unknown if the patients sought medical attention. Additional information is not expected.
Right when I received the vaccine, I got nauseous and a headache that was like a migraine.  I felt immediately felt sick and tired.  The next day I had chills, headache, loss of appetite, very fatigued.  I continued feeling worse and had body aches.  I lost my voice a little bit.  As of today, I still have barely any energy and I cannot quench my thirst.  I have not had an appetite, either.
There was no concomitant medication. On 06/01/1999 the pt broke out in varicella with 15 lesions. There was no fever associated with her rash. Follow up states on 08/21/2000 the patient again broke out with chicken pox. About 30-40 lesions were noted. Subsequently the patient recovered. No further information is expected.
Rash over entire body, including face.  No fever.  Therapy: watch for fever and other worsening symptoms
Some arm pain first couple of days on arm of injection, gradually getting worse until severe deltoid bursitis with pain down the arm, across the chest, across the back, up the left side of the neck.  Also uncontrollable jaw contractions.  All of this for about 13 days.  After  that, much milder bursitis pain and arm and body involvement, but jaw contractions still present and now causing bad headaches through day 15....ongoing.
Case number PHEH2015US019859, is an initial spontaneous report received from a pharmacist on 02 OCT 2015. This report refers to a 61 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
7 days after vacation a large goose egg 6 inches across arm and 3inches length. Extremely hard goose egg formed at injection site. Felt no pain at time of shot or days after until 7th day. I took Benadryl and swelling subsided.  Took 5 days to fully go away. Swollen lymph nodes and swelling in arm. I am extremely hesitant for my 2nd vaccine. I do not want to experience this pain and rash again.
Pt was a healthy and developmentally normal 6 month old. She received her regular 2, 4, and 6 month vaccinations. She had no immediate reactions to any vaccines. Her last set of vaccinations was 7/27/20.  She was in her usual state of health until 8/12/20 when she acutely developed seizures that progressed into status epilepticus and encephalopathy.  She was also found to be febrile and hypoglycemic on presentation. She spent about two weeks admitted and required multiple different anti-epileptic agents to combat her seizures.  She has not had any further seizures since that hospitalization.  She is improving but now carries a diagnosis of cerebral palsy and significant developmental delay.    All work up (infectious, metabolic, genetic) has essentially been unrevealing/undiagnostic thus far so etiology is unclear.  Neurologist favors infectious/viral etiology, but no pathogen was identified.   It is unclear whether vaccinations were related to these events or not but given lack of known etiology, cannot completely exclude the possibility.
This case was reported by a physician and described the occurrence of sweating in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). On 21 September 2011, within 2 weeks of vaccination with FLULAVAL, the subject experienced "profuse" sweating. At the time of reporting the event was unresolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported administering over 100 flu vaccinations and had 8 subjects report very unusual adverse events. This is case 2 of 8 (see case IDs A0946057A, A0946062A, A0946073A-A0946077A) for details of the other reports).
Erythema, swelling and blisters at injection site. Swelling entire upper thigh, warm to touch.
Patient became very diaphoretic shortly after receiving vaccine with lightheadedness. Patient passed out. Ammonia inhalent was used. Ambulance was called d/t patient going in & out of consciousness. Patient was transported to ED.
Mid-morning the day after the injection (3/25/21), I noticed slight swelling and moderate tenderness in my underarm area on my left side.  By this morning (3/26/21), the swelling is about as large around as a softball and is very tender.  That seems to be my only side affect.
Started with pain in arm of injection site moved throughout whole body; Brain fog; Felt like flu; Headache; Light headed; Feverish; Started with pain in arm of injection site.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. 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 29Mar2021 at 10:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 20:00, the patient experienced pain in arm of injection site, moved throughout whole body and felt like flu. It had been 5 days since the 2nd shot and the patient was still feverish and had headache, was light headed, and what google described as brain fog. It appeared to be diminishing slowly but the patient still felt it. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events started with pain in arm of injection site, started with pain in arm of injection site moved throughout whole body, felt like flu, feverish, headache, light headed, and brain fog were resolving at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd 2nd dose of Engerix-B & exp muscle pain, joint tenderness, always tired, feels hot, muscle weakness, & exhaustion; fatigue, crushing pain in rt elbow & gradual spread of deep aching pain from neck to feet to present;
Diagnosed with Bells Palsy at ER.  Treatment was 60mg prednisone once daily and 1gm Valacyclovir 3 x a day both for 7 days.  Bells Palsy cleared up within 12 days but while being treated for bells palsy head pressure and pain occurred and was diagnosed with a sinus infection.
