chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach infection; This spontaneous case was reported by a physician and describes the occurrence of GASTRIC INFECTION (Stomach infection) in a 68-year-old 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.    No medical history was provided by the reporter.  Concomitant products included CALCIUM, VITAMIN D3, GABAPENTIN, OMEPRAZOLE, DICLOFENAC, METHOTREXATE SODIUM, METOPROLOL TARTRATE, LOSARTAN POTASSIUM and SIMVASTATIN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In January 2021, the patient experienced GASTRIC INFECTION (Stomach infection) (seriousness criterion medically significant). At the time of the report, GASTRIC INFECTION (Stomach infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: normal (normal) No infections found in body. On 19-May-2021, Blood test: inconclusive (Inconclusive) Inconclusive.     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.   At end of Jan 2021, the patient had stomach infection around the time she got the first Moderna Vaccine.  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-216522 (Patient Link).; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
I have a flu shot through the system of flu clinics.  I had a very severe reaction including fever, vomiting, yellow discharge from the eyes, spasmodic coughing and coughing up white blobs of mucous.  Shot was administered approximately 9:15 a.m. on 10/27/08.  The effects started about 2 hours after shot was administered and ended enough to allow sleep at 2 a.m. on 10/28/08.  Today, 10/28/08, I felt well enough to drive and eat and do some grocery shopping.  I am concerned about long-term effect of this awful experience.  I was not treated for this but just stayed in bed until the problem subsided.
Advised by the local authority that Pfizer Covid Vaccine adminstered was stable based on manufacturer but was not stored in accordance of approved guidelines. Patient's are not recommended to be revaccinated  241  patients were effected
sore arm; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (Vaccination site pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010mz0a and 039k20a) for COVID-19 vaccination.     Concurrent medical conditions included Vegetable allergy (Shrimp).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant product was not provided by the  reporter                                                                                          The patient had numb check from the first dose reaction, the patient had second dose reaction of sore arm the day after the shot.    This case was linked to MOD-2021-159363 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-JUN-2021 contains No New Information
Extremely high sugar levels; Shortness of Breath (am COPD to begin with); flu-like symptoms; Malaise; Chills with no fever; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EN6198, expiration date not provided) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 02Mar2021 at 08:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The medical history included chronic obstructive pulmonary disease, diabetes mellitus, coronary artery disease, and reaction to preservatives (known allergy: Food sulfites (MSG)) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9269) administered in Right arm on 12Feb2021 at 08:00 AM for COVID-19 immunization. There was no COVID prior vaccination reported. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. On 03Mar2021 at 03:30 AM the patient experienced extremely high sugar levels, shortness of breath, flu-like symptoms, chills with no fever and malaise. It was reported that extreme onset of flu-like symptoms almost 20 hours after shoot. Chills with no fever. Shortness of Breath (am COPD to begin with). That relaxed after about 12 hours, but SOB continued. General malaise continued for a few days. Extremely high sugar levels persisted for a few days, readings over 500 and once even over 600 which is rare for me (diabetic). The patient underwent lab tests and procedures which included blood glucose increased: 500 (over 500) and blood glucose increased: 600 (over 600) on 03Mar2021. No treatment was received for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Induration post vaccination with ZOSTAVAX increased induration in 24 hrs from 5 x 3.5 cm to 8 x 7 cm. Red, very warm, swollen, painful and itchy.
pt seen @ ER on 10NOV96 by MD for rash & hives;pt recv vax 6NOV95 & MD stated pt has hx of asthma & is on inhaler;pt given ATB for cold sx 8NOV95;grandma states pt had one dose only but does not believe the rxn was from ATB;
Clinical Summary A 73 y.o. female with a history of ILD on chronic steroids, Sjogren's syndrome, iatrogenic Cushing's disease, anxiety and depression who presented to hospital 10/5/2022 with dyspnea and hypoxia SAT level 79% RA, CTPA showed multilobar ground glass opacities consistent with inflammatory or infectious process. COVID-19 negative initially then repeat 10/08/22 positive. Patient received empiric antibiotics, IV steroids, and Remdesivir with minimal improvement in hypoxia. She developed severe esophagitis with poor PO intake on chronic malnutrition. She also experienced acute RLE limb ischemia. Pulmonology, GI, peripheral cardiology, and palliative care followed. She was eventual changed to a DNRCC and was discharged.   