chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning an 84 year old female with an allergy to penicillin, vancomycin and gentamicin. On 10/19/05, the pt was vaccianted with Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included metoprolol succinate Toprol XL tablets, alendronate sodium and cyclobenzaprine HCL. On 10/19/05, the pt developed from the injection site to the elbow, her arm was red, swollen and very warm. The pt sought unspecified medical attention. There were no lab diag studies performed. At the time of this report, the pt had not recovered. from the events. Additional information has been requested.
Moderna Covid-19 Vaccine EUA    Arm pain at injection site, body and joint aches , chills, fever to 102.5, severe headache
patient called stating her mouth was dry and tongue was dry and she felt dizzy upon walking--after further talking with patient, she had only eaten a banana all day.  I told patient she probably not eaten enough today nor drank enough liquids.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 11-NOV-2013, the patient was vaccinated with PNEUMOVAX23 lot # J007786 (expiry date: 25-SEP-2014), intramuscularly. No concomitant medications were reported. On 12-NOV-2013, the patient experienced injection site reactions. The reporter also reported that 3 other patients also experienced injections site reactions following the vaccination with PNEUMOVAX23. The patient sought medical attention and contacted the pharmacist. The reporter described reaction as red swollen upper and lower arm at the injections site. Approximately on 17-NOV-2013 (reported as within 5 to 6 days), the patient recovered from the event. Causality was not provided. This is one of the four reports from the same source. Additional information has been requested.
Initial consumer report received on 19 Jan 2010: This patient with a history of hypertension was vaccinated with FLUVIRIN, Lot number 104041P1. Shortly after the vaccination the patient experienced injection site pain and became dizzy, for which he took ADVIL and kept ice at the injection site. On the morning of 16 Jan 2010, the patient experienced a scratchy sore throat, swollen glands, headache, fatigue, decreased appetite, nasal congestion and muscle aches. The patient treated his symptoms with bed rest, TYLENOL and Aspirin and ADVIL. The patient was taking AVAPRO for mild hypertension. The outcome of the events was that the patient felt much better, but symptoms, although milder still continue.
Patient presented with hematochezia and bright red blood per rectum. Platelets were severely down to 1k. This was about 2 weeks after receiving the moderna COVID-19 vaccine first dose. Patient also with extensive ecchymosis on upper extremities and petechial rash on legs. Concern for ITP related to the drug. Patient received IVIg, Platelet transfussion, and steroids. Platelets slowly increasing, patient received NPLATE. The patient remains hospitalized with platelets up trending from 1--- >4--- >6--- >5--- >9--- >11.
redness & swelling 3inches x 1 1/2inches diameter, hot, arm sore to move;
pt recv vax &  exp macular pap rash both thighs;seen by MD 18NOV96;
Fever, chills, headache,  body ache, sore arm.  Worse symptoms than shots 1 or 2.  Lingering symptoms of nausea and lightheadedness from the first 2 shots.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non- health care professional office staff. This case involves a 63 years old male patient and reported that employee administered FLUZONE HIGH DOSE to a 63 year old patient, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if the patient had any adverse event. 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.
Information has been received from a pharmacist concerning his friend's daughter who on unspecified date was vaccinated with a dose of GARDASIL (lot# not reported). After she got the vaccine while she was waiting at the physician's office she experienced seizure. Couple days later she experienced lost of short term memory. At the time on the report on 17-JUN-2009 the patient had not recovered. Upon internal review, seizure was considered to be an Other Important Medical Event. No further information is available.
4/24/21 - low grade fever, chills, body aches, joint pain, fatigue, 4/25/21 - low grade fever, chills, body aches, joint pain. fatigue, 4/26/21 - swollen left arm pit lymph nodes, fatigue, 4/27/21 - swollen left arm pit lymph nodes, fatigue, 4/28/21 - swollen left arm pit lymph nodes, fatigue, 4/29/21 - feeling better and tried a little workout, 4/30/21 - chest pain begins, mostly left-hand side, when I breathed deeply, fatigue beginning, 5/1/21 - chest pain increases, breathing deeply uncomfortable, 5/2/21 - chest pain increases enough that I call advice nurse to find out if need to be seen, 5/3/21 - visit Health Emergency Dept, chest pain increased, breathing deeply more painful, fatigue, 5/4/21 - chest pain increased, breathing deeply much more painful, more fatigue, 5/5/21 - found leaning forward feels better to breath. Chest pain lessens, 5/6/21 - virtual dr appt, chest pain subsiding more, by evening feeling much better, 5/13/21 - had in person follow up, here is her summary: Went to ER with pleuritic chest pain that worsened with lying supine and improved with leaning forward. Took ibuprofen and tylenol alternating and pain subsided and resolved last Thursday. Had CT angiogram and ECG in hospital, negative except mild left sided atelectasis. Occurred after booster of COVID-19 vaccination. Breast cancer patient on tamoxifen. No ST elevation on ECG.