Patient verbalized feeling "fast heartbeats and tingling in the feet" immediately after receiving the vaccine. Patient denied experiencing similar reaction to previous doses of COVID vaccine. Patient's vitals checked, BP=140/64, HR=79, SPO2=99%, RR=18 non-labored. Patient was advised to relax, take deep breaths and take her time until she feels better. Anaphylactic shock kit was brought near the patient. Team lead and managers attended to the patient. Patient verbalized feeling better after a few minutes, was able to walk independently to the post vax observation area, accompanied by manager.
hand shaking; eye twitching; he couldn't write normally; caller was confused; He panicked; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER6207) at the age of 68 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Blood sugar" (unspecified if ongoing); "heart attack and stroke" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN taken for blood pressure measurement, start date: 2004. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Mar2021, for COVID-19 Immunization, reaction(s): "shaking of hand".  The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "hand shaking"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "eye twitching"; DYSGRAPHIA (non-serious) with onset 2021, outcome "unknown", described as "he couldn't write normally"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "caller was confused"; PANIC REACTION (non-serious) with onset 2021, outcome "unknown", described as "He panicked".  No follow-up attempts are possible. No further information is expected.
She started having nasal congestion, mucus and coughing. We thought it was allergies that got progressively worse on Sunday. We took her to the doctor on Tuesday because she had started coughing up wads of gunk. After examination the doctor said she was not sure if it was a delayed reaction from the vaccine. She was prescribed SINGULAIR and we were told to use her albuterol nebulizer to help clear her lungs.
Patient was given an expired Moderna Booster vaccine on 02/23/22 while patient was having dialysis treatment on the machine. Patient did not have any adverse reaction after medication was administration. Moderna Booster vaccine expired on 02/22/2022 @ 6:30pm.
Note:Tested positive to CV19 27th October 2020 Pharmacy.  CV19 Symptoms: High fever and fatigue.  No loss sense of taste and/or smell.  No breathing problems. 5th February 2021 Pfizer 1st dose CV19 vaccine.  Scary symptoms started in grocery store parking lot around 6PM (after vaccine at 8:35A) my legs felt like they were partially paralyzed and I would not be able to walk to the car.  I struggled to walk.  Got home and laid down.  Thought it was side effects to vaccine and it would pass if I went to sleep.  Woke up and felt totally paralyzed and it required a lot of effort to turn on my side to try to reach my phone.  All my muscles and joints ached.  I am never sick and not a complainer.
Initial report received from a healthcare professional on 26 SEPTEMBER 2012. A female patient who was born on 27 NOVEMBER 1958, which unknown medical history, had received dose of FLUZONE (site, route, and lot no. unknown) on an unknown date. On an unknown date, the patient swelled up for 06 days and was seeking form medical attention and physical therapy. Lab investigations and corrective treatments were not reported. The patient's outcome was unknown. List of documents held by the sender: none.
Patient called pharmacy 6-29-21 at 2:15PM.  Patient states she has been having chest pain. difficulty concentrating, and dizziness today.  Advised patient to go to the Emergency Room due to chest pain.
This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 59267-1000-01) via an unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 49-year-old), as a single dose for COVID-19 immunization. The patient medical history included trigeminal neuralgia, depression, high blood pressure, overweight and allergy to ginger. The patient past historical drug included hydrocodone (MANUFACTURER UNKNOWN). Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN), thyroxine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) all started since an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 14Mar2021 at 13:00, the patient experienced headache, sore joints, chills, sweats, and extreme tiredness. The patient reported that what she had weren't adverse, but she wanted to let us know of side-effects she had. The patient reported that she was still having sweats and chills. But the others were gone. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The patient did not receive any treatment for the events. The clinical outcome of the events headache, sore joints, chills, sweats, and extreme tiredness were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 25 year old male patient. No concomitant medication or pertinent medical history reported. On 09-MAR-2016, the patient was vaccinated with his first dose of GARDASIL 9 lot # L017407 exp. 15-AUG-2017 (dose, site and route of administration were not reported). On 11-MAR-2016, the patient began to experience "waves of dizziness" and pain in his temples bilaterally. On 19-MAR-2016, the patient sought medical attention at an unspecified urgent care clinic, who referred him to the emergency department. The patient received REGLAN, BENADRYL, unspecified intravenous fluids and ketorolac, with unspecified results. On 19-MAR-2016 lab diagnostic studies included: Blood test with results: "unremarkable" or within normal limits. Computerised tomogram (CT scan) with results: "negative" or within normal limits. Emergency department assessment with results: no abnormalities were identified. On 21-MAR-2016, the patient was still experiencing dizziness and headaches. On 21-MAR-2016, the physician, who was examining the patient, stated that the patient reported that his sinuses felt "stuffy," but he was not experiencing vertigo or nystagmus. The physician reported that the patient was afebrile, normotensive, and his neurological assessment was within normal limits during exam on 21-MAR-2016. The patient was in the physician's care at the time of this report. The outcome of the events was reported as not recovered/not resolved at the time of the report. The relatedness between the adverse events and the suspect therapy was not reported. Additional information has been requested.
After patient was administered the second dose of TWINRIX, she began to have pain in her left arm. She stated that her arm was sore the same day and the pain began to move down her arm and to her elbow. She has been having pain and weakness in her left arm since the vaccination and states that she is not able to lift things with her left arm. She states that after sleeping, when she wakes up and tries to stretch her arm out, the pain is severe. She also states that her arm hurts constantly throughout the day, especially in her bicep to her elbow. She states that her arm tingles and is numb at times.