chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting getting the chills and shaking. I lost all energy and struggled to get out of bed and walk. Laid in bed all day, took Tylenol, slept off and on. Didn't subside until 6:00pm the next evening when I broke out in a sweat and got some energy back.
Other severe and personal injuries; Transverse Myelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient female patient of 60-year-old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified). As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2008, the pt was caused to suffered transverse myelitis including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the pt was caused to suffered serious and dangerous side effects including Transverse myelitis, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and or medications. As a result of the foregoing acts and omission the pt required or will require more health care and services and did incur medical, health, incidental and related expenses. As a foreseeable, direct, and proximate consequence, the pt suffered transverse myelitis and other related health complications. In addition, the pt required and will continue to require healthcare and services. The pt had incurred and will continue to incur in medical and related expenses. The pt had suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, an other losses and damages. The pt direct medical losses and costs included physician care, monitoring, and treatment. The pt had incurred and will continue to incur mental and physical pain and suffering. The pt was informed and believed and further alleged that pt will in the future required to obtained further medical and hospital care, attention, and services.The outcome of the events was reported as not recovered. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX)  Upon internal review, the event Myelitis transverse was considered to be medically significant. Also, the lawyer considered  Myelitis transverse and ill-defined disorder to be disabling events.
Today marks 2 weeks since my shot and my right arm is as sore as it was on day one.  It?s primarily in the right bicep I feel like muscle is getting weak.   I have iced it and taken Advil and Tylenol.  Nothing takes the pain away. Additionally the pain wakes me up from sleep.
Benadryl 25mg taken at 1620 Vaccine #2 given at 1630 Rash developed on forearms with chest tightness and "feeling strange" at 1643, temp 99.2F Throat became itchy at 1650 1654 Vitals: 119/63 MAP 81, RR 20 SpO2 98% RA, 98.2F     Lungs clear, rash has not spread as of 1654 Transfer care to ED 1656 Admitted early morning after discharge from ED due to increase in sxs. Unable to enter Hospital Name under 21. Unknown days, Hospital same as giving facility.
Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Her medical history included heart disease. The patient had no drug reactions/allergies. On 22-NOV-2013 the patient was vaccinated with a 0.5ml dose of PNEUMOVAX (lot# J004196, expiry date: 06-DEC-2014) intramuscular at left arm. No concomitant medication was reported. The pharmacist reported that after the patient received PNEUMOVAX23, she developed redness at the injections site and swelling of the "entire" injected arm on 23-NOV-2013. No treatment was given for the events. No lab diagnostics studies were performed. The patient came back into the pharmacy on 23-NOV-2013 to report this reaction. At the time of report, the outcome of events was unknown. Additional information has been requested.
a patient was administered an improperly stored ROTATEQ and RECOMBIVAX HB; no adverse events; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R021372, expiration date 25-MAY-2021 (dose and route of administration were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R030929, expiration date 23-JUL-2020 (dose and route of administration were not reported), both for prophylaxis. The vaccines had been stored improperly in temperature above 47 degrees Fahrenheit / 9 degrees Celsius (11.3 C) for 9 hours and 55 minutes. The temperature was measured with Digital Data Logger. There were no previous temperature excursions reported. No adverse effects were reported.
Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vitals taking, pt reassured, symptoms resolved within minutes
w/in 24hrs pt had bulging fontanelle,fever (time  104.4) & had sz while in ER & was receiving IV Ceftriaxone;f/o sepsis;pt had drooping rt eyelid x 2 days;hospitalized x 3days
Patient is DECEASED;  hospitalized (1.11.2022);  COVID-19 positive (1.5.22);  fully vaccinated (no booster)  Admission Date: 1/11/2022  Date of Death: 1/16/22 Time of Death:  4:37 AM Preliminary Cause of Death: Shock  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Atrial fibrillation with RVR  [I48.91] Hypervolemia, unspecified hypervolemia type [E87.70] Shock  [R57.9] HOSPITAL COURSE: Patient is a 63 y.o. female with a past medical history of ESRD on HD, COPD on 3L at baseline, OSA on BiPAP, tob use disorder, BiFV HF with diastolic dysfunction, T2DM, HTN and obesity who initially presented after missing two days of HD and was admitted with afib with RVR now with worsening lactic acidosis and requiring CRRT.    Patient was transferred to ICU service after found to be more altered and the unresponsive even to noxious stimuli. Patient intubated. Vancomycin, flagyl, cefepime started empirically. Nephrology consulted for CRRT and this was started the morning of 1/14. Patient had increasing pressor needs up to 3 pressors. Bedside echo was done by the ICU fellow and showed a largely dilated RV and possible clot present in RV and RA. An official echo was ordered stat and did not show evidence of clot but did see a vegetation on pulmonic valve. PERT was activated in case of need for systemic tPA or thrombectomy was needed. IR recommended CTA of the thorax and head first to assess for clot burden. Cardiology did not see signs of a clot either and recommended further imaging. Heparin was started for possible PE and rising Ddimer. Blood cultures grew E. Coli. Bilateral upper and lower extremity ultrasounds showed no signs of DVT. CTA of head and thorax were done emergently. CT head showed no signs of infarction. CTA thorax showed a small segmental PE in the right lower lobe. IR was contacted and they did not recommend systemic tPA or thrombectomy. General surgery consulted to assess for bowel ischemia, but based on CT A/P findings and physical exam, they did not have any intervention to benefit the patient at that time. Patient improved with increase in Epinephrine infusion. CRRT was started by nephrology and fluid removal was set to 25ml/hr in the afternoon of 1/14. Bedside echo and bubble study was performed and showed no signs of VSD but there was very poor forward flow. Veletri, duonebs were started. Peep was reduced to 5 in order to reduce RV stress. Evening of 1/15 she developed worsening acidosis and increasing pressor requirements eventually being placed on angiotensin II. She had worsening acidosis as well. She did have cardiac arrest in the early morning with ROSC after 2 rounds of compressions. At that point further discussion was had with family who were present at bedside who decided to change code status to DNR. Shortly thereafter she passed away with family around her at bedside. Official TOD 4:37am.
BLOOD POOLING AT INJECTION SITE; ADMINISTRATIVE ERROR; 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: unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAY-2021, the subject experienced blood pooling at injection site. On 06-MAY-2021, the subject experienced administrative error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pooling at injection site, and the outcome of administrative error was not reported. This report was non-serious.
Patient received extra primary dose of Pfizer Lot#: FT1551 instead of Pfizer Bivalent booster. Parents notified and informed child qualifies for bivalent dose if desired in 2-3 months from today. No adverse effects. All questions and concerns addressed.
Treatment of COVID-19; Treatment of COVID-19; Dose 1= Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Moderna, Dose 5= Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 87 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 0061N20A), on 13Mar2021 as dose 2, single (Lot number: 013A21A), on 24Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: 046L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart (bypass and aneurysm surgeries)" (unspecified if ongoing), notes: Heart (bypass and aneurysm surgeries); "Heart (bypass and aneurysm surgeries)" (unspecified if ongoing), notes: Heart (bypass and aneurysm surgeries). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Sep2022 at 11:00, outcome "unknown", described as "Dose 1= Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Moderna, Dose 5= Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine. Antiviral details: product: COVID-19 Treatment. The treatment was started on 14Nov2022 and stopped on 19Nov2022. The patient has no known allergies.
Administration error: Booster vaccine at 3 months, instead of recommended 6 month interval. Hx of Heart disease.  Pt monitored for 1.5 hours after administration, no side effects noted. VS Stable.
Redness at site of vaccine; vaccine site visibly swollen; Injection site is warm to touch; ITCHY; TENDER; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness), INJECTION SITE ERYTHEMA (Redness at site of vaccine), VACCINATION SITE SWELLING (vaccine site visibly swollen), INJECTION SITE WARMTH (Injection site is warm to touch) and PRURITUS (ITCHY) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness). On 20-Jan-2021, the patient experienced PRURITUS (ITCHY) and TENDERNESS (TENDER). On 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of vaccine), VACCINATION SITE SWELLING (vaccine site visibly swollen) and INJECTION SITE WARMTH (Injection site is warm to touch). At the time of the report, INJECTION SITE PAIN (Soreness), INJECTION SITE ERYTHEMA (Redness at site of vaccine), VACCINATION SITE SWELLING (vaccine site visibly swollen), INJECTION SITE WARMTH (Injection site is warm to touch), PRURITUS (ITCHY) and TENDERNESS (TENDER) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications are not reported.  No treatment information was provided.