1. Acute on chronic hypoxic respiratory failure: Suspect ILD exacerbation, complicated by COVID-19 infection, less likely bacterial process. CTPA showed multilobar ground glass opacities consistent with inflammatory or infectious process, RA sat 79%. Worsened clinically 10/07/22 and progressed from NC to HHF. Completed 5 day course of empiric Rocephin/Azithromycin 10/10/22. S/p IV solumedrol, switched to PO prednisone 10/12/22. Failed attempt at nasal oxymizer 10/12/22, successful on second attempt 10/14/22. Transitioned to DNRCC 10/15/22 given additional co-morbidities below. Symptom management per hospice. 2. Esophagitis: Concern for candida esophagitis given thrush and high dose steroids, possibly erosive given high dose steroids. GI consulted, recommended IV PPI BID and IV Pepcid. Symptom management per hospice. 3. Acute RLE limb ischemia: Patient noted pain and discoloration of RLE toes. ABIs with severe PAD. Peripheral cardiology evaluated, suspected embolic, poor candidate for intervention. Symptom management per hospice. 4. Hypercalcemia: Secondary to TUMS use. Initiated TUMS for above, patient/family requesting more, discussed risks of hypercalcemia. Notified that husband was also giving TUMS from home. Discontinued TUMS order and re-educated patient/husband. iCal improved with IVF. No further lab draws given goals of care. 5. COVID-19 pneumonia: COVID-19 initially negative but repeat 10/07/22 positive. Steroids as above. Completed Remdesivir 10/12/22. Pulmonology followed. 6. ILD: diagnosed 2019, follows with Dr. has been on chronic Prednisone 10 mg daily, was started on Dapson for prophylaxis 2020 but not taking now. Continued high dose steroids per pulmonology.  7. Sjogren's syndrome: mild, no specific organ involvement.  8. Anxiety and depression: continued home meds.  9. Thrush: Oral nystatin started 10/10/2022  10. Underweight/Severe malnutrition present on admission: BMI 16.19, patient denies anorexia. PO diet as tolerated, doesn't like any of the available protein supplements. Dietician followed. Patient and family decline artificial nutrition given goals of care.
Redness around injection site, approx 3" in diameter.Pt also has itching of arm.
50-year-old female patient c/o dizziness, feeling faint and racing heartbeat 10 minutes after her 1st dose of the Pfizer vaccine. Staff member notified on-site EMS and NP. Patient was placed in wheelchair and escorted to the triage area to be evaluated.  Patient continued to state her heart was beating too fast. Patient denies nausea, SOB or headache currently. Patient stated she had not taking any of her medications prior to coming in for the shot. Patient was placed on a cardiac monitor and EKG initiated. VS= 160/95, 105, 22, 99% o2. EKG (NSR) Patient has PMH of Hypertension and Anxiety. NKDA. After about 15 minutes, patient was reevaluated by NP and EMS. VS= BP 159/92 90, 18 99%02. Patient stated she was feeling better and agreed to allow her husband to drive her home. Patient was discharge home in stable condition.
muscle spasm type reaction w/screaming, tight clenched fist-assoc w/fever to 102, lasting 5 mins; 9AM evening following 2nd DTP had afebrile seizures, treated w/Valproic also has hypopigmented macules;
Chills and Muscle aches Started about 18 hrs after the shot. Muscle Aches, Chills and Fever for the next 12 hours. Overnight aches continued with Nausea and hard to sleep. After relaxing the next day...roughly 48 hrs after getting the Vaccine, All symptoms were gone. The next day I developed a considerable amount Fever Blisters around my whole mouth. They are finally under control 1 week later. I hope this helps.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX and developed erythema going down her arm from the injection site approximately the size of a softball. The reported batch number of SHINGRIX B5EKZ did not exist and was updated to B5EK2 as per sales data sheet.
Mom reporting rednes/swelling (lg area)/pain/site warm to touch. Giving Tylenol X1 dose which has helped with the pain. Advised to apply cool compress and give Tylenol Q 4 hrs. Followed up with parent 4/8/2010 at 9:30 AM, Mom reporting swelling/redness/pain has decreased and only giving Tylenol BID. Sending child back to school. Advised to keep monitering.
Possible powder reconstituted with another diluent; Possible powder reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 424JG, expiry date 28th July 2023) and (batch number FA95N, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The reporter was clinical coordinator.  The reporter stated that they had found 3 vials of Shingrix diluent and were doing an investigation, was unsure if three patients were given the powder reconstituted with another diluent.  The reporter had asked if there was any safety information provided or any harm to the patient.  The reporter had asked what he could do for it. The reporter was unsure and did not had a specific person/patient involved at that moment due to Healthcare professional investigating back from 15th August 2022 to 29th August 2022. The permission for consent to follow-up was denied. Additional Supportive Information: The patient was given the powder reconstituted with another diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2022135794 and US2022135797 reported by same reporter.; Sender's Comments:  US-GSK-US2022135794:Same reporter US-GSK-US2022135798:Same reporter
Starting 2/6/22, hives, itchiness, skin sensitivity/pain appeared all over body, including scalp, face, neck, chest, torso, arms, hands, and legs. Experiencing the feeling of a "pill stuck in throat" and heat in ears. Started taking Benadryl and Pepcid to help relieve itchiness and pain, but haven't seen any changes.
Following 1 week of the normal symptoms, 2 weeks of weakness, muscle pain and mild depression.
