chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She felt well immediately after the vaccination, however, the following day, she felt tired and on 5/7/2021 (1 week later), she developed a red rash at the site of the injection that was very itchy.  She then noticed pain in her neck and swelling in the left armpit area of her body.  She continues to have a significant amount of pain in both arms and upper body.  She has not been able to chop vegetables and also, she has not been able to wear her backpack which he uses to carry her laptop when she goes to work.  - This per her allergist's note. o n 5/14/21
A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 42-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
SECOND DOSE OF SERIES WAS GIVEN 15 DAYS LATER. 2 DAYS SHY OF THE MINIMUM 17 DAY RECOMMENDATION.
Large red inflamed area, itchy, hot to touch. Received Cephalexin 500mg every 8 hours for 7 days.
Received vaccine mid-morning on 1/20 First evening around 7:00P:  Chills, then fever. Overnight:  Continued fever, reaching 102.9.  Upon dosing with Tylenol, fever broke midday next day. Next evening around 6:30P, chills & fever returned.  Took Tylenol and fever broke again by 11:00P Injection site hurt for 4 days  As a point of reference, Patient contracted Covid-19 end of August, 2020 -- mild case; required no hospitalization.   Low grade fever and loss of taste/smell.
medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023; This spontaneous safety report, was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a health professional. Additional information was received by partner on 03-AUG-2023 and forwarded to agency on 09-AUG-2023.  Due to the nature of the event, the causality between the event "medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023" and Vaxelis was not applicable.   For reference purposes, the case is linked to MCM-005121, MCM-005126, MCM-005127, MCM--005136, MCM-005135, MCM-005138, MCM-005140, MCM-005128.  Further information is expected.
16yo previously healthy male presenting with chest pain. He received second dose of Pfizer Covid vaccine on Wednesday at 3p. That evening, he developed fevers, chills and had trouble sleeping. On Thursday, he began feeling heart palpitations and again slept. Overnight, he developed midline chest pain, and decided to present to the emergency room. His EKG showed elevated ST segments. Labs were remarkable for elevated troponin, leukocytosis, and elevated CRP; echo showed normal function but subtle hypokinesis of the apex. He was given morphine, Tylenol, Ketorolac, 1L NS, and possibly aspirin before being transferred to the ED.   In our ED, he had a reassuring exam, was no longer reporting chest pain. He had labs drawn which showed a white count to 15.3, normal H/H, Plt 152, ESR 12, CRP 10, and Trop T 1.14.   Aside from the above symptoms, he has been in his usual well state without viral symptoms, nausea, vomiting, diarrhea, rash, joint pain, or other symptoms. He has no past medical or surgical history. Immunizations are up to date. His social history is benign.  Patient was admitted to the cardiology floor for continued monitoring of his troponin levels and EKG. An echocardiogram was performed which showed mild LV systolic dysfunction. He was then treated with IVIG 2g/kg and started on methylprednisolone IV q12h. He remained asymptomatic with no chest pain throughout his admission. He was transitioned over to PO steroids on 6/13 which he tolerated well. On day of discharge, his troponin levels were trending down. Cardiac MRI showed an area of late gadolinium enhancement in the LV, with no abnormal function.   By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake including tolerance of PO steroid. Prescriptions sent to preferred pharmacy. Follow up with cardiology to be arranged. Discharge instructions and return precautions reviewed with patient and parent, who expressed good understanding and agreement with plan.  Reasons for new, changed, and discontinued medications:  - Prednisone  - Famotidine Patient was admitted for management of myocarditis thought to be due to his SARS-CoV2 vaccination. He received IVIG and steroids. He had multiple EKGs, echocardiogram, and a cardiac MRI. He showed improvement during his hospitalization. He will be followed closely by Cardiology who will advise return to exercise and repeat imaging needs.  **Please note that we do not have access to the vaccination records (lot, etc)**
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to influenza vaccine. Additional details were received as follows: The GSK field sales representative was speaking with a nurse practitioner (patient) and during the conversation, the patient told that she received the flu shot for this flu season and just recently experienced the flu. The representative asked the patient if she tested positive for the flu and the nurse said she did not get tested, but she just knew she had the flu. The representative did not have any information on what flu vaccine she was given or any other details. No other information was provided and not all questions asked. The adverse event was determined after call. This case was considered as suspected vaccination failure because the time to onset and confirmatory lab test results for flu was not provided.