As reported to me the manager on site by my charge RN, Member presented to vaccine site for second dose of Moderna. Member did not check-in and sat inside the clinic in an injection chair. Injection nurse did not confirm check-in status or date of next injection and gave the second dose of Moderna because the nurse assumed the member checked-in. If this member checked-in accordingly it would have been caught that his next dose wasn't due until 06-09-2021. Member was observed for 30 minutes and left per RN charge.  Doctor of the day was called and Infectious Disease provider on-call was contacted. Advised to complete VAERS adverse reaction form  due to member having second dose of Moderna given to soon. Today the second dose was given on 05/27/21.
VERY sore arm starting that night. Next day-- fever up to near 102, chills, aches, fatigue. Following day- low-grade fever and fatigue. 4th day- itching at injection site.
Approximately 8 hours after receiving vaccines child spiked fever of 104 degrees(rectal) with vomiting and diarrhea. Twin sister had fever spike as well without the vomiting and diarrhea. Mother took both children to urgent care and was told by the attending physician that is was likely caused by the flu vaccine.  Child was treated with alternating tylenol and motrin with resolution three days later.
03/17/2003  09:20am received Hep B #1. 30 mins later left arm sore and nauseated feeling. Felt better next day but still sore. Nausea stayed for 3 days. Hep B site still sore today 03/25/2003.
This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored VAQTA (lot # K012457 exp. 04-JUN-2017 and L023232 exp. 25-FEB-2017. There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Severe flu-like symptoms 4 days Fainting/ vomiting 2 days heart palpitations 4 days   I had Covid 19 in November and was still positive for the antibodies as of 4/8/2021
Red painful area 2 inch in diameter, at injection site - suggested hydrocortisone cream. Headache.
flu; Initial information received on 28-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number:).  This case involves Adult and unknown gender patient who experienced flu  (influenza)  after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown
patient reported that late Saturday night into sunday morning she developed a fever up to 101f. fever subsided around 2am Tuesday. Monday am a rash developed at injection site, growing to size of a baseball. patient went to doctor who said she was ok, and rash was reducing but not gone by Wednesday when patient called us to report reaction.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 08-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 62 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Breakthrough case admission after 3 vaccines Pfizer 3/9/21 lot# EN6206;  Pfizer 3/30/21 lot# ER2613;  Pfizer 10/15/21 Lot# FF8841
Day 58 of these symptoms which started approximately 1.5 hours after my shot:  Flushing, severe headaches (especially at the base of my skull), fever, weakness, confusion and brain fog, vision changes, fatigue, rapid heart rate, sweats, rash (appears more now when I eat), shortness of breath, ringing ears, severely bleeding gums, incredibly dry skin, extremely bad dizziness even while sitting still, edema, muscle aches
Amaurosis fugax, loss of vision in right eye for 4 minutes.  Vision returned without treatment and the condition has not reoccurred.  Treated with Aspirin 325 mg QD (started 3/17/23) and Atorvastatin (Lipitor) 40 mg QD (started 3/17/23)
5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
12NOV92 in evening pt was put to bed then started crying & shaking for 1/2 hr; mom took pt to ER t39.3; pt was then okay; no seizures since; pt's skin temp was cold while was shaking;
Feel Suicidal; Brain fog; severe tinnitus; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Feel Suicidal) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 02UMZUD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concurrent medical conditions included Drug allergy (Fluroquinoline antibiotics). Concomitant products included ALPRAZOLAM from 02-Feb-2012 to an unknown date for Sleep disorder NOS, DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (severe tinnitus) and VERTIGO (vertigo). On an unknown date, the patient experienced SUICIDAL IDEATION (Feel Suicidal) (seriousness criterion medically significant) and FEELING ABNORMAL (Brain fog). At the time of the report, SUICIDAL IDEATION (Feel Suicidal) outcome was unknown and FEELING ABNORMAL (Brain fog), TINNITUS (severe tinnitus) and VERTIGO (vertigo) had not resolved.            It was still debilitating an had remained the same for the last 3 weeks. Doctor cleaned patient's ears and told him it was an inflammation from the vaccine, that it would go away.  No treatment information 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new events suicidal ideation and feeling abnormal; 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.
Developed facial weakness and (left side) asymmetrical maxillary 04-19-12. Vaccines HIB, MMR, Varicella, PREVNAR 13 were given 04-16-12.