Severe headache and bodyache, fever with chills and sweating (not sure how high fever was), dizziness, weakness, hoarseness, slight sore throat, dry mouth. Moderate to severe symptoms lasted 5-6 hours. Mild symptoms lasted 24+ hours. 1000 mg acetaminophen helped symptoms. I did not have any rash or swelling at injection site, just minor tenderness. I had a flu shot 2 years ago with no adverse reaction.
pt recv vax 24FEB96 & 2 days post vax pt devel a feverish & sick feeling;
dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer of larynx extrinsic (excl vocal cord) (Vocal cords cancer).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (dry mouth). At the time of the report, DRY MOUTH (dry mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.  .   This case was linked to MOD-2021-245824 (Patient Link).
I started having a headache and felt listless and tired. body aches. lack of appetite. fever of 100. took a tylenol. I woke up at 5am the 10th and I was shaking and having chills and I was hot and cold... I was dizzy and my eyes hurt. My arm was hurting. I took another tylenol. at 6am I called my NP daughter for advice and she told her it was a reaction of the vaccine. my fever was 102.5. I was advised to take more tylenol and to rest. the fever broke later that morning but I was still experiencing those side effects. 3 days later I'm still not 100%.
Diagnosed with shingles; began to experience the development of a painful rash; blisters on body, specifically chest area; Difficulty breathing; nerve pain; Permanent skin markings; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings) and HERPES ZOSTER (Diagnosed with shingles) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings) and RASH (began to experience the development of a painful rash). On 04-Jul-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at a dose of UNK dosage form; PREDNISONE for Adverse event, at a dose of 20 mg once a day and LIDOCAINE (LIDODERM) for Adverse event, at a dose of UNK dosage form. At the time of the report, BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings), HERPES ZOSTER (Diagnosed with shingles) and RASH (began to experience the development of a painful rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. The treatment medication included OTC sprays for unknown indication. The patient visited an urgent care for treatment on 04 Jul 2021, she was diagnosed with shingles, and prescribed medications. Patient claimed she is not immunocompromised and had no other health conditions       Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Event outcome updated to not resolved. Urgent case visit and indication for treatment medication was updated.
Headache, Myalgia, NauseaVomiting, chills, fatigue
soreness lt arm, neck stiffness, back pain, headache, nausea/vomiting 1st2-3 days, fatigue, no appetite, knot @ inject site lt arm;
temporal arteritis/severe headaches, dyspnea, chest pain, near syncope. Pt has been hospitalized several times with neg work up, but continues to have chronic dyspnea on exertion, fatigue/weakness, chest pain, near syncope, HA, visual changes
Patient experienced rash and swelling from the injection site to the elbow. Also experienced nausea and upset stomach the first night; symptoms resolved within three days after the immunization was given. Patient was not deterred from receiving the second vaccine, stating that it was better than having shingles.
From initial information received on 07/28/03 from a physician regarding an adverse event occurring in the USA, it was reported that a five and a half year old female pt received at DT ADS PSD USP vaccination, Lot # U0746AC, route and site of administration unknown, on an unspecified date. Five minutes after receiving the vaccination, the pt experienced a vasovagal response. The pt was placed on a bed with her bead in a downward position and was given oxygen. It was reported that the pt recovered nicely and was sent home. The reporter of this case is the same reporter of case  2003-01479.
my joints are aching so bad; I can't even sleep; This case was reported by a consumer via (Shingrix GSK Chatbot ) interactive digital media and described the occurrence of joint pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced joint pain and sleeplessness. On an unknown date, the outcome of the joint pain and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and sleeplessness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient got his/her second shingle shot on Thursday evening. The patient had a bunch of side effects and right now patient could not even sleep because joints were aching so bad. The patient was asked how long these side effects normally last. The patient consent to follow up was not asked.
Patient was given .5ml of Moderna vaccine instead of .25ml, for 2nd covid booster. No adverse reactions reported.
SHINGRIX provides better protection against Shingles than ZOSTAVAX.; This spontaneous report was received from a male patient of unknown age referring to himself. The patient's concurrent condition, pertinent medical history and concomitant medication were not reported.  In 2018 (reported as approximately 2-3 years ago), the patient received one dose of a shingles vaccine that he believed was zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) shot in the arm for prevention of shingles (prophylaxis), however, the patient could not confirm the brand name of the vaccine at the time of the call.   On 21-JUL-2021, the patient received first dose of varicella zoster vaccine rge (cho) (SHINGRIX). The patient decided to receive varicella zoster vaccine rge (cho) (SHINGRIX) in addition to his vaccination with zoster vaccine live (ZOSTAVAX) due to the fact that "varicella zoster vaccine rge (cho) (SHINGRIX) provided better protection against shingles than zoster vaccine live (ZOSTAVAX)" (drug effect less than expected). The outcome was not reported. The causality assessment was related.
Patient began to feel sick (cough, aches, chills) 1 day after his vaccine, and then 2 days after began to have intractable shortness of breath and chest tightness that required hospitalization for an asthma exacerbation