Vaccination related malaise; a little achy in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination related malaise) and PAIN IN EXTREMITY (a little achy in her arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Knee replacement (two knee replacements). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), CARVEDILOL and CANDESARTAN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION COMPLICATION (Vaccination related malaise) and PAIN IN EXTREMITY (a little achy in her arm). At the time of the report, VACCINATION COMPLICATION (Vaccination related malaise) and PAIN IN EXTREMITY (a little achy in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-362401 (Patient Link).
Physician ordered RotaTeq to a 5 month old as a first dose. It was given by MA and should not have been given due to patients age .
11/9/12 Within 1 hour of vaccination I could taste a metallic taste. Reported to nurse on site & was advised may be from preservative in vaccine. Taste remained throughout the day. Arm very sore. 11/11/12 Developed a severe cold with persisting cough for the rest of month. 12/1/12 Developed (L) ear pain/ache. 12/10/12 Continuing ear pain with decreased hearing & moist feeling with continuing unproductive cough. 12/17/12 To clinic with dx of ear infection. (L) ear cleaned with prescription for ear drops and 10 day antibiotic. Continued with underlying cold symptoms with unproductive cough and (L) ear pain with decreased hearing. 2/18/13 Went to specialist and dx with fungal ear infection. Ear cleaned and fungal powder used. 2/28/13 Follow up with Dr. Improved with follow as needed. 3/6/13 Another cold like symptoms with ear ache in both ears. I have never had this many medical issues in the winter. I have not had an ear infection (prior to now) since I was a child. Have never been sick off and on like this.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 11 months old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
88 Y male with history significant for mild cognitive impairment, obesity (BMI 33), OSA not on CPAP, T2DM (A1c 7), HTN, HLD, HFpEF(60-65%), pAfib not on AC due to frequent falls, diabetic ESRD on PD, ACD, and h/o prostate CA s/p EBXRT(2004), who presented 1/6/22 with 4 days of AMS. He was found to have severe sepsis due to COVID PNA s/p toci x 2 (1/16, 1/17), decadron 10 mg IV (1/12 - ), no remdesivir 2/2 ESRD, hospital course c/b encephalopathy thought 2/2 COVID with reassuring LP and paracenteses and lacunar stroke 1/12, with rapidly increasing O2 requirement over 1/19 and became obtunded, and admitted to the ICU 1/19/2021 for AHRF requiring BiPAP and hypotension requiring pressor support.  Given severe disease, decided to make patient DNR 1/19. Continued to have increasing hypoxic respiratory failure with worsening hypotension refractory to peripheral pressors.  Transitioned to comfort care 1/20/22.      Complications: none   Diagnoses:   Active Hospital Problems   Diagnosis   ? (Principal) CORONAVIRUS COVID-19 PNEUMONIA   ? SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION   ? ACUTE HYPOXEMIC RESPIRATORY FAILURE   ? ENCEPHALOPATHY       covid encephalopathy    ? ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY       MRI brain 1/12/22:  1. Small acute left precentral and postcentral gyri infarcts without hemorrhagic transformation, mass effect or herniation. 2. Severe microvascular ischemic disease       ? ESRD ON PERITONEAL DIALYSIS   ? DM 2 W CKD STAGE 5 (GFR <15) W HTN     Resolved Hospital Problems   Diagnosis Date Resolved ? EPISTAXIS 01/18/2022     Primary Procedures:  Procedure(s): LUMBAR PUNCTURE   Secondary Procedures:  DIAGNOSTIC LUMBAR PUNCTURE   Consults: NEPHROLOGY - INITIAL INPATIENT CONSULTATION. NEPHROLOGY - ONGOING INPATIENT CONSULTATION.   Condition on Discharge/Discharge Disposition:  Expired
Pt woke up dizzy in middle of night and fell and hit head.  now is having dizziness and vomiting  the morning after fall.
Allergic to beef, pork and dairy products.  Apparently the gelatin in the vaccine contains pork ingredients.  Had life threatening adverse reaction to the vaccine, was rushed to the emergency room and then admitted to the hospital for overnight stay for observation.   2/22/08-records received for DOS 1/16/08-observed overnight. Assessment:Anaphylactic reaction status post vaccine. Suspect this was due to a reaction to gelatin preservation in vaccine which was porcine.  C/O difficulty breathing, throat swelling. Shortness of breath. Hypotensive.
Flu like symptoms dreadfully so, more aches and pains and fatigue and double of worsening of my dry eye syndrome, neuropathy and Raynauds's/numbness in hands and legs, dizziness/ataxia, low blood pressure, fainting if stand too quickly, immense fatigue and cognitive dysfunction (brain fog), worsening of digestive issues, like IBS and bloating and increased anxiety. I have waited to report this hoping that the lingering symptoms would vanish. they have not. the fever subsided, but all of my chronic auto-immune issues have gotten much worse with both shots now.
Approximately 1 hour after receiving the flu shot, my daughter reported feeling dizziness and weakness and arm pain extending from her shoulder to her hand and tingling in her fingers. She also appeared pale. Gave her TYLENOL and clear fluids and continued to monitor her closely. At 11:00 PM, the weakness and dizziness had decreased, but she reported feeling extreme fatigue and the arm pain/tingling continued. At 7:00 AM, she still felt fatigued and pain in entire arm, but the tingling in her fingers has resolved. Antihistamines and MOTRIN given.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and injection site swelling. On an unknown date, the outcome of the influenza-like symptoms, fever and injection site swelling were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had flu like symptoms, fever (body temperature: 101 degree F) and swelling at the injection site. The reporter did not have any additional information as she did not speak to this specific patient. The pharmacy tech spoke with the patient. Lab Comments: On an unknown date, the patient's body temperature was 101 degree F.
C/O L arm pain, arm swollen, numb in areas of arm, fingers tingling. We referred to ER. Saw MD next day after injection.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Consumer called about the Paxlovid pill. She had her Pfizer COVID-19 vaccine including the booster shot. She said that she tested positive for COVID-19. She mentioned that she started taking Paxlovid yesterday. But the caller insisted on talking to a supervisor. Resolutions: Swap survey from First Connect to Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effcet; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R00550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 11-year-old female patient. on 18-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with lot number R00550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
RASH TO SITE OF INJECTION FOR 2 DAYS THEN SPREAD TO OTHER LEG AND ABDOMEN, BENADRYL GIVEN FOR 1 DAY, DOING BETTER, STOPPED THE BENADRYL THEN RASH RETURN TO TORSO AREA ON 4/25/2017. SEEN IN DOCTORS OFFICE 4/26/2017, PLACED ON ORAPRED 15MG/5ML 2.5 MLS PO BID FOR 3 DAYS.
6PM FEVER STARTED AND CHILLS INCREASING TO 105.4 BY 7:30PM. HIGH GRADE FEVER- LASTED UNTIL 10AM ON 1/14 FOLLOWED BY LOW GRADE FEVER 101 UNTIL 4PM 1/14. MOTRIN & TYLENOL ALTERNATING EVERY 4 HRS AND HYDRATION.
Information has been received from a health professional concerning a 5 yr old male who on 23Jun00 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot632606/1694J). On 09May05 the pt developed breakthrough chickenpox with less than 50 lesions and no fever. Unspecified medical attention was sought. Diphenhydramine hydrochloride (Benadryl) was ordered for itching. There was no product quality complaint involved. Additional information has been requested.
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on  20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
first shot years ago, never got second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose, several years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete vaccination schedule. The reporter asked, if he/she should start over.
DIZZINESS; WEAKNESS; SEVERE HEADACHES; EXTREME FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, chronic sinusitus, and allergic to sulfa septra. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced extreme fatigue. On 09-MAR-2021, the subject experienced severe headaches. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headaches, dizziness, and weakness, and the outcome of extreme fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Severe radiating headaches, ringing in left ear, radiating pain in the inner ear, extreme heat, extreme sweating, left arm pain, shoulder pain and lingering ache in shoulder,