Information has been received from a RN concerning an 11 year old male who was vaccinated "on the usual schedule" with a first and second dose of MMRII. On approximately 09/06/03 the pt was seen in the physician's office with what appeared to be mumps. It was noted that the pt had a possible exposure one week ago. A titer was obtained on 09/06/03, but results were not available as of this report. It was unknown if treatment was required. Follow up information was received on 10/28/03 in which a RN reported that it was determined that the adverse event filed was not due to the MMRII vaccine, but due to a virus. Additional information is not expected.
vaccine given to person under 18. no adverse as far as i am aware, just reporting the error
Complete paralysis. Guillain Barre diagnosis. Ventilator dependent respiratory failure. Cardiac arrest. Urinary incontinence. Dysarthria.  Dysphasia. Gait abnormality. 18 day trauma ICU hospitalization.
About 8 hours after shot had headache and bad chills. Was in bed for about 12 hours. Woke with back pain and even teeth seemed to hurt. I had no reaction ex a sore arm from the 1st shot.
Red rash around injection site around 10 days after vaccination (approx. 1 1/2 inches in diameter). No pain, itching, or swelling, and not bothersome.
I contracted COVID-19 on 06/05/2022 with symptoms of fever, chills, headache, nausea, cough, sore throat, loss of taste, loss of smell, and muscle aches. I was not prescribed any medication or treatment due to my overall health and age. I was ill for 6 days before my symptoms began to resolve. I was ill for 14 days before I fully recovered. I am fully recovered with no lingering symptoms.
Fatigue; A spontaneous report was received from a healthcare professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, fatigue was unknown.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 02-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours excursion. This lot number was received on 08-APR-2015. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Patient experienced feeling dizzy, woozy, chest tightness, she was flushed and had trouble breathing immediately after the shot.  She sat for 30 minutes waiting for it to subside.  She was still flushed when she left the pharmacy
I was 36 weeks and 5 days pregnant at the time I received my 2nd dose of the Moderna vaccination. This is my 2nd pregnancy, both low risk, and my due date is June 21. I have been monitoring my blood glucose regularly as I failed the glucose tolerance test but have had no problems with high blood glucose levels and do not have gestational diabetes. My normal BP during this pregnancy has been in the 90-100/50's-60's range. I got my 2nd vaccine on May 29 around 9:15 am, by 9:21 I suddenly got a strong feeling as if I was about to vomit, then my heart began to pound and was racing, then I felt dizzy and light headed, then my mouth went extremely dry. I told the people at the pharmacy that I was ill and they had me sit in the vaccination room, took my blood pressure and gave me water and an ice pack. The blood pressure cuff was not the right size, but read my BP as being 117/72. After sitting for about 30 minutes I began to feel better so I went to sit in the observation area again. I waited until it was an hour after I felt sick before leaving to do shopping. I walked the store for about 30 minutes before returning to the pharmacy. I kept getting waves of nausea, heart palpitations, and dizziness and extreme dry mouth, I was feeling very lethargic. By the time I got back to the pharmacy I was begining to feel out of it and decided to call the paramedics. They took my BP again and it was 127/41. I began to shake by the time the paramedics arrived and needed help onto the stretcher to take me out to the ambulance. In the ambulance my BP was 149/85.  I began to feel better on my way to the ER, but kept getting waves of nausea/ feeling like my BP was high/dizziness with the addition of heat flashes. I told the nurses and doctor at the ER that I thought I was having a reaction to my vaccine and described what happened, but they only treated me for nausea and on my discharge papers said I was there because of nausea. They gave me anti-nausea medicine and after a few hours they gave me the option of going home or staying to get I.V fluids. I chose to get I.V. fluids and stayed a few hours longer until I felt less out of it and like the waves of sickness were less intense/ frequent. I continued experiencing waves of sickness until June 9th and spent most of that time on bed rest.
Patient received Td vaccine on 11/13/06. Next day, patient experienced shortness of breath, anxiety, pain at anterior chest wall, bilateral, and pain in left side of middle back. Patient came in to see the doctor and was advised to take over the counter Tylenol. Patient came back on 11/16/06 for a follow up visit and completely recovered.
pt recvd vax 11JAN92 & mom states aobut 4 hrs later pt awoke from sleep screaming & was unconsolable from 300 til 500; seen by 5PM & was still very much unconsolable;
Pt came in for a 3yr WCC with mother. Pt is on a delayed scheduled and mother requested to specific vaccines to be given that day. Hib and Influenza pres/free. Pt was not given flu but was given Hib. I did not verify if pt had all doses and gave pt 5th dose of Hib.
Reaction started about 5 days after vaccination. Arm become bright red down to the elbow, site was hot and painful. Went to primary doctor who considered the reaction an allergic response to the immunization. Doctor prescribed 2 prescriptions that were filled on 12-16-2020, methylprednisolone 4 mg oral tablet therapy pack and cephalexin 500mg oral tablets. The reaction is improving. It is pink, itching, and site of injection is flaky where the reaction occurred.
Patient received ZOSTAVAX vaccine on 11/11. On 11/14 patient stated her arm was swollen, red, and hard. Patient went to her physician and a prescription antibiotics (Zithromax) was given to her as precaution.
Developed full body rash about 5 days after shot. Bright red, hot, itchy splotches tarted on upper arms (symmetrical on both), buttocks, abdomen and eventually worked it's way down arms, legs and feet. Cleared up by next morning, just in time for my in-person Dr. visit. Resurfaced a few hours later before completely clearing up the following am. Rash lasted about 36-48 hrs total.
This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in left arm on 26Mar2021 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The medical history was reported as no. The patient had no known allergies. The concomitant medications included celecoxib (CELEXA), cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), acetylsalicylic acid; paracetamol; caffeine; salicylamide (EXCEDRIN) all for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The vaccine was administered at the doctors office or urgent care. On 26Mar2021 at 10:15, the patient experienced extremely dry mouth within 10 minutes of vaccine and severe chills. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events extremely dry mouth and severe chills was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received 1st moderna vaccine on 4/13/2021. He then began to have urinary issues and diagnosed with a bladder tumor on 4/29. He then tested positive for covid 19 on May1st. He got his 2nd covid 19 vaccine on 5/11/2021 and was hospitalized on 05/20 with new onset rapid atrial fibrillation and NSTEMI. He reports he was healthy with no medical problems and took no medications prior to his vaccines. A pulmonary emboli was ruled out, no history or suspicion of sleep apnea.
first dose of Shingrix on August 24, 2020/ received the second dose 10 months later; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th August 2020).   On 14th June 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The patient received the 2nd dose of Shingrix, 10 months later, which led to lengthening of vaccination schedule. The patient stated, she did not read the paper the pharmacy gave her on Shingrix and was not aware the second dose had to be administered 2-6 months after first dose. The reporter enquired if she needs to receive 3rd dose. The reporter consented to follow up.
Pt claims she has been sneezing and has had runny nose. Started about 1 week after shot. Explained to pt she may be having allergies or cold, but she thinks it might be b/c of flu shot.
Approx 3 hrs after the injection, I felt tightness in my throat like a lump, then noticed a blotchy vibrant red rash over both arms, legs, neck and shoulders. I took Benadryl, Claritin and Pepcid ( these were meds previously recommended for my daughters allergies). It took about 30 mins after the meds to be able to swallow comfortably without coughing. The rash however lasted three weeks. I has a telemedicine consult with my allergist who was hesitant to advise the second shot.
vaccination adverse reaction; Tested positive for Covid-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) and VACCINATION COMPLICATION (vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) and VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        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 provided. Treatment information was not reported.; 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. However,   the event  SARS-COV-2 test positive is unlikely related to mRNA-1273.
Normal arm soreness about hr. later - worsened at day advanced. Unable to Lift arm - Sl. Temp. 99 but felt flushed, shakey, dizzy as evening progressed. Felt miserable & not able to sleep. Noticed several welts on Left upper arm Anterior and Toward chest. No breathing problems etc. Went to Dr. (clinic) and saw available Doctor. No treatment (Just Reporting).
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of VAQTA (lots # L014068 exp date 02-NOV-2017 and L018499 exp date 25-FEB-2017) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, rash, vomiting, infection of blood, lesions of the skin, lethargic, loss of appetite.  3/2/07 Received medical records from hospital which reveal patient experienced croupy barky cough, mild low grade fever & rhinorrhea on day of vax.  Continued w/fever for next 10 days, decreased oral intake.  Itchy lesions started forming on head, then trunk & diaper area approx 2 days prior to hospital admission on 6/20/06 for observation & w/u for sepsis.  Temp in ER was 104.7.  Continued to have nasal congestion & clear discharge.  Exam revealed shotty adenopathy greater in the posterior triangles.  Well scabbed lesions of forehead, neck, thorax & diaper area.  Left thigh injection site had erythema w/vesicle overlying it & a fresh vesicle over dorsum of right foot.  D/C to home on continued antibiotics & f/u w/PCP.  Parents advised patient remains infective until all lesions crusted over. FINAL DX: vaccine induced varicella & possible streptococcus/scarlet fever.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: injection site was hard to the touch but hardness subsiding over few days, did not affect daily activities.
Soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK citrate free. On an unknown date, the patient experienced PAIN (Soreness) and FATIGUE (Tiredness). At the time of the report, PAIN (Soreness) and FATIGUE (Tiredness